Inventory of Effective Food Contact Substance (FCS) Notifications
-
FCN No. 2464
Hydrite Chemical Co.
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: | An aqueous mixture of peroxyacetic acid (PAA) (CAS Reg. No. 79-21-0), hydrogen peroxide (HP) (CAS Reg. No. 7722-84-1), acetic acid (AA) (CAS Reg. No. 64-19-7), and optionally, sulfuric acid (SA) (CAS Reg. No. 7664-93-9). |
|---|---|
| Notifier: | Hydrite Chemical Co. |
| Manufacturer/Supplier: | Hydrite Chemical Co. |
| Intended Use: | As an antimicrobial additive to liquid, pasteurized whey used in the production of whey protein concentrate and whey protein isolate, including whey protein concentrate and whey protein isolate used as an ingredient in infant formula. |
| Limitations/Specifications: | The components of the FCS will not exceed 16 ppm PAA, 76 ppm HP, 21 ppm AA, and 1 ppm SA in the whey solution used to manufacture whey protein concentrate and whey protein isolate, including whey protein concentrate and whey protein isolate used as an ingredient in infant formula. |
| Effective Date: | Dec 27, 2025 |
| National Environmental Policy Act (NEPA)** Submission: | Environmental Assessment |
| FDA Decision: | Finding of No Significant Impact (FONSI) |
-
