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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. 2090

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: Zinc pyrithione (CAS Reg. No. 13463-41-7).
Notifier: Troy Corporation
Manufacturer/Supplier: Troy Corporation
Intended Use: The FCS is intended for use:
  1. As an antimicrobial agent 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; and
  2. As an antimicrobial agent to inhibit the growth of bacteria on the surface of linear low-density polyethylene (LLDPE) film.
Limitations/Specifications: The FCS will be used:
  1. At a level 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 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; and
  2. At a level not to exceed 230 ppm in LLDPE film with a maximum thickness of 6.5 microns for contact with Type VII-B bread only, under Conditions of Use E through G.
Effective Date: Dec 12, 2020
National Environmental Policy Act (NEPA)** Submission: Categorical Exclusion 25.32(i)
FDA Decision: Categorical Exclusion Memo

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