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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. 1634

Clordisys Solutions, Inc.

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: Chlorine dioxide (CAS Reg. No. 10049-04-4).
Notifier: Clordisys Solutions, Inc.
Manufacturer/Supplier: Clordisys Solutions, Inc.
Intended Use: As an antimicrobial agent in water used in poultry processing and to wash fruits and vegetables, including raw agricultural commodities (RAC).
Limitations/Specifications: The FCS will be used in an amount not to exceed 3 ppm residual chlorine dioxide as determined by Method 4500-ClO2-D1, modified for use with the Hach Spectrophotometer, or equivalent. The FCS will be generated by the reaction between chlorine gas and a solid matrix of sodium chlorite. When used on RAC, the FCS will be applied as a spray or dip in the preparing, packaging, or holding of food for commercial purposes, consistent with the FD&C Act section 201(q)(1)(B)(i) but not applied for use under 201(q)(1)(B)(i)(I), (q)(1)(B)(i)(II) or (q)(I)(B)(i)(III). Treatment of fruits and vegetables, including raw agricultural commodities, shall be followed by a potable water rinse, blanching, cooking, or canning.
Effective Date: Jun 21, 2016
National Environmental Policy Act (NEPA)** Submission: Environmental Assessment (in PDF, 2.2 MB)
FDA Decision: Finding of No Significant Impact (FONSI)

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