http://www.defra.gov.uk/corporate/vla/science/science-tse-rl-confirm.htm
Design prevalence is used to determine the size of a testing survey expressed in terms of target points. If the actual prevalence is greater than the selected design prevalence, the survey is highly likely to detect disease.
OJ L 139, 30.4.2004, p. 55, as corrected by OJ L 226, 25.6.2004, p. 22.
For the purpose of this Regulation, the following definitions set out in Regulation (EC) No 1774/2002 of the European Parliament and of the Council
Regulation (EC) No 1774/2002:
‘farmed animal’ in Article 2(1)(f);
‘petfood’ in point 41 of Annex I;
‘processed animal protein’ in point 42 of Annex I;
‘gelatine’ in point 26 of Annex I;
‘blood products’ in point 4 of Annex I;
‘bloodmeal’ in point 6 of Annex I; and
‘fishmeal’ in point 24 of Annex I.
the definition of ‘feedingstuff’ in Article 3(4) of Regulation (EC) No 178/2002;
the definition of ‘complete feedingstuff’ in Article 2(d) of Directive 79/373/EEC.
For the purpose of this Regulation, the following definitions shall also apply:
‘indigenous case of BSE’ means a case of bovine spongiform encephalopathy which has not been clearly demonstrated to be due to infection prior to importation as a live animal;
‘discrete adipose tissue’ means internal and external body fat removed during the slaughter and cutting process, in particular fresh fat from the heart, caul and kidney of bovine animals, and fat from cutting rooms;
‘cohort’ means a group of bovine animals which includes both:
animals born in the same herd as the affected bovine animal, and within 12 months preceding or following the date of birth of the affected bovine animal; and
animals which at any time during the first year of their lives were reared together with the affected bovine animal during the first year of its life;
‘index case’ means the first animal on a holding, or in an epidemiologically defined group, in which a TSE infection is confirmed;
‘TSE in Small Ruminants’ means a transmissible spongiform encephalopathy case detected in an ovine or caprine animal following a confirmatory test for abnormal PrP protein;
‘scrapie case’ means a transmissible spongiform encephalopathy confirmed case in an ovine or caprine animal where a diagnosis of BSE has been excluded in accordance with the criteria laid down in the Community reference laboratory's technical handbook on TSE strain characterisation in small ruminants
‘classical scrapie case’ means a scrapie confirmed case classified as classical in accordance with the criteria laid down in the Community reference laboratory's technical handbook on TSE strain characterisation in small ruminants;
‘atypical scrapie case’ means a scrapie confirmed case which is distinguishable from classical Scrapie in accordance with the criteria laid down in the Community reference laboratory's technical handbook on TSE strain characterisation in small ruminants.
The BSE status of Member States or third countries or regions thereof (hereinafter referred to as countries or regions), shall be determined on the basis of the criteria set out in points (a) to (e).
In the country or region:
a risk analysis in accordance with the provisions of Chapter B, identifying all the potential factors for BSE occurrence and their historic perspective in the country or region, is carried out;
a system of continuous surveillance and monitoring of BSE relating in particular to the risks described in Chapter B and complying with the minimal surveillance requirements laid down in Chapter D is in place;
an on-going awareness programme for veterinarians, farmers, and workers involved in transportation, marketing and slaughter of bovine animals, to encourage reporting of all cases showing clinical signs consistent with BSE in target sub-populations as defined in Chapter D of this Annex is in place;
an obligation to notify and investigate all bovine animals showing clinical signs consistent with BSE is in force;
the examination of brain or other tissues collected within the framework of the surveillance and monitoring system referred to in point (b) is carried out in an approved laboratory.
The risk analyses shall comprise a release assessment and an exposure assessment.
The following risk factors shall be taken into account:
the presence or absence of the BSE agent in the country or region and, if the agent is present, its prevalence based on the outcome of surveillance activities;
the production of meat-and-bone meal or greaves from the BSE indigenous ruminant population;
imported meat-and-bone meal or greaves;
imported bovine and ovine and caprine animals;
imported animal feed and feed ingredients;
imported products of ruminant origin for human consumption, which may have contained tissues listed in point 1 of Annex V and may have been fed to bovine animals;
imported products of ruminant origin for in vivo use in bovine animals.
Special eradication schemes, surveillance and other epidemiological investigations (especially surveillance for BSE conducted on the bovine animals population) relevant to the risk factors listed in point 2.1 should be taken into account in carrying out the release assessment.
The exposure assessment shall consist of assessing the likelihood of exposure of bovine animals to the BSE agent, through a consideration of the following:
recycling and amplification of the BSE agent through consumption by bovine animals of meat-and-bone meal or greaves of ruminant origin, or other feed or feed ingredients contaminated with these;
the use of ruminant carcasses (including from fallen stock), by-products and slaughterhouse waste, the parameters of the rendering processes and the methods of animal feed manufacture;
the feeding or not of ruminants with meat-and-bone meal and greaves derived from ruminants, including measures to prevent cross-contamination of animal feed;
the level of surveillance for BSE conducted on the bovine animals population to that time and the results of that surveillance.
