23.10.2010

EN

Official Journal of the European Union

L 279/33

COMMISSION DECISION

of 22 October 2010

amending Decision 93/152/EEC laying down the criteria for vaccines to be used against Newcastle disease in the context of routine vaccination programmes

(notified under document C(2010) 7109)

(Text with EEA relevance)

(2010/633/EU)

THE EUROPEAN COMMISSION,

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

Having regard to Council Directive 2009/158/EC of 30 November 2009 on animal health conditions governing intra-Community trade in, and imports from third countries of, poultry and hatching eggs (1), and in particular point 2 of Annex III thereto,

Whereas:

(1)

Commission Decision 93/152/EEC (2) lays down certain rules concerning the vaccines to be used in routine vaccination programmes against Newcastle disease.

(2)

In particular, that Decision sets out the criteria that have to be met for the intracerebral pathogenicity index (ICPI) in respect of the Newcastle disease virus strain used in live attenuated and inactivated vaccines against that disease.

(3)

Directive 2001/82/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to veterinary medicinal products (3) provides for certain requirements for immunological veterinary medicinal products, including requirements for safety tests.

(4)

In view of the technical progress which has been made in relation to the manufacture of vaccines, in particular as regards inactivation techniques and the requirements of Directive 2001/82/EC and the European Pharmacopoeia, it is therefore appropriate to delete the specific requirement for inactivated vaccines regarding the intracerebral pathogenicity index (ICPI) in respect of the Newcastle disease virus strain used in such vaccines currently laid down in point (b) of Article 1 of Decision 93/152/EEC.

(5)

Decision 93/152/EEC should therefore be amended accordingly.

(6)

It is appropriate to lay down a date of application of this Decision, in order to align it with the date of application of Commission Regulation (EC) No 798/2008 (4), as amended by Regulation (EU) No 955/2010 (5), which introduces corresponding amendments for the criteria for inactivated vaccines against Newcastle disease used in third countries,

HAS ADOPTED THIS DECISION:

Article 1

Point (b) of Article 1 of Decision 93/152/EEC is deleted.

Article 2

This Decision shall apply from 1 December 2010.

This Decision is addressed to the Member States.

Done at Brussels, 22 October 2010.

For the Commission

John DALLI

Member of the Commission

(1) OJ L 343, 22.12.2009, p. 74.

(2) OJ L 59, 12.3.1993, p. 35.

(3) OJ L 311, 28.11.2001, p. 1.

(4) OJ L 226, 23.8.2008, p. 1.

(5) See page 3 of this Official Journal.