EXPLANATORY MEMORANDUM
1.CONTEXT OF THE DELEGATED ACT
Regulation (EU) 2016/429 of the European Parliament and of the Council of 9 March 2016 on transmissible animal diseases and amending and repealing certain acts in the area of animal health (‘Animal Health Law’) 1 (hereinafter the ‘AHL’) establishes a list of transmissible animal diseases (listed diseases). That list is set out in Article 5 and Annex II to that Regulation, and it comprises diseases which pose a risk to animal or public health in the Union and which can have an impact on animal or public health, the economy or the environment.
The list of diseases in Annex II to Regulation (EU) 2016/429 is not comprehensive and up-to-date. Pursuant to Article 275 of that Regulation, the Commission is required to review that list by 20 April 2019 at the latest. Should it be apparent from that review that an application of the rules set out in Regulation (EU) 2016/429 requires Annex II to be amended, the Commission is required to amend that Annex.
2.CONSULTATIONS PRIOR TO THE ADOPTION OF THE DELEGATED ACT
Rules on animal diseases are currently laid down in various Union acts, mainly Directives and some Regulations according to subject matter such as disease notification (e.g. Council Directive 82/894/EEC on the notification of animal diseases within the Community 2 ), disease control (e.g. Council Directive 2003/85/EC on Community measures for the control of foot-and-mouth disease 3 , Council Directive 2001/89/EC on Community measures for the control of classical swine fever 4 ) or cross-border trade in animals (e.g. Council Directive 92/65/EEC laying down animal health requirements governing trade in and imports into the Community of animals, semen, ova and embryos not subject to animal health requirements laid down in specific Community rules referred to in Annex A (I) to Directive 90/425/EEC 5 ).
Pursuant to Article 5 of the AHL, a disease fulfils the criteria to be listed if it complies with all of the following requirements: it is transmissible and the susceptible species, reservoir or vectors are present in the EU and it has negative effects on animal health or poses a risk to public health and there are diagnostic tools available and the risk mitigating measures or surveillance is effective and proportionate in the Union. In addition, in order for a disease to fulfil the criteria to be listed, it needs to fulfil at least one of the following requirements: it causes significant negative effects on animal health or public health or the economy or the environment or biodiversity or has the potential to generate a crisis or to be used in bioterrorism actions or has developed resistance to treatments.
Following the analysis of the criteria laid down in Article 5 of the AHL, a comprehensive evaluation of the diseases that could be relevant for Union intervention has been carried out together with the European Food Safety Authority (EFSA), the EU Animal Health Reference Laboratories (EURLs) and available information from the World Organisation for Animal Health (OIE), the international standard setting body for animal health.
The review of the list of diseases has taken into account both the diseases listed in Annex II of the AHL, and additional diseases currently listed for disease prevention, control or trade measures such as enzootic bovine leukosis, infectious bovine rhinotracheitis 6 or Ebola virus disease 7 . In addition, other diseases of special relevance, such as contagious caprine pleuropneumonia or surra (Trypanosoma evansi), which are currently not covered by Union acts, were also assessed due to the importance that the OIE attaches to them.
All these diseases have been scrutinised against the set of criteria laid down in Article 5 of the AHL for the protection of animal health, public health and the environment in the Union.
To avoid duplication, this evaluation did not take into consideration zoonotic diseases and transmissible spongiform encephalopathies (TSE) which are already covered by specific EU legislation. 8
For some diseases (infection with Rift Valley fever virus 9 , infection with rabies virus 10 , infestation with Echinococcus multilocularis 11 , infection with epizootic haemorrhagic disease virus 12 , Q fever 13 , infection with lumpy skin disease virus 14 , sheep pox and goat pox 15 , infection with peste des petits ruminants virus 16 , swine vesicular disease 17 , vesicular stomatitis 18 , infection with Newcastle disease virus 19 , avian chlamydiosis 20 , infestation with Aethina tumida (Small hive beetle) 21 , infestation with Tropilaelaps spp 22 and epizootic ulcerative syndrome 23 , infection with highly polymorphic region (HPR) deleted infectious salmon anaemia virus 24 ) the EFSA delivered opinions which were adopted shortly before this review and independently of it. In the cases where these opinions gave sufficient information on the criteria for the listing of diseases, the conclusions of the opinions were used to complete the assessment of those diseases.
