Introductory text

THE EUROPEAN COMMISSION,

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

Having regard to Council Directive 2006/88/EC of 24 October 2006 on animal health requirements for aquaculture animals and products thereof, and on the prevention and control of certain diseases in aquatic animals^f1, and in particular Articles 49(3), 50(4), 57(b) and 61(3) thereof,

Whereas:

Directive 2006/88/EC lays down minimum preventive measures for the surveillance and early detection in aquatic animals of the listed diseases set out in Annex IV to that Directive (‘the listed diseases’) and the control measures to be applied in the event of the suspicion of or an outbreak of the listed diseases. It also lays down the requirements for the achievement of disease-free status for Member States or for zones or compartments thereof.

The eradication of the listed diseases and the achievement of disease-free status for a Member State, zone or compartment should be based on the same principles and follow the same scientific approach throughout the Union. For that reason, it is necessary to lay down at Union level specific requirements for eradication and surveillance schemes, and the sampling and diagnostic methods to be used by the Member States to obtain disease-free status for the whole of a Member State or a zone or compartment thereof.

The laboratory examinations to be carried out in the event of the suspicion or confirmation of the presence of the listed diseases, should be the same at Union level and should follow the same scientific standards and protocols. In accordance with Directive 2006/88/EC, it is necessary to establish specific diagnostic methods and procedures to be used by the laboratories designated for that purpose by the competent authority of the Member States.

The Aquatic Animal Health Code adopted by the World Organisation for Animal Health (OIE) (the ‘Aquatic Code’) sets out standards for improving the health of aquatic animals and the welfare of farmed fish worldwide, including standards for safe international trade in aquatic animals and products thereof. A number of chapters of the Aquatic Code set out recommendations concerning the use of certain diagnostic tests. Such tests provided for by the OIE are laid down in the OIE Manual of Diagnostic Tests for Aquatic Animals (the ‘Aquatic Manual’). In order to ensure that Union's requirements with regard to aquatic animal disease diagnostics are consistent with international standards, the rules laid down in this Decision should take into account the standards and recommendations of the Aquatic Code.

In this respect, for many of the listed diseases, the Aquatic Manual lists several tests and procedures to be used for the purpose of laboratory examinations. In order to uniform the scientific basis for the diagnostic work for the listed diseases at Union level, it is necessary to choose among the diagnostic tests and procedures recommended by the OIE and to specify which tests should be mandatory for the purpose of laboratory examination when carrying out surveillance programmes and to rule out the suspicion of or to confirm the presence of the listed diseases. While there also will be a need for having alternative methods and procedures available in certain cases, descriptions and some scientific explanations for when and how the alternative methods could be applied should be provided. This is in particular necessary for the more detailed diagnostic procedures.

In order to produce precise and reproducible diagnostic results, it is important that the detailed procedures and protocols to be used are validated in accordance with the relevant quality standards referred to in Part I of Annex VI to Directive 2006/88/EC. For many of the diagnostic methods provided for in this Decision, the use of commercial test kits is a necessary part of the diagnostic protocols and those test kits have been validated in accredited tests by the European Reference laboratories (EURL) for the respective diseases. In the interest of legal certainty, the commercial names of those validated commercial test kits should be referred to in this Decision.

It may be difficult for certain Member States to achieve disease-free status for the whole of the Member State or for a zone or compartment thereof with regard to one or more of the listed diseases. In such situations the Member State may wish not to obtain or regain disease-free status for those listed diseases. The minimum control measures to be applied in cases where the Member State concerned does not wish to obtain or regain disease-free status, should be the same at Union level and should follow the same criteria. It is therefore necessary in accordance with Directive 2006/88/EC to lay down detailed rules for the containment of those listed diseases and the minimum requirements for the lifting of those containment measures.

Commission Decision 2001/183/EC^f2 lays down the requirements concerning sampling plans and diagnostic methods for the detection and confirmation of the listed diseases infectious haematopoietic necrosis and viral haemorrhagic septicaemia. Commission Decision 2003/466/EC^f3 lays down requirements concerning sampling plans and diagnostic methods for the detection of infectious salmon anaemia, as well as criteria for zoning and official surveillance following suspicion and confirmations of the presence of that disease. Commission Decision 2002/878/EC^f4 lays down the requirements concerning the sampling plans and the diagnostic methods for the detection and confirmation of the mollusc diseases Bonamiosis and Marteiliosis. In order to update the requirements, those three Decisions should be replaced by this Decision. Accordingly, Decision 2001/183/EC, Decision 2002/878/EC and Decision 2003/466/EC should be repealed.

As certain Member States require time to update their national reference laboratories in order to comply with the requirements laid down in this Decision, it should apply from 1 April 2016.

The measures laid down in this Decision are in accordance with the opinion of the Standing Committee on Plants, Animals, Food and Feed,

HAS ADOPTED THIS DECISION: