Commission Delegated Regulation (EU) 2018/1629 of 25 July 2018 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)
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Address https://gelex.eu/eli/EU/regulation/2018/1629@2018-07-25/en
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 (Animal Health Law), 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) 2016/429 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. 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), enzootic bovine leukosis, Venezuelan equine encephalomyelitis, infestation with Varroa spp. (Varroosis) and Koi herpes virus disease. Taking into account the discussions held at the meetings of the expert group on animal health, 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, vesicular stomatitis, epizootic ulcerative syndrome 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), Ebola virus disease, paratuberculosis, Japanese encephalitis, West Nile fever, Q fever, infectious bovine rhinotracheitis/infectious pustular vulvovaginitis, bovine viral diarrhoea, bovine genital campylobacteriosis, trichomonosis, enzootic bovine leukosis, contagious caprine pleuropneumonia, ovine epididymitis (Brucella ovis), infection with Burkholderia mallei (Glanders), infection with equine arteritis virus, equine infectious anaemia, dourine, contagious equine metritis, equine encephalomyelitis (Eastern and Western), infection with Aujeszky's disease virus, infection with porcine reproductive and respiratory syndrome virus, avian mycoplasmosis (Mycoplasma gallisepticum and M. meleagridis), 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 and infection with Batrachochytrium salamandrivorans 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, Regulation (EC) No 999/2001 of the European Parliament and of the Council, Directive 2003/99/EC of the European Parliament and of the Council and Regulation (EC) No 2160/2003 of the European Parliament and of the Council. 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, 25 July 2018. For the Commission The President Jean-Claude Juncker
ANNEX
ANNEX
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
Versions
Cited by
- Commission Delegated Regulation (EU) 2020/688 of 17 December 2019 supplementing Regulation (EU) 2016/429 of the European Parliament and of the Council, as regards animal health requirements for movements within the Union of terrestrial animals and hatching eggs (Text with EEA relevance) Regulation · Grade B
The rules and risk mitigation measures laid down in this Regulation are required to supplement the animal health requirements laid down in Chapters 3-5 of Title I of Part IV of Regulation (EU) 2016/429 as regards the movements within the Union of kept and wild terrestrial animals and of hatching eggs, to ensure that those commodities do not pose a significant risk of spread of listed diseases referred to in Article 5(1) and Annex II of the same Regulation, as amended by Commission Delegated Regulation (EU) 2018/1629 and categorised in accordance with Article 9(1)(d) of Regulation (EU) 2016/429
- Commission Delegated Regulation (EU) 2020/688 of 17 December 2019 supplementing Regulation (EU) 2016/429 of the European Parliament and of the Council, as regards animal health requirements for movements within the Union of terrestrial animals and hatching eggs (Text with EEA relevance) Regulation · Grade B
Article 5(1) and Annex II to Regulation (EU) 2016/429, as amended by Commission Delegated Regulation (EU) 2018/1629, provide the list of animal diseases of special relevance for Union intervention, while Commission Implementing Regulation (EU) 2018/1882 categorises them on the basis of the specific measures to apply to them, and lists the animal species to which those rules should apply. Category D diseases are considered to pose a considerable risk of spread when animals are moved between Member States.
- Commission Delegated Regulation (EU) 2020/688 of 17 December 2019 supplementing Regulation (EU) 2016/429 of the European Parliament and of the Council, as regards animal health requirements for movements within the Union of terrestrial animals and hatching eggs (Text with EEA relevance) Regulation · Grade B
In respect of movements to other Member States of kept ungulates and poultry, Article 131(1) of Regulation (EU) 2016/429 empowers the Commission to lay down rules concerning residency periods, the period of time necessary to limit the introduction of kept ungulates or poultry into establishments prior to movement, and supplementary animal health requirements to mitigate the risk of spread of listed diseases as referred to in Article 9(1)(d) thereof. It is therefore necessary to lay down appropriate measures in this Regulation to safeguard the health of animals and prevent the spread of disease
- Commission Implementing Decision (EU) 2021/597 of 12 April 2021 laying down emergency measures in relation to confirmed cases of infestation with small hive beetle in Italy (notified under document C(2021) 2365) (Only the Italian text is authentic) (Text with EEA relevance) Decision · Grade B
The small hive beetle (Aethina tumida) is an insect native to sub-Saharan Africa, which has spread worldwide in recent decades and is capable of multiplying rapidly in the presence, in particular, of bee brood, pollen and honey in honeycomb. Adult specimens can fly up to several kilometres to invade other places. Infestation with small hive beetle is listed in Annex II to Regulation (EU) 2016/429, as amended by Commission Delegated Regulation (EU) 2018/1629, and in the Annex to Commission Implementing Regulation (EU) 2018/1882.
- Commission Delegated Regulation (EU) 2020/689 of 17 December 2019 supplementing Regulation (EU) 2016/429 of the European Parliament and of the Council as regards rules for surveillance, eradication programmes, and disease-free status for certain listed and emerging diseases (Text with EEA relevance) Regulation · Grade B
Conditions for granting, maintaining, suspending and withdrawing disease-free status at establishment level were set out in the following Union rules in place before the date of application of this Regulation: Council Directive 64/432/EEC for bovine brucellosis and bovine tuberculosis and Council Directive 91/68/EEC for brucellosis in sheep and goats. The Animal Health Law repealed those provisions. Also, Commission Delegated Regulation (EU) 2018/1629 has aligned the scope of disease agents involved in brucellosis and bovine tuberculosis with the Terrestrial Animal Health Code of the World Org
- Commission Implementing Regulation (EU) 2018/1882 of 3 December 2018 on the application of certain disease prevention and control rules to categories of listed diseases and establishing a list of species and groups of species posing a considerable risk for the spread of those listed diseases (Text with EEA relevance) Regulation · Grade B
Regulation (EU) 2016/429 lays down rules for the prevention and control of diseases which are transmissible to animals or humans, including rules for the prioritisation and categorisation of listed diseases that are of concern at Union level. Article 5 of Regulation (EU) 2016/429 provides that disease-specific rules for the prevention and control of diseases apply to the listed diseases, as referred to in that Article and in Annex II to that Regulation. Annex II to Regulation (EU) 2016/429 was amended by Commission Delegated Regulation (EU) 2018/1629, and those amendments apply from 21 April 2