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U.S. Department of Health and Human Services

Inventory of Effective Food Contact Substance (FCS) Notifications
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FCN No. 1957

TOYOBO Co., Ltd.

According to Section 409(h)(1)(C) of the Federal Food, Drug, and Cosmetic Act, food contact substance notifications (FCNs) are effective only for the listed manufacturer and its customers. Other manufacturers must submit their own FCN for the same food contact substance and intended use.
Food Contact Substance: The FCS is a reaction product of three polymers:
  1. 2-propenoic acid, 2-methyl-, methyl ester, polymer with 4,5-dihydro-2-(1-methylethenyl)oxazole and ethyl 2-propenoate (CAS Reg. No. 57460-65-8);
  2. methyl methacrylate, ethyl acrylate, methacrylic acid, butanoic acid 3-oxo-2-[(2-methyl-1-oxo-2-propenyl)oxy]ethyl ester, 3-(trimethoxysilyl)propyl methacrylate with poly(oxy-1,2-ethanediyl), alpha-sulfo-omega-[4-nonyl-2-(1-propen-1-yl)phenoxy]-, branched, ammonium salts copolymer; and
  3. 1,3-benzenedicarboxylic acid, polymer with 2-[(2-aminoethyl)amino]ethanol, 1,3-bis(isocyanatomethyl)cyclohexane, decanedioic acid, 1,3-diisocyanatomethylbenzene, 2,2-dimethyl-1,3-propanediol, 1,2-ethanediol and 3-hydroxy-2-(hydroxymethyl)-2- methylpropanoic acid, compound with 1,1',1''-nitrilotris[2-propanol] (CAS Reg. No. 1239020-50-8).
REPLACES FCN 1767
Notifier: TOYOBO Co., Ltd.
Manufacturer/Supplier: TOYOBO Co., Ltd.
Intended Use: As a coating on poly(ethylene terephthalate) (PET) and poly(butylene terephthalate) (PBT) food packaging films, except for use in contact with infant formula and human milk.
Limitations/Specifications: The minimum thickness of the coated film is 0.5 mil., or 11.5 μm. The FCS coating on the films will not exceed 37 nm. The films may be used in contact with all types of food under Conditions of Use A through H as described in Tables 1 and 2. The FCS is not for use in contact with infant formula and human milk. Such uses were not included as part of the intended use of the substance in the FCN.
Effective Date: Jul 3, 2019
National Environmental Policy Act (NEPA)** Submission: Categorical Exclusion 25.32(i)
FDA Decision: Categorical Exclusion Memo

*See Food Types and Conditions of Use for Food Contact Substances (Tables 1 and 2).

**More about Environmental Decisions and Definitions of Environmental Terms.
See also Inventory of Environmental Impact Decisions for Food Contact Substance Notifications.
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