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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. 189

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: Di-(para-methylbenzylidene)sorbitol (CAS Reg. No. 54686-97-4, 197809-37-3 and 81541-12-0) containing up to 1 percent triisopropanolamine.
Notifier: Ciba Specialty Chemicals Corporation
Manufacturer/Supplier: BASF Corporation
Intended Use: As a clarifying agent for polypropylene homopolymers complying with 21 CFR 177.1520(c) Items 1.1a and 1.1b
Limitations/Specifications: For use at levels not to exceed 0.32 percent by weight of the finished polymer under Conditions of Use B through H as described in Table 2. The finished polymer may be used in contact with all food types.
Effective Date: May 24, 2002
National Environmental Policy Act (NEPA)** Submission: Categorical Exclusion 25.32(i)
FDA Decision: Categorical Exclusion Memo