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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. 1646

Troy 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: A mixture of 5-chloro-2-methyl-4-isothiazolin-3-one (CMIT; CAS Reg. No. 26172-55-4) and 2-methyl-4-isothiazolin-3-one (MIT; CAS Reg. No. 2682-20-4) at a ratio of 3 parts to 1 part by weight, stabilized with magnesium nitrate (CAS Reg. No.: 10377-60-3) and/or magnesium chloride (CAS Reg. No. 7786-30-3), and further stabilized with 0.15% copper (II) nitrate (CAS Reg. No.: 19004-19-4).
Notifier: Troy Corporation
Manufacturer/Supplier: Troy Corporation
Intended Use: As an antimicrobial agent in polymer latex solutions used in adhesives complying with 21 CFR 175.105; as a preservative in resinous and polymeric coatings and/or coating components complying with 21 CFR 175.300; as a preservative in resinous and polymeric coatings for polyolefin films complying with 21 CFR 175.320; as an antimicrobial for polymer latex emulsions in paper coatings complying with 21 CFR 176.170; and as an antimicrobial for finished coating formulations and for additives used in the manufacture of paper and paperboard, including fillers, binders, pigment slurries, and sizing solutions, complying with 21 CFR 176.170; except for use in contact with infant formula and human milk (see Limitations/Specifications).
Limitations/Specifications: For use at CMIT and MIT levels equivalent to those specified in the referenced regulations, further stabilized with up to 0.15% copper (II) nitrate. The mixture may contain magnesium nitrate up to 2.04% and/or magnesium chloride up to 0.9%. The FCS is not for use in contact with infant formula and human milk. Such uses were not included as part of the intended use of the substance in the FCN.
Effective Date: Aug 4, 2016
National Environmental Policy Act (NEPA)** Submission: Categorical Exclusion 25.32(i), (j), and (q)
FDA Decision: Categorical Exclusion Memo

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