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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. 2342

Asahi Kasei Corporation

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: 1,3,5-trioxane, polymer with 1,3-dioxolane (CAS Reg. No. 24969-26-4).
Notifier: Asahi Kasei Corporation
Manufacturer/Supplier: Asahi Kasei Corporation
Intended Use: As articles or components of articles intended for repeated-use, except for use in contact with infant formula and human milk (see Limitations/Specifications).
Limitations/Specifications: The FCS may be used in contact with all food types, except those containing more than 15 percent alcohol, at a maximum use temperature of 250 °F. The FCS may contain optional adjuvants permitted for use in polyoxymethylene copolymer resins complying with 21 CFR 177.2470, subject to the prescribed limitations and specifications in the authorizing regulation or notification. 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: Apr 6, 2024
National Environmental Policy Act (NEPA)** Submission: Categorical Exclusion 25.32(j)
FDA Decision: Categorical Exclusion Memo

*See Food Types and Conditions of Use for Food Contact Substances (Tables 1 and 2).

**More about Environmental Decisions and Definitions of Environmental Terms.
See also Inventory of Environmental Impact Decisions for Food Contact Substance Notifications.
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