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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. 2436

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 agent used in process water during the production of lactose, including lactose used as an ingredient in infant formula.
Limitations/Specifications: The components of the FCS will not exceed 33 ppm PAA, 155 ppm HP, 42 ppm AA and 1 ppm SA in process water used in the production of lactose, including lactose used as an ingredient in infant formula.
Effective Date: Sep 11, 2025
National Environmental Policy Act (NEPA)** Submission: Environmental Assessment
FDA Decision: Finding of No Significant Impact (FONSI)

*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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