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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. 176

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: Phenol, 2-(1,1-dimethylethyl)-6-methyl-4-(3-((2,4,8,10-tetrakis(1,1-dimethylethyl)dibenzo(d,f)(1,3,2)dioxaphosphepin-6-yl)oxy)propyl)- (CAS Reg. No. 203255-81-6).
Notifier: Sumitomo Chemical Company, Ltd.
Manufacturer: Sumitomo Chemical Company, Ltd.
Intended Use: As an antioxidant and/or stabilizer for olefin polymers for use in contact with food.
Limitations/Specifications*: The FCS will be used in the following olefin polymers that are intended to contact food under Conditions of Use A through H as described in Table 2, without limitation on the thickness of the food-contact article: 1. In low-density polyethylene (LDPE), linear low-density polyethylene (LLDPE), and polypropylene (PP), including homopolymers and copolymers, at levels not to exceed 0.2 percent by weight in contact with all food types. 2. In high-density polyethylene (HDPE), including homopolymers and copolymers, at levels not to exceed 0.12 percent by weight in contact with aqueous, acidic, and fatty foods, and at levels not to exceed 0.2 percent by weight in contact with alcoholic foods.
Effective Date: Dec 27, 2001
National Environmental Policy Act (NEPA)** Submission: Categorical Exclusion 25.32(i)
FDA Decision: Categorical Exclusion Memo
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