Commission Delegated Regulation (EU) 2023/2515 of 8 September 2023 amending Delegated Regulation (EU) 2020/688 as regards certain animal health requirements for movements within the Union of terrestrial animals

Official Journal EN of the European Union L series 2023/2515 14.11.2023 COMMISSION DELEGATED REGULATION (EU) 2023/2515 of 8 September 2023 amending Delegated Regulation (EU) 2020/688 as regards certain animal health requirements for movements within the Union of terrestrial animals (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 to Articles 131(1), points (c) and (d), 132(2), 140(b), Article 144(1), points (a) and (b), Article 146(1), and Article 149(4) thereof,

Whereas:

(1) Regulation (EU) 2016/429 lays down rules for the prevention and control of animal diseases that are transmissible to animals or to humans. That Regulation lays down in its Part IV, Title I, Chapter 3, the animal health requirements for movements within the Union of kept terrestrial animals.

(2) Commission Delegated Regulation (EU) 2020/688(2)supplements the rules for the prevention and control of animal diseases transmissible to animals laid down in Article 5(1) of Regulation (EU) 2016/429 as regards movements within the Union of kept terrestrial animals, wild terrestrial animals and hatching eggs. It also aims to collect the rules on animal diseases in a single act, rather than their being scattered over a number of different acts. The various risk mitigation measures to prevent spread of listed diseases by movements within the Union of animals and the content of the rules is substantively inter-linked, and they are to apply to all operators moving kept or wild terrestrial animals. In the interest of simplicity and transparency, as well as to facilitate the application of the rules and avoid duplication, this amendment should be laid down in a single act rather than in a number of cross- referenced separate acts.

(3) Infection with epizootic haemorrhagic disease virus is listed in the Annex to Commission Implementing Regulation

(EU) 2018/1882(3)as a Category D disease for which measures are needed to prevent it from spreading on account of movements between Member States. The epidemiological situation of the disease in the Union has changed since the entry into force of Regulation (EU) 2016/429 and Delegated Regulation (EU) 2020/688, with the first ever

notification of outbreaks in the Union in several Member States.

(4) Article 132(2) of Regulation (EU) 2016/429 provides that the Commission determines a maximum timeframe within which the operator of a slaughterhouse receiving kept ungulates for slaughter from another Member State should ensure that those animals are slaughtered. Movement of consignments of certain ungulates susceptible to infection with epizootic haemorrhagic disease virus to a slaughterhouse in another Member State may have a specific risk of spread due to the vector-borne transmission of the disease. This Regulation should therefore provide for a maximum timeframe within which animals should be slaughtered, to ensure that their health status would not compromise the health status of the animals at the place of destination.

(1) OJ L 84, 31.3.2016, p. 1.

(2) 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 (OJ L 174, 3.6.2020, p. 140).

(3) 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).

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(5) To address the new epidemiological situation as regards infection with epizootic haemorrhagic disease virus while continuing the prevention of its spreading on account of movements between Member States, Delegated Regulation

(EU) 2020/688 should be adapted. This Regulation provides for two new risk-mitigating measures: the establishment of zones seasonally free from infection with epizootic haemorrhagic disease and the use of vector protected establishments, that are applicable to the movements from areas surrounding outbreaks of infection with epizootic haemorrhagic disease virus. The new risk mitigating measures are aligned with the international standards of the World Organisation for Animal Health (WOAH).

(6) Article 67 of Delegated Regulation (EU) 2020/688 lays down requirements for movements of captive birds intended for exhibitions and their movement from those exhibitions. However, that Regulation provides that those birds should only be returned to their Member State of origin. However, some captive birds may change ownership during the exhibition and should thereafter be dispatched to a Member State which is not the Member State of origin. It is therefore necessary to authorise such movements and, as the birds are moved from an exhibition in a Member State which is not the Member State of origin to an establishment in a third Member State, to establish the conditions of that particular movement between Member States.

