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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. 1676

Asahi Glass Co., Ltd.
AGC Chemicals Americas, Inc.

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: Introduction into interstate commerce and delivery for introduction into interstate commerce will be voluntarily ceased by the manufacturer
2-propenoic acid, 2-methyl-, 2-hydroxyethyl ester, polymer with 2-propenoic acid and 3,3,4,4,5,5,6,6,7,7,8,8,8-tridecafluorooctyl 2-methyl-2-propenoate, sodium salt (CAS Reg. No. 1878204-24-0).
Notifier: AGC Chemicals Americas, Inc.
Manufacturer/Supplier: Asahi Glass Co., Ltd.
AGC Chemicals Americas, Inc.
Intended Use: As an oil, water and grease proofing agent in paper and paperboard, except for use in contact with infant formula and breast milk (see Limitations/Specifications).
Limitations/Specifications: Introduction into interstate commerce and delivery for introduction into interstate commerce will be voluntarily ceased by the manufacturer
For use at a maximum level of 1.2 % by weight of the finished paper, in contact with all food types under Conditions of Use B through H, as described in Table 2. The FCS is not for use in contact with infant formula and breast milk. Such uses were not included as part of the intended use of the substance in the FCN.
Effective Date: Sep 21, 2016
National Environmental Policy Act (NEPA)** Submission: Categorical Exclusion 25.32(i)
FDA Decision: Categorical Exclusion Memo
Additional Information: Company commitment letter and FDA acknowledgement
AGC Chemicals Americas, Inc Commitment Letter Regarding FCN Nos. 599, 604, 1186, and 1676 (July 2020)
Acknowledgement Receipt to AGC Chemicals Americas, Inc Commitment Letter Regarding FCN Nos. 599, 604, 1186, and 1676 (July 2020)

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