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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. 2064

Nylon Corporation of America, Inc. (NYCOA)

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: Fatty acids, C18-unsaturated, dimers, hydrogenated, polymers with caprolactam and hexamethylenediamine (CAS Reg. No.475994-94-6).
Notifier: Nylon Corporation of America, Inc. (NYCOA)
Manufacturer/Supplier: Nylon Corporation of America, Inc. (NYCOA)
Intended Use: As a single polymer layer in multilayer, single use food packaging, except for use in contact with infant formula and human milk (see Limitations/Specifications).
Limitations/Specifications: The FCS may be used at a maximum basis weight of 22.0 g/m2 (14.2 mg/in2) in the final multilayer food packaging, in contact with all food types, under Conditions of Use E through G, as described in Table 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 19, 2020
National Environmental Policy Act (NEPA)** Submission: Environmental Assessment
FDA Decision: Finding of No Significant Impact (FONSI)

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