(7) Article 91(2), point (b), of Delegated Regulation (EU) 2020/688 provides for a timeframe for an identity check and a clinical examination of equine animals before issuing an animal health certificate. Currently the possibility for checks and examinations on the last working day before departure is restricted to certain equine animals. To facilitate movement of all equine animals to other Member States over weekends and holidays, including of those taking part in competitions, races and other equestrian events, a possibility of such checks and examinations on those animals to be carried on the last working day before departure from the establishment of origin, should be allowed.

(8) Article 92(2) of Delegated Regulation (EU) 2020/688 provides for a derogation from the 10-day validity period of the animal health certificate. It is necessary, based on the experience with implementation of this provision, to clarify that the animal health certificate should be valid for 30 days if it is issued for an individual equine animal accompanied by its single lifetime identification document which includes a valid validation mark or a valid licence, but not for a consignment of equine animals.

(9) Part 6 of Annex I to Delegated Regulation (EU) 2020/688 provides for bovine viral diarrhoea diagnostic methods that should be used for the purposes of movements of animals within the Union. Virus neutralisation, a diagnostic method, is not included in that annex, although it is fit for the purpose of demonstrating individual animal freedom from infection prior to movement in accordance with the Manual of Diagnostic Tests and Vaccines for Terrestrial Animals of WOAH. Therefore, virus neutralisation should be added to the list of authorised diagnostic methods.

(10) Article 45(2) of Commission Delegated Regulation (EU) 2019/2035(4) provides for the compulsory individual identification of ovine and caprine animals which are not intended to be moved directly to a slaughterhouse from their establishment of birth. Article 18, point (a), of Delegated Regulation (EU) 2020/688 erroneously provides alternatives to the compulsory individual identification of kept ovine and caprine animals intended for slaughter in another Member State. For reasons of clarity and consistency, Article 18 of Delegated Regulation (EU) 2020/688 should be corrected.

(11) Article 43(4) of Delegated Regulation (EU) 2020/688 erroneously refers to the possibility of non-identification of ovine and caprine animals intended for slaughter, in contravention to Article 45 of Delegated Regulation

(EU) 2019/2035. For reasons of clarity and consistency, Article 43(4) of Delegated Regulation (EU) 2020/688 should be corrected.

(12) Experience from the Member States with the application of the rules laid down in Delegated Regulation

(EU) 2020/688 concerning movements of dogs, cats and ferrets for commercial purposes has indicated that greater clarity is required concerning the documentation that should accompany such animals and the check to be performed on such documentation. In particular, Article 53(b) erroneously requires that the individual identification documents should document that the animals come from an establishment in which infection with

(4) Commission Delegated Regulation (EU) 2019/2035 of 28 June 2019 supplementing Regulation (EU) 2016/429 of the European Parliament and of the Council as regards rules for establishments keeping terrestrial animals and hatcheries, and the traceability of certain kept terrestrial animals and hatching eggs (OJ L 314, 5.12.2019, p. 115).

2/11 ELI: http://data.europa.eu/eli/reg_del/2023/2515/ojEN OJ L, 14.11.2023 rabies virus has not been reported prior to departure, whereby that is a requirement to be stated in the accompanying animal health certificate. In Article 86(1) a reference to the link to the identification document is missing, therefore it is not consistent with the comparable Article 86(2) and the reference must be added. In Article 91(1), point (j), the documentary check on the identification document that is already implied to be done as part of an identity check of the animals, should be more clearly spelt out. Articles 53(b), 86(1) and 91(1), point (j), should therefore be corrected accordingly.

(13) Article 69 of Delegated Regulation (EU) 2020/688 provides for a derogation for movements of kept equine animals to other Member States. It allows movements of registered equine animals to other Member States without an animal health certificate under certain conditions. It is necessary to correct that provision to clarify the sequence of the steps that need to be implemented by Member States to be able to use that derogation. A clarification is also required that a Member State of origin could only move kept equine animals to a territory of a Member State of destination under the derogation if the conditions established by the Member State of destination are fulfilled by the Member State of origin and an intention of using the derogation had been communicated to the Member State of destination by the Member State of origin.

