# L_2010209EN.01001801.xml

| 10.8.2010 | EN | Official Journal of the European Union | L 209/18 |
| --- | --- | --- | --- |

10.8.2010

EN

Official Journal of the European Union

L 209/18

---

COMMISSION DECISION

of 9 August 2010

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

(notified under document C(2010) 5420)

(Text with EEA relevance)

(2010/435/EU)

THE EUROPEAN COMMISSION,

Having regard to the Treaty on the Functioning of the European Union,

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 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. |
| --- | --- |

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

(2)

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

| (3) | Bulgaria has officially informed the Commission that following the checks carried out in accordance with Article 66 of Directive 2003/85/EC, their national reference laboratory is no longer considered to meet the bio-security standards provided for in Article 65(d) of Directive 2003/85/EC. |
| --- | --- |

(3)

Bulgaria has officially informed the Commission that following the checks carried out in accordance with Article 66 of Directive 2003/85/EC, their national reference laboratory is no longer considered to meet the bio-security standards provided for in Article 65(d) of Directive 2003/85/EC.

| (4) | The Netherlands have officially informed the Commission of certain changes relating to the name of a laboratory listed in Part B of Annex XI to Directive 2003/85/EC situated in the Netherlands. |
| --- | --- |

(4)

The Netherlands have officially informed the Commission of certain changes relating to the name of a laboratory listed in Part B of Annex XI to Directive 2003/85/EC situated in the Netherlands.

| (5) | For security reasons, it is important to keep the list of laboratories set out in Annex XI to Directive 2003/85/EC updated. |
| --- | --- |

(5)

For security reasons, it is important to keep the list of laboratories set out in Annex XI to Directive 2003/85/EC updated.

| (6) | Accordingly, it is necessary to delete the entry for Bulgaria in the list of laboratories set out in Part A and to replace the entry for the Netherlands in the list of laboratories set out in Part B of Annex XI to Directive 2003/85/EC. Annex XI to Directive 2003/85/EC should therefore be amended accordingly. |
| --- | --- |

(6)

Accordingly, it is necessary to delete the entry for Bulgaria in the list of laboratories set out in Part A and to replace the entry for the Netherlands in the list of laboratories set out in Part B of Annex XI to Directive 2003/85/EC. Annex XI to Directive 2003/85/EC should therefore be amended accordingly.

| (7) | The measures provided for in this Decision are in accordance with the opinion of the Standing Committee on the Food Chain and Animal Health, |
| --- | --- |

(7)

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

Annex XI to Directive 2003/85/EC is amended as follows:

| 1. | in Part A, the entry for Bulgaria is deleted; |
| --- | --- |

1.

in Part A, the entry for Bulgaria is deleted;

| 2. | in Part B, the entry for the Netherlands is replaced by the following:







  ‘NL | Netherlands | Merial S.A.S., Lelystad Laboratory, Lelystad’ |
| --- | --- | --- | --- |

2.

in Part B, the entry for the Netherlands is replaced by the following:

‘NL

Netherlands

Merial S.A.S., Lelystad Laboratory, Lelystad’

Article 2

This Decision is addressed to the Member States.

Done at Brussels, 9 August 2010.

For the Commission

John DALLI

Member of the Commission

---

(1)  
  OJ L 306, 22.11.2003, p. 1.

1

---