COMMISSION DIRECTIVE 2009/8/EC
of 10 February 2009
amending Annex I to Directive 2002/32/EC of the European Parliament and of the Council as
regards maximum levels of unavoidable carry-over of coccidiostats or histomonostats 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 Directive 2002/32/EC of the European
Parliament and of the Council of 7 May 2002 on undesirablesubstances in animal feed (
1), and in particular Article 8(1)
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 as
the target animal species or categories for which the
additives 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. This
may result in the contamination of feed produced subse­
quently 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) Regulation (EC) No 183/2005 of the EuropeanParliament and of the Council of 12 January 2005
laying down requirements for feed hygiene (
3) provides
for specific requirements for feed businesses using cocci­diostats and histomonostats in the production of feed. Inparticular, the operators concerned have to take allappropriate measures concerning facilities andequipment, production, storage and transport in orderto avoid any cross-contamination, and this in accordancewith the obligations provided for in Articles 4 and 5 ofthe above mentioned Regulation. The establishment ofmaximum levels of unavoidable carry-over of cocci­diostats and histomonostats in non-target feed inaccordance with Directive 2002/32/EC should notinterfere with the primary obligation of operators toapply good manufacturing practices aiming at avoidingthis cross-contamination. Continued effort is thereforestill needed by the operators concerned in order to
avoid the presence of such undesirable substances in
animal feed.
(4) Taking into account the application of good manufac­
turing practices, the maximum levels of unavoidable
carry-over of coccidiostats or histomonostats in non-target feed should be established following the ALARA(As Low As Reasonably Achievable) principle. For thepurpose of enabling the feed manufacturer to managethe above mentioned unavoidable carry-over, a carry-over rate of approximately 3 % compared to theauthorised maximum content should be considered asregards feed for less sensitive non-target animal species,while a carry-over rate of approximately 1 % comparedto the authorised maximum content should be retainedfor feed intended to sensitive non-target animal speciesand ‘withdrawal feed ’, i.e. feed used for the period before
slaughter. The carry-over rate of 1 % should also beconsidered for cross-contamination of other feed fortarget species to which no coccidiostats or histomo­nostats are added, and as regards non-target feed for
‘continuous food-producing animals ’, such as dairy
cows or laying hens, where there is evidence of transferfrom feed to food of animal origin. If feed materials arefed directly to the animals or if complementary feeding­stuffs are used, their use in a daily ration should not leadto the animal being exposed to a higher levels of ancoccidiostat or histomonostat than the correspondingmaximum levels of exposure where only completefeedingstuffs are used in a daily ration.EN 11.2.2009 Official Journal of the European Union L 40/19(5) In order to prevent the adoption by Member States of
national rules addressing the issue of unavoidable carry-over of authorised coccidiostats or histomonostats innon-target feed and their resulting presence in derivedfoodstuffs, which would hinder the functioning of theinternal market, it is necessary to adopt harmonisedCommunity rules in this matter.
(6) The unavoidable carry-over in non-target feed of activesubstances contained in authorised coccidiostats andhistomonostats should be considered as undesirablesubstances in animal feed within the meaning ofDirective 2002/32/EC and their presence should notendanger animal health, human health or the environ­ment. Therefore, maximum levels for these substances inanimal feed should be established within Annex I of thesaid Directive in order to prevent undesirable andharmful effects.
(7) Where MRLs have been laid down in the frame ofCouncil Regulation (EEC) No 2377/90 of 26 June1990 laying down a Community procedure for the estab­lishment of maximum residue limits of veterinarymedicinal products in foodstuffs of animal origin (
4)o r
in the frame of Regulation (EC) No 1831/2003,compliance with those provisions should be ensuredwhen establishing maximum levels of unavoidablecarry-over of coccidiostats or histomonostats in non-target feed.
(8) The occurrence of unavoidable carry-over of coccidiostatsand histomonostats in non-target feed, even belowmaximum levels that should be set under Directive
2002/32/EC, may result in the presence of residues of
these substances in food products of animal origin.Therefore, in order to protect public health, and insofarthere is no maximum residue limit (MRL) yet fixed forthe specific food concerned, maximum tolerances for thepresence of active substances contained in coccidiostatsand histomonostats have been established byCommission Regulation (EC) No 124/2009 of10 February 2009 setting maximum levels for thepresence of coccidiostats or histomonostats in foodresulting from the unavoidable carry-over of thesesubstances in non-target feed (
5), in the context of
Council Regulation (EEC) No 315/93 of 8 February1993 laying down Community procedures forcontaminants in food (
6).
(9) On a request from the Commission, the European FoodSafety Authority (the Authority) adopted severalopinions (
7) 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, the
Authority ’s assessment took into account hypothetical
carry-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.
(10) Considering the conclusions of the individual scientificopinions, 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 inproducts from animals exposed to cross-contaminatedfeed is negligible.
(11) Taking into account the Authority ’s opinions and the
currently different approaches applied in the MemberStates to address the unavoidable cross-contamination,it is proposed to set maximum levels for feed as laiddown in the Annexes to this Directive, in order toensure a proper functioning of the internal market andto protect animal and public health.
(12) The establishment of maximum levels of undesirablesubstances in animal feed should take place through anadaptation of Annex I of Directive 2002/32/EC, asprovided for in Article 8(1) of that Directive. Whenadapting the technical provisions in Annex I of
Directive 2002/32/EC, developments in scientific and
technical knowledge have been taken into accountthrough the consideration of scientific opinions of theAuthority and of the development of analyticalmethods in feed. The provisions provided in Annexshould be reviewed by 1 July 2011 at the latest totake account of developments in scientific and technicalknowledge.
(13) The maximum levels set in the Annex to this Directiveshould be continuously adapted to the conditions of useprovided for in the authorisations of coccidiostats andhistomonostats as feed additives. In view of the
occurrence of a possible time gap between the authoris­
ation –or modification, suspension or revocation of the
authorisation –of a coccidiostat or histomonostat as feed
additive and the consequent amendment to themaximum levels laid down in the Annexes to thisDirective, the latter should be considered as withoutprejudice to the levels of coccidiostats or histomonostatsauthorised as feed additives in the frame of Regulation(EC) No 1831/2003.EN L 40/20 Official Journal of the European Union 11.2.2009(14) Due to the fact that the unavoidable carry-over of cocci­
diostats 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 Directive setting maximum levels for theunavoidable carry-over of coccidiostats or histomonostats
into non-target feed and the Commission Regulation
setting maximum levels for the resulting presence ofthese substances in food.
(15) The measures provided for in this Directive are inaccordance with the opinion of the StandingCommittee on the Food Chain and Animal Health,
HAS ADOPTED THIS DIRECTVE:
Article 1
Annex I to Directive 2002/32/EC is amended in accordance
with the Annex to this Directive.
Article 2
Member States shall bring into force the laws, regulations and
administrative provisions necessary to comply with thisDirective by 1 July 2009 at the latest. They shall forthwith
communicate to the Commission the text of those provisionsand a correlation table between those provisions and thisDirective. When Member States adopt those provisions, theyshall contain a reference to this Directive or be accompaniedby such a reference on the occasion of their official publication.Member States shall determine how such reference is to bemade.
Article 3
This Directive shall enter into force on the 20
thday following
that of its publication in the Official Journal of the European
Union .
Article 4
This Directive is addressed to the Member States.
Done at Brussels, 10 February 2009.
For the Commission
Androulla VASSILIOU
Member of the CommissionEN 11.2.2009 Official Journal of the European Union L 40/21(1) OJ L 140, 30.5.2002, p. 10.
(2) OJ L 268, 18.10.2003, p. 29.
(3) OJ L 35, 8.2.2005, p. 1.
(4) OJ L 224, 18.8.1990, p. 1.
(5) See page 7 of this Official Journal.
(6) OJ L 37, 13.2.1993, p. 1.
(7) 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 oncross-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=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 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 on
cross-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 oncross-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=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 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 on
cross-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 L 40/22 Official Journal of the European Union 11.2.2009ANNEX
The following points are added in Annex I to Directive 2002/32/EC:
‘Undesirable substances Products intended for animal feed (*)Maximum content in
mg/kg (ppm) relative to a
feedingstuff with a
moisture content of 12 %
1. Lasalocid sodium Feed materials 1,25
Compound feed for—dogs, calves, rabbits, equine species, dairy animals, laying birds,
turkeys (> 12 weeks) and chickens reared for laying (> 16weeks);1,25
—chickens for fattening, chickens reared for laying (< 16 weeks)
and turkeys (< 12 weeks) for the period before slaughter inwhich the use of lasalocid sodium is prohibited (withdrawal
feed);1,25
—other animal species. 3,75
Premixtures for use in feed in which the use of lasalocid sodium is
not authorised.(**)
2. Narasin Feed materials 0,7
Compound feed for—turkeys, rabbits, equine species, laying birds and chickens reared
for laying (> 16 weeks);0,7
