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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. 117

Rohm and Haas Company

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-butyl acrylate copolymers.
Notifier: Rohm and Haas Company
Manufacturer/Supplier: Rohm and Haas Company
Intended Use: Components of coatings for paper and paperboard in compliance with 21 CFR 176.170(b).
Limitations/Specifications*: 1. Styrene-butyl acrylate acrylic copolymers are produced by the emulsion polymerization of a minimum of 68 parts by weight styrene with a maximum of 26 parts butyl acrylate and up to 12 parts of any one or more of the following monomers: acrylic acid, methacrylic acid, methyl methacrylate, allyl methacrylate and butyl methacrylate, as further described in the notification. 2. The subject copolymers are for use in pigmented coatings that contain mixtures of other components such as inorganic pigments (e.g., clay, titanium dioxide, calcium carbonate) and binders applied to paper and paperboard at levels not to exceed 20 percent by weight based on total coating solids. 3. The copolymers may also be used in coatings applied to the interior, food contact paper and paperboard surface at levels not to exceed 50 percent by weight of total coating solids levels. 4. The finished copolymers must be used in accordance with 21 CFR 176.170(c).
Effective Date: May 17, 2001
National Environmental Policy Act (NEPA)** Submission: Categorical Exclusion 25.32(i)
FDA Decision: Categorical Exclusion Memo