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)
Date: 2009-02-10
Institutions: European Commission
Subjects: animal nutrition, food additive, food industry, food inspection, marketing standard, traceability

11.2.2009

EN

Official Journal of the European Union

L 40/7

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
Community,

establishing the European

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)

(2)

Coccidiostats and histomonostats are substances intended
inter alia, be
to kill or inhibit protozoa, which may,
authorised for use as feed additives in accordance with
Regulation (EC) No 1831/2003 of
the European
Parliament and of the Council of 22 September 2003
on additives for use in animal nutrition (2). Authoris­
ations of
feed
additives lay down specific conditions for use such as
the target animal species or categories for which the
additives are intended.

coccidiostats and histomonostats as

Feed business operators may produce within one estab­
lishment a broad range of feeds and different types of
products may have to be manufactured after each other
in the same production line.
It may happen that
unavoidable traces of a product remain in the production
line and end up in the beginning of the production of
another feed product. This transfer from one production
lot 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 traces
of those substances in ‘non-target feed’, i.e. in feed for
which the use of coccidiostats or histomonostats are not
authorised, such as feed intended for animal species or
categories not provided for in the additive authorisation.
This unavoidable cross-contamination may occur at all
stages of production and processing of
feed but also
during storage and transport of feed.

(3)

In order to prevent the adoption by Member States of
national rules addressing the issue of unavoidable carry-

(4)

(5)

(6)

over of authorised coccidiostats or histomonostats in
non-target feed and their resulting presence in derived
foodstuffs, which would hinder the functioning of the
internal market,
is necessary to adopt harmonised
Community rules in this matter.

it

The unavoidable carry-over in non-target feed of active
substances contained in authorised coccidiostats and
histomonostats are considered as undesirable substances
feed within the meaning of Directive
in animal
2002/32/EC of
the
the European Parliament and of
Council (3) and their presence should not endanger
environment.
animal health, human health or
Therefore, maximum levels
in
for
feed are established by Commission Directive
animal
2009/8/EC (4)
to Directive
2002/32/EC.

amending Annex

these substances

the

I

fixed for

(MRL) yet

The occurrence of unavoidable carry-over of coccidiostats
and histomonostats
feed, even below
in non-target
maximum levels 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 insofar there is no maximum
residue limit
the specific food
concerned in the frame of Council Regulation (EEC) No
2377/90 of 26 June 1990 laying down a Community
procedure for the establishment of maximum residue
limits of veterinary medicinal products in foodstuffs of
animal origin (5) or in the frame of Regulation (EC) No
1831/2003, maximum tolerances for the presence of
active substances contained in coccidiostats and histomo­
nostats should be established in food of animal origin
originating from the non-target feed concerned,
in the
context of Regulation (EEC) No 315/93 laying down
Community procedures for contaminants in food.

adopted

On a request from the Commission, the European Food
(‘the Authority’)
Safety Authority
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 as
feed additives into non-target feed. For each coccidiostat
the
authorised as
or histomonostat
Authority's assessment
took into account hypothetical
carry-over
rates of 2 %, 5 % and 10 % from feed
produced with the highest authorised dose of the cocci­
diostats or histomonostats into the afterwards produced
non-target feed.

feed additive,

L 40/8

EN

Official Journal of the European Union

11.2.2009

(7)

(8)

(9)

Considering the conclusions of the individual scientific
opinions,
it can be stated that generally the Authority
concluded that the presence of the coccidiostats or histo­
monostats authorised as feed additives, in non-target feed
at levels resulting from an unavoidable carry-over, and
taking into account all prevention measures, is unlikely
to result in adverse animal health effects and that the risk
to consumers' health from the ingestion of residues in
products from animals exposed to cross-contaminated
feed is negligible.

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 laid
down in the Annexes to this Regulation,
in order to
ensure a proper functioning of the internal market and
to protect public health. The provisions provided in
Annex should be reviewed by 1 July 2011 at the latest
in scientific and
to take account of developments
technical knowledge.

