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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. 310

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: 5,7-bis(1,1-dimethylethyl)-3-hydroxy-2(3H)-benzofuranone, reaction products with o-xylene (CAS Reg. No. 181314-48-7).
Notifier: Ciba Specialty Chemicals Corporation
Manufacturer: BASF Corporation
Intended Use: For use as an antioxidant/stabilizer in olefin polymers and copolymers.
Limitations/Specifications*: For use 1) at levels not to exceed 0.1 percent by weight in all polyolefins listed in 21 CFR 177.1520 in contact with aqueous, acidic and low-alcohol foods (i.e. food types I, II, IV-B, VI-A, VI-B, VII-B, and VIII), under Conditions of Use A through H, as described in Tables 1 and 2, respectively; 2) at levels not to exceed 0.03 percent by weight in polypropylene homopolymers listed in 21 CFR 177.1520 for fatty and high-alcohol foods (i.e. food types III, IV-A, V, VI-C, VII-A, IX), under Conditions of Use A through H, as described in Tables 1 and 2, respectively; and 3) at levels not to exceed 0.0062 mg/in2 in low density polyethylene polymers and linear low density polyethylene polymers and copolymers listed in 21 CFR 177.1520 where the average polymer thickness may be ≥ 50 µm (2 mils) in contact with fatty and high-alcohol foods (i.e. food types III, IV-A, V, VI-C, VII-A, IX) under Conditions of Use A through H, as described in Tables 1 and 2, respectively.
Effective Date: Apr 12, 2003
National Environmental Policy Act (NEPA)** Submission: Categorical Exclusion 25.32(i) and (j)
FDA Decision: Categorical Exclusion Memo
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