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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. 983

Thor GmbH of Speyer 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: 2-methyl-4-isothiazolin-3-one (CAS Reg. No. 2682-20-4).
Notifier: Thor GmbH of Speyer Germany
Manufacturer/Supplier: Thor GmbH of Speyer Germany
Intended Use: As a preservative in: (1) coatings that comply with 21 CFR 175.300 (Resinous and polymeric coatings) and 175.320 (Resinous and polymeric coatings for polyolefin films) and (2) can-end and side-seam cements that comply with 21 CFR 175.300. Furthermore, the FCS will not be used in products for infants.
Limitations/Specifications: The FCS may be used in contact with all food types, except infant formula, under Conditions of Use A through H. The maximum level of the FCS in the aqueous emulsions for the can coatings or polymeric coatings on polyolefin film would be 100 ppm. The maximum level of the FCS in the aqueous emulsion of the can-end or side-seam cement is 150 pm.
Effective Date: Oct 22, 2010
National Environmental Policy Act (NEPA)** Submission: Categorical Exclusion 25.32(q)
FDA Decision: Categorical Exclusion Memo