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

11.2.2009

EN

Official Journal of the European Union

L 40/19

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,

(3)

Having regard to the Treaty
Community,

establishing the European

Having regard to Directive 2002/32/EC of
the European
Parliament and of the Council of 7 May 2002 on undesirable
feed (1), and in particular Article 8(1)
substances in animal
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

(4)

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.

the

facilities

concerning

European
Regulation (EC) No 183/2005 of
Parliament and of
the Council of 12 January 2005
laying down requirements for feed hygiene (3) provides
for specific requirements for feed businesses using cocci­
diostats and histomonostats in the production of feed. In
the operators concerned have to take all
particular,
appropriate measures
and
equipment, production, storage and transport in order
to avoid any cross-contamination, and this in accordance
with the obligations provided for in Articles 4 and 5 of
the above mentioned Regulation. The establishment of
maximum levels of unavoidable carry-over of cocci­
diostats
feed in
accordance with Directive 2002/32/EC should not
interfere with the primary obligation of operators to
apply good manufacturing practices aiming at avoiding
this cross-contamination. Continued effort is therefore
still needed by the operators concerned in order to
avoid the presence of such undesirable substances in
animal feed.

and histomonostats

in non-target

rate of

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 the
purpose of enabling the feed manufacturer to manage
the above mentioned unavoidable carry-over, a carry-
approximately 3 % compared to the
over
authorised maximum content should be considered as
regards feed for less sensitive non-target animal species,
while a carry-over rate of approximately 1 % compared
to the authorised maximum content should be retained
for feed intended to sensitive non-target animal species
and ‘withdrawal feed’, i.e. feed used for the period before
slaughter. The carry-over rate of 1 % should also be
considered for cross-contamination of other feed for
target species to which no coccidiostats or histomo­
nostats are added, and as regards non-target feed for
‘continuous
such as dairy
cows or laying hens, where there is evidence of transfer
from feed to food of animal origin. If feed materials are
fed directly to the animals or if complementary feeding­
stuffs are used, their use in a daily ration should not lead
to the animal being exposed to a higher levels of an
coccidiostat or histomonostat
than the corresponding
maximum levels of exposure where only complete
feedingstuffs are used in a daily ration.

food-producing animals’,

L 40/20

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Official Journal of the European Union

11.2.2009

(5)

(6)

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

in animal

The unavoidable carry-over in non-target feed of active
substances contained in authorised coccidiostats and
histomonostats
should be considered as undesirable
feed within the meaning of
substances
Directive 2002/32/EC and their presence should not
endanger animal health, human health or the environ­
ment. Therefore, maximum levels for these substances in
animal feed should be established within Annex I of the
to prevent undesirable and
said Directive in order
harmful effects.

(7) Where MRLs have been laid down in the frame of
Council Regulation (EEC) No 2377/90 of 26 June
1990 laying down a Community procedure for the estab­
limits of veterinary
lishment of maximum residue
medicinal products in foodstuffs of animal origin (4) or
in the
frame of Regulation (EC) No 1831/2003,
compliance with those provisions should be ensured
when establishing maximum levels of unavoidable
carry-over of coccidiostats or histomonostats in non-
target feed.

(8)

The occurrence of unavoidable carry-over of coccidiostats
and histomonostats
feed, even below
in non-target
maximum 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 insofar
there is no maximum residue limit (MRL) yet fixed for
the specific food concerned, maximum tolerances for the
presence of active substances contained in coccidiostats
by
and
have
established
of
Commission
124/2009
for
10 February 2009 setting maximum levels
the
in food
presence of coccidiostats or histomonostats
these
resulting from the unavoidable carry-over of
in the context of
substances
Council Regulation (EEC) No 315/93 of 8 February
1993
for
laying
contaminants in food (6).

histomonostats

in non-target

Community

procedures

Regulation

(EC) No

feed (5),

down

been

(9)

On a request from the Commission, the European Food
Safety Authority
several
(the Authority)
opinions (7) 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

adopted

(10)

(11)

(12)

(13)

feed additive,

authorised as

the
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.

