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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. 2217

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: Poly-1-butene homopolymer (CAS Reg. No. 9003-28-5).
Notifier: LyondellBasell Industries
Manufacturer/Supplier: LyondellBasell Industries
Intended Use: As the basic polymer in the production of articles intended to contact food, including infant formula and human milk.
Limitations/Specifications: The FCS may be used in contact with all types of food under Conditions of Use A through H as described in Tables 1 and 2. The density of the FCS will range from 0.904 to 0.940 g/cm3. The intrinsic viscosity will not exceed 3.2 dl/g. Additives permitted for use in butene polymers complying with 21 C.F.R. 177.1570 or in olefin polymers complying with 21 C.F.R. 177.1520(c), items 3.1, and 3.2 may also be used in the FCS, subject to the prescribed limitations and specifications. The FCS may be used in repeated-use articles (excluding baby bottle nipples) intended to contact infant formula and human milk.
Effective Date: Jul 6, 2022
National Environmental Policy Act (NEPA)** Submission: Environmental Assessment (in PDF, 651 kB)
FDA Decision: Finding of No Significant Impact (FONSI) (in PDF, 188 kB)
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