(14) Delegated Regulation (EU) 2020/688 should therefore be amended and corrected accordingly,

HAS ADOPTED THIS REGULATION:

Article 1 Amendments to Delegated Regulation (EU) 2020/688 Delegated Regulation (EU) 2020/688 is amended as follows:

(1) in Article 9, the following paragraph 3 is added: ‘3. Operators of slaughterhouses shall ensure that animals of listed species for infection with epizootic haemorrhagic disease virus are slaughtered at the latest within 24 hours of arrival at the slaughterhouse when they come from another Member State and do not fulfil the requirements laid down in Article 10(1), point (f), Article 15(1), point (e), Article 23(1), point (g), Article 26(1), point (g) or Article 29(1), point (f) respectively, for each species concerned.’;

(2) Article 10, paragraph 1 is amended as follows:

(a) point (f) is replaced by the following: ‘(f) the animals come from an establishment situated in an area of at least 150 km radius around that

establishment in which infection with epizootic haemorrhagic disease virus:

(i) has not been reported in kept animals of listed species for that disease during the last 2 years prior to departure; or

(ii) has been reported in kept animals of listed species for that disease during the last 2 years prior to

departure but one of the following set of requirements is complied with:

1. the animals have been kept in a zone seasonally free from epizootic haemorrhagic disease in accordance with Parts 1 and 2 of Annex IX: — for at least 60 days prior to the date of movement; or — for at least 28 days prior to the date of movement and have been subjected to a serological test, with negative results, carried out on samples collected at least 28 days following the entry date of the animal into the seasonally disease-free area; or — for at least 14 days prior to the date of movement and have been subjected to a PCR test, with negative results, carried out on samples collected at least 14 days following the entry date of the animal into the seasonally disease-free area; or

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2. the animals have been protected against attacks by the vectors during transportation to the place of destination and they have been kept protected against attacks by vectors in a vector protected establishment fulfilling the requirements provided for in Part 3 of Annex IX:

— for at least 60 days prior to the date of movement; or — for at least 28 days prior to the date of movement and have been subjected to a serological test, with negative results, carried out on samples collected at least 28 days following the date of the commencement of the period of protection against attacks by vectors; or — for at least 14 days prior to the date of movement and have been subjected to a PCR test, with negative results, carried out on samples collected at least 14 days following the date of commencement of the period of protection against attacks by vectors.’;

(b) a new subparagraph is added: ‘By way of derogation from point (f)(ii), the competent authority of the Member State of origin may authorise movements which do not meet one of the requirements laid down in that point, to another Member State or area

thereof if the Member State of destination:

(a) has informed the Commission and the other Member States that such movements are authorised; and

(b) accepts the animals regardless of the Member State or area thereof of their origin.’;

(3) Article 15, paragraph 1 is amended as follows:

(a) point (e) is replaced by the following: ‘(e) the animals come from an establishment situated in an area of at least 150 km radius around that

establishment in which infection with epizootic haemorrhagic disease virus:

(i) has not been reported in kept animals of listed species for that disease during the last 2 years prior to departure; or

(ii) has been reported in kept animals of listed species for that disease during the last 2 years prior to

departure but one of the following set of requirements is complied with:

1. the animals have been kept in a zone seasonally free from epizootic haemorrhagic disease in accordance with Parts 1 and 2 of Annex IX: — for at least 60 days prior to the date of movement; or — for at least 28 days prior to the date of movement and have been subjected to a serological test, with negative results, carried out on samples collected at least 28 days following the entry date of the animal into the seasonally disease -free area; or — for at least 14 days prior to the date of movement and have been subjected to a PCR test, with negative results, carried out on samples collected at least 14 days following the entry date of the animal into the seasonally disease-free area; or

2. the animals have been protected against attacks by the vectors during transportation to the place of destination and they have been kept protected against attacks by vectors in a vector protected establishment fulfilling the requirements provided for in Part 3 of Annex IX:

