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U.S. Department of Health and Human Services

Final Rules: Food Additives and Color Additives

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One of the charges of the Center for Food Safety and Applied Nutrition is to assure that the use of food ingredients and color additives is safe. The authority for this mission is derived from the 1958 food additive and 1960 color additive amendments to the Federal Food, Drug and Cosmetic Act. Towards this end, CFSAN's Office of Food Additive Safety (OFAS) evaluates new petitions to determine if substances are considered safe for addition to the food supply. When a petition for a food additive or color additive is approved, a regulation identifying the conditions of use is published in the Federal Register. For information about additional food ingredient and food contact substance review programs in the Office of Food Additive Safety, consult the Inventory of Effective Food Contact Substance (FCS) Notifications and the Summary of all GRAS Notices; you may also search multiple Food Ingredient and Packaging Inventories.

This dataset documents the final rules issued by the Office of Food Additive Safety since 2000 (and a few others). The Federal Register publication history, with the dates and citations for the final rules, is included along with other identifying information (such as docket numbers), on the individual pages for each petition (click on the petition numbers).

For more information about the petition process, see Questions and Answers About the Petition Process.


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Records Found: 150 Show All Page 1 of 3
Date of first
Final Rule

(sorted Z-A)
Petition No. Petitioner Subject Additive and Intended Use 21 CFR*
Nov 10, 2022 CAP 0C0316 GNT USA, Inc. amending the color additive regulations to provide for the expanded safe use of spirulina (Arthrospira platensis) extract as a color additive in alcoholic beverages with less than 20 percent alcohol-by-volume content, non-alcoholic beverages, condiments and sauces, dips, dairy product alternatives (identified as non-dairy yogurt alternatives, non-dairy frozen desserts, and non-dairy puddings), salad dressings, and seasoning mixes (unheated). 73.530
May 20, 2022 FAP 8B4820 Flexible Vinyl Alliance (FVA) amending the food additive regulations to no longer provide for the use of 25 plasticizers (23 ortho-phthalates and 2 related compounds) in various food contact applications because these uses have been abandoned. 175.105
175.300
175.320
175.380
175.390
176.170
176.180
176.300
177.1010
177.1200
177.1210
177.1400
177.1460
177.1590
177.2420
177.2600
178.3740
178.3910
May 20, 2022 FAP 6B4815 Breast Cancer Fund (now Breast Cancer Prevention Partners), Center for Environmental Health, Center for Food Safety, Center for Science in the Public Interest, Clean Water Action, Consumer Federation of America, Earthjustice, Environmental Defense Fund, Improving Kids’ Environment, Learning Disabilities Association of America, and Natural Resources Defense Council denying a food additive petition (FAP 6B4815) submitted by Natural Resources Defense Council, et al., requesting that we amend or revoke specified regulations to no longer provide for the food contact use of 28 ortho-phthalates.
May 10, 2022 CAP 5C0303 Aker BioMarine Antarctic AS amending the color additive regulations to provide for the safe use of Antarctic krill meal, composed of the ground and dried tissue of Euphausia superba, with or without the lipid fraction, for use in the feed of salmonid fish, to enhance the color of their flesh. 73.32
Oct 6, 2021 CAP 8C0312 GW Cosmetics GmbH amending 21 CFR Part 73 to provide for the safe use of silver nitrate in professional-use only cosmetics to color eyebrows and eyelashes. This final rule is effective on November 8, 2021, except as to any provisions that may be stayed by the filing of proper objections. 73.2550
Sep 2, 2021 CAP 8C0313 Sensient Colors, LLC amending the color additive regulations to provide for the safe use of an aqueous extract of butterfly pea flower (Clitoria ternatea) as a color additive in various food categories at levels consistent with good manufacturing practice.  73.69
Jul 13, 2020 FAP 8A4821 Oakshire Naturals LP amending the food additive regulations to provide for the safe use of vitamin D2 mushroom powder as a nutrient supplement in specific food categories. 172.382
Aug 1, 2019 CAP 9C0314 Impossible Foods, Inc. amending the color additive regulations to provide for the safe use of soy leghemoglobin as a color additive in ground beef analogue products. 73.520
Nov 1, 2018 CAP 7C0308 Colorcon, Inc. amending the color additive regulations to provide for the expanded safe use of synthetic iron oxides as color additives to include use in dietary supplement tablets and capsules. 73.200
