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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. 1436

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: Butene/ethylene copolymers (CAS Reg. No. 25087-34-7).
Notifier: LyondellBasell Industries
Manufacturer/Supplier: LyondellBasell Industries
Intended Use: As the basic polymer in the production of articles intended to contact food.
Limitations/Specifications: The FCS is a copolymer of 1-butene and ethylene such that the amount of polymer units derived from ethylene is more than 4.5 percent and no greater than 9.5 percent. The finished copolymers may be used in contact with all types of food under FDAs Conditions of Use A through H, as described in Tables 1 and 2. The density of the copolymers will range from 0.865 0.90 g/cm3. Additives permitted for use in butene polymers complying with 21 CFR 177.1570 or in olefin polymers complying with 21 CFR 177.1520(c), items 3.1 and 3.2 may also be used in the FCS, provided that the limitations and specifications on the use of the additives are met. Permitted uses in contact with infant formula and breast milk: The FCS may be used in repeated-use articles (excluding baby bottle nipples) intended for the feeding of infants (e.g., baby bottles).
Effective Date: Oct 16, 2014
National Environmental Policy Act (NEPA)** Submission: Environmental Assessment (in PDF, 475 kB)
FDA Decision: Finding of No Significant Impact (FONSI)