# L_2011029EN.01000101.xml

| 3.2.2011 | EN | Official Journal of the European Union | L 29/1 |
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3.2.2011

EN

Official Journal of the European Union

L 29/1

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COMMISSION REGULATION (EU) No 87/2011

of 2 February 2011

designating the EU reference laboratory for bee health, laying down additional responsibilities and tasks for that laboratory and amending Annex VII to Regulation (EC) No 882/2004 of the European Parliament and of the Council

THE EUROPEAN COMMISSION,

Having regard to the Treaty on the Functioning of the European Union,

Having regard to Regulation (EC) No 882/2004 of the European Parliament and of the Council of 29 April 2004 on official controls performed to ensure the verification of compliance with feed and food law, animal health and animal welfare rules (1), and in particular Article 32(5) and (6) thereof,

Whereas:

| (1) | Regulation (EC) No 882/2004 lays down the general tasks, duties and requirements for EU reference laboratories for food and feed and for animal health. The EU reference laboratories for animal health and live animals are listed in Part II of Annex VII to that Regulation. |
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(1)

Regulation (EC) No 882/2004 lays down the general tasks, duties and requirements for EU reference laboratories for food and feed and for animal health. The EU reference laboratories for animal health and live animals are listed in Part II of Annex VII to that Regulation.

| (2) | Following the completion of a selection procedure, the successful laboratory, Agence Nationale de Sécurité Sanitaire de l’alimentation, de l’environnement et du travail (ANSES), with its research laboratory for bee diseases, Sophia-Antipolis Laboratory, France, should be designated as the EU reference laboratory in the field of bee health, for a period of five years from 1 April 2011. |
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(2)

Following the completion of a selection procedure, the successful laboratory, Agence Nationale de Sécurité Sanitaire de l’alimentation, de l’environnement et du travail (ANSES), with its research laboratory for bee diseases, Sophia-Antipolis Laboratory, France, should be designated as the EU reference laboratory in the field of bee health, for a period of five years from 1 April 2011.

| (3) | In addition to the general functions and duties laid down in Article 32(2) of Regulation (EC) No 882/2004, certain specific responsibilities and tasks linked to the characteristics of agents liable to affect bee health should be carried out at Union level to ensure enhanced coordination. Therefore, these additional specific responsibilities and tasks of the EU reference laboratory in the field of bee health should be laid down in this Regulation. |
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(3)

In addition to the general functions and duties laid down in Article 32(2) of Regulation (EC) No 882/2004, certain specific responsibilities and tasks linked to the characteristics of agents liable to affect bee health should be carried out at Union level to ensure enhanced coordination. Therefore, these additional specific responsibilities and tasks of the EU reference laboratory in the field of bee health should be laid down in this Regulation.

| (4) | Part II of Annex VII to Regulation (EC) No 882/2004 should therefore be amended accordingly. |
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(4)

Part II of Annex VII to Regulation (EC) No 882/2004 should therefore be amended accordingly.

| (5) | The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee of the Food Chain and Animal Health, |
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(5)

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

HAS ADOPTED THIS REGULATION:

Article 1

Agence Nationale de Sécurité Sanitaire de l’alimentation, de l’environnement et du travail (ANSES) with its research laboratory for bee diseases, Sophia-Antipolis Laboratory, France, is hereby designated as the EU reference laboratory in the field of bee health from 1 April 2011 to 31 March 2016.

Certain responsibilities and tasks for that laboratory are set out in the Annex to this Regulation.

Article 2

In Part II of Annex VII to Regulation (EC) No 882/2004, the following point 18 is added:

| ‘18. | EU reference laboratory for bee health





  Agence Nationale de Sécurité Sanitaire de l’alimentation, de l’environnement et du travail |
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| Sophia-Antipolis Laboratory |
| Les Templiers |
| 105 route des Chappes |
| BP 111 |
| 06902 Sophia-Antipolis |
| France.’ |

‘18.

