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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. 869

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: Mitsui Chemicals, Inc.
Intended Use: As a component of articles used in contact with all types of food.
Limitations/Specifications*: The FCS may contain up to 28 weight percent polymer units derived from 1-butene. The FCS may be used in contact with all foods 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 24, 2009
National Environmental Policy Act (NEPA)** Submission: Environmental Assessment (in PDF) (435 kB)
FDA Decision: Finding of No Significant Impact (FONSI)