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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. 1123

Nalco Company

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: Nalco Company
Manufacturer: Nalco Company
Intended Use: As an antimicrobial agent in water used to process fruit, vegetables, and poultry and in the pre-treatment of water that is subsequently bottled for drinking, or used as an ingredient in the manufacture of beverages.
Limitations/Specifications*: The FCS will be used in an amount not to exceed 3ppm residual chlorine dioxide in water used to process fruits, vegetables, and poultry. Additionally, the FCS may be used in an amount not to exceed 2 ppm residual chlorine dioxide in the pre-treatment of water that is subsequently bottled for drinking, or in the pretreatment of water for use in the manufacture of beverages subsequently bottled for drinking. 1) When used in water to process fruits and vegetables, treatment of the fruits and vegetables shall be followed by blanching, cooking, canning, or a potable water rinse to remove, to the extent possible, residues of the FCS. 2) When used in the pretreatment of beverage ingredient water that is subsequently bottled for drinking or used in other bottled beverages, the FCS must be subsequently removed from the water prior to bottling, such that the final beverage may not contain more than 0.8 milligrams per liter of residual chlorine dioxide and no more than 250 milligrams per liter chloride, as specified in 21 CFR 165.110. 3) When used in the pretreatment of beverage ingredient water that is subsequently used in bottling drinking water, the final bottled water must also comply with all other applicable requirements for bottled water in 21 CFR 165.110. The FCS will be added at the minimum amount necessary and not at a level at which it could have a technical effect in the finished food.
Effective Date: Feb 23, 2012
National Environmental Policy Act (NEPA)** Submission: Environmental Assessment (in PDF) (608 kB)
FDA Decision: Finding of No Significant Impact (FONSI)
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