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7.5.2013 Official
Journal
of
the
European
Union L
125/7
COMMISSION REGULATION (EU) No 415/2013
of 6 May 2013
laying down additional responsibilities and tasks for the EU reference laboratories for rabies, bovine
tuberculosis and bee health, amending Regulation (EC) No 737/2008 and repealing Regulation (EU)
No 87/2011
(Text with EEA relevance)
THE EUROPEAN COMMISSION,
(4) By
Commission
Regulation
(EU)
No
87/2011
of
2 February 2011 designating the EU reference laboratory
for bee health, laying down additional responsibilities
Having regard to the Treaty on the Functioning of the European
and tasks for that laboratory and amending Annex VII
Union,
to Regulation (EC) No 882/2004 of the European
Parliament and of the Council ( 3 ), the Commission
designated the EU reference laboratory for bee health
and, consequently, inserted the relevant entry concerning
Having regard to Regulation (EC) No 882/2004 of the European
that laboratory in Annex VII to Regulation (EC) No
Parliament and of the Council of 29 April 2004 on official
882/2004. In addition, the Annex to Regulation (EU)
controls performed to ensure the verification of compliance
No 87/2011 sets out certain specific responsibilities
with feed and food law, animal health and welfare rules ( 1 ),
and tasks linked to the characteristics of the agents
and in particular Article 32(6) thereof,
liable to affect bee health. Those responsibilities and
tasks are additional to those laid down in Regulation
(EC) No 882/2004.
Whereas:
(5) The definition of certain tasks of the EU reference
(1) Regulation
(EC)
No
882/2004
lays
down
the
general
laboratory for bee health in the Annex to Regulation
functions and duties for the EU reference laboratories
(EU) No 87/2011 needs to be amended as regards sero
for food and feed and for animal health set out in
logical tests because they are not applicable to testing on
Annex VII thereto. In addition, Regulation (EC) No
bees. As well the mention of colony collapse disorder
882/2004 provides that the Commission may include
(CCD) should be modified in order to ensure consistency
in Annex VII thereto other EU reference laboratories
with the terminology used in the surveillance studies on
relevant to the areas falling within the scope of that
bee mortality established in Commission Implementing
Regulation.
Decision 2012/362/EU ( 4 ).
(2) Regulation
(EC)
No
882/2004
also
provides
that,
in (6) In
the
interest
of
clarity
and
simplification
of
Union
addition to the general functions and duties of EU
legislation, it is appropriate that the provisions
reference laboratories in the animal health sector laid
concerning those additional responsibilities and tasks of
down therein, additional responsibilities and tasks for
the EU reference laboratories for rabies, bovine tuber
those EU reference laboratories may be laid down by
culosis and bee health be set out in only one act.
the Commission.
(7) Regulation
(EC)
No
737/2008
should
therefore
be
(3) By
Commission
Regulation
(EC)
No
737/2008
of
28
July
amended accordingly and Regulation (EU) No 87/2011
2008 designating the Community reference laboratories
be repealed.
for crustacean diseases, rabies and bovine tuberculosis,
laying down additional responsibilities and tasks for the
Community reference laboratories for rabies and bovine
(8) The
measures
provided
for
in
this
Regulation
are
in
tuberculosis and amending Annex VII to Regulation (EC)
accordance with the opinion of the Standing
No 882/2004 of the European Parliament and of the
Committee on the Food Chain and Animal Health,
Council ( 2 ), the Commission designated, inter alia, the
EU reference laboratories for rabies and bovine tuber
culosis and, consequently, inserted the relevant entries
HAS ADOPTED THIS REGULATION:
concerning those laboratories in Annex VII to Regulation
(EC) No 882/2004. In addition, Annexes I and II to
Regulation (EC) No 737/2008 set out certain specific
Article 1
responsibilities and tasks linked to the characteristics of
the pathogens. Those responsibilities and tasks are
In addition to the general functions and duties of EU reference
additional to those laid down in Regulation (EC) No
laboratories in the animal health sector laid down in
882/2004.
Article 32(2) of Regulation (EC) No 882/2004, the EU
( 1 ) OJ L 165, 30.4.2004, p. 1.
( 3 ) OJ L 29, 3.2.2011, p. 1.
( 2 ) OJ L 201, 30.7.2008, p. 29.
( 4 ) OJ L 176, 6.7.2012, p. 65.

