Transmissible Spongiform Encephalopathies (TSEs)
The European Union (EU) establishes rules for the prevention, control and eradication of transmissible spongiform encephalopathies. Its aim is to prevent a new food crisis like those in the ‘90s and to ensure a high level of public health and food safety.
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 [See amending act(s)].
Since the early ’80s, the appearance of several transmissible spongiform encephalopathies (TSEs) has been ascertained separately in man (Creutzfeldt-Jakob Disease and its variants) and in animals (bovine spongiform encephalopathy or BSE).
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.
This 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 not used in the production of human food, animal feed or fertilisers;
- products of animal origin intended for exhibitions, teaching, scientific research, special studies or analyses, provided those products are not consumed finally or reused by humans or by animals;
- live animals used in or intended for research.
DETERMINATION OF BSE STATUS
The Commission establishes a list which ranks the Member States, the third countries or their regions in different categories according to the BSE risk. The European system for the classification of countries according to their level of risk is similar to that recommended by the World Organisation for Animal Health (OIE).
BSE status is determined on the basis of (Annex II):
- 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 contaminated 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 populations 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 the potential factors for the appearance of BSE and their development over time; the training 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 reports for seven years); examination in an approved laboratory of samples of encephala or other tissues collected.
There are three levels for classifying the BSE status of a country or one of its regions:
- level 1: countries or regions with a negligible BSE risk;
- level 2: countries or regions with a controlled BSE risk;
- level 3: countries or regions with undetermined BSE risk.
PREVENTION OF TSEs
Each Member State must carry out an annual programme for monitoring BSE and scrapie, which includes a screening programme using rapid tests. Annex III gives details of the monitoring system to be put in place for these two diseases. Besides the compulsory controls for all animals which show signs giving rise to a suspicion of TSE, rapid post mortem screening must be performed on:
- all bovine animals over 24 months of age that are intended for human consumption and have undergone emergency slaughter;
- all bovine animals over 30 months of age slaughtered normally for the purposes of human consumption or as part of a BSE eradication campaign;
- all bovine animals over 24 months of age that are not intended for human consumption and have died or been slaughtered, but not in connection with an epidemic such as foot-and-mouth disease. Member States may derogate from these provisions in remote areas with a low animal density, where no collection of dead animals is organised. They shall inform the Commission thereof. The derogation shall not cover more than 10 % of the bovine population in the Member State;
- all bovine animals over 24 months of age that have been declared sick following an ante mortem inspection;
- an annual sample of ovine or caprine animals over 18 months of age or which have more than two permanent incisors erupted through the gum and slaughtered for the purposes of human consumption. This provision concerns those Member States where the population of ewes or female goats exceeds 750 000 animals;
- an annual sample of ovine or caprine animals which are not intended for human consumption and are over 18 months of age or have more than two permanent incisors erupted through the gum;
- any 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, and animals which have consumed potentially contaminated feedingstuffs.
At the latest by 31 March each year, Member States must submit to the Commission an annual report containing, in particular, information on the number of suspected cases per animal species placed under movement restrictions. Within three months following receipt of the report, the Commission has to present a consolidated report on the epidemiological situation in the Community.
The Member States must also inform the Commission and the other Member States of the occurrence in their territory of other cases of TSEs, notably those detected in animals with resistant genotypes. The prion protein genotype shall be determined for each positive TSE case in sheep.
Prohibitions concerning animal feeding
The Regulation prohibits the feeding to ruminants of animal protein and animal feed containing such protein. As regards the feeding of farm animals with the exception of carnivorous fur-producing animals, it is forbidden to use processed animal protein, gelatine of ruminant origin, blood products, hydrolysed protein, dicalcium and tricalcium phosphates of animal origin.
These prohibitions do not apply to the use of the following feedingstuffs and proteins which, where appropriate, have been processed in accordance with the provisions of Regulation (EC) No 1069/2009 on animal by-products not intended for human consumption:
- in the feeding of non-ruminants: fishmeal, hydrolised proteins derived from non-ruminants and ruminant hides and skins, dicalcium phosphate and tricalcium phosphate;
- in the feeding of ruminants: milk, milk-based products and colostrum, eggs and egg products, gelatine derived from non-ruminants, fishmeal where they are used for the production of milk replacers used solely in the feeding of young ruminants;
- in the feeding of fish: blood products and bloodmeal derived from non-ruminants.
Since 1 November 2003, the Member States have had to provide the other Member States and the Commission with an up-to-date list of EU-approved slaughterhouses which do not slaughter ruminants. They must also send a list of the establishments authorised to produce the animal feedingstuffs and animal proteins specified above.
The export to a third country of processed animal proteins of ruminant origin and of products containing such proteins must comply with the legislation in force within the European Union. In advance and in writing, the third country of destination must undertake to use and/or re-export the products taking due account of their intended final use. The Member State authorising the export must inform the other Member States and the Commission.
Specified risk material
Besides establishing procedures for disposing of specified risk materials (SRMs), Regulation (EC) No 999/2001 also defines their specific nature for countries or regions with a controlled or undetermined BSE risk:
- in relation to bovine animals:
- the skull excluding the mandible and including the brain and eyes, and spinal cord of bovine animals aged over 12 months;
- 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 of bovine animals aged over 30 months, and the tonsils, the intestines from the duodenum to the rectum and the mesentery of bovine animals of all ages;
- in relation to ovine and caprine animals:
- the skull including the brain and eyes, the tonsils and the spinal cord of ovine and caprine animals aged over 12 months or which have a permanent incisor erupted through the gum, and the spleen and ileum of ovine and caprine animals of all ages.
