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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. 1557

BASF Schweiz AG

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: Octadecyl 3,5-di-tert-butyl-4-hydroxyhydrocinnamate (CAS Reg. No. 2082-79-3).REPLACES FCN 1206
Notifier: BASF Schweiz AG
Manufacturer/Supplier: BASF Schweiz AG
Intended Use: As a stabilizer in polycyclooctene (PCOE) polymers.
Limitations/Specifications: The maximum level of the FCS will not exceed 600 parts per million (ppm) by weight in polycyclooctene (PCOE) polymers. The maximum thickness of the PCOE polymers will not exceed 100 microns in thickness. PCOE polymers containing the FCS may be used as the non-food contact article which may contact all food types under Conditions of Use A through H as described in Tables 1 and 2. The FCS is not for use in contact with infant formulaand breast milk. Such uses were not included as part of the intended use of the substance in the FCN.
Effective Date: Aug 26, 2015
National Environmental Policy Act (NEPA)** Submission: Categorical Exclusion 25.32(i)
FDA Decision: Categorical Exclusion Memo