# L_2006217EN.01002901.xml

| 8.8.2006 | EN | Official Journal of the European Union | L 217/29 |
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8.8.2006

EN

Official Journal of the European Union

L 217/29

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COMMISSION DECISION

of 3 August 2006

amending Annex XI to Council Directive 2003/85/EC as regards the list of laboratories authorised to handle live foot-and-mouth disease virus for vaccine production

(notified under document number C(2006) 3447)

(Text with EEA relevance)

(2006/552/EC)

THE COMMISSION OF THE EUROPEAN COMMUNITIES,

Having regard to the Treaty establishing the European Community,

Having regard to Council Directive 2003/85/EC of 29 September 2003 on Community measures for the control of foot-and-mouth disease repealing Directive 85/511/EEC and Decisions 89/531/EEC and 91/665/EEC and amending Directive 92/46/EEC (1), and in particular Article 67(2) thereof,

Whereas:

| (1) | Directive 2003/85/EC sets out minimum control measures to be applied in the event of an outbreak of foot-and-mouth disease and certain preventive measures aimed at increasing the awareness and preparedness of the competent authorities and the farming community concerning that disease. |
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(1)

Directive 2003/85/EC sets out minimum control measures to be applied in the event of an outbreak of foot-and-mouth disease and certain preventive measures aimed at increasing the awareness and preparedness of the competent authorities and the farming community concerning that disease.

| (2) | The preventive measures set out in Directive 2003/85/EC include the provision that Member States are to ensure that the handling of the live foot-and-mouth disease virus for the manufacturing of either inactivated antigens for the production of vaccines or vaccines and related research is carried out only in approved laboratories listed in Part B of Annex XI to that Directive. |
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(2)

The preventive measures set out in Directive 2003/85/EC include the provision that Member States are to ensure that the handling of the live foot-and-mouth disease virus for the manufacturing of either inactivated antigens for the production of vaccines or vaccines and related research is carried out only in approved laboratories listed in Part B of Annex XI to that Directive.

| (3) | The competent authorities of Germany have officially informed the Commission of some changes relating to manufacturers of foot-and-mouth disease vaccines in this Member State. Germany has renewed the necessary security guarantees for the laboratory situated on its territory. |
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(3)

The competent authorities of Germany have officially informed the Commission of some changes relating to manufacturers of foot-and-mouth disease vaccines in this Member State. Germany has renewed the necessary security guarantees for the laboratory situated on its territory.

| (4) | For security reasons it is important to keep the list of laboratories authorised to handle live foot-and-mouth disease virus for vaccine production in Directive 2003/85/EC updated. |
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(4)

For security reasons it is important to keep the list of laboratories authorised to handle live foot-and-mouth disease virus for vaccine production in Directive 2003/85/EC updated.

| (5) | Accordingly, it is necessary to replace the list of laboratories authorised to handle live foot-and-mouth disease virus for vaccine production in Part B of Annex XI to Directive 2003/85/EC by the list set out in the Annex to this Decision. |
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(5)

Accordingly, it is necessary to replace the list of laboratories authorised to handle live foot-and-mouth disease virus for vaccine production in Part B of Annex XI to Directive 2003/85/EC by the list set out in the Annex to this Decision.

| (6) | The measures provided for in this Decision are in accordance with the opinion of the Standing Committee on the Food Chain and Animal Health, |
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(6)

The measures provided for in this Decision are in accordance with the opinion of the Standing Committee on the Food Chain and Animal Health,

HAS ADOPTED THIS DECISION:

Article 1

In Annex XI to Directive 2003/85/EC, Part B is replaced by the text in the Annex to this Decision.

Article 2

This Decision shall apply from 3 July 2006.

Article 3

This Decision is addressed to the Member States.

Done at Brussels, 3 August 2006.

For the Commission

Markos KYPRIANOU

Member of the Commission

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(1)  
  OJ L 306, 22.11.2003, p. 1. Directive as amended by Commission Decision 2005/615/EC (OJ L 213, 18.8.2005, p. 14).

1

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ANNEX

In Annex XI to Directive 2003/85/EC, Part B is replaced by the following:

‘Laboratories authorised to handle live foot-and-mouth disease virus for vaccine production

| Member State where laboratory is situated | Laboratory |
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| ISO-code | Name |
| DE | Germany | Intervet International GmbH, Köln |
| FR | France | Merial, S.A.S., Laboratoire IFFA, Lyon |
| GB | United Kingdom | Merial, S.A.S., Pirbright Laboratory, Pirbright |
| NL | Netherlands | CIDC-Lelystad,
  Central Institute for Animal Disease Control, Lelystad’ |

Member State where laboratory is situated

Laboratory

ISO-code

Name

DE

Germany

Intervet International GmbH, Köln

FR

France

Merial, S.A.S., Laboratoire IFFA, Lyon

GB

United Kingdom

Merial, S.A.S., Pirbright Laboratory, Pirbright

NL

Netherlands

CIDC-Lelystad,

Central Institute for Animal Disease Control, Lelystad’

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