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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. 2139

Symphony Environmental Technologies Plc

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) REPLACES FCN 2031
Notifier: Symphony Environmental Technologies Plc
Manufacturer/Supplier: Symphony Environmental Technologies Plc
Intended Use: The FCS is intended for use as an antimicrobial agent to inhibit the growth of bacteria on the surface of polyolefin and polyester films.
Limitations/Specifications: The FCS will be used in polyolefin and polyester films in contact with Type VII-B bread only, under Conditions of Use E through G. When the FCS is used only in the food-contact layer of the film, the FCS may be used at a level not to exceed 500 ppm in the film layer with a maximum thickness of 6.5 microns. When the FCS is used in both the food-contact layer of the film and the inner, non-food contact layer of a multi-layer film, the FCS may be used at a level not to exceed 230 ppm in the food-contact layer with a maximum thickness of 6.5 microns and at a level not to exceed 460 ppm in the inner, non-food contact layer, with a maximum thickness of 19.5 microns.
Effective Date: Jul 13, 2021
National Environmental Policy Act (NEPA)** Submission: Categorical Exclusion 25.32(j)
FDA Decision: Categorical Exclusion Memo

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