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Prevention, control and eradication of transmissible spongiform encephalopathies (TSEs)

1) OBJECTIVE

To establish the rules for the prevention, control and eradication of transmissible spongiform encephalopathies in order to ensure a high level of public health and food safety.

2) ACT

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 [Official Journal L 147, 31.05.2001].

Amended by:
Commission Regulation (EC) No 1248/2001 of 22 June 2001 [Official Journal L 173, 27.06.2001].
Commission Regulation (EC) No 1326/2001 of 29 June 2001 [Official Journal L 177, 30.06.2001].
Commission Regulation (EC) No 270/2002 of 14 February 2002 [Official Journal L 45, 15.02.2002].
Commission Regulation (EC) No 1494/2002 of 21 August 2002 [Official Journal L 225, 22.08.2002].
Commission Regulation (EC) No 260/2003 of 12 February 2003 [Official Journal L 037, 13.02.2003].

3) SUMMARY

1. Since the early 1980s, the appearance of several transmissible spongiform encephalopathies (TSEs) has been ascertained both in man (the Creutzfeldt-Jakob Disease and its variants) and in animals (bovine spongiform encephalopathy or BSE, scrapie).

2. During the 1990s the Commission adopted safeguard provisions based on animal health measures. This Regulation directly concerns public health and the operation of the internal market . It covers both products which are included and not included in Annex I of the Treaty establishing the Community. Consequently, bearing in mind the extent of the public health risk, Article 152 of the Treaty is the basis of this Regulation.

SCOPE

3. This Regulation lays down rules for the prevention, control and eradication of transmissible spongiform encephalopathies in animals. It applies to the production, placing on the market and in certain cases the exportation of live animals and products of animal origin.

4. The Regulation does not apply to:

• cosmetic products, medicaments, raw materials or any other product of animal origin used in their production;
• raw materials or any other product of animal origin (starting materials or intermediate products) not used in human food, animal feed or fertilisers;
• products of animal origin intended for exhibitions/fairs, teaching , scientific research, special studies or analysis, provided those products are not eventually consumed or reused by humans or by animals;
• live animals used in research or intended for research.

DETERMINATION OF BSE STATUS

5. The Commission establishes a list which ranks the Member States, the third countries or their regions in different categories as a function of the BSE risk

6. These lists (Annex II) are set out on the basis of:

• the results of a risk analysis based on the following factors: the consumption by bovine animals of meat and bone meal or greaves derived from ruminants; the importation of such meat and bone meal or greaves potentially contaminated by a TSE agent; the importation of potentially infected animals or ova/embryos; the epidemiological status of the country or region in regard to TSEs; knowledge about the structure of the bovine, ovine and caprine population of the zone in question; the source and treatment of animal waste and the methods of producing animal feed;
• the evaluation of specific criteria: the outcome of a risk analysis identifying all the potential factors for the appearance of BSE and their development over time; an educational programme for veterinarians, breeders, and those who transport, trade in or slaughter bovine animals; the compulsory reporting and examination of all bovine animals showing clinical signs of BSE; the system of surveillance and monitoring of BSE (obligation to keep the results for seven years); examination in an approved laboratory of samples of encephala or other tissues collected.

7. There are five levels for classifying the BSE status of a country or one of its regions:

• Category 1: country or region free of BSE;
• Category 2: BSE provisionally free country or region where no indigenous case has been reported;
• Category 3: BSE provisionally free country or region where at least one indigenous case has been reported;
• Category 4: country or region with low incidence of BSE;
• Category 5: country or region with high incidence of BSE.

8. Member States or third countries present a request to the Commission for their status to be determined. The decision is taken within six months of presentation of all the information required. Member States or third countries which have not submitted such a request within six months as from 1 July 2001 are officially classified in Category 5.

9. Member States and third countries must notify the Commission of any epidemiological evidence or other information which might lead to a change (or maintenance) of their status. Furthermore, the results of the Community monitoring programmes may affect the classification by category.

10. Transitional measures are adopted for a maximum period of two years to permit the changeover from the current arrangements to the arrangements established by the Regulation. Pending the adoption of a Community decision concerning the BSE classification of the country under consideration, transitional measures apply. They are based on the classical geographical BSE risk assessment.

