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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. 208

Harlow Chemical Co. 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 ethenol and dimethyl maleate (DMM). This material is equivalent to poly(vinyl acetate-vinyl alcohol) (CAS Reg. No. 25213-24-5), polymerized with DMM (CAS Reg. No. 624-48-6)).
Notifier: Harlow Chemical Co. Ltd.
Manufacturer/Supplier: Harlow Chemical Co. Ltd.
Intended Use: As a stabilizer in the suspension polymerization of polyvinyl chloride (PVC).
Limitations/Specifications: At a level not to exceed 0.1 percent by weight of the vinyl chloride monomer in single use PVC articles of a thickness not to exceed 0.25 mm (10 Mil).
Effective Date: Apr 3, 2002
National Environmental Policy Act (NEPA)** Submission: Categorical Exclusion 25.32(i)
FDA Decision: Categorical Exclusion Memo