Oct 31, 2018 CAP 7C0309 Environmental Defense Fund, Earthjustice, Environmental Working Group, Center for Environmental Health, Healthy Homes Collaborative, Health Justice Project of Loyola University Chicago School of Law, Breast Cancer Fund, Improving Kids' Environment, Consumers Union, Natural Resources Defense Council, Consumer Federation of America, Learning Disabilities Association, Maricel Maffini, and Howard Mielke amending the color additive regulations to no longer provide for the use of lead acetate in cosmetics intended for coloring hair on the scalp because new data available since lead acetate was permanently listed demonstrate that there is no longer a reasonable certainty of no harm from the use of this color additive. 73.2396
Oct 9, 2018 FAP 6A4817 Styrene Information and Research Center amending the food additive regulations to no longer provide for the use of styrene as a flavoring substance and adjuvant for use in food because these uses have been abandoned. 172.515
Oct 9, 2018 FAP 5A4810 Breast Cancer Fund (now the Breast Cancer Prevention Partners), Center for Environmental Health, Center for Food Safety, Center for Science in the Public Interest, Consumers Union, Environmental Defense Fund, Environmental Working Group, Improving Kids' Environment, Natural Resources Defense Council, WE ACT for Environmental Justice, and Mr. James Huff partially granting a petition by amending the food additive regulations to no longer authorize the use of benzophenone, ethyl acrylate, eugenyl methyl ether, myrcene, pulegone, and pyridine as synthetic flavoring substances for use in food. FDA is denying as moot the portions of the petition proposing that the food additive regulations be amended to no longer authorize the use of styrene as a synthetic flavoring substance because this use has been permanently and completely abandoned. In addition, FDA is declining to act on the petitioners' request to issue a regulation to prohibit the use of these synthetic flavoring substances in food because that issue is not the proper subject of a food additive petition. 172.515
177.2600
Sep 25, 2018 CAP 7C0311 Glo Eyes, LLC amending the color additive regulations to provide for the expanded safe use of D&C Yellow No. 8 as a color additive in contact lens solution. 74.3708
Sep 20, 2018 FAP 7A4818  Juice Products Association amending the food additive regulation for vitamin D3 to replace the current Reference Daily Intake (RDI) percentage values of calcium in 100 percent fruit juices and fruit juice drinks with absolute values and to update the reference for vitamin D3 specifications. 172.380
Jun 7, 2018 CAP 7C0310 DSM Biomedical amending the color additive regulations to provide for the safe use of D&C Black No. 4 for coloring ultra-high molecular weight polyethylene (UHMWPE) non-absorbable sutures for use in general surgery. 74.3054
May 21, 2018 FAP 5A4811 Grocery Manufacturers Association (GMA) denying a petition requesting that the food additive regulations be amended to provide for the safe use of partially hydrogenated vegetable oils (PHOs) in certain food applications.
Nov 7, 2017 CAP 6C0307 Wm. Wrigley Jr. Company amending the color additive regulations to provide for the safe use of calcium carbonate to color hard and soft candy, mints, and chewing gum. 73.70
Jul 3, 2017 CAP 6C0306 McCormick & Company, Inc. amending the color additive regulations to provide for the expanded safe use of spirulina extract to seasonally color hard-boiled shell eggs at levels consistent with good manufacturing practice (GMP). 73.530
May 4, 2017 FAP 6B4816 Society of the Plastics Industry, Inc. amending the food additive regulations to no longer provide for the use of potassium perchlorate as an additive in closure-sealing gaskets for food containers because this use has been abandoned. 177.1210
May 4, 2017 FAP 4B4808 Environmental Defense Fund, Natural Resources Defense Council, Center for Food Safety, Clean Water Action, Center for Science in the Public Interest, Breast Cancer Prevention Partners, Center for Environmental Health, Environmental Working Group, and Improving Kids' Environment denying a petition to revoke the Threshold of Regulation (TOR) exemption No. 2005-006 to no longer exempt from our food additive regulations the use of sodium perchlorate monohydrate as a conductivity enhancer in antistatic agents for use in finished articles in contact with dry foods; issue a new FDA regulation to prohibit the use of perchlorates in antistatic agents for use in food-contact articles; and amend our food additive regulations to no longer provide for the use of potassium perchlorate as an additive in closure-sealing gaskets for food containers.
Nov 22, 2016 FAP 6B4814 3M Corporation amending the food additive regulations to no longer provide for the use of two specific perfluoroalkyl containing substances as oil and water repellents for paper and paperboard for use in contact with aqueous and fatty foods because these uses have been abandoned. 176.170
