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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. 1086

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: LyondellBasell Industries
Intended Use: As the basic polymer used in the production of single- and repeat-use 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 under Conditions of Use A through H, 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.
Effective Date: Jul 8, 2011
National Environmental Policy Act (NEPA)** Submission: Categorical Exclusion 23.32(j)
Environmental Assessment (in PDF)
(39 kB)
FDA Decision: Categorical Exclusion Memo/Finding of No Significant Impact (FONSI)