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Commission Implementing Decision (EU) 2015/1554 of 11 September 2015 laying down rules for the application of Directive 2006/88/EC as regards requirements for surveillance and diagnostic methods (notified under document C(2015) 6188) (Text with EEA relevance)

EU Decision 2015/1554 · Adopted 11 September 2015 · Extends to United Kingdom

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Commission Implementing Decision (EU) 2015/1554

of 11 September 2015

laying down rules for the application of Directive 2006/88/EC as regards requirements for surveillance and diagnostic methods

(notified under document C(2015) 6188)

(Text with EEA relevance)

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 animalsf1, and in particular Articles 49(3), 50(4), 57(b) and 61(3) thereof,

Whereas:

(1)

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.

(2)

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.

(3)

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.

(4)

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.

(5)

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.

(6)

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.

(7)

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.

(8)

Commission Decision 2001/183/ECf2 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/ECf3 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/ECf4 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.

(9)

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.

(10)

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:

Annotations to the whole text

Footnotes

f1

OJ L 328, 24.11.2006, p. 14.

f2

Commission Decision 2001/183/EC of 22 February 2001 laying down the sampling plans and diagnostic methods for the detection and confirmation of certain fish diseases and repealing Decision 92/532/EEC (OJ L 67, 9.3.2001, p. 65).

f3

Commission Decision 2003/466/EC of 13 June 2003 establishing criteria for zoning and official surveillance following suspicion or confirmation of the presence of infectious salmon anaemia (ISA) (OJ L 156, 25.6.2003, p. 61).

f4

Commission Decision 2002/878/EC of 6 November 2002 establishing the sampling plans and diagnostic methods for the detection and confirmation of the presence of the mollusc diseases Bonamiosis (Bonamia ostreae) and Marteiliosis (Marteilia refringens) (OJ L 305, 7.11.2002, p. 57).