—chickens for fattening for the period before slaughter in which
the use of narasin is prohibited (withdrawal feed);0,7
—other animal species. 2,1
Premixtures for use in feed in which the use of narasin is not
authorised.(**)
3. Salinomycin
sodiumFeed materials 0,7
Compound feed for—equine species, turkeys, laying birds and chickens reared for
laying (> 12 weeks);0,7
—chickens for fattening, chickens reared for laying (< 12 weeks)
and rabbits for fattening for the period before slaughter in which
the use of salinomycin sodium is prohibited (withdrawal feed);0,7
—other animal species. 2,1
Premixtures for use in feed in which the use of salinomycin sodium
is not authorised.(**)
4. Monensin sodium Feed materials 1,25
Compound feed for—equine species, dogs, small ruminants (sheep and goat), ducks,
bovine, dairy cattle, laying birds, chickens reared for laying (> 16weeks) and turkeys (> 16 weeks);1,25
—chickens for fattening, chickens reared for laying (< 16 weeks)
and turkeys (< 16 weeks) for the period before slaughter in
which the use of monensin sodium is prohibited (withdrawal
feed);1,25
—other animal species. 3,75
Premixtures for use in feed in which the use of monensin sodium is
not authorised.(**)EN 11.2.2009 Official Journal of the European Union L 40/23Undesirable substances Products intended for animal feed (*)Maximum content in
mg/kg (ppm) relative to a
feedingstuff with a
moisture content of 12 %
5. Semduramicin
sodiumFeed materials 0,25
Compound feed for
—laying birds and chickens reared for laying (> 16 weeks); 0,25
—chickens for fattening for the period before slaughter in which
the use of semduramicin sodium is prohibited (withdrawal feed);0,25
—other animal species. 0,75
Premixtures for use in feed in which the use of semduramicin
sodium is not authorised.(**)
6. Maduramicin
ammonium alphaFeed materials 0,05
Compound feed for—equine species, rabbits, turkeys (> 16 weeks), laying birds and
chickens reared for laying (> 16 weeks);0,05
—chickens for fattening and turkeys (< 16 weeks) for the period
before slaughter in which the use of maduramicin ammoniumalpha is prohibited (withdrawal feed);0,05
—other animal species. 0,15
Premixtures for use in feed in which the use of maduramicin
ammonium alpha is not authorised.(**)
7. Robenidine
hydrochlorideFeed materials 0,7
Compound feed for
—laying birds and chickens reared for laying (> 16 weeks); 0,7
—chickens for fattening, rabbits for fattening and breeding and
turkeys for the period before slaughter in which the use ofrobenidine hydrochloride is prohibited (withdrawal feed);0,7
—other animal species. 2,1
Premixtures for use in feed in which the use of robenidine hydro­
chloride is not authorised.(**)
8. Decoquinate Feed materials 0,4
Compound feed for
—laying birds and chickens reared for laying (> 16 weeks); 0,4
—chickens for fattening for the period before slaughter in which
the use of decoquinate is prohibited (withdrawal feed);0,4
—other animal species. 1,2
Premixtures for use in feed in which the use of decoquinate is not
authorised.(**)
9. Halofuginone
hydrobromideFeed materials 0,03
Compound feed for—laying birds, chickens reared for laying (> 16 weeks) and turkeys
(> 12 weeks);0,03
—chickens for fattening and turkeys (< 12 weeks) for the period
before slaughter in which the use of halofuginone hydrobromideis prohibited (withdrawal feed);0,03
—other animal species other than chickens reared for laying (< 16
weeks).0,09
Premixtures for use in feed in which the use of halofuginone hydro­
bromide is not authorised.(**)EN L 40/24 Official Journal of the European Union 11.2.2009Undesirable substances Products intended for animal feed (*)Maximum content in
mg/kg (ppm) relative to a
feedingstuff with a
moisture content of 12 %
10. Nicarbazin Feed materials 0,5
Compound feed for
—equine species, laying birds and chickens reared for laying (> 16
weeks);0,5
—chickens for fattening for the period before slaughter in which
the use of nicarbazin (in combination with narasin) is prohibited
(withdrawal feed);0,5
—other animal species. 1,5
Premixtures for use in feed in which the use of nicarbazin (in
combination with narasin) is not authorised.(**)
11. Diclazuril Feed materials 0,01
Compound feed for
—laying birds, chickens reared for laying (> 16 weeks) and turkeys
for fattening (> 12 weeks);0,01
—rabbits for fattening and breeding for the period before slaughter
in which the use of diclazuril is prohibited (withdrawal feed);0,01
—other animal species other than chickens reared for laying (< 16
weeks), chickens for fattening and turkeys for fattening (< 12
weeks).0,03
Premixtures for use in feed in which the use of diclazuril is not
authorised.(**)
(*) Without prejudice to the authorised levels in the frame 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.
(**) The maximum level of the substance in the premixture is the concentration which shall not result in a level of the substance higher
than 50 % of the maximum levels established in the feed when the instructions for use of the premixture are followed. ’EN 11.2.2009 Official Journal of the European Union L 40/25