Division 1 The status free from infection with Brucella abortus, B. melitensis and B. suis without vaccination may only be granted to an establishment keeping bovine, ovine or caprine animals if:

during the past 12 months there has been no confirmed case of infection with Brucella abortus, B. melitensis and B. suis in bovine, ovine or caprine animals kept in the establishment;

during the past 3 years none of the bovine, ovine or caprine animals in the establishment has been vaccinated against infection with Brucella abortus, B. melitensis and B. suis;

the entire bovine animals over 12 months of age and the entire ovine or caprine animals over 6 months of age present in the establishment at the time of sampling have tested negative to serological test, on two occasions as follows:

1. (i)

   the first test must be carried out on samples taken not earlier than 3 months after the removal of the last confirmed case and of the last animal that tested positive in an immunological test;

2. (ii)

   the second test must be carried out on samples taken not earlier than 6 months and not later than 12 months following the date of sampling referred to in point (i);

animals showing clinical signs consistent with infection with Brucella abortus, B. melitensis and B. suis, such as abortions, have been subjected to investigations with negative results;

since the beginning of the sampling referred to in point (c)(i) all bovine, ovine or caprine animals introduced into the establishment originate from establishments free from infection with Brucella abortus, B. melitensis and B. suis without vaccination, or free with vaccination and have not been vaccinated against infection with Brucella abortus, B. melitensis and B. suis during the past 3 years, and

1. (i)

   originate from a Member State or a zone free from infection with Brucella abortus, B. melitensis and B. suis for the relevant animal population;

2. (ii)

   are entire bovine animals over 12 months of age or entire ovine or caprine animals over 6 months of age and must have tested negative in a serological test carried out on a sample taken:

   • during the 30 days prior to their introduction into the establishment; or

   • during the 30 days following their introduction provided they have been kept isolated during this period; or

3. (iii)

   are post-parturient females kept in isolation since their introduction into the establishment until they have tested negative in a serological test carried out on a sample taken not earlier than 30 days after parturition; and

since the beginning of the sampling referred to in point (c)(i), all germinal products of bovine, ovine or caprine origin introduced into or used in the establishment originate from:

1. (i)

   establishments free from infection with Brucella abortus, B. melitensis and B. suis without vaccination; or

2. (ii)

   approved germinal product establishments.