A country or region:
where a risk analysis in accordance with Chapter B has been conducted in order to identify the historical and existing risk factors;
which has demonstrated that appropriate specific measures have been taken for the relevant period of time defined below to manage each identified risk;
which has demonstrated that Type B surveillance, in accordance with Chapter D, is in place, and the relevant points target, in accordance with Table 2 thereof, has been met; and
which is:
either in the following situation:
in the country or region there has been no case of BSE, or, any case of BSE has been demonstrated to have been imported and has been completely destroyed;
the criteria in points (c), (d) and (e) of Chapter A of this Annex have been complied with for at least seven years; and
it has been demonstrated through an appropriate level of control and audit that for at least eight years neither meat-and-bone meal nor greaves derived from ruminants has been fed to ruminants;
or in the following situation:
there has been one or more BSE indigenous cases in the country or region but every BSE indigenous case was born more than 11 years ago;
the criteria in points (c), (d) and (e) of Chapter A have been complied with for at least seven years;
it has been demonstrated through an appropriate level of control and audit that for at least eight years neither meat-and-bone meal nor greaves derived from ruminants has been fed to ruminants;
the following animals, if alive in the country or region, are permanently identified, and their movements controlled, and, when slaughtered or at death, are completely destroyed:
all BSE cases,
all bovine animals which, during their first year of life, were reared with the BSE cases during their first year of life, and which investigation showed consumed the same potentially contaminated feed during that period, or
if the results of the investigation referred to in the second indent are inconclusive, all bovine animals born in the same herd as, and within 12 months of the birth of, the BSE cases.
A country or region
where a risk analysis based on the information laid down in Chapter B has been conducted in order to identify the historical and existing risk factors;
which has demonstrated that appropriate measures are been taken to manage all identified risks, but those measures have not been taken for the relevant period of time;
which has demonstrated that Type A surveillance, in accordance with Chapter D, is in place and the relevant points target, in accordance with Table 2, has been met. Type B surveillance may replace Type A surveillance once the relevant points target is met; and
which is:
either in the following situation:
in the country or region there has been no case of BSE, or, any case of BSE has been demonstrated to have been imported and has been completely destroyed, the criteria in points (c), (d) and (e) of Chapter A are complied with, and it can be demonstrated through an appropriate level of control and audit that neither meat-and-bone meal nor greaves derived from ruminants has been fed to ruminants;
the criteria in points (c), (d) and (e) of Chapter A have been complied with for a period shorter than seven years; and/or
it cannot be demonstrated that controls over the feeding of meat-and-bone meal or greaves derived from ruminants to ruminants have been in place for eight years;
or in the following situation:
in the country or region there has been a BSE indigenous case, the criteria in points (c), (d) and (e) of Chapter A are complied with, and it can be demonstrated through an appropriate level of control and audit that neither meat-and-bone meal nor greaves derived from ruminants has been fed to ruminants;
the criteria in points (c) to (e) of Chapter A of this Annex have been complied with for a period shorter than seven years; and/or
it cannot be demonstrated that controls over the feeding of meat-and-bone meal or greaves derived from ruminants to ruminants have been in place for at least eight years;
the following animals, if alive in the country or region, are permanently identified, and their movements controlled, and, when slaughtered or at death, are completely destroyed: and
all BSE cases, and
all bovine animals which, during their first year of life, were reared with the BSE cases during their first year of life, and which investigation showed consumed the same potentially contaminated feed during that period, or
if the results of the investigation referred to in the second indent are inconclusive, all bovine animals born in the same herd as, and within 12 months of the birth of, the BSE cases.
A country or region for which the determination of BSE status has not been concluded, or which does not meet the conditions to be fulfilled by the country or region to be classified in one of the other categories.
For the purpose of this Annex, the following definitions shall apply:
Type A surveillance
The application of Type A surveillance will allow the detection of BSE at a design prevalence
Type B surveillance
The application of Type B surveillance will allow the detection of BSE at a design prevalence of at least one case per 50 000 in the adult bovine animals population in the country or region of concern, at a confidence level of 95 %.
Type B surveillance may be carried out by countries or region of negligible BSE risk status to confirm the conclusions of the risk analysis, for example by demonstrating the effectiveness of the measures mitigating any risk factors identified, through surveillance targeted to maximise the likelihood of identifying failures of such measures.
Type B surveillance may also be carried out by countries or regions of controlled BSE risk status, following the achievement of the relevant points target using Type A surveillance, to maintain confidence in the knowledge gained through Type A surveillance.
For the purpose of this Annex, the following four sub-populations of bovine animals have been identified for surveillance purposes:
bovine animals over 30 months of age displaying behavioural or clinical signs consistent with BSE (clinical suspects);
bovine animals over 30 months of age that are non-ambulatory, recumbent, unable to rise or to walk without assistance; bovine animals over 30 months of age sent for emergency slaughter or with abnormal observations at ante-mortem inspection (casualty or emergency slaughter);
bovine animals over 30 months of age which are found dead or killed on farm, during transport or at an abattoir (fallen stock);
bovine animals over 36 months of age at routine slaughter.
The surveillance strategy shall be designed to ensure that samples are representative of the herd of the country or region, and include consideration of demographic factors such as production type and geographic location, and the potential influence of culturally unique husbandry practices. The approach used and the assumptions made shall be fully documented, and the documentation retained for seven years.
In order to implement the surveillance strategy for BSE, a country shall use documented records or reliable estimates of the age distribution of the adult bovine animals population and the number of bovine animals tested for BSE stratified by age and by sub-population within the country or region.
Surveillance samples must meet the point targets set out in Table 2, on the basis of ‘point values’ fixed in Table 1. All clinical suspects shall be investigated, regardless of the number of points accumulated. A country shall sample at least three out of the four sub-populations. The total points for samples collected shall be accumulated over a period of a maximum of seven consecutive years to achieve the target number of points. The total points accumulation shall be periodically compared to the target number of points for a country or region.
