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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. 143

BASF Corporation

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: Octadecanoic acid, methyl ester, reaction products with 1-(2-hydroxy-2-methylpropoxy)-2,2,6,6-tetramethyl-4-piperidinol (CAS Reg. No. 300711-92-6).
Notifier: Ciba Specialty Chemicals Corporation
Manufacturer: BASF Corporation
Intended Use: For use as a light stabilizer in polypropylene polymers and copolymers, and polyethylene polymers and copolymers (with a density not less than 0.94 grams per cubic centimeter), complying with 21 CFR 177.1520.
Limitations/Specifications*: Maximum use level of 0.1 percent by weight of the finished polypropylene and polyethylene polymers and copolymers (as described) in contact with non-fatty food (food types I, II, IV-B, VI-A, VI-B, VII-B, and VIII) under Conditions of Use B through H, as described in Tables 1 and 2, respectively. Maximum use level of 0.01 percent by weight of the finished polypropylene and polyethylene polymers and copolymers (as described) in contact with fatty food (food types III, IV-A, V, VI-C, VII-A, and IX) under Conditions of Use B through H, as described in Tables 1 and 2, respectively.
Effective Date: Jul 20, 2001
National Environmental Policy Act (NEPA)** Submission: Categorical Exclusion 25.32(i)
FDA Decision: Categorical Exclusion Memo
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