— for at least 60 days prior to the date of movement; or — for at least 28 days prior to the date of movement and have been subjected to a serological test, with negative results, carried out on samples collected at least 28 days following the date of the commencement of the period of protection against attacks by vectors; or — for at least 14 days prior to the date of movement and have been subjected to a PCR test, with negative results, carried out on samples collected at least 14 days following the date of commencement of the period of protection against attacks by vectors.’;

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(b) a new subparagraph is added: ‘By way of derogation from point (e)(ii), the competent authority of the Member State of origin may authorise movements which do not meet one of the requirements laid down in that point to another to another Member

State or area thereof if the Member State of destination:

(a) has informed the Commission and the other Member States that such movements are authorised; and

(b) accepts the animals regardless of the Member State or area thereof of their origin.’;

(4) Article 23, paragraph 1 is amended as follows:

(a) point (g) is replaced by the following: ‘(g) the animals come from an establishment situated in an area of at least 150 km radius around that

establishment in which infection with epizootic haemorrhagic disease virus:

(i) has not been reported in kept animals of listed species for that disease during the last 2 years prior to departure; or

(ii) has been reported in kept animals of listed species for that disease during the last 2 years prior to

departure but one of the following set of requirements is complied with:

1. the animals have been kept in a zone seasonally free from epizootic haemorrhagic disease in accordance with Parts 1 and 2 of Annex IX: — for at least 60 days prior to the date of movement; or — for at least 28 days prior to the date of movement and have been subjected to a serological test, with negative results, carried out on samples collected at least 28 days following the entry date of the animal into the seasonally disease-free area; or — for at least 14 days prior to the date of movement and have been subjected to a PCR test, with negative results, carried out on samples collected at least 14 days following the entry date of the animal into the seasonally disease-free area; or

2. the animals have been protected against attacks by the vectors during transportation to the place of destination and they have been kept protected against attacks by vectors in a vector protected establishment fulfilling the requirements provided for in Part 3 of Annex IX:

— for at least 60 days prior to the date of movement: or — for at least 28 days prior to the date of movement and have been subjected to a serological test, with negative results, carried out on samples collected at least 28 days following the date of the commencement of the period of protection against attacks by vectors; or — for at least 14 days prior to the date of movement and have been subjected to a PCR test, with negative results, carried out on samples collected at least 14 days following the date of commencement of the period of protection against attacks by vectors.’;

(b) a new subparagraph is added: ‘By way of derogation from point (g)(ii), the competent authority of the Member State of origin may authorise movements which do not meet one of the requirements laid down in that point to another Member State or area

thereof if the Member State of destination:

(a) has informed the Commission and the other Member States that such movements are authorised; and

(b) accepts the animals regardless of the Member State or area thereof of their origin.’;

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(5) Article 26, paragraph 1 is amended as follows:

(a) point (g) is replaced by the following: ‘(g) the animals come from an establishment situated in an area of at least 150 km radius around that

establishment in which infection with epizootic haemorrhagic disease virus:

(i) has not been reported in kept animals of listed species for that disease during the last 2 years prior to departure; or

(ii) has been reported in kept animals of listed species for that disease during the last 2 years prior to

departure but one of the following set of requirements is complied with:

1. the animals have been kept in a zone seasonally free from epizootic haemorrhagic disease in accordance with Parts 1 and 2 of Annex IX: — for at least 60 days prior to the date of movement; or — for at least 28 days prior to the date of movement and have been subjected to a serological test, with negative results, carried out on samples collected at least 28 days following the entry date of the animal into the seasonally disease-free area; or — for at least 14 days prior to the date of movement and have been subjected to a PCR test, with negative results, carried out on samples collected at least 14 days following the entry date of the animal into the seasonally disease-free area; or

2. the animals have been protected against attacks by the vectors during transportation to the place of destination and they have been kept protected against attacks by vectors in a vector protected establishment fulfilling the requirements provided for in Part 3 of Annex IX:

— for at least 60 days prior to the date of movement: or — for at least 28 days prior to the date of movement and have been subjected to a serological test, with negative results, carried out on samples collected at least 28 days following the date of the commencement of the period of protection against attacks by vectors; or — for at least 14 days prior to the date of movement and have been subjected to a PCR test, with negative results, carried out on samples collected at least 14 days following the date of commencement of the period of protection against attacks by vectors.’;

