Home / Agencies / FDA / 2025-16859
Proposed Rule

Biomin GmbH; Filing of Food Additive Petition (Animal Use)

Agency
FDA
Document Number
2025-16859
Published
September 3, 2025
Effective Date
-

Abstract

The Food and Drug Administration (FDA or we) is announcing that we have filed a food additive petition, submitted by Biomin GmbH, proposing that we amend our food additive regulations to provide for the safe use of zearalenone hydrolase to degrade zearalenone in swine food at no less than 10 U/kg complete feed (U = the five-fold enzymatic activity that hydrolyzes 1 [micro]mol zearalenone per minute in a solution of 5 mg/L zearalenone).

Federal Register Source

This document is published by the Office of the Federal Register, National Archives and Records Administration. Access the full regulatory text, preamble, and docket comments below.

View Full Text on FederalRegister.gov →

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Frequently Asked Questions

What is the 2025-16859 Federal Register document?
Document 2025-16859 is a Proposed Rule published by the Food and Drug Administration in the Federal Register on September 3, 2025. The Food and Drug Administration (FDA or we) is announcing that we have filed a food additive petition, submitted by Biomin GmbH, proposing that we amend our food additive regulations to provide for the safe use of zearalenone hydrolase to degrade zearalenone in swine food at no less than 10 U/kg complete feed (U = the five-fold enzymatic activity that hydrolyzes 1 [micro]mol zearalenone per minute in a solution of 5 mg/L zearalenone). View the original at https://www.federalregister.gov/documents/2025/09/03/2025-16859/biomin-gmbh-filing-of-food-additive-petition-animal-use.
Is document 2025-16859 an economically significant rule?
No. Document 2025-16859 is not classified as economically significant under Executive Order 12866. Economically significant rules require OIRA review and are estimated to have impacts of $100 million or more per year.

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