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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. 1958

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: Fluorocarbon cured elastomer produced by copolymerizing tetrafluoroethylene (CAS Reg. No. 116-14-3) and propylene (CAS Reg. No. 115-07-1) and subsequent curing with triallylisocyanurate (CAS Reg. No. 1025-15-6) or triallylcyanurate (CAS Reg. No. 101-37-1) and 2,2-bis(tert-butylperoxy)diisopropylbenzene (CAS Reg. No. 25155-25-3).
Notifier: AGC Chemicals Americas, Inc.
Manufacturer/Supplier: AGC Chemicals Americas, Inc.
Intended Use: The FCS will be used in the fabrication of molded parts for food processing equipment such as seals, gaskets, o-rings and other parts, except for use in contact with infant formula and human milk (see Limitations/Specifications).
Limitations/Specifications: The fluorocarbon base polymer shall contain no less than 63 weight-percent of polymer units derived from tetrafluoroethylene and no less than 26 weight-percent of polymer units derived from propylene. The elastomer shall be composed of no more than 5 weight-percent of triallylisocyanurate or triallylcyanurate and no uncured more than 5 weight-percent 2,2-bis(tert-butylperoxy)diisopropylbenzene. Finished articles formed from the FCS must comply with the extractive limitations prescribed in 21 CFR 177.2600(e) and (f). Finished articles formed from the FCS will be used in contact with all food types under Conditions of Use A through H, as described in 21 CFR 176.170(c). 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 17, 2019
National Environmental Policy Act (NEPA)** Submission: Categorical Exclusion 25.32(j)
FDA Decision: Categorical Exclusion Memo