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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. 917

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, polymer with ethene (CAS Reg. No. 9019-29-8).
Notifier: Mitsui Chemicals, Inc.
Manufacturer: Mitsui Chemicals, Inc.
Intended Use: The FCS will be used in blends with olefin polymers intended for use in food contact applications.
Limitations/Specifications*: The FCS may be used at a level not to exceed 3 weight percent in polyolefin films with a maximum thickness of 100 (μm). The finished film will be used in contact with all foods under Condition of Use A through H as described in Table 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.
Effective Date: Oct 22, 2009
National Environmental Policy Act (NEPA)** Submission: Categorical Exclusion 25.32(i)
FDA Decision: Categorical Exclusion Memo
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