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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. 2007

Coatex and Affiliates

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: 2-Propenoic acid, polymer with sodium phosphinate (1:1), neutralized with sodium, calcium, and/or magnesium (including CAS Reg. No. 129898-01-7 (Na salt), CAS Reg. No. 935545-65-6 (Mg Na salt)).
Notifier: Coatex SAS
Manufacturer/Supplier: Coatex and Affiliates
Intended Use: As an aid for dispersing and grinding pigments in mineral coatings of food-contact paper and paperboard, except for use in contact with infant formula and human milk (see Limitations/Specifications).
Limitations/Specifications: The FCS may be used in mineral coatings at a level not to exceed 1.25 percent by weight of solid pigment. The FCS may contact all food types under Conditions of Use A through H, as described in Table 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: Jan 3, 2020
National Environmental Policy Act (NEPA)** Submission: Categorical Exclusion 25.32(i)
FDA Decision: Categorical Exclusion Memo

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