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). |
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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) |
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