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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. 1462

Showa Denko Materials Co., 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: Copolymer of 1,2,4-benzenetricarboxylic anhydride, 4,4'-diphenylmethane diisocyanate, and 3,3'-dimethyl-4,4'-biphenylene diisocyanate (CAS Reg. No. 133078-67-8).
Notifier: Hitachi Chemical Co., Ltd.
Manufacturer/Supplier: Showa Denko Materials Co., Ltd.
Intended Use: The FCS will be used as a component of a coating layer for repeat-use food-contact articles.
Limitations/Specifications: The FCS will be used as a component of a coating layer for repeat-use food-contact articles. The articles will contact all types of food (I-IX) under Conditions of Use A through H and J, as defined in Tables 1 and 2, respectively.
Effective Date: Oct 21, 2014
National Environmental Policy Act (NEPA)** Submission: Categorical Exclusion 25.32(j)
FDA Decision: Categorical Exclusion Memo

*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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