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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. 1538

Pinnacle Polymers

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: Ethylene-propylene copolymers (CAS Reg. No. 9010-79-1)
Notifier: Pinnacle Polymers
Manufacturer/Supplier: Pinnacle Polymers
Intended Use: As the basic polymer used in the production of single- and repeat-use articles intended to contact food, except for use in contact with infant formula and breast milk (see Limitations and Specifications).
Limitations/Specifications: The FCS has a minimum number-average molecular weight of 25,000 Daltons and may be used in contact with all types of food under Conditions of Use A through H and J, as described in Tables 1 and 2, respectively. Additives permitted for use in olefin polymers complying with 21 CFR 177.1520(c), items 1.1, 3.1, and 3.2 may also be used in the FCS, subject to the prescribed limitations and specifications. The FCS is not for use in contact with infant formula and breast milk. Such use was not included as part of the intended use of the substance in the FCN.
Effective Date: Jun 9, 2015
National Environmental Policy Act (NEPA)** Submission: Environmental Assessment (in PDF, 524 kb)
FDA Decision: Finding of No Significant Impact (FONSI)