Contents

  1. 1Subject matter
  2. 2Definitions
  3. 2aSurveillance and eradication programmes
  4. 3Minimum requirements for eradication and surveillance programmes
  5. 4Minimum requirements for diagnostic methods and specific procedures
  6. 5Minimum control measures for the containment of listed diseases and minimum requirements for the lifting of containment measures in constituent GB territories, zones or compartments not declared free of listed diseases
  7. 6Repeals Repealed
  8. 7Date of application Repealed
  9. 8Addresses Repealed
  10. Signature
  11. Annex I: SURVEILLANCE AND CONTROL METHODS
  12. IIntroduction
  13. IIDefinitions
  14. 1SURVEILLANCE AND CONTROL METHODS FOR VIRAL HAEMORRHAGIC SEPTICAEMIA (VHS) AND INFECTIOUS HEMATOPOIETIC NECROSIS (IHN)
  15. Requirements for surveillance and eradication programmes to obtain and maintain disease free-health statuses with regard to VHS and IHN and containment measures for those listed diseases
  16. I.1Division I.1
  17. Specific requirements to obtain disease-free health status (category I) with regard to VHS and IHN
  18. I.2.1Surveillance programmes:
  19. Eradication programmes
  20. I.2.2.1General requirements
  21. I.2.2.2Requirements for regaining disease-free status for continental compartments comprising one single farm previously being declared free of either IHN or VHS or both
  22. I.3Specific requirements for the maintenance of disease-free health status (Category I) with regard to either VHS or IHN or both
  23. I.4Requirements for the lifting of containment measures provided for in Part 4 of the Aquatic Animal Health Regulations, namely the change from Category V to Category III health status
  24. Diagnostic and sampling methods
  25. II.1Division II.1
  26. II.2Diagnostic methods to obtain and maintain disease-free status for either VHS or IHN or both
  27. II.3Sampling and diagnostic methods to rule out or to confirm the presence of VHS or IHN
  28. 2SURVEILLANCE AND CONTROL METHODS FOR KOI HERPESVIRUS DISEASE (KHVD)
  29. Requirements for surveillance and eradication programmes to obtain and maintain disease-free health status with regard to KHVD and to contain infection with koi herpesvirus (KHV)
  30. I.1General requirements
  31. Specific requirements to achieve disease-free health status (Category I) with regard to KHVD
  32. I.2.1Surveillance programmes
  33. Eradication programmes
  34. I.2.2.1General requirements
  35. I.2.2.2Requirements for regaining disease free status for continental compartments comprising one single farm previously declared free of KHVD
  36. I.3Specific requirements for the maintenance of Category I status with regard to KHVD
  37. I.4Specific requirements for lifting the containment measures provided for in Part 4 of the Aquatic Animal Health Regulations to obtain Category III health status with regard to KHVD in constituent GB territories, compartments or zones that have Category V health status
  38. Diagnostic and sampling methods for surveillance to obtain and maintain disease-free status with regard to KHVD
  39. II.1Samples
  40. II.2Diagnostic methods for the surveillance to obtain and maintain disease-free status with regard to KHVD
  41. Diagnostic and sampling methods for official investigations for confirmation or to rule out a suspicion of KHVD
  42. III.1Samples
  43. III.2Official investigation and diagnostic methods to rule out and to confirm the presence of infection with KHV
  44. 3SURVEILLANCE AND CONTROL METHODS FOR INFECTIOUS SALMON ANEMIA (ISA)
  45. Requirements for surveillance and eradication programmes to obtain and to maintain disease-free health statuses with regard to ISA and to contain infection with HPR deleted ISAV
  46. I.1General requirements
  47. Specific requirements to achieve Category I health status with regard to ISA
  48. I.2.1Surveillance programmes
  49. Eradication programmes
  50. I.2.2.1General requirements
  51. I.2.2.2Requirements concerning regaining disease-free status for continental compartments comprising one single farm that was previously declared as having Category I health status
  52. I.3Minimum control measures for the maintenance of Category I status with regard to ISA
  53. I.4Specific requirements to achieve Category III health status with regard to HPR-deleted ISAV in constituent GB territories, zones or compartments that previously held Category V health status
  54. Diagnostic methods and official investigations
  55. II.1Samples
  56. II.2Diagnostic methods to obtain or maintain disease-free status with regard to ISA
  57. II.3Official investigation and diagnostic methods to rule out or to confirm the presence of ISA