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L 125/8
EN
Official Journal of the European Union
7.5.2013
reference laboratory for rabies set out in point 16 of Part II of
Article 4
Annex VII to that Regulation shall also have the responsibilities
and tasks set out in Annex I to this Regulation.
Regulation (EC) No 737/2008 is amended as follows:
Article 2
(1) Articles 2 and 3 are deleted;
In addition to the general functions and duties of EU reference
laboratories in the animal health sector laid down in
(2) Annexes I and II are deleted.
Article 32(2) of Regulation (EC) No 882/2004, the EU
reference laboratory for bovine tuberculosis set out in point
17 of Part II of Annex VII to that Regulation shall also have
Article 5
the responsibilities and tasks set out in Annex II to this Regu
Regulation (EU) No 87/2011 is repealed.
lation.
References to the repealed Regulation shall be construed as
Article 3
references to this Regulation.
In addition to the general functions and duties of EU reference
laboratories in the animal health sector laid down in
Article 6
Article 32(2) of Regulation (EC) No 882/2004, the EU
reference laboratory for bee health set out in point 18 of Part
This Regulation shall enter into force on the twentieth day
II of Annex VII to that Regulation shall also have the respon
following that of its publication in the Official Journal of the
sibilities and tasks set out in Annex III to this Regulation.
European Union.
This Regulation shall be binding in its entirety and directly applicable in all Member States.
Done at Brussels, 6 May 2013.
For the Commission
The President
José Manuel BARROSO

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EN
7.5.2013 Official
Journal
of
the
European
Union L
125/9
ANNEX I
Responsibilities and tasks of the EU reference laboratory for rabies, additional to those laid down in
Article 32(2) of Regulation (EC) No 882/2004
1. The EU reference laboratory for rabies shall coordinate, in consultation with the Commission, the methods employed
in the Member States for diagnosing rabies, in particular by:
(a) typing, storing and supplying strains of rabies virus;
(b) preparing, controlling and supplying international standard sera and other reference reagents to the national
reference laboratories in order to standardise the tests and reagents used in the Member States;
(c) validating reference reagents including antigens and national standard sera submitted by the national reference
laboratories;
(d) building up and maintaining a sera bank and a collection of rabies virus, and maintaining a database of strains
isolated across the Union, including typing;
(e) organising periodical comparative tests of diagnostic procedures at Union level and operating laboratory profi
ciency tests of national reference laboratories;
(f) collecting and collating data and information on the methods of diagnosis used and the results of tests carried out
in the Union;
(g) characterising rabies virus by the most up-to-date methods available to allow a greater understanding of the
epidemiology of that disease;
(h) keeping abreast of developments in rabies surveillance, epidemiology and prevention throughout the world;
(i) acquiring a thorough knowledge of the preparation and use of the products of veterinary immunology used to
eradicate and control rabies including the evaluation of vaccines.
2. The EU reference laboratory for rabies shall also:
(a) facilitate the harmonisation of techniques throughout the Union, in particular by specifying standard test method
ologies;
(b) organise workshops for the benefit of national reference laboratories as agreed in the work programme and
estimated budget referred to in Article 2 of Commission Implementing Regulation (EU) No 926/2011 ( 1 ),
including training of experts from the Member States and, as appropriate, from third countries, in new analytical
methodologies;
(c) provide technical assistance to the Commission and, upon its request, participate in international forums relating
to rabies, concerning in particular the standardisation of analytical diagnostic methods and their implementation.
3. In addition, the EU reference laboratory for rabies shall perform research activities and, whenever possible, coordinate
research activities directed towards the improved control and eradication of rabies, in particular by:
(a) carrying out or collaborating with national reference laboratories in carrying out test validation trials;
(b) providing scientific advice to the Commission and collecting information and reports associated with the activities
of the EU reference laboratory.
( 1 ) OJ L 241, 17.9.2011, p. 2.

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L 125/10
EN
Official Journal of the European Union
7.5.2013
ANNEX II
Responsibilities and tasks of the EU reference laboratory for bovine tuberculosis, additional to those laid down
in Article 32(2) of Regulation (EC) No 882/2004
1. The EU reference laboratory for bovine tuberculosis shall coordinate, in consultation with the Commission, the
methods employed in the Member States for diagnosing bovine tuberculosis, in particular by:
(a) typing, storing and supplying strains of Mycobacterium sp. causing tuberculosis in animals;
(b) preparing, controlling and supplying reference reagents to the national reference laboratories in order to stan
dardise the tests and reagents used in the Member States;
(c) validating reference reagents including antigens and tuberculins submitted by the national reference laboratories for
bovine tuberculosis;
(d) building up and maintaining a collection of Mycobacterium sp. causing tuberculosis in animals, and maintaining a
database of strains isolated across the Union including typing;
(e) organising periodical comparative tests of diagnostic procedures at Union level and operating laboratory profi
ciency tests of national reference laboratories;
(f) collecting and collating data and information on the methods of diagnosis used and the results of tests carried out
in the Union;
(g) characterising Mycobacterium sp. causing tuberculosis in animals by the most up-to-date methods available to
allow a greater understanding of the epidemiology of that disease;
(h) keeping abreast of developments in bovine tuberculosis surveillance, epidemiology and prevention throughout the
world;
(i) acquiring a thorough knowledge of the preparation and use of the products of veterinary immunology used to
eradicate and control bovine tuberculosis including the evaluation of vaccines.
2. The EU reference laboratory for bovine tuberculosis shall also:
(a) facilitate the harmonisation of techniques throughout the Union, in particular by specifying standard test method
ologies;
(b) organise workshops for the benefit of national reference laboratories as agreed in the work programme and
estimated budget referred to in Article 2 of Implementing Regulation (EU) No 926/2011, including training of
experts from the Member States and, as appropriate, from third countries, in new analytical methodologies;
(c) provide technical assistance to the Commission and, upon its request, to participate in international forums
relating to the diagnostic of bovine tuberculosis, concerning in particular the standardisation of analytical diag
nostic methods and their implementation.
3. In addition, the EU reference laboratory for bovine tuberculosis shall perform research activities and, whenever
possible, coordinate research activities directed towards the improved control and eradication of bovine tuberculosis,
in particular by:
(a) carrying out or collaborating with national reference laboratories in carrying out test validation trials;
(b) providing scientific advice to the Commission and collecting information and reports associated with the activities
of the EU reference laboratory.

