COMMISSION IMPLEMENTING DECISION (EU) 2021/361

26.2.2021 | EN | Official Journal of the European Union | L 69/12 ---|---|---|--- * * * COMMISSION IMPLEMENTING DECISION (EU) 2021/361 of 22 February 2021 laying down emergency measures for movements between Member States and the entry into the Union of consignments of salamanders in relation to infection with Batrachochytrium salamandrivorans (notified under document C(2021) 1018) (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 (Animal Health Law) (1), and in particular the introductory phrase and point (a) of Article 259(1) and 261(1) thereof, Whereas: (1) | Batrachochytrium salamandrivorans (Bsal) is a pathogen fungus of salamanders which affects kept and wild salamander populations, and can cause significant morbidity and mortality in those populations. Bsal is lethal to certain species of salamanders, while other species are fully or partly resistant to it, but may carry Bsal on their skin and act as a reservoir and source of infection for other species of salamanders or contamination for their environment. ---|--- (2) | Infection with Bsal has been occurring in Belgium, Germany, the Netherlands, the United Kingdom, and in Spain, both in kept and in wild populations of salamanders according to data collected in the context of, and subsequent to, the European project ‘Mitigating a new infectious disease in salamanders to counteract the loss of European biodiversity’ (2). Bsal is thought to have originated in East Asia and to be widespread there, being endemic at least in Japan, Thailand and Vietnam. At the same time, there is a lack of information on its distribution in other parts of the Union and globally. Trade in infected or carrier salamanders contributes to the spread of Bsal and the disease represents an important risk for biodiversity in the areas it colonises. ---|--- (3) | Commission Implementing Decision (EU) 2018/320 (3) as amended by Commission Implementing Decision (EU) 2019/1998 (4), lays down the animal health protection measures for intra-Union trade in consignments of salamanders and the introduction of such consignments into the Union. Implementing Decision (EU) 2018/320 was adopted on the basis of a Scientific Opinion of the European Food Safety Authority of 25 October 2017 (5) (‘EFSA Opinion’), and the Scientific and Technical Assistance of the European Food Safety Authority of 21 February 2017 (6) (‘EFSA Scientific and Technical Assistance’). That Decision applies until 20 April 2021. ---|--- (4) | The EFSA Opinion and the EFSA Technical Assistance and more recent scientific publications (7) also have highlighted many gaps and uncertainties in the state of knowledge as regards many aspects of the nature of Bsal. International trade standards of the World Organisation of the Animal Health (OIE) are not yet fully developed as regards the methods of diagnostics for Bsal and have not been reviewed as regards recommendations for international trade in salamanders. ---|--- (5) | Bsal is listed in Annex II to Regulation (EU) 2016/429, and accordingly falls within the definition of a listed disease for the purposes of Regulation (EU) 2016/429. Bsal also falls within the definition of a category D disease, as laid down in Commission Implementing Regulation (EU) 2018/1882 (8) for animals of the Order Caudata, which includes salamanders. However, Union rules concerning movements within the Union and the entry into Union of consignments of terrestrial animals and aquatic animals laid in Commission delegated and implementing acts adopted pursuant to Regulation (EU) 2016/429 do not apply to Caudata, as Caudata fall within the definition of ‘other animals’ in that Regulation. Given the current lack of knowledge as regards many aspects of the nature of Bsal as well as the absence of any appropriate international guidelines and recommendations as regards trade in those animals, Commission delegated and implementing acts have not yet been adopted for Caudata, whilst they have been adopted for terrestrial and aquatic animals. ---|--- (6) | The Commission has reviewed the animal health situation as regards Bsal in the Union and the animal health protection measures provided for in Implementing Decision (EU) 2018/320 with the competent authorities of the Member States. As the measures laid down in Implementing Decision (EU) 2018/320 have been considered appropriate, the Member States have not taken any additional trade measures to combat Bsal. Although outbreaks of Bsal seem to be currently limited to certain regions of certain Member States, the further spread of Bsal by intra-Union trade represents a significant risk. ---|--- (7) | Accordingly, it is appropriate that emergency measures be adopted at Union level to prevent the spread of Bsal and to avoid unjustified disruptions in trade in salamanders. Taking into account the effectiveness of the measures laid down in Implementing Decision (EU) 2018/320, it is appropriate to adopt similar measures on movements within the Union and on the entry into the Union of consignments of salamanders as from 21 April 2021 for a limited period of time pending the adoption of more permanent animal health measures, as is the case for diseases affecting terrestrial and aquatic animals. ---|--- (8) | Bsal may be transmitted between salamander