Surveillance sub-population | |||
---|---|---|---|
Routine slaughter | Fallen stock | Casualty slaughter | Clinical suspect |
Age ≥ 1 year and < 2 years | |||
0,01 | 0,2 | 0,4 | N/A |
Age ≥ 2 years and < 4 years (young adult) | |||
0,1 | 0,2 | 0,4 | 260 |
Age ≥ 4 years and < 7 years (middle adult) | |||
0,2 | 0,9 | 1,6 | 750 |
Age ≥ 7 years and < 9 years (older adult) | |||
0,1 | 0,4 | 0,7 | 220 |
Age ≥ 9 years (aged) | |||
0,0 | 0,1 | 0,2 | 45 |
Bovine animals over 36 months of age at routine slaughter. | |||
Bovine animals over 30 months of age which are found dead or killed on farm, during transport or at an abattoir (fallen stock). | |||
Bovine animals over 30 months of age that are non-ambulatory, recumbent, unable to rise or to walk without assistance; bovine animals over 30 months of age sent for emergency slaughter or with abnormal observations at ante-mortem inspection (casualty or emergency slaughter). | |||
Bovine animals over 30 months of age displaying behavioural or clinical signs consistent with BSE (clinical suspects). |
Points targets for countries or regions | ||
---|---|---|
Adult bovine animals population size(24 months and older) | Type A surveillance | Type B surveillance |
≥ 1 000 000 | 300 000 | 150 000 |
800 000-1 000 000 | 240 000 | 120 000 |
600 000-800 000 | 180 000 | 90 000 |
400 000-600 000 | 120 000 | 60 000 |
200 000-400 000 | 60 000 | 30 000 |
100 000-200 000 | 30 000 | 15 000 |
50 000-100 000 | 15 000 | 7 500 |
25 000-50 000 | 7 500 | 3 750 |
Within each of the sub-populations above in a country or region, a country may target bovine animals identifiable as imported from countries or regions where BSE has been detected and bovine animals which have consumed potentially contaminated feedstuffs from countries or regions where BSE has been detected.
A country may choose to use the full BSurvE model or an alternative method based on the BSurvE model to estimate its BSE presence/prevalence.
Once the points target has been achieved, and in order to continue to designate the status of a country or region as controlled BSE risk or negligible risk, surveillance can be reduced to Type B surveillance (provided all other indicators remain positive). However, to continue to comply with the requirements laid down in this Chapter, ongoing annual surveillance must continue to include at least three of the four prescribed sub-populations. In addition all bovine animals clinically suspected of being infected with BSE shall be investigated regardless of the number of points accumulated. The annual surveillance in a country or region following the achievement of the required points target, shall be no less than the amount required for one-seventh of its total Type B surveillancetarget.
Monitoring in bovine animals shall be carried out in accordance with the laboratory methods laid down in Annex X, Chapter C, point 3(1)(b).
subject to ‘special emergency slaughtering’ as defined in Article 2(n) of Council Directive 64/433/EEC
slaughtered in accordance with Annex I, Chapter VI, point 28(c), to Directive 64/433/EEC, except animals without clinical signs of disease slaughtered in the context of a disease eradication campaign,
shall be tested for BSE.
subject to normal slaughter for human consumption, or
slaughtered in the context of a disease eradication campaign in accordance with Annex I, Chapter VI, point 28(c), to Directive 64/433/EEC, but showing no clinical signs of disease,
shall be tested for BSE.
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
killed for destruction pursuant to Commission Regulation (EC) No 716/96
killed in the framework of an epidemic, such as foot-and-mouth disease,
slaughtered for human consumption,
shall be tested for BSE.
Member States may decide to derogate from the provisions of point 3.1 in remote areas with a low animal density, where no collection of dead animals is organised. Member States making use of this derogation shall inform the Commission thereof, and submit a list of the derogated areas. The derogation shall not cover more than 10 % of the bovine population in the Member State.
All animals born between 1 August 1995 and 1 August 1996 killed for destruction pursuant Regulation (EC) No 716/96 shall be tested for BSE.
In addition to the testing referred to in points 2 to 4, Member States may on a voluntary basis decide to test other bovine animals on their territory, in particular where those animals originate from countries with indigenous BSE, have consumed potentially contaminated feedingstuffs or were born or derived from BSE infected dams.
Where an animal slaughtered for human consumption has been selected for testing for BSE, the health marking provided for in Chapter XI of Annex I to Directive 64/433/EEC shall not be carried out on the carcase of that animal until a negative result to the rapid test has been obtained.
Member States may derogate from the provisions of point 6.1 where an official system is in place in the slaughterhouse ensuring that no parts of examined animals bearing the health mark leave the slaughterhouse until a negative result to the rapid test has been obtained.
All parts of the body of an animal tested for BSE including the hide shall be retained under official control until a negative result to the rapid test has been obtained, unless they are disposed of in accordance with Article 4(2)(a) and (b) of Regulation (EC) No 1774/2002 of the European Parliament and of the Council
All parts of the body of an animal found positive or inconclusive to the rapid test including the hide shall be disposed of in accordance with Article 4(2)(a) and (b) of Regulation (EC) No 1774/2002, apart from material to be retained in conjunction with the records provided for in Chapter B(III).
Where an animal slaughtered for human consumption is found positive or inconclusive to the rapid test, at least the carcase immediately preceding and the two carcases immediately following the tested positive or inconclusive animal on the same slaughter line shall be destroyed in accordance with point 6.4. By way of derogation, Member States may decide to destroy the aforementioned carcases only if the result of the rapid test is confirmed to be positive or inconclusive by confirmatory examinations referred to in Annex X, Chapter C, point 3.1(b).
