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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. 1697


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: Tetrakis(hydroxymethyl)phosphonium sulfate (THPS) (CAS Reg. No. 55566-30-8).
Notifier: The Dow Chemical Company
Manufacturer/Supplier: MC (US) 3 LLC
Intended Use: As a preservative in coatings intended for use on paper and paperboard that may contact food, except for use in contact with infant formula and human milk (see Limitations/Specifications).
Limitations/Specifications: The FCS may be used at levels not to exceed 400 ppm in water-based coatings, starches, pigments, and filler slurries that may contact all food types, except for infant formula and human milk, under all Conditions of Use, as described in Tables 1 and 2. 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: Oct 21, 2016
National Environmental Policy Act (NEPA)** Submission: Categorical Exclusion 25.32(q)
FDA Decision: Categorical Exclusion Memo