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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. 1396

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: Mixture of 5-chloro-2-methyl-4-isothiazolin-3-one (CIT; 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, optionally stabilized with magnesium or sodium nitrate and copper (II) nitrate.
Notifier: Thor GmbH
Manufacturer/Supplier: Thor GmbH
Intended Use: As a biocide in polymer latex emulsions, coating formulations and additives for coating formulations used for food packaging, except for use in contact with infant formula and breast milk (see Limitations/Specifications).
Limitations/Specifications: For use at CIT and MIT levels equivalent to those specified in 21 CFR 176.170, further stabilized with up to 0.15% copper (II) nitrate. The safety of usage of the FCS in contact with infant formula and breast milk has not been evaluated.
Effective Date: Mar 25, 2014
National Environmental Policy Act (NEPA)** Submission: Categorical Exclusion 25.32(q)
FDA Decision: Categorical Exclusion Memo

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