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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. 1226

Sherwin-Williams 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: 3a,4,7,7a-tetrahydro-4,7-methanoisobenzofuran-1,3-dione (CAS Reg. No. 826-62-0).
Notifier: Valspar Corporation
Manufacturer/Supplier: Sherwin-Williams Company
Intended Use: For use as a monomer in the production of polyester coating resins as described in 21 CFR 175.300(b)(3)(vii). The resin may be used in the production of coatings on (1) metal substrates for single use food-contact articles or (2) any substrate for repeated use food-contact articles. The FCS may be safely reacted with monomers listed in 21 CFR 175.300(b)(3)(vii)(a, b, c,and d) and polybasic acids and their anhydrides, monobasic acids, polyhydric alcohols, and monohydric alcohols that are authorized through an effective Food Contact Notification (FCN) for use as components of polyester coating resins. The above materials that are reacted with the FCS to form a polyester coating resin must be authorized for the intended conditions of use for the final coating.
Limitations/Specifications: The FCS shall not exceed 8.7 percent by weight of the final coating formulation and may contact all food types, except food type VI (beverage), under Conditions of Use A through H as described in Tables 1 and 2. The FCS will not be used in contact with infant formula products.
Effective Date: Dec 26, 2012
National Environmental Policy Act (NEPA)** Submission: Categorical Exclusion 25.32(i)
FDA Decision: Categorical Exclusion Memo