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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. 978

Mitsui Chemicals, Inc. and Prime Polymer Co., Ltd.

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: Oxirane, 2-methyl, polymer with oxirane (CAS Reg. No. 9003-11-6)
Notifier: Mitsui Chemicals, Inc. and Prime Polymer Co., Ltd.
Manufacturer: Mitsui Chemicals, Inc. and Prime Polymer Co., Ltd.
Intended Use: As an additive in the manufacture of polyolefins.
Limitations/Specifications*: The FCS may be used at a level not to exceed 87 ppm of the final polyolefin resin. The finished polyolefin resin will be used in contact with all foods under Conditions of Use A through H as described in Tables 1 and 2.
Effective Date: Jul 20, 2010
National Environmental Policy Act (NEPA)** Submission: Categorical Exclusion 25.32(i)
FDA Decision: Categorical Exclusion Memo
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