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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. 1775

Coatex SAS
Coatex Netherlands BV
Coatex, Inc.
Changshu Coatex Additive
COATEX Latin America Industria e Comérico Ltda

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, sodium salt, homopolymer (CAS Reg. No. 9003-04-7). REPLACES FCN 946
Notifier: Coatex SAS
Coatex Netherlands BV
Coatex, Inc.
Changshu Coatex Additive
COATEX Latin America Industria e Comérico Ltda
Manufacturer/Supplier: Coatex SAS
Coatex Netherlands BV
Coatex, Inc.
Changshu Coatex Additive
COATEX Latin America Industria e Comérico Ltda
Intended Use: As a mineral pigment dispersant in the manufacture 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 coatings at a level not to exceed 1.25 weight percent of solid pigment. The FCS may be used 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: Jun 2, 2017
National Environmental Policy Act (NEPA)** Submission: Categorical Exclusion 25.32(i)
FDA Decision: Categorical Exclusion Memo

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