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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. 2079

Omya International AG and its Affiliates

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: Ethanol, 2-amino- (CAS Reg. No. 141-43-5). REPLACES FCN 1756
Notifier: Omya International AG and its Affiliates
Manufacturer/Supplier: Omya International AG and its Affiliates
Intended Use: As a component of fillers or coatings for paper and paperboard, including for use in contact with dry (powdered) infant formula (see Limitations/Specifications).
Limitations/Specifications: At a maximum rate in the finished paper of 0.041 weight-percent for filler applications and 0.01 weight-percentfor coating applications. Finished materials and articles containing the FCS may be used in single use applications, for contact with all types of food, including dry (powdered) infant formula, under the Conditions of Use A through H.
Effective Date: Oct 20, 2020
National Environmental Policy Act (NEPA)** Submission: Environmental Assessment (in PDF, 994 kB)
FDA Decision: Finding of No Significant Impact (FONSI) and EA Revision Sheet (in PDF, 227 kB)

*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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