Directive 2012/5/EU of the European Parliament and of the Council of 14 March 2012 amending Council Directive 2000/75/EC as regards vaccination against bluetongue

21.3.2012

EN

Official Journal of the European Union

L 81/1

(1)

Council Directive 2000/75/EC of 20 November 2000 laying down specific provisions for the control and eradication of bluetongue (3) lays down control rules and measures to combat and eradicate bluetongue, including rules on the establishment of protection and surveillance zones and the use of vaccines against bluetongue.

(2)

In the past, only sporadic incursions of certain serotypes of the bluetongue virus were recorded in the Union. Those incursions mainly occurred in the southern parts of the Union. However, since the adoption of Directive 2000/75/EC, and particularly since the introduction into the Union of bluetongue virus serotypes 1 and 8 in the years 2006 and 2007, the bluetongue virus has become more widespread in the Union, with the potential to become endemic in certain areas. It has therefore become difficult to control the spread of that virus.

(3)

The rules on vaccination against bluetongue laid down in Directive 2000/75/EC are based on experience of the use of so-called ‘modified live vaccines’, or ‘live attenuated vaccines’, which were the only vaccines available when that Directive was adopted. The use of those vaccines may lead to an undesired local circulation of the vaccine virus in unvaccinated animals.

(4)

In recent years, as a result of new technology, ‘inactivated vaccines’ against bluetongue have become available which do not pose the risk of undesired local circulation of the vaccine virus to unvaccinated animals. The extensive use of such vaccines during the vaccination campaign in the years 2008 and 2009 has led to a significant improvement in the disease situation. It is now widely accepted that vaccination with inactivated vaccines is the preferred tool for the control of bluetongue and for the prevention of clinical disease in the Union.

(5)

In order to ensure better control of the spread of the bluetongue virus and to reduce the burden on the agricultural sector posed by that disease, it is appropriate to amend the current rules on vaccination laid down in Directive 2000/75/EC in order to take account of the recent technological developments in vaccine production.

(6)

In order to enable the vaccination season 2012 to benefit from the new rules, this Directive should enter into force on the day following its publication in the Official Journal of the European Union.

(7)

The amendments provided for in this Directive should make the rules on vaccination more flexible and also take into account the fact that inactivated vaccines that can also be successfully used outside areas subject to animal movement restrictions are now available.

(8)

In addition, and provided that appropriate precautionary measures are taken, the use of live attenuated vaccines should not be excluded, as their use might still be necessary under certain circumstances, such as following the introduction of a new bluetongue virus serotype against which inactivated vaccines may not be available.

(9)

Directive 2000/75/EC should therefore be amended accordingly,

(1)

in Article 2, the following point is added:

‘(j)   “live attenuated vaccines”: vaccines which are produced by adapting bluetongue virus field isolates through serial passages in tissue culture or in embryonated hens’ eggs.’;

(2)

Article 5 is replaced by the following:

‘Article 5

1.   The competent authority of a Member State may decide to allow the use of vaccines against bluetongue provided that:

2.   Whenever live attenuated vaccines are used, Member States shall ensure that the competent authority demarcates:

(3)

in Article 6(1), point (d) is replaced by the following:

(4)

in Article 8(2), point (b) is replaced by the following:

(5)

in Article 10, point 2 is replaced by the following: