COMMISSION IMPLEMENTING REGUL ATION (EU) 2020/43 
of 17 Januar y 2020 
amending Regulation (EU) No 37/2010 to classify the subst ance ciclesonide as regards its maximum 
residue limit 
(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 the Council (1), and in 
particular Article 14 in conjunction with Article 17 thereof, 
Havi ng regard to the opinion of the European Medicines Agen cy formulated on 21 Febr uary 2019 by the Committee for 
Medicinal Products for Veterinar y Use, 
Whereas: 
(1) Article 17 of Regulation (EC) No 470/2009 requires that the maximum residue limit (‘MRL ’) for phar macologically 
active substances intended for use in the Union in veteri nary medicinal products for food-producing animals or in 
biocidal products used in animal husbandr y is established in a Regulation. 
(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) The substance ciclesonide is not included in that table. 
(4) An application for the establishment of MRLs for ciclesonide in equidae has been submitt ed to the European 
Medicines Agen cy (‘EMA ’). 
(5) The EMA, based on the opinion of the Committee for Medicinal Products for Veterinar y Use, has recommended the 
establishment of an MRL for ciclesonide in equidae tissues, excluding animals producing milk for human 
consum ption. 
(6) According to Article 5 of Regulation (EC) No 470/2009, the EMA 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 EMA has considered that the extrapolation of the MRL for ciclesonide from equidae to other food-producing 
species is not appropr iate at this time due to insufficient data. 
(8) Regulation (EU) No 37/2010 should theref ore be amended according ly. 
(9) The measures provid ed for in this Regulation are in accordance with the opinion of the Standing Committ ee on 
Veterinar y Medicinal Products, 
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. 
(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 20.1.2020                                                                                                                                            L 15/5   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 Januar y 2020.  
For the Commission 
The President 
Ursula VON DER LEYEN     EN Offi cial Jour nal of the European Union L 15/6                                                                                                                                            20.1.2020   ANNEX 
In Table 1 of the Annex to Regulation (EU) No 37/2010, an entr y for the followi ng substance is inser ted in alphabetical order :                                                                
Phar macologically active 
Substance Mark er residue Animal Species MRLs Target Tissues Other Provisions (according to Article 
14(7) of Regulation (EC) No 
470/2009) Therapeutic 
Classific ation 
‘Ciclesonide The sum of ciclesonide and desi­
sobutyr yl-ciclesonide, measured 
as desisobutyr yl-ciclesonide after 
hydrolysis of ciclesonide to desi­
sobutyr yl-ciclesonide Equidae 0,6 μg/kg 
4 μg/kg 
0,6 μg/kg 
0,6 μg/kg Muscle 
Fat 
Liver 
Kidney Not for use in animals from which 
milk is produced for human 
consump tion Corticoides/Glucocor­
ticoides’   EN Offi cial Jour nal of the European Union 20.1.2020                                                                                                                                            L 15/7