species native to different regions and cross-contamination may take place in various establishments run by operators who keep and exchange salamanders. This increases the risk of the transmission of Bsal by traded salamanders irrespective of the health status of their place of origin and their health situation in the wild. Therefore, consignments of salamanders destined for movements between Member States or for the entry into the Union should be subject to measures which mitigate that risk. However, these measures should not apply to the non-commercial movements of pet salamanders, as such non-commercial movements are covered by the rules laid down in Regulation (EU) No 576/2013 of the European Parliament and of the Council (9). Those non-commercial movements concern, and are limited to, animals under the care of, and accompanying their owners or authorised persons and do not involve the transfer of ownership. Therefore non-commercial movements of pet salamanders represent a negligible risk for the spread of Bsal either to traded salamanders or to salamanders living in the wild. ---|--- (9) | Salamanders which are exchanged only between confined establishments approved by the competent authority in accordance with Regulation (EU) 2016/429 should not be subjected to quarantine or testing as the biosecurity measures in place in those confined establishments are appropriate to mitigate the risk of the spread of Bsal. ---|--- (10) | Consignments of salamanders which have entered into the Union and have already undergone quarantine with testing with negative results, or which have received satisfactory treatment in the Union in an appropriate establishment after their entry into the Union, should not be subjected to repeated quarantine or testing, if they are intended to be moved to another Member State, provided that they were kept isolated from salamanders of a different health status. ---|--- (11) | There is a lack of information on the technical capabilities of veterinary services and laboratories around the world to test for Bsal, while various bodies in the European Union are in the forefront of progress on the diagnosis and treatment of Bsal. It is therefore appropriate that consignments of salamanders entering the Union should be quarantined in an appropriate establishment, and tested and treated after their entry into the Union. ---|--- (12) | Third countries and territories approved for the issuing of animal health certificates for the entry into the Union of consignments of salamanders should be limited to those that are members of the OIE and which are thereby obliged to observe the international standards for issuing animal health certificates. ---|--- (13) | Treatments should be specified and in line with the protocols already described in peer-reviewed scientific literature as highlighted by the EFSA Scientific and Technical assistance, or with comparable ones. ---|--- (14) | Consignments of salamanders should only be authorised to enter into the Union by the competent authority of the border control post of arrival into the Union, if that authority receives an attestation by the natural or legal person responsible for the establishment of destination confirming that the consignments will be accepted. ---|--- (15) | The emergency measures provided for by this Decision should apply from the date of application of Regulation (EU) 2016/429 and should be reviewed taking into account the gravity of the epidemiological situation due to new developments and annual reporting by the competent authorities of the Member States. ---|--- (16) | 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: Article 1 Subject and scope This Decision lays down emergency measures for movements of consignments of salamanders between Member States and the entry into the Union (10) of such consignments. This Decision shall not apply to non-commercial movements of pet salamanders. Article 2 Definitions For the purposes of this Decision, the following definitions shall apply: (a) | ‘salamanders’ means all amphibians of the Order of Caudata; ---|--- (b) | ‘Bsal’ means an infection with Batrachochytrium salamandrivorans (Kingdom Fungi, Phylum Chytridiomycota, Order Rhizophydiales); ---|--- (c) | ‘appropriate establishment’ means premises: | (i) | where salamanders are kept in quarantine before being dispatched to another Member State or after their entry into the Union where they are intended for the internal market; and ---|--- (ii) | which are registered by the competent authority prior to the date of commencement of any period of quarantine; ---|--- (d) | ‘appropriate diagnostic test’ means a real-time quantitative polymerase chain reaction (qPCR) assay containing species-specific STerF and STerR primers amplifying a 119 nucleotide long fragment of Bsal DNA. ---|--- Article 3 Animal health requirements for movements of consignments of salamanders between Member States Member States shall prohibit the dispatch of consignments of salamanders to other Member States, except where such consignments comply with the following animal health requirements: (a) | the salamanders must come from a population where there are: | (i) | no mortalities with an undetermined cause; ---|--- (ii) | no mortalities due to Bsal; ---|--- (iii) | no clinical signs of Bsal, in