Downloaded from FDA GRAS Notices; http://www.cfsanappsexternal.fda.gov/scripts/fdcc/?set=GRASNotices; Last updated 3/15/2024; downloaded 3/19/2024. GRAS Notice (GRN) No.,Substance,Intended Use,Basis,Notifier,Notifier Address,Date of filing,GRN Part 1,GRN Part 2,GRN Part 3,GRN Part 4,GRN Part 5,GRN Part 6,GRN Part 7,Date of closure,Date of correction letter,FDA's Letter,Date additional correspondence,Additional correspondence,Date additinoal correspondence 2,Additional correspondence 2,Date additional correspondence 3,Additional correspondence 3,Resubmission,Resubmitted,Notes,Related submission =T("1")," Soy isoflavone extract"," Ingredient in performance bars, mature adult meal replacements, and beverages at a level of 25 milligrams per serving"," Scientific procedures"," Archer Daniels Midland Company"," Box 1470; Decatur, IL 62525",02/10/1998," GRN 1 (in PDF)",,,,,,,11/03/1998,," At the notifier's request, FDA ceased to evaluate this notice",,,,,,,,,, =T("2")," Solin oil (low linolenic acid flaxseed oil or low linolenic acid linseed oil)"," Use as a general purpose cooking, frying, and salad oil; and as an ingredient in margarines, shortenings, and other food products"," Scientific procedures"," United Grain Growers Ltd."," TD Centre; 201 Portage Avenue; Box 6600; Winnipeg, Manitoba; CANADA R3C 3A7",02/11/1998," GRN 2 (in PDF)",,,,,,,05/27/1998,," FDA has no questions",,,,,,,,," Incorporates GRAS Affirmation Petition"," GRP 5G0416" =T("3")," Sodium bisulfate"," Use in cake mixes as a pH control agent and a leavening agent at a level of 0.1 to 1.0 percent by weight; use in foods in general as a pH control agent and processing aid at levels not to exceed good manufacturing practices"," Scientific procedures"," Jones Hamilton Co."," 30354 Tracy Road; Walbridge, OH 43465",02/26/1998," GRN 3 (in PDF)",,,,,,,06/05/1998,," FDA has no questions",,,,,,,,,, =T("4")," Transglutaminase from Streptoverticillium mobaraense"," Use in processed seafood as a crosslinking agent at levels not to exceed 65 parts per million"," Scientific procedures"," Ajinomoto USA"," 1120 Connecticut Ave., NW; Suite 416; Washington, DC 20036",03/04/1998," GRN 4 (in PDF)",,,,,,,06/22/1998,," FDA has no questions",,,,,,,,,, =T("5")," Tasteless smoke"," Use in red-meat seafoods such as tuna and salmon to preserve the taste, aroma, and color"," Common use in food"," Hawaii International Seafood Inc."," Honolulu International Airport; P.O. Box 30486; Honolulu, HI 96820",04/29/1998," GRN 5 (in PDF)",,,,,,,11/09/1998,," At the notifier's request, FDA ceased to evaluate this notice",,,,,,,,=T("15"),, =T("6")," Dioctyl sodium sulfosuccinate"," Use in carbonated and non-carbonated soft drinks as a wetting agent or solubilizer for flavor emulsion stabilizers at levels up to 10 parts per million of the finished beverage"," Scientific procedures"," Cytec Industries, Inc."," Five Garret Mountain Plaza; West Paterson, NJ 07424",07/21/1998," GRN 6 (in PDF)",,,,,,,12/28/1998,," FDA has no questions",,,,,,,,,, =T("7")," ARASCO (arachidonic acid-rich single-cell oil) and DHASCO (docosahexaenoic acid-rich single-cell oil) as sources of the fatty acids ARA (arachidonic acid) and DHA (docosahexaenoic acid)"," ARASCO as a source of ARA and DHASCO as a source of DHA in infant formula"," Scientific procedures"," Wyeth Nutritionals International"," 145 King of Prussia Road; Radnor, PA 19087",09/01/1998," GRN 7 (in PDF)",,,,,,,03/04/1999,," Notice does not provide a basis for a GRAS determination",,,,,,,,=T("41"),, =T("8")," Pectin esterase derived from Aspergillus oryzae carrying a gene encoding pectin esterase from Aspergillus aculeatus"," Use in fruit and vegetable products as a processing aid at minimal level needed to accomplish the intended technical effect"," Scientific procedures"," Novo Nordisk"," 77 Perry Chapel Church Road; Box 576; Franklinton, NC 27525-0576",10/14/1998," GRN 8 (in PDF)",,,,,,,03/02/1999,," FDA has no questions",,,,,,,,,, =T("9")," Polyglycerol polyricinoleic acid"," Use in chocolate as an emulsifier at a level up to 0.3 percent"," Scientific procedures"," Quest International"," 5115 Sedge Blvd.; Hoffman Estates, IL 60192",10/22/1998," GRN 9 (in PDF)",,,,,,,03/02/1999,04/02/1999," FDA has no questions",,,,,,,,,, =T("10")," Exopeptidase derived from Aspergillus oryzae carrying a gene encoding a leucine aminopeptidase from Aspergillus sojae"," Use as a food processing aid at a level ranging from 0.2 to 0.8 percent"," Scientific procedures"," Rohm Enzyme Finland Oy"," Tykkimaentie 15; 05200 Rajamaki; FINLAND",10/28/1998," GRN 10 (in PDF)",,,,,,,01/29/1999,," Notice does not provide a basis for a GRAS determination",,,,,,,,,, =T("11")," Calcium casein peptone-calcium phosphate"," Use in chewing gum as a texturizer at a use level of up to 5 percent wt/wt"," Scientific procedures"," Bonlac Foods Limited"," P.O. Box 4313 Melbourne; Victoria, AUSTRALIA 3001",11/23/1998," GRN 11 (in PDF)",,,,,,,01/29/1999,," FDA has no questions",,,,,,,,,, =T("12")," Mesquite wood alcoholic extract"," Use in several food categories, including alcoholic beverages, as a flavor"," Common use in food"," Givaudan Roure Flavors"," 1199 Edison Drive; Cincinnati, OH 45216",12/30/1998," GRN 12 (in PDF)",,,,,,,03/11/1999,," At the notifier's request, FDA ceased to evaluate this notice",,,,,,,,=T("18"),, =T("13")," Botanicals: Chrysanthemum; Licorice; Jellywort AND
Honeysuckle; Lophatherum; Mulberry leaf; Frangipani; Selfheal; Sophora flower bud"," Use in herbal tea as a flavor"," Common use in food"," Vitasoy International Holdings Ltd."," 1, Kin Wong Street; Tuen Mun, New Territories; HONG KONG",01/11/1999," GRN 13 (in PDF)",,,,,,,06/02/1999,," Notice does not provide a basis AND
FDA has no questions",,,,,,,,," Notice only provided basis for subset of notified ingredients", =T("14")," Hydrogen peroxide"," Use in the manufacture of dehydrated onions as a processing aid to extend their shelf life"," Scientific procedures"," Basic Vegetable Products"," 700 Airport Drive; King City, CA 93930",02/17/1999," GRN 14 (in PDF)",,,,,,,05/26/1999,," Notice does not provide a basis for a GRAS determination",,,,,,,,,, =T("15")," Tasteless smoke"," Use in raw tuna, before it is frozen, to preserve its taste, aroma, texture and color at levels sufficient to accomplish this purpose"," Scientific procedures"," Hawaii International Seafood Inc."," Honolulu International Airport; P.O. Box 30486; Honolulu, HI 96820",03/17/1999," GRN 15 (in PDF)",,,,,,,03/10/2000,," FDA has no questions",,,,,,,=T("5"),,, =T("16")," Menhaden oil"," Use in a variety of foods as a source of fat at levels ranging from 0.5 to 12 percent by weight"," Scientific procedures"," BASF Corporation"," 3000 Continental Drive North; Mount Olive, NJ 07828-1234",03/11/1999," GRN 16 (in PDF)",,,,,,,06/08/1999,," At the notifier's request, FDA ceased to evaluate this notice",,,,,,,,,, =T("17")," Arabinogalactan"," Use in foods in general for multiple technical effects"," Scientific procedures"," Larex, Inc."," 2852 Patton Road; St. Paul, MN 55113",03/11/1999," GRN 17 (in PDF)",,,,,,,04/11/2000,," At the notifier's request, FDA ceased to evaluate this notice",,,,,,,,=T("47"),, =T("18")," Mesquite (Prosopis spp.) wood alcoholic extract"," Use in distilled spirits as a flavor at a use level of one pound per 400 wine gallons"," Scientific procedures"," Givaudan Roure Flavors"," 1199 Edison Drive; Cincinnati, OH 45216",03/12/1999," GRN 18 (in PDF)",,,,,,,05/12/1999,," FDA has no questions",,,,,,,=T("12"),,, =T("19")," Ferrous bisglycinate chelate"," Use in foods in general as a source of dietary iron for food enrichment and fortification purposes consistent with iron supplementation guidelines"," Scientific procedures"," Albion Laboratories, Inc."," P.O. Box 750; 101 North Main St.; Clearfield, UT 84015-2243",04/22/1999," GRN 19 (in PDF)",,,,,,,09/30/1999,," FDA has no questions",,,,,,,,,, =T("20")," Pullulanase derived from Bacillus subtilis carrying a gene encoding pullulanase from Bacillus naganoensis"," Use in hydrolyzing starch and starch-related compounds in the production of corn sweeteners, baked goods, and alcoholic beverages at minimum levels necessary to accomplish the intended effect in accordance with current good manufacturing practices"," Scientific procedures"," Enzyme Bio-Systems Ltd."," Enzyme Bio-Systems Ltd.; 2600 Kennedy Drive; Beloit, WI 53511-3992",04/22/1999," GRN 20 (in PDF)",,,,,,,09/30/1999,," FDA has no questions",,,,,,,,,, =T("21")," Pork collagen"," Use in meat products as a binder and purge reducing agent at levels of 1.0 to 3.5 percent"," Scientific procedures"," AMPC, Inc."," 2325 North Loop Drive; Ames, IA 50010",04/26/1999," GRN 21 (in PDF)",,,,,,,07/29/1999,," FDA has no questions",,,,,,,,,, =T("22")," alpha-Amylase derived from Bacillus licheniformis carrying a gene encoding a modified alpha-amylase derived from Bacillus lichenformis and Bacillus amyloliquefaciens"," Use in the starch industry (for the liquefaction of starch in the production of syrups), and in the alcohol industry (for the thinning of starch in distilling mashes) as a processing aid at minimum levels necessary to accomplish the intended technical effect in accordance with current good manufacturing practices"," Scientific procedures"," Novo Nordisk"," 77 Perry Chapel Church Rd., Box 576; Franklinton, NC 27525",05/24/1999," GRN 22 (in PDF)",,,,,,,12/29/1999,," FDA has no questions",,,,,,,,,, =T("23")," Protein preparation from animal blood"," Use in foods in general, including meat products, to provide protein nutritional value"," Scientific procedures"," Desanguination Products, LLC"," 2613 Newcomb Street; Lubbock, TX 79415",06/04/1999," GRN 23 (in PDF)",,,,,,,08/02/1999,," At the notifier's request, FDA ceased to evaluate this notice",,,,,,,,,, =T("24")," alpha-Amylase derived from Bacillus licheniformis carrying a gene encoding alpha-amylase from Bacillus stearothermophilus"," Use in the starch industry (for the liquefaction of starch in the production of syrups) and in the alcohol industry (for the thinning of starch in distilling mashes) as a processing aid at minimum levels necessary to accomplish the intended technical effect in accordance with current good manufacturing practices"," Scientific procedures"," Novo Nordisk"," 77 Perry Chapel Church Rd., Box 576; Franklinton, NC 27525",06/07/1999," GRN 24 (in PDF)",,,,,,,05/15/2000,," FDA has no questions",,,,,,,,,, =T("25")," Extract of Garcinia kola seed (""bitter cola"")"," Use in an alcoholic beverage as a flavor enhancer"," Scientific procedures"," Pharaoh Palmier"," 155 Wilson St.; Albany, CA 94710",06/25/1999," GRN 25 (in PDF)",,,,,,,10/12/1999,," Notice does not provide a basis for a GRAS determination",,,,,,,,,, =T("26")," Isolated wheat protein"," Use in powdered shortenings in baked goods, milk-like beverages, beverage whiteners, cheese analogues, meat and fish products, cooked meats, soups, sauces and marinades, mousses and meringues, edible films and coatings for various technical effects at levels ranging from 1 to 50 grams per kilogram"," Scientific procedures"," Manildra Group"," The Crescent; Auburn; Sydney, NSW 2144 AUSTRALIA",07/08/1999," GRN 26 (in PDF)",,,,,,,12/16/1999,," FDA has no questions",,,,,,,,,, =T("27")," Dextranase from Chaetomium gracile"," Use in cane and beet sugar as a processing aid"," Scientific procedures"," Sankyo Co., Ltd."," 7-12, Ginza 2-ChomeChuo-ku; Tokyo 104-8113; JAPAN",07/14/1999," GRN 27 (in PDF)",,,,,,,12/16/1999,," FDA has no questions",,,,,,,,," Incorporates GRAS Affirmation Petition"," GRP 6G0420" =T("28")," Seaweed-derived calcium"," Use in foods in general as a source of dietary calcium for food enrichment and fortification purposes at various levels that range up to 4.0 percent"," Scientific procedures"," Marigot Ltd./Celtic Sea Minerals"," Strand Farm; Currabinny; Carrigaline, Co. Cork; IRELAND",07/28/1999," GRN 28 (in PDF)",,,,,,,04/21/2000,," FDA has no questions",03/19/2014," Additional correspondence about intended uses",03/27/2007," Additional corresopndence about intended uses",,,,,, =T("29")," Transglutaminase from Streptoverticillium mobaraense"," Use in processed cheeses, natural hard cheeses (domestic), cream cheese, refrigerated yogurt, frozen desserts, and vegetable protein dishes/vegeburgers/meat substitutes as a crosslinking agent at varying levels"," Scientific procedures"," Ajinomoto USA"," 1120 Connecticut Ave, NW; Suite 416; Washington, DC 20036",07/28/1999," GRN 29 (in PDF)",,,,,,,12/29/1999,," FDA has no questions",,,,,,,,,, =T("30")," Crospovidone-cranberry juice extract"," Ingredient in foods and beverages"," Scientific procedures"," ShanStar Biotech, Inc."," P.O. Box 10; Chadwick Bay, NY 14048",08/03/1999," GRN 30 part 1 (in PDF)"," GRN 30 part 2 (in PDF)",,,,,,12/20/1999,," Notice does not provide a basis for a GRAS determination",02/20/2001," Additional correspondence that does not provide a basis for a GRAS determination",,,,,,,, =T("31")," Cetylpyridinium chloride"," Use on raw and fully cooked foods including, poultry, red meat, fish and shellfish, eggs, fruits, vegetables, cereal grains, nutmeats, and dairy products as an antimicrobial agent at levels not to exceed 1.0 percent"," Scientific procedures"," Safe Foods Corporation"," 1505 Rebsamen Park Road; Little Rock, AR 72202",09/20/1999," GRN 31 (in PDF)",,,,,,,01/10/2000,," At the notifier's request, FDA ceased to evaluate this notice",,,,,,,,=T("38"),, =T("32")," Pectin lyase derived from Trichoderma reesei carrying a gene encoding pectin lyase from Aspergillus niger"," Use in the preparation of fruit and vegetable juices, purees, and concentrates as a processing aid at levels ranging from 5 to 100 parts per million to accomplish the intended technical effect in accordance with current good manufacturing practices"," Scientific procedures"," Rohm Enzyme GmbH"," Kirschenallee 45; D-64293 Darmstadt, GERMANY",10/14/1999," GRN 32 (in PDF)",,,,,,,04/20/2000,," FDA has no questions",,,,,,,,,, =T("33")," Low erucic acid oil derived from Brassica juncea"," Use in food processing, in the manufacture of margarines and shortenings, and as a salad and frying oil"," Scientific procedures"," Canola Council of Canada"," 400-167 Lombard Avenue; Winnipeg, Manitoba; CANADA R3B 0T6",10/22/1999," GRN 33 (in PDF)",,,,,,,01/27/2000,," FDA has no questions",,,,,,,,,, =T("34")," Aspartic proteinase derived from Aspergillus oryzae carrying a gene encoding aspartic proteinase from Rhizomucor miehei"," Use in meat as a tenderizing agent at minimum levels necessary to accomplish the intended technical effect in accordance with current good manufacturing practices"," Scientific procedures"," Novo Nordisk"," 77 Perry Chapel Church Rd., Box 576; Franklinton, NC 27525",11/17/1999," GRN 34 (in PDF)",,,,,,,04/19/2000,," FDA has no questions",,,,,,,,,, =T("35")," Hempseed oil"," Use in food as a flavoring agent, adjuvant solvent, vehicle, stabilizer, thickener, emulsifier, or texturizer at the minimum required to produce the intended technical effect"," Common use in food"," Consolidated Growers and Processors, Inc."," P.O. Box 2228; Monterey, CA 93942",11/17/1999," GRN 35 (in PDF)",,,,,,,08/24/2000,," Notice does not provide a basis for a GRAS determination",,,,,,,,,, =T("36")," Chromium picolinate; Ginkgo biloba leaf extract; and Ginseng extract"," Ingredients in non-carbonated beverage or tea"," Scientific procedures"," Vancol Industries, Inc."," 1700 E. 68th Ave; Denver, CO 80229",01/03/2000," GRN 36 (in PDF)",,,,,,,04/10/2000,," At the notifier's request, FDA ceased to evaluate this notice",,,,,,,,,, =T("37")," Whey protein isolate and dairy product solids"," Whey protein isolate - use in foods in general, including meat, for multiple technical effects; dairy product solids - use in foods in general, including alcohol, for multiple technical effects"," Scientific procedures"," American Dairy Products Institute"," 300 West Washington Street #400; Chicago, IL 60606",01/14/2000," GRN 37 (in PDF)",,,,,,,04/21/2000,," FDA has no questions",01/30/2001," Additional correspondence clarifying the term ""dairy product solids""",,,,,,," Incorporates GRAS Affirmation Petition"," GRP 1G0371" =T("38")," Cetylpyridinium chloride"," Use on the outside surface of raw and fully cooked meat and poultry products as an antimicrobial agent at a level not to exceed 1.0 percent"," Scientific procedures"," Safe Foods Corporation"," 1505 Rebsamen Park Road; Little Rock, AR 72202",01/19/2000," GRN 38 (in PDF)",,,,,,,02/29/2000,," Notice does not provide a basis for a GRAS determination",,,,,,,=T("31"),," Resubmitted as"," FAP 6A4767" =T("39")," Tall oil phytosterols"," Ingredient in vegetable oil spreads at a level up to 12 percent free phytosterols"," Scientific procedures"," Novartis Consumer Health, Inc."," 560 Morris Avenue; Summit, NJ 07901",01/28/2000," GRN 39 (in PDF)",,,,,,,04/24/2000,," FDA has no questions",11/02/2000," Additional correspondence clarifying intended use",,,,,,,, =T("40")," Mineral oil"," Use on food processing equipment as a sprayed release agent resulting in a presence on food at no more than 5 parts per million"," Common use in food"," American Ingredients Company"," 3947 Broadway; Kansas City, MO 64111",02/28/2000," GRN 40 (in PDF)",,,,,,,12/11/2000,," Notice does not provide a basis for a GRAS determination",,,,,,,,=T("71"),, =T("41")," DHASCO (docosahexaenoic acid-rich single-cell oil) and ARASCO (arachidonic acid-rich single-cell oil)"," Provide DHASCO (as a source of docosahexaenoic acid) and ARASCO (as a source of arachidonic acid) in term infant formula, at a maximum level of 1.25 percent each of the total dietary fat and at a ratio ranging from 1:1 to 1:2 (DHASCO:ARASCO)"," Scientific procedures"," Martek Biosciences Corporation"," 6480 Dobbin Road; Columbia, MD 21045",03/01/2000," GRN 41 (in PDF)",,,,,,,05/17/2001,," FDA has no questions",,,,,,,=T("7"),,, =T("42")," Milk-derived lactoferrin"," Ingredient in sports and functional foods"," Scientific procedures"," DMV International"," 1712 Deltown Plaza; Fraser, NY 13753",04/10/2000," GRN 42 (in PDF)",,,,,,,03/26/2001,," Notice does not provide a basis for a GRAS determination",04/23/2001," Additional correspondence clarifying the appropriate mechanism to ""supplement"" a notice after FDA has responded to that notice",,,,,,=T("77"),, =T("43")," Lipase derived from Aspergillus oryzae carrying a gene encoding lipase from Thermomyces lanuginosus"," Use in dough, baked goods, and the fats and oil industry as a processing aid for the interesterification or hydrolysis of glycerides at minimum levels necessary to achieve the desired effect; use as an enzyme in brewing beer (per additional correspondence of April 21, 2010)"," Scientific procedures"," Novo Nordisk"," 77 Perry Chapel Church Road; Box 576; Franklinton, NC 27525",04/28/2000," GRN 43 (in PDF)",,,,,,,09/22/2000,," FDA has no questions",04/21/2010," Additional correspondence about intended use",,,,,,,, =T("44")," Fructooligosaccharide"," Use as a bulking agent in acidophilus milk, nutritional bars, baby food, nutritional beverages, biscuits, cakes, confectionery, cookies, crackers, flavored and unflavored milks, hard candy, ice cream and frozen yogurt, jams and jellies, muffins, ready-to-eat cereals, sorbet, soup and yogurt at varying levels"," Scientific procedures"," GTC Nutrition Company"," 14252 W. 44th Ave.; Unit F; Golden, CO 80403",05/02/2000," GRN 44 (in PDF)",,,,,,,11/22/2000,," FDA has no questions",06/01/2007," Additional correspondence about intended uses",,,,,,,, =T("45")," Trehalose"," Use in foods in general, including meat products, for multiple technical effects at levels in accordance with good manufacturing practice"," Scientific procedures"," Hayashibara International Inc."," 8670 Wolff Court; Suite 200; Westminster, CO 80030",05/17/2000," GRN 45 (in PDF)",,,,,,,10/05/2000,," FDA has no questions",,,,,,,,,, =T("46")," Gamma cyclodextrin"," Use in bread spreads, frozen dairy desserts, ready-to-eat dairy desserts, desserts prepared from dry mixes, fruit fillings, cheese and cream fillings, and chewing gum as a stabilizer, emulsifier, carrier and formulation aid at varying levels"," Scientific procedures"," Wacker Biochem Corp."," 3301 Sutton Road; Adrian, MI 49221",05/22/2000," GRN 46 (in PDF)",,,,,,,09/22/2000,," FDA has no questions",,,,,,,,,, =T("47")," Arabinogalactan from Larix occidentalis"," Use in foods in general, including meat products, for multiple technical effects"," Scientific procedures"," Larex Inc."," 4815 White Bear Lake Parkway; White Bear Lake, MN 55110",05/30/2000," GRN 47 (in PDF)",,,,,,,06/06/2000,," FDA has no questions",,,,,,,=T("17"),,, =T("48")," Vegetable oil phytosterol esters"," Ingredient in vegetable oil spread, dressings for salad, bars, and yogurt"," Scientific procedures"," Cargill Inc."," 15407 McGinty Road West, MS110; Wayzata, MN 55391",06/02/2000," GRN 48 (in PDF)",,,,,,,11/27/2000,," FDA has no questions",,,,,,,,,, =T("49")," Bifidobacterium lactis strain Bb12 and Streptococcus thermophilus strain Th4"," Ingredients in milk-based infant formula that is intended for consumption by infants four months and older, at levels not to exceed good manufacturing practice"," Scientific procedures"," Nestle USA"," 800 North Brand Boulevard; Glendale, CA 91203",06/14/2000," GRN 49 part 1 (in PDF)"," GRN 49 part 2 with amendments (in PDF)",,,,,,03/19/2002,," FDA has no questions",11/28/2005," Additional correspondence clarifying new information on B. lactis strain Bb12",,,,,,,, =T("50")," Bohenin"," Use in chocolate and chocolate coatings as a tempering aid and anti-bloom agent at a level not to exceed 5 percent by weight of the total fat"," Scientific procedures"," Fuji Oil Co., Ltd."," Hannan R&D Center; 1 Sumiyoshi-cho; Izumisano-shi Osaka 598-8540; JAPAN",06/20/2000," GRN 50 (in PDF)",,,,,,,08/31/2000,," FDA has no questions",,,,,,,,," Incorporates GRAS Affirmation Petition"," GRP 4G0407" =T("51")," Cassia gum from Cassia tora/obtusifolia"," Use in foods in general in accordance with good manufacturing practice"," Scientific procedures"," B.F. Goodrich"," Performance Materials; Food & Beverage Ingredients Division; 2235 Langdon Farm Road; Cincinnati, OH 45237",06/23/2000," GRN 51 (in PDF)",,,,,,,02/27/2001,," At the notifier's request, FDA ceased to evaluate this notice",,,,,,,,=T("139"),, =T("52")," Whey mineral concentrate"," Use in beverages, foods, and dairy products as a source of calcium at levels consistent with current calcium supplementation guidelines"," Scientific procedures"," Glanbia Ingredients, Inc."," 523 6th Street; Monroe, WI 53566",06/27/2000," GRN 52 (in PDF)",,,,,,,01/30/2001,," FDA has no questions",,,,,,,,,, =T("53")," Phytosterol esters"," Ingredient in vegetable oil, at a level up to 13.3 percent by weight, for home use applications such as baking, frying, and salad dressings"," Scientific procedures"," Procter & Gamble Company"," Winton Hill Technical Center; 6071 Center Hill Avenue; Cincinnati, OH 45224",07/24/2000," GRN 53 (in PDF)",,,,,,,12/20/2000,," FDA has no questions",,,,,,,,,, =T("54")," Xylanase derived from Fusarium venenatum carrying a gene encoding xylanase from Thermomyces lanuginosus"," Use in the baking industry as a processing aid at minimum levels necessary in accordance with good manufacturing practices"," Scientific procedures"," Novo Nordisk"," 77 Perry Chapel Church Road; Box 576; Franklinton, NC 27525",07/28/2000," GRN 54 (in PDF)",,,,,,,02/23/2001,," FDA has no questions",,,,,,,,,, =T("55")," Transglutaminase from Streptoverticillium mobaraense"," Use in pasta, bread, pastries, ready to eat cereal products, pizza dough, and grain mixtures as a crosslinking agent at varying levels"," Scientific procedures"," Ajinomoto USA"," 1120 Connecticut Ave, NW; Suite 416; Washington, DC 20036",08/08/2000," GRN 55 (in PDF)",,,,,,,01/30/2001,," FDA has no questions",,,,,,,,,, =T("56")," Diacylglycerol oil"," Substitute for vegetable oils"," Scientific procedures"," Kao Corporation"," 1-3, Bunka 2-chome; Tokyo 131 8501, JAPAN",08/11/2000," GRN 56 (in PDF)",,,,,,,12/04/2000,," FDA has no questions",,,,,,,,,, =T("57")," Argon gas"," Use in wines, fruit juices and vegetable juices to replace the normal air atmosphere in sealed containers"," Scientific procedures"," Permafresh Corporation"," 8911 Osuna Road NE; Albuquerque, NM 87111",09/08/2000," GRN 57 (in PDF)",,,,,,,11/02/2000,," FDA has no questions",,,,,,,,,, =T("58")," Gum arabic"," Use in creamers for alcoholic beverages as a thickener, emulsifier or stabilizer at levels not to exceed 20 percent by weight of the alcoholic beverage"," Scientific procedures"," Kerry Ingredients"," 352 East Grand Avenue; Beloit, WI 53511",09/25/2000," GRN 58 (in PDF)",,,,,,,09/10/2001,10/01/2001," At the notifier's request, FDA ceased to evaluate this notice",,,,,,,,," Incorporates Food Additive Petition"," FAP 1A4730" =T("59")," Hydrogenated starch hydrolysate"," Use in foods in general as a flavoring agent, adjuvant, formulation aid, humectant, processing aid, stabilizer, thickener, surface-finishing agent, or texturizer at levels not to exceed good manufacturing practice"," Scientific procedures"," Grain Processing Corporation"," 1600 Oregon Street; Muscatine, IA 52761",10/04/2000," GRN 59 (in PDF)",,,,,,,09/24/2001,," At the notifier's request, FDA ceased to evaluate this notice",,,,,,,,,, =T("60")," Potassium bisulfate"," Use in cake mixes as a pH control agent and leavening agent at a level of 0.1 to 1.0 percent by weight; use in foods in general as a pH control agent and processing aid at levels not to exceed good manufacturing practices"," Scientific procedures"," Jones-Hamilton Company"," 30354 Tracy Road; Walbridge, OH 43465",10/31/2000," GRN 60 (in PDF)",,,,,,,01/19/2001,," FDA has no questions",,,,,,,,,, =T("61")," Plant sterols/Plant sterol esters"," Plant sterols as an ingredient in vegetable oil spreads, dressings for salad, health drinks, health bars, yogurt-type products at a level of 1 gram per serving; and as a raw material in the manufacture of plant sterol esters for use as an ingredient in the same foods at a level of 1.65 grams (i.e., 1 gram sterol equivalent) per serving"," Scientific procedures"," Archer Daniels Midland Company"," 1001 North Brush College Road; Decatur, IL 62521",11/27/2000," GRN 61 (in PDF)",,,,,,,04/18/2001,," FDA has no questions",,,,,,,,,, =T("62")," Chlorine dioxide generated from particles (<30μm) composed of sodium polyphosphate, magnesium sulfate, sodium silicate and sodium chlorite that are incorporated into low density polyethylene (LDPE) food-packaging films, at levels not exceeding 17.5 micrograms chlorite/in2 of finished package film."," Use for packaging meats, poultry and seafood that will be cooked prior to being consumed, and for packaging fresh fruits and vegetables and foods in transit or storage from producers to processors, or institutional users, that will be washed with a potable water rinse and further processed before being consumed, to extend the shelf life and extend the freshness of the contained foods; Use for fresh pasta products that will be cooked prior to being consumed, and for prepared dough products that will be baked, or otherwise cooked, prior to being consumed"," Scientific procedures"," Bernard Technologies, Inc."," 919 North Michigan Avenue; Chicago, IL 60611",12/04/2000," GRN 62 part 1 (in PDF)"," GRN 62 part 2 with amendments (in PDF)",,,,,,06/19/2001,," FDA has no questions",08/20/2003," Additional correspondence about intended uses",,,,,,,, =T("63")," Hops beta acids"," Use on casings for frankfurters and on cooked meat and poultry products as an antimicrobial agent"," Scientific procedures"," Rhodia, Inc."," CN 7500; 259 Prospect Plains Road; Cranbury, NJ 08512",12/20/2000," GRN 63 (in PDF)",,,,,,,03/15/2001,," FDA has no questions",,,,,,,,,, =T("64")," Egg white lysozyme"," Use on casings for frankfurters and on cooked meat and poultry products as an antimicrobial agent"," Scientific procedures"," Rhodia, Inc."," CN 7500; 259 Prospect Plains Road; Cranbury, NJ 08512",12/20/2000," GRN 64 (in PDF)",,,,,,,04/02/2001,," FDA has no questions",,,,,,,,,, =T("65")," Nisin"," Use on casings for frankfurters and on cooked meat and poultry products as an antimicrobial agent"," Scientific procedures"," Rhodia, Inc."," CN 7500; 259 Prospect Plains Road; Cranbury, NJ 08512",12/20/2000," GRN 65 (in PDF)",,,,,,,04/20/2001,," FDA has no questions",,,,,,,,,, =T("66")," Milk thistle extract"," Use in a malt-based beverage as a bittering agent"," Scientific procedures"," JHB Inc."," 26216 Alizia Cyn. Drive; Calabasas, CA 91302",01/03/2001," GRN 66 (in PDF)",,,,,,,04/23/2001,," Notice does not provide a basis for a GRAS determination",,,,,,,,,, =T("67")," Milk-derived lactoferrin"," Use on uncooked beef as an antimicrobial agent at a level not to exceed 2 percent"," Scientific procedures"," Farmland National Packaging Company, L.P."," 1501 East 8th Street; Liberal, KS 67905",01/09/2001," GRN 67 (in PDF)",,,,,,,10/23/2001,," FDA has no questions",,,,,,,,,, =T("68")," Lipase from Penicillium camembertii"," Use on fats and oils to produce fatty acids or glycerides at a level up to one percent of the weight of the fat or oil"," Scientific procedures"," Amano Enzyme Inc."," 2-7, 1-Chome, Nishiki; Naka-ku, Nagoya 460, JAPAN",01/31/2001," GRN 68 (in PDF)",,,,,,,05/29/2001,," FDA has no questions",,,,,,,,,, =T("69")," Behenic acid"," Use in margarine, shortening, and food products that require the use of semi-solid and solid fats as a texturizer at levels up to 8 percent of the oil mass of the food product"," Scientific procedures"," Thixo Limited"," 2 Hashaked Street; Ness Ziona, 74104 ISRAEL",02/15/2001," GRN 69 (in PDF)",,,,,,,05/14/2001,," FDA has no questions",,,,,,,,,, =T("70")," Stearyl alcohol"," Use in margarine, shortening, and food products that require the use of semi-solid and solid fats as a texturizer at levels up to 10 percent of the oil mass of the food product"," Scientific procedures"," Thixo Limited"," 2 Hashaked Street; Ness Ziona, 74104 ISRAEL",02/21/2001," GRN 70 (in PDF)",,,,,,,04/23/2001,," FDA has no questions",,,,,,,,,, =T("71")," White mineral oil, USP (viscosity ISO 100 )"," Use on potato processing equipment as a sprayed release agent resulting in a presence on food at no more than 5 parts per million"," Scientific procedures"," American Ingredients Company"," 3947 Broadway; Kansas City, MO 64111",03/07/2001," GRN 71 (in PDF)",,,,,,,04/20/2001,," FDA has no questions",,,,,,,=T("40"),,, =T("72")," Pullulanase derived from Bacillus licheniformis carrying a gene encoding pullulanase from B. deramificans"," Use in the manufacture of starch hydrolysates and high fructose corn syrup as a processing aid at a minimum level necessary in accordance with good manufacturing practice"," Scientific procedures"," Genencor International Inc."," 925 Page Mill Road; Palo Alto, CA 94304",03/10/2001," GRN 72 (in PDF)",,,,,,,06/12/2001,," FDA has no questions",,,,,,,,," Incorporates GRAS Affirmation Petition"," GRP 5G0415" =T("73")," Shrimp-derived chitosan"," Use in foods in general for multiple technical effects in accordance with good manufacturing practice"," Scientific procedures"," Primex Ingredients ASA"," Karmsund Fiskerihavn; P.O. Box 114; N-4299 Avaldsnes, NORWAY",03/14/2001," GRN 73 (in PDF)",,,,,,,01/31/2002,," At the notifier's request, FDA ceased to evaluate this notice",,,,,,,,,, =T("74")," Beta-cyclodextrin"," Use in baked goods prepared from dry mixes, breakfast cereal, chewing gum, gelatins and puddings, dry mix for soups, flavored coffee and tea, compressed candies, processed cheese products, flavored savory snacks and crackers, dry mix for beverages as a flavor carrier or protectant at varying levels"," Scientific procedures"," Wacker Biochem Corp."," 3301 Sutton Road; Adrian, MI 49221",03/28/2001," GRN 74 (in PDF)",,,,,,,10/25/2001,," FDA has no questions",,,,,,,,,, =T("75")," Lipase derived from Aspergillus oryzae carrying a gene encoding lipase from Fusarium oxysporum"," Use in the fats and oils industry, the baking industry, the hydrolysis of lecithin, and the modification of egg yolks as a processing aid at a minimum level necessary in accordance with good manufacturing practices"," Scientific procedures"," Novozymes North America Inc."," 77 Perry Chapel Church Rd.; Box 576; Franklinton, NC 27525",04/13/2001," GRN 75 (in PDF)",,,,,,,08/14/2001,," FDA has no questions",,,,,,,,,, =T("76")," Erythritol"," Use in bakery fillings, cakes and cookies, chewing gum, dairy drinks, fat-based cream used in modified fat/calorie cookies, pastries, hard candies, frozen dairy desserts, puddings, reduced and low-calorie beverages, soft candies, sugar substitutes and yogurt as a flavor enhancer, formulation aid, humectant, nutritive sweetener, stabilizer and thickener, sequestrant, and texturizer at varying levels"," Scientific procedures"," Cerestar Holding B.V."," Havenstraat 84; B-1800 Vilvoorde; BELGIUM",04/30/2001," GRN 76 (in PDF)",,,,,,,09/11/2001,," FDA has no questions",,,,,,,,,, =T("77")," Milk-derived lactoferrin"," Ingredient in sports and functional foods at a level of 100 milligrams per product serving"," Scientific procedures"," DMV International"," 1712 Deltown Plaza; Fraser; NY 13753",05/04/2001," GRN 77 (in PDF)",,,,,,,08/14/2001,," FDA has no questions",,,,,,,=T("42"),,, =T("78")," D-Tagatose"," Use in diet/sugar-free carbonated beverages, ready-to-eat cereals, sugar-less/sugar-free chewing gum, low calorie ready-to-drink tea beverages, icings or glazes used on baked goods, frozen dairy desserts, bars, hard candies, dietetic soft candies, and meal replacements as a bulk sweetener, humectant, texturizer or stabilizer at varying levels"," Scientific procedures"," Arla Foods Ingredients amba"," Skanderborgvej 277; P.O. Box 2510; DK-8260 Viby; DENMARK",05/11/2001," GRN 78 (in PDF)",,,,,,,10/25/2001,," FDA has no questions",,,,,,,,,, =T("79")," alpha-Amylase derived from Bacillus licheniformis carrying a gene encoding a modified alpha-amylase from Bacillus licheniformis"," Use as a processing aid for the liquefaction of starch in the production of syrups and for the thinning of starch in distilling mashes in the production of alcohol. The alpha-amylase enzyme preparation is used at minimum levels necessary to achieve the intended effects. The recommended use level for the alpha-amylase enzyme preparation is 0.35 kilogram per ton of starch."," Scientific procedures"," Novozymes North America Inc."," 77 Perry Chapel Church Rd., Box 576, Franklinton, NC 27525",07/03/2001," GRN 79 (in PDF)",,,,,,,12/19/2001,," FDA has no questions",,,,,,,,,, =T("80")," ARASCO (arachidonic acid-rich single-cell oil)"," Provide ARASCO (as a source of arachidonic acid) in term infant formula, at a maximum level of 1.88 percent of total dietary fat when used in combination with DHASCO (docosahexaenoic acid-rich single-cell oil; as a source of docosahexaenoic acid) at a maximum level of 1.25 per cent of the total dietary fat and at a ratio ranging from 1:1 to 1:2 (DHASCO:ARASCO)"," Scientific procedures"," Mead Johnson Nutritionals"," 2400 West Lloyd Expressway, Evansville, IN 47721",08/06/2001," GRN 80 part 1 (in PDF)"," GRN 80 part 2 with amendments (in PDF)",,,,,,12/11/2001,," FDA has no questions",,,,,,,,,, =T("81")," Lipase from Candida rugosa"," Use on fats and oils to produce fatty acids or glycerides at a level up to one percent of the weight of the fat or oil; use in the esterification of fatty acids to produce glycerides at a level up to one percent of the weight of the fatty acids"," Scientific procedures"," Amano Enzyme, Inc."," 2-7, 1-Chome, Nishiki, Naka-ku, Nagoya 460, JAPAN",09/05/2001," GRN 81 (in PDF)",,,,,,,02/07/2002,," FDA has no questions",,,,,,,,,, =T("82")," 1,1,1,2-Tetrafluoroethane (HFC-134a)"," Use in the production of food flavors and flavorings as an extraction solvent"," Scientific procedures"," INEOS Fluor, Ltd."," Runcorn Technical Centre, P.O. Pox 13, The Heath, Runcorn, Cheshire WA7 4QF, UNITED KINGDOM",09/04/2001," GRN 82 (in PDF)",,,,,,,06/05/2002,," FDA has no questions",,,,,,,,,, =T("83")," Carbon monoxide"," Use in the packaging of fresh cuts of muscle meat and ground meat as a component of a gas mixture in a modified atmosphere packaging system to maintain wholesomeness, provide flexibility in distribution, and reduce shrinkage within a system that results in traditional product display to consumers in fresh cuts of muscle meat or ground meat"," Scientific procedures"," Pactiv Corporation"," 1900 West Field Court, Lake Forest, IL 60045",09/04/2001," GRN 83 part 1 (in PDF)"," GRN 83 part 2 with amendments (in PDF)",,,,,,02/21/2002,," FDA has no questions",,,,,,,,,, =T("84")," Arabinogalactan from Eastern Larch (Larix laricina)"," Use in foods in general, including meat and poultry products, for multiple technical effects"," Scientific procedures"," Larex, Inc."," 4815 White Bear Parkway, White Bear Lake, MN 55110",09/06/2001," GRN 84 (in PDF)",,,,,,,02/19/2002,," FDA has no questions",,,,,,,,,, =T("85")," Isoamylase from Pseudomonas amyloderamosa"," Use as a debranching enzyme that hydrolyzes alpha-1,6-glucosidic linkages in glycogen, amylopectin, and their alpha-limit dextrins"," Scientific procedures"," Hayashibara International, Inc."," 8670 Wolff Court, Suite 200, Westminster, CO 80030",09/21/2001," GRN 85 (in PDF)",,,,,,,02/19/2002,," FDA has no questions",,,,,,,,,, =T("86")," Coagulated potato protein, hydrolyzed potato protein, or clarified hydrolyzed potato protein"," Use in foods in general, including meat products, as a substitute for other protein products that accomplish a range of functional effects (such as water binding, emulsifying, and foaming)"," Scientific procedures"," AVEBE b.a."," Prins Hendrikplein 20, 9641 GK Veendam, NETHERLANDS",10/22/2001," GRN 86 (in PDF)",,,,,,,04/03/2002,," FDA has no questions",,,,,,,,,, =T("87")," Composite filtration media (diatomaceous earth and perlite)"," Use in food processing as a filtration aid"," Scientific procedures"," World Minerals, Inc."," 2500 Miguelito Road, Lompoc, CA 93436",11/06/2001," GRN 87 (in PDF)",,,,,,,02/26/2002,," FDA has no questions",,,,,,,,,, =T("88")," Invertase enzyme preparation from Saccharomyces cerevisiae and lactase enzyme preparation from Kluyveromyces marxianus"," Use in foods in general as an enzyme in accordance with current good manufacturing practices"," Common use in food"," Enzyme Technical Association"," 1800 Massachusetts Avenue, N.W., Second Floor, Washington, DC 20036",11/16/2001," GRN 88 (in PDF)",,,,,,,04/03/2002,," FDA has no questions",,,,,,,,," Incorporates GRAS Affirmation Petition"," GRP 3G0016" =T("89")," Five enzyme preparations from Aspergillus niger: Carbohydrase enzyme preparation, catalase enzyme preparation, glucose oxidase enzyme preparation, pectinase enzyme preparation, and protease enzyme preparation"," Use in foods in general as an enzyme in accordance with current good manufacturing practices"," Common use in food"," Enzyme Technical Association"," 1800 Massachusetts Avenue, N.W., Second Floor, Washington, DC 20036",11/16/2001," GRN 89 (in PDF)",,,,,,,04/03/2002,," FDA has no questions",01/13/2004," Additional correspondence",,,,,,," Incorporates GRAS Affirmation Petition"," GRP 3G0016" =T("90")," Carbohydrase enzyme preparation from Aspergillus oryzae, protease enzyme preparation from Aspergillus oryzae, and carbohydrase enzyme preparation from Rhizopus oryzae"," Use in foods in general as an enzyme in accordance with current good manufacturing practices"," Common use in food"," Enzyme Technical Association"," 1800 Massachusetts Avenue, N.W., Second Floor, Washington, DC 20036",11/16/2001," GRN 90 (in PDF)",,,,,,,04/04/2002,," FDA has no questions",01/13/2004," Additional correspondence",,,,,,," Incorporates GRAS Affirmation Petition"," GRP 3G0016" =T("91")," Mycoprotein"," Use in food in general, excluding meat products, poultry products, and infant formula"," Scientific procedures"," Marlow Foods Ltd."," Station Road Stokesley, North Yorkshire TS9 7AB, UNITED KINGDOM",12/03/2001," GRN 91 (in PDF)",,,,,,,01/07/2002,," FDA has no questions",09/28/2023," Additional correspondence",,,,,,,, =T("92")," Sucrose fatty acid esters"," Use in beta carotene color preparations intended for use in orange-colored beverages such as soft drinks and juice beverages as an emulsifier at a maximum level of 2 per cent of the beta-carotene color preparation"," Scientific procedures"," Mitsubishi Chemical Corporation"," 5-2, Marunochi 2-chome, Chiyoda-ku, Tokyo 100-0005 JAPAN",12/12/2001," GRN 92 (in PDF)",,,,,,,02/04/2002,," Notice does not provide a basis for a GRAS determination",,,,,,,,=T("129"),, =T("93")," Grape seed extract and grape skin extract"," Use in fruit juice and fruit flavored beverages as an antioxidant to prevent deterioration at a composite total concentration up to 210 parts per million"," Scientific procedures"," Polyphenolics, Inc."," 12667 Road 24, Madera, CA 93637",12/17/2001," GRN 93 (in PDF)",,,,,,,06/05/2002,," Notice does not provide a basis for a GRAS determination",,,,,,,,=T("125"),, =T("94")," Docosahexaenoic acid-rich oil from tuna (DHA-rich tuna oil) and arachidonic acid-rich oil from Mortierella alpina (AA-rich fungal oil)"," Provide arachidonic acid (AA) at a mean level of 0.4 percent of total fatty acids and docosahexaenoic acid (DHA) at a mean level of 0.25 percent of total fatty acids in preterm infant formula used by hospitalized premature infants; AA at a mean level of 0.4 percent of total fatty acids and DHA at a mean level of 0.15 percent of total fatty acids in preterm infant formula used by post-discharge premature infants; and AA at a mean level of 0.4 percent of total fatty acids and DHA at a mean level of 0.15 percent of total fatty acids in term infant formula"," Scientific procedures"," Ross Products Division, Abbott Laboratories"," 625 Cleveland Avenue, Columbus, OH 43215-1724",01/02/2002," GRN 94 part 1 (in PDF)"," GRN 94 part 2 (in PDF)",,,,,,04/18/2006,," FDA has no questions",,,,,,,,,, =T("95")," Transglutaminase from Streptoverticillium mobaraense"," Use in food in general as a crosslinking agent"," Scientific procedures"," Ajinomoto USA"," 1120 Connecticut Ave, NW Suite 416 Washington, DC 20036",01/03/2002," GRN 95 (in PDF)",,,,,,,07/03/2002,," FDA has no questions",,,,,,,,,, =T("96")," Silk protein food powder"," Use in food as a source of protein"," Scientific procedures"," The New Silk Road, Inc."," Box 105, Montpelier, VT 05601",01/03/2002," GRN 96 (in PDF)",,,,,,,05/20/2002,," Notice does not provide a basis for a GRAS determination",,,,,,,,,, =T("97")," Tuna oil"," Use in food as described in 21 CFR 184.1472(a)(3) with respect to food categories and the level of use in those food categories"," Scientific procedures"," Clover Corporation Limited"," Level 5, 231 Miller Street, P.O. Box 458, North Sydney NSW 2060, AUSTRALIA",01/25/2002," GRN 97 (in PDF)",,,,,,,06/24/2002,," At the notifier's request, FDA ceased to evaluate this notice",,,,,,,,=T("109"),, =T("98")," Small planktivorous pelagic fish body oil"," Use in food as described in 21 CFR 184.1472(a)(3) with respect to food categories and the level of use in those food categories"," Scientific procedures"," Jedwards International"," 10 Furnace Brook Parkway, Quincy, MA 02169",02/11/2002," GRN 98 (in PDF)",,,,,,,03/25/2002,," At the notifier's request, FDA ceased to evaluate this notice",,,,,,,,=T("102"),, =T("99")," Pullulan"," Use in food in general, including meat products, for multiple technical effects"," Scientific procedures"," Hayashibara International"," 8670 Wolff Court, Suite 200, Westminster, CO 80030",03/01/2002," GRN 99 (in PDF)",,,,,,,08/01/2002,," FDA has no questions",,,,,,,,,, =T("100")," D-Ribose"," Use in food in general, including meat and poultry products, for multiple technical effects"," Scientific procedures"," Bioenergy, Inc."," 13840 Johnson St. N.E., Ham Lake, MN 55304",03/14/2002," GRN 100 (in PDF)",,,,,,,09/03/2002,," Notice does not provide a basis for a GRAS determination",,,,,,,,=T("243"),, =T("101")," Spirulina"," Ingredient in foods such as bars, powdered nutritional drink mixes, and as a condiment in salads and pasta, at levels ranging from 0.5 to 3 grams per serving size"," Scientific procedures"," Cyanotech Corporation
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Earthrise Nutritionals, Inc."," 73-4460 Queen Kaahumanu Hwy, #102, Kailua-Kona HI 96740
AND
Earthrise Nutritionals, Inc.; 424 Payran Street, Petaluma, CA 94952",03/19/2002," GRN 101 (in PDF)",,,,,,,05/28/2002,," At the notifier's request, FDA ceased to evaluate this notice",,,,,,,,=T("127"),, =T("102")," Small planktivorous pelagic fish body oil"," Use in food as described in 21 CFR 184.1472(a)(3) with respect to food categories listed"," Scientific procedures"," Jedwards International"," 10 Furnace Brook Parkway, Quincy, MA 02169",04/04/2002," GRN 102 (in PDF)",,,,,,,09/03/2002,," FDA has no questions",,,,,,,=T("98"),,, =T("103")," Lipase enzyme preparation from Aspergillus oryzae carrying a gene constructed from a modified Thermomyces lanuginosus lipase gene and a portion of the Fusarium oxysporum lipase gene"," Use in bakery products, egg yolks, whole eggs, and fats and oils as an enzyme at minimum levels necessary in accordance with good manufacturing practice"," Scientific procedures"," Novozymes North America, Inc.;"," 77 Perry Chapel Church Rd., Box 576, Franklinton, NC 27525",04/24/2002," GRN 103 (in PDF)",,,,,,,08/19/2002,," FDA has no questions",,,,,,,,,, =T("104")," Sucrose acetate isobutyrate"," Use as a stabilizer of emulsions of flavoring oils in alcoholic beverages"," Scientific procedures"," Eastman Chemical Company"," 100 North Eastman Road, Kingsport, TN 37662-5054",04/17/2002," GRN 104 (in PDF)",,,,,,,08/16/2002,," FDA has no questions",,,,,,,,,, =T("105")," Fish oil concentrate"," Use as an ingredient in the foods described in FDA's proposed rule for the use of menhaden oil (67 FR 8744; Feb. 26, 2002) at a level that is approximately 57 percent of the levels listed in that proposed rule"," Scientific procedures"," Unilever United States, Inc."," Lever House, 390 Park Avenue, New York, NY 10022-4968",04/19/2002," GRN 105 (in PDF)",,,,,,,10/15/2002,," FDA has no questions",,,,,,,,,, =T("106")," Glucose oxidase enzyme preparation from Aspergillus oryzae carrying a gene encoding a glucose oxidase from Aspergillus niger"," Use as an enzyme in baking applications and (in combination with a catalyze enzyme preparation) in the manufacture of foods such as cheese, beer, carbonated beverages, and fruit juice"," Scientific procedures"," Novozymes North America, Inc."," 77 Perry Chapel Church Rd., Box 576, Franklinton, NC 27525",04/29/2002," GRN 106 (in PDF)",,,,,,,10/03/2002,," FDA has no questions",,,,,,,,,, =T("107")," Polydextrose"," Use in non-sweet baked goods, breading and batter coatings, flavor bits on crackers, snack chips, ready-to-eat breakfast cereals, surimi (minced fish and meat), ready-to-drink nutritional beverages, noncarbonated beverages and dry beverage mixes for multiple technical effects at varying levels"," Scientific procedures"," Danisco Cultor America"," 440 Saw Mill River Road, Ardsley, NY 10502-2605",05/01/2002," GRN 107 (in PDF)",,,,,,,10/17/2002,," At the notifier's request, FDA ceased to evaluate this notice",,,,,,,,,, =T("108")," Glycerol ester of gum rosin"," Use in citrus oils that are added to beverages to increase the density of the citrus oil and to act as an emulsifier at a maximum level of 100 parts per million"," Scientific procedures"," T&R Chemicals, Inc."," P.O. Box 330, 700 Celum Road, Clint, TX 79836",06/28/2002," GRN 108 (in PDF)",,,,,,,12/20/2002,," Notice does not provide a basis for a GRAS determination",,,,,,,,," Resubmitted as"," FAP 3A4749" =T("109")," Tuna oil"," Use in the food categories listed in 21 CFR 184.1472(a)(3) as a direct food ingredient at levels that are no more than 62 percent of the levels specified in 21 CFR 184.1472(a)(3)"," Scientific procedures"," Clover Corporation Limited"," Level 5, 231 Miller Street, P.O. Box 458, North Sydney NSW 2060, AUSTRALIA",07/11/2002," GRN 109 (in PDF)",,,,,,,12/04/2002,," FDA has no questions",,,,,,,=T("97"),,, =T("110")," Lutein esters"," Ingredient in baked goods and baking mixes, soy milk, beverages and beverage powders, frozen dairy desserts and mixes, processed fruit and vegetable products, egg products and egg substitutes, breakfast cereals (ready-to-eat and hot), fats and oils, hard candy, fruit snacks, dairy products, and medical foods intended as the sole item of the diet"," Scientific procedures"," Cognis Corporation"," 5325 South Ninth Avenue, LaGrange, IL 60525",07/25/2002," GRN 110 (in PDF)",,,,,,,01/21/2003,," FDA has no questions; some uses may require a color additive listing",,,,,,,,,, =T("111")," Lipase enzyme preparation from Aspergillus niger"," Use in dairy-based flavoring preparations, cheeses, liquid and dried egg white, bread, flour, unstandardized bakery products, modified triglycerides, hydrolyzed lecithin, edible fats and oils, and modified egg yolk as an enzyme"," Scientific procedures"," Enzyme Technical Association"," 1800 Massachusetts Avenue, N.W., Second Floor, Washington, DC 20036",08/16/2002," GRN 111 (in PDF)",,,,,,,12/20/2002,," FDA has no questions",,,,,,,,," Incorporates GRAS Affirmation Petition"," GRP 3G0016" =T("112")," Phytosterols"," Ingredient in vegetable spread, yogurt, milk-based juice beverages, ice cream, cream cheese, snack bars, salad dressings, and white bread products"," Scientific procedures"," Teriaka Ltd."," Leikosaarentie 32, POB 15, FIN-00981, Helsinki, FINLAND",08/19/2002," GRN 112 (in PDF)",,,,,,,02/04/2003,," FDA has no questions",,,,,,,,,, =T("113")," Lipase enzyme preparation from Aspergillus oryzae"," Use in dairy-based flavoring preparations, cheeses, liquid and dried egg white, bread, flour, unstandardized bakery products, modified triglycerides, hydrolyzed lecithin, edible fats and oils, and modified egg yolk as an enzyme"," Scientific procedures"," Enzyme Technical Association"," 1800 Massachusetts Avenue, N.W., Second Floor, Washington, DC 20036",08/21/2002," GRN 113 (in PDF)",,,,,,,01/27/2003,," FDA has no questions",,,,,,,,," Incorporates GRAS Affirmation Petition"," GRP 3G0016" =T("114")," Pectate lyase enzyme preparation from Bacillus subtilis"," Use in fruit and vegetable purees and concentrates as an enzyme"," Scientific procedures"," Japan Cellfoods Co., Ltd."," SORIO 3-5F, 2-2-1 Sakaemachi, Takarazuka, Hyogo 665-0845 JAPAN",09/05/2002," GRN 114 (in PDF)",,,,,,,01/27/2003,," FDA has no questions",,,,,,,,,, =T("115")," Diacylglycerol oil"," Use as a substitute for vegetable oils in bakery products, salad dressings, mayonnaise, pizza, breakfast/snack/power bars, soups and gravies, meal replacements, and frozen dinner entrees"," Scientific procedures"," ADM Kao L.L.C."," 466 Faries Parkway, Decatur, IL 62526",09/05/2002," GRN 115 (in PDF)",,,,,,,02/24/2003,," FDA has no questions",,,,,,,,,, =T("116")," Carrot fiber"," Use in baked goods as a texturizer at a maximum level of 5 percent by weight of flour; use in meat substitutes (e.g., meatless sausages and meatless patties) at a maximum level of 5 percent; use in meat and poultry products as a binder/extender and to reduce water purging/gelling at a maximum level of 5 percent"," Scientific procedures"," Wm. Bolthouse Farms, Inc."," 7200 Brundage Lane, Bakersfield, CA 93307-3099",10/03/2002," GRN 116 (in PDF)",,,,,,,03/20/2003,," FDA has no questions",,,,,,,,,, =T("117")," Ice structuring protein preparation"," "," Scientific procedures"," Unilever (Good Humor - Breyers)"," 390 Park Avenue, New York, NY 10036",10/30/2002," GRN 117 (in PDF)",,,,,,,04/17/2003,," FDA has no questions",04/10/2013," Additional correspondence expanding intended uses",,,,,,,, =T("118")," Inulin"," Use in food in general, including meat and poultry products, as a bulking agent"," Scientific procedures"," Imperial-Sensus, LLC"," P. O. Box 9, Sugar Land, TX 77487-0009",11/14/2002," GRN 118 (in PDF)",,,,,,,05/05/2003,," FDA has no questions",01/16/2008," Additional correspondence about intended uses",,,,,,,, =T("119")," Synthetic lycopene"," Ingredient in food in general, except meat and poultry products"," Scientific procedures"," BASF Corporation"," 3000 Continental Drive North, Mount Olive, NJ 07828-1234",11/27/2002," GRN 119 (in PDF)",,,,,,,05/22/2003,04/07/2005," FDA has no questions; some uses may require a color additive listing",,,,,,,,,, =T("120")," Saccharomyces cerevisiae strain ML01 carrying a gene encoding the malolactic enzyme from Oenococcus oeni and a gene encoding malate permease from Schizosaccharomyces pombe"," Use in winemaking as a yeast starter culture for grape must fermentation"," Scientific procedures"," Lesaffre Yeast Corporation"," 433 East Michigan Street, Milwaukee, WI 53202",01/10/2003," GRN 120 (in PDF)",,,,,,,06/30/2003,," FDA has no questions",,,,,,,,,, =T("121")," Xanthan gum"," Use in food in general, including meat products"," Scientific procedures"," Ingredients Solutions, Inc.