Member States may derogate from the provisions of point 6.5 where a system is in place in the slaughterhouse preventing contamination between carcase.
Monitoring in ovine and caprine animals shall be carried out in accordance with the laboratory methods laid down in Annex X, Chapter C, point 3.2(b).
Member States in which the population of ewes and ewe lambs put to the ram exceeds 750 000 animals shall test in accordance with the sampling rules set out in point 4 a minimum annual sample of 10 000 ovine animals slaughtered for human consumption;
Member States in which the population of goats which have already kidded and goats mated exceeds 750 000 animals shall test in accordance with the sampling rules set out in point 4 a minimum annual sample of 10 000 caprine animals slaughtered for human consumption;
Where a Member State experiences difficulty in collecting sufficient numbers of healthy slaughtered ovine or caprine animals to reach its allotted minimum sample size established in points (a) and (b), it may choose to replace a maximum of 50 % of its minimum sample size by testing dead ovine or caprine animals over the age of 18 months at the ratio of one to one and in addition to the minimum sample size set out in point 3. In addition a Member State may choose to replace a maximum of 10 % of its minimum sample size by testing ovine or caprine animals killed in the framework of a disease eradication campaign over the age of 18 months at the ratio of one to one.
Member States shall test, in accordance with the sampling rules set out in point 4 and the minimum sample sizes indicated in Table A and Table B, ovine and caprine animals which have died or been killed, but which were not:
killed in the framework of a disease eradication campaign, or
slaughtered for human consumption.
Member State population of ewes and ewe lambs put to the ram | Minimum sample size of dead ovine animals |
---|---|
> 750 000 | 10 000 |
100 000-750 000 | 1 500 |
40 000-100 000 | 100 % up to 500 |
< 40 000 | 100 % up to 100 |
Minimum sample sizes are set to take account of the size of the ovine populations in the individual Member States and are intended to provide achievable targets. |
Member State population of goats which have already kidded and goats mated | Minimum sample size of dead caprine animals |
---|---|
> 750 000 | 10 000 |
250 000-750 000 | 1 500 |
40 000-250 000 | 100 % up to 500 |
< 40 000 | 100 % up to 100 |
Minimum sample sizes are set to take account of the size of the caprine population in the individual Member States and are intended to provide achievable targets. |
The animals shall be over 18 months of age or have more than two permanent incisors erupted through the gum.
The age of the animals shall be estimated on the basis of dentition, obvious signs of maturity, or any other reliable information.
The sample selection shall be designed with a view to avoid the over-representation of any group as regards the origin, age, breed, production type or any other characteristic.
The sampling shall be representative for each region and season. Multiple sampling in the same flock shall be avoided, wherever possible. Member States shall aim their monitoring programmes to achieve, wherever possible, that in successive sampling years all officially registered holdings with more than 100 animals and where TSE cases have never been detected are subject to TSE testing.
The Member States shall put in place a system to check, on a targeted or other basis, that animals are not being diverted from sampling.
However, Member States may decide to exclude from the sampling remote areas with a low animal density, where no collection of dead animals is organised. Member States making use of this derogation shall inform the Commission thereof, and shall submit a list of those remote areas where the derogation applies. The derogation shall not cover more than 10 % of the ovine and caprine population in the Member State concerned.
Animals over 18 months of age or have more than two permanent incisors erupted through the gum, and which are killed for destruction in accordance with Annex VII, point 2.3(b)(i) or (ii) or point 5(a), shall be tested based on the selection of a simple random sample, in accordance with the sample size indicated in the following table.
Number of animals over 18 months of age or which have more than two permanent incisors erupted through the gum, killed for destruction in the herd or flock | Minimum sample size |
---|---|
70 or less | All eligible animals |
80 | 68 |
90 | 73 |
100 | 78 |
120 | 86 |
140 | 92 |
160 | 97 |
180 | 101 |
200 | 105 |
250 | 112 |
300 | 117 |
350 | 121 |
400 | 124 |
450 | 127 |
500 or more | 150 |
In addition to the monitoring programmes set out in points 2, 3 and 4, Member States may on a voluntary basis carry out monitoring in other animals, in particular:
animals used for dairy production,
animals originating from countries with indigenous TSEs,
animals which have consumed potentially contaminated feedingstuffs,
animals born or derived from TSE infected dams.
Where an ovine or caprine animal slaughtered for human consumption has been selected for TSE testing in accordance with point 2, its carcase shall not be marked with the health marking provided for in Section I, Chapter III of Annex I to Regulation (EC) No 854/2004 until a negative result to the rapid test has been obtained.
Member States may derogate from point 7.1. where a system approved by the competent authority is in place in the slaughterhouse ensuring that all parts of an animal can be traced and that no parts of the animals tested bearing the health mark can leave the slaughterhouse until a negative result to the rapid test has been obtained.
All parts of the body of a tested animal, including the hide, shall be retained under official control until a negative result has been obtained to the rapid test, except for animal by-products directly disposed of in accordance with Article 4(2)(a), (b) or (e) of Regulation (EC) No 1774/2002.
Except for the material to be retained in conjunction with the records provided for in Chapter B, Part III of this Annex, all parts of the body of an animal found positive to the rapid test, including the hide, shall be directly disposed of in accordance with Article 4(2)(a), (b) or (e) of Regulation (EC) No 1774/2002.
The prion protein genotype for the codons 136, 154 and 171 shall be determined for each positive TSE case in sheep. TSE cases found in sheep of genotypes which encode alanine on both alleles at codon 136, arginine on both alleles at codon 154 and arginine on both alleles at codon 171 shall immediately be reported to the Commission. Where the positive TSE case is an atypical scrapie case the prion protein genotype for the codon 141 shall be determined.
