Commission Regulation (EU) No 415/2013Show full title

ANNEX I U.K. 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: U.K.

(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 proficiency 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: U.K.

(a)

facilitate the harmonisation of techniques throughout the Union, in particular by specifying standard test methodologies;

(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: U.K.

(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.

ANNEX II U.K. 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: U.K.

(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 standardise 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 proficiency 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: U.K.

(a)

facilitate the harmonisation of techniques throughout the Union, in particular by specifying standard test methodologies;

(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 diagnostic 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: U.K.

(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.

ANNEX III U.K. 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: U.K.

(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 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;

(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: U.K.

(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 (Tropilaelaps 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.

3. In addition, the EU reference laboratory for bee health shall: U.K.

(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.

(1)

OJ L 241, 17.9.2011, p. 2.