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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. 1446

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: 1,2-Benzisothiazolin-3-one (CAS Reg. No. 2634-33-5).
Notifier: Thor Specialties, Inc.
Manufacturer/Supplier: Thor GmbH
Intended Use: As a preservative in mineral slurries (such as clay, kaolin clay, calcium carbonate, titanium dioxide) used as fillers in the manufacture of paper and paperboard for use in contact with food, except for infant formula and breast milk (see Limitations/Specifications).
Limitations/Specifications: For use at levels not to exceed 300 ppm in the slurry. 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: Aug 21, 2014
National Environmental Policy Act (NEPA)** Submission: Environmental Assessment (in PDF, 1.6 MB)
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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