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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. 1493

Archroma Management GmbH

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
Copolymer of 2-(dimethylamino) ethyl methacrylate with 3,3,4,4,5,5,6,6,7,7,8,8,8-tridecafluorooctyl methacrylate, N-oxide, acetate (CAS Reg. 1440528-04-0)
Notifier: Archroma Management GmbH
Manufacturer/Supplier: Archroma Management GmbH
Intended Use: As a grease resistant treatment employed either prior to or after the sheet forming operation for paper and paperboard intended to contact food, 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
The FCS may be used at a level not to exceed 0.26 mg/in2 paper on a polymer solids basis. The finished paper may be used in contact with all food types under Conditions of Use B through H as described in Tables 1 and 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: Dec 31, 2014
National Environmental Policy Act (NEPA)** Submission: Categorical Exclusion 25.32(i)
FDA Decision: Categorical Exclusion Memo
Additional Information: Company commitment letter and FDA acknowledgement
Archroma Management GmbH Commitment Letter Regarding FCN No. 1493 (July 2020)
Acknowledgement Receipt to Archroma Management GmbH Commitment Letter Regarding FCN No. 1493 (July 2020)

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