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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. 111

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) as a 20 percent solution.
Notifier: Thor GmbH
Manufacturer: Thor GmbH
Intended Use: As an antimicrobial agent in adhesives and in components of adhesives for food-contact articles. As an antimicrobial agent in coating formulations and in additives used in the manufacture of paper and paperboard intended for use in contact with all food types.
Limitations/Specifications*: 2-Methyl-4-isothiazolin-3-one is not to exceed 150 mg/kg in the coating formulations and additives; except for use as an antimicrobial agent for polymer latex emulsions in paper coatings, 2-methyl-4-isothiazolin-3-one shall not exceed 250 mg/kg. The use of 2-methyl-4-isothiazolin-3-one in adhesives shall be in accordance with 21 CFR 175.105.
Effective Date: Feb 20, 2001
National Environmental Policy Act (NEPA)** Submission: Environmental Assessment
FDA Decision: Finding of No Significant Impact (FONSI)
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