COMMISSION IMPLEMENTING REGUL ATION (EU) 2020/42 
of 17 Januar y 2020 
amending Regulation (EU) No 37/2010 to classify the subst ance bamber mycin 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 formulate d on 16 Apr il 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 bamber mycin is not included in that table. 
(4) An application for the establishment of MRLs for bamber mycin in rabbit tissue has been submitted to the European 
Medicines Agen cy (‘EMA ’). 
(5) The EMA, based on the opinion of the Committ ee for Medicinal Products for Veterinar y Use, has recommended that 
the establishment of an MRL for bamber mycin in rabbits is not necessar y for the prot ection of human health. 
(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 ‘no MRL required’ classif ication for bamber mycin from rabbit 
tissue to the tissue of other food-producing species is not appropr iate at this time due to insuffi cient 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 L 15/2                                                                                                                                            20.1.2020   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 20.1.2020                                                                                                                                            L 15/3   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 Classif ication 
‘Bamber mycin NOT APPLICABLE Rabbit No MRL required NOT APPLICABLE For oral use only Anti-infe ctious agent/An­
tibiotics’   EN Offi cial Jour nal of the European Union L 15/4                                                                                                                                            20.1.2020