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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. 1095

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: Maleic anhydride grafted polypropylene (CAS Reg. No. 25722-45-6).
Notifier: The Dow Chemical Company
Manufacturer/Supplier: The Dow Chemical Company
Intended Use: As a component of metal coatings.
Limitations/Specifications: The level of maleic anhydride incorporation in the FCS may not exceed 6 percent by weight. The FCS is used as a component of an aqueous dispersion with polypropylene complying with 21 CFR 177.1520( c)(1.1) or polypropylene copolymer complying with FCN 843 or 909, 2-(dimethylamino)ethanol (CAS Reg. No. 108-01-0), and optionally ethylene-acrylic acid copolymer complying with FCN 1087. The FCS, the ethylene-acrylic acid copolymer, and 2-(dimethylamino)ethanol will be present at no more than 10, 25 and 10 percent, respectively, by weight of the solids in the dispersion. The FCS may be a component of finished coatings used in contact with all food types under Conditions of Use A through H, as described in Table 2; not for use with infant formula.
Effective Date: Aug 19, 2011
National Environmental Policy Act (NEPA)** Submission: Categorical Exclusion 25.32(i)
FDA Decision: Categorical Exclusion Memo