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Zibo Zhongxuan Biological Product Co., Ltd."," 33 Mt. Ephraim Road, Searsport, ME 04974-0407
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Zibo Zhongxuan Biological Product Co., Ltd.; 33 Yongliu West Road, Linzi Zibo Shandong, PEOPLE'S REPUBLIC OF CHINA",01/21/2003," GRN 121 part 1 (in PDF)"," GRN 121 part 2 with amendments (in PDF)",,,,,,07/18/2003,," FDA has no questions",,,,,,,,,, =T("122")," Laccase enzyme preparation produced by Aspergillus oryzae expressing the gene encoding a laccase from Myceliophthora thermophila"," Use in breath freshening products (such as breath mints and chewing gum) as an enzyme"," Scientific procedures"," Novozymes North America, Inc."," 77 Perry Chapel Church Road, Box 576, Franklinton, NC 27525",01/22/2003," GRN 122 (in PDF)",,,,,,,07/18/2003,," FDA has no questions",,,,,,,,,, =T("123")," Laminaria japonica broth and extract powder"," Use as a flavoring agent in meat products, poultry, fish products, soups, gravies and seasonings"," Scientific procedures"," Fuji Foods, Inc."," 6206 Corporate Park Drive, Browns Summit, NC 27214",01/28/2003," GRN 123 (in PDF)",,,,,,,07/25/2003,," FDA has no questions",,,,,,,,,, =T("124")," Grape seed extract"," Use as an antioxidant or emulsifier in beverages and beverage bases, breakfast cereals, fats and oils, frozen dairy desserts and mixes, grain products, milk (whole and skim), milk products, processed fruits and fruit juices at levels ranging from 0.01 to 0.08 percent"," Scientific procedures"," San Joaquin Valley Concentrates"," 5631 E. Olive Avenue, Fresno, CA 93727",02/14/2003," GRN 124 (in PDF)",,,,,,,08/01/2003,," FDA has no questions",,,,,,,,,, =T("125")," Grape seed extract and grape pomace extract"," Use as an antioxidant in fruit juices, fruit flavored beverages, fruit flavored beverage mixes and carbonated fruit flavored beverages at a concentration of 210 parts per million (alone or in combination with other safe and appropriate antioxidant substances)"," Scientific procedures"," Polyphenolics, Inc."," 12667 Road 24, Madera, CA 93639",02/26/2003," GRN 125 part 1 (in PDF)"," GRN 125 part 2 with amendments (in PDF)",,,,,,08/18/2003,," FDA has no questions; some uses may require a color additive listing",,,,,,,=T("93"),,, =T("126")," alpha-Amylase enzyme preparation from Pseudomonas fluorescens Biovar I expressing a gene encoding a hybrid alpha-amylase derived from three microorganisms within the order Thermococcales"," Use as an enzyme for the hydrolysis of edible starch to produce various starch hydrolysis products and to produce fermentable sugars for use in the production of distilled ethanol for alcoholic beverages"," Scientific procedures"," Innovase LLC"," 5501 Oberlin Drive, San Diego, CA 92121",04/03/2003," GRN 126 (in PDF)",,,,,,,09/26/2003,," FDA has no questions",,,,,,,,,, =T("127")," Spirulina, the dried biomass of Arthrospira platensis"," Ingredient in foods such as bars, powdered nutritional drink mixes, popcorn, and as a condiment in salads and pasta, at levels ranging from 0.5 to 3 grams per serving size"," Scientific procedures"," Cyanotech Corporation and Earthrise Nutritionals, Inc."," 73-4460 Queen Kaahumanu Hwy, #102, Kailua-Kona HI 96740;
AND
Earthrise Nutritionals, Inc.; 424 Payran Street, Petaluma, CA 94952",04/10/2003," GRN 127 (in PDF)",,,,,,,10/06/2003,," FDA has no questions; some uses may require a color additive listing",,,,,,,=T("101"),,, =T("128")," Skim milk or dextrose cultured with Propionibacterium freudenreichii subsp. shermanii"," Use as an antimicrobial agent in cheeses, sauces, salad dressings, sausages, soups, deli salads, salsas, pasta, tortillas, muffins, cereal bars, sour cream, yogurt, and hash brown potatoes at a maximum level of 2 percent (w/w) in the finished product"," Scientific procedures"," Rhodia Inc."," CN 7500, 259 Prospect Plains Road, Cranbury, NJ 08512-7500",05/21/2003," GRN 128 (in PDF)",,,,,,,11/26/2003,," FDA has no questions",,,,,,,,,, =T("129")," Sucrose fatty acid esters"," Use as an emulsifier in beta-carotene, beta-apo-8-carotenal (apocarotenal), and canthaxanthin color additive preparations that will be added to beverages, crackers, soups and sauces"," Scientific procedures"," Mitsubishi Chemical Corporation"," 3-9, Ginza 1-chome, Chuo-ku, Tokyo 104-0061, JAPAN",05/21/2003," GRN 129 (in PDF)",,,,,,,11/07/2003,," FDA has no questions",,,,,,,,,, =T("130")," Bovine milk-derived lactoferrin"," Use as an antimicrobial spray on beef carcasses that will subsequently be washed to reduce the levels of exogenously applied lactoferrin"," Scientific procedures"," aLF Ventures, LLC"," 299 South Main Street, Suite 2310, Salt Lake City, Utah 84111",05/28/2003," GRN 130 (in PDF)",,,,,,,08/21/2003,," FDA has no questions",05/27/2004," Additional correspondence",,,,,,,, =T("131")," High 2-palmitic vegetable oil"," Use in infant formula for term and preterm infants at levels of up to 80 percent total fat intake"," Scientific procedures"," Loders Croklaan B. V."," P. O. Box 4, 1520 AA Wormerveer, NETHERLANDS",06/09/2003," GRN 131 (in PDF)",,,,,,,12/04/2003,," FDA has no questions",05/07/2004," Additional correspondence",,,,,,,, =T("132")," Lactase enzyme preparation from Aspergillus niger"," Use in the dairy industry to hydrolyze lactose found in milk, whey, cheese, yogurt, and other dairy products"," Scientific procedures"," Enzyme Technical Association"," 1800 Massachusetts Avenue, N.W., Second Floor Washington, DC 20036-1800",06/20/2003," GRN 132 (in PDF)",,,,,,,12/12/2003,," FDA has no questions",,,,,,,,," Incorporates GRAS Affirmation Petition"," GRP 3G0016" =T("133")," Volatile oil of mustard"," Use in or on meats, poultry, fish and shellfish, baked goods, and food products derived therefrom, and either in bulk, in holding, or transport containers, in display cases, or in consumer packaged forms as an antimicrobial agent"," Scientific procedures"," CAREX, Inc."," 1-1-47, Chuo, Joto-ku, Osaka, 536-0005, JAPAN",07/10/2003," GRN 133 (in PDF)",,,,,,,01/05/2004,," FDA has no questions",,,,,,,,,, =T("134")," Soy protein hydrolyzate with enzyme-modified lecithin"," Ingredient in baked goods and baking mixes, breakfast cereals, dairy product analogs, fats and oils, grain products and pastas, health beverages, meat products, milk products, plant protein products, processed fruits and fruit juices, processed vegetables and vegetable juices, and soups and soup mixes at varying levels"," Scientific procedures"," Kyowa Hakko U.S.A., Inc."," 767 Third Avenue, 19th Floor, New York, NY 10017",07/14/2003," GRN 134 (in PDF)",,,,,,,01/08/2004,," FDA has no questions",,,,,,,,,, =T("135")," ε-Polylysine"," Use as an antimicrobial agent in cooked rice and sushi rice at levels from 5 to 50 parts per million"," Scientific procedures"," Chisso Corporation"," Forefront Tower II, 13-1 Kachidoki 3-chome, chuo-ku, Tokyo, JAPAN, 104-8555",07/15/2003," GRN 135 (in PDF)",,,,,,,01/16/2004,," FDA has no questions",,,,,,,,,, =T("136")," Calcium gluconate"," Use in food in general as a source of calcium"," Scientific procedures"," Purac Biochem b.v."," Arkelsedijk 46, P.O. Box 21, 4200 AA Gorinchem, NETHERLANDS",08/19/2003," GRN 136 (in PDF)",,,,,,,02/05/2004,," FDA has no questions",,,,,,,,,, =T("137")," Algal oil (Schizochytrium sp.)"," Use as a direct food ingredient in the food categories listed in 21 CFR 184.1472(a)(3) at levels that are no more than 29 percent of the levels specified in 21 CFR 184.1472(a)(3) and in the additional food categories listed in GRN 000105 at levels that are no more than 50 percent of the levels specified in GRN 000105"," Scientific procedures"," Martek Biosciences Corporation"," 6480 Dobbin Road, Columbia, MD 21045",08/21/2003," GRN 137 (in PDF)",,,,,,,02/12/2004,," FDA has no questions",,,,,,,,,, =T("138")," Fish oil"," For use as a direct food ingredient in the food categories listed in 21 CFR 184.1472(a)(3). Two formulations are provided: an oil (to be used at a levels that are no more than 67 percent of the levels specified in 21 CFR 184.1472(a)(3)) and a microencapsulated oil (to be used at levels that are no more than 120 percent of the levels specified in 21 CFR 184.1472(a)(3))"," Scientific procedures"," Ocean Nutrition Canada Ltd"," 757 Bedford Highway, Bedford, Nova Scotia B4A3Z7, CANADA",10/03/2003," GRN 138 (in PDF)",,,,,,,04/20/2004,," FDA has no questions",,,,,,,,,, =T("139")," Cassia gum"," Use as a thickening agent, texturizer, and water retention aid in cheese-creme filling in pastries and other cheese-creme desserts, dry soup mixes, oil-free salad dressings, and meat and poultry products at a maximum level of 5,000 parts per million"," Scientific procedures"," Noveon, Inc."," 9911 Brecksville Road, Cleveland, OH 44141",11/21/2003," GRN 139 (in PDF)",,,,,,,05/03/2004,," At the notifier's request, FDA ceased to evaluate this notice",,,,,,,=T("51"),,, =T("140")," Crystalline lutein"," Ingredient in baked goods and baking mixes, beverages and beverage bases, breakfast cereals, chewing gum, dairy products analogs, egg products, fats and oils, frozen dairy desserts and mixes, gravies and sauces, hard candy, infant and toddler foods (other than infant formula), milk products, processed fruit and vegetable products, soft candy, soups and soup mixes, and medical foods intended as the sole item of the diet"," Scientific procedures"," Kemin Foods, L.C."," 600 E Court Avenue, Suite A, Des Moines, IA 50309-2021",11/21/2003," GRN 140 (in PDF)",,,,,,,06/14/2004,," FDA has no questions; some uses may require a color additive listing",07/29/2016," Additional Correspondence regarding an increase in intended use",,,,,,,, =T("141")," Polyvinyl alcohol"," Use in aqueous film coatings applied to dietary supplements (tablets/capsules)"," Scientific procedures"," Colorcon"," 415 Moyer Boulevard, P. O. Box 24, West Point, PA 19486",12/23/2003," GRN 141 (in PDF)",,,,,,,04/28/2004,," FDA has no questions",,,,,,,,,, =T("142")," Phospholipase enzyme preparation from Aspergillus oryzae expressing the gene encoding a phospholipase A1 from Fusarium venenatum"," Use as an enzyme in the production of cheese"," Scientific procedures"," Novozymes North America Inc."," 77 Perry Church Road, Box 576, Franklinton, NC 27525",12/29/2003," GRN 142 (in PDF)",,,,,,,06/23/2004,," FDA has no questions",,,,,,,,,, =T("143")," Carbon monoxide"," Use as a component of a modified atmosphere packaging (MAP) system for case-ready fresh beef and pork"," Scientific procedures"," Precept Foods, LLC."," 1 Hormel Pl., Austin, MN 55912-3680",01/12/2004," GRN 143 (in PDF)",,,,,,,07/29/2004,," FDA has no questions",,,,,,,,,, =T("144")," Adenosine 5'-monophosphoric acid and its monosodium and disodium salts"," Use as a flavor enhancer in chewing gum, coffee and tea, snack foods, novelty snacks, soups and soup mixes (including meat and poultry), and sugar substitutes (as defined by those food categories in 21 CFR 170.3(n)(6), (7), (37), (40), and (42), respectively), and salt substitutes"," Scientific procedures"," Linguagen Corp."," 2005 Eastpark Blvd., Cranbury, NJ 08512-3515",02/06/2004," GRN 144 (in PDF)",,,,,,,07/29/2004,," FDA has no questions",,,,,,,,,, =T("145")," Phospholipase A2 enzyme preparation from Streptomyces violaceoruber"," Use as a enzyme to hydrolyze soy and egg yolk lechithins"," Scientific procedures"," Genencor International, Inc."," 925 Page Mill Road, Palo Alto, CA 94304",02/11/2004," GRN 145 (in PDF)",,,,,,,07/29/2004,," FDA has no questions",,,,,,,,,, =T("146")," Salmon oil"," For use as a direct food ingredient in the food categories listed in 21 CFR 184.1472(a)(3) and not to be combined or augmented with any other food ingredient containing EPA and DHA"," Scientific procedures"," Jedwards International"," 10 Furnace Brook Parkway, Quincy, MA 02169",02/20/2004," GRN 146 (in PDF)",,,,,,,08/17/2004,," FDA has no questions",,,,,,,,,, =T("147")," Extracted "seafood species" protein"," Use as a protein source in finished seafood products of the same species as the extracted seafood protein; Use in fresh or frozen seafood (1) as a protein coating (only) by dip; (2) applied as a portion of the batter (only); or; (3) as a portion of the batter and coating (together), added to seafood of the same species or to a secondary processed seafood product of a different species, and identified as ""(species) protein"" on the finished product label"," Scientific procedures"," Proteus Industries, Inc."," 21 Great Republic Drive, Gloucester, MA 01930",03/10/2004," GRN 147 (in PDF)",,,,,,,08/26/2004,," FDA has no questions",11/21/2008," Additional correspondence about intended uses",11/14/2008," Additional correspondence clarifying the subject of the notice",,,,,, =T("148")," Vegetable oil conjugated linoleic acid preparation"," Ingredient in yogurt, milk-based meal replacements, frozen or shelf-stable plate meals (with meat, poultry, or fish as the major ingredient), bars (e.g., protein, breakfast, meal replacement, granola, power), and low-calorie and reduced calorie salad dressings (and similar non-standardized versions of standardized foods), at levels ranging from 0.3 to 3.0 percent conjugated linoleic acid"," Scientific procedures"," Loders Croklaan B. V."," P. O. Box 4, 1520 AA Wormerveer, NETHERLANDS",03/16/2004," GRN 148 (in PDF)",,,,,,,08/31/2004,," At the notifier's request, FDA ceased to evaluate this notice",,,,,,,,=T("232"),, =T("149")," Beta-glucanase enzyme preparation from Trichoderma harzianum"," Use as an enzyme to improve the clarification and filtration of wines"," Scientific procedures"," Novozymes North America Inc."," 77 Perry Chapel Road, Box 576, Franklinton, NC 27525",03/31/2004," GRN 149 (in PDF)",,,,,,,09/27/2004,," FDA has no questions",,,,,,,,,, =T("150")," Glucosamine hydrochloride prepared from chitin obtained from Aspergillus niger"," Use in certain beverages at 0.75 g glucosamine hydrochloride per 8 ounce serving"," Scientific procedures"," Cargill, Inc."," 15407 McGinty Road West, MS110 Wayzata, MN 55391-2399",04/09/2004," GRN 150 (in PDF)",,,,,,,09/09/2004,," At the notifier's request, FDA ceased to evaluate this notice",,,,,,,,,, =T("151")," Ethanol (ethyl alcohol)"," Use as a preservative in the filling used in shelf-stable croissants at a concentration of 3000 ppm"," Scientific procedures"," Frito-Lay, Inc."," 7701 Legacy Drive, Plano, TX 75024",05/14/2004," GRN 151 (in PDF)",,,,,,,10/29/2004,," FDA has no questions",,,,,,,,,, =T("152")," Sodium iron EDTA"," Use in iron fortification of powdered soft drinks in areas of the world with a high prevalence of iron deficiency at a level of 2.5 milligram iron/200 milliliter of reconstituted beverage"," Scientific procedures"," Kraft Foods Global"," Three Lakes Drive, Northfield, IL 60093",06/15/2004," GRN 152 (in PDF)",,,,,,,12/09/2004,," FDA has no questions",,,,,,,,,, =T("153")," Conjugated linoleic acid"," Ingredient in yogurt, meal replacement beverages, meal replacement bars, fruit juices, milk-based fruit drinks, and milk-based beverages at a level of 1680 milligram per serving; in liquid cream substitute, powdered cream substitute, and milk chocolate at a level of 400 milligram per serving"," Scientific procedures"," Cognis Corporation"," 5325 South Ninth Avenue, La Grange, IL 60525-3602",06/15/2004," GRN 153 (in PDF)",,,,,,,08/16/2004,," At the notifier's request, FDA ceased to evaluate this notice",,,,,,,,=T("232"),, =T("154")," Dried orange pulp"," Use in baked goods, pastas, salad dressings, confectionery, processed cheese spreads, non-carbonated beverages and fruit drinks, frozen food entrees, such as frozen doughs, frozen meat products, frozen baked goods, frozen desserts, and frozen dairy products, and meat and poultry products at a maximum use level of 5 percent"," Scientific procedures"," Fiberstar, Inc."," 3023 15th Street, S. W., Willmar, MN 56201",06/21/2004," GRN 154 (in PDF)",,,,,,,12/13/2004,," FDA has no questions",,,,,,,,,, =T("155")," alpha-Cyclodextrin"," Use in selected foods, except meat and poultry, for fiber supplementation, as a carrier or stabilizer for flavors (flavor adjuvant), as a carrier or stabilizer for colors, vitamins and fatty acids and to improve mouthfeel in beverages"," Scientific procedures"," Wacker Chemical Corporation"," 3301 Sutton Road, Adrian, MI 49221-9397",06/30/2004," GRN 155 (in PDF)",,,,,,,12/22/2004,," FDA has no questions",,,,,,,,,, =T("156")," Tomato lycopene extract 6 percent, tomato lycopene extract 1.5 percent, and crystallized tomato lycopene extract"," Ingredient in baked goods, breakfast cereals, cheeses, condiments and relishes, confections, dairy product analogs, frozen dairy desserts, gelatins, puddings and fillings, grain products, gravies and sauces, jams and jellies, meat products, milk products, processed vegetables and vegetable juices, snack foods, soft candies, and soups and soup mixes at a maximum final concentration of lycopene in food of 10 milligrams/kilogram (mg/kg)
Use in medical foods at a level not to exceed 3 mg of lycopene per 100 kilocalories or 36 mg of lycopene per day"," Scientific procedures"," LycoRed Natural Products Industries, Ltd."," P.O. Box 320, Hebron Road, Industrial Zone, Beer-Shiva 84102, ISRAEL",08/11/2004," GRN 156 (in PDF)",,,,,,,02/07/2005,," FDA has no questions; some uses may require a color additive listing",09/15/2010," Additional correspondence about intended use in medical foods",,,,,,,, =T("157")," Calcium propionate (alternative method of manufacture)"," Described in 21 CFR 184.1221"," Scientific procedures"," Solutia Inc."," 575 Maryville Centre Drive, St. Louis, MO 63141",08/13/2004," GRN 157 (in PDF)",,,,,,,12/13/2004,," FDA has no questions",,,,,,,,,, =T("158")," Lipase preparation from Aspergillus niger expressing a gene encoding a lipase from Candida antartica"," Use as an enzyme in the production of triglyceride products"," Scientific procedures"," Novozymes North America Inc."," 77 Perry Chapel Church Road, P. O. Box 576, Franklinton, NC 27525",10/13/2004," GRN 158 (in PDF)",,,,,,,03/16/2005,," FDA has no questions",,,,,,,,,, =T("159")," Carnobacterium maltaromaticum strain CB1"," Used to inhibit the growth of Listeria monocytogenes in ready-to-eat meat products"," Scientific procedures"," Griffith Laboratories"," 1 Griffith Center, Alsip, IL 60803",10/24/2004," GRN 159 (in PDF)",,,,,,,05/27/2005,," FDA has no questions",,,,,,,,," Additional uses in"," GRN 305" =T("160")," Micro-algal oil (Ulkenia sp.)"," For use as a direct food ingredient in the food categories listed in 21 CFR 184.1472(a)(3) at levels that are no more than 40 percent of the levels specified in 21 CFR 184.1472(a)(3) and not to be combined with any other added oil that is a significant source of EPA or DHA"," Scientific procedures"," Nutrinova Nutrition Specialities & Food Ingredients GmbH"," Industriepark Höchst, D 706, 65926 Frankfurt, GERMANY",11/19/2004," GRN 160 (in PDF)",,,,,,,04/01/2005,," At the notifier's request, FDA ceased to evaluate this notice",,,,,,,,=T("319"),, =T("161")," Chlorine dioxide, generated using sodium chlorite in calcined or sulfated kaolin clay"," Used in packaging materials for fresh fruits and vegetables"," Scientific procedures"," Englehard Corporation"," 101 Wood Avenue, Iselin, NJ 08832",12/15/2004," GRN 161 (in PDF)",,,,,,,04/04/2005,," FDA has no questions",,,,,,,,,, =T("162")," Lactoferrin (human) purified from rice"," Ingredient in foods and beverages at levels not to exceed 1000 milligrams (mg)/serving and in medical foods at levels not to exceed 1 mg/milliliter"," Scientific procedures"," Ventria Bioscience"," 4110 N. Freeway Blvd., Sacramento, CA 95834",12/22/2004," GRN 162 (in PDF)",,,,,,,11/16/2006,," At the notifier's request, FDA ceased to evaluate this notice",,,,,,,,,, =T("163")," Tomato pulp powder"," Ingredient in baked goods, ground meat products, meat analogs, dairy products, soups, and sauces
Ingredient in beverages
Use in medical foods at a level not to exceed 3 milligrams (mg) of lycopene per 100 kilocalories or 36 mg of lycopene per day"," Scientific procedures"," LycoRed Natural Products Industries, Ltd."," P.O. Box 320, Hebron Road, Industrial Zone, Beer-Shiva 84102, ISRAEL",02/14/2005," GRN 163 (in PDF)",,,,,,,08/08/2005,," FDA has no questions",09/15/2010," Additional correspondence about intended use in medical foods",01/26/2007," Additional correspondence about intended use in beverages",,,,,, =T("164")," Lauramide arginine ethyl ester"," Antimicrobial ingredient added directly to food, including meat and poultry"," Scientific procedures"," Laboratorios Miret, S.A. (LAMIRSA)"," Polig. Industrial Can Parellada, Geminis, 4, 08228 Terrassa, Barcelona, SPAIN",03/08/2005," GRN 164 (in PDF)",,,,,,,09/01/2005,," FDA has no questions",07/25/2010," Additional correspondence about intended use",,,,,,,, =T("165")," Quillaia extract type 1"," Foaming agent in semi-frozen carbonated and non-carbonated beverages at levels not to exceed 500 milligrams dry weight per killogram beverage"," Scientific procedures"," American Beverage Association"," 1101 16th Street NW, Washington, DC 20036",03/10/2005," GRN 165 (in PDF)",,,,,,,11/09/2005,," FDA has no questions",,,,,,,,,, =T("166")," Carbon monoxide"," Use in water-based brine or marinade for modified atmosphere packaging for red meat products"," Scientific procedures"," Freezing Machines, Inc."," 891 Two Rivers Drive, Dakota Dunes, SD 57049",03/09/2005," GRN 166 (in PDF)",,,,,,,09/29/2005,," At the notifier's request, FDA ceased to evaluate this notice",,,,,,,,,, =T("167")," Carbon monoxide"," Use in modified atmosphere packing for red meat products"," Scientific procedures"," Tyson Foods, Inc."," 2210 Oaklawn Drive Springdale, AR 72765",04/05/2005," GRN 167 (in PDF)",,,,,,,09/29/2005,," FDA has no questions",,,,,,,,,, =T("168")," Poultry protein"," Use as a protein source in finished poultry products of the same species as the extracted protein"," Scientific procedures"," Proteus Industries, Inc."," 21 Great Republic Drive, Gloucester, MA 01930",05/24/2005," GRN 168 (in PDF)",,,,,,,11/18/2005,," FDA has no questions",,,,,,,,,, =T("169")," Bovine globulin"," Ingredient in dairy products, juices/beverages, nutritional bars, snack foods and sports nutrition protein supplements"," Scientific procedures"," Proliant, Inc."," Southeast Oak Tree Court, Ankeny, IA 50021",05/24/2005," GRN 169 (in PDF)",,,,,,,07/19/2005,," At the notifier's request, FDA ceased to evaluate this notice",,,,,,,,=T("234"),, =T("170")," Shrimp-derived chitosan"," Ingredient in food including meat and poultry products"," Scientific procedures"," Primex ehf"," Oskarsgata 7, 580 Siglufjordur, ICELAND",06/03/2005," GRN 170 (in PDF)",,,,,,,10/31/2005,," At the notifier's request, FDA ceased to evaluate this notice",,,,,,,,=T("443"),, =T("171")," Lactobacillus acidophilus, Lactobacillus lactis, and Pediococcus acidilactici"," Antimicrobial to control pathogenic bacteria in meat and poultry products"," Scientific procedures"," Nutrition Physiology Corporation"," 11358 Woods Bay Lane, Indianapolis, IN 46236",06/10/2005," GRN 171 (in PDF)",,,,,,,12/07/2005,," FDA has no questions",09/13/2006," Additional correspondence about intended use",,,,,,,, =T("172")," Isomalto-oligosaccharide"," Ingredient in foods in general, except meat and poultry"," Scientific procedures"," BioNeutra, Inc."," #132 Advanced Technology Center, Edmonton Research Park, 9650-20 Avenue, Edmonton, Alberta T6N 1G1, CANADA",06/21/2005," GRN 172 (in PDF)",,,,,,,10/17/2005,," At the notifier's request, FDA ceased to evaluate this notice",,,,,,,,=T("246"),, =T("173")," Lycopene from Blakeslea trispora"," Ingredient in foods in general, except meat and poultry, at levels ranging from 5-575 parts per million"," Scientific procedures"," Vitatene S.A."," Avda. Saenz de Miera, 50, 24009 Leon, SPAIN",06/22/2005," GRN 173 (in PDF)",,,,,,,12/01/2005,," FDA has no questions; some uses may require a color additive listing",,,,,,,,,, =T("174")," Lysozyme (human) enzyme preparation from rice"," Antimicrobial agent in cheese, processed meats, beer production, and winemaking; ingredient in meal replacements, frozen dairy desserts, yogurt, snack bars, sports beverages, and medical foods"," Scientific procedures"," Ventria Bioscience"," 4110 N. Freeway Blvd., Sacramento, CA 95834",06/28/2005," GRN 174 (in PDF)",,,,,,,09/13/2005,," At the notifier's request, FDA ceased to evaluate this notice",,,,,,,,,, =T("175")," Saccharomyces cerevisiae strain ECMo01 with enhanced expression of urea amidolyase"," Reduction of ethyl carbamate in fermented beverages"," Scientific procedures"," First Venture Technologies Corp."," Suite 1500, 885 West Georgia Street, Vancouver, British Columbia, V6C 3E8, CANADA",07/12/2005," GRN 175 (in PDF)",,,,,,,01/06/2006,," FDA has no questions",,,,,,,,,, =T("176")," Plant sterols and plant sterol esters from vegetable oils or sterols/stanols from tall oil"," Ingredient in margarines and vegetable oil spreads, dressings for salads, beverages, snack bars, dairy analogs (including soy milk, ice cream and cream substitutes), cheese and cream, baked foods, ready-to-eat breakfast cereals, mayonnaise, pasta and noodles, sauces, salty snacks, processed soups, puddings, yogurt, confections, vegetarian meat analogs at a level up to 0.4 gram (g) sterol equivalents per serving; in fruit/vegetable juices at a level up to 1 g sterol equivalents per serving; and in edible vegetable oils, including diacylglycerol oil as a replacement, at a level up to 4 g/100g sterol equivalents per serving"," Scientific procedures"," Archer Daniels Midland Company"," 1001 N. Brush College Road, Decatur, IL 62521",07/14/2005," GRN 176 (in PDF)",,,,,,,01/13/2006,," FDA has no questions",,,,,,,,,, =T("177")," Plant sterol esters"," Ingredient in ground coffee at a level of 1.0 gram per 8 ounce serving of brewed coffee"," Scientific procedures"," Heart Blend Foods LLC"," 14 Silver's Lane, Cranbury, NJ 08512",07/20/2005," GRN 177 (in PDF)",,,,,,,12/20/2005,," FDA has no questions",,,,,,,,,, =T("178")," Sodium iron EDTA"," Iron fortification of soy, fish, hoisin and teriyaki sauces at an iron level of 0.024 percent; and of sweet and sour sauce at an iron level of 0.012 percent"," Scientific procedures"," Akzo Nobel Chemicals"," 525 West Van Buren St., Chicago, IL 60607",07/21/2005," GRN 178 (in PDF)",,,,,,,01/11/2006,," FDA has no questions",,,,,,,,,, =T("179")," Polyglycerol polyricinoleic acid"," Emulsifier in margarines, low fat margarines, spreads, creamers and dairy analogs at levels no greater than 1.0 percent"," Scientific procedures"," Stepan Company"," 22 West Frontage Rd., Northfield, IL 60093",07/25/2005," GRN 179 (in PDF)",,,,,,,01/20/2006,," FDA has no questions",,,,,,,,,, =T("180")," Allyl isothiocyanate"," For use as an antimicrobial agent (in packaged foods)"," Scientific procedures"," Mitsubishi-Kagaku Foods Corporation"," 3-9 Ginza, 1-chome, Tokyo, JAPAN",08/16/2005," GRN 180 (in PDF)",,,,,,,03/16/2006,," FDA has no questions",,,,,,,,,, =T("181")," Phytosterols"," Ingredient in egg products including egg whites and egg substitutes"," Scientific procedures"," Michael Foods, Inc."," 120 Tower Street South, Gaylord, MN 55334",08/23/2005," GRN 181 (in PDF)",,,,,,,03/16/2006,," FDA has no questions",,,,,,,,,, =T("182")," Hydrolyzed wheat gluten isolate; pea protein isolate"," Fining agent in wine making"," Scientific procedures"," Martin Vialatte"," 79, Ave. A. Thevenet BP 1031-Magenta, 51319 Eperney Cedex, FRANCE",10/27/2005," GRN 182 (in PDF)",,,,,,,06/27/2006,," FDA has no questions",,,,,,,,,, =T("183")," Phospholipase A2 enzyme preparation from Aspergillus niger expressing a gene encoding a porcine phospholipase A2"," Use as an enzyme to hydrolyze phospholipids in bread dough, fine bakery wares, and egg yolk-based products"," Scientific procedures"," DSM Food Specialties"," P.O. Box 1, 2600 MA Delft, The NETHERLANDS",11/02/2005," GRN 183 (in PDF)",,,,,,,05/11/2006,," FDA has no questions",11/18/2014," Additional correspondence (in PDF)",,,,,,,, =T("184")," Isomaltulose"," Nutrative sweetener in a variety of food categories and beverages"," Scientific procedures"," SUDZUCKER AG Mannheim/Ochsenfurt"," Gorrlieb-Daimler-Str. 12, D-68165 Mannheim, GERMANY",11/04/2005," GRN 184 (in PDF)",,,,,,,03/20/2006,," FDA has no questions",,,,,,,,,, =T("185")," Concentrated tomato lycopene extract"," Ingredient in non-alcoholic beverages up to a maximum level of 20 parts per million"," Scientific procedures"," San-Ei Gen F.F.I., Inc."," 1-1-11 Sanwa-cho, Toyonaka, Osaka 561-8588, JAPAN",11/30/2005," GRN 185 (in PDF)",,,,,,,05/30/2006,," FDA has no questions; some uses may require a color additive listing",,,,,,,,,, =T("186")," Soy lecithin enzymatically modified to have increased phosphatidylserine"," Ingredient in food in general, except meat and poultry"," Scientific procedures"," Lipogen Products (9000) Ltd."," 60 Harofeh Street, P.O. Box 7687, Haifa, ISRAEL 31076",12/14/2005," GRN 186 (in PDF)",,,,,,,07/20/2006,," FDA has no questions",,,,,,,,,, =T("187")," L(+) Tartaric acid (alternative method of manufacture)"," As described in 21 CFR 184.1099"," Scientific procedures"," S & G Resources, Inc
AND
Changmao Biochemical Engineering Co."," 266 Main street, Medfield, MA 02052
AND
West Chemical Area, Jlangblan Developing Zone, CHINA",12/15/2005," GRN 187 (in PDF)",,,,,,,03/20/2006,," FDA has no questions",,,,,,,,,, =T("188")," Carbon monoxide"," In modified atmosphere packing (MAP) for red meat products at levels of 5.5 milligrams/pound (12 milligrams/kilogram) of packaged meat"," Scientific procedures"," Tyson Foods, Inc."," 2210 Oaklawn Drive, Springdale, Arkansas 72765",12/28/2005," GRN 188 (in PDF)",,,,,,,11/05/2008,," At the notifier's request, FDA ceased to evaluate this notice",,,,,,,,,, =T("189")," Lactoferrin (human) purified from bovine milk"," Ingredient for use in a variety of foods at a level of 100 milligrams per serving"," Scientific procedures"," Pharming Group, N.V."," Archimedesweg 4, 2333 CN Leiden, The NETHERLANDS",01/12/2006," GRN 189 (in PDF)",,,,,,,12/10/2009,," At the notifier's request, FDA ceased to evaluate this notice",,,,,,,,,, =T("190")," Hydroxypropyl methylcellulose"," Use in food in general including meat products"," Scientific procedures"," The Dow Chemical Company"," 171 River Road, Piscataway, NJ 08854",01/17/2006," GRN 190 (in PDF)",,,,,,,04/06/2006,," At the notifier's request, FDA ceased to evaluate this notice",,,,,,,,=T("213"),, =T("191")," Human lysozyme purified from rice"," Ingredient in term infant formulas, pre-term infant formulas, and fortifiers at levels up to 0.3 grams per liter (g/L); and in oral rehydration solutions that are medical foods intended for short-term consumption by children up to three years of age at levels up to 0.2 g/L"," Scientific procedures"," Ventria Bioscience"," 2120 Milestone Drive, Suite 102
Fort Collins, CO 80525",01/26/2006," GRN 191 (in PDF)",,,,,,,03/12/2010,," At the notifier's request, FDA ceased to evaluate this notice",,,,,,,,,, =T("192")," High 2-palmitic vegetable oil"," Use in term infant and pre-term infant formulas; in baby and toddler foods, including meat and poultry products; and in food in general, excluding meat and poultry products"," Scientific procedures"," Enzymotec Ltd."," P.O. Box 6, Migdal HaEmeq, ISRAEL 23106",02/06/2006," GRN 192 (in PDF)",,,,,,,08/03/2006,," FDA has no questions",12/14/2012," Additional correspondence regarding method of manufacture and specifications",,,,,,,, =T("193")," Fish oil (predominantly sardine and anchovy); tuna oil"," Use as direct food ingredients in the food categories listed in 21 CFR 184.1472(a)(3) at levels that are no more than 67 percent of the levels specified in 21 CFR 184.1472(a)(3)"," Scientific procedures"," Peluva Biotech"," Camino de Purchil 66, 18004 Granada, SPAIN",02/07/2006," GRN 193 (in PDF)",,,,,,,08/03/2006,," FDA has no questions",,,,,,,,,, =T("194")," Carbon monoxide"," As a dissolved gas at a concentration of 21.4 milliliters per liter of brine/marinade solution that is injected into beef muscle parts that are vacuum-packed, and prepared for case-ready marketing. The brine/marinade is limited to no more than 27.8 percent by weight of the muscle parts."," Scientific procedures"," Freezing Machines, Inc."," 891 Two Rivers Drive, Dakota Dunes, SD 57049",03/02/2006," GRN 194 (in PDF)",,,,,,,01/25/2012,," FDA has no questions",,,,,,,,,, =T("195")," Mixed beta-Glucanase and xylanase enzyme preparation from Humicola insolens"," Use in the brewing industry as an enzyme for clarifying beer"," Scientific procedures"," Novozymes North America, Inc."," 77 Perry Chapel Church Road, P.O. Box 576, Franklinton, NC 27525",03/03/2006," GRN 195 (in PDF)",,,,,,,09/21/2006,," FDA has no questions",,,,,,,,,, =T("196")," Bovine milk basic protein fraction"," Ingredient in certain foods and beverages at 10 - 40 milligrams per serving"," Scientific procedures"," Snow Brand Milk Products Co., Ltd., AND IAS Co., Ltd."," 13, Honshio-cho, Shinjuku-ku, Tokyo, 160-8575, JAPAN AND IAS Co., Ltd.; 5-1, Kita-Aoyama 2-chome, Minato-ku, Tokyo 107-0061, JAPAN",03/08/2006," GRN 196 (in PDF)",,,,,,,09/01/2006,," FDA has no questions",,,,,,,,,, =T("197")," Phosphatidylserine"," Ingredient in yogurt (excluding fat-free yogurts), powdered milk, ready to drink soymilk, meal replacements, cereal bars, powdered beverage mixes, chewing gum, and breakfast cereals at 20 milligrams per serving"," Scientific procedures"," Degussa Food Ingredients GmbH"," Lise-Meitner-Str. 34, D-85354 Freising, GERMANY",03/24/2006," GRN 197 (in PDF)",,,,,,,09/20/2006,," FDA has no questions",,,,,,,,,, =T("198")," Bacteriophage P100 preparation from Listeria innocua"," Antimicrobial to control Listeria monocytogenes in brie, cheddar, Swiss, and other cheeses that are normally aged and ripened"," Scientific procedures"," EBI Food Safety B.V."," Johan v. Oldenbarneveltlaan 9, 2582 NE Den Haag, The NETHERLANDS",04/20/2006," GRN 198 (in PDF)",,,,,,,10/17/2006,," FDA has no questions",,,,,,,,,, =T("199")," Concentrated hydrolyzed milk protein"," Ingredient in orange juice, yogurt (including yogurt drinks), nutrition bars and margarine spread;Ingredient in hard and soft candies, cereal, cheese, chewing gum, chocolate, cookies, crackers, cranberry juice, energy drinks, frozen dinners, grape juice, ketchup, meal replacements, milk and dairy-based beverages, tea beverages and tomato juice"," Scientific procedures"," Calpis Co. Ltd."," 4-1, 2-chome, Ebisu-minami, Shibuya-ku, Tokyo 150-0022, JAPAN",05/09/2006," GRN 199 (in PDF)",,,,,,,05/11/2007,," FDA has no questions",10/31/2008," Additional correspondence about intended use",,,,,,,, =T("200")," Tailored triglycerides enriched in omega-3 fatty acids from fish oil"," As a direct food ingredient in the food categories listed in 21 CFR 184.1472(a)(3) at levels that are no more than 36 percent of the levels specified in 21 CFR 184.1472(a)(3)"," Scientific procedures"," Twin Rivers Technologies"," 780 Washington St., Quincy, MA 02169",06/01/2006," GRN 200 (in PDF)",,,,,,,11/24/2006,," FDA has no questions",,,,,,,,,, =T("201")," Asparaginase enzyme preparation from Aspergillus oryzae expressing the asparaginase gene from A. oryzae"," As an enzyme for use in reducing asparagine levels in wheat dough-based products such as cookies and crackers, fabricated potato chips, and cut or sliced potato products"," Scientific procedures"," Novozymes North America Inc."," 77 Perry Chapel Church Rd., Box 576, Franklington, NC 27525",06/05/2006," GRN 201 (in PDF)",,,,,,,11/24/2006,," FDA has no questions",,,,,,,,,, =T("202")," Polyoxyethanyl-alpha-tocopheryl sebacate (PTS)"," As a solubilizer for the dietary ingredient coenzyme Q10 in dietary supplements"," Scientific procedures"," Zymes LLC"," 777 Terrace Ave., Hasbrouk Heights, NJ 07604",06/05/2006," GRN 202 (in PDF)",,,,,,,12/06/2006,," FDA has no questions",,,,,,,,,, =T("203")," Erythritol fatty acid esters"," As a surface active agent or microencapsulant in certain foods at the minimum level required to achieve the intended technical effect"," Scientific procedures"," Stepan Company"," 22 West Frontage Rd., Northfield, IL 60093",06/09/2006," GRN 203 (in PDF)",,,,,,,11/15/2006,," At the notifier's request, FDA ceased to evaluate this notice",,,,,,,,=T("297"),, =T("204")," Phospholipase C enzyme preparation from Pichia pastoris expressing a heterologous phospholipase C gene"," As an enzyme in degumming vegetable oils for food use"," Scientific procedures"," Diversa Corporation"," 4995 Directors Place, San Diego, CA 92121",06/09/2006," GRN 204 (in PDF)",,,,,,,12/05/2006,," FDA has no questions",,,,,,,,,, =T("205")," Pullulanase enzyme preparation from Bacillus subtilis expressing the pullulanase gene from B. acidopullulyticus"," As an enzyme in the brewing industry (to hydrolyze 1-6- alpha-D-glucosidic linkages in pullulan, amylopectin, and glycogen)"," Scientific procedures"," Novozymes North America Inc."," 77 Perry Chapel Church Rd., Box 576, Franklington, NC 27525",06/09/2006," GRN 205 (in PDF)",,,,,,,12/04/2006,," FDA has no questions",,,,,,,,,, =T("206")," Phytosterol esters and diglycerides resulting from transesterification of vegetable oils/fats with phytosterols"," Ingredient in baked goods and baking mixes; fats and oils; frozen dairy desserts and mixes; gelatins, puddings, and fillings; grain products and pastas; gravies and sauces; hard candy; milk and milk products; soft candy, soups and soup mixes; and snack foods at a level of 0.65 gram phytosterol esters per serving"," Scientific procedures"," Enzymotec Ltd."," P.O. Box 6, Migdal HaEmeq, ISRAEL, 23106",06/14/2006," GRN 206 (in PDF)",,,,,,,12/07/2006,," FDA has no questions",,,,,,,,,, =T("207")," Barley fiber"," Use in food in general, except for infant formula and meat and poultry products"," Scientific procedures"," Cargill Inc."," 15407 McGinty Road West, Wayzata, MN 55391",06/23/2006," GRN 207 (in PDF)",,,,,,,12/19/2006,," FDA has no questions",,,,,,,,,, =T("208")," Erythritol"," Use in bakery fillings, cakes and cookies, chewing gum, dairy drinks, fat-based cream used in modified fat/calorie cookies, pastries, hard candies, frozen dairy desserts, puddings, reduced and low-calorie beverages, soft candies, sugar substitutes and yogurt as a flavor enhancer, formulation aid, humectant, nutritive sweetener, stabilizer and thickener, sequestrant, and texturizer at varying levels"," Scientific procedures"," Mitsubishi Kagaku-Foods Corporation"," 3-9, Ginza 1-chrome, Chuo-ku, Tokyo 104-0061 JAPAN",08/03/2006," GRN 208 (in PDF)",,,,,,,01/25/2007,11/20/2007," FDA has no questions",,,,,,,,,, =T("209")," L-theanine"," Ingredient in several food categories up to 250 milligrams per serving"," Scientific procedures"," Taiyo International, Inc."," 5960 Golden Hills Drive, Minneapolis, MN 55416",08/09/2006," GRN 209 (in PDF)",,,,,,,02/05/2007,," FDA has no questions",,,,,,,,,, =T("210")," Water soluble tomato concentrate"," Ingredient in yogurt drinks, fruit juices, and fruit flavored drints at 3 grams per serving"," Scientific procedures"," Provexis plc"," 20 Mortlake High Street, London, SW14 8JN, UNITED KINGDOM [Updated in letter dated March 15, 2007]",08/15/2006," GRN 210 (in PDF)",,,,,,,02/08/2007,," FDA has no questions; some uses may require a color additive listing",,,,,,,,,, =T("211")," Xanthan gum (lower pyruvate levels)"," Use in foods in general, excluding meat and poultry products"," Scientific procedures"," CP Kelco"," 8355 Aero Drive, San Diego, CA 92123",08/30/2006," GRN 211 (in PDF)",,,,,,,04/11/2007,," FDA has no questions",,,,,,,,,, =T("212")," Phospholipase A2 enzyme preparation from Streptomyces violaceruber expressing a gene encoding phospholipase A2 from the same species"," Use as a enzyme to hydrolyze soy and egg yolk lecithins"," Scientific procedures"," Nagase ChemteX Corporation"," 2-2-3 Murotani, Nishi-ku, Kobe 651-2241, JAPAN",09/05/2006," GRN 212 (in PDF)",,,,,,,03/22/2007,," FDA has no questions",,,,,,,,,, =T("213")," Hydroxypropyl methylcellulose - expanded substitution pattern (HPMC-ESP)"," Use in food in general, including meat products"," Scientific procedures"," The Dow Chemical Company"," 171 River Road, Piscataway, NJ 08854",09/27/2006," GRN 213 (in PDF)",,,,,,,03/27/2007,," FDA has no questions",,,,,,,=T("190"),,, =T("214")," Asparaginase enzyme preparation from Aspergillus niger expressing the asparaginase gene from A. niger"," As an enzyme to lower free L-asparagine levels in breads, cereal-based products, potato-based products, and reaction flavors"," Scientific procedures"," DSM Food Specialties"," P.O. Box 1, 2600 MA Delft, The NETHERLANDS",10/11/2006," GRN 214 (in PDF)",,,,,,,03/12/2007,," FDA has no questions",02/08/2017," Additional correspondence regarding an additional intended use (in PDF)",05/02/2016," Additional correspondence regarding additional intended uses",,,,,, =T("215")," Actinidia arguta extract"," Ingredient in a variety of food categories"," Scientific procedures"," Efficas, Inc."," 7007 Winchester Circle, Suite 120, Boulder, CO 80301",10/30/2006," GRN 215 (in PDF)",,,,,,,09/27/2007,," FDA has no questions",,,,,,,,,, =T("216")," Lipase enzyme preparation from Rhizopus oryzae"," As an enzyme to produce tailored triglycerides for use in infant formula"," Scientific procedures"," Amano Enzyme Inc."," 2-7, 1-Chome, Nishiki, Naka-ku, Nagoya, 460-8630, JAPAN",11/27/2006," GRN 216 (in PDF)",,,,,,,05/18/2007,," FDA has no questions",,,,,,,,,, =T("217")," Tailored triglycerides containing approximately 12 percent medium-chain fatty acids"," Oil used in cooking, salad dressings, vegetable oil spreads, and frozen dinners"," Scientific procedures"," The Nisshin OilliO Group USA, Inc."," 120 Charlotte Place, Mid Level, Englewood Cliffs, NJ 07632",12/21/2006," GRN 217 (in PDF)",,,,,,,08/20/2007,," FDA has no questions",,,,,,,,,, =T("218")," Bacteriophage P100 preparation from Listeria innocua"," For use as an antimicrobial processing aid to control of Listeria monocytogenes in foods in general, including meat and poultry products, at levels up to 109 plaque forming units per gram"," Scientific procedures"," EBI Food Safety B.V."," Johan v. Oldenbarneveltlaan 9, 2582 NE Den Haag, The NETHERLANDS",12/27/2006," GRN 218 (in PDF)",,,,,,,06/22/2007,," FDA has no questions",,,,,,,,,, =T("219")," Ammonium phosphatide"," As an emulsifier in chocolate and vegetable fat coatings at levels up to 0.7%"," Scientific procedures"," Palsgaard A/S"," Palsgaardvej 10, 7130 Juelsminde, DENMARK",01/03/2007," GRN 219 (in PDF)",,,,,,,06/29/2007,," FDA has no questions",,,,,,,,,, =T("220")," alpha-Glycosyl isoquercitrin"," As an antioxidant in multiple food categories at 150 milligrams per kilogram (mg/kg) and in chewing gum at 1500 mg/kg"," Scientific procedures"," San-Ei Gen F.F.I., Inc."," 1-1-11 Sanwa-cho, Toyonaka, Osaka 561-8588, JAPAN",04/03/2007," GRN 220 (in PDF)",,,,,,,11/19/2007,," FDA has no questions",,,,,,,,,, =T("221")," Suspended lutein"," Ingredient in term infant formula at a maximum level of 250 micrograms/liter"," Scientific procedures"," Kemin Health, L.C."," 600 E. Court Avenue, Suite A, Des Moines, IA 50309",04/11/2007," GRN 221 (in PDF)",,,,,,,10/23/2007,," FDA has no questions; some uses may require a color additive listing",,,,,,,,,, =T("222")," Citric acid esters of mono- and diglycerides"," As an emulsifier in combination with lauramide ethyl ester in food in general, including meat and poultry"," Scientific procedures"," Laboratorios Miret S.A. (LAMIRSA)"," Polig. Industrial Can Parellada, Geminis, 4, 08228 Terrassa, Barcelona, SPAIN",05/01/2007," GRN 222 (in PDF)",,,,,,,12/20/2007,," FDA has no questions",,,,,,,,,, =T("223")," Phosphatidylserine"," Ingredient in milk, flavored milk, milk drinks (excluding milk, fluid), milk imitation (soy milk), milk-based meal replacement , yogurt, breakfast bars, and fruit flavored drink at levels of 100 milligrams (mg) phosphatidylserine per serving and in breakfast cereals and milk, fluid at 50 mg/serving"," Scientific procedures"," Enzymotec Ltd."," P.O. Box 6, Migdal HaEmeq, ISRAEL, 23106",05/22/2007," GRN 223 (in PDF)",,,,,,,12/20/2007,," FDA has no questions",,,,,,,,,, =T("224")," trans-Resveratrol"," Ingredient in bottled water products at levels up to 10 milligrams per liter"," Scientific procedures"," ATLA Holdings, LLC"," 75 Fifth Street, NW, Suite 325, Atlanta, GA 30308",05/22/2007," GRN 224 (in PDF)",,,,,,,08/01/2007,," At the notifier's request, FDA ceased to evaluate this notice",,,,,,,,,, =T("225")," Catechins from green tea extract"," Ingredient in beverages, including bottled teas, sport drinks, carbonated soft drinks and juice, at levels according to current good manufacturing practices"," Scientific procedures"," Kao Corporation"," 2-1-3 Bunka Sumida-ku, Tokyo 131-8501 JAPAN",05/24/2007," GRN 225 (in PDF)",,,,,,,11/26/2007,," At the notifier's request, FDA ceased to evaluate this notice",,,,,,,,=T("259"),, =T("226")," Lecithin derived from krill"," Ingredient in breakfast bars at a level of 3.8 per cent, dairy product analogs (soy products) and milk-based beverages at a level of 0.6 per cent, fat spreads at a level of 10 per cent, yogurt at a level of 0.7 per cent, and soft candy at a level of 3.3 per cent"," Scientific procedures"," Enzymotec Ltd."," P.O. Box 6, Migdal HaEmeq, ISRAEL, 23106",05/31/2007," GRN 226 (in PDF)",,,,,,,01/03/2008,," FDA has no questions",,,,,,,,,, =T("227")," Olestra"," Use as a total replacement for fats and oils in pre-packaged, ready-to-eat cookies"," Scientific procedures"," The Procter & Gamble Company"," Beckett Ridge Technical Center, 8611 Beckett Road, West Chester, OH 45069",06/27/2007," GRN 227 (in PDF)",,,,,,,10/09/2008,," FDA has no questions",,,,,,,,,, =T("228")," Sodium nitrite embedded on one side of a food packaging film at a maximum level of 113 milligrams per square meter"," Use in maintaining the characteristic color of raw ground beef and raw whole muscle cuts of beef when vacuum packaged in the film"," Scientific procedures"," Bemis Company, Inc"," One Neenah Center, 4th floor, P.O. Box 669, Neenah, WI 54957",07/10/2007," GRN 228 (in PDF)",,,,,,,07/26/2010,," FDA has no questions",05/31/2011," Additional correspondence about intended use",,,,,,,, =T("229")," Methylsulfonylmethane"," Ingredient in meal supplement and meal replacement foods, fruit smoothie-type drinks and fruit-flavored thirst quencher-type beverages at levels up to 4000 milligrams per kilogram (mg/kg); and in food bars such as granola bars and energy-type bars at levels up to 30,000 mg/kg"," Scientific procedures"," Bergstrom Nutrition"," 1000 West Eighth Street, Vancouver, WA 98660",07/25/2007," GRN 229 (in PDF)",,,,,,,02/18/2008,," FDA has no questions",02/27/2017," Additional correspondence regarding a specification change (in PDF)",,,,,,,, =T("230")," Chymosin enzyme preparation from Trichoderma reesei expressing the bovine prochymosin B gene"," As an enzyme for milk coagulation during cheese making"," Scientific procedures"," Genencor, a Danisco Division"," 200 Meridian Centre Boulevard, Rochester, NY 14618-3916",07/27/2007," GRN 230 (in PDF)",,,,,,,02/19/2008,04/30/2008," FDA has no questions",,,,,,,,,, =T("231")," Lactobacillus casei subsp. rhamnosus strain GG"," Ingredient in term infant formula, at levels not to exceed 108 colony forming units per gram of powdered formula"," Scientific procedures"," Mead Johnson & Company"," 2400 W. Lloyd Expressway, Evansville, Indiana 47721-0001",08/09/2007," GRN 231 (in PDF)",,,,,,,05/29/2008,," FDA has no questions",,,,,,,,,, =T("232")," Conjugated linoleic acid isomers"," Ingredient in certain specified foods within the general categories of soy milk, meal replacement beverages and bars, milk products and fruit juices at levels not to exceed 1.5 grams per serving"," Scientific procedures"," Lipid Nutrition B.V. and Cognis GmbH"," P.O.Box 4, 1520 AA, Wormerveer, The NETHERLANDS and Rheinpromenade 1, 40789 Monheim, GERMANY",08/13/2007," GRN 232 (in PDF)",,,,,,,07/11/2008,," FDA has no questions",09/08/2009," Additional correspondence about intended use",,,,,=T("153"),,, =T("233")," Combination of galacto-oligosaccharides and polydextrose"," Ingredient in milk-based term infant formula at levels not to exceed 2 grams per liter (g/L) for galacto-oligosaccharides and 2 g/L for polydextrose"," Scientific procedures"," Mead Johnson & Company"," 2400 W. Lloyd Expressway, Evansville, Indiana 47721-0001",09/05/2007," GRN 233 (in PDF)",,,,,,,09/04/2009,," FDA has no questions",,,,,,,,,, =T("234")," Bovine globulin"," Ingredient in dairy foods, juices, snack foods, beverages and meal replacements at maximum levels of 5 per cent of the finished product"," Scientific procedures"," Proliant Health Ingredients Inc."," 2425 Oak Tree Court, Ankeny, Iowa 50021",09/17/2007," GRN 234 (in PDF)",,,,,,,02/14/2008,," At the notifier's request, FDA ceased to evaluate this notice",,,,,,,=T("169"),=T("255"),, =T("235")," Human lactoferrin purified from rice"," Ingredient in oral rehydration solutions that are medical foods intended for short-term consumption by children less than five years of age at levels up to one gram per liter of solution"," Scientific procedures"," Ventria BioScience"," 2120 Milestone Drive, Suite 102
Fort Collins, CO 80525",10/19/2007," GRN 235 (in PDF)",,,,,,,03/12/2010,," At the notifier's request, FDA ceased to evaluate this notice",,,,,,,,,, =T("236")," Galacto-oligosaccharides"," Ingredient in term infant formula at a level of 5 grams (g) per liter, and in bars, yogurt, frozen dairy desserts, fruit drinks and energy drinks, fitness water and thirst quenchers, fruit pie filling, fruit preparation, jelly and jam, baby juice, baby yogurt drink, baby dessert, baby snack, milk, milk drinks, syrup flavorings for milk, meal replacement drinks, meal replacement drinks for children, and milk substitutes at levels ranging from 1 to 7.5 g per serving"," Scientific procedures"," Friesland Foods Domo"," P.O. Box 499 8000 AK Zwolle, The NETHERLANDS",11/07/2007," GRN 236 (in PDF)",,,,,,,07/28/2008,," FDA has no questions",04/24/2014," Additional correspondence about manufacturing process",,,,,,,, =T("237")," Alkyl polyglycosides"," Use in the cleaning of foods, including fruits, vegetables, meat, and poultry products"," Scientific procedures"," Cognis Corporation"," 5051 Estecreek Drive, Cincinnati, OH 45232",12/19/2007," GRN 237 (in PDF)",,,,,,,10/14/2008,," FDA has no questions",,,,,,,,,, =T("238")," Lipase enzyme preparation derived from Hansenula polymorpha expressing a gene encoding a lipase from Fusarium heterosporum"," As an enzyme to modify lipids in dough for bakery and noodle applications, in egg yolks for bakery applications and mayonnaise production, and in the refining process of soy bean oil"," Scientific procedures"," Genencor, a Danisco Division"," 925 Page Mill Road, Palo Alto, CA 94304",12/27/2007," GRN 238 (in PDF)",,,,,,,07/28/2008,," FDA has no questions",,,,,,,,,, =T("239")," Bakers yeast beta-glucan"," Ingredient in a variety of food products including baked goods and baking mixes, beverages and beverage bases, cereals and cereal products, dairy product analogs, milk and milk products, plant protein products, processed fruits and fruit juices, soft candy, soups and soup mixes at a level of up to 200 milligrams per serving"," Scientific procedures"," Biothera, Inc."," Healthcare Group; 3388 Mike Collins Drive, Eagan, MN 55121",01/24/2008," GRN 239 (in PDF)",,,,,,,07/22/2008,," FDA has no questions",,,,,,,,,, =T("240")," Corn, cane, or beet sugar cultured with Lactobacillus paracasei subsp. paracasei, Bacillus coagulans LA-1, or Propionibacterium freudenreichii subsp. shermanii, or mixtures of these microorganisms"," Use as an antimicrobial agent in meat and poultry products at a level of 4.8 percent"," Scientific procedures"," PURAC"," Arkelsedijk 46, P.O.Box 21, 4200 AA Gorinchem, The NETHERLANDS",01/28/2008," GRN 240 (in PDF)",,,,,,,10/24/2008,," FDA has no questions",,,,,,,,,, =T("241")," High-selenium yeast"," Ingredient in baked products, non-alcoholic beverages, breakfast cereals, grain products and pastas, milk products, processed fruits/fruit juices, processed vegetables/ vegetables juices, commercial soups and soup mixes and medical foods as a source of selenium at levels yielding 5 micrograms selenium per serving"," Scientific procedures"," Cypress Systems, Inc."," 3381 North Bond Avenue, Suite 101, Fresno, CA 93726",01/30/2008," GRN 241 (in PDF)",,,,,,,04/09/2008,," At the notifier's request, FDA ceased to evaluate this notice",,,,,,,,=T("260"),, =T("242")," Krill oil"," Use as a direct food ingredient in breakfast cereals, cheese, beverages (nonalcoholic), fruit juices, frozen dairy desserts, milk products, and medical foods at levels up to 500 milligrams per serving"," Scientific procedures"," Neptune Technologies and Bioressources"," 2740 Pierre Peladeau Avenue, Suite H200, Laval (Quebec), H7T 3B3, CANADA",02/04/2008," GRN 242 (in PDF)",,,,,,,10/14/2008,," FDA has no questions; some uses may require a color additive listing",,,,,,,,,, =T("243")," D-Ribose"," Ingredient in several food categories provided that D-ribose is used in conjunction with an additional carbohydrate energy source"," Scientific procedures"," Bioenergy, Inc."," 13840 Johnson St. NE Ham Lake, Minnesota 55304",02/08/2008," GRN 243 (in PDF)",,,,,,,11/10/2008,," FDA has no questions",,,,,,,=T("100"),,, =T("244")," Glutathione"," Ingredient in several food categories, including meat products, at levels ranging from 5 to 300 milligrams per serving; and in milk- and soy-based infant formula at levels up to 0.167 grams per 100 milliliters"," Scientific procedures"," Kohjin Co., Ltd."," 1-21, Nihombashi Muromachi 4 Chome, Chou-ku, Tokyo, 103-0022, JAPAN",02/14/2008," GRN 244 (in PDF)",,,,,,,05/09/2008,," At the notifier's request, FDA ceased to evaluate this notice",,,,,,,,=T("293"),, =T("245")," Menaquinone-7"," As a nutrient supplement in dairy products, margarine substitutes, and dairy products including yoghurt, cottage cheese, hard cheeses, milk drinks and substitute products at levels up to 50 micrograms per day"," Scientific procedures"," NattoPharma ASA"," Lysaker Torg 5, PO Box 397 Lysaker, NO-1326 Lysaker, NORWAY",04/02/2008," GRN 245 (in PDF)",,,,,,,06/02/2008,," At the notifier's request, FDA ceased to evaluate this notice",,,,,,,,,, =T("246")," Isomalto-oligosaccharide mixture"," Use in a variety of foods, including meat products, at maximum levels ranging from 1.5 to 15 grams per serving"," Scientific procedures"," BioNeutra Inc."," 9419-20th Avenue, Edmonton, Alberta T6N 1E5, CANADA",04/04/2008," GRN 246 (in PDF)",,,,,,,02/10/2009,," FDA has no questions",06/01/2016," Additional correspondence",,,,,=T("172"),,, =T("247")," Modified gum acacia"," Use as an emulsifier in icings, salad dressings, sauces, pure fruit juices (100 percent), select fruit flavored drinks, select beverages, select breads (whole grain and high fiber breads), and select cereals (low fat, low sugar and high fiber health foods) at levels from 350 to 10,000 milligrams per kilogram"," Scientific procedures"," TIC Gums, Inc."," 4609 Richlynn Drive, Belcamp, MD 21017",04/09/2008," GRN 247 (in PDF)",,,,,,,10/07/2008,," FDA has no questions",,,,,,,,,, =T("248")," Sucrose fatty acid esters (i.e., sucrose monoesters of lauric acid, palmitic acid, and stearic acid) manufactured by reaction of sucrose with vinyl esters of lauric, palmitic, and stearic acids"," Use as emulsifiers in fruit-flavored beverages and beverage concentrates, at levels up to 50 milligrams per Liter as consumed"," Scientific procedures"," Compass Foods Pte Ltd"," 12 Tuas Avenue 1, 639497, SINGAPORE",04/10/2008," GRN 248 (in PDF)",,,,,,,10/24/2008,," FDA has no questions",,,,,,,,,, =T("249")," Synthetic dihydrocapsiate"," Ingredient to provide 1 milligram of capsiate per standard serving in the following food categories: meal replacement and yogurt beverages (low calorie); tea (sugar free); fruit juice; vegetable juice; fruit-ades, drinks and powders (low calorie); beverage concentrates (low calorie); beverage soft drinks (sugar free); non-carbonated water (low calorie); 'energy' drinks; yogurt (plain, vanilla, fruit, chocolate (non- and low fat)); oatmeal (instant, low sugar); chewing gum (sugarless); mints (dietetic, low calorie); breakfast and meal replacement bars; gelatin/puddings (low calorie); salad dressings (low calorie), sweeteners (low calorie); snack foods (popped popcorn, low fat popcorn, fat free popcorn, popped and puffed rice); frozen desserts - light (ice pops and fruit bars); frozen desserts - light (dairy); ready to eat meals - frozen diet (excludes meat and poultry); ready to eat meals - soup; nutritional meal - (e.g., Ensure)"," Scientific procedures"," SRA International Inc."," 5235 Ragged Point Road, Cambridge, MD 21613-3518",04/22/2008," GRN 249 (in PDF)",,,,,,,03/09/2009,," FDA has no questions",,,,,,,,,, =T("250")," Plant sterols and stanols from pine trees"," Ingredient in multiple food categories including margarine and vegetable based spreads, yogurt and yogurt-like products, milk-based juice beverages, ice cream and non-standardized ice cream products, cream cheese and cream cheese-like products, snack bars, salad dressings, standardized and non-standardized bread products, baked foods, beverages, dairy analogs, cheeses and cream, breakfast cereals, mayonnaise, pasta and noodles, sauces, salty snacks, processed soups, puddings, confections, vegetarian meat analogs, fruit/vegetable juices, vegetable oils, egg products, including egg whites and substitute egg products"," Scientific procedures"," Arboris LLC"," 1201 W. Lathrop Avenue, Gate 16, Savannah GA, 31415",05/05/2008," GRN 250 (in PDF)",,,,,,,02/09/2009,," FDA has no questions",,,,,,,,,, =T("251")," Carbon monoxide"," At a concentration of 0.4% as a component of a modified atmosphere packaging system for fresh ground and muscle red meat"," Scientific procedures"," Vincent Mercogliano"," 8310 Shorecrest Drive, Fort Meyers, FL 33912",05/08/2008," GRN 251 (in PDF)",,,,,,,01/25/2012,," FDA has no questions",,,,,,,,,, =T("252")," Rebaudioside A purified from Stevia rebaudiana (Bertoni) Bertoni"," As a sweetener in a variety of food categories, and as a table top sweetener, formulated to provide 30 milligrams of rebaudioside A per gram of finished product"," Scientific procedures"," Whole Earth Sweetener Company LLC (a wholly owned subsidiary of Merisant Company)"," 33 N. Dearborn, Suite 200, Chicago, IL 60602",05/13/2008," GRN 252 (in PDF)",,,,,,,12/17/2008,," FDA has no questions",,,,,,,,,, =T("253")," Rebaudioside A purified from Stevia rebaudiana (Bertoni) Bertoni"," As a general-purpose sweetener in foods, excluding meat and poultry products, provided that food standards of identity do not preclude such use, at levels determined by current good manufacturing practices"," Scientific procedures"," Cargill, Inc."," 15407 McGinty Road W, Wayazata, MN 55345",05/20/2008," GRN 253 (in PDF)",,,,,,,12/17/2008,," FDA has no questions",,,,,,,,,, =T("254")," Lactobacillus reuteri strain DSM 17938"," Ingredient in processed cheeses, yogurt, ice cream, fruit juices, fruit drinks, processed vegetables, processed vegetable drinks, beverage bases, energy bars, energy drinks, and chewing gum at a level up to 109 colony forming units (cfu) per serving, and in a drinking straw at a level of 109 cfu per straw"," Scientific procedures"," BioGaia AB"," P.O. Box 3242, Kungsbroplan 3B; SE-103 64 Stockholm, SWEDEN",05/29/2008," GRN 254 (in PDF)",,,,,,,11/18/2008,," FDA has no questions",,,,,,,,,, =T("255")," Bovine globulin"," Ingredient in dairy foods, fruit juices, vegetable juices, snack foods, beverages, and meal replacement products at a maximum use level not exceeding 50 grams per kilogram (5 percent) in the finished food"," Scientific procedures"," Proliant Health Ingredients, Inc."," 2425 Oak Tree Court, Ankeny, Iowa 50021",06/09/2008," GRN 255 (in PDF)",,,,,,,12/24/2008,," FDA has no questions",,,,,,,=T("234"),,, =T("256")," High linolenic acid flaxseed oil"," Ingredient in a variety of categories"," Scientific procedures"," Polar Foods, Inc."," P.O. Box 293 Fisher Branch, Manitoba R0C 0Z0, CANADA",06/10/2008," GRN 256 (in PDF)",,,,,,,01/16/2009,," FDA has no questions",,,,,,,,,, =T("257")," gamma-Amino butyric acid"," Ingredient in beverages and beverage bases, chewing gum, ready-to-drink coffee and tea products, and candy at levels ranging from 0.04% to 4%"," Scientific procedures"," Pharma Foods International Co., Ltd."," 1-49 Goryo-Ohara, Nishikyo-Ku, Kyoto, 615-8245, JAPAN",08/11/2008," GRN 257 (in PDF)",,,,,,,12/22/2008,," At the notifier's request, FDA ceased to evaluate this notice",,,,,,,,,, =T("258")," Sucromalt"," As a nutritive sweetener in baked goods, non-alcoholic beverages, alcoholic beverages, breakfast cereals, chewing gum, condiments and relishes, confectionery and frostings, frozen dairy, fruit ices, gelatins and puddings, hard candy, dairy products and non-dairy analogs, jams and jellies, milk, milk products, processed fruits and fruit juices, snack foods, soft candy, sweet sauce, and salad dressings at use levels of 1.5% to 85%"," Scientific procedures"," Cargill, Inc."," 15407 McGinty Road W, Wayazata, MN 55345",09/08/2008," GRN 258 (in PDF)",,,,,,,02/03/2009,," FDA has no questions",,,,,,,,,, =T("259")," Catechins from green tea extract"," Ingredient in bottled teas, sport drinks, carbonated soft drinks and juices at levels up to 540 milligrams per serving"," Scientific procedures"," Kao Corporation"," 2-1-3 Bunka Sumida-ku, Tokyo, 131-8501, JAPAN",09/08/2008," GRN 259 part 1 (in PDF)"," GRN 259 part 2 with amendments (in PDF)",,,,,,08/21/2009,," At the notifier's request, FDA ceased to evaluate this notice",,,,,,,=T("225"),,, =T("260")," High-selenium yeast"," Ingredient in baked products, non-alcoholic beverages, breakfast cereals, grain products and pastas, milk products, processed fruit and fruit juices, processed vegetables and vegetable juices, commercial soups and soup mixes, and medical foods at levels yielding 5 micrograms selenium per serving"," Scientific procedures"," Cypress Systems, Inc."," Cypress Systems, Inc.; 3381 North Bond Avenue, Suite 101, Fresno, CA 93726",09/12/2008," GRN 260 (in PDF)",,,,,,,03/09/2009,," FDA has no questions",,,,,,,=T("241"),,, =T("261")," Oat hull fiber"," Use (1) as an ingredient in bread/pizza crust, cookies/crackers/bars, cereal (hot and cold), baby food cereal, and snacks (fried and baked) at levels ranging from 5 percent to 14 percent by weight; (2) as an ingredient in breaders and batters applied in coating onto meat and poultry at levels ranging from 2 percent by weight of the total food system (breaded or coated meats) to 5 percent by weight of the dry coating system (breader and batter); and (3) as an extender in meat products at levels ranging from 3 percent to 5 percent"," Scientific procedures"," Grain Millers, Inc."," 315 Madison Street, Eugene, OR 97402",09/22/2008," GRN 261 (in PDF)",,,,,,,02/03/2009,," FDA has no questions",10/14/2016," Additional correspondence",,,,,,,, =T("262")," Sweet lupin protein"," Ingredient in baked goods and baking mixes, dairy product analogs, frozen dairy desserts and mixes, gelatins, puddings, and fillings, jams and jellies, meat products, milk products and soft candy at levels ranging from 1 to 20 per cent"," Scientific procedures"," George Weston Foods Ltd."," 1 Braidwood Street, Enfield, NSW, 2136, AUSTRALIA",10/08/2008," GRN 262 (in PDF)",,,,,,,12/16/2008,," At the notifier's request, FDA ceased to evaluate this notice",,,,,,,,,, =T("263")," Sweet lupin fiber"," Ingredient in baked goods and baking mixes, beverages and beverage bases, breakfast cereals, jams and jellies, processed fruits and fruit juices and soft candy at levels ranging from 1 to 20 per cent"," Scientific procedures"," George Weston Foods Ltd."," 1 Braidwood Street, Enfield, NSW, 2136, AUSTRALIA",10/08/2008," GRN 263 (in PDF)",,,,,,,12/16/2008,," At the notifier's request, FDA ceased to evaluate this notice",,,,,,,,,, =T("264")," Sweet lupin flour"," Ingredient in baked goods and baking mixes and grain products and pastas at a maximum level of 25 per cent"," Scientific procedures"," George Weston Foods Ltd."," 1 Braidwood Street, Enfield, NSW, 2136, AUSTRALIA",10/08/2008," GRN 264 (in PDF)",,,,,,,12/16/2008,," At the notifier's request, FDA ceased to evaluate this notice",,,,,,,,,, =T("265")," Glycerophospholipid cholesterol acyltransferase (GCAT) enzyme preparation from Bacillus licheniformis expressing a modified GCAT gene from Aeromonas salmonicida subsp. salmonicida"," As an enzyme to modify phospholipids to lyso-phospholipids and cholesterol ester in egg yolks to avoid product separation during mayonnaise production; processed meat products for emulsification, better consistency, and reduced cooking loss; cheese for increased yield; eggs to give a softer and more tender crumb in bakery products, and degumming of vegetable oils

As an enzyme in the production of ultra-high temperature processed milk, powdered milk, and yogurt at concentrations ranging from 0.38 to 1.5 milligrams total organic solids per kilogram of food"," Scientific procedures"," Genencor, a Danisco Division"," Genencor, a Danisco Division
925 Page Mill Road
Palo Alto, CA 94304",11/07/2008," GRN 265 (in PDF)",,,,,,,06/13/2009,," FDA has no questions",07/15/2010," Additional correspondence about intended use",,,,,,,, =T("266")," Polyglycerol polyricinoleate"," As an emulsifier in chocolate-type products based on vegetable fats other than cocoa butter, at levels up to 0.3 percent and in accordance with good manufacturing practices"," Scientific procedures"," Palsgaard A/S"," Palsgaardvej 10
7130 Juelsminde
DENMARK",11/14/2008," GRN 266 (in PDF)",,,,,,,05/29/2009,," FDA has no questions",,,,,,,,,, =T("267")," Protein glutaminase enzyme preparation derived from Chryseobacterium proteolyticum"," As an enzyme to deamidate vegetable proteins (cereal, soy, and pea), milk proteins, and yeast proteins; and, to deamidate proteins in baked goods, dairy foods such as yogurt, cheese, and ice-cream, egg-based foods such as mayonnaise, and cakes"," Scientific procedures"," Amano Enzyme, Inc."," 2-7, 1-Chome, Nishiki, Naka-ku, Nagoya 460-8630, JAPAN",11/14/2008," GRN 267 (in PDF)",,,,,,,07/15/2009,," FDA has no questions",,,,,,,,,, =T("268")," Bifidobacterium longum strain BB536"," Ingredient in breads/baked goods, cereals, dairy products/dairy-based foods and dairy substitutes, fruit products, candy, chewing gum, cocoa powder, condiment sauces, flavored beverage syrups, fruit flavored powder beverage mixes, gelatin desserts, gravies, margarine, peanut and other nut butter/spreads, snack foods, weaning foods at a maximum level of 1x1010 colony forming units (cfu) per serving and in milk based powdered infant formula at a level of 1x1010 cfu per gram of infant formula powder that is intended for consumption for term infants aged 9 months and older"," Scientific procedures"," Morinaga Milk Industry Co., Ltd"," 33-1, Shiba 5-Chome, Minato-ku, Tokyo 108-8384, JAPAN",11/21/2008," GRN 268 (in PDF)",,,,,,,07/08/2009,," FDA has no questions",,,,,,,,,, =T("269")," Polyglycerol fatty acid esters with a degree of polymerization of 11 to 40 for the polyglycerol backbone"," As emulsifiers at levels ranging from 0.05 - 0.5 per cent in conventional food and zinc- or iron-providing dietary supplements, and as cloud inhibitors at levels ranging from 0.05 - 0.5 per cent in vegetable oils and salad oils"," Scientific procedures"," Taiyo-Kagaku Co., Ltd."," 800 Yamada-Cho, Yokkaichi, Mie 512-1111, JAPAN",11/25/2008," GRN 269 (in PDF)",,,,,,,05/21/2009,," FDA has no questions",,,,,,,,,, =T("270")," Polyglycerol polyricinoleic acid"," As an emulsifier in the formulation of color additives, intended for use in processed foods for which colors are permitted, with limitation based on good manufacturing practices"," Scientific procedures"," Stepan Company"," 22 West Frontage Road, Northfield, IL 60093",12/03/2008," GRN 270 (in PDF)",,,,,,,06/15/2009,," FDA has no questions",,,,,,,,,, =T("271")," Ferrous ammonium phosphate"," Use in various food categories as a source of dietary iron for food enrichment and fortification purposes consistent with iron supplementation guidelines"," Scientific procedures"," Nestle USA, Inc."," 800 North Brand Boulevard, Glendale, CA 91203-1244",12/12/2008," GRN 271 (in PDF)",,,,,,,05/29/2009,," FDA has no questions",,,,,,,,,, =T("272")," Triple salt of magnesium, ammonium, and potassium chloride, hexahydrate"," As a substitute for a portion of the sodium chloride used in food in general, including meat, poultry, and egg products, but excluding infant formula"," Scientific procedures"," Smart Salt, Inc."," 1261 Prospect Street, Suite 9
La Jolla, CA 92037",12/18/2008," GRN 272 (in PDF)",,,,,,,06/24/2009,," FDA has no questions",,,,,,,,,, =T("273")," Baobab (Adansonia digitata) dried fruit pulp"," Ingredient in blended fruit drinks and fruit cereal bars at levels up to 10 percent and 15 percent, respectively"," Scientific procedures"," Cyril Lombard/PhytoTrade Africa"," 5 Calvert Avenue
London E2 7JP
UNITED KINGDOM
[Updated in letter dated October 10, 2012]",12/19/2008," GRN 273 (in PDF)",,,,,,,07/25/2009,," FDA has no questions",09/05/2013," Additional correspondence about intended use",,,,,,,, =T("274")," Branching glycosyltransferase enzyme preparation from Bacillus subtilis expressing a branching glycosyltransferase gene from Rhodothermus obamensis"," As an enzyme in the starch industry to obtain dextrins with improved physical properties, such as higher solubility, lower viscosity, and reduced retrogradation"," Scientific procedures"," Novozymes North America, Inc."," 77 Perry Chapel Church Rd.
Box 576
Franklinton, NC  27525",12/30/2008," GRN 274 (in PDF)",,,,,,,06/25/2009,," FDA has no questions",,,,,,,,,, =T("275")," Purified steviol glycosides with rebaudioside A as the principal component"," As a tabletop sweetener"," Scientific procedures"," McNeil Nutritionals, LLC"," 601 Office Center Drive
Fort Washington, PA
19034",01/02/2009," GRN 275 (in PDF)",,,,,,,06/11/2009,," FDA has no questions",,,,,,,,,, =T("276")," Dunaliella bardawil alga"," Ingredient in the following foods: dairy products, cakes, mayonnaise and salad oils, pudding and custards, crackers and cookies, wheat noodles, bread/rolls, tofu, Kimchi and fermented soybean products"," Scientific procedures"," Nikken Sohonsha Corporation"," 1-32 Asahira, Fukuju-cho, Gifu-Pref 501-6255 Hashima-city, JAPAN",01/02/2009," GRN 276 (in PDF)",,,,,,,03/06/2009,," At the notifier's request, FDA ceased to evaluate this notice",,,,,,,,=T("351"),, =T("277")," Maltotetraohydrolase enzyme preparation from Bacillus licheniformis expressing a modified maltotetraohydrolase gene from Pseudomonas stutzeri"," As an enzyme in bread and other baked goods to delay the staling process"," Scientific procedures"," Genencor, a Danisco Division"," 925 Page Mill Road, Palo Alto, CA 94304",01/13/2009," GRN 277 (in PDF)",,,,,,,05/15/2009,," FDA has no questions",,,,,,,,,, =T("278")," Rebaudioside A purified from the leaves of Stevia rebaudiana (Bertoni) Bertoni"," As a sweetener in baked products, beverages (non-alcoholic), breakfast cereals, coffee and tea, confections and frostings, dairy product analogs, fats and oils, frozen dairy desserts, fruit and water ices, milk (whole and skim), milk products, processed fruits and fruit juices, processed vegetables and vegetable juices, snack foods, soft candy, sugar substitutes, sweet sauces, toppings and syrups, meal replacement food products, and medical foods at levels determined by good manufacturing practices, as well as use as a table top sweetener"," Scientific procedures"," Blue California"," 30111 Tomas, Rancho Santa Margarita, CA 92688",01/22/2009," GRN 278 (in PDF)",,,,,,,07/20/2009,," FDA has no questions",,,,,,,,,, =T("279")," Phosphatidylserine derived from fish"," Ingredient in breakfast cereals, dairy product analogs, grain products and pastas, milk products, and processed fruits and fruit juices at levels intended to provide 30 milligrams (mg) of phosphatidylserine per serving; and, as an ingredient of medical foods at levels that would not exceed 300 mg of phosphatidylserine per day"," Scientific procedures"," Enzymotec Ltd."," P.O. Box 6, Migdal HaEmeq, ISRAEL 23106",01/30/2009," GRN 279 (in PDF)",,,,,,,07/25/2009,," FDA has no questions",,,,,,,,,, =T("280")," Whole and milled flaxseed"," Ingredients in foods, excluding meat and poultry products, limited only by current good manufacturing practices"," Scientific procedures"," Flax Canada 2015"," 465-167 Lombard Avenue
Winnipeg, Manitoba R3B 0T6
CANADA",02/04/2009," GRN 280 (in PDF)",,,,,,,08/24/2009,," FDA has no questions",,,,,,,,,, =T("281")," Lactobacillus rhamnosus strain HN001 produced in a milk-based medium"," Ingredient in milk-based powdered term infant formula that is intended for consumption from the time of birth, as well as in milk-based powdered follow-on formula, at a level of 108 colony forming units per gram of the formula powder"," Scientific procedures"," Fonterra Co-operative Group"," Private Bag 92032 Auckland 1142
Fonterra Centre 9 Princes St. Auckland 1010
NEW ZEALAND",02/04/2009," GRN 281 (in PDF)",,,,,,,08/31/2009,," FDA has no questions",,,,,,,,,, =T("282")," Rebaudioside A purified from the leaves of Stevia rebaudiana (Bertoni) Bertoni"," As a general-purpose sweetener in foods, excluding meat and poultry products, provided that food standards of identity do not preclude such use, at levels determined by current good manufacturing practices"," Scientific procedures"," Sweet Green Fields, LLC"," 4164 Meridian Street, Suite 304
Bellingham, WA 98226",02/18/2009," GRN 282 (in PDF)",,,,,,,08/11/2009,," FDA has no questions",,,,,,,,,, =T("283")," Stearidonic acid soybean oil"," Ingredient in baked goods and baking mixes, breakfast cereals and grains, cheeses, dairy product analogs, fats and oils, fish products, frozen dairy desserts and mixes, grain products and pastas, gravies and sauces, meat products, milk products, nuts and nut products, poultry products, processed fruit juices, processed vegetable products, puddings and fillings, snack foods, soft candy, and soups and soup mixes, at levels that will provide 375 milligrams of stearidonic acid soybean oil per serving."," Scientific procedures"," Monsanto Company"," 800 North Lindbergh Blvd.
St. Louis, MO  63167",03/03/2009," GRN 283 (in PDF)",,,,,,,09/04/2009,," FDA has no questions",,,,,,,,,, =T("284")," Bakers yeast mannoprotein"," As a stabilizing agent in wines, at levels ranging from 50 to 400 milligrams per liter, to prevent tartaric acid precipitation"," Scientific procedures"," DSM Food Specialties"," Alexander Fleminglaan 1
2613 AX Delft
The NETHERLANDS",03/12/2009," GRN 284 (in PDF)",,,,,,,08/28/2009,," FDA has no questions",,,,,,,,,, =T("285")," Galacto-oligosaccharides"," Ingredient in certain baby, infant, and toddler foods at levels ranging from 0.86 to 1.28 grams (g) per serving; and, in certain beverages and beverage bases, dairy product analogs, milk products, bakery products, cereal and other grain products, desserts, dessert toppings and fillings, fruit and fruit juices, snacks, soups, and soft and hard candy at a level of 1.28 g/serving"," Scientific procedures"," GTC Nutrition"," 523 Park Point Drive, Suite 300
Golden, CO 80401",03/12/2009," GRN 285 (in PDF)",,,,,,,09/04/2009,," FDA has no questions",01/06/2015," Additional correspondence received regarding manufacturing and specification changes",04/15/2011," Additional correspondence received regarding manufacturing and specification changes",,,,,, =T("286")," Galacto-oligosaccharides"," Ingredient in term infant formula and follow-on formula at a level of 7.2 grams of galacto-oligosaccharides per liter"," Scientific procedures"," GTC Nutrition"," 523 Park Point Drive, Suite 300
Golden, CO 80401",03/12/2009," GRN 286 (in PDF)",,,,,,,09/04/2009,," FDA has no questions",01/06/2015," Additional correspondence regarding manufacturing and specification changes",04/15/2011," Additional correspondence regarding manufacturing and specification changes",,,,,, =T("287")," Purified steviol glycosides with rebaudioside A and stevioside as the principal components"," General-purpose sweetener in foods, excluding meat and poultry products and infant formulas, at levels determined by current good manufacturing practice"," Scientific procedures"," Wisdom Natural Brands"," 1203 W. San Pedro Street
Gilbert, AZ 85233",03/17/2009," GRN 287 (in PDF)",,,,,,,08/28/2009,," FDA has no questions",,,,,,,,,, =T("288")," Lactobacillus rhamnosus strain HN001"," Ingredient in various foods, including certain beverages and beverage bases (excluding soft drinks); cheeses; milk drinks; milk products; meal replacements; energy bars; ready-to-eat cereals; fruit juices, nectars, ades, and drinks; confections; chewing gum, and hard candies at a level to provide up to 109 colony forming units per standard serving"," Scientific procedures"," Fonterra Co-operative Group"," Private Bag 92032 Auckland 1142
Fonterra Centre 9 Princes St. Auckland 1010
NEW ZEALAND",03/27/2009," GRN 288 (in PDF)",,,,,,,11/01/2009,," FDA has no questions",,,,,,,,,, =T("289")," Colicin E1 purified from Escherichia coli"," As an antimicrobial to control Escherichia coli on fresh beef carcasses, beef cuts, and ground beef components pre-grind at a level not to exceed 5 milligrams per kilogram on cut meat and trim"," Scientific procedures"," Ivy Animal Health, Inc."," 9111 Barton Street
Overland Park, KS  66214",04/16/2009," GRN 289 (in PDF)",,,,,,,06/25/2009,," At the notifier's request, FDA ceased to evaluate this notice",,,,,,,,,, =T("290")," L-arginine"," As an ingredient in a brine solution to be injected into beef subprimals, or mixed with ground beef to make beef patties. The brine solution contains levels of L-arginine between 0.2 - 0.6 percent"," Scientific procedures"," Ranzell Nickelson II, Ph.D."," 455 Sansom Boulevard
Saginaw, TX  76179",05/06/2009," GRN 290 (in PDF)",,,,,,,11/02/2009,," FDA has no questions",,,,,,,,,, =T("291")," Crystalline lutein"," Ingredient in baked goods and baking mixes, beverages and beverage bases, breakfast cereals, chewing gum, dairy product analogs, fats and oils, frozen dairy desserts and mixes, gravies and sauces, hard candy, infant and toddler foods, milk products, processed fruits and fruit juices, and soft candy at levels ranging from 0.3 to 3.0 milligrams per reference amount customarily consumed"," Scientific procedures"," Industrial Organica S.A. de C. V."," Ave. Almazan No. 100
Col. Topo Chico 64260
Monterrey, MEXICO",05/11/2009," GRN 291 (in PDF)",,,,,,,11/06/2009,," FDA has no questions; some uses may require a color additive listing",,,,,,,,,, =T("292")," Cellulase enzyme preparation derived from a genetically modified strain of Myceliophthora thermophila"," Enzyme in the production of wine, beer and fruit juices"," Scientific procedures"," Dyadic International (USA) Inc."," 140 Intracoastal Pointe Dr.
Suite 404
Jupiter FL 33477-5094",06/02/2009," GRN 292 (in PDF)",,,,,,,09/29/2009,," FDA has no questions",,,,,,,,,, =T("293")," Glutathione"," Ingredient in baked goods and baking mixes, beverages and beverages bases, breakfast cereals, cheeses, chewing gum, coffee and tea, condiments and relishes, dairy product analogs, gelatins, puddings and fillings, grain products and pastas, gravies and sauces, hard candy, milk products, plant protein products, processed fruits and fruit juices, processed vegetables and vegetables juices, salty snacks, soft candy, soups and soup mixes, and sugar substitutes, at levels ranging from 5 to 742.5 milligrams per serving"," Scientific procedures"," Kohjin Co., Ltd."," 1-21, Nihombashi Muromachi 4 Chome
Chou-ku, Tokyo, 103-0022
JAPAN",07/02/2009," GRN 293 (in PDF)",,,,,,,12/22/2009,," FDA has no questions",,,,,,,=T("244"),,, =T("294")," Haematococcus pluvialis extract containing astaxanthin esters"," Ingredient in baked goods, beverages, cereals, chewing gum, coffee and tea, dairy product analogs, frozen dairy desserts and mixes, hard candy, milk products, processed fruits and fruit juices, processed vegetables and vegetable juices, and soft candy, at a use level to provide 0.1 milligrams of astaxanthin per serving"," Scientific procedures"," Fuji Chemical Industry Co., Ltd."," 55 Yokohoonji, Kamiichi
Toyama 930-0397
JAPAN",07/10/2009," GRN 294 (in PDF)",,,,,,,01/06/2010,," FDA has no questions; some uses may require a color additive listing",,,,,,,,,, =T("295")," Aqueous extract of Emblica officinalis"," Ingredient in nonalcoholic beverages and processed fruits and fruit juices at levels ranging from 100 to 150 milligrams per serving"," Common use in food"," Natreon, Inc."," 2D Janine Place
New Brunswick, NJ 08901",07/10/2009," GRN 295 (in PDF)",,,,,,,11/23/2009,," At the notifier's request, FDA ceased to evaluate this notice",,,,,,,,=T("322"),, =T("296")," Lipase enzyme preparation from a genetically modified strain of Aspergillus niger"," Use in baked goods to enhance the gas holding capacity of the dough, leading to an increased stability of the dough upon proofing"," Scientific procedures"," DSM Food Specialties"," P.O. Box 1
2600 MA Delft
The NETHERLANDS",07/10/2009," GRN 296 (in PDF)",,,,,,,10/01/2009,," FDA has no questions",,,,,,,,,, =T("297")," Erythritol fatty acid esters"," As a microencapsulant of ingredients such as baking powder in certain foods, primarily baked goods, at the minimum level required to achieve the intended technical effect"," Scientific procedures"," Stepan Company"," 22 West Frontage Road
Northfield, IL 60093",07/13/2009," GRN 297 (in PDF)",,,,,,,12/15/2009,," FDA has no questions",,,,,,,=T("203"),,, =T("298")," Silicon dioxide"," Use in a variety of foods and food-packing materials"," Scientific procedures"," Cabot Corporation"," Two Seaport Lane
Suite 1300
Boston, MA 02210",07/14/2009," GRN 298 (in PDF)",,,,,,,10/09/2009,," At the notifier's request, FDA ceased to evaluate this notice",,,,,,,,=T("321"),, =T("299")," Lycopene from Escherichia coli expressing lycopene biosynthetic enzymes"," Ingredient in baked goods and baking mixes, beverages and beverage bases, breakfast cereals, cheeses, frozen dairy desserts and mixes, milk products, processed fruits and fruit juices, snack foods, and soft candy"," Scientific procedures"," Echem Hightech Co., Ltd."," 331 Bautista Place
San Jose, CA  95126",07/15/2009," GRN 299 (in PDF)",,,,,,,09/22/2009,," At the notifier's request, FDA ceased to evaluate this notice",,,,,,,,,, =T("300")," Trisodium diphosphate"," Stabilizer, moisturizer and sequestrant in sausages (fine emulsions); fish and seafood products (excluding catfish and scallops) at levels in accordance with current good manufacturing practices (levels of addition shall not exceed 0.5 percent, as P2O5)"," Scientific procedures"," Chemische Fabrik Budenheim KG"," Rheinstr. 27
D 55257 Budenheim
GERMANY",07/21/2009," GRN 300 (in PDF)",,,,,,,12/16/2009,," FDA has no questions",,,,,,,,,, =T("301")," Siraitia grosvenorii Swingle (Luo Han Guo) fruit extract (SGFE)"," For use as a sweetener and flavor enhancer in foods, excluding meat and poultry products, at levels determined by current good manufacturing practice, as well as use as a table top sweetener"," Scientific procedures"," BioVittoria Ltd."," Waikato Innovation Park
Ruakura Road
P.O. Box 9466
Hamilton
NEW ZEALAND",07/23/2009," GRN 301 (in PDF)",,,,,,,01/15/2010,," FDA has no questions",04/08/2011," Additional correspondence regarding specifications",,,,,,,, =T("302")," 1,3-propanediol"," To be used in place of 1,2-propanediol (as specified in 21 CFR 184.1666(c)) at levels not to exceed current good manufacturing practice; maximum levels of 5 percent for alcoholic beverages, 24 percent for confections and frostings, 2.5 percent for frozen dairy products, 97 percent for seasonings and flavorings, 5 percent for nuts and nut products and 2 percent for all other food categories (excluding infant formula, fish, meat, and poultry)"," Scientific procedures"," DuPont Tate & Lyle BioProducts"," 198 Blair Bend Road
Loudon, TN  37774",09/08/2009,,,,,,,,03/05/2010,," FDA has no questions",,,,,,,,,, =T("303")," Rebaudioside A purified from the leaves of Stevia rebaudiana (Bertoni) Bertoni"," General-purpose sweetener in foods, excluding meat and poultry products, at levels determined by good manufacturing practice"," Scientific procedures"," Sunwin USA, LLC
AND
WILD Flavors
"," PO Box 1017
Frisco, TX  75034
(Sunwin)
AND
1261 Pacific Avenue
Erlanger, KY  41018
(WILD Flavors)",09/24/2009," GRN 303 (in PDF)",,,,,,,03/22/2010,," FDA has no questions",,,,,,,,,, =T("304")," Purified steviol glycosides with rebaudioside A and stevioside as the principal components"," General-purpose sweetener in foods, excluding meat and poultry products, at levels determined by good manufacturing practice"," Scientific procedures"," Sunwin USA, LLC
AND
WILD Flavors
"," PO Box 1017
Frisco, TX  75034
(Sunwin)
AND
1261 Pacific Avenue
Erlanger, KY  41018
(WILD Flavors)",09/24/2009," GRN 304 (in PDF)",,,,,,,03/22/2010,," FDA has no questions",,,,,,,,,, =T("305")," Carnobacterium maltaromaticum strain CB1 (viable and heat-treated)"," Inhibitor of Listeria monocytogenes in a variety of foods including meat and poultry as follows: (1) viable C. maltaromaticum CB1 in ready-to-eat meat products; meat, poultry, and fish products; frozen meals; processed fruit salads and vegetable salads; sauces; and, soft cheese and cheese spread-type products and (2) heat-treated C. maltaromaticum CB1 as an inhibitor of L. monocytogenes in ready-to-eat meat products, meat, poultry, fish, and mixtures; fruits and vegetables; soups and stews; sauces and dressings; and, cheese and cheese spread-type products"," Scientific procedures"," Griffith Laboratories"," 757 Pharmacy Avenue
Toronto, Ontario
M1L 3J8 CANADA",10/15/2009," GRN 305 (in PDF)",,,,,,,04/19/2010,," FDA has no questions",,,,,,,,," Additional uses in"," GRN 159" =T("306")," Soybean oil with reduced palmitic and linolenic acids and increased oleic acid"," For frying and spraying applications in a variety of food products including meat, poultry, and fish dishes (commercial and restaurant), fried eggs (commercial and restaurant), French fries, potato chips and puffs, creamy salad dressings, salty snacks, and grain mixture dishes"," Scientific procedures"," Monsanto Company"," 800 North Lindbergh Boulevard.
St. Louis, MO  63167",10/20/2009," GRN 306 (in PDF)",,,,,,,04/07/2010,," FDA has no questions",07/07/2014," Additional correspondence regarding expanded uses",,,,,,,, =T("307")," Palm oil-derived tocols with tocotrienols and α-tocopherol as the principal components"," Ingredient in margarines and spreads; designer fats and oils; salad dressings and mayonnaises; potato chips and salty snacks; bakery products (breads, rolls, croissants); cookies and crackers; ready-to-eat cereals, cereal bars, granola bars, protein bars, and power bars; meal replacement and other functional beverage products and mixes; meatless meat products (soy based); meatless soups and soup mixes; meatless gravies, sauces and pasta sauces; processed juices; processed fruits, juice drinks and punch; soft drinks; frozen dairy desserts and mixes; yogurt, pudding and jello; chocolate milk, flavored milk, soy milk and products; chocolate, candy, confectionary and sweets; chewing gum"," Scientific procedures"," Malaysian Palm Oil Board TAS America"," 3516 International Court, N.W.
Washington, DC 20008",10/27/2009," GRN 307 (in PDF)",,,,,,,04/23/2010,," FDA has no questions; some uses may require a color additive listing",,,,,,,,,, =T("308")," L-leucine"," Ingredient in non-milk and milk based meal replacements, sports and isotonic beverages, vitamin enhanced waters, and meal replacement bars, at levels of 0.5 to 3 grams per serving"," Scientific procedures"," Ajinomoto Aminoscience, LLC"," 4020 Ajinomoto Drive
Raleigh, NC  27610",11/02/2009," GRN 308 (in PDF)",,,,,,,04/30/2010,," FDA has no questions",,,,,,,,,, =T("309")," Beta-glucan derived from Aureobasidium pullulans"," Ingredient in baked goods and baking mixes, beverages and beverage bases, cereal and cereal products, dairy product analogs, milk and milk products, plant protein products, processed fruits and fruit juices, and soft candy, at concentrations ranging from 120 to 150 milligrams per serving"," Scientific procedures"," Glucan Corporation, Limited"," Marine Bio Center 221, Silla University
Gwaebop-Dong, Sasang-Gu
Busan, 617-736
SOUTH KOREA",12/17/2009," GRN 309 (in PDF)",,,,,,,06/14/2010,," FDA has no questions",,,,,,,,,, =T("310")," Potato fiber"," Use to improve the texture, stability, and oil/water binding capacity of whole muscle poultry products and comminuted meat and poultry products at a maximum level of 3.5 percent in the final product"," Scientific Procedures"," J. Rettenmaier USA LP"," 16369 US Highway 131
Schoolcraft, MI 49087",12/24/2009," GRN 310 (in PDF)",,,,,,,06/10/2010,11/06/2010," FDA has no questions",,,,,,,,,, =T("311")," Krill-based phosphatidylserine"," Ingredient in breakfast cereals, dairy product analogs, grain products and pastas, milk products, and processed fruits and fruit juices, at a use level intended to provide 30 milligrams (mg) of phosphatidylserine per serving; and, as an ingredient in medical foods at levels that would not exceed 300 mg of phosphatidylserine per day"," Scientific procedures"," Enzymotec Ltd."," P.O. Box 6
Migdal HaEmeq
ISRAEL, 23106",01/05/2010," GRN 311 (in PDF)",,,,,,,06/15/2010,," FDA has no questions; some uses may require a color additive listing",,,,,,,,,, =T("312")," Synthetic dihydrocapsiate"," Ingredient in a variety of food categories to provide three miligrams (mg) per serving (bars breakfast and meal replacement; beverage concentrates (as powder) (low calorie); beverages soft drinks (sugar free); chewing gum (sugarless); cookies (low fat, fat free); creamer; energy drinks; frozen desserts (ice pops, fruit bars); frozen desserts (dairy); fruit-ades, drinks, and powders (low calorie); fruit juice (fresh orange juice); gelatin/pudding (low calorie); hard candy (dietetic); liquid coffee; crackers (low fat and fat free); meal replacement beverages; non-carbonated water (low calorie); nutritional meal (e.g., Ensure); oatmeal - instant (low sugar); protein based meat alternative (from vegetable and/or dairy); ready-to-eat meals - frozen diet (excludes meat, poultry, seafood); ready-to-eat meals - soup; ready-to-eat cereals (cold); salad dressings (low calorie); snack foods (low calorie) - popcorn (low fat, fat free, low sodium) or rice cake (puffed, cracker-type); sweeteners (low calorie); tea, liquid (low sugar or sugar free); vegetable juice; yogurt fruit (low fat and fat free); yogurt chocolate, vanilla, plain (low fat and fat free)), with the exception of chewing gum which would be at a level of ten mg per serving"," Scientific procedures"," Ajinomoto USA, Inc."," 1120 Connecticut Ave., Suite 1010
Washington, DC 20036",01/05/2010," GRN 312 (in PDF)",,,,,,,06/06/2010,," FDA has no questions",,,,,,,,,, =T("313")," Beef protein"," Water binding agent and coating to increase moistness and reduce volume shrinkage in beef products, applied as a coating at up to 0.8% (by weight of final product), as a component of batter at up to 0.14%, and as both at a combined total of up to 0.89%"," Scientific procedures"," Proteus Industries, Inc."," 15 Great Republic Drive
Gloucester, MA 01930",01/05/2010," GRN 313 (in PDF)",,,,,,,08/11/2010,12/13/2010," FDA has no questions",,,,,,,,,, =T("314")," Pork protein"," Water binding agent and coating to increase moistness and reduce volume shrinkage in pork products, applied as a coating at up to 0.8% (by weight of final product), as a component of batter at up to 0.14%, and as both at a combined total of up to 0.89%"," Scientific procedures"," Proteus Industries, Inc."," 15 Great Republic Drive
Gloucester, MA 01930",01/05/2010," GRN 314 (in PDF)",,,,,,,08/11/2010,12/13/2010," FDA has no questions",,,,,,,,,, =T("315")," Transglucosidase enzyme preparation from Trichoderma reesei expressing the gene encoding transglucosidase from Aspergillus niger"," Use in the production of isomalto-oligosaccharide syrups from starch and potable ethanol from molasses"," Scientific procedures"," Genencor, a Danisco Division"," 925 Page Mill Road
Palo Alto, CA 94304",01/06/2010," GRN 315 (in PDF)",,,,,,,05/04/2010,," FDA has no questions",,,,,,,,,, =T("316")," Sodium potassium hexametaphosphate"," Use in food generally, including meat and poultry products, to achieve a variety of technical effects in food at levels in accordance with current good manufacturing practice"," Scientific procedures"," ICL Performance Products LP"," 622 Emerson Road, Suite 500
St. Louis, MO 63141",01/08/2010," GRN 316 (in PDF)",,,,,,,06/28/2010,," FDA has no questions",,,,,,,,,, =T("317")," L-arginine"," Component in a brine solution to be injected into whole muscle cuts of pork or poultry, or mixed with ground pork or poultry to make patties. The brine solution contains concentrations of L-arginine between 0.2 - 0.6 percent"," Scientific procedures"," Edge Food Products, LLC"," 455 Sansom Boulevard
Saginaw, TX  76179",01/13/2010," GRN 317 (in PDF)",,,,,,,07/12/2010,," FDA has no questions",,,,,,,,,, =T("318")," Rebaudioside A purified from the leaves of Stevia rebaudiana (Bertoni) Bertoni"," General-purpose sweetener in foods, excluding meat and poultry products and infant formulas, at levels determined by good manufacturing practice, as well as use as a table top sweetener"," Scientific procedures"," Pyure Brands, LLC"," 4532 Tamiami Trail E., Suite 303
Naples, FL 34112",01/20/2010," GRN 318 (in PDF)",,,,,,,05/15/2010,," FDA has no questions",,,,,,,,,, =T("319")," Micro-algal oil Ulkenia sp. SAM2179"," For use as an ingredient in the food categories listed in 21 CFR 184.1472(a)(3) at levels up to 40 percent of the levels specified in 21 CFR 184.1472(a)(3) and not to be combined with any other added oil that is a significant source of eicosapentaenoic acid or docosahexaenoic acid"," Scientific procedures"," Lonza Ltd."," Muenchensteinerstrasse 38
CH-4002
Basel, CH-4002
SWITZERLAND",01/21/2010," GRN 319 (in PDF)",,,,,,,08/04/2010,," FDA has no questions; some uses may require a color additive listing",,,,,,,=T("160"),,, =T("320")," Palm oil-derived carotenoids with β-carotene, α-carotene, γ-carotene, and lycopene"," Use in medical foods at a level of 180 milligrams of β-carotene per day
Ingredient in fats and oils, and margarine; canned green peas, canned mangoes, and mayonnaise; meatless bouillons and consommé; picked cucumber; baked goods, bread, rolls, and cakes; meatless soups and soup mixes; baking mixes, cookies, crackers, and salty snacks; grain products (such as pastas or rice dishes); ready-to-eat cereals; frozen dairy desserts and mixes, ice cream and mixes; processed fruits, juices, juice drinks, and punches; meatless meat products (soy-based imitation meat); processed vegetables, juices; sweet sauces, toppings, syrups; egg substitute products (imitation egg products); soft drink (orange drink type only); granola bars, cereal bars; meal replacement shakes and mixes, functional beverages"," Scientific procedures"," Malaysian Palm Oil Board TAS America"," 3516 International Court, N.W.
