Inventory of Environmental Impact Decisions for Food Contact Substance Notifications
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This is a listing of the environmental decisions for food contact substance notifications. Each listing comprises an index, which is the Food Contact Notification (FCN) number, an abbreviated identity for the corresponding food contact substance (FCS), the assessment of environmental impacts prepared according to the National Environmental Policy Act (NEPA) and FDA’s determination of the potential environmental impacts.
Not all environmental documents may have been included in the inventory of decisions. Some documents or portions of some documents may not be displayed because they contain information and data that are protected from disclosure under 18 U.S.C. 1905, 21 U.S.C. 331(j) or 360j(c), or their distribution is protected by copyright. Additional information about environmental terms used in this listing and the basis for environmental decisions are available through the NEPA submission.
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- To obtain the FDA Decision Memo or Categorical Exclusion (Cat Ex) Memo for a Food Contact Substance Notification, select the appropriate term, if available, in the FDA Decision column.
- If an Environmental Assessment (EA) was required to be submitted by industry, it is available in the NEPA Submission column.
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More about Environmental Decisions and Definitions of Environmental Terms.
| FCN No | Food Contact Substance | NEPA Submission |
FDA Decision
(sorted A-Z) |
|---|---|---|---|
| 2050 | Copolymer of acrylamide, 2-methacryloxyethyltrimethylammonium chloride, itaconic acid, and N,N'-methylenebis(acrylamide) (CAS Reg. No. 214495-32-6). |
EA (in PDF, 681 kB) |
FONSI (in PDF, 105 kB) |
| 2047 | Hydrogenated castor oil monoglycerides, acetylated (CAS Reg. No. 736150-63-3). |
EA (in PDF, 570 kB) |
FONSI (in PDF, 103 kB) |
| 2043 | Cellulose acetate (CAS Reg. No. 9004-35-7), and optionally modified with propionate to form cellulose acetate propanoate (CAS Reg. No. 9004-39-1) resulting in up to 49 weight-percent propionate esters. |
EA (in PDF, 584 kB) |
FONSI (in PDF, 108 kB) |
| 2038 | Benzenesulfonic acid, 2-[2-(2,4-diamino-1,6-dihydro-6-oxo-5-pyrimidinyl)diazenyl]-5-methyl- (CAS Reg No. 1021701-36-9). |
EA (in PDF, 1.0 MB) |
FONSI (in PDF, 106 kB) |
| 2037 | Oleic acid, mono ester with oxybis(propanediol) (also known as diglyceryl monooleate) (CAS Reg. No. 49553-76-6). |
EA (in PDF, 62 kB) |
FONSI (in PDF, 112 kB) |
| 2036 | An aqueous mixture of peroxyacetic acid (PAA) (CAS Reg. No. 79-21-0), hydrogen peroxide (HP) (CAS Reg. No. 7722-84-1), acetic acid (AA) (CAS Reg. No. 64-19-7), 1-hydroxyethylidene-1,1-diphosphonic acid (HEDP) (CAS Reg. No. 2809-21-4), dipicolinic acid (DPA) (CAS Reg. No. 499-83-2), and optionally sulfuric acid (CAS Reg. No. 7664-93-9). REPLACES FCN 1639 |
EA (in PDF, 554 kB) |
FONSI (in PDF, 133 kB) |
| 2035 | Octadecyl 3,5-di-tert-butyl-4-hydroxyhydrocinnamate (CAS Reg. No. 2082-79-3). |
