II 
(Non-legislative acts)  
REGULATIONS  
COMMISSION REGULATION (EU) No 610/2012  
of 9 July 2012  
amending Regulation (EC) No 124/2009 of 10 February 2009 setting maximum levels for the 
presence of coccidiostats or histomonostats in food resulting from the unavoidable carry-over of 
these substances in non-target feed  
(Text with EEA relevance)  
THE EUROPEAN COMMISSION,  
Having regard to the Treaty on the Functioning of the European 
Union,  
Having regard to Council Regulation (EEC) No 315/93 of 
8 February 1993 laying down Community procedures for 
contaminants in food (  1 ), and in particular Article 2(3) thereof,  
Whereas:  
(1) Maximum levels have been set for certain coccidiostats 
and histomonostats in food by Commission Regulation 
(EC) No 124/2009 of 10 February 2009 setting 
maximum levels for the presence of coccidiostats or 
histomonostats in food resulting from the unavoidable 
carry-over of these substances in non-target feed (  2 ) in 
order to ensure a proper functioning of the internal 
market and to protect public health.  
(2) The maximum levels should be continuously adapted in 
order to take account of developments in scientific and 
technical knowledge and the changes of maximum 
residue limits established for the specific food 
concerned in the framework of 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 (  3 ) or in the framework of Regulation (EC) No 1831/2003 of the European Parliament and of 
the Council of 22 September 2003 on additives for use 
in animal nutrition (  4 ). 
(3) Maximum residue limits have been established for 
lasalocid sodium in food of animal origin from bovine 
species in the framework of Regulation (EC) No 
470/2009 by Commission Implementing Regulation 
(EU) No 86/2012 of 1 February 2012 amending the 
Annex to Regulation (EU) No 37/2010 on pharmaco ­
logically active substances and their classification 
regarding maximum residue limits in foodstuffs of 
animal origin, as regards the substance lasalocid (  5 ). 
Therefore, it is necessary to amend the provisions as 
regards lasalocid sodium.  
(4) New technical information, namely specific studies on 
transfer ratio of maduramicin from feed into eggs from 
laying hens has become available. These studies demon ­
strate that feed for laying hens containing maduramicin 
due to cross-contamination but below the maximum 
level results in levels of maduramicin in eggs higher 
than the currently allowed maximum level. In accordance 
with the conclusions of the EFSA opinion on cross- 
contamination of non-target feedingstuffs by madurami ­
cin (  6 ) and the scientific opinion on safety and efficacy of 
maduramicin ammonium for chickens for fattening (  7 ), 
these higher levels do not result in an appreciable riskEN 10.7.2012 Official Journal of the European Union L 178/1  
( 1 ) OJ L 37, 13.2.1993, p. 1.  
( 2 ) OJ L 40, 11.2.2009, p. 7.  
( 3 ) OJ L 152, 16.6.2009, p. 11.  ( 4 ) OJ L 268, 18.10.2003, p. 29.  
( 5 ) OJ L 30, 2.2.2012, p. 6.  
( 6 ) Opinion of the Scientific Panel on Contaminants in the Food Chain 
on a request from the European Commission on cross-contami ­
nation of non-target feedingstuffs by maduramicin authorised for 
use as a feed additive,  The EFSA Journal  (2008) 594, 1-30, 
Available online: http://www.efsa.europa.eu/en/efsajournal/doc/594. 
pdf 
( 7 ) EFSA Panel on Additives and Products or Substances used in Animal 
Feed (FEEDAP); Scientific Opinion on safety and efficacy of Cygro® 
10G (maduramicin ammonium α) for chickens for fattening. EFSA 
Journal 2011;9(1):1952. [2 pp.]. doi:10.2903/j.efsa.2011.1952. 
Available online: www.efsa.europa.eu/efsajournalto consumers’ health. Therefore it is appropriate to 
amend the provisions as regards maduramicin accord ­
ingly.  
(5) The conditions of authorisation of nicarbazin and 
diclazuril as feed additives have been modified by 
Commission Regulation (EU) No 875/2010 of 
5 October 2010 concerning the authorisation for 10 
years of an additive in feedingstuffs (  1 ) and Commission 
Regulation (EU) No 169/2011 of 23 February 2011 
concerning the authorisation of diclazuril as a feed 
additive for guinea fowls (  2 ) respectively. Those devel ­
opments require significant changes to the maximum 
levels set for nicarbazin and minor changes for diclazuril 
in the Annex to Regulation (EC) No 124/2009. In 
accordance with the conclusions of the EFSA opinion 
on cross-contamination of non-target feedingstuffs by 
nicarbazin (  3 ) and the scientific opinion on safety and 
efficacy of nicarbazin for chickens for fattening (  4 ), the 
proposed maximum levels for nicarbazin in food as a 
consequence of unavoidable carry-over in non-target 
feed do not result in an appreciable risk to consumers’ health. Therefore it is appropriate to amend the 
provisions as regards diclazuril and nicarbazin.  
(6) Therefore, Regulation (EC) No 124/2009 should be 
amended accordingly.  
(7) The measures provided for in this Regulation are in 
accordance with the opinion of the Standing 
Committee on the Food Chain and Animal Health,  
HAS ADOPTED THIS REGULATION:  
Article 1  
The Annex to Regulation (EC) No 124/2009 is amended in 
accordance with 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, 9 July 2012.  
For the Commission  
The President  
José Manuel BARROSOEN L 178/2 Official Journal of the European Union 10.7.2012  
( 1 ) OJ L 263, 6.10.2010, p. 4.  
( 2 ) OJ L 49, 24.2.2001, p. 6.  
( 3 ) Opinion of the Scientific Panel on Contaminants in the Food Chain 
on a request from the European Commission on cross-contami ­
nation of non-target feedingstuffs by nicarbazin authorised for use 
as a feed additive,  The EFSA Journal  (2008) 690, 1-34, Available 
online: http://www.efsa.europa.eu/en/efsajournal/doc/690.pd f  
( 4 ) EFSA Panel on Additives and Products or Substances used in Animal 
Feed (FEEDAP); Scientific Opinion on the safety and efficacy of 
Koffogran (nicarbazin) as a feed additive for chickens for fattening. 
EFSA Journal 2010; 8(3):1551. [40 pp.]. doi:10.2903/ 
j.efsa.2010.1551. Available online: www.efsa.europa.euANNEX  
The Annex to Regulation (EC) No 124/2009 is amended as follows:  
(1) The entry No 1 concerning Lasalocid sodium is replaced by the following:  
"1. Lasalocid sodium  Food of animal origin from animal species 
other than poultry and bovine:  
— milk;  1  
— liver;  50  
— kidney;  20  
— other food.  5 " 
(2) he entry No 6 concerning Maduramicin is replaced by the following:  
"6. Maduramicin  Food of animal origin from animal species 
other than chickens for fattening and 
turkeys:  
— eggs;  12  
— other food.  2 " 
(3) The entry No 10 concerning Nicarbazin is replaced by the following:  
"10. Nicarbazin 
(residue: 4,4'- 
dinitrocarbanilide (DNC))  Food of animal origin from animal species 
other than chickens for fattening:  
— eggs;  300  
— milk;  5  
— liver;  300  
— kidney;  100  
— other food.  50 " 
(4) The entry No 11 concerning Diclazuril is replaced by the following:  
"11. Diclazuril  Food of animal origin from animal species 
other than chickens for fattening, turkeys 
for fattening, guinea fowl, rabbits for 
fattening and breeding, ruminants and 
porcine:  
— eggs;  2  
— liver and kidney;  40  
— other food.  5 "EN 10.7.2012 Official Journal of the European Union L 178/3