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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. 68

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: Butene-1, polymer with propylene (CAS Reg. No. 29160-13-2), containing more than 15 but not greater than 35 weight percent of polymer units derived from butene-1.
Notifier: Mitsui Chemicals Inc.
Manufacturer/Supplier: Mitsui Chemicals Inc.
Intended Use: In blends with polypropylene-based olefin polymers complying with 21 CFR 177.1520(c), items 1.1, 3.1 and 3.2, at levels not to exceed 30 weight percent of the total blend.
Limitations/Specifications*: The FCS shall comply with the specifications of 21 CFR 177.1520(c), item 3.2b, except the thickness limitation shall not apply to the polymer blend. Additionally, optional adjuvant substances listed in 21 CFR 177.1520(b) may be used in the manufacture of the FCS in accordance with the limitations/specifications as specified for the subject adjuvant.
Effective Date: Jul 27, 2000
National Environmental Policy Act (NEPA)** Submission: Environmental Assessment (in PDF) (697 kB)
FDA Decision: Finding of No Significant Impact (FONSI)