Washington, DC 20008",02/01/2010," GRN 320 (in PDF)",,,,,,,09/03/2010,," FDA has no questions; some uses may require a color additive listing",,,,,,,,,, =T("321")," Synthetic amorphous silica"," Anticaking agent, defoaming agent, stabilizer, adsorbent, carrier, conditioning agent, chill proofing agent, filter aid, emulsifying agent, viscosity control agent, and anti-settling agent in a variety of food categories defined by the Codex Alimentarius General Standard for Food Additives"," Scientific procedures"," Cabot Corporation"," Two Seaport Lane
Suite 1300
Boston, MA 02210",02/18/2010," GRN 321 (in PDF)",,,,,,,08/18/2010,," FDA has no questions",,,,,,,=T("298"),,, =T("322")," Aqueous extract of Emblica officinalis"," Ingredient in nonalcoholic beverages and processed fruits and fruit juices at levels ranging from 100 to 150 milligrams per serving"," Common use in food"," Natreon, Inc."," 2D Janine Place
New Brunswick, NJ 08901",02/18/2010," GRN 322 (in PDF)",,,,,,,06/16/2010,," At the notifier's request, FDA ceased to evaluate this notice",,,,,,,=T("295"),=T("483"),, =T("323")," Purified steviol glycosides with rebaudioside A and stevioside as the principal components"," General-purpose sweetener in foods, excluding meat and poultry products and infant formulas, at levels determined by good manufacturing practice, as well as use as a table top sweetener"," Scientific procedures"," PureCircle USA, Inc."," 915 Harger Road, Suite 250
Oak Brook, IL 60523",02/18/2010," GRN 323 (in PDF)",,,,,,,07/09/2010,," FDA has no questions",03/04/2011," Additional correspondence regarding specifications",,,,,,,, =T("324")," Heat-killed Lactobacillus plantarum"," Ingredient in baked goods and baking mixes, beverages and beverage bases, breakfast cereals, dairy product analogs, fats and oils, frozen dairy desserts, grain products and pastas, milk and milk products, plant protein products, processed fruits and fruit juices, processed vegetables and vegetable juices, soft candy, and soups and soup mixes, excluding meat and poultry, at a maximum level of 150 milligrams per serving"," Scientific procedures"," House Wellness Foods Corporation"," Imoji 3-20, Itami
Hyogo 664-0011
JAPAN",02/18/2010," GRN 324 (in PDF)",,,,,,,07/07/2010,," At the notifier's request, FDA ceased to evaluate this notice",,,,,,,,,, =T("325")," Olestra"," Use as a replacement for fats and oils in the following:
"," Scientific procedures"," The Procter & Gamble Company"," 11530 Reed Hartman Highway
Cincinnati, Ohio 45241",02/25/2010," GRN 325 (in PDF)",,,,,,,08/30/2010,," FDA has no questions",,,,,,,,,, =T("326")," Arachidonic acid rich oil from M. alpina strain I49-N18"," Provide arachidonic acid (ARA), at mean concentrations of 0.75 grams (g) per 100 g total fat for term infants and 0.40 g per 100 g total fat for preterm infants, when used in combination with a GRAS source of docosahexaenoic acid (DHA) and at a ratio ranging from 1:1 to 2.7:1 ARA to DHA"," Scientific procedures"," Cargill, Inc."," 15407 McGinty Road West
Wayzata, MN 55391",03/02/2010," GRN 326 (in PDF)",,,,,,,10/24/2010,02/16/2011," FDA has no questions",,,,,,,,,, =T("327")," Cruciferin-rich canola/rapeseed protein isolate and napin-rich canola/rapeseed protein isolate"," Ingredient in dairy products, grain products, fruit and vegetable juices and beverages, salad dressings, meal replacements, and nutritional bars"," Scientific procedures"," Archer Daniels Midland Company"," 4666 East Faries Parkway
Decatur, IL 62526",03/09/2010," GRN 327 (in PDF)",,,,,,,08/23/2010,," FDA has no questions",,,,,,,,,, =T("328")," Polysaccharide complex of konjac glucomannan (konjac), sodium alginate, and xanthan gum (polysaccharide complex KAX)"," Ingredient in yogurts, milk shakes and fruit smoothie-type drinks, frozen yogurt, ice cream bars, puddings, white and whole wheat breads, cookies, breakfast bars, granola-type bars, noodles, whole wheat cereals, meatless lasagna and macaroni/cheese, fruit juices, fruit juice bars, and cereal beverages"," Scientific procedures"," Inovo Biologic, Inc."," 104-1240 Kensington Road NW, Suite 409
Calgary, Alberta
Y2N4Y7
CANADA",03/12/2010," GRN 328 (in PDF)",,,,,,,05/20/2011,," Notice does not provide a basis for a GRAS determination",,,,,,,,,, =T("329")," Rebaudioside A purified from the leaves of Stevia rebaudiana (Bertoni) Bertoni"," General-purpose sweetener in foods, excluding meat and poultry products, at levels determined by current good manufacturing practices"," Scientific procedures"," GLG Life Tech, Ltd."," World Trade Centre, 999 Canada Place
Suite 519
Vancouver, British Columbia
V6C3E1
CANADA",03/12/2010," GRN 329 (in PDF)",,,,,,,09/10/2010,," FDA has no questions",,,,,,,,,, =T("330")," Algal flour (Chlorella protothecoides)"," Ingredient in baked goods and baking mixes, beverages and beverage bases, dairy product analogs, egg products, fats and oils, gravies and sauces, and meat and poultry containing soup and soup mixes at levels ranging from 3.5 to 50 percent of the reference amounts customarily consumed"," Scientific procedures"," Solazyme, Inc."," 561 Eccles Avenue South
San Francisco, CA 94080",03/31/2010," GRN 330 (in PDF)",,,,,,,06/01/2010,," At the notifier's request, FDA ceased to evaluate this notice",,,,,,,,,, =T("331")," Algal oil (Chlorella protothecoides)"," Substitute for vegetable oils in baked goods and baking mixes, beverages and beverage bases, confections and frostings, frozen dairy desserts and mixes, gelatins, pudding, and fillings, grain products and pastas, milk products, nut and nut products, processed fruit and fruit juices, snack foods, soft candy, soups and soup mixes, and sweet sauces, toppings, and syrups. Use levels range from 1.8 percent to 26 percent, depending on the intended technical effect in the food, with the exception of frying, cooking, and specialty oils where use levels will be 100 percent"," Scientific procedures"," Solazyme, Inc."," 561 Eccles Avenue South
San Francisco, CA 94080",03/31/2010," GRN 331 (in PDF)",,,,,,,06/01/2010,," At the notifier's request, FDA ceased to evaluate this notice",,,,,,,,,, =T("332")," Oil from the seeds of the Korean pine (Pinus koraiensis) (Korean-pine nut oil)"," Replacement for other oils at a level of 3 grams per serving in baked goods and baking mixes, beverages and beverage bases, breakfast cereals, dairy product analogs, fats and oils, grain products and pasta, milk and milk products, nuts and nut products, processed fruit and fruit juices, processed vegetables and vegetable juices, snack foods, soft candy, and soups and soup mixes; does not include any meat or meat-containing products"," Scientific procedures"," Lipid Nutrition B.V."," Hogeweg 1
1521 AZ Wormerveer
The NETHERLANDS",03/31/2010," GRN 332 (in PDF)",,,,,,,09/24/2010,," FDA has no questions",,,,,,,,,, =T("333")," Acid fungal protease enzyme preparation from Trichoderma reesei expressing the gene encoding acid fungal protease from T. reesei"," Use as an enzyme in grain processing (corn steeping), alcoholic beverage (potable alcohol) manufacture, and degumming of membranes during orange juice manufacturing"," Scientific procedures"," Genencor, a Danisco Division"," 925 Page Mill Road
Palo Alto, CA 94304",03/31/2010," GRN 333 (in PDF)",,,,,,,09/24/2010,," FDA has no questions",,,,,,,,,, =T("334")," Galacto-oligosaccharides"," Ingredient in term infant formula at a concentration of 7.2 grams per liter and in the following food categories at levels ranging from 0.3 to 9.5 grams per serving: "," Scientific procedures"," Yakult Pharmaceutical Industry Co., Ltd."," 1796 Yaho, Kunitachi-shi
Tokyo, 186-8650
JAPAN",05/03/2010," GRN 334 (in PDF)",,,,,,,10/27/2010,," FDA has no questions",,,,,,,,,, =T("335")," Pine tree phytosterol esters"," Ingredient in multiple food categories including margarine and vegetable-based spreads, yogurt and yogurt-like products, milk-based juice beverages, ice cream and non-standardized ice cream products, cream cheese and cream cheese-like products, snack bars, salad dressing, standardized and non-standardized bread products, baked goods, beverages, dairy analogs, cheese and cream, breakfast cereal, mayonnaise, pasta and noodles, sauces, salty snacks, processed soups, puddings, confections, vegetarian meat analogs, fruit/vegetable juice, vegetable oils, egg products, including egg whites and substitute egg products"," Scientific procedures"," Arboris LLC"," 1101 West Lathrop Ave., Gate 16
Savannah, GA 31415",05/04/2010," GRN 335 (in PDF)",,,,,,,10/27/2010,," FDA has no questions",,,,,,,,,, =T("336")," ε-Polylysine (polylysine)"," Antimicrobial agent in a wide variety of food categories at levels of up to 0.025% by weight"," Scientific procedures"," Purac Biochem b.v."," Arkelsedijk 45
PO Box 21
4206 AA Gorinchem
The NETHERLANDS",05/05/2010," GRN 336 (in PDF)",,,,,,,08/24/2011,," FDA has no questions",,,,,,,,,, =T("337")," Enzyme-modified steviol glycosides preparation (EMSGP)"," General-purpose sweetener in foods, excluding meat and poultry products, at levels determined by good manufacturing practices"," Scientific procedures"," NOW Foods"," 395 S. Glen Ellyn Road
Bloomingdale, IL 60108",05/07/2010," GRN 337 (in PDF)",,,,,,,06/17/2011,," FDA has no questions",,,,,,,,,, =T("338")," L-theanine extracted from tea leaves (Camellia sinensis)"," Ingredient in fruit juices and drinks, non-herbal teas, sports beverages, bottled waters, chocolate bars and chews, hard candies, breath mints, and chewing gum at levels up to 250 milligrams per serving"," Scientific procedures"," Blue California"," 30111 Tomas
Rancho Santa Margarita, CA 92688",05/11/2010," GRN 338 (in PDF)",,,,,,,11/05/2010,," FDA has no questions",,,,,,,,,, =T("339")," Polyglutamic acid"," Debittering agent in salt substitute products for table top, food preparation or for food production applications, containing potassium chloride at concentrations ranging from 0.15 to 0.4 percent by weight of the salt substitute product"," Scientific procedures"," Ajinomoto Corporate Services, LLC"," 1120 Connecticut Ave., NW
Suite 416
Washington, DC 20036",05/13/2010," GRN 339 (in PDF)",,,,,,,11/06/2010,," FDA has no questions",,,,,,,,,, =T("340")," Theobromine"," Ingredient in bread, ready-to-eat cereals, instant and regular oatmeal, sports and isotonic drinks, vitamin and enhanced bottled waters, chewing gums, tea, soy milk, gelatins, hard mint candy, meal replacement beverages (non-chocolate), yogurt and yogurt drinks (non-chocolate), fruit smoothies, and powdered fruit flavored drinks at levels ranging from 5-75 milligrams per serving"," Scientific procedures"," Theocorp Holding Company, LLC"," 3512 8th Street
Metairie, LA 70002",05/17/2010," GRN 340 (in PDF)",,,,,,,11/10/2010,," At the notifier's request, FDA ceased to evaluate this notice",,,,,,,,,, =T("341")," Quercetin"," Ingredient in beverages and beverage bases, grain products and pastas, processed fruits and fruit juices, and soft candies at levels up to 500 milligrams per serving"," Scientific procedures"," Quercegen Pharma LLC"," 275 Grove Street, Suite 2-400
Newton, MA 02466",05/26/2010," GRN 341 part 1 (in PDF)"," GRN 341 part 2 (in PDF)"," GRN 341 part 3 (in PDF)",,,,,11/22/2010,," FDA has no questions; some uses may require a color additive listing",,,,,,,,,, =T("342")," Oat hull fiber"," Ingredient in comminuted meat products and in both whole muscle and comminuted poultry products at levels consistent with current good manufacturing practice"," Scientific procedures"," J. Rettenmaier USA LP"," 16369 US Highway 131
Schoolcraft, MI 49087",05/27/2010," GRN 342 (in PDF)",,,,,,,12/23/2010,," FDA has no questions",,,,,,,,,, =T("343")," Wheat bran extract composed primarily of xylo- and arabinoxylo-oligosaccharides"," Ingredient in baked goods and baking mixes, beverages and beverage bases, breakfast cereals, frozen dairy desserts, gelatin and puddings, grain products and pastas, jams and jellies, milk products, processed fruits and fruit juices, processed vegetables and vegetable juices, and snack foods at concentrations ranging from 2.4 to 3.2 grams of wheat bran extract per serving"," Scientific procedures"," Fugeia NV"," Gaston Geenslaan 1
B-3001 Leuven (Heverlee)
BELGIUM",05/28/2010," GRN 343 (in PDF)",,,,,,,11/22/2010,," FDA has no questions",,,,,,,,,, =T("344")," Barley fiber"," Ingredient in food generally, except infant formula and meat and poultry products"," Scientific procedures"," Cargill, Incorporated"," 15407 McGinty Road West Wayzata,
Minnesota 55391",06/22/2010," GRN 344 (in PDF)",,,,,,,05/23/2011,," FDA has no questions",,,,,,,,,, =T("345")," Carboxypeptidase enzyme preparation from modified Aspergillus niger"," Use as an enzyme in production of cheese to accelerate the ripening process, in production of enzyme-modified cheese as a debittering aid, and in fermented meat to accelerate the development of flavor during the ripening process"," Scientific procedures"," DSM Food Specialties"," PO Box 1
2600 MA Delft
The NETHERLANDS",06/28/2010," GRN 345 (in PDF)",,,,,,,12/22/2010,," FDA has no questions",,,,,,,,,, =T("346")," Freeze-dried fruit gac powder"," Ingredient in juice mixtures or beverages, nutritional bars, and functional foods as a source of lycopene and beta carotene"," Scientific procedures"," VitaGac, LLC"," 9454 Wilshire Blvd., Suite 500
Beverly Hills, CA 90212",06/28/2010," GRN 346 (in PDF)",,,,,,,09/10/2010,," At the notifier's request, FDA ceased to evaluate this notice",,,,,,,,,, =T("347")," Caffeine"," Flavoring ingredient in alcoholic beverages at levels of up to 200 parts per million"," Scientific procedures"," Phusion Projects, LLC"," 1658 N. Milwaukee Ave., Suite 424
Chicago, IL 60647-5651",06/30/2010," GRN 347 (in PDF)",,,,,,,11/24/2010,," At the notifier's request, FDA ceased to evaluate this notice",,,,,,,,,, =T("348")," Stevioside purified from the leaves of Stevia rebaudiana (Bertoni) Bertoni (stevioside)"," General-purpose sweetener in foods, excluding meat and poultry products and infant formulas, at levels determined by good manufacturing practice, as well as use as a table top sweetener"," Scientific procedures"," GLG Life Tech, Ltd."," World Trade Centre, 999 Canada Place
Suite 519
Vancouver, British Columbia
V6C3E1
CANADA",08/16/2010," GRN 348 (in PDF)",,,,,,,07/14/2011,," FDA has no questions",,,,,,,,,, =T("349")," Purified steviol glycosides with rebaudioside A and stevioside as the principal components"," General-purpose sweetener in foods, excluding meat and poultry products and infant formulas, at levels determined by good manufacturing practice, as well as use as a table top sweetener"," Scientific procedures"," GLG Life Tech, Ltd."," World Trade Centre, 999 Canada Place
Suite 519
Vancouver, British Columbia
V6C3E1
CANADA",08/17/2010," GRN 349 (in PDF)",,,,,,,07/14/2011,," FDA has no questions",,,,,,,,,, =T("350")," Saccharomyces cerevisiae strain P1Y0, a variant of S. cerevisiae parent strain UCD2034"," Use as a starter culture for alcoholic beverage fermentation such as grape must, brewing wort, and rice fermentations"," Scientific procedures"," Phyterra Yeast, Inc."," P.O. Box 21147
Charlottetown, Prince Edward Island
C1A 9H6
CANADA",08/19/2010," GRN 350 (in PDF)",,,,,,,02/04/2011,," FDA has no questions",,,,,,,,,, =T("351")," Dunaliella bardawil"," Ingredient in cheese, bread and rolls, mayonnaise, cookies, crackers, tofu, and soybean fermentation products at a level of 100 milligrams per kilogram"," Scientific procedures"," Nikken Sohonsha Corporation"," 1-32 Asahira
Fukuju-cho
Gifu-Pref
501-6255 Hashima-city
JAPAN",08/19/2010," GRN 351 (in PDF)",,,,,,,02/11/2011,," FDA has no questions; some uses may require a color additive listing",,,,,,,=T("276"),,, =T("352")," D-Tagatose"," Intended for use as a sweetener, texturizer, humectant, and stabilizer in ready-to-eat breakfast cereals, soft drinks, confectionery, formula diets for meal replacement, meal replacement drink mix (powder), cake, pie, cake mix, frostings, ice cream and frozen yogurt, yogurt, frostings, chewing gum (sugar free), jelly and pudding, coffee mix powder, biscuits, cookies, and cereal bars"," Scientific procedures"," CJ Cheiljedang, Inc."," Namdaemunro, 5-ga, Jung-gu
Seoul
KOREA",08/20/2010," GRN 352 (in PDF)",,,,,,,02/01/2011,," FDA has no questions",,,,,,,,,, =T("353")," High-selenium yeast"," "," Scientific procedures"," Alltech"," 3031 Catnip Hill Pike,
Nicholasville, KY 40356",09/02/2010," GRN 353 (in PDF)",,,,,,,03/01/2011,," FDA has no questions",,,,,,,,,, =T("354")," Rebaudioside A purified from the leaves of Stevia rebaudiana (Bertoni) Bertoni (rebaudioside A)"," General-purpose sweetener in foods, excluding meat and poultry products and infant formulas, at levels determined by good manufacturing practice, as well as use as a table top sweetener"," Scientific procedures"," Guilin Layn Natural Ingredients, Corp."," #18 Xiangjiang Rd. Xing'an County, Guilin 541300 China
Xicheng Rd. Lingui County, Guilin 541100
CHINA",09/03/2010," GRN 354 (in PDF)",,,,,,,07/15/2011,," FDA has no questions",,,,,,,,,, =T("355")," Eicosapentaenoic acid (EPA)-rich triglyceride oil from Yarrowia lipolytica"," Ingredient in food categories as listed in 21 CFR 184.1472(a)(3) at a maximum intake of 3.0 grams per person per day (g/p/d) EPA and not to be combined or augmented with any other food ingredient containing EPA and/or another omega-3 fatty acid, docosahexaenoic acid"," Scientific procedures"," DuPont Applied Biosciences"," Rt 141 & Powder Mill Road
Wilmington, DE 19803",09/08/2010," GRN 355 (in PDF)",,,,,,,03/07/2011,," FDA has no questions",,,,,,,,,, =T("356")," Haematococcus pluvialis extract containing astaxanthin esters"," Ingredient in baked goods, beverages, cereals, chewing gum, coffee and tea, dairy product analogs, frozen dairy desserts and mixes, hard candy, milk products, processed fruits and fruit juices, processed vegetables and vegetable juices, and soft candy at use levels of 0.5 milligrams astaxanthin per serving"," Scientific procedures"," Algatechnologies Ltd."," Kibbutz Ketura
88840
ISRAEL",09/28/2010," GRN 356 (in PDF)",,,,,,,11/15/2010,," At the notifier's request, FDA ceased to evaluate this notice",,,,,,,,,, =T("357")," Lactobacillus acidophilus NCFM"," Ingredient in certain dairy products, functional beverages, nutritional powders, juices, bars, ready-to-eat breakfast cereals, chewing gum and confections, at levels not to exceed current good manufacturing practice in accordance with 21 CFR 184.1(b)"," Scientific procedures"," Danisco USA, Inc."," 3329 Agricultural Drive,
Madison, WI 53716",10/27/2010," GRN 357 (in PDF)",,,,,,,04/19/2011,," FDA has no questions",,,,,,,,,, =T("358")," Cyclic dextrin, highly branched"," Ingredient in baked goods and baking mixes, beverages and beverage bases, breakfast cereals, tea, grain products, seasonings, milk and plant protein products, processed fruits and vegetables and fruit and vegetable juices, soft candy and powdered soups at a level of up to 30 percent in ready-to-eat foods and beverages and up to 75 percent in mixes requiring further preparation prior to consumption"," Scientific procedures"," Takashi Kuriki
Ezaki Glico Co., Ltd."," 4-6-5, Utajima Nishioyogogawa
Osaka
JAPAN",11/05/2010," GRN 358 (in PDF)",,,,,,,02/01/2011,," At the notifier's request, FDA ceased to evaluate this notice",,,,,,,,,, =T("359")," Siraitia grosvenorii Swingle (Luo Han Guo) fruit extracts (SGFE)"," Use as a sweetener and flavor enhancer in foods, excluding meat and poultry products, at levels determined by current good manufacturing practice"," Scientific procedures"," Guilin Layn Natural Ingredients Corp."," 3/F, Block A, No. 22
Lijiang Road
Guilin 541004
Guangxi
CHINA",11/10/2010," GRN 359 (in PDF)",,,,,,,04/11/2011,," FDA has no questions",,,,,,,,,, =T("360")," Hydrolyzed sardine protein"," Ingredient in beverages and breakfast cereals, frozen dairy desserts and mixes, milk and milk products, fish products, pastas, hard and soft candy, soups and soup mixes, and processed fruits and vegetables and fruit and vegetable juices"," Scientific procedures"," Katsuhiro Osajima
Senmi Ekisu Co. Ltd."," 779-2 Noda, Hirano-Cho
Ohzu-City, Ehime
795-0021
JAPAN",11/18/2010," GRN 360 (in PDF)",,,,,,,05/16/2011,," FDA has no questions",,,,,,,,,, =T("361")," 1,4-α-D-glucan branching enzyme preparation"," Use as an enzyme to catalyze the production of modified food starch ingredients including highly branched cyclic dextrins and enzymatically-synthesized glycogen"," Scientific procedures"," Takashi Kuriki
Ezaki Glico Co., Ltd."," 4-6-5, Utajima Nishioyogogawa
Osaka
JAPAN",11/18/2010," GRN 361 (in PDF)",,,,,,,01/31/2011,," At the notifier's request, FDA ceased to evaluate this notice",,,,,,,,,, =T("362")," Levocarnitine"," Ingredient in several food categories, which do not include meat or poultry products"," Scientific procedures"," Northeast Pharmaceutical Group Co., Ltd. (NEPG)"," No. 37, Zhonggong Bei Street
Tiexi District, Shenyang
Liaoning Province P.R. CHINA, Postcode:110026",12/08/2010," GRN 362 (in PDF)",,,,,,,03/09/2011,," At the notifier's request, FDA ceased to evaluate this notice",,,,,,,,,, =T("363")," Calcium disodium ethylenediaminetetraacetic acid (EDTA) and disodium EDTA"," Use alone or together as color, flavor, and/or texture retention agents in packaged cooked sweet corn products with or without sauce, including mixed vegetable and similar products that contain 8 to 50% corn by weight, at levels up to 200 milligrams per kilogram (mg/kg) calcium disodium EDTA and 165 mg/kg disodium EDTA"," Scientific procedures"," Del Monte Foods"," 205 N. Wiget Lane
Walnut Creek, CA 94598",12/21/2010," GRN 363 (in PDF)",,,,,,,06/06/2011,," FDA has no questions",,,,,,,,,, =T("364")," Bacteriophages LAND12, OLB1, TSRW1, DSMP1, DP1"," Use as an antimicrobial in foods in general, including meat and poultry products, and in food contact applications to control Escherichia coli O157:H7 at a level up to 5 x 109 plaque forming units (pfu) per milliliter or pfu/gram"," Scientific procedures"," OmniLytics, Inc."," 5450 W. Wiley Post Way
Salt Lake City, Utah 84116",12/21/2010," GRN 364 (in PDF)",,,,,,,03/16/2011,," At the notifier's request, FDA ceased to evaluate this notice",,,,,,,,,, =T("365")," Rebaudioside A purified from the leaves of Stevia rebaudiana (Bertoni) Bertoni (rebaudioside A)  "," General-purpose sweetener in foods, excluding meat and poultry products and infant formulas, at levels determined by good manufacturing practice, as well as use as a table top sweetener"," Scientific procedures"," BrazTek International Inc.
d/b/a Rio Natural"," 5050 Robert J. Matthews Pkwy.
Suite 200
El Dorado Hills, CA 95762",12/28/2010," GRN 365 (in PDF)",,,,,,,08/18/2011,," FDA has no questions",,,,,,,,,, =T("366")," Oat hull fiber"," Use as an ingredient in various food categories including meat and poultry"," Scientific procedures"," Z Trim Holdings, Inc."," 1011 Campus Drive
Mundelein, IL 60060",01/11/2011," GRN 366 (in PDF)",,,,,,,04/06/2011,," At the notifier's request, FDA ceased to evaluate this notice",,,,,,,,,, =T("367")," Purified steviol glycosides with rebaudioside A and stevioside as the principal components"," General-purpose sweetener in foods, excluding meat and poultry products and infant formulas, at levels determined by good manufacturing practice, as well as use as a table top sweetener"," Scientific procedures"," Sinochem Health Company, Ltd."," The North Building, Golden Plaza
20 Xianggang Zhong Road
Quingdao, CHINA 266071
[Updated in letter dated August 1, 2018]",01/11/2011," GRN 367 (in PDF)",,,,,,,07/08/2011,," FDA has no questions",12/07/2016," Additional correspondence regarding specification changes",,,,,,,, =T("368")," Corn hull fiber"," Use as an ingredient in various food categories including meat and poultry"," Scientific procedures"," Z Trim Holdings, Inc."," 1011 Campus Drive
Mundelein, IL 60060",01/12/2011," GRN 368 (in PDF)",,,,,,,04/06/2011,," At the notifier's request, FDA ceased to evaluate this notice",,,,,,,,,, =T("369")," Rebaudioside A purified from the leaves of Stevia rebaudiana (Bertoni) Bertoni  "," General-purpose sweetener in foods, excluding meat and poultry products, at levels determined by current good manufacturing practices"," Scientific procedures"," Zhucheng Haotian Pharm Co., Ltd.
C/O Shanghai Freemen Americas, LLC"," 377 Hoes Lane, Suite 306
Piscataway, NJ 08854",01/12/2011," GRN 369 (in PDF)",,,,,,,10/11/2011,," FDA has no questions",,,,,,,,,, =T("370")," Xylooligosaccharide"," Ingredient in a variety of foods including baby and toddler foods"," Scientific procedures"," Shangdong Longlive Bio-technology Co., Ltd."," Room 806, D&D Fortune Center, No. 182-6 Haier Road, Laoshan District
Qingdao, CHINA",01/20/2011," GRN 370 (in PDF)",,,,,,,03/28/2011,," At the notifier's request, FDA ceased to evaluate this notice",,,,,,,,,, =T("371")," Krill oil"," Use as a direct food ingredient in breakfast cereals, cheese, beverages (nonalcoholic), fruit juices, frozen dairy desserts, milk products, and medical foods at levels up to 500 milligrams per serving"," Scientific procedures"," EVP Documentation"," Aker Biomarine Antartic AS
Fjordalleen 16, 0115 Oslo
NORWAY",02/07/2011," GRN 371 (in PDF)",,,,,,,07/22/2011,," FDA has no questions; some uses may require a color additive listing",,,,,,,,,, =T("372")," Glucoamylase enzyme preparation from Trichoderma reesei expressing the glucoamylase gene from T. reesei (glucoamylase enzyme preparation)"," Use as an enzyme in grain processing, including the manufacture of corn sweeteners such as high fructose corn syrup, brewing, potable alcohol manufacture, and lactic acid production"," Scientific procedures"," Genencor, a Danisco Division"," 925 Page Mill Road,
Palo Alto, CA 94304",02/23/2011," GRN 372 (in PDF)",,,,,,,07/25/2011,," FDA has no questions",,,,,,,,,, =T("373")," Rice bran fiber"," As an ingredient in food, excluding meat and poultry, at levels consistent with current good manufacturing practice"," Scientific procedures"," CJ America, Inc."," 3500 Lacey Road, Suite 320,
Downers Grove, IL 60515",02/28/2011," GRN 373 (in PDF)",,,,,,,08/19/2011,," FDA has no questions",,,,,,,,,, =T("374")," Maleated isoprenyl polymer with methoxy-polyethylene glycol (MIP-MPEG)"," As a gum base polymer additive in chewing gum formulations at levels up to 15% of gum base. MIP-MPEG is added to improve gum removability from a variety of surfaces"," Scientific procedures"," Revolymer Limited"," Dock Road, Mostyn, Holywell,
Flintshire, CH8 9HE
UNITED KINGDOM",03/08/2011," GRN 374 (in PDF)",,,,,,,08/16/2011,," FDA has no questions",,,,,,,,,, =T("375")," Enzyme-modified steviol glycosides"," General-purpose sweetener in foods, excluding meat and poultry products, at levels determined by good manufacturing practices"," Scientific procedures"," Toyo Sugar Refining Co., Ltd.
AND
Nippon Paper Chemicals Co., Ltd.

"," 18-20, Nihonbashi, Koami-cho, Chuo-ku
Tokyo 103-0016
JAPAN
AND
1-2-2, Hitotsubashi, Chiyoda-ku
Tokyo 100-0003
JAPAN",03/09/2011," GRN 375 (in PDF)",,,,,,,09/02/2011,," FDA has no questions",,,,,,,,,, =T("376")," Milk mineral concentrate"," As a salt (sodium chloride) substitute in foods, excluding meat and poultry"," Scientific procedures"," Armour Proteines"," Z.I. Le Pont
35460 Saint-Brice en Cogles
FRANCE",03/24/2011," GRN 376 (in PDF)",,,,,,,10/11/2011,," FDA has no questions",,,,,,,,,, =T("377")," Bifidobacterium animalis subsp. lactis strain Bf-6"," As an ingredient in foods"," Scientific procedures"," Cargill, Inc."," 15407 McGinty Road West,
Wayzata, MN 55391",04/06/2011," GRN 377 (in PDF)",,,,,,,09/29/2011,," FDA has no questions",,,,,,,,,, =T("378")," Cultured [dairy sources, sugars, wheat, malt, and fruit- and vegetable-based sources] fermented by [Streptococcus thermophilus, Bacillus coagulans, Lactobacillus acidophilus, Lactobacillus paracasei subsp. paracasei, Lactobacillus plantarum, Lactobacillus sakei, Lactobacillus bulgaricus and Proprionibacterium freudenreichii subsp. shermanii or mixtures of these strains]"," As antimicrobial agents in a variety of food categories typically at levels of 0.1 to 4.5%, including meat and poultry, but excepting infant formula and infant foods"," Scientific procedures"," PURAC"," Arkelsedijk 46, 4206 AC Gorinchem,
The NETHERLANDS",05/03/2011," GRN 378 (in PDF)",,,,,,,03/26/2012,," FDA has no questions",,,,,,,,,, =T("379")," Tuna oil"," Provide docosahexaenoic acid in term and preterm infant formula, at a maximum level of 0.5 grams per 100 grams of total fatty acids, when used in combination with an appropriate source of arachidonic acid"," Scientific procedures"," Ocean Nutrition Canada Ltd"," 101 Research Drive, Dartmouth
Nova Scotia B2Y 4T6
CANADA",05/12/2011," GRN 379 with amendments (in PDF)",,,,,,,11/08/2011,," FDA has no questions",,,,,,,,,, =T("380")," Rebaudioside A purified from the leaves of Stevia rebaudiana (Bertoni) Bertoni (rebaudioside A)"," General purpose sweetener in foods, excluding meat and poultry products, at levels determined by good manufacturing practices, as well as use as a table top sweetener"," Scientific procedures"," GLG Life Tech Corporation"," World Trade Centre, 999 Canada Place
Suite 519
Vancouver, British Columbia, V6C3E1
CANADA",06/01/2011," GRN 380 (in PDF)",,,,,,,11/28/2011,," FDA has no questions",,,,,,,,,, =T("381")," Phytic acid"," As an antioxidant, chelating agent, and antimicrobial agent in beverages and beverage bases, milk products, processed vegetables, and vegetable juices at a level of 0.2%

Use in limiting solubility reduction and providing strength to dietary supplement capsules at a level of 8.0%"," Scientific procedures"," Tsuno Food Industrial Co., Ltd."," 94 Shinden, Katsuragi
Ito-gun, Wakayama 649-7194
JAPAN",06/01/2011," GRN 381 (in PDF)",,,,,,,06/04/2012,," FDA has no questions",,,,,,,,,, =T("382")," Erythritol"," As a flavor enhancer, formulation aid, humectant, nutritive sweetener, stabilizer and thickener, sequestrant, and texturizer in a variety of foods"," Scientific procedures"," Baolingbao Biology Co., Ltd."," NO. 1, Dongwai Huan Road
High Tech Development Zone Yucheng
Shangdong
CHINA",06/02/2011," GRN 382 (in PDF)",,,,,,,11/21/2011,," FDA has no questions",,,,,,,,,, =T("383")," Magnesium dihydrogen pyrophosphate (MDPP)"," As a stabilizer, leavening agent, and acidifying agent in self-rising flour, noodles (oriental style), batters and breading, processed cereals, and bakery products, at a level ranging from 2 grams per kilogram (g/kg) to 15 g/kg"," Scientific procedures"," Chemische Fabrik Budenheim KG"," Rheinstr. 27
D 55257 Budenheim
GERMANY",06/08/2011," GRN 383 (in PDF)",,,,,,,12/02/2011,," FDA has no questions",,,,,,,,,, =T("384")," Algal oil derived from Chlorella protothecoides strain S106 (Cp algal oil)"," As a substitute for vegetable oil for cooking

As a substitute for vegetable oil at levels ranging from 1.8 to 26% in specified foods: baked goods and baking mixes, beverages and beverage bases, confections and frostings, fats and oils, frozen dairy desserts and mixes, gelatins, puddings, and fillings, grain products and pastas, milk products, nut and nut products, processed fruit and fruit juices, snack foods, soft candy, soups and soup mixes, and sweet sauces, toppings, and syrups"," Scientific procedures"," Solazyme, Inc."," 225 Gateway Blvd.
South San Francisco, CA 94080",06/15/2011," GRN 384 (in PDF)",,,,,,,06/13/2012,," FDA has no questions",,,,,,,,,, =T("385")," Lutein"," Ingredient in baked goods and baking mixes, beverages and beverage bases, breakfast cereals, chewing gum, dairy product analogs, egg products, fats and oils, frozen dairy desserts and mixes, gravies and sauces, hard candy, infant and toddler foods (other than infant formula), milk products, processed fruit and fruit juices, soft candy, soups and soup mixes, and medical foods intended as the sole item of the diet, at levels ranging from 0.3 to 3.0 milligrams (mg) per reference amount customarily consumed"," Scientific procedures"," OmniActive Health Technologies Ltd."," Cyber House, Ground Floor
J B Sawant Marg. Wagle Industrial Estate,
Thane (West) 400 604
INDIA",06/21/2011," GRN 385 (in PDF)",,,,,,,12/16/2011,," FDA has no questions; some uses may require a color additive listing",,,,,,,,,, =T("386")," Canola protein isolate and hydrolyzed canola protein isolate"," Ingredients in foods such as bakery products, snack foods, beverages, soups, dairy products, dry instant milkshake mixes and protein drinks, instant powdered nutritional beverages, processed meat and poultry products, vegetarian food products/meat analogues, and meal replacement and nutritional bars"," Scientific procedures"," BioExx Specialty Proteins Ltd."," 219 (North) Dufferin Street, Suite 100 B
Toronto, Ontario
M6K 3J1
CANADA",06/22/2011," GRN 386 (in PDF)",,,,,,,12/28/2011,," FDA has no questions",,,,,,,,,, =T("387")," Plant-derived esterified and non-esterified sterols and stanols (phytosterols)"," As an ingredient in food"," Scientific procedures"," Cognis Corporation, Nutrition and Health"," 5325 S. 9th Ave.
La Grande, IL 60525",07/06/2011," GRN 387 (in PDF)",,,,,,,12/19/2011,," FDA has no questions",,,,,,,,,, =T("388")," Rebaudioside A purified from the leaves of Stevia rebaudiana (Bertoni) Bertoni (rebaudioside A)"," General-purpose sweetener in foods, excluding meat and poultry products, at levels determined by current good manufacturing practices, as well as use as a table top sweetener"," Scientific procedures"," Chengdu Wagott Pharmaceutical"," Company facility: 5/F, A Building, Tianhe Incubator, Hi-tech Incubating Park, Tianfu Ave.,
Chengdu, Sichuan 610041 CHINA",07/13/2011," GRN 388 (in PDF)",,,,,,,01/09/2012,," FDA has no questions",,,,,,,,,, =T("389")," Steviol glycosides with stevioside as the principal component"," General-purpose sweetener in foods, excluding meat and poultry products, at levels determined by current good manufacturing practices, as well as use as a table top sweetener"," Scientific procedures"," Chengdu Wagott Pharmaceutical"," Company facility: 5/F, A Building, Tianhe Incubator, Hi-tech Incubating Park, Tianfu Ave.,
Chengdu, Sichuan 610041 CHINA",07/26/2011," GRN 389 (in PDF)",,,,,,,01/18/2012,," FDA has no questions",,,,,,,,,, =T("390")," Suspended lutein"," Ingredient in formulas intended for premature infants at levels up to 210 micrograms of lutein per liter of formula"," Scientific procedures"," Abbott Nutrition"," 3300 Stelzer Road
Columbus, OH 43219",07/26/2011," GRN 390 (in PDF)",,,,,,,01/09/2012,," FDA has no questions; some uses may require a color additive listing",,,,,,,,,, =T("391")," Spirulina (Arthrospira platensis)"," As an ingredient in the following food categories; beverages and beverage bases (nonalcoholic, including only special or spiced teas, soft drinks, coffee substitutes, and fruit and vegetable flavored gelatin drinks); breakfast cereals (including ready-to-eat and instant and regular hot cereals); fresh fruits and fruit juices (including only raw fruits, citrus, melons, berries, and home-prepared ades and punches made there from); frozen dairy desserts and mixes, (including ice cream, ice milks, sherbets, and other frozen dairy desserts and specialties); grain products and pastas (including macaroni and noodle products, rice dishes, and frozen multicourse meals, without meat or vegetables); milk products (including flavored milks and milk drinks, dry milks, toppings, snack dips, spreads, weight control milk beverages, and other milk origin products); plants protein products (including the National Academy of Sciences/National Research Council reconstituted vegetable protein category, and meat, poultry, and fish substitutes, analogs, and extended products made from plant proteins); processed fruits and fruit juices (including all commercially processed fruits, citrus, berries and mixtures, salads, juices and juice punches, concentrates, dilutions, ades, and drink substitutes made there from); processed vegetables and vegetable juices (including all commercially processed vegetables, vegetable dishes, frozen multicourse vegetable meals, and vegetable juices and blends) snack foods (including chips, pretzels, and other novelty snacks), soft candy (including candy bars, chocolates, fudge, mints, and other chewy or nougat candies), and soup and soup mixes (including commercially prepared meat, fish, poultry (at levels that fall within FDA jurisdiction), vegetable, and combination soups and soup mixes)"," Scientific procedures"," E.I.D. Parry (India) Limited
Parry Nutraceuticals Division
""Dare House"""," No. 234, N.S.C. Bose Road
Chennai-600 001
INDIA",07/27/2011," GRN 391 (in PDF)",,,,,,,10/06/2011,," At the notifier's request, FDA ceased to evaluate this notice",,,,,,,,,, =T("392")," Oligofructose"," Ingredient in milk-based term infant formula powder at a maximum level of three grams per liter of formula as consumed"," Scientific procedures"," Pfizer Nutrition
and
BENEO-Orafti"," RC/RC3161
500 Arcola Road
Collegeville, PA 19426

Gottlieb-Daimler Strasse 12
68165 Mannheim
GERMANY",07/27/2011," GRN 392 (in PDF)",,,,,,,05/07/2012,," FDA has no questions",,,,,,,,,, =T("393")," Rebaudioside A purified from the leaves of Stevia rebaudiana (Bertoni) Bertoni (rebaudioside A)"," General-purpose sweetener in foods, excluding meat and poultry products, at levels determined by current good manufacturing practices, as well as use as a table top sweetener"," Scientific procedures"," Daepyung Co., Ltd."," Leaders B/D 604, #274-4 Seohyeon-Dong
Bundang-Gu, Seongnam-Si, Gyeonggi-Do
Republic of SOUTH KOREA (463-824)",07/29/2011," GRN 393 (in PDF)",,,,,,,01/23/2012,," FDA has no questions",,,,,,,,,, =T("394")," Dried biomass of Arthrospira platensis, also known as Spirulina platensis (Spirulina)"," As an ingredient in beverages and beverage bases, breakfast cereals, fresh fruits and fruit juices, frozen dairy desserts and mixes, grain products and pastas, milk products, plant protein products, processed fruits and fruit juices, processed vegetables and vegetable juices, snack foods, soft candy, and soups and soup mixes at a level of 0.5 to 3 grams spirulina per serving"," Scientific procedures"," RFI, Inc."," 300 Corporate Drive, Suite 14
Blauvelt, NY 10913",07/29/2011," GRN 394 (in PDF)",,,,,,,06/04/2012,," FDA has no questions; some uses may require a color additive listing",12/27/2012," Additional correspondence about intended use",,,,,,,, =T("395")," Steviol glycosides with rebaudioside A and stevioside as the principal components"," General-purpose sweetener in foods, excluding meat and poultry products, at levels determined by current good manufacturing practices, as well as use as a table top sweetener"," Scientific procedures"," Daepyung Co., Ltd."," Leaders B/D 604, #274-4 Seohyeon-Dong
Bundang-Gu, Seongnam-Si, Gyeonggi-Do
Republic of SOUTH KOREA (463-824)",08/01/2011," GRN 395 (in PDF)",,,,,,,01/24/2012,," FDA has no questions",,,,,,,,,, =T("396")," Chlorella vulgaris strain Beij"," As an ingredient in a variety of foods excluding meat and poultry"," Scientific procedures"," RFI, Inc."," 300 Corporate Drive, Suite 14
Blauvelt, NY 10913",08/03/2011," GRN 396 (in PDF)",,,,,,,07/05/2012,," At the notifier's request, FDA ceased to evaluate this notice",,,,,,,,,, =T("397")," Chitosan from Aspergillus niger"," As a secondary direct food ingredient in alcoholic beverage production at levels between 10 and 500 grams per hectoliter (100 liters)"," Scientific procedures"," KitoZyme sa"," Rue Haute Claire, 4
Parc Industriel des Hauts-Sarts, Zone 2
BE-4040 Herstal
BELGIUM",08/08/2011," GRN 397 (in PDF)",,,,,,,12/19/2011,," FDA has no questions",,,,,,,,,, =T("398")," Vegetable oil and tall oil derived phytosterol and phytosterol ester formulations"," As an ingredient in baked goods and baking mixes; beverages and beverage bases; breakfast cereals; cheeses; coffee and tea; condiments and relishes; dairy product analogs; egg products; fats and oils; fish products; frozen dairy desserts and mixes; grain products and pastas; gravies and sauces; hard candy; herbs, seeds, spices, seasonings, blends, extracts, and flavorings; jams and jellies; whole and skim milk; milk products; nuts and nut products; processed fruits and fruit juices; processed vegetables and vegetables juices; snack foods; soft candy; and soups and soup mixes at levels of 0.5 or 1.0 grams per serving"," Scientific procedures"," Cargill Inc."," 15407 McGinty Road West
Wayzata, MN 55391",08/18/2011," GRN 398 (in PDF)",,,,,,,02/13/2012,," FDA has no questions",,,,,,,,,, =T("399")," Preparation of Bacillus coagulans strain GBI-30, 6086 spores"," As an ingredient in baked goods and baking mixes; beverages and beverage bases; breakfast cereals; chewing gum; coffee and tea; condiments and relishes; confections and frostings; dairy product analogs; fruit juices; frozen dairy desserts and mixes; fruit and water ices; gelatins, puddings, and fillings; grain products and pastas; hard candy; herbs, seeds, spices, seasonings, blends, extracts, and flavorings; jams and jellies; milk; milk products; nuts and nut products; plant protein products; processed fruits; processed vegetables and vegetable juices; snack foods; soft candy; soups and soup mixes; sugar; and sweet sauces, toppings, and syrups at a maximum level of approximately 2 x 109 colony forming units per serving"," Scientific procedures"," Ganeden Biotech, Inc."," 5915 Landerbrook Drive, Suite 304
Mayfield Heights, OH 44124",08/23/2011," GRN 399 (in PDF)"," GRN 399 amendments",,,,,,07/31/2012,," FDA has no questions",,,,,,,,,, =T("400")," D-psicose"," As a sugar substitute in the following food categories:
"," Scientific procedures"," CJ Cheiljedang, Inc."," Namdaemunro, 5-ga, Jung-gu
Seoul
Republic of SOUTH KOREA",08/25/2011," GRN 400 (in PDF)",,,,,,,06/18/2012,," FDA has no questions",,,,,,,,,, =T("401")," Erythritol"," Use as a flavor enhancer, formulation aid, humectant, nutritive sweetener, stabilizer and thickener, sequestrant, and texturizer in a variety of foods"," Scientific procedures"," O'Laughlin (Tianjin) Biotechnology Company"," Suite 1704 Chinachem Tower, No. 34-27
Connaught Road, Centarl
HONG KONG",09/28/2011," GRN 401 (in PDF)",,,,,,,03/22/2012,," FDA has no questions",,,,,,,,,, =T("402")," Peroxidase enzyme preparation derived from a genetically modified strain of Aspergillus niger"," As an enzyme for bleaching cheese whey that will be used in dairy products, bakery products, beverages, and infant formula"," Scientific procedures"," DSM Food Specialties"," P.O. Box 1
2600 MA Delft
The NETHERLANDS",09/28/2011," GRN 402 (in PDF)",,,,,,,11/23/2012,," FDA has no questions",,,,,,,,,, =T("403")," Carnallite sea salt (magnesium chloride, potassium chloride, salt)"," As a substitute for a portion of the sodium chloride used in food in general, including meat and poultry, but excluding infant formula"," Scientific procedures"," ICL Performance Products LP"," 622 Emerson Road, Suite 500
St. Louis, MO 63141",10/04/2011," GRN 403 (in PDF)",,,,,,,05/15/2012,," FDA has no questions",,,,,,,,,, =T("404")," Cyclic dextrin, highly branched"," As a carbohydrate source, flavoring agent or spray-drying aid in a variety of food products, including baked goods and baking mixes, beverages and beverage bases, breakfast cereals, tea, grain products, seasonings, milk and plant protein products, processed fruits and vegetables, fruit and vegetable juices, soft candy and powdered soups excluding meat and poultry products at a level ranging from 0.25 to 24 grams per reference amount customarily consumed per eating occasion"," Scientific procedures"," Ezaki Glico Co., Ltd."," 4-6-5, Utajima Nishioyogogawa
Osaka
JAPAN",10/11/2011," GRN 404 (in PDF)",,,,,,,09/10/2012,10/31/2012," FDA has no questions",,,,,,,,,, =T("405")," 1,4-α-glucan branching enzyme preparation from Geobacillus stearothermophilus strain TRBE14"," As an enzyme in the production of cyclic dextran"," Scientific procedures"," Ezaki Glico Co., Ltd."," 4-6-5, Utajima Nishioyogogawa
Osaka
JAPAN",10/11/2011," GRN 405 (in PDF)",,,,,,,09/11/2012,11/01/2012," FDA has no questions",12/15/2014," Additional correspondence regarding changes to the intended use received",,,,,,,, =T("406")," 1,4-α-glucan branching enzyme preparation from Bacillus subtilis strain 168 expressing the glucan branching enzyme gene from Aquifex aeolicus strain VF5"," As an enzyme in the production of cyclic dextran and enzymatically-synthesized glycogen"," Scientific procedures"," Ezaki Glico Co., Ltd."," 4-6-5, Utajima Nishioyogogawa
Osaka
JAPAN",10/11/2011," GRN 406 (in PDF)",,,,,,,09/11/2012,11/01/2012," FDA has no questions",,,,,,,,,, =T("407")," Polysaccharide complex of konjac glucomannan (konjac), sodium alginate, and xanthan gum (polysaccharide complex KAX)"," Use at levels up to seven percent as an ingredient to provide dietary fiber or to provide thickening or a stabilizing effect in yogurts, milk shakes and fruit smoothie-type drinks, frozen yogurt, ice cream bars, puddings, white and whole wheat breads, cookies, breakfast bars, granola-type bars, noodles, whole wheat cereals, meatless lasagna and macaroni/cheese, fruit juices, fruit juice bars, cereal beverages, and medical foods"," Scientific procedures"," Inovo Biologic, Inc."," 104-1240 Kensington Road NW, Suite 409
Calgary, Alberta
Y2N4Y7
CANADA",10/14/2011," GRN 407 (in PDF)",,,,,,,04/10/2012,," FDA has no questions",,,,,,,,,, =T("408")," Sulfuric acid and sodium sulfate"," As an acidifier or antimicrobial agent on meat and poultry to reduce levels of microorganisms and to prevent microbial growth"," Scientific procedures"," Advanced Food Technologies, LLC"," 11230 Magnolia Glen
Shrevport, LA 71106",10/14/2011," GRN 408 (in PDF)",,,,,,,03/06/2012,," FDA has no questions",,,,,,,,,, =T("409")," Lactobacillus reuteri strain NCIMB 30242"," As an ingredient for use in multiple foods and beverages"," Scientific procedures"," Micropharma Ltd."," 141 avenue du President Kennedy
5th Floor, UQAM - Biological Sciences Building
Unit 5569
Montreal, Quebec, CANADA
H2C 3Y7",10/18/2011," GRN 409 (in PDF)",,,,,,,01/10/2012,," At the notifier's request, FDA ceased to evaluate this notice",,,,,,,,,, =T("410")," Lactobacillus reuteri strain DSM 17938"," As an ingredient in powdered whey-based term infant formula at a minimum level of 106 colony forming units per gram (cfu/g), but not higher than 108 cfu/g of powdered formula, produced in accordance with current good manufacturing practices"," Scientific procedures"," Nestle Nutrition, U.S."," 12 Vreeland Road
Florham Park, NJ 07932",11/16/2011," GRN 410 (in PDF)",,,,,,,03/26/2012,," FDA has no questions",,,,,,,,,, =T("411")," Egg yolk-derived phospholipids"," As an ingredient in term and preterm infant formula at levels up to 2 grams phospholipids per liter of formula, providing a maximum of 0.28% and 0.18% of total fatty acids as arachidonic acid and docosahexaenoic acid, respectively"," Scientific procedures"," Laurent PHILIPPIN
OVOLIFE"," BNLfood Investments SARL
1, z.a. Salzbaach
L 9559 - Wiltz - LUXEMBOURG",01/04/2012," GRN 411 (in PDF)",,,,,,,11/20/2012,," FDA has no questions",,,,,,,,,, =T("412")," Chitin-glucan from Aspergillus niger"," Use in microbial stabilization, removal of contaminants, and/or clarification in alcoholic beverage production at levels between 10 and 500 grams per hectoliter"," Scientific procedures"," KitoZyme sa"," Rue Haute Claire, 4
Parc Industriel des Hauts-Sarts, Zone 2
BE-4040 Herstal
BELGIUM",01/05/2012," GRN 412 (in PDF)",,,,,,,06/18/2012,," FDA has no questions",,,,,,,,,, =T("413")," Beta glucans derived from Ganoderma lucidum mycelium"," As an ingredient in baked goods and baking mixes, beverages and beverage bases, cereal and cereal products, dairy product analogs, milk and milk products, plant protein products, processed fruits and fruit juices, and soft candy at a level of 150 milligrams β-glucans derived from G. lucidum mycelium per serving"," Scientific procedures"," Super Beta Glucan, Inc."," 5 Holland, Suite 109
Irvina, CA 92618",01/11/2012," GRN 413 (in PDF)",,,,,,,08/10/2012,," FDA has no questions",,,,,,,,,, =T("414")," L-lysine monohydrochloride"," To reduce the formation of acrylamide in fabricated snack products at use levels up to 1.5% (1.2% as lysine)"," Scientific procedures"," The Procter & Gamble Company"," Winston Hill Business Center
6300 Center Hill Road
Cincinnati, OH 45224",01/12/2012," GRN 414 (in PDF)",,,,,,,11/20/2012,," FDA has no questions",,,,,,,,,, =T("415")," Heat-killed Propionibacterium freudenreichii ET-3 culture (powder)"," As an ingredient in beverages and beverage bases, breakfast cereals, cheeses, coffee and tea, fats and oils, frozen dairy desserts and mixes, gelatins, puddings, and fillings, grain products and pastas, milk products, processed fruits and fruit juices, processed vegetables and vegetable juices, and soft candy at levels ranging from 0.2 to 0.6 grams per serving"," Scientific procedures"," Meiju Co., Ltd."," 1-2-10 Shinsuna
Koto-ku, Tokyo 136-8908
JAPAN",01/19/2012," GRN 415 (in PDF)",,,,,,,12/26/2012,," FDA has no questions; some uses may require a color additive listing",,,,,,,,,, =T("416")," Lutein diacetate"," As an ingredient in baked goods and baking mixes, beverages and beverage bases, breakfast cereals, chewing gum, dairy products analogs, fats and oils, frozen dairy desserts and mixes, gravies and sauces, hard candy, infant and toddler foods (other than infant formula), milk products, processed fruit and vegetable products, soft candy, soups and soup mixes, and medical foods intended as the sole item of the diet"," Scientific procedures"," Industrial Organica S.A. de C. V."," Ave. Almazan No. 100
Col. Topo Chico 64260
Monterrey
MEXICO",01/26/2012," GRN 416 (in PDF)",,,,,,,03/20/2012,," At the notifier's request, FDA ceased to evaluate this notice",,,,,,,,=T("432"),, =T("417")," Dried biomass of Arthrospira platensis also known as Spirulina platensis (spirulina)"," As an ingredient in beverages and beverage bases, breakfast cereals, fresh fruits and fruit juices, frozen dairy desserts and mixes, grain products and pastas, milk products, plant protein products, processed fruits and fruit juices, processed vegetables and vegetable juices, snack foods, soft candy, and soups and soup mixes at a level of 0.5 to 3 grams spirulina per serving"," Scientific procedures"," E.I.D. Parry (India) Limited
Parry Nutraceuticals Division
""Dare House"""," No. 234, N.S.C. Bose Road
Chennai-600 001
INDIA",02/01/2012," GRN 417 (in PDF)",,,,,,,08/10/2012,," FDA has no questions; some uses may require a color additive listing",,,,,,,,,, =T("418")," Rebaudioside A purified from the leaves of Stevia rebaudiana (Bertoni) Bertoni (rebaudioside A)"," General-purpose sweetener in foods, excluding meat and poultry products and infant formulas, at levels determined by good manufacturing practice"," Scientific procedures"," MiniStar International, Inc."," 21118 Commerce Pointe Drive
City of Industry, CA 91789",02/03/2012," GRN 418 (in PDF)",,,,,,,06/07/2012,," FDA has no questions",,,,,,,,,, =T("419")," L-alpha-glycerylphosphorylcholine"," As a source of choline in conventional beverage and beverage bases, including coffee, tea, milk (fluid), powdered milk, flavored milk/milk drinks, carbonated beverages, powdered beverages, meal replacement liquids, foods including yogurt, grain-based bars, protein bars, ready-to-eat breakfast cereals, and snack foods including chocolates, candies, and chewing gum at levels ranging from 10-100 milligrams"," Scientific procedures"," ChemiNutra, Inc."," 4463 White Bear Pkwy., Ste. 105
White Bear Lake, MN 55110",02/14/2012," GRN 419 (in PDF)",,,,,,,11/20/2012,," FDA has no questions",,,,,,,,,, =T("420")," Calcium acid pyrophosphate"," As a leavening agent in baked products"," Scientific procedures"," Innophos, Inc."," 259 Prospect Plains Road, Building N
P.O. Box 8000
Cranbury, NJ 08512-8000",02/14/2012," GRN 420 (in PDF)",,,,,,,08/10/2012,," FDA has no questions",,,,,,,,,, =T("421")," Sucrose fatty acid esters"," As surface-active agents (i.e., foaming agents) at a maximum level of 0.2 percent in foams produced using alcoholic beverages"," Scientific procedures"," Libaeration Ltd."," Ash Tree Farm, 25 Mill Lane
Boston, Lincolnshire PE22 0JE
UNITED KINGDOM",02/23/2012," GRN 421 (in PDF)",,,,,,,08/10/2012,," FDA has no questions",,,,,,,,,, =T("422")," Modified baker's yeast Saccharomyces cerevisiae"," To reduce acrylamide production in a variety of grain-based foods, vegetable-based food (potato), and coffee and coffee substitutes at a level of 0.5 to 5 percent"," Scientific procedures"," Functional Technologies Corporation"," Suite 1500, 885 West Georgia Street
Vancouver, British Columbia, V6C 3E8
CANADA",03/05/2012," GRN 422 (in PDF)",,,,,,,08/31/2012,," FDA has no questions",,,,,,,,,, =T("423")," Cow's milk-derived lactoferrin"," Use as an ingredient in cow's milk-based term infant formulas at a level of 13 milligram per 100 milliliter (mg/mL) formula (ready-to-feed or prepared from powder or concentrate) and in other cow's milk-based products including yogurts (100 mg per 100 gram (g)), powdered milk (400 mg/100 g), and milk-based frozen desserts (200 mg/100 g), and in chewing gum (30 mg/g)"," Scientific procedures"," Morinaga Milk Industry Co., Ltd"," 33-1, Shiba 5-Chome, Minato-ku,
Tokyo 108-8384
JAPAN",03/07/2012," GRN 423 (in PDF)",,,,,,,05/02/2012,," At the notifier's request, FDA ceased to evaluate this notice",,,,,,,,,, =T("424")," C-c-phycocyanin-enriched water extract of the cyanobacterium Arthrospira maxima or Arthrospira platensis, (also known as Spirulina maxima or Spirulina platensis)"," As an ingredient in all foods except infant formulas and foods under USDA's jurisdiction at levels up to a maximum of 250 milligrams per serving"," Scientific procedures"," Desert Lake Technologies, LLC"," 3735 Washburn Way
Klamath Falls, Oregon 97603",03/20/2012," GRN 424 (in PDF)",,,,,,,12/06/2012,," FDA has no questions; some uses may require a color additive listing",,,,,,,,,, =T("425")," Canola oil (low erucic acid rapeseed oil)"," As a source of fat in term infant formulas at levels up to 31% of total fat blend in formula"," Scientific procedures"," Danone Trading B.V."," Schiphol Boulevard 105
1118 BG Schiphol Airport
THE NETHERLANDS",03/21/2012," GRN 425 (in PDF)",,,,,,,11/20/2012,," FDA has no questions",,,,,,,,,, =T("426")," Rice hull fiber"," As an anti-caking agent and flow aid in a variety of foods including meat, poultry, and egg products at levels consistent with current good manufacturing practices"," Scientific procedures"," RIBUS, Inc."," 8000 Maryland, Suite 460
St. Louis, MO 63105",03/21/2012," GRN 426 (in PDF)",,,,,,,05/29/2012,," At the notifier's request, FDA ceased to evaluate this notice",,,,,,,,,, =T("427")," Corn hull fiber"," Use as a formulation aid and/or source of fiber at levels ranging from 0.25 to 3.0 percent in:
"," Scientific procedures"," Z Trim Holdings, Inc."," 1011 Campus Drive
Mundelein, IL 60060",03/21/2012," GRN 427 (in PDF)",,,,,,,09/12/2012,," FDA has no questions",,,,,,,,,, =T("428")," Asparaginase enzyme preparation from genetically modified Aspergillus niger"," As an enzyme at specified levels to reduce the levels of free L-asparagine, specifically in (1) bread (such as tin bread, buns, rolls, French sticks or batards, variety breads like multigrain types of bread, raisin bread, biscuits, crackers); (2) other cereal-based products (such as corn crackers, cakes, Swiss rolls, Dutch honey cake, breakfast cereals); and (3) potato-based products (such as French fries, potato chips)"," Scientific procedures"," DSM Food Specialties"," PO Box 1
2600 MA Delft
The NETHERLANDS",03/28/2012," GRN 428 (in PDF)",,,,,,,11/26/2012,," FDA has no questions",,,,,,,,,, =T("429")," Lactobacillus casei strain Shirota"," As an ingredient in fermented dairy products at a maximum level of 4x108 colony forming units per milliliter"," Scientific procedures"," Yakult Honsha Co., Ltd."," 1-19, Higashi-Shinbashi, 1-chome, Minato-ku
Tokyo, 105-8600
JAPAN",04/10/2012," GRN 429 (in PDF)",,,,,,,12/10/2012,," FDA has no questions",,,,,,,,,, =T("430")," Sugar beet fiber"," Use in various non-standardized meat and poultry products as a binder and texturizing agent, in bakery products as a binder and source of fiber, in cereals and muesli as a texturizing agent and source of fiber, in sauces as a thickening agent, and in cheese as an anti-caking and/or dispersing agent"," Scientific procedures"," Nordic Sugar A/S"," Langebrogade 1
P.O. Box 2100
DK-1014 Copenhagen K
DENMARK",05/15/2012," GRN 430 (in PDF)",,,,,,,03/06/2013,," FDA has no questions",,,,,,,,,, =T("431")," Colostral whey protein concentrate"," As an ingredient in multiple food categories at a level of either 1 gram or 100 milligrams per serving of food, depending on which of two product formulations is used"," Scientific procedures"," Sterling Technology, Inc."," 133 32nd Ave.
Brookings, SD 57006",05/21/2012," GRN 431 (in PDF)",,,,,,,10/12/2012,," At the notifier's request, FDA ceased to evaluate this notice",,,,,,,,,, =T("432")," Lutein diacetate"," As an ingredient in baked goods and baking mixes, beverages and beverage bases, breakfast cereals, chewing gum, dairy product analogs, fats and oils, frozen dairy desserts and mixes, gravies and sauces, hard candy, infant and toddler foods (excluding infant formula), milk products, processed fruits and fruit juices, soft candy, and soups and soup mixes at levels of 0.3 to 3 milligram per serving"," Scientific procedures"," Industrial Organica S.A. de CV"," Ave. Almazan No. 100
Col. Topo Chico 64260
Monterrey
MEXICO",05/22/2012," GRN 432 (in PDF)",,,,,,,11/14/2012,," FDA has no questions; some uses may require a color additive listing",,,,,,,=T("416"),,, =T("433")," Poloxamer fatty acid esters"," As a pulping agent aid in the alkaline pulping of lignocellulosic material at levels not to exceed 0.5 percent by weight of raw lignocellulosic material"," Scientific procedures"," Chemical Products Corporation"," 102 Old Mill Road SE
P.O. Box 2470
Cantersville, GA 30120-1692",05/29/2012," GRN 433 (in PDF)",,,,,,,08/03/2012,," At the notifier's request, FDA ceased to evaluate this notice",,,,,,,,,, =T("434")," Dried aqueous extract derived from white kidney bean (Phaseolus vulgaris)"," As an ingredient in food providing an aggregate intake of up to 10 grams per person per day"," Scientific procedures"," Pharmachem Laboratories, Inc."," 265 Harrison Avenue
Kearny, NJ 07032",06/21/2012," GRN 434 (in PDF)",,,,,,,10/10/2012,," At the notifier's request, FDA ceased to evaluate this notice",,,,,,,,=T("480"),, =T("435")," Preparation consisting of six bacterial monophage specific to Salmonella enterica (monophage cocktail)"," As an antimicrobial for ready-to-eat and raw poultry products; ready-to-eat and raw red meat carcasses, subprimals, and trimmings; fish; shellfish; and fresh and processed fruits and vegetables at 107 plaque-forming units per gram of food."," Scientific procedures"," Intralytix, Inc."," 701 E. Pratt Street
Baltimore, MD 21202",07/06/2012," GRN 435 (in PDF)",,,,,,,02/22/2013,," FDA has no questions",06/28/2021," Second Supplement letter (in PDF)",11/15/2019," Supplemental Letter (in PDF)",02/13/2015," Additional correspondence regarding an additional intended use",,,, =T("436")," Enzyme-modified dextrins"," As bulking agents or as sources of fiber in baked goods, beverages (liquid non-dairy), cereals and granola bars, condiments and dressings, confections, dairy beverages, dairy (non-beverages), frozen desserts, gravies and sauces, meal replacements, pasta and grain products, prepared meals and soups (excluding meat and poultry products), processed fruits, shelf-stable desserts, snacks and crackers, and dry beverage powders, at levels of 3 to 9 grams per serving"," Scientific procedures"," Roquette Freres"," Batiment Alpha 3
Lestrem 62136
FRANCE",07/23/2012," GRN 436 (in PDF)",,,,,,,01/18/2013,," FDA has no questions",,,,,,,,,, =T("437")," Beta-glucans from oat bran"," As a source of fiber at levels resulting in 0.75 to 3.0 grams of beta-glucans per serving, in bars; beverages; whole grain and specialty breads; breakfast cereals; lite cookies; reduced fat crackers; lite gravies and sauces; instant rice; macaroni products; reduced fat muffins; lite salad dressing; reduced fat snack chips; soups; tomato-based sauces; tortillas and taco shells; vegetarian patties and crumbles; reduced fat yogurt; and medical foods. Use in foods for infants and toddlers or in meat and poultry products is excluded."," Scientific procedures"," Garuda International, Inc."," P.O. Box 159
Exeter, CA 93221",07/31/2012," GRN 437 (in PDF)",,,,,,,01/27/2013,," FDA has no questions",,,,,,,,,, =T("438")," Plant stanol esters"," As an ingredient in baked goods and baking mixes, beverages and beverage bases, breakfast cereals; cheeses, coffee and tea, dairy product analogs, fats and oils, grain products and pastas, gravies and sauces, milk, milk products, processed fruits and fruit juices, processed vegetables and vegetable juices, soft candy, and soups and soup mixes at a level ranging between 0.5 to 2.0 grams plant stanols per serving (provided as plant stanol esters). Use in gravies, sauces, soup and soup mixes under USDA's jurisdiction is excluded."," Scientific procedures"," Raiso Nutrition Ltd., Benecol Division"," P.O. Box 101 (Raisiokaari 55)
FI-21201
FINLAND",08/01/2012," GRN 438 (in PDF)",,,,,,,01/16/2013,," FDA has no questions",,,,,,,,,, =T("439")," Iron complex of tartaric acid"," As an anti-caking agent in salt at a maximum level of 12 parts per million"," Scientific procedures"," Akzo Nobel Industrial Chemicals BV"," P.O Box 107400
AA Deventer
The NETHERLANDS",09/16/2012," GRN 439 (in PDF)",,,,,,,11/09/2012,," At the notifier's request, FDA ceased to evaluate this notice",,,,,,,,,, =T("440")," Lactobacillus reuteri strain NCIMB 30242"," As an ingredient in beverages and beverage bases, breakfast cereals, cheeses, dairy product analogs, fats and oils, frozen dairy desserts, grain products and pastas, milk products, processed fruits and fruit juices, and sugar substitutes at levels ranging from 3.3 X 108 to 1010 colony forming units per serving"," Scientific procedures"," Micropharma Ltd."," 141 avenue du President Kennedy
5th Floor, UQAM - Biological Sciences Building
Unit 5569
Montreal, Quebec, CANADA
H2C 3Y7",08/16/2012," GRN 440 (in PDF)",,,,,,,02/12/2013,," FDA has no questions",,,,,,,,,, =T("441")," Sodium ferrous citrate"," Use in various food categories as a source of dietary iron for food enrichment and fortification purposes consistent with iron supplementation guidelines"," Scientific procedures"," Eisai Food and Chemical Co., Ltd."," 5th Floor, Nihonbashi Sunrise Building
3-13-10 Nihonbashi Chuo-ku
Tokyo 103-0027
JAPAN",08/23/2012," GRN 441 (in PDF)",,,,,,,05/10/2013,," FDA has no questions; some uses may require a color additive listing",,,,,,,,,, =T("442")," Volatile oil of mustard (white)"," As an antimicrobial in non-carbonated beverages, ketchup, sauces and gravies, and egg substitutes"," Scientific procedures"," ConAgra Foods, Inc."," ConAgra Drive
Mail Stop 6-460
Omaha, Nebraska 68102",08/28/2012," GRN 442 (in PDF)",,,,,,,01/03/2013,," At the notifier's request, FDA ceased to evaluate this notice",,,,,,,,,, =T("443")," Shrimp-derived chitosan"," Use in foods generally including meat and poultry, for multiple technical effects"," Scientific procedures"," Primex ehf"," Oskarsgata 7, 580 Siglufjordur
ICELAND",09/04/2012," GRN 443 (in PDF)",,,,,,,02/11/2013,," At the notifier's request, FDA ceased to evaluate this notice",,,,,,,=T("170"),,, =T("444")," Milk protein concentrate and milk protein isolate"," As ingredients in meal replacements and bars, term infant formula, milk products, non-standardized cheese products, confections and frosting, puddings and fillings, and dressings, soups, sauces, and snack foods"," Scientific procedures"," American Dairy Products Institute
and
U.S. Dairy Export Council
"," 116 N. York Street
Elmhurst, IL 60126
and
2101 Wilson Boulevard, Suite 400
Arlington, VA 22201",09/25/2012," GRN 444 (in PDF)",,,,,,,03/18/2013,," At the notifier's request, FDA ceased to evaluate this notice",,,,,,,,=T("504"),, =T("445")," Bifidobacterium animalis subsp. lactis strains HN019, Bi-07, Bl-04 and B420"," As ingredients in ready-to-eat breakfast cereals, bars, cheeses, milk drinks and milk products, bottled water and teas, fruit juices, fruit nectars, fruit 'ades' and fruit drinks, chewing gum, and confections at a maximum level of 2 x 1011 colony forming units per serving"," Scientific procedures"," Danisco USA, Inc."," 3329 Agricultural Drive,
Madison, WI 53716",10/12/2012," GRN 445 (in PDF)",,,,,,,04/10/2013,," FDA has no questions",,,,,,,,,, =T("446")," Red grape pomace extract"," As an antioxidant in fruit juices (except those for which a standard of identity exists), fruit flavored beverages, fruit flavored beverage mixes and carbonated fruit flavored beverages at a concentration of up to 210 milligrams/kilogram (alone or in combination with other safe and appropriate antioxidant substances)"," Scientific procedures"," Groupe GRAP'SUD"," 30 360 Cruvier-Lascours
FRANCE",10/16/2012," GRN 446 (in PDF)",,,,,,,04/15/2013,," FDA has no questions; some uses may require a color additive listing",,,,,,,,,, =T("447")," Potato protein isolates"," "," Scientific procedures"," Solanic B.V."," P.O. Box 15
9640 AA Veendam
The NETHERLANDS",11/05/2012," GRN 447 (in PDF)",,,,,,,05/24/2013,07/03/2013," FDA has no questions",02/11/2015," Additional correspondence regarding an additional intended use",01/23/2015," Additional correspondence regarding an additional intended use",,,,,, =T("448")," Enzyme-modified steviol glycosides"," As a general purpose sweetener in foods excluding meat and poultry products and infant formula, at levels determined by good manufacturing practice, as well as for use as a table top sweetener"," Scientific procedures"," Daepyung Co., Ltd."," Leaders B/D 604, #274-4 Seohyeon-Dong
Bundang-Gu, Seongnam-Si, Gyeonggi-Do
Republic of SOUTH KOREA (463-824)",11/05/2012," GRN 448 (in PDF)",,,,,,,05/03/2013,," FDA has no questions",,,,,,,,,, =T("449")," Medium chain triglycerides"," For a number of technical effects in baked goods, beverages, chewing gum, confections and frostings, dairy product analogues, fats and oils, frozen dairy desserts, processed fruits, snack foods, adult nutritionals, cheeses and cheese spreads and soft candies"," Scientific procedures"," Lonza, Inc."," 90 Boroline Road
Allendale, NJ",12/06/2012," GRN 449 (in PDF)",,,,,,,02/19/2014,," At the notifier's request, FDA ceased to evaluate this notice",,,,,,,,,, =T("450")," Chlorella protothecoides S106 flour with 40-70% lipid"," As an ingredient in baked goods, beverages and beverage bases, breakfast cereals, cheese, non-diary, egg products, fats and oils, frozen dairy, desserts and mixes, meal replacements, milk and milk products, snack foods, vegetable and seafood soups, and sweet sauces at levels ranging from 10 to 120 grams per kilogram of food"," Scientific procedures"," Solazyme Roquette Nutritionals, LLC"," 225 Gateway Blvd.
South San Francisco, CA 94080",12/12/2012," GRN 450 (in PDF)",,,,,,,04/19/2013,," At the notifier's request, FDA ceased to evaluate this notice",,,,,,,,=T("469"),, =T("451")," Calcium ascorbate with added threonate"," As a source of ascorbic acid (vitamin C) in beverages and beverage bases, breakfast cereals, chewing gum, coffee and tea, grain products, processed fruits and fruit juices, and medical foods at levels of up to 500 milligrams of vitamin C per serving"," Scientific procedures"," The Ester C Company"," 6735 Inter-Cal Way
Prescott, AZ 86301",12/12/2012," GRN 451 (in PDF)",,,,,,,08/05/2013,," FDA has no questions",,,,,,,,,, =T("452")," Enzyme-modified steviol glycosides"," General-purpose sweetener in foods, excluding infant formula and meat and poultry products, at levels determined by good manufacturing practices, as well as use as a table top sweetener"," Scientific procedures"," Daepyung Co., Ltd."," Leaders B/D 604, #274-4 Seohyeon-Dong
Bundang-Gu, Seongnam-Si, Gyeonggi-Do
Republic of SOUTH KOREA (463-824)",01/14/2013," GRN 452 (in PDF)",,,,,,,07/01/2013,," FDA has no questions",12/10/2018," Additional correspondence (in PDF)",,,,,,,, =T("453")," Bifidobacterium breve M-16V"," As an ingredient in baked goods, breakfast cereals, fruit juices and nectars, fruit ices, vegetable juices, milk-based drinks and powders, dairy product analogs, frozen dairy desserts, processed cheese, imitation cheese, cheese spreads, butter-type products, snack foods, gelatin, pudding, fillings, meal replacements, snack bars, nut and peanut spreads, hard and soft candies, cocoa-type powder, and condiment sauces at levels up to 5 x 109 colony forming units per serving"," Scientific procedures"," Morinaga Milk Industry Co., Ltd"," 33-1, Shiba 5-Chome, Minato-ku
Tokyo 108-8384, JAPAN",01/22/2013," GRN 453 (in PDF)",,,,,,,09/27/2013,," FDA has no questions",,,,,,,,,, =T("454")," Bifidobacterium breve M-16V"," As an ingredient in non-exempt powdered term infant formulas (milk- or soy-based) and exempt powdered term infant formula containing partially-hydrolyzed milk or soy proteins, at levels up to 108 colony forming units per gram of infant formula powder"," Scientific procedures"," Morinaga Milk Industry Co., Ltd"," 33-1, Shiba 5-Chome, Minato-ku
Tokyo 108-8384, JAPAN",01/22/2013," GRN 454 (in PDF)",,,,,,,09/27/2013,," FDA has no questions",,,,,,,,,, =T("455")," Bifidobacterium breve M-16V"," As an ingredient in exempt term powdered amino acid-based formulas, at levels providing 108 colony forming units per gram of infant formula powder"," Scientific procedures"," Danone Trading B.V."," Schiphol Boulevard 105
1118 BG Schiphol Airport
THE NETHERLANDS",01/23/2013," GRN 455 (in PDF)",,,,,,,09/30/2013,," FDA has no questions",,,,,,,,,, =T("456")," Rebaudioside D purified from the leaves of Stevia rebaudiana (Bertoni) Bertoni (rebaudioside D)"," General-purpose sweetener in foods, excluding infant formula and meat and poultry products, at levels determined by good manufacturing practices, as well as use as a table top sweetener"," Scientific procedures"," PureCircle USA, Inc."," 915 Harger Road, Suite 250
Oak Brook, IL 60523",01/23/2013," GRN 456 (in PDF)",,,,,,,07/01/2013,," FDA has no questions",,,,,,,,,, =T("457")," Bacteroides xylanisolvens strain DSM 23964"," As an ingredient in fermented low-fat and skim milk and milk products at 0.5x1012 B. xylanisolvens DSM 23964 heat inactivated cells or 150-300 milligrams of B. xylanisolvens DSM 23964 per 100 grams of food"," Scientific procedures"," Avitop GmbH"," Robert-Rössel-Str. 10
13125 Berlin-Buch
GERMANY",02/08/2013," GRN 457 (in PDF)",,,,,,,12/16/2013,," FDA has no questions",,,,,,,,,, =T("458")," Xylooligosaccharides"," "," Scientific procedures"," Shandong Longlive Bio-technology Co., Ltd."," R&D Fortune Center, Room 806
182-6 Haier Road
Laoshan District, Qingdoa
CHINA",02/08/2013," GRN 458 (in PDF)",,,,,,,08/23/2013,," FDA has no questions",,,,,,,,,, =T("459")," Olive pulp extract"," As an antioxidant in baked goods, beverages, cereals, sauces and dressings, seasonings, snacks, and functional foods at a level up to 3,000 milligrams per kilogram in the final food"," Scientific procedures"," Phenofarm s.r.l."," Domenico Chelini 5
00197, Rome
ITALY",02/04/2013," GRN 459 (in PDF)",,,,,,,03/25/2013,," At the notifier's request, FDA ceased to evaluate this notice",,,,,,,,,, =T("460")," Curcuminoids purified from turmeric (Curcuma longa L.)"," As a flavor, flavor enhancer, or an ingredient in baked goods, soups, snack foods, imitation dairy products, and seasoning, at levels up to 20 milligrams per serving"," Scientific procedures"," Sabinsa Corporation"," 20 Lake Drive
East Windsor, NJ
08520",02/28/2013," GRN 460 (in PDF)",,,,,,,08/23/2013,," FDA has no questions; some uses may require a color additive listing",,,,,,,,,, =T("461")," Rebaudioside A purified from the leaves of Stevia rebaudiana (Bertoni) Bertoni (rebaudioside A)"," General-purpose sweetener in foods, excluding infant formula and meat and poultry products, at levels determined by good manufacturing practices, as well as use as a table top sweetener"," Scientific procedures"," Almendra Limited"," All Seasons Places, 23rd Floor, M-Thai Tower
87 Wireless Road, Lumpini, Phatumwan, Bangkok
THAILAND",03/01/2013," GRN 461 (in PDF)",,,,,,,08/14/2013,," FDA has no questions",,,,,,,,,, =T("462")," Lipase enzyme preparation from modified Pseudomonas fluorescens Biovar I"," As an enzyme in the production of refined triacylglycerol-based oils used in food, at specified levels"," Scientific procedures"," Verenium Corporation"," 3550 John Hopkins Court
San Diego, CA 92121",03/04/2013," GRN 462 (in PDF)",,,,,,,06/06/2013,," FDA has no questions",,,,,,,,,, =T("463")," Lactobacillus acidophilus strain NP 28, Lactobacillus acidophilus strain NP51, Lactobacillus subsp. lactis strain NP7, and Pediococcus acidilactici strain NP3"," As an antimicrobial, up to 1x108 colony-forming units per gram of food, to control pathogenic bacteria in fresh chopped/ground, whole muscle cuts, and carcasses of meat and poultry and ready-to-eat meat products"," Scientific procedures"," Guardian Food Technologies, LLC"," 4550 West 109th Street, Suite 10
Overland Park, KS
66211",03/22/2013," GRN 463 (in PDF)",,,,,,,01/16/2014,," At the notifier's request, FDA ceased to evaluate this notice",,,,,,,,,, =T("464")," Cow's milk-derived lactoferrin"," As an ingredient in cow's milk-based food products,  including yogurt (100 milligrams (mg) per 100 grams (g)), powdered milk (400 mg/100 g), and ice cream and sherbets (200 mg/100 g), and in chewing gum (30 mg/g)"," Scientific procedures"," Morinaga Milk Industry Co., Ltd"," 33-1, Shiba 5-Chome, Minato-ku
Tokyo 108-8384, JAPAN",03/22/2013," GRN 464 (in PDF)",,,,,,,02/18/2014,," FDA has no questions",,,,,,,,,, =T("465")," Cow's milk-derived lactoferrin"," As an ingredient in cow's milk-based term infant formulas at a levels of  100 milligrams (mg) per 100 grams (g) powdered formulas, 26 mg per 100 milliliters (ml) liquid concentrates, and 13 mg /100ml ready-to-feed formula"," Scientific procedures"," Morinaga Milk Industry Co., Ltd"," 33-1, Shiba 5-Chome, Minato-ku
Tokyo 108-8384, JAPAN",03/22/2013," GRN 465 (in PDF)",,,,,,,02/18/2014,," FDA has no questions",,,,,,,,,, =T("466")," Polyglycerol polyricinoleic acid"," As an emulsifier in condiments and spreads at levels up to 0.28%, in flavors at levels up to 0.1%, and in snacks (cheese powders) at levels up to 0.15%"," Scientific procedures"," McCormick & Company, Inc."," 18 Loveton Circle, PO Box 6000
Sparks Glencoe, MD 21152",04/03/2013," GRN 466 (in PDF)",,,,,,,09/25/2013,," FDA has no questions",,,,,,,,,, =T("467")," Rebaudioside A purified from the leaves of Stevia rebaudiana (Bertoni) Bertoni"," As a table-top sweetener and as a general purpose non-nutritive sweetener in foods"," Scientific procedures"," Qufu Xiangzhou Stevia Products Co., Ltd."," Yulong Road No. 11
Qufu, Shangdong
CHINA 273100",04/30/2013," GRN 467 (in PDF)",,,,,,,11/25/2013,," FDA has no questions",,,,,,,,,, =T("468")," Preparation containing the bacterial monophages, Fo1a and S16, specific to Salmonella"," As an antimicrobial to control Salmonella serovars on certain pork and poultry products; beef; vegetables; and fresh and saltwater seafood (excluding Siluriformes (catfish)) at levels up to 108 plaque forming units (PFU)/g of food."," Scientific procedures"," Micreos B.V."," Nieuwe Kanaal 7P
6709 PA Wageningen
The NETHERLANDS",04/30/2013," GRN 468 (in PDF)",,,,,,,12/23/2013,," FDA has no questions",04/06/2021," Additional correspondence responding to a supplement (in PDF)",12/02/2016," Additional correspondence",,,,,, =T("469")," Chlorella protothecoides strain S106 flour with 40-70% lipid (algal flour)"," As a partial replacement for cream, milk, eggs/egg yolks, and/or butter/shortening. Algal flour is intended for use in baked goods, beverages and beverage bases, breakfast cereals, cheese, non-dairy, egg products, fats and oils (including salad dressing and mayonnaise), frozen dairy products, puddings and custards, meal replacements, milk and milk products, snack foods, vegetable and seafood soups, and sweet sauces at levels ranging from 5 to 120 grams per kilogram of food"," Scientific procedures"," Solazyme Roquette Nutritionals, LLC"," 225 Gateway Blvd
South San Francisco, CA, 94080",05/15/2013," GRN 469 (in PDF)",,,,,,,06/07/2013,," FDA has no questions; some uses may require a color additive listing",,,,,,,=T("450"),,, =T("470")," Ethyl cellulose"," For uses including viscosity modification, thickening, film-forming, stabilization, acting as a filler, and for thermal gelation in grain products, vegetables, fruits, milk and milk products, legumes, nuts and seeds, fats and oils, sugars and sweets, and beverages at levels ranging from 0.0075 to 5%"," Scientific procedures"," Dow Wolff Cellulosics"," 1691 N. Swede Road
Midland, MI 48674",05/15/2013," GRN 470 (in PDF)",,,,,,,12/16/2013,," FDA has no questions",,,,,,,,,, =T("471")," Annatto seed extract"," As a source of vitamin E in food at a level of up to 100 milligrams of tocotrienols per serving"," Scientific procedures"," American River Nutrition, Inc."," 31 Campus Plaza Road
Hadley, MA 01035",05/17/2013," GRN 471 (in PDF)",,,,,,,05/19/2014,," FDA has no questions; some uses may require a color additive listing",,,,,,,,,, =T("472")," Xylanase enzyme preparation derived from Bacillus licheniformis carrying a gene encoding a modified xylanase from B. licheniformis"," For use in the baking industry at a level of 0.5 grams of xylanase enzyme preparation per 100 kilograms of flour to modify arabinoxylans, resulting in improved dough handling and bread characteristics"," Scientific procedures"," Novozymes North America, Inc."," 77 Perry Chapel Church Road, P.O. Box 576
Franklinton, NC 27525",05/23/2013," GRN 472 (in PDF)",,,,,,,01/10/2014,," FDA has no questions",,,,,,,,,, =T("473")," Purified steviol glycosides with rebaudioside X as the principal component"," As an ingredient in food"," Scientific procedures"," PureCircle, Ltd."," 915 Harger Road, Suite 250
Oak Brook, IL 60523",05/23/2013," GRN 473 (in PDF)",,,,,,,12/17/2013,," FDA has no questions",,,,,,,,,, =T("474")," Piperine derived from the fruits of Piper nigrum L (black pepper) or P. longum (long pepper)"," As a flavoring agent in food"," Scientific procedures"," Sabinsa Corporation"," 20 Lake Drive
East Windsor, NJ
08520",06/17/2013," GRN 474 (in PDF)",,,,,,,09/19/2013,," At the notifier's request, FDA ceased to evaluate this notice",,,,,,,,,, =T("475")," Citrus fruit extract"," For use as antimicrobial and preservative in all nonstandardized food categories, excluding uses in infant formula and in food products regulated by the United States Department of Agriculture (USDA), at levels up to 1500 milligrams (mg) per kilogram (kg) of food."," Scientific procedures"," BIOSECUR Lab, Inc."," P.O. Box 85123
Mont St-Hilaire, Quebec J3H 5W1
CANADA",06/17/2013," GRN 475 (in PDF)",,,,,,,05/08/2014,," FDA has no questions",,,,,,,,,, =T("476")," Asparaginase enzyme preparation produced by genetically modified Bacillus subtilis"," As an enzyme in bread, potato, cereals, coffee and chocolate products, at a level of up to 20 milligram Total Organic Solids per kilogram of food"," Scientific procedures"," Novozymes North America, Inc."," 77 Perry Chapel Church Road, P.O. Box 576
Franklinton, NC 27525",06/19/2013," GRN 476 (in PDF)",,,,,,,02/03/2014,," FDA has no questions",,,,,,,,,, =T("477")," Long-chain inulin"," As an ingredient in term infant formulas, toddler formulas, and medical foods"," Scientific procedures"," Danone Trading B.V."," Schiphol Boulevard 105
1118 BG Schiphol Airport
THE NETHERLANDS",07/22/2013," GRN 477 (in PDF)",,,,,,,03/04/2014,," FDA has no questions",,,,,,,,,, =T("478")," Rice hull fiber"," As a source of dietary fiber"," Scientific procedures"," SunOpta Ingredients Group"," 1001 S. Cleveland Street
Cambridge, MN 55008",07/30/2013," GRN 478 (in PDF)",,,,,,,09/14/2015,," FDA has no questions",,,,,,,,,, =T("479")," Beta-glucanase, cellulase, and xylanase enzyme preparation from Talaromyces emersonii"," As an enzyme in the production of beer and fermented beverages at levels up to 500 grams per metric ton of grist"," Scientific procedures"," DSM Food Specialties"," P.O. Box 1
2600 MA Delft
The NETHERLANDS",08/05/2013," GRN 479 (in PDF)",,,,,,,03/07/2014,," FDA has no questions",,,,,,,,,, =T("480")," Dried aqueous extract derived from white kidney bean (Phaseolus vulgaris)"," As an ingredient in food providing an aggregate intake of up to 10 grams per person per day"," Scientific procedures"," Pharmachem Laboratories, Inc."," 265 Harrison Avenue
Kearny, NJ 07032",08/14/2013," GRN 480 (in PDF)",,,,,,,05/30/2014,," FDA has no questions",,,,,,,=T("434"),,, =T("481")," Meso-zeaxanthin"," As an ingredient in a variety of food and beverage applications"," Scientific procedures"," Industrial Organical S.A. de C.V."," Ave. Almazan No. 100
Col. Topo Chico, Monterrey, N.L.
