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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. 1447

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 that may contact food, except for use in contact with infant formula and breast milk (see Limitations/Specifications).
Limitations/Specifications: The FCS may contain up to 38 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. The FCS is not for use in contact with infant formula and breast milk.
Effective Date: Aug 28, 2014
National Environmental Policy Act (NEPA)** Submission: Categorical Exclusion 25.32(j) and Environmental Assessment (in PDF, 4.2 MB)
FDA Decision: Categorical Exclusion Memo/Finding of No Significant Impact (FONSI)

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