(b) a new subparagraph is added: ‘By way of derogation from point (g)(ii), the competent authority of the Member State of origin may authorise movements which do not meet one of the requirements laid down in that point to another Member State or area

thereof if the Member State of destination:

(a) has informed the Commission and the other Member States that such movements are authorised; and

(b) accepts the animals regardless of the Member State or area thereof of their origin.’;

(6) Article 29, paragraph 1 is amended as follows:

(a) point (f) is replaced by the following: ‘(f) the animals come from an establishment situated in an area of at least 150 km radius around that

establishment in which infection with epizootic haemorrhagic disease virus:

(i) has not been reported in kept animals of listed species for that disease during the last 2 years prior to departure; or

(ii) has been reported in kept animals of listed species for that disease during the last 2 years prior to

departure but one of the following set of requirements is complied with:

1. the animals have been kept in a zone seasonally free from epizootic haemorrhagic disease in accordance with Parts 1 and 2 of Annex IX: — for at least 60 days prior to the date of movement; or 6/11 ELI: http://data.europa.eu/eli/reg_del/2023/2515/ojEN OJ L, 14.11.2023 — for at least 28 days prior to the date of movement and have been subjected to a serological test, with negative results, carried out on samples collected at least 28 days following the entry date of the animal into the seasonally disease-free area; or — for at least 14 days prior to the date of movement and have been subjected to a PCR test, with negative results, carried out on samples collected at least 14 days following the entry date of the animal into the seasonally disease-free area; or

2. the animals have been protected against attacks by the vectors during transportation to the place of destination and they have been kept protected against attacks by vectors in a vector protected establishment fulfilling the requirements provided for in Part 3 of Annex IX:

— for at least 60 days prior to the date of movement: or — for at least 28 days prior to the date of movement and have been subjected to a serological test, with negative results, carried out on samples collected at least 28 days following the date of the commencement of the period of protection against attacks by vectors; or — for at least 14 days prior to the date of movement and have been subjected to a PCR test, with negative results, carried out on samples collected at least 14 days following the date of commencement of the period of protection against attacks by vectors.’;

(b) a new subparagraph is added: ‘By way of derogation from point (f)(ii), the competent authority of the Member State of origin may authorise movements which do not meet one of the requirements laid down in that point to another Member State or area

thereof if the Member State of destination:

(a) has informed the Commission and the other Member States that such movements are authorised; and

(b) accepts the animals regardless of the Member State or area thereof of their origin.’;

(7) in Article 67, paragraphs 4 and 5 are replaced by the following: ‘4. Operators shall ensure that captive birds which have been moved to an exhibition in accordance with paragraphs 1 and 2, are only moved back to the Member State of origin when the following requirements are met:

(a) the birds are accompanied by an animal health certificate, issued either by the competent authority of the Member State of origin in accordance with Article 71(1) or by that of the Member State of the exhibition. The latter authority shall issue the animal health certificate based on official information provided in the certificate issued by the competent authority of the Member State of origin;

(b) the movement takes place within the period of validity of the certificate issued by the competent authority of the Member State of origin;

(c) the birds have not been in contact with birds of a lower health status during the exhibition.

Where the animal health certificate was issued by the competent authority of the Member State of origin, a declaration stating that the birds have not been in contact with birds of a lower health status during the exhibition shall be issued by the veterinarian referred to in paragraph 3, point (c) for birds other than those participating in flight exhibitions, or by the operator responsible for the birds that participated in a flight exhibition.

