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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. 830

SI Group, Inc.

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).
Notifier: SI Group, Inc.
Manufacturer/Supplier: SI Group, Inc.
Intended Use: As a stabilizer for flexible polyvinyl chloride (PVC) and as an antioxidant for olefin polymers.
Limitations/Specifications: The FCS will be used as: (1) a stabilizer at levels not to exceed 0.006 percent by weight of flexible PVC film (maximum thickness shall not exceed 1 mil) that may contact food types I, II, IV-B, VI-B, VII-B and VIII under Conditions of Use A through H as described in Tables 1 and 2 and (2) an antioxidant for olefin polymers complying with 21 CFR 177.1520(c), item 3.6, at levels not to exceed 0.25 percent by weight of the finished articles that may contact all food types under Conditions of Use A through H as described in Tables 1 and 2.
Effective Date: Oct 8, 2008
National Environmental Policy Act (NEPA)** Submission: Categorical Exclusion 25.32(i) and (j)
FDA Decision: Categorical Exclusion Memo