Commission Decision

of 10 February 2011

authorising a laboratory in the Republic of Korea to carry out serological tests to monitor the effectiveness of rabies vaccines

(notified under document C(2011) 656)

(Text with EEA relevance)

(2011/91/EU)

THE EUROPEAN COMMISSION,

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

Having regard to Council Decision 2000/258/EC of 20 March 2000 designating a specific institute responsible for establishing the criteria necessary for standardising the serological tests to monitor the effectiveness of rabies vaccines1, and in particular Article 3(2) thereof,

Whereas:

(1)

Decision 2000/258/EC designates the laboratory of the Agence nationale de sécurité sanitaire de l’alimentation, de l’environnement et du travail (ANSES) in Nancy (previously Agence française de sécurité sanitaire des aliments (AFSSA)) as the specific institute responsible for establishing the criteria necessary for standardising the serological tests to monitor the effectiveness of rabies vaccines. That Decision also lays down the duties of that laboratory.

(2)

In particular, ANSES, Nancy, is to appraise the laboratories in Member States and third countries in order to decide whether to authorise the laboratories to carry out serological tests to monitor the effectiveness of rabies vaccines.

(3)

The competent authority of South Korea has submitted an application for approval of a laboratory in that third country to perform such serological tests.

(4)

ANSES, Nancy has carried out an appraisal of that laboratory and provided the Commission with a favourable report of that appraisal on 6 September 2010.

(5)

That laboratory should therefore be authorised to carry out serological tests to monitor the effectiveness of rabies vaccines in dogs, cats and ferrets.

(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 accordance with Article 3(2) of Decision 2000/258/EC, the following laboratory is authorised to perform the serological tests to monitor the effectiveness of rabies vaccines in dogs, cats and ferrets:

Komipharm International Co. Ltd

1236-6 Jeoungwang-dong

420-450 Siheung-si, Gyeonggi-do

South Korea

Article 2

This Decision shall apply from 1 March 2011.

Article 3

This Decision is addressed to the Member States.

Done at Brussels, 10 February 2011.

For the Commission

John Dalli

Member of the Commission