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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. 1453

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: 1,2-Benzisothiazolin-3-one (BIT) (CAS Reg. No. 2634-33-5).
Notifier: Thor GmbH
Manufacturer/Supplier: Thor GmbH
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) articles complying with 21 CFR 175.320, except for use in contact with infant formula and breast milk (see Limitations/Specifications).
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. The FCS is not for use in contact with infant formula and breast milk. Such uses were not included as part of the intended use of the food contact substance in the FCN.
Effective Date: Sep 5, 2014
National Environmental Policy Act (NEPA)** Submission: Categorical Exclusion 25.32(i)
FDA Decision: Categorical Exclusion Memo

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