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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. 2247

Amano Enzyme U.S.A. 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: 2-Propenoic acid, 2-methyl-, 1,1-(1,2-ethanediyl) ester, polymer with phenylmethyl 2-methyl-2-propenoate (CAS Reg. No. 126969-53-7).
Notifier: Amano Enzyme U.S.A. Co., Ltd.
Manufacturer/Supplier: Amano Enzyme U.S.A. Co., Ltd.
Intended Use: For use as a component of a solid support for immobilizing enzymes that are used to process food oils, except for use in contact with infant formula and human milk (see Limitations/Specifications).
Limitations/Specifications: The FCS will comprise up to 90% by weight of the finished FCS with immobilized enzyme. 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: Jan 25, 2023
National Environmental Policy Act (NEPA)** Submission: Environmental Assessment (in PDF, 853 kB)
FDA Decision: Finding of No Significant Impact (FONSI) (in PDF, 245 kB)

*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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