Annexes to COM(1998)623-1 - Rules for the prevention and control of certain transmissible spongiform encephalopathies - Main contents
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This page contains a limited version of this dossier in the EU Monitor.
| dossier | COM(1998)623-1 - Rules for the prevention and control of certain transmissible spongiform encephalopathies. |
|---|---|
| document | COM(1998)623  |
| date | May 22, 2001 |
ANNEX I
SPECIFIC DEFINITIONS
For the purpose of this Regulation:
(a) "indigenous case of BSE" means a case of bovine spongiform encephalitis which has not been clearly demonstrated to be due to infection prior to importation as a live animal, embryo or ovum;
(b) "discrete adipose tissue" means internal and external body fat removed during the slaughter and cutting process, in particular fresh fat from the heart, caul, kidneys and mesentery of bovine animals, and fat from cutting rooms;
(c) "cohort" means a group of bovine animals which were either born in the same herd as, and within 12 months preceding or following the birth of, the affected cattle or reared together with the affected animal at any time during the first year of their life and which may have consumed the same feed as that which the affected animal consumed during the first year of its life;
(d) "landfill site" means a waste disposal site as defined by Directive 1999/31/EC(1).
(1) Council Directive 1999/31/EC of 26 April 1999 on the landfill of waste (OJ L 182, 16.7.1999, p. 1).
ANNEX II
DETERMINATION OF BSE STATUS
CHAPTER A
The BSE status of a Member State or a third country or of one of their regions, hereinafter referred to as "country or region", shall be determined on the basis of the following criteria:
(a) the outcome of a risk analysis identifying all the potential factors for the appearance of BSE referred to in Chapter B and their development over time;
(b) an education programme for veterinarians, breeders and those who transport, trade in and slaughter bovine animals, which seeks to encourage them to report all cases of neurological manifestations in adult bovine animals;
(c) the compulsory reporting and examination of all bovine animals showing clinical signs of BSE;
(d) a system of continuous surveillance and monitoring of BSE with particular reference to the risks described in Chapter B, taking account of the guidelines in the table of Chapter A of Annex III or in accordance with the appropriate international standards; reports on the number of examinations carried out and the results thereof must be kept for at least seven years;
(e) the examination in an approved laboratory of samples of encephala or other tissues collected under the surveillance system mentioned in point (d).
CHAPTER B
The risk analysis referred to in Chapter A(a) shall be based on the following factors:
- the consumption by bovine animals of meat and bone meal or greaves derived from ruminants;
- the importation of meat and bone meal or greaves potentially contaminated by a TSE or animal feed containing meat and bone meal or greaves;
- the importation of animals or ova/embryos potentially infected by a TSE;
- the epidemiological status of the country or region in regard to animal TSEs;
- the extent of knowledge about the structure of the bovine, ovine and caprine population in the country or region;
- the source of animal waste, the parameters of the processes for treating such waste and the methods of producing animal feed.
CHAPTER C
Definition of categories
The BSE status of Member States or third countries or one of the regions thereof shall be determined by classification into the following categories:
A. CATEGORY 1: Country or region free of BSE
A country or region where a risk analysis based on the information laid down in Chapter B has been conducted which demonstrated that appropriate measures have been taken for the relevant period of time, to manage any risk identified and
1. EITHER no BSE case has been recorded and:
(i) the criteria in Chapter A(b) to (e) have been complied with for at least seven years, or
(ii) the criteria in Chapter A(c) have been complied with for at least seven years and it has been demonstrated that for at least eight years no meat and bone meal or greaves derived from ruminants or mammals has been fed to ruminants;
2. OR where all cases of BSE have been clearly demonstrated to originate directly from the importation of live bovine animals or bovine embryos/ova, and all the affected bovine animals as well as, if these are females, their last progeny born within two years prior to, or after, the first clinical signs of onset of the disease, if alive in the country or region, have been killed and completely destroyed and, either
(i) the criteria in Chapter A(b) to (e) have been complied with for at least seven years, or
(ii) the criteria in Chapter A(c) have been complied with for at least seven years and it has been demonstrated that for at least eight years no meat and bone meal or greaves have been fed to ruminants;
3. OR where the last indigenous case of BSE was reported more than seven years ago, the criteria in Chapter A(b) to (e) have been complied with for at least seven years and the feeding of ruminants with meat and bone meal and greaves derived from ruminants has been banned and the ban has been effectively enforced for at least eight years.
B. CATEGORY 2: BSE provisionally free country or region where no indigenous case has been reported
Country or region where a risk analysis as described in Chapter B has been conducted which demonstrates that appropriate measures have been taken for the relevant period of time to manage any risk identified, and
1. EITHER where there has been no case of BSE and:
(i) the criteria in Chapter A(b) to (e) are complied with, but have not been complied with for seven years, or
(ii) it has been demonstrated that for at least eight years no meat and bone meal or greaves has been fed to ruminants, but the criteria in Chapter A(c) have not been complied with for seven years;
2. OR where all cases of BSE have been clearly demonstrated to originate directly from the importation of live bovine animals or bovine embryos/ova, and all the affected bovine animals as well as, if these are females, their last progeny born within two years prior to, or after, the first clinical signs of onset of the disease, if alive in the country or region, have been killed and completely destroyed, and either:
(i) the criteria in Chapter A(b) to (e) are complied with, but have not been complied with for seven years, or
(ii) it has been demonstrated that for at least eight years no meat and bone meal or greaves has been fed to ruminants, but the criteria in Chapter A(c) have not been complied with for seven years.
C. CATEGORY 3: BSE provisionally free country or region where at least one indigenous case has been reported
Any country or region where a risk analysis based on the information referred to in Chapter B has been conducted which demonstrates that appropriate measures have been taken for the relevant period of time to manage any risk identified and:
1. EITHER the last indigenous case of BSE was reported more than seven years ago, the criteria in Chapter A(b) to (e) are complied with and the ban on feeding ruminants with meat and bone meal and greaves derived from ruminants is effectively enforced, but:
(i) the criteria in Chapter A(b) to (e) have not been complied with for seven years, or
(ii) the ban on feeding ruminants with meat and bone meal and greaves derived from ruminants has not been effectively enforced for eight years;
2. OR where the last indigenous case has been reported less than seven years ago, the BSE incidence rate, calculated on the basis of indigenous cases, has been less than one case per million during each of the last four consecutive twelve-month periods within the bovine animal population over 24 months of age in the country or region or - when in a country or a region the bovine animal population over 24 months of age is less than 1 million animals - one case per real number of this population (calculated on the basis of Eurostat statistics), and where:
(i) the ban on feeding ruminants with meat and bone meal and greaves derived from ruminants has been effectively enforced for at least eight years;
(ii) the criteria in Chapter A(b) to (e) have been complied with for at least seven years;
(iii) the affected bovine animals as well as:
- if these are females, their last progeny born within two years prior to, or after, clinical onset of the disease;
- all bovine animals from the cohort,
are killed and completely destroyed if they are still alive in the country or region concerned.
For this classification account may be taken, by way of derogation from point (iii), of the existence of other measures offering an equivalent level of protection in relation to the killing of animals at risk.
D. CATEGORY 4: Country or region with low incidence of BSE
Any country or region where:
1. the criteria listed in Chapter A are complied with, and the BSE incidence rate, calculated over the past 12 months, has been greater than or equal to one indigenous case per million and less than or equal to one hundred cases per million within the bovine animal population over 24 months of age in the country or region; or
2. the criteria listed in Chapter A are complied with and the BSE incidence rate, calculated as specified in point 1 has been less than one indigenous case per million for less than four consecutive 12 month periods and the affected cattle as well as:
- if these are females, their last progeny born within two years prior to, or after the first clinical signs of onset of the disease,
- all bovine animals from the cohort,
if alive in the country or region, are killed and completely destroyed.
