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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. 1401

Eastern Technologies, 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: Polyethylene glycol (400) monooleate (CAS Reg. No. 9004-96-0).
Notifier: Eastern Technologies, Inc.
Manufacturer/Supplier: Eastern Technologies, Inc.
Intended Use: As an anti-corrosive agent in the steam header and steam lines of boiler systems in which the steam will contact food, except for infant formula and its ingredients (see Limitations/Specifications).
Limitations/Specifications: The FCS is to be continuously added into the steam header to maintain a maximum concentration of 2 ppm in the steam. Usage of the FCS must meet any applicable provisions prescribed in 21 CFR 173.310. The FCS is not for use in the processing of infant formula or its ingredients. Such use was not included as part of the intended use of the substance in the FCN.
Effective Date: Jun 26, 2014
National Environmental Policy Act (NEPA)** Submission: Environmental Assessment (in PDF, 486 kB)
FDA Decision: Finding of No Significant Impact (FONSI)