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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. 945

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: Fatty acids, C16-18 and C18-unsaturated, methyl esters, hydroformylation products, hydrogenated.
Notifier: The Dow Chemical Company
Manufacturer: The Dow Chemical Company
Intended Use: As a component of adhesives.
Limitations/Specifications*: The FCS will be used as an acid monomer for the production of polyester resins used in polyurethane adhesives complying with 21 CFR 175.105 or adhesives authorized by an effective FCN or a Threshold of Regulation Exemption. The FCS shall be used at temperatures not to exceed 120°F. The alcohols in the polyester resin will be listed in 21 CFR 175.105 or be authorized by an effective FCN or a threshold of regulation (TOR) exemption or an effective FCN.
Effective Date: Feb 17, 2010
National Environmental Policy Act (NEPA)** Submission: Environmental Assessment (in PDF) (306 kB)
FDA Decision: Finding of No Significant Impact (FONSI)
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