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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. 102

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*: 1. In polypropylene and high density polyethylene, including homopolymers and copolymers, at levels not to exceed 0.1 percent by weight in contact with aqueous, acidic, fatty and dry foods, and at levels not to exceed 0.2 percent by weight in contact with alcoholic foods, under conditions for use A through H as described in Table 2. 2. In low density polyethylene and linear low density polyethylene, and all other olefin polymers permitted for use in contact with food, but not included in (1), above, at levels not to exceed 0.1 percent by weight, under conditions of use A through H as described in Table 2, in contact with all food types; provided that when used with fatty food, the finished food contact material does not exceed 0.002 inches (2 mil) in thickness, or alternatively, the concentration of the food-contact substance shall not exceed a total of 0.03 milligrams per square inch of food contact surface.
Effective Date: Feb 27, 2001
National Environmental Policy Act (NEPA)** Submission: Environmental Assessment (in PDF) (130 kB)
FDA Decision: Finding of No Significant Impact (FONSI)
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