MRL for fluralaner in fin fish
- Veterinary residues
Summary
The European Union (EU) has set a maximum residue limit (MRL) for the substance fluralaner, used in veterinary medicines in fin fish.
EU establishes MRL for fluralaner in fin fish
Commission Implementing Regulation (EU) 2025/1908 of 24 September 2025 amending Regulation (EU) No 37/2010 as regards the classification of the substance fluralaner with respect to its maximum residue limit in foodstuffs of animal origin
Update
The European Union (EU) has set a maximum residue limit (MRL) for the substance fluralaner, used in veterinary medicines in fin fish.
Impacted Products
Fin fish
What is changing?
The EU has set an MRL for fluralaner of 65 μg/kg for Salmonidae and other fin fish, applicable to muscle and skin in natural proportions. MRLs were already in place for poultry.
Why?
In April 2024, Farmacologia En Aquacultura Veterinaria submitted an application to the European Medicines Agency (EMA) regarding MRLs for fluralaner in fin fish. Following this application, and based on the opinion of the Committee for Veterinary Medicinal Products, the EMA has recommended the establishment of MRLs for fluralaner used in Salmonidae (CVMP 2025).
Timeline
The new MRL applies from 15 October 2025.
Background
Regulation 470/2009 requires that MRLs for pharmacologically active substances intended for use in veterinary medicinal products administered to food-producing animals in the EU are subject to the opinion of the EMA.
Active substances and their MRLs in foods of animal origin are set out in Regulation 37/2010. The use of fluralaner in veterinary medicines for poultry was already permitted.
Resources
CVMP (2025) Opinion of 12 February 2025 on the establishment of maximum residue limits (EMA/CVMP/27344/2025). Committee for Veterinary Medicinal Products.
European Commission (2023) Control plans for residues of veterinary medicines, pesticides and contaminants.
European Commission: Residues of veterinary medicinal products
Sources
Commission Implementing Regulation (EU) 2025/1908 as regards the classification of the substance fluralaner with respect to its maximum residue limit in foodstuffs of animal origin
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EU establishes MRL for fluralaner in fin fish
Commission Implementing Regulation (EU) 2025/1908 as regards the classification of the substance fluralaner with respect to its maximum residue limit in foodstuffs of animal origin
What is changing and why?
The European Union (EU) has set a maximum residue limit (MRL) for fluralaner of 65 μg/kg for Salmonidae and other fin fish, applicable to muscle and skin in natural proportions.
Timeline
The new MRL applies from 15 October 2025.
Disclaimer: Under no circumstances shall COLEAD be liable for any loss, damage, liability or expense incurred or suffered that is claimed to have resulted from the use of information available on this website or any link to external sites. The use of the website is at the user’s sole risk and responsibility. This information platform was created and maintained with the financial support of the European Union. Its contents do not, however, reflect the views of the European Union.