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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. 2408

Metlac S.p.A. and its stewarded affiliates around the world

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: Tricyclodecanedimethanol (CAS Reg. No. 26160-83-8 and 26896-48-0).
Notifier: Metlac S.p.A.
Manufacturer/Supplier: Metlac S.p.A. and its stewarded affiliates around the world
Intended Use: The FCS is intended for use as a monomer in the production of polyester or polyester/polyurethane resins for use as coatings on metal substrates for food-contact articles, except for contact with infant formula and human milk (see Limitations/Specifications).
Limitations/Specifications: The level of the FCS in the final coating may not exceed 46.1 percent by weight. Coatings containing the FCS may contact all food types under Conditions of Use A through H, as described in Tables 1 and 2. The FCS is not for use 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: Feb 4, 2025
National Environmental Policy Act (NEPA)** Submission: Categorical Exclusion 25.32(i) and (j)
FDA Decision: Categorical Exclusion Memo
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