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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. 268


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: Tris(2,4-di-tert-butylphenyl)phosphite (CAS Reg. No. 31570-04-4).
Notifier: Addivant
Manufacturer: Addivant
Intended Use: For use as a stabilizer in olefin copolymers described in 21 CFR 177.1520(a)(3)(iii) and meeting the specifications in 21 CFR 177.1520(c), item 3.4.
Limitations/Specifications*: 1) The FCS will be used at maximum level of 0.2 percent by weight of the finished copolymer. 2) The finished copolymers are intended to contact food types I, II, III, IV-B, VI, VII, VIII, and IX, under Conditions of Use A through H as described in Tables 1 and 2 respectively.
Effective Date: Oct 18, 2002
National Environmental Policy Act (NEPA)** Submission: Categorical Exclusion 25.32(i)
FDA Decision: Categorical Exclusion Memo