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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. 60

Addivant

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: As an antioxidant in the manufacture of polypropylene homopolymer and copolymers complying with 21 CFR 177.1520.
Limitations/Specifications: The FCS will be used at levels not to exceed 0.1 weight percent in polypropylene homopolymers and copolymers. The finished homopolymers and copolymers may be used in contact with food types III, IV-A, V, VII-A, and IX (i.e., fatty foods) and VI-C (foods containing up to 15 percent alcohol), under Conditions of Use B through H as described in Tables 1 and 2, respectively.
Effective Date: Jul 15, 2000
National Environmental Policy Act (NEPA)** Submission: Environmental Assessment (in PDF, 162 kB)
FDA Decision: Finding of No Significant Impact (FONSI)

*See Food Types and Conditions of Use for Food Contact Substances (Tables 1 and 2).

**More about Environmental Decisions and Definitions of Environmental Terms.
See also Inventory of Environmental Impact Decisions for Food Contact Substance Notifications.
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