MEXICO",08/28/2013," GRN 481 (in PDF)",,,,,,,04/11/2014,," FDA has no questions; some uses may require a color additive listing",,,,,,,,,, =T("482")," Beta-glucanase and xylanase enzyme preparation from Disporotrichum dimorphosporum"," As an enzyme in production of beer and other fermented beverages at levels up to 6.32 milligrams of total organic solids per liter"," Scientific procedures"," DSM Food Specialties"," P.O. Box 1
2600 MA Delft
The NETHERLANDS",09/16/2013," GRN 482 (in PDF)",,,,,,,07/03/2014,," FDA has no questions",,,,,,,,,, =T("483")," Aqueous extract of Emblica officinalis"," As a flavoring agent in foods"," Scientific procedures"," Natreon, Inc."," 2D Janine Place
New Brunswick, NJ 08901",09/18/2013," GRN 483 (in PDF)",,,,,,,04/17/2014,07/21/2014," FDA has no questions",,,,,,,=T("322"),,, =T("484")," Galacto-oligosaccharides"," As an ingredient in food and beverage products"," Scientific procedures"," Clasado, Inc."," 1620 Pinetree Drive
Pittsburg, PA 15241",09/19/2013," GRN 484 (in PDF)",,,,,,,05/08/2014,," FDA has no questions",,,,,,,,,, =T("485")," Beta-galactosidase enzyme preparation"," As an ingredient in foods"," Scientific procedures"," Clasado, Inc."," 1620 Pinetree Drive
Pittsburg, PA 15241",09/23/2013," GRN 485 (in PDF)",,,,,,,04/15/2014,," FDA has no questions",,,,,,,,,, =T("486")," Oil from the seeds of Buglossoides arvensis"," As an ingredient in foods"," Scientific procedures"," Technology Crops International, LLC"," P.O. Box 11925
Winston Salem, NC 27116",10/28/2013," GRN 486 (in PDF)",,,,,,,12/23/2014,," FDA has no questions",,,,,,,,,, =T("487")," Dried citrus pulp"," As a moisture retention agent, a flavor enhancing agent, and a processing aid in foods"," Scientific procedures"," Fiberstar, Inc."," 713 St. Croix Street
River Falls, WI 54022",10/28/2013," GRN 487 (in PDF)",,,,,,,06/06/2014,09/24/2014," FDA has no questions",,,,,,,,,, =T("488")," Benzalkonium chloride"," As a processing aid for lettuce and carrot products"," Scientific procedures"," Marvel Technologies USA, LLC"," 1224 Columbia Avenue
Franklin, TN 37064",10/31/2013," GRN 488 (in PDF)",,,,,,,05/15/2014,," At the notifier's request, FDA ceased to evaluate this notice",,,,,,,,,, =T("489")," Galacto-oligosaccharides"," Ingredient in infant formula at a maximum concentration of 4 grams per liter, infant and toddler foods at 3.8 milligrams per gram of food, and in the following food categories at a level 2.66 grams per serving:
"," Scientific procedures"," International Dairy Ingredients, Inc."," 26-1525 Cornwall Road
Oakville, ON L6J 0B2
CANADA",11/25/2013," GRN 489 (in PDF)",,,,,,,05/22/2014,," FDA has no questions",,,,,,,,,, =T("490")," Phospholipase A2 enzyme preparation from Trichoderma reesei"," As an enzyme to degum oils"," Scientific procedures"," AB Enzymes GmbH"," Feldbergstr. 78
D-64293 Darmstadt
GERMANY",11/27/2013," GRN 490 (in PDF)",,,,,,,03/05/2014,," At the notifier's request, FDA ceased to evaluate this notice",,,,,,,,,, =T("491")," Rooster combs extract"," As an ingredient in food"," Scientific procedures"," Bioberica S.A."," Plaça Francesc Macià, 7 08029 Barcelona SPAIN",12/19/2013," GRN 491 (in PDF)",,,,,,,06/06/2014,," FDA has no questions",,,,,,,,,, =T("492")," Phytosterols and phytosterol esters"," As an ingredient in foods"," Scientific procedures"," Vitae Naturals"," C/ Gutemberg 356. Polígono Torrehierro 45614 Talavera de la Reina Toledo SPAIN",12/20/2013," GRN 492 (in PDF)",,,,,,,06/24/2014,," FDA has no questions",,,,,,,,,, =T("493")," High purity steviol glycosides (minimum purity 95%)"," As a sugar substitute in certain food categories"," Scientific procedures"," GLG Life Tech Corporation"," 1050 West Pender Street, Suite 2168, Vancouver, British Columbia V6E 3S7 CANADA",12/23/2013," GRN 493 (in PDF)",,,,,,,05/30/2014,," FDA has no questions",,,,,,,,,, =T("494")," Fatty acid ethyl ester from anchovy or menhaden oil, standardized to approximately 50 percent palmitoleic acid"," As an ingredient in foods"," Scientific Procedures"," Tersus Pharmaceuticals, LLC"," 387 Golf View Lane, Suite 201 Cleveland, OH 44143",12/24/2013," GRN 494 (in PDF)",,,,,,,12/16/2014,," FDA has no questions",,,,,,,,,, =T("495")," Galacto-oligosaccharides"," As an Ingredient in term infant formula and follow-on formula up to 7.2 grams per liter of reconstituted or RTC product"," Scientific procedures"," Clasado Inc."," 1620 Pinetree Drive Pittsburg, PA 15241",01/02/2014," GRN 495 (in PDF)",,,,,,,05/30/2014,," FDA has no questions",,,,,,,,,, =T("496")," Aqueous extract of Brassica oleracea var. italica Plenck seeds."," Use as an ingredient in teas, energy drinks, thirst quenching drinks, and non-carbonated flavored waters at a level of 115 milligrams per serving."," Scientific procedures"," Brassica Products LLC"," 250 South President Street, Suite 2000 Baltimore, MD 21202",01/08/2014," GRN 496 (in PDF)",,,,,,,01/11/2016,," FDA has no questions",,,,,,,,,, =T("497")," Polyphenols from the fruit of Litchi chinensis Sonn. and from leaves of Camellia sinensis (L.) Sinensis"," As an ingredient in certain food catefories at levels ranging from 12 to 192 milligrams per serving."," Scientific Procedures"," Amino Up Chemical Co., Ltd."," 363-32 Shin-ei,Kiyota-ku,Sapporo 004-0839 JAPAN",01/13/2014," GRN 497 (in PDF)",,,,,,,06/12/2014,," FDA has no questions; some uses may require a color additive listing",,,,,,,,,, =T("498")," D-psicose"," As a sugar substitute in certain food categories"," Scientific Procedures"," Matustani Chemical Industry Company, Ltd."," 5-3 KitaitamiItami-city, Hyogo JAPAN 664-8508",01/13/2014," GRN 498 (in PDF)",,,,,,,06/12/2014,," FDA has no questions",,,,,,,,,, =T("499")," Magnesium L-threonate hydrate"," Use as a source of dietary magnesium in certain food categories [listed in the notice]at levels ranging up to 0.12 percent."," Scientific Procedures"," Magceutics, Inc."," 3159 Corporate Place Hayward, California 94545",02/18/2014," GRN 499 (in PDF)",,,,,,,09/03/2014,," FDA has no questions",,,,,,,,,, =T("500")," Hydroethanolic extract of Caralluma fimbriata"," As an ingredient in foods for special dietary use in meal replacement products (baked goods/bars, soups, and drinks/shakes) at a level up to 500 milligrams per serving."," Scientific Procedures"," GE Nutrients"," 920 East Orangethorpe Avenue, Suite B Anaheim, California 92801",02/18/2014," GRN 500 (in PDF)",,,,,,,08/11/2014,," FDA has no questions",,,,,,,,,, =T("501")," L-theanine (chemically synthesized)"," As an ingredient in foods"," Scientific Procedures"," Zhejiang Tianrui Chemical Co., Ltd."," No. 12 Xingye Road, South Industrial Zone Longyou County, Zhejiang Province, China 324400",02/18/2014," GRN 501 (in PDF)",,,,,,,07/30/2014,09/10/2014," FDA has no questions",,,,,,,,,, =T("502")," Lactobacillus acidophilus La-14"," As an ingredient in certain food categories [listed in the notice] at a level of 109 colony forming units per 250 gram serving of food at the time of consumption."," Scientific Procedures"," Danisco USA, Inc."," 3329 Agricultural Drive Madison, WI 53716",02/27/2014," GRN 502 (in PDF)",,,,,,,08/19/2014,," FDA has no questions",,,,,,,,,, =T("503")," Tamarind seed polysaccharide"," Use as a thickener, stabilizer, emulsifier, and gelling agent in certain food categories"," Scientific Procedures"," DSP GOKYO FOOD & CHEMICAL Co., Ltd."," HERBIS OSAKA 20th Floor 2-5-25 Umeda Kita-ku, Osaka, 530-0001 Japan",03/05/2014," GRN 503 (in PDF)",,,,,,,08/12/2014,," FDA has no questions",,,,,,,,,, =T("504")," Milk protein concentrate and milk protein isolate"," Use as an ingredient in food categories and at specific levels [listed in the notice]"," Scientific Procedures"," American Dairy Products Institute/U.S. Dairy Export Council"," 126 N. Addison Avenue/2101 Wilson Blvd, Suite 400Elmhurst, IL/Arlington, VA 60126/22201",03/20/2014," GRN 504 (in PDF)",,,,,,,11/21/2014,," FDA has no questions",,,,,,,=T("444"),,, =T("505")," Phosphodiesterase I enzyme preparation from Leptographium procerum"," As an enzyme in the production of yeast extracts or yeast autolysates at levels ranging from 1.6 to 41 grams enzyme preparation per kilogram of yeast dry matter."," Scientific Procedures"," DSM Food Specialties"," PO Box 1 2600 MA Delft The Netherlands",03/20/2014," GRN 505 (in PDF)",,,,,,,08/12/2014,," FDA has no questions",,,,,,,,,, =T("506")," Sacha inchi oil, a vegetable oil derived from Plukenetia volubilis."," As use as an ingredient in food categories at use levels [described in the notice]"," Scientific Procedures"," Agronidustrias Amasonicas S.A./Agronidustrias OSHO S.A.C./Amazon Health Products"," Calle Omega Mz A Lote 79 Urb Juan XXIII- San Bmja Lima 41 Peru / Calle Manuel Arispe 210 Urb, Industrial La Chalaca Callao-Peru / 1801 Camino Real, Planta B5 Parque Industrial San Pedrito I - Santiago de Surco Lima 33 - Peru",03/26/2014," GRN 506 (in PDF)",,,,,,,09/10/2014,," FDA has no questions",,,,,,,,,, =T("507")," Amylomaltase enzyme preparation from Bacillus amyloliquefaciens carrying an amylomaltase gene from Thermus thermophiles"," As an enzyme in the production of starch at levels ranging from 1 to 5 grams enzyme preparation per kilogram of dry starch"," Scientific Procedures"," DSM Food Specialties"," PO Box 1 2600 MA Delft, The Netherlands",04/08/2014," GRN 507 (in PDF)",,,,,,,09/11/2014,," FDA has no questions",,,,,,,,,, =T("508")," Salts from dried mineral water (65% NaCl)"," For flavoring uses of a reduced sodium sea salt in food,including meat and poultry products"," Scientific Procedures"," Salinity Food, AB"," Hanson & Mohring Box 222 301 06 Halmstad Sweden",04/09/2014," GRN 508 (in PDF)",,,,,,,09/24/2014,," At the notifier's request, FDA ceased to evaluate this notice",,,,,,,,,, =T("509")," Glucose oxidase enzyme preparation derived from Penicillium chrysogenum"," For use as an enzyme in various foods and powdered, dried eggs up to 30 mg TOS per kg food"," Scientific Procedures"," Shin Nihon Chemical Co., Ltd."," 19-10 Showamachi, Anjou-city Aichi prefecture Japan 446-0063",04/24/2014," GRN 509 (in PDF)",,,,,,,11/06/2014,," FDA has no questions",,,,,,,,,, =T("510")," Acid lactase from Aspergillus oryzae expressed in Aspergillus niger"," For use as an enzyme in the hydrolysis of lactose in milk and whey."," Scientific Procedures"," DSM Food Specialties"," PO Box 1 2600 MA Delft The Netherlands",04/22/2014," GRN 510 (in PDF)",,,,,,,09/29/2014,," FDA has no questions",,,,,,,,,, =T("511")," Citric acid esters of mono- and diglycerides"," As an antioxidant, emulsifier, stabilizer and thickener in infant formula at levels described in the notice."," Scientific Procedures"," Nestle Nutrition U.S."," 1200 Vreeland Road Florham Park, NJ 07932",04/23/2014," GRN 511 (in PDF)",,,,,,,11/10/2014,," FDA has no questions",,,,,,,,,, =T("512")," High purity Rebaudioside M"," As a table-top sweetener and as a general purpose non-nutritive sweetener in foods"," Scientific Procedures"," GLG Life Tech Corporation"," 1050 West Pender Street, Suite 2168 Vancover, BC V6E 3S7",04/28/2014," GRN 512 (in PDF)",,,,,,,10/24/2014,," FDA has no questions",,,,,,,,,, =T("513")," Dried biomass of Euglena gracilis containing beta-1,3-glucan from Euglena gracilis"," As an ingredient in food"," Scientific Procedures"," Algaeon, Inc."," 8440 West 82nd St. Indianapolis, IN 46278",04/30/2014," GRN 513 (in PDF)",,,,,,,07/09/2014,," At the notifier's request, FDA ceased to evaluate this notice",,,,,,,,,, =T("514")," Sucrose fatty acid esters"," For use as an emulsifier, stabilizer and diluent at levels ranging from 0.0003 to 2.9% in multiple food categories as described in the notice."," Scientific Procedures"," Sisterna B.V."," Belder 30A, 4704 RK Roosendaal The Netherlands",05/07/2014," GRN 514 (in PDF)",,,,,,,12/03/2014,," FDA has no questions",,,,,,,,,, =T("515")," D-beta-hydroxybutyrate ester"," For use in bars, gels, and beverages at a use level intended to provide 0.36 g/kg bw/serving."," Scientific Procedures"," TdeltaS Limited"," Registered Office 30 Upper High Street Thame Oxfordshire OX9 3EZ",05/08/2014," GRN 515 (in PDF)",,,,,,,03/05/2015,," FDA has no questions",,,,,,,,,, =T("516")," Steviol glycosides with rebaudioside A and stevioside as the principal components"," For use as a table top sweetener and general purpose non-nutritive sweetener for incorporation into foods, other than infant formulas and meat and poultry products."," Scientific Procedures"," Almenda (Thailand) Limited"," Amata City Industrial Estate, 7/313^, Tumbol Mapyangporn Amphoe Pluakdaeng, 21140 Thailand",04/28/2014," GRN 516 (in PDF)",,,,,,,10/31/2014,," FDA has no questions",,,,,,,,,, =T("517")," Natamycin"," For use as an inhibitor against yeast and mold growth in yogurt at levels not to exceed 5 ppm in the finished product."," Scientific Procedures"," DSM Food Specialties B.V."," Alexander Fleminglann 1, 2613 AX Delft The Netherlands",05/29/2014," GRN 517 (in PDF)",,,,,,,11/21/2014,," FDA has no questions",,,,,,,,,, =T("518")," Galacto-oligosaccharides"," For use as an ingredient in food categories and at use levels descsribed in GRAS Notice No. 000334 and 000285."," Scientific Procedures"," New Francisco Biotechnology Corporation"," Swan-kan-chiau Industrial District, Kaofong Village, Yunfu City, Guangdong Province, CHINA 527343",06/02/2014," GRN 518 (in PDF)",,,,,,,12/22/2014,," FDA has no questions",,,,,,,,,, =T("519")," Chlorella protothecoides strain S106 flour with 40-75% protein"," For use an as a source of protein in baked goods and mixes, breakfast cereals, meal replacements, cheeses, milk products, dairy and nondairy products, egg products, fish producis, plant protein products, grain products and pastas, gravies and sauces, salad dressings, margarines, processed vegetables and vegetable juices, fresh and processed fruit juices, nonalcoholic beverages, gelatins and puddings, frozen dairy, soups, nut products, snack foods and soft candy at a level intended to provide up to 5562 milligrams of the ingredient per day."," Scientific Procedures"," Solazyme, Inc."," 225 Gateway Blvd. South San Francisco, CA 94080",06/12/2014," GRN 519 (in PDF)",,,,,,,12/23/2014,," FDA has no questions; some uses may require a color additive listing",,,,,,,,,, =T("520")," Hydrogen gas"," For use as an ingredient in drinking water, flavored beverages, and soda drinks at a level up to 2.14% by volume."," Scientific Procedures"," MitoGene Beverage Company, LLC"," 1544 Avilla Vincintage Road, Alexander AK 72002",06/02/2014," GRN 520 (in PDF)",,,,,,,11/28/2014,," FDA has no questions",,,,,,,,,, =T("521")," Conjugated linoleic acid isomers"," For use as an ingredient in beverages and beverage bases, grain products and pasta, milk and milk products, and processed fruit and fruit juices at a level intended to no more than 1.5 grams per serving."," Scientific Procedures"," INNOBIO Limited"," No. 49, DDA, Dalian, Liaoning 116600, China",06/03/2014," GRN 521 (in PDF)",,,,,,,12/08/2014,," FDA has no questions",,,,,,,,,, =T("522")," Siraitia grosvenorii Swingle (Luo Han Guo) fruit extract"," For use as a table top sweetener and as a sweetener in foods."," Scientific Procedures"," GLG Life Tech Corporation"," 1050 West Pender Street, Suite 2168, Vancouver, British Columbia V6E 3S7 CANADA",06/09/2014," GRN 522 (in PDF)",,,,,,,12/08/2014,," FDA has no questions",,,,,,,,,, =T("523")," l-leucine"," For use as an ingredient in milk and non-milk meal replacement beverages, sports beverages, and vitamin enhanced waters, and meal replacement bars at levels of use intended to provide between 1.5 and 3 g of added L-leucine per serving."," Scientific Procedures"," INNOBIO Limited"," No. 49, DDA, Dalian, Liaoning 116600, China",06/12/2014," GRN 523 (in PDF)",,,,,,,12/11/2014,," FDA has no questions",,,,,,,,,, =T("524")," Phospholipase A2 enzyme preparation from Trichoderma reesei carrying a phospholipase A2 gene from Aspergillus nishimurae"," For use as a processing aid in edible oil refining."," Scientific Procedures"," AB Enzymes GmbH"," Feldbergstrasse 78, D-64293, Darmstadt, Germany",06/13/2014," GRN 524 with amendments (in PDF)",,,,,,,11/10/2014,," FDA has no questions",,,,,,,,,, =T("525")," Pea fiber"," For use as a texturizer and humectant in baked goods (bread, cakes, and noodles), fruit juices, and milk (acidified) at levels up to 0.5 grams/serving"," Scientific Procedures"," Fuji Oil Company Limited"," 1 Sumiyoshi-cho, Izumisano-Shi, Osaka 598-8540, Japan",06/30/2014," GRN 525 (in PDF)",,,,,,,09/24/2014,," FDA has no questions; some uses may require a color additive listing",,,,,,,,,, =T("526")," Bacillus coagulans strain Unique IS2 spores preparation"," For use as an ingredient in baked goods and baking mixes; beverages and beverage bases; breakfast cereals; chewing gum; coffee and tea; condiments and relishes; confections and frostings; dairy product analogs; fruit juices; frozen dairy desserts and mixes; fruit and water ices; gelatins, puddings and fillings; grain products and pastas; hard and soft candy; herbs, seeds, spices, seasonings, blends, extracts, and flavorings; jams and jellies; milk; milk products; nuts and nut products; plant protein products; processed fruits; processed vegetables and vegetable juices; snack foods; soups and soup mixes; sugar; and sweet sauces, toppings and syrups at a maximum level of approximately 2 x 109 colony forming units per serving."," Scientific Procedures"," Unique Biotech Limited"," G-43, Madhura Nagar, Yousufguda, Hyderabad, A.P., 500034 INDIA",07/02/2014," GRN 526 (in PDF)",,,,,,,03/23/2015,," FDA has no questions",,,,,,,,,, =T("527")," Algal oil (87% oleic acid) derived from Prototheca moriformis strain S2532"," For use in a variety of food categories at levels of use intended to provide up to 12,500 milligrams of the algal oil per person per day."," Scientific Procedures"," Solazyme, Inc."," 225 Gateway Blvd. South San Francisco, CA 94080",07/31/2014," GRN 527 (in PDF)",,,,,,,02/06/2015,," FDA has no questions",,,,,,,,,, =T("528")," Preparation containing six bacterial monophages (LIST-36, LMSP-25, LMTA-34, LMTA-57, LMTA-94 and LMTA-148) specific to Listeria monocytogenes"," For use as an antimicrobial to control Listeria monocytogenes in fish and shellfish, fresh and processed fruits, fresh and processed vegetables, and dairy products applied to food surfaces up to 1 x 106 plaque forming units per gram of food."," Scientific Procedures"," Intralytix, Inc."," 701 E Pratt Street, Baltimore MD 21202",07/31/2014," GRN 528 (in PDF)",,,,,,,12/23/2014,," FDA has no questions",,,,,,,,,, =T("529")," Seed of Phalaris canariensis L. (canary seed)"," For use as an ingredient in baked goods and baking mixes, breakfast cereals, grain and pasta products, and snack foods at use levels up to 50%."," Scientific Procedures"," Canaryseed Development Commission of Saskatchewan"," Bay 6A-3602 Taylor Street, Saskatchewan S7H 5H9, Canada",08/04/2014," GRN 529 with amendment (in PDF)",,,,,,,01/29/2015,," FDA has no questions",,,,,,,,,, =T("530")," Extract of Apocynum venetum leaves"," For use as an ingredient in food generally at a level intended to provide 50 milligrams of the extract per person per day."," Scientific Procedures"," Tokiwa Phytochemical Co., LTD"," 158 Kinoko, Sakura-Shi, Chiba, 285-0801, JAPAN",08/08/2014," GRN 530 (in PDF)",,,,,,,11/05/2014,," At the notifier's request, FDA ceased to evaluate this notice",,,,,,,,,, =T("531")," Lactobacillus fermentum CECT5716"," For use in powdered milk-based infant formula at 107 colony forming units per gram of powdered formula."," Scientific Procedures"," Biosearch Life, S.A."," Camino de Purchil, 66, 18004, Granada, SPAIN",08/14/2014," GRN 531 (in PDF)",,,,,,,03/20/2015,," FDA has no questions",,,,,,,,,, =T("532")," Complexation products of sodium tartrates with iron (III) chloride"," For use as an anti-caking agent in salt at a maximum level of 12 parts per million."," Scientific Procedures"," Nobian Industrial Chemicals B.V."," Zutphenseweg 10, P.O. Box 10, 7400 AA Deventer, The Netherlands",08/14/2014," GRN 532 (in PDF)",,,,,,,02/06/2015,," FDA has no questions; some uses may require a color additive listing",,,,,,,,,, =T("533")," Lecithin from canola"," For general use in foods with no limitations other than current good manufacturing practices."," Scientific Procedures"," American Lecithin Company"," 115 Hurley Road, Unit 2B, Oxford, CT 06478",08/15/2014," GRN 533 (in PDF)",,,,,,,03/20/2015,," FDA has no questions",,,,,,,,,, =T("534")," Hydrogenated lecithin from soy"," For general use in foods with no limitations other than current good manufacturing practices."," Scientific Procedures"," American Lecithin Company"," 115 Hurley Road, Unit 2B, Oxford, CT 06478",08/15/2014," GRN 534 (in PDF)",,,,,,,12/22/2014,," FDA has no questions",,,,,,,,,, =T("535")," Beta-glucanase from Streptomyces violaceoruber"," For use as a processing aid in the production of yeast extracts and alcoholic beverages."," Scientific Procedures"," Nagase America Corporation"," 546 5th Avenue 16th Floor, New York, NY 10036",08/18/2014," GRN 535 (in PDF)",,,,,,,02/03/2015,," FDA has no questions",,,,,,,,,, =T("536")," High purity rebaudioside C"," Intended for use as a table top sweetener and general purpose sweetener for use in foods other than infant formula and meat and poultry products."," Scientific Procedures"," GLG Life Tech Corporation"," 1050 West Pender Street, Vancouver, BC V6E 3S7, CANADA",08/18/2014," GRN 536 (in PDF)",,,,,,,02/12/2015,," FDA has no questions",,,,,,,,,, =T("537")," Short-chain fructo-oligosaccharides"," Intended for use as an ingredient in infant formula."," Scientific procedures"," Ingredion Incorporated"," 10 Finderne Ave, Bridgewater, NJ 08807",08/22/2014," GRN 537 (in PDF)",,,,,,,02/06/2015,," FDA has no questions",,,,,,,,,, =T("538")," Potassium-rich extract from Saccharum officinarum L. (sugarcane)"," Intended for use as an ingredient in fruit juice and flavored water at a maximum use level of 7.75%."," Scientific Procedures"," Nutraceutical and Natural Products AG and Department of Agriculture, Fisheries, and Forestry (Australia)"," Bahnhofstrosse 27 6300 ZUG, Zug, SWITZERLAND and Queensland, Australia",08/28/2014," GRN 538 (in PDF)",,,,,,,04/19/2015,," FDA has no questions",,,,,,,,,, =T("539")," Fish meal-based lipid extract"," Intended for use as an ingredient in the food categories and at use levels listed in 21 CFR 184.1472(a)(3)."," Scientific Procedures"," Enzymotec Ltd."," Sagi 2000 Industrial Park, P.O. Box 6,Migdal HaEmeq 23106 ISRAEL",08/29/2014," GRN 539 (in PDF)",,,,,,,06/15/2015,," At the notifier's request, FDA ceased to evaluate this notice",,,,,,,,,, =T("540")," Soybean leghemoglobin from Pichia pastoris"," Intended for use as a flavor in meat analogue products at a level not to exceed 1.4 percent in the finished product."," Scientific Procedures"," Impossible Foods, Inc."," 525 Chesapeake Drive, Redwood City CA 94063",09/18/2014," GRN 540 (in PDF)",,,,,,,11/10/2015,," At the notifier's request, FDA ceased to evaluate this notice",,,,,,,,=T("737"),, =T("541")," Insoluble fiber from citrus peel"," Intended for use as a moisture retention agent, flavor enhancing agent, or processing aid in baked goods, pastas, salad dressings, confectionery, processed cheese spreads, frozen food entrees, and comminuted and whole muscle meat and poultry products at a maximum level of 5%; and as a flavor enhancer in non-carbonated beverages and fruit drinks; as a seasoning in brine and in comminuted and whole muscle meat and poultry products, and as an ingredient in salads, sauces, meats, fillings, dips, baked goods, dairy products, fruit- and vegetable based products, and pizza at a maximum level of 5%."," Scientific Procedures"," Ceamsa"," Poligono Industrial As Gandaras s/n36418 Porririo-Pontevedra Spain",09/19/2014," GRN 541 (in PDF)",,,,,,,03/24/2015,," FDA has no questions",,,,,,,,,, =T("542")," Lutein"," Intended for use in baked goods and baking mixes, beverages and beverage bases, breakfast cereals, chewing gum, dairy product analogs, egg substitute products, fats and oils, frozen dairy desserts and mixes, gravies and sauces, infant and toddler foods (other than infant formula), milk products, processed fruits and fruit juices, soft candy, hard candy, and soups and soup mixes at use levels of 0.3 to 3 mg lutein equivalent/serving."," Scientific Procedures"," INNOBIO Limited"," No. 49, DDA, Dalian, Liaoning 116600, China",09/29/2014," GRN 542 (in PDF)",,,,,,,03/16/2015,," FDA has no questions; some uses may require a color additive listing",,,,,,,,,, =T("543")," Lutein esters"," Intended for use in baked goods and baking mixes, beverages and beverage bases, breakfast cereals, chewing gum, dairy product analogs, egg substitute products, fats and oils, frozen dairy desserts and mixes, gravies and sauces, infant and toddler foods (other than infant formula), milk products, processed fruits and fruit juices, soft candy, hard candy, and soups and soup mixes at use levels of 0.3 to 3 mg lutein equivalent/serving."," Scientific Procedures"," INNOBIO Limited"," No. 49, DDA, Dalian, Liaoning 116600, China",09/30/2014," GRN 543 (in PDF)",,,,,,,03/16/2015,," FDA has no questions; some uses may require a color additive listing",,,,,,,,,, =T("544")," β-glucans from oat bran"," Intended for general use in foods at levels consistent with good manufacturing practices"," Scientific Procedures"," Tate and Lyle"," 5450 Prairie Stone Parkway, Hoffman Estates, Illinois 60192",10/10/2014," GRN 544 (in PDF)",,,,,,,05/05/2015,," FDA has no questions",,,,,,,,,, =T("545")," Phosphatidylserine derived from sunflower"," Intended for use in milk, flavored milk, milk drinks (excluding milk, fluid), milk imitation (soy milk), milk-based meal replacement , yogurt, breakfast bars, and fruit flavored drink at levels of 100 milligrams (mg) phosphatidylserine per serving; in breakfast cereals and milk, fluid at 50 mg/serving; and in medical foods at levels not to exceed 300 mg/serving."," Scientific Procedures"," Enzymotec"," Sagi 2000 Industrial Park, P.O. Box 6, Migdal HaEmeq 23106 ISRAEL",10/10/2014," GRN 545 (in PDF)",,,,,,,06/05/2015,," FDA has no questions; some uses may require a color additive listing",,,,,,,,,, =T("546")," 2'-O-fucosyllactose"," Intended for use in term infant formula at a maximum level of 2,400 milligrams (mg)/Liter. Also intended for use in baked goods and baking mixes, beverages and beverages bases, coffee and tea, dairy product analogs, infant and toddler foods, grain products and pastas, milk (whole and skim), processed fruits and juices, processed vegetables and juices, and sugar substitutes at maximum levels ranging from 0.084 to 2.4 grams/serving."," Scientific Procedures"," Glycom A/S"," Diplomvej 373DK-2800 Kgs. LyngbyDenmark",10/10/2014," GRN 546 (in PDF)",,,,,,,09/16/2015,09/24/2014," FDA has no questions",,,,,,,,,, =T("547")," Lacto-N-neotetraose"," Intended for use in term infant formula at a maximum level of 600 milligrams (mg)/Liter. Also intended for use in baked goods and baking mixes, beverages and beverages bases, coffee and tea, dairy product analogs, infant and toddler foods, grain products and pastas, milk (whole and skim), processed fruits and juices, processed vegetables and juices, and sugar substitutes at maximum levels ranging from 0.02 to 1.2 grams/serving."," Scientific Procedures"," Glycom A/S"," Diplomvej 373, DK-2800 Kgs. Lyngby, Denmark",10/10/2014," GRN 547 (in PDF)",,,,,,,10/02/2015,," FDA has no questions",,,,,,,,,, =T("548")," High purity rebaudioside D"," For use as a table-top sweetener and general purpose non-nutritive sweetener in foods generally, excluding infant formula and meat and poultry products"," Scientific Procedures"," GLG Life Tech Corporation"," 1050 West Pender Street, Suite 2168 Vancouver, British Columbia CANADA V6E 3S7",10/27/2014," GRN 548 (in PDF)",,,,,,,04/22/2015,," FDA has no questions",,,,,,,,,, =T("549")," Sodium salts of fatty acids from Mortierella alpina oil"," For use as a source of arachidonic acid in term infant formula at a maximum level of 5 percent of total dietary fat when used in combination with docosahexaenoic acid at a maximum level of 0.50 percent of total dietary fat."," Scientific Procedures"," Jost Chemical Company"," 8150 Lackland Road, St. Louis, MO 63111",10/28/2014," GRN 549 (in PDF)",,,,,,,06/05/2015,," At the notifier's request, FDA ceased to evaluate this notice",,,,,,,,,, =T("550")," Meso-zeaxanthin"," For use as an ingredient in baked goods and baking mixes, beverages and beverage bases, breakfast cereals, chewing gum, dairy product analogs, egg substitute products, fats and oils, frozen dairy desserts and mixes, gravies and sauces, hard candy, infant and toddler foods (other than infant formula), milk products, processed fruits and fruit juices, soft candy, and soups and soup mixes at use levels of 0.18 to 1.8 milligrams of meso-zeaxanthin per serving."," Scientific Procedures"," INNOBIO Limited"," No. 49, DDA, Dalian, Liaoning 116600, China",10/29/2014," GRN 550 (in PDF)",,,,,,,03/27/2015,03/27/2015," FDA has no questions; some uses may require a color additive listing",,,,,,,,,, =T("551")," Aspartic protease derived from the flowers of Cynera cardunculus L."," For use as a coagulant in the production of cheese and cheese products."," Scientific procedures"," Fytozimus Biotech, Inc."," 13915- 96 Street, Edmonton, Alberta, Canada T5E5Z1",12/05/2014," GRN 551 (in PDF)",,,,,,,03/26/2015,," FDA has no questions",,,,,,,,,, =T("552")," Succinic acid"," For use as a flavor enhancer and pH control agent for use in foods at levels not to exceed good manufacturing practice."," Scientific procedures"," BioAmber Inc."," 1250 Rene Levesque Boulevard West, Montreal, Quebec, Canada H3B 4W8",12/05/2014," GRN 552 (in PDF)",,,,,,,05/13/2015,," FDA has no questions",,,,,,,,,, =T("553")," Algal oil (40% docosahexaenoic acid) derived from Schizochytrium sp."," For use as an ingredient in preterm and term infant formula at a maximum use level of 1.25% of dietary fat (maximum of 0.5% of total fat as docosahexaenoic acid)."," Scientific procedures"," DSM Nutritional Products"," 6480 Dobbins Road, Columbia, Maryland 21045",12/23/2014," GRN 553 (in PDF)",,,,,,,06/19/2015,," FDA has no questions; some uses may require a color additive listing",,,,,,,,,, =T("554")," Synthetic amorphous silica"," For use as a multi-functional direct ingredient in a broad range of food categories at levels not to exceed 2% of the finished food. Also intended for use as an indirect ingredient in the manufacture of adhesives; coatings; defoaming agents; greases and lubricants; paper and paperboard; and polymers that are used as components of food-packaging material."," Scientific procedures"," Evonik Corporation"," 299 Jefferson Road, Parsippany, New Jersey 07054",12/23/2014," GRN 554 (in PDF)",,,,,,,05/14/2015,," FDA has no questions",,,,,,,,,, =T("555")," High purity steviol glycosides (minimum purity 95%) consisting primarily of rebaudioside A."," For use as a table top sweetener and general purpose non-nutritive sweetener for use in foods other than infant formula and meat and poultry products."," Scientific procedures"," Procuctora Alysa SpA"," Calle Tress No. 600, Quilpue, 2420549, Chile",12/23/2014," GRN 555 (in PDF)",,,,,,,04/21/2015,," FDA has no questions",,,,,,,,,, =T("556")," Siraitia grosvenorii Swingle (Luo Han Guo) fruit extract"," For use as a table top sweetener and general purpose non-nutritive sweetener for use in foods other than infant formula and meat and poultry products."," Scientific procedures"," Hunan Huacheng Biotech, Inc."," N0 188, Tongzi'po West. Rd., Changsha, China",12/29/2014," GRN 556 (in PDF)",,,,,,,06/17/2015,11/05/2015," FDA has no questions",,,,,,,,,, =T("557")," Polygalacturonase from Aspergillus tubingensis expressed in Trichoderma reesei"," For use in fruit and vegetable processing, wine, coffee and flavoring production, and grain treatment."," Scientific procedures"," AB Enzymes GmbH"," Feldbergstr. 78, D-64293, Darmstadt, Germany",12/29/2014," GRN 557 (in PDF)",,,,,,,07/23/2015,," FDA has no questions",,,,,,,,,, =T("558")," Pectin esterase from Aspergillus tubingensis expressed in Trichoderma reesei"," For use in fruit and vegetable processing, wine, coffee and flavoring production, and grain treatment at GMP use levels."," Scientific procedures"," AB Enzymes GmbH"," Feldbergstr. 78, D-64293, Darmstadt, Germany",12/30/2014," GRN 558 (in PDF)",,,,,,,07/23/2015,," FDA has no questions",,,,,,,,,, =T("559")," Bacillus coagulans"," For use in post-harvest processing of bananas as an ingredient added to wash water."," Scientific procedures"," BiOWiSH Technologies, Inc."," 2724 Erie Avenue, Suite B, Cincinnati, Ohio 45208",12/30/2014," GRN 559 (in PDF)",,,,,,,04/02/2015,," At the notifier's request, FDA ceased to evaluate this notice",,,,,,,,,, =T("560")," Bacillus licheniformis"," For use in post-harvest processing of bananas as an ingredient added to wash water."," Scientific procedures"," BiOWiSH Technologies, Inc."," 2724 Erie Avenue, Suite B, Cincinnati, Ohio 45208",12/30/2014," GRN 560 (in PDF)",,,,,,,04/02/2015,," At the notifier's request, FDA ceased to evaluate this notice",,,,,,,,,, =T("561")," Bacillus pumilus"," For use in post-harvest processing of bananas as an ingredient added to wash water."," Scientific procedures"," BiOWiSH Technologies, Inc."," 2724 Erie Avenue, Suite B, Cincinnati, Ohio 45208",12/30/2014," GRN 561 (in PDF)",,,,,,,04/02/2015,," At the notifier's request, FDA ceased to evaluate this notice",,,,,,,,,, =T("562")," Bacillus subtilis"," For use in post-harvest processing of bananas as an ingredient added to wash water."," Scientific procedures"," BiOWiSH Technologies, Inc."," 2724 Erie Avenue, Suite B, Cincinnati, Ohio 45208",12/30/2014," GRN 562 (in PDF)",,,,,,,04/02/2015,," At the notifier's request, FDA ceased to evaluate this notice",,,,,,,,,, =T("563")," Protease from Fusarium venenatum"," For use in the production of partially or extensively hydrolyzed proteins for use in a variety of food and beverage products."," Scientific procedures"," Novozymes North America, Inc."," 77 Perry Chapel Church Road, P.O. Box 576, Franklinton, NC 27525",12/31/2014," GRN 563 (in PDF)",,,,,,,07/08/2015,07/23/2015," FDA has no questions",,,,,,,,,, =T("564")," Protease from Bacillus licheniformis"," For use in the production of partially or extensively hydrolyzed proteins for use in a variety of food and beverage products."," Scientific procedures"," Novozymes North America, Inc."," 77 Perry Chapel Church Road, P.O. Box 576, Franklinton, NC 27525",01/02/2015," GRN 564 (in PDF)",,,,,,,07/07/2015,," FDA has no questions",,,,,,,,,, =T("565")," Fucoidan from Undaria pinnatifida"," For use in baked goods (bread, cake, noodles), soups, snack foods, imitation dairy products, and seasonings and flavors at use levels up to 30 milligrams per serving."," Scientific procedures"," Marinova Pty. Ltd."," 249 Kennedy Drive, Cambridge, Tasmania, 7170 Australia",01/29/2015," GRN565 (in PDF)",,,,,,,07/02/2015,," FDA has no questions",,,,,,,,,, =T("566")," Mannanase from Trichoderma reesei"," For use in fruit and vegetable processing, oil processing, and coffee production at levels up to 26 milligrams TOS per kilogram of raw material."," Scientific procedures"," AB Enzymes GmgH"," 155 Claremont St., Toronto, Ontario, M6J2M7, Canada",02/02/2015," GRN 566 (in PDF)",,,,,,,05/21/2015,," FDA has no questions",,,,,,,,,, =T("567")," Xylanase from Trichoderma reesei"," For use as a processing aid in brewing, potable alcohol, cereal beverage manufacture and bakery applications."," Scientific procedures"," Danisco USA, Inc."," 925 Page Mill Road, Palo Alto, CA 94304",02/04/2015," GRN 567 (in PDF)",,,,,,,05/08/2015,," FDA has no questions",,,,,,,,,, =T("568")," Apoaequorin"," For use as an ingredient in dairy products (shakes and smoothies) at a level intended to provide 6 milligrams of apoaequorin per serving."," Scientific procedures"," Quincy Bioscience Manufacturing, Inc."," 301 S Westfield Road, Suite 200, Madison, WI 53717",03/17/2015," GRN 568 (in PDF)",,,,,,,10/21/2015,," At the notifier's request, FDA ceased to evaluate this notice",,,,,,,,,, =T("569")," Galacto-oligosaccharides (GOS)"," For use as an ingredient in term infant formula, and follow-on formula at a use level providing up to 7.2 g of GOS per liter of reconstituted or ready to consume product."," Scientific procedures"," New Francisco Biotechnology Corporation"," Swan-kan-chiau Industrial District, Kaofong Village Yunfu City, Guangdong Province, CHINA 527343",03/20/2015," GRN 569 (in PDF)",,,,,,,11/25/2015,," FDA has no questions",,,,,,,,,, =T("570")," Magnesium lactate"," For use as a source of dietary magnesium in fruit flavored beverages at a level intended to provide 25.2 milligrams of magnesium lactate per serving."," Scientific procedures"," Exponent"," 1150 Connecticut Avenue, NW, Suite 1100, Washington, DC, 20036",03/20/2015," GRN 570 (in PDF)",,,,,,,01/26/2016,," At the notifier's request, FDA ceased to evaluate this notice",,,,,,,,,, =T("571")," 2'-Fucosyllactose"," For use as an ingredient in infant and toddler formula at a level of not more than 2 grams 2-fucosyllactose per liter of formula."," Scientific procedures"," Jennewein Biotechnologie, GmgH"," Maarweg 32, D-53619 Reinbreitbach, GERMANY",03/20/2015," GRN 571 part 1 (in PDF)"," GRN 571 part 2 (in PDF)",,,,,,11/06/2015,," FDA has no questions",,,,,,,,,, =T("572")," Lactase from Bifidobacterium bifidum produced in Bacillus licheniformis"," For use in the dairy industry to catalyze the hydrolysis of lactose in the production of lactose reduced products at levels not to exceed the minimum amount necessary to achieve the intended technical effect."," Scientific procedures"," Novozymes North America, Inc."," 77 Perry Chapel Church Road, P.O. Box 576, Franklinton, NC, 27525",03/23/2015," GRN 572 (in PDF)",,,,,,,08/28/2015,," FDA has no questions",,,,,,,,,, =T("573")," Calcium disodium ethylenediaminetetraacetate (EDTA)"," For use in soft drinks, coffees and teas, flavored coffees and teas, concentrated flavor enhancer drops, energy drinks, enhanced water beverages, flavored milk beverages, fruit juice and juice drinks, sports drinks, and vegetable juice at a level not to exceed 33 mg/kg as consumed."," Scientific procedures"," Exponent Inc."," 1150 Connecticut Avenue, NW, Suite 1100, Washington, DC 20036",04/10/2015," GRN 573 (in PDF)",,,,,,,10/22/2015,," FDA has no questions",,,,,,,,,, =T("574")," Phospholipase C from Pseudomonas fluorescens"," For use as a processing aid in the refining of vegetable oils intended for use in foods at levels no higher than necessary to achieve the intended effect."," Scientific Procedures"," DSM Food Specialties"," PO Box 12600 MA Delft, The Netherlands",04/13/2015," GRN 574 (in PDF)",,,,,,,07/23/2015,," FDA has no questions",,,,,,,,,, =T("575")," Oat protein"," For use as a protein source for use in foods generally, including meat and poultry."," Scientific procedures"," Tate & Lyle"," 5450 Prairie Stone Parkway, Hoffinan Estates, IL 60192",04/15/2015," GRN 575 (in PDF)",,,,,,,09/18/2015,," FDA has no questions",,,,,,,,,, =T("576")," Oligofructose and inulin"," For use in exempt powdered amino-acid based term infant formula used for the dietary management of food allergies at a level not to exceed 6.8 grams per liter as consumed."," Scientific procedures"," Nutricia North America, Inc."," 9900 Belward Campus Drive, Suite 100, Rockville, MD 20850",04/28/2015," GRN 576 (in PDF)",,,,,,,12/09/2015,," FDA has no questions",,,,,,,,,, =T("577")," Salts from dried mineral water (65% NaCl)"," For use in processed foods, including meat and poultry."," Scientific procedures"," Salinity Food"," AB Hanson & Mohring, Box 222,30106 Halmstad, Sweden",04/28/2015," GRN 577 (in PDF)",,,,,,,12/04/2015,," FDA has no questions",,,,,,,,,, =T("578")," Natamycin"," For use in ready-to-drink tea beverages, fruit flavored energy drinks, sport and isotonic drinks, and fruit flavored beverages at levels not to exceed 5 parts per million."," Scientific procedures"," DM Food Specialties B.V"," Alexander Fleminglaan 1, 2613 AX Delft, The Netherlands",05/19/2015," GRN 578 (in PDF)",,,,,,,11/06/2015,," FDA has no questions",,,,,,,,,, =T("579")," Lactase from Bifidobacterium bifidum produced in Bacillus subtilis"," For use in the production of galacto-oligosaccharide for infant formula and in the production of fresh dairy products"," Scientific procedures"," Danisco US Inc."," 925 Page Mill Road, Palo Alto, CA 94304",05/21/2015," GRN 579 (in PDF)",,,,,,,11/05/2015,," FDA has no questions",,,,,,,,,, =T("580")," Haematococcus pluvialis extract containing astaxanthin esters"," Ingredient in baked goods and baking mixes, beverages and beverage bases, energy, sports and isotonic drinks, non-milk based meal replacements, cereals and cereal products, chewing gums, coffee, tea, dairy product analogs, frozen dairy desserts and mixes, hard and soft candy, milk products, processed fruits and fruit juices, and processed vegetables and vegetable juices at a maximum level of 0.15 milligrams (mg) astaxanthin per serving.1

1INNOBIO states that a serving is based on reference amounts customarily consumed as specified in 21 CFR 101.12."," Scientific procedures"," INNOBIO Limited"," No.49, DDA, Dalian, Liaoning, 116600, China",06/04/2015," GRN 580 (in PDF)",,,,,,,12/18/2015,," FDA has no questions; some uses may require a color additive listing",,,,,,,,,, =T("581")," Un-hydrolyzed and hydrolyzed pea protein"," For use as an ingredient in bakery products, snack foods, beverages (including nutritional beverages), soups, dairy products, dry instant milk shake mixes and protein drinks, instant powdered nutritional beverages, processed meat products, vegetarian food products/meat analogues, and meal replacement/nutritional bars at levels ranging from 2-90% of the finished food."," Scientific procedures"," World Food Processing, LLC"," 4301 World Food Ave, Oskaloosa, IA",06/19/2015," GRN 581 (in PDF)",,,,,,,01/25/2016,," FDA has no questions",,,,,,,,,, =T("582")," Inulin from Agave tequilana"," For use as a bulking agent and sweetener in foods in general, excluding meat and poultry, infant formula, and baby foods."," Scientific procedures"," NSF International"," l51 Stone Pine Ln, Menlo Park, CA 94025",06/30/2015," GRN 582 (in PDF)",,,,,,,11/25/2015,," At the notifier's request, FDA ceased to evaluate this notice",,,,,,,,,, =T("583")," Esterified propoxylated glycerol"," For use as a fat replacer at up to 34.5 % in confectionary coatings used in baked goods and baking mixes (biscuit items, bakery items and ice-cream inclusions), frozen dairy desserts and mixes (ice cream novelties), grain products and pasta (snack and meal replacement bars), hard candy and cough drops (panned confectionary items, sugar-shelled confectionary pieces), snack foods (snack items, trail mix) and soft candy (molded and hollow molded confectionery pieces)."," Scientific procedures"," Choco Finesse, LLC"," 5019 N. Meridian Street, 5019 N. Meridian Street, IN 46208",07/01/2015," GRN 583 (in PDF)",,,,,,,11/12/2015,," FDA has no questions",,,,,,,,,, =T("584")," Cellulase from Penicillium funiculosum"," For use as a processing aid in brewing, baking and potable alcohol production."," Scientific procedures"," Danisco US Inc."," 925 Page Mill Road, Palo Alto, CA 94304",07/02/2015," GRN 584 (in PDF)",,,,,,,09/30/2015,," FDA has no questions",,,,,,,,,, =T("585")," 1-methylcyclopropene"," For use as an ingredient in food packaging intended to inhibit maturation of packaged fruits and vegetables."," Scientific procedures"," Cellresin Technologies, LLC"," 1789 Buerkle Circle, St. Paul, MN 55110",07/10/2015," GRN 585 (in PDF)",,,,,,,01/29/2016,," FDA has no questions",,,,,,,,,, =T("586")," Taurine"," For use as an ingredient in enhanced water beverages at a concentration of 45 parts per million (0.0045%)."," Scientific procedures"," Intertek Scientific & Regulatory Consultancy"," 2233 Argentia Road, Mississauga, Ontario, L5N 2X7, Canada",07/21/2015," GRN 586 (in PDF)",,,,,,,12/09/2015,," FDA has no questions",,,,,,,,,, =T("587")," Acetolactate decarboxylase from Bacillus brevis produced in Bacillus licheniformis"," For use as a processing aid in beer brewing at levels in accordance with cGMP."," Scientific procedures"," Novozymes North America, Inc."," 77 Perry Chapel Church Road, PO Box 576, Franklinton, NC 27525",07/22/2015," GRN 587 (in PDF)",,,,,,,09/08/2015,," FDA has no questions",,,,,,,,,, =T("588")," Zeaxanthin from Capsicum annum (paprika)"," For use as an ingredient in baked goods and baking mixes, beverages and beverage bases, breakfast cereals, chewing gum, dairy products analogs, fats and oils, frozen dairy desserts and mixes, gravies and sauces, hard candy, milk products, processed fruit and vegetable products, soft candy, and soups and soup mixes at levels ranging from 0.3 to 3 milligrams of zeathanthin per serving."," Scientific procedures"," OmniActive Health Technologies Ltd"," Cybertech House, Ground Floor, J B Sawant Marg, Wagle Industrial Estate, Thane (West) 400 604, India",07/24/2015," GRN 588 (in PDF)",,,,,,,02/29/2016,," FDA has no questions; some uses may require a color additive listing",,,,,,,,,, =T("589")," Xylanase from Aspergillus niger"," For use as a processing aid in brewing and the manufacture of baking products."," Scientific procedures"," DSM Food Specialties"," PO Box 1, 2600, MA Delft, The Netherlands",08/03/2015," GRN 589 (in PDF)",,,,,,,09/17/2015,," FDA has no questions",,,,,,,,,, =T("590")," Pyrroloquinoline quinone"," For use as an ingredient in energy, sport, and isotonic drinks; non-milk based meal replacement beverages; water (bottled, enhanced, fortified); milk-based meal replacementbeverages; cereal and granola bars; and energy, meal replacement, and fortified bars at levels ranging from 0.008 to 0.05 percent."," Scientific procedures"," Nascent Health Sciences, LLC"," PO Box 325, Allentown, NJ 08501",07/29/2015," GRN 590 (in PDF)",,,,,,,01/18/2016,," At the notifier's request, FDA ceased to evaluate this notice",,,,,,,,=T("625"),, =T("591")," Streptococcus salivarius K12"," For use as an ingredient in baby, infant, and toddler food (excluding infant formula), baked goods and baking mixes, beverage and beverage bases, breakfast cereals, cheeses, chewing gum, dairy product analogs, frozen dairy desserts and mixes, gelatins, puddings and fillings, grain products and pastas, hard candy, milk, whole and skim; milk products, nuts and nut products, processed fruits and fruit juices, soft candy, sweet sauces, toppings and syrups, and medical foods, at levels up to 20 milligrams per serving (providing a minimum of 2x109 colony forming units (CFU) per serving)."," Scientific procedures"," BLIS Technologies Ltd."," 10 Birch Street, P.O. Box 5804, Dunedin, New Zealand",08/05/2015," GRN 591 (in PDF)",,,,,,,01/25/2016,06/05/2019," FDA has no questions (in PDF)",,,,,,,,,, =T("592")," β-glucanase from Bacillus subtilis"," For use as a processing aid in brewing and potable alcohol production."," Scientific procedures"," Danisco US Inc., 925 Page Mill Road, Palo Alto, CA",,08/06/2015," GRN 592 (in PDF)",,,,,,,10/07/2015,," FDA has no questions",,,,,,,,,, =T("593")," Colicin preparations"," For use as an antimicrobial on fresh or processed vegetables and fruits, including ready to eat produce at an application rate of 1-10 milligrams of colicin per kilogram of vegetable or fruit product."," Scientific procedures"," Nomad Bioscience GmbH"," Biozentrum Halle, Weinbergweg 22, Halle/Saale, Germany",08/06/2015," GRN 593 (in PDF)",,,,,,,12/18/2015,," FDA has no questions",,,,,,,,,, =T("594")," α-amylase from Geobacillus stearothermophilus produced in Bacillus licheniformis"," For use as a processing aid in grain processing and tuber starch processing, brewing, cereal beverage manufacture and potable alcohol manufacture."," Scientific procedures"," Danisco US Inc."," 925 Page Mill Road, Palo Alto, CA 94304",08/27/2015," GRN 594 (in PDF)",,,,,,,12/18/2015,12/30/2015," FDA has no questions",,,,,,,,,, =T("595")," gamma-aminobutyric acid"," For use as an ingredient in snack bars, breakfast cereals, processed cheese, chewing gum, yogurts, hard and soft candies, chocolate, and beverages and beverage bases including carbonated, energy, flavored, powdered and sports drinks, flavored milk and milk drinks and coffee and tea at a level intended to provide 100 milligrams of GABA per serving."," Scientific procedures"," Pharma Foods International Co., LTD."," 1-49 Goryo-Ohara, Nishikyo-ku, Kyoto, 615-8245, Japan",09/01/2015," GRN 595 (in PDF)",,,,,,,11/10/2015,," At the notifier's request, FDA ceased to evaluate this notice",,,,,,,,,, =T("596")," Breadfruit flour"," For use as a gluten-free substitute for other flours in baked goods, breads, cereals, porridges, and pasta."," Scientific procedures"," PlantSMART Labs"," 3247 University Way, University of British Columbia, Room 350, Fipke Centre, Canada",09/10/2015," GRN 596 (in PDF)",,,,,,,02/21/2016,," FDA has no questions",,,,,,,,,, =T("597")," Bacillus coagulans SNZ1969 spore preparation"," Ingredient in baked goods and baking mixes; beverages and beverage bases; breakfast cereals; chewing gum; coffee and tea; condiments and relishes; confections and frostings; dairy product analogs; fruit juices; frozen dairy desserts and mixes; fruit and water ices; gelatins, puddings, and fillings; grain products and pastas; hard candy; herbs, seeds, spices, seasonings, blends, extracts, and flavorings; jams and jellies; milk; milk products; nuts and nut products; plant protein products; processed fruits; processed vegetables and vegetable juices; snack foods; soft candy; soups and soup mixes; sugar; and sweet sauces, toppings, and syrups at a level not to exceed 2 x 10^9 colony forming units (cfu)/serving."," Scientific procedures"," Sanzyme Limited"," Plot No. 13, Sagar Society, Banjara Hills Road, 2, Hyderabad ¿ 500 034, AP, India",09/10/2015," GRN 597 (in PDF)",,,,,,,02/29/2016,," FDA has no questions",,,,,,,,,, =T("598")," Thermolysin enzyme preparation derived from Geobacillus stearothermophilus"," Intended for use as a processing aid in the production of yeast extract; cooked fish; egg white hydrolysates; enzyme-modified dairy ingredients; and protein hydrolysates (soy, wheat gluten, milk protein, fish) to improve the protein solubility, taste and digestibility of these products."," Scientific procedures"," Amano Enzyme, Inc."," 27 Hanno, Kunotsubo, Kita-Nagoya, Aichi Prefecture, 481-8533, JAPAN",09/11/2015," GRN 598 (in PDF)",,,,,,,02/29/2016,," FDA has no questions",,,,,,,,,, =T("599")," Citrus fiber"," Texturizer and moisture retention agent in yogurt, low-fat mayonnaise, ice cream, ice pops, and sorbet at a maximum level of 4%, and in whole muscle and comminuted meat and poultry products and ready-to-eat (RTE) meat and poultry products at a maximum level of 5%."," Scientific procedures"," Cargill, Inc."," 15407 McGinty Road West, Wayzata, MN 55391",09/11/2015," GRN 599 (in PDF)",,,,,,,02/17/2016,," FDA has no questions",,,,,,,,,, =T("600")," Hydroxytyrosol"," Intended for use as an antioxidant and antimicrobial in beverages, fats and oils, fresh and processed fruits and vegetables and juices, and gravy and sauces at use levels of 5.0 milligrams per serving."," Scientific procedures"," Seprox Biotech S.L"," Calle Conde de Aranda, 16, 1 D, Madrid, 28001, SPAIN",10/02/2015," GRN 600 (in PDF)",,,,,,,05/13/2016,," FDA has no questions",,,,,,,,,, =T("601")," Bacillus coagulans SBC37-01 spore preparation"," Intended for use as an ingredient in the following food categories: baked goods and baking mixes; beverages and beverage bases; breakfast cereals; chewing gum; coffee and tea; condiments and relishes; confections and frostings; dairy product analogs; fruit juices; frozen dairy desserts and mixes; fruit and water ices; gelatins, puddings, and fillings; grain products and pastas; hard candy; herbs, seeds, spices, seasonings, blends, extracts, and flavorings; jams and jellies; milk; milk products; nuts and nut products; plant protein products; processed fruits; processed vegetables and vegetable juices; snack foods; soft candy; soups and soup mixes; sugar; and sweet sauces, toppings, and syrups at a maximum level of approximately 2 x 109 colony forming units (CFU)/serving (reference amounts customarily consumed, 21CFR 101.12)."," Scientific procedures"," Sabinsa Corporation"," 750 Innovation Circle, Payson, UT 84651",10/05/2015," GRN 601 (in PDF)",,,,,,,04/28/2016,," FDA has no questions",,,,,,,,,, =T("602")," N-acetyl-D-neuraminic acid"," Intended for use as an ingredient in term infant formula at a maximum use level of 50 milligrams per liter."," Scientific procedures"," Glycom A/S"," Diplomvej 373, DK-2800, Kgs Lyngby, DENMARK",10/13/2015," GRN 602 (in PDF)",,,,,,,02/01/2016,," FDA has no questions",,,,,,,,,, =T("603")," Preparation containing the bacterial monophages, BP-63 and BP-12, specific to Salmonella"," As an antimicrobial to control Salmonella in food, applied to surfaces up to 108 plaque forming units per gram of food."," Scientific procedures"," Phagelux"," 6100 Royalmount, Montreal, Quebec, HAP 2R2 CANADA",10/29/2015," GRN 603 (in PDF)",,,,,,,07/28/2016,," FDA has no questions",,,,,,,,,, =T("604")," Baker's Yeast (Saccharomyces cerevisiae) expressing asparaginase II"," For use as an ingredient in bread, toasted bread, cereals, cookies, tortillas, baguettes, doughnuts, bagels, biscuits, pizza crust, crackers, wheat-based snacks, extruded snacks and other snack foods, extruded snacks and other snack foods, French fried potatoes, potato chips, formed potato products, potato-based snack foods, coffee, and coffee substitutes at levels ranging from 0.5 to 5% (on a dry weight basis) to reduce acrylamide formation during production."," Scientific Procedures"," Renaissance BioScience Corporation"," Suite 410, 2389 Health Sciences Mall, Vancouver, British Columbia, V6T1Z3, Canada",11/02/2015," GRN 604 (in PDF)",,,,,,,04/27/2016,," FDA has no questions",,,,,,,,,, =T("605")," Fructo-oligosaccharides"," For use as an ingredient in Acidophilus milk; analogs and substitutes for meat, poultry or fish; bars; breakfast cereals; beverages and juices; cakes; cheese; cream; confectionery; cookies; crackers; dessert toppings and fillings; hard candy; ice cream; infant foods (0-12 months); jams and jellies; milk, flavored and unflavored; milk, evaporated and condensed; muffins and quick bread, sauces, gravies and condiments; snacks, sorbet and sherbert; soup; toddler foods (12-24 months); yogurt at levels ranging from 0.4 to 6.7 percent."," Scientific procedures"," Tata Chemicals Limited"," Survey No 315, Hissa No 1-14, Ambedveth (V), Paud road, Mulshi,Pune,41211, India",11/19/2015," GRN 605 (in PDF)",,,,,,,03/17/2016,," FDA has no questions",,,,,,,,,, =T("606")," Vinyl acetate-vinyl laurate copolymers"," For use as an ingredient in chewing gum base at level not to exceed 9 percent in the finished product."," Scientific procedures"," Thomas Wimmer, PhD"," Wacker Chemie AG, Hanns-Seidel-Platz 4, 81737 Muchen, Germany",11/19/2015," GRN 606 (in PDF)",,,,,,,05/27/2016,," FDA has no questions",,,,,,,,,, =T("607")," Glucosylated steviol glycosides (minimum purity 80%)"," For use as a flavor modifier in foods, excluding infant formula and products under jurisdiction of the United States Department of Agriculture (USDA). The maximum recommended use level of EMSG in food is 600 milligrams per kilogram (mg/kg) and in chewing gum is 1500 mg/kg."," Scientific procedures"," PureCircle Limited"," 915 Harger Road, Suite 250, Oak Brook, IL 60523",11/24/2015," GRN 607 (in PDF)",,,,,,,10/14/2016,," FDA has no questions",11/15/2019," Additional Correspondence regarding an additional intended use of Sweetener (in PDF)",,,,,,,, =T("608")," Pea protein concentrate"," For use as an ingredient, formulation aid and texturizer in baked goods and baking mixes, beverages and beverage bases, breakfast cereals, dairy product analogs, fats and oils, grain products and pastas, milk products, plant protein products, processed fruits and fruit juices, processed vegetables and vegetable juices, soups and soup mixes at levels ranging from 0.96 to 34.3 percent."," Scientific procedures",," Axiom Foods, Inc., 785 Grand Ave, Suite 212, Carlsbad, CA 92008; SPRIM Strategy & Intelligent Innovations, 12001 Research Parkway, Suite 236, Orlando, FL 32826",12/04/2015," GRN 608 (in PDF)",,,,,,,05/27/2016,," FDA has no questions",,,,,,,,,, =T("609")," Rice protein"," For use as an ingredient, formulation aid and texturizer in baked goods and baking mixes, beverages and beverage bases, breakfast cereals, dairy product analogs, fats and oils, grain products and pastas, milk products, plant protein products, processed fruits and fruit juices, processed vegetables and vegetable juices, soups and soup mixes at levels ranging from 0.96 to 34.3 percent."," Scientific procedures",," Axiom Foods Inc., 785 Grand Ave, Suite 212, Carlsbad, CA 92008; SPRIM Strategy & Intelligent Innovations, 12001 Research Parkway, Suite 236, Orlando, FL 32826",12/04/2015," GRN 609 (in PDF)",,,,,,,06/06/2016,," FDA has no questions",06/14/2018," Additional correspondence (in PDF)",,,,,,,, =T("610")," Isomaltodextrin"," Ingredient and as a dietary fiber in milk and milk products; fish and fish mixtures; legumes; meat substitutes, mainly legume protein and cereal protein products; baked products; crackers and salty snacks from grain products; pancakes, waffles, French toast, and other grain products; pastas, cooked cereals, and rice; cereals; grain mixtures, frozen plate meals, sauces, and soups; fruits and fruit products; vegetable products; salad dressings; sugars, sweets, and beverages, selected waters; and in formulated nutrition beverages, energy drinks, sports drinks, and functional beverages at a level of 3.2 to 6.3 grams (g) per serving."," Scientific procedures"," Hayashibara Co., Ltd."," 675-1 Fujisaki, Naka-ku, Okayama, 702-8006, JAPAN",12/10/2015," GRN 610 (in PDF)",,,,,,,06/06/2016,," FDA has no questions",,,,,,,,,, =T("611")," Fractionated whey protein isolate containing cows milk derived lactoferrin, lactoperoxidase, and transforming growth factor β2"," For use as an ingredient in meal replacement beverages at levels up to 100 milligrams (mg) per serving (240 milliliter) and in medical foods at varying levels so that resulting intake of ingredient does not exceed 610 mg per person per day."," Scientific procedures"," Armor Protéines S.A.S"," 9 bis, rue de la Libération, 35460 Saint-Brice-en -Coglés,FRANCE",12/15/2015," GRN 611 (in PDF)",,,,,,,04/15/2016,," At the notifier's request, FDA ceased to evaluate this notice",,,,,,,,,, =T("612")," Fractionated whey protein isolate containing cows milk derived lactoferrin, lactoperoxidase, and transforming growth factor β2"," For use as an ingredient in powdered, nonexempt term infant formulas and toddler formulas at levels up to 30 milligrams per 100 gram of powdered formula."," Scientific procedures"," Armor Protéines S.A.S"," 19 bis, rue de la Libération, 35460 Saint-Brice-en -Coglés, FRANCE",12/15/2015," GRN 612 (in PDF)",,,,,,,05/19/2016,," At the notifier's request, FDA ceased to evaluate this notice",,,,,,,,,, =T("613")," Apple peel powder"," For use as an ingredient in fruit and fruit juices, vegetable juices, milk and milk products, bakery products, dairy products and substitutes, ready-to-eat cereal, sauces, and dips, gravies and condiments at levels ranging from 0.1 to 20 percent in the finished food."," Scientific procedures"," Leahy Orchards, Inc."," 1772 Route 209, Franklin, Quebec, J0S 1E0, CANADA",12/15/2015," GRN 613 (in PDF)",,,,,,,03/08/2016,," At the notifier's request, FDA ceased to evaluate this notice",,,,,,,,,, =T("614")," Chromium polynicotinate"," For use as an ingredient in enhanced water beverages at a maximum use level of 575 micrograms per liter."," Scientific procedures"," Exponent, Inc."," 1150 Connecticut Avenue, NW, Suite 1100, Washington DC, 20036",," GRN 614 (in PDF)",,,,,,,04/12/2016,," FDA has no questions",,,,,,,,,, =T("615")," High-amylose cornstarch"," For use as an ingredient in oral rehydration solutions at 50 grams per liter."," Scientific procedures"," Yale University, Yale School of Medicine"," LMP 1080, New Haven, CT, 06519",01/04/2016," GRN 615 (in PDF)",,,,,,,06/24/2016,," FDA has no questions",,,,,,,,,, =T("616")," High-amylose cornstarch acetate"," For use as an ingredient in oral rehydration solutions at 50 grams per liter."," Scientific procedures"," Yale University, Yale School of Medicine"," LMP 1080, New Haven, CT, 06519",01/04/2016," GRN 616 (in PDF)",,,,,,,06/24/2016,," FDA has no questions",,,,,,,,,, =T("617")," α-amylase from Cytophaga sp. produced in Bacillus licheniformis"," For use as a processing aid in carbohydrate processing to produce sugar syrups and in fermentation to produce products such as potable alcohol, organic acids, and amino acids."," Scientific procedures"," Danisco US Inc. (DuPont Industrial Biosciences)"," 925 Page Mill Road, Palo Alto, CA, 94304",01/04/2016," GRN 617 (in PDF)",,,,,,,04/08/2016,," At the notifier's request, FDA ceased to evaluate this notice",,,,,,,,,, =T("618")," Purified seawater"," For use as a salt replacer in foods generally at levels not to exceed good manufacturing practices."," Scientific procedures"," Seawater Solutions, Inc."," 34 Terrace Court, Tiburon, CA, 94920",01/04/2016," GRN 618 (in PDF)",,,,,,,05/27/2016,," FDA has no questions",,,,,,,,,, =T("619")," Purified steviol glycosides"," Intended for use as a general purpose sweetener in accordance with good manufacturing practices (cGMP) (excluding USDA regulated products and infant formula) and as a table-top sweetener."," Scientific procedures"," PureCircle Ltd."," 915 Harger Road, Suite 250, Oak Brook, IL 60523",02/02/2016," GRN 619 (in PDF)",,,,,,,05/27/2016,," FDA has no questions",,,,,,,,,, =T("620")," Galacto-oligosaccharides"," Ingredient in non-exempt infant formulas for term infants and in follow-on formulas at a level providing up to 7.8 grams of GOS per liter (g/L) of reconstituted or ready-to-drink formula."," Scientific procedures"," Nestle Nutrition"," 12 Vreeland Road, Florham Park, NJ 07932",02/08/2016," GRN 620 (in PDF)",,,,,,,07/21/2016,," FDA has no questions",,,,,,,,,, =T("621")," Emulsified algal oil"," For use as an ingredient in beverage and beverage bases; coffee and tea; gelatins, puddings, and fillings; processed fruit and fruit juices; and soft candy at levels up to 0.04 percent."," Scientific procedures"," MyCell Technologies, LLC"," 160 Summit Avenue, Suite 101, Montvale, NJ 07645",02/11/2016," GRN 621 (in PDF)",,,,,,,05/13/2016,," At the notifier's request, FDA ceased to evaluate this notice",,,,,,,,,, =T("622")," Emulsified fish oil"," For use as an ingredient in beverage and beverage bases; coffee and tea; gelatins, puddings, and fillings; processed fruit and fruit juices; and soft candy at levels up to 0.04 percent."," Scientific procedures"," MyCell Technologies, LLC"," 160 Summit Avenue, Suite 101, Montvale, NJ 07645",02/12/2016," GRN 622 (in PDF)",,,,,,,05/13/2016,," At the notifier's request, FDA ceased to evaluate this notice",,,,,,,,,, =T("623")," Fructooligosaccharides"," Ingredient in conventional foods, including substitutes for meat, poultry, and fish; nutritional bars; breakfast cereals; beverages and juices; cakes; cheese; cream; confectionery; cookies; crackers; dessert toppings and fillings; hard candy; ice cream; infant foods; jams and jellies; milks (acidophilus; flavored and unflavored; evaporated and condensed); muffins and quick bread; sauces, gravies, and condiments; snacks; sorbet and sherbet; soups; toddler (12-24 months old) foods; and yogurt at levels in the range 0.4 to 6.7%."," Scientific procedures"," Hank Tsai"," New Francisco Biotechnology CorporationSwan-kan-chiau Industrial Dirstrict, Kaofong Village, Yunfu City, Guangdong Province, CHINA 527343",02/12/2016," GRN 623 (in PDF)",,,,,,,08/01/2016,," FDA has no questions",,,,,,,,,, =T("624")," D-allulose 3-epimerase from Arthrobacter globiformis M30 produced in Escherichia coli"," For use as in the production of D-allulose and other keto sugars."," Scientific procedures"," Matsutani Chemical Industry Co. Ltd"," 5-3 Kita-Itami, Itami City, Hyogo, JAPAN 664-8508",02/17/2016," GRN 624 (in PDF)",,,,,,,08/18/2016,," FDA has no questions",,,,,,,,,, =T("625")," Pyrroloquinoline quinone disodium salt"," For use as an ingredient in energy, sport, and isotonic drinks; non-milk based meal replacement beverages; water (bottled, enhanced, fortified); milk-based meal replacement beverages; at levels intended to provide 8 milligrams PQQ per serving."," Scientific procedures"," Nascent Health Sciences, LLC"," PO Box 325, Allentown, NJ 08501",02/29/2016," GRN 625 (in PDF)",,,,,,,08/18/2016,," FDA has no questions",,,,,,,=T("590"),,, =T("626")," Steviol glycosides produced in Saccharomyces cerevisiae"," For use as a general use sweetener in foods in accordance with good manufacturing practices."," Scientific procedures"," Cargill, Inc."," 15407 McGinty Road West, Wayzata, MN, 55391",03/01/2016," GRN 626 (in PDF)",,,,,,,05/27/2016,," FDA has no questions",,,,,,,,,, =T("627")," Siraitia grosvenorii Swingle (Luo Han Guo) fruit juice concentrate"," For use as a flavoring and sweetener in conventional foods other than infant formula."," Scientific procedures"," JHeimbach, LLC"," 923 Water Street, P.O. Box 66, Port Royal, VA 22535",03/01/2016," GRN 627 (in PDF)",,,,,,,10/11/2016,," FDA has no questions",,,,,,,,,, =T("628")," endo-1,4-beta-xylanase from Trichoderma reesei"," For use as a processing aid in the manufacture of bakery products, and potable alcohol."," Scientific procedures"," AB Enzymes GmbH"," AB Enzymes GmbH, Feldbergstr. 78, D-64293 DarmstadtGermanyUA",03/01/2016," GRN 628 (in PDF)",,,,,,,09/14/2016,," FDA has no questions",,,,,,,,,, =T("629")," Siraitia grosvenorii Swingle (Luo Han Guo) fruit extract"," For use as a table top sweetener and general purpose non-nutritive sweetener for use in foods other than infant formula and meat and poultry products."," Scientific procedures"," Hunan NutraMax, Inc."," Changhai Base, 627 Lugu Rd, Changsa High-Tech Industrial Development Zone, Changsa, Hunan, China",03/02/2016," GRN 629 (in PDF)",,,,,,,07/15/2016,," At the notifier's request, FDA ceased to evaluate this notice",,,,,,,,,, =T("630")," Preparation containing the bacterial monophages, Fo1a and S16, specific to Salmonella"," As an antimicrobial to control Salmonella in beef and vegetables, at up to 108 plaque forming units per gram of food"," Scientific procedures"," Micreos B.V."," Nieuwe kanaal 7P, 6709 PA Wageningen, The Netherlands",03/02/2016," GRN 630 (in PDF)",,,,,,,05/17/2016,," At the notifier's request, FDA ceased to evaluate this notice",,,,,,,,,, =T("631")," Triacylglycerol lipase from Fusarium oxysporum produced in Trichoderma reesei"," For use in the production of baked goods not to exceed 10 mg TOS/kg"," Scientific procedures"," AB Enzymes GmbH"," Feldbergstr. 78, D-64293 Darmstadt, Germany",03/10/2016," GRN 631 (in PDF)",,,,,,,07/18/2016,," FDA has no questions",,,,,,,,,, =T("632")," Rebaudioside A from Yarrowia lipolytica"," For use as a general purpose sweetener, excluding meat and poultry products and infant formula."," Scientific procedures"," DSM Nutritional Products, LLC"," 45 Waterview Boulevard, Parsippany, NJ 07054",03/18/2016," GRN 632 (in PDF)",,,,,,,06/24/2016,," FDA has no questions",,,,,,,,,, =T("633")," Concentrated milk protein with a ≥ 60:40 whey:casein ratio"," For use as an emulsifier, flavoring agent, formulation aid, humectants, stabilizer, thickener, texturizers, and protein source in the following food categories at varying use levels depending on technical effect: meal replacements and meal supplements; powdered nutritional beverages; nutritional bars; acidified sports beverages; milk products; yogurt and fermented milk products; non-standardized cheese products; spreads, dips and cream substitutes; frozen dairy desserts and mixes; desserts and mousses; confections; snack foods; coatings and fillings; salad dressings; soups, soup mixes, and sauces."," Scientific procedures"," Leprino Foods Company"," 1830 West 38th Avenue, Denver, CO 80211",03/18/2016," GRN 633 (in PDF)",,,,,,,09/21/2016,," FDA has no questions",,,,,,,,,, =T("634")," Calcium chloride"," For use in the manufacturing of potato snacks to reduce the formation of acrylamide at use levels of 1 percent or less."," Scientific procedures"," PepsiCo, Inc."," 700 Anderson Hill Road, Purchase, NY 10577",03/18/2016," GRN 634 (in PDF)",,,,,,,08/08/2016,," FDA has no questions",,,,,,,,,, =T("635")," Nicotinamide riboside chloride"," Source of vitamin B3 in vitamin waters, protein shakes, nutrition bars, gum, chews, and powdered beverages at a maximum level of 0.0057% by weight as consumed."," Scientific procedures"," ChromaDex, Inc."," 10005 Muirlands Boulevard, Suite G, Irvine, CA 92618",03/29/2016," GRN 635 (in PDF)",,,,,,,08/03/2016,," FDA has no questions",,,,,,,,,, =T("636")," Phosphatidylserine derived from sunflower lecithin"," Nutrient and as an alternative to other sunflower PS sources at levels up to 100 milligrams (mg) per serving in dairy product analogs (imitation milk and soy milk), grain products (nutritional bars: breakfast, granola, and protein), milk products (flavored milk and milk drinks, excluding fluid milk, milk-based meal replacements, and yogurt), and processed fruits and fruit juices (fruit flavored drinks); at levels of 50 mg per serving in breakfast cereals and milk (fluid: regular, filled, buttermilk, and dry reconstituted); and at levels up to 300 mg per day in medical foods.  "," Scientific procedures"," ECA Healthcare, Inc."," 1017 North Building, 1839 Qixin Rd, Shanghai, 201101, China",03/29/2016," GRN 636 (in PDF)",,,,,,,07/01/2016,," At the notifier's request, FDA ceased to evaluate this notice",,,,,,,,,, =T("637")," Phosphatidylserine derived from soy lecithin"," Nutrient and as an alternative to other soy PS sources at levels up to 100 milligrams (mg) per serving in dairy product analogs (imitation milk and soy milk), grain products (nutritional bars: breakfast, granola, and protein), milk products (flavored milk and milk drinks excluding fluid milk, milk-based meal replacements, and yogurt), and processed fruits and fruit juices (fruit flavored drinks); at levels of 50 mg per serving in breakfast cereals and milk (fluid: regular, filled, buttermilk, and dry reconstituted); and at levels up to 300 mg per day in medical foods."," Scientific procedures"," ECA Healthcare, Inc."," 1017 North Building, 1839 Qixin Rd.,Shanghai, 201101, China",03/30/2016," GRN 637 (in PDF)",,,,,,,08/04/2016,," At the notifier's request, FDA ceased to evaluate this notice",,,,,,,,,, =T("638")," High purity steviol glycosides (minimum purity 97%) consisting primarily of rebaudioside A"," For use as a table top sweetener and general purpose non-nutritive sweetener for use in foods other than infant formula and meat and poultry products."," Scientific procedures"," Hunan Huacheng Biotech Inc."," 188#, Tongzipo West. Rd., Changsha, Hunan, CHINA",04/07/2016," GRN 638 (in PDF)",,,,,,,07/10/2016,," FDA has no questions",,,,,,,,,, =T("639")," Zeaxanthin from marigold"," For use as an ingredient in baby and toddler foods, candies, cereals, dairy products, soups, and beverages at up to 300 micrograms of zeaxanthin per serving"," Scientific procedures"," Kemin Foods, L. C."," 2100 Maury St., Des Moines, IA 50317",04/11/2016," GRN 639 (in PDF)",,,,,,,09/28/2016,," FDA has no questions; some uses may require a color additive listing",,,,,,,,,, =T("640")," Esterified propoxylated glycerol"," For use as a fat replacer at levels up to 38 percent by weight in baked goods and baking mixes, frozen dairy desserts and mixes, grain products and pasta, gravies and sauces, nuts and nut products, and soft candy."," Scientific procedures"," Choco Finesse, LLC"," 12403 W. 101 Terrace, Lenexa, KS 662155019 N. Meridian Street, Indianapolis, IN 46208",04/08/2016," GRN 640 (in PDF)",,,,,,,09/21/2016,," FDA has no questions",,,,,,,,,, =T("641")," Pyrroloquinoline quinone disodium salt"," For use as an ingredient in energy, sport, and electrolyte drinks; and enhanced and fortified water at a maximum use level of up to 5 and 20 milligrams per serving, respectively."," Scientific procedures"," Zhejiang Hisun Pharmaceutical Co. Ltd."," 46 Waisha Road, Jiaojiang District, Taizhou City, Zhejiang Province, P.R. CHINA 318000",04/12/2016," GRN 641 (in pdf)",,,,,,,10/14/2016,," FDA has no questions",,,,,,,,,, =T("642")," Camelina oil"," For use as a replacement for other edible oils in baked goods and baking mixes, beverages and beverage bases, breakfast cereals, dairy replacements, fats and oils, grain products and pasta, milk and milk products, processed fruits and fruit juices, processed vegetables and vegetable juices, snack foods, soft candy, and soup and soup mixes at a level of 3.0 grams of camelina oil per serving."," Scientific procedures"," CamStar, Inc"," PO Box 2671, Bigfork, MT 59911 [updated in letter dated May 25, 2018}",05/04/2016," GRN 642 (in PDF)",,,,,,,10/12/2016,," FDA has no questions",,,,,,,,,, =T("643")," Phosphatidylserine derived from fish"," For use as a nutrient in breakfast cereals, dairy product analogs, grain products, milk products, and processed fruits and fruit juices at level up to 100 milligrams per serving."," Scientific procedures"," ECA Healthcare, Inc."," 1017 North Building, 1839 Qixin Rd., Shanghai, CHINA, 201101",05/04/2016," GRN 643 (in PDF)",,,,,,,07/01/2016,," At the notifier's request, FDA ceased to evaluate this notice",,,,,,,,,, =T("644")," Non-fat dry goat milk and goat whey protein"," For use as a source of protein in infant formula for full-term gestation infants to 12 months of age. Non-fat dry goat milk will be added at 57% (±5%) of the protein blend. The remaining 43% (±5%) of total protein will be provided by goat whey protein"," Scientific procedures"," Ausnutria B.V."," P.O. Box 50078, 8002 LB Zwolle
