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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. 494

Sumitomo 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: 2,4-di-tert-pentyl-6-[1-(3,5-di-tert-pentyl-2-hydroxyphenyl) ethyl]phenyl acrylate (CAS Reg. No. 123968-25-2).
Notifier: Sumitomo Chemical Company, Ltd.
Manufacturer/Supplier: Sumitomo Chemical Company, Ltd.
Intended Use: The FCS will be used as a stabilizer in polystyrene(PS) and rubber-modified polystyrene(RMPS) complying with 21CFR 177.1640, styrene block copolymers(SB) complying with 21CFR 177.1810, and PS, RMPS, or SB complying with an effective FCN.
Limitations/Specifications: Maximum use level of 1 percent by weight of the polymer. The finished polymers are intended to contact all types of food under Conditions of Use A through H, as described in Table 2 unless otherwise restricted by the applicable limitations for styrene block polymers in 177.1810 or in an effective FCN.
Effective Date: Jul 27, 2005
National Environmental Policy Act (NEPA)** Submission: Categorical Exclusion 25.32(i) and (j)
FDA Decision: Categorical Exclusion Memo