Date: 2025-09-25Category: Not ApplicableState: Union GovernmentCountry: Europe
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
Issued by European Commission
· Directorate-General for Health and Food Safety
**Executive Summary**
Commission Implementing Regulation (EU) 2025/1908, dated 24 September 2025, amends Regulation (EU) No 37/2010 concerning the classification of the substance fluralaner regarding its maximum residue limit (MRL) in foodstuffs of animal origin. This regulation aims to establish recommended MRLs for fluralaner in all fin fish. The regulation enters into force 20 days after its publication in the Official Journal of the European Union.
**Key Points / Main Content**
* **Regulation Amendment:** Regulation (EU) No 37/2010 is amended as outlined in the Annex of the new regulation.
* **Fluralaner MRLs for Poultry:** Fluralaner is an allowed substance for poultry.
* Muscle: 65 µg/kg
* Skin and fat in natural proportions: 650 µg/kg
* Liver: 650 µg/kg
* Kidney: 420 µg/kg
* Eggs: 1300 µg/kg
* **Fluralaner MRLs for Fin Fish:** MRLs are established for fluralaner in fin fish.
* Muscle and skin in natural proportions: 65 µg/kg
* **Entry into Force:** The regulation becomes effective twenty days after its publication in the Official Journal of the European Union.
**Impact Analysis**
**Stakeholder: Member States**
**Impact:** The regulation is binding and directly applicable in all Member States.
**Action Required:** Implement the updated MRLs for fluralaner in poultry and fin fish.
**Stakeholder: Food Producers (Poultry and Fin Fish)**
**Impact:** Producers must ensure fluralaner residues in their products do not exceed the established MRLs.
**Action Required:** Adjust production practices to comply with the new MRL limits for fluralaner.
Key Entities Referenced
Regulation (EU) No 37/2010: European Commission regulation setting out pharmacologically active substances and their classification regarding maximum residue limits (MRLs) in foodstuffs of animal origin.
Regulation (EC) No 470/2009: European Parliament and Council regulation laying down Community procedures for the establishment of residue limits of pharmacologically active substances in foodstuffs of animal origin.
fluralaner: A pharmacologically active substance used as a veterinary medicinal product; the regulation amends the classification of fluralaner with respect to its maximum residue limit in foodstuffs of animal origin.
European Medicines Agency ('the Agency'): Agency to which an application was submitted for the establishment of maximum residue limits of fluralaner.
Brussels: The location where the regulation was adopted.
Official Journal EN
of the European Union L series
2025/1908 25.9.2025
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
(Text with EEA relevance)
THE EUROPEAN COMMISSION,
Having regard to the Treaty on the Functioning of the European Union,
Having regard to Regulation (EC) No 470/2009 of the European Parliament and of the Council of 6 May 2009 laying down
Community procedures for the establishment of residue limits of pharmacologically active substances in foodstuffs of
animal origin, repealing Council Regulation (EEC) No 2377/90 and amending Directive 2001/82/EC of the European
Parliament and of the Council and Regulation (EC) No 726/2004 of the European Parliament and of the Council(1), and in
particular Article 14, in conjunction with Article 17, thereof,
Whereas:
(1) In accordance with Regulation (EC) No 470/2009, the Commission is to establish, by way of a Regulation, maximum
residue limits (‘MRLs’) for pharmacologically active substances intended for use in the Union in veterinary medicinal
products for food-producing animals or in biocidal products used in animal husbandry.
(2) Commission Regulation (EU) No 37/2010(2)sets out the pharmacologically active substances and their classification
regarding MRLs in foodstuffs of animal origin.
(3) The substance fluralaner is included in that Regulation as an allowed substance for poultry.
(4) On 24 April 2024, Farmacologia En Aquacultura Veterinaria FAV S.A. submitted an application to the European
Medicines Agency (‘the Agency’) in accordance with Article 3 of Regulation (EC) No 470/2009 for the establishment
of the maximum residue limits of the substance fluralaner in Salmonidae and other fin fish.
(5) In accordance with Article 5 of Regulation (EC) No 470/2009, the Agency is to consider using MRLs established for a
pharmacologically active substance in a particular foodstuff for another foodstuff derived from the same species, or
MRLs established for a pharmacologically active substance in one or more species for other species.
(6) On 12 February 2025(3), the Agency, based on the opinion of the Committee for Veterinary Medicinal Products,
recommended the establishment of MRLs for fluralaner use in Salmonidae, applicable to muscle and skin in natural
proportions. The Agency concluded that the extension by extrapolation of the MRLs for fluralaner to all fin fish is
appropriate.
(7) In view of the opinion of the Agency, the Commission considers it appropriate to establish the recommended MRLs
for fluralaner in all fin fish.
(8) Regulation (EU) No 37/2010 should therefore be amended accordingly.
(9) The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on
Veterinary Medicinal Products,
(1) OJ L 152, 16.6.2009, p. 11, ELI: http://data.europa.eu/eli/reg/2009/470/oj.
(2) Commission Regulation (EU) No 37/2010 of 22 December 2009 on pharmacologically active substances and their classification
regarding maximum residue limits in foodstuffs of animal origin (OJ L 15, 20.1.2010, p. 1, ELI: http://data.europa.eu/eli/reg/2010/
37(1)/oj).
(3) Opinion of the Committee for Veterinary Medicinal Products of 12 February 2025 on the establishment of maximum residue limits
(EMA/CVMP/27344/2025).
ELI: http://data.europa.eu/eli/reg_impl/2025/1908/oj 1/3EN
OJ L, 25.9.2025
HAS ADOPTED THIS REGULATION:
Article 1
The Annex to Regulation (EU) No 37/2010 is amended as set out in the Annex to this Regulation.
Article 2
This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the
European Union.
This Regulation shall be binding in its entirety and directly applicable in all Member States.
Done at Brussels, 24 September 2025.
For the Commission
The President
Ursula VON DER LEYEN
2/3 ELI: http://data.europa.eu/eli/reg_impl/2025/1908/ojANNEX
In Table 1 of the Annex to Regulation (EU) No 37/2010, the entry for the substance ‘fluralaner’ is replaced by the following:
Other provisions
Pharmacologically active (according to Article 14(7) Therapeutic
Marker residue Animal species MRL Target tissues
substance of Regulation (EC) classification
No 470/2009)
‘Fluralaner Fluralaner Poultry 65 μg/kg Muscle NO ENTRY Antiparasitic
agents/Agents
650 μg/kg Skin and fat in natural proportions
against ectoparasites’
650 μg/kg Liver
420 μg/kg Kidney
1 300 μg/kg Eggs
Fluralaner Fin fish 65 μg/kg Muscle and skin in natural proportions
ELI:
http://data.europa.eu/eli/reg_impl/2025/1908/oj
3/3
OJ
L,
25.9.2025
EN