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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. 336

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: Styrene-acrylic copolymers as further described in your submission (FCN 336).
Notifier: BASF Corporation
Manufacturer/Supplier: BASF Corporation
Intended Use: For use as components of printing inks or coatings that are applied to polyester films intended for contact with food.
Limitations/Specifications: The styrene-acrylic copolymers are produced by the polymerization of the following monomers in various combinations with the maximum use levels as noted: 100 percent styrene, 48 percent butyl acrylate, 21 percent methyl methacrylate, 39 percent alpha methyl styrene, 39 percent acrylic acid, and 50 percent 2-ethylhexyl acrylate. The finished copolymers may contact all food types under Conditions of Use B through H as described in Table 2, including contact with food during cooking (initial temperature covered by Condition of Use A, but without extended shelf storage).
Effective Date: Aug 12, 2003
National Environmental Policy Act (NEPA)** Submission: Categorical Exclusion 25.32(i)
FDA Decision: Categorical Exclusion Memo