PREVENTION OF TSE

Monitoring system

11. Each Member State carries out an annual programme for monitoring BSE and scrapie, which includes a screening programme using rapid tests. Annex III fleshes out the monitoring system to be put in place for these two diseases. Besides the compulsory controls for all animals which show signs making it possible to suspect a TSE, since 1 January 2001 rapid post mortem screening must be performed on:

• all bovine animals subject to special emergency slaughtering or showing signs of any form of disease at the time of ante mortem inspection at the slaughterhouse;
• all bovine animals over 30 months of age slaughtered normally for human consumption;
  Sweden may derogate from this rule by examining only a random sample of animals.
• all bovine animals found dead, slaughtered in the holding or during transport, but not slaughtered for human consumption;
• all animals slaughtered in the United Kingdom in the framework of a world animal health organisation programme;
  This programme provides for the destruction of all the carcasses of bovine animals subjected to emergency slaughter, of bovine animals over 30 months of age, of bovine animals aged over 42 months of age and born after 1 August 1996 and slaughtered in normal conditions, as well as a random sample of bovine animals born after 1 August 1996 and slaughtered in normal conditions.
• all ovine and caprine animals over 18 months of age, whether slaughtered for human consumption or not ;
• all other animals.
  The Member States may carry out monitoring programmes in respect of animals used for dairy production, animals derived from herds infected with TSE or derived from TSE infected dams, animals which have consumed potentially contaminated feeding stuffs.

12. At the latest by 31 March each year, Member States must submit to the Commission an annual report notably containing information on the number of suspected cases per animal species placed under movement restrictions. Within three months following receipt of the report, the Commission presents a consolidated report on the epidemiological situation in the Community.

13. The Member States must also inform the Commission and the other Member States of the occurrence in their territory of cases of other TSEs, notably those detected in animals with resistant genotypes. The prion protein genotype is determined for each positive TSE case in sheep.

Prohibitions concerning animal feeding

14. The Regulation prohibits the feeding to ruminants of protein derived from mammals. In countries or regions in category 5, this restriction applies to all farmed animals except for dogs and cats.

15. The countries or regions in this category may not export or store feed intended for farm animals (except for dogs and cats) which contains proteins derived from mammals.

16. Several specific provisions on animal feeding supplement the provisions of this Regulation. They are defined in the fact sheet setting out a new state of play as regards BSE .

Specified risk material

17. Specified risk material (SRM) is the subject of transitional measures. These measures apply for at least six months as from 1 July 2001 and pending the adoption of a Community decision on the classification of the country considered as regards BSE.

18. Besides laying down procedures for eliminating specified risk material, Regulation (EC) No 999/2001 also defines their specific nature:

• the skull including the brain and eyes, the tonsils, the vertebral column excluding the vertebrae of the tail, the transverse processes of the lumbar and thoracic vertebrae and the wings of the sacrum, but including dorsal root ganglia, and spinal cord of bovine animals aged over 12 months, and the intestines from the duodenum to the rectum and the mesentery of bovine animals of all ages;
• the skull including the brain and eyes, the tonsils, the spinal chord of ovine and caprine animals aged over 12 months or which have a permanent incisor erupted through the gum, and the spleen of ovine and caprine animals of all ages.

19. Besides the SRM listed above, the following tissues from the United Kingdom and Portugal (with the exception of the Autonomous Region of the Azores) must be indicated as such: the entire head, excluding the tongue, including the brain, eyes, trigeminal ganglia and tonsils; the thymus; the spleen and the spinal chord of bovine animals aged over six months.

20. On removal, all specified risk material must be stained with a dye or marked with a marker. SRM may be placed on the market only with a view to its destruction, the methods of which are set out in the Regulation. Member States must carry out frequent official inspections to verify the application of these rules and to ensure that measures are taken to avoid contamination at all levels.

Education programmes

21. Member States must ensure that staff of the competent authority, of diagnostic laboratories and colleges of agriculture and veterinary medicine, as well as official veterinarians, slaughterhouse personnel and animal breeders, have been given training in the clinical signs and epidemiology of TSE. To this end, the Community may grant financial assistance.

