Commission Implementing Decision (EU) 2016/1840
of 14 October 2016
amending Annex IV to Council Directive 2009/156/EC as regards methods for African horse sickness diagnosis
(notified under document C(2016) 6509)
(Text with EEA relevance)
THE EUROPEAN COMMISSION,
Having regard to the Treaty on the Functioning of the European Union,
Having regard to Council Directive 2009/156/EC of 30 November 2009 on animal health conditions governing the movement and importation from third countries of equidae , and in particular Article 20 thereof,
Whereas:
(1)
Annex IV to Directive 2009/156/EC sets out diagnostic methods for African horse sickness to be used, when necessary, for testing equidae prior to their movement within the Union or imports from non-EU countries.
(2)
Since the adoption of Directive 2009/156/EC, laboratory capacities to carry out advanced, highly sensitive and efficient tests for the diagnosis of African horse sickness have developed. In parallel, the Chapter related to the diagnosis of African horse sickness in the Manual of Diagnostic Tests and Vaccines for Terrestrial Animals of the World Organisation for Animal Health (OIE) has been amended to reflect that development.
(3)
As part of their 2014 work programme, the European Union Reference Laboratory for African horse sickness produced a report on the technical assessment of the diagnostic methods described in Annex IV to Directive 2009/156/EC. The assessment, which was presented to the Commission in May 2015, concluded that the competitive enzyme-linked immunosorbent assay (ELISA) is no longer available, indirect ELISA is not in common use but could be provided in 4-6 months after the request and that the blocking ELISA is commercially available and commonly used for analysis of samples during the Proficiency Test exercises organised by the European Union Reference Laboratory for African horse sickness.
(4)
In addition, the report points out that the nucleic acid recognition by reverse-transcription polymerase chain reaction (RT-PCR) methods have advantages over serological diagnostic methods, because they allow for the detection of the disease at an early stage of infection. In addition, most of the national reference laboratories of the European Union Member States use real-time RT-PCR methods, including for the diagnosis of African horse sickness, which have proven to be fit for purpose in the annual Proficiency Test exercises performed from 2009 to 2014. The report also indicates that outside the Union there are a number of OIE reference laboratories and other laboratories with specific African horse sickness expertise that have implemented at least one of the real-time RT-PCR methods for the detection of African horse sickness genome.
(5)
On the 24-25 November 2015, the Joined Workshop of African Horse Sickness/Bluetongue European Union Reference Laboratories together with national reference laboratories held in Ascot, United Kingdom, recommended the inclusion in Annex IV to Directive 2009/156/EC of real time reverse transcription (RRT)-polymerase chain reaction (PCR) methods for the detection of the African horse sickness virus.
(6)
Although all available real-time RT-PCR methods for the African horse sickness genome detection are sufficiently sensitive, the procedure described by Agüero et al. (2008) is the most widely used by laboratories. The method described by Guthrie et al. (2013) was specifically designed to ensure that horses from areas at risk of African horse sickness can be transported safely after the minimum quarantine period required in accordance with the Terrestrial Animal Health Code of the OIE.
(7)
It is therefore appropriate to incorporate in Annex IV to Directive 2009/156/EC methods for agent identification and for the detection of antibody as complementary methods for a rapid diagnosis of African horse sickness.
(8)
Annex IV to Directive 2009/156/EC should be therefore amended by deletion of the competitive ELISA test and by an updating the procedures for the indirect and blocking ELISA tests in accordance with Chapter 2.5.1. of the Manual of Diagnostic Tests and Vaccines for Terrestrial Animals of the OIE, Edition 2016 based on the Version adopted by the World Assembly of Delegates of the OIE in May 2012 . At the same time, real-time RT-PCR procedures as described by Agüero et al. (2008) as well as by Guthrie et al. (2013) should be included in that Annex to make those agent identification tests available for the purpose of pre-movement testing.
(9)
Directive 2009/156/EC should therefore be amended accordingly.
(10)
The measures provided for in this Decision are in accordance with the opinion of the Standing Committee on Plants, Animals, Food and Feed,
HAS ADOPTED THIS DECISION:
OJ L 192, 23.7.2010, p. 1.
http://www.oie.int/fileadmin/Home/eng/Health_standards/tahm/2.05.01_AHS.pdf
Council Directive 92/35/EEC of 29 April 1992 laying down control rules and measures to combat African horse sickness (OJ L 157, 10.6.1992, p. 19).
Agüero M., Gomez-Tejedor C., Angeles Cubillo M., Rubio C., Romero E. and Jimenez-Clavero A. (2008). Real-time fluorogenic reverse transcription polymerase chain reaction assay for detection of African horse sickness virus. J. Vet. Diagn. Invest., 20, 325-328.
Guthrie AJ, MacLachlan NJ, Joone C, Lourens CW, Weyer CT, Quan M, Monyai MS, Gardner IA. Diagnostic accuracy of a duplex real-time reverse transcription quantitative PCR assay for detection of African horse sickness virus. Journal of Virological Methods. 2013;189(1):30-35.
http://www.oie.int/fileadmin/Home/eng/Health_standards/tahc/current/chapitre_ahs.pdf
See footnote 2.