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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. 1804

Selective Micro Technologies

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: Selective Micro Technologies
Manufacturer/Supplier: Selective Micro Technologies
Intended Use: As an antimicrobial agent in water used to wash fruits and vegetables that are 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 methods specified in 21 CFR 173.300. The chlorine dioxide solution will contain at least 90 percent by weight of chlorine dioxide with respect to all chlorine species as determined by Method 4500-ClO2-E. When used on RAC, the FCS will be applied in the preparing, packing, 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)(1)(B)(i)(III).
Effective Date: Dec 6, 2017
National Environmental Policy Act (NEPA)** Submission: Environmental Assessment (in PDF, 523 kB)
FDA Decision: Finding of No Significant Impact (FONSI)

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