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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. 2360

Wanhua Chemical Group Co., Ltd.

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: 1H-Azepine-1-carboxamide,N,N′,N″-[(2,4,6-trioxo-1,3,5-triazine-1,3,5(2H,4H,6H)-triyl)tris[methylene(3,5,5-trimethyl-3,1-cyclohexanediyl)]]tris[hexahydro-2-oxo- (CAS Reg. No. 68975-83-7).
Notifier: Wanhua Chemical Group Co., Ltd.
Manufacturer/Supplier: Wanhua Chemical Group Co., Ltd.
Intended Use: To be used as a reactant with one or more polybasic acids or polyhydric alcohols in the formation of coatings on metal substrates in single-use food-contact applications and any suitable substrate in repeated-use food-contact applications, complying with 21 CFR 175.300(b)(3)(vii), except for use in contact with infant formula and human milk (see Limitations/Specifications).
Limitations/Specifications: The FCS will be used in contact with 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 FCS.
Effective Date: Jun 5, 2024
National Environmental Policy Act (NEPA)** Submission: Environmental Assessment (in PDF, 292 kB)
FDA Decision: Finding of No Significant Impact (FONSI) (in PDF, 220 kB)
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