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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. 203

Harlow Chemical Company, Ltd.

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: Acetic acid ethenyl ester, polymer with α-hydro-ω-hydroxypoly(oxy-1,2-ethanediyl), hydrolyzed.
Notifier: Harlow Chemical Company, Ltd.
Manufacturer/Supplier: Harlow Chemical Company, Ltd.
Intended Use: As a secondary stabilizer in the suspension polymerization of polyvinyl chloride.
Limitations/Specifications: At a level not exceed 0.1 percent by weight of the starting vinyl chloride monomer used in the manufacture of polyvinyl chloride films. The films will have a maximum thickness of 0.25 mm and will be used only in single-use applications.
Effective Date: May 24, 2002
National Environmental Policy Act (NEPA)** Submission: Categorical Exclusion 25.32(i)
FDA Decision: Categorical Exclusion Memo