COMMISSION IMPLEMENTING REGULATION (EU) No 176/2012
of 1 March 2012
amending Annexes B, C and D to Council Directive 90/429/EEC as regards animal health requirements for brucellosis and Aujeszky’s disease
(Text with EEA relevance)
THE EUROPEAN COMMISSION,
Having regard to the Treaty on the Functioning of the European Union,
Having regard to Council Directive 90/429/EEC of 26 June 1990 laying down the animal health requirements applicable to intra-Community trade in and imports of semen of domestic animals of the porcine species (1), and in particular Article 17 thereof,
Whereas:
(1)
Directive 90/429/EEC lays down the animal health conditions governing intra-Union trade in and imports from third countries of semen of domestic animals of the porcine species.
(2)
Directive 90/429/EEC provides that semen intended for trade must have been collected from domestic animals of the porcine species whose health status complies with Annex B to that Directive. Chapter I of Annex B sets out conditions applying to the admission of animals to approved semen collection centres. Chapter II of that Annex sets outs compulsory routine tests for animals kept at an approved semen collection centre.
(3)
In addition, Directive 90/429/EEC provides that semen intended for trade must have been collected, processed, stored and transported in accordance with Annex C to that Directive. That Annex sets out conditions which semen collected at approved centres must satisfy for the purposes of intra-Union trade. Point 4 of Annex C to Directive 90/429/EEC provides that Member States may refuse admission of semen from collection centres where boars vaccinated against Aujeszky’s disease are admitted to their territory, or to a region of their territory, when it has been recognised as free of Aujeszky’s disease.
(4)
Finally, Annex D to Directive 90/429/EEC establishes a model animal health certificate for trade in that commodity.
(5)
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 (2) lays down additional guarantees applicable to intra-Union trade in pigs relating to Aujeszky’s disease. In the interest of consistency of Union legislation, the animal health requirements applicable to donor male animals of the porcine species and their semen set out in Annex B to Directive 90/429/EEC should be aligned with Decision 2008/185/EC.
(6)
Equally should a provision be inserted in point 4 of Annex C to Directive 90/429/EEC obliging Member States to inform the other Member States and the Commission when they use the right to refuse porcine semen produced in the semen collection centres keeping animals of the porcine species vaccinated against Aujeszky’s disease.
(7)
The Commission requested the European Food Safety Authority (EFSA) to assess the suitability of the buffered Brucella antigen test (rose Bengal test) which currently is the only authorised test for brucellosis diagnosis in Annex B to Directive 90/429/EEC and to provide a scientific opinion on the suitability of other available diagnostic tests for inclusion in that Annex.
(8)
On 5 June 2009, EFSA adopted a Scientific Opinion of the Panel on Animal Health and Welfare (AHAW) on a request from the Commission on porcine brucellosis (Brucella suis) (3). EFSA concluded that a competitive enzyme-linked immunosorbent assay (cELISA) and an indirect enzyme-linked immunosorbent assay (iELISA) for the detection of antibodies to a Brucella suis infection may be considered for the purpose of testing donor animals of the porcine species for admission to the semen collection centres and for compulsory routine testing during the stay or on exit from such centres. Therefore, these tests should be included in Annex B to Directive 90/429/EEC along with the current buffered Brucella antigen test (rose Bengal test).
(9)
In addition, it is necessary to revise the protocol provided for in Chapter I of Annex B to Directive 90/429/EEC to rule out or confirm a suspicion of brucellosis on admission of animals to the semen collection centres and to provide in Chapter II of that Annex that the re-establishment of the health status of a semen collection centre shall be carried out under the responsibility of the competent authority of a Member State.
(10)
It is also necessary to align the model animal health certificate for intra-Union trade in semen of animals of the porcine species provided for in Annex D to Directive 90/429/EEC with the amendments in Annexes B and C. The model animal health certificate should also be presented in accordance with the standardised layout of veterinary certificates as set out in Commission Regulation (EC) No 599/2004 of 30 March 2004 concerning the adoption of a harmonised model certificate and inspection report linked to intra-Community trade in animals and products of animal origin (4).
(11)
Annexes B, C and D to Directive 90/429/EEC should therefore be amended accordingly.
(12)
To avoid any disruption of trade, the use of animal health certificates issued in accordance with Annex D to Directive 90/429/EEC, before the amendments introduced by this Regulation, should be authorised during a transitional period subject to certain conditions.
(13)
The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee of the Food Chain and Animal Health,
HAS ADOPTED THIS REGULATION:
Article 1
Annexes B, C and D to Directive 90/429/EEC are replaced by the text set out in the Annex to this Regulation.
Article 2
For a transitional period until 31 July 2012, Member States may authorise trade in semen of domestic animals of the porcine species accompanied by an animal health certificate issued not later than 31 May 2012 in accordance with the model set out in Annex D to Directive 90/429/EEC in its version prior to the amendments introduced by this Regulation.
Article 3
This Regulation shall enter into force on the 20th day following its publication in the Official Journal of the European Union.
It shall apply from 1 June 2012.
This Regulation shall be binding in its entirety and directly applicable in all Member States.
Done at Brussels, 1 March 2012.