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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. 181

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: Benzenepropanoic acid, 3,5-bis(1,1-dimethylethyl)-4-hydroxy-,octadecyl ester (CAS Reg. No. 2082-79-3). The FCS is also known as octadecyl 3,5-di-tert-butyl-4-hydroxyhydrocinnamate.
Notifier: Ciba Specialty Chemicals
Manufacturer/Supplier: BASF Corporation
Intended Use: As a stabilizer for flexible polyvinyl chloride (PVC). The FCS is added to vinyl chloride monomer during the polymerization process.
Limitations/Specifications: For use as a stabilizer, at levels not to exceed 0.006 percent by weight of the flexible polyvinyl chloride film intended for use in contact with food types I, II, IV-B, VI-B, VII-B and VIII, under Conditions of Use A through H , as described in Tables 1 and 2 respectively. The maximum thickness of the film shall not exceed 1 mil.
Effective Date: Jan 15, 2002
National Environmental Policy Act (NEPA)** Submission: Categorical Exclusion 25.32(i)
FDA Decision: Categorical Exclusion Memo