  58. 4SURVEILLANCE AND CONTROL METHODS FOR INFECTION WITH MARTEILIA REFRINGENS
  59. Requirements for surveillance and eradication programmes to obtain and to maintain disease-free health statuses with regard to infection with Marteilia refringens
  60. I.1General requirements
  61. Specific requirements to achieve Category I health status with regard to Marteilia refringens
  62. I.2.1Surveillance programmes
  63. I.2.2Eradication programmes
  64. I.3Specific requirements for the maintenance of disease-free health status (Category I) with regard to infection with Marteilia refringens
  65. I.4Requirements for the lifting of the containment measures provided for in Part 4 of the Aquatic Animal Health Regulations (change from Category V to Category III health status) with regard to infection with Marteilia refringens
  66. Diagnostic methods and official investigations
  67. II.1Samples
  68. II.2Diagnostic methods to obtain or maintain disease-free status for infection with Marteilia refringens
  69. II.3Official investigation and diagnostic methods to confirm the presence of or to rule out the suspicion of infection with Marteilia refringens
  70. 5SURVEILLANCE AND CONTROL METHODS FOR INFECTION WITH BONAMIA OSTREAE
  71. Requirements for surveillance or eradication programmes to obtain and maintain disease-free health statuses with regard to infection with Bonamia ostreae
  72. I.1General requirements
  73. Specific requirements to achieve Category I health status as regards Bonamia ostreae
  74. I.2.1Surveillance programmes
  75. I.2.2Eradication programmes
  76. I.3Specific requirements for the maintenance of disease-free health status (Category I) with regard to infection with Bonamia ostreae
  77. I.4Requirements for the lifting of the containment measures provided for in Part 4 of the Aquatic Animal Health Regulations (the change from Category V to Category III health status) with regard to infection with Bonamia ostreae.
  78. Diagnostic methods and diagnostic criteria
  79. II.1Samples
  80. II.2Diagnostic methods to obtain or maintain disease-free status for infection with Bonamia ostreae
  81. II.3Diagnostic criteria to confirm of the presence of or to rule out the suspicion of infection with Bonamia ostreae
  82. 6SURVEILLANCE AND CONTROL METHODS FOR WHITE SPOT DISEASE (WSD)
  83. Requirements for surveillance and eradication programmes to obtain and maintain disease-free health statuses with regard to WSD and to contain infection with WSSV
  84. I.1General requirements for inspections and sampling
  85. Specific requirements to obtain Category I health status with regard to WSD
  86. I.2.1Surveillance programmes
  87. Eradication programmes
  88. I.2.2.1General requirements
  89. I.2.2.2Requirements for regaining disease-free status with regard to WSD for continental compartments comprising one single farm that previously was declared free of WSD
  90. I.3Specific requirements for the maintenance of disease-free health status (Category I) with regard to WSD
  91. I.4Requirements for the lifting of the containment measures provided for in Part 4 of the Aquatic Animal Health Regulations (the change from Category V to Category III health status) with regard to WSD
  92. Diagnostic and sampling methods
  93. II.1Samples
  94. II.2Diagnostic methods to obtain or maintain disease-free status with regard to WSD
  95. II.3Official investigation and diagnostic methods to rule out the suspicion of or to confirm the presence of infection with WSD
  96. Annex II: DETAILED DIAGNOSTIC METHODS AND PROCEDURES
  97. IIntroduction
  98. IIDefinitions
  99. Part 1: DETAILED DIAGNOSTIC METHODS AND PROCEDURES FOR THE SURVEILLANCE AND CONFIRMATION OF IHN AND VHS
  100. IDiagnostic methods and procedures for the surveillance of VHS and IHN
  101. Preparation and shipment of samples from fish
  102. I.1.1Tissues for virological examination on cell culture
  103. I.1.2Samples for reversed transcriptase polymerase chain reaction (RT-PCR or RT-qPCR) analysis
  104. I.2Shipment of samples for fish
  105. I.3Collection of supplementary diagnostic material
  106. Preparation of samples for cell culture examination and RT-qPCR
  107. I.4.1Freezing in exceptional cases
  108. I.4.2Homogenisation of organs
  109. I.4.3Centrifugation of homogenate
  110. I.4.4Sample preparation for RT-PCR and RT-qPCR based surveillance programmes
  111. I.4.5Pooling of samples for RT-qPCR
  112. Virological examination on cell culture
  113. I.5.1Cell cultures and media
  114. I.5.2Inoculation of cell cultures
  115. I.5.3Incubation of cell cultures
