Commission Regulation (EC) No 36/2005 of 12 January 2005 amending Annexes III and X to Regulation (EC) No 999/2001 of the European Parliament and of the Council as regards epidemio-surveillance for transmissible spongiform encephalopathies in bovine, ovine and caprine animalsText with EEA relevance

of 12 January 2005

amending Annexes III and X to Regulation (EC) No 999/2001 of the European Parliament and of the Council as regards epidemio-surveillance for transmissible spongiform encephalopathies in bovine, ovine and caprine animals

(Text with EEA relevance)

Preamble

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 Article 23 thereof,

Whereas:

(1) Regulation (EC) No 999/2001 lays down rules for the monitoring of transmissible spongiform encephalopathies (TSEs) in bovine, ovine and caprine animals.

(2) In its opinion of 4 and 5 April 2002 on a strategy to investigate the possible presence of bovine spongiform encephalopathy (BSE) in small ruminants, the Scientific Steering Committee (SSC) recommended a strategy for such investigation concerning the Community’s small ruminant population.

(3) A panel of experts on strain typing has been assembled by the Community Reference Laboratory (CRL) for TSEs for further defining the strategy recommended by the SSC. The strategy includes firstly implementing a screening method of all confirmed TSE cases in small ruminants at the level of the national reference laboratories. Secondly, a ring trial with at least three different methods in selected laboratories under the heading of the CRL to be carried out on all cases in which the first screening test could not exclude BSE. Finally, mouse strain typing is required if the outcome of the molecular typing methods needs confirmation.

(4) It is necessary to ensure that brain material of an optimal quality and in sufficient quantity from positive scrapie cases is delivered to the laboratories carrying out confirmatory examinations.

(5) When molecular typing of confirmed scrapie cases reveals a BSE-like or unusual isolate, it is desirable that the competent authority should have access to brain material from other infected animals on the holding, to further assist the investigation of the case.

(6) Four laboratories have successfully participated in a ring trial conducted by the CRL between July 2003 and March 2004 to test their proficiency in using molecular typing methods. The CRL should organise proficiency testing for other laboratories in the use of one of these molecular typing methods before April 2005.

(7) In the meantime, in view of the necessity to extend and accelerate the monitoring of caprine animals following a suspect case found in a goat, and considering the information forwarded to the CRL panel of experts by the laboratories of certain Member States on their capacity to carry out molecular testing, those laboratories should be provisionally approved for such testing pending the results of the proficiency test.

(8) Member States are submitting monthly TSE reports on a voluntary basis in addition to the annual report required by Article 6(4) of Regulation (EC) No 999/2001. The information forwarded in the annual and monthly reports should be harmonised and additional information, in particular on the age distribution of tested bovine animals, should be provided in order to evaluate the prevalence of BSE in different age groups.

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

(10) In view of the increasing urgency to differentiate BSE from scrapie, the amendments made by this Regulation should enter into force without delay.

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

HAS ADOPTED THIS REGULATION:

Article 1

Annexes III and X 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 day following that of its publication in the Official Journal of the European Union .

Final provisions

This Regulation shall be binding in its entirety and directly applicable in all Member States. Done at Brussels, 12 January 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 1993/2004 ( OJ L 344, 20.11.2004, p. 12 ).

Annexes III and X to Regulation (EC) No 999/2001 are amended as follows:

