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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. 1308

Thor GmbH

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: 2-Methyl-4-isothiazolin-3-one (CAS Reg. No. 2682-20-4).
Notifier: Thor GmbH
Manufacturer: Thor GmbH
Intended Use: As an antimicrobial in uncured liquid rubber latex used to manufacture repeat-use rubber gloves intended for use in contact with all types of food.
Limitations/Specifications*: For use at a level not to exceed 250 ppm (based on 2-methyl-4-isothiazolin-3-one) in the latex emulsion.
Effective Date: Oct 2, 2013
National Environmental Policy Act (NEPA)** Submission: Categorical Exclusion 25.32(q)
FDA Decision: Categorical Exclusion Memo
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