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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. 1740

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: Decanedioic acid, polymer with 11-aminoundecanoic acid and 4,4'-methylenebis[2-methylcyclohexanamine] (CAS Reg. No. 1107603-83-7).
Notifier: Arkema
Manufacturer/Supplier: Arkema
Intended Use: As a repeat-use food-contact article, except for use in contact with infant formula and human milk (see Limitations/Specifications).
Limitations/Specifications: The final article may 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: Mar 31, 2017
National Environmental Policy Act (NEPA)** Submission: Categorical Exclusion 25.32(j)
FDA Decision: Categorical Exclusion Memo

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