In addition to the animals genotyped in accordance with point 8.1, the prion protein genotype for the codons 136, 141, 154 and 171 of a minimum sample of ovine animals shall be determined. In the case of Member States with an adult sheep population of more than 750 000 animals, this minimum sample shall consist of at least 600 animals. In the case of other Member States the minimum sample shall consist of at least 100 animals. The samples may be chosen from animals slaughtered for human consumption, from animals dead-on-farm or from live animals. The sampling should be representative of the entire ovine population.
Member States may on a voluntary basis carry out monitoring for TSEs in animal species other than bovine, ovine and caprine animals.
The number of suspected cases placed under official movement restrictions in accordance with Article 12(1), per animal species.
The number of suspected cases subject to laboratory examination in accordance with Article 12(2), per animal species, including the results of the rapid and confirmatory tests (number of positives and negatives) and, with regard to bovine animals, an estimation of the age distribution of all tested animals. The age distribution should be grouped whenever possible as follows: ‘below 24 months’, distribution per 12 months between 24 and 155 months, and ‘above 155 months’ of age.
The number of flocks where suspected cases in ovine and caprine animals have been reported and investigated pursuant to Article 12(1) and (2).
The number of bovine animals tested within each subpopulation referred to in Chapter A, Part (I), points 2.1., 2.2., 2.3., 3.1., 4.1., 4.2., 4.3. and 5. The method for the sample selection, the results of the rapid and confirmatory tests and an estimation of the age distribution of the tested animals grouped as set out in point 2 shall be provided.
The number of ovine and caprine animals and flocks tested within each subpopulation referred to in Chapter A, Part II, points 2, 3 and 5 together with the method for sample selection and the results of the rapid and confirmatory tests.
The geographical distribution, including the country of origin if not the same as the reporting country, of positive cases of BSE and scrapie. The year, and where possible the month of birth shall be given for each TSE case in bovine, ovine and caprine animals. TSE cases which have been considered atypical and the reasons why shall be indicated. For scrapie cases, the results of the primary molecular testing with a discriminatory immuno-blotting, referred to in Annex X, Chapter C, point 3.2.(c)(i), shall be reported.
In animals other than bovine, ovine and caprine, the number of samples and confirmed TSE cases per species.
The genotype, and where possible the breed, of each ovine animal either found positive to TSE or sampled in accordance with Chapter A, Part II, points 8.1. and 8.2.
The compilation of reports containing the information referred to in A and forwarded to the Commission on a monthly basis or, with regard to the information referred to in point 8 on a quarterly basis, may constitute the annual report as required by Article 6(4), provided that the information is updated whenever additional information becomes available.
The summary shall be presented in a tabled format covering at least the information referred to in part I for each Member State.
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 Chapter A and, where possible, age, breed and anamnestic information,
the prion protein genotype of positive TSE cases in sheep.
The investigating laboratory shall keep, for seven years, all records of testing, in particular laboratory workbooks and, where appropriate, paraffin blocks and photographs of western blots.
The prohibition provided for in Article 7(1) shall be extended to the feeding:
to farmed animals, with the exception of the feeding to carnivorous fur producing animals, of:
processed animal protein;
gelatine of ruminant origin;
blood products;
hydrolysed protein;
dicalcium phosphate and tricalcium phosphate of animal origin (dicalcium phosphate and tricalcium phosphate);
feedingstuffs containing the proteins listed in points (i) to (v).
to ruminants, of animal protein and feedingstuffs containing such protein.
The prohibitions provided for in Article 7(1) and (2) shall not apply to:
the feeding to farmed animals of the proteins referred to in points (i), (ii), (iii) and (iv) and of feedingstuffs derived from such proteins:
milk, milk-based products and colostrum;
eggs and egg products;
gelatine derived from non-ruminants;
hydrolysed proteins derived from parts of non-ruminants and from ruminant hides and skins;
the feeding to non-ruminant farmed animals of the proteins referred to in points (i), (ii) and (iii), and of products derived from such proteins:
fishmeal, in accordance with the conditions laid down in point B;
dicalcium phosphate and tricalcium phosphate, in accordance with the conditions laid down in point C;
blood products derived from non-ruminants in accordance with the conditions laid down in point D;
the feeding to fish of blood meal derived from non-ruminants in accordance with the conditions laid down in point D;
the feeding to farmed animals of tuber and root crops and feedingstuffs containing such products following the detection of bone spicules may be permitted by the Member States if there has been a favourable risk assessment. The risk assessment shall take into account at least the amount and possible source of contamination and the final destination of the consignment.
The following conditions shall apply for the use of fishmeal referred to in point A(b)(i) and feedingstuffs containing fishmeal in the feeding of non-ruminant farmed animals (not applicable to the feeding of carnivorous fur producing animals):
the fishmeal shall be produced in processing plants dedicated exclusively to the production of fish derived products;
before release for free circulation in the Community, each consignment of imported fishmeal shall be analysed by microscopy in accordance with Directive 2003/126/EC;
feedingstuffs containing fishmeal shall be produced in establishments which do not produce feedingstuffs for ruminants and which are authorised for this purpose by the competent authority.
