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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. 393

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: Phosphonic acid, [[3,5-bis(1,1-dimethylethyl)-4-hydroxyphenyl]methyl]-, diethyl ester (CAS Reg. No. 976-56-7).
Notifier: Ciba Specialty Chemicals Corporation
Manufacturer: BASF Corporation
Intended Use: As a chemically bound component of the polymeric backbone for use in polyethylene terephthalate homopolymers as described in 21 CFR 177.1630(e)(4)(ii) items 2 and 3, and complying with all applicable provisions of 21 CFR 177.1630.
Limitations/Specifications*: For use as an antioxidant/stabilizer in food contact polyethylene terephthalate homopolymers at levels not to exceed 0.11 weight percent of the finished polymer. To be used, in accordance with existing polyethylene terephthalate regulations, in contact with all food types under Conditions of Use E through G as described in Table 2, with expanded Conditions of Use C through G when used in contact with aqueous and acidic foods.
Effective Date: Feb 25, 2004
National Environmental Policy Act (NEPA)** Submission: Environmental Assessment
FDA Decision: Finding of No Significant Impact (FONSI)
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