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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. 2267

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: 2-Propenoic acid, polymer with 2,5-furandione, sodium salt (CAS Reg. No. 52255-49-9).
Notifier: Omya International AG and its Affiliates
Manufacturer/Supplier: Omya International AG and its Affiliates
Intended Use: As a component of fillers or mineral coatings for uncoated and clay-coated paper and paperboard in contact with all foods, except for use in contact with infant formula and human milk (see Limitations/Specifications).
Limitations/Specifications: The FCS will be used at a maximum level of 0.07 percent by weight in the finished paper. The finished paper and paperboard containing the FCS may contact all food types under Conditions of Use A through H, as described in Tables 1 and 2. The FCS is not for use in contact with infant formula and human milk. Such uses were not included as part of the intended use of the substance in the FCN.
Effective Date: Feb 10, 2023
National Environmental Policy Act (NEPA)** Submission: Environmental Assessment (in PDF, 5.6 MB)
FDA Decision: Finding of No Significant Impact (FONSI) (in PDF, 311 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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