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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. 312

Mitsui Chemical, Inc.

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-Ethyl-2-(hydroxymethyl)-1,3-propanediol (Trimethylolpropane, TMP, CAS Reg. No. 77-99-6).
Notifier: Mitsui Chemical, Inc.
Manufacturer: Mitsui Chemical, Inc.
Intended Use: For use as a modifier of polyethylene phthalate polymers. The finished polymer may contact all food types under the Conditions of Use B or the Conditions of Use permitted for the complaint polymers, whichever is less severe.
Limitations/Specifications*: For use at levels not exceeding 0.1 mole percent of the total alcoholic reactants used in the manufacture of polyethylene phthalate polymers complying with 21 CFR 177.1630 or applicable Food Contact Notifications (FCN).
Effective Date: Apr 15, 2003
National Environmental Policy Act (NEPA)** Submission: Categorical Exclusion 25.32(i)
FDA Decision: Categorical Exclusion Memo
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