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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. 1108

Lanxess Corporation

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: 1,2-Benzisothiazolin-3-one (CAS Reg. No. 2634-33-5).
Notifier: Lanxess Corporation
Manufacturer/Supplier: Lanxess Corporation
Intended Use: As a biocide preservative in aqueous latex/silicone formulations used for coatings on metal substrates complying with 21 CFR 175.300 and on polypropylene (PP) sheets complying with 21 CFR 175.320, excluding use in contact with infant formula.
Limitations/Specifications: For use at a level not to exceed 5 weight-percent of the preservative formulation which may be added to the latex/silicone formulations at a level not to exceed 0.3 weight-percent. Coatings containing the FCS may not exceed an applied coating rate of 7.74 mg/in2, and are not intended for use in contact with infant formula.
Effective Date: Dec 14, 2011
National Environmental Policy Act (NEPA)** Submission: Environmental Assessment (in PDF, 76 kB)
FDA Decision: Finding of No Significant Impact (FONSI)