Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Inventory of Effective Food Contact Substance (FCS) Notifications
  • Print
  • Share
  • E-mail
-

FCN No. 163

Arxada, 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: 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/Supplier: Arxada, LLC
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

*See Food Types and Conditions of Use for Food Contact Substances (Tables 1 and 2).

**More about Environmental Decisions and Definitions of Environmental Terms.
See also Inventory of Environmental Impact Decisions for Food Contact Substance Notifications.
-
-