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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. 1515

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, optionally stabilized with magnesium or sodium nitrate and further stabilized with 0.15% copper (II) nitrate.
Notifier: Thor Specialties, Inc.
Manufacturer/Supplier: Thor GmbH
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 and in coatings and/or coating components complying with 21 CFR 175.300, except for use in contact with infant formula and breast milk (see Limitations/Specifications).
Limitations/Specifications: For use at CIT and MIT levels equivalent to those specified in 21 CFR 175.300 and 21 CFR 175.320, further stabilized with up to 0.15% copper (II) nitrate. 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: Mar 6, 2015
National Environmental Policy Act (NEPA)** Submission: Categorical Exclusion 25.32(i)
FDA Decision: Categorical Exclusion Memo