Division 1 All domestic animals of the porcine species (‘animals’) admitted to the semen collection centre must, prior to admission:F1

have been subjected to a period of quarantine of at least 30 days in accommodation specifically approved for that purpose by the competent authority, and where only animals having at least the same health status are present (quarantine accommodation);

prior to entering the quarantine accommodation referred to in point 1.1:

1. 1.2.1.

   have been chosen from herds or holdings:

   1. (a)

      which are free of brucellosis in accordance with the Chapter on porcine brucellosis of the Terrestrial Animal Health Code of the World Organisation for Animal Health (OIE);

   2. (b)

      in which no animal vaccinated against foot-and-mouth disease has been present in the preceding 12 months;

   3. (c)

      in which no clinical, serological, virological or pathological evidence of Aujeszky’s disease has been detected in the preceding 12 months;

   4. (d)

      which are not situated in a restricted area defined under the provisions of Union legislation due to the emergence of an infectious or contagious disease in domestic pigs, including foot-and-mouth disease, swine vesicular disease, vesicular stomatitis, classical swine fever and African swine fever;

2. 1.2.2.

   not have been kept previously in any herd of a lower status than described in point 1.2.1;

within 30 days prior to entering the quarantine accommodation referred to in point 1.1 have been subjected to the following tests, performed in accordance with standards laid down or referred to in relevant Union legislation, with negative results:

1. (a)

   as regards brucellosis, a buffered Brucella antigen test (rose Bengal test), or a cELISA or an iELISA;

2. (b)

   as regards Aujeszky’s disease:

   1. (i)

      in the case of non-vaccinated animals, an ELISA for detecting antibodies to the whole Aujeszky’s disease virus or to its glycoprotein B (ADV-gB) or glycoprotein D (ADV-gD) or a serum neutralisation test;

   2. (ii)

      in the case of animals vaccinated with a gE deleted vaccine, an ELISA for detecting antibodies to Aujeszky’s disease virus glycoprotein E (ADV-gE);

3. (c)

   as regards classical swine fever, an antibody ELISA or a serum neutralisation test.

If any of the animals proves positive in the tests for brucellosis referred to in (a), animals with negative results in the same holding must not be admitted in the quarantine accommodation until the brucellosis-free status of the herds or holdings of origin of the positive reactors was confirmed.

The competent authority may give authorisation for the tests referred to in this point to be carried out in the quarantine accommodation, provided that the results are known before the beginning of the period of quarantine set out in point 1.1.

With regard to Aujeszky’s disease, the serological tests carried out in accordance with this Directive must meet the standards set out in Annex III to Commission Decision 2008/185/EC of 21 February 2008 on additional guarantees in intra-Community trade of pigs relating to Aujeszky’s disease and criteria to provide information on this disease ^f1 ;

have been subjected to the following tests carried out on samples collected during the last 15 days of the period of quarantine set out in point 1.1:

1. (a)

   as regards brucellosis, a buffered Brucella antigen test (rose Bengal test), or a cELISA or an iELISA;

2. (b)

   as regards Aujeszky’s disease:

   1. (i)

      in the case of non-vaccinated animals, an ELISA for detecting antibodies to whole Aujeszky’s disease virus or its glycoprotein B (ADV-gB) or glycoprotein D (ADV-gD) or a serum neutralisation test;

   2. (ii)

      in the case of animals vaccinated with a gE deleted vaccine, an ELISA for detecting antibodies to Aujeszky’s disease virus glycoprotein E (ADV-gE).

If any of the animals proves positive in the tests for brucellosis referred to in (a) and the suspicion of brucellosis has not been ruled out in accordance with point 1.5.2, those animals must be removed immediately from the quarantine accommodation.

If any of the animals proves positive in the tests for Aujeszky’s disease referred to in (b), those animals must be removed immediately from the quarantine accommodation.

In case where a group of animals is quarantined, the competent authority must take all necessary measures to ensure that the remaining animals which responded negatively to the tests referred to in (a) and (b) have a satisfactory health status before being admitted to the semen collection centre in accordance with this Annex;

measures taken in case of a suspicion of brucellosis:

1. 1.5.1.

   the following protocol must be implemented with regard to animals which tested positive to brucellosis in the test referred to in point 1.4(a):

   1. (a)

      the positive sera are subjected to at least one of the alternative tests set out in point 1.4(a) which has not been carried out on the samples referred to in point 1.4;

   2. (b)

      an epidemiological enquiry is carried out on the holding(s) of origin of the reacting animals;

   3. (c)

      on the animals which have tested positive in the tests referred to in point 1.4(a) and point 1.5.1(a), at least one of the following tests is carried out on samples collected at least 7 days following the date of the collection of the samples referred to in point 1.4:

      1. (i)

         buffered Brucella antigen test (rose Bengal test);

      2. (ii)

         serum agglutination test;

      3. (iii)

         complement fixation test;

      4. (iv)

         cELISA;

      5. (v)

         iELISA;

2. 1.5.2.

   the suspicion of brucellosis will be ruled out provided:

   1. (a)

      either the repeat testing referred to in point 1.5.1(a) produced a negative result, the epidemiological enquiry on the holding(s) of origin did not reveal the presence of porcine brucellosis and the test referred to in point 1.5.1(c) was carried out with negative result; or

   2. (b)

      the epidemiological enquiry on the holding(s) of origin did not reveal the presence of porcine brucellosis and all of the animals which produced a positive result in the testing referred to in point 1.5.1(a) or (c) have been subjected with negative results in each case to a post-mortem examination and an agent identification test for porcine brucellosis;

3. 1.5.3.

   after the suspicion of brucellosis is ruled out, all of the animals from the quarantine accommodation referred to in the second paragraph of point 1.4 may be admitted into the semen collection centre.