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EN
7.5.2013 Official
Journal
of
the
European
Union L
125/11
ANNEX III
Responsibilities and tasks of the EU reference laboratory for bee health, additional to those laid down in
Article 32(2) of Regulation (EC) No 882/2004
1. The EU reference laboratory for bee health shall coordinate, in consultation with the Commission, the methods
employed in the Member States for diagnosing the relevant bee diseases, as necessary, in particular by:
(a) typing, storing and, where appropriate, supplying strains of the pathogenic agents to facilitate the diagnostic
service in the Union;
(b) typing and antigenic and genomic characterisation of pathogenic agents, where relevant and necessary, for example
for epidemiological follow-ups or verification of diagnosis;
(c) supplying standard sera and other reference reagents to the national reference laboratories in order to standardise
the test and the reagents used in each Member State, where reference reagents are required;
(d) organising periodic comparative tests of diagnostic procedures at Union level with the national reference labora
tories, in order to provide information on the methods of diagnosis used and the result of the tests carried out in
the Union;
(e) retaining expertise on the Tropilaelaps mites and the small hive beetle (Aethina tumida) and other pertinent
pathogenic agents to enable rapid differential diagnosis;
(f) determining the identity of the causative pathogenic agents, where necessary in close collaboration with regional
reference laboratories designated by the World Organisation for Animal Health (OIE);
(g) building up and maintaining an up-to-date collection of pathogenic agents and their strains and an up-to-date
collection of other reagents against bee disease pathogens when or if available;
(h) carrying out an inventory of the currently used techniques in the various laboratories;
(i) proposing standardised tests and test procedures or reference reagents for internal quality control;
(j) advising the Commission on scientific aspects related to bee health.
2. The EU reference laboratory for bee health shall also:
(a) assist actively in the diagnosis of outbreaks of the relevant disease in Member States by receiving pathogen isolates
for confirmatory diagnosis, characterisation and epizootic studies and communicating without delay the results of
any investigations to the Commission, the Member States and the national reference laboratories concerned;
(b) facilitate the training or retraining of experts in laboratory diagnosis with a view to harmonising diagnostic
techniques throughout the Union;
(c) organise workshops for the benefit of national reference laboratories as agreed in the work programme and
estimated budget referred to in Article 2 of Regulation (EU) No 926/2011, including training of experts from
the Member States and, as appropriate, from third countries, in new analytical methodologies;
(d) provide technical assistance to the Commission and, at its request, participate in international forums concerning,
in particular, the standardisation of analytical methods and their implementation;
(e) develop monitoring activities and whenever possible coordinate activities directed towards an improvement of the
bee health status in the Union, in particular by:
(i) carrying out or collaborating with national reference laboratories concerned in carrying out test validation
trials;
(ii) providing scientific and technical support to the Commission and collecting information and reports
associated with the activities of the EU reference laboratory;
(iii) establishing and coordinating a survey on honeybee colony losses in the Union with regard to establishing a
baseline for ‘normal’ seasonal mortality of bees;
(f) collaborate with the relevant competent laboratories in third countries where those diseases are prevalent as
regards methods of diagnosing bee diseases;
(g) collaborate with the relevant regional laboratories designated by the OIE with regard to exotic diseases (Tropi
laelaps mites and the small hive beetle (Aethina tumida) and any other disease exotic to the Union);
(h) collate and forward information to the Commission and to national reference laboratories concerned on exotic and
endemic diseases or pests that are potentially emerging and could affect the Union, including honeybee colony
losses.

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L 125/12
EN
Official Journal of the European Union
7.5.2013
3. In addition, the EU reference laboratory for bee health shall:
(a) perform experiments and field trials, in consultation with the Commission, directed towards an improved control
of specific bee diseases;
(b) review at the annual meeting of national reference laboratories the relevant requirements for testing laid down in
the OIE Terrestrial Animal Health Code and Manual of Diagnostic Tests and Vaccines for Terrestrial Animals;
(c) assist the Commission in reviewing the OIE’s recommendations in the Terrestrial Animal Health Code and Manual
of Diagnostic Tests and Vaccines for Terrestrial Animals.

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