Dokter van Deenweg 150
8025 BM Zwolle
The Netherlands
[Updated in letter dated March 7, 2018]",05/05/2016," GRN 644 (in PDF)",,,,,,,10/11/2016,," FDA has no questions",,,,,,,,,, =T("645")," Pullulanase from Bacillus deramificans and Bacillus acidopullulyticus expressed in Bacillus licheniformis"," For use as a processing aid in the production of dextrose and maltose syrups."," Scientific procedures"," Novozymes North America, Inc."," 77 Perry Chapel Church Road, P.O. Box 576, Franklinton, NC, 27525",05/05/2016," GRN 645 (in PDF)",,,,,,,11/01/2016,," FDA has no questions",,,,,,,,,, =T("646")," Pecan shell fiber"," For use as a source of fiber and antioxidants in baked goods and baking mixes, breakfast cereals, confections and frostings, gelatins, puddings and fillings, grain products and pastas, meal replacements, snack food, soft candy, sweet sauces at levels ranging from 2 to 10 percent."," Scientific procedures"," Southeastern Reduction Company"," 309 South Lee Street, Valdosta, GA 31601",05/05/2016," GRN 646 (in PDF)",,,,,,,10/12/2016,," FDA has no questions",,,,,,,,,, =T("647")," D-psicose"," For use as a sugar substitute and/or flavor modifier in food applications at use levels ranging from 1 to 100%; selected (low or reduced calorie) bakery products, alcoholic beverages (as a flavor modifier), soft drinks, fruit juice and fruit-flavored drinks, yogurt, frozen dairy desserts, hard and soft candies, chocolate, chewing gums, coffee mix, sauce, fat-based cream, sugar substitutes, nutrition bars, meal replacement shakes, and medical foods."," Scientific procedures"," Samyang Corporation"," 730 Daedeok-daero, Yuseong-gu, Daejeon, Chung-chung nam do, Korea, 34055",05/17/2016," GRN 647 (in PDF)",,,,,,,10/11/2016,," At the notifier's request, FDA ceased to evaluate this notice",,,,,,,,,, =T("648")," Monoglycerides"," For use as a surface-finishing agent and/or texturizer, creating a thin and edible physical barrier against moisture loss and oxidation to protect the freshness and extend the shelf-life of agricultural products such as fruits (e.g., berries, grapes, stone fruit, citrus, bananas, mangoes, avocados) and vegetables (e.g., legumes, roots, tubers) when applied to their surfaces."," Scientific procedures"," Apeel Sciences"," 819 Reddick Street, Santa Barbara, CA 93103",05/17/2016," GRN 648 (in PDF)",,,,,,,12/13/2016,," FDA has no questions",,,,,,,,,, =T("649")," β-galactosidase enzyme preparation from Bacillus circulans produced in Bacillus subtilis"," For use as a processing aid in the production of galacto-oligosaccharides (GOS)."," Scientific procedures"," GenoFocus, Inc."," 65, Techno 1-ro, Yuseong-gu, Daejeon, Korea, 34014",05/25/2016," GRN 649 (in PDF)",,,,,,,11/28/2016,," FDA has no questions",,,,,,,,,, =T("650")," 2'-O-fucosyllactose"," For use in term infant formula at a maximum level of 2,400 milligrams (mg)/Liter. Also intended for use in baby foods and drinks for young children, beverages and beverages bases, dairy product analogs, grain products and pastas, milk (whole and skim), milk products, processed fruits and juices, and processed vegetables and juices at maximum levels ranging from 0.084 to 2.04 grams/serving"," Scientific procedures"," Glycom A/S"," Diplomvej 373, DK-2800 Kongens. Lyngby, Denmark",05/26/2016," GRN 650 (in PDF)",,,,,,,11/23/2016,," FDA has no questions",09/11/2020," Supplemental Letter (in PDF)",09/09/2020," Supplemental Letter (in PDF)",,,,,, =T("651")," Phospholipase A1 from Talaromyces leycettanus produced in Aspergillus niger"," For use as a processing aid in the de-gumming of vegetable oil."," Scientific procedures"," Novozymes North America, Inc."," 77 Perry Chapel Church Road, P.O. Box 576, Franklinton, NC, 27525",06/06/2016," GRN 651 (in PDF)",,,,,,,11/23/2016,," FDA has no questions",,,,,,,,,, =T("652")," Gamma linolenic acid safflower oil"," For use as an ingredient in nutritional beverages, medical foods, salad dressings, mayonnaise and yogurt at levels ranging from 0.05 to 4 grams of gamma linolenic acid per serving."," Scientific procedures"," Arcadia Biosciences, Inc."," 200 Cousteau Place, Suite 200, Davis, CA 95618",06/21/2016," GRN 652 (in PDF)"," GRN 652 amendments (in PDF)",,,,,,12/16/2016,," FDA has no questions",,,,,,,,,, =T("653")," Lysophospholipase from Aspergillus nishimurae expressed in Trichoderma reesei."," For use as a processing aid in starch processing."," Scientific procedures"," AB Enzymes GmbH"," Feldbergstr 78, D-64293 Darmstadt, Germany",06/21/2016," GRN 653 (in PDF)",,,,,,,10/13/2016,," FDA has no questions",,,,,,,,,, =T("654")," Cocoa butter substitute manufactured using palm oil stearin and stearic acid"," Intended for use in confections and Frostings as defined in 21 CFR 170.3(n)(9); Coatings of Soft Candy, as defined in 21 CFR 170.3(n)(38); and Sweet Sauces, Toppings, as defined in 21 CFR 170.3(n)(43) at levels not to exceed good manufacturing practices."," Scientific procedures"," IOI Loders Croklaan, USA, LLC"," 24708 W. Durkee Road, Channahon, IL 60410",06/28/2016," GRN 654 (in PDF)",,,,,,,12/19/2016,," FDA has no questions",,,,,,,,,, =T("655")," Rice bran wax"," Intended for use as a texturizing agent in peanut butter used in nutrition and granola-type bar products at levels between 3 to 4 percent."," Scientific procedures"," J.M. Smucker Company"," 1 Strawberry Lane, Orville, OH, 44667",06/28/2016," GRN 655 (in PDF)",,,,,,,09/20/2016,," At the notifier's request, FDA ceased to evaluate this notice",,,,,,,,,, =T("656")," Enzyme-modified steviol glycosides"," Intended for use as a general purpose sweetener in foods excluding meat and poultry products and infant formula, at levels determined by good manufacturing practice, as well as for use as a table top sweetener"," Scientific procedures"," GLG Life Tech Corporation"," 27499 Riverview Center Blvd., Bonita Springs, FL 34134",07/26/2016," GRN 656 (in PDF)",,,,,,,09/28/2016,," FDA has no questions",,,,,,,,,, =T("657")," Glucoamylase from Penicillum oxalicum produced in Aspergillus niger"," Intended for use as a processing aid in starch-containing foods."," Scientific procedures"," Novozymes"," 77 Perry Chapel Church Road, P.O. Box 576, Franklinton, North Carolina 27525",07/26/2016," GRN 657 (in PDF)",,,,,,,11/23/2016,," FDA has no questions",,,,,,,,,, =T("658")," Grapefruit extract"," Intended for use as an ingredient in foods generally, excluding U.S.D.A regulated products and infant formula."," Scientific procedures"," Chemie Research and Manufacturing"," 160 Concord Drive, Casselberry, FL. 32707",07/27/2016," GRN 658 (in PDF)",,,,,,,09/28/2016,," At the notifier's request, FDA ceased to evaluate this notice",,,,,,,,,, =T("659")," Lacto-N-neotetraose"," Ingredient in nonexempt infant formulas for term infants at a maximum use level of 600 milligrams (mg)/liter (L) and in beverages and beverage bases, dairy product analogs, milk (whole and skim), milk products, processed fruits and juices, grain products and pastas, infant foods, and toddler foods (including follow-on formulas) at use levels ranging from 0.02 to 3 grams (g)/serving."," Scientific procedures"," Glycom A/S"," Diplomvej 373, DK-2800 Kgs. Lyngby, Denmark",08/10/2016," GRN 659 with supplements (in PDF)",,,,,,,11/23/2016,," FDA has no questions",12/22/2021," Supplemental Letter (in PDF)",,,,,,,, =T("660")," Bacillus coagulans GBI-30, 6086 spores"," Ingredient in non-exempt powdered and liquid infant formulas for term infants (infant formula) at levels up to 2 x 10^8 colony forming units (CFU) per 100 milliliters (mL) infant formula as consumed."," Scientific procedures"," Ganeden Biotech, Inc."," 5800 Landerbrook Drive, Suite 300; Mayfield Heights, Ohio 44124",08/16/2016," GRN 660 (in PDF)",,,,,,,01/13/2017,," FDA has no questions (in PDF)",,,,,,,,," Infant formula uses. Same strain as GRN 399, though not a spore, and for use in infant formula (not covered in GRN 399)"," GRN 399" =T("661")," Fucoidan concentrate from Fucus vesiculosus"," Intended for use as an ingredient in baked goods (bread, cake, noodles), soups, snack foods, imitation dairy products, and seasonings and flavors at use levels up to 30 milligrams per serving."," Scientific procedures"," Marinova Pty. Ltd."," 249 Kennedy Drive; Cambridge, Tasmania 7170 AUSTRALIA",08/19/2016," GRN 661 (in PDF)",,,,,,,02/10/2017,," FDA has no questions (in PDF)",,,,,,,,,, =T("662")," Glucosylated steviol glycosides (minimum purity 95%)"," Intended for use as a general purpose sweetener in foods, excluding infant formula and meat and poultry products."," Scientific procedures"," PureCircle USA"," 915 Harger Road, Suite 250; Oak Brook, Illinois 60523",08/22/2016," GRN 662 (in PDF)",,,,,,,09/29/2016,," FDA has no questions",,,,,,,,,, =T("663")," Distarch phosphate"," Intended for use as a source of dietary fiber and as a thickener or texturizing agent in foods at levels consistent with good manufacturing practices."," Scientific procedures"," Ingredion, Inc."," 5 Westbrook Corporate Center; Westchester, IL 60154 USA",08/22/2016," GRN 663 (in PDF)",,,,,,,09/30/2016,," At the notifier's request, FDA ceased to evaluate this notice",,,,,,,,,, =T("664")," Alpha-amylase from Cytophaga sp. expressed in Bacillus licheniformis"," Intended for use as a processing aid in carbohydrate processing, to produce sugar syrups, and in fermentation to produce products such as potable alcohol and organic acids."," Scientific procedures"," Dupont"," 925 Page Mill Road, Palo Alto, CA 94304",08/25/2016," GRN 664 (in PDF)",,,,,,,01/31/2017,," FDA has no questions (in PDF)",,,,,,,,,, =T("665")," Lactoperoxidase system"," Intended for use as a processing aid to extend the shelf life of a variety of dairy products, specifically fresh cheese including mozzarella and cottage cheeses, frozen dairy desserts, fermented milk, flavored milk drinks, and yogurt, at levels not to exceed 300 milligrams per liter."," Scientific procedures"," Taradon Laboratory"," Avenue Leon Champagne, 2; B-1480 Tubize Belgium",08/26/2016," GRN 665 (in PDF)",,,,,,,12/14/2016,," At the notifier's request, FDA ceased to evaluate this notice",,,,,,,,,, =T("666")," Chondroitin sulfate sodium"," Intended for use as an ingredient in beverage and beverage bases, milk and milk products, and chewing gum at levels ranging from 50 to 200 milligrams per serving."," Scientific procedures"," Gnosis S.P.A."," Via Lavoratori Autobianchi, 1 20832 Desio (MB) ITLY",09/13/2016," GRN 666 (in PDF)",,,,,,,03/15/2017,," FDA has no questions (in PDF)",,,,,,,,,, =T("667")," Rebaudioside M"," Intended to be used as a table top sweetener and as a general purpose non-nutritive sweetener for incorporation into foods in general, other than infant formulas and meat and poultry products, at per serving levels reflecting good manufacturing practices and principles, in that the quantity added to foods should not exceed the amount reasonably required to accomplish its intended technical effect."," Scientific procedures"," Blue California"," 30111 Tomas, Rancho Santa Margarita, CA 92688",09/14/2016," GRN 667 (in PDF)",,,,,,,02/17/2017,," FDA has no questions (in PDF)",,,,,,,,,, =T("668")," Sodium formate"," Intended to be used to support the growth of Streptococcus, Lactobacillus, and Leuconostoc species in fermented dairy and soy products at levels not to exceed 20 parts per million."," Scientific procedures"," International Food Additives Council"," 750 National Press Building, 529 14th Street NW, Washington, D. C. 20045",09/21/2016," GRN 668 (in PDF)",,,,,,,03/09/2017,," FDA has no questions (in PDF)",,,,,,,,,, =T("669")," Cows milk-derived lactoferrin"," Ingredient in cows milk-based non-exempt infant formula for term infants at a level of 100 mg/100 g formula solids, which corresponds to approximately 13-14 mg/100 mL infant formula (ready-to-feed (RTF) or prepared for consumption from powder or liquid concentrate), and in follow-on formula at a level of 15 mg/100 mL RTF or prepared for consumption from powder."," Scientific procedures"," Synlait Milk Ltd"," 1028 Heslerton Road, RD 13, Rakaia 7783 New Zealand",09/27/2016," GRN 669 part 1 (in PDF)"," GRN 669 part 2 (in PDF)"," GRN 669 part 3 (in PDF)"," GRN 669 amendments part 4",,,,03/09/2017,," FDA has no questions (in PDF)",,,,,,,,,, =T("670")," Inactivated Bacillus coagulans GBI-30, 6086"," Intended for use as an ingredient at a maximum level of approximately 2 x 109 inactivated colony forming units (CFU) per serving in baked goods and baking mixes; beverages and beverage bases; breakfast cereals; chewing gum; coffee and tea; condiments and relishes; confections and frostings; dairy product analogs; fruit juices; frozen dairy desserts and mixes; fruit and water ices; gelatins, puddings, and fillings; grain products and pastas; hard candy; herbs, seeds, spices, seasonings, blends, extracts, and flavorings; jams and jellies; milk and milk products; nuts and nut products; plant protein products; processed fruits; processed vegetables and vegetable juices; snack foods; soft candy; and soups and soup mixes (excluding foods for infants and toddlers, or in any meat and poultry products under the jurisdiction of the United States Department of Agriculture)."," Scientific procedures"," Ganeden, Inc."," 5800 Landerbrook Drive, Suite 300, Mayfield Heights, Ohio 44124",10/12/2016," GRN 670 (in PDF)",,,,,,,03/15/2017,," FDA has no questions (in PDF)",,,,,,,,,, =T("671")," Galacto-oligosaccharides (GOS)"," Intended for use in powdered non-exempt term infant formulas, selected conventional foods, coffees, and teas at levels not exceeding 7.2 grams per liter in reconstituted infant formula and 11 grams per serving in selected conventional foods, coffees, and teas."," Scientific procedures"," Vitalus Nutrition Inc."," 3911 Mt. Lehman Road; Abbotsford, BC V2T 5W5 Canada",," GRN 671 (in PDF)",,,,,,,04/11/2017,," At the notifier's request, FDA ceased to evaluate this notice (in PDF)",,,,,,,,,, =T("672")," Preparation containing five bacterial monophages specific to Shigella spp."," Intended for use as an antimicrobial to control Shigella spp. on food when applied to food surfaces up to 1x108 PFU per gram of food including ready-to-eat meats, fish and shellfish, fresh and processed fruits, fresh and processed vegetables, and dairy products."," Scientific procedures"," Intralytix, Inc."," 701 E Pratt St.; Baltimore, MD 21202",10/13/2016," GRN 672 (in PDF)",,,,,,,03/27/2017,," FDA has no questions (in PDF)",,,,,,,,,, =T("673")," Algal fat derived from Prototheca moriformis (S7737)"," Intended for use as a replacement for stearic acid-containing dietary fats or oils in a variety of conventional food groups (margarines and margarine-like spreads, butter-like spreads, vegetable shortenings, nut spreads, milk products, non-dairy products, baked goods, chocolate-based sauces and syrups, baked desserts, cookies and frozen dairy desserts) that contain fats that are solid at room temperature."," Scientific procedures"," TerraVia Holdings (Previously Solazyme, Inc.)"," 225 Gateway Blvd, South San Francisco, CA 94080",10/13/2016," GRN 673 (in pdf)",,,,,,,03/27/2017,," FDA has no questions (in PDF)",,,,,,,,,, =T("674")," Isomalto-oligosaccharides"," Intended for use as an ingredient in baked goods and baking mixes; beverages and beverage bases; breakfast cereals; condiments and relishes; dairy product analogs; mayonnaise and mayonnaise-type dressings; salad dressings; frozen dairy desserts and mixes; gelatins, puddings, and fillings; gravies and sauces; hard candies; jams and jellies; meal replacement bars and mixes; meat products; milk and milk products; nut products; processed fruits and fruit juices; snack foods; soft candy; sugar substitutes; sweet sauces, toppings and syrups; processed vegetables and vegetable juices; soups and soup mixes at levels ranging from 5 percent to 100 percent."," Scientific procedures"," BioNeutra North America Inc."," 9608-25 Ave NW, Edmonton, Alberta, Canada",10/14/2016," GRN 674 (in PDF)",,,,,,,07/05/2017,," FDA has no questions (in PDF)",,,,,,,,,, =T("675")," Xylanase enzyme preparation produced by Trichoderma reesei carrying a xylanase gene from Talaromyces leycettanus"," Intended for use as an enzyme in brewing, cereal beverage processing, potable alcohol processing, bakery applications, and grain processing from cereal grains such as corn, wheat, barley, and oats, at levels up to 46.1 milligrams Total Organic Solids per kilogram raw material."," Scientific procedures"," Novozymes"," 77 Perry Chapel Church Rd., Box 576, Franklinton, NC 27525",10/14/2016," GRN 675 (in PDF)",,,,,,,04/06/2017,," FDA has no questions (in PDF)",,,,,,,,,, =T("676")," Colicin preparations"," Intended for use as an antimicrobial on meats (e.g., beef, pork, lamb, mutton, and veal) at an application rate of 1-10 milligrams per kilogram of meat."," Scientific procedures"," Nomad BioScience GmbH"," Biozentrum Halle, Weinbergweg 22, D-06120 Halle/Saale; Germany",," GRN 676 (in PDF)",,,,,,,05/15/2017,," FDA has no questions (in PDF)",,,,,,,,,, =T("677")," Docosahexaenoic acid oil produced in Schizochytrium sp."," Intended for use as an ingredient in exempt (pre-term) and non-exempt (term) infant formula (ages from birth to 12 months) in accordance with current good manufacturing practices and in combination with a source of arachidonic acid."," Scientific procedures"," Mara Renewables Corporation"," 101 Research Drive; Dartmouth NS B2Y 4 T6, Canada",," GRN 677 (in PDF)",,,,,,,05/02/2017,," FDA has no questions (in PDF)",,,,,,,,,, =T("678")," Alpha-cyclodextrin"," Intended for general use in processed and ultra-processed foods at use levels up to 3 percent, and in certain beverages at a level up to 1.05 percent."," Scientific procedures"," Wacker Chemical Corporation"," 3301 Sutton Road, Adrian, Michigan 49221-9397",," GRN 678 with amendments (in PDF)",,,,,,,04/14/2017,," At the notifier's request, FDA ceased to evaluate this notice (in PDF)",,,,,,,,,, =T("679")," Orange juice desugared by fermentation"," Intended for general use as an ingredient in carbonated and non-carbonated beverages"," Scientific procedures"," Sumol + Compal Marcas S.A."," Rua Dr. António João Eusébio, 24
2790-179 Carnaxide
Portugal",," GRN 679 (in PDF)",,,,,,,05/10/2017,," FDA has no questions (in PDF)",,,,,,,,,, =T("680")," Alpha-L-arabinofuranosidase from Talaromyces pinophilus produced by Trichoderma reesei"," for use as a processing aid to increase the yield of starch and gluten meal during the corn wet milling process at minimum levels necessary to achieve the desired effect and according to good manufacturing practices."," Scientific procedures"," Novozymes North America"," 77 Perry Chapel Church Rd, Franklinton, NC 27525",," GRN 680 (in PDF)",,,,,,,05/24/2017,," FDA has no questions (in PDF)",,,,,,,,,, =T("681")," Dried isomaltulose syrup"," for use as a sucrose substitute in foods where sucrose is an ingredient or is directly added by the consumer."," Scientific procedures"," Evonik Creavis GmbH"," Paul-Baumann-Straße 1
45772 Marl, Germany",," GRN 681 (in PDF)",,,,,,,06/21/2017,," FDA has no questions (in PDF)",,,,,,,,,, =T("682")," Lecithin from canola"," for use as an emulsifier, surfactant, and dispersing agent in foods generally."," Scientific procedures"," Cargill"," 15407 McGinty Road West
Wayzata, MN 55391",," GRN 682 (in PDF)",,,,,,,07/07/2017,," FDA has no questions (in PDF)",,,,,,,,,, =T("683")," Canola protein isolate"," Intended for use as a protein source, thickener, water binder, emulsifier, gelling agent, foaming agent or texturizer in prepared food (e.g. ready-to-eat meals, soups, pasta, snacks), meat analogues, bakery products (e.g. bread, rolls, doughnut, cookies, cakes, pies, batters, muffins, pasta, and cereal bars, cereals), protein enriched bakery products (e.g. bars, cookies), sports nutrition (e.g. protein drinks, energy bars), weight management (e.g. meal replacement, nutritional bars), beverages (e.g. fruit juices, soft drinks, juice blends), dairy products (e.g. desserts, ice cream, cheese, yogurt), medical nutrition (e.g. protein fortified drinks, ready-to-drink), elderly nutrition (e.g. foods specifically meant for the needs of elderly people) at use levels ranging from 5 to 30 percent."," Scientific procedures"," DSM Nutritional Products, LLC"," 45 Waterview Blvd.
Parsippany, New Jersey, 07054",," GRN 683 (in pdf)",,,,,,,05/10/2017,," FDA has no questions (in PDF)",,,,,,,,,, =T("684")," Mung bean protein isolate"," Intended for use as a protein source in baked goods and baking mixes; beverages and beverage bases; breakfast cereals; condiments and relishes; dairy product analogs, frozen dairy desserts and mixes; fruit and water ices; gelatins, puddings, and fillings; grain products and pasta; milk products; plant protein products; and snack foods."," Scientific procedures"," Hampton Creek, Inc."," 2000 Folsom Street
San Francisco, CA
94110",," GRN 684 (in pdf)",,,,,,,08/04/2017,," FDA has no questions (in PDF)",,,,,,,,,, =T("685")," Lactobacillus plantarum strain 299v"," Intended for use as an ingredient in conventional foods at a use level up to 1011 CFU per serving."," Scientific procedures"," Probi AB"," Sölvegatan 41 A
SE-223 70 Lund, Sweden",," GRN 685 (in pdf)",,,,,,,10/31/2017,," FDA has no questions (in PDF)",,,,,,,,,, =T("686")," Curcumin from turmeric (Curcuma longa L.)"," Intended for use as a nutrient supplement in yogurt, nutrition bars, smoothies, and medical foods) at levels intended to provide up to 60 milligrams of curcumin per serving"," Scientific procedures"," DolCas Biotech, LLC"," 9 Lenel Road
Landing, NJ 07850",," GRN 686 (in PDF)",,,,,,,07/11/2017,," FDA has no questions (in PDF)",,,,,,,,,, =T("687")," Inulin from Agave tequilana"," Intended for use as a bulking agent, texturizing agent, or source of reduced energy carbohydrate in foods generally (excluding meat and poultry products, and infant formula) at levels not to exceed the amount reasonably required to accomplish the intended technical effect.  "," Scientific procedures"," IIDEA (Industrializadora Integral del Agave SA de CV)"," Av. Periférico Sur 7750
Tlaquepaque Jalisco
Mexico",," GRN 687 (in PDF)",,,,,,,05/08/2017,," At the notifier's request, FDA ceased to evaluate this notice (in PDF)",,,,,,,,,, =T("688")," Sodium thiocyanate"," Intended for use in the lactoperoxidase system. The lactoperoxidase system is used in fresh cheese including mozzarella and cottage cheeses, frozen dairy desserts, fermented milk, flavored milk drinks, and yogurt."," Scientific procedures"," Taradon Laboratory"," Avenue Leon Champagne, 2
B-1480 Tubize
Belgium",," GRN 688 (in PDF)",,,,,,,08/25/2017,," At the notifier's request, FDA ceased to evaluate this notice (in PDF)",,,,,,,,,, =T("689")," Phospholipase C from Bacillus thuringiensis produced in Bacillus licheniformis"," In degumming of vegetable oils intended for human consumption at levels no higher than necessary to achieve the intended effect."," Scientific procedures"," Novozymes"," 77 Perry Chapel Church Rd., Box 576
Franklinton, NC 27525",," GRN 689 (in PDF)",,,,,,,08/04/2017,," FDA has no questions (in PDF)",,,,,,,,,, =T("690")," Fruit and vegetable vitamin extract"," As an alternative source of vitamins in foods at levels intended to provide up to 100 percent of the daily value per serving."," Scientific procedures"," Hogan Lovells US LLP"," 555 Thirteenth Street, NW
Washington, DC 20004",," GRN 690 with amendments (in PDF)",,,,,,,08/01/2017,," At the notifier's request, FDA ceased to evaluate this notice (in PDF)",,,,,,,,,, =T("691")," Bacillus coagulans SANK 70258 spore preparation"," As an ingredient providing up to 2 x109 CFU/serving in baked goods and baking mixes; beverages and beverage bases; breakfast cereals; chewing gum; coffee and tea; condiments and relishes; confections and frostings; dairy product analogs; fruit juices; frozen dairy desserts and mixes; fruit and water ices; gelatins, puddings, and fillings; grain products and pastas; hard candy; herbs, seeds, spices, seasonings, blends, extracts, and flavorings; jams and jellies; milk; milk products; nuts and nut products; plant protein products; processed fruits; processed vegetables and vegetable juices; snack foods; soft candy; soups and soup mixes; sugar; and sweet sauces, toppings and syrups."," Scientific procedures"," Mitsubishi-Kagaku Foods Corporation"," 1-1 , Marunouch i
1-chome Chiyoda-ku,
Tokyo 100-8251
Japan",," GRN 691 (in PDF)",,,,,,,08/28/2017,," FDA has no questions (in PDF)",,,,,,,,,, =T("692")," Quinoa sprout extract"," Intended for use as a nutrient at a maximum concentration of up to 300 mg/serving in foods such as baked goods, ready-to-eat cereals, and snack foods."," Scientific procedures"," VIS VITALIS gmbh"," A-5585 Unternberg - Moosham 29
AUSTRIA",," GRN 692 (in PDF)",,,,,,,11/03/2017,," At the notifier's request, FDA ceased to evaluate this notice (in PDF)",,,,,,,,,, =T("693")," D-psicose"," For use as a sugar substitute in bakery products (rolls, cakes, pastries, cakes, low calorie or dietetics); beverages (non-alcoholic), low calorie, reduced calorie, sugar-free; cereals, regular cereals, low calorie, reduced calorie, sugar-free; chewing gum; confections and frostings; frozen dairy desserts (ice cream, soft serve, sorbet), low calorie, reduced calorie, sugar-free; yogurt and frozen yogurt, low calorie, reduced calorie, sugar-free; dressings for salads; gelatins, pudding and fillings, low calorie, reduced calorie, sugar-free; hard candies, low calorie, reduced calorie, sugar-free; soft candies, low calorie, reduced calorie, sugar-free; jams and jellies; sugar; sugar substitutes; sweet sauces and syrups, low calorie, reduced calorie, sugar-free; fat-based cream (used in modified fat/calorie cookies cakes, pastries and pies) at levels ranging from 2 to 100 percent (w/w)."," Scientific procedures"," Samyang Corporation"," 295 Pangyo-ro, Bundang-gu,
Seongnam-si, Gyeonggi-do,
Korea",," GRN 693 (in PDF)",,,,,,,08/28/2017,," FDA has no questions (in PDF)",,,,,,,,,, =T("694")," Pyrroloquinoline quinone disodium salt (PQQ)"," Intended for use as an ingredient in beverages and beverage bases up to 0.083 percent in the final product."," Scientific procedures"," Fuzhou Contay",,," GRN 694 (in PDF)",,,,,,,09/28/2017,," FDA has no questions (in PDF)",,,,,,,,,, =T("695")," Dimethyl ether"," For use as an extraction solvent in the processing of various food products, such as marine lipids, egg phospholipids, bacteria-derived lipids, algae-derived lipids, plant lipids, egg proteins, plant proteins, meat proteins, and fruit sugars, which would then serve as ingredients added to food."," Scientific procedures"," Callaghan Innovation"," 69 Gracefield Road
Lower Hutt 5040
New Zealand",," GRN 695 (in PDF)",,,,,,,08/29/2017,," At the notifier's request, FDA ceased to evaluate this notice (in PDF)",,,,,,,,,, =T("696")," Dolomite"," For use as a substitute for calcium and magnesium salts to enhance the mineral content of purified bottled water, with a maximum use level intended to provide 90.16 mg/L of calcium ions and 55 mg/L of magnesium ions."," Scientific procedures"," Hogan Lovells US LLP"," 555 Thirteenth Street, NW
Washington, DC 20004",," GRN 696 (in PDF)",,,,,,,10/03/2017,," At the notifier's request, FDA ceased to evaluate this notice (in PDF)",,,,,,,,,, =T("697")," Dried biomass of Euglena gracilis"," For use as an ingredient in baked goods and baking mixes, beverages and beverage bases, cereal and cereal products, dairy product analogs, milk and milk products, processed fruits and fruit juices, soft candy, and soup and soup mixes at use levels up to 500 mg/serving."," Scientific procedures"," Kemin Foods, L.C."," 2100 Maury Street
Des Moines, IA 50317",," GRN 697 (in PDF)",,,,,,,07/19/2017,," At the notifier's request, FDA ceased to evaluate this notice (in PDF)",,,,,,,,,, =T("698")," Paramylon isolate from Euglena gracilis"," For use as an ingredient in baked goods and baking mixes, beverages and beverage bases, cereal and cereal products, dairy product analogs, milk and milk products, processed fruits and fruit juices, soft candy, and soup and soup mixes at use levels up to 250 mg/serving."," Scientific procedures"," Kemin Foods, L.C."," 2100 Maury Street
Des Moines, IA 50317",," GRN 698 (in PDF)",,,,,,,07/19/2017,," At the notifier's request, FDA ceased to evaluate this notice (in PDF)",,,,,,,,,, =T("699")," Trehalase from Myceliophthora sepedonium produced by Aspergillus niger"," For use as a processing aid in the ethanol distillation process."," Scientific procedures"," Novozymes North America, Inc."," 77 Perrys Chapel Church Road
Franklinton, NC 27525",05/30/2017," GRN 699 (in PDF)",,,,,,,11/13/2017,," FDA has no questions (in PDF)",,,,,,,,,, =T("700")," Paracoccus carotinifaciens extract containing carotenoids"," For use as a source of dietary astaxanthin in baked goods and baking mixes, beverages and beverage bases, energy, sports and isotonic drinks, non-milk based meal replacements, cereals and cereal products, chewing gums, coffee, tea, dairy product analogs, frozen dairy desserts and mixes, hard candy, milk products, processed fruits and fruit juices, and processed vegetables and vegetable juices, and soft candy at levels providing 0.15 milligrams (mg) astaxanthin per serving."," Scientific procedures"," JX Nippon Oil & Energy Corporation"," 1-2, Otemachi 1-chrome
Chiyoda-ku, Tokyo 100-8162
JAPAN",," GRN 700 (in PDF)",,,,,,,10/23/2017,," FDA has no questions; some uses may require a color additive listing (in PDF)",,,,,,,,,, =T("701")," Pyrroloquinoline quinone disodium salt"," For use as an ingredient in energy, sport, and electrolyte drinks; bottled, enhanced, and fortified water; and non-milk based meal replacement beverages at a maximum use level of up to 8 to 20 mg/serving."," Scientific procedures"," Nutraland USA, Inc."," 212 Technology Drive
Irvine, CA 92618",," GRN 701 (in PDF)",,,,,,,09/08/2017,," FDA has no questions (in PDF)",,,,,,,,,, =T("702")," Purified steviol glycosides"," For use as a table top and general purpose sweetener in accordance with current good manufacturing practices."," Scientific procedures"," Xinghua GL Stevia Co., Ltd."," No. 26 Kaifu Road, Xinghua Economic Development Zone
Xinghua City, Jiangsu Province
CHINA",," GRN 702 (in PDF)",,,,,,,09/28/2017,," FDA has no questions (in PDF)",,,,,,,,,, =T("703")," Alpha-glucosidase from Aspergillus niger produced by Trichoderma reesi"," For use in fermentations to manufacture potable alcohol, organic acids, and monosodium glutamate at 4 kg of product per metric ton of substrate (235 mg TOS/kg substrate)."," Scientific procedures"," Danisco US Inc. (DuPont Industrial Biosciences)"," 925 Page Mill Road
Palo Alto, CA 94304",," GRN 703 (in PDF)",,,,,,,11/09/2017,," FDA has no questions (in PDF)",,,,,,,,,, =T("704")," Corn oil (by-product of ethanol production)"," For use as an ingredient in food where vegetable oil would be used, such as in baked goods and confections, and in processes where standard oil would be used, such as frying and cooking."," Scientific procedures"," CoPack Strategies, LLC"," 2815 100th St., Ste 316
Des Moines, IA 50322",," GRN 704 in PDF",,,,,,,10/10/2017,," At the notifier's request, FDA ceased to evaluate this notice (in PDF)",,,,,,,,,, =T("705")," Distarch phosphate"," For use as an ingredient, thickener, or texturing agent in bread, pancakes/waffles, nutrition bars, RTE cereal, muffins, tortillas, pretzels, dry uncooked plain pasta, and meal replacements."," Scientific procedures"," Ingredion, Inc."," 10 Finderne Avenue
Bridgewater, NJ 08807",," GRN 705 (in PDF)",,,,,,,11/09/2017,," FDA has no questions (in PDF)",,,,,,,,,, =T("706")," Siraitia grosvenorii Swingle (Luo Han Guo) fruit extract"," Table top sweetener and a general purpose sweetener in foods, at levels determined by current good manufacturing practices"," Scientific procedures"," Hunan NutraMax, Inc"," Baiyashi Industrial District, Dong'an
Yongzhou City, Hunan Province, 425900
CHINA",," GRN 706 (in PDF)",,,,,,,08/17/2017,," FDA has no questions (in PDF)",,,,,,,,,, =T("707")," Glucose oxidase from Penicillium produced in Trichoderma reesei"," For use in baking processes at the minimum amount necessary to achieve the intended technical effect."," Scientific procedures"," AB Enzymes GmbH"," Feldbergstr. 78, D-64293
Darmstadt
GERMANY",," GRN 707 (in PDF)",,,,,,,11/24/2017,," FDA has no questions (in PDF)",,,,,,,,,, =T("708")," Triacylglycerol lipase from Rhizopus oryzae produced in Aspergillus niger"," For use in the production of cocoa butter substitutes at a rate of 0.3-1 kg of lipase (and carrier) per ton of lipid."," Scientific procedures"," Advanced Enzyme Technologies Ltd."," 5th Floor, Sun Magnetica LIC Service Road, Louiswadi
Thane West, Maharashtra
INDIA",," GRN 708 part 1 (in PDF)"," GRN 708 part 2 (in PDF)"," GRN 708 part 3 (in PDF)",,,,,10/10/2017,," At the notifier's request, FDA ceased to evaluate this notice (in PDF)",,,,,,,,,, =T("709")," Pyrroloquinoline quinone disodium salt"," For use as an ingredient in energy, sport, and electrolyte drinks; bottled, enhanced, and fortified water; and non-milk based meal replacement beverages at a maximum use level of up to 8 to 20 mg/serving."," Scientific procedures"," Shandong Jincheng Bio-Pharmaceutical Co., Ltd."," Zichuan Economic Development Zone
Zibo City, Shandong Province
CHINA",," GRN 709 (in PDF)",,,,,,,03/06/2018,," FDA has no questions (in PDF)",,,,,,,,,, =T("710")," Basic methacrylate copolymer"," Coating for various micronutrients to prevent degradation at a level up to 2.3 g/day."," Scientific procedures"," Ramboll Environ"," 4350 North Fairfax Drive, Suite 300
Arlington, VA 22201",," GRN 710 (in PDF)"," GRN 710 amendments (in PDF)",,,,,,12/08/2017,," At the notifier's request, FDA ceased to evaluate this notice (in PDF)",,,,,,,,,, =T("711")," Glucan"," For use as a low calorie bulking agent, formulation aid, humectant and texturizer in baked goods and baking mixes; beverages and beverage bases; breakfast cereals; chewing gum; fats and oils; frozen dairy desserts and mixes; gelatins, puddings, and fillings, hard candy; jams and jellies, commercial; milk products; nuts and nut products; snack foods; soft candy; soups and soup mixes; sugar substitutes; and dietary supplements (as a binder, filler or excipient) at levels ranging from 1.9 to 93% of the finished food."," Scientific procedures"," Nihon Shokuhin Kako Co., Ltd."," 30 Tajima Fuji
Shizuoka
JAPAN",," GRN 711 (in PDF)",,,,,,,12/26/2017,," FDA has no questions (in PDF)",,,,,,,,,, =T("712")," Calcium acetate"," Firming agent, flavor enhancer, nutrient supplement, pH control agent, processing aid, sequestrant, stabilizer, thickener, and texturizer with no limitations other than current good manufacturing practices."," Scientific procedures"," Niacet Corporation"," 400 47th Street
Niagara Falls, NY, 14304",," GRN 712 (in PDF)",,,,,,,02/05/2018,," At the notifier's request, FDA ceased to evaluate this notice (in PDF)",,,,,,,,,, =T("713")," Hydrolyzed pork cartilage"," For use as an ingredient in active nutrition and nutritionally complete bars, granola bars, enhanced fortified water beverages, sports nutrition gels, fortified flavored milk beverages (excluding milkshakes), enhanced or fortified fruit-flavored beverages, and gummies at use levels of up to 5.0%."," Scientific procedures"," Rousselot BVBA; Darling Ingredients"," Kanaaldijk Noord 20-21
5691 NM Son
The Netherlands",," GRN 713 (in PDF)",,,,,,,04/05/2018,," FDA has no questions (in PDF)",,,,,,,,,, =T("714")," Subtilisin from Bacillus amyloliquefaciens produced in Bacillus subtilis"," For use in the processing of protein at 58-369 mg TOS/kg substrate to facilitate protein hydrolysis."," Scientific procedures"," Danisco US Inc. (Dupont Industrial Biosciences)"," 925 Page Mill Road
Palo Alto, CA, 94304",," GRN 714 (in PDF)",,,,,,,02/06/2018,," FDA has no questions (in PDF)",,,,,,,,,, =T("715")," Rebaudioside D"," For use as a table top sweetener and as a general purpose non-nutritive sweetener for use in foods in general, other than infant formula and meat and poultry products, at levels consistent with good manufacturing practices."," Scientific procedures"," Blue California"," 30111 Tomas
Rancho Santa Margarita, CA, 92688",," GRN 715 (in PDF)",,,,,,,10/24/2017,," FDA has no questions (in PDF)",,,,,,,,,, =T("716")," Bovine milk osteopontin"," For use in non-exempt cows milk-based infant formula and cows milk powdered beverages for children 1-3 years of age at levels intended to result in an estimated intake at the 90th percentile of 39.5 mg/kg body weight/day."," Scientific procedures"," Arla Foods Ingredients Group P/S"," Soenderhoej 10-12
DK-8260 Viby J
Denmark",," GRN 716 part 1 with amendments (in PDF)"," GRN 716 Form 3667 (in PDF)",,,,,,02/01/2018,," At the notifier's request, FDA ceased to evaluate this notice (in PDF)",,,,,,,,,, =T("717")," Short-chain fructo-oligosaccharides"," For use as an ingredient in cow milk- and soy-based non-exempt infant formula, as consumed, at a level up to 4 g/L for term infants aged 06 months and at a level up to 5 g/L for term infants aged >6 months; and in acidophilus milk, nutritional bars, baby food, nutritional beverages, biscuits, cakes, confectionery, cookies, crackers, flavored and unflavored milks, hard candy, ice cream and frozen yogurt, jams and jellies, muffins, ready-to-eat cereals, sorbet, soup and yogurt at levels ranging from 0.8 to 6.7%."," Scientific procedures"," Galam, Ltd."," Kibbutz Maanit
M.P. Menashe, 3785500
Israel",," GRN 717 (in PDF)",,,,,,,02/13/2018,," FDA has no questions (in PDF)",04/21/2023," Supplemental Letter (in PDF)",,,,,,,, =T("718")," Calcium acid pyrophosphate"," Leavening agent, stabilizer, dough strengthener, texturizer, and acidifier in self-rising flours, noodles (Asian), batters and breadings, breads (baguettes and rolls; bread crumbs), processed cereals, bagels, tortillas, fine bakery wares, vegetable masses (spring rolls), and popcorn at levels between 0.3 and 1.3% in accordance with current good manufacturing practice."," Scientific procedures"," Chemische Fabrik Budenheim KG"," Rheinstrasse 27
Budehneim,55257
Germany",," GRN 718 with amendments (in PDF)",,,,,,,10/17/2017,," At the notifier's request, FDA ceased to evaluate this notice (in PDF)",,,,,,,,,, =T("719")," Orange pomace and enzyme-treated orange pomace"," For use as a source of nutrients, stabilizer, thickener, and texturizer in orange juice; fruit juice blends; juice drinks; smoothies; spoonable sauce; grain-based bars; hot cereals; pies, cobblers, fruit crisps, turnovers, rolls, cakes, muffins or other pastries; pie filling; salad dressings; sauces and dips; condiments, major; condiments, minor; pastes (up to 75% water content); fruit butters (orange); fruit leathers at levels ranging from 1 to 50%."," Scientific procedures"," PepsiCo, Inc."," 700 Anderson Hill Road
Purchase, NY, 10577",," GRN 719 (in PDF)",,,,,,,12/26/2017,," FDA has no questions (in PDF)",,,,,,,,,, =T("720")," Rice bran wax"," Intended for use as a texturizing agent in peanut butter used in nutrition and granola-type bar products at levels up to 3 percent."," Scientific procedures"," The J.M. Smucker Company"," 1 Strawberry Lane
Orrville, OH, 44667",," GRN 720 (in PDF)",,,,,,,01/16/2018,," FDA has no questions (in PDF)",,,,,,,,,, =T("721")," Galacto-oligosaccharides"," Ingredient in milk-based, non-exempt infant formula for term infants at a level up to 7.2 g GOS/L of reconstituted or ready-to-feed formula; and in milk and milk products, soups, bakery products, cereals, fruit and vegetable juices, jellies and jams, and nonalcoholic beverages at a maximum level up to 33.4%."," Scientific procedures"," Vitalus Nutrition Inc."," 3911 Mt. Lehman Road Abbotsford, BC V2T 5W5 CANADA",," GRN 721 (in PDF)",,,,,,,12/19/2017,," FDA has no questions (in PDF)",,,,,,,,,, =T("722")," Lactobacillus plantarum Lp-115"," For use as an ingredient in yogurt and other dairy products; soy products; beverages; chewing gum, confectionary snacks and other foods at levels not more than 5 x 1011 CFU/serving."," Scientific procedures"," Dupont Nutrition & Health"," 3329 Agriculture Drive Madison, WI, 53716",," GRN 722 (in PDF)",,,,,,,02/16/2018,," FDA has no questions (in PDF)",,,,,,,,,, =T("723")," Benzalkonium chloride"," As a processing aid for lettuce and carrot products"," Scientific procedures"," Marvel Technologies USA, LLC"," 8161 TN-100 Bellevue, TN, 37221",," GRN 723 (in PDF)",,,,,,,12/18/2017,," At the notifier's request, FDA ceased to evaluate this notice (in PDF)",,,,,,,,,, =T("724")," Preparation containing six bacterial phages specific to shiga-toxin producing Escherichia coli"," As a processing aid antimicrobial agent to control shiga-toxin producing Escherichia coli on beef carcasses."," Scientific procedures"," FINK TEC GmbH"," Oberster Kamp 23 Hamm D-59069 GERMANY",," GRN 724 (in PDF)",,,,,,,04/10/2018,," FDA has no questions (in PDF)",,,,,,,,,, =T("725")," Inactivated Bacillus coagulans GBI-30, 6086"," For use as an ingredient in non-exempt term infant formula at levels up to 2 x 108 CFU inactivated cells per 100 mL of infant formula as consumed."," Scientific procedures"," Ganeden Biotech, Inc."," 5800 Landerbrook Drive, Suite 300 Mayfield Heights, OH, 44124",," GRN 725 (in PDF)",,,,,,,02/12/2018,," FDA has no questions (in PDF)",,,,,,,,,, =T("726")," Phenolic preparation from olive fruit"," For use as an ingredient in bakery products; beverages; dairy products and substitutes; desserts; fats and oils; fruit juices and nectars; dry seasoning mixes for meat, poultry and fish; chewing gum; sauces, dips, gravies and condiments; snacks; and vegetable juices to provide 5 to 10 mg of hydroxytyrosol per serving of food."," Scientific procedures"," DSM Nutritional Products, LLC."," 45 Waterview Blvd. Parsippany, NJ, 07054",," GRN 726 (in PDF)",,,,,,,02/28/2018,," FDA has no questions (in PDF)",,,,,,,,,, =T("727")," Trehalase from Trichoderma reesei produced in Trichoderma reesei"," For use as a processing aid during the fermentation process to produce organic acids, monosodium glutamate, and potable alcohol at 100 mg product/kg starch (36.72 mg TOS/kg starch)."," Scientific procedures"," Danisco US Inc. (Dupont Industrial Biosciences)"," 925 Page Mill Road Palo Alto, CA, 94304",," GRN 727 (in PDF)",,,,,,,03/05/2018,," FDA has no questions (in PDF)",,,,,,,,,, =T("728")," Phospholipase C from Pseudomonas sp. 62186 produced in Bacillus licheniformis"," For use in degumming vegetable oils intended for food use at a maximum use level of 75 PLC(E) per kilo of oil."," Scientific procedures"," Novozymes North America, Inc."," 77 Perrys Chapel Church Road P.O. Box 576 Franklinton, NC, 27525",," GRN 728 (in PDF)",,,,,,,11/13/2017,," FDA has no questions (in PDF)",,,,,,,,,, =T("729")," Galacto-oligosaccharides"," For use as an ingredient in food categories as described in GRN 484 at levels ranging from 0.3 to 11 grams of GOS per serving, and for use as an ingredient in term infant formula and follow-on formula at 7.8 grams of GOS per liter of formula."," Scientific procedures"," Neo Cremar, Co., Ltd."," A-714, Hyundai Knowledge Center 11,
Beobwon-Ro 11-gil, Songpa-gu, Seoul,
05836, South Korea",," GRN 729 (in PDF)",,,,,,,03/27/2018,," FDA has no questions (in PDF)",,,,,,,,,, =T("730")," Arachidonic-acid rich oil from Mortierella alpina strain LU 166"," Ingredient in milk-and soy-based infant formulas. The maximum level for non-exempt term infant formula is 0.75% ARA and for exempt preterm infant formula is 0.40% ARA by weight of total fatty acids in combination with docosahexaenoic acid (DHA) at a ratio ranging from 1:1 to 2:1."," Scientific procedures"," Linyi Youkang Biology Co., Ltd."," Lianbang Road, Economical and Technical Development Area,
Linyi City, Shangdong Province,
China",," GRN 730 (in PDF)",,,,,,,03/30/2018,," FDA has no questions (in PDF)",,,,,,,,,, =T("731")," Docosahexaenoic acid oil produced in Schizochytrium sp."," For use as an ingredient in term and pre-term infant formula at a maximum level of 0.5% total fat as docosahexaenoic acid and in combination with a safe and suitable source of arachidonic acid. The ratio of DHA to ARA would range from 1:1 to 1:2."," Scientific procedures"," Linyi Youkang Biology Co., Ltd."," Lianbang Road, Economical and Technical Development Area,
Linyi City, Shangdong Province,
China",," GRN 731 (in PDF)",,,,,,,04/06/2018,," FDA has no questions (in PDF)",,,,,,,,,, =T("732")," Docosahexaenoic acid oil produced in Schizochytrium sp."," For use as an ingredient in the same food categories as those listed in 21 CFR 184.1472(a)(3) (menhaden oil) at maximum use levels that are 22.22% of those specified in the regulation."," Scientific procedures"," Linyi Youkang Biology Co, Ltd."," Lianbang Road, Economical and Technical Development Area,
Linyi City, Shangdong Province,
China",," GRN 732 (in PDF)",,,,,,,04/06/2018,," FDA has no questions (in PDF)",,,,,,,,,, =T("733")," Purified steviol glycosides"," For use as a general-purpose sweetener in foods, excluding meat and poultry products and infant formula, at levels in accordance with current good manufacturing practices."," Scientific procedures"," Shangdong Shengxiangyuan Biotechnology"," Chuangye Road, Xizou Industrial Park,
Qufu,Shandong Province, 273100,
China",," GRN 733 part 1 (in PDF)"," GRN 733 part 2 (in PDF)",,,,,,01/09/2018,," FDA has no questions (in PDF)",,,,,,,,,, =T("734")," Ergothionine"," For use as a nutrient supplement in cakes, cookies, pastries (including granola bars); coffee; tea; fruit drinks and ades; carbonated soft drinks; and candy containing chocolate at a levels intended to provide 5 mg/serving ergothionine."," Scientific procedures"," Blue California"," 30111 Tomas
Rancho Santa Margarita, CA 92688",," GRN 734 (in PDF)",,,,,,,05/07/2018,," FDA has no questions (in PDF)",,,,,,,,,, =T("735")," 2'-Fucosyllactose"," Ingredient in milk-and soy-based, non-exempt infant formulas for term infants and in toddler formulas at a maximum level of 2.4 g/L of formula as consumed; infant and toddler foods at levels of 0.24-1.2 g/serving; and in the following food categories at levels of 0.28-1.2 g/serving: beverages and beverage bases; breakfast cereals; dairy product analogs; frozen dairy desserts and mixes; gelatins, puddings, and fillings; grain products and pastas; jams and jellies; milk and milk products; processed fruits and fruit juices; and sweet sauces, toppings, and syrups."," Scientific procedures"," Glycosyn, LLC and Friesland Campina Domo B.V."," 890 Winter Street
Suite 208
Waltham, MA 02451",," GRN 735 part 1 (in PDF)"," GRN 735 part 2 (in PDF)"," GRN 735 part 3 (in PDF)"," GRN 735 part 4 (in PDF)"," GRN 735 part 5 (in PDF)",,,04/06/2018,," FDA has no questions (in PDF)",04/30/2020," Supplemental Letter (in PDF)",,,,,,,, =T("736")," Lactobacillus casei subsp. paracasei Lpc-37"," For use as an ingredient in yogurt and other dairy products, soy products, beverages, chewing gum, and confectionary snacks."," Scientific procedures"," DuPont Nutrition and Health"," 3329 Agriculture Drive
Madison, WI 53716",," GRN 736 (in PDF)",,,,,,,04/11/2018,," FDA has no questions (in PDF)",,,,,,,,,, =T("737")," Soy leghemoglobin preparation from a strain of Pichia pastoris"," For use at levels up to 0.8% soybean leghemoglobin protein to optimize flavor in ground beef analogue products intended to be cooked."," Scientific procedures"," Impossible Foods Inc."," 525 Chesapeake Drive
Redwood City, CA 94063",," GRN 737 part 1 (in PDF)"," GRN 737 part 2 (in PDF)"," GRN 737 part 3 (in PDF)",,,,,07/23/2018,," FDA has no questions (in PDF)",,,,,,,=T("540"),,, =T("738")," Thaumatin"," For use as a sweetener in wine, beer, and other fermented beverages; jams, jellies, marmalades; potato-based and similar snacks; breakfast cereals; chewing gum (with other sweeteners); chewing gum (without other sweeteners); ice cream and other edible ices; cocoa and chocolate products; breath mints and similar; confectionary; decorations, coatings, and fillings; fine bakery items; and dietary supplements (capsules, tablets, syrups, and similar)at use levels ranging from 5 mg/kg to 400 mg/kg. Also for use as a sweetener in table-top sweeteners in accordance with good manufacturing practice."," Scientific procedures"," Nomad Bioscience GmbH"," Biozentrum Halle, Weinbergweg 22, Halle/Saale
Saxony-Anhalt, D-06120
Germany",," GRN 738 (in PDF)",,,,,,,04/18/2018,," FDA has no questions (in PDF)",,,,,,,,,, =T("739")," Mannanase enzyme from Talaromyces leycettanus produced in Aspergillus niger"," For use as a processing aid during instant coffee production at the minimum levels necessary to achieve the intended technical effect."," Scientific procedures"," Novozymes North America, Inc."," 77 Perry Chapel Church Road, Box 576
Franklinton, NC 27525",," GRN 739 (in PDF)",,,,,,,04/25/2018,," FDA has no questions (in PDF)",,,,,,,,,, =T("740")," Glycolipids from Dacryopinax spathularia"," For use as an antimicrobial agent in select non-alcoholic beverages at use levels ranging from 2 to 100 ppm."," Scientific procedures"," IMD Natural Solutions GmbH"," Otto-Hahn-Str. 15, 44227
Dortmund
Germany",," GRN 740 (in PDF)",,,,,,,05/17/2018,," FDA has no questions (in PDF)",,,,,,,,,, =T("741")," Dimethyl ether"," For use as an extraction solvent in the processing of various food products."," Scientific procedures"," Callaghan Innovation"," 69 Gracefield Road
Lower Hutt 5040
New Zealand",," GRN 741 (in PDF)",,,,,,,05/18/2018,," FDA has no questions (in PDF)",,,,,,,,,, =T("742")," Duckweed (subfamily Lemnoideae) powder"," For use as an ingredient in at levels ranging from 1.0 to 24 grams per serving in baked goods and baking mixes, including all ready-to-eat and ready-to-bake products, flours, and mixes requiring preparation before serving; beverages and beverage bases, nonalcoholic, including only special or spiced teas, soft drinks, coffee substitutes, and fruit- and vegetable-flavored gelatin drinks; breakfast cereals, including ready-to-eat and instant and regular hot cereals; confections and frostings, including candy and flavored frostings, marshmallows, baking chocolate, and brown, lump, rock, maple, powdered, and raw sugars; fresh fruits and fruit juices, including only raw fruits, citrus, melons, and berries, and home-prepared ""ades"" and punches made therefrom; frozen dairy desserts and mixes, including ice cream, ice milks, sherbets, and other frozen dairy desserts and specialties; grain products and pastas, including macaroni and noodle products, rice dishes, and frozen multicourse meals, without meat or vegetables; hard candy and cough drops, including all hard type candies; jams and jellies, commercial, including only commercially processed jams, jellies, fruit butters, preserves, and sweet spreads; milk products, including flavored milks and milk drinks, dry milks, toppings, snack dips, spreads, weight control milk beverages, and other milk origin products; plant protein products, including the National Academy of Sciences/National Research Council ""reconstituted vegetable protein"" category, and meat, poultry, and fish substitutes, analogs, and extender products made from plant proteins; processed fruits and fruit juices, including all commercially processed fruits, citrus, berries, and mixtures; salads, juices and juice punches, concentrates, dilutions, ""ades"", and drink substitutes made therefrom; processed vegetables and vegetable juices, including all commercially processed vegetables, vegetable dishes, frozen multicourse vegetable meals, and vegetable juices and blends; snack foods, including chips, pretzels, and other novelty snacks; soft candy, including candy bars, chocolates, fudge, mints, and other chewy or nougat candies; soups and soup mixes, including commercially prepared meat, fish, poultry, vegetable, and combination soups and soup mixes."," Scientific procedures"," Parabel Ltd."," 7898 Headwaters Commerce St.
Fellsmere, FL 32948, USA",," GRN 742 part 1 (in PDF)"," GRN 742 part 2 (in PDF)"," GRN 742 part 3 (in PDF)",,,,,08/22/2018,," FDA has no questions (in PDF)",,,,,,,,,, =T("743")," β-galactosidase from Papiliotrema terrestris"," For use in the production of galacto-oligosaccharides."," Scientific procedures"," Amano Enzyme, Inc."," 2-7, 1-Chome, Nishiki
Naka-ku, Nagoya, 460-8630
Japan",," GRN 743 (in PDF)",,,,,,,06/01/2018,," FDA has no questions (in PDF)",,,,,,,,,, =T("744")," Steviol glycosides consisting primarily of rebaudioside M"," For use as a general-purpose sweetener in foods, excluding meat and poultry products and infant formula, at levels in accordance with current good manufacturing practices."," Scientific procedures"," PureCircle Limited"," 915 Harger Road, Suite 250
Oak Brook, Illinois
60523",," GRN 744 (in PDF)",,,,,,,03/23/2018,," FDA has no questions (in PDF)",,,,,,,,,, =T("745")," Steviol glycosides consisting primarily of rebaudioside M"," For use as a general-purpose sweetener in foods, excluding meat and poultry products and infant formula, at levels in accordance with current good manufacturing practices."," Scientific procedures"," PureCircle Limited"," 915 Harger Road, Suite 250
Oak Brook, Illinois
60523",," GRN 745 (in PDF)",,,,,,,04/20/2018,," FDA has no questions (in PDF)",,,,,,,,,, =T("746")," Maltogenic amylase from Geobacillus stearothermophilus produced in Bacillus subtilis"," For use in baking processes at the minimum levels necessary to achieve the intended technical effect."," Scientific procedures"," AB Enzymes"," Feldbergstr. 78, D-64293
Darmstadt
Germany",," GRN 746 (in PDF)",,,,,,,06/13/2018,," FDA has no questions (in PDF)",,,,,,,,,, =T("747")," Calcium lactate"," For use in the manufacturing of potato and vegetable snacks and sweetened cookies to reduce the formation of acrylamide at a proposed use level of up to 4% in the finished product."," Scientific procedures"," PepsiCo, Inc."," 700 Anderson Hill Road
Purchase, NY 10577",," GRN 747 (in PDF)",,,,,,,06/01/2018,," FDA has no questions (in PDF)",,,,,,,,,, =T("748")," Tomato powder"," For use as a source of phytoene and phytofluene in breakfast cereals, gravies and sauces, jams and jellies, processed vegetables and vegetable juices, snack foods, soft candies, and soups and soup mixes at a maximum level of 5 milligrams of phytoene and phytofluene per serving."," Scientific procedures"," IBR LTD"," 4 Faran Street, Yavne Technological Park
Yavne,8122503
Israel",," GRN 748 (in PDF)",,,,,,,04/19/2018,," At the notifier's request, FDA ceased to evaluate this notice (in PDF)",,,,,,,,,, =T("749")," 2'-O-fucosyllactose"," Ingredient in nonexempt infant formulas for term infants and in toddler formulas up to 2.4 g/L, in infant and toddler foods up to 12 g/kg, and in toddler drinks up to 1.2 g/L."," Scientific procedures"," DuPont Nutrition & Health"," 200 Powder Mill Road
Wilmington, DE 19803",," GRN 749 part 1 (in PDF)"," GRN 749 part 2 (in PDF)",,,,,,04/23/2018,," FDA has no questions (in PDF)",,,,,,,,,, =T("750")," Beta-glucosidase from Aspergillus niger"," For use as a processing aid in brewing fermented beverages."," Scientific procedures"," DSM Food Specialties"," PO Box 1
2600 MA Delft
The Netherlands",," GRN 750 part 1 (in PDF)"," GRN 750 part 2 (in PDF)"," GRN 750 part 3 (in PDF)"," GRN 750 part 4 (in PDF)",,,,10/02/2018,," FDA has no questions (in PDF)",,,,,,,,,, =T("751")," Maltogenic alpha-amylase from Bacillus stearothermophilus produced in Bacillus subtilis"," For use in processing starch in food manufacturing at the minimum levels necessary to achieve the intended technical effect."," Scientific procedures"," Novozymes North America, Inc."," 77 Perry Chapel Church Road, Box 576
Franklinton, NC 27525",," GRN 751 (in PDF)",,,,,,,07/31/2018,," FDA has no questions (in PDF)",,,,,,,,,, =T("752")," Preparation containing the bacterial monophages, BP-63 and LVR16-A, specific to Salmonella"," For use as an antimicrobial processing aid"," Scientific procedures"," Phagelux, Inc."," 1600 Royalmount
Montreal, Quebec, H4P 2R2
Canada",," GRN 752 (in PDF)",,,,,,,07/13/2018,," FDA has no questions (in PDF)",01/07/2022," Supplemental Letter (in PDF)",,,,,,,, =T("753")," Sodium thiocyanate"," For use in the lactoperoxidase system. The lactoperoxidase system is used in fresh cheese, including mozzarella and cottage cheeses, frozen dairy desserts, fermented milk, flavored milk drinks, and yogurt."," Scientific procedures"," Taradon Laboratory"," Avenue Leon Champagne, 2
B-1480 Tubize
Belgium",," GRN 753 in (PDF)",,,,,,,07/31/2018,," FDA has no questions (in PDF)",,,,,,,,,, =T("754")," Algal oil (87% oleic acid) derived from Prototheca moriformis strain S6697"," For use as a replacement for conventional vegetable and non-vegetable oils in baked goods; baked desserts; meal replacement bars, drinks, and protein supplements; cereals and bars; cheese spreads; margarine and margarine-like spreads; butter-like spreads; vegetable oil and shortening; salad dressings and mayonnaise; sauces, gravies and dressings; nut spreads, nuts, and seeds; dairy and milk products (including analogs); gelatins and puddings; soups and broth; meat products; frozen dairy desserts; snacks; soft candy; and confectionary at levels ranging from 20,000 to 1,000,000 ppm."," Scientific procedures"," Corbion Biotech, Inc."," 1 Tower Place, Suite 600 South San Francisco, CA 94080
[Notifier information updated by letter dated June 15, 2018]",," GRN 754 (in PDF)",,,,,,,07/23/2018,," FDA has no questions (in PDF)",,,,,,,,,, =T("755")," D-psicose"," For use as a sugar substitute in bakery products (rolls, cakes, pastries, cakes, low calorie or dietetics); beverages (non-alcoholic), low calorie, reduced calorie, sugar-free; cereals, regular cereals, low calorie, reduced calorie, sugar-free; chewing gum; confections and frostings; frozen dairy desserts (ice cream, soft serve, sorbet), low calorie, reduced calorie, sugar-free; yogurt and frozen yogurt, low calorie, reduced calorie, sugar-free; dressings for salads; gelatins, pudding and fillings, low calorie, reduced calorie, sugar-free; hard candies, low calorie, reduced calorie, sugar-free; soft candies, low calorie, reduced calorie, sugar-free; jams and jellies; sugar; sugar substitutes; sweet sauces and syrups, low calorie, reduced calorie, sugar-free; fat-based cream (used in modified fat/calorie cookies cakes, pastries and pies) at levels ranging from 2 to 100 percent (w/w)."," Scientific procedures"," SamYang Corp."," 295 Pangyo-ro, Bundang-gu
Seongnam-si, Gyeonggi-do
Korea",," GRN 755 (in PDF)",,,,,,,05/10/2018,," At the notifier's request, FDA ceased to evaluate this notice (in PDF)",,,,,,,,,, =T("756")," Endo-1,4-beta-glucanase from Trichoderma reesei"," For use in the production and processing of potable alcohol from grain at levels consistent with current good manufacturing practices."," Scientific procedures"," AB Enzymes GmbH"," Feldbergstr. 78
D-64293 Darmstadt, Germany",," GRN 756 (in PDF)",,,,,,,09/12/2018,," FDA has no questions (in PDF)",,,,,,,,,, =T("757")," Preparation containing two bacterial phages specific to Escherichia coli O157"," For use as an antimicrobial on beef carcasses, subprimals, beef cuts and trimmings intended for ground beef at an application rate of up to 1x109 plaque forming units per gram of food."," Scientific procedures"," Micreos B.V."," Nieuwe Kanaal 7P
6709 PA Wageningen
The Netherlands",," GRN 757 (in PDF)",,,,,,,08/03/2018,," FDA has no questions (in PDF)",10/25/2019," Supplemental Letter (in PDF)",,,,,,,, =T("758")," Lactobacillus helveticus R0052, Bifidobacterium longum subsp. infantis R0033, and Bifidobacterium bifidum R0071"," For use, both individually and in combination, as an ingredient of powdered infant formulas at 5 x 107 cfu/g of powder in formulas with hydration rates of 12.5 to 13/5 g/100 ml."," Scientific procedures"," Lallemand Health Solutions"," 17975 rue des Gouverneurs
Mirabel, Quebec, J7J 2K7
Canada",," GRN 758 (in PDF)"," GRN 758 amendments (in PDF)",,,,,,08/20/2018,," FDA has no questions (in PDF)",,,,,,,,,, =T("759")," Steviol glycosides consisting primarily of rebaudioside M produced in Yarrowia lipolytica"," For use as a flavor and general-purpose sweetener in foods such as beverages, baked goods, confections, and dairy products at levels that do not exceed the amounts reasonably required to accomplish its intended technical effect in the food."," Scientific procedures"," DSM Food Specialties / DSM Nutritional Products North America"," Alexander Fleminglann 1
2613 AX Delft
Netherlands",," GRN 759 (in PDF)",,,,,,,05/25/2018,," FDA has no questions (in PDF)",,,,,,,,,, =T("760")," Lactobacillus curvatus DSM 18775"," For use to suppress the growth of Listeria monocytogenes in ready-to-eat cooked meat and poultry products."," Scientific procedures"," Chr. Hansen Inc."," 9017 West Mable Street
Milwaukee 53214",," GRN 760 (in PDF)",,,,,,,01/29/2019,," FDA has no questions (in PDF)",,,,,,,,,, =T("761")," Esterified propoxylated glycerol"," For use as a fry oil in commercial French fries and doughnut production."," Scientific procedures"," Choco Finesse, LLC"," 5019 N. Meridian Street
Indianapolis, IN 46208",," GRN 761 (in PDF)",,,,,,,05/25/2018,," FDA has no questions (in PDF)",,,,,,,,,, =T("762")," Carnobacterium divergens M35 preparation"," For use as an antimicrobial to inhibit the growth of Listeria monocytogenes in smoked Coho, Sockeye, Atlantic Salmon, and Trout at a level of 1x106 cfu per gram of smoked product."," Scientific procedures"," Fumoir Grizzly, Inc."," 159 Rue d'Amsterdam
Saint-Augustin-de-Desmaures, Quebec, G3A 2V5
Canada",," GRN 762 (in PDF)",,,,,,,08/14/2018,," At the notifier's request, FDA ceased to evaluate this notice (in PDF)",,,,,,,,,, =T("763")," Alpha-lactalbumin"," For use as an ingredient in powdered nutritional beverages, sports beverages, nutritional bars, and milk products at levels ranging from 10 -20 percent."," Scientific procedures"," Agropur, Inc."," 3500 E. Destination Drive
Appleton, WI, 54915",," GRN 763 with amendments (in PDF)",,,,,,,12/10/2018,," FDA has no questions (in PDF)",,,,,,,,,, =T("764")," Rebaudioside D"," For use as a general purpose sweetening agent in foods, excluding infant formula and products under USDAs jurisdiction, at levels determined by good manufacturing practices (GMP)"," Scientific procedures"," Sichuan Ingia Biosynthetic Co., Ltd."," Room 7-701#, Tongwei International Centre, No., 588
Central Tianfu Avenue, High-tech Zone
Chengdu, Sichuan Province
China",," GRN 764 (in PDF)",,,,,,,07/10/2018,," FDA has no questions (in PDF)",,,,,,,,,, =T("765")," Dehulled hemp seed"," For use as an ingredient in ready to drink beverages; soups; sauces; nutritional beverages (e.g. protein fortified smoothies, fruit juices, high protein drinks, vegetable based soups, etc.); smoothies; non-dairy products/milk alternatives/creamer alternatives; dairy imitation products (e.g. dairy-free cheeses, dairy-free spreads, dairy-free desserts, dairy-free dips, dairy-free whipped toppings, etc.); grain products, baked goods and baking mixes (e.g., breads, rolls, bars, cakes, pasta, cookies, gluten free backed products, etc.); spreads, salad dressings, etc.; cereals/instant cereals/breakfast cereals; snack foods (e.g. chips, crackers, candy, energy bars, etc.); meal replacement/nutritional bars at levels ranging from 1 to 40 percent and excluding USDA regulated products."," Scientific procedures"," Fresh Hemp Foods, Ltd."," 69 Eagle Drive
Winnipeg, MB, R2R1V4
Canada",," GRN 765 part 1 (in PDF)"," GRN 765 part 2 (in PDF)",,,,,,12/20/2018,," FDA has no questions (in PDF)",02/10/2020," Supplemental Letter (in PDF)",,,,,,,, =T("766")," 3'-sialyllactose sodium salt"," For use as an ingredient in non-exempt term infant formula at a maximum level of 238 mg/L as consumed. Also for use as an ingredient in dairy product analogs, infant and toddler foods, milk (whole and skim), milk products, grain products, beverages and beverages bases, and sugar substitutes at levels ranging from 24 to 3000 mg/RACC."," Scientific procedures"," GeneChem, Inc."," Migun Techno World II
A-201, 187 Techno 2-ro
Yuseong-gu, 34025, Daejeon
Republic of Korea",," GRN 766 with amendments (in PDF)",,,,,,,09/26/2018,05/07/2019," FDA has no questions (in PDF)",,,,,,,,,, =T("767")," Polyvinyl alcohol"," Component of water soluble, edible film that may be used to form pouches containing pre-portioned aliquots of (1) certain dry ingredients (i.e., instant tea, instant coffee, hot chocolate mix, flavored drink powder, and whey protein supplement powder) to be used by the consumer in preparing ready-to-serve foods and beverages at a level up to 0.734 g PVOH/serving, (2) approved color additives to be used in manufacturing flavored beverages (non-dairy and non-alcohol) at a level up to 0.0006 g PVOH/serving, and (3) dry ingredients to be used by commercial establishments in making pizza dough at a level up to 0.0075 g"," Scientific procedures"," MonoSol LLC"," 707 E. 80th Place, Suite 301
Merrillville, IN 46410",," GRN 767 (in PDF)",,,,,,,09/07/2018,09/19/2018," FDA has no questions (in PDF)",,,,,,,,,, =T("768")," Stevia leaf extract"," Intended for use as a general-purpose sweetener in accordance with good manufacturing practices (cGMP) (excluding USDA regulated products and infant formula) and as a table-top sweetener."," Scientific procedures"," Cargill, Inc."," 15407 McGinty Road West, M.S. 163
Wayzata, MN, 55391",," GRN 768 (in PDF)",,,,,,,08/13/2018,," FDA has no questions (in PDF)",,,,,,,,,, =T("769")," Vitamin C (fruit and vegetable derived)"," Intended for use as a substitute for other commercially available forms of ascorbic acid used in accordance with cGMPs."," Scientific procedures"," NutriFusion LLC"," 10641 Airport Pulling Rd N., Suite 31
Naples, FL, 34109-7330",," GRN 769 (in PDF)",,,,,,,10/23/2018,," FDA has no questions (in PDF)",,,,,,,,,, =T("770")," Potassium polyaspartate"," Intended for use as a stabilizer in wine at levels up to 300 mg/L."," Scientific procedures"," Enartis USA, Inc."," 7795 Bell Road
Windsor, CA 95492",," GRN 770 (in PDF)",,,,,,,09/11/2018,," FDA has no questions (in PDF)",,,,,,,,,, =T("771")," Hemp seed protein"," For use as an ingredient for general use in foods, excluding USDA/FSIS regulated products and infant formula."," Scientific procedures"," Fresh Hemp Foods Ltd."," 69 Eagle Drive
Winnipeg, MB, R2R1V4
Canada",," GRN 771 part 1 (in PDF)"," GRN 771 part 2 (in PDF)"," GRN 771 part 3 (in PDF)",,,,,12/20/2018,," FDA has no questions (in PDF)",02/10/2020," Supplemental Letter (in PDF)",,,,,,,, =T("772")," Palmitoylated green tea catechins"," For use as an antioxidant in baked goods and baking mixes (biscuits; cookies; crackers; and pizza crust), breakfast cereals (instant and regular hot breakfast cereals; and ready-to-eat breakfast cereals), Cheeses (processed cheese), confections and frostings (frosting, icings, and coatings), dairy product analogs (coffee whiteners), fats and oils (butter; fat-based sauces; margarine and margarine-like spreads; mayonnaise and mayonnaise-type dressings; oils; and salad dressings), grain products and pastas (cereals and granola bars; energy bars, meal replacement bars, and fortified bars; noodle products), herbs, seeds, spices, seasonings, blends, extracts, and flavorings (spices, seasonings, and blends), nut and nut products (nut spreads; processed whole nuts, coated nuts, and mixtures), snack foods, soft candy (chocolate confectionary) at levels ranging from 0.05 to 0.28 percent of the finished product."," Scientific procedures"," Kemin Industries, Inc."," 2100 Maury St.
