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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. 698

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: 2-n-octyl-4-isothiazolin-3-one(OIT) (CAS Reg. No. 26530-20-1).
Notifier: Thor GmbH, Germany
Manufacturer: Thor GmbH, Germany
Intended Use: The FCS is intended for use as an antimicrobial active ingredient of industrial technical formulations for use in preserving polymeric latex emulsion products destined for use in the manufacture of paper and paperboard.
Limitations/Specifications*: The FCS will be used as a preservative in latex emulsions used as a component in paper/paperboard in compliance with 21 CFR 176.170 and 176.180. The use level will not exceed 35 ppm in latex emulsions. 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 as described in Tables 1 and 2. More specifically, the FCS will be added to polymer emulsions to prevent fungal growth during storage and shipment of the polymer emulsion.
Effective Date: Jun 15, 2007
National Environmental Policy Act (NEPA)** Submission: Categorical Exclusion 25.32(q)
FDA Decision: Categorical Exclusion Memo
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