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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. 328

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: Phosphorous acid, bis[2,4-bis(1,1-dimethylethyl)-6-methylphenyl]ethyl ester (CAS Reg. No. 145650-60-8). The FCS is also known as bis(2,4-di-tert-butyl-6-methylphenyl)ethyl phosphite.
Notifier: Ciba Specialty Chemicals Corporation
Manufacturer: BASF Corporation
Intended Use: As an antioxidant and/or stabilizer in adhesives.
Limitations/Specifications*: As an antioxidant and/or stabilizer in: 1) adhesives complying with the limitations of 21 CFR 175.105, paragraph (a)(2), in contact with all food types at temperatures not to exceed 120°F. 2) pressure-sensitive adhesives, at levels not to exceed 0.5 percent by weight of the finished adhesive, used as the food contact surface of labels and/or tapes applied to poultry, dry food and processed, frozen, dried or partially dehydrated fruits and vegetables as well as raw fruits and vegetables under Conditions of Use E through G (room temperature or below), as described in Table 2
Effective Date: Jul 17, 2003
National Environmental Policy Act (NEPA)** Submission: Categorical Exclusion 25.32(i) and (j)
FDA Decision: Categorical Exclusion Memo