For this classification account may be taken, by way of derogation from this point, of the existence of other measures offering an equivalent level of protection in relation to the killing of animals at risk.
Countries or regions where the BSE incidence rate, calculated over the past 12 months, has been less than one indigenous case per million within the cattle population over 24 months of age in the country or region, but where a risk analysis as described in Chapter A has been conducted which demonstrates that at least one of the criteria enabling the country or region to be classified in category 2 or 3 is not complied with, must be regarded as countries or regions belonging to category 4.
E. CATEGORY 5: Country or region with high incidence of BSE
Any country or region where:
1. the criteria listed in Chapter A are complied with, and the BSE incidence rate, calculated over the past 12 months, has been greater than one hundred cases per million within the bovine animal population over 24 months of age in the country or region; or
2. the BSE incidence rate, calculated over the past 12 months, has been greater than or equal to one case per million and less than or equal to one hundred cases per million within the bovine animal population over 24 months of age in the country or region, and at least one of the criteria listed in Chapter A is not complied with.
ANNEX III
MONITORING SYSTEM
CHAPTER A
I. MINIMUM REQUIREMENTS FOR A PROGRAMME FOR MONITORING BSE IN BOVINE ANIMALS
1. Selection of sub-populations
Bovine animals over 30 months of age as follows:
1.1 Animals subject to "special emergency slaughtering" as defined in Article 2(n) of Directive 64/433/EEC(1) and animals slaughtered in accordance with Annex I, Chapter VI, point 28(c), of Directive 64/433/EEC (including animals referred to in Regulation (EC) No 716/96(2), and subject to "special emergency slaughtering" as referred to above or slaughtered in accordance with Annex I, Chapter VI, point 28(c), of Directive 64/433/EEC).
1.2 Dead animals not slaughtered for human consumption, having died on the farm or during transport (excluding animals referred to in Commission Regulation (EC) No 716/96).
1.3 Animals slaughtered normally for human consumption.
1.4 Animals displaying a neurological disorder.
2. Sample size
2.1. The number of samples tested annually in each Member State from the sub-population referred to in point 1.1 must include all animals in that sub-population.
2.2. The number of samples tested annually in each Member State from the sub-populations referred to in point 1.2 must not be less than the sample sizes indicated in the table. The selection of samples shall be random. The sampling must be representative for each region and continuous.
2.3. The number of samples tested annually in each Member State from the sub-population referred to in point 1.3 must include all animals in that sub-population.
>TABLE>
II. MINIMUM REQUIREMENTS FOR A PROGRAMME FOR MONITORING SCRAPIE IN OVINE AND CAPRINE ANIMALS
1. Selection of sub-populations
Selection must be by means of a risk assessment of sub-populations of native-born animals displaying clinical signs compatible with scrapie. Within each sub-population and age group, selection must be random.
The following shall be the criteria for the selection:
- animals displaying a neurological or behavioural disorder lasting for at least 15 days and resistant to treatment;
- moribund animals without signs of infectious or traumatic illness;
- animals displaying other progressive disease conditions.
Ovine and caprine animals must be examined for scrapie and, when tests that can differentiate in practice between TSEs are available, for BSE.
2. Age of targeted animals
The sample must target the oldest animals in the sub-population. However, all targeted animals must be over 12 months of age.
3. Sample size
The minimum number of animals to be examined on an annual basis must comply with the sample sizes referred to in the table. Animals examined in accordance with Article 12 may be included within the minimum sample size.
Table
Minimum number of annual neurohistological investigations of animals showing signs compatible with TSE
>TABLE>
III. MONITORING IN HIGHER RISK ANIMALS
Monitoring in higher risk animals
In addition to the monitoring programmes set out in Parts I and II, Member States may on a voluntary basis carry out targeted surveillance for TSE in higher risk animals, such as:
- animals originating from countries with indigenous TSE,
- animals which have consumed potentially contaminated feedingstuffs,
- animals born or derived from TSE-infected dams.
IV. COMMON PROVISIONS
Member States shall ensure that no parts of the body of animals sampled pursuant to this Annex are used for human food, animal feed and fertilisers, until the laboratory examination has been concluded with negative results.
CHAPTER B
I. INFORMATION TO BE PRESENTED BY MEMBER STATES IN THEIR REPORTS
1. the number of suspected cases per animal species placed under movement restrictions in accordance with Article 12(1);
2. the number of suspected cases per animal species subject to laboratory examination in accordance with Article 12(2) and the outcome of the examination;
3. the estimated size of each sub-population referred to in Chapter A, Part I, point 1;
4. the number of bovine animals tested within each sub-population as referred to in Chapter A, Part I, point 1, and in Chapter A, Part III, the method for sample selection and the outcome of the tests;
5. the number of ovine and caprine animals examined within each sub-population as referred to in Chapter A, Part II, point 1, and in Chapter A, Part III, and the outcome of the examination;
6. number, age distribution and geographical distribution of positive cases of BSE and scrapie. The year and, where possible, month of birth should be given for BSE cases born after the introduction of a ban on using ruminant protein in animal feed;
7. positive TSE cases confirmed in animals other than bovine, ovine, and caprine animals.
II. INFORMATION TO BE PRESENTED BY THE COMMISSION IN ITS SUMMARY
The summary shall be presented in a tabled format covering at least the following information for each Member State:
1. the total population of bovine animals over 24 months of age and the estimated size of each sub-population referred to in Chapter A, Part I, point 1;
2. the number of suspected cases per animal species as referred to in Article 12;
3. the number of bovine animals tested as referred to in Chapter A, Part I, point 1;
4. the number of ovine and caprine animals examined as referred to in Chapter A, Part II, point 1;
5. the number and age distribution of positive BSE cases;
6. positive BSE cases born after the introduction of a feed ban and the year and month of birth;
7. positive cases of scrapie;
8. positive TSE cases in animals other than bovine, ovine and caprine animals.
III. RECORDS
1. The competent authority shall keep, for seven years, records of:
- the number and types of animals placed under movement restrictions as referred to in Article 12(1);
- the number and outcome of clinical and epidemiological investigations as referred to in Article 12(1);
- the number and outcome of laboratory examinations as referred to in Article 12(2);
- the number, identity and origin of animals sampled in the framework of the monitoring programmes as referred to in Part I and, where possible, age, breed and anamnestic information.
2. The investigating laboratory shall keep, for seven years, all records of testing, in particular laboratory workbooks, paraffin blocks and, where appropriate, photographs of Western blots.
(1) Council Directive 64/433/EEC of 26 June 1964 on health problems affecting intra-Community trade in fresh meat (OJ 121, 29.7.1964, p. 2012/64). Directive as last amended by Directive 95/23/EC (OJ L 243, 11.10. 1993, p. 7).
(2) Commission Regulation (EC) No 716/96 of 19 April 1996 adopting exceptional support measures for the beef market in the United Kingdom (OJ L 99, 20.4.1996, p. 14). Regulation as last amended by Regulation (EC) No 1176/2000 of the Commission (OJ L 131, 1.6.2000, p. 37).
ANNEX IV
ANIMAL FEEDING
1. In Member States or regions thereof placed in category 5, the prohibition referred to in Article 7(1) shall be extended to:
(a) the feeding to any farmed animal of protein derived from mammals;
(b) the feeding to any mammal of processed animal protein derived from mammals; this prohibition shall not apply to feeding to dogs and cats nor to the production of dog and cat food;
(c) the feeding to any ruminant of rendered ruminant fat.
