Inventory of Effective Food Contact Substance (FCS) Notifications
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FCN No. 2498
Laboratorios Argenol SL
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: | Silver-zinc-calcium-sodium-borate-phosphate glass |
|---|---|
| Notifier: | Laboratorios Argenol SL |
| Manufacturer/Supplier: | Laboratorios Argenol SL |
| Intended Use: | As an antimicrobial agent in food contact polymers, except for use in contact with infant formula and human milk (see Limitations/Specifications). |
| Limitations/Specifications: | For use only at levels not to exceed 1.0 percent by weight of the finished article in which the silver content of the finished article shall not exceed 0.022 percent by weight. Finished articles 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: | May 22, 2026 |
| National Environmental Policy Act (NEPA)** Submission: | Environmental Assessment (in PDF, 195 kB) |
| FDA Decision: | Finding of No Significant Impact (FONSI) (in PDF, 192 kB) |
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