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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 (notified under document C(2018) 1208) (Text with EEA relevance. )

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 (notified under document C(2018) 1208) (Text with EEA relevance. )

THE EUROPEAN COMMISSION,

Having regard to the Treaty on the Functioning of the European Union,

Having regard to Council Directive 90/425/EEC of 26 June 1990 concerning veterinary and zootechnical checks applicable in intra-Community trade in certain live animals and products with a view to the completion of the internal market(1), and in particular Article 10(4) thereof,

Having regard to Council Directive 91/496/EEC of 15 July 1991 laying down the principles governing the organisation of veterinary checks on animals entering the Community from third countries and amending Directives 89/662/EEC, 90/425/EEC and 90/675/EEC(2), and in particular Article 18(1) thereof,

Whereas:

  1. Since 2013, Batrachochytrium salamandrivorans (Bsal), which is an emerging pathogen fungus of salamanders, has been occuring in Belgium, Germany, the Netherlands and the United Kingdom. It affects kept and wild salamander populations, and it 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 therefore act as a reservoir and source of infection or contamination for other species of salamanders.

  2. According to current scientific knowledge concerning Bsal, compiled by a scientific opinion(3) of the European Food Safety Authority (EFSA) about Bsal within its Assessment of listing and categorisation of animal diseases in the framework of Regulation (EU) 2016/429 of the European Parliament and of the Council(4), Bsal seems to be endemic at least in Japan, Thailand and Vietnam with around a 3 % prevalence rate in wild salamander populations. It is generally thought to have originated in East Asia and to be widespread and endemic there. At the same time, there is a lack of information on how widespread it is in other parts of the world. It is also generally thought that trade in infected or carrier salamanders contributes to the spread of Bsal.

  3. According to available data, both resistant and susceptible salamander species are traded. Council Directive 92/65/EEC(5) lays down the animal health requirements governing trade in and imports into the Union of animals not subject to the animal health requirements laid down in the specific Union acts listed in Annex F thereto. Union animal health legislation, including Directive 92/65/EEC, currently lays down no specific animal health requirements for trade in salamanders or for their imports into the Union that would be effective in protecting animal health against the spread of Bsal in the Union.

  4. The EFSA, in its scientific and technical assistance concerning the survival, establishment and spread of Batrachochytrium salamandrivorans (Bsal) in the EU(6) (the EFSA Assistance), assessed the potential of Bsal to affect the health of wild and kept salamanders in the Union, the effectiveness and feasibility of a movement ban on traded salamanders, the validity, reliability and robustness of available diagnostic methods for Bsal detection and possible alternative methods and feasible risk mitigation measures to ensure safe international and intra-Union trade in salamanders.

  5. According to the EFSA Assistance, quarantining salamanders, the testing of salamanders to demonstrate that they are free of infection from Bsal, restricting movements of salamanders, hygienic procedures and biosecurity measures or treating salamanders against Bsal are important risk mitigation measures in preventing the spread of that disease.

  6. The EFSA Assistance also highlighted many gaps and uncertainties in the current state of knowledge as regards Bsal. In particular, it concluded, that due to the complexity of the taxonomy as well as the lack of current evidence concerning which species are susceptible to Bsal, rules at the level of the taxonomic order are likely to be both more effective and more feasible than species-specific rules.

  7. It is therefore appropriate to lay down animal health protection measures for intra-Union trade in consignments of salamanders and the introduction of such consignments into the Union on the taxonomic order of Caudata, in order to ensure that Bsal is not spread by intra-Union trade in those animals and the introduction of such animals into the Union. These measures should take into account the risk mitigation measures referred to in the EFSA Assistance and in particular provide for the appropriate quarantine, diagnostic testing and treatment of salamanders as well as for certification of their health status for their trade in and introduction into the Union. These measures are of an emergency nature and are not deemed specific measures within the meaning of Article 18(2) of Council Directive 92/65/EEC.

  8. Regulation (EU) No 576/2013 of the European Parliament and of the Council(7) lays down the animal health requirements applicable to the non-commercial movements of pet animals listed in Annex I thereto, and amphibia are included in the animals listed in that Annex. The animal health protection measures laid down in this Decision should not apply to the non-commercial movements of pet salamanders which fall within the scope of Regulation (EU) No 576/2013, due the specificities of those movements and given the lack of information concerning such movements.

  9. These measures should apply regardless of other Union rules potentially relevant for trade in and introduction of salamanders, in particular Council Regulation (EC) No 338/97(8).

