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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. 1892

BASF SE and affiliated companies

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: BASF SE
Manufacturer/Supplier: BASF SE and affiliated companies
Intended Use: For use as articles or components of articles intended for repeated-use complying with 21 CFR 177.2470, 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 at a maximum use temperature of 121°C. 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: Jul 13, 2018
National Environmental Policy Act (NEPA)** Submission: Categorical Exclusion 25.32(j)
FDA Decision: Categorical Exclusion Memo