By way of derogation from point (c):
a specific authorisation for the production of complete feedingstuffs from feedingstuffs containing fishmeal shall not be required for home compounders:
registered by the competent authority,
keeping only non-ruminants,
producing complete feedingstuffs for use only in the same holding, and
provided that the feedingstuffs containing fishmeal used in the production contain less than 50 % crude protein;
the production of feedingstuffs for ruminants in establishments which also produce feedingstuffs containing fishmeal for other animal species may be authorised by the competent authority subject to the following conditions:
bulk and packaged feedingstuffs destined for ruminants are kept in facilities physically separate from those for bulk fishmeal and bulk feedingstuffs containing fishmeal during storage, transport and packaging,
feedingstuffs destined for ruminants are manufactured in facilities physically separate from facilities where feedingstuffs containing fishmeal are manufactured,
records detailing the purchases and uses of fishmeal and the sales of feedingstuffs containing fishmeal are kept available to the competent authority for at least five years, and
routine tests are carried out on feedingstuffs destined for ruminants to ensure that prohibited proteins including fishmeal are not present.
The label and accompanying document of feedingstuffs containing fishmeal shall clearly indicate the words contains fishmeal — shall not be fed to ruminants.
Bulk feedingstuffs containing fishmeal shall be transported by means of vehicles which do not at the same time transport feedingstuffs for ruminants. If the vehicle is subsequently used for the transport of feedingstuffs intended for ruminants, it shall be thoroughly cleaned in accordance with a procedure approved by the competent authority to avoid cross-contamination.
The use and storage of feedingstuffs containing fishmeal shall be prohibited in farms where ruminants are kept.
By way of derogation from that condition, the competent authority may permit the use and storage of feedingstuffs containing fishmeal in farms where ruminants are kept, if it is satisfied that on-farm measures are implemented to prevent that feedingstuffs containing fishmeal are fed to ruminants.
The following conditions shall apply for the use of dicalcium phosphate and tricalcium phosphate referred to in point A(b)(ii) and feedingstuffs containing such proteins in the feeding of non-ruminant farmed animals (not applicable to the feeding of carnivorous fur producing animals):
Feedingstuffs containing dicalcium phosphate or tricalcium phosphate shall be produced in establishments which do not prepare feedingstuffs for ruminants and which are authorised for this purpose by the competent authority.
By way of derogation from that condition:
a specific authorisation for the production of complete feedingstuffs from feedingstuffs containing dicalcium phosphate or tricalcium phosphate shall not be required for home compounders:
registered by the competent authority,
keeping only non-ruminants,
producing complete feedingstuffs for use only in the same holding, and
provided that the feedingstuffs containing dicalcium phosphate or tricalcium phosphate used in the production contain less than 10 % total phosphorus;
the production of feedingstuffs for ruminants in establishments which also produce feedingstuffs containing dicalcium phosphate or tricalcium phosphate for other animal species may be authorised by the competent authority subject to the following conditions:
bulk and packaged feedingstuffs destined for ruminants are manufactured in facilities physically separate from those where feedingstuffs containing dicalcium phosphate or tricalcium phosphate are manufactured,
bulk feedingstuffs destined for ruminants are during storage, transport and packaging kept in facilities physically separate from those for bulk dicalcium phosphate, bulk tricalcium phosphate and bulk feedingstuffs containing dicalcium phosphate or tricalcium phosphate,
records detailing the purchases and uses of dicalcium phosphate or tricalcium phosphate and the sales of feedingstuff containing dicalcium phosphate or tricalcium phosphate are kept available to the competent authority for at least five years.
The label and accompanying document of the feedingstuffs containing dicalcium phosphate or tricalcium phosphate shall clearly indicate the words ‘contains dicalcium/tricalcium phosphate of animal origin – shall not be fed to ruminants’.
Bulk feedingstuffs containing dicalcium phosphate or tricalcium phosphate shall be transported by means of vehicles which do not at the same time transport feedingstuffs for ruminants. If the vehicle is subsequently used for the transport of feedingstuffs intended for ruminants, it shall be thoroughly cleaned in accordance with a procedure approved by the competent authority to avoid cross-contamination.
The use and storage of feedingstuffs containing dicalcium phosphate or tricalcium phosphate shall be prohibited in farms where ruminants are kept.
By way of derogation from that condition, the competent authority may permit the use and storage of feedingstuffs containing dicalcium phosphate or tricalcium phosphate in farms where ruminants are kept, if it is satisfied that on-farm measures are implemented to prevent that feedingstuffs containing dicalcium phosphate or tricalcium phosphate are fed to ruminants.
The following conditions shall apply for the use of blood products referred to in point A(b)(iii) and blood meal referred to in point A(c) and of feedingstuffs containing such proteins, in the feeding of respectively non-ruminant farmed animals and fish:
The blood shall be derived from EU approved slaughterhouses which do not slaughter ruminants and which are registered as not slaughtering ruminants, and it shall be transported directly to the processing plant in vehicles dedicated exclusively to the transport of non-ruminant blood. If the vehicle was previously used for the transport of ruminant blood, it shall be, following cleaning, inspected by the competent authority before the transport of non-ruminant blood.
By way of derogation from that condition, the competent authority may permit the slaughter of ruminants in a slaughterhouse collecting non-ruminant blood intended for the production of blood products and blood meal for use in feed for respectively non-ruminant farmed animals and fish if the slaughterhouse has a recognised control system. That control system shall at least include:
keeping the slaughtering of non-ruminants physically separate from the slaughtering of ruminants,
keeping collection, storage, transport and packaging facilities for blood of ruminant origin physically separate from those for blood of non-ruminant origin, and
regular sampling and analysis of blood of non-ruminant origin to detect the presence of ruminant proteins
The blood products and blood meal shall be produced in an establishment exclusively processing non-ruminant blood.
