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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. 1589

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: 2,5-Furandione, dihydro-, mono-C15-20-alkenyl derivs. (CAS Reg. No. 68784-12-3)
Notifier: Omya International AG and its affiliates
Manufacturer/Supplier: Omya International AG and its affiliates
Intended Use: As a surface treatment for calcium carbonate, used as pigment and/or filler in food contact polyolefin materials and articles, except for use in contact with infant formula and breast milk (see Limitations/Specifications).
Limitations/Specifications: The FCS contained in the calcium carbonate may be present at levels not to exceed 0.48 percent by weight of polyolefin materials and articles in contact with all food types under Conditions of Use B through H, as described in Table 2. 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: Nov 24, 2015
National Environmental Policy Act (NEPA)** Submission: Categorical Exclusion 25.32(i) and (j)
FDA Decision: Categorical Exclusion Memo

*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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