2. The prohibition laid down in Article 7(1) and (2) shall not apply to the following products from healthy animals:
(a) milk and milk products;
(b) gelatine derived from hides and skins;
(c) hydrolysed proteins with a molecular weight below 10000 daltons which:
(i) have been derived from hides and skins obtained from animals which have been slaughtered in a slaughterhouse and have undergone an ante mortem inspection by an official veterinarian in accordance with Chapter VI of Annex I to Directive 64/433/EEC and passed fit, as a result of such inspection, for slaughter for the purpose of that Directive,
and
(ii) have been produced by a production process which involves appropriate measures to minimise contamination of hides and skins, preparation of the hides and skins by brining, liming and intensive washing followed by exposure of the material to a pH of more than 11 for more than three hours at a temperature of more than 80 °C and followed by heat treatment of more than 140 °C for 30 minutes at more than 3,6 bar or by an equivalent production process approved by the Commission after consultation of the appropriate Scientific Committee in accordance with the procedure laid down in Article 24(2),
and
(iii) come from establishments which carry out an own checks programme (HACCP);
(d) dicalcium phosphate (with no trace of protein or fat);
(e) dried plasma and other blood products, with the exception of bovine blood products for feeding to ruminants.
ANNEX V
SPECIFIED RISK MATERIAL
1. The following tissues shall be designated as specified risk material depending on the category of the Member State or third country of origin or residence of the animal, determined in accordance with Article 5:
CATEGORIES 1 AND 2
None.
CATEGORIES 3 AND 4
(a) the skull including the brain and eyes, the tonsils and the spinal cord of bovine animals aged over 12 months, and the intestines from the duodenum to the rectum of bovine animals of all ages;
(b) 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 of ovine and caprine animals of all ages.
CATEGORY 5
(a) the entire head (excluding the tongue), including the brain, eyes, trigeminal ganglia and tonsils; the thymus; the spleen and the spinal cord of bovine animals aged over six months, and the intestines from the duodenum to the rectum of animals of all ages;
(b) the vertebral column, including dorsal root ganglia, of bovine animals aged over 30 months;
(c) the skull including the brain and eyes, the tonsils, 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 of ovine and caprine animals of all ages.
2. Specified risk material must be removed at:
(a) slaughterhouses;
(b) cutting plants, high-risk processing plants or premises referred to in Articles 3 and 7 of Directive 90/667/EEC(1), under the supervision of a designated agent appointed by the competent authority. Those establishments shall be approved for that purpose by the competent authority.
However, the vertebral column may be removed at points of sale to the consumer situated in the territory of the Member State concerned.
Where specified risk material is not removed from dead animals which have not been slaughtered for human consumption, the parts of the body containing specified risk material or the entire body will be treated as specified risk material.
3. All specified risk material must be stained with a dye and, as appropriate, marked with a marker immediately on removal, and completely destroyed:
(a) by incineration without pre-processing; or,
(b) provided that the dye or marker remains detectable, after pre-processing:
(i) in accordance with the systems described in Chapters I to IV, VI and VII of the Annex to Decision 92/562/EEC(2):
- by incineration;
- by co-incineration;
(ii) in accordance with at least the standards referred to in Annex I to Decision 1999/534/EC(3), by burial in an approved landfill site.
4. Member States may derogate from the provisions of points 2 and 3 to allow the incineration or burial of specified risk material or entire bodies, without prior staining, or, as appropriate, removal of the specified risk materials, in the circumstances set out in Article 3(2) of Directive 90/667/EEC and by a method which precludes all risk of transmission of a TSE and is authorised and supervised by the competent authority, in particular where animals have died or have been killed in the context of disease control measures and without prejudice to Articles 12 and 13.
5. The use of an alternative test to the removal of specified risk material may be authorised under the following conditions:
(a) tests must be carried out in slaughterhouses on all animals eligible for the removal of specified risk material;
(b) no bovine, ovine or caprine product intended for human food or animal feed may leave the slaughterhouse before the competent authority has received and accepted the results of the tests on all slaughtered animals potentially contaminated if BSE has been confirmed in one of them;
(c) when an alternative test gives a positive result, all bovine, ovine and caprine material which has been potentially contaminated in the slaughterhouse is destroyed in accordance with point 3, unless all parts of the body including the hide of the affected animal can be identified and kept separate.
6. Member States are to carry out frequent official inspections to verify the correct application of this Annex and ensure that measures are taken to avoid contamination, particularly in slaughterhouses, cutting plants, animal waste processing plants, high risk processing plants or premises authorised by the Member States in accordance with Article 7 of Directive 90/667/EEC, points of sale to the consumer, landfill sites and other facilities for storage or incineration.
7. Member States shall in particular set up a system to ensure and check that:
(a) specified risk material used in the production of products referred to in Article 1(2) are used solely for the authorised purpose;
(b) where bovine, ovine or caprine animals enter a Member State placed in a numerically lower category, indicating a better BSE status, than that of the animals that enter, those animals remain under official supervision until slaughter or dispatch from its territory;
(c) specified risk material, in particular where disposal takes place at establishments or premises other than slaughterhouses, is completely separated from other waste not destined for incineration, is collected separately and is disposed of in accordance with points 2, 3 and 4. Member States may allow dispatch of heads or carcasses containing specified risk material to another Member State after agreement with that other Member State both to receive the material and to apply the specific conditions applicable to such movements.
8. Member States may send specified risk material or the material processed therefrom to other Member States for incineration only under the conditions laid down in Article 4(2) of Decision 97/735/EC(4), where applicable.
These points may be amended at the request of a Member State to allow the dispatch of specified risk material or the material processed therefrom to third countries for incineration. The conditions governing export shall be adopted at the same time, by the same procedure.
(1) Council Directive 90/667/EEC of 27 November 1990 laying down the veterinary rules for the disposal and processing of animal waste, for its placing on the market and for the prevention of pathogens in feedstuffs of animal or fish origin and amending Directive 90/425/EEC (OJ L 363, 27.12.1990, p. 51). Directive as last amended by the 1994 Act of Accession.
(2) Commission Decision 92/562/EEC of 17 November 1992 on the approval of alternative heat treatment systems for processing high-risk material (OJ L 359, 9.12.1992, p. 23). Decision as amended by the 1994 Act of Accession.
(3) Council Decision 1999/534/EC of 19 July 1999 on measures applying to the processing of certain animal waste to protect against transmissible spongiform encephalopathies and amending Commission Decision 97/735/EC (OJ L 204, 4.8.1999, p. 37).
(4) Commission Decision 97/735/EC of 21 October 1997 concerning certain protection measures with regard to trade in certain types of mammalian animal waste (OJ L 294, 28.10.1997, p. 7). Decision as amended by Council Decision 1999/534/EC (OJ L 204, 4.8.1999, p. 37).
ANNEX VI
STANDARDS FOR CERTAIN PRODUCTS OF ANIMAL ORIGIN DERIVED FROM OR CONTAINING RUMINANT MATERIAL
The use of ruminant material for the production of the following products of animal origin is prohibited as referred to in Article 9(1):
(a) mechanically recovered meat;
(b) dicalcium phosphate intended as feedingstuffs for livestock;
(c) gelatine, unless it is produced from ruminant hides;
(d) derivatives made from rendered ruminant fat;
(e) rendered ruminant fat, unless it was produced from:
(i) discrete adipose tissue declared fit for human consumption;
(ii) raw materials which were processed in accordance with the standards referred to in Directive 90/667/EEC.
