Commission Implementing Decision (EU) 2018/1143 of 10 August 2018 amending Decisions 92/260/EEC and 93/197/EEC as regards the testing for equine viral arteritis (notified under document C(2018) 5071) (Text with EEA relevance.)

L 207/58 EN Official Journal of the European Union 16.8.2018 DECISIONS COMMISSION IMPLEMENTING DECISION (EU) 2018/1143 of 10 August 2018 amending Decisions 92/260/EEC and 93/197/EEC as regards the testing for equine viral arteritis (notified under document C(2018) 5071) (Text with EEA relevance) THE EUROPEAN COMMISSION, Having regard to the Treaty on the Functioning of the European Union, Having regard to Council Directive 2009/156/EC of 30 November 2009 on animal health conditions governing the movement and importation from third countries of equidae (1), and in particular point (a) and the first subparagraph of point (b)(ii) of Article 15, Article 16(2) and the introductory phrase and point (b) of Article 19 thereof, Whereas: (1) Directive 2009/156/EC lays down animal health conditions for the importation into the Union of live equidae. It empowers the Commission to lay down, amongst others, the special conditions for the temporary admission of registered equidae and imports into the Union of equidae. (2) Commission Decision 92/260/EEC (2) provides that Member States are to authorise the temporary admission into the Union of registered horses complying with the animal health conditions and veterinary certification requirements set out, amongst others in Annex II (A) to (E) thereto. (3) Commission Decision 93/197/EEC (3) provides that Member States are to authorise imports into the Union of registered equidae and equidae for breeding and production complying with the animal health conditions and veterinary certification requirements set out, amongst others in Annex II (A) to (E) thereto. (4) If they come from a third country in which equine viral arteritis was officially reported during the past 6 months prior to dispatch to the Union, uncastrated male equidae may only be introduced into the Union after they have been tested with negative result for equine viral arteritis or have been vaccinated and regularly revaccinated against this disease. (5) In addition to the Union requirements for testing or vaccination of uncastrated male equidae intended for entry into the Union, Chapter 12.9 of the Terrestrial Animal Health Code (‘the Code’) of the World Organisation for Animal Health (OIE), Edition 2017 (4), contains recommendation on testing of uncastrated male equidae for equine viral arteritis. (6) Where a semen sample cannot be obtained for testing of a seropositive uncastrated male equid and uninterrupted vaccination cannot be certified, test mating of the male equid to two seronegative mares as described in point 4(a) of Article 12.9.2 of the Code is a suitable alternative protocol to ensure that those uncastrated male equids do not shed equine arteritis virus in their semen. (7) Due to shortages in the supply of vaccine against equine viral arteritis, it is necessary to provide a test protocol for equine viral arteritis in line with OIE recommendations and to amend the health certificates set out in Annex II (A) to (E) to Decisions 92/260/EEC and 93/197/EEC accordingly. (1) OJ L 192, 23.7.2010, p. 1. (2) Commission Decision 92/260/EEC of 10 April 1992 on animal health conditions and veterinary certification for temporary admission of registered horses (OJ L 130, 15.5.1992, p. 67). (3) Commission Decision 93/197/EEC of 5 February 1993 on animal health conditions and veterinary certification for imports of registered equidae and equidae for breeding and production (OJ L 86, 6.4.1993, p. 16). (4) http://www.oie.int/index.php?id=169&L=0&htmfile=chapitre_eav.htm16.8.2018 EN Official Journal of the European Union L 207/59 (8) Decisions 92/260/EEC and 93/197/EEC should therefore be amended accordingly. (9) 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 Annex II (A) to (E) to Decision 92/260/EEC is amended in accordance with Annex I to this Decision. Article 2 Annex II (A) to (E) to Decision 93/197/EEC is amended in accordance with Annex II to this Decision. Article 3 This Decision is addressed to the Member States. Done at Brussels, 10 August 2018. For the Commission Vytenis ANDRIUKAITIS Member of the CommissionL 207/60 EN Official Journal of the European Union 16.8.2018 ANNEX I Decision 92/260/EEC is amended as follows: (1) in each of the health certificates in Annex II (A) to (E), point (e)(v) of Section III is replaced by the following: ‘(3) (v) in the case of an uncastrated male animal older than 180 days, — either equine viral arteritis has been officially recorded during the last 6 months (3); or — the animal was tested on a blood sample taken within 21 days prior to export on ............................ (5) by virus neutralisation test for equine viral arteritis with negative result at a serum dilution of 1 in 4 (3); or an aliquot of its entire semen taken within 21 days prior to export on .............................. (5) was tested by virus isolation test for equine viral arteritis with negative result (3); or the animal was subjected to a virus isolation test, polymerase chain reaction (PCR) or real-time PCR for equine viral arteritis carried out with negative result on an aliquot of its entire semen collected after a blood sample of that animal was taken on ........................................ (5), within a period of 6 months prior to the date of dispatch, and tested in a virus neutralisation test for equine viral arteritis with positive result at a serum dilution of at least 1 in 4 (3); or within a period of 6 months prior to the date of dispatch, the male equine animal, previously tested positive for antibodies against the equine arteritis virus or vaccinated against equine viral arteritis, was: (a) test mated, on two consecutive days, to at least two mares kept in isolation during the 7 days prior to and until at least 28 days after test mating, which were subjected to two serological tests for equine viral arteritis with negative results at a serum dilution of 1 in 4 on blood samples collected at the time of test mating and at least 28 days after the test mating; and (b) subjected to a virus neutralisation test for equine viral arteritis carried out on a blood sample taken within 21 days prior to the date of dispatch on ......................................................................... (5): — either with positive result at a serum dilution of at least 1 in 4 (3), or — with negative result at a serum dilution of 1 in 4 (3); or — the animal was vaccinated on ........................................... (5) against equine viral arteritis under official veterinary supervision with a vaccine approved by the competent authority, according to the following programmes for initial vaccination and has been revaccinated at regular intervals (3): Programmes for initial vaccination against equine viral arteritis: Instruction: Cross out vaccination programmes that do not apply to the animal described above. Verify supporting certification on testing before vaccination, on vaccination and re-vaccination. (a) Vaccination was carried out on the day a blood sample was taken that subsequently proved negative in a virus neutralisation test at a serum dilution of 1 in 4 (3); or (b) Vaccination was carried out during a period of isolation of not more than 15 days under official veter­ inary supervision, commencing on the day a blood sample was taken that was tested during that time with negative result in a virus neutralisation test at a serum dilution of 1 in 4 (3); or (c) Vaccination was carried out when the animal was at an age of 180 to 270 days, during a period of isolation under official veterinary supervision. During the isolation period two blood samples taken at least 10 days apart proved a stable or declining antibody titre in a virus neutralisation test for equine viral arteritis (3); or16.8.2018 EN Official Journal of the European Union L 207/61 (d) Vaccination was carried out after the animal was subjected to a virus neutralisation test for equine viral arteritis with negative result at a serum dilution of 1 in 4, carried out on a blood sample taken not earlier than 7 days after commencing a period of uninterrupted isolation which lasted until 21 days following vaccination (3); or (e) Vaccination was carried out at the age of 180 to 250 days, after the animal was subjected to a virus neutralisation test for equine viral arteritis carried out with negative result at a serum dilution of 1 in 4 or carried out on the same day by the same laboratory with stable or declining titres on two blood samples taken at least 14 days apart (3); or — any requirements for testing for equine viral arteritis or vaccination against equine viral arteritis have been waived by Union legislation ..................................... (insert reference to the applicable Union legal act) on the ground that the animal is temporarily admitted into the Union for participation in the equestrian event specified in that legal act and that the animal is kept separated from other equidae not participating in such event and that any breeding activity, including the collection of semen, is prohibited during the temporary residence in the Union (3);’; (2) in each of the health certificates in Annex II (A), (B) and (D), footnote 6 is deleted; (3) in each of the health certificates in Annex II (C) and (E), footnote 7 is deleted.L 207/62 EN Official Journal of the European Union 16.8.2018 ANNEX II Decision 93/197/EEC is amended as follows: (1) in each of the health certificates in Annex II (A), (C), (D) and (E), point (e)(v) of Section III is replaced by the following: ‘(3) (v) in the case of an uncastrated male animal older than 180 days, — either equine viral arteritis has not been officially recorded during the last 6 months (3); or — the animal was tested on a blood sample taken within 21 days prior to export on ............................ (4) by virus neutralisation test for equine viral arteritis with negative result at a serum dilution of 1 in 4 (3); or an aliquot of its entire semen taken within 21 days prior to export on .............................. (4) was tested by virus isolation test for equine viral arteritis with negative result (3); or the animal was subjected to a virus isolation test, polymerase chain reaction (PCR) or real-time PCR for equine viral arteritis carried out with negative result on an aliquot of its entire semen collected after the date a blood sample of that animal taken on ........................................ (4), within a period of 6 months prior to the date of dispatch, was tested in a virus neutralisation test for equine viral arteritis with positive result at a serum dilution of at least 1 in 4 (3); or within a period of 6 months prior to the date of dispatch, the male equine animal, previously tested positive for antibodies against the equine arteritis virus or vaccinated against equine viral arteritis, was: (a) test mated, on two consecutive days, to at least two mares kept in isolation during the 7 days prior to and until at least 28 days after test mating, which were subjected to two serological tests for equine viral arteritis with negative results at a serum dilution of 1 in 4 on blood samples collected at the time of test mating and at least 28 days after the test mating; and (b) subjected to a virus neutralisation test for equine viral arteritis carried out on a blood sample taken within 21 days prior to the date of dispatch on ......................................................................... (4): — either with positive result at a serum dilution of at least 1 in 4 (3), or — with negative result at a serum dilution of 1 in 4 (3); or — the animal was vaccinated on ........................................... (4) against equine viral arteritis under official veterinary supervision with a vaccine approved by the competent authority, according to the following programmes for initial vaccination and has been revaccinated at regular intervals (3): Programmes for initial vaccination against