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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. 2509

ElringKlinger Kunststofftechnik 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: Poly(oxy-1,4-phenylenecarbonyl) (CAS Reg. No. 26099-71-8).
Notifier: ElringKlinger Kunststofftechnik GmbH
Manufacturer/Supplier: ElringKlinger Kunststofftechnik GmbH
Intended Use: As an additive in polytetrafluoroethylene (PTFE) polymers intended for molded parts for sealing applications such as seals, gaskets, and O-rings, except for use in contact with infant formula and human milk (see Limitations/Specifications).
Limitations/Specifications: The FCS will be used at levels not to exceed 25 weight percent in PTFE polymers. The finished polymers produced using the FCS may be used in repeat-use molded parts for sealing applications used in food processing equipment such as seals, gaskets, and O-rings, intended to contact beverages.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: Aug 5, 2026
National Environmental Policy Act (NEPA)** Submission: Categorical Exclusion 25.32(j)
FDA Decision: Categorical Exclusion Memo
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