particular skin lesions and ulcers; ---|--- (b) | the salamanders must not show any clinical signs or symptoms of Bsal, in particular they must show no skin lesions or ulcers at the time of examination by the official veterinarian; that examination must be carried out within a period of 48 hours prior to the time of dispatch of the consignment to the Member State of destination; ---|--- (c) | the consignment must consist of salamanders which comply with at least one of the following sets of requirements: | (i) | they must have undergone quarantine in an appropriate establishment for a period of at least six weeks immediately prior to the date of issuing of the animal health certificate in accordance with the model set out in Part A of Annex I; and skin swab samples from the salamanders in the consignment must have been tested for Bsal with negative results during the fifth week of the period of quarantine with the appropriate diagnostic test, in accordance with the sample sizes set out in point 1(a) of Annex III; or ---|--- (ii) | they must have been treated to the satisfaction of the competent authority against Bsal in accordance with the reference table set out in point 1(b) of Annex III; or ---|--- (iii) | they must come from a confined establishment and are intended for another confined establishment; or ---|--- (iv) | they must have entered into the Union from a third country, had undergone quarantine in an appropriate establishment of destination in accordance with Article 6 and have been kept isolated from other salamanders between the end of that quarantine period and the issuing of the animal health certificate referred to in point (d); ---|--- (d) | the consignments must be accompanied by an animal health certificate which is drawn up in accordance with the model animal health certificate set out in Part A of Annex I. ---|--- Article 4 Animal health requirements for the entry into the Union of consignments of salamanders The competent authority at the border control post of arrival into the Union shall only authorise the entry into the Union of consignments of salamanders from third countries and territories, presented for the purpose of official controls as provided for in Article 47(1) of Regulation (EU) 2017/625 (11) of the European Parliament and of the Council, if the outcome of those official controls at the border control post is favourable and such consignments comply with the following requirements: (a) | they must come from a third country or territory of origin which is a member of the World Organisation for Animal Health (OIE); ---|--- (b) | the salamanders in the consignment must not show any clinical signs of Bsal, in particular there must be no signs of skin lesions or ulcers at the time of a clinical examination by the official veterinarian for the purpose of issuing the animal health certificate referred to in point (d); and that clinical examination must have been carried out within a period of 48 hours prior to the time of loading for dispatch of the consignment to the Union; ---|--- (c) | before issuing the animal health certificate referred to in point (d), the epidemiological unit comprising the salamanders in the consignment must have been isolated from other salamanders at the latest at the time of the clinical examination for the purpose of issuing the animal health certificate referred to in point (d) and they must not have been in contact with other salamanders since that time; ---|--- (d) | they must be accompanied by an animal health certificate which is drawn up in accordance with the model certificate set out in Part B of Annex I. ---|--- Article 5 Attestation of acceptance regarding the establishment of destination Member States shall ensure that where consignments of salamanders are intended for the internal market, the operator responsible for the consignment must provide a written attestation in one of the official languages of the Member State of the border control post and signed by the natural or legal person responsible for an appropriate establishment of destination or for a confined establishment, stating the following: (a) | the name, address and registration number of the establishment of destination or the approval number in case of a confined establishment; ---|--- (b) | in case of an appropriate establishment of destination that it complies with the minimum conditions set out in Annex II; ---|--- (c) | that the consignment of salamanders will be accepted for quarantine at the establishment of destination or at the confined establishment. ---|--- Article 6 Quarantine rules for consignments of salamanders which have entered into the Union and into an appropriate establishment of destination Member States shall ensure that: (a) | the operator keeps the consignment of salamanders in quarantine in the appropriate establishment of destination until released from that establishment by the official veterinarian; ---|--- (b) | an official veterinarian inspects the conditions of quarantine in the appropriate establishment of destination for each consignment of salamanders, including an examination of the mortality records and a clinical inspection of the salamanders, checking in particular for skin lesions and ulcers; ---|--- (c) | the official veterinarian carries out the