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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. 1050

Mitsui Chemicals, 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: Propylene/1-butene/ethylene copolymer (CAS Reg. No. 25895-47-0).
Notifier: Mitsui Chemicals, Inc.
Manufacturer/Supplier: Mitsui Chemicals, Inc.
Intended Use: As a component of articles used in contact with food.
Limitations/Specifications: The FCS may contain from 15 to 32 weight percent polymer units derived from 1-butene. The FCS may be used in contact with all food types under Conditions of Use A through H, as described in Table 2. Adjuvant substances permitted for use in olefin polymers complying with 21 CFR 177.1520(c), item 3.1 may be used in the subject copolymers, provided that the limitations on the use of the adjuvant substances are met.
Effective Date: Mar 18, 2011
National Environmental Policy Act (NEPA)** Submission: Environmental Assessment (in PDF, 4,424 kB)
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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