CELEX: 
Language: en
Date: 2018-05-02
Title: COMMISSION DELEGATED REGULATION (EU) …/... amending the list of diseases set out in Annex II to Regulation (EU) 2016/429 of the European Parliament and of the Council on transmissible animal diseases and amending and repealing certain acts in the area of animal health (‛Animal Health Law’)

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
               . 
            
            
               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. 
            
            
               COMMISSION DELEGATED REGULATION (EU) …/...
            
            
               of XXX
            
         
         
            
               amending the list of diseases set out in Annex II to Regulation (EU) 2016/429 of the European Parliament and of the Council on transmissible animal diseases and amending and repealing certain acts in the area of animal health (‛Animal Health Law’)
            
            
               (Text with EEA relevance)
            
            
               THE EUROPEAN COMMISSION,
            
            
               Having regard to the Treaty on the Functioning of the European Union,
            
            
               Having regard to 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 (ʻAnimal Health Lawʼ)
                  55
               , and in particular Article 5(2) and (4) thereof,
            
            
               Whereas:
            
            
               (1)Regulation (EU) 2016/429 lays down rules for the prevention and control of animal diseases which are transmissible to animals or to humans, including rules for the prioritisation and categorisation of diseases of Union concern. Article 5 of Regulation (EU) 2016/429 provides that disease-specific rules for the prevention and control of diseases apply to the diseases listed in that Article and in Annex II to that Regulation. In addition, Article 5(3) of that Regulation lays down certain criteria to be taken into account in amending the list in that Annex, while the assessment parameters to be used in order to determine whether a disease meets the conditions requiring it to be listed in accordance with that Article are laid down in Article 7 of that Regulation. 
            
            
               (2)In addition, Article 275 of Regulation (EU) 2016/429 provides that the Commission is to review the list of diseases set out in Annex II to that Regulation by 20 April 2019 at the latest.
            
            
               (3)The Commission systematically assessed the animal diseases which require Union intervention with the assistance of the European Food Safety Authority (EFSA), drawing on the scientific expertise provided by the EU Animal Health Reference Laboratories and the international standards of the World Organisation for Animal Health (OIE). For the purposes of that assessment, it used the criteria laid down in Article 5(3) of Regulation (EU) 2016/2014 and the assessment parameters laid down in Article 7 of that Regulation.
            
            
               (4)The assessed diseases consist of 39 diseases that are currently listed in Annex II to Regulation (EU) 2016/429, as well as another 19 diseases of special relevance for disease prevention, control or trade measures, such as enzootic bovine leukosis, infectious bovine rhinotracheitis or infection with Aujeszky's disease virus, and certain other diseases which have been listed by the OIE, such as surra (Trypanosoma evansi) or contagious caprine pleuropneumonia. 
            
            
               (5)For the purposes of the assessments, 29 scientific opinions were requested from EFSA on different animal diseases. In providing them, EFSA followed the method set out in its Scientific Opinion adopted on 5 April 2017 on ad hoc method for the assessment on listing and categorisation of animal diseases within the framework of the Animal Health Law
                  56
               . For the remaining diseases, the assessments were based on recent EFSA opinions or on information provided by the EU Animal Health Reference Laboratories. As regards all assessed diseases, the relevant OIE standards were considered. 
            
            
               (6)The results of the scientific assessments by EFSA were inconclusive for certain diseases such as surra (Trypanosoma evansi)
                  57
               , enzootic bovine leukosis
                  58
               , Venezuelan equine encephalomyelitis
                  59
               , infestation with Varroa spp. (Varroosis)
                  60
                and Koi herpes virus disease
                  61
               . Taking into account the discussions held at the meetings of the expert group on animal health
                  62
               , those five diseases fulfil the requirements laid down in Article 5(3) of Regulation (EU) 2016/429. Therefore those diseases should be included in the list set out in Annex II to that Regulation. 
            
            
               (7)The results of the scientific assessments carried out showed that swine vesicular disease
                  63
               , vesicular stomatitis
                  64
               , epizootic ulcerative syndrome
                  65
                and Teschen disease do not fulfil the requirements laid down in Article 5(3) of Regulation (EU) 2016/429. Therefore, those diseases should be removed from the list set out in Annex II to that Regulation. 
            
            
               (8)At the same time, surra (Trypanosoma evansi)
                  66
               , Ebola virus disease
                  67
               , paratuberculosis
                  68
               , Japanese encephalitis
                  69
               , West Nile fever
                  70
               , Q fever
                  71
               , infectious bovine rhinotracheitis/infectious pustular vulvovaginitis
                  72
               , bovine viral diarrhoea
                  73
               , bovine genital campylobacteriosis
                  74
               , trichomonosis
                  75
               , enzootic bovine leukosis
                  76
               , contagious caprine pleuropneumonia
                  77
               , ovine epididymitis (Brucella ovis)
                  78
               , infection with Burkholderia mallei (Glanders), infection with equine arteritis, virus equine infectious anaemia, dourine, contagious equine metritis, equine encephalomyelitis (Eastern and Western)
                  79
               , infection with Aujeszky's disease virus
                  80
               , infection with porcine reproductive and respiratory syndrome virus
                  81
               , avian mycoplasmosis (Mycoplasma gallisepticum and M. meleagridis)
                  82
               , infection with low pathogenic avian influenza viruses
                  83
               , avian chlamydiosis
                  84
               , infestation with Varroa spp. (Varroosis)
                  85
               , infestation with Aethina tumida (Small hive beetle)
                  86
               , American foulbrood, infestation with Tropilaelaps spp
                  87
                and infection with Batrachochytrium salamandrivorans
                  88
                do fulfil the requirements laid down in Article 5(3) of Regulation (EU) 2016/429. Therefore those diseases should be included in the list set out in Annex II to that Regulation. 
            
