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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. 1208

Prom Chemie AG

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: Prom Chem Limited
Manufacturer/Supplier: Prom Chemie AG
Intended Use: For use as a biocide in uncured liquid rubber latex solutions used to manufacture repeat-use rubber gloves.
Limitations/Specifications: The FCS may be used at a level not to exceed 0.05 weight percent of the latex on a solids basis. The finished glove may be used in contact with all food types.
Effective Date: Oct 24, 2012
National Environmental Policy Act (NEPA)** Submission: Environmental Assessment (in PDF, 300 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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