Nov 1, 2016 CAP 6C0305 Milton W. Chu, M.D. amending the color additive regulations to provide for the safe use of titanium dioxide and [phthalocyaninato (2-)] copper to color orientation marks for intraocular lenses (IOLs). 73.3126
74.3045
Jul 18, 2016 FAP 3A4801 Dean Foods Company and WhiteWave Foods Company amending the food additive regulations to expand the safe uses of vitamin D2 as a nutrient supplement in edible plant-based beverages intended for use as milk alternatives and in edible plant-based yogurt alternatives and vitamin D3 as a nutrient supplement in milk at levels higher than those currently permitted. 172.379
172.380
Apr 15, 2016 FAP 2A4796 Gruma Corporation, Spina Bifida Association, March of Dimes Foundation, American Academy of Pediatrics, and National Council of La Raza amending the food additive regulations to provide for the safe use of folic acid in corn masa flour. 172.345
Jan 4, 2016 FAP 4B4809 Natural Resources Defense Council, Center for Food Safety, Clean Water Action, Center for Science in the Public Interest, Children's Environmental Health Network, Breast Cancer Fund, Center for Environmental Health, Environmental Working Group, and Improving Kids' Environment amending the food additive regulations to no longer provide for the use of three specific perfluoroalkyl ethyl containing food-contact substances (FCSs) as oil and water repellants for paper and paperboard for use in contact with aqueous and fatty foods because new data are available as to the toxicity of substances structurally similar to these compounds that demonstrate there is no longer a reasonable certainty of no harm from the food-contact use of these FCSs. 176.170
Sep 30, 2015 CAP 5C0302 E. & J. Gallo Winery amending the color additive regulations to provide for the safe use of mica-based pearlescent pigments prepared from titanium dioxide and mica as color additives in certain distilled spirits. 73.350
Aug 21, 2015 CAP 4C0300 Colorcon, Inc. amending the color additive regulations to provide for the safe use of spirulina extract as a color additive in coating formulations applied to dietary supplement and drug tablets and capsules. 73.1530
Jun 16, 2015 FAP 4A4803 Eastman Chemical Company amending the food additive regulations by removing the upper bound of the melting point range in the regulation for the antioxidant tertiary butylhydroquinone (TBHQ) and adding a purity acceptance criterion. 172.185
Jun 8, 2015 CAP 5C0301 Signature Brands, LLC amending the color additive regulations to provide for the safe use of mica-based pearlescent pigments prepared from titanium dioxide and mica in egg decorating kits for coloring boiled shell eggs,  in amounts consistent with good manufacturing practice (GMP). 73.350
Jun 8, 2015 CAP 4C0299  EMD Millipore Corp. amending the color additive regulations to expand the safe use of mica-based pearlescent pigments in alcoholic beverages to include cordials, liqueurs, cocktails, and certain other alcoholic beverages, and non-alcoholic mixers and mixes. 73.350
Mar 20, 2015 CAP 3C0298 Wm. Wrigley Jr. Company amending the color additive regulations to provide for the expanded safe use of synthetic iron oxide as a color additive to include use in soft and hard candy, mints, and chewing gum. 73.200
Aug 12, 2014 FAP 2A4788 Abbott Laboratories amending the food additive regulations in 21 CFR 172.380 to provide for the safe use of vitamin D3 as a nutrient supplement in meal replacement beverages and meal replacement bars that are not intended for special dietary use in reducing or maintaining body weight and for use in foods that are sole sources of nutrition for enteral feeding. 172.380
May 21, 2014 FAP 9A4778 Ajinomoto Co., Inc. amending the food additive regulations in part 172 Food Additives Permitted for Direct Addition to Food for Human Consumption (21 CFR part 172), to provide for the safe use of advantame as a non-nutritive sweetener in tabletop applications and powdered beverage mixes. 172.803
Apr 14, 2014 FAP 1M4727 National Fisheries Institute amending the food additive regulations to provide for the safe use of ionizing radiation for control of food-borne pathogens in crustaceans at a maximum absorbed dose of 6.0 kiloGray (kGy). 179.26
Apr 11, 2014 CAP 2C0297 GNT USA, Inc. amending the color additive regulations to provide for the expanded safe use of spirulina extract as a color additive in food. 73.530
Dec 6, 2013 FAP 1A4784 Nexira amending the food additive regulations to provide for the expanded safe use of acacia (gum arabic) in foods. 172.780
Nov 29, 2013 FAP 0A4782 United States Pharmacopeial Convention amending select food additive regulations that incorporate by reference food-grade specifications from prior editions of the Food Chemicals Codex (FCC) to incorporate by reference food-grade specifications from the FCC 7th Edition (FCC 7). 172.345
