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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. 2219

The 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: β3,β3,β9,β9-Tetramethyl-2,4,8,10-tetraoxaspiro[5.5]undecane-3,9-diethanol (CAS Reg. No. 1455-42-1).
Notifier: The Sherwin-Williams Company
Manufacturer/Supplier: The Sherwin-Williams Company
Intended Use: For use as a monomer in the manufacture of polyester or polyester/polyurethane resins for use as components of coatings on metal substrates for food-contact articles, except for use in contact with infant formula and human milk (see Limitations/ Specifications).
Limitations/Specifications: The FCS may be used at a maximum level not to exceed 5% (weight solids) of the final coating. The FCS may be used in contact with all food types 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 or human milk. Such uses were not included as part of the intended use of the substance in the FCN.
Effective Date: May 25, 2022
National Environmental Policy Act (NEPA)** Submission: Categorical Exclusion 25.32(i)
FDA Decision: Categorical Exclusion Memo
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