5. Operators shall ensure that captive birds which have been moved to an exhibition in accordance with paragraphs 1 and 2, are only moved to a Member State which is not the Member State of origin when the following

requirements are met:

(a) the birds are accompanied by the animal health certificate issued by the competent authority of the Member State of the exhibition, and completed based on official information provided in the certificate issued by the competent authority of the Member State of origin in accordance with Article 71(1);

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(b) the movement takes place within the period of validity of the certificate issued by the competent authority of the Member State of origin;

(c) the birds have not been in contact with birds of a lower health status during the exhibition;

(d) if the exhibition takes place in a Member State or zone thereof not having the status free from infection with Newcastle disease virus without vaccination, birds of galliformes species are not moved to a Member State or zone thereof having the status free from infection with Newcastle disease virus without vaccination, except if all birds of galliformes species of the exhibition comply with the requirements of Article 62, point (a).

The operator at the place of destination shall ensure that the birds are kept isolated from any other birds for 21 days after arrival.’;

(8) in Article 91(2), point (b) is replaced by the following: ‘(b) within the last 48 hours or on the last working day before departure from the establishment of origin, in relation to equine animals;’;

(9) in Article 92, paragraph 2 is replaced by the following: ‘2. By way of derogation from the validity period of the animal health certificate referred to in Article 91(3), the animal health certificate issued for an individual equine animal referred to in Article 76(2), point (a), shall be valid for 30 days provided that:

(a) the equine animal to be moved is accompanied by its single lifetime identification document as provided for in Article 114(1)(c) of Regulation (EU) 2016/429 which includes a valid validation mark issued by the competent authority, or the body to which this activity was delegated, for a period not exceeding 4 years, to document that the animal is habitually resident in an establishment recognised by the competent authority as an establishment of low health risk due to frequent animal health visits, additional identity checks and health testing and the absence of natural breeding on the establishment, except in dedicated and separated premises;

or

(b) the registered equine animal to be moved is accompanied by its single lifetime identification document as

provided for in Article 114(1)(c) of Regulation (EU) 2016/429 which includes a valid license issued, for a period not exceeding 4 years, by the national federation of the Fédération Équestre Internationale for participation in equestrian competitions or by the competent racing authority for participation in races, and which documents at least two visits per year by a veterinarian, including those necessary to carry out regular equine influenza vaccinations and examinations required for movements to other Member States or third countries.’;

(10) in point 2 of Part 6 of Annex I, point (c) is added: ‘(c) virus neutralisation.’;

(11) Annex IX is added as set out in the Annex to this Regulation.

Article 2 Corrections to Delegated Regulation (EU) 2020/688 Delegated Regulation (EU) 2020/688 is corrected as follows:

(1) in Article 18, point (a) is deleted;

(2) in Article 43, paragraph 4 is replaced by the following: ‘4. In case of kept ungulates intended for slaughter, the assembly of animals from more than one establishment for a period of less than 20 days, after leaving the establishment of origin, shall be considered as an assembly operation.’;

(3) in Article 53, the introductory phrase of point (b) is replaced by the following: ‘(b) the animals are accompanied by an individual identification document as provided for in Article 71 of Delegated Regulation (EU) 2019/2035, and’;

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(4) Article 69 is replaced by the following: ‘Article 69 Derogation for movements of kept equine animals to other Member States The competent authority of the Member State of origin may authorise the movement to another Member State of registered equine animals not complying with animal health certification requirements laid down in Article 143(1) of Regulation (EU) 2016/429, provided that:

(a) the competent authority of the Member State of destination established the conditions based on the requirements referred to in points (b) and (c) and has informed the Commission and the other Member States that such movements are authorised;

(b) the animals kept and moved on the respective territories of the Member State of origin and of the Member State of destination fulfil at least the animal health requirements for movement of kept equine animals to other Member States, and in particular the specific animal health requirements laid down in Article 22;

(c) the competent authority of the Member State of origin fulfils the condition, established by the competent authority of the Member State of destination, for the traceability of the animals moved and notifies the competent authority of the Member State of destination about the intention of using the derogation.’;

(5) in Article 86, paragraph 1 is replaced by the following: ‘1. The animal health certificate for dogs, cats and ferrets, except those dogs, cats and ferrets referred to in paragraph 2, that is issued by the competent authority of the Member State of origin in accordance with Article 71(1), shall contain the general information provided for in point 1 of Part 1 of Annex VIII and an attestation of compliance with the requirements provided for in Article 53, and in Article 54 where applicable, and a link to the identification document referred to in Article 71 of Delegated Regulation (EU) 2019/2035.’;