Member States with a negligible BSE risk shall continue to be subject to the obligation to remove SRMs.
For countries or regions with a controlled or undetermined BSE risk, the bones of bovine, ovine and caprine animals may not be used to produce mechanically separated meat. The head meat and vertebral column of bovine animals over 30 months of age and the tongues of bovine animals of all ages must be harvested using specific methods.
Specified risk material must be removed in slaughterhouses, in cutting plants in the case of the vertebral column of bovine animals, and where appropriate in the approved establishments referred to in Regulation (EC) No 1069/2009 on animal by-products not intended for human consumption. On removal, all SRMs or by-products must be stained with a dye or marked with a marker. They must be used and destroyed in accordance with Regulation (EC) No 1069/2009. 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.
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 animals suspected of being infected by a TSE
Without prejudice to European measures concerning the notification of 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.
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. All other ruminants on the holding are also subject to an official movement restriction until the results are available.
If it appears that a suspect animal may have been exposed to the TSE on a holding other than the one where 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 surveillance.
Measures in cases where a TSE has been confirmed
When a case of TSE has been officially confirmed, the following measures must be applied:
- an inquiry must be launched to identify the possible origin of the disease and all animals and derived products which may be contaminated;
- in case of confirmation of BSE in a bovine animal, killing and complete destruction of the bovine animals identified as being at risk by the inquiry (in particular, animals belonging to the birth or feed cohort of the infected animal). The Member State may decide to defer the killing and destruction of the animals until the end of their productive life in the case of breeding bulls intended for semen collection, provided it can be ensured that they are destroyed after their death;
- in case of confirmation of BSE in an ovine or caprine animal, killing and complete destruction of all ovine and caprine animals in the herd;
- in case of confirmation of TSE in an ovine or caprine animal, BSE being excluded, killing and complete destruction of all ovine and caprine animals in the herd or, and solely in the case of ovine animals, killing and selective destruction of animals with a genotype susceptible to TSEs. If the infected animal has been introduced from another holding, the Member State may decide to apply eradication measures on the holding of origin in addition to, or instead of, the holding where the infection was confirmed.
Pending the results of the inquiry, the holding in which the infection was confirmed is placed under official control and any 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 movements of animals (or derived products). If it is discovered that the holding on which the TSE was confirmed is not that where the animal was exposed to the agent responsible for the TSE, the authorities may place several holdings under control in addition to the holding on which the animal was exposed. Derogations from these general rules may be granted.
Owners are compensated without delay for the loss of animals or products of animal origin.
Member States must draw up guidelines specifying the national measures to be implemented, as well as competences and responsibilities where cases of TSE are confirmed.
PLACING ON THE MARKET, IMPORTATION AND EXPORTATION
Live animals, their semen, embryos and ova
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. In the case of ovine and caprine animals, the certificates must attest that the animals come from holdings in which no case of scrapie has ever been diagnosed or, in the case of ovine animals, that they are of a genotype resistant to TSEs.
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
This Regulation imposes a high level of safety as regards BSE. It requires the application to imports of bovine meat into the European Union of the same measures as those applicable within the Union, with the exception of third countries with a negligible BSE risk. For example, it prohibits imports from third countries with a controlled BSE risk of specified risk material or meat-based products containing SRM. Hence the third countries concerned must ensure that the animal slaughtering techniques comply with the European rules.
These rules also apply to a list of bovine, ovine and caprine products from third countries: rendered fats, gelatine, petfood, bones and bone-based products, raw materials for the manufacture of animal feed.
The Regulation provides for safeguard measures which may be applied to intra-European trade and trade with third countries. These measures are basically derived from existing Directives in this field (notably Directives 89/662/EEC, 90/425/EEC, 91/496/EEC and 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
To ensure the uniformity of scientific analysis and reliable results, national and European reference laboratories must be designated. If necessary, experts from the Commission may check the functioning of their installations.
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 are required to cooperate with the Community reference laboratory.
A Member State without a national reference laboratory must be entitled to use a European reference laboratory or that of another Member State.
Together with the Commission, the European reference laboratory has to coordinate the methods employed in the Member States for diagnosing BSE and contributes to identifying outbreaks of TSE.
The analysis and sampling methods used must comply with the standards laid down in the Manual of the World Organisation for Animal Health (OIE). Inter alia they must set out procedures to be used in the event of suspect cases and in the framework of the annual monitoring programme.
The Commission is assisted by the Standing Committee on the Food Chain and Animal Health and by the appropriate scientific committees on measures which could have an impact on public health.
|Act||Entry into force||Deadline for transposition in the Member States||Official Journal|
Regulation (EC) No 999/2001
OJ L 147, 31.5.2004.
|Amending act(s)||Entry into force||Deadline for transposition in the Member States||Official Journal|
Regulation (EC) No 1128/2003
OJ L 160, 28.6.2003.
Regulation (EC) No 932/2005
OJ L 163, 23.6.2005.
Regulation (EC) No 1923/2006
OJ L 404, 30.12.2006
Regulation (EC) No 220/2009
OJ L 87, 31.3.2009
The successive amendments and corrections to Regulation (EC) No 999/2001 have been incorporated into the basic text. This consolidated version is for reference only.