examination, sampling, testing and treatment procedures for Bsal in accordance with the procedures referred to in points 1 and 2 of Annex III; ---|--- (d) | the official veterinarian only releases the consignment of salamanders from that establishment by a written authorisation: | (i) | in the case of testing as referred to in point 1(a) of Annex III, provided that at least six weeks have elapsed since the date of the commencement of the period of quarantine and not before the receipt of the negative results of the testing, whichever is the later; or ---|--- (ii) | in the case of treatment as referred to in point 1(b) of Annex III, only after satisfactory completion of that treatment. ---|--- Article 7 Measures to be taken in the event of an outbreak of Bsal in an appropriate establishment of destination 1\. The competent authority shall ensure that where there is an outbreak of Bsal in an epidemiological unit, the following measures are taken by the appropriate establishment of destination: (a) | all salamanders in the same epidemiological unit are either: | (i) | treated to the satisfaction of the competent authority against Bsal in accordance with point 3 of Annex III; or ---|--- (ii) | killed and disposed of as animal by-products referred to in Article 8(a)(iii) of Regulation (EC) No 1069/2009 of the European Parliament and of the Council (12) in accordance with Article 12 thereof; ---|--- (b) | following completion of the measures referred to in point (a), the area of the appropriate establishment of destination where the epidemiological unit had been kept is cleaned and disinfected to the satisfaction of the competent authority. ---|--- 2\. The competent authority may require testing of the treated salamanders to verify the effectiveness of the treatment referred to in paragraph 1(a)(i) and may require repeated treatments, as appropriate, to prevent the spread of Bsal. Article 8 Annual reporting requirements At the latest by 30 June each year, those Member States which have handled consignments of salamanders in the previous year, shall submit to the Commission the following information concerning the previous year, differentiating between information related to the movements of such consignments between Member States and to the entry of such salamander consignments into the Union: (a) | the number of epidemiological units with an outbreak of Bsal; ---|--- (b) | the number of epidemiological units treated without an outbreak of Bsal; ---|--- (c) | any further information they deem relevant on the testing, treating or handling of consignments of salamanders and on the implementation of this Decision. ---|--- Article 9 Applicability This Decision shall apply from 21 April 2021 until 31 December 2022. Article 10 Addressees This Decision is addressed to the Member States. Done at Brussels, 22 February 2021. For the Commission Stella KYRIAKIDES Member of the Commission * * * (1) OJ L 84, 31.3.2016, p. 1. (2) http://bsaleurope.com/european-distribution/ (3) Commission Implementing Decision (EU) 2018/320 of 28 February 2018 on certain animal health protection measures for intra-Union trade in salamanders and the introduction into the Union of such animals in relation to the fungus Batrachochytrium salamandrivorans (OJ L 62, 5.3.2018, p. 18). (4) Commission Implementing Decision (EU) 2019/1998 of 28 November 2019 amending Implementing Decision (EU) 2018/320 as regards the period of application of the animal health protection measures for salamanders in relation to the fungus Batrachochytrium salamandrivorans (OJ L 310, 2.12.2019, p. 35). (5) EFSA Journal 2017;15(11):5071 (6) EFSA Journal 2017;15(2):4739. (7) http://bsaleurope.com/scientific-publications/ (8) 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 (OJ L 308, 4.12.2018, p. 21). (9) Regulation (EU) No 576/2013 of the European Parliament and of the Council of 12 June 2013 on the non-commercial movement of pet animals and repealing Regulation (EC) No 998/2003 (OJ L 178, 28.6.2013, p. 1). (10) In accordance with the Agreement on the withdrawal of the United Kingdom of Great Britain and Northern Ireland from the European Union and the European Atomic Energy Community, and in particular Article 5(4) of the Protocol on Ireland / Northern Ireland in conjunction with Annex 2 to that Protocol, for the purposes of this Decision references to the 'Union' include the United Kingdom in respect of Northern Ireland. (11) Regulation (EU) 2017/625 of the European Parliament and of the Council of 15 March 2017 on official controls and other official activities performed to ensure the application of food and feed law, rules on animal health and welfare, plant health and plant protection products, amending Regulations (EC) No 999/2001, (EC) No 396/2005, (EC) No 1069/2009, (EC) No 1107/2009, (EU) No 1151/2012, (EU) No 652/2014, (EU) 2016/429 and (EU) 2016/2031 of the European Parliament and of the Council, Council Regulations (EC) No 1/2005 and (EC) No 1099/2009 and Council Directives 98/58/EC, 1999/74/EC, 2007/43/EC, 2008/119/EC and 2008/120/EC and repealing Regulations (EC) No 854/2004 and (EC) No 882/2004 of the European Parliament and of the Council, Council Directives 89/608/EEC, 89/662/EEC, 90/425/EEC, 91/496/EEC, 96/23/EC, 96/93/EC and 97/78/EC and Council Decision 92/438/EEC (Official Controls