ANNEX VII
ERADICATION OF TRANSMISSIBLE SPONGIFORM ENCEPHALOPATHY
1. The inquiry referred to in Article 13(1)(b) must identify:
(a) in the case of bovine animals:
- all other ruminants on the holding of the animal in which the disease was confirmed;
- all embryos, ova and the last progeny of a female animal in which the disease was confirmed and the embryos or progeny of which were collected or born within two years prior to, or after, clinical onset of the disease in its dam;
- all animals of the cohort of the animal in which the disease was confirmed;
- the possible origin of the disease and other holdings on which there are animals, embryos or ova which may have become infected by the TSE agent or been exposed to the same feed or contamination source;
- the movement of potentially contaminated feedingstuffs, other material, or any other means of transmission, which may have transmitted the TSE agent to or from the holding in question;
(b) in the case of ovine and caprine animals:
- all ruminants other than ovine and caprine animals on the holding of the animal in which the disease was confirmed;
- insofar as they are identifiable, the parents, all embryos, ova and the last progeny of the animal in which the disease was confirmed;
- all animals of the cohort, to be defined in accordance with the procedure laid down in Article 24(2), of the animal in which the disease was confirmed;
- all other ovine and caprine animals on the holding of the animal in which the disease was confirmed in addition to those mentioned in the second and third indents;
- the possible origin of the disease and the identification of other holdings on which there are animals, embryos or ova which may have become infected by the TSE agent or been exposed to the same feed or contamination source;
- the movement of potentially contaminated feedingstuffs, other material or any other means of transmission, which may have transmitted the BSE agent to or from the holding in question.
2. The measures laid down in Article 13(1) shall comprise at least:
(a) in case of confirmation of BSE in a bovine animal, killing and complete destruction of bovine animals and destruction of embryos and ova identified by the inquiry referred to in point 1(a), first, second and third indents;
(b) in case of confirmation of BSE in an ovine or caprine animal, killing and complete destruction of all animals, embryos and ova identified by the inquiry referred to in point 1(b), second to sixth indents.
ANNEX VIII
PLACING ON THE MARKET AND EXPORT
CHAPTER A
Conditions for intra-Community trade in live animals, embryos and ova
I. CONDITIONS WHICH APPLY IRRESPECTIVE OF THE CATEGORY OF THE MEMBER STATE OR THIRD COUNTRY OF ORIGIN OR RESIDENCE OF THE ANIMAL
1. Dispatch to other Member States must follow the rules of Article 15(1).
2. The following conditions shall apply to the movement of bovine embryos and ova:
Bovine embryos and ova must be derived from female animals which, at the time of collection:
- were not suspected of being infected by BSE;
- themselves complied with the conditions laid down in Part II.
3. The following conditions shall apply to trade in ovine and caprine animals:
(a) Ovine and caprine animals for breeding must:
(i) come from a holding satisfying the following requirements:
- it is subject to regular official veterinary checks;
- the animals are marked;
- no case of scrapie has been confirmed for at least three years;
- checking by sampling is carried out on the holding on old female animals intended for culling;
- females are introduced into that holding only if they come from a holding which complies with the same requirements;
(ii) have been continuously kept on a holding or holdings complying with the requirements laid down in point (i) since birth or for the last three years;
(iii) if they are destined for a Member State which benefits, for all or part of its territory, from the provisions laid down in point (b), comply with the guarantees provided for in the programmes referred to in that point.
(b) A Member State which has a compulsory or voluntary national scrapie control programme for all or part of its territory:
(i) may submit the said programme to the Commission, outlining in particular:
- the distribution of the disease in the Member State;
- the reasons for the programme, taking into consideration the importance of the disease and the cost/benefit ratio;
- the geographical area in which the programme will be implemented;
- the status categories to be applied to the holdings, the standards which must be attained in each category and the test procedures to be used;
- the programme monitoring procedures;
- the action to be taken if, for any reason, a holding loses its status;
- the measures to be taken if the results of checks carried out in accordance with the provisions of the programme are positive;
(ii) the programmes referred to in point (i) may be approved in compliance with the criteria laid down in that point in accordance with the procedure referred to in Article 24(2). According to the same procedure, the additional guarantees, general or specific, which may be required in intra-Community trade, shall be defined at the same time or at the latest three months after approval of the programmes. Such guarantees must not exceed those which the Member State implements nationally;
(iii) programmes submitted by Member States may be amended or supplemented in accordance with the procedure referred to in Article 24(2). According to the same procedure, an amendment or an addition to a programme which has already been approved or to guarantees which have been defined in accordance with subparagraph (ii) may be approved.
(c) Where a Member State considers that its territory or part of its territory is free from ovine scrapie:
(i) it is to submit to the Commission appropriate supporting documentation, setting out in particular:
- the history of the occurrence of the disease in its territory;
- the results of surveillance testing based on serological, microbiological, pathological or epidemiological investigation;
- the period over which the surveillance was carried out;
- the arrangements for verifying the absence of the disease;
(ii) the additional guarantees, general or specific, which may be required in intra-Community trade are to be defined in accordance with the procedure referred to in Article 24(2). Such guarantees must not exceed those which the Member State implements nationally;
(iii) the Member State concerned is to notify the Commission of any change in the details specified in point (i) which relate to the disease. The guarantees defined in accordance with point (ii) may, in the light of such notification, be amended or withdrawn in accordance with the procedure referred to in Article 24(2).
II. CONDITIONS WHICH APPLY DEPENDING ON THE CATEGORY OF THE MEMBER STATE OF ORIGIN OR RESIDENCE OF THE ANIMAL DETERMINED IN ACCORDANCE WITH ANNEX II, CHAPTER C
1. Dispatch to other Member States is to follow the rules of Article 15(1).
2. The BSE category of the Member State of origin of bovine, ovine and caprine animals are to be communicated to the Member State of destination.
3. The following conditions are to apply to movements as referred to in point 1 of bovine animals coming from or having resided in the Member States or one of the regions thereof placed in:
CATEGORIES 3 AND 4
The animals must have:
(a) been born, raised and have remained in herds in which no case of BSE has been confirmed for at least seven years; or
(b) been born after the date from which the ban on the feeding of ruminants with proteins derived from mammals has been effectively enforced.
CATEGORY 5
The animals must have:
(a) been born after the date from which the ban on the feeding of farmed animals with proteins derived from mammals has been effectively enforced; and
(b) been born, raised and have remained in herds in which no case of BSE has been confirmed for at least seven years, and which contain only bovine animals born on the farm or coming from a herd of equivalent status.
CHAPTER B
Conditions relating to progeny of TSE suspect or confirmed animals referred to in Article 15(2)
It shall be prohibited to place on the market the last-born progeny to which female bovine animals infected with a TSE or BSE-confirmed ovine or caprine animals gave birth during the preceding two-year period or during the period that followed the appearance of the first clinical signs of the onset of the disease.
CHAPTER C
Conditions for intra-Community trade in certain products of animal origin
I. The following products of animal origin are exempt from the prohibition referred to in Article 16(3), provided that they are derived from bovine animals that satisfy the requirements of Parts II or III below:
- fresh meat;
- minced meat;
- meat preparations;
- meat products;
- petfood which is destined for domestic carnivores.
Date-based Scheme
II. Deboned fresh meat from which all adherent tissues, including obvious nervous and lymphatic tissue, has been removed, and products of animal origin referred to in Part I deriving therefrom obtained from eligible animals from countries or regions in category 5 may be marketed in accordance with the second subparagraph of Article 16(3) when they are obtained from animals born after the date from which the animal feeding standards laid down in Article 7(2) were effectively enforced and certified as meeting the conditions laid down in point 1 and they are produced in establishments which meet the condition laid down in point 9. The competent authority shall ensure that the conditions with respect to controls laid down in points 2 to 8 and point 10 are complied with.
1. A bovine animal shall be eligible for the Date-based Scheme if it was born and raised in the Member State concerned and if at the time of slaughter it is shown that the following conditions are fulfilled:
(a) the animal has been clearly identifiable throughout its life, enabling it to be traced back to its dam and herd of origin; its unique eartag number, date and holding of birth and all movements after birth are recorded either in the animal's official passport or in an official computerised identification and tracing system; the identity of its dam is known;
(b) the animal is more than six months but less than 30 months of age, determined by reference to an official computer record of its date of birth, or to the animal's official passport;
(c) the competent authority has obtained and verified positive evidence that the dam of the animal has lived for at least six months after the birth of the eligible animal;
(d) the dam of the animal has not developed BSE and is not suspected of having contracted BSE.
