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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. 1900

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: Zinc pyrithione (CAS Reg No. 13463-41-7).
Notifier: Thor Specialties, Inc.
Manufacturer/Supplier: Thor GmbH
Intended Use: The FCS is intended for use as an antimicrobial active ingredient for preservation of the components of paper coatings (non-polymeric substrates) used in the manufacture of food-contact paper and paperboard, except for use in contact with infant formula and human milk (see Limitations/Specifications).
Limitations/Specifications*: The FCS use level is not to exceed 500 ppm in the individual components and not to exceed 100 ppm in the finished coating formulation. The FCS may be used in contact with all types of food under Conditions of Use E through G as described in in Tables 1 and 2. The coated paper is a single use article. 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: Jul 27, 2018
National Environmental Policy Act (NEPA)** Submission: Categorical Exclusion 25.32(i)
FDA Decision: Categorical Exclusion Memo

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