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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. 1356

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, polymer with ethene and 1-hexene (CAS Reg. No. 86286-09-1).
Notifier: The Dow Chemical Company
Manufacturer/Supplier: The Dow Chemical Company
Intended Use: As a component of metal coatings, except for use in contact with infant formula and breast milk (see Limitations/Specifications).
Limitations/Specifications: The level of maleic anhydride used to produce the FCS may not exceed 1.6 percent of the FCS by weight. The FCS may be used at a level not to exceed 20 percent by weight as a component of an aqueous dispersion of a polyethylene homopolymer compliant with 21 CFR 177.1520(c)2.2 or a polyethylene copolymer compliant with 177.1520(c)3.2a or any polyethylene copolymer with an effective FCN allowing for contact with all food types under Conditions of Use A through H, as described in Table 2. The safety of usage of the FCS in contact with infant formula and breast milk has not been evaluated.
Effective Date: Feb 21, 2014
National Environmental Policy Act (NEPA)** Submission: Categorical Exclusion 25.32(i)
FDA Decision: Categorical Exclusion Memo

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