Controls
2. If any animal presented for slaughter or any circumstance surrounding its slaughter does not meet all of the requirements of this Regulation, the animal must be automatically rejected and its passport confiscated. If that information becomes available after slaughter, the competent authority must immediately cease issuing certificates and cancel certificates issued. If dispatch has already taken place, the competent authority must notify the competent authority of the place of destination. The competent authority of the place of destination must take the appropriate measures.
3. Slaughter of eligible animals must take place in slaughterhouses which are not used for the slaughter of bovine animals other than those slaughtered under a Date-based Scheme or under a Certified Herd Scheme.
4. The competent authority must satisfy itself that procedures used in the cutting plants ensure that the following lymph nodes have been removed:
popliteal, ischiatic, superficial inguinal, deep inguinal, medial and lateral iliac, renal, prefemoral, lumbar, costocervical, sternal, prescapular, axilliary, caudal and deep cervical.
5. Meat must be traceable back to the eligible animal, or after cutting, to the animals cut in the same batch, by means of an official tracing system until the time of slaughter. After slaughter, labels must be capable of tracing fresh meat and products referred to in Part I back to the eligible animal to enable the consignment concerned to be recalled. In the case of petfood, accompanying documents and records must allow tracing.
6. All approved eligible carcasses must have individual numbers correlated with the eartag number.
7. The Member State must have detailed protocols in place covering:
(a) tracing and controls prior to slaughter;
(b) controls during slaughter;
(c) controls during processing of petfood;
(d) all labelling and certification requirements after slaughter to the point of sale.
8. The competent authority must set up a system for recording checks on compliance so that control can be demonstrated.
The establishment
9. To obtain approval, the establishment must devise and implement a system whereby the eligible meat and/or eligible product is identifiable and all meat can be traced back to the eligible animal, or after cutting, to the animals cut in the same batch. The system must allow full traceability of the meat or products of animal origin at all stages and records must be retained for at least two years. Details of the system employed must be given, in writing, by the management of the establishment to the competent authority.
10. The competent authority must assess, approve and monitor the system provided by the establishment in order to ensure that it provides full segregation and traceability both backwards and forwards.
Certified herd Scheme
III. Deboned fresh meat from which all adherent tissues, including obvious lymphatic and nervous tissue, has been removed, and products of animal origin referred to in Part I, deriving therefrom which are obtained from eligible animals from countries or regions in category 5, may be marketed in accordance with the second subparagraph of Article 16(3) when obtained from animals which are certified as meeting the conditions laid down in point 2 and coming from herds in which no case of BSE has occurred in the last seven years and which are certified as meeting the conditions laid down in point 1 and produced in establishments which meet the condition laid down in point 11. The competent authority shall ensure that the conditions laid down in points 3 to 10 and 12 with respect to the computerised tracing system and the controls are complied with.
Conditions relating to herds
1. (a) A herd is a group of animals forming a separate and distinct unit, that is a group of animals which is managed, housed and kept separately from any other group of animals and which is identified with unique herd and animal identification numbers.
(b) A herd is eligible when for at least seven years there has been no confirmed case of BSE, nor a suspect case for which the diagnosis of BSE has not been ruled out, in any animal which was still in or had moved through or from the herd.
(c) As an exception to the provisions in point (b), a herd that has been in existence for less than seven years may be considered eligible, after a thorough investigation by the competent veterinary authority, on condition that:
(i) all animals born or moved into the newly established herd complied with the conditions set out in point (2)(a), (d) and (e); and,
(ii) the herd has complied with the conditions set out in point (b) during its entire existence.
(d) If a herd is newly established on a holding which experienced a confirmed case of BSE in any animal which was still in or had moved through or from a herd on that holding, the newly established herd can only be eligible after a thorough investigation by the competent veterinary authority, certifying compliance with each of the following conditions to the satisfaction of that authority:
(i) all animals of the affected herd previously held on the same holding have been removed or killed;
(ii) all feed has been removed and destroyed and all feed containers thoroughly cleansed;
(iii) all buildings have been emptied and thoroughly cleansed before the new animals were admitted;
(iv) all conditions set out in point (c) have been complied with.
Conditions relating to the animal
2. (a) all records of the animal's birth, identity and movements are recorded on an official computerised tracing system;
(b) the animal is more than six months but less than 30 months of age, determined by reference to an official computer record of its date of birth;
(c) its dam has lived for at least six months after its birth;
(d) its dam has not developed BSE and is not suspected of having contracted BSE;
(e) the herd of birth of the animal and all herds through which it has moved are eligible.
Computerised tracing system
3. The official computerised tracing system referred to in point 2(a) will be approved only where it has been in operation for sufficient time to contain all the information, relating to the lifetime and movements of the animals, needed to check compliance with the requirements of this Regulation, and concerns only animals born after the system came into operation. Historical data loaded into a computer for any period before the system was operational will not be accepted for this purpose.
Controls
4. If any animal presented for slaughter or any circumstance surrounding its slaughter does not meet all of the requirements of this Regulation, the animal must be automatically rejected and its passport confiscated. If that information becomes available after slaughter, the competent authority must immediately cease issuing certificates, and cancel certificates issued. If dispatch has already taken place, the competent authority must notify the competent authority of the place of destination. The competent authority of the place of destination must take the appropriate measures.
5. Slaughter of eligible animals must take place in slaughterhouses used exclusively for the slaughter of animals under a Date-based Scheme or under a Certified Herd Scheme.
6. The competent authority must satisfy itself that procedures used in the cutting plants ensure that the following lymph nodes have been removed:
popliteal, ischiatic, superficial inguinal, deep inguinal, medial and lateral iliac, renal, prefemoral, lumbar, costocervical, sternal, prescapular, axilliary, caudal and deep cervical.
7. Meat must be traceable back to the herd of the eligible animal, or after cutting, to the animals cut in the same batch, by means of the computerised tracing system until the time of slaughter. After slaughter, labels must be capable of tracing fresh meat and products referred to in Part I back to the herd to enable the consignment concerned to be recalled. In the case of petfood, accompanying documents and records must allow tracing.
8. All approved eligible carcasses must have individual numbers correlated with the eartag number.
9. The Member State must have detailed protocols in place covering:
(a) tracing and controls prior to slaughter;
(b) controls during slaughter;
(c) controls during processing of petfood;
(d) all labelling and certification requirements after slaughter to the point of sale.
10. The competent authority must set up a system for recording checks on compliance so that control can be demonstrated.
The establishment
11. To obtain approval, the establishment must devise and implement a system whereby the eligible meat and/or eligible product is identifiable and all meat can be traced back to its herds of origin, or after cutting, to the animals cut in the same batch. The system must facilitate full traceability of the meat or products of animal origin at all stages and records must be retained for at least two years. Details of the system employed must be given, in writing, by the management of the establishment to the competent authority.
12. The competent authority must assess, approve and monitor the system provided by the establishment in order to ensure that it provides full segregation and traceability both backwards and forwards.
CHAPTER D
Conditions applicable to exports
Live bovine animals and products of animal origin derived therefrom are to be subject - as regards exports to third countries - to the rules laid down in this Regulation for intra-Community trade.
ANNEX IX
IMPORTATION INTO THE COMMUNITY OF LIVE ANIMALS, EMBRYOS, OVA AND PRODUCTS OF ANIMAL ORIGIN
CHAPTER A
When importing from countries or regions placed in category 1, the competent authority is, for bovine animals and all commodities of bovine origin for which this Regulation lays down specific rules, to take account of the presentation of an international animal health certificate attesting that the country or region complies with the conditions in Annex II, Chapter C, to be placed in that category.