Regulation) (OJ L 95, 7.4.2017, p. 1). (12) Regulation (EC) No 1069/2009 of the European Parliament and of the Council of 21 October 2009 laying down health rules as regards animal by- products and derived products not intended for human consumption and repealing Regulation (EC) No 1774/2002 (OJ L 300, 14.11.2009, p. 1). * * * ANNEX I PART A MODEL ANIMAL HEALTH CERTIFICATE for the movement between Member States of salamanders PART B MODEL ANIMAL HEALTH CERTIFICATE for the entry into the Union of salamanders * * * ANNEX II MINIMUM CONDITIONS FOR THE APPROPRIATE ESTABLISHMENTS OF DESTINATION (1) | The appropriate establishment of destination shall: | (a) | have a system that ensures adequate surveillance of the salamanders; ---|--- (b) | be under the control of the competent authority; ---|--- (c) | be cleaned and disinfected in accordance with the instructions of the competent authority. ---|--- (2) | The operator of the appropriate establishment shall ensure that: | (a) | cleaning and disinfection of the tanks, crates, equipment, means of transport or other fomites used for the transport of the salamanders is carried out unless they are destroyed, in a way to prevent the spread of Bsal; ---|--- (b) | waste material and waste water is collected regularly, stored and subsequently treated in a way to prevent the spread of Bsal; ---|--- (c) | carcases of quarantined salamanders which die are examined in a laboratory indicated by the competent authority; ---|--- (d) | the necessary tests and treatments of salamanders are carried out in consultation with and under the control of the competent authority. ---|--- (3) | The operator of the appropriate establishments of destination shall inform the competent authority of all diseases and deaths of salamanders during the period of quarantine. ---|--- (4) | The operator of the appropriate establishments of destination keeps a record of: | (a) | the date, number and species of salamanders entering and leaving the appropriate establishment of destination for each consignment; ---|--- (b) | copies of the animal health certificates and the common health entry documents accompanying the consignment of salamanders; ---|--- (c) | cases of all illnesses and the number of deaths on a daily basis; ---|--- (d) | dates and results of testing; ---|--- (e) | types and dates of treatment and the number of salamanders subjected to it. ---|--- * * * ANNEX III EXAMINATION, SAMPLING, TESTING AND TREATMENT PROCEDURES FOR BSAL (1) | During quarantine, the salamanders are subjected to the following procedures: | (a) | Skin swab samples from quarantined salamanders must be examined under the control of the competent authority with the appropriate diagnostic test during the fifth week following the date of their entry into the appropriate establishment in accordance with the sample sizes set out in the reference table, unless the operator opts for treatment in accordance with point (b). Reference Table (1): | Size of the epidemiological unit | 62 or less | 186 | 200 | 250 | 300 | 350 | 400 | 450 ---|---|---|---|---|---|---|---|--- Sample size | all | 96 | 98 | 102 | 106 | 108 | 110 | 111 (b) | If the operator opts for one of the treatments listed in point (3) all salamanders in the consignment must be treated by the operator against Bsal under the control of the official veterinarian to the satisfaction of the competent authority. ---|--- (c) | In cases referred to in point (b) the official veterinarian may require representative sample of the epidemiological unit to be analysed with the appropriate diagnostic test before the treatment to monitor the presence of Bsal or after treatment to verify the absence of Bsal. In this case pooling of skin swab samples from up to four animals may be done. ---|--- (d) | Skin swab samples from all dead or clinically sick salamanders, in particular those with skin lesions, must be examined under the control of the official veterinarian with the appropriate diagnostic test at the time they show lesions or other clinical signs or at the time of death, whichever happens sooner. ---|--- (e) | All salamanders which die in the appropriate establishment must be subjected to a post-mortem examination under the control of the official veterinarian, in particular to check for signs of Bsal and, to the extent possible, to confirm or to exclude Bsal as the cause of death. ---|--- (2) | All testing of samples taken and post-mortem examination during quarantine must be carried out in laboratories indicated by the competent authority. ---|--- (3) | The following treatments are considered to be satisfactory: | (a) | keeping salamanders at a temperature of at least 25 °C for at least 12 days; ---|--- (b) | keeping salamanders at a temperature of at least 20 °C for at least 10 days combined with a treatment with polymyxin E submersion baths (2 000 IU/ml) for 10 minutes twice per day, followed by applying voriconazole spray (12,5 μg/ml); ---|--- (c) | any other treatment with comparable results in eliminating Bsal as reported in a peer-reviewed article published in a scientific journal. ---|--- * * * (1) Assuming 3 % prevalence of Bsal in the epidemiological unit and ensuring its detection with a 95 % confidence rate with the sensitivity of the appropriate diagnostic test calculated to be at 80 %. * * *