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 feed as laid
down in the Annexes to this Directive,
in order to
ensure a proper functioning of the internal market and
to protect animal and public health.

technical provisions

The establishment of maximum levels of undesirable
substances in animal feed should take place through an
adaptation of Annex I of Directive 2002/32/EC, as
that Directive. When
provided for in Article 8(1) of
adapting the
in Annex I of
Directive 2002/32/EC, developments in scientific and
technical knowledge have been taken into account
through the consideration of scientific opinions of the
Authority
analytical
methods in feed. The provisions provided in Annex
should be reviewed by 1 July 2011 at
to
take account of developments in scientific and technical
knowledge.

development of

the latest

and of

the

as

In view of

The maximum levels set in the Annex to this Directive
should be continuously adapted to the conditions of use
provided for in the authorisations of coccidiostats and
the
feed additives.
histomonostats
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
to the
consequent
additive
maximum levels laid down in the Annexes to this
Directive,
the latter should be considered as without
prejudice to the levels of coccidiostats or histomonostats
authorised as feed additives in the frame of Regulation
(EC) No 1831/2003.

amendment

and

the

11.2.2009

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Official Journal of the European Union

L 40/21

in

of

the

these

substances

(14) 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
of
the
unavoidable carry-over of coccidiostats or histomonostats
into non-target
feed and the Commission Regulation
setting maximum levels for the resulting presence of
these substances in food.

setting maximum levels

this Directive

for

(15)

The measures provided for
accordance with
Committee on the Food Chain and Animal Health,

in this Directive are in
Standing
the

opinion

the

of

Directive by 1 July 2009 at the latest. They shall forthwith
communicate to the Commission the text of those provisions
and a correlation table between those provisions and this
Directive. When Member States adopt those provisions, they
shall contain a reference to this Directive or be accompanied
by such a reference on the occasion of their official publication.
Member States shall determine how such reference is to be
made.

Article 3

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

its publication in the Official

Journal of

Article 4

HAS ADOPTED THIS DIRECTVE:

This Directive is addressed to the Member States.

Article 1

Annex I to Directive 2002/32/EC is amended in accordance
with the Annex to this Directive.

Done at Brussels, 10 February 2009.

Article 2

Member States shall bring into force the laws, regulations and
to comply with this
administrative provisions necessary

For the Commission

Androulla VASSILIOU
Member of the Commission

L 40/22

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Official Journal of the European Union

11.2.2009

(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=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

11.2.2009

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Official Journal of the European Union

L 40/23

The following points are added in Annex I to Directive 2002/32/EC:

ANNEX

‘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

Compound feed for

— dogs, calves, rabbits, equine species, dairy animals, laying birds,
turkeys (> 12 weeks) and chickens reared for laying (> 16
weeks);

— chickens for fattening, chickens reared for laying (< 16 weeks)
and turkeys (< 12 weeks) for the period before slaughter in
which the use of
lasalocid sodium is prohibited (withdrawal
feed);

— other animal species.

Premixtures for use in feed in which the use of lasalocid sodium is
not authorised.

2. Narasin

Feed materials

Compound feed for

— turkeys, rabbits, equine species, laying birds and chickens reared

for laying (> 16 weeks);

— chickens for fattening for the period before slaughter in which

the use of narasin is prohibited (withdrawal feed);

— other animal species.

Premixtures for use in feed in which the use of narasin is not
authorised.

3. Salinomycin
sodium

Feed materials

Compound feed for

— equine species, turkeys,
laying (> 12 weeks);

laying birds and chickens reared for

— 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);

— other animal species.

Premixtures for use in feed in which the use of salinomycin sodium
is not authorised.

4. Monensin sodium

Feed materials

Compound feed for

— equine species, dogs, small ruminants (sheep and goat), ducks,
bovine, dairy cattle, laying birds, chickens reared for laying (> 16
weeks) and turkeys (> 16 weeks);

— 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);

— other animal species.

