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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. 1350

LyondellBasell Industries

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: LyondellBasell Industries
Manufacturer/Supplier: LyondellBasell Industries
Intended Use: As the 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 FCS has a minimum number-average molecular weight of 25,000 Daltons and may be used in contact with all types of food in applications for which the FCS is technically suitable under Condition of Use 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 safety of usage of the FCS in contact with infant formula and breast milk has not been evaluated.
Effective Date: Feb 18, 2014
National Environmental Policy Act (NEPA)** Submission: Environmental Assessment (in PDF, 67 kB)
FDA Decision: Finding of No Significant Impact (FONSI)

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