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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. 96

Mitsubishi Engineering-Plastics Corp.

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: Polyoxymethylene copolymer (CAS Reg. No. 24969-26-4) produced from the reaction of trioxane (cyclic trimer of formaldehyde) and 1,3-dioxolane.
Notifier: Mitsubishi Engineering-Plastics Corp.
Manufacturer: Mitsubishi Engineering-Plastics Corp.
Intended Use: As a component of articles intended for repeat use complying with 21 CFR 177.2470.
Limitations/Specifications*: Polyoxymethylene copolymers shall contain no more than 5 percent by weight of the polymer units derived from 1,3-dioxolane. The maximum use temperature is 250°F.
Effective Date: Nov 22, 2000
National Environmental Policy Act (NEPA)** Submission: Categorical Exclusion 25.32(j)
FDA Decision: Categorical Exclusion Memo
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