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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. 21

Asahi Denka Kogyo K.K.

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: 2,2'-Methylenebis(4,6-di-tert-butylphenyl) 2-ethylhexyl phosphite (CAS Reg. No. 126050-54-2)
Notifier: Asahi Denka Kogyo K.K.
Manufacturer/Supplier: Asahi Denka Kogyo K.K.
Intended Use: As an antioxidant and/or stabilizer in high-density polyethylene articles intended for contact with food.
Limitations/Specifications: The food contact substance shall be used at levels not to exceed 0.15 percent by weight of high-density polyethylene homo- and copolymers complying with 21 CFR 177.1520 (where the density of the polymer is not less than 0.94 g/cc). The finished polymers may only be used in contact with food types I, II, IV-B, VI-B, VII-B, and VIII under Conditions of Use B through H as described in Tables 1 and 2, and with food types III, IV-A, V, VI-A, VI-C, VII-A, and IX under Conditions of Use C through G as described in Tables 1 and 2.
Effective Date: Apr 7, 2000
National Environmental Policy Act (NEPA)** Submission: Environmental Assessment
FDA Decision: Finding of No Significant Impact (FONSI)

*See Food Types and Conditions of Use for Food Contact Substances (Tables 1 and 2).

**More about Environmental Decisions and Definitions of Environmental Terms.
See also Inventory of Environmental Impact Decisions for Food Contact Substance Notifications.
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