  10. The World Organisation for Animal Health (OIE) listed infection with Bsal in its Aquatic Animal Health Code during its 85th General Session on 21-26 May 2017. But detailed international standards are not yet available and there is a lack of information on the technical capabilities of veterinary services and laboratories around the world to test for Bsal, while various concerned stakeholders in the European Union are in the forefront of progress on the diagnosis and treatment of Bsal and the safe handling of traded salamanders. It is therefore appropriate that most risk-mitigating measures, in particular the quarantining in an appropriate establishment, testing and treatment of traded and introduced salamanders are to be done by competent veterinary authorities, operators and laboratories located within the Union.

  11. According to the EFSA Assistance, it is possible that Bsal is transmitted between salamander species native to different areas and cross-contamination may take place in various establishments breeding, collecting or distributing salamanders. This makes the risk of Bsal occurring in traded salamanders independent from their place of origin and from the situation in the wild. Therefore all consignments of salamanders destined for intra-Union trade or introduced into the Union should be subject to risk mitigation measures.

  12. Minimum conditions for appropriate establishments to be used for quarantining salamanders should be laid down to ensure their biosecurity, while the handling of salamanders which die in those establishments should be done according to existing specific rules laid down in the Animal by-products Regulation(9).

  13. As regards the size of the quarantined epidemiological units, a minimum size eligible for certification for negative diagnostic test results should be specified due to the limited sensitivity of the best available real-time quantitative polymerase chain reaction (qPCR) assay which is sufficiently reliable to be used only if the epidemiological units comprise at least 62 salamanders.

  14. Salamanders which have undergone quarantine with testing with negative results or satisfactory treatment in the Union should not be subjected to quarantine or testing again, provided that they have been kept isolated from salamanders of a different health status in an appropriate establishment.

  15. As regards treatments, these should be specified and be in line with the protocols already described in peer-reviewed scientific literature as highlighted by the EFSA Assistance or with comparable ones.

  16. A list of third countries approved for issuing animal health certificates for the introduction into the Union of consignments of salamanders should be established and limited to those countries which have already provided sufficient guarantees for issuing certificates to prevent misleading and fraudulent certification, at least equivalent to Council Directive 96/93/EC(10). Therefore, it is appropriate to refer to already available lists existing in the context of introduction into the Union of other commodities. Such third countries are listed in Annex I to Commission Decision 2004/211/EC(11), Part 2 of Annex II to Commission Decision 2007/777/EC(12), Annex I to Commission Regulation (EC) No 798/2008(13), Part 1 of Annex I to Commission Regulation (EC) No 119/2009(14), Part 1 of Annex II to Commission Regulation (EU) No 206/2010(15), or Annex I to Commission Regulation (EU) No 605/2010(16), respectively.

  17. Consignments of salamanders should be introduced in the Union only if they comply with all the requirements and the competent veterinary authority of the border inspection post of entry can also ascertain that the consignments will be accepted by an operator responsible for an appropriate establishment of destination to be duly quarantined.

  18. The actual arrival of consignments of salamanders introduced into the Union from third countries at their place of quarantine in the Union should be recorded in the electronic version of the common veterinary entry document set out in Annex I to Commission Regulation (EC) No 282/2004(17) and managed by the integrated computerised veterinary system known as Traces, so that the competent veterinary authority of the border inspection post of entry can be reliably informed of their arrival.

  19. This Decision should provide for a transitional period in order to give the Member States, the competent authorities and economic operators time to put in place the necessary procedures so that they are in a position to comply with the rules laid down in this Decision. The length of this period should be limited to a few months. At the same time, risk mitigation measures based on the required level of protection by the Member States of destination should already apply.

  20. It is expected that more information will be available in the coming years about Bsal from scientific sources and from results of official controls carried out by the Member States, supplementing the current knowledge concerning that disease. Therefore, the animal health protection measures laid down in this Decision should be of a temporary nature. Nevertheless, they should apply at least until 31 December 2019 to allow for 1 year of implementation by the Member States and subsequent annual reporting and consideration thereof, while permanent EU animal health rules may be laid down under the new Regulation (EU) 2016/429 on transmissible animal diseases to apply from the date of application of that Regulation.

  21. 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 the animal health protection measures for intra-Union trade in consignments of salamanders and the introduction of such consignments into the Union.