CHAPTER B
Imports of bovine animals
A. Imports of bovine animals from a country or a region placed in category 2 are to be subject to the presentation of an international animal health certificate attesting that:
(a) the feeding of ruminants with proteins derived from mammals has been banned and the ban has been effectively enforced;
(b) the bovine animals intended for export to the Community are identified by a permanent identification system enabling them to be traced back to the dam and herd of origin and are not the progeny of BSE-suspected females.
B. Imports of bovine animals from countries or regions placed in category 3 are to be subject to the presentation of an international animal health certificate attesting that:
1. the feeding of ruminants with proteins derived from mammals has been banned and the ban has been effectively enforced;
2. bovine animals intended for export to the Community:
- are identified by a permanent identification system enabling them to be traced back to the dam and herd of origin and making it possible to establish that they are not the progeny of BSE suspect or confirmed females;
- were born, raised and had remained in herds in which no case of BSE had been confirmed for at least seven years; or
- were born after the date from which the ban on the feeding of ruminants with proteins derived from mammals has been effectively enforced.
C. Imports of bovine animals from countries or regions placed in category 4 are to be subject to the presentation of an international animal health certificate attesting that:
1. the feeding of ruminants with proteins derived from mammals has been banned and the ban has been effectively enforced;
2. bovine animals intended for export to the Community:
(a) are identified by a permanent identification system enabling them to be traced back to the dam and herd of origin and making it possible to establish that they are not the progeny of BSE suspect or confirmed females; and
(b) were born, raised and have remained in herds in which no case of BSE has been confirmed for at least seven years; or
(c) were born after the date from which the ban on the feeding of ruminants with proteins derived from mammals has been effectively enforced.
D. Imports of bovine animals from countries or regions placed in category 5 are to be subject to the presentation of an international animal health certificate attesting that:
1. the feeding of farmed animals with proteins derived from mammals has been banned and the ban has been effectively enforced;
2. the affected bovine animals are killed and completely destroyed as well as:
(a) if these are females, their last progeny born within two years prior to, or after the first clinical signs of the onset of the disease;
(b) all bovine animals from the same cohort
if such animals are still alive in the country or region;
3. the animals intended for export to the Community:
(a) were born after the date from which the ban on the feeding of farmed animals with proteins derived from mammals was effectively enforced;
(b) are identified by a permanent identification system enabling them to be traced back to the dam and herd of origin and are not the progeny of BSE suspect or confirmed females;
AND
(c) either were born, raised and have remained in herds in which no case of BSE has ever been confirmed, and which contain only bovine animals born on the farm or coming from a herd of equal health status; or
(d) were born, raised and have remained in herds in which no case of BSE has been confirmed for at least seven years, and which contain only bovine animals born on the farm or coming from a herd of equal health status.
CHAPTER C
Imports of fresh meat and products of bovine animal origin
A. Imports of fresh meat (on the bone or deboned) and products of bovine animal origin from countries or regions placed in category 2 are to be subject to the presentation of an international health certificate attesting that the feeding of ruminants with proteins derived from mammals has been banned and the ban has been effectively enforced.
B. Imports of fresh meat (on the bone or deboned) and products of bovine animal origin from countries or regions placed in category 3 are to be subject to the presentation of an international health certificate attesting that:
(a) the feeding of ruminants with proteins derived from mammals has been banned and the ban has been effectively enforced;
(b) the fresh meat and products of bovine animal origin intended for export to the Community do not contain or are not derived from specified risk material referred to in Annex V or mechanically recovered meat obtained from the bone of the head or vertebral column.
C. Imports of fresh meat (on the bone or deboned) and meat products of bovine origin from countries or regions placed in category 4 are to be subject to the presentation of an international health certificate attesting that:
1. the feeding of ruminants with proteins derived from mammals has been banned and the ban has been effectively enforced;
2. the fresh meat and products of bovine animal origin intended for export to the Community do not contain or are not derived from specified risk material referred to in Annex V or mechanically recovered meat obtained from the head or vertebral column.
D. Imports of fresh meat and products of bovine animal origin from countries or regions placed in category 5 are to be prohibited except for the products of animal origin listed in section I of Chapter C, Annex VIII. These imports are to be subject to the presentation of an international health certificate attesting that:
1. they fulfil the conditions of Article 16(2) and those set out in sections II or III of Chapter C of Annex VIII;
2. the meat products intended for export to the Community do not contain or are not derived from any product referred to in Chapter F, nor from any specified risk material as defined in Annex V;
3. a system is in operation enabling the fresh meat and products of bovine animal origin intended for export to the Community to be traced back to the establishments from which they are derived;
4. the bovine animals from which the meat or meat products intended for export to the Community originate:
(a) were identified by a permanent identification system enabling them to be traced back to the dam and herd of origin;
(b) are not the progeny of BSE-suspect or confirmed females; and either:
- were born after the date from which the ban on the feeding of farmed animals with proteins derived from mammals was effectively enforced; or
- were born, raised and have remained in herds in which no case of BSE has been confirmed for at least seven years;
5. the feeding of farmed animals with proteins derived from mammals has been banned and the ban has been effectively enforced;
6. the affected bovine animals are slaughtered and completely destroyed as well as:
(a) if these are females, their last progeny born within two years prior to, or after, the first clinical signs of the onset of the disease;
(b) all bovine animals from the same cohort
if they are still alive in the country or region.
CHAPTER D
Imports of bovine embryos and ova
A. Imports of bovine embryos/ova from countries or regions placed in category 2 are to be subject to the presentation of an international animal health certificate attesting that:
1. the feeding of ruminants with proteins derived from mammals has been banned and the ban has been effectively enforced;
2. the embryos/ova were collected, processed and stored in conformity with the provisions of Annexes A and B to Directive 89/556/EC(1).
B. Imports of bovine ova/embryos from countries or regions placed in category 3 are to be subject to the presentation of an international animal health certificate attesting that:
1. the feeding of ruminants with proteins derived from mammals has been banned and the ban has been effectively enforced;
2. ova/embryos destined for export to the Community are derived from females which:
(a) are identified by a permanent identification system enabling them to be traced back to the dam and herd of origin, and are not the progeny of BSE-confirmed females;
(b) are not the progeny of BSE-suspect or confirmed females;
(c) were not suspected of being affected by BSE at the time of embryo collection;
3. the ova/embryos were collected, processed and stored in accordance with the provisions of Annexes A and B to Directive 89/556/EEC.
C. Imports of ova/embryos from countries or regions placed in category 4 are to be subject to the presentation of an international animal health certificate attesting that:
1. the feeding of ruminants with proteins derived from mammals has been banned and the ban has been effectively enforced;
2. the ova/embryos intended for export to the Community are derived from females which:
(a) are identified by a permanent identification system enabling them to be traced back to the dam and herd of origin, and are not the progeny of BSE-suspected or affected females;
(b) are not affected with BSE;
(c) were not suspected of being affected with BSE at the time of embryo collection; and
(i) either were born after the date from which the ban on the feeding of ruminants with proteins derived from mammals was effectively enforced; or
(ii) were born, raised and have remained in herds in which no case of BSE has been confirmed for at least seven years;
3. the ova/embryos were collected, processed and stored in conformity with the provisions of Annexes A and B to Directive 89/556/EEC.
