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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. 1686

Shanghai Miken Biotech 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: 1,2-Benzisothiazolin-3-one (CAS Reg. No. 2634-33-5).
Notifier: Shanghai Miken Biotech Co., Ltd.
Manufacturer/Supplier: Shanghai Miken Biotech Co., Ltd.
Intended Use: As a biocide in uncured liquid rubber latex used to manufacture repeat-use rubber gloves intended for use in contact with all types of food, except for use in contact with infant formula and human milk (see Limitations/ Specifications).
Limitations/Specifications: For use at levels not to exceed 0.05 percent by weight of the latex solids. The finished food contact articles will not be used in contact with infant formula or human milk. Such uses were not included as part of the intended use of the substance in the FCN.
Effective Date: Dec 1, 2016
National Environmental Policy Act (NEPA)** Submission: Environmental Assessment (in PDF, 497 kB)
FDA Decision: Finding of No Significant Impact (FONSI)

*See Food Types and Conditions of Use for Food Contact Substances (Tables 1 and 2).

**More about Environmental Decisions and Definitions of Environmental Terms.
See also Inventory of Environmental Impact Decisions for Food Contact Substance Notifications.
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