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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. 1492

Solvay USA Inc.; Solvay, S.A.; Rhodia Operations; Solvay (Zhenjiang) Chemicals Co., Ltd.

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: Sodium alkyl (C10-16) ethoxylated sulfate
Notifier: Solvay USA Inc.
Manufacturer/Supplier: Solvay USA Inc.; Solvay, S.A.; Rhodia Operations; Solvay (Zhenjiang) Chemicals Co., Ltd.
Intended Use: For use as an emulsifier in the production of acrylic and modified acrylic polymers, styrene-acrylic copolymers, and vinyl acetate copolymers used as pigment binders in coatings for paper and paperboard that contact all food types.
Limitations/Specifications: At levels not to exceed 2.0 percent by weight of acrylic and modified acrylic polymers, styrene-acrylic copolymers, and vinyl acetate copolymers used as pigment binders in coatings for paper and paperboard complying with 21 CFR 176.170 and 176.180. Permitted uses in contact with infant formula: the paperboard containing the FCS may contact powdered infant formula. Paperboard containing the FCS may be incorporated in brick-pack packaging holding ready-to-eat infant formula or concentrate provided that there are functional barriers separating the formula from the FCS-containing layer. Cap liners containing the FCS may be used in contact with ready-to-eat formula.
Effective Date: Dec 26, 2014
National Environmental Policy Act (NEPA)** Submission: Categorical Exclusion 25.32(i)
FDA Decision: Categorical Exclusion Memo

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