D. Imports of bovine ova/embryos from countries or regions placed in category 5 are to be subject to the presentation of an international animal health certificate attesting that:
1. the feeding of animals for breeding with proteins derived from mammals has been banned and the ban has been effectively enforced;
2. the affected bovine animals, and, if these are females, their last progeny born within two years prior to, or after, clinical onset of the disease, if alive in the country or region, are killed and completely destroyed;
3. ova/embryos intended for export to the Community are derived from females which:
(a) are identified by a permanent identification system enabling them to be traced back to the dam and herd of origin, and are not the progeny of BSE-suspected or confirmed females;
(b) are not affected with BSE;
(c) were not suspected of being affected with BSE at the time of embryo collection; and
(i) either were born after the date from which the ban on the feeding of animals for breeding with proteins derived from mammals was effectively enforced;
(ii) or have never been fed with proteins derived from mammals and were born, raised and have remained in herds in which no case of BSE has been confirmed for at least seven years, and which contain only bovine animals born on the farm or coming from a herd of equal health status;
4. the ova/embryos were collected, processed and stored strictly in conformity with the provisions of Annexes A and B to Directive 89/556/EEC.
CHAPTER E
Imports of ovine and caprine animals
Ovine and caprine animals imported into the Community are to meet the requirements which provide health guarantees equivalent to those required by this Regulation or pursuant to this Regulation.
CHAPTER F
Imports into the Community from third countries or regions thereof, placed in category 5, of the products of animal origin referred to in Annex VIII, Chapter C, in accordance with Article 16(3) are to be prohibited if they contain or are derived from the following products or material derived from ruminant animals:
- mechanically recovered meat;
- dicalcium phosphate intended for feeding livestock;
- gelatine unless produced from hides or skins;
- rendered ruminant fat and derivatives made from it unless they were produced from discrete adipose tissue which was itself declared fit for human consumption, or from raw materials which were processed in accordance with the standards referred to in Decision 1999/534/EC.
CHAPTER G
When importing products of animal origin from third countries or regions thereof which are not placed in category 1, the appropriate certificates, as required by Community legislation, are to be supplemented by a declaration signed by the competent authority of the country of production, worded as follows: "The product of animal origin does not contain, and is not derived from, specified risk material as defined in Annex V 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 or mechanically recovered meat obtained from bones of the head or vertebral column of bovine animals. The animals have not been slaughtered after stunning by means of a gas injected into the cranial cavity or killed instantaneously by the same method or slaughtered by laceration after stunning of central nervous tissue by means of an elongated rod-shaped instrument introduced into the cranial cavity."
(1) Council Directive 89/556/EEC of 25 September 1989 on animal health conditions governing intra-Community trade in importation from third countries of embryos of domestic animals of the bovine species (OJ L 302, 19.10.1989, p. 1). Directive as last amended by Commission Decision 94/113/EC (OJ L 53, 24.2.1994, p. 23).
ANNEX X
REFERENCE LABORATORIES, SAMPLING AND LABORATORY ANALYSIS METHODS
CHAPTER A
National reference laboratories
1. The designated national reference laboratory is to:
(a) have at its disposal facilities and expert personnel enabling it to show at all times, and especially when the disease in question first appears, the type and strain of the agent of TSE, and to confirm results obtained by regional diagnostic laboratories. Where it is not capable of identifying the strain-type of the agent, it shall set up a procedure to ensure that the identification of the strain is referred to the Community reference laboratory;
(b) verify diagnostic methods used in regional diagnostic laboratories;
(c) be responsible for coordination of diagnostic standards and methods within the Member State. To this end, it:
- may provide diagnostic reagents to laboratories approved by the Member State;
- is to control the quality of all diagnostic reagents used in the Member State;
- is to periodically arrange comparative tests;
- is to hold isolates of the agents of the disease in question, or corresponding tissues containing such agents, coming from cases confirmed in the Member State;
- is to ensure confirmation of results obtained in diagnostic laboratories designated by the Member State;
(d) is to cooperate with the Community reference laboratory.
2. However, by way of derogation from point 1, Member States which do not have a national reference laboratory are to use the services of the Community reference laboratory or of national reference laboratories in other Member States.
3.
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CHAPTER B
Community reference laboratory
1. The Community reference laboratory for TSEs is: The Veterinary Laboratories Agency Woodham Lane New Haw
Addlestone
Surrey KT15 3NB United Kingdom
2. The functions and duties of the Community reference laboratory are:
(a) to coordinate, in consultation with the Commission, the methods employed in the Member States for diagnosing BSE, specifically by:
- storing and supplying corresponding tissues containing the agent, for the development or production of the relevant diagnostic tests or for typing strains of the agent;
- supplying standard sera and other reference reagents to the national reference laboratories in order to standardise the tests and reagents used in the Member States;
- building up and retaining a collection of corresponding tissues containing the agents and strains of TSEs;
- organising periodic comparative tests of diagnostic procedures at Community level;
- collecting and collating data and information on the methods of diagnosis used and the results of tests carried out in the Community;
- characterising isolates of the TSE agent by the most up-to-date methods to allow greater understanding of the epidemiology of the disease;
- keeping abreast of trends in surveillance, epidemiology and prevention of TSEs throughout the world;
- maintaining expertise on prion diseases to enable rapid differential diagnosis;
- acquiring a thorough knowledge of the preparation and use of diagnostic methods used to control and eradicate TSEs;
(b) to assist actively in the diagnosis of outbreaks of TSEs in Member States by studying samples from TSE-infected animals sent for confirmatory diagnosis, characterisation and epidemiological studies;
(c) to facilitate the training or retraining of experts in laboratory diagnosis with a view to the harmonisation of diagnostic techniques throughout the Community.
CHAPTER C
Sampling and laboratory testing
1. Sampling and laboratory testing for the presence of BSE in bovine animals
1.1. Collection of samples
The competent authority shall ensure that samples are collected using the methods and protocols laid down in the latest edition of the Manual of Standards for Diagnostic Tests and Vaccines of the International Office of Epizootic Diseases (OIE), (hereinafter referred to as the "Manual"). In the absence of such methods and protocols, the competent authority shall ensure that the samples are collected in a manner appropriate for the correct application of tests.
1.2. Laboratory testing
1.2.1. Suspect cases
Tissues from bovine animals sent for laboratory testing in accordance with Article 12(2) shall be subject to a histopathological examination as laid down in the latest edition of the Manual, except where the material is autolysed. Where the result of the histopathological examination is inconclusive or negative or where the material is autolysed, the tissues shall be subjected to an examination by one of the other diagnostic methods laid down in the above Manual (immonucytochemistry, immuno-blotting or demonstration of characteristic fibrils by electron microscopy).
1.2.2. Animals examined in the framework of the annual monitoring programme
Bovine animals examined in the framework of the annual monitoring programme as laid down in Annex III, Chapter A, point I, and the targeted surveillance programme provided for in Annex III, Chapter A, Part III, shall be examined by one of the tests listed in point 4.
Where the result of the rapid test is inconclusive or positive, the tissues shall be subject to a histopathological examination of the brainstem as laid down in the latest edition of the Manual, except where the material is autolysed or otherwise not suitable for examination by histopathology. Where the result of the histopathological examination is inconclusive or negative or where the material is autolysed, the tissues shall be subjected to an examination by one of the other diagnostic methods mentioned in 1.2.1; however, the method must not be the same as the method used in the screening test.
1.3. Interpretation of results
An animal examined as referred to in point 1.2.1 shall be regarded a positive BSE case, if the result of one of the tests is positive.
An animal examined as referred to in point 1.2.2 shall be regarded as a positive BSE case if the result of the screening test is positive or inconclusive, and
- the result of the subsequent histopathological examination is positive, or
- the result of another diagnostic method mentioned in point 1.2.1 is positive.
2. Sampling and laboratory testing for the presence of a TSE in ovine and caprine animals
Sampling and laboratory testing for the presence of scrapie in ovine and caprine animals shall be carried out in accordance with the methods and protocols laid down in the latest edition of the Manual.
Rules concerning sampling and laboratory testing for the presence of BSE in ovine and caprine animals shall be drawn up in accordance with the procedure referred to in Article 24(2).
