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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. 1824

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 polymers (CAS Reg. No. 9003-28-5) and 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, including infant formula and human milk.
Limitations/Specifications: The FCS will contain no more than 7.5 weight percent of polymer units derived from ethylene 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. The density of the FCS will range from 0.87-0.93 g/cm3. The melt index will range from 0.1 - 3000. The intrinsic viscosity will not exceed 3.2 dl/g. 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. The FCS polymers may be used in repeat-use articles (excluding baby bottle nipples) intended to contact infant formula and human milk.
Effective Date: Dec 1, 2017
National Environmental Policy Act (NEPA)** Submission: Environmental Assessment (in PDF, 79 kB)
FDA Decision: Finding of No Significant Impact (FONSI)

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