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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. 2148

Topy Industries, Limited

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: Magnesium sodium fluoride silicate (CAS Reg. No. 56450-90-9).
Notifier: Topy Industries, Limited
Manufacturer/Supplier: Topy Industries, Limited
Intended Use: As a barrier to water vapor in coatings applied to food-contact paper and paperboard, except for use in contact with infant formula and human milk (see Limitations/Specifications).
Limitations/Specifications: The finished paper and paperboard containing the FCS may contact all food types under conditions of use B through H. The maximum application rate of the FCS onto paper and paperboard will not exceed 10 g/m2 (or 6.45 mg/in2). 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 31, 2021
National Environmental Policy Act (NEPA)** Submission: Categorical Exclusion 25.32(i)
FDA Decision: Categorical Exclusion Memo