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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. 2255

EMS-CHEMIE AG, Business Unit EMS-GRIVORY Europe

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: Copolymer of 1,3-benzenedicarboxylic acid, azacyclotridecan-2-one, 1,4-benzenedicarboxylic acid, dodecanedioic acid, and 4,4'-methylenebis[2-methylcyclohexanamine] (CAS Reg. No. 2080394-29-0).
Notifier: EMS-CHEMIE AG, Business Unit EMS-GRIVORY Europe
Manufacturer/Supplier: EMS-CHEMIE AG, Business Unit EMS-GRIVORY Europe
Intended Use: For use in repeat-use food-contact articles, including baby bottles for holding infant formula and human milk.
Limitations/Specifications: For use in contact with aqueous, acidic, and low alcoholic foods (up to 8% alcohol content) at a maximum temperature not to exceed 100°C. The FCS may be used in contact with infant formula or human milk (other than baby bottle nipples) intended for the feeding of infants (e.g., baby bottles).
Effective Date: Feb 9, 2023
National Environmental Policy Act (NEPA)** Submission: Categorical Exclusion 25.32(j)
FDA Decision: Categorical Exclusion Memo
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