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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. 1902

PPG Industries, Inc.

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-hydroxyethyl methacrylate (HEMA; CAS Reg. No. 868-77-9).
Notifier: PPG Industries, Inc.
Manufacturer/Supplier: PPG Industries, Inc.
Intended Use: As a monomer in the manufacture of acrylic copolymers complying with 175.300(b)(3)(xx), for use as components of resinous and polymeric coatings on metal substrates for food-contact articles, except for use in contact with infant formula and human milk (see Limitations/Specifications).
Limitations/Specifications: The monomer shall not exceed 8.4 percent by weight of the finished coating. 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: Aug 8, 2018
National Environmental Policy Act (NEPA)** Submission: Categorical Exclusion 25.32(i)
FDA Decision: Categorical Exclusion Memo
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