Premixtures for use in feed in which the use of monensin sodium is
not authorised.

1,25

1,25

1,25

3,75

(**)

0,7

0,7

0,7

2,1

(**)

0,7

0,7

0,7

2,1

(**)

1,25

1,25

1,25

3,75

(**)

L 40/24

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Official Journal of the European Union

11.2.2009

Undesirable substances

Products intended for animal feed (*)

5. Semduramicin

Feed materials

sodium

Compound feed for
— laying birds and chickens reared for laying (> 16 weeks);
— chickens for fattening for the period before slaughter in which
the use of semduramicin sodium is prohibited (withdrawal feed);

— other animal species.

Premixtures for use in feed in which the use of semduramicin
sodium is not authorised.

6. Maduramicin

Feed materials

ammonium alpha

7. Robenidine

hydrochloride

Compound feed for
— equine species, rabbits, turkeys (> 16 weeks), laying birds and

chickens reared for laying (> 16 weeks);

— chickens for fattening and turkeys (< 16 weeks) for the period
before slaughter in which the use of maduramicin ammonium
alpha is prohibited (withdrawal feed);

— other animal species.

Premixtures for use in feed in which the use of maduramicin
ammonium alpha is not authorised.

Feed materials

Compound feed for
— laying birds and chickens reared for laying (> 16 weeks);
— chickens for fattening, rabbits for fattening and breeding and
turkeys for the period before slaughter in which the use of
robenidine hydrochloride is prohibited (withdrawal feed);

— other animal species.

Premixtures for use in feed in which the use of robenidine hydro­
chloride is not authorised.

8. Decoquinate

Feed materials

9. Halofuginone
hydrobromide

Compound feed for
— laying birds and chickens reared for laying (> 16 weeks);
— chickens for fattening for the period before slaughter in which

the use of decoquinate is prohibited (withdrawal feed);

— other animal species.

Premixtures for use in feed in which the use of decoquinate is not
authorised.

Feed materials

Compound feed for
— laying birds, chickens reared for laying (> 16 weeks) and turkeys

(> 12 weeks);

— chickens for fattening and turkeys (< 12 weeks) for the period
before slaughter in which the use of halofuginone hydrobromide
is prohibited (withdrawal feed);

— other animal species other than chickens reared for laying (< 16

weeks).

Premixtures for use in feed in which the use of halofuginone hydro­
bromide is not authorised.

Maximum content in
mg/kg (ppm) relative to a
feedingstuff with a
moisture content of 12 %

0,25

0,25

0,25

0,75

(**)

0,05

0,05

0,05

0,15

(**)

0,7

0,7

0,7

2,1

(**)

0,4

0,4

0,4

1,2

(**)

0,03

0,03

0,03

0,09

(**)

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Official Journal of the European Union

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Undesirable substances

Products intended for animal feed (*)

10. Nicarbazin

Feed materials

Compound feed for
— equine species, laying birds and chickens reared for laying (> 16

weeks);

— chickens for fattening for the period before slaughter in which
the use of nicarbazin (in combination with narasin) is prohibited
(withdrawal feed);
— other animal species.

Premixtures for use in feed in which the use of nicarbazin (in
combination with narasin) is not authorised.

11. Diclazuril

Feed materials

Compound feed for
— laying birds, chickens reared for laying (> 16 weeks) and turkeys

for fattening (> 12 weeks);

in which the use of diclazuril

— rabbits for fattening and breeding for the period before slaughter
is prohibited (withdrawal feed);
— other animal species other than chickens reared for laying (< 16
weeks), chickens for fattening and turkeys for fattening (< 12
weeks).

Premixtures for use in feed in which the use of diclazuril
authorised.

is not

Maximum content in
mg/kg (ppm) relative to a
feedingstuff with a
moisture content of 12 %

0,5

0,5

0,5

1,5

(**)

0,01

0,01

0,01

0,03

(**)

(*) 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.’