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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. 556

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: The FCS is intended for use as an antioxidant/stabilizer in (a) ethylene phthalate polymers compliant with 21 CFR 177.1630 and (b) ethylene phthalate polymers compliant with the specifications in 21 CFR 177.1630(f) for which there is an effective food contact notification.
Limitations/Specifications*: The FCS will be used at levels not to exceed 1100 ppm (0.11 weight percent) in the finished ethylene phthalate polymers, in contact with all food types as listed in Table 1 under the Conditions of Use A through H as described in Table 2.
Effective Date: Apr 19, 2006
National Environmental Policy Act (NEPA)** Submission: Environmental Assessment (in PDF) (37 kB)
FDA Decision: Finding of No Significant Impact (FONSI)
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