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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. 2453

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 as sodium salt (CAS Reg. No. 129898-01-7), magnesium sodium salt (CAS Reg. No. 935545-65-6), calcium sodium salt, or calcium magnesium sodium salt. REPLACES FCN 1956
Notifier: Coatex SAS
Manufacturer/Supplier: Coatex and Affiliates
Intended Use: As an aid for dispersing and grinding mineral fillers in the wet-end process during the manufacture of food contact paper and paperboard used as packaging, including for use in contact with powdered (dry) infant formula (see Limitations/Specifications).
Limitations/Specifications: The FCS will be used at levels not to exceed 0.5 percent by weight in the filler. For use in contact with all foods types except food types VIA and VIC under Conditions of Use C through G as described in Tables 1 and 2. The FCS may be used in contact with powdered (dry) infant formula.
Effective Date: Oct 2, 2025
National Environmental Policy Act (NEPA)** Submission: Environmental Assessment
FDA Decision: Finding of No Significant Impact (FONSI)
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