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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. 232

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. REPLACES FCN 51.
Notifier: Ciba Specialty Chemicals Corporation
Manufacturer: BASF Corporation
Intended Use: As a process stabilizer in olefin polymers.
Limitations/Specifications*: 1) At levels not to exceed 0.5 percent by weight of olefin polymers complying with 21 CFR 177.1520(c). The finished polymers may only be used in contact with food types I, II, IV-B, VI-A, VI-B, VII-B and VIII identified in Table 1, under Condition of Use A as described in Table 2. 2) At levels not to exceed 0.1 percent by weight of high density ethylene polymers and copolymers complying with 21 CFR 177.1520(c). The finished polymers may be used in contact with food types III, IV-A, V, VI-C, VII-A and IX identified in Table 1, under Condition of Use B as described in Table 2. Provided, that the finished food contact articles have a volume of at least 18.9 liters(5 gallons). 3) At levels not to exceed 0.1 percent by weight of linear low density ethylene polymers and copolymers complying with 21 CFR 177.1520(c). The finished polymers may be used in contact with food types III, IV-A, V, VI-C, VII-A and IX identified in Table 1, under Conditions of Use B through H as described in Table 2. The finished polymers containing the process stabilizer may be used alone or mixed with low density ethylene polymers and copolymers and used in accordance with the limitations in 21 CFR 178.2010(b), under item 4 for the FCS.
Effective Date: Jul 10, 2002
National Environmental Policy Act (NEPA)** Submission: Categorical Exclusion 25.32(i) and (j)
FDA Decision: Categorical Exclusion Memo
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