  116. I.5.4Microscopy
  117. I.5.5Subcultivation
  118. I.6Virus identification
  119. I.6.1ELISA
  120. I.6.2Immunofluorescence- IF
  121. I.6.3Neutralisation
  122. RT-PCR/RT-qPCR
  123. I.6.4.1Preparation of viral RNA
  124. I.6.4.2RT-PCR
  125. I.6.4.3RT-qPCR for VHSV
  126. I.6.4.4RT-qPCR for IHNV
  127. IIDetailed diagnostic methods and procedures for the confirmation of or to rule out the suspicion of VHS or IHN or both in suspected outbreaks
  128. Conventional virus isolation with subsequent virus identification
  129. II.1.1Selection of samples
  130. II.1.2Preparation and shipment of samples from fish
  131. II.1.3Collection of supplementary diagnostic material
  132. II.1.4Preparation of samples for cell culture examination
  133. II.1.5Virological examination on cell culture
  134. II.1.6Virus identification
  135. Virus detection by RT-qPCR
  136. II.2.1Selection of samples
  137. II.2.2Preparation and shipment of samples from fish
  138. II.2.3Collection of supplementary diagnostic material
  139. II.2.4Sample preparation for RT-qPCR
  140. II.2.5RT-qPCR
  141. II.3Other diagnostic techniques
  142. IIIProcedure for titration to verify the susceptibility of the cell cultures to infection
  143. Part 2: DETAILED DIAGNOSTIC METHODS AND PROCEDURES FOR THE SURVEILLANCE AND CONFIRMATION OF KHV DISEASE (KHVD)
  144. IDetailed diagnostic methods and procedures for the confirmation of the presence of or to rule out the suspicion of KHVD
  145. I.1Preparation of samples from fish
  146. I.1.1DNA extraction
  147. Agent detection and identification by Polymerase chain reaction (PCR) based methods
  148. I.2.1qPCR for KHV detection
  149. I.2.2Conventional PCR for KHV detection
  150. IIDetailed diagnostic methods and procedures for the surveillance of KHVD
  151. II.1Preparation of samples from fish
  152. II.1.1DNA extraction
  153. II.2Surveillance of KHVD by PCR based methods
  154. II.2.1qPCR for KHV detection
  155. II.2.2Conventional PCR for confirmation of KHV detection
  156. Part 3: DETAILED DIAGNOSTIC METHODS AND PROCEDURES FOR THE SURVEILLANCE AND CONFIRMATION OF INFECTIOUS SALMON ANEMIA (ISA)
  157. ISampling procedures for the surveillance and control of ISA
  158. I.1Preparation of samples from fish
  159. I.2Shipment of samples from fish
  160. I.3Collection of supplementary diagnostic material
  161. IIDetailed diagnostic methods and procedures for the surveillance and for the confirmation of the presence of or to rule out the suspicion of ISA
  162. II.1Examination of samples by RT-PCR
  163. II.1.1Total RNA extraction
  164. II.1.2RT-PCR for ISAV detection
  165. II.1.3RT-qPCR for ISAV detection
  166. II.1.4Sequencing of amplified PCR products
  167. ISAV isolation on cell cultures
  168. II.2.1Preparation of samples
  169. II.2.2Inoculation on cell cultures
  170. II.2.3Subcultivation
  171. II.2.4Virus identification tests
  172. II.2.5Haemadsorption
  173. II.2.6Immunofluorescence (IF)
  174. II.3Examination of other tissues
  175. II.4Histology
  176. II.5Immunohistochemistry (IHC)
  177. Part 4: DETAILED DIAGNOSTIC METHODS AND PROCEDURES FOR THE SURVEILLANCE AND CONFIRMATION OF INFECTION WITH MARTEILIA REFRINGENS
  178. IDetailed diagnostic methods and procedures for the diagnosis of infection with Marteilia refringens
  179. I.1Sampling procedure
  180. Microscopic techniques
  181. I.2.1Cytology (imprint cytology)
  182. I.2.2Histology
  183. Molecular techniques
  184. I.3.1DNA extraction
  185. I.3.2Polymerase chain reaction (PCR)
  186. I.3.3In-situ hybridisation (ISH)
  187. I.3.4Sequencing
  188. IIDetailed diagnostic methods and procedures for surveillance and confirmation of infection with Marteilia refringens
  189. Part 5: DETAILED DIAGNOSTIC METHODS AND PROCEDURES FOR THE SURVEILLANCE AND CONFIRMATION OF INFECTION WITH BONAMIA OSTREAE
  190. IProcedures for diagnosis of Infection with Bonamia ostreae
  191. I.1Sample process
  192. Microscopic techniques
  193. I.2.1Cytology (imprint cytology)
  194. I.2.2Histology
  195. Molecular techniques
  196. I.3.1DNA extraction
  197. I.3.2Polymerase chain reaction (PCR)
  198. I.3.3In-situ hybridisation (ISH)
  199. I.3.4Sequencing
  200. IIProcedures for surveillance and confirmation of infection with Bonamia ostreae
  201. Part 6: DETAILED DIAGNOSTIC METHODS AND PROCEDURES FOR SURVEILLANCE AND CONFIRMATION OF WHITE SPOT DISEASE (WSD)
  202. 1Diagnostic procedures for detection of WSSV
  203. 2Sample process
  204. 3Tissue homogenisation
  205. 4DNA extraction
  206. 5WSSV Polymerase Chain Reaction (PCR)
  207. 6Gel electrophoresis
  208. 7Sequencing of PCR products