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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. 768

Songwon International - Americas, 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: Songwon International - Americas, Inc.
Manufacturer/Supplier: Songwon International - Americas, Inc.
Intended Use: As an antioxidant for olefin polymers.
Limitations/Specifications: As an antioxidant for olefin polymers complying with 21 CFR 177.1520(c), Section 3.6, at levels not to exceed 0.25 percent by weight of the finished article in contact with all food types under Conditions of Use A through H, as described in Tables 1 and 2.
Effective Date: Jan 11, 2008
National Environmental Policy Act (NEPA)** Submission: Categorical Exclusion 25.32(i) and (j)
FDA Decision: Categorical Exclusion Memo