Annex

Annexes I, VI and VII to Regulation (EC) No 798/2008 are amended as follows:

1. (a)

   in Part 2 of Annex I the model veterinary certificate for meat of poultry (POU) is replaced by the following:

   ‘ Model veterinary certificate for meat of poultry (POU) ’

   

   

   

   

2. (b)

   Annex VI is replaced by the following:

   ‘ANNEX VI

   (as referred to in Article 12(1)(b), Article 12(2)(c)(ii) and Article 13(1)(a))

   CRITERIA FOR RECOGNISED NEWCASTLE DISEASE VACCINES

   I.

   General criteria

   1.

   Vaccines must comply with the standards set out in the Manual of Diagnostic Tests and Vaccines for Terrestrial Animals of the World Organisation for Animal Health (OIE) in the Chapter on Newcastle disease.

   2.

   Vaccines must be registered by the competent authorities of the third country concerned before being allowed to be distributed and used. For such registration, the competent authorities of the third country concerned must rely on a complete file containing data on the efficacy and innocuity of the vaccine; for imported vaccines the competent authorities may rely on data checked by the competent authorities of the country where the vaccine is produced, as far as these checks have been carried out in conformity with OIE standards.

   3.

   In addition, imports or production and distribution of the vaccines must be controlled by the competent authorities of the third country concerned.

   4.

   Before distribution is allowed, each batch of vaccines must be tested on innocuity, in particular regarding attenuation or inactivation and absence of undesired contaminating agents, and on efficacy on behalf of the competent authorities.

   II.

   Specific criteria

   Live attenuated Newcastle disease vaccines must be prepared from a Newcastle disease virus strain for which the master seed has been tested and shown to have an intracerebral pathogenicity index (ICPI) of:

   1. (a)

      less than 0,4, if not less than 10⁷ EID₅₀ are administered to each bird in the ICPI test; or

   2. (b)

      less than 0,5, if not less than 10⁸ EID₅₀ are administered to each bird in the ICPI test.’;

3. (c)

   in Annex VII, in Part II, point (a) is replaced by the following:

   1. (a)

      ‘has not been vaccinated with live attenuated vaccines prepared from a Newcastle disease virus master seed showing a higher pathogenicity than lentogenic strains of the virus within the period of 30 days preceding slaughter;’