EA (in PDF, 588 kB) |
FONSI (in PDF, 84 kB) |
| 2032 | 1,4-benzenedicarboxylic acid, (or dimethyl ester) polymer with 1,4-butanediol, adipic or sebacic acid, hexamethylene diisocyanate and further reacted with no more than 1 percent by weight of the polyhydric alcohol described in the notification. REPLACES FCN 907 and FCN 916 |
EA (in PDF, 641 kB) |
FONSI (in PDF, 87 kB) |
| 2029 | An aqueous solution of hydrogen peroxide (CAS Reg. No. 7722-84-1) stabilized with 1-hydroxyethylidene-1,1-diphosphonic acid (HEDP) (CAS Reg. No. 2809-21-4). |
EA (in PDF, 623 kB) |
FONSI (in PDF, 86 kB) |
| 2027 | Silicic acid, aluminum magnesium sodium salt, (CAS Reg. No. 12040-43-6). |
EA (in PDF, 475 kB) |
FONSI (in PDF, 123 kB) |
| 96 | Polyoxymethylene copolymer (CAS Reg. No. 24969-26-4) produced from the reaction of trioxane (cyclic trimer of formaldehyde) and 1,3-dioxolane. | Cat Ex 25.32(j) | Cat Ex Memo |
| 106 | Styrene/ butadiene/ acrylonitrile copolymers (SBAN) (CAS Reg. No., exclusive of minor monomers, is 9003-56-9), copolymerized with not more than 10 percent of one or more of the monomers of acrylic acid, fumaric acid, 2-hydroxyethyl acrylate, itaconic acid and methacrylic acid, manufactured according to the method described in this notification. | Cat Ex 25.32(i) | Cat Ex Memo |
| 107 | Polyethylene glycol (CAS Reg. No. 25322-68-3). | Cat Ex 25.32(j) | Cat Ex Memo |
| 109 | ((1,2,5,6-η)-1,5-cyclooctadiene)bis((4-(trimethylsilyl)phenyl)ethynyl)platinum (CAS Reg. No. 234112-62-0). | Cat Ex 25.32(j) | Cat Ex Memo |
| 112 | Tris (2,4-di-tert-butylphenyl)phosphite (CAS Reg. No. 31570-04-4). | Cat Ex 25.32(i) | Cat Ex Memo |
| 113 | 2,4-dimethyl-6-(1-methylpentadecyl)phenol (CAS Reg. No. 134701-20-5). | Cat Ex 25.32(i) | Cat Ex Memo |
| 115 | 2,9-bis(3,5-dimethylphenyl)anthra(2,1,9-def:6,5,10-d'e'f')diisoquinoline-1,3,8,10(2 H, 9H)-tetrone (C.I. Pigment Red 149; CAS Reg. No. 4948-15-6). | Cat Ex 25.32(i) | Cat Ex Memo |
| 116 | Benzene propanoic acid, 3,5-bis(1,1-dimethylethyl)-4-hydroxy, C13-C15 branched and linear alkyl esters (CAS Reg. No. 171090-93-0). | Cat Ex 25.32(i) | Cat Ex Memo |
| 117 | Styrene-butyl acrylate copolymers. | Cat Ex 25.32(i) | Cat Ex Memo |
| 118 | 2,9-bis(4-(phenylazo)phenyl)anthra (2,1,9-def:6,5,10-d'e'f')diisoquinoline-1,3,8,10(2H, 9H)-tetrone (C.I. Pigment Red 178; CAS Reg. No. 3049-71-6). | Cat Ex 25.32(i) | Cat Ex Memo |
| 119 | Xanthan Gum (CAS Reg. No. 11138-66-2). | Cat Ex 25.32(i) | Cat Ex Memo |
| 123 | Polyester-epoxy-urethane adhesives formulated from: 1. Polyester resins described in 21 CFR 177.1390(c)(2)(v)(a). 1,6-Hexanediol may also be used as an optional polyhydric alcohol. 2. Optional epoxy resin listed in 21 CFR 175.300(b)(3)(viii)(a) and comprising up to 30 percent by weight of the cured adhesive. 3. Urethane cross-linking agent, as described in 21 CFR 177.1390(c)(2)(v)(c). 4. Optional trimethoxysilane coupling agents containing epoxy and/or ether groups not to exceed 3 percent by weight of the cured adhesive. | Cat Ex 25.32(i) | Cat Ex Memo |
