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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. 163

Lonza, 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: A mixture of ca. 49 percent by weight of polyethylene glycol (400) monooleate and ca. 34 percent by weight of polyethylene glycol (400) dioleate.
Notifier: Lonza, Inc.
Manufacturer: Lonza, Inc.
Intended Use: The FCS will be used as an anti-corrosive agent in the steam header and steam lines of boiler systems where the steam will contact food.
Limitations/Specifications*: The FCS is to be continuously added into the steam header to maintain a maximum concentration of 2 ppm in the steam. The FCS shall contain no more than 1 ppm and 10 ppm residual ethylene oxide and 1,4-dioxane, respectively, and must meet any applicable specifications prescribed in 21 CFR 173.310.
Effective Date: Oct 11, 2001
National Environmental Policy Act (NEPA)** Submission: Environmental Assessment (in PDF) (370 kB)
FDA Decision: Finding of No Significant Impact (FONSI)/EA Supplement