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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. 631

Mitsui Chemicals, Incorporated

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: 2,5-Furandione, polymer with 1-propene (CAS Reg. No. 25722-45-6).
Notifier: Mitsui Chemicals, Incorporated
Manufacturer/Supplier: Mitsui Chemicals, Incorporated
Intended Use: As a component in blends with polypropylene (homopolymers and copolymers) for use in contact with food.
Limitations/Specifications: The FCS is intended to contact all food types under Conditions of Use A through H, as described in Tables 1 and 2. The FCS is used such that the level of the FCS (fraction by weight of polypropylene) multiplied by the thickness of the polypropylene layer containing the FCS in micrometers (um) does not exceed the value of 3.7.
Effective Date: Aug 24, 2006
National Environmental Policy Act (NEPA)** Submission: Environmental Assessment (in PDF, 455 kB)
FDA Decision: Finding of No Significant Impact (FONSI)

*See Food Types and Conditions of Use for Food Contact Substances.

**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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