COMMISSION IMPLEMENTING REGUL ATION (EU) 2023/981 
of 17 May 2023
amending Regulation (EU) No 37/2010 as regards the classif ication of the subst ance praziquantel 
with respect to its maximum residue limit in foods tuffs of animal origin 
(Text with EEA relevance) 
THE EUR OPEAN COMMISSION,
Havi ng regar d to the Treaty on the Functioning of the European Union,
Havi ng regar d 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 phar macologically 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 phar macologically active substances intended for use in the Union in vete rinar y medicinal 
products for food-producing animals or in biocidal products used in animal husbandr y.
(2) Table 1 of the Annex to Commission Regulation (EU) No 37/2010 (2)sets out the phar macologically active 
substances and their classification regar ding MRLs in foodstuffs of animal origin.
(3) Praziquantel is already included in that table as an allowed substance for ovine and equidae species. The existing entr y 
has a ‘no MRL required’ classification.
(4) In accordance with Article 3 of Regulation (EC) No 470/2009, on 27 July 2021 , VETHELL AS AEBE submitted a 
request to the European Medicines Age ncy (‘Age ncy’) for the extension of the existing entr y for praziquantel to fin 
fish.
(5) On 8 Sept ember 2022 , the Agen cy, through the opinion of the Committ ee for Medicinal Products for Veterinar y 
Use, concluded that the establishment of an MRL for praziquantel in fin fish, in relation to muscle and skin in 
natural propor tions, was appropr iate.
(6) In accordance with Article 5 of Regulation (EC) No 470/2009, the Age ncy is to consider using MRLs established for 
a phar macologically active substance in a particular foodstuff for another foodstuff derived from the same species, or 
MRLs established for a phar macologically active substance in one or more species for other species.
(7) The Agen cy concluded that the extrapolation of the ‘no MRL required’ classif ication for praziquantel in ovine species 
to other ruminants, excep t cattle, is appropr iate.
(8) In view of the opinion of the Agency , the Commission considers it appropr iate to establish an MRL for praziquantel 
in fin fish, in relation to muscle and skin in natural propor tions and to establish the recommended ‘no MRL required’ 
classificat ion for praziquante l in all ruminants excep t bovine species.
(9) Regulation (EU) No 37/2010 should theref ore be amended according ly.
(10) The measures provid ed for in this Regulation are in accordance with the opinion of the Standing Committ ee on 
Veterinar y Medicinal Products,
(1)OJ L 152, 16.6.2009, p. 11.
(2)Commission Regulation (EU) No 37/2010 of 22 December 2009 on phar macologically active substances and their classif ication 
regar ding maximum residue limits in foodstuffs of animal origin (OJ L 15, 20.1.2010, p. 1).EN Offi cial Jour nal of the European Union L 134/36 22.5.2023  HAS ADOPTED THIS REGUL ATION:
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 followi ng 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, 17 May 2023 .
For the Commission
The President
Ursula VON DER LEYENEN Offi cial Jour nal of the European Union 22.5.2023 L 134/37  ANNEX 
In Table 1 of the Annex to Regulation (EU) No 37/2010, the entr y for the substance ‘praziquante l’ is replaced by the followi ng:
Phar macologically active 
SubstanceMarker residue Animal Species MRL Target TissuesOther Provisions
(according to Article 14(7) 
of Regulation (EC) 
No 470/2009)Therapeutic Classif ication
‘Praziquant el NOT APPLICABLE All ruminants excep t 
bovin e, EquidaeNo MRL required NOT APPLICABLE NO ENTR Y NO ENTR Y
Praziquantel (sum of 
isomers)Fin fish 20 μg/kg Muscle and skin in natural 
propor tionsNO ENTR Y NO ENTR Y’EN Offi cial Jour nal of the European Union L 134/38 22.5.2023