Inventory of Effective Food Contact Substance (FCS) Notifications
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FCN No. 2428
Solenis LLC
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: | 5,5-Dimethylhydantoin (DMH) (CAS Reg. No. 77-71-4) |
|---|---|
| Notifier: | Solenis LLC |
| Manufacturer/Supplier: | Solenis LLC |
| Intended Use: | For use as a stabilizer for hypohalite slimicides used in the manufacture of food-contact paper and paperboard, except for use in contact with infant formula and human milk (see Limitations/Specifications). |
| Limitations/Specifications: | The FCS will be used at a level not to exceed 0.5 g DMH per kg of dry fiber. The paper and paperboard containing the FCS may 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 or human milk. Such uses were not included as part of the intended use of the substance in the FCN. |
| Effective Date: | May 13, 2025 |
| National Environmental Policy Act (NEPA)** Submission: | Environmental Assessment (in PDF, 416 kB) |
| FDA Decision: | Finding of No Significant Impact (FONSI) (in PDF, 233 kB) |
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