Des Moines, IA 50317",," GRN 772 (in PDF)",,,,,,,12/13/2018,," FDA has no questions (in PDF)",,,,,,,,,, =T("773")," Dried biomass of Chlamydomonas reinhardtii"," Intended for use as a replacement for other sources of dietary protein in foods generally, excluding foods where a standard of identity would preclude such use, infant formula, and foods under USDA jurisdiction."," Scientific procedures"," Triton Algae Innovations"," 11558 Sorrento Valley Road, Suite 3
San Diego, CA 92121",," GRN 773 (in PDF)",,,,,,,02/22/2019,03/13/2019," FDA has no questions (in PDF)",,,,,,,,,, =T("774")," Glutaminase from Bacillus licheniformis produced in Bacillus licheniformis"," Intended for use as a processing aid in various food ingredients such as casein, whey protein, soy and wheat protein, breads, noodles, tofu, fish, cheese and seasonings at levels that are the minimum amount necessary to achieve the desired technical effect."," Scientific procedures"," Novozymes North America, Inc."," 77 Perrys Chapel Church Road, Box 576
Franklinton, NC 27525",," GRN 774 (in PDF)",,,,,,,11/26/2018,," FDA has no questions (in PDF)",,,,,,,,,, =T("775")," Colicin preparations"," Intended for use as an antimicrobial on vegetables, fruits, or meat products at a concentration ranging from 0.5-5 mg/lb."," Scientific procedures"," Nomad Bioscience GmbH"," Biozentrum Halle, Weinbergweg 22, Halle/Saale
Saxony-Anhalt, D-06120
Germany",," GRN 775 (in PDF)",,,,,,,10/26/2018,," FDA has no questions (in PDF)",,,,,,,,,, =T("776")," Algal oil (35% docosahexaenoic acid) from Schizochytrium sp. strain FCC-1324"," Ingredient in non-exempt and exempt infant formulas for term and pre-term infants at use levels up to 0.5% (wt/wt) of fatty acids as DHA in combination with a safe and suitable source of arachidonic acid (ARA) at a ratio ranging from 1:1 to 1:2 of DHA to ARA."," Scientific procedures"," Fermentalg"," 4 Rue Riviere
33500 Libourne
France",," GRN 776 part 1 (in PDF)"," GRN 776 part 2 (in PDF)",,,,,,10/26/2018,," FDA has no questions (in PDF)",,,,,,,,,, =T("777")," Algal oil (55% docosahexaenoic acid) from Schizochytrium sp. strain FCC-3204"," Ingredient in non-exempt and exempt infant formulas for term and pre-term infants at use levels up to 0.5% (wt/wt) of fatty acids as DHA in combination with a safe and suitable source of arachidonic acid (ARA) at a ratio ranging from 1:1 to 1:2 of DHA to ARA."," Scientific procedures"," Fermentalg"," 4 Rue Riviere
33500 Libourne
France",," GRN 777 (in PDF)",,,,,,,10/26/2018,," FDA has no questions (in PDF)",,,,,,,,,, =T("778")," Hemp seed oil"," Intended for use as an ingredient for general use in foods, excluding USDA/FSIS regulated products and infant formula."," Scientific procedures"," Fresh Hemp Foods Ltd."," 69 Eagle Drive
Winnipeg, MB R2R1V4
Canada",," GRN 778 part 1 (in PDF)"," GRN 778 part 2 (in PDF)",,,,,,12/20/2018,," FDA has no questions (in PDF)",02/10/2020," Supplemental Letter (in PDF)",,,,,,,, =T("779")," Isomalto-oligosaccharide mixture"," Intended for use as an ingredient in baked goods and baking mixes; beverages and beverage bases; breakfast cereals; condiments and relishes; dairy product analogs; mayonnaise and mayonnaise-type dressings; salad dressings; frozen dairy desserts and mixes; gelatins, puddings, and fillings; gravies and sauces; hard candies; jams and jellies; milk and milk products; nut products; processed fruits and fruit juices; snack foods; soft candy; sugar substitutes; sweet sauces, toppings and syrups; processed vegetables and vegetable juices; at levels ranging from 5 percent to 100 percent."," Scientific procedures"," Baolingbao Biology Co., Ltd."," 1 Dongwaihuan Road, High-tech Development Zone
Yucheng, Shandong Province
China",," GRN 779 (in PDF)",,,,,,,10/19/2018,," FDA has no questions (in PDF)",,,,,,,,,, =T("780")," Rebaudioside M"," For use as a general-purpose sweetening agent in foods, excluding infant formula and products under USDAs jurisdiction, at levels in accordance with good manufacturing practices (GMP)"," Scientific procedures"," Tate and Lyle"," 5450 Prairie Stone Parkway
Hoffman Estates, IL 60192",," GRN 780 (in PDF)",,,,,,,07/31/2018,," FDA has no questions (in PDF)",,,,,,,,,, =T("781")," Alpha-tocopherol (fruit and vegetable derived)"," Intended for use as a substitute for other commercially available forms of vitamin E in foods generally, including baby foods for infants from 6 to 12 months of age and children from one to four years old, and excluding infant formula. Use levels range from maximum levels of 2.5 mg/serving to 15 mg/serving."," Scientific procedures"," NutriFusion LLC"," 10641 Airport Pulling Rd N., Suite 31
Naples, FL, 34109-7330",," GRN 781 (in PDF)",,,,,,,11/05/2018,," FDA has no questions (in PDF)",,,,,,,,,, =T("782")," L-arabinose"," Intended for use as a carbohydrate source, sucrose replacement, or as a replacement for other sweeteners in baked foods and baking mixes, beverages and bars (energy, snack, and sports nutrition), cereal-based products, confectionary and frostings, chewing gum, condiments, dairy products (frozen desserts, ice creams and yogurts), desserts (gelatins, puddings, etc.), fruit and water ices, spreads, snack foods, sweet sauces and syrups at levels ranging from 0.1% to 10% by weight."," Scientific procedures"," Sensus America, Inc."," Princeton Pike Corporate Center
100 Lenox Drive, Suite 104
Lawrenceville, NJ 08648",," GRN 782 (in PDF)",,,,,,,08/29/2018,," At the notifier's request, FDA ceased to evaluate this notice (in PDF)",,,,,,,,,, =T("783")," Triacylglycerol lipase from Rhizopus oryzae produced in Aspergillus niger"," For use in the in the production of cocoa butter substitutes and human milk fat substitutes at a maximum level of 1 kg of lipase enzyme preparation per ton of fat raw material."," Scientific procedures"," Advanced Enzyme Technologies Ltd"," Sun Magnetica
A wing, 5th Floor
LIC Service Road
Louiswadi, Thane, Maharashtra
India, 400 604",," GRN 783 part 1 (in PDF)"," GRN 783 part 2 (in PDF)"," GRN 783 part 3 (in PDF)"," GRN 783 part 4 (in PDF)",,,,12/20/2018,05/07/2019," FDA has no questions (in PDF)",,,,,,,,,, =T("784")," Siraitia grosvenorii Swingle (Luo Han Guo) fruit juice concentrate"," Intended for use as a general-purpose sweetener (excluding USDA regulated products) at levels limited by good manufacturing practice."," Scientific procedures"," Hunan Huacheng Biotech, Inc."," Apricot Road 8
Changsha National High-Tech Industry Development Zone
Hunan 410205
China",," GRN 784 (in PDF)",,,,,,,11/20/2018,," FDA has no questions (in PDF)",,,,,,,,,, =T("785")," Calcium chloride"," Intended for use as an anti-browning agent in processed fruits and vegetables"," Scientific procedures"," Wonderful Citrus, LLC"," 1901 S. Lexington Street
Delano, CA 93215",," GRN 785 (in PDF)",,,,,,,11/20/2018,," FDA has no questions (in PDF)",,,,,,,,,, =T("786")," Calcium propionate"," Intended for use as an anti-browning agent in processed fruits and vegetables"," Scientific procedures"," Wonderful Citrus, LLC"," 1901 S. Lexington Street
Delano, CA 93215",," GRN 786 (in PDF)",,,,,,,11/20/2018,," FDA has no questions (in PDF)",,,,,,,,,, =T("787")," Quinoa sprout powder"," Intended for use as a nutrient in baked goods and ready-to-eat cereals at a concentration of up to 150 mg/serving."," Scientific procedures"," Vis Vitalis Gmbh"," Moosham 29
5585 Unternberg
Austria",," GRN 787 (in PDF)",,,,,,,09/09/2018,," FDA has no questions (in PDF)",,,,,,,,,, =T("788")," Pea protein concentrate"," Ingredient, formulation aid, source of protein, stabilizer, thickener, and texturizer in conventional foods, such as baked goods and baking mixes, beverages and beverage bases, breakfast cereals, milk products, dairy product analogs, fats and oils, grain products and pastas, plant protein products, processed fruits and fruit juices, processed vegetables and vegetable juices, and soups and soup mixes1 at levels from 0.96 to 34.3%."," Scientific procedures"," Yantai Oriental Protein Tech Co., Ltd."," #668 Jincheng Road
Zhaoyuan City 265400
CHINA",," GRN 788 (in PDF)",,,,,,,10/12/2018,," FDA has no questions (in PDF)",,,,,,,,,, =T("789")," Erythritol"," For use as a flavor enhancer, formulation aid, humectant, nutritive sweetener, stabilizer and thickener, sequestrant, or texturizer in baked goods and baking mixes; alcoholic beverages; beverage and beverage bases; breakfast cereals; chewing gum; condiments and relishes; dairy product analogs; fats and oils; frozen dairy desserts and mixes; fruit and water ices; gelatins, puddings, and filings; hard candy; jams and jellies; milk products; processed fruits and fruit juices; snack foods; soft candy; sugar substitutes; and sweet sauces, toppings, and syrups at a concentration ranging from 3 to 99 percent."," Scientific procedures"," Cargill, Inc."," 15407 McGinty Road
Wayzata, NM 55391",," GRN 789 part 1 (in PDF)"," GRN 789 part 2 (in PDF)",,,,,,02/20/2019,," FDA has no questions (in PDF)",,,,,,,,,, =T("790")," Steviol glycosides (minimum purity 95%)"," For use as a table top sweetener and as general purpose non-nutritive sweetener in foods in general, other than infant formulas, at levels reflecting good manufacturing practices. Also intended for use as an ingredient in cured meat products, at a maximum use level of 2,500 ppm."," Scientific procedures"," GLG Life Tech Corporation"," 10271 Shellbridge Way, Suite 100
Richmond, British Columbia, V6X 2W8
Canada",," GRN 790 (in PDF)",,,,,,,02/26/2019,," FDA has no questions (in PDF)",,,,,,,,,, =T("791")," Urolithin A"," For use as an ingredient in powdered (reconstituted) protein shakes, beverages (ready-to-drink protein shakes, non-milk based meal replacement beverages, instant oatmeal, protein and nutrition bars, and yogurts (Greek yogurts, high-protein yogurts, and yogurt drinks) at typical use levels of 250 mg/serving or 500 mg/serving up to a maximum of 500 mg/serving or 1,000 mg/serving."," Scientific procedures"," Amazentis SA"," EPFL Innovation Park, Building C
1015 Lausanne
Switzerland",," GRN 791 (in PDF)",,,,,,,12/20/2018,," FDA has no questions (in PDF)",,,,,,,,,, =T("792")," Cultured corn starch fermented by Corynebacterium glutamicum"," For use as an ingredient in relishes, mayonnaise, gravies and sauces (includes sauces and gravies for use with cooked meat and poultry products), herb and spice mixes and seasonings, meat and fish analogues, and soup and broths, at use levels up to 0.76% of the final product."," Scientific procedures"," Nestec, S.A. (Nestle)"," Avenue Nestle 55
CH-1800, Vevey
Switzerland",," GRN 792 (in PDF)",,,,,,,04/26/2019,," FDA has no questions (in PDF)",,,,,,,,,, =T("793")," Cultured corn starch fermented by Corynebacterium stationis"," For use as an ingredient in relishes, mayonnaise, gravies and sauces (includes sauces and gravies for use with cooked meat and poultry products), herb and spice mixes and seasonings, meat and fish analogues, and soup and broths, at use levels up to 0.25% of the final product."," Scientific procedures"," Nestec, S.A. (Nestle)"," Avenue Nestle 55
CH-1800, Vevey
Switzerland",," GRN 793 (in PDF)",,,,,,,04/26/2019,," FDA has no questions (in PDF)",,,,,,,,,, =T("794")," Shiitake, pea, and rice protein fermented with Lentinula edodes"," For use as an ingredient in nutritional protein bars; meal replacements (non-milk based); plant based, non-meal replacement beverage; ready to mi beverage powder; soy/nut plant based beverages; plant based frozen yogurt; salad dressings; fruit smoothie; vegetable smoothie; tomato juice; chocolate; soup"," Scientific procedures"," MycoTechnology Inc."," 3155 North Chambers Road
Aurora, CO 80011",," GRN 794 (in PDF)",,,,,,,11/09/2018,," At the notifier's request, FDA ceased to evaluate this notice (in PDF)",,,,,,,,,, =T("795")," Purified steviol glycosides"," For use as a table top sweetener and as general purpose non-nutritive sweetener in foods in general, excluding infant formula and products under USDAs jurisdiction, at levels reflecting good manufacturing practice (GMP)."," Scientific procedures"," Steviana Bioscience (Suzhou) Inc."," Building A, 48 Dongfu Road, SIP
Suzhou, Jiangsu Province
China",," GRN 795 (in PDF)",,,,,,,09/25/2018,," FDA has no questions (in PDF)",,,,,,,,,, =T("796")," Orange extract (85% hesperidin)"," For use as an ingredient in flavored milk and imitation milk drinks, dry powdered milk mixtures (not reconstituted), yogurt, coconut beverages, cookies, cereal, cereal/granola/nutrition bars, fruit/fruit flavored and vegetable juices/drinks, table fats and vegetable oils, candies (chocolate and dietetic candy), tea, carbonated soft drinks, fortified water, nutrition drinks, nutrition powders, energy drinks, and sports drinks at a level of 500 mg per serving."," Scientific procedures"," Ferrer HealthTech"," Carretera de Zeneta, 143-145
30130 Beniel (Murcia)
Spain",," GRN 796 (in PDF)",,,,,,,02/20/2019,," FDA has no questions (in PDF)",,,,,,,,,, =T("797")," Fructooligosaccharides"," Ingredient in nonexempt infant formulas for term infants, as consumed, at a level up to 400 mg FOS/100 mL formula for infants o-6 months and up to 500 mg FOS/100 mL formula for infants >6 months."," Scientific procedures"," New Francisco (Yunfu City) Biotechnology Corporation"," Swan-kan-chiau Industrial District
Kaofong Village, Yunfu City, Guangdong Province 527343
China",," GRN 797 (in PDF)",,,,,,,11/15/2018,," FDA has no questions (in PDF)",,,,,,,,,, =T("798")," Saccharomyces cerevisiae strain yBBS002"," For use as a starter culture for brewing beer in accordance with good manufacturing practice (GMP)."," Scientific procedures"," Berkeley Brewing Science, Inc."," 2332 4th Street Space E
Berkeley, CA 94710",," GRN 798 (in PDF)",,,,,,,08/13/2019,," FDA has no questions (in PDF)",,,,,,,,,, =T("799")," Rebaudioside M"," For use as a general-purpose sweetener, in accordance with current Good Manufacturing Practice (cGMP), excluding infant formula and meat and poultry products."," Scientific procedures"," Sichuan Ingia Biosynthetic Co., Ltd."," Room 7-701#, Tongwei International Centre
No., 588, Central Tianfu Avenue, High-tech Zone
Chengdu, Sichuan Province
China",," GRN 799 (in PDF)",,,,,,,09/25/2018,," FDA has no questions (in PDF)",,,,,,,,,, =T("800")," gamma-oryzanol"," Ingredient at a level of 0.1% in milk and milk products; soups, broths, and extracts from meat/poultry /fish base (fish, shellfish soups);2 dry beans, peas, other legumes, nuts, and seeds; grain products; fruits; vegetables; fats, oils, and salad dressings; and sugars, sweets, and beverages."," Scientific procedures"," Oryza Oil and Fat Chemical Co., Ltd."," 1 Aza Numata Kitagata
Kitagato-cho, Ichinomiya-city
Aichi-pref, 493-8001
Japan",," GRN 800 part 1 (in PDF)"," GRN 800 part 2 (in PDF)",,,,,,03/08/2019,," FDA has no questions (in PDF)",,,,,,,,,, =T("801")," Chymosin enzyme from Camelus dromedarius produced in Aspergillus niger"," For use as a processing aid in the production of cheese at the minimum amount necessary to achieve the desired effect."," Scientific procedures"," Chr. Hansen Inc."," 9015 West Mable Street
Milwaukee, WI 53214",," GRN 801 (in PDF)",,,,,,,06/06/2019,," FDA has no questions (in PDF)",,,,,,,,,, =T("802")," Endolysin"," For use as an antimicrobial controlling Clostridium perfringens on cooked red meats, poultry, sauces and gravy, or other cooked or baked foods, at an application rate of 1-10 mg endolysin per kg of treated food."," Scientific procedures"," Nomad BioScience GmbH"," Biozentrum Halle, Weinbergweg 22
Halle/Saale, Saxony-Anhalt, D-06120
Germany",," GRN 802 (in PDF)",,,,,,,05/10/2019,," FDA has no questions (in PDF)",,,,,,,,,, =T("803")," Pea protein"," For use as a formulation aid, nutrient supplement, stabilizer and thickener, and texturizer in conventional food products including meat and poultry products."," Scientific procedures"," Ingredion Incorporated and Shandong Jianyuan Bioengineering Co. Ltd."," 5 Westbrook Corporate Center
Westchester, IL 60154",," GRN 803 (in PDF)",,,,,,,11/08/2019,," FDA has no questions (in PDF)",,,,,,,,,, =T("804")," Pea protein"," Intended for use as a source of protein in baked goods and baking mixes, beverages and beverage bases, breakfast cereals, cheeses, coffee and tea, confections and frostings, dairy product analogs, egg products, fats and oils, fish products, frozen dairy desserts, fruit and water ices, gelatins, puddings, and fillings, grain products and pastas, gravies and sauces, meat products, milk products, nut and nut products, plant protein products, poultry products, processed fruits and fruit juices, processed vegetables and vegetable juices, snack foods, soft candy, and soups and soup mixes at use levels ranging from 1 to 35 g pea protein per 100g of food."," Scientific procedures"," Burcon NutraScience Corporation"," 1946 West Broadway
Vancouver, BC
V6J 1Z2
Canada",," GRN 804 (in PDF)",,,,,,,11/08/2019,," FDA has no questions (in PDF)",,,,,,,,,, =T("805")," Apple peel powder"," For use as an ingredient in fruits and fruit juices; vegetable juices; milk and milk products; baker products; dairy products and substitutes; ready-to-eat cereal; and sauces, dips, gravies and condiments at levels ranging from 0.1 to 20 percent."," Scientific procedures"," Leahy Orchards Inc."," 1772 Route 209
Franklin, Quebec
J0S 1E0
Canada",," GRN 805 (in PDF)",,,,,,,03/08/2019,," FDA has no questions (in PDF)",,,,,,,,,, =T("806")," Dolomite"," For use as a substitute for calcium and magnesium salts to enhance the mineral content of purified bottled water beverage at a level to provide a concentration of 40 mg/L calcium ions and 25 mg/L magnesium ions."," Scientific procedures"," Hogan Lovells US LLP"," 555 Thirteenth Street, NW
Washington, DC, 20004",," GRN 806 (in PDF)",,,,,,,05/17/2019,," FDA has no questions (in PDF)",,,,,,,,,, =T("807")," Streptococcus salivarius M18"," For use as an ingredient in baby, infant, and toddler foods (excluding infant formula); baked goods and baking mixes; beverage and beverage bases; breakfast cereals; cheeses; chewing gum; dairy product analogs; frozen dairy desserts and mixes; gelatins, puddings, and fillings; grain products and pastas; hard candy; milk, whole and skim; milk products; nuts and nut products; processed fruits and fruit juices; soft candy; sweet sauces, toppings, and syrups at a level of 20 mg per serving, providing a minimum of 1x109 CFU/serving."," Scientific procedures"," BLIS Technologies Ltd."," 81 Glasgow Street
South Dunedin, Dunedin 9012
New Zealand",," GRN 807 (in PDF)",,,,,,,04/18/2019,06/06/2019," FDA has no questions (in PDF)",,,,,,,,,, =T("808")," Lipase from Aspergillus tubingensis produced in Trichoderma reesei"," For use as a processing aid in baking at 21.2 mg TOS/kg, in brewing processes and cereal manufacturing at 52.2 mg TOS/kg, in pasta production at 2.03 mg TOS/kg, and in potable alcohol production at 3.6 mg TOS/kg."," Scientific procedures"," Danisco US Inc. (Dupont Industrial Biosciences)"," 925 Page Mill Road
Palo Alto, CA, 94304",," GRN 808 (in PDF)",,,,,,,05/28/2019,," FDA has no questions (in PDF)",,,,,,,,,, =T("809")," Fractionated whey protein concentrate containing 41% alpha-lactalbumin"," Ingredient in cows milk-based, non-exempt infant formula for term infants at a level up to 8.3 g/L."," Scientific procedures"," Arla Foods Ingredients P/S"," Sonderhoj 10-12
8260 DK- Viby J
Denmark",," GRN 809 (in PDF)",,,,,,,05/06/2019,," FDA has no questions (in PDF)",,,,,,,,,, =T("810")," Lactobacillus paracasei subsp. paracasei strain F-19e"," For use as an ingredient in powdered milk-based non-exempt infant formula at levels intended to provide a daily intake of 109 CFU of the strain."," Scientific procedures"," Arla Foods Ingredients Group P/S"," 106 Allen Road
Basking Ridge, NJ 07920",," GRN 810 (in PDF)",,,,,,,04/05/2019,," FDA has no questions (in PDF)",,,,,,,,,, =T("811")," Phospholipase A1 produced by Aspergillus oryzae"," For use as a processing aid during the manufacture of baked goods at a level no more than 20 PLA(B) per kg of flour."," Scientific procedures"," Novozymes NA"," 77 Perrys Chapel Church Road, Box 576
Franklinton, NC, 27525",," GRN 811 (in PDF)",,,,,,,07/19/2019,," FDA has no questions (in PDF)",,,,,,,,,, =T("812")," Rebaudioside M"," For use as a general purpose sweetening agent in accordance with current Good Manufacturing Practice, excluding infant formula and meat and poultry products."," Scientific procedures"," Amyris, Inc."," 5885 Hollis Street
Suite 100
Emeryville, CA 94608",," GRN 812 (in PDF)",,,,,,,12/08/2018,," FDA has no questions (in PDF)",,,,,,,,,, =T("813")," Bifidobacterium longum BORI"," For use as an ingredient in powdered non-exempt term infant formula at up to 108 CFU per gram of powdered formula. Also for use in fermented milk; includes buttermilk and kefir; flavored milk beverages mixes, dried milk powder; imitation milk; yogurt; baby cereals and foods, powder form; meal replacement powder and nutrition drink mix powder; and sugar substitute, powder form at up to 109 CFU per serving."," Scientific procedures"," BIFICO CO., LTD"," 23-16 Nonggongdanji-gil
Hongcheon-eup, Hongcheon-gun
Gangwon-do, 25117
Republic of Korea",06/21/2019," GRN 813 with amendment (in PDF)",,,,,,,06/21/2019,," FDA has no questions (in PDF)",,,,,,,,,, =T("814")," Bifidobacterium bifidum BGN4"," For use as an ingredient in powdered non-exempt term infant formula at up to 108 CFU per gram of powdered formula. Also for use in fermented milk; includes buttermilk and kefir; flavored milk beverages mixes, dried milk powder; imitation milk; yogurt; baby cereals and foods, powder form; meal replacement powder and nutrition drink mix powder; and sugar substitute, powder form at up to 109 CFU per serving"," Scientific procedures"," BIFICO CO., LTD"," 23-16 Nonggongdanji-gil
Hongcheon-eup, Hongcheon-gun
Gangwon-do, 25117
Republic of Korea",," GRN 814 (in PDF)",,,,,,,06/25/2019,," FDA has no questions (in PDF)",,,,,,,,,, =T("815")," 2'-fucosyllactose and difucosyllactose"," For use as an ingredient in non-exempt infant formulas for term infants at a maximum level of 1.6 grams per liter (g/L); in toddler formula and in other drinks for young children (between 1 and 3 years of age) at 1.2 g/L; in other foods for infants and young children at 10 grams per kilogram (g/kg); and, in beverages and beverage bases, grain products and pastas, milk (whole and skim), and milk products that are conventional food products used by the general population, at levels ranging from 2 to 40 g/kg."," Scientific procedures"," Glycom A/S"," Kogle Allé 4
Hørsholm, Denmark",," GRN 815 (in PDF)",,,,,,,08/20/2019,09/11/2020," FDA has no questions (in PDF)",09/11/2020," Correction letter (in PDF)",05/07/2020," Correction Letter (in PDF)",,,,,, =T("816")," Xylooligosaccharides from sugarcane"," For use as an ingredient in bars; crackers and salty snacks; chewing gums; breads, grains and pastas; coconut beverages, juices and nectars; bottled and canned coffees and prepared teas; fruit drinks and non-fruit beverages; beverage concentrates, dry, not reconstituted; nutrition drinks; nutrition powders; energy and sports drinks, fluid replacements, and other functional beverages; cookies; gelatin desserts or salads; cereal grains, not cooked; pancakes and waffles; cooked cereals; ready-to-eat cereals; cheese and imitation cheese; imitation milk, fluid; yogurt; flavored milk and milk drinks, fluid; mild, dry, and powdered mixes with dry milk, not reconstituted; cream substitutes; milk desserts, frozen; puddings, custards, and other milk desserts; cheese soups; nut butters; and sugar substitutes at levels ranging from 0.10 to 100 g/100g"," Scientific procedures"," Prenexus Health, Inc."," 1343 N Colorado Street
Gilbert, AZ 85233",," GRN 816 (in PDF)",,,,,,,04/29/2019,," FDA has no questions (in PDF)",,,,,,,,,, =T("817")," Serine endopeptidase from Malbranchea cinnamomea produced in Trichoderma reesei"," For use as an enzyme to be used in the processing of partially or extensively hydrolyzed proteins from both animal and vegetable sources at a recommended level of 10 mg TOS/kg RM."," Scientific procedures"," AB Enzymes GmbH"," Feldbergstr. 78
Darmstadt, D-64293
Germany",," GRN 817 (in PDF)",,,,,,,08/26/2019,," FDA has no questions (in PDF)",,,,,,,,,, =T("818")," Isomalto-oligosaccharides"," For use as an all-purpose sweetener and bulking agent in foods generally, excluding infant formula and foods subject to regulation by the U.S. Department of Agriculture, at levels determined by current Good Manufacturing Practices."," Scientific procedures"," Ingredion, Inc."," 10 Finderne Avenue, Suite C
Bridgewater, NJ 08807",," GRN 818 (in PDF)",,,,,,,12/18/2019,," FDA has no questions (in PDF)",,,,,,,,,, =T("819")," Fatty acid ethyl esters from Alaskan Pollock"," For use as a nutritive ingredient to replace other edible fats and oils in foods generally, excluding foods where standards of identity would preclude such use, infant formula and foods subject to regulation by the U.S. Department of Agriculture."," Scientific procedures"," Organic Technologies"," 545 Walnut Street
Coshocton, OH 43812",," GRN 819 (in PDF)",,,,,,,09/03/2019,," FDA has no questions (in PDF)",,,,,,,,,, =T("820")," Lactobacillus fermentum CECT5716"," For use as an ingredient in multiple food categories, excluding foods subject to regulation by the U.S. Department of Agriculture, at use levels providing 3 x 109 CFU/serving."," Scientific procedures"," Biosearch, S.A."," C/ Cabeza Mesada, 5
5 planta
28031 Madrid
SPAIN",," GRN 820 (in PDF)",,,,,,,04/03/2019,," At the notifier's request, FDA ceased to evaluate this notice (in PDF)",,,,,,,,,, =T("821")," Glucosylated steviol glycosides"," For use as a table top and general purpose sweetener in conventional foods, other than infant formula and foods under the jurisdiction of the U.S.D.A, in accordance with current Good Manufacturing Practice."," Scientific procedures"," Haigen-BGG Natural Ingredients Limited"," 11038, 11/F, Tower A
Gateway Square No. 18, Xiaguangli
North Road East Third Ring
Chaoyang District, Beijing
CHINA",," GRN 821 (in PDF)",,,,,,,05/07/2019,," FDA has no questions (in PDF)",,,,,,,,,, =T("822")," Curcumin"," For use as an ingredient in a variety of food categories, excluding infant formula and foods under the jurisdiction of USDA, at levels ranging from 0.5 to 100 mg/100g."," Scientific procedures"," Laurus Labs Private Ltd."," 2nd Floor, Serene Chambers Road No: 7
Banjara Hills, Hyderabad 500 034, Telangana
India",," GRN 822 (in PDF)",,,,,,,06/04/2019,," FDA has no questions (in PDF)",,,,,,,,,, =T("823")," Rebaudioside E"," For use as table top sweetener and as a general purposed non-nutritive sweetener for incorporation into foods in general, other than infant formula and meat and poultry products, at per serving levels reflecting Good Manufacturing Practice."," Scientific procedures"," Blue California"," 30111 Tomas
Rancho Santa Margarita, CA 92688",," GRN 823 (in PDF)",,,,,,,06/21/2019,," FDA has no questions (in PDF)",,,,,,,,,, =T("824")," Bacteriocin preparations specific to Salmonella"," For use as an antimicrobial with red meats, poultry, and egg products at an application rate not to exceed 3 mg per kg or liter of treated food product."," Scientific procedures"," Nomad BioScience GmbH"," Biozentrum Halle, Weinbergweg 22
Halle/Saale, Saxony-Anhalt, D-06120
Germany",10/21/2019," GRN 824 (in PDF)",,,,,,,10/21/2019,," FDA has no questions (in PDF)",,,,,,,,,, =T("825")," Beta-galactosidase from Kluyveromyces lactis"," For use in dairy products such as milk, milk powder, fermented milk products, an yogurt, fresh cheeses, milk-based desserts, whey, and milk-based infant and follow-on formula."," Scientific procedures"," DSM Food Specialties"," PO Box 1, 2600 MA
Delft, Netherlands",," GRN 825 (in PDF)",,,,,,,11/07/2019,," FDA has no questions (in PDF)",,,,,,,,,, =T("826")," Dihydroquercetin"," For use as an ingredient in conventional non-alcoholic beverages (up to 0.02 g per L), flavored fermented milk and dairy products (up to 0.02 g per kg), and chocolate products (up to 0.07 g per kg)."," Scientific procedures"," Blue California"," 30111 Tomas
Rancho Santa Margarita, CA 92688
",," GRN 826 (in PDF)",,,,,,,09/25/2019,," At the notifier's request, FDA ceased to evaluate this notice (in PDF)",,,,,,,,,, =T("827")," Preparation containing three bacterial phages specific to several Escherichia coli serotypes"," For use as an antimicrobial processing aid to control specific E. coli serotypes on poultry, red meats, fruits, vegetables, eggs, fish, and shellfish applied to food surfaces at up to 1 x 108 PFU per gram."," Scientific procedures"," OmniLytics"," 9075 South Sandy Parkway
Sandy, UT 84070",," GRN 827 (in PDF)",,,,,,,08/12/2019,," FDA has no questions (in PDF)",10/09/2019," Additional correspondence (in PDF)",,,,,,,, =T("828")," D-psicose"," For use as sugar substitute in bakery products (rolls, cakes, pastries, cakes, low calorie or dietetics); beverages (non-alcoholic), low calorie, reduced calorie, sugar-free; cereals, regular cereals, low calorie, reduced calorie, sugar-free; chewing gum; confections and frostings; frozen dairy desserts (ice cream, soft serve, sorbet), low calorie, reduced calorie, sugar-free; yogurt and frozen yogurt, low calorie, reduced calorie, sugar-free; dressings for salads; gelatins, pudding and fillings, low calorie, reduced calorie, sugar-free; hard candies, low calorie, reduced calorie, sugar-free; soft candies, low calorie, reduced calorie, sugar-free; jams and jellies; sugar; sugar substitutes; sweet sauces and syrups, low calorie, reduced calorie, sugar-free; fat-based cream (used in modified fat/calorie cookies cakes, pastries and pies) at levels ranging from 2 to 100 percent (w/w)."," Scientific procedures"," Samyang Corporation"," 295 Pangyo-ro, Bundang-gu
Seongnam-si, Gyeonggi-do
Korea",," GRN 828 with amendments (in PDF)",,,,,,,03/02/2020,," FDA has no questions (in PDF)",,,,,,,,,, =T("829")," Powdered Aspergillus oryzae grown with one or more added minerals"," For use in conventional foods at a level that provides 25% of the Daily Value (DV) for each mineral contained in the product, up to 250 mg powder per serving."," Scientific procedures"," Cura Global Health, Inc."," 2635 Food Science Bldg
Iowa State University
Ames, IA 50011",," GRN 829 with amendments (in PDF)",,,,,,,12/09/2019,," FDA has no questions (in PDF)",05/18/2020," Supplemental Letter (in PDF)",,,,,,,, =T("830")," Chicory flour"," For use to incorporate inulin into bakery products; beverages; cereals and other grain products; dairy products and dairy substitutes; desserts; snacks; and soups at a level up to 42 percent by weight."," Scientific procedures"," Blue Prairie Brands, Inc."," 101 South Hanley Road, Suite 800
St. Louis, MO 63105",," GRN 830 (in PDF)",,,,,,,05/22/2019,," At the notifier's request, FDA ceased to evaluate this notice (in PDF)",,,,,,,,,, =T("831")," Bacillus subtilis DE111"," Ingredient in cows-milk and soy-based non-exempt infant formula for term infants at a maximum level of 2 x 10^8 colony forming units (CFU)/100 mL and in baked goods and baking mixes; beverages and beverage bases; breakfast cereals; chewing gum; coffee and tea; condiments and relishes; confections and frostings; dairy product analogs; fats and oils; fruit juices; frozen dairy desserts and mixes; fruit and water ices; gelatins, puddings, and fillings; grain products and pastas; soft/hard candy and cough drops; herbs, seeds, spices, seasonings, blends, extracts, and flavorings; jams and jellies; milk and milk products; nuts and nut products; plant protein products; processed fruits; processed vegetables and vegetable juices; snack foods; soups and soup mixes;1 sugar; and sweet sauces, toppings, and syrups at levels from 1 x 10^6 to 1 x 10^10 CFU/serving."," Scientific procedures"," Deerland Probiotics and Enzymes"," 3800 Cobb International Blvd
Kennesaw, GA 30152",," GRN 831 with amendments (in PDF)",,,,,,,08/13/2019,10/07/2019," FDA has no questions (in PDF)",,,,,,,,,, =T("832")," Acid prolyl endopeptidase produced by Aspergillus niger"," For use as an enzyme in the production of beer and other fermented beverages in accordance with current Good Manufacturing Practice (cGMP)."," Scientific procedures"," DSM Food Specialties B.V."," PO Box 1
2600 MA Delft
Netherlands",," GRN 832 (in PDF)",,,,,,,12/09/2019,," FDA has no questions (in PDF)",,,,,,,,,, =T("833")," Lacto-N-tetraose"," Ingredient at levels up to 0.8 g/L in non-exempt, cows milk-based infant formula for term infants; 0.6 g/L in drinks for young children (including toddler formulas); 5 g/kg in foods for infants and young children (including toddler foods); 10 g/kg in yogurt; 1 g/L in fluid milk (flavored and unflavored); 2 g/L in meal replacement drinks; 20 g/kg in meal replacement bars; 10 g/kg in cereal and granola bars; and 1 g/L in soft drinks, fruit-based -ades, sports drinks, energy drinks, and enhanced waters."," Scientific procedures"," Glycom A/S"," Kogle Allé 4
2970 Hørsholm
Denmark",," GRN 833 with amendments (in PDF)",,,,,,,10/07/2019,04/13/2020," FDA has no questions (in PDF)",,,,,,,,,, =T("834")," Preparation containing bacterial phages specific to shiga-toxin producing Escherichia coli"," For use as an antimicrobial to control E. coli on food when applied to ground and whole meat and poultry, including whole carcasses, primals and subprimals, trimmings and organs; ready-to-eat meats and poultry; fresh and processed fruits; fresh and processed vegetables; dairy products (including cheese); and fish and other seafood at up to 1x108 PFU/gram of food."," Scientific procedures"," Intralytix, Inc."," 701 E. Pratt Street
Baltimore, MD 21202",," GRN 834 (in PDF)",,,,,,,11/08/2019,," FDA has no questions (in PDF)",,,,,,,,,, =T("835")," Ilex guayusa leaf extract"," For use as an ingredient in energy bars, energy drinks, ready-to-drink tea beverages, carbonated drinks, coffee-like beverages, and enhanced waters at levels based on the maximum caffeine concentration of 60-125 mg/serving."," Scientific procedures"," Applied Food Sciences, Inc."," 8708 South Congress Ave, Ste B-290
Austin, TX 78745",," GRN 835 (in PDF)",,,,,,,05/22/2019,," At the notifier's request, FDA ceased to evaluate this notice (in PDF)",,,,,,,,,, =T("836")," Algal oil (50-60% docosahexaenoic acid) from Schizochytrium sp. HS01"," For use as an ingredient in gelatin desserts or salads, and vegetable oils at levels ranging from 0.33 to 3%."," Scientific procedures"," Xiamen Huison Biotech Co., LTD"," Number 1337, Middle of Tongji Road
Tongi Industrial Area
Tongan District, Xiamen
Peoples Republic of China",," GRN 836 (in PDF)",,,,,,,09/03/2019,," FDA has no questions (in PDF)",,,,,,,,,, =T("837")," Hydroxytyrosol"," For use as an antioxidant in bakery products; beverages; dairy products and substitutes; desserts; fats and oils; fruit juices and nectars; dry seasoning mixes for meat, poultry and fish; chewing gum; sauces, dips, gravies and condiments; snacks; and vegetable juices at 5-10 mg hydroxytyrosol per serving of food."," Scientific procedures"," Nova Mentis Ltd."," Nova UCD, Belfield
Dublin4, D04 V1W8
Ireland",," GRN 837 (in PDF)",,,,,,,06/05/2019,," At the notifier's request, FDA ceased to evaluate this notice (in PDF)",,,,,,,,,, =T("838")," Purified steviol glycosides"," For use as a general-purpose sweetener in foods, excluding meat and poultry products and infant formulas, at levels determined by Current Good Manufacturing Practices (cGMP)"," Scientific procedures"," Jiang Su Svetia Biotechnology Co., Ltd."," No. 15 Huihe Road
Huishan District
Wuxi, Jiangsu
CHINA",," GRN 838 (in PDF)",,,,,,,07/12/2019,," FDA has no questions (in PDF)",,,,,,,,,, =T("839")," Purified steviol glycosides"," For use as a general-purpose sweetener in foods, excluding meat and poultry products and infant formulas, at levels determined by Current Good Manufacturing Practices (cGMP)"," Scientific procedures"," Sinochem Health Company Ltd."," 20 Xianggang Zhong Road
Qingdao,266071
CHINA",," GRN 839 (in PDF)",,,,,,,07/08/2019,," FDA has no questions (in PDF)",,,,,,,,,, =T("840")," Lactobacillus paracasei strain F19"," For use as an ingredient in conventional foods, excluding USDA-regulated foods, at levels intended to provide at a minimum of 109 CFU/serving."," Scientific procedures"," Arla Foods Ingredients Group P/S"," Sonderhoh 10-12
8260 DK-Viby J
Denmark",," GRN 840 (in PDF)",,,,,,,08/27/2019,," FDA has no questions (in PDF)",,,,,,,,,, =T("841")," Saccharomyces cerevisiae expressing L-lactate dehydrogenase from Rhizopus oryzae"," For use in the production of beer to produce alcohol and impart a sour flavor and is intended to replace yeast from other available commercial sources in the fermentation of beer."," Scientific procedures"," Mascoma LLC"," 67 Etna Road, Suite 200
Lebanon, NH 03766",," GRN 841 (in PDF)",,,,,,,03/10/2020,," FDA has no questions (in PDF)",,,,,,,,,, =T("842")," Maltogenic alpha-amylase"," For use as an enzyme in the production of baked goods according to current good manufacturing practice (cGMP)"," Scientific procedures"," Mascoma LLC"," 67 Etna Road, Suite 200
Lebanon, NH 03766",," GRN 842 (in PDF)",,,,,,,01/21/2020,," FDA has no questions (in PDF)",,,,,,,,,, =T("843")," Algal oil (35% docosahexaenoic acid) from Schizochytrium sp. strain FCC-1324"," Ingredient in food categories listed in 21 CFR 184.1472(a)(3) at levels up to 50% of the levels specified in 21 CFR 184.1472(a)(3) and as the sole added source of DHA in any given food category and, if blended with another source of DHA or eicosapentaenoic acid (EPA), the levels will be no more than 1.5 g of DHA/person (p)/day (d) and no more than 3.0 g/p/d of DHA and EPA combined."," Scientific procedures"," Fermentalg"," 4 Rue Riviere
33500 Libourne
France",," GRN 843 (in PDF)",,,,,,,10/18/2019,," FDA has no questions (in PDF)",,,,,,,,,, =T("844")," Algal oil (55% docosahexaenoic acid) from Schizochytrium sp. strain FCC-3204"," Ingredient in food categories listed in 21 CFR 184.1472(a)(3) at levels up to 35% of the levels specified in 21 CFR 184.1472(a)(3) and as the sole added source of DHA in any given food category and, if blended with another source of DHA or eicosapentaenoic acid (EPA), the levels will be no more than 1.5 g of DHA/person (p)/day (d) and no more than 3.0 g/p/d of DHA and EPA combined."," Scientific procedures"," Fermentalg"," 4 Rue Riviere
33500 Libourne
France",," GRN 844 (in PDF)",,,,,,,10/18/2019,," FDA has no questions (in PDF)",,,,,,,,,, =T("845")," Lactobacillus rhamnosus LGG"," For use as an ingredient conventional foods, including milk and dairy products such as yogurt and other fermented milk products; dairy alternatives (plant-based (oat, soy, almond, coconut, pea, etc.); fermented milk and yogurt products; beverages such as juice and protein shakes; shelf-stable products such as bars (granola, protein, meal replacement bars), confectionary (gummy candy, hard candy, soft chew candy, chewing gum, coatings); breakfast cereals (RTE and hot) at use levels between 108 to 1010 cfu/serving."," Scientific procedures"," Chr. Hansen, Inc."," 9015 West Mable Street
Milwaukee, WI 53214",," GRN 845 (in PDF)",,,,,,,10/30/2019,," At the notifier's request, FDA ceased to evaluate this notice (in PDF)",,,,,,,,,, =T("846")," Rebaudioside M"," For use as table top sweetener and as a general purposed non-nutritive sweetener for incorporation into foods in general, other than infant formula and meat and poultry products, at per serving levels reflecting current good manufacturing practice (cGMP)."," Scientific procedures"," GLG Life Tech Corporation"," 10271 Shellbridge Way, Suite 100
Richmond, BC V6X 2W8
Canada",," GRN 846 (in PDF)",,,,,,,08/23/2019,," FDA has no questions (in PDF)",,,,,,,,,, =T("847")," Lactobacillus plantarum ECGC 13110402"," For use as an ingredient in foods generally, excluding infant formula and foods that would require additional regulatory review by USDA, at levels up to 1 x 1010 CFU per serving."," Scientific procedures"," ProBiotix Health Ltd."," Cavalier Suite The Barracks
Wakefield Road
WF8 4HH Pontefract
United Kingdom",," GRN 847 (in PDF)",,,,,,,09/30/2019,," FDA has no questions (in PDF)",,,,,,,,,, =T("848")," Pea and rice protein fermented by shiitake mycelia"," For use as an ingredient in baked goods and baking mixes, beverages and beverage bases, breakfast cereals, dairy product analogs, fats and oils, grain products and pastas, milk products, plant proteins and products, processed fruits and fruit juices, processed vegetable and vegetable juices, soups and soup mixes, non-baked goods (bars), and confectionary at levels ranging from 1.04 to 33.3%."," Scientific procedures"," Myco Technology, Inc."," 3155 Chambers Rd Suite E
Aurora, CO USA 80011
",," GRN 848 with amendments (in PDF)",,,,,,,01/09/2020,," FDA has no questions (in PDF)",,,,,,,,,, =T("849")," Inulin from artichoke"," For use as a bulking agent, sugar replacer, humectant, fat-replacer and texture modifier in multiple food categories, excluding infant formula, at either 0.35 g/serving in the case of the syrup form, or 0.25 g/serving in the powdered form."," Scientific procedures"," Intrinsic Organics, LLC"," 1410 Organic Way
Weiser, Idaho 83672
",," GRN 849 (in PDF)",,,,,,,10/30/2019,," FDA has no questions (in PDF)",,,,,,,,,, =T("850")," Olein from shea tree nut extract"," For use as a replacement for animal fats and vegetable fats rich in palmitic, myristic, and lauric fatty acids at in convention foods (excluding foods subject to regulation by the USDA) at levels within current good manufacturing practices and principles."," Scientific procedures"," BUNGE Loders Croklaan BV"," Hogewegl
Wormerveer, 1521 AZ
Netherlands",," GRN 850 with amendment (in PDF)",,,,,,,03/20/2020,," FDA has no questions (in PDF)",,,,,,,,,, =T("851")," Pea protein"," For use as a source of protein in foods at levels ranging from 1 to 90 percent in bakery products (e.g., bread, rolls, cakes, pasta), cereals, snack foods (e.g.,chips, crackers, energy bars), ready-to-drink (RTD) beverages, soups, smoothies, fruit juices, protein beverages, dairy and dairy alternatives (e.g., yogurt, ice cream), meal replacements, nutritional bars, clinical nutrition, fruit and vegetable preparation, meat analog products, processed meat, dry blend protein products, extruded products, chocolate and confection compound coatings, non-chocolate confections, and as a binder and extender in meat and poultry applications. Infant formula is excluded from the intended uses. It is also intended for use in specialty foods intended to meet the protein requirements for sports activity or for weight control. Pea protein isolate is also intended to be used as a binder and extender in the following meat and poultry applications: raw comminuted poultry, raw comminuted meat, sausage/hot dogs, and soups/stews/salad/similar products."," Scientific procedures"," Roquette Freres"," Batiment Alpha 3
Lestrem 62080
FRANCE",," GRN 851 with amendments (in PDF)",,,,,,,04/15/2020,," FDA has no questions (in PDF)",,,,,,,,,, =T("852")," 2'-fucosyllactose"," For use as an ingredient in beverages and beverage bases; breakfast cereals; dairy product analogues; frozen dairy desserts and mixes; gelatins, puddings, and fillings; grain products and pastas; jams and jellies; whole and skim milk; milk products; processed fruits and fruit juices; and sweet sauces, toppings, and syrups at levels ranging from 0.28 to 1.2 g/serving; in non-exempt formulas for term infants at 0.24 g/serving (2.4 g/L); in toddler formulas at 0.24 g/serving (2.4 g/L); and in baby foods at levels ranging from 0.24 to 1.2 g/serving."," Scientific procedures"," BASF SE"," 100 Park Avenue
Florham Park, NJ 07932",," GRN 852 (in PDF)",,,,,,,11/15/2019,," FDA has no questions (in PDF)",,,,,,,,,, =T("853")," Lysozyme produced by Trichoderma reesei"," For use as an enzyme in the production of ingredients produced by microbial fermentation such as xanthan gum, gellan gum, and yeast extracts to assist in the removal of cellular debris."," Scientific procedures"," Novozymes NA"," 77 Perry Chapel Church Road, Box 576
Franklinton, NC, 27525",," GRN 853 (in PDF)",,,,,,,05/27/2020,," FDA has no questions (in PDF)",,,,,,,,,, =T("854")," Agave mixed fructans from Agave tequilana"," Intended for use as a bulking agent, texturizing agent, or source of reduced energy carbohydrate in food categories described in the submission (excluding meat and poultry products, and infant formula) at levels not to exceed the amount reasonably required to accomplish the intended technical effect."," Scientific procedures"," IIDEA (Industrializadora Integral del Agave SA de CV)"," Av. Periférico Sur 7750
Tlaquepaque Jalisco
Mexico",," GRN 854 (in PDF)",,,,,,,01/21/2020,," FDA has no questions (in PDF)",,,,,,,,,, =T("855")," Bifidobacterium animalis subsp. lactis strain R0421"," Intended for use as an ingredient in non-exempt powdered milk-based infant formula intended for healthy term infants at a level to provide 5 x 109 CFU/800 ml of formula as prepared."," Scientific procedures"," Lallemand Health Solutions"," 17975 rue des Gouverneurs
Mirabel, Quebec, J7J 2K7
Canada",," GRN 855 w amendments (in PDF)",,,,,,,02/05/2020,," FDA has no questions (in PDF)",,,,,,,,,, =T("856")," Bifidobacterium animalis subsp. lactis strain BB-12"," For use as an ingredient in conventional foods for use by the general population, excluding foods subject to regulation by the USDA, at levels intended to provide 5 x 1011 CFU/serving."," Scientific procedures"," Chr. Hansen, Inc."," 9015 West Mable Street
Milwaukee, WI 53214",," GRN 856 (in PDF)",,,,,,,12/09/2019,," FDA has no questions (in PDF)",,,,,,,,,, =T("857")," Phospholipase A1 produced by Aspergillus niger"," For use as an enzyme in the processing of edible oils and fats, including vegetable oil, algal oil, animal fats, and fish oil."," Scientific procedures"," DSM Food Specialties"," PO Box 1
2600 MA Delft
Netherlands",," GRN 857 with amendment (in PDF)",,,,,,,12/20/2019,," FDA has no questions (in PDF)",,,,,,,,,, =T("858")," Glucosylated steviol glycosides"," For use as a table top sweetener and as a general purpose sweetener for use in foods in general, excluding infant formula and meat and poultry products, at levels in accordance with cGMP."," Scientific procedures"," Qufu Shengren Pharmaceutical Co., Ltd"," No. 6 Shengwang Ave.
Qufu, Shandong, 273100
China",," GRN 858 part 1 (in PDF)"," GRN 858 part 2 (in PDF)"," GRN 858 part 3 (in PDF)",,,,,10/04/2019,," FDA has no questions (in PDF)",,,,,,,,,, =T("859")," 2'-fucosyllactose"," For use an ingredient in whey, milk, and soy-based, non-exempt infant formulas at a level of 2.4 g/L of formula as consumed; infant and toddler foods at levels ranging from 0.24-1.2 g/serving; and 0 in beverage and beverage bases; breakfast cereals; dairy product analogs; frozen dairy desserts and mixes; gelatins, puddings, and fillings; grain products and pastas; jams and jellies; milk and milk products; processed fruits and fruit juices; and sweet sauces, toppings and syrup at levels ranging from 0.28-1.2 g/serving"," Scientific procedures"," Advanced Protein Technologies, Corp."," 5 Mosan-gil, Jeongnam-myeon
Hwasung City, Gyeonggi-do, 18516
Republic of Korea",," GRN 859 (in PDF)",,,,,,,09/06/2019,," At the notifier's request, FDA ceased to evaluate this notice (in PDF)",,,,,,,,,, =T("860")," Algal oil (36% docosahexaenoic acid) from Schizochytrium sp. strain DHF"," Ingredient in the same food categories as those currently listed in 21 CFR 184.1472(a)(3) (Menhaden oil), at use levels of algal oil (≥36% DHA) that are no more than 27.775% of the levels specified for menhaden oil in that regulation. Hubei Fuxing also intends to use algal oil (≥36% DHA) as an ingredient in exempt and non-exempt, soy-, whey-, cows milk-, amino acid-, and hydrolyzed protein-based infant formula for pre-term and term infants at a maximum level of 0.5% of total fat as DHA in combination with a safe and suitable source of arachidonic acid (ARA) at a ratio ranging from 1:1 to 1:2 of DHA to ARA."," Scientific procedures"," Hubei Fuxing BioTechnology"," Floor 11th, Bldg.23, Yinhu Enterprise Zone, Baishazhou Ave.
Hongshan District, Hubei Province
China",," GRN 860 (in PDF)",,,,,,,09/03/2019,," At the notifier's request, FDA ceased to evaluate this notice (in PDF)",,,,,,,,,, =T("861")," Pullulanase from Bacillus deramificans produced in Bacillus subtilis"," Intended for use as an enzyme in the saccharification of liquified starch in the production of dextrose and maltose syrups."," Scientific procedures"," GenScript/Bestzyme"," 860 Centennial Ave.
Piscataway, NJ 08854",," GRN 861 (in PDF)",,,,,,,07/21/2020,," FDA has no questions (in PDF)",,,,,,,,,, =T("862")," Algal oil (40% docosahexaenoic acid) from Schizochytrium sp. strain ONC-T18"," Algal oil is intended for use in milk- and soy-based non-exempt infant formula for term infants and milk- and soy-based exempt infant formula for pre-term infants at levels up to 0.5% (w/w) of total fat as DHA with the provision that algal oil will be used in infant formula in combination with a safe and suitable source of arachidonic acid (ARA) at a ratio ranging from 1:1 to 1:2 of DHA to ARA. The oil formulation is intended for use in the food categories listed in 21 CFR 184.1472(a)(3) at up to 25% of the levels specified and the powder formulation is intended for use in the food categories listed in 21 CFR 184.1472(a)(3), excluding those products under USDA jurisdiction, at up to 100% of the levels specified; and, with the provision that if algal oil is blended with another source of DHA or eicosapentaenoic acid (EPA), the levels will be no more than 1.5 g of DHA/person (p)/day (d) and no more than 3.0 g/p/d of DHA and EPA combined."," Scientific procedures"," BASF Corporation"," 100 Park Avenue
Florham Park, NJ 07932",," GRN 862 with amendments (in PDF)",,,,,,,06/15/2020,," FDA has no questions (in PDF)",,,,,,,,,, =T("863")," β-lactoglobulin produced by Trichoderma reesei"," Intended for use as a substitute for dairy and plant derived proteins in foods that currently use protein from milk or plants and a source of dietary protein."," Scientific procedures"," Perfect Day, Inc."," 813 Heinz Avenue
Berkeley, CA 94710",," GRN 863 (in PDF)",,,,,,,03/25/2020,," FDA has no questions (in PDF)",,,,,,,,,, =T("864")," Bacillus coagulans SNZ 1969 spore preparation"," As an ingredient in non-exempt infant formulas for term infants, at levels up to 2 x 108 colony forming units (CFU) per 100 mL infant formula, as consumed."," Scientific procedures"," Sanzyme Biologics Pvt. Ltd."," Plot No. 13, Sagar Society, Banjara Hills, Road Number 2 Hyderabad 500 034, Telengana
INDIA",," GRN 864 with amendments (in PDF)",,,,,,,02/06/2020,," FDA has no questions (in PDF)",,,,,,,,,, =T("865")," Lactobacillus acidophilus NCFM"," Intended for use as an ingredient in non-exempt term infant formula and toddler formulas at a level of 108 CFU/g."," Scientific procedures"," Dupont Nutrition and Biosciences (Danisco USA, Inc.)"," 3329 Agriculture Drive
Madison, WI, 53716",," GRN 865 (in PDF)",,,,,,,03/10/2020,04/01/2020," FDA has no questions (in PDF)",,,,,,,,,, =T("866")," Lipase from Penicillium camemberti"," Intended for use in dairy processing and fats and oil processing."," Scientific procedures"," Amano Enzyme, Inc."," 27 Hanno, Kunotsubo, Kita-Nagoya
Aichi Prefecture 460-8630
JAPAN",," GRN 866 (in PDF)",,,,,,,02/05/2020,," At the notifier's request, FDA ceased to evaluate this notice (in PDF)",,,,,,,,,, =T("867")," Rebaudioside M"," Intended for use as a general-purpose sweetener in foods, excluding infant formula and products under USDAs jurisdiction, at levels determined by good manufacturing practices (GMP), as well as use as a table top sweetener."," Scientific procedures"," Cargill, Inc."," 15407 McGinty Road West, M.S. 163
Wayzata, MN, 55391",," GRN 867 (in PDF)",,,,,,,09/03/2019,," At the notifier's request, FDA ceased to evaluate this notice (in PDF)",,,,,,,,,, =T("868")," Coffee fruit extract"," Intended for use as an ingredient in flavored water/energy drinks; coffee/tea; RTM beverages; milk products; clusters/bars; fruit juices; vegetable juices/blends; chocolate; candy; and chewing gum at levels ranging from 20-300 mg/serving."," Scientific procedures"," VDF FutureCeuticals, Inc."," 2692 N. St. Rt. 1-17
Momence, IL 60954",," GRN 868 with amendments (in PDF)",,,,,,,03/24/2020,," FDA has no questions (in PDF)",,,,,,,,,, =T("869")," Ilex guayusa leaf aqueous extract"," Intended for use as an ingredient in energy bars; energy drinks; RTD tea; carbonated drinks; coffee-like beverages; and enhanced water at levels ranging from 706-3570 mg/serving."," Scientific procedures"," Applied Food Sciences, Inc."," 8708 South Congress Ave, Suite B-290
Austin, Texas 78745",," GRN 869 (in PDF)",,,,,,,03/20/2020,," FDA has no questions (in PDF)",,,,,,,,,, =T("870")," Ilex guayusa leaf hydroethanolic extract"," Intended for use as an ingredient in energy bars; energy drinks; RTD tea; carbonated drinks; coffee-like beverages; and enhanced water at levels ranging from 267-715 mg/serving."," Scientific procedures"," Applied Food Sciences, Inc."," 8708 South Congress Ave, Suite B-290
Austin, Texas 78745",," GRN 870 (in PDF)",,,,,,,03/20/2020,," FDA has no questions (in PDF)",,,,,,,,,, =T("871")," Lactobacillus acidophilus DDS-1"," Intended for use as an ingredient in foods generally, excluding infant formula and foods under the authority of the USDA at levels intended to provide 109 to 1011 CFU per serving."," Scientific procedures"," UAS Laboratories, LLC"," 4375 Duraform Lane
Windsor, Wisconsin 53598",," GRN 871 (in PDF)",,,,,,,10/23/2019,," FDA has no questions (in PDF)",,,,,,,,,, =T("872")," Bifidobacterium animalis subsp. lactis UABla-12"," Intended for use as an ingredient in foods generally, excluding infant formula and foods under the authority of USDA at levels intended to provide 109 to 1011 CFU per serving."," Scientific procedures"," UAS Laboratories, LLC"," 4375 Duraform Lane
Windsor, Wisconsin 53598",," GRN 872 (in PDF)",,,,,,,12/09/2019,," FDA has no questions (in PDF)",,,,,,,,,, =T("873")," Cranberry extract"," Intended for use as an ingredient in beverages and beverage bases, coffee and tea, and processed fruits and fruit juices at levels ranging from 150 to 300 mg per serving."," Scientific procedures"," Ocean Spray Cranberries, Inc."," One Ocean Spray Drive
Lakeville-Middleboro, MA 02349",," GRN 873 (in PDF)",,,,,,,05/06/2020,," FDA has no questions (in PDF)",,,,,,,,,, =T("874")," Corn protein"," Intended for use as a source of protein in bakery products; batter/breading/coating for frying; ready-to-eat cereal; daily product analogs; meat analogs and vegetarian products; mixed dishes with sauce; non-dairy beverages; nut butters (except full fat peanut butter), nutritional bars; cooked pasta; protein and nutritional powders; ready-to-drink protein beverages; cream based sauces; and snack foods at levels ranging from 0.08 to 25%."," Scientific procedures"," Cargill, Inc."," 15407 McGinty Road West/Ms-163
Wayzata, MN 55391",," GRN 874 with amendment (in PDF)",,,,,,,04/29/2020,," At the notifier's request, FDA ceased to evaluate this notice (in PDF)",,,,,,,,,, =T("875")," Bifidobacterium animalis subsp. lactis AD011"," Intended for use as a food ingredient in non-exempt term infant formula (milk-, soy-, and whey-based); and foods (dairy products/dairy-based foods and dairy substitutes, including fermented milk including butter milk and kefir; flavored milk beverage mixes; dried milk powder; imitation milk and yogurt; powdered baby cereals and foods; meal replacement and nutritional drink mix powders; and powdered sugar substitutes) for the general population. Powdered non-exempt term infant formulas (milk-, soy-, or whey-based) will contain up to 108 colony forming units (CFU) of B. lactis AD011 per gram of powdered formulas; and the other foods will contain up to 1010 CFU B. lactis AD011 per serving."," Scientific procedures"," BIFIDO CO., LTD."," 23-16, Nonggongdanji gil, Hongcheon-eup
Hongcheon-gun, Gangwon-do,25117
Republic of Korea",," GRN 875 (in PDF)",,,,,,,10/30/2019,," At the notifier's request, FDA ceased to evaluate this notice (in PDF)",,,,,,,,=T("952"),, =T("876")," Hydroxytyrosol"," As an antioxidant at a level of 5 to 10 mg per serving in bakery products (snack crackers, croutons, grain-based bars with or without filling or coating, protein-based meal replacement and energy bars); beverages (sports drinks, energy drinks, milk-based meal replacements, flavored waters, fruit-flavored drinks); yogurt; frozen yogurt; fats and oils (butter, margarine, oil and shortening; salad dressing; mayonnaise; mayonnaise-type sandwich spreads); fruit juices and fruit nectars; dry coating mixes for meat, poultry, and fish; dry seasoning mixes; chewing gum; sauces, dips, gravies, and condiments; snacks (chips, pretzels, popcorn, extruded snacks, fruit chips, grain-based snack mixes); and vegetable juice."," Scientific procedures"," Nova Mentis Ltd"," Nova UCD, Belfield
Dublin 4, D04 V1W8
Ireland",," GRN 876 with amendments (in PDF)",,,,,,,01/21/2020,," FDA has no questions (in PDF)",,,,,,,,,, =T("877")," Bifidobacterium longum BB536"," Intended for use as an ingredient in term infant formula at a level of 1 x 108 CFU per gram of product."," Scientific procedures"," Morinaga Milk Industry Co., Ltd."," 331, Shiba 5-Chrome, Minato-ku
Tokyo, Japan 108-8384",," GRN 877 (in PDF)",,,,,,,12/26/2019,," FDA has no questions (in PDF)",,,,,,,,,, =T("878")," Glucosylated steviol glycosides"," Intended for use as a table top sweetener and as a general purpose non-nutritive sweetener for incorporation into foods in general, other than infant formulas and meat and poultry products, at per serving levels reflecting good manufacturing practices and principles, in that the quantity added to foods should not exceed the amount reasonably required to accomplish its intended technical effect."," Scientific procedures"," Daepyung Co., Ltd."," Leaders B/D 604, #274-4 Seohyeon-Dong
Bundang-Gu, Seongnam-Si, Gyeonggi-Do,
Republic of Korea, 463-824",," GRN 878 (in PDF)",,,,,,,12/19/2019,," FDA has no questions (in PDF)",05/11/2020," Supplemental Letter (in PDF)",,,,,,,, =T("879")," Fava bean protein isolate"," Intended for use as a source of protein in bakery products; snack foods; beverages, soups, and nutritional beverages; imitation dairy products; meal replacement/nutritional bars; meat analogs; and dry blend protein powders at levels ranging from 10 to 90 percent as consumed."," Scientific procedures"," Yantai T.FULL Biotech Co., Ltd"," Shiduitou, Zhangxing Town
Zhaoyuan City, Shandong Province
China",," GRN 879 with amendments (in PDF)",,,,,,,03/23/2020,," FDA has no questions (in PDF)",,,,,,,,,, =T("880")," 3'-sialyllactose sodium salt"," Ingredient at levels up to 0.2 g/L in cows milk-based, non-exempt infant formula for term infants; 0.15 g/L in beverages and formula for young children (>12 months of age); 1.25 g/kg in foods for infants and young children; 2.5 g/kg in yogurt; 0.25 g/L in buttermilk and fluid milk (flavored and unflavored); 0.5 g/L in meal replacement drinks; 5 g/kg in meal replacement bars; 2.5 g/kg in cereal and granola bars; and 0.25 g/L in soft drinks, fruit-based drinks, sports drinks, energy drinks, and enhanced waters."," Scientific procedures"," Glycom A/S"," Kogle Allé 4
2970 Hørsholm, Denmark",," GRN 880 with amendments (in PDF)",,,,,,,02/21/2020,04/13/2020," FDA has no questions (in PDF)",,,,,,,,,, =T("881")," 6'-sialyllactose sodium salt"," Ingredient at levels up to 0.4 g/L in non-exempt infant formula for term infants; 1 0.3 g/L in beverages and formula for young children (>12 months of age); 2.5 g/kg in foods for infants and young children; 5 g/kg in yogurt; 0.5 g/L in buttermilk and fluid milk (flavored and unflavored); 1 g/L in meal replacement drinks; 10 g/kg in meal replacement bars; 5 g/kg in cereal and granola bars; and 0.5 g/L in soft drinks, fruit-based drinks, sports drinks, energy drinks, and enhanced waters."," Scientific procedures"," Glycom A/S"," 2970 Kogle Allé 4
Hørsholm, Denmark",," GRN 881 with amendments (in PDF)",,,,,,,02/24/2020,04/13/2020," FDA has no questions (in PDF)",,,,,,,,,, =T("882")," Rebaudioside M"," Intended for use as a general-purpose sweetener in foods, excluding infant formula and products under USDAs jurisdiction, at levels determined by good manufacturing practices (GMP), as well as use as a table top sweetener."," Scientific procedures"," Cargill, Inc."," 15407 McGinty Road West/Ms-163
Wayzata, MN 55391",," GRN 882 (in PDF)",,,,,,,02/02/2020,," FDA has no questions (in PDF)",,,,,,,,,, =T("883")," Ilex guayusa leaf aqueous extract"," Intended for use as an ingredient in carbonated and still energy beverages at a level of 5000 mg per serving."," Scientific procedures"," All Market Inc."," 250 Park Ave South (at 20th Str) 7th Floor
New York, NY 10003",," GRN 883 with amendments (in PDF)",,,,,,,04/28/2020,," FDA has no questions (in PDF)",,,,,,,,,, =T("884")," Rice bran extract"," Intended for use as a moisture retention agent and an alternative to sodium phosphate at a maximum level of 1.25% by weight in meat and poultry, meat and poultry products, and processed meats."," Scientific procedures"," Florida Food Products, LLC"," 2231 W. CR 44
Eustis, FL 32726",," GRN 884 w amendments (in PDF)",,,,,,,08/19/2020,," FDA has no questions (in PDF)",,,,,,,,,, =T("885")," Vinyl acetate-vinyl laurate copolymer"," Intended for use as a component of chewing gum base at a level of up to 26% by weight to reduce or eliminate the use of additional softeners"," Scientific procedures"," Wacker Chemie AG"," Johannes-Hess-Strasse 24
Burghausen, 84489
Germany",," GRN 885 w amendments (in PDF)",,,,,,,04/22/2020,," FDA has no questions (in PDF)",,,,,,,,,, =T("887")," Menaquinone-7"," Ingredient and as a nutrient according to 21 CFR 170.3(o)(20) in nutritional beverage products intended for consumers ages 1-13 years at a use level of 4 g/serving."," Scientific procedures"," Synergia Life Sciences Pvt. Ltd."," 6/312, Jogani Industrial complex
V.N. Purav Marg, Chunabhatti
Mumbai 400 022
INDIA",," GRN 887 (in PDF)",,,,,,,06/12/2020,," FDA has no questions (in PDF)",,,,,,,,,, =T("888")," Preparation containing three bacterial phages specific to Salmonella"," Intended for use as an antimicrobial on food to control Salmonella at an application rate of up to 1 x 1010 PFU/mL per gram of food."," Scientific procedures"," Gum Products International"," 1255 Journeys End Circle
Newmarket, Ontario L3Y 8T7
Canada",," GRN 888 (in PDF)",,,,,,,02/28/2020,," At the notifier's request, FDA ceased to evaluate this notice (in PDF)",,,,,,,,,, =T("889")," Spermidine rich wheat germ extract"," As an ingredient in food bars and yogurt at levels up to 2.7 grams per serving."," Scientific procedures"," TLL The Longevity Labs GmbH"," Kratkystrasse 2
8020 GRAZ
AUSTRIA",," GRN 889 (in PDF)",,,,,,,03/20/2020,," At the notifier's request, FDA ceased to evaluate this notice (in PDF)",,,,,,,,,, =T("890")," Corn oil derived from distillers grains"," Intended for use as an edible corn oil."," Scientific procedures"," Corn oil ONE"," 4400 E. University Ave
Pleasant Hill, IA 50327",," GRN 890 part 1"," GRN 890 part 2"," GRN 890 amendments part 3 (in PDF)",,,,,12/23/2020,," At the notifier's request, FDA ceased to evaluate this notice (in PDF)",,,,,,,,,, =T("891")," Cellulase produced by Trichoderma reesei"," Intended for use as an enzyme in fruit and vegetable processing, wine processing, starch and grain processing, brewing and other cereal based beverages and potable/fuel alcohol."," Scientific procedures"," Novozymes North America Inc."," 77 Perry Chapel Church Road, Box 576
Franklinton, NC, 27525",," GRN 891 with amendments(in PDF)",,,,,,,10/20/2020,," FDA has no questions (in PDF)",,,,,,,,,, =T("892")," Refined shea butter"," Intended for use as replacement or partial replacement for vegetable and animal fats in baked goods and baking mixes; beverages and beverage bases, non-alcoholic; breakfast cereals; cheeses; cheese analogs / substitutes / imitation cheese; condiments and relishes; confections and frostings;; dairy product analogs; fats and oils; fish products (excluding catfish); frozen dairy desserts and mixes; gelatins, puddings, and fillings; grain products and pastas; gravies and sauces; hard candy and cough drops; herbs, seeds, spices, seasonings, blends, extracts, and flavorings; milk products; nuts and nut products; plant protein products; processed vegetables and vegetable juice; snack foods; soft candy; soups and soup mixes; sweet sauces, toppings, and syrups at levels limited to current Good Manufacturing Practice (cGMP)."," Scientific procedures"," AAK USA Inc."," 499 Thornall Street
Edison, NJ 08837",," GRN 892 with amendments (in PDF)",,,,,,,07/07/2020,," At the notifier's request, FDA ceased to evaluate this notice (in PDF)",,,,,,,,,, =T("893")," D-psicose"," Intended for use as a bulk sweetener in alcoholic beverages, meat and poultry products, grain-based cereal bars, dried cranberries, and pre-sweetened cereals at levels ranging from 2 to 25 percent of the finished food."," Scientific procedures"," Tate & Lyle"," 5450 Prairie Stone Parkway
Hoffman Estates, IL 60192",," GRN 893 with amendments (in PDF)",,,,,,,06/05/2020,," At the notifier's request, FDA ceased to evaluate this notice (in PDF)",,,,,,,,,, =T("894")," White mulberry leaf extract"," Intended for use as an ingredient in bars; low sodium crackers; nonsweet crackers; salty snacks from grain products; oat breads; cornbread, corn muffins, tortillas; flour-milk dumplings, plain; flour-water patties; bread, rolls; biscuits; mixtures, mainly grain, pasta or bread; multigrain breads, rolls; other breads; wheat, cracked wheat breads, rolls; other quick breads; pastas; rye bread, rolls; white breads, rolls; coffee; citrus fruit juices; energy drinks; sports drinks; other functional beverages; tea; water, bottled, fortified; fruit drinks; nutritional drinks; cakes; candies; cookies; cobblers, eclairs, turnovers, other pastries; other muffins, popovers; pies; sugar and sugar substitutes blends; sweet crackers; jellies, jams, preserves; Danish, breakfast pastries, doughnuts; cereal grains, not cooked; ready-to-eat cereals; cooked cereals, rice; pancakes; waffles; flavored milk and milk drinks, fluid; yogurt; puddings, custards, and other milk desserts; tomato sauces; potato recipes; potato soups; white potatoes, chips, sticks; dark green vegetable soups; deep yellow vegetable soups; frozen plate meals with grain mixture as major ingredient; other cooked vegetables, cooked with sauces, batters, casseroles; and soups with grain product as a major ingredient at levels ranging from 120 to 294 mg per serving."," Scientific procedures"," Phynova Group Limited"," 16 Fenlock Court, Blenheim Office Park
Long Hanborough, OX29 8LN
United Kingdom",," GRN 894 (in PDF)",,,,,,,11/19/2020,," At the notifier's request, FDA ceased to evaluate this notice (in PDF)",,,,,,,,,, =T("895")," Lacto-N-neotetraose"," Intended for use as an ingredient in beverage and beverage bases; dairy product analogs; infant and toddler foods (including term infant formula); grain products and pastas; milk, whole and skim; milk products; and processed fruits and fruit juices and levels ranging from 0.02 to 0.68 g per serving."," Scientific procedures"," Glycom A/S"," Kogle Allé 4
Hørsholm, Denmark",," GRN 895 with amendments (in PDF)",,,,,,,12/03/2020,," FDA has no questions (in PDF)",,,,,,,,,, =T("896")," Alpha-galacto-oligosaccharides"," Intended for use as an ingredient in beverages, carbonated/non-carbonated, juice, flavored water; ready-to-drink iced tea, coffee and teas; sports drinks; energy drinks; soups; meal-replacement drinks; processed fruits and vegetable juices; dairy products analogs; dairy and analogs; sugars and sweets; coffee and tea; infant formulas; growing-up milks; baby cereals; baby foods; and toddler foods at levels ranging from 0.29 to 13.33 percent"," Scientific procedures"," Olygose"," Parc Technologique des Rives de lOise
BP 50149, Compiegne Cedex, F-60201
France",," GRN 896 with amendments (in PDF)",,,,,,,09/18/2020,," FDA has no questions (in PDF)",,,,,,,,,, =T("897")," 2'-O-fucosyllactose"," Intended for use as an ingredient in term infant formula, toddler formulas, baby foods and beverages for young children at levels ranging from 0.24 to 2.04 grams per serving, and baked goods and baking mixes; non-alcoholic beverages and beverage bases; breakfast cereals; milk products; dairy product analogs; processed fruits and fruit juices; processed vegetables and vegetable juices; and tube-feeding formulas at levels ranging from 1.2 to 40 g/kg."," Scientific procedures"," DuPont Nutrition and Health"," DuPont Experimental Station E-320
200 Powder Mill Road
Wilmington DE 19803",," GRN 897 with amendments (in PDF)",,,,,,,06/12/2020,," FDA has no questions (in PDF)",,,,,,,,,, =T("898")," Anhydrous milk fat"," Intended for use as a source of fat in cow milk-based, calorically dense, ready-to-feed and exempt infant formula for term infants at a maximum level of 7% of the fat blend"," Scientific procedures"," Hogan Lovells US LLP"," 555 Thirteenth Street, NW
Washington, DC, 20004",," GRN 898 (in PDF)"," GRN 898 amendments (in PDF)",,,,,,10/28/2020,," FDA has no questions (in PDF)",,,,,,,,,, =T("899")," Citric acid esters of mono- and diglycerides"," Intended for use as an emulsifier in exempt infant formula at a maximum level of 233 mg per 100 mL of formula."," Scientific procedures"," Hogan Lovells US LLP"," 555 Thirteenth Street, NW
Washington, DC, 20004",," GRN 899 with amendments (in PDF)",,,,,,,10/30/2020,," FDA has no questions (in PDF)",,,,,,,,,, =T("900")," Corn oil"," Intended for use as a source of fat in cow milk-based, calorically dense, ready-to-feed, and exempt infant formula for term infants at a maximum use level of 3.0% by weight of the fat blend in formulas containing up to 50% of kilocalories (kcal) as fat."," Scientific procedures"," Hogan Lovells US LLP"," 555 Thirteenth Street, NW
Washington, DC, 20004",," GRN 900 with amendments (in PDF)",,,,,,,10/30/2020,," FDA has no questions (in PDF)",,,,,,,,,, =T("901")," Glucosyl hesperidin"," Intended for use as a source of antioxidants, a coloring adjunct, flavor enhancer, and flavoring agent and adjuvant in beverages and beverage bases, coffee and tea, hard candy and cough drops, milk products, processed fruits and fruit juices, processed vegetable and vegetable juices, and soft candy at 500 mg of glucosyl hesperidin per serving."," Scientific procedures"," Hayashibara Co., Ltd."," 675-1 Fujisaki, Naka-ku
Okayama 702-8006
Japan",," GRN 901 (in PDF)"," GRN 901 amendments (in PDF)",,,,,,11/09/2020,," FDA has no questions (in PDF)",,,,,,,,,, =T("902")," Neohesperidin dihydrochalcone"," Intended for use as as a sweetener in sweet crackers; biscuits; cornbread, corn muffins, tortillas; other muffins, popovers; other quick breads; fruit juices (with and without citrus); nectars; carbonated soft drinks; fruit drinks; nonfruit beverages; nutrition drinks and powders (reconstituted powders); energy drinks; sports drinks; cakes; cookies; pies; cobblers, eclairs, turnovers, pastries; Danish, doughnuts; coffee cake; sugar replacement or substitutes; jellies, jams, preserves; ices and popsicles; candies; cottage cheeses; yogurt; flavored milk and milk drinks; frozen milk desserts; puddings, custards and other milk desserts; soups with legumes as major ingredient; soups with grain as major ingredient; dark-green vegetable soups; deep yellow vegetable soups; tomato soups; vegetable soups; Puerto Rican stews/soups with starchy vegetables at levels ranging from 10-1000 ppm"," Scientific procedures"," HealthTech BioActives, S.L.U."," Ctra. Beniel a Zeneta, 143-145
El Raiguero-La Villa, 30130 Beniel (Murcia)
Spain",," GRN 902 (in PDF)",,,,,,,11/23/2020,," FDA has no questions (in PDF)",,,,,,,,,, =T("903")," Quillaia extract type 2"," Intended for use as an emulsifier in beverages, alcoholic; beverage and beverage bases; chewing gum; coffee and tea; condiments and relishes; confections and frostings; dairy product analogs; fats and oils; frozen dairy desserts; fruit and water ices; hard candy; jams and jellies; soft candy; and dietary supplements (non-dietary ingredient use) at levels ranging from 30 to 185 mg/100g."," Scientific procedures"," Naturex SA"," 250 rue Pierre Bayle, BP 81218 84911
Avignon, Cedex 9
France",," GRN 903 (in PDF)"," GRN 903 amendments (in PDF)",,,,,,04/21/2021,," FDA has no questions (in PDF)",,,,,,,,,, =T("904")," Fungal protein from fermented Fusarium sp. mycelia"," Intended for use as an ingredient or macronutrient in plant protein products, including meat and poultry analogs; dairy product analogs; milk products; beverage and beverage bases; breakfast cereals; fruit juices and vegetable juices; grain products and pastas; baked goods and baking mixes; soups and soup mixes and fats and oils at levels ranging from up to 7.5 to 23.3%"," Scientific procedures"," Natures Fynd"," 815 W Pershing Rd
Chicago, IL 60609",," GRN 904 with amendments (in PDF)",,,,,,,03/26/2021,," FDA has no questions (in PDF)",,,,,,,,,, =T("905")," Bacillus subtilis SG188"," Intended for use as an ingredient in beverages, such as milk drinks, protein high energy sports drinks, hot beverages and juices; and dry and shelf-stable products such as cereals, cookies, gums and confectionary at a maximum of 109 spores per serving."," Scientific procedures"," SporeGen Ltd"," Bourne Laboratories
Royal Holloway University of London Egham
Surrey, TW20 0EX
United Kingdom",," GRN 905 with amendments(in PDF)",,,,,,,06/08/2020,," FDA has no questions (in PDF)",,,,,,,,,, =T("906")," Wheat seed polar lipids"," Ingredient in fruit and vegetable juice drinks at a level of 0.1 mg/g."," Scientific procedures"," SEPPIC Air Liquide Healthcare"," 50 Boulevard National
CS 90020
92257 La Garenne Colombes Cedex
France",," GRN 906 w amendments (in PDF)",,,,,,,08/24/2020,," FDA has no questions (in PDF)",,,,,,,,,, =T("907")," Wheat seed oil"," Ingredient in bars at a level of 2.0 mg/g."," Scientific procedures"," SEPPIC Air Liquide Healthcare"," 50 boulevard national
CS 90020
92257 La Garenne Colombes Cedex
France",," GRN 907 with amendment (in PDF)",,,,,,,08/21/2020,," FDA has no questions (in PDF)",,,,,,,,,, =T("908")," Lipase from Penicillium camemberti"," Intended for use as an enzyme in dairy and fats and oils processing."," Scientific procedures"," Amano Enzyme, Inc."," 2-7, 1-Chome, Nishiki Naka-ku
Nagoya 460-8630
Japan",," GRN 908 with amendments (in PDF)",,,,,,,02/05/2021,," FDA has no questions (in PDF)",,,,,,,,,, =T("909")," Whey protein containing 41% alpha-lactalbumin"," Intended for use as an ingredient in protein-enriched baked products and nutrition bars; RTD milk-based nutritional beverages and meal replacements; protein enriched milks, sports drinks; protein-enriched water or fruit juice based beverages; yogurt, spoonable milk products; fermented milk drinks, drinkable yogurt; and other nutritional beverages and powders at levels ranging from 8.5 to 12 grams per serving."," Scientific procedures"," Arla Foods Ingredients Group P/S"," Sonderhoh 10-12
8260 DK-Viby J
Denmark",," GRN 909 with amendments (in PDF)"," 1.1 MB",,,,,,09/08/2021,," At the notifier's request, FDA ceased to evaluate this notice (in PDF)",,,,,,,,,, =T("910")," Thaumatin II"," Intended for use as a sweetener in wine, beer, and other fermented or distilled beverages; jams, jellies, marmalades, etc.; potato-based and similar snacks; breakfast cereals; chewing gum; ice cream and other edible ices; cocoa and chocolate products; breath mints and similar; confectionary; decorations, coating and fillings; fine bakery items; food supplements (capsules, tablets, syrups, and similar) as a sweetener only not a dietary ingredient at levels ranging from 5 to 400 ppm."," Scientific procedures"," Nomad BioScience GmbH"," Biozentrum Halle
Weinbergweg 22
Halle/Saale, Saxony-Anhalt
D-06120
Germany",," GRN 910 with amendments (in PDF)",,,,,,,09/09/2020,," FDA has no questions (in PDF)",,,,,,,,,, =T("911")," Rebaudioside I"," Intended for use as a table top sweetener and as a general-purpose, non-nutritive sweetener for use in foods generally, excluding infant formula and meat and poultry products"," Scientific procedures"," Blue California"," 30111 Tomas
Rancho Santa Margarita, CA 92688",," GRN 911 (in PDF)",,,,,,,06/08/2021,," FDA has no questions (in PDF)",,,,,,,,,, =T("912")," Trehalose"," Intended for use in foods as a sweetener, flavor enhancer, texturizer, and humectant in foods generally, excluding infant formulas."," Scientific procedures"," c-LEcta GmbH"," Perlickstrasse 5
04103 Leipzig
Germany",," GRN 912 (in PDF)",,,,,,,10/01/2021,," At the notifier's request, FDA ceased to evaluate this notice (in PDF)",,,,,,,,,, =T("913")," Algal oil (minimum 35% DHA)"," ingredient in the food categories listed in 21 CFR 184.1472(a)(3) at up to 20% of the levels specified, and as the sole added source of DHA in any given food category and, if blended with another source of DHA or eicosapentaenoic acid (EPA), the levels will be no more than 1.5 g of DHA/person (p)/day (d) and no more than 3.0 g/p/d of DHA and EPA combined"," Scientific procedures"," Mara Renewables Corporation"," 101A Research Drive
Dartmouth NS B2Y 4T6
Canada",," GRN 913 with amendments (in PDF)",,,,,,,11/10/2020,," FDA has no questions (in PDF)",,,,,,,,,, =T("914")," Alpha-linolenic acid diacylglycerol"," Intended for use as a partial replacement for edible salad oils and other dressings sprayed onto salads, vegetables and other finished foods at a level of 2.5 g per serving."," Scientific procedures"," Kao Corporation"," 2-1-3 Bunka,Sumida-ku
Tokyo, 131-8501
Japan",," GRN 914 with amendments (in PDF)",,,,,,,03/15/2021,," FDA has no questions (in PDF)",,,,,,,,,, =T("915")," Calcium L-methylfolate"," Intended for use in non-exempt and exempt infant formulas as a partial or complete replacement for folic acid as a source of the vitamin folate."," Scientific procedures"," DSM Nutritional Products"," 45 Waterview Boulevard
Parsippany, NJ 07054",," GRN 915 with amendments (in PDF)",,,,,,,02/23/2021,," FDA has no questions (in PDF)",,,,,,,,,, =T("916")," Dihydroquercetin"," Intended for use as an ingredient in non-alcoholic beverages at a level not to exceed 0.02 g/L, flavored fermented milk and dairy products at a level not to exceed 0.02 g/kg, and chocolate products at a level not to exceed 0.07 g/kg."," Scientific procedures"," Blue California"," 30111 Tomas
Rancho Santa Margarita, CA, 92688",," GRN 916 with amendments (in PDF)",,,,,,,05/19/2021,," FDA has no questions (in PDF)",,,,,,,,,, =T("917")," Preparation containing three bacterial phages specific to Salmonella"," Intended for use as antimicrobial on food to control Salmonella at an application rate of up to 2 x 108 PFU/mL per gram of food."," Scientific procedures"," Gum Products International"," 1255 Journeys End Circle
Newmarket, Ontario L3Y 8T7
CANADA",," GRN 917 with amendments (in PDF)",,,,,,,09/10/2020,," FDA has no questions (in PDF)",,,,,,,,,, =T("918")," Partially defatted almond protein flour"," Intended for use as a source of plant protein in baked goods and baking mixes (biscuits; cakes; cookies; cornbread, corn muffins, or tortillas; crackers; doughnuts; French toast, pancakes, waffles; muffins); beverages and beverage bases (non-milk-based nutritional powders; protein powders); coffee and tea (ready-to-drink coffee drinks); grain products and pastas (cereal and granola bars; energy bars or protein bars; meal replacement bars); milk products (milk-based smoothies, milk-based nutritional powders); processed fruits and fruit juices (fruit smoothies) at use levels ranging from 5 to 80 percent."," Scientific procedures"," Blue Diamond Growers"," 1802 C Street
Sacramento, CA 95811",," GRN 918 (in PDF)"," GRN 918 amendments (in PDF)",,,,,,07/07/2021,," FDA has no questions",,,,,,,,,, =T("919")," Lacto-N-neotetraose"," Intended for use as an ingredient in non-exempt infant formula for term infants; in toddler formula and other drinks for young children at a maximum level of 0.6 g/L; in beverages and beverage bases, dairy product analogs, milk (whole and skim), milk products, and processed fruits and juices at levels up to 2.5 g/L; and in grain products, pastas, and infant and toddler foods at levels up to 20 g/kg."," Scientific procedures"," Jennewein Biotechnologie GmgH"," Maarweg 32
D-53619 Reinbreitbach
GERMANY",," GRN 919 with amendments (in PDF)",,,,,,,10/30/2020,," FDA has no questions (in PDF)",,,,,,,,,, =T("920")," Thaumatin II"," Intended for use as a flavor modifier at 1-150 ppm in foods generally, excluding infant formula and foods regulated by USDA."," Scientific procedures"," Nomad BioScience GmbH"," Biozentrum Halle
Weinbergweg 22
Halle/Saale, Saxony-Anhalt, D-06120
Germany",," GRN 920 with amendment (in PDF)",,,,,,,11/24/2020,," FDA has no questions (in PDF)",,,,,,,,,, =T("921")," 3'-sialyllactose sodium salt"," Intended for use as an ingredient in cow milk-based, non-exempt infant formula for term infants at a level of 0.28 g/L."," Scientific procedures"," Jennewein Biotechnologie GmgH"," Maarweg 32
D-53619 Reinbreitbach
GERMANY",," GRN 921 with amendments (in PDF)",,,,,,,10/30/2020,," FDA has no questions (in PDF)",,,,,,,,,, =T("922")," 6'-sialyllactose sodium salt"," Intended for use as a substitute for other forms of 6-SL in cows milk-based, non-exempt infant formula for term infants at a level of 0.4 g/L."," Scientific procedures"," Jennewein Biotechnologie GmgH"," Maarweg 32
D-53619 Reinbreitbach
GERMANY",," GRN 922 with amendments (in PDF)",,,,,,,04/23/2021,," FDA has no questions (in PDF)",,,,,,,,,, =T("923")," Lacto-N-tetraose"," Intended for use as an ingredient in cow milk-based, non-exempt infant formula for term infants at a level of 0.8 g/L"," Scientific procedures"," Jennewein Biotechnologie GmgH"," Maarweg 32
D-53619 Reinbreitbach
GERMANY",," GRN 923 with amendments (in PDF)",,,,,,,02/02/2021,," FDA has no questions (in PDF)",,,,,,,,,, =T("924")," 2'-fucosyllactose"," Intended for use as an ingredient in cows milk-based, non-exempt term infant formula at a level of 3.64 g/L."," Scientific procedures"," Jennewein Biotechnologie GmbH"," Maarweg 32
D-53619 Reinbreitbach
GERMANY",," GRN 924 with amendments (in PDF)",,,,,,,11/23/2020,," At the notifier's request, FDA ceased to evaluate this notice (in PDF)",,,,,,,,,, =T("925")," 3-fucosyllactose"," As an ingredient in cow milk-based, non-exempt infant formula for term infants at a level of 0.44 g/L infant formula as consumed."," Scientific procedures"," Jennewein Biotechnologie GmgH"," Maarweg 32
D-53619 Reinbreitbach
GERMANY",," GRN 925 with amendments (in PDF)",,,,,,,02/08/2021,," FDA has no questions (in PDF)",,,,,,,,,, =T("926")," Soluble rice flour"," Intended for use as a binder, bulking agent, carrier, texturizer, and film-former at levels up to 80% in bakery products; ready-to-drink beverages; flavor blends; reduced-sugar, ready-to-eat cereals and cereal bars; soft and hard candies; confectionary; dairy and imitation dairy products; dry mix seasonings and blends; instant soup and broth mixes; infant food, cereals, porridges, bakery products; powdered beverage mixes; instant and prepared sauces; reduced-fat salad dressings; reduced-sugar snack-based fillings; and reduced-fat or reduced-sugar condiments."," Scientific procedures"," Cargill Incorporated"," 15407 McGinty Road
Wayzata, MN 55391",," GRN 926 with amendments (in PDF)",,,,,,,01/05/2021,," FDA has no questions (in PDF)",,,,,,,,,, =T("927")," Polyvinyl alcohol"," A component of water-soluble anus plugs for use in abattoirs to block fecal material during processing of sheep, lambs, and hogs at levels up to 59% of the plug formulation"," Scientific procedures"," Adept Limited"," 2 McDonald Street
Morningside, Auckland
NEW ZEALAND",," GRN 927 (in PDF)"," GRN 927 amendments",,,,,,02/26/2021,," FDA has no questions (in PDF)",,,,,,,,,, =T("928")," Dried Saccharomyces cerevisiae yeast fermentate"," Intended for use as an ingredient in milk, flavored milks and milk drinks, milk products, frozen yogurt, 100% fruit juices, processed juice drinks, ready-to-drink (RTD) tea, sport/fitness water beverages, fruit flavored drinks, breads, ready-to-eat (RTE) bars, RTE dry cereals, hard candy, mints, tofu, and soups/broth at a level of 500 mg/serving."," Scientific procedures"," Cargill, Inc."," 15407 McGinty Road West
Wayzata, MN 55391",," GRN 928 (in PDF)"," GRN 928 amendments (in PDF)",,,,,,05/14/2021,," FDA has no questions (in PDF)",,,,,,,,,, =T("929")," 2'-fucosyllactose"," Intended for use as an ingredient in exempt hypoallergenic infant formula for term infants and hypoallergenic toddler formula at a level of 2 g/L of formula, as consumed. The notifier states that hypoallergenic formula includes both extensively hydrolyzed cow milk protein- and amino acid-based formula."," Scientific procedures"," Jennewein Biotechnologie GmbH"," Maarweg 32
D-53619 Reinbreitbach
GERMANY",," GRN 929 (in PDF)"," GRN 929 amendments",,,,,,02/26/2021,," FDA has no questions",,,,,,,,,, =T("930")," Silk fibroin derived from Bombyx mori cocoons"," Intended for use as a coating to preserve fruits, vegetables, fish, cheeses, and candy at levels up to 880 mg silk fibroin per kg of food."," Scientific procedures"," Cambridge Crops, Inc."," 444 Somerville Avenue
Somerville, MA 02143",," GRN 930 part 1"," GRN 930 part 2"," GRN 930 with amendments part 3",,,,,05/25/2021,," At the notifier's request, FDA ceased to evaluate this notice (in PDF)",,,,,,,,,, =T("931")," Creatine monohydrate"," Intended for use as an ingredient in energy drinks, protein bars and powders, milk shakes, meal replacement bars and powders, meat analogs, and dry powdered drink mixes at a level of 1.2 grams (g)/serving (equivalent to 1.0 g creatine/ serving)."," Scientific procedures"," AlzChem Trostberg GmbH"," Dr. Albert_Frank_Str. 32
D-83308 Trostbreg
GERMANY",," GRN 931 with amendments (in PDF)",,,,,,,11/12/2020,12/03/2020," FDA has no questions (in PDF)",,,,,,,,,, =T("932")," 2'-fucosyllactose"," Intended for use as an ingredient at a level of 2.4 g/L of formula as consumed in milk- and soy-based, non-exempt infant formula for term infants; at a level of 2.4 g/L in drinks for toddlers and children ages 1-3 years, as consumed; at levels ranging from 0.24-1.2 g/serving in infant and toddler foods; and at levels ranging from 0.28-1.2 g/serving in beverage and beverages bases, breakfast cereals, dairy product analogs, frozen dairy desserts and mixes, gelatins, puddings, fillings, grain products and pastas, jams and jellies, milk and milk products, processed fruits and fruit juices, and sweet sauces, toppings and syrup."," Scientific procedures"," Advanced Protein Technologies Corp."," 59-5 Seogeunnae-gil
Paltan-myeon, Hwasung City
Gyeonggi-do, 18575
REPUBLIC OF KOREA",," GRN 932 (in PDF)"," GRN 932 amendments",,,,,,02/18/2021,," FDA has no questions (in PDF)",,,,,,,,,, =T("933")," Algal oil (≥36% docosahexaenoic acid) from Schizochytrium sp. strain DHF"," For use as an ingredient in the same food categories as those currently listed in 21 CFR 184.1472(a)(3) (Menhaden oil),* at use levels of algal oil (≥36% DHA) that are no more than 27.78% of the levels specified for menhaden oil in that regulation, and as the sole added source of DHA in any given food category, and if blended with another source of DHA or eicosapentaenoic acid (EPA), the total dietary exposure to DHA will be no more than 1.5 g/person (p)/day (d) and no more than 3.0 g/p/d of DHA and EPA combined. Hubei Fuxing also intends to use algal oil (≥36% DHA) as an ingredient in cow milk-, soy-, amino acid-, and extensively hydrolyzed protein-based, exempt and non-exempt infant formula for pre-term, low birth weight, and term infants at a maximum level of 0.5% of total fat as DHA in combination with a safe and suitable source of arachidonic acid (ARA) at a ratio ranging from 1:1 to 1:2 of DHA to ARA.

