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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. 1573

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: Poly[imino-1,4-butanediylimino(1,10-dioxo-1,10-decanediyl)] (CAS Reg. No. 26247-06-3)
Notifier: DSM Engineering Plastics B.V.
Manufacturer/Supplier: DSM Engineering Plastics B.V.
Intended Use: As a component of single- and repeated-use food contact articles, except for use in contact with infant formula and breast milk (see Limitations/Specifications).
Limitations/Specifications: For single-use articles at a thickness not to exceed 2 mils (50 μm) and repeated-use articles in contact with all types of food under Conditions of Use A through H, and J, as described in Table 2. Adjuvant substances permitted for use in nylon 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 breast milk. Such uses were not included as part of the intended use of the substance in the FCN.
Effective Date: Dec 11, 2015
National Environmental Policy Act (NEPA)** Submission: Environmental Assessment (in PDF, 1.0 MB)
FDA Decision: Finding of No Significant Impact (FONSI)