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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. 1021

Ecolab, 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: Polyoxyethylene (20) sorbitan monooleate.
Notifier: Ecolab, Inc.
Manufacturer/Supplier: Ecolab, Inc.
Intended Use: As an emulsifier for wash solutions intended for use on raw and processed fruits and vegetables when applied in restaurants, cafeterias, food service operations, commercial kitchens, commissaries, grocery stores, and other food processing facilities.
Limitations/Specifications: At levels not to exceed 50 parts per million of the wash solution. Raw and/or processed fruits and vegetables are to be immersed for a minimum of 90 seconds but not more than 5 minutes then followed by adequate draining prior to further processing and/or serving.
Effective Date: Dec 7, 2010
National Environmental Policy Act (NEPA)** Submission: Environmental Assessment (in PDF, 1.0 MB)
FDA Decision: Finding of No Significant Impact (FONSI)