(6) in Article 91(1), point (j) is replaced by the following: ‘(j) in relation to dogs, cats, ferrets, a documentary check of the individual identification document provided for in Article 71 of Delegated Regulation (EU) 2019/2035, and in relation to dogs, cats, ferrets and other carnivores, an identity check and a clinical examination, and where this is not possible, a clinical inspection, of the animals of the consignment for the purpose of detection of clinical signs or suspicion of listed diseases relevant for the species;’.

Article 3 Entry into force This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union.

This Regulation shall be binding in its entirety and directly applicable in all Member States.

Done at Brussels, 8 September 2023.

For the Commission The President Ursula VON DER LEYEN

ELI: http://data.europa.eu/eli/reg_del/2023/2515/oj 9/11EN OJ L, 14.11.2023 ANNEX ‘ANNEX IX RISK MITIGATING MEASURES FOR INFECTION WITH EPIZOOTIC HAEMORRHAGIC DISEASE VIRUS IN THE EVENT OF MOVEMENTS TO OTHER MEMBER STATES OF KEPT UNGULATES Part 1 Zones seasonally-free from epizootic hemorrhagic disease

1. In the event of movements to other Member States of kept ungulates, zones seasonally-free from epizootic haemorrhagic disease may be established if the beginning and the end of the vector-free period has been demonstrated by the competent authority based on entomological surveillance in accordance with Part 2.

2. By way of derogation from point 1, if the vector-free period has been successfully demonstrated for a period of 3 consecutive years, additional criteria such as temperature may replace entomological surveillance to substantiate the beginning and the end of the vector-free period on the basis of scientific evidence.

3. The zones seasonally-free from epizootic haemorrhagic disease shall immediately be eliminated when there is evidence of the end of the vector-free period or of circulation of the epizootic haemorrhagic disease virus.

Part 2 Entomological surveillance

1. Entomological surveillance shall consist of at least an active annual programme of vector catching by means of permanently sited aspiration traps intended to determine the population dynamics of the vector and, where relevant, the vector-free period.

2. Aspiration traps equipped with ultraviolet light shall be used in accordance with pre-established protocols; the traps

shall be operated throughout the night and operate at least:

(a) one night per week during the month before the expected beginning and during the month before the expected end of the vector-free period; and

(b) one night per month during the vector-free period.

On the basis of the evidence obtained in the first 3 years of operating the aspiration traps, the frequency of operation of those traps may be adjusted.

3. At least one aspiration trap must be placed in each geographical unit of 45 km by 45 km throughout the zone seasonally-free from epizootic haemorrhagic disease and the geographical units can be adapted to the epidemiological situation. A proportion of the midges collected in the aspiration traps shall be sent to a specialised laboratory capable of counting and identifying the suspected vector species or complexes.

4. When entomological surveillance is organised in the context of determination of a vector-free period, a maximum threshold of Culicoides species shall be defined for the interpretation of the results. In the absence of sound evidence supporting the determination of the maximum threshold, total absence of Culicoides imicola specimens and less than five parous Culicoides per trap shall be used as maximum threshold..

Part 3 Vector protected establishment

Vector protected establishment shall comply with the following requirements:

(a) it has appropriate physical barriers at entry and exit points;

(b) openings shall be vector screened with mesh of appropriate gauge which shall be impregnated regularly with an approved insecticide according to the manufacturers’ instructions;

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(c) vector surveillance and control shall be carried out within and around the vector protected establishment;

(d) measures shall be taken to limit or eliminate breeding sites for vectors in the vicinity of the vector protected establishment; and

(e) standard operating procedures shall be in place, including descriptions of back-up and alarm systems, for operation of the vector protected establishment and transport of animals to the place of loading.’

ELI: http://data.europa.eu/eli/reg_del/2023/2515/oj 11/11