CONTROL AND ERADICATION OF TSEs

Measures with respect to suspect animals

22. Without prejudice to Community measures concerning the notification of the diseases , the Member States must ensure that any animal suspected of being infected by a TSE is notified to the competent authorities. They must regularly inform each other and the Commission of the cases notified.

23. Any animal suspected of being infected by a TSE must be placed under an official movement restriction until the results of a clinical and epidemiological examination are known, or must be killed for laboratory examination under official control. Specific rules exist, depending on the animal:

• bovine animals: if BSE is suspected in a bovine animal at a holding in a Member State, all other bovine animals from that holding must be placed under an official movement restriction until the results of the examination are available;
• ovine and caprine animals: the preceding rule applies on the basis of objective evidence, such as the results of tests capable of differentiating between the various TSEs.

24. If it appears that a suspect animal may have been exposed to BSE at a holding other than the one at which the suspicion occurred, the competent authority may decide that only the suspect animal shall be placed under an official movement restriction and may also place other holdings under control.

Measures in the case of infections

25. When a case of TSE has been officially confirmed, the following measures must be applied:

• all parts of the body of the animal must be completely destroyed;
• an inquiry must be carried out to identify the possible origin of the disease and all animals and derived products which may be contaminated.

26. Pending the results of the inquiry, the holding in which the infection was confirmed is placed under official control and all movement of animals susceptible to TSEs (and products of animal origin) from or to the holding must be strictly authorised by the competent authority. This measure guarantees the identification and effective traceability of animal movements (or derived products). If it is discovered that the holding at which the TSE was confirmed is not that of the animal which was exposed, the authorities may place both holdings under control or only the holding at which the animal was exposed. Derogations to these general rules may be granted.

27. Owners are compensated without delay for the loss of animals or products of animal origin.

28. Member States must draw up a contingency plan specifying the national measures to be implemented and indicating competences and responsibilities where cases of TSE are confirmed. These guidelines may be harmonised at Community level.

PLACING ON THE MARKET, IMPORTATION AND EXPORTATION

Live animals, their semen, embryos and ova

29. When their importation, placing on the market or exportation is authorised, live animals and their embryo and ova must be accompanied by appropriate animal health certificates.

30. The placing on the market, the importation and exportation of bovine, ovine or caprine animals and their semen, embryos and ova are currently subject to transitional measures. Once the Community decision classifying the country in question as regards BSE is adopted, the placing on the market, import and export of bovine, ovine and caprine animals will be subject to the specific conditions of this Regulation (Annex VIII on placing on the market and exportation, Annex IX on importation).

31. It is prohibited to place on the market the last-born progeny to which female bovine, ovine or caprine animals infected with a TSE gave birth during the years preceding the appearance of the first clinical signs of the disease.

Placing on the market and importation of products of animal origin

32. This Regulation imposes a high level of safety as regards BSE. It requires the application to importations of bovine meat into the European Union the same measures as those applicable within the Union, with the exception of countries where the presence of BSE is highly unlikely. For example, it prohibits importations from third countries of specified risk material or meat-based products containing SRM. Hence the third countries must ensure that the animal slaughtering techniques comply with Community rules.

33. These rules also apply to a list of bovine, ovine and caprine products from third countries: rendered fat, gelatine, petfood, bones and bone-based products, raw materials for the manufacture of animal feed.

Safeguard measures

34. The Regulation provides for safeguard measures which may be applied to intra-Community trade and trade with third countries. These measures are basically derived from existing directives in this field (notably Directive 89/662/EEC , Directive 90/425/EEC , Directive 91/496/EEC and Directive 97/78/EC ). There are several such measures. For example, if an importing Member State ascertains, during official controls, the presence of a disease which presents a serious threat to human or animal health, the authorities may take more restrictive measures, including the quarantining of the animals concerned. The Commission may also adopt such measures.

Reference laboratories, sampling, testing and controls

35. To ensure the uniformity of scientific analysis and reliable results, national and Community reference laboratories are designated. If necessary, experts from the Commission may check the functioning of their installations.