Agence Nationale de Sécurité Sanitaire de l’alimentation, de l’environnement et du travail

Sophia-Antipolis Laboratory

Les Templiers

105 route des Chappes

BP 111

06902 Sophia-Antipolis

France.’

Article 3

This Regulation shall enter into force on the 20th day following its publication in the Official Journal of the European Union.

This Regulation shall be binding in its entirety and directly applicable in all Member States.

Done at Brussels, 2 February 2011.

For the Commission

The President

José Manuel BARROSO

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(1)  
  OJ L 165, 30.4.2004, p. 1.

1

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ANNEX

Certain responsibilities and tasks of the EU reference laboratory for bee health

In addition to the general functions and duties of EU reference laboratories in the animal health sector pursuant to Article 32(2) of Regulation (EC) No 882/2004, the EU reference laboratory for bee health shall have the following responsibilities and tasks:

| 1. | 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; |
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1.

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; |
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(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 serological tests are required; |
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(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 serological tests are required;

| (d) | organising periodic comparative tests of diagnostic procedures at Union level with the national reference laboratories , in order to provide information on the methods of diagnosis used and the result of the tests carried out in the Union; |
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(d)

organising periodic comparative tests of diagnostic procedures at Union level with the national reference laboratories , 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; |
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(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); |
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(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 specific sera and other reagents against bee disease pathogens when or if available; |
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(g)

building up and maintaining an up-to-date collection of pathogenic agents and their strains and an up-to-date collection of specific sera and other reagents against bee disease pathogens when or if available;

| (h) | being entrusted to carry out an inventory of the currently used techniques in the various laboratories; |
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(h)

being entrusted to carry out an inventory of the currently used techniques in the various laboratories;

| (i) | propose standardised tests and test procedures or reference reagents for internal quality control; |
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(i)

propose standardised tests and test procedures or reference reagents for internal quality control;

| (j) | advising the Commission on scientific aspects related to bee health. |
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(j)

advising the Commission on scientific aspects related to bee health.

| 2. | The EU reference laboratory shall:






  (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; |
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2.

The EU reference laboratory shall:

(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; |
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(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, including training of experts from the Member States and, as appropriate, from third countries, in new analytical methodologies; |
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(c)

organise workshops for the benefit of national reference laboratories as agreed in the work programme, 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; |
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(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; |
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(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; |
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(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 colony collapse disorder in the Union with regard to establishing a baseline for ‘normal’ seasonal mortality of bees; |
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(iii)

establishing and coordinating a survey on colony collapse disorder in the Union with regard to establishing a baseline for ‘normal’ seasonal mortality of bees;

| (f) | collaborating with the relevant competent laboratories in third countries where those diseases are prevalent as regards methods of diagnosing bee diseases; |
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(f)

collaborating with the relevant competent laboratories in third countries where those diseases are prevalent as regards methods of diagnosing bee diseases;

| (g) | collaborating with the relevant regional laboratories designated by the OIE with regard to exotic diseases (Tropilaelaps mites and the small hive beetle (Aethina tumida) and any other disease exotic to the Union); |
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(g)

collaborating with the relevant regional laboratories designated by the OIE with regard to exotic diseases (Tropilaelaps mites and the small hive beetle (Aethina tumida) and any other disease exotic to the Union);

| (h) | collating and forwarding 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 colony collapse disorder. |
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(h)

collating and forwarding 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 colony collapse disorder.

| 3. | The EU reference laboratory shall also:






  (a) | perform experiments and field trials, in consultation with the Commission, directed towards an improved control of specific bee diseases; |
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3.

The EU reference laboratory shall also:

(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; |
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(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 the Manual of Diagnostic Tests and Vaccines for Terrestrial Animals. |
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(c)

assist the Commission in reviewing the OIE’s recommendations in the Terrestrial Animal Health Code and the Manual of Diagnostic Tests and Vaccines for Terrestrial Animals.

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