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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. 2530

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-[1- hydroxymethyl)-2-(2-propen-1-yloxy)ethoxy]-, C11-rich C10-14-branched alkyl ethers, ammonium salts copolymer (CAS Reg. No. 3088423-12-2); 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).
Notifier: Toyobo Co., Ltd.
Manufacturer/Supplier: Toyobo Co., Ltd.
Intended Use: As a coating on polyethylene terephthalate (PET) food packaging films, except for use in contact with infant formula and human milk (see Limitations/Specifications).
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 food types 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: Aug 15, 2026
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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