Inventory of Effective Food Contact Substance (FCS) Notifications
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FCN No. 2496
Troy Corporation, an Arxada Company
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). |
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| Notifier: | Troy Corporation, an Arxada Company |
| Manufacturer/Supplier: | Troy Corporation, an Arxada Company |
| Intended Use: | (1) 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) films complying with 21 CFR 175.320; and (2) as an antimicrobial agent in can-end and side-seam cements, except for use in contact with infant formula and human milk (see Limitations/Specifications). |
| Limitations/Specifications: |
(1) For use as a biocide preservative at a level not to exceed 5 percent by weight of the preservative formulation, which may be added to the latex/silicone formulations at a level not to exceed 0.3 percent by weight. Coatings containing the FCS may not exceed an applied coating rate of 7.74 mg/in2. The FCS is intended for contact with all food types, under Conditions of Use A through H, as described in Tables 1 and; (2) For use at levels not to exceed 0.015 percent by weight (150 parts per million, ppm) in can-end and side-seam cements that will contact aqueous, acidic, low alcoholic (up to 8 percent v/v alcohol content) and fatty food under Conditions of Use A through H, and high alcoholic food (greater than 8 percent alcohol content) under Conditions of Use C through G, as described in Tables 1 and 2. The FCS is not for use in contact with infant formula or human milk; such uses were not included as part of the intended use of the substance in the FCN. |
| Effective Date: | Jun 17, 2026 |
| National Environmental Policy Act (NEPA)** Submission: | Environmental Assessment |
| FDA Decision: | Finding of No Significant Impact (FONSI) |
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