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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. 1528

The Dow Chemical Company

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: Polymers composed of a 50-60 weight-percent ethyl acrylate (CAS Reg. No. 140-88-5), 36-40 weight-percent methacrylic acid (CAS Reg. No. 79-41-4), and up to 10 weight-percent mixture of poly(oxy-1,3-ethanediyl), α-(2-methyl-1-oxo-2-propen-1-yl)-ω-hydoxy-, C16-18-alkyl ethers (CAS Reg. No. 70879-51-5) and/or poly(oxy-1,3-ethanediyl), α-(2-methyl-1-oxo-2-propen-1-yl)-ω-hydoxy-, C12-14-alkyl ethers (CAS Reg. No. 72275-82-2).
Notifier: The Dow Chemical Company
Manufacturer/Supplier: The Dow Chemical Company
Intended Use: As a rheology modifier in pigmented coatings applied to paper and paperboard, except for use in contact with infant formula and breast milk (see Limitations and Specifications).
Limitations/Specifications: To be used at a level not exceeding 1.7% by weight of total coating solids, for contact with 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 breast milk. Such uses were not included as part of the intended use of the substance in the FCN.
Effective Date: Jun 27, 2015
National Environmental Policy Act (NEPA)** Submission: Categorical Exclusion 25.32(i)
FDA Decision: Categorical Exclusion Memo