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
(Text with EEA relevance)
THE COMMISSION OF THE EUROPEAN COMMUNITIES,
Having regard to the Treaty establishing the European
Community,
Having regard to Council Regulation (EEC) No 315/93 of
8 February 1993 laying down Community procedures forcontaminants in food (
1), and in particular Article 2(3) thereof,
Whereas:
(1) Coccidiostats and histomonostats are substances intended
to kill or inhibit protozoa, which may, inter alia ,b e
authorised for use as feed additives in accordance withRegulation (EC) No 1831/2003 of the EuropeanParliament and of the Council of 22 September 2003on additives for use in animal nutrition (
2). Authoris­
ations of coccidiostats and histomonostats as feedadditives lay down specific conditions for use such asthe target animal species or categories for which theadditives are intended.
(2) Feed business operators may produce within one estab­lishment a broad range of feeds and different types ofproducts may have to be manufactured after each otherin the same production line. It may happen thatunavoidable traces of a product remain in the productionline and end up in the beginning of the production ofanother feed product. This transfer from one productionlot to another is called ‘carry-over ’or‘cross-contamina­
tion’and may occur for instance when coccidiostats or
histomonostats are used as authorised feed additives. Thismay result in the contamination of feed produced subse­quently by the presence of technically unavoidable tracesof those substances in ‘non-target feed ’, i.e. in feed for
which the use of coccidiostats or histomonostats are notauthorised, such as feed intended for animal species orcategories not provided for in the additive authorisation.This unavoidable cross-contamination may occur at allstages of production and processing of feed but alsoduring storage and transport of feed.
(3) In order to prevent the adoption by Member States ofnational rules addressing the issue of unavoidable carry-over of authorised coccidiostats or histomonostats in
non-target feed and their resulting presence in derivedfoodstuffs, which would hinder the functioning of the
internal market, it is necessary to adopt harmonised
Community rules in this matter.
(4) The unavoidable carry-over in non-target feed of activesubstances contained in authorised coccidiostats andhistomonostats are considered as undesirable substancesin animal feed within the meaning of Directive2002/32/EC of the European Parliament and of theCouncil (
3) and their presence should not endanger
animal health, human health or the environment.Therefore, maximum levels for these substances inanimal feed are established by Commission Directive2009/8/EC (
4) amending Annex I to Directive
2002/32/EC.
(5) The occurrence of unavoidable carry-over of coccidiostatsand histomonostats in non-target feed, even belowmaximum levels set under Directive 2002/32/EC, mayresult in the presence of residues of these substances in
food products of animal origin. Therefore, in order to
protect public health, and insofar there is no maximumresidue limit (MRL) yet fixed for the specific foodconcerned in the frame of Council Regulation (EEC) No2377/90 of 26 June 1990 laying down a Communityprocedure for the establishment of maximum residuelimits of veterinary medicinal products in foodstuffs ofanimal origin (
5) or in the frame of Regulation (EC) No
1831/2003, maximum tolerances for the presence ofactive substances contained in coccidiostats and histomo­nostats should be established in food of animal originoriginating from the non-target feed concerned, in thecontext of Regulation (EEC) No 315/93 laying downCommunity procedures for contaminants in food.
(6) On a request from the Commission, the European FoodSafety Authority ( ‘the Authority ’) adopted several
opinions (
6) on the risks involved for animal health and
public health as the consequence of unavoidable carry-
over of coccidiostats or histomonostats authorised asfeed additives into non-target feed. For each coccidiostator histomonostat authorised as feed additive, theAuthority's assessment took into account hypotheticalcarry-over rates of 2 %, 5 % and 10 % from feedproduced with the highest authorised dose of the cocci­diostats or histomonostats into the afterwards producednon-target feed.EN 11.2.2009 Official Journal of the European Union L 40/7(7) Considering the conclusions of the individual scientific
opinions, it can be stated that generally the Authorityconcluded that the presence of the coccidiostats or histo­monostats authorised as feed additives, in non-target feedat levels resulting from an unavoidable carry-over, andtaking into account all prevention measures, is unlikelyto result in adverse animal health effects and that the riskto consumers' health from the ingestion of residues in
products from animals exposed to cross-contaminated
feed is negligible.
(8) Taking into account the Authority's opinions and the
currently different approaches applied in the Member
States to address the unavoidable cross-contamination,it is proposed to set maximum levels for food as laiddown in the Annexes to this Regulation, in order toensure a proper functioning of the internal market andto protect public health. The provisions provided inAnnex should be reviewed by 1 July 2011 at the latestto take account of developments in scientific andtechnical knowledge.
