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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. 884

Arkema, Inc. and its affiliates around the world.

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: Acrylic polymers are composed of a minimum of 60 weight percent of the polymer consisting of ethyl acrylate and methacrylic acid. The balance of the polymer consists of one or more of the following monomers:

2-Sulfoethyl methacrylate (monomer) <2%; Macromonomers as follows:

  • Poly(oxy-1,2-ethanediyl) (20-50 moles), α-[[[1-methyl-1-[3-(1-methylethenyl)phenyl]ethyl]amino]carbonyl]-ω-(nonylphenoxy)-;
  • Poly(oxy-1,2-ethanediyl) (20-50 moles), α-[[[1-methyl-1-[3-(1-methylethenyl)phenyl]ethyl]amino]carbonyl]-ω-(dinonylphenoxy)-;
  • Poly(oxy-1,2-ethanediyl) (20-50 moles), α-[[[1-methyl-1-[3-(1-methylethenyl)phenyl]ethyl]amino]carbonyl]-ω-[2-(nonylphenoxy)-1-[(nonylphenoxy)methyl]ethoxy]-;
  • Poly(oxy-1,2-ethanediyl) (20-50 moles), α-[[[1-methyl-1-[3-(1-methylethenyl)phenyl]ethyl]amino]carbonyl]-ω-(alkyloxy (produced from linear alcohols in the range of C6-C30-.
Notifier: The Dow Chemical Company
Manufacturer/Supplier: Arkema, Inc. and its affiliates around the world.
Intended Use: As a thickener in adhesives complying with 21 CFR 175.105
Limitations/Specifications: For use at up to 0.5%, on a dry weight basis, of adhesives complying with 21 CFR 175.105 (or adhesives currently authorized by an effective FCN or a threshold of regulation (TOR) exemption). The acrylic polymer shall contain no more than 100 ppm of residual ethyl acrylate monomer. The FCS shall be used at temperatures not to exceed 120°F.
Effective Date: Jun 5, 2009
National Environmental Policy Act (NEPA)** Submission: Categorical Exclusion 25.32(i)
FDA Decision: Categorical Exclusion Memo