Inventory of Effective Food Contact Substance (FCS) Notifications
-
FCN No. 2359
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 a pigment and/or filler in food contact materials and articles, except for use in contact with infant formula and human milk (see Limitations/ Specifications). |
| Limitations/Specifications: | The FCS contained in the calcium carbonate may be present at levels of up to 0.85 weight percent in cellulose acetate, polyamide, and polycarbonate materials and articles. The finished materials and articles will be used in contact with 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: | May 31, 2024 |
| National Environmental Policy Act (NEPA)** Submission: | Environmental Assessment (in PDF, 354 kB) |
| FDA Decision: | Finding of No Significant Impact (FONSI) (in PDF, 175 kB) |
-
