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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. 1696

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: Pyromellitic dianhydride (CAS Reg. No. 89-32-7).
REPLACES FCNs 1140 and 1238
Notifier: The Valspar Corporation
Manufacturer/Supplier: Sherwin-Williams Company
Intended Use: The FCS in intended for use as a monomer in the production of polyester coating resins, except for use in contact with infant formula and human milk (see Limitations/Specifications).
Limitations/Specifications: 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 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. The FCS shall not exceed 3.7 percent by weight of the dry coating formulation. Coatings containing the FCS may contact all food types under Conditions of Use A through H, as described in Tables 1 and 2. The finished food contact articles will not be used in contact with infant formula and human milk. Such uses were not included as part of the intended use of the substance in the FCN.
Effective Date: Oct 19, 2016
National Environmental Policy Act (NEPA)** Submission: Categorical Exclusion 25.32(i)
FDA Decision: Categorical Exclusion Memo