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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. 1707

DSM Engineering Plastics B.V.

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: 1,4-Benzenedicarboxylic acid, polymer with 5-amino-1,3,3-trimethylcyclohexanemethanamine and hexahydro-2H-azepin-2-one (CAS Reg. No. 1105025-82-8).
Notifier: DSM Engineering Plastics B.V.
Manufacturer/Supplier: DSM Engineering Plastics B.V.
Intended Use: The FCS will be used as a component of articles used in contact with food for single- and repeat-use applications. (see Limitations/Specifications)
Limitations/Specifications:
  1. For single-use articles: The FCS will be used at a maximum thickness of 2 mils (approximately 50 μm) in contact with all food types under Conditions of Use A through H and J.
  2. For repeat-use articles: The FCS will be for use in contact with all food types under Conditions of Use A through H and J.

Adjuvant substances permitted for use in Nylon 6 polymers complying with 21 CFR 177.1500 may be used in the FCS, provided that any limitations on the use of the adjuvant substance are met. 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 22, 2017
National Environmental Policy Act (NEPA)** Submission: Environmental Assessment (in PDF, 3.8 MB)
FDA Decision: Finding of No Significant Impact (FONSI)

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