Article 2 Definitions

For the purposes of this Decision, the following definitions shall apply:

  1. ‘salamanders’ means all amphibians of the order Caudata;

  2. ‘Bsal’ means the fungus Batrachochytrium salamandrivorans (kingdom fungi, Phylum Chytridiomycota, order Rhizophydiales);

  3. ‘epidemiological unit’ means a group of salamanders with the same likelihood of exposure to Bsal;

  4. ‘quarantine’ means the keeping of salamanders in isolation with no direct or indirect contact with salamanders outside their epidemiological unit, for the purposes of ensuring that there is no spread of Bsal while the animals in isolation are undergoing observation for a specified length of time and testing and, if appropriate, treatment;

  5. ‘operator’ means any natural or legal person having salamanders under its responsibility, including for a limited duration of time, but excluding pet keepers;

  6. ‘appropriate establishment’ means premises:

    1. where salamanders are kept in quarantine before being dispatched to another Member State or after their introduction into the Union; and

    2. which are registered by the competent authority prior to the date of commencement of any quarantine;

  7. ‘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;

  8. ‘common veterinary entry document’ or ‘CVED’ means the document notifying the arrival of animals into the Union as provided for in Article 1 of Regulation (EC) No 282/2004 and drawn up in accordance with the model set out in Annex I thereto and managed by the integrated computerised veterinary system known as Traces;

  9. ‘confirmed case of Bsal’ means the confirmation of the presence of Bsal or its genetic material on or in the tissues of salamanders by the appropriate diagnostic test;

Article 3 Animal health conditions for intra-Union trade in salamanders

1.

Member States shall prohibit the dispatch of consignments of salamanders to another Member State, except where such consignments comply with the following animal health conditions:

  1. they are accompanied by an animal health certificate which complies with the model animal health certificate set out in Part A of Annex I;

  2. the salamanders must not show clinical signs of Bsal, in particular they must show no skin lesions and ulcers at the time of examination by the official veterinarian; that examination must be carried out within a period of 24 hours prior to the time of dispatch of the consignment to the Member State of destination;

  3. the salamanders must come from a population where there have been no mortalities due to Bsal and no clinical signs of Bsal, in particular skin lesions and ulcers must not have been observed by the operator;

  4. the consignment must consist of:

    1. at least 62 salamanders which have undergone quarantine as one epidemiological unit in an appropriate establishment which complies with the minimum conditions set out in Annex II for a period of at least 6 weeks immediately prior to the date of the issuing of the animal health certificate 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

    2. salamanders which have been treated to the satisfaction of the competent authority against Bsal in accordance with point 1(b) of Annex III.

2.

Where consignments of salamanders have been introduced into the Union from a third country and they have already undergone quarantine in an appropriate establishment of destination in accordance with Article 6, Member States shall only authorise their dispatch to another Member State where such consignments comply with the following conditions:

  1. the animal health conditions laid down in paragraph 1(a), (b) and (c);

  2. the salamanders have been kept in quarantine in the appropriate establishment which complies with the minimum conditions set out in Annex II, between the end of the period of quarantine following their introduction into the Union and the issuing of the animal health certificate set out in Part A of Annex I.

Article 4 Animal health conditions for the introduction into the Union of consignments of salamanders

Member States shall prohibit the introduction into the Union of consignments of salamanders from a third country, except where such consignments comply with the following conditions:

  1. they come from third countries listed in one of the following:

    1. Annex I to Decision 2004/211/EC;

    2. Part 2 of Annex II to Decision 2007/777/EC;

    3. Annex I to Regulation (EC) No 798/2008;

    4. Part 1 of Annex I to Regulation (EC) No 119/2009;

    5. Part 1 of Annex II to Regulation (EU) No 206/2010;

      or

    6. Annex I to Regulation (EU) No 605/2010;

  2. they are accompanied by an animal health certificate which complies with the model animal health certificate set out in Part B of Annex I;

  3. the salamanders must not show clinical signs of Bsal, in particular there must be no signs of skin lesions and ulcers at the time of examination by the official veterinarian; and that examination must have been carried out within a period of 24 hours prior to the time of dispatch of the consignment to the Union;

  4. before issuing the animal health certificate referred to in point (b), the epidemiological unit comprising the salamanders in the consignment must have been isolated from other salamanders at the latest at the time of the examination for the purposes of issuing of animal health certificate and they must not have been in contact with other salamanders since that time.

Article 5 Attestation regarding the appropriate establishment of destination

Article 6 Quarantine rules for consignments of salamanders introduced into the Union

Article 7 Measures to be taken in the event of a confirmed case of Bsal in an appropriate establishment of destination

Article 8 Costs

Article 9 Annual reporting requirements

Article 10 Transitional measures

Article 11 Applicability

Article 12 Addressees

ANNEX I

ANNEX II

ANNEX III