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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. 1805

Solvay Specialty Polymers USA, LLC

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: A polymer produced from tetrafluoroethylene (CAS Reg. No. 116-14-3) and 1,1,2,2-tetrafluoro-2-((1,2,2-trifluoroethenyl)oxy)ethanesulfonyl fluoride (CAS Reg. No. 29514-94-1). The polymer is hydrolyzed and may optionally be further neutralized to its ammonium salt.
Notifier: Solvay Specialty Polymers USA, LLC
Manufacturer/Supplier: Solvay Specialty Polymers USA, LLC
Intended Use: As a component of coatings for repeat-use food filtration membranes, except for use in contact with infant formula or ingredients used for making infant formula (see Limitations/Specifications).
Limitations/Specifications: The FCS will be used as a coating for food filtration membranes in contact with all food types as described in Table 1. The coatings comprised of the FCS shall have a thickness not to exceed 0.5 microns. The FCS is not for use in contact with infant formula or ingredients used for making infant formula. Such uses were not included as part of the intended use of the substance in the FCN.
Effective Date: Dec 20, 2017
National Environmental Policy Act (NEPA)** Submission: Categorical Exclusion 25.32(j)
FDA Decision: Categorical Exclusion Memo

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