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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. 2153

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: 5-Chloro-2-methyl-4-isothiazolin-3-one (CIT; CAS Reg. No. 26172-55-4).
Notifier: Thor Specialties, Inc.
Manufacturer/Supplier: THOR GmbH
Intended Use: As an antimicrobial agent used in:
  1. polymer latex emulsions in paper coatings complying with 21 CFR 176.170 and 21 CFR 176.180.
  2. finished coating formulations and additives used in the dry end of the manufacture of paper and paperboard.
  3. resinous and polymeric coatings complying with 21 CFR 175.320 for polyolefin films.
  4. resinous and polymeric coatings complying with 21 CFR 175.300 for repeated food-contact use.
  5. polymer latex emulsions used in adhesives complying with 21 CFR 175.105.
Except for use in contact with infant formula and human milk (see Limitations and Specifications)
Limitations/Specifications: The components of the FCS will not exceed:
  1. 37.5 ppm in the polymer latex emulsions in paper coating formulation.
  2. 18.75 ppm in the coating formulations and additives used in the manufacture of paper and paperboard.
  3. 37.5 ppm in the resinous and polymeric coating formulation for polyolefin films.
  4. 37.5 ppm in the resinous and polymeric coating formulation for repeated food-contact use.
The FCS is not for use in contact with infant formula and human milk. Such use was not included as part of the intended use of the substance in the FCN.
Effective Date: Nov 17, 2021
National Environmental Policy Act (NEPA)** Submission: Categorical Exclusion 25.32(i)
FDA Decision: Categorical Exclusion Memo

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