* Hubei Fuxing states that algal oil (≥36% DHA) is not intended for use in products under the U.S. Department of Agricultures jurisdiction or in products defined in 21 CFR 170.3(n)(13)."," Scientific procedures"," Hubei Fuxing BioTechnology, Co., Ltd."," Floor 11th, Bldg. 23
Yinhu Enterprise Zone, Baishazhou Ave
Hongshan District, Hubei Province
CHINA",," GRN 933 with amendments (in PDF)",,,,,,,11/13/2020,," FDA has no questions (in PDF)",,,,,,,,,, =T("934")," Algal oil (≥35% docosahexanoic acid (DHA)) derived from Schizochytrium sp. strain CABIO-A-2"," Intended for use as an ingredient, at up to 5.8 % (w/w) in food categories as listed in 21 CFR 184.1472(a)(3), and at up to 0.5% (w/w) of fatty acids as DHA in non-exempt infant formula for term infants."," Scientific procedures"," CABIO Biotech (Wuhan) Co., Ltd."," Wuhan Pharmacy Park, Jiangxia Avenue
Jiangxia Economic Development Zone Wuhan, Wuhan
CHINA",," GRN 934",,,,,,,07/20/2021,," FDA has no questions (in PDF)",,,,,,,,,, =T("935")," L-carnitine-L-tartrate"," Intended for use as an ingredient in non-exempt formulas for term infants at a level of 11 mg/L of the infant formula as consumed."," Scientific procedures"," Ausnutria B.V."," Dokter van Deenweg 150
8025 BM Zwolle
The Netherlands",," GRN 935 (in PDF)",,,,,,,11/30/2020,," At the notifier's request, FDA ceased to evaluate this notice (in PDF)",,,,,,,,,, =T("936")," Leuconostoc carnosum DSM 32756"," Intended for use to inhibit the spoilage of raw cured meat products including but not limited to cured ham and bacon throughout its shelf-life at levels up to 109 CFU/g of bacon."," Scientific procedures"," Chr. Hansen, Inc."," 9015 West Mable Street
Milwaukee, WI 53214",," GRN 936 (in PDF)",,,,,,,04/19/2021,," FDA has no questions (in PDF)",,,,,,,,,, =T("937")," Staphylococcus carnosus DSM 25010"," Intended for use to inhibit the spoilage of raw cured meat products including but not limited to cured ham and bacon throughout its shelf-life at levels up to 109 CFU/g of bacon."," Scientific procedures"," Chr. Hansen, Inc."," 9015 West Mable Street
Milwaukee, WI 53214",," GRN 937 (in PDF)",,,,,,,04/21/2021,," FDA has no questions (in PDF)",,,,,,,,,, =T("938")," Pichia kluyveri DSM 33235"," Intended for use as a starter culture in the fermentation of low alcohol and alcohol-free beer to enhance flavor and aromatic profiles at an inoculation level of 0.1 g/L (approximately 108 colony forming units/L)."," Scientific procedures"," Chr. Hansen, Inc."," 9015 W Maple St.
Milwaukee, WI 53214",," GRN 938 (in PDF)",,,,,,,04/14/2021,," FDA has no questions (in PDF)",,,,,,,,,, =T("939")," Sunflower lecithin"," Intended for use as an emulsifier, dispersing agent, wetting agent and as a release agent at levels not to exceed current good manufacturing practice (cGMP) in food (including as an emulsifying agent in meat and poultry products), and as a dietary source of choline at levels up to 3 g per 100 g in milk-based, non-exempt infant formula for term infants."," Scientific procedures"," Sternchemie GmbH & Co. KG"," An der Alster 81
20099 Hamburg
Germany",," GRN 939 part 1"," GRN 939 part 2 with amendments",,,,,,03/03/2021,," FDA has no questions (in PDF)",,,,,,,,,, =T("940")," Phospholipase A2 enzyme from Sus scrofa (wild pig) produced by Yarrowia lipolytica"," Intended for use as an enzyme at up to 33.9 mg Total Organic Solids/tonne of egg yolk during the manufacture of sauces and dressings, such as mayonnaise."," Scientific procedures"," Biocatalysts Limited"," Cefn Coed, Pare Nantgarw
Cardiff, CFlS 7QQ
United Kingdom",," GRN 940 (in PDF)",,,,,,,05/12/2021,," FDA has no questions (in PDF)",,,,,,,,,, =T("941")," Oat polar lipid extract"," Intended for use as a source of oat phospholipids, an emulsifier, or as a partial substitute for other fats and oils in baby food, pan or flat bread products, beverages and beverage bases, breakfast cereals, specialty coffee drinks and combined coffee and whitener, dairy product analogues, fats and oils, frozen dairy desserts, grain products and pastas, milk products, plant protein products, snack foods, chocolate, nougat, and toffee up to 2.0 g/100 g, in flavored or carbonated waters up to 0.8 g/100 g, and in sport or electrolyte drinks and fluid replacement drinks up to 0.2 g/100 g."," Scientific procedures"," Swedish Oat Fiber"," Batafjordsvagen 12
SE-43263 BUA
Sweden",," GRN 941 (in PDF)",,,,,,,06/11/2021,," At the notifier's request, FDA ceased to evaluate this notice (in PDF)",,,,,,,,,, =T("942")," Whey permeate"," Intended for use as a nutritive carbohydrate sweetener in chocolates, where standards of identity do not preclude its use, at a typical level of 2 8% and maximum level of 20%."," Scientific procedures"," ProLiant Dairy, LLC"," 2425 SE Oak Tree Ct
Ankeny, IA 50021",," GRN 942 (in PDF)",,,,,,,12/21/2020,," At the notifier's request, FDA ceased to evaluate this notice (in PDF)",,,,,,,,,, =T("943")," Citrus fiber from the peels of oranges, lemons, or limes"," Intended for use as a source of dietary fiber and multipurpose (e.g., water binding, gelling aid, thickening aid, bulking aid, emulsion stabilizer, cloud stabilizer) food ingredient in baked goods and baking mixes; alcoholic beverages; beverage and beverage bases; breakfast cereals; cheeses; coffee and tea; condiments and relishes; confections and frostings; dairy product analogs; egg products; fats and oils; fish products; frozen dairy desserts; fruit and water ices; gelatins, puddings, and fillings; grain products and pastas; gravies and sauces; jams and jellies; milk products; nuts and nut products; plant protein products; processed fruits and fruit juices; processed vegetables and vegetable juices; soft candy; soups and soup mixes; sweet sauces, toppings, and syrups at levels up to 3%."," Scientific procedures"," CP Kelco ApS"," Ved Banen 16,
4623 Lille Skensved
Denmark",," GRN 943 (in PDF)",,,,,,,04/09/2021,," FDA has no questions (in PDF)",,,,,,,,,, =T("944")," Rice protein hydrolysate"," Intended for use as a protein source in sports nutrition protein bars; health bars (other than protein bars) and grain bars; flavored milk drinks; yogurt; frozen yogurt; fruit smoothies; meat alternatives and imitation meat products; vegetable/tomato juice including vegetable smoothies; prepared soups, dry soup mixes, and condensed soups; bread; rolls, high protein cookies; soy, vegetable, and nut-based milk analogues; meal replacements; yogurt; frozen yogurt; high protein ready-to-eat breakfast cereals; flavored milk drinks; at levels ranging from 1.0 to 83 %."," Scientific procedures"," BASF Corporation"," Florham Park, NJ 07932
",," GRN 944 with amendments (in PDF)",,,,,,,10/08/2021,," FDA has no questions (in PDF)",,,,,,,,,, =T("945")," Fungal protein from Fusarium sp. mycelia"," Intended for use as an ingredient in food, excluding meat and poultry products and infant formula, at use levels up to 90% of the final product."," Scientific procedures"," 3F BIO Limited"," 163 Bath Street
Glasgow, G2 4SQ
United Kingdom",," GRN 945 (in PDF)",,,,,,,04/22/2022,," FDA has no questions (in PDF)",,,,,,,,,, =T("946")," Lactobacillus plantarum strain DSM 33452"," Intended for use in the production of wine and musts at a level of 107 colony forming units (CFU)/g."," Scientific procedures"," Chr. Hansen, Inc."," 9015 West Maple St.
Milwaukee, WI 53214
",," GRN 946 with amendments (in PDF)",,,,,,,02/05/2021,," FDA has no questions (in PDF)",,,,,,,,,, =T("947")," Cacao pulp and cacao fruit juice concentrate"," Intended for use as an ingredient in bakery products at levels of 15% of the pulp and 50% of the juice concentrate, beverages at levels of 20% of the pulp, 100% of the juice, and 20% of the juice concentrate, candy and confections at levels of 25% of the pulp and 65% of the juice concentrate, cereal bars, chips and crackers at levels of 15% of the juice concentrate, cocoa and chocolate products at levels of 50% of the juice concentrate, edible ices at levels of 30% of the juice concentrate for the ice cream type and 50% of the juice concentrate for the sorbet type, gelatin and fruit mousse spreads at levels of 30% of the juice concentrate, jams, jellies, fruit syrups and toppings at levels of 50% of the pulp and 25% of the juice concentrate, nutritional bars at levels of 50% of the juice concentrate, plant-based spreads at levels of 20% of the pulp and 25% of the juice concentrate, and yogurts and yogurt drinks at levels of 25% of the pulp and 10% of the juice concentrate (all by weight)."," Scientific procedures"," CABOSSE Naturals NV"," Brusselsesteenweg 450
1500 HALLE
Belgium",," GRN 947 (in PDF)",,,,,,,12/21/2021,," FDA has no questions (in PDF)",,,,,,,,,, =T("948")," Enzyme-treated pea protein"," Intended for use as a food ingredient, formulation aid, nutrient supplement, stabilizer and thickener, and texturizer in baked goods and baking mixes, beverages and beverage bases, breakfast cereals, dairy product analogs, fats and oils, grain products and pastas, milk products, plant protein products, processed fruits and fruit juices, processed vegetables and vegetable juices, soups and soup mixes at levels from 0.96 to 34.3%."," Scientific procedures"," Yantai Oriental Protein Tech Co., Ltd."," Jincheng Road, Zhaoyuan 265400
Shandong, Yantai
China",," GRN 948 with amendments (in PDF)",,,,,,,09/09/2021,," FDA has no questions (in PDF)",,,,,,,,,, =T("949")," Bacillus coagulans strain DSM 17654 spore preparation"," Intended for use at a maximum level of 2 x 109 colony forming units (CFU)/serving as an ingredient in baked goods and baking mixes; breakfast cereals; beverages and beverage bases; coffee and tea; milk and milk products; dairy product analogs; fruit juices; condiments and relishes; confections and frostings; frozen dairy desserts and mixes; fruit and water ices; jams and jellies; gelatins, puddings and fillings; grain products and pastas; hard and soft candy; chewing gum; extracts, flavorings, herbs, seeds, spices, seasonings and blends; nuts and nut products; plant protein products; processed fruits; processed vegetables and vegetable juices; snack foods; soups and soup mixes; sugar; and sweet sauces, toppings and syrups (excluding infant formula, foods formulated for infants, or any products under the jurisdiction of the United States Department of Agriculture)."," Scientific procedures"," Advanced Enzymes Technologies Ltd."," 5th Floor, A wing, Sun Magnetica
L.I.C. Service Road, Louiswadi
Thane (W) 400 064
India",," GRN 949 with amendments (in PDF)",,,,,,,01/07/2021,," FDA has no questions (in PDF)",,,,,,,,,, =T("950")," Bifidobacterium longum subsp. infantis DSM 33361"," For use as an ingredient in cow milk-, soy-, and partially hydrolyzed protein-based, non-exempt infant formula for term infants at a level up to 1 x 1010 colony forming units (CFU)/g, and in conventional foods, including but not limited to milk and dairy products; plant-based dairy alternatives; beverages; bars; confectionery; and cereals and at a use level up to 2.8 x 1010 CFU/serving."," Scientific procedures"," Chr. Hansen, Inc."," 9015 West Maple Street
Milwaukee, WI 53214",," GRN 950 Part 1 (in PDF)"," GRN 950 Part 2 (in PDF)"," GRN 950 amendments",,,,,03/01/2021,," FDA has no questions (in PDF)",,,,,,,,,, =T("951")," 3-fucosyllactose"," Intended for use as an ingredient in cow milk-based and soy-based non-exempt infant formula for term infants and formula intended for young children aged 1-3 years at a level of 0.04 g/serving (0.44 g/L) as consumed; juices, drinks, and foods for infants and young children under 3 years of age at levels ranging from 0.03 to 0.09 g/serving (0.44 to 4.4 g/kg); cereal and nutrition bars; enhanced and fortified waters; energy and sport drinks and mixes; breakfast cereals; milk substitutes; yogurts; fermented milk, flavored milk, and mixes; smoothies; milk-based meal replacement beverages; fruit juices and nectars (including fruit-based beverages); vegetable juices; and in oral and enteral tube feeding formulas at levels ranging from 0.07 to 0.88 g/serving (0.26 to 8.8 g/kg)."," Scientific procedures"," Danisco, USA"," DuPont Experimental Station - E320
200 Powder Mill Road
Wilmington, DE 19803",," GRN 951 with amendments (in PDF)",,,,,,,08/12/2021,," FDA has no questions (in PDF)",,,,,,,,,, =T("952")," Bifidobacterium animalis subsp. lactis strain AD011"," Ingredient in non-exempt infant formula (milk- and soy-based) for term infants at levels up to 108 colony forming units (CFU)/g of powdered formula; and, in fermented milk, including buttermilk and kefir, flavored milk beverage mixes, dried milk powder, imitation milk, yogurt, powdered baby cereals and foods, meal replacement and nutritional drink mix powders, and powdered sugar substitutes at levels up to 1010 CFU B. lactis AD011/serving."," Scientific procedures"," BIFIDO Co., Ltd."," 23-16, Nonggongdanji-gil, Hongcheon-eup
Hongcheon-gun, Gangwon-do, 25117
Republic of Korea",," GRN 952 with amendments (in PDF)",,,,,,,03/17/2021,," FDA has no questions (in PDF)",,,,,,,=T("875"),,, =T("953")," Lactobacillus plantarum strain CECT 7527, CECT 7528, and CECT 7529"," For use individually or in combination, as an ingredient in conventional foods, such as yogurt and other dairy products, soy products, chewing gum, and confectionary snacks at a maximum level of 4 x 109 colony forming units (CFU)/serving, when used individually and at a maximum level of 1.2 x 1010 CFU/serving, when used in combination."," Scientific procedurews"," Kaneka Americas Holding, Inc"," 6161 Underwood Road
Pasadena, Texas 77507",," GRN 953 with amendments (in PDF)",,,,,,,02/05/2021,," FDA has no questions (in PDF)",,,,,,,,,, =T("954")," Fibrillated cellulose"," Intended for use as a rheology modifier, stabilizer, low calorie fat substitute and bulking agent, source of fiber, component to improve food quality (e.g. humectant and texturizer), and processing aid in baked goods and baking mixes (at levels of 0.5-5.0%), puffed snacks (at levels of 2-5%), alcoholic beverages (at levels of 0.3-0.5%), non-alcoholic beverages (at levels of 0.28-1.0%), cheeses (at levels of 0.1-1.25%), confections and frostings (at levels of 0.2-5.0%), salad dressings (at levels of 1.0-3.0%), fruit juices and drinks (at levels of 0.5-2.0%), frozen dairy desserts and mixes (at levels of 0.1-1.0%), gelatins, puddings and fillings (at levels of 1.4-4.8%), gravies and sauces (at levels of 0.25-1.3%), milk and milk products (at levels of 0.25-0.7%)(all calculated as a weight/weight percentage). Additionally, it is intended for use as a protective coating for fresh fruits and vegetables at levels up to 10 g per square meter of produce."," Scientific procedures"," Vireo Advisors, LLC"," 111 Perkins St, # 223
Boston, Massachusetts 02130",," GRN 954 with amendments (in PDF)",,,,,,,06/10/2021,," At the notifier's request, FDA ceased to evaluate this notice (in PDF)",,,,,,,,,, =T("955")," Bacillus subtilis strain BS-MB40 PTA-122264 spore preparation"," Intended for use as an ingredient in baked goods and baking mixes; beverage and beverage bases, nonalcoholic; breakfast cereals; cheeses; chewing gum; coffee and tea; condiments and relishes; confections and frostings; dairy product analogs; fats and oils; fruit juices; frozen dairy desserts and mixes; fruit and water ices; gelatins, puddings, and fillings; grain products and pasta; hard candy and soft candy; herbs, seeds, spices, seasonings, blends, extracts, and flavorings; jams and jellies; milk and milk products; nut and nut products; plant protein products; processed fruits and fruit juices; processed vegetables and vegetables juices; snack foods; soups and soup mixes; sugar and sugar substitutes; and sweet sauces, toppings, and syrups at a maximum level of 2 x 109 colony forming units (CFU)/serving (excluding infant formula, or in any products under the jurisdiction of the United States Department of Agriculture)."," Scientific procedures"," BIO-CAT Microbials, LLC"," 689 Canterbury Rd
Shakopee, MN 55379",," GRN 955 with amendments (in PDF)",,,,,,,03/26/2021,," FDA has no questions (in PDF)",09/11/2023," Supplemental Response Letter",,,,,,,, =T("956")," Bacillus subtilis ATCC SD-7280"," Intended for use as an ingredient in baked goods and baking mixes, breakfast cereals, beverages and beverage bases, coffee and tea, milk and milk products, dairy product analogs, fruit juices, condiments and relishes, confections and frostings, frozen dairy desserts and mixes, fruit and water ices, drinking water, sports drinks, gelatins, jams and jellies, puddings and fillings; grain products and pastas, hard candy, soft candy, chewing gum, extracts, and flavorings, herbs, seeds, spices, seasonings, blends, nuts and nut products, plant protein products, processed fruits, processed vegetables and vegetable juices, snack foods, soups and soup mixes, sugar and sweet sauces, toppings, and syrups at up to 6x109 spores/serving."," Scientific procedures"," Advanced Enzyme Technologies Ltd."," Magnetica LIC Service Road, Louiswadi
Thane (W) 400604
India",," GRN 956 with amendments (in PDF)",,,,,,,08/18/2021,," FDA has no questions (in PDF)",,,,,,,,,, =T("957")," Lactobacillus johnsonii strain ATCC PTA-124205"," Intended for use as an ingredient in dairy, cereal, chocolate, grain, and juice-based foods and beverages1 at up to 1011 colony forming units (CFU)/serving."," Scientific procedures"," Prozure, Inc."," 22224 Collington Drive
Boca Raton, FL 33428",," GRN 957 (in PDF)",,,,,,,10/26/2021,," FDA has no questions (in PDF)",,,,,,,,,, =T("958")," Fungal oil (≥40% arachidonic acid) from Mortierella alpina strain AF"," Intended for use as an ingredient in cow milk- and soy-based, non-exempt infant formula for term infants and exempt infant formula for pre-term infants at levels of 0.75 g/100 g total fat for term infants and 0.40 g/100 g total fat for preterm infants."," Scientific procedures"," Hubei Fuxing Biotechnology Co., Ltd."," FL. 11, Bldg 23, Baishazhou Avenue
Baishazhou Enterprise City
Wuhan 43000
China",," GRN 958 with amendments (in PDF)",,,,,,,03/26/2021,," At the notifier's request, FDA ceased to evaluate this notice (in PDF)",,,,,,,,,, =T("959")," Iron milk proteinate"," Intended for use as a dietary source of iron in the same food categories as other iron salts at levels consistent with current good manufacturing practice."," Scientific procedures"," Société des Produits Nestlé S.A."," Avenue Nestle 55
1800 Vevey
Switzerland",," GRN 959 with amendments",,,,,,,03/17/2021,," FDA has no questions (in PDF)",,,,,,,,,, =T("960")," Hypromellose acetate succinate"," Intended for use as an enteric coating agent, carrier for solid dispersions, and an enteric agent in tablets/caplets, granules, pellets, and capsules (including gel caps, pills, soft gels, and vegi caps) at levels ranging from 5% to 80% of the final product weight."," Scientific procedures"," Shin-Etsu Chemical Co., Ltd."," YBP Technical Center, 134 Godo-cho
Hodogaya-ku, Yokohama 240-0005
Japan",," GRN 960 with amendments (in PDF)",,,,,,,12/21/2021,," FDA has no questions",,,,,,,,,, =T("961")," β-glucan derived from Agrobacterium sp. CCTCC No. M2010020"," Intended for use as an ingredient in baked goods and baking mixes; beverages and beverage bases; breakfast cereals; dairy product analogs; frozen dairy desserts; grain products and pastas; gravies and sauces; jams and jellies; milk products; processed fruits and fruit juices; and processed vegetables and vegetable juices at levels ranging from 0.1 to 0.9%"," Scientific procedures"," Sichuan Synlight Biotech, Ltd."," Chengnan Industrial Park
Economic Development Area
Luojiang District, Deyang City
Sichuan Province
China",," GRN 961 with amendments (in PDF)",,,,,,,05/19/2021,," At the notifier's request, FDA ceased to evaluate this notice (in PDF)",,,,,,,,,, =T("962")," Rice bran wax"," Intended for use in oils at levels up to 0.15% to improve heat transfer and stability for frying selected potato products."," Scientific procedures"," McCain Foods Ltd."," 439 King Street W
Toronto, ON M5V 1K4
Canada",," GRN 962 with amendments (in PDF)",,,,,,,03/17/2022,," At the notifier's request, FDA ceased to evaluate this notice (in PDF)",,,,,,,,,, =T("963")," Fungal oil (≥40% arachidonic acid) from Mortierella alpina"," Intended for use as an ingredient in cow milk-and soy-based non-exempt infant formulas for term infants at levels providing up to 0.75% of fat as arachidonic acid (ARA) and in exempt infant formula for pre-term infants at levels providing up to 0.4% of fat as ARA, in combination with a safe and suitable source of docosahexaenoic acid (DHA) at a ratio ranging from 1:1 to 2:1 ARA:DHA."," Scientific procedures"," BASF Corporation"," 100 Park Avenue
Florham Park, NJ 07932
",," GRN 963 (in PDF)"," GRN 963 amendments",,,,,,10/19/2021,," FDA has no questions (in PDF)",,,,,,,,,, =T("964")," Lysophospholipase enzyme preparation from Aspergillus niger produced by Trichoderma reesei"," Intended for use as an enzyme in carbohydrate processing (e.g., high fructose corn syrup) at 24.16 mg Total Organic Solids/kg raw material."," Scientific procedures"," DuPont Nutrition & Biosciences)"," 925 Page Mill Road
Palo Alto, CA 94304",," GRN 964 (in PDF)"," GRN 964 amendment (in PDF)",,,,,,09/09/2021,," FDA has no questions (in PDF)",,,,,,,,,, =T("965")," Arabinase enzyme preparation produced by Aspergillus tubingensis"," Intended for use as an enzyme in the processing of fruit- and vegetable- based purees, pastes, and juices and in winemaking at levels up to 24 mg Total Organic Solids/kg food."," Scientific procedures"," Shin Nihon Chemical Co., Ltd."," 19-10 Showa-cho, Anjo
Aichi 446-0063
Japan",," GRN 965 (in PDF)"," GRN 965 amendments",,,,,,07/20/2021,," FDA has no questions (in PDF)",,,,,,,,,, =T("966")," Preparations containing three to eight bacteriophages specific to Campylobacter jejuni"," Intended for use as an antimicrobial on raw red meat, including whole carcasses, primals, subprimals, cuts, trimmings, and organs; and raw poultry, including carcasses and parts at levels up to 108 plaque-forming units (PFU)/g of food."," Scientific procedures"," Intralytix, Inc."," 8681 Robert Fulton Drive
Columbia, MD 21046",," GRN 966 with amendments (in PDF)",,,,,,,10/06/2021,," FDA has no questions (in PDF)",,,,,,,,,, =T("967")," Soluble egg-white protein produced by Komagataella phaffii strain GSD-1209"," Intended for use as a substitute for egg-white protein in foods containing eggs; and as a source of protein in nutritional powders and drinks; bars; and certain snack foods at levels in accordance with current good manufacturing practices (excluding infant formula, or in any products under the jurisdiction of the United States Department of Agriculture)."," Scientific procedures"," Clara Foods Co."," 1 Tower Place Suite 800
South San Francisco, CA 94080",," GRN 967 (in PDF)"," GRN 967 amendments (in PDF)",,,,,,09/09/2021,," FDA has no questions (in PDF)",,,,,,,,,, =T("968")," Rebaudioside B"," Intended for use as a general-purpose sweetener in foods, excluding infant formula and meat and poultry products, at levels determined by good manufacturing practices."," Scientific procedures"," Blue California"," 30111 Tomas
Rancho Santa Margarita, CA 92688",," GRN 968 (in PDF)",,,,,,,03/10/2022,," FDA has no questions (in PDF)",,,,,,,,,, =T("969")," Bacillus subtilis Bss-19 spore preparation"," Intended for use as an ingredient in foods generally (excluding infant formula and foods under the jurisdiction of the United States Department of Agriculture) at 1 x 1010 colony forming units (CFU)/serving."," Scientific procedures"," Danisco USA, Inc. (Dupont Nutrition and Biosciences)"," Four New Century Parkway
New Century, Kansas 66031",," GRN 969 with amendments (in PDF)",,,,,,,10/06/2021,," FDA has no questions (in PDF)",,,,,,,,,, =T("970")," Enzyme-modified steviol glycosides"," Intended for use as a general-purpose sweetener in foods, excluding infant formula and meat and poultry products, at levels determined by current good manufacturing practices."," Scientific procedures"," Shandong Shengxiangyuan Biotechnology Co., Ltd"," No. 58 East Haiguan Rd.
Qufu, Shandong 273100
China",," GRN 970 (in PDF)",,,,,,,04/09/2021,," FDA has no questions (in PDF)",,,,,,,,,, =T("971")," Bacillus clausii strain 088AE spore preparation"," Intended for use as an ingredient at a maximum level of 2 x 109 colony forming units (cfu)/serving in baked goods and baking mixes, breakfast cereals, cheeses, alcoholic beverages, nonalcoholic beverages and beverage bases, coffee and tea, milk and milk products, dairy product analogs, fats and oils, fresh fruit juices, condiments and relishes, confections and frostings, frozen dairy desserts and mixes, fruit and water ices, gelatins, puddings and fillings, jams and jellies, alcoholic beverages, grain products and pastas, hard candy and cough drops, soft candy, chewing gum, herbs, seeds, spices, seasonings, blends, extracts, and flavorings, nuts and nut products, plant protein products, processed fruits, processed vegetables and vegetable juices, snack foods, soups and soup mixes, sugar and sweet sauces, toppings, and syrups."," Scientific procedures"," Advanced Enzyme Technologies Ltd."," 5th Floor, A wing, Sun Magnetica
L.I.C. Service Road, Louiswadi
Thane (W) 400 064
India",," GRN 971 with amendments (in PDF)",,,,,,,03/03/2022,," FDA has no questions (in PDF)",,,,,,,,,, =T("972")," Pectin hydrolysate from carrot pomace"," Intended for use as an ingredient at a maximum level of 25 grams per 100 grams of food in nonalcoholic beverages and beverage bases, breakfast cereals, dairy product analogs, grain products and pastas, baby food, milk products, processed fruits and fruit juices, processed vegetables and vegetable juices, snack foods, and, soups and soup mixes."," Scientific procedures"," NutriLeads B.V."," Bronland 12N
6708 WH Wageningen
The Netherlands",," GRN 972 (in PDF)"," GRN 972 amendments (in PDF)",,,,,,03/25/2022,," FDA has no questions",,,,,,,,,, =T("973")," Maple wood fiber"," Intended for use as a bulking agent, emulsifier, humectant, stabilizer, and texturizer in bread and bakery products; mayonnaise-based spreads, dips, and dressings; tomato-based sauces; dairy products; pasta; flour tortillas and flatbreads; granola and granola bars; batters; phyllo pastry, eggroll/dumpling wraps and similar products; margarine and emulsified spreads; icing; confectionery; chocolate and chocolate products; and nut butters and spreads at levels ranging from 1.4 to 34%."," Scientific procedures"," Renmatrix, Inc."," 660 Allendale Road
King of Prussia, PA 19406",," GRN 973 (in PDF)"," GRN 973 amendments",,,,,,05/13/2021,," At the notifier's request, FDA ceased to evaluate this notice (in PDF)",,,,,,,,,, =T("974")," Maltogenic alpha-amylase enzyme preparation produced by Bacillus subtilis"," Intended for use as an enzyme in baking and other cereal-based processes at 22 mg Total Organic Solids per kg raw material."," Scientific procedures"," AB Enzymes Inc."," 8211 W. Broward Blvd., Suite 375
Plantation, FL 33324",," GRN 974 (in PDF)",,,,,,,02/02/2022,," FDA has no questions (in PDF)",,,,,,,,,, =T("975")," Maltogenic alpha-amylase enzyme preparation produced by Bacillus licheniformis carrying the gene coding for maltogenic alpha-amylase from Geobacillus stearothermophilus"," Intended for use as an enzyme at 25 milligrams Total Organic Solids (TOS) per kilogram starch-derived dry matter during processing of starch, cereals, and cereal-based beverages, brewing and baking."," Scientific procedures"," Novazymes NA"," 77 Perry Chapel Church Rd
Franklinton NC, 27525",," GRN 975 with amendments (in PDF)",,,,,,,07/08/2021,08/05/2021," FDA has no questions (in PDF)",,,,,,,,,, =T("976")," Sodium hyaluronate"," Intended for use as an ingredient in fruit drinks/ades, carbonated soft drinks, candy, milk drinks, yogurt, and ready-to-eat cereals at levels ranging from 40-60 mg/serving."," Scientific procedures"," Bloomage Biotechnology Corp., Ltd."," No. 678 Tianchen St., High-Tech Development Zone
Jinan, Shandong, 250101
China",," GRN 976 (in PDF)",,,,,,,05/24/2021,," At the notifier's request, FDA ceased to evaluate this notice (in PDF)",,,,,,,,,, =T("977")," D-tagatose produced via novel enzymatic cascade"," Intended for use as a nutritive sweetener, flavor enhancer, humectant, texturizer, and stabilizer at levels ranging from 1 to 100% in multiple food categories."," Scientific procedures"," Bonumose, LLC"," 1725 Discovery Drive, Suite 220
Charlottesville, VA 22911",," GRN 977 with amendment (in PDF)",,,,,,,10/21/2021,," FDA has no questions (in PDF)",,,,,,,,,, =T("978")," Hydrolyzed aqueous olive pulp extract"," Intended for use as an antioxidant at up to 300 mg per serving, to provide 5 to 10 mg of hydroxytyrosol per serving, in bakery products; beverages; dairy products and substitutes; desserts; fats and oils; fruit juices and nectars; dry seasoning mixes for meat, poultry and fish; chewing gum; sauces, dips, gravies and condiments; snacks; and vegetable juices."," Scientific procedures"," Oliphenol LLC"," 26225 Eden Landing Road, Suite C
Hayward, CA 94545",," GRN 978 with amendment (in PDF)",,,,,,,12/10/2021,," FDA has no questions (in PDF)",,,,,,,,,, =T("979")," Pectin esterase enzyme preparation produced by Aspergillus oryzae expressing a pectin esterase gene from A. tubingensis"," Intended for use as an enzyme at up to 26 mg Total Organic Solids (TOS) per kg raw material, in the processing of fruits, vegetables, coffee, wine and flavoring."," AB Enzymes Inc."," 8211 W. Broward Blvd. Suite 375
Plantation, FL 33324",,," GRN 979 with amendments (in PDF)",,,,,,,10/18/2021,," FDA has no questions (in PDF)",,,,,,,,,, =T("980")," Dry whole milk"," Intended for use as an ingredient in cow milk-based, non-exempt infant formula for term infants at a maximum level of 16% (w/w) of powdered infant formula."," Scientific procedures"," ByHeart, Inc."," 689 5th Avenue
14th Floor
New York, NY 10022",," GRN 980 (in PDF)"," GRN 980 amendments (in PDF)",,,,,,07/13/2021,," FDA has no questions (in PDF)",,,,,,,,,, =T("981")," Sterol esterase enzyme preparation produced by Trichoderma reesei expressing a gene encoding sterol esterase from Melanocarpus albomyces"," Intended for use as an enzyme in the manufacture of baked goods at up to 10 mg Total Organic solids per kg flour."," Scientific procedures"," AB Enzymes Inc."," 8211 W. Broward Blvd.
Plantation, FL 33324",," GRN 981 with amendments (in PDF)",,,,,,,05/10/2022,," FDA has no questions (in PDF)",,,,,,,,,, =T("982")," Polygalacturonase enzyme preparation produced by Aspergillus oryzae expressing a polygalacturonase gene from A. tubingensis Mosseray"," Intended for use as an enzyme at up to 2 mg Total Organic Solids (TOS) per kg raw material in coffee, fruit and vegetable processing, and in the production of flavoring and wine."," Scientific procedures"," AB Enzymes Inc."," 8211 W. Broward Blvd. Suite 375
Plantation, FL 33324",," GRN 982 (in PDF)",,,,,,,02/02/2022,," FDA has no questions (in PDF)",,,,,,,,,, =T("983")," Purified steviol glycosides from the leaves of Stevia rebaudiana (Bertoni)"," Intended for use as a general-purpose sweetener in foods, excluding infant formula and meat and poultry products, at levels determined by good manufacturing practices."," Scientific procedures"," Zhucheng Haotian Pharm Co., Ltd"," Xinxing, Zhucheng,
Shandong Province
262218
The People's Republic of China",," GRN 983 (in PDF)",,,,,,,06/28/2021,," FDA has no questions (in PDF)",,,,,,,,,, =T("984")," Wolffia globosa"," Ingredient in baked goods and baking mixes, beverages and beverage bases, breakfast cereals, condiments and relishes, gravies and sauces, dairy product analogs, milk products, processed fruit including juices and drinks, frozen dairy desserts and mixes, grain products and pasta, processed vegetable and vegetable juices, snack foods, soups and soup mixes (including meat and poultry1), and dressings at levels up to 5%.

 :  1 In response to an FSIS question about products under FSIS purview, we received an amendment on May 12, 2021, that describes the intended use as protein."," Scientific procedures"," Hinoman Ltd."," 2 Nim Blvd., P.O.B 49
Rishon Lezion 7546302
Israel
",," GRN 984 with amendments (in PDF)",,,,,,,10/08/2021,," At the notifier's request, FDA ceased to evaluate this notice (in PDF)",,,,,,,,,, =T("985")," Bifidobacterium longum subsp. infantis strain ATCC SD 6720"," Intended for use as an ingredient in non-exempt powdered infant formula for term infants and powdered toddler formula at a level of 1 x 108 colony forming units/g of powdered formula."," Scientific procedures"," Danisco, USA Inc."," 200 Powder Mill Road E320
Wilmington, DE 19803",," GRN 985 with amendments (in PDF)",,,,,,,12/21/2021,," FDA has no questions (in PDF)",,,,,,,,,, =T("986")," Chlorella sorokiniana powder and C. sorokiniana micro powder"," Intended for use as an ingredient in yeast breads, doughnuts, nutrition bars, protein and nutritional powders, pasta, and noodles at levels ranging from 5 to 10 mg/g."," Scientific procedures"," Chlorella Industry Co., Ltd."," 1-18-16 Hamamatsucho, Minato-ku
Tokyo 105-0013 Sumitomo Hamamatsucho Building 7F
Japan",," GRN 986 (in PDF)",,,,,,,12/21/2021,," FDA has no questions (in PDF)",,,,,,,,,, =T("987")," 2'-fucosyllactose"," Intended for use as an ingredient in nonexempt infant formula for term infants at a maximum level of 2.4 g/L of formula, as consumed; in toddler formulas and meal replacement drinks for children ages 1 3 years at a maximum level of 2.4 g/L, as consumed; in infant and toddler foods at maximum levels of 10.0 g/L in drinks, 10.9 g/kg in ready-to-eat cereals and desserts, 12 g/kg in processed cereal-based food and other foods, and 57 g/kg in dry snacks; in beverages (sports and energy drinks, flavored waters, fruit juices and drinks, milk drinks, dairy analogs, and milk-based meal replacements) at maximum levels ranging from 0.8-6 g/L; in oral nutritional supplements and enteral tube feeding products at a level of 20 g/L; and in the following foods, at maximum levels ranging from 4.8-80 g/kg: breakfast cereals; frozen dairy desserts; puddings, fillings, mousses; yogurt and non-dairy analogs; meal replacement and snack bars; syrups; and jams and jellies."," Scientific procedures"," Amyris, Inc."," 5885 Hollis Street, Suite 100
Emeryville, CA 94608",," GRN 987 with amendments (in PDF)",,,,,,,02/02/2022,," At the notifier's request, FDA ceased to evaluate this notice (in PDF)",,,,,,,,,, =T("988")," Lactobacillus fermentum LfQi6"," Intended for use as an ingredient in dairy products (fluid milk and milk drinks, milk-based desserts and meal replacements, dry and powdered milk, yogurt, and cheese); ready-to-eat cereals; fruit juices, nectars, ades, and drinks; confections; and chewing gum at levels up to 2 x 108 colony forming unit (CFU)/serving."," Scientific procedures"," Quorum Innovations, LLC"," 2068 Hawthorne, Suite 102
Sarasota, FL 34239",," GRN 988 with amendments (in PDF)",,,,,,,03/28/2022,," FDA has no questions (in PDF)",,,,,,,,,, =T("989")," Bacillus subtilis expressing a modified gene encoding a variant of the wild-type subtilisin from B. clausii"," Intended for use as an enzyme to hydrolyze proteins from microbial, plant, milk, and seafood sources at up to 569 mg Total Organic Solids (TOS)/kg raw material."," Scientific procedures"," Danisco US Inc. (operating as DuPont Nutrition and Biosciences)"," 925 Page Mill Road
Palo Alto, CA 94304",," GRN 989 with amendments (in PDF)",,,,,,,06/30/2022,," FDA has no questions (in PDF)",,,,,,,,,, =T("990")," Short-chain fructooligosaccharides"," Intended for use as an ingredient in cow milk-based, non-exempt infant formulas for term infants at a level, as consumed, up to 400 mg scFOS/100 mL formula for infants 0-6 months of age and up to 500 mg scFOS/100 mL formula for infants >6 months of age."," Scientific procedures"," Tata Chemicals Limited"," Bombay House, 24 Homi Modi Street
Fort, Mumbai Maharashtra 400001
INDIA",," GRN 990 with amendments (in PDF)",,,,,,,10/08/2021,," FDA has no questions (in PDF)",,,,,,,,,, =T("991")," Chitosanase enzyme preparation produced by Bacillus subtilis"," Intended for use as an enzyme at up to 2.55 g Total Organic Solids (TOS)/kg chitosan in the manufacture of water-soluble chitosan."," Scientific procedures"," Advanced Enzyme Technologies Ltd."," 5th Floor, A wing, Sun Magnetica LIC Service Road, Louiswadi
Thane (W) 400604
Maharashtra
INDIA",," GRN 991 with amendments (in PDF)",,,,,,,08/31/2022,," FDA has no questions (in PDF)",,,,,,,,,, =T("992")," White mulberry (Morus alba Linn) leaf extract"," Intended for use as an ingredient in a variety of food categories at levels ranging from 120 mg to 294 mg/serving."," Scientific procedures"," Phynova Group Limited"," 16 Fenlock Court
Blenheim Office Park
Long Hanborough, OX29 8Ln
UK",," GRN 992 with amendments (in PDF)",,,,,,,05/06/2022,," At the notifier's request, FDA ceased to evaluate this notice (in PDF)",,,,,,,,,, =T("993")," L-carnitine-L-tartrate"," Intended for use as an ingredient in cow or goat milk-based, non-exempt infant formula for term infants at a maximum level of 0.88 mg/100 kcal, providing 0.6 mg L-carnitine/100 kcal."," Scientific procedures"," Ausnutria B.V."," Dokter van Deenweg 150
8025 BM Zwolle
THE NETHERLANDS",," GRN 993 with amendments (in PDF)",,,,,,,10/18/2021,," FDA has no questions (in PDF)",,,,,,,,,, =T("994")," Miracle fruit (Synsepalum dulcificum), in pulp, powder, or protein forms"," Intended for use as a taste modifier at levels up to 5 g pulp/serving, 0.7 g powder/serving, and 0.005 g protein/serving, in cheesecake; alcoholic beverages; water-based beverages; non-dairy meal replacement beverages and protein drinks; chewing gum; ready-to-drink coffees and teas; milk-based beverages and yogurt; dairy product analogs; frozen dairy desserts and mixes; fruit and water ices; snack bars; meal-replacement bars; granola; fruit juices, nectars, drinks, ades, and smoothies; vegetable juices; and soft candy."," Scientific procedures"," Joywell Foods Inc."," 202 Cousteau Place, Suite 210
Davis, CA 95618",," GRN 994 (in PDF)",,,,,,,10/26/2021,," At the notifier's request, FDA ceased to evaluate this notice (in PDF)",,,,,,,,,, =T("995")," β-glucans from Antrodia cinnamomea strain ATCC 200183"," Intended for use as an ingredient in various foods at specified maximum use levels (excluding use in infant formula, or in any products under the jurisdiction of the United States Department of Agriculture)."," Scientific procedures"," Super Beta Glucan"," 5 Holland, Unit 109
Irvine, CA 92618",," GRN 995 with amendments (in PDF)",,,,,,,06/14/2022,," FDA has no questions (in PDF)",,,,,,,,,, =T("996")," Synthetic amorphous silica"," Intended for use as a carrier in white sugar at levels from 0.05 to 0.30 g/100 g."," Scientific procedures"," DouxMatok Ltd."," 9 Shimshon Street
Petach-Tikva 49517
ISRAEL",," GRN 996 with amendments (in PDF)",,,,,,,02/04/2022,02/17/2022," FDA has no questions (in PDF)",,,,,,,,,, =T("997")," Chitosan and beta-1,3-glucans from white button mushrooms (Agaricus bisporus)"," Intended for use as an antimicrobial at levels ranging from 0.015 g to 0.15 g per 100 g of food in baked goods and mixes, alcoholic cocktail drinks, sports drinks, soft drinks, flavored waters, ready-to-drink coffee and tea, cheeses, imitation cheese, yogurt, condiments and relishes, confections and frostings, bars (meal replacement, snack), pastas, gravies and sauces, jams and jellies, processed fruit and fruit juices, vegetable juices and purees, soups, dressings and spreads, puddings and fillings, sugar substitutes, meat analogs, and sweet sauces, syrups and toppings."," Scientific procedures"," Chinova Bioworks Inc."," 50 Crowther Lane, Suite 100
Fredericton, New Brunswick E3C 0J1
CANADA",," GRN 997 (in PDF)"," GRN 997 amendments (in PDF)",,,,,,02/28/2022,," FDA has no questions (in PDF)",,,,,,,,,, =T("998")," Corn bran arabinoxylan"," Intended for use as a formulation aid (binder/gelling agent/texturizer/stabilizer/thickener/emulsifier) at a maximum use level of 3% and as source of dietary fiber at a maximum use level of 3.8 g/serving in a variety of food categories and a maximum use level of 7.6 g/serving in yogurt, smoothies and grain drinks, and powdered nutritional supplements."," Scientific procedures"," AgriFiber Solutions, LLC"," 1011 Campus Drive
Mundelein, IL 60060",," GRN 998 (in PDF)",,,,,,,10/25/2021,," At the notifier's request, FDA ceased to evaluate this notice (in PDF)",,,,,,,,,, =T("999")," Enzyme-modified steviol glycosides"," Intended for use as a general-purpose sweetener in foods, excluding infant formula and meat and poultry products, at levels determined by current good manufacturing practices."," Scientific procedures"," Zhucheng Haotian Pharm Co., Ltd"," Xinxing, Zhucheng, Shandong Province
262218
CHINA",," GRN 999 (in PDF)",,,,,,,12/03/2021,," FDA has no questions (in PDF)",,,,,,,,,, =T("1000")," Phycocyanin-rich extract of Galdieria sulphuraria (G. sulphuraria strain FCC3424)"," Intended for use as an ingredient in foods and beverages at levels up to 250 mg/serving."," Scientific procedures"," Fermentalg"," 4 Rue Rivière
33500 Libourne
FRANCE",," GRN 1000 (in PDF)",,,,,,,03/08/2022,," At the notifier's request, FDA ceased to evaluate this notice (in PDF)",,,,,,,,,, =T("1001")," Myoglobin preparation from a strain of Pichia pastoris expressing the myoglobin gene from Bos taurus"," Intended to impart flavor and aroma at levels up to 2% myoglobin in ground meat and poultry analogue products."," Scientific procedures"," Motif FoodWorks, Inc."," 27 Drydock Avenue, 2nd Floor
Boston, MA 02210",," GRN 1001 with amendments (in PDF)",,,,,,,12/03/2021,," FDA has no questions (in PDF)",,,,,,,,,, =T("1002")," Bifidobacterium breve strain MCC1274"," Intended for use as an ingredient in conventional foods including baked goods, breakfast cereals, fruit juices and nectars, fruit ices, vegetable juices, milk-based drinks and powders, yogurt, dairy product analogs, frozen dairy desserts, cheeses, condiments and spreads, nut and peanut spreads, gelatins and puddings, milk and non-milk meal replacements, and soft and hard candies and snack foods at a maximum level of 5 x 1010 colony forming units (CFU)/serving."," Scientific procedures"," Morinaga Milk Industry Co., Ltd."," 33-1, Shiba 5-Chome, Minato-ku
Tokyo 108-8384
JAPAN",," GRN 1002 with amendments (in PDF)",,,,,,,07/22/2022,," FDA has no questions (in PDF)",,,,,,,,,, =T("1003")," Bifidobacterium longum subsp. infantis M-63"," Intended for use as an ingredient in non-exempt cow milk- and soy-based infant formula for term infants at a level up to 1 x 108 colony forming units (CFU)/g of powdered formula, and in certain conventional foods in the following categories at a level up to 1.25 x 1010 CFU per serving: breads and baked goods; ready-to-eat and hot breakfast cereals; fruit juices, nectars, and blends; dairy products and dairy substitutes; candy; condiment sauces; gelatin desserts; peanut and other nut butters and spreads; snack foods; and infant and toddler foods."," Scientific procedures"," Morinaga Milk Industry Co., Ltd"," 33-1, Shiba 5-Chome, Minato-ku
Tokyo 108-8384
JAPAN",," GRN 1003 with amendments (in PDF)",,,,,,,04/26/2022,," FDA has no questions (in PDF)",,,,,,,,,, =T("1004")," Maltosyltrehalose syrup"," Intended for use as a carbohydrate source in various foods and beverages at levels up to 60%."," Scientific procedures"," Hayashibara Co., Ltd."," 675-1 Fujisaki, Naka-ku
Okayama 702-8006
JAPAN",," GRN 1004 with amendments (in PDF)",,,,,,,01/20/2022,," At the notifier's request, FDA ceased to evaluate this notice (in PDF)",,,,,,,,,, =T("1005")," β-Lactoglobulin from cow milk"," Intended for use as a source of protein in ready to drink (RTD) sports drinks, RTD energy drinks, RTD milk-based drinks, fruit juice drinks, meal replacement and protein shakes, yogurt, and medical foods at levels ranging from 4-25 g/100 mL."," Scientific procedures"," Arla Foods Ingredients Group P/S"," Sønderhøj 10-12, 8260 Viby J
DENMARK",," GRN 1005 with amendments (in PDF)",,,,,,,03/03/2022,," At the notifier's request, FDA ceased to evaluate this notice (in PDF)",,,,,,,,,, =T("1006")," Short-chain fructooligosaccharides"," Intended for use as a bulking agent and a general-purpose food ingredient in various food categories, including substitutes for meat, poultry, and fish; nutritional bars; breakfast cereals; beverages and juices; cakes; cheese; cream; confectionery; cookies; crackers; dessert toppings and fillings; hard candy; ice cream; infant foods; jams and jellies; milks (acidophilus; flavored and unflavored; evaporated and condensed); cultured dairy beverages; dairy product analogs; muffins and quick bread; sauces, gravies, and condiments; snacks; sorbet and sherbet; soups; toddler (12-24 months old) foods; yogurt; drinkable yogurt; and meal replacement shakes at levels ranging from 0.4 to 15%."," Scientific procedures"," Ingredion Incorporated"," 10 Finderne Avenue
Bridgewater, NJ 08807",," GRN 1006 with amendments (in PDF)",,,,,,,01/19/2022,," FDA has no questions (in PDF)",,,,,,,,,, =T("1007")," Bacillus subtilis strain R0179"," Intended for use as an ingredient in baked goods and baking mixes, beverage and beverage bases, breakfast cereals, chewing gum, confections and frostings, dairy product analogs, fruit and water ices, nuts and nut products, plant protein products, processed fruits and fruit juices, and snack foods at a maximum level of 109 colony forming units/serving."," Scientific procedures"," Lallemand Health Solutions"," 17975 rue des Gouverneurs
Mirabel, Québec
J7J2K7
CANADA",," GRN 1007 part 1 (in PDF)"," GRN 1007 part 2 (in PDF)"," GRN 1007 part 3 (in PDF)"," GRN 1007 part 4 (in PDF)"," GRN 1007 part 5 (in PDF)"," GRN 1007 part 6 (in PDF)"," GRN 1007 part 7 (in PDF)",12/16/2022,," At the notifier's request, FDA ceased to evaluate this notice (in PDF)",,,,,,,,,, =T("1008")," Algal oil (≥45% docosahexaenoic acid) from Aurantiochytrium limacinum TKD-1"," For use as an ingredient in the same food categories as those listed in 21 CFR 184.1472(a)(3) (Menhaden oil) at use levels that are no more than 18% of the levels specified for menhaden oil in that regulation. ATK Biotech states that if algal oil (≥45% DHA) is blended with another source of DHA or eicosapentaenoic acid (EPA), the levels will be no more than 1.5 g of DHA/person (p)/d and no more than 3.0 g/p/d of DHA and EPA combined. Algal oil (≥45% DHA) also will be used as an ingredient in cow milk- and soy-based, non-exempt and exempt infant formula for term and pre-term infants, respectively, at a maximum level of 0.5% (w/w) of total fat as DHA in combination with a safe and suitable source of arachidonic acid (ARA) at a ratio ranging from 1:1 to 1:2 of DHA to ARA."," Scientific procedures"," ATK Biotech Co., Ltd."," 109 Husong Road
Shitan Industrial Park
Shizi Town, Quanjiao County
Chuzhou City
CHINA",," GRN 1008 with amendments (in PDF)",,,,,,,02/25/2022,," FDA has no questions (in PDF)",,,,,,,,,, =T("1009")," Water-soluble palm fruit extract"," Intended for use as an ingredient in cookies, nonalcoholic beverages and beverage bases, milk- and non-milk-based meal replacement drinks, instant coffee, instant tea, ready-to-drink (RTD) tea beverages, specialty RTD coffee drinks, dairy product analogs, margarine, ice cream, frozen dairy desserts, cereal and granola bars, protein bars, milk-based beverages (including flavored milks, smoothies), yogurt, yogurt drinks, fermented milks, nuts and nut products, fruit juices and nectars, fruit drinks and ades, vegetable juices and blends, chocolate and gummy candies, and cocoa syrup at levels ranging from 0.11% to 2.67%, and in sugar substitutes at levels between 10% and 40%."," Scientific procedures"," Malaysian Palm Oil Board"," 6, Persiaran Institusi
Bandar Baru Bangi
43000 Kajang, Selangor
MALAYSIA",," GRN 1009 (in PDF)",,,,,,,06/24/2022,," At the notifier's request, FDA ceased to evaluate this notice (in PDF)",,,,,,,,,, =T("1010")," Rebaudioside M obtained by enzymatic treatment of steviol glycosides purified from the leaves of Stevia rebaudiana (Bertoni)"," Intended for use as a general-purpose sweetener in foods, excluding infant formula and meat and poultry products, at levels determined by good manufacturing practices."," Scientific procedures"," Manus Bio, Inc."," 1030 Massachusetts Ave
Unit #300
Cambridge, MA 02138",," GRN 1010 (in PDF)",,,,,,,01/26/2022,," FDA has no questions (in PDF)",,,,,,,,,, =T("1011")," Alpha-amylase enzyme preparation produced by Bacillus subtilis strain AR-651 expressing the gene encoding alpha-amylase from Thermoactinomyces vulgaris"," Intended for use as an enzyme at a maximum level of 100 mg total organic solids/kg flour during baking."," Scientific procedures"," AB Enzymes Inc."," 8211 W. Broward Blvd.
