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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. 668

Solenis LLC

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: Drew Industrial Division, Ashland Specialty Chemical Company, Ashland, Incorporated
Manufacturer/Supplier: Solenis LLC
Intended Use: As an antimicrobial agent to be applied to red meat (including meat parts and organs), raw agricultural commodities, processed, comminuted or formed meat products, and seafood.
Limitations/Specifications: The FCS is to be manufactured as described in the notification. The FCS will be applied to food commodities in accordance with current industry GMPs, in an amount not to exceed 3 ppm residual chlorine dioxide as determined by Method 4500-ClO2-E (referenced at 21 CFR 173.300(a)(2)) or an equivalent method. The following conditions apply according to use in red meat (including meat parts and organs), the FCS will be applied as a spray to red meat, meat parts and organs or as a dip to red meat parts and organs. In processed, comminuted or formed meat products, the FCS will be applied as a spray or dip, unless precluded by standards of identity in 9 CFR 319, prior to the packaging of food for commercial purposes. The FCS will not be used on ready-to-eat meats. In raw agricultural commodities, 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) of the FD&C Act. Treatment of raw agricultural commodities shall be followed by a potable water rinse or by blanching, cooking or canning. And, in seafood, the FCS will be used in water and ice that are used to rinse, wash, thaw, transport or store seafood. Treatment of seafood products that will be consumed raw shall be subjected to a potable water rinse prior to consumption
Effective Date: Mar 16, 2007
National Environmental Policy Act (NEPA)** Submission: Environmental Assessment (in PDF, 7.63 MB)
FDA Decision: Finding of No Significant Impact (FONSI)/EA Supplement