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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. 1053

Kaneka Corporation

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: Poly(butyl acrylate-co-methyl methacrylate-co-styrene), cross-linked with glycidyl methacrylate, 2-ethylhexyl 2-mercaptoacetate terminated.
Notifier: Kaneka Corporation
Manufacturer/Supplier: Kaneka Corporation
Intended Use: As a modifier of polyvinyl chloride (PVC) resin for single-use food contact applications.
Limitations/Specifications: The FCS is used at concentrations of up to 2.0 weight percent in PVC films, which will not exceed 0.8 mils in thickness under conditions up to and including hot-filled at 165°F (74°C). The FCS will not be used in can coatings or in contact with infant formula.
Effective Date: Mar 29, 2011
National Environmental Policy Act (NEPA)** Submission: Categorical Exclusion 25.32(i)
FDA Decision: Categorical Exclusion Memo