The maximum levels set in the Annex to this Regulation
should be continuously adapted to changes of maximum
residue levels (MRL) established for the specific food
concerned in the
frame of Regulation (EEC) No
2377/90 laying down a Community procedure for the
establishment of maximum residue limits of veterinary
medicinal products in foodstuffs of animal origin or in
the frame of Regulation (EC) No 1831/2003. In view of
the occurrence of a possible time gap between these
amendments and the consequent adaptation to the
maximum levels laid down in the Annex to this Regu­
should be considered as without
lation,
prejudice to the maximum residue levels of coccidiostats
or histomonostats established in the frame of Regulation
(EEC) No 2377/90 or in the frame of Regulation (EC) No
1831/2003.

the latter

(10) Due to the fact that the unavoidable carry-over of cocci­
feed may
diostats or histomonostats into non-target
result
as
presence
contaminants in derived food, it is appropriate to take
a comprehensive and integrated approach to address the
issue through the simultaneous adoption and application

substances

these

the

of

in

of this Regulation and the Directive 2009/8/EC setting
maximum levels for the unavoidable carry-over of cocci­
diostats or histomonostats into non-target feed.

(11)

The measures provided for in this Regulation are in
Standing
accordance with
Committee on the Food Chain and Animal Health,

opinion

the

the

of

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 contaminant
listed in this Annex at a level exceeding the maximum levels
set 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 competent
authority to carry out investigations to confirm that the residue
is present as a consequence of unavoidable carry over in the
feed 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 these
maximum 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, changes
of
the contaminant caused by drying,
diluting or processing, as well as the relative proportion of
the ingredients in the product, shall be taken into account.

the concentration of

The maximum levels established in Annex to this Regu­
3.
lation are without prejudice to the provisions and the MRLs
established by Regulation (EEC) No 2377/90 and the MRLs
established by Regulation (EC) No 1831/2003.

Article 2

This Regulation shall enter into force on the 20th day following
the European
that of
Union.

its publication in the Official

Journal of

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 Commission

11.2.2009

EN

Official Journal of the European Union

L 40/9

(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=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 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=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 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 on
cross-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=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 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=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 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=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 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 on
cross-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=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 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=true

L 40/10

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Official Journal of the European Union

11.2.2009

ANNEX

Maximum levels in foodstuffs

Substance

Foodstuffs

Maximum content
in μg/kg (ppb) wet
weight

1. Lasalocid sodium

Food of animal origin from animal species other than poultry:

— milk;

— liver and kidney;

— other food,

2. Narasin

Food of animal origin from animal species other than chickens for
fattening:

— eggs;

— milk;

— liver;

— other food.

3. Salinomycin sodium

Food of animal origin from animal species other than chickens for
fattening and rabbits for fattening:

— eggs;

— liver;

— other food.

4. Monensin sodium

Food of animal origin from animal species other than chickens for
fattening, turkeys and bovine (including dairy cattle):

— liver;

— other food.

5. Semduramicin

6. Maduramicin

7. Robenidine

Food of animal origin from animal species other than chickens for
fattening.

Food of animal origin from animal species other than chickens for
fattening and turkeys.

Food of animal origin from animal species other than chickens for
fattening, turkey and rabbits for fattening and breeding:

— eggs;

— liver, kidney, skin and fat;

— other food.

8. Decoquinate

9. Halofuginone

Food of animal origin from animal species other than chickens for
fattening, bovine and ovine except dairy animals.

Food of animal origin from animal species other than chickens for
fattening, turkeys and bovine except dairy cattle:

— eggs;

— liver and kidney;

— milk;

— other food.

1

50

5

2

1

50

5

3

5

2

8

2

2

2

25

50

5

20

6

30

1

3

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Official Journal of the European Union

L 40/11

Substance

Foodstuffs

Maximum content
in μg/kg (ppb) wet
weight

10. Nicarbazin

Food of animal origin from animal species other than chickens for
fattening:

— eggs;

— milk;

— liver and kidney;

— other food.

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;

— liver and kidney;

— other food.

100

5

100

25

2

40

5