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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. 1301

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), 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. REPLACES FCN 1051
Notifier: LyondellBasell Industries
Manufacturer/Supplier: LyondellBasell Industries
Intended Use: As the basic polymer used in the production of articles intended to contact food.
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 Conditions of Use A through H, and J, as described in Tables 1 and 2. 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.
Effective Date: Sep 10, 2013
National Environmental Policy Act (NEPA)** Submission: Environmental Assessment (in PDF, 301 kB)
FDA Decision: Finding of No Significant Impact (FONSI)
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