3. Confirmation of the presence of other TSEs
The tests carried out to confirm the suspected presence of a TSE different from those referred to in points 1 and 2 shall include at least a histopathological examination of brain tissue. The competent authority may also require laboratory tests such as immunocytochemical and immunodiagnostic tests for the detection of scrapie-associated fibrils if it deems it necessary. In any case at least one other laboratory examination should be carried out in accordance with the previous sentence if the initial histopathological examination proves negative. The three tests must be carried out in the event of the first appearance of the disease.
4. Rapid tests
For the purposes of carrying out the tests in accordance with Article 5(3) and Article 6(1), the following methods shall be used as rapid tests within the meaning of this Regulation:
- Western blot test for the detection of the protease-resistant fragment PrPRes (Prionics Check test);
- Chemiluminescent ELISA test involving an extraction method and an ELISA technique, using an enhanced chemiluminescent reagent (Enfer test);
- Sandwich immunoassay for PrPRes carried out following denaturation and concentration steps (BIORADE test).
5. Alternative tests
(To be defined)
ANNEX XI
TRANSITIONAL MEASURES
TRANSITIONAL MEASURES REFERRED TO IN ARTICLE 22
A. Concerning the removal of specified risk material
1. Member States shall ensure that the specified risk material designated below is removed and destroyed in accordance with points 6 to 11.
(a) The following tissues are designated as specified risk material:
(i) the skull including the brain and eyes, the tonsils and the spinal cord of bovine animals aged over 12 months, and the intestines from the duodenum to the rectum of bovine animals of all ages;
(ii) 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 of ovine and caprine animals of all ages.
(b) In addition to the specified risk material listed in (a), the following tissues must be designated as specified risk material in the United Kingdom of Great Britain and Northern Ireland and in Portugal, with the exception of the Autonomous Region of the Azores:
(i) the entire head excluding the tongue, including the brain, eyes, trigeminal ganglia and tonsils; the thymus, the spleen and the spinal cord of bovine animals aged over six months, and the intestines from the duodenum to the rectum of bovine animals of all ages;
(ii) the vertebral column, including dorsal root ganglia, of bovine animals aged over 30 months.
2. Specified risk material or processed material derived from it may be despatched only with a view to subsequent incineration, in accordance with point 11 or, where appropriate, point 7(b).
3. Member States shall ensure that bones from the head and vertebral column of bovine, ovine and caprine animals are not used for the production of mechanically recovered meat.
4. Member States shall ensure that laceration after stunning of central nervous tissue by means of an elongated rod-shaped instrument introduced into the cranial cavity is not effected within their territory with regard to bovine, ovine or caprine animals whose meat is intended for human or animal consumption.
5. The specified risk material referred to in point 1(a) shall not be imported into the Community after 31 March 2001.
The products of animal origin listed below shall be subject to restrictions on import into the Community:
- fresh meat: the meat defined by Directive 64/433/EEC,
- minced meat and meat preparations: the minced meat and meat preparations defined by Directive 94/65/EC(1);
- meat products: the meat products defined by Directive 77/99/EEC(2);
- the processed animal protein referred to in Directive 92/118/EEC;
- the bovine intestines referred to in Article 2(b) subparagraph (v) of Directive 77/99/EEC.
(a) When the abovementioned products of animal origin, containing material from bovine, ovine or caprine animals are imported into the Community after 31 March 2001 from third countries or regions thereof, the health certificates shall be accompanied by a declaration signed by the competent authority of the country of production, worded as follows: "The product of animal origin does not contain, and is not derived from any product referred to in Chapter F of Annex IX to Regulation (EC) No 999/2001 of 22 May 2001 laying down rules for the prevention, control and eradication of certain transmissible spongiform encephalopathies, nor from specified risk material as defined in Annex V to that Regulation, produced after 31 March 2001, or mechanically recovered meat obtained from bones of the head or vertebral column of bovine, ovine or caprine animals, produced after 31 March 2001. After 31 March 2001 the animals have not been slaughtered after stunning by means of gas injected into the cranial cavity or killed by the same method or slaughtered by laceration after stunning of central nervous tissue by means of an elongated rod-shaped instrument introduced into the cranial cavity."
(b) Any reference to "products of animal origin" designates products of animal origin listed in this point and does not concern other products of animal origin containing or derived from those products of animal origin.
6. Point 5 shall only apply to imports from third countries:
(a) which have not submitted to the Commission a file in support of their request for exemption from these provisions;
(b) which have submitted such a file in which the result of evaluation of the risks determining all the potential risk factors is nonetheless not satisfactory.
7. Member States shall carry out frequent official inspections to verify the correct application of this Annex and shall ensure that measures are taken to avoid any contamination, particularly in slaughterhouses, cutting plants, animal waste processing plants, high-risk processing plants or premises approved by the Member States in accordance with Article 7 of Directive 90/667/EEC, points of sale to the consumer, landfill sites and other facilities for storage or incineration. Member States shall in particular set up a system to ensure and check that:
(a) specified risk material used in the production of products referred to in Article 1(2) are used solely for authorised purposes;
(b) specified risk material, especially where the removal takes place at establishments or premises other than slaughterhouses, is completely separated from other waste not intended for incineration, is collected separately and is disposed of in accordance with point l and points 8 to 11. Member States may decide to allow dispatch of heads or carcasses containing specified risk material to another Member State after that other Member State has agreed to receive the material and has approved the specific conditions applicable to such transport.
8. Member States shall ensure that specified risk material is removed at:
(a) slaughterhouses;
(b) cutting plants, high-risk processing plants or premises referred to in Articles 3 and 7 of Directive 90/667/EEC, under the supervision of a designated agent appointed by the competent authority. Those establishments shall be approved for that purpose by the competent authority.
However, the vertebral column may be removed at points of sale to the consumer situated in their territory.
Where specified risk material is not removed from dead animals which have not been slaughtered for human consumption, the parts of the body containing specified risk material or the entire body must be treated as specified risk material.
9. Member States shall ensure that all specified risk material is stained with a dye and, as appropriate, marked immediately on removal, and completely destroyed:
(a) by incineration without pre-processing; or,
(b) provided that the dye or marking remains detectable, after pre-processing:
(i) in accordance with the systems described in Chapters I to IV, VI and VII of the Annex to Decision 92/562/EEC:
- by incineration;
- by co-incineration;
(ii) in accordance at least with the standards set out in Annex I to Council Decision 1999/534/EC, by burial in an approved landfill site.
10. Member States may derogate from the provisions of points 8 and 9 to allow the incineration or burial of specified risk material or entire bodies, without prior staining, or, as appropriate, without removal of the specified risk material, in the circumstances set out in Article 3(2) of Directive 90/667/EEC and by a method which precludes all risk of transmission of a TSE and is approved and verified by the competent authority, in particular where animals have died or have been killed in the context of disease control measures.
11. Member States may despatch specified risk material or the material processed therefrom to other Member States for incineration under the conditions laid down in Article 4(2) of Commission Decision 97/735/EC, where applicable.
This point may be amended at the request of a Member State to allow the dispatch of specified risk material or the material processed therefrom to third countries for incineration, conditions governing such export having been adopted.
B. Concerning statistical surveys
The statistical survey referred to in Article 22 must cover all animals referred to in Annex III, Chapter A, Section I, points 1.1 and 1.2.
This provision, applicable for a period of one year, may be reviewed in the light of experience gained in the first six months.
(1) Council Directive 94/65/EC of 14 December 1994 laying down the requirements for the production and placing on the market of minced meat and meat preparations (OJ L 368, 31.12.1994, p. 10).
(2) Council Directive 77/99/EEC of 21 December 1976 on health problems affecting intra-Community trade in meat products (OJ L 26, 31.1.1977, p. 85). Directive as last amended by Council Directive 97/76/EC (OJ L 10, 16.1.1998, p. 25).