EN Official Journal of the European Union L 317/4

COMMISSION REGULATION (EC) No 1974/2005

of 2 December 2005

amending Annexes X and XI to Regulation (EC) No 999/2001 of the European Parliament and of the Council as regards national reference laboratories and specified risk material

(Text with EEA relevance)

THE COMMISSION OF THE EUROPEAN COMMUNITIES,

Having regard to the Treaty establishing the European Community,

Having regard to Regulation (EC) No 999/2001 of the European Parliament and of the Council of 22 May 2001 laying down rules for the prevention, control and eradication of certain transmissible spongiform encephalopathies (1), and in particular the first paragraph of Article 23 thereof,

Whereas:

(1) Regulation (EC) No 999/2001 sets out a list of designated national reference laboratories for Transmissible Spongiform Encephalopathies (TSEs).

(2) Certain Member States have notified to the Commission changes in the name or address of their national reference laboratories, therefore the list of those laboratories should be updated.

(3) Regulation (EC) No 999/2001 designates certain bovine tissues as specified risk materials and lays down the rules for its removal.

(4) Regulation (EC) No 999/2001 provides that export of specified risk material is prohibited but can be authorised only with view to their final destruction. Transitional measures set out in Annex XI to that Regulation provide that carcases, half-carcases or quarters containing no specified risk material other than vertebral column, may be dispatched to another Member State, where the vertebral column is to be removed in accordance with Community legislation. Such removal is not certain in case of exports to third countries. For food safety reasons, such an exception should not be allowed for exports of specified risk material to third countries.

(5) In its opinion of 9 December 1997 the Scientific Steering Committee (SSC) suggested a list of specified risk materials (SRM) in bovine animals to be excluded from human and animal consumption on the basis of relative tissue infectivity, species and age. This opinion was revised and updated by SSC opinions on Bovine Spongiform Encephalopathy (BSE) risk on February 1998, on the human exposure risk via food with respect to BSE in December 1999, on the oral exposure of humans to the BSE agent in April 2000 and on TSE infectivity distribution in ruminant tissues in January 2002.

(6) The SSC considered extremely unlikely that the central nervous system was detectably infected below the age of 30 months even in cattle exposed to infection as calves. However, the exceptional detection of young animals with clinical signs of BSE supported a cautious approach and, therefore, the SSC recommended the removal of various SRM from cattle 12 months of age or older. That recommendation led to the management decision to set the age limit for the removal of certain SRM in bovine animals at 12 months.

(7) Different factors indicate a favourable trend in the BSE epidemic and a clear improvement of the situation in recent years due to the risk-reducing measures in place, in particular the total feed ban and the removal and destruction of SRM. Furthermore inspection reports indicate that implementation of BSE requirements in the Member States has improved. Taking into account the favourable evolution of the BSE epidemic and new data available from BSE pathogenesis studies, the European Commission submitted a new mandate to the European Food Safety Authority in October 2004 for an assessment of the age limit for the removal of SRM in bovines.

(8) The average age of BSE positive cases reported in the EU increased from 86 to 108 months between 2001 and 2004. Only four BSE cases under the age of 35 months of a total of 6 520 BSE cases on a total of close to 41 million animals tested since 2001 have been reported.

(9) In its opinion of 28 April 2005 the EFSA concluded that on the basis of the current scientific knowledge likely detectable infectivity appears at about three quarters of the incubation period.

(10) Therefore a scientific basis exists to review the age limit for the removal of certain SRM in bovine animals, in particular as regards the vertebral column. In view of the development of the infectivity in the central nervous system during the incubation period, the age structure of positive BSE cases and the decrease in exposure of cattle born after 1 January 2001 the age limit for removing vertebral column, including dorsal root ganglia of bovine animals as specified risk material can be increased to 24 months. This age limit can be reviewed in the light of the evaluation of the BSE epidemic.

(11) Regulation (EC) No 999/2001 should therefore be amended accordingly.

(12) The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee of the Food Chain and Animal Health,

HAS ADOPTED THIS REGULATION:

Article 1

Annexes X and XI to Regulation (EC) No 999/2001 are amended in accordance with the Annex to this Regulation.

Article 2

This Regulation shall enter into force on the 20th day following its publication in the Official Journal of the European Union.

It shall apply from 1 January 2006.

This Regulation shall be binding in its entirety and directly applicable in all Member States. Done at Brussels, 2 December 2005. For the Commission Markos KYPRIANOU Member of the Commission

(1) OJ L 147, 31.5.2001, p. 1. Regulation as last amended by Commission Regulation (EC) No 1292/2005 (OJ L 205, 6.8.2005, p. 3).