Proposed Rule2025-16859
Biomin GmbH; Filing of Food Additive Petition (Animal Use)
Primary source
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Published
September 3, 2025
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
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).
Full Text
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<title>Federal Register, Volume 90 Issue 168 (Wednesday, September 3, 2025)</title>
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[Federal Register Volume 90, Number 168 (Wednesday, September 3, 2025)]
[Proposed Rules]
[Pages 42550-42551]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2025-16859]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Part 573
[Docket No. FDA-2025-F-3179]
Biomin GmbH; Filing of Food Additive Petition (Animal Use)
AGENCY: Food and Drug Administration, HHS.
ACTION: Notification of petition.
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SUMMARY: 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
[[Page 42551]]
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).
DATES: The food additive petition was filed on August 6, 2025.
ADDRESSES: For access to the docket to read background documents or
comments received, go to <a href="https://www.regulations.gov">https://www.regulations.gov</a> and insert the
docket number found in brackets in the heading of this document into
the ``Search'' box and follow the prompts, and/or go to the Dockets
Management Staff, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
FOR FURTHER INFORMATION CONTACT: Lauren Howell, Center for Veterinary
Medicine, Food and Drug Administration, 5001 Campus Drive, College
Park, MD 20740, 240-402-8012, <a href="/cdn-cgi/l/email-protection#8ac6ebfff8efe4a4c2e5fdefe6e6caeceeeba4e2e2f9a4ede5fc"><span class="__cf_email__" data-cfemail="a9e5c8dcdbccc787e1c6deccc5c5e9cfcdc887c1c1da87cec6df">[email protected]</span></a>.
SUPPLEMENTARY INFORMATION: Under section 409(b)(5) of the Federal Food,
Drug, and Cosmetic Act (21 U.S.C. 348(b)(5)), we are giving notice that
we have filed a food additive petition (FAP 2324), submitted by Biomin
GmbH, Erber Campus 1, 3131 Getzersdorf, Austria. The petition proposes
that we amend our food additive regulations in 21 CFR part 573--Food
Additives Permitted in Feed and Drinking Water of Animals, 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).
The petitioner has claimed that this action is categorically
excluded under 21 CFR 25.32(r) because it is of a type that does not
individually or cumulatively have a significant effect on the human
environment. In addition, the petitioner has stated that, to their
knowledge, no extraordinary circumstances exist that may significantly
affect the quality of the human environment. If FDA determines a
categorical exclusion applies, neither an environmental assessment nor
an environmental impact statement is required. If FDA determines a
categorical exclusion does not apply, we will request an environmental
assessment and make it available for public inspection.
Grace R. Graham,
Deputy Commissioner for Policy, Legislation, and International Affairs.
[FR Doc. 2025-16859 Filed 9-2-25; 8:45 am]
BILLING CODE 4164-01-P
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