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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. 1529

Mitsui Fine 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: Silanediol, 1,1-dimethyl-, polymer with ethene, triblock (CAS Reg. No. 837387-70-9)
Notifier: Mitsui Fine Chemicals, Inc.
Manufacturer/Supplier: Mitsui Fine Chemicals, Inc.
Intended Use: As an additive in food-contact articles, except for use in contact with infant formula and breast milk (see Limitations/Specifications).
Limitations/Specifications: At a level not to exceed 30 percent by weight in any of authorized polymers that may be used in articles for contact with all types of food under Conditions of Use A through H, as described in Table 2. The FCS is not for use in contact with infant formula and breast milk. Such use was not included as part of the intended use of the substance in the FCN.
Effective Date: May 5, 2015
National Environmental Policy Act (NEPA)** Submission: Environmental Assessment (in PDF, 5.2 Mb)
FDA Decision: Finding of No Significant Impact (FONSI)