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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. 704

Thor GmbH, Germany

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: 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.
Notifier: Thor GmbH, Germany
Manufacturer/Supplier: Thor GmbH, Germany
Intended Use: The FCS is intended for use as a preservative in resinous and polymeric coatings for polyolefin films complying with 21 CFR 175.320.
Limitations/Specifications: The FCS will be used at a level not to exceed 45 milligrams per kilogram (based on isothiazolone active ingredient) in the aqueous coating formulation. For use with aqueous, acidic, and low-alcoholic foods under Conditions of Use A through H and with fatty food under Conditions of Use C through G.
Effective Date: May 22, 2007
National Environmental Policy Act (NEPA)** Submission: Categorical Exclusion 25.32(i)
FDA Decision: Categorical Exclusion Memo