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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. 1712

Arkema

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: 1,3-Benzenedicarboxylic acid, polymer with azacyclotridecan-2-one, 1,4-benzenedicarboxylic acid and 4,4'-methylenebis[2-methylcyclohexanamine] (CAS Reg. No. 62694-40-0).
Notifier: Arkema
Manufacturer/Supplier: Arkema
Intended Use: For use in repeat-use food contact articles, except for use in contact with infant formula and human milk (see Limitations/Specifications).
Limitations/Specifications: The final product will be used in contact with all food types at a maximum temperature of 250°F. 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: Dec 13, 2016
National Environmental Policy Act (NEPA)** Submission: Categorical Exclusion 25.32(j)
FDA Decision: Categorical Exclusion Memo

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