(9) The maximum levels set in the Annex to this Regulationshould be continuously adapted to changes of maximumresidue levels (MRL) established for the specific foodconcerned in the frame of Regulation (EEC) No2377/90 laying down a Community procedure for theestablishment of maximum residue limits of veterinarymedicinal products in foodstuffs of animal origin or inthe frame of Regulation (EC) No 1831/2003. In view ofthe occurrence of a possible time gap between theseamendments and the consequent adaptation to the
maximum levels laid down in the Annex to this Regu­
lation, the latter should be considered as withoutprejudice to the maximum residue levels of coccidiostatsor histomonostats established in the frame of Regulation(EEC) No 2377/90 or in the frame of Regulation (EC) No1831/2003.
(10) Due to the fact that the unavoidable carry-over of cocci­diostats or histomonostats into non-target feed mayresult in the presence of these substances ascontaminants in derived food, it is appropriate to takea comprehensive and integrated approach to address theissue through the simultaneous adoption and applicationof this Regulation and the Directive 2009/8/EC setting
maximum levels for the unavoidable carry-over of cocci­diostats or histomonostats into non-target feed.
(11) The measures provided for in this Regulation are inaccordance with the opinion of the StandingCommittee on the Food Chain and Animal Health,
HAS ADOPTED THIS REGULATION:
Article 1
1. The foodstuffs listed in Annex to this Regulation shall not
be placed on the market where they contain a contaminantlisted in this Annex at a level exceeding the maximum levelsset in the Annex.
In case of a finding of a significant residue below the maximum
level set out in the Annex, it is appropriate for the competentauthority to carry out investigations to confirm that the residueis present as a consequence of unavoidable carry over in thefeed and not as the consequence of illegal administration of the
coccidiostat or histomonostat.
Foodstuffs complying with the maximum levels set out in the
Annex shall not be mixed with foodstuffs which exceed thesemaximum levels.
2. When applying the maximum levels set out in the Annex
to this Regulation to foodstuffs which are dried, diluted,processed or composed of more than one ingredient, changesof the concentration of the contaminant caused by drying,diluting or processing, as well as the relative proportion ofthe ingredients in the product, shall be taken into account.
3. The maximum levels established in Annex to this Regu­
lation are without prejudice to the provisions and the MRLsestablished by Regulation (EEC) No 2377/90 and the MRLsestablished by Regulation (EC) No 1831/2003.
Article 2
This Regulation shall enter into force on the 20th day following
that of its publication in the Official Journal of the European
Union .
It shall apply from 1 July 2009.
This Regulation shall be binding in its entirety and directly applicable in all Member States.
Done at Brussels, 10 February 2009.
For the Commission
Androulla VASSILIOU
Member of the CommissionEN L 40/8 Official Journal of the European Union 11.2.2009(1) OJ L 37, 13.2.1993, p. 1.
(2) OJ L 268, 18.10.2003, p. 29.
(3) OJ L 140, 30.5.2002, p. 10.
(4) See page 19 of this Official Journal.
(5) OJ L 224, 18.8.1990, p. 1.
(6) Opinion of the Scientific Panel on Contaminants in the Food Chain on a request from the European Commission on
cross-contamination of non-target feedingstuffs by lasalocid authorised for use as a feed additive, The EFSA Journal
(2007) 553, 1-46.http://www.efsa.europa.eu/cs/BlobServer/Scientific_Opinion/CONTAM_ej553_lasalocid_en.pdf?ssbinary=trueOpinion of the Scientific Panel on Contaminants in the Food Chain on a request from the European Commission oncross-contamination of non-target feedingstuffs by narasin authorised for use as a feed additive, The EFSA Journal
(2007) 552, 1-35.http://www.efsa.europa.eu/cs/BlobServer/Scientific_Opinion/CONTAM_ej552_narasin_en.pdf?ssbinary=true
Opinion of the Scientific Panel on Contaminants in the Food Chain on a request from the European Commission on
cross-contamination of non-target feedingstuffs by maduramicin authorised for use as a feed additive, The EFSA Journal
(2008) 594, 1-30.http://www.efsa.europa.eu/cs/BlobServer/Scientific_Opinion/contam_op_ej594_maduramicin_en.pdf?ssbinary=trueOpinion of the Scientific Panel on Contaminants in the Food Chain on a request from the European Commission oncross-contamination of non-target feedingstuffs by semduramicin authorised for use as a feed additive, The EFSA
Journal (2008) 593, 1-27.
