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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. 569

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: A mixture of 5-chloro-2-methyl-4-isothiazolin-3-one (CAS Reg. No. 26172-55-4) and 2-methyl-4-isothiazolin-3-one (CAS Reg. No. 2682-20-4) at a ratio of 3 parts to 1 part by weight. The mixture may contain magnesium or sodium nitrate at a 1 to 1 ratio (weight/weight) with the sum of the isothiazolinone ingredients.
Notifier: Thor GmbH
Manufacturer/Supplier: Thor GmbH
Intended Use: As an antimicrobial agent in polymer latex solutions intended for use in adhesives complying with 21 CFR 175.105.
Limitations/Specifications: For use at temperatures not to exceed 120°F.
Effective Date: Mar 21, 2006
National Environmental Policy Act (NEPA)** Submission: Categorical Exclusion 25.32(q)
FDA Decision: Categorical Exclusion Memo

*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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