MRL for fluralaner in fin fish
- Veterinary residues
Summary
The European Commission has informed the World Trade Organization Sanitary and Phytosanitary Measures (WTO SPS) Committee that it will set a maximum residue limit (MRL) for the substance fluralaner (used in veterinary medicines) in Salmonidae and other fin fish (G/SPS/N/EU/847).
EU to establish MRL for Salmonidae and other fin fish
Draft Commission Implementing Regulation (EU) 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
Draft Annex
Update
The European Commission has informed the World Trade Organization Sanitary and Phytosanitary Measures (WTO SPS) Committee that it will set a maximum residue limit (MRL) for the substance fluralaner (used in veterinary medicines) in Salmonidae and other fin fish (G/SPS/N/EU/847).
Impacted Products
Fin fish
What is changing?
MRLs are currently in place for the substance fluralaner in poultry.
The EU proposes to set an MRL of 65 µg/kg for fin fish (Salmonidae and other fin fish), applicable to muscle and skin in natural proportions.
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 is expected to apply from August 2025.
Recommended Actions
Countries that are members of the WTO can submit comments or concerns about potential impacts, via the National SPS notification authority of the country concerned, to the EU SPS Enquiry Point until 28 June 2025.
Background
Pharmacologically active substances and their MRLs in foods of animal origin are given in Regulation 37/2010 (Annex), which already allows the use of fluralaner in veterinary medicines for poultry.
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
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.
EU to establish MRL for Salmonidae and other fin fish
Draft Commission Implementing Regulation as regards the classification of the substance fluralaner with respect to its maximum residue limit in foodstuffs of animal origin
Draft Annex
What is changing and why?
The European Union (EU) proposes to set a maximum residue limit (MRL) of 65 µg/kg for fin fish (Salmonidae and other fin fish), applicable to muscle and skin in natural proportions.
Actions
Countries that are members of the World Trade Organization can submit comments or concerns about potential impacts, via the National SPS notification authority of the country concerned, to the EU SPS Enquiry Point until 28 June 2025.
Timeline
The new MRL is expected to apply from August 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.