Legal provisions of COM(2010)666 - Amendment of Directive 2000/75/EC as regards vaccination against bluetongue

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dossier COM(2010)666 - Amendment of Directive 2000/75/EC as regards vaccination against bluetongue.
document COM(2010)666 EN
date March 14, 2012

Contents

Article 1

Directive 2000/75/EC is hereby amended as follows:

(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:

(a)such decision is based on the result of a specific risk assessment carried out by the competent authority;

(b)the Commission is informed before such vaccination is carried out.

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

(a)a protection zone, consisting of at least the vaccination area;

(b)a surveillance zone, consisting of a part of the Union territory with a depth of at least 50 kilometres extending beyond the limits of the protection zone.’;

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

‘(d)implement the measures adopted in accordance with the procedure laid down in Article 20(2), in particular with regard to the introduction of any vaccination programme or other alternative measures;’;

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

‘(b)The surveillance zone shall consist of a part of the Union territory with a depth of at least 50 kilometres extending beyond the limits of the protection zone and in which no vaccination against bluetongue with live attenuated vaccines has been carried out during the previous 12 months.’;

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

‘2.any vaccination against bluetongue using live attenuated vaccines is prohibited in the surveillance zone.’.

Article 2

1. Member States shall adopt and publish, by 23 September 2012 at the latest, the laws, regulations and administrative provisions necessary to comply with this Directive. They shall communicate immediately to the Commission the text of those provisions.

They shall apply those provisions from 24 September 2012 at the latest.

When Member States adopt those provisions, they shall contain a reference to this Directive or shall be accompanied by such a reference on the occasion of their official publication. Member States shall determine how such reference is to be made.

2. Member States shall communicate to the Commission the text of the main provisions of national law which they adopt in the field covered by this Directive.

Article 3

This Directive shall enter into force on the day following its publication in the Official Journal of the European Union.

Article 4

This Directive is addressed to the Member States.