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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. 1955

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 mineral filler to be used in polyolefin food contact materials, except for use in contact with infant formula and human milk (see Limitations/Specifications).
Limitations/Specifications*: The FCS will be used at levels not to exceed 0.25 percent by weight of the finished polyolefin, for use in contact with Food Types I, III (non-acidic), IVA, IVB, V, VIB, VIIA, VIIB, VIII, and IX under Conditions of Use E through G 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: May 13, 2019
National Environmental Policy Act (NEPA)** Submission: Categorical Exclusion 25.32(i)
FDA Decision: Categorical Exclusion Memo

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