1.	—: killed in the framework of a disease eradication campaign, or

2.	—: the result of the subsequent histopathological examination is positive, or	—	the result of the subsequent histopathological examination is positive, or	—	the result of another diagnostic method referred to in (a) is positive.	(i)	—: Agence Française de Sécurité Sanitaire des Aliments, Laboratoire de pathologie bovine, 31, avenue Tony Garnier, BP 7033, F-69342, Lyon Cedex, France, or	—	Agence Française de Sécurité Sanitaire des Aliments, Laboratoire de pathologie bovine, 31, avenue Tony Garnier, BP 7033, F-69342, Lyon Cedex, France, or
—	the result of the subsequent histopathological examination is positive, or
—	the result of another diagnostic method referred to in (a) is positive.
(i)	—: Agence Française de Sécurité Sanitaire des Aliments, Laboratoire de pathologie bovine, 31, avenue Tony Garnier, BP 7033, F-69342, Lyon Cedex, France, or	—	Agence Française de Sécurité Sanitaire des Aliments, Laboratoire de pathologie bovine, 31, avenue Tony Garnier, BP 7033, F-69342, Lyon Cedex, France, or	—	Veterinary Laboratories Agency, Woodham Lane, New Haw, Addlestone, Surrey KT15 3NB, United Kingdom, or	—	to a laboratory, appointed by the competent authority, which has participated successfully in proficiency testing organised by the Community Reference Laboratory for the use of a molecular typing method, or	—	on a provisional basis until 1 May 2005, the laboratories approved for this purpose by the CRL panel of experts.
—	Agence Française de Sécurité Sanitaire des Aliments, Laboratoire de pathologie bovine, 31, avenue Tony Garnier, BP 7033, F-69342, Lyon Cedex, France, or
—	Veterinary Laboratories Agency, Woodham Lane, New Haw, Addlestone, Surrey KT15 3NB, United Kingdom, or
—	to a laboratory, appointed by the competent authority, which has participated successfully in proficiency testing organised by the Community Reference Laboratory for the use of a molecular typing method, or
—	on a provisional basis until 1 May 2005, the laboratories approved for this purpose by the CRL panel of experts.
(ii)	—: a second discriminatory immuno-blotting,	—	a second discriminatory immuno-blotting,	—	a discriminatory immunocytochemistry, and	—	a discriminatory ELISA (Enzyme linked ImmunoSorbent Assay)
—	a second discriminatory immuno-blotting,
—	a discriminatory immunocytochemistry, and
—	a discriminatory ELISA (Enzyme linked ImmunoSorbent Assay)
Agence Française de Sécurité Sanitaire des Aliments Laboratoire de pathologie bovine 31, avenue Tony Garnier BP 7033 F-69342 Lyon Cedex	Agence Française de Sécurité Sanitaire des Aliments	Laboratoire de pathologie bovine	31, avenue Tony Garnier	BP 7033	F-69342 Lyon Cedex
Agence Française de Sécurité Sanitaire des Aliments
Laboratoire de pathologie bovine
31, avenue Tony Garnier
BP 7033
F-69342 Lyon Cedex
Centre CEA Fontenay-aux-Roses, BP 6 F-92265 Fontenay-aux-Roses Cedex	Centre CEA Fontenay-aux-Roses, BP 6	F-92265 Fontenay-aux-Roses Cedex
Centre CEA Fontenay-aux-Roses, BP 6
F-92265 Fontenay-aux-Roses Cedex
Service de Pharmacologie et d’Immunologie Centre CEA Saclay, bâtiment 136 F-91191 Gif-sur-Yvette Cedex	Service de Pharmacologie et d’Immunologie	Centre CEA Saclay, bâtiment 136	F-91191 Gif-sur-Yvette Cedex
Service de Pharmacologie et d’Immunologie
Centre CEA Saclay, bâtiment 136
F-91191 Gif-sur-Yvette Cedex
Veterinary Laboratories Agency Woodham Lane New Haw Addlestone Surrey KT15 3NB United Kingdom	Veterinary Laboratories Agency	Woodham Lane	New Haw	Addlestone	Surrey KT15 3NB	United Kingdom
Veterinary Laboratories Agency
Woodham Lane
New Haw
Addlestone
Surrey KT15 3NB
United Kingdom
—	immuno-blotting test based on a western blotting procedure for the detection of the protease-resistant fragment PrP Res (Prionics-Check Western test),
—	chemiluminescent ELISA test involving an extraction procedure and an ELISA technique, using an enhanced chemiluminescent reagent (Enfer test),
—	sandwich immunoassay for PrP Res carried out following denaturation and concentration steps (Bio-Rad TeSeE test, the former Bio-Rad Platelia test),
—	microplate based immunoassay (ELISA) which detects protease-resistant PrP Res with monoclonal antibodies (Prionics-Check LIA test),
—	automated conformation-dependent immunoassay comparing the reactivity of a detection antibody to the protease-sensitive and protease-resistant forms of PrP Sc (some fraction of the protease-resistant PrP Sc is equivalent to PrP Res ) and to PrP C (InPro CDI-5 test).

The minimum sample size has been calculated to detect a prevalence in slaughtered animals of 0,03 % with a 95 % confidence.’

¹ Sample sizes are set to take account of the size of the ovine populations in the individual Member States and are intended to provide achievable targets. The sample sizes of 10 000, 1 500, 500 and 100 animals will allow the detection of a prevalence of 0,03 %, 0,2 %, 0,6 % and 3 % respectively with a 95 % confidence.

² Sample sizes are set to take account of the size of the caprine populations in the individual Member States and are intended to provide achievable targets. The sample sizes of 5 000, 1 500, 500 and 50 animals will allow the detection of a prevalence of 0,06 %, 0,2 %, 0,6 % and 6 % respectively with a 95 % confidence. Where a Member State experiences difficulty in collecting sufficient numbers of dead caprine animals to reach its allotted sample size, it may choose to supplement its sample by testing caprine animals slaughtered for human consumption over the age of 18 months at the ratio of three caprine animals slaughtered for human consumption to one dead caprine animal.

Sample sizes are set to take account of the size of the ovine populations in the individual Member States and are intended to provide achievable targets. The sample sizes of 10 000, 1 500, 500 and 100 animals will allow the detection of a prevalence of 0,03 %, 0,2 %, 0,6 % and 3 % respectively with a 95 % confidence. ↩ ↩² ↩³
Sample sizes are set to take account of the size of the caprine populations in the individual Member States and are intended to provide achievable targets. The sample sizes of 5 000, 1 500, 500 and 50 animals will allow the detection of a prevalence of 0,06 %, 0,2 %, 0,6 % and 6 % respectively with a 95 % confidence. Where a Member State experiences difficulty in collecting sufficient numbers of dead caprine animals to reach its allotted sample size, it may choose to supplement its sample by testing caprine animals slaughtered for human consumption over the age of 18 months at the ratio of three caprine animals slaughtered for human consumption to one dead caprine animal. ↩