equine viral arteritis: Instruction: Cross out vaccination programmes that do not apply to the animal described above. Verify supporting certification on testing before vaccination, on vaccination and re-vaccination. (a) Vaccination was carried out on the day a blood sample was taken that subsequently proved negative in a virus neutralisation test at a serum dilution of 1 in 4 (3); or (b) Vaccination was carried out during a period of isolation of not more than 15 days under official veter­ inary supervision, commencing on the day a blood sample was taken that was tested during that time with negative result in a virus neutralisation test at a serum dilution of 1 in 4 (3); or (c) Vaccination was carried out when the animal was at an age of 180 to 270 days, during a period of isolation under official veterinary supervision. During the isolation period two blood samples taken at least 10 days apart proved a stable or declining antibody titre in a virus neutralisation test for equine viral arteritis (3); or16.8.2018 EN Official Journal of the European Union L 207/63 (d) Vaccination was carried out after the animal was subjected to a virus neutralisation test for equine viral arteritis with negative result at a serum dilution of 1 in 4, carried out on a blood sample taken not earlier than 7 days after commencing a period of uninterrupted isolation which lasted until 21 days following vaccination (3); or (e) Vaccination was carried out at the age of 180 to 250 days, after the animal was subjected to a virus neutralisation test for equine viral arteritis carried out with negative result at a serum dilution of 1 in 4, or carried out on the same day by the same laboratory with stable or declining titres on two blood samples taken at least 14 days apart (3);’; (2) in the health certificate in Annex II (B), point (e)(v) of Section III is replaced by the following: ‘(2) (v) in the case of an uncastrated male animal older than 180 days, — either equine viral arteritis has not been officially recorded during the last 6 months (2); or — the animal was tested on a blood sample taken within 21 days prior to export on ............................ (4) by virus neutralisation test for equine viral arteritis with negative result at a serum dilution of 1 in 4 (2); or an aliquot of its entire semen taken within 21 days prior to export on .............................. (4) was tested by virus isolation test for equine viral arteritis with negative result (2); or the animal was subjected to a virus isolation test, polymerase chain reaction (PCR) or real-time PCR for equine viral arteritis carried out with negative result on an aliquot of its entire semen collected after the date a blood sample of that animal taken on ........................................ (4), within a period of 6 months prior to the date of dispatch, was tested in a virus neutralisation test for equine viral arteritis with positive result at a serum dilution of at least 1 in 4 (2); or within a period of 6 months prior to the date of dispatch, the male equine animal, previously tested positive for antibodies against the equine arteritis virus or vaccinated against equine viral arteritis, was: (a) test mated, on two consecutive days, to at least two mares kept in isolation during the 7 days prior to and until at least 28 days after test mating, which were subjected to two serological tests for equine viral arteritis with negative results at a serum dilution of 1 in 4 on blood samples collected at the time of test mating and at least 28 days after the test mating; and (b) subjected to a virus neutralisation test for equine viral arteritis carried out on a blood sample taken within 21 days prior to the date of dispatch on ......................................................................... (4): — either with positive result at a serum dilution of at least 1 in 4 (2), or — with negative result at a serum dilution of 1 in 4 (2); or — the animal was vaccinated on ........................................... (4) against equine viral arteritis under official veterinary supervision with a vaccine approved by the competent authority, according to the following programmes for initial vaccination and has been revaccinated at regular intervals (2): Programmes for initial vaccination against equine viral arteritis: Instruction: Cross out vaccination programmes that do not apply to the animal described above. Verify supporting certification on testing before vaccination, on vaccination and re-vaccination. (a) Vaccination was carried out on the day a blood sample was taken that subsequently proved negative in a virus neutralisation test at a serum dilution of 1 in 4 (2); or (b) Vaccination was carried out during a period of isolation of not more than 15 days under official veter­ inary supervision, commencing on the day a blood sample was taken that was tested during that time with negative result in a virus neutralisation test at a serum dilution of 1 in 4 (2); orL 207/64 EN Official Journal of the European Union 16.8.2018 (c) Vaccination was carried out when the animal was at an age of 180 to 270 days, during a period of isolation under official veterinary supervision. During the isolation period two blood samples taken at least 10 days apart proved a stable or declining antibody titre in a virus neutralisation test for equine viral arteritis (2); or (d) Vaccination was carried out after the animal was subjected to a virus neutralisation test for equine viral arteritis with negative result at a serum dilution of 1 in 4, carried out on a blood sample taken not earlier than 7 days after commencing a period of uninterrupted isolation which lasted until 21 days following vaccination (2); or (e) Vaccination was carried out at the age of 180 to 250 days, after the animal was subjected to a virus neutralisation test for equine viral arteritis carried out with negative result at a serum dilution of 1 in 4, or carried out on the same day by the same laboratory with stable or declining titres on two blood samples taken at least 14 days apart (2);’.