By way of derogation from that condition, the competent authority may permit the production of blood products and blood meal for use in feed for respectively non-ruminant farmed animals and fish in establishments processing ruminant blood, which have a recognised control system in place preventing cross-contamination. That control system shall at least include:
processing of non-ruminant blood in a closed system physically separate from the processing of ruminant blood,
keeping of bulk raw material and bulk finished products of ruminant origin during storage, transport and packaging in facilities physically separate from those for bulk raw material and bulk finished products of non-ruminant origin, and
regular sampling and analysis of non-ruminant blood products and blood meal to detect the presence of ruminant proteins.
Feedingstuffs containing blood products or blood meal shall be produced in establishments which do not prepare feedingstuffs for respectively ruminants or farmed animals other than fish and which are authorised for this purpose by the competent authority.
By way of derogation from that condition:
a specific authorisation for the production of complete feedingstuffs from feedingstuffs containing blood products or blood meal shall not be required for home compounders:
registered by the competent authority,
keeping only non-ruminants in case blood products are used, or only fish in case blood meal is used,
producing complete feedingstuffs for use only in the same holding, and
provided that the feedingstuffs containing blood products or blood meal used in the production contain less than 50 % total protein.
the production of feedingstuffs for ruminants in establishments which also produce feedingstuffs containing blood products or blood meal for respectively non-ruminant farmed animals or fish may be authorised by the competent authority subject to the following conditions:
bulk and packaged feedingstuffs destined for ruminants or farmed animals other than fish are manufactured in facilities physically separate from those where feedingstuffs containing respectively blood products or blood meal are manufactured,
bulk feedingstuffs kept, during storage transport and packaging, in physically separate facilities as follow:
feedingstuff destined for ruminants is kept separate from blood products and from feedingstuffs containing blood products;
feedingstuff destined for farmed animals other than fish is kept separate from blood meal and feedingstuffs containing blood meal,
records detailing the purchases and uses of blood products and blood meal, and the sales of feedingstuffs containing such products, are kept available to the competent authority for at least five years.
The label, accompanying commercial document or health certificate, as appropriate, of the feedingstuffs containing blood products or blood meal shall clearly indicate the words ‘contains blood products – shall not be fed to ruminants’ or ‘contains blood meal – shall only be fed to fish’ as appropriate.
Bulk feedingstuffs containing blood products shall be transported by means of vehicles which do not transport at the same time feedingstuffs for ruminants and bulk feedingstuffs containing blood meal by means of vehicles which do not transport at the same time feedingstuffs for farmed animals other than fish. If the vehicle is subsequently used for the transport of feedingstuffs intended for respectively ruminants or farmed animals other than fish, it shall be thoroughly cleaned in accordance with a procedure to avoid cross-contamination approved by the competent authority.
The use and storage of feedingstuffs containing blood products shall be prohibited in farms where ruminants are kept, and that of feedingstuffs containing blood meal shall be prohibited in farms where farmed animals other than fish are kept.
By way of derogation, the competent authority may permit the use and storage of feedingstuffs containing respectively blood products or blood meal in farms where respectively ruminants or farmed animals other than fish are kept, if it is satisfied that on-farm measures are implemented to prevent that feedingstuffs containing respectively blood products or blood meal are fed to respectively ruminants or species other than fish.
This Annex shall apply without prejudice to the provisions in Regulation (EC) No 1774/2002.
Member States shall keep up-to-date lists of:
slaughterhouses approved for the collection of blood in accordance with point D(a) of Part II;
approved processing plants producing dicalcium phosphate, tricalcium phosphate, blood products or blood meal, and
establishments, with the exception of home compounders, authorised for manufacturing feedingstuffs containing fishmeal and the proteins referred to in point (b) which operate in accordance with the conditions laid down in points B(c), C(a) and D(c) of Part II.
Bulk processed animal protein, with the exception of fishmeal, and bulk products, including feedingstuffs, organic fertilisers and soil improvers, containing such proteins, shall be stored and transported in dedicated facilities. The store or vehicle may only be used for other purposes, following cleaning, and after having been inspected by the competent authority.
Bulk fishmeal referred to in point A(b)(i) of Part II, bulk dicalcium phosphate and bulk tricalcium phosphate referred to in point A(b)(ii) of Part II, blood products referred to in point A(b)(iii) of Part II and blood meal referred to in point A(c) of Part II shall be stored and transported in stores and vehicles dedicated to that purpose.
By way of derogation from point (b):
stores or vehicles may be used for the storage and transport of feedingstuffs containing the same protein;
stores or vehicles, following cleaning, may be used for other purposes after having been inspected by the competent authority; and
stores and vehicles transporting fishmeal may be used for other purposes if the company has a control system in place, recognised by the competent authority, to prevent cross-contamination. The control system shall at least include:
records on material transported and cleaning of the vehicle, and
regular sampling and analysis of feedingstuffs transported to detect the presence of fishmeal.
The competent authority shall carry out frequent on-the-spot checks to verify the correct application of the above control system.
Feedingstuffs, including petfood, which contain blood products of ruminant origin or processed animal proteins, other than fishmeal, shall not be manufactured in establishments which produce feedingstuffs for farmed animals, with the exception of feedingstuffs for carnivorous fur producing animals.
Bulk feedingstuffs, including petfood, which contain blood products of ruminant origin or processed animal proteins, other than fishmeal, shall during storage, transport and packaging be kept in facilities physically separate from facilities for bulk feedingstuffs for farmed animals, with the exception of feedingstuffs for carnivorous fur producing animals.