In addition, for some diseases the evaluation drew on the EURLs’ scientific expertise and the international standards of the OIE (infection with rinderpest virus, infection with Burkholderia mallei (Glanders), infection with equine arteritis virus, equine infectious anaemia, dourine, contagious equine metritis, Teschen disease, American foulbrood, epizootic haematopoietic necrosis, viral haemorrhagic septicaemia, infectious haematopoietic necrosis, infection with Mikrocytos mackini, infection with Perkinsus marinus, infection with Bonamia ostreae, infection with Bonamia exitiosa, infection with Marteilia refringens, infection with Taura syndrome virus, infection with yellow head virus and infection with white spot syndrome virus).
Furthermore, for those diseases for which either no recent scientific information was available, or due to their particularities and likely implications for farmers and Member States, the EFSA adopted new scientific opinions within the framework of Regulation (EU) 2016/429 (infection with Brucella abortus, B. melitensis and B. suis 25 , infection with Mycobacterium tuberculosis complex (M. bovis, M. caprae and M. tuberculosis) 26 , infection with bluetongue virus (serotypes 1-24) 27 , anthrax 28 , surra (Trypanosoma evansi) 29 , Ebola virus disease 30 , Borna disease 31 , paratuberculosis 32 , Japanese encephalitis 33 , West Nile fever 34 , infection with Mycoplasma mycoides subsp. mycoides SC (Contagious bovine pleuropneumonia) 35 , infectious bovine rhinotracheitis/infectious pustular vulvovaginitis 36 , bovine viral diarrhoea 37 , bovine genital campylobacteriosis 38 , trichomonosis 39 , enzootic bovine leukosis 40 , contagious caprine pleuropneumonia 41 , ovine epididymitis (Brucella ovis) 42 , Border disease 43 , Venezuelan equine encephalomyelitis 44 , equine encephalomyelitis (Eastern and Western) 45 , infection with Aujeszky's disease virus 46 , infection with porcine reproductive and respiratory syndrome virus 47 , avian mycoplasmosis (Mycoplasma gallisepticum and M. meleagridis) 48 , infection with Salmonella Pullorum, S. Gallinarum and S. arizonae 49 , infection with low pathogenic avian influenza viruses 50 , infestation with Varroa spp. (Varroosis) 51 , infection with Batrachochytrium salamandrivorans 52 and Koi herpes virus disease 53 ).
In addition to this science-based preparatory work, extensive consultations with experts from Member States and interested stakeholders have been held which contributed to the review of the list of diseases set out in Annex II to Regulation (EU) 2016/429 54 .
The draft delegated regulation was available to public for feedback through the Commission's 'Better regulation portal' during the period between 2 May and 30 May 2018. 21 feedbacks were received in total, including opinion of 13 stakeholders (Copa-Cogeca, FESASS, Dogs Trust, British and Irish association of Zoos and aquariums, European Association of Zoo and Wildlife Veterinarians, Ornamental Fish International (OFI) and European Pet organization, (EPO), Comité Interprofessionnel des Produits de l'aquaculture, Federation of Veterinarians of Europe, World Horse Welfare, European association of Zoos and Aquaria (EAZA), Swedish Association for the Protection of animals, Federation of Swedish Farmers) and 8 citizens opinions. The following comments were made: inclusion of some new diseases into the list and exemptions for certain categories of animals (e.g. captive birds, zoo animals) from the general requirements for some diseases.
3.LEGAL ELEMENTS OF THE DELEGATED ACT
Article 5(2) and (4) of Regulation (EU) 2016/429 provide for the adoption of delegated acts concerning amendments to the list of diseases set out in Annex II thereto.
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