36. The national reference laboratories are mainly responsible for verifying the diagnostic methods used in the regional laboratories and their coordination within the Member State. They cooperate with the Community reference laboratory.

37. A Member State without a national reference laboratory must be entitled to use a Community reference laboratory or that of another Member State.

38. Together with the Commission, the Community reference laboratory coordinates the methods employed in the Member States for diagnosing BSE and contributes to identifying outbreaks of TSE. It facilitates the training of scientific experts with a view to the harmonisation of diagnostic techniques throughout the Community.

39. The analysis and sampling methods used comply with the Manual of Standards established by the International Office of Epizootic Diseases ( OIE ). Inter alia they concern procedures to be used in the event of suspect cases and in the framework of the annual monitoring programme.

Transitional measures

40. Transitional measures apply for at least six months as from 1 July 2001 and pending the adoption of a Community decision concerning the BSE classification of the country concerned. These measures notably concern:

• specified risk material (cf. below);
• restrictions on importations into the Community as from 1 March 2002; these restrictions concern a large number of products of animal origin: specified risk material, fresh meat, minced meat, meat products, rendered fats, gelatine, certain animal feed, bones and bone-based products, raw materials for the production of animal feed, bovine intestines.
  These restrictions do not apply to the following countries: Argentina, Australia, Botswana, Brazil, Chile, Costa Rica, Iceland, Salvador, Namibia, New Zealand, Nicaragua, Panama, Paraguay, Singapore, Swaziland, Uruguay, Vanuatu.

41. A Community decision concerning the classification of a Member State or third country as regards BSE has not yet been adopted. Hence, other transitional measures have been adopted for a maximum period of two years (date of reference: 1 July 2001) so as to permit the change-over from the current arrangements to those established by this Regulation. They notably concern the placing on the market of live animals and products of animal origin and animal health certificates relating to trade.

Institutional provisions

42. The Commission is assisted by the Standing Veterinary Committee or the Scientific Steering Committee.

43. Repealed legislative instruments:

Decision 92/290/EC [Official Journal L 152, 4.06.1992]
Decision 94/381/EC [Official Journal L 172, 7.07.1994]
Decision 94/474/EC [Official Journal L 194, 29.07.1994]
Decision 98/272/EC [Official Journal L 122, 24.04.1998]
Decision 2000/418/EC [Official Journal L 158, 30.06.2000]
Decision 2000/764/EC [Official Journal L 305, 6.12.2000]
Decision 2001/8/EC [Official Journal L 2, 5.01.2001]

44. Legislative acts relating to TSEs still in force

4) IMPLEMENTING MEASURES

Commission Decision 2002/1003/EC laying down minimum requirements for a survey of prion protein genotypes of sheep breeds [Official Journal L 349, 24.12.2002].
By 1 July 2003 at the latest, each Member State must complete a survey of the prion protein genotype of each of its sheep breeds which are native, or form a significant population in its territory. It provides a report to the Commission by 1 October 2003 at the latest.

Commission Decision 2003/100/EC of 13 February 2003 laying down minimum requirements for the establishment of breeding programmes for resistance to transmissible spongiform encephalopathies in sheep [Official Journal L 041, 14.02.2003].
By 1 January 2004 at the latest, and on the basis of the survey provided for in Decision 2002/1003/EC, each Member State must introduce a breeding programme to select for resistance to TSEs in sheep. Adopted on a voluntary basis, this programme is compulsory for all flocks as from 1 January 2005. Each Member State provides a report on the requirements of their breeding programmes by 1 April 2004 and a first annual progress report by 1 April 2005.

5) FOLLOW-UP WORK

Proposal for a Regulation of the European Parliament and of the Council amending Regulation (EC) No 999/2001 as regards the extension of the period for transitional measures [COM(2003)103 - not published in the Official Journal].
By now a third of the scientific assessments of the Member States and the third countries as regards the BSE status have been carried out. Moreover, the Commission has submitted to the OIE a proposal to amend the criteria of classification by category. The current period of application of the transitional measures is due to end on 1 July 2003; this communication proposes to extend it to 1 July 2005.
Codecision procedure (2003/0046/COD)

Last updated: 12.03.2003