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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. 385

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: Tris (2,4-di-tert-butylphenyl)phosphite (CAS Reg. No. 31570-04-4).
Notifier: Ciba Specialty Chemicals Corporation
Manufacturer: BASF Corporation
Intended Use: The FCS will be used as an antioxidant in the manufacture of olefin polymers complying with the provisions of 21 CFR 177.1520(c), items 3.2c and 3.6.
Limitations/Specifications*: The FCS will be used as follows: 1) When used as components of olefin polymers complying with the provisions of 21 CFR 177.1520(c), item 3.2c, the FCS will be used at levels not to exceed 0.2 percent by weight of the finished articles; and in contact with all types of food under temperature Conditions of Use C through H as described in Tables 1 and 2, respectively. 2) When used as components of olefin polymers complying with the provisions of 21 CFR 177.1520(c), item 3.6, the FCS will be used at levels not to exceed 0.2 percent by weight of the finished articles; and in contact with all types of food under temperature Conditions of Use A through H as described in Tables 1 and 2, respectively.
Effective Date: Jan 13, 2004
National Environmental Policy Act (NEPA)** Submission: Categorical Exclusion 25.32(i) and (j)
FDA Decision: Categorical Exclusion Memo
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