| 125 | Polyphenylene ether (CAS Reg. No. 25134-01-4). | Cat Ex 25.32(i) | Cat Ex Memo |
| 126 | 1,9-Decadiene,3,3,4,4,5,5,6,6,7,7,8,8-dodecafluoro-, polymer with tetrafluoroethene and trifluoro(trifluoromethoxy)ethene (CAS Reg. No. 190062-24-9), manufactured and characterized as further described in the notification. | Cat Ex 25.32(j) | Cat Ex Memo |
| 127 | 1-Propene,1,1,2,3,3,3-hexafluoro-, polymer with 1,1-difluoroethene and tetrafluoroethene (CAS Reg. No. 25190-89-0) modified with triallyl isocyanurate and 3,3,4,4,5,5,6,6,7,7,8,8-dodecafluoro-1,9-diene, manufactured and characterized as further described in the notification. | Cat Ex 25.32(j) | Cat Ex Memo |
| 128 | A copolymer of tetrafluoroethylene (TFE) and perfluoromethylvinyl ether (PFMVE) (CAS Reg. No. 26425-79-6) modified with 1,3,5-triallyl isocyanurate (TAIC) and 3,3,4,4,5,5,6,6,7,7,8,8-dodecafluoro-1,9-diene, manufactured and characterized as further described in the notification. | Cat Ex 25.32(j) | Cat Ex Memo |
| 129 | Ethene, tetrafluoro-, polymer with 1,1-difluoroethene and trifluoro(trifluoromethoxy)ethene (CAS Reg. No. 56357-87-0) modified with 1,3,5-triallyl isocyanurate (TAIC) and 3,3,4,4,5,5,6,6,7,7,8,8-dodecafluoro-1,9-diene, manufactured and characterized as further described in the notification. | Cat Ex 25.32(j) | Cat Ex Memo |
| 130 | Styrene-acrylic copolymers. | Cat Ex 25.32(i) | Cat Ex Memo |
| 131 | 2-Methyl-4-isothiazolin-3-one (CAS Reg. No. 2682-20-4). | Cat Ex 25.32(q) | Cat Ex Memo |
| 134 | Sodium zeolite A (CAS Reg. No. 68989-22-0). |
Cat Ex 25.32(i) and (j) |
Cat Ex Memo |
| 135 | Dimethyl 2,6-naphthalenedicarboxylate (NDC, CAS Reg. No. 840-65-3) or 2,6-naphthalenedicarboxylic acid (NDA, CAS Reg. No. 1141-38-4). | Cat Ex 25.32(i) | Cat Ex Memo |
| 137 | Anthranilamide. The Chemical Abstracts Service (CAS) name is 2-aminobenzamide (CAS Reg. No. 88-68-6). | Cat Ex 25.32(i) | Cat Ex Memo |
| 143 | Octadecanoic acid, methyl ester, reaction products with 1-(2-hydroxy-2-methylpropoxy)-2,2,6,6-tetramethyl-4-piperidinol (CAS Reg. No. 300711-92-6). | Cat Ex 25.32(i) | Cat Ex Memo |
| 144 | 5-sulfo-1,3-benzenedicarboxylic acid, monosodium salt (CAS Reg. No. 6362-79-4). |
Cat Ex 25.32(i) and (j) |
Cat Ex Memo |
| 147 | Ethylene phthalate polymers identified in 21 CFR 177.1630(e)(4)(i) and 177.1630(e)(4)(ii), items 2 and 3, 177.1637 and FCN numbers 4, 13, 14, 135 and 145 modified with polybutadienediol (PBD) (CAS Reg. Name: 1,3-Butadiene, homopolymer, hydroxy-terminated) (CAS Reg. No. 69102-90-5). | Cat Ex 25.32(i) | Cat Ex Memo |
| 148 | 2-Acrylamido-2-methylpropanesulfonic acid, in its free acid form (CAS Reg. No. 15214-89-8), and its sodium (CAS Reg. No. 5165-97-9), calcium (CAS Reg. No. 95176-15-1), potassium (CAS Reg. No. 52825-28-2), ammonium (CAS Reg. No. 58374-69-9), and lithium (CAS Reg. No. 77817-87-9) salts. | Cat Ex 25.32(i) | Cat Ex Memo |
| 150 | Quinacridone red (Alternate names: (1) Quino(2,3-b)acridine-7,14-dione, 5, 12-dihydro- and (2) C.I. Pigment violet 19, C.I. 73900) (CAS Reg. No. 1047-16-1). | Cat Ex 25.32(i) | Cat Ex Memo |