            
               (9)In addition, Article 2(2) of Regulation (EU) 2016/429 provides that that Regulation is to apply to transmissible diseases, including zoonosis, without prejudice to rules laid down in Decision No 1082/2013/EU of the European Parliament and of the Council
                  89
               , Regulation (EC) No 999/2001 of the European Parliament and of the Council
                  90
               , Directive 2003/99/EC of the European Parliament and of the Council
                  91
                and Regulation (EC) No 2160/2003 of the European Parliament and of the Council
                  92
               . As the diseases covered by the rules laid down in those acts, namely listeriosis, salmonellosis (zoonotic salmonella), trichinellosis, verotoxigenic E. coli and transmissible spongiform encephalopathies (TSE) are already covered by sector-specify rules, they should therefore be removed from the list set out in Annex II to Regulation (EU) 2016/429.
            
            
               (10)The list of diseases in Annex II to Regulation (EU) 2016/429 should therefore be amended accordingly.
            
            
               (11)Regulation (EU) 2016/429 should therefore be amended.
            
            
               (12)As Regulation (EU) 2016/429 applies with effect from 21 April 2021, the amendments made to it by this Regulation should also apply from that date,
            
            
               HAS ADOPTED THIS REGULATION:
            
            
               Article 1 
            
         
         
            
               Annex II to Regulation (EU) 2016/429 is replaced by the text set out in the Annex to this Regulation.
            
            
               Article 2 
            
            
               This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union.
            
            
               It shall apply from 21 April 2021.
            
            
               This Regulation shall be binding in its entirety and directly applicable in all Member States.
            
            
               Done at Brussels,
            
            
               
                     For the Commission
               
               
                     The President
               
               
                     Jean-Claude JUNCKER
               
            
         
         
            
                  
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    ---documentbreak--- 
      
         
         
            
               ANNEX
            
            
               ANNEX II
            
            
               LIST OF ANIMAL DISEASES
            
            
               –Infection with rinderpest virus
            
            
               –Infection with Rift Valley fever virus
            
            
               –Infection with Brucella abortus, B. melitensis and B. suis
            
            
               –Infection with Mycobacterium tuberculosis complex (M. bovis, M. caprae and M. tuberculosis)
            
            
               –Infection with rabies virus
            
            
               –Infection with bluetongue virus (serotypes 1-24)
            
            
               –Infestation with Echinococcus multilocularis
            
            
               –Infection with epizootic haemorrhagic disease virus
            
            
               –Anthrax
            
            
               –Surra (Trypanosoma evansi)
            
            
               –Ebola virus disease
            
            
               –Paratuberculosis
            
            
               –Japanese encephalitis
            
            
               –West Nile fever
            
            
               –Q fever
            
            
               –Infection with lumpy skin disease virus 
            
         
         
            
               –Infection with Mycoplasma mycoides subsp. mycoides SC (Contagious bovine pleuropneumonia)
            
            
               –Infectious bovine rhinotracheitis/infectious pustular vulvovaginitis
            
            
               –Bovine viral diarrhoea
            
            
               –Bovine genital campylobacteriosis
            
            
               –Trichomonosis
            
            
               –Enzootic bovine leukosis
            
            
               –Sheep pox and goat pox
            
            
               –Infection with peste des petits ruminants virus
            
            
               –Contagious caprine pleuropneumonia
            
            
               –Ovine epididymitis (Brucella ovis)
            
            
               –Infection with Burkholderia mallei (Glanders)
            
            
               –Infection with equine arteritis virus
            
            
               –Equine infectious anaemia
            
            
               –Dourine
            
            
               –Venezuelan equine encephalomyelitis
            
            
               –Contagious equine metritis
            
            
               –Equine encephalomyelitis (Eastern and Western)
            
            
               –Infection with Aujeszky's disease virus
            
            
               –Infection with porcine reproductive and respiratory syndrome virus
            
            
               –Infection with Newcastle disease virus
            
         
         
            
               –Avian mycoplasmosis (Mycoplasma gallisepticum and M. meleagridis)
            
            
               –Infection with Salmonella Pullorum, S. Gallinarum and S. arizonae
            
            
               –Infection with low pathogenic avian influenza viruses
            
            
               –Avian chlamydiosis
            
            
               –Infestation with Varroa spp. (Varroosis)
            
            
               –Infestation with Aethina tumida (Small hive beetle)
            
            
               –American foulbrood
            
            
               –Infestation with Tropilaelaps spp.
            
            
               –Infection with Batrachochytrium salamandrivorans
            
            
               –Epizootic haematopoietic necrosis
            
            
               –Viral haemorrhagic septicaemia 
            
            
               –Infectious haematopoietic necrosis 
            
            
               –Infection with highly polymorphic region (HPR) deleted infectious salmon anaemia virus
            
            
               –Koi herpes virus disease
            
            
               –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
            
            
               –Infection with white spot syndrome virus