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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. 2123

COIM S.p.A., Italy

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: Hexanedioic acid, polymer with 1,4-butanediol, 2,2-dimethyl-1,3-propanediol, and 1,1’- methylenebis[4-isocyanatobenzene] (CAS Reg. No. 56815-45-3).
Notifier: COIM S.p.A., Italy
Manufacturer/Supplier: COIM S.p.A., Italy
Intended Use: For use in the fabrication of conveyor belts and molded parts such as o-rings and gaskets for food processing equipment, except for use in contact with infant formula and human milk (see Limitations/Specifications).
Limitations/Specifications: The FCS may be used as a component of molded articles used in food processing equipment such as conveyor belts, o-rings, and gaskets intended to 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: May 15, 2021
National Environmental Policy Act (NEPA)** Submission: Categorical Exclusion 25.32(j)
FDA Decision: Categorical Exclusion Memo

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