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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. 1355

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: 1-butene, polymer with 1-propene (CAS Reg. No. 29160-13-2) containing 75 - 99.5 weight-percent of polymer units derived from 1-butene. REPLACES FCN 913
Notifier: Mitsui Chemicals, Inc.
Manufacturer/Supplier: Mitsui Chemicals, Inc.
Intended Use: As a component of articles for food contact use, except for use in contact with infant formula and breast milk (see Limitations/Specifications).
Limitations/Specifications: The FCS may be used in contact with all foods under Conditions of Use A through H, as described in Tables 1 and 2. Adjuvant substances permitted for use in olefin copolymers complying with 21 CFR 177.1520 may be used in the subject FCS, provided that the limitations on the use of the adjuvant substance are met. The safety of usage of the FCS in contact with infant formula and breast milk has not been evaluated.
Effective Date: Feb 19, 2014
National Environmental Policy Act (NEPA)** Submission: Environmental Assessment (in PDF, 2.11 MB)
FDA Decision: Finding of No Significant Impact (FONSI)