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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. 2


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: GENOXTM EP, chemically identified as Amines, bis(hydrogenated rape-oil alkyl)methyl, N-oxides (CAS Reg. No. 204933-93-7)
Notifier: Addivant
Manufacturer/Supplier: Addivant
Intended Use: An antioxidant and/or stabilizer
Limitations/Specifications: For use only at levels not to exceed 0.1 weight percent polypropylene complying with 21 CFR 177.1520. The finished copolymers may be safely used in single-use as well as repeated-use applications involving contact with food of types I, II, IV-B, VI, VII-B, and VIII, under Conditions of Use B through H, as described in Tables 1 and 2
Effective Date: Mar 9, 2000
National Environmental Policy Act (NEPA)** Submission: Environmental Assessment
FDA Decision: Finding of No Significant Impact (FONSI)