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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. 639

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: 2,4-bis[(dodecylthio)methyl]-6-methylphenol (CAS Reg. No. 110675-26-8).
Notifier: Ciba Specialty Chemicals Corporation
Manufacturer: BASF Corporation
Intended Use: As an antioxidant/stabilizer for use in (1) styrene block polymers, and (2) polystyrene and rubber-modified polystyrene.
Limitations/Specifications*: 1. At levels not to exceed 0.3 percent by weight of styrene block polymers complying with 21 CFR 177.1810 in contact with Food Types I, II, IV-B, VI, VII-B, and VIII under Conditions of Use C through H, as described in Tables 1 and 2. 2. At levels not to exceed 0.1 percent by weight of polystyrene and rubber-modified polystyrene complying with 21 CFR 177.1640 in contact with all Food Types under Conditions of Use A through H as described in Tables 1 and 2.
Effective Date: Sep 19, 2006
National Environmental Policy Act (NEPA)** Submission: Categorical Exclusion 25.32(i) and (j)
FDA Decision: Categorical Exclusion Memo