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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. 2104

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, 2-methyl-, polymer with 2-methyloxirane polymer with oxirane monoether with 1,2-propanediol mono(2-methyl-2-propenoate) and 2-propenoic acid, sodium salt (CAS Reg. No. 2272985-43-8).
Notifier: Coatex
Manufacturer/Supplier: Coatex and affiliates
Intended Use: As an adjuvant for mineral coatings applied to 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 at levels not to exceed 167 µg/in2 in finished paper and paperboard for contact with all food types under Conditions of Use C through G, as described in Table 2. The FCS is not for use in contact with infant formula and human milk. Such use was not included as part of the intended use of the substance in the FCN.
Effective Date: Jan 19, 2021
National Environmental Policy Act (NEPA)** Submission: Categorical Exclusion 25.32(i)
FDA Decision: Categorical Exclusion Memo

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