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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. 1409

Esenttia S.A.

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) polymerized in the presence of propylene homopolymer (CAS Reg. No. 9003-07-0) complying with 21 CFR 177.1520(c) Item 1.1, to produce an inseparable blend of the two polymers.
Notifier: Propilco S.A.
Manufacturer/Supplier: Esenttia S.A.
Intended Use: As a basic polymer used in the production of articles intended to contact food, except for use in contact with infant formula and breast milk (see Limitations/Specifications).
Limitations/Specifications: The final blend incorporating the FCS has a minimum number-average molecular weight of 25,000 Daltons and is intended for use in contact with all types of food under Conditions of Use A through H as described in Tables 1 and 2. Adjuvant substances 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 this food-contact substance, subject to the prescribed limitations and specifications. 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: Apr 22, 2014
National Environmental Policy Act (NEPA)** Submission: Environmental Assessment (in PDF, 494 kB)
FDA Decision: Finding of No Significant Impact (FONSI)