Suite 375
Plantation, FL 33324",," GRN 1011 with amendments (in PDF)",,,,,,,07/18/2022,01/11/2023," FDA has no questions (in PDF)",,,,,,,,,, =T("1012")," Powdered sap from Angelica keiskei (ashitaba) containing 8% chalcones (ashitaba sap)"," Intended for use as an ingredient in soft drinks, jellies and jams, candy containing chocolate, and butter at levels up to 0.834% per serving."," Scientific procedures"," Japan Bio Science Laboratory-USA, Inc."," 1547 Palos Verdes Mall, #131
Walnut Creek, CA 94597",," GRN 1012 (in PDF)",,,,,,,04/07/2022,," At the notifier's request, FDA ceased to evaluate this notice (in PDF)",,,,,,,,,, =T("1013")," Lactobacillus rhamnosus DSM 33156"," Intended for use as an ingredient in conventional foods at a maximum use level of 1 x 1011 colony forming units (CFU)/serving and in cow-milk-, soy-milk-, and partially hydrolyzed protein-based, non-exempt infant formula for term infants at a use level of 1 x 108 CFU/g."," Scientific procedures"," Chr. Hansen, Inc."," 9015 West Maple Street
Milwaukee, WI 53214",," GRN 1013 with amendments (in PDF)",,,,,,,12/15/2021,," FDA has no questions (in PDF)",,,,,,,,,, =T("1014")," 2-fucosyllactose"," Intended for use as an ingredient at a level of 2.4 g/L in formula for young children (> 12 months); at a level of 12 g/kg (or g/L) in milk- and soy-based meal replacement beverages for children, ready-to-serve and dry instant cereals for infants and young children, meal replacement drinks, meal replacement bars, snack bars, and breakfast bars; at a level of 6 g/L in non-carbonated sports drinks and flavored waters; and at a level of 20 g/L in enteral tube feeding formulas."," Scientific procedures"," Chr. Hansen A/S"," 9015 West Maple Street
Milwaukee, WI 53214",," GRN 1014 with amendments (in PDF)",,,,,,,07/15/2022,," FDA has no questions (in PDF)",,,,,,,,,, =T("1015")," 3'-sialyllactose sodium salt"," Intended for use as an ingredient at 0.28 g/L in formulas for young children (> 12 months); 0.9 g/L in milk- and soy-based meal replacement beverages for children and meal replacements drinks for adults; 1.0 g/kg in instant and ready-to-eat cereals for infants and young children under 3 years of age, snack bars, breakfast bars, and meal replacement bars; 0.45 g/L in non-carbonated sports drinks and flavored waters; and 1.5 g/L in food for enteral feeding."," Scientific procedures"," Chr. Hansen A/S"," 9015 West Maple Street
Milwaukee, WI 53214",," GRN 1015 with amendments (in PDF)",,,,,,,07/15/2022,," FDA has no questions (in PDF)",,,,,,,,,, =T("1016")," 6'-sialyllactose sodium salt"," Intended for use as an ingredient at 0.4 g/L in formulas for young children (> 12 months); 2.28 g/L in milk-based meal replacement beverages for children and meal replacements drinks for adults; 1.5 g/kg in instant and ready-to-eat cereals for infants and young children under 3 years of age, snack bars, breakfast bars, and meal replacement bars; 0.7 g/L in non-carbonated sports drinks and flavored waters; and 3.8 g/L in food for enteral feeding"," Scientific procedures"," Chr. Hansen A/S"," 9015 West Maple Street
Milwaukee, WI 53214",," GRN 1016 with amendments (in PDF)",,,,,,,07/15/2022,," FDA has no questions (in PDF)",,,,,,,,,, =T("1017")," Lacto-N-tetraose"," Intended for use as an ingredient at 0.6 g/L in toddler formulas and in electrolyte solutions; at 6 g/L in milk-based meal replacement beverages for children, ready-to-serve and dry instant cereals for infants and young children, meal replacement drinks, meal-replacement bars, snack bars, and breakfast bars; at 3 g/L in non-carbonated drinks; and at 10 g/L in enteral tube feeding formulas."," Scientific procedures"," Chr. Hansen A/S"," 9015 West Maple Street
Milwaukee, WI 53214",," GRN 1017 (in PDF)",,,,,,,08/23/2022,," FDA has no questions (in PDF)",,,,,,,,,, =T("1018")," Carbon monoxide"," Intended for use as a component of a modified atmosphere packaging (MAP) system at levels up to 0.4% of the MAP system in fully cooked, sliced, pre-packed, ready-to-eat (RTE) deli meats and poultry."," Scientific procedures"," Cargill, Incorporated"," 15407 McGinty Road
Wayzata, MN 55391",," GRN 1018 with amendments (in PDF)",,,,,,,08/11/2022,," FDA has no questions (in PDF)",,,,,,,,,, =T("1019")," Agave mixed fructans from Agave tequilana Weber var. azul"," Intended for use as a bulking agent, texturizing agent, or source of reduced energy carbohydrate for use as a sugar replacer, fat replacer, and/or texture modifier in select foods (excluding infant formula and meat and poultry products) at use levels of 1 g/serving in infant and toddler foods, 5 g/serving in ready to-eat breakfast cereals, and 0.5-15 g/100 g in other foods."," Scientific procedures"," Inulina Y Miel de Agave S.A. de C.V."," Calle Extramuros No. 125
Capilla de Guadalupe
Jalisco, CP 47700
Mexico",," GRN 1019 with Amendments (in PDF)",,,,,,,02/27/2023,," FDA has no questions (in PDF)",,,,,,,,,, =T("1020")," Protein from Helianthus annuus (sunflower protein)"," Intended for use as a source of protein at levels ranging from 3 to 30% in a variety of food categories described in the notice."," Scientific procedures"," Austrade, Inc."," 3309 Northlake Blvd. #201
Palm Beach Gardens, FL 33403",," GRN 1020 with amendments (in PDF)",,,,,,,06/14/2022,," At the notifier's request, FDA ceased to evaluate this notice (in PDF)",,,,,,,,,, =T("1021")," Transglutaminase enzyme preparation produced by Streptomyces mobaraensis strain M2020197"," Intended for use as an enzyme at a maximum level of 97.56 mg Total Organic Solids/kg (TOS/kg) food in meat products, fish products, dairy products, vegetable protein and soybean products, baked goods (including pastries) and bread products, pasta and noodles, grain mixtures, and ready-to-eat cereals."," Scientific procedures"," Taixing Dongsheng Bio-Tech Co., Ltd."," No. 1 Tonglian Rd., Huangqiao Town
Taixing City, Jiangsu Province
The People's Republic of China
225411",," GRN 1021 with amendments (in PDF)",,,,,,,11/03/2022,," FDA has no questions (in PDF)",,,,,,,,,, =T("1022")," Streptococcus salivarius DB-B5"," Intended for use as an ingredient in conventional foods at a use level up to 109 CFU of S. salivarius DB-B5/serving."," Scientific procedures"," Dose Biosystems Inc."," 661 University Ave, Suite 1300
Toronto, Ontario
Canada
M5G0B7",," GRN 1022 with amendments (in PDF)",,,,,,,08/22/2022,," FDA has no questions (in PDF)",,,,,,,,,, =T("1023")," Monosodium L-5-methyltetrahydrofolate"," Intended for use as a replacement for folic acid as a source of the vitamin folate in the same food categories as listed under 21 CFR 172.345, except for corn masa flour, at a level equivalent on a molar basis to that of folic acid."," Scientific procedures"," Merck & Cie"," Im Laternenacker 5
8200 Schaffhausen
Switzerland",," GRN 1023 part 1"," GRN 1023 with amendment part 2",,,,,,01/25/2022,," At the notifier's request, FDA ceased to evaluate this notice (in PDF)",,,,,,,,,, =T("1024")," D-psicose"," Intended for use as a sweetener at levels ranging from 2 to 100% in a variety of food categories (excluding use in infant formula, or in any products under the jurisdiction of the United States Department of Agriculture). The intended uses and use levels are shown in Table 1 of the response letter."," Scientific procedures"," Blue California"," 30111 Tomas
Rancho Santa Margarita, CA 92688",," GRN 1024 with Amendments (in PDF)",,,,,,,03/02/2023,," FDA Has no Questions (in PDF)",,,,,,,,,, =T("1025")," Pepsin A enzyme preparation produced by Pichia pastoris to overexpress the gene encoding pepsin A"," Intended for use as an enzyme at a maximum level of 34 mg total organic solids/kg raw material, in the production of hydrolyzed vegetable and animal protein ingredients."," Scientific procedures"," Clara Foods Co."," 1 Tower Place
Suite 800
South San Francisco, CA 94080",," GRN 1025 with Amendments (in PDF)",,,,,,,01/06/2023,," FDA Has No Questions (in PDF)",,,,,,,,,, =T("1026")," Silk fibroin derived from Bombyx mori cocoons"," For use as a surface-finishing agent to extend the shelf life of the foods listed in Table 1 in FDAs response letter of August 11, 2022."," Scientific procedures"," Cambridge Crops, Inc. d/b/a Mori"," Rutherford Avenue
Boston, MA 02129",," GRN 1026 part 1 with Appx. A-D (in PDF)"," GRN 1026 part 2 Appx. E-G1 (in PDF)"," GRN 1026 part 3 Appx. G.2, G.3, part of G.4 (in PDF)"," GRN 1026 part 4 Appx. G.4 (contd) (subsections Appendices A-F) (in PDF)"," GRN 1026 part 5 Appx. G.4 (subsections Appendices G-O, part of P) (in PDF)"," GRN 1026 part 6 Appx. G.4 (subsection Appendix P (cont'd)) - Appx. H (in PDF)"," GRN 1026 part 7 Appx. I-K and amendments (in PDF)",08/11/2022,," FDA has no questions (in PDF)",,,,,,,,,, =T("1027")," Miracle fruit (Synsepalum dulcificum) powder"," Intended for use as a taste modifier at levels up to 6% in water-based beverages, carbonated beverages, fruit juices and nectars, fruit-based smoothies, fruit drinks and ades, fermented dairy products (buttermilk, acidophilus milk, kefir), yogurts, and ready-to-drink tea beverages."," Scientific procedures"," Miracle Fruit Farm, LLC"," 16300 SW 184th Street
Miami, FL 33187",," GRN 1027",,,,,,,12/22/2021,," At the notifier's request, FDA ceased to evaluate this notice (in PDF)",,,,,,,,,, =T("1028")," Metschnikowia pulcherrima DANMET-A and M. fructicola DANMET-B"," Intended for use individually and in combination at a maximum level of 1 g yeast/kg fresh coffee cherries, post-harvest, to provide up to 2 x 107 colony forming units/g coffee."," Scientific procedures"," Danstar Ferment AG"," Poststrasse 30
6300 Zug
Switzerland",," GRN 1028 (in PDF)",,,,,,,,," Pending",,,,,,,,,, =T("1029")," D-psicose"," Intended for use as an ingredient in reduced or low-calorie foods, including bakery products, chewing gums, fat-based creams, hard and soft candies, frozen dairy desserts, beverages, sugar substitutes, yogurt, ready-to-eatbreakfast cereals, coffee mix, and medical foods at levels from 2.1% to 100%."," Scientific procedures"," L&P Food Ingredient Co., Ltd"," Wengcheng Industrial Park
Wengchen Town, Wenyuan County
Shaoguan, Guangdong 512627
The People's Republic of China",," GRN 1029 with amendments (in PDF)",,,,,,,08/04/2023,," FDA has no questions (in PDF)",,,,,,,,,, =T("1030")," Cellulase enzyme preparation produced by Aspergillus niger genetically engineered to express a cellulase gene from Trichoderma reesei"," Intended for use as an enzyme at a maximum level of 100 mg total organic solids/kg raw material in brewing, processing of other cereal based beverages, fruits and vegetables, starch and grain, and baked goods."," Scientific procedures"," Novozymes North America Inc."," 77 Perry Chapel Church Road
Franklinton, NC 27525",," GRN 1030 with amendment (in PDF)",,,,,,,02/15/2023,," FDA has no questions (in PDF)",,,,,,,,,, =T("1031")," Barley and rice protein hydrolysate"," Intended for use as a protein source at levels ranging from 0.5 to 90% for use in baked goods and baking mixes, beverages and beverage bases, breakfast cereals, dairy product analogs, fats and oils, grain products and pastas, gravies and sauces, jams and jellies, nuts and nut products, plant protein products, snack foods, soft candy, soup and soup mixes, and sweet sauces, toppings, and syrups."," Scientific procedures"," EverGrain, LLC"," 3205 S. 9th St
St. Louis, MO 63118",," GRN 1031 with Amendments (in PDF)",,,,,,,10/20/2022,," FDA has no questions (in PDF)",,,,,,,,,, =T("1032")," D-β-hydroxybutyrate"," Intended for use as an ingredient at levels up to 6 g per serving in sports and nutritional beverages, bars, and gels."," Scientific procedures"," Osaka Gas Chemicals Co. Ltd."," 2-37, Chiyozaki 3-cyome-minami
Nishi-ku, Osaka, 550-0023
Japan",," GRN 1032 with amendments (in PDF)",,,,,,,06/02/2022,," FDA has no questions (in PDF)",,,,,,,,,, =T("1033")," Hydrolyzed Saccharomyces cerevisiae"," Intended for use as an ingredient in snacks (e.g., popcorn, chips, and crackers); meal replacement and snack bars; and dry mixes (e.g., protein powders) for non-alcoholic beverages at levels up to 250 mg/serving."," Scientific procedures"," Fytexia Corp"," ZAE Via Europa
3, rue d'Athenes
34350 Vendres
France",," GRN 1033 (in PDF)",,,,,,,,," Pending",,,,,,,,,, =T("1034")," 2'-fucosyllactose"," Intended for use as an ingredient in exempt hypoallergenic extensively hydrolyzed cow milk or goat milk protein- and amino acid-based infant formula for term infants with cow milk protein allergy at a level of 2.4 g/L infant formula as consumed."," Scientific procedures"," Glycom A/S"," Kogle Allé 4
2970 Hørsholm
Denmark",," GRN 1034 with amendments (in PDF)",,,,,,,10/21/2022,," FDA has no questions (in PDF)",,,,,,,,,, =T("1035")," Lacto-N-fucopentaose I with 2'-fucosyllactose"," Intended for use as an ingredient in non-exempt infant formula for term infants at use levels providing up to 0.8 g LNFP-I/L infant formula as consumed. LNFP-I/2'-FL is also intended for use as an ingredient in other foods at use levels providing LNFP-I up to the maximum levels specified."," Scientific procedures"," Glycom A/S"," Kogle Allé 4
2970 Hørsholm
Denmark",," GRN 1035 with amendments (in PDF)",,,,,,,01/19/2023,03/01/2023," FDA has no questions (in PDF)",03/01/2023," Correction Letter (in PDF)",,,,,,,, =T("1036")," Complexation products of iron with sodium citrate"," Intended for use as an anti-caking agent in salt at a maximum use level of 135 mg/kg (or 30 mg/kg as iron)."," Scientific procedures"," Cargill, Inc."," 15407 McGinty Road
Wayzata, MN 55391",," GRN 1036 with Amendments (in PDF)",,,,,,,10/06/2022,," FDA Has No Questions (in PDF)",,,,,,,,,, =T("1037")," 3-fucosyllactose"," Intended for use as an ingredient in non-exempt infant formula for term infants at a level up to 0.75 g/L as consumed; formula and drinks for young children (>12 months) at levels up to 0.90 g/L as consumed; foods for infants and young children at levels up to 6.25 g/kg; and in the following foods at maximum levels ranging from 1.25 to 25 g/kg: meal replacement and nutritional beverages; sports, isotonic, and energy drinks, soft drinks, and enhanced or fortified water; meal replacement bars; cereal and nutrition bars; unflavored and flavored milk; buttermilk; yogurt drinks and beverages containing live microorganisms; yogurt; and fruit drinks and ades."," Scientific procedures"," Glycom A/S"," Kogle Allé 4
2970 Hørsholm
Denmark",," GRN 1037 with amendments (in PDF)",,,,,,,11/07/2022,," FDA has no questions (in PDF)",,,,,,,,,, =T("1038")," Preparation containing six bacteriophages (phage) specific to Salmonella enterica spp. serovars"," Intended for use as an antimicrobial on ground and whole red meat and poultry, including whole carcasses, primals, subprimals, trimmings, and organs, at levels ranging from 5 x 109 to 1010 plaque-forming units (PFU)/g of food."," Scientific procedures"," FINK TEC GmbH"," Oberster Kamp
23 D-59069
Hamm
Germany",," GRN 1038 with amendments (in PDF)",,,,,,,05/11/2023,," FDA has no questions (in PDF)",,,,,,,,,, =T("1039")," Lactase enzyme preparation produced by Aspergillus oryzae"," Intended for use as an enzyme at up to 130 mg Total Organic Solids/kg raw material (TOS/kg) in the processing of milk, milk powder, fermented milk products and yogurt, fresh cheeses, milk-based desserts, whey, baked goods, confectionary, cereal bars and soft drinks, and at 36 mg TOS/kg raw material in the processing of milk used for non-exempt infant formulas for ages 0 to 12 months and milk-based products for ages 12 to 36 months, respectively."," Scientific procedures"," Godo Shusei Co., Ltd."," 250, Aza-Nakahara, Kamihongo
Matsudo, Chiba 271-0064
Japan",," GRN 1039 (in PDF)",,,,,,,,," Pending",,,,,,,,,, =T("1040")," 2'-fucosyllactose"," Intended for use as an ingredient in cow milk-based, exempt infant formula for post-discharge preterm infants at a level up to 2.0 g/L, as consumed."," Scientific procedures"," Chr. Hansen A/S"," Boege Allé 10-12
2970 Hoersholm
Denmark",," GRN 1040 (in PDF)",,,,,,,09/22/2022,," At the notifier's request, FDA ceased to evaluate this notice (in PDF)",,,,,,,,,, =T("1041")," Dry whole milk"," Intended for use as an ingredient in cow milk-based, non-exempt infant formula for term infants at a maximum level of 22% (w/w) powdered infant formula."," Scientific procedures"," Nara Organics, Inc."," 335 Madison Avenue, 4th Floor
New York, NY 10017",," GRN 1041 (in PDF)",,,,,,,05/10/2022,," FDA has no questions (in PDF)",,,,,,,,,, =T("1042")," Menaquinone-7 derived from a specific strain of Bacillus subtilis natto"," Intended for use as an ingredient in beverages and beverage bases, breakfast cereals, cheeses, fats and oils, frozen dairy desserts, grain products and pastas, milk, milk products, processed fruits and fruit juices, and processed vegetables and vegetable juices at a maximum use level of 10 µg per serving of food."," Scientific procedures"," GF Fermentech, Inc."," (30007) 74-12 Geumhoseonmal-gil
Bugang-myeon, Sejong-si
Republic of Korea",," GRN 1042 (in PDF)",,,,,,,04/03/2023,," At the notifier's request, FDA ceased to evaluate this notice (in PDF)",,,,,,,,,, =T("1043")," Cetylated fatty acids"," Intended for use as a source of dietary fatty acids at levels ranging from 0.13 to 2.5 g per 100 g or 100 mL in a variety of food categories."," Scientific procedures"," Pharmanutra S.p.A."," Via Delle Lenze 216/b
Pisa 56122
Italy",," GRN 1043 with Amendments(in PDF)",,,,,,,10/26/2022,," FDA has no Questions (in PDF)",,,,,,,,,, =T("1044")," Calcium disodium ethylenediaminetetraacetic acid"," Intended for use as a color retention agent for canned abalone in brine. The concentration of calcium disodium EDTA in the canned abalone is up to 250 mg/kg."," Scientific procedures"," Jade Tiger Abalone"," 366 The Esplanade, Indented Head
Victoria, 3223
Australia",," GRN 1044 (in PDF)",,,,,,,05/25/2022,," At the notifier's request, FDA ceased to evaluate this notice (in PDF)",,,,,,,,,, =T("1045")," Resistant dextrin from tapioca"," Intended for use as a source of dietary fiber at maximum levels ranging from 1.2 to 10 g per serving in baked goods; beverages; cereals and granola bars; condiments and dressings; confections; dairy products; frozen desserts; gravies and sauces; meal replacements; pasta and grain products; prepared meals and soups; processed fruits; shelf-stable desserts; snacks and crackers; and nutrition bars."," Scientific procedures"," Anderson Global Group"," 2030 Main Street
Irvine, CA 92614",," GRN 1045 with Amendments (in PDF)",,,,,,,08/26/2022,," FDA has no Questions (in PDF)",,,,,,,,,, =T("1046")," Collagenase enzyme preparation from genetically modified Streptomyces violaceoruber expressing a collagenase gene"," Intended for use as an enzyme in processing beef jerky, marinated and injected meat, and sausage casings, at a level up to 10.9 mg Total Organic Solids (TOS)/kg."," Scientific procedures"," Nagase & Co. Ltd."," 5-1 Nihonbashi-Kobunacho Chuo-ku
Tokyo 103-8355
Japan",," GRN 1046 with amendments (in PDF)",,,,,,,06/22/2023,," FDA has no questions (in PDF)",,,,,,,,,, =T("1047")," Lipase enzyme preparation produced by Saccharomyces cerevisiae expressing a gene encoding a lipase from Fusarium oxysporum"," Intended for use as an enzyme at up to 29.8 mg Total Organic Solids (TOS)/kg flour in the manufacture of baked goods."," Scientific procedures"," Lallemand Inc."," 1620 Prefontaine Street
H1W 2N8, Montreal, QC
Canada",," GRN 1047 (in PDF)",,,,,,,,," Pending",,,,,,,,,, =T("1048")," Aminopeptidase enzyme preparation produced by Trichoderma reesei expressing a gene encoding an aminopeptidase from Aspergillus clavatus"," Intended for use as an enzyme at up to 2.1g Total Organic Solids (TOS)/kg protein in protein processing, at up to 4.3 g TOS/kg yeast in yeast processing, and at up to 7 g TOS/kg protein in flavoring production."," Scientific procedures"," Danisco US Inc. (A Wholly Owned-Subsidiary of International Flavors & Fragrances)"," 925 Page Mill Road
Palo Alto, CA 94304",,,,,,,,,,," Pending",,,,,,,,,, =T("1049")," Medium-chain triacylglycerols"," Intended for use as a source of fat in cow milk-based, exempt infant formula for term infants at a level up to 50% of total fat by weight."," Scientific procedures"," Nestlé Nutrition"," 1812 North Moore Street
Arlington, VA 22209",," GRN 1049 with amendments (in PDF)",,,,,,,09/21/2022,," FDA has no questions (in PDF)",,,,,,,,,, =T("1050")," High 2-palmitic acid vegetable oil"," Intended for use as a source of fat in non-exempt and exempt infant formula for term and pre-term infants, respectively, at a level up to 70% of total fat. High 2-palmitic acid vegetable oil is also intended to replace other sources of fat in a variety of foods, including use in infant and toddler foods, and in baked goods and baking mixes, breakfast cereals, cheese-based spreads, snack dips, dairy product analogs, meal-replacements, margarine-type spreads, mayonnaise-type dressing, salad dressings, frozen dairy desserts and mixes, gelatins, puddings and fillings, grain products and pastas, white sauces and milk gravies, hard candy, milk drinks, meat analogs, grain-based soups, soft candy, and grain-based salty snacks at a level of 100% of total fat."," Scientific procedures"," The Nisshin OilliO Group, Ltd."," 1-23-1 Shinkawa, Chou-ku
Tokyo 104-8285
Japan",," GRN 1050 with amendments (in PDF)",,,,,,,07/18/2022,," At the notifier's request, FDA ceased to evaluate this notice (in PDF)",,,,,,,,,, =T("1052")," 3'-sialyllactose sodium salt"," Intended for use as an ingredient in non-exempt infant formula for term infants and formulas for young children (>12 months) at a level of 0.24 g/L, as consumed; in drinks for infants and young children at 0.15-1.0 g/L; in hot cereals, desserts, dry snacks, and other foods for infants and young children at 1.1-5.7 g/kg; in non-alcoholic beverages (sports and ""energy drinks"", fortified and flavored waters, soft drinks, coffee and tea, fruit juices and nectars, fruit-flavored drinks, vegetable juices and nectars, milk, flavored milk, buttermilk, milk substitutes, meal replacements, and protein drinks) at 0.126.0 g/L; in oral nutritional supplements and enteral tube feeding products (?11 years and older) at 2.0 g/L; in chewing gum at 30 g/kg; in table-top sweeteners at 30 g/kg; in beverage whiteners and cream substitutes at 60 g/kg; and in breads and baked goods; breakfast cereals; frozen dairy desserts; fruit and water ices; gelatins, puddings, and fillings; cereal and granola bars (including meal-replacement bars); jams and jellies; yogurt (including non-dairy yogurt); evaporated and condensed milk; canned fruits; fruit-based desserts; and syrups at 0.12-8.0 g/kg."," Scientific procedures"," Kyowa Hakko Bio Co., Ltd."," 1-9-2, Otemachi, Choyoda-ku
Tokyo, 100-0004
Japan",," GRN 1052 with amendments (in PDF)",,,,,,,04/18/2023,," FDA has no questions (in PDF)",,,,,,,,,, =T("1053")," 6'-sialyllactose sodium salt"," Intended for use as an ingredient in non-exempt infant formula for term infants at a level of 0.40 g/L of formula as consumed; in toddler formulas at a level of 0.50 g/L, as consumed; in infant and toddler drinks at 2.1 g/L and in hot cereals, desserts, dry snacks and other infant and toddler foods at 2.3 12 g/kg; in non-alcoholic beverages (sports and energy drinks, flavored waters, soft drinks, coffee and tea, fruit juices and drinks, vegetable juices, milk, milk substitutes, meal replacements, and protein drinks) at 0.25 12.5 g/L; in oral nutritional and enteral tube feeding products at 4.1 g/L; in chewing gum and sugar substitutes at 62 g/kg; in beverage whiteners and cream substitutes at 125 g/kg; and in baked goods and baking mixes; breakfast cereals; frozen dairy desserts; fruit and water ices; gelatins, puddings, and fillings; cereal and granola bars (including meal-replacement bars); jams and jellies; yogurt (including non-dairy yogurt); canned fruits; fruit-based desserts; and syrups at 1.0 17.0 g/kg."," Scientific procedures"," Kyowa Hakko Bio Co., Ltd."," 1-9-2, Otemachi, Choyoda-ku
Tokyo, 100-0004
Japan",," GRN 1053 with Amendments (in PDF)",,,,,,,05/12/2023,," FDA Has No Questions (in PDF)",,,,,,,,,, =T("1054")," Glucose oxidase enzyme preparation produced by Aspergillus niger expressing the gene encoding glucose oxidase from A. niger"," Intended for use as an enzyme at up to 7.72 mg Total Organic Solids (TOS)/kg raw material, in baking, and processing of cheese, de-sugared eggs, mayonnaise, and salad dressing."," Scientific procedures"," Danisco US Inc. (A Wholly Owned-Subsidiary of International Flavors & Fragrances)"," 925 Page Mill Road
Palo Alto, CA 94304",," GRN 1054 with amendments (in PDF)",,,,,,,07/14/2023,," FDA has no questions (in PDF)",,,,,,,,,, =T("1055")," Xylanase enzyme preparation produced by Bacillus licheniformis strain expressing the xylanase gene from Chryseobacterium"," Intended for use as an enzyme at up to 68.5 mg Total Organic Solids (TOS)/kg raw material in grain processing, brewing, and manufacture of cereal-based beverages."," Scientific procedures"," Novozymes North America Inc."," 77 Perrys Chapel Church Road
Franklinton, NC 27525",," GRN 1055 with Amendments (in PDF)",,,,,,,04/04/2023,," FDA Has No Questions (in PDF)",,,,,,,,,, =T("1056")," β-lactoglobulin produced by Komagataella phaffii strain yRMK-66"," Intended for use as a source of protein at levels ranging from 5 to 35% in meal replacements and supplements, powdered nutritional beverages, electrolyte-type sport drinks, high protein performance nutritional beverages and bars, milk, milk drinks, yogurts, milk substitutes, creams and cream substitutes, cheeses, spreads and dips, milk-based desserts, mousses, confections, coatings and fillings, cookies, brownies, snack foods, baked goods, creamy salad dressings, minor main entrée sauces, and egg substitutes."," Scientific procedures"," Remilk Ltd."," Holtzman 2
Rehovot, Israel 7670402",," GRN 1056 with Amendments (in PDF)",,,,,,,02/15/2023,," FDA Has No Questions (in PDF)",,,,,,,,,, =T("1057")," D-psicose"," Intended for use as a sweetener at levels ranging from 2.5 to 25% in a variety of food categories (excluding use in infant formula). The intended uses and use levels are shown in Table 1 of the response letter."," Scientific procedures"," Tate & Lyle"," 5450 Prairie Stone Parkway
Hoffman Estates, IL 60192",," GRN 1057 with amendments (in PDF)",,,,,,,01/25/2024,," FDA has no questions (in PDF)",,,,,,,,,, =T("1058")," Polyvinyl alcohol"," For use at a maximum level of 0.29 g PVOH/kg of food as a component of a coating for fruits and vegetables."," Scientific procedures"," NABACO LLC"," 5040 SH 123
Bldg. 500
San Marcos, Texas 78666",," GRN 1058 with amendments (in PDF)",,,,,,,06/09/2023,," FDA has no questions (in PDF)",,,,,,,,,, =T("1059")," Lacto-N-neotetraose"," Intended for use as an ingredient in exempt infant formula for term infants with cow milk protein allergy, multiple food allergies, non-allergenic gut impairment, and malabsorptive conditions at a level up to 600 mg/L as consumed."," Scientific procedures"," Glycom A/S"," Kogle Allé 4
2970 Hørsholm
Denmark",," GRN 1059 with amendments (in PDF)",,,,,,,12/02/2022,," FDA has no questions (in PDF)",,,,,,,,,, =T("1060")," 2'-fucosyllactose"," Intended for use as an ingredient in non-exempt infant formula for term infants at a maximum level of 2.4 g/L as consumed, and in other food categories at the maximum levels specified."," Scientific procedures"," Glycom A/S"," Kogle Allé 4
2970 Hørsholm
Denmark",," GRN 1060 with Amendments (in PDF)",,,,,,,04/04/2023,," FDA has no questions (in PDF)",,,,,,,,,, =T("1061")," Deactivated alkaline serine protease produced by Bacillus licheniformis strain CICC 10266"," Intended for use as a source of low (less than 25 mg phenylalanine per serving) phenylalanine protein in nutritionally complete medical food in the diet of individuals with phenylketonuria (PKU) ages one year and older. The intended use as the primary protein source (up to 15 g/serving) in medical foods would not result in an excess of 80% of the total protein intake per day."," Scientific procedures"," Tanea Medical AB"," Bredgrand 14
75320 Uppsala
Sweden",,,,,,,,,,," Pending",,,,,,,,,, =T("1062")," Saccharomyces cerevisiae strain OYR-185"," Intended for use as a starter culture at a level of approximately 1 million cells per ml of wort per degree of Plato in the production of beer to enhance the flavor profile."," Scientific procedures"," Omega Yeast Labs, LLC"," 4720 W Pensacola Ave
Chicago, IL 60641",," GRN 1062 with Amendments (in PDF)",,,,,,,04/05/2023,," FDA has no questions (in PDF)",,,,,,,,,, =T("1063")," Weissella cibaria CMU"," Intended for use as an ingredient at levels up to 8 x 109 colony forming units/serving in yogurt, frozen desserts (dairy, ices, sorbets, and sherbets) and mixes, hard candy, and chewing gum."," Scientific procedures"," OraPharm, Inc."," 905 ho, Bluestone Tower
9-16, Yeonmujang
5-gil, Seongdong-gu, Seoul
Republic of Korea",," GRN 1063 (in PDF)",,,,,,,,," Pending",,,,,,,,,, =T("1064")," Pomegranate extract"," Intended for use as an ingredient in dairy products, non-alcoholic beverages, and chocolate candy at levels up to 50 mg per serving, based on the Reference Amounts Customarily Consumed in 21 CFR 101.12 Table 2."," Scientific procedures"," Verdure Sciences"," 17150 Metro Park Court
Noblesville, IN 46060",," GRN 1064 (in PDF)",,,,,,,,," Pending",,,,,,,,,, =T("1065")," Anaerobutyricum soehngenii CH106"," Intended for use as an ingredient in sports drinks and fluid replacement drinks; ready-to-eat breakfast cereals; cereal and granola bars, energy bars, protein bars, and meal replacement bars; ice cream; plain fermented milks; yogurts (including non-dairy yogurt); nut spreads; and chocolate at a maximum level of 1.0 x 1010 total fluorescent unit (FU)/serving."," Scientific procedures"," Caelus Health"," Rondweg 50
3474 KG Zegveld
Netherlands",," GRN 1065 (in PDF)",,,,,,,,," Pending",,,,,,,,,, =T("1066")," Carnobacterium divergens strain M35"," Intended for use as an antimicrobial agent at levels up to 106 CFU/g of fresh, frozen, or smoked fish products (excluding catfish) to inhibit the growth of Listeria monocytogenes."," Scientific procedures"," Fumoir Grizzly Inc."," 159 d'Amsterdam Street
Saint-Augustin-De-Desmaures
Quebec, G3A 2V5
Canada",," GRN 1066 (in PDF)",,,,,,,,," Pending",,,,,,,,,, =T("1067")," Lacto-N-neotetraose"," Intended for use as an ingredient in nonexempt infant formula for term infants at a level up to 0.60 g/L; in formula for young children (> 12 months) at up to 0.6 g/L; in drinks for young children at up to 0.58 g/L; in foods for infants and young children at up to 3.0 g/kg; in sports, isotonic, and energy drinks; milk (unflavored and flavored), imitation milk, and buttermilk; and fruit juices and nectars at up to 0.58 g/L; in yogurt (including non-dairy yogurt) at up to 2.67 g/kg; in meal replacement drinks at up to 2.5 g/L; and in meal replacement bars at up to 20 g/kg."," Scientific procedures"," Inbiose N.V."," Technologiepark Zwijnaarde 82 - bus 41
B-9052 Gent
Belgium",," GRN 1067 with amendments (in PDF)",,,,,,,04/04/2023,," FDA has no questions (in PDF)",,,,,,,,,, =T("1068")," Lacto-N-tetraose"," Intended for use as an ingredient in nonexempt infant formula for term infants at a level up to 0.8 g/L; in formula and other drinks for young children at up to 0.6 g/L; in foods for infants and young children at up to 5.0 g/kg; in sports and isotonic drinks, energy drinks, soft drinks, enhanced or fortified water, fruit-based ades, milk (unflavored and flavored), and buttermilk at up to 1.0 g/L; in meal replacement drinks at up to 2.0 g/L; in meal replacement bars at up to 20 g/kg; in cereal and granola bars at 10 g/kg; and in yogurt at up to 10 g/kg."," Scientific procedures"," Inbiose N.V."," Technologiepark Zwijnaarde 82 - bus 41
B-9052 Gent
Belgium",," GRN 1068 with amendments (in PDF)",,,,,,,06/05/2023,," FDA has no questions (in PDF)",,,,,,,,,, =T("1069")," Corn protein"," Intended for use as a source of protein and for additional technical effects including use as a stabilizer and thickener, formulation aid (binder, filler), and emulsifier, in baked goods, pasta, dairy product analogs, fruit and water ices, margarine-type spreads, nut butters and reduced-fat peanut butter, meal replacement drinks, and shakes at levels up to 5-10%; snack foods (including cereal bars, crackers, chips, pretzels) at levels up to 15%; ready-to-eat (RTE) cereals at levels up to 30%; meal replacement and protein bars at levels up to 25%; meat analogs and plant protein products at levels up to 40%; processed meats at levels up to 7%; cream-based sauces at levels up to 1.5%; mixed dishes with sauces at levels up to 0.08%; and batter/breading/coating mixes for frying at levels up to 2%."," Scientific procedures"," Cargill, Inc."," 15407 McGinty Road West/MS-163
Wayzata, MN 55391",," GRN 1069 (in PDF)",,,,,,,,," Pending",,,,,,,,,, =T("1070")," Preparations containing six bacteriophages (phage) specific to Salmonella enterica"," Intended for use as an antimicrobial at levels ranging from 1 x 105 to 1 x 107 plaque-forming units (PFU)/g of fresh and processed fruit and vegetables."," Scientific procedures"," FINK TEC GmbH"," Oberster Kamp
23 D-59069
Hamm
Germany",," GRN 1070 with amendments (in PDF)",,,,,,,03/10/2023,," FDA has no Questions (in PDF)",,,,,,,,,, =T("1071")," Glucose oxidase enzyme preparation produced by Saccharomyces cerevisiae expressing a gene encoding a glucose oxidase from Aspergillus niger"," Intended for use as an enzyme at up to 30.4 mg Total Organic Solids/kg flour in the manufacture of baked goods."," Scientific procedures"," Lallemand Inc."," 1620 Prefontaine Street
Montreal, QC
H1W2N8
Canada",," GRN 1071 (in PDF)",,,,,,,,," Pending",,,,,,,,,, =T("1072")," Lemnaceae fiber"," Intended for use as an ingredient, source of dietary fiber, anticaking agent, water binding agent, thickening aid, bulking aid, emulsion stabilizer, formulation aid or binder, or purge reduction aid at levels ranging from 0.5-10% of the food (baked goods and baking mixes; meal replacement/nutritional bars, cereal bars, and granola bars; protein and nutritional drinks; breakfast cereals, soft candy; imitation cheese and cheese dips; condiments and spreads; confections and frostings; dairy product analogs, salad dressings, fish products; frozen dairy desserts (ice cream); gelatins, puddings, pie fillings; gravies and sauces; hard candy; jams and jellies; pastas; processed meat and poultry products; plant protein products (meat analogs); processed fruit and vegetable juices; snack foods and chips; soups and soup mixes; spices, seasonings, and blends; and sweet sauces, toppings, and syrups)."," Scientific procedures"," Lemnature AquaFarms USA, Inc."," 1991 74th Ave., Suite B
Vero Beach, FL 32966",," GRN 1072 with amendments (in PDF)",,,,,,,01/30/2023,," At the notifier's request, FDA ceased to evaluate this notice (in PDF)",,,,,,,,,, =T("1073")," Corn bran arabinoxylan"," Intended for use as a formulation aid (binder/gelling agent/texturizer/stabilizer/thickener/emulsifier) and a source of dietary fiber at maximum use levels ranging from 0.75% to 54.3% by weight in a variety of food categories."," Scientific procedures"," AgriFiber Solutions, LLC"," 1011 Campus Drive
Mundelein, IL 60060",," GRN 1073 (in PDF)",,,,,,,,," Pending",,,,,,,,,, =T("1074")," 3'-sialyllactose sodium salt"," Intended for use as an ingredient in non-exempt infant formula for term infants at a level up to 0.28 g/L, as consumed, and in other food categories at the maximum levels specified."," Scientific procedures"," Inbiose N.V."," Technologiepark Zwijnaarde 82 bus 41
B-9052 Gent
Belgium",," GRN 1074 with amendments (in PDF)",,,,,,,04/05/2023,," FDA has no Questions (in PDF)",,,,,,,,,, =T("1075")," 6'-sialyllactose sodium salt"," Intended for use as an ingredient in non-exempt infant formula for term infants at a maximum level of 0.4 g/L. 6?-SL will also be used as an ingredient at a maximum level of 0.3 g/L in beverages and formula for young children (>12 months of age); 2.5 g/kg in foods for infants and young children; 5 g/kg in yogurt; 0.5 g/L in buttermilk and fluid milk (flavored and unflavored); 1 g/L in meal replacement drinks; 10 g/kg in meal replacement bars; 5 g/kg in cereal and granola bars; and 0.5 g/L in soft drinks, fruit-based drinks, sports drinks, energy drinks, and enhanced waters."," Scientific procedures"," Inbiose N.V."," Technologiepark Zwijnaarde 82 bus 41
B-9052 Gent
Belgium",," GRN 1075 with amendments (in PDF)",,,,,,,03/22/2023,," FDA has no questions (in PDF)",,,,,,,,,, =T("1076")," Galacto-oligosaccharides"," Intended for use as an ingredient in powdered, ready-to-feed, and concentrated liquid forms of cow milk-based, non-exempt infant formula for term infants at a maximum level of 7.8 g/L of infant formula, as consumed. GOS is also for use as an ingredient in milk and milk products; soups; coconut beverages; bakery products; ready-to-eat cereals; jams, jellies, and preserves; and non-alcoholic beverages at maximum levels ranging from 0.55 to 33.4%."," Scientific procedures"," Vitalus Nutrition, Inc."," 3911 Mt. Lehman Rd.
Abbotsford, BC
V2T 5W5
Canada",," GRN 1076 with amendments (in PDF)",,,,,,,03/02/2023,," FDA has no questions (in PDF)",,,,,,,,,, =T("1077")," Oat polar lipid extract"," Intended for use as a source of oat phospholipids, an emulsifier, or as a partial substitute for other fats and oils in cakes, muffins and biscuits, margarine and margarine-like spreads, and chocolate at levels up to 1.0 g/100 g; white chocolate at levels up to 1.5 g/100 g; nut spreads and non-milk-based meal replacement beverages at levels up to 2.0 g/100 g; and coffee and tea whiteners at levels up to 3.0 g/100 g of finished food."," Scientific procedures"," Naturex"," Givaudan International SA
Kemptpark 50
8310 Kemptthal
Switzerland",," GRN 1077 (in PDF)",,,,,,,,," Pending",,,,,,,,,, =T("1078")," Bifidobacterium bifidum strain KCTC 12199BP"," Intended for use as an ingredient at a level up to 109 colony forming units (CFU)/serving in liquid unflavored milk, excluding use in infant formula, food products intended for infants and young children, and any products under the jurisdiction of the U.S. Department of Agriculture."," Scientific procedures"," Rejimus, Inc."," 600 W. Santa Ana Blvd.
Suite 1100
Santa Ana, CA 92701",," GRN 1078 (in PDF)",,,,,,,,," Pending",,,,,,,,,, =T("1079")," Bifidobacterium longum strain KCTC 12200BP"," Intended for use as an ingredient at a level up to 109 colony forming units (CFU)/serving in liquid unflavored milk, excluding use in infant formula, food products intended for infants and young children, and any products under the jurisdiction of the U.S. Department of Agriculture."," Scientific procedures"," Rejimus, Inc."," 600 W. Santa Ana Blvd.
Suite 1100
Santa Ana, CA 92701",," GRN 1079 (in PDF)",,,,,,,,," Pending",,,,,,,,,, =T("1080")," Bifidobacterium breve strain KCTC 12201BP"," Intended for use as an ingredient at a level up to 109 colony forming units (CFU)/serving in liquid unflavored milk, excluding use in infant formula, food products intended for infants and young children, and any products under the jurisdiction of the U.S. Department of Agriculture."," Scientific procedures"," Rejimus, Inc."," 600 W. Santa Ana Blvd.
Suite 1100
Santa Ana, CA 92701",," GRN 1080 (in PDF)",,,,,,,,," Pending",,,,,,,,,, =T("1081")," Bifidobacterium infantis strain KCTC 11859BP"," Intended for use as an ingredient at a level up to 109 colony forming units (CFU)/serving in liquid unflavored milk, excluding use in infant formula, food products intended for infants and young children, and any products under the jurisdiction of the U.S. Department of Agriculture."," Scientific procedures"," Rejimus, Inc."," 600 W. Santa Ana Blvd.
Suite 1100
Santa Ana, CA 92701",," GRN 1081 (in PDF)",,,,,,,,," Pending",,,,,,,,,, =T("1083")," Lactobacillus acidophilus CBT LA1"," Intended for use as an ingredient in dairy products at a use level up to 1011 colony forming units (CFU) per serving of food."," Scientific procedures"," Rejimus, Inc."," 600 W. Santa Ana Blvd.
Suite 1100
Santa Ana, CA 92701",," GRN 1083 (in PDF)",,,,,,,,," Pending",,,,,,,,,, =T("1084")," Lactobacillus rhamnosus CBT LR5"," Intended for use as an ingredient in dairy products at a use level up to 1011 colony forming units (CFU) per serving of food."," Scientific procedures"," Rejimus, Inc."," 600 W. Santa Ana Blvd.
Suite 1100
Santa Ana, CA 92701",," GRN 1084",,,,,,,,," Pending",,,,,,,,,, =T("1085")," Lactobacillus casei strain KCTC 12398BP"," Intended for use as an ingredient at a level up to 1011 colony forming units (CFU)/serving in dairy products."," Scientific procedures"," Cell Biotech Co. Ltd."," 50, Agibong-ro, 409 Beon-gil
Wolgot-myeon, Gimpo
Republic of Korea",," GRN 1085 (in PDF)",,,,,,,10/27/2023,," FDA has no questions (in PDF)",,,,,,,,,, =T("1086")," Lactobacillus plantarum CBT LP3"," Intended for use as an ingredient at a level up to 1011 colony forming units (CFU)/serving in dairy products."," Scientific procedures"," Cell Biotech Co. Ltd."," 50, Agibong-ro, 409 Beon-gil
Wolgot-myeon, Gimpo
Republic of Korea",," GRN 1086 (in PDF)",,,,,,,10/27/2023,," FDA has no questions (in PDF)",,,,,,,,,, =T("1087")," Streptococcus thermophilus strain KCTC 11870BP"," Intended for use as an ingredient at a level up to 1011 colony forming units (CFU)/serving in dairy products."," Scientific procedures"," Cell Biotech Co. Ltd."," 50, Agibong-ro, 409 Beon-gil
Wolgot-myeon, Gimpo
Republic of Korea",," GRN 1087 (in PDF)",,,,,,,,," Pending",,,,,,,,,, =T("1088")," Lactococcus lactis strain KCTC 11865BP"," Intended for use as an ingredient at a level up to 1011 colony forming units (CFU)/serving in dairy products."," Scientific procedures"," Cell Biotech Co. Ltd."," 50, Agibong-ro, 409 Beon-gil
Wolgot-myeon, Gimpo
Republic of Korea",," GRN 1088 (in PDF)",,,,,,,,," Pending",,,,,,,,,, =T("1089")," Lactobacillus gasseri strain NCIMB 30370"," Intended for use as an ingredient in conventional foods at levels up to 1011 colony forming units (CFU)/serving."," Scientific procedures"," Chr. Hansen"," Boege Allé 10-12
2970 Hoersholm
Denmark",," GRN 1089 with amendments (in PDF)",,,,,,,06/20/2023,," FDA has no questions (in PDF)",,,,,,,,,, =T("1090")," Bifidobacterium bifidum strain NITE BP-31"," Intended for use as an ingredient in non-exempt infant formula for term infants at a level of 2.28 x 106 colony forming units/mL."," Scientific procedures"," Meiji Co., Ltd."," 1-29-1 Nanakuni, Hachiouji
Tokyo 192-0919
Japan",," GRN 1090 with amendments (in PDF)",,,,,,,04/05/2023,," FDA has no questions (in PDF)",,,,,,,,,, =T("1091")," 2'-fucosyllactose"," Intended for use as an ingredient in non-exempt infant formula for term infants and formula intended for young children (>12 months) at up to 2.4 g/L; foods intended for infants and young children at up to 57 g/kg, drinks for young children at up to 10 g/L; and in the following food categories at maximum levels in the range of 1.2 to 80 g/kg: meal replacement drinks; sports, isotonic, energy, and soft drinks; enhanced or fortified waters; hot cereals; ready-to-eat cereals; cereal and granola bars; buttermilk; flavored milks; yogurts; nondairy milk and yogurt; fruit-based ades; fruit juices, drinks, and nectars; vegetable juices; and oral nutritional food supplements and enteral and oral tube-feeding formulas for patients ≥11 years of age."," Scientific procedures"," Inbiose N.V."," Technologiepark 82 - bus 41
B-9052 Zwijnaarde
Belgium",," GRN 1091 (in PDF)",,,,,,,,," Pending",,,,,,,,,, =T("1092")," Bifidobacterium animalis subsp. lactis IDCC 4301"," Intended for use as an ingredient at levels up to 1.02 x 1011 colony forming units (CFU)/serving in conventional foods."," Scientific procedures"," Ildong Bioscience Co., Ltd."," 17 Poseunggongdan-ro, Poseung-eup, Pyeongtaek-si
Gyonggi-do, 17957
Republic of Korea",," GRN 1092 with amendments(in PDF)",,,,,,,06/23/2023,," FDA has no Questions",,,,,,,,,, =T("1093")," Lacticaseibacillus rhamnosus IDCC 3201"," Intended for use as an ingredient at levels up to 1.02 x 1011 colony forming units (CFU)/serving in conventional foods."," Scientific procedures"," Ildong Bioscience Co., Ltd."," 17 Poseunggongdan-ro, Poseung-eup, Pyeongtaek-si
Gyonggi-do, 17957
Republic of Korea",," GRN 1093 with amendments(in PDF)",,,,,,,06/09/2023,," FDA has no Questions",,,,,,,,,, =T("1094")," Saccharomyces cerevisiae strain BY-989 expressing a gene encoding a carbon-sulfur lyase from Citrobacter freundii"," Intended for use at up to 1.5 x 107 cells per mL of wort in the production of beer to enhance the flavor profile."," Scientific procedures"," Berkeley Fermentation Science Inc."," 2451 Peralta Street
Oakland, CA 94607",," GRN 1094 (in PDF)",,,,,,,,," Pending",,,,,,,,,, =T("1095")," Bacillus subtilis strain ATCC AAN000002 spore preparation"," Intended for use as a tracer at a level of approximately 106 spores/g in fruit, vegetables, grains, oils, dairy products, nuts and seeds, and seafood to track and trace these foods through supply chains, excluding use in infant formula, any products under the jurisdiction of the U.S. Department of Agriculture, or in foods for which standards of identity do not permit its addition."," Scientific procedures"," Aanika Biosciences, Inc."," 86 34th St. Suite D-605
Brooklyn, NY 11232",," GRN 1095 with amendments (in PDF)",,,,,,,09/11/2023,," FDA has no questions (in PDF)",,,,,,,,,, =T("1096")," Saccharomyces cerevisiae strain OYR-243"," Intended for use as a starter culture at a level of approximately 1 million cells per milliliter of wort per degree Plato in the fermentation of beer to enhance the flavor profile."," Scientific procedures"," Omega Yeast Labs, LLC"," 4720 W Pensacola Ave
Chicago, IL 60641",," GRN 1096 with amendments (in PDF)",,,,,,,07/05/2023,," FDA has no questions (in PDF)",,,,,,,,,, =T("1097")," Maltogenic alpha-amylase enzyme preparation produced by Escherichia coli expressing a gene encoding a maltogenic alpha-amylase from Geobacillus stearothermophilus"," Intended for use as an enzyme at up to 34 mg total organic solids (TOS)/kg raw material in baking, brewing, and starch processing."," Scientific procedures"," Advanced Enzymes Technologies Ltd."," 5th Floor, 'A' wing, Sun Magnetica
L.I.C. Service Road, Louiswadi
Thane (W) - 400 064
India",," GRN 1097 (in PDF)",,,,,,,,," Pending",,,,,,,,,, =T("1098")," Chickpea protein concentrate"," Intended for use as a source of protein at a maximum level of 30% by weight in pasta, snacks, and sugar-free, gluten-free, and high-fiber bakery products; at a maximum level of 50% by weight in extruded snacks and non-dairy nutritional drinks and shakes; at a maximum level of 90% by weight in dry-blend protein powders; at a maximum level of 60% by weight in meal replacement and nutritional bars; at a level of 13.3-53.3% by weight in plant-based protein products and meat alternatives; at a maximum level of 25% by weight in dairy alternatives (milk, cheese, cream cheese, coffee creamer, frozen desserts, yogurt, and whipped topping); and at a maximum level of 10% by weight in vegetarian soups."," Scientific procedures"," Tate & Lyle, PLC"," 5450 Prairie Stone Parkway
Hoffman Estates, IL 60192",," GRN 1098 (in PDF)",,,,,,,,," Pending",,,,,,,,,, =T("1099")," 3-fucosyllactose"," Intended for use as an ingredient in cow milk-, soy-, and partially hydrolyzed protein-based, non-exempt infant formulas for term infants up to 0.9 g/L of formula (as consumed); formula intended for young children aged 1 to 3 years up to 1.2 g/L of formula (as consumed); other drinks and foods for infants and young children under 3 years of age that include yogurt and juice beverages up to 0.44 g/kg and hot cereals, crackers, pretzels, cookies, and snack items up to 4.4 g/kg; cereal, granola, energy, protein, and meal replacement bars; enhanced and fortified waters; sports, isotonic and energy drinks; breakfast cereals; fermented milk, flavored milk and mixes; smoothies, yogurts, meal replacement beverages (milk- and non-milk based), and milk substitutes; fruit juices and nectars; fruit-flavored beverages and vegetable juices; and gummy candies at maximum levels ranging from 0.26 to 8.8 g/kg; and in oral and enteral tube feeding formulas (11 years and older) up to 6.6 g/L (as consumed)."," Scientific procedures"," Chr. Hansen A/S"," Boege Allé 10-12
2970 Hoersholm
Denmark",," GRN 1099 with amendments (in PDF)",,,,,,,08/29/2023,," FDA has no questions (in PDF)",,,,,,,,,, =T("1101")," Dried biomass of Chlamydomonas reinhardtii strain TAI114"," Intended for use as a flavoring agent, adjuvant, and nutritive ingredient in meat, seafood, and fish alternatives at levels up to 0.7% w/w in themeat/seafood/fish alternative fraction of the finished food."," Scientific procedures"," Triton Algae Innovations"," 11760 Sorrento Valley Road, Suite R
San Diego, CA 92121",," GRN 1101 (in PDF)",,,,,,,09/01/2023,," At the notifier's request, FDA ceased to evaluate this notice (in PDF)",,,,,,,,,, =T("1102")," Invertase enzyme preparation produced by Trichoderma reesei expressing a gene for invertase from Aspergillus niger"," Intended for use as an enzyme at up to 7 mg Total Organic Solids (TOS)/kg sucrose in the production of short chain fructooligosaccharides and up to 14 mg TOS/raw material in fruit and vegetable processing."," Scientific procedures"," AB Enzymes Inc."," 8211 W. Broward Blvd., Suite 375
Plantation, FL 33324",," GRN 1102 (in PDF)",,,,,,,,," Pending",,,,,,,,,, =T("1103")," Canola protein isolate"," Intended for use as a protein source, formulation aid, nutrient supplement, stabilizer and thickener, and texturizer at maximum levels ranging from 5 to 100% in baked goods and baking mixes, non-alcoholic beverages and beverage bases, coffee and tea, breakfast cereals, grain products and pastas, dairy products and dairy product analogs, egg product analogs, fats and oils, meat product analogs, fruit and water ices, batter/breadings, protein and nutritional powders and bars, spices and seasoning mixes, nut products, processed fruits and vegetables, gravies and sauces, condiments, dips, snacks, soups and soup mixes, confections, candies and frostings, jams and jellies, gelatins, puddings, fillings, sweet sauces, toppings and syrups."," Scientific procedures"," NapiFeryn BioTech Sp. z o. o."," ul. Dubois 114/116
93-465 ?ód?
Poland",,,,,,,,,,," Pending",,,,,,,,,, =T("1104")," Egg-white protein produced by Komagataella phaffii ATCC GSD-1235"," Intended for use as a substitute for egg-white protein in foods containing eggs; and as a source of protein in baked goods; prepared foods including plant-based meat alternatives and egg noodles and pasta; ready-to-eat cereals; scrambled eggs and egg patties; pancakes and waffles; protein and snack bars; salad dressings; eggnog; egg white cocktails, and powdered shake mixes at levels in accordance with current good manufacturing practices; and as a fining agent in wine."," Scientific procedures"," Clara Foods Co. DBA The EVERY Company"," 1 Tower Place, Suite 800
South San Francisco, CA 94080",," GRN 1104 with amendments (in PDF)",,,,,,,10/17/2023,," FDA has no questions (in PDF)",,,,,,,,,, =T("1105")," Polyglycerol polyricinoleic acid"," Intended for use as an emulsifier at levels up to 0.5% in chocolate and chocolate-type products based on vegetable fats other than cocoa butter, and at levels up to 0.8% in mayonnaise and spreads."," Scientific procedures"," Unilever"," 700 Sylvan Avenue
Englewood Cliffs, NJ 07632",," GRN 1105 with amendments (in PDF)",,,,,,,06/14/2023,," FDA has no questions (in PDF)",,,,,,,,,, =T("1106")," Rebaudioside I obtained by enzymatic treatment of steviol glycosides purified from the leaves of Stevia rebaudiana (Bertoni) Bertoni (rebaudioside I)"," Intended for use as a general-purpose sweetener in foods, excluding infant formula and meat and poultry products, at levels determined by good manufacturing practices."," Scientific procedures"," Manus Bio, Inc."," 1030 Massachusetts Ave
Unit #300
Cambridge, MA 02138",," GRN 1106 with amendments (in PDF)",,,,,,,06/16/2023,," FDA has no questions (in PDF)",,,,,,,,,, =T("1107")," Bifidobacterium longum subsp. infantis strain LMG 11588"," Intended for use in non-exempt powdered infant formula for term infants and powdered formula for young children (> 12 months) at a level up to 1.2 x 108 colony forming units/g of powdered formula."," Scientific procedures"," Nestlé Nutrition"," 1812 North Moore Street
Arlington, VA 22209",," GRN 1107 (in PDF)",,,,,,,,," Pending",,,,,,,,,, =T("1108")," Lactiplantibacillus plantarum strain MCC 0537"," Intended for use as an ingredient at approximately up to 1010 colony forming units (CFU)/serving in yogurt and other milk-based products, dairy alternatives, soy products, fruit drinks, frostings, frozen dairy desserts and mixes, fruit and water ices, drinking water, sports drinks, chewing gum, extracts, and flavorings, condiments, herbs, seeds, spices, seasonings, blends, nuts and nut products, plant-protein products, cereals, processed fruits, processed vegetables and vegetable juices, snack foods, and toppings."," Scientific procedures"," Advanced Enzyme Technologies, Ltd."," 5th Floor, 'A' wing, Sun Magnetica
L.I.C. Service Road, Louiswadi
Thane (W) - 400 064
India",," GRN 1108 with amendments (in PDF)",,,,,,,08/16/2023,," FDA has no questions (In PDF)",,,,,,,,,, =T("1109")," β-agarase enzyme preparation produced by Streptomyces coelicolor"," Intended for use as an enzyme at up to 20 mg Total Organic Solids (TOS)/g agar-agar in the production of neoagarooligosaccharides (NAO) intended for use in food."," Scientific procedures"," Dyne Bio Inc."," B-B205 14 Sagimakgol-ro 45beon-gil Jungwon-gu
Seongnam-si Gyeonggi-do 13209
Korea",," GRN 1109 (in PDF)",,,,,,,,," Pending",,,,,,,,,, =T("1110")," Polygalacturonase enzyme preparation produced by Trichoderma reesei expressing a gene encoding a polygalacturonase from Aspergillus kawachii"," Intended for use as an enzyme at up to 5 mg total organic solids (TOS)/kg raw material in the processing of fruits, vegetables, and coffee, and in the production of flavorings and wine."," Scientific procedures"," AB Enzymes Inc."," 8211 W. Broward Blvd., Suite 375
Plantation, FL 33324",," GRN 1110 (in PDF)",,,,,,,,," Pending",,,,,,,,,, =T("1111")," Endo-1,4-β-xylanase enzyme preparation produced by Bacillus subtilis expressing the gene encoding xylanase from B. subtilis"," Intended for use as an enzyme at up to 50 mg total organic solids (TOS)/kg raw material in baking, brewing, and in grain processing."," Scientific procedures"," AB Enzymes Inc."," 8212 W. Broward Blvd., Suite 375
Plantation, FL 33324",," GRN 1111 (in PDF)",,,,,,,,," Pending",,,,,,,,,, =T("1112")," Limosilactobacillus reuteri strain ATCC PTA-126787 and L. reuteri strain ATCC PTA-126788, in combination, on a 1:1 ratio of colony forming unit (CFU) basis"," Intended for use as an ingredient at a maximum level up to 5 x 108 CFU/serving in cream cheese, natural cheese, processed cheese and spreads; sour cream; and energy, granola, and meal replacement bars; and up to 1 x 109 CFU/serving in ice cream, frozen yogurt and novelties; yogurt and yogurt drinks; flavored milk, fermented milk, and milk drinks; meal-replacement beverages; soy-based beverages; and refrigerated fruit and vegetable beverages."," Scientific procedures"," BiomEdit, LLC"," 10100 Lantern Rd, Suite 150
Fishers, IN 46037",,,,,,,,,,," Pending",,,,,,,,,, =T("1113")," Lactobacillus plantarum NCIMB 30562"," Intended for use as an ingredient in non-exempt infant formula for term infants at a level up to 1.1 x 108 colony forming units (CFU)/g, as well as in conventional foods at levels up to 1.0 x 1011 CFU/g."," Scientific procedures"," Chr. Hansen A/S"," Boege Allé 10-12
2970 Hoersholm
Denmark",," GRN 1113 with amendments (in PDF)",,,,,,,07/20/2023,," FDA has no questions (in PDF)",,,,,,,,,, =T("1114")," Bifidobacterium breve DSM 33444"," Intended for use as an ingredient in non-exempt infant formula for term infants at a level up to 1.0 x 108 colony forming units (CFU)/g, as well as in conventional foods at levels up to 5.0 x 109 CFU/g."," Scientific procedures"," Chr. Hansen A/S"," Boege Allé 10-12
2970 Hoersholm
Denmark",," GRN 1114 with amendments (in PDF)",,,,,,,07/10/2023,," FDA has no questions (in PDF)",,,,,,,,,, =T("1115")," Fungal oil (≥40% arachidonic acid (ARA)) from Mortierella alpina strain AF"," Intended for use as an ingredient in cow milk- and soy-based, non-exempt infant formula for term infants at levels providing up to 0.75% of fat as ARA and in exempt infant formula for pre-term infants at levels providing up to 0.4% of fat as ARA. Hubei Fuxing states that M. alpina oil will be used in combination with a safe and suitable source of docosahexaenoic acid (DHA) at a ratio ranging from 1:1 to 2:1 ARA:DHA."," Scientific procedures"," Hubei Fuxing Biotechnology Co., Ltd."," No. 18 Fuxing Ave
Chenhu Town, Hanchuan City 431608, Hubei Province
China",," GRN 1115 with amendments (in PDF)",,,,,,,09/18/2023,," FDA has no questions (in PDF)",,,,,,,,,, =T("1116")," Shea stearin"," Intended for use as a source of fat in plant-based burgers/ground meat and sausages at a use level of 14%, plant-based dairy alternatives and dairy analogues at use levels from 3.5% to 45%, fillings in cookies and wafers at a use level of 40%, fillings in confectionery products at a use level of 35%, nut/seed spreads and butters at a use level of 45%, margarines and spreads at a use level of 35%, and bakery products a use levels from 15% to 20%."," Scientific procedures"," AAK USA, Inc."," 499 Thornall Street
Edison, NJ 08837",," GRN 1116 part 1 (GRN Parts 1 - 4) (in PDF)"," GRN 1116 part 2 (GRN Parts 5 - 7) (in PDF)"," GRN 1116 part 3 (GRN Appendix A and B) (in PDF)"," GRN 1116 part 4 (GRN Appendix C) (in PDF)"," GRN 1116 part 5 (GRN Appendix C Cont.) (in PDF)"," GRN 1116 part 6 (GRN Appendix D - H) (in PDF)",,,," Pending",,,,,,,,,, =T("1117")," Mycelial biomass from Neurospora crassa"," Intended for use as an ingredient and a source of protein at levels up to 90% in meat (including pork), poultry, and seafood, and in meat, poultry, seafood, and dairy alternatives."," Scientific procedures"," The Better Meat Co."," 2939 Promenade Street
West Sacramento, CA 95691",," GRN 1117 (in PDF)",,,,,,,,," Pending",,,,,,,,,, =T("1118")," Pyrroloquinoline quinone disodium salt"," Intended for use as an ingredient at a level up to 20 mg/serving in enhanced and fortified water beverages; up to 12 mg/serving in energy drinks; and up to 8 mg/serving in sports and electrolyte drinks, bottled waters, and non-milk based meal replacement beverages."," Scientific procedures"," Zhejiang Medicine Co., ltd."," 98 East Xinchang Dadao Road
Xinchang, Zhejiang Province
China",," GRN 1118 with amendments (in PDF)",,,,,,,07/31/2023,," FDA has no questions (in PDF)",,,,,,,,,, =T("1119")," Olea europaea L. leaf extract"," Intended for use as an ingredient at levels up to 0.1% in yogurt, flavored milk drinks, coconut beverages, fruit juices and nectars, vegetable juices, fruit-flavored beverages, fortified water, teas and coffees, nutrition drinks and powders, and sports drinks; at levels up to 0.83% in dry powdered milk and milk mixtures that are not reconstituted, certain cookies, cereal, granola, and nutrition bars, and dark chocolate, gum drops, hard candy, and dietetic candy; at levels up to 1.7% in table fats and vegetable oils; and at levels up to 8.3% in chewing gum."," Scientific procedures"," BioActor B.V."," Gaetano Martinolaan 50
6229 GS Maastricht
Netherlands",," GRN 1119 (in PDF)",,,,,,,,," Pending",,,,,,,,,, =T("1120")," α-galactosidase enzyme preparation produced by Aspergillus niger"," Intended for use as an enzyme at up to 2.54 g Total Organic Solids (TOS)/kg legume or wheat in the production of plant-based yogurt and dairy analogues, as well as plant-based meat analogues."," Scientific procedures"," Novozymes North America"," 77 Perrys Chapel Church Rd., Box 576
Franklinton, NC 27525",," GRN 1120 (in PDF)",,,,,,,,," Pending",,,,,,,,,, =T("1121")," Fructanase enzyme preparation produced by Trichoderma reesei expressing the gene encoding fructanase from Lactobacillus sp."," Intended for use as an enzyme at up to 12 mg total organic solids (TOS)/kg raw material in baking."," Scientific procedures"," AB Enzymes Inc."," 8211 W. Broward Blvd., Suite 375
Plantation, FL 33324",," GRN 1121 (in PDF)",,,,,,,,," Pending",,,,,,,,,, =T("1122")," Canola concentrate"," Intended for use as a protein source, fiber source, thickener, or texturizer in nutritional powders at a maximum use level of 100%; snack foods at a maximum use level of 40%; breakfast cereals at a maximum use level of 35%; nut spreads, nut butters, processed fruits, vegetables, and legumes, and jams, jellies, puddings, and fillings at a maximum use level of 30%; bakery products and baking mixes, grain products and pastas, meat product alternatives, nutritional bars, and confections, candies, and frostings at a maximum use level of 20%;dairy products and dairy alternatives, processed meat and poultry, soups, and soup mixes at a maximum use level of 15%; fats, oils, and salad dressings, batters and breadings, sauces, gravies, condiments, dips, sweet sauces, toppings, and syrups at a maximum use level of 10%; non-alcoholic beverages and beverage bases, coffee, tea, egg substitutes, fruit and water ices at a maximum use level of 7%; and spices and seasoning mixes at a maximum use level of 5%."," Scientific procedures"," NapiFeryn BioTech Sp. Z o. o."," Ul. Dubois 114/116
?ód? 93-465
Poland",,,,,,,,,,," Pending",,,,,,,,,, =T("1123")," Sucrose fatty acid esters"," Intended for use as an emulsifier or stabilizer in chocolate and chocolate-containing products, including imitation and chocolate substitute products, at a maximum use level of 0.3%."," Scientific procedures"," Mitsubishi Chemical Corporation"," 1-1, Marunouchi 1-chrome
Chiyoda-ku, Tokyo
Japan",," GRN 1123 with amendments (in PDF)",,,,,,,11/03/2023,," FDA has no questions (in PDF)",,,,,,,,,, =T("1124")," β-glucans from Hericium erinaceus strain BCRC 35669"," Intended for use as an ingredient at levels up to 150 mg/serving in cookies; non-milk and milk-based meal replacement beverages; cereal bars (breakfast, granola, and protein); soy protein bars; soy milk; yogurt, yogurt beverages, and milk-based beverages containing live microorganisms; fruit juices, drinks, and smoothies); and chocolate confections."," Scientific procedures"," Super Beta Glucan, Inc."," 5 Holland, Unit 109
Irvine, CA 92618",," GRN 1124 with amendments (in PDF)",,,,,,,09/28/2023,," At the notifier's request, FDA Ceased to evaluate this notice (in PDF)",,,,,,,,,, =T("1125")," Pea protein fermented by shiitake mycelia"," Intended for use at levels up to 40% in baked goods and baking mixes, beverages and beverages bases, breakfast cereals, coffee and tea, dairy product alternatives, grain products and pastas, milk products, nut and nut products, plant protein products, snack foods, and soups and soup mixes."," Scientific procedures"," MycoTechnology, inc."," 18250 E 40th Ave Suite 50
Aurora, CO 80011",,,,,,,,,,," Pending",,,,,,,,,, =T("1126")," Calcium acetate"," Intended for use as an antimicrobial agent at a maximum use level of 0.2% in baked goods, gelatins, puddings, and fillings; 0.15% in sweet sauces, toppings, and syrups, 0.02% in cheese; and 0.0001% for all other food categories. Calcium acetate is also intended to be used as a firming agent, flavor enhancer, flavoring agent or adjuvant, nutrient supplement, and stabilizer and thickener in food at levels not to exceed current good manufacturing practices."," Scientific procedures"," Niacet Corporation"," 400 47th Street
Niagara Falls, NY 14304",," GRN 1126 (in PDF)",,,,,,,,," Pending",,,,,,,,,, =T("1127")," Lactiplantibacillus plantarum ATCC-202195"," Intended for use in non-exempt cow milk- or soy-based infant formula for term infants, non-exempt partially hydrolyzed cow milk-based infant formula for term infants, exempt extensively hydrolyzed cow milk-based infant formula for term infants, and formula for young children (> 12 months) at a level up to 108 colony forming units (CFU)/g of powdered formula; in juices and drinks, cereal and grain products, and fruit and vegetable purees for infants and young children at 2 x 1010 CFU/serving; and in flavored milk beverages, dairy and non-dairy yogurt and smoothies, soy products, powdered meal replacement beverages, fruit juices and nectars, fruit-based beverages, candy, and cereal and nutrition bars at 2 x 1010 CFU/serving."," Scientific procedures"," Danisco USA, Inc."," DuPont Experimental Station
E353 200 Powder Mill Road
Wilmington, DE 19803",,,,,,,,,,," Pending",,,,,,,,,, =T("1128")," Algal oil (≥35% docosahexaenoic acid) from Schizochytrium sp."," Intended for use as an ingredient at levels up to 2.4% in the food categories listed in 21 CFR 184.1472(a)(3) (Menhaden oil)."," Scientific procedures"," Jiangsu Grand Xianle Pharmaceutical Co."," No. 1 Zhongshan Seven Road Costal Industrial Park
Yancheng, Jiangsu
China",,,,,,,,,,," Pending",,,,,,,,,, =T("1129")," Heat-killed Clostridium tyrobutyricum strain ASM#19"," Intended for use as a source of protein in a variety of foods and beverages at levels ranging from 5 to 90%."," Scientific procedures"," Superbrewed Food, Inc."," 239 Lisa Drive
New Castle, DE 19720",," GRN 1129 (in PDF)",,,,,,,,," Pending",,,,,,,,,, =T("1130")," Lactobacillus rhamnosus CGMCC21225"," Intended for use as an ingredient at a maximum level of 1 x 109 CFU/serving in energy and sports drinks; flavored, carbonated, enhanced and fortified waters; meal replacement, protein, and nutritional drinks; bottled tea; processed fruits and fruit juices; breakfast cereals; cheeses; chewing gum; buttermilk; plain fermented milks; flavored milks, milk drinks, and mixes; milk shakes; evaporated and condensed milks; yogurt and yogurt drinks; milk-based gelatins, puddings, and filings; soy-based drinks and other soy-based products; bars; soft and hard candies; and foods intended for infants (cereals, fruits, vegetables, and fruit juices)."," Scientific procedures"," Glac Biotech Co., Ltd."," 3F-2, No. 17, Guoji Rd.
Xinshi Dist., Tainan City 74442
Taiwan",,,,,,,,,,," Pending",,,,,,,,,, =T("1131")," Bacillus subtilis ATCC BS50 PTA-127287"," Intended for use as an ingredient at a maximum level of 2 x 109 colony forming units (CFU)/serving in baked goods and baking mixes, non-alcoholic beverages and beverage bases, breakfast cereals, cheese, chewing gum, coffee and tea, confections and frostings, dairy product alternatives, frozen desserts, fruit and water ices, gelatins, puddings and fillings, grain products and pastas, hard candy and cough drops, milk products, plant protein products, processed fruits and fruit juices, processed vegetables and vegetable juices, snack foods and soft candy."," Scientific procedures"," BIO-CAT Microbials, LLC"," 689 Canterbury Rd
Shakopee, MN 55379",," GRN 1131 with amendments (in PDF)",,,,,,,10/20/2023,," FDA has no questions (in PDF)",,,,,,,,,, =T("1132")," Hydrolyzed poultry protein"," Intended for use as a flavoring agent and source of protein at levels up to 2 g per serving in gravies; at levels up to 5 g per serving in mayonnaise and other condiments, tomato-based juices, popcorn, pretzels, chips, and crackers; at levels up to 10 g per serving in soups; and at levels up to 20 g per serving in nutrition bars, protein drinks and protein powder mixes, ready-to-drink meal replacement and nutritional beverages, and medical foods; and at levels up to 2% (w/w) in seasonings for meat coatings and rubs and in seasoning pastes."," Scientific procedures"," Norilia AS"," Lørenveien 37
Oslo 0585
Norway",," GRN 1132 (in PDF)",,,,,,,,," Pending",,,,,,,,,, =T("1133")," Resistant dextrin from corn"," Intended for use as an ingredient (powder or syrup form) at maximum levels ranging from 1.2 to 10 g (powder) per serving or 1.56 to 13 g (syrup) per serving in baked goods; beverages and beverage powders; cereals and granola bars; condiments and dressings; confections; dairy products; frozen desserts; gravies and sauces; meal replacements; pasta and grain products; prepared meals and soups; processed fruits; shelf-stable desserts; snacks and crackers; and nutrition bars."," Scientific procedures"," Anderson Global Group"," 2020 Main Street
Irvine, CA 92614",," GRN 1133 (in PDF)",,,,,,,,," Pending",,,,,,,,,, =T("1134")," Bacteriophage preparation specific to Salmonella Enteritidis"," Intended for use as an antimicrobial on ground chicken at levels up to 2 x 108 plaque forming units (PFU)/g of food."," Scientific procedures"," Qingdao Phagepharm Bio-Tech Co., Ltd"," Future Science and Technology Industrial Park No. 106
Xiangyang Road
Chenyang District, Qingdao, Shandong
China",,,,,,,,,,," Pending",,,,,,,,,, =T("1135")," Galacto-oligosaccharides"," Intended for use as an ingredient in powdered, ready-to-feed, and concentrated liquid forms of cow milk-based, non-exempt infant formula for term infants at a maximum level of 7.8 g/L of infant formula, as consumed. GOS is also for use as an ingredient in cereals, pudding, and custards for infants at levels up to 14 g/kg; drinks for infants at levels up to 16 g/L; milk and milk-based drinks, yogurt, meal replacement drinks and bars, imitation milk, milk-based desserts, soups and soup mixes, coconut beverages, baked goods, cereal bars, ready-to-eat breakfast cereals, soft and hard candies, jams, jellies, preserves, fruit juices, fruit drinks, nectars, vegetable juices, coffee and coffee drinks, smoothies, soft drinks, and non-alcoholic fermented drinks at maximum levels ranging from 0.42 to 25%; and chewing gum up to 42.7%."," Scientific procedures"," Vitalus Nutrition, Inc."," 3911 Mt. Lehman Rd.
Abbotsford, BC
V2T 525
Canada",," GRN 1135 with amendments (in PDF)",,,,,,,11/03/2023,," At the notifier's request, FDA ceased to evaluate this notice (in PDF)",,,,,,,,,, =T("1136")," Dry whole goat milk"," Intended for use as a source of protein in ready-to-feed or powdered, non-exempt infant formula for term infants at a typical level of 5.5 g/100 mL of infant formula as consumed."," Scientific procedures"," Jovie USA LLC"," 1600 Golf Road Corporate Center
Suite 1200
Rolling Meadows, IL 60008",," GRN 1136 with amendments (in PDF)",,,,,,,10/31/2023,," FDA has no questions (in PDF)",,,,,,,,,, =T("1138")," Hydroxytyrosol"," Intended for use as an antioxidant at levels of 5 mg per serving in ready-to-drink beverages (sports drinks, energy drinks, nutritional drinks and shakes, fruit-flavored drinks and flavored waters); and at levels of 10 mg per serving in fats and oils (butter, margarine, oil and shortening, salad dressing, mayonnaise and mayonnaise-type sandwich spreads); and fruit and vegetable juices."," Scientific procedures"," Hangzhou Viablife Biotech"," 3rd Floor, Building 5 University Park of Liangzhu
Hangzhou, Zhejiang 311111
China",,,,,,,,,,," Pending",,,,,,,,,, =T("1139")," Transglutaminase enzyme preparation produced by Bacillus licheniformis carrying a gene encoding transglutaminase from Streptomyces mobaraensis"," Intended for use as an enzyme at up to 1.2 g Total Organic Solids /kg protein in the production of dairy foods (milk, fermented milk, yogurt, cheese), plant-based dairy analogues, plant-based egg analogues, plant-based meat analogues, tofu, processed fish (non-Siluriformes only), seafood and plant-based seafood analogues, baked goods, cereals and grain-based products, and brewing and other cereal-based or plant-based beverages."," Scientific procedures"," Novozymes North America"," 77 Perrys Chapel Church Rd., Box 576
Franklinton, NC 27525",,,,,,,,,,," Pending",,,,,,,,,, =T("1140")," Enzyme-modified steviol glycosides"," Intended for use as a general-purpose sweetener in foods, excluding infant formula and meat and poultry products, at levels determined by good manufacturing practices."," Scientific procedures"," Tate & Lyle"," 5450 Prairie Stone Parkway
Hoffman Estates, IL 60192",,,,,,,,,,," Pending",,,,,,,,,, =T("1141")," L-α-glycerophosphorylcholine"," Intended for use as a source of choline at levels up to 600 mg/serving in soft drinks, sports and energy drinks, powdered beverage mixes, coffee and tea, gummy candy, nutritional beverages, protein and nutritional powders, and cereal and nutrition bars."," Scientific procedures"," Shenyang Gold Jyouki Technology Co., Ltd"," Shenyang Gold Jyouki Technology Co., Ltd
Room 401, Building F8, No. 860-1
Shenben Avenue, Hunnan District,
Shenyang, Liaoning
China",,,,,,,,,,," Pending",,,,,,,,,, =T("1142")," Brazzein produced by Komagataella phaffii expressing a gene encoding for brazzein from Pentadiplandra brazzeana"," Intended for use as a sweetener at maximum levels ranging from 2 to 99 mg/100 g in packaged alcoholic cocktail drinks; packaged water-based beverages; non-milk-based meal replacement beverages and protein drinks; chewing gum; ready-to-drink coffee and tea beverages; milk substitutes; non-dairy yogurts; ice cream; frozen yogurt; frozen milk desserts and bars; edible ices; sherbet; sorbet; cereal, granola, energy, protein, and meal replacement bars; granola; packaged milk-based beverages; yogurt and yogurt drinks; packaged fruit drinks, nectars, and fruit-based smoothies; fruit-based bars; truffles; and gummy bears."," Scientific procedures"," Oobli, Inc."," 202 Cousteau Place, Suite 210
Davis, CA 95618",,,,,,,,,,," Pending",,,,,,,,,, =T("1143")," Bacillus subtilis NRRL 68053"," Intended for use as an ingredient at a maximum level of 1 x 1010 colony forming units (CFU)/serving in conventional foods"," Scientific procedures"," Microbial Discovery Group"," 5200 W. Ashland Way
Franklin, WI 53132",,,,,,,,,,," Pending",,,,,,,,,, =T("1144")," Miracle fruit (Synsepalum dulcificum) powder"," Intended for use as a taste modifier at a maximum level of 0.005% in water-based beverages."," Scientific procedures"," Miracle Fruit Farm LLC"," 16300 SW 184th Street
Miami, FL 33187",,,,,,,,,,," Pending",,,,,,,,,, =T("1145")," β-lactoglobulin produced by Aspergillus oryzae strain Ao_st0002"," Intended for use as a source of protein at levels ranging from 5 to 35 % in meal replacements and supplements, powdered nutritional beverages, electrolyte-sports drinks, high protein performance nutritional beverages, and nutritional bars; milk and milk substitutes, milk drinks, yogurt and fermented milk products, creams and cream substitutes, cheeses, spreads and dips, dairy-based frozen desserts and mixes; desserts and mousses; confections, coatings and fillings; baked goods; salad dressings, minor main entrée sauces; and egg substitutes."," Scientific procedures"," Imagindairy Ltd."," Nahum Het St 7, Tirat Carmel
3508504
Israel",,,,,,,,,,," Pending",,,,,,,,,, =T("1146")," Nuclease enzyme preparation produced by Bacillus amyloliquefaciens expressing the gene encoding a nuclease from Serratia marcescens"," Intended for use as an enzyme at up to 143.1 mg total organic solids (TOS)/ kg microbial biomass in manufacturing of microbial-derived ingredients."," Scientific procedures"," c-LEcta GmbH"," Perlickstr. 5
04103 Leipzig
Germany",,,,,,,,,,," Pending",,,,,,,,,, =T("1147")," Copper(II) ion"," Intended for use as an antimicrobial agent in linear low-density polyethylene food packaging at a maximum level of 100 mg/m2. The packaging is intended to be used for fresh beef, fresh poultry, fresh pork, sausage, deli meat, fresh salmon and fresh cheese."," Scientific procedures"," Copperprotek SPA"," Cerro Los Cóndores 9881 A,
Quilicura, Región Metropolitana
Chile",,,,,,,,,,," Pending",,,,,,,,,, =T("1148")," D-psicose"," Intended for use as a sweetener at levels ranging from 2-100% in bakery products (rolls, cakes, pies, pastries, and cookies: low calorie or dietetic); non-alcoholic beverages (low- and reduced-calorie, sugar-free); cereals (<5% sugar (ready-to-eat), regular, low- and reduced-calorie, sugar free); chewing gums; coffee mix; confections and frostings; dressings for salads; fat-based creams; frozen dairy desserts (ice cream, soft serve, and sorbet: low- and reduced-calorie, sugar-free); gelatins, pudding, and fillings (low- and reduced-calorie, sugar-free); hard candies (low-calorie); soft candies (non-chocolate, plain chocolate, and chocolate coated: low-and reduced-calorie, sugar-free); jams and jellies; sugar; sugar substitutes; sweet sauces and syrups (low- and reduced-calorie, sugar-free); yogurt (regular and frozen: low- and reduced-calorie, sugar-free); nutrition bars, grain-based cereal bars, and protein bars; and alcoholic beverages (premixed cocktails, wine cooler, hard seltzer, and malt beverage: low- or reduced-calorie, low- or reduced-sugar)."," Scientific procedures"," Daesang Corporation"," Jongno Place, 120, Changgyeonggung-ro
Jongno-gu, Seoul
South Korea",,,,,,,,,,," Pending",,,,,,,,,, =T("1149")," High-selenium Saccharomyces cerevisiae yeast"," Intended for use as a nutrient in non-exempt infant formula for term infants at use levels ranging from 2.0 7.0 ?g selenium/100 kcal infant formula, intended to comply with use levels of selenium established in 21 CFR 107.100(a)."," Scientific procedures"," Cypress Systems, Inc."," 40365 Brickyard Drive, Suite 101
Madera, CA 93636",,,,,,,,,,," Pending",,,,,,,,,, =T("1150")," Triacylglycerol lipase enzyme preparation produced by Trichoderma reesei expressing a gene for triacylglycerol lipase from Thermomyces lanuginosis"," Intended for use as an enzyme at up to 4 mg Total Organic Solids/kg cereal in the production of baked goods and other cereal based products."," Scientific procedures"," AB Enzymes Inc."," 8211 W. Broward Blvd., Suite 420
Plantation, FL 33324",,,,,,,,,,," Pending",,,,,,,,,, =T("1151")," Fava bean protein"," Intended for use as a source of protein in dry-blend protein powders at levels up to 90%; beverages, soups and nutritional beverages at levels up to 50%; meat alternatives at levels up to 30%; meal replacement and nutritional bars at levels up to 20%; imitation dairy products, snack foods, and bakery products at levels up to 10%; and processed meat products at levels up to 7% by weight in the food as consumed."," Scientific procedures"," Cooperative Koninklijke Cosun U.A."," Kreekweg 1, 4671 VA Dinteloord
The Netherlands",,,,,,,,,,," Pending",,,,,,,,,, =T("1152")," Phoenix oyster mushroom (Pleurotus pulmonarius) mycelia biomass"," Intended for use as a source of protein and fiber in dairy alternatives (milk, cream, yogurt, ice cream, and processed cheese); meat alternatives; fish and seafood alternatives; and baked goods at maximum levels ranging from 10 to 25 g/100g."," Scientific procedures"," Mushlabs GmbH"," Humboldtstr. 59
22083 Hamburg
Germany",,,,,,,,,,," Pending",,,,,,,,,, =T("1153")," Pongamia bean oil"," Intended for use as a substitute for existing fats and oils in dairy drinks and alternatives, cheeses (including alternatives and spreads), meat and poultry alternatives, seafood alternatives, egg product alternatives, plant-based protein foods (nuts and seeds, processed soy products), breads and bread products, rolls and tortillas, cooked cereals, crackers, snack and meal bars, sweet bakery products, chips, popcorn, pretzels, cooked vegetables, sweetened beverages, nutritional and smoothie-type beverages, protein and nutritional powders, fats and oils, and condiments and sauces at levels up to 351 g/kg."," Scientific procedures"," Terviva, Inc."," 980 Atlantic Ave. #105
Alameda, CA 94501",,,,,,,,,,," Pending",,,,,,,,,, =T("1154")," Triacylglycerol lipase enzyme preparation produced by Komagataella phaffii expressing the gene encoding lipase from Fusarium oxysporum"," Intended for use as an enzyme at up to 8.46 mg total organic solids (TOS)/kg flour in baking."," Scientific procedures"," Lallemand Inc."," 1620 Préfontaine
Montreal, Quebec
H1W 2N8
Canada",,,,,,,,,,," Pending",,,,,,,,,, =T("1155")," 1-methylcyclopropene"," Intended for use as an ethylene inhibitor in food packaging for cut fresh produce (sliced melon, pineapple, apple, mushroom and shredded cabbage/coleslaw) to extend shelf life of the fresh produce at a maximum level of 9.086 ?g/kg of produce."," Scientific procedures"," Fresh Inset S.A."," Wilenska 4/A017
87-100 Torun
Poland
",,,,,,,,,,," Pending",,,,,,,,,, =T("1157")," 2'-fucosyllactose"," Intended for use as an ingredient in milk- and soy-based, non-exempt infant formula for term infants at up to 2.4 g/L of formula as consumed; in formula intended for young children (> 12 months 3 years) and meal replacement drinks for young children ages 1 3 years at up to 2.4 g/L, as consumed; in foods intended for infants and young children: up to 10.0 g/L in yogurt and juice drinks, 10.9 g/kg in cereals and desserts, and 57 g/kg in dry snacks; in sports and ""energy"" drinks, flavored water, fruit juices and drinks, milk drinks, dairy alternatives, milk-based meal replacements, and nutritional drinks for pregnant women at maximum levels in the range of 0.8-6 g/L; and in the following food categories at maximum levels in the range of 4.8-80 g/kg: breakfast cereals; frozen dairy desserts; puddings, custards, mousses, and fruit fillings; yogurt; meal replacement and snack bars; syrups; and jams, jellies, fruit preserves, and fruit butters."," Scientific procedures"," Synaura Biotechnology (Shanghai) Co., Ltd."," Floor l-2, Building 2, Lane 500
Furong Hua Road, Pudong New Area
Shanghai
China",,,,,,,,,,," Pending",,,,,,,,,, =T("1158")," Lactiplantibacillus plantarum DSM 34613"," Intended for use at a maximum level of 1.5 x 108 colony forming units (CFU)/g in wine production to induce malolactic fermentation and to prevent the growth of microorganisms that could cause off flavors in the finished product."," Scientific procedures"," Scott Laboratories, Inc."," 1480 Cader Ln.
Petaluma, CA 94954",,,,,,,,,,," Pending",,,,,,,,,, =T("1159")," Bacillus coagulans strain BCP92 spore preparation"," Intended for use as an ingredient at a maximum level of 2 x 109 colony forming units (CFU)/serving in baked goods and baking mixes; breakfast cereals; non-alcoholic beverages and beverages bases; coffee and tea; milk and milk products; dairy product alternative; fruit juices; condiments and relishes; confections and frostings; frozen dairy desserts and mixes; fruit and water ices; jams and jellies; gelatins, puddings and fillings; alcoholic beverages; grain products and pastas; hard candy; soft candy; chewing gum; extracts, flavorings, herbs, seeds, spices, seasonings, and blends; nuts and nut products; plant protein products; processed fruits; processed vegetables and vegetable juices; snack foods; soups and soup mixes; sugar; and sweet sauces, toppings, and syrups."," Scientific procedures"," Pellucid Lifesciences Pvt., Limited"," Plot No. 3538, Phase 4, GIDC Industrial Estate
Chhatral 382729, Gandhinagar, Gujarat
India",,,,,,,,,,," Pending",,,,,,,,,, =T("1160")," Lemna leaf protein"," Intended for use as an ingredient, source of protein, emulsifier, gelation agent/thickener at a maximum level of 20% in baked goods and baking mixes, non-alcoholic beverages, breakfast cereals, frozen dairy desserts, pasta, milk substitutes, milk products (spreads, dips, cream substitutes), plant protein products, processed fruit and fruit juices, snack foods, desserts and mousses, confections, soups and soup mixes, salad dressings, savory extracts, and sauce ingredients."," Scientific procedures"," Plantible Foods"," 2600 Sarver Lane
San Marcos, CA 92069",,,,,,,,,,," Pending",,,,,,,,,, =T("1161")," Triacylglycerol lipase enzyme preparation produced by Candida cylindracea"," Intended for use as an enzyme at up to 1500 mg Total Organic Solids/kg raw material in the manufacture of cheeses and edible oils, as well as in various brewing, flavoring, and baking applications."," Scientific procedures"," Meito Sangyo Co., Ltd."," 2973-2 Ishikawa-machi
Hachioji 192-8509, Tokyo
Japan",,,,,,,,,,," Pending",,,,,,,,,, =T("1163")," A preparation containing two bacteriophages (phage) specific to Salmonella enterica"," Intended for use as an antimicrobial on the surface of raw poultry at levels up to 2 x 108 plaque forming units (PFU)/g of food."," Scientific procedures"," Cytophage Technologies inc."," 26 Henlow Bay
Winnipeg, MB
R3Y 1G4
Canada",,,,,,,,,,," Pending",,,,,,,,,, =T("1100")," Fractionated whey protein concentrate containing 41% alpha-lactalbumin"," Intended for use as a source of protein at levels up to 30% (w/w) in meal replacement and nutrition bars and at levels in foods, as consumed, up to 5% (w/w), in milk-based drinks and meal replacements, sport drinks, enhanced waters, fruit-juice drinks, yogurt, and fermented milk drinks."," Scientific procedures"," Arla Foods Ingredients Group P/S"," Sonderhog 10-12
8260 DK- Viby J
Denmark",," GRN 1100 with amendments(in PDF)",,,,,,,10/27/2023,," FDA has no questions",,,,,,,,,, =T("1082")," Bifidobacterium lactis strain KCTC 11904BP"," Intended for use as an ingredient at a level up to 109 colony forming units (CFU)/serving in liquid unflavored milk, excluding use in infant formula, food products intended for infants and young children, and any products under the jurisdiction of the U.S. Department of Agriculture."," Scientific procedures"," Rejimus, Inc."," 600 W. Santa Ana Blvd.
Suite 1100
Santa Ana, CA 92701",," GRN 1082 with amendments(in PDF)",,,,,,,10/31/2023,," FDA has no questions",,,,,,,,,, =T("886")," Monoacylglycerides from grape seed"," Intended for use as a component of a surface finishing agent to protect the freshness and extend the shelf life of fresh produce at levels not to exceed good manufacturing practice (GMP). The use is self-limiting for technological reasons and that will be used at a level up to 1.52 grams per kilogram of produce."," Scientific procedures"," Apeel Sciences"," 71 S Los Carneros Road
Goleta, CA 93117",," GRN 886 (in PDF)",,,,,,,07/13/2020,09/11/2020," FDA has no questions",,,,,,,,,, =T("1137")," Protein-sucrose"," Intended to be used at levels ranging from 0.01 to 0.8% on a protein basis to improve the perception of sweetness of white granulated sugar."," Scientific procedures"," Incredo Ltd."," 9 Shimson Street
Petach-Tikva 49517
Israel",," GRN 1137 with amendments (in PDF)",,,,,,,01/19/2024,," FDA has no questions (in PDF)",,,,,,,,,, =T("1051")," 2'-fucosyllactose"," Intended for use as an ingredient in non-exempt infant formula for term infants at a level of 2.4 g/L of formula as consumed; in toddler formulas intended for children ages 1-3 years at a level of 2.4 g/L, as consumed; in other infant and toddler foods at maximum levels of 10.0 g/L in drinks, 10.9-12 g/kg in hot cereals, desserts, and other infant foods, and 57 g/kg in dry snacks; in non-alcoholic beverages (sports and energy drinks, flavored waters, soft drinks, fruit juices and drinks, vegetable juices, milk, dairy analogs, meal replacements, and protein drinks) at maximum levels ranging from 0.8-6 g/L; in oral nutritional supplements and enteral tube feeding products at 20 g/L; in coffee and tea at levels from 5-10 g/L; in chewing gum and sugar substitutes at 300 g/kg; in beverage whiteners at 600 g/kg; and in the following foods, at maximum levels ranging from 4.8-80 g/kg in baked goods and baking mixes; breakfast cereals; dairy product analogs (cream substitutes, frozen desserts, yogurt-type foods); frozen dairy desserts and mixes; fruit and water ices; gelatins, puddings, and fillings; meal-replacement and snack bars; jams and jellies; yogurt; canned fruits and fruit-based desserts; and syrups."," Scientific procedures"," Kyowa Hakko Bio Co., Ltd."," 1-9-2, Otemachi, Choyoda-ku
Tokyo, 100-0004
Japan",," GRN 1051 (in PDF)"," GRN 1051 part 2 amendments (in PDF)",,,,,,11/21/2023,," FDA has no questions (in PDF)",,,,,,,,,, =T("1156")," Algal oil (≥35% docosahexaenoic acid) from Schizochytrium sp. FJRK-SCH3"," Intended for use as an ingredient in the same food categories as those listed in 21 CFR 184.1472(a)(3) (Menhaden oil) at use levels that are no more than 28.57% of the levels specified for menhaden oil in that regulation. Runke states that if algal oil (≥35% DHA) is blended with another source of DHA or eicosapentaenoic acid (EPA), the levels will be no more than 1.5 g of DHA/person (p)/d and no more than 3.0 g/p/d of DHA and EPA combined. Algal oil (≥35% DHA) also will be used as an ingredient in cow milk-, goat milk-, soy-, amino acid-, and extensively hydrolyzed protein-based, non-exempt infant formula for term infants and exempt infant formula for pre-term and low birthweight infants, at a maximum level of 0.5% (w/w) of total fat as DHA in combination with a safe and suitable source of arachidonic acid (ARA) at a ratio ranging from 1:1 to 1:2 of DHA to ARA."," Scientific procedures"," Runke Bioengineering (Fujian) Co., Ltd."," West of No. 552 Rd.
Jindu Industrial Clusters Zone, Zhaoan, Zhangzhou
Fujian Province 363500
China",," GRN 1156 (in PDF)",,,,,,,02/08/2024,," At the notifier's request, FDA ceased to evaluate this notice (in PDF)",,,,,,,,,, =T("1162")," Fungal oil (≥38% arachidonic acid (ARA)) from Mortierella alpina FJRK-MA01"," Intended for use as an ingredient in cow milk-, goat milk-, soy-, amino acid-, and extensively hydrolyzed protein-based, non-exempt infant formula for term infants and exempt infant formula for pre-term and low birthweight infants, at a level of 0.75% and 0.50% (w/w) of total fatty acids for term and pre-term or low-birthweight infants, respectively, and in combination with a safe and suitable source of docosahexaenoic acid (DHA) at a ratio ranging from 2:1 to 1:1 of ARA to DHA."," Scientific procedures"," Runke Bioengineering (Fujian) Co., Ltd."," West of No. 552 Rd.
Jindu Industrial Clusters Zone, Zhaoan, Zhangzhou
Fujian Province 363500
China",," GRN 1162 (in PDF)",,,,,,,02/08/2024,," At the notifier's request, FDA ceased to evaluate this notice (in PDF)",,,,,,,,,,