| 156 | Cellulose, regenerated polymer with epichlorohydrin, carboxymethyl 2-hydroxypropyl ether (CAS Reg. No. 343844-23-5). The FCS is also referred to as carboxymethyl (CM) ion exchange cellulose resin. | Cat Ex 25.32(j) | Cat Ex Memo |
| 157 | 1. Cellulose, regenerated, polymer with epichlorohydrin, 2-(diethylamino) ethyl 2-hydroxypropyl ether, (CAS Reg. No. 343845-30-7) (High Capacity). The FCS is also referred to as diethylaminoethyl (DEAE) ion exchange cellulose resin (High Capacity). 2. Cellulose, regenerated, polymer with epichlorohydrin, 2-(diethylamino) ethyl ether, (CAS Reg. No. 343846-01-5) (Medium Capacity). The FCS is also referred to as diethylaminoethyl (DEAE) ion exchange cellulose resin (Medium Capacity). | Cat Ex 25.32(j) | Cat Ex Memo |
| 161 | Piperylene/2-methyl-2-butene copolymer resins (CAS Reg. No. 26813-14-9) and Piperylene/2-methyl-2-butene/α-methylstyrene terpolymer resins (CAS Reg. No. 62258-49-5), and as further described in the identity and manufacturing sections of the notification. | Cat Ex 25.32(i) | Cat Ex Memo |
| 162 | 2-Propenoic acid, methyl ester, telomer with 1-dodecanethiol, C16-C18 alkyl esters (CAS Reg. No. 174254-23-0). | Cat Ex 25.32(i) | Cat Ex Memo |
| 164 | Phenol, 2-(5-chloro-2H-benzotriazol-2-yl)-4,6-bis(1,1-dimethylethyl)- (CAS Reg. No. 3864-99-1). | Cat Ex 25.32(i) | Cat Ex Memo |
| 165 | Polyphenylene sulfide (CAS Reg. No. 25212-74-2 or 26125-40-6). | Cat Ex 25.32(j) | Cat Ex Memo |
| 172 | 5,7-bis(1,1-dimethylethyl)-3-hydroxy-2(3H)-benzofuranone, reaction products with o-xylene (CAS Reg. No. 181314-48-7). | Cat Ex 25.32(i) | Cat Ex Memo |
| 175 | 2-Pyridinethiol-1-oxide, sodium salt (CAS Reg. No. 3811-73-2). | Cat Ex 25.32(i) | Cat Ex Memo |
| 176 | Phenol, 2-(1,1-dimethylethyl)-6-methyl-4-(3-((2,4,8,10-tetrakis(1,1-dimethylethyl)dibenzo(d,f)(1,3,2)dioxaphosphepin-6-yl)oxy)propyl)- (CAS Reg. No. 203255-81-6). | Cat Ex 25.32(i) | Cat Ex Memo |
| 177 | Aluminum lithium carbonate hydroxide trihydrate (CAS Reg. No. 150607-28-6). | Cat Ex 25.32(i) | Cat Ex Memo |
| 180 | Benzenesulfonic acid, 2,2'-(1,2-ethenediyl)bis(5-((4-(bis(2-hydroxyethyl)amino)-6-((4-sulfophenyl)amino)-1,3,5-triazin -2-yl)amino)-, tetrasodium salt (CAS Reg. No. 16470-24-9). | Cat Ex 25.32(i) | Cat Ex Memo |
| 181 | Benzenepropanoic acid, 3,5-bis(1,1-dimethylethyl)-4-hydroxy-,octadecyl ester (CAS Reg. No. 2082-79-3). The FCS is also known as octadecyl 3,5-di-tert-butyl-4-hydroxyhydrocinnamate. | Cat Ex 25.32(i) | Cat Ex Memo |
| 182 | Polyamidoamine-ethyleneimine-epichlorohydrin resin prepared by reacting hexanedioic acid, 1,2-ethanediamine, N-(2-aminoethyl)-1,3-propanediamine, N,N''-1,2-ethanediylbis-1,3-propanediamine, (chloromethyl)oxirane, ethyleneimine(aziridine), and polyethylene glycol, and partly neutralized with sulfuric acid (CAS Reg. No. 167678-43-5) or formic acid (CAS Reg. No. 114133-44-7). | Cat Ex 25.32(i) | Cat Ex Memo |
| FCN No | Food Contact Substance | NEPA Submission |
FDA Decision
(sorted A-Z) |
|---|
2362
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