Petfood and feedingstuffs intended for carnivorous fur producing animals containing dicalcium phosphate or tricalcium phosphate referred to in point A(b)(ii) of Part II, and blood products referred to in point A(b)(iii) of Part II shall be manufactured and transported in accordance with points C(a) and (c) and points D(c) and (e), respectively of Part II.
The export to third countries of processed animal proteins derived from ruminants, and of products containing such processed animal proteins, shall be prohibited.
The export of processed animal proteins derived from non-ruminants and of products containing such proteins shall only be permitted by the competent authority subject to the following conditions:
they are destined for uses not prohibited by Article 7,
a written agreement with the third country is made prior to exportation, which includes an undertaking from the third country to respect the final use and not to re-export the processed animal protein or products containing such proteins for uses prohibited by Article 7.
Member States which permit exports in accordance with point 2 shall for the effective implementation of this Regulation inform the Commission and the other Member States of all terms and conditions as agreed with the third country concerned, in the context of the Standing Committee on the Food Chain and Animal Health.
Points 2 and 3 shall not apply to:
exports of fishmeal, provided it fulfils the conditions set out in point B of Part II,
products containing fishmeal,
petfood.
The competent authority shall carry out documentary and physical checks, including tests on feedingstuffs, throughout the production and distribution chain in accordance with Directive 95/53/EC to control compliance with its provisions and with the provisions of this Regulation. Where any presence of prohibited animal protein is detected, Directive 95/53/EC shall apply. The competent authority shall verify on a regular basis the competence of laboratories carrying out analyses for such official controls, in particular by evaluating the results of ring trials. If the competence is considered unsatisfactory, a re-training of the laboratory staff shall be undertaken as the minimal corrective measure.
The following tissues shall be designated as specified risk material if they come from animals whose origin is in a Member State or third country or of one of their region with a controlled or undetermined BSE risk:
as regards bovine animals:
the skull excluding the mandible and including the brain and eyes, and the spinal cord of animals aged over 12 months;
the tonsils, the intestines from the duodenum to the rectum and the mesentery of animals of all ages.
as regards ovine and caprine animals
the skull including the brain and eyes, the tonsils and the spinal cord of animals aged over 12 months or which have a permanent incisor erupted through the gum, and
the spleen and ileum of animals of all ages.
By way of derogation from point 1, tissues listed in that point whose origin is in Member States with a negligible BSE risk shall continue to be considered as specified risk material.
Specified risk material shall be stained with a dye or, as appropriate, otherwise marked, immediately on removal, and disposed of in accordance with the provisions laid down in Regulation (EC) No 1774/2002, and in particular in Article 4(2) thereof.
slaughterhouses, or, as appropriate, other places of slaughter;
cutting plants, in the case of vertebral column of bovine animals;
where appropriate, in intermediate plants referred to in Article 10 of Regulation (EC) No 1774/2002 or users and collection centres authorised and registered pursuant to Article 23(2)(c)(iv), (vi) and (vii) of Regulation (EC) No 1774/2002.
tests must be carried out in slaughterhouses on all animals eligible for the removal of specified risk material;
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;
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.
the removal of spinal cord of ovine and caprine animals in cutting plants specifically authorised for this purpose;
the removal of bovine vertebral column from carcasses or parts of carcasses in butcher shops specifically authorised, monitored and registered for this purpose;
the harvesting of head meat from bovine animals in cutting plants specifically authorised for this purpose in accordance with the provisions laid down in point 9.
The rules on removal of specified risk material laid down in this Chapter shall not apply to Category 1 material as defined in Regulation (EC) No 1774/2002 used under the supervision of competent authorities for feeding of endangered and protected species of necrophagous birds.
Notwithstanding the individual decisions referred to in Article 5(2), and by way of derogation from Article 9(3), it shall be prohibited in all Member States to use bones or bone-in cuts of bovine, ovine and caprine animals for the production of mechanically separated meat.
Notwithstanding the individual decisions referred to in Article 5(2), and by way of derogation from Article 8(3), in all Member States, until all Member States are classified as countries with negligible BSE risk, laceration of central nervous tissue by means of an elongated rod-shaped instrument introduced into the cranial cavity after stunning shall be prohibited in bovine, ovine or caprine animals whose meat is intended for human or animal consumption.
Tongues of bovine animals of all ages intended for human or animal consumption shall be harvested at the slaughterhouse by a transverse cut rostral to the lingual process of the basihyoid bone.
harvesting shall take place in a dedicated area, physically separated from the other parts of the slaughterline;
where the heads are removed from the conveyor or hooks before harvesting the head meat, the frontal shot hole and foramen magnum shall be sealed with an impermeable and durable stopper. Where the brainstem is sampled for laboratory testing for BSE, the foramen magnum shall be sealed immediately after that sampling;
head meat shall not be harvested from heads where the eyes are damaged or lost immediately prior to, or after slaughter, or which are otherwise damaged in a way which might result in contamination of the head with central nervous tissue;
head meat shall not be harvested from heads which have not been properly sealed in accordance with the second indent;
without prejudice to general rules on hygiene, specific working instructions shall be in place to prevent contamination of the head meat during the harvesting, in particular in the case when the seal referred to in the second indent is lost or the eyes damaged during the activity:
a sampling plan using an appropriate laboratory test to detect central nervous system tissue shall be in place to verify that the measures to reduce contamination are properly implemented.
By way of derogation from the requirements of point 8.1, Member States may decide to apply at the slaughterhouse an alternative control system for the harvesting of bovine head meat, leading to an equivalent reduction in the level of contamination of head