172.379
172.380
172.665
172.712
172.736
172.780
172.800
172.804
172.810
172.812
172.831
172.841
172.862
172.867
172.869
173.160
173.165
173.228
173.280
173.310
Aug 13, 2013 CAP 2C0293 Mars, Inc. amending the color additive regulations to provide for the safe use of spirulina extract made from the dried biomass of the cyanobacteria Arthrospira platensis (A. platensis), as a color additive in candy and chewing gum. 73.530
Jul 12, 2013 FAP 2B4791 U.S. Representative Edward J. Markey amending the food additive regulations to no longer provide for the use of Bisphenol A (BPA)-based epoxy resins as coatings in packaging for infant formula because these uses have been abandoned. 175.300
Jun 12, 2013 CAP 2C0294 E. & J. Gallo Winery amending the color additive regulations to provide for the expanded safe use of mica-based pearlescent pigments as color additives in certain distilled spirits. 73.350
Apr 1, 2013 CAP 1C0291 CooperVision, Inc. amending the color additive regulations to provide for the safe use of additional copolymers of 1,4-bis[4-(2-methacryloxyethyl)phenylamino]anthraquinone (C.I. Reactive Blue 246) ... as color additives in contact lenses. 73.3106
Apr 1, 2013 CAP 1C0292 CooperVision, Inc. amending the color additive regulations to provide for the safe use of additional ... copolymers of 1,4-bis[(2-hydroxyethyl)amino]-9,10-anthracenedione bis(2-methyl-2-propenoic)ester (C.I. Reactive Blue 247) as color additives in contact lenses. 73.3100
Dec 4, 2012 FAP 2A4785 Ecolab, Inc. amending the food additive regulations to provide for the safe use of sodium dodecylbenzenesulfonate (CAS No. 25155-30-0) as an antimicrobial agent for use in wash water for fruits and vegetables without the requirement of a potable water rinse. 173.405
Nov 30, 2012 FAP 9M4695 U.S. Department of Agriculture, Food Safety and Inspection Service amending the food additive regulations to provide for the safe use of a 4.5 kilogray (kGy) maximum absorbed dose of ionizing radiation to treat unrefrigerated (as well as refrigerated) uncooked meat, meat byproducts, and certain meat food products to reduce levels of foodborne pathogens and extend shelf life. 179.26
Nov 30, 2012 FAP 9M4696 U.S. Department of Agriculture, Food Safety and Inspection Service amending the food additive regulations to increase the maximum dose of ionizing radiation permitted in the treatment of poultry products, to include specific language intended to clarify the poultry products covered by the regulations, and to remove the limitation that any packaging used during irradiation of poultry shall not exclude oxygen. 179.26
Aug 29, 2012 FAP 9A4779 Lallemand, Inc. amending the food additive regulations to provide for the safe use of vitamin D2 bakers yeast as a source of vitamin D2 and as a leavening agent in yeast-leavened baked products at levels not to exceed 400 International Units (IU) of vitamin D2 per 100 grams (g) in the finished food. 172.381
Jul 17, 2012 FAP 1B4783 American Chemistry Council (ACC) amending the food additive regulations to no longer provide for the use of polycarbonate (PC) resins in infant feeding bottles (baby bottles) and spill-proof cups, including their closures and lids, designed to help train babies and toddlers to drink from cups (sippy cups) because these uses have been abandoned. 177.1580
Jul 6, 2012 CAP 1C0290 Sun Chemical Corp. revising the requirements for D&C Red No. 6 and D&C Red No. 7 by replacing the current specification for Ether-soluble matter with a maximum limit of 0.015 percent for the recently identified impurity 1-[(4-methylphenyl)azo]-2-naphthalenol. 74.1306
74.1307
Jun 11, 2012 FAP 7M4768 Durand-Wayland, Inc. amending the food additive regulations to provide for the safe use of a carbon dioxide laser for etching information on the surface of fresh, intact citrus fruit. 179.43
Jul 15, 2011 FAP 0A4780 Nisso America, Inc. amending the food additive regulations for hydroxypropyl cellulose by lowering the minimum permitted viscosity from 145 centipoises (cPs) to 10 cPs and to permit its use as a binder in dietary supplements. 172.870

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*Definitions

  • 21 CFR: Title 21 of the Code of Federal Regulations.
  • Substance: The name of the substance listed in the CFR.
  • CAS Registry® No.: Chemical Abstract Service (CAS) Registry Number® for the substance.
  • Petitions (see also Questions and Answers About the Petition Process)
    • FAP: Food Additive Petition
    • CAP: Color Additive Petition
    • GRP: GRAS Affirmation Petition (replaced by GRAS Notification Program in 2016)
Date of first
Final Rule

(sorted Z-A)
Petition No. Petitioner Subject Additive and Intended Use 21 CFR*

96  

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