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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. 1382

The Dow Chemical 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: Oxirane, 2-ethyl, polymer with 2-methyloxirane, monododecyl ether (CAS Reg. No. 139873-90-8).
Notifier: The Dow Chemical Company
Manufacturer/Supplier: The Dow Chemical Company
Intended Use: As a lubricant with incidental food contact, consistent with 21 CFR 178.3570 for repeat-use applications, except for use in contact with infant formula and breast milk (see Limitations/Specifications).
Limitations/Specifications: For use at levels not to exceed the minimum amount necessary to achieve the intended technical effect on machinery used in the production or processing of food. Addition to food not to exceed 10 parts per million. The FCS is not for use in contact with infant formula and breast milk. Such uses were not included as part of the intended use of the substance in the FCN.
Effective Date: May 16, 2014
National Environmental Policy Act (NEPA)** Submission: Environmental Assessment (in PDF, 572 kB)
FDA Decision: Finding of No Significant Impact (FONSI)

*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.
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