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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. 1256

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 GmbH
Manufacturer: THOR GmbH
Intended Use: As an antimicrobial agent in can-end cements.
Limitations/Specifications*: For use at levels not to exceed 0.015 percent by weight (150 parts per million, ppm) in can-end cements that will contact aqueous, acidic, low alcoholic (up to 8 percent v/v alcohol content) and fatty food under Conditions of Use A through H, and high alcoholic food (greater than 8 percent alcohol content) under Conditions of Use C through G, as described in Tables 1 and 2. The FCS is not intended to be used in packaging for infant formula.
Effective Date: Apr 16, 2013
National Environmental Policy Act (NEPA)** Submission: Categorical Exclusion 25.32(i)
FDA Decision: Categorical Exclusion Memo
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