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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. 906

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: 3,9-Bis[2-[3-(3-tert-butyl-4-hydroxy-5-methylphenyl)propionyloxy]-1,1-dimethylethyl]-2,4,8,10-tetraoxaspiro[5.5]undecane (CAS Reg. No. 90498-90-1).
Notifier: Sumitomo Chemical Company, Ltd.
Manufacturer: Sumitomo Chemical Company, Ltd.
Intended Use: As an antioxidant in propylene homopolymers and copolymers complying with 21 CFR 177.1520.
Limitations/Specifications*: The FCS may be used at a level not to exceed 0.2 weight percent of the finished polymer, as follows: a) In polypropylene complying with 21 CFR 177.1520(c) item 1.1, for use in contact with fatty foods (food types III, IV-A, V, VII-A and IX) under Conditions of Use A through C (note: 21 CFR 178.2010 permits use of the FCS in these polymers at a level not to exceed 0.2 percent in contact with fatty foods under Conditions of Use D through H, and at a level not to exceed 0.3 percent in contact with food types I, II,IV-B,VI, VII-B and VIII under Conditions of Use A through H). b) In olefin polymers complying with 21 CFR 1520(c) items 3.1 or 3.2 that contain not less than 85 weight percent of polymer units derived from propylene for use in contact with fatty foods (food types III, IV-A, V, VII-A and IX) under Conditions of Use A through H (note: 21 CFR 178.2010 permits use of the FCS in these polymers at a level not to exceed 0.3 percent in contact with food types I, II,IV-B,VI, VII-B and VIII under Conditions of Use A through H).
Effective Date: Sep 18, 2009
National Environmental Policy Act (NEPA)** Submission: Categorical Exclusion 25.32(i) and (j)
FDA Decision: Categorical Exclusion Memo
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