http://www.efsa.europa.eu/cs/BlobServer/Scientific_Opinion/contam_op_ej593_semduramicin_en.pdf?ssbinary=true
Opinion of the Scientific Panel on Contaminants in the Food Chain on a request from the European Commission oncross-contamination of non-target feedingstuffs by salinomycin authorised for use as a feed additive, The EFSA Journal
(2008) 591, 1-38.http://www.efsa.europa.eu/cs/BlobServer/Scientific_Opinion/contam_op_ej591_salinomycin_en.pdf?ssbinary=trueOpinion of the Scientific Panel on Contaminants in the Food Chain on a request from the European Commission oncross-contamination of non-target feedingstuffs by monensin authorised for use as a feed additive, The EFSA Journal
(2008) 592, 1-40.
http://www.efsa.europa.eu/cs/BlobServer/Scientific_Opinion/contam_op_ej592_monensin_en.pdf?ssbinary=trueOpinion of the Scientific Panel on Contaminants in the Food Chain on a request from the European Commission oncross-contamination of non-target feedingstuffs by halofuginone hydrobromide authorised for use as a feed additive,The EFSA Journal (2008) 657, 1-31.
http://www.efsa.europa.eu/cs/BlobServer/Scientific_Opinion/contam_op_ej657_halofuginone_en.pdf?ssbinary=true
Opinion of the Scientific Panel on Contaminants in the Food Chain on a request from the European Commission on
cross-contamination of non-target feedingstuffs by decoquinate authorised for use as a feed additive, The EFSA Journal
(2008) 656, 1-26.http://www.efsa.europa.eu/cs/BlobServer/Scientific_Opinion/contam_op_ej656_decoquinate_en.pdf?ssbinary=trueOpinion of the Scientific Panel on Contaminants in the Food Chain on a request from the European Commission oncross-contamination of non-target feedingstuffs by robenidine authorised for use as a feed additive, The EFSA Journal
(2008) 655, 1-29.
http://www.efsa.europa.eu/cs/BlobServer/Scientific_Opinion/contam_op_ej655_robenidine_en,0.pdf?ssbinary=true
Opinion of the Scientific Panel on Contaminants in the Food Chain on a request from the European Commission oncross-contamination of non-target feedingstuffs by nicarbazin authorised for use as a feed additive, The EFSA Journal
(2008) 690, 1-34.http://www.efsa.europa.eu/cs/BlobServer/Scientific_Opinion/contam_op_ej690_nicarbazin_en.pdf?ssbinary=trueOpinion of the Scientific Panel on Contaminants in the Food Chain on a request from the European Commission oncross-contamination of non-target feedingstuffs by diclazuril authorised for use as a feed additive, The EFSA Journal
(2008) 716, 1-31.
http://www.efsa.europa.eu/cs/BlobServer/Scientific_Opinion/contam_op_ej716_diclazuril_en.pdf?ssbinary=trueEN 11.2.2009 Official Journal of the European Union L 40/9ANNEX
Maximum levels in foodstuffs
Substance FoodstuffsMaximum content
inμg/kg (ppb) wet
weight
1. Lasalocid sodium Food of animal origin from animal species other than poultry:
—milk; 1
—liver and kidney; 50
—other food, 5
2. Narasin Food of animal origin from animal species other than chickens for
fattening:
—eggs; 2
—milk; 1
—liver; 50
—other food. 5
3. Salinomycin sodium Food of animal origin from animal species other than chickens for
fattening and rabbits for fattening:
—eggs; 3
—liver; 5
—other food. 2
4. Monensin sodium Food of animal origin from animal species other than chickens for
fattening, turkeys and bovine (including dairy cattle):
—liver; 8
—other food. 2
5. Semduramicin Food of animal origin from animal species other than chickens for
fattening.2
6. Maduramicin Food of animal origin from animal species other than chickens for
fattening and turkeys.2
7. Robenidine Food of animal origin from animal species other than chickens for
fattening, turkey and rabbits for fattening and breeding:
—eggs; 25
—liver, kidney, skin and fat; 50
—other food. 5
8. Decoquinate Food of animal origin from animal species other than chickens for
fattening, bovine and ovine except dairy animals.20
9. Halofuginone Food of animal origin from animal species other than chickens for
fattening, turkeys and bovine except dairy cattle:
—eggs; 6
—liver and kidney; 30
—milk; 1
—other food. 3EN L 40/10 Official Journal of the European Union 11.2.2009Substance FoodstuffsMaximum content
inμg/kg (ppb) wet
weight
10. Nicarbazin Food of animal origin from animal species other than chickens for
fattening:
—eggs; 100
—milk; 5
—liver and kidney; 100
—other food. 25
11. Diclazuril Food of animal origin from animal species other than chickens for
fattening, turkeys for fattening, rabbits for fattening and breeding,
ruminants and porcine:
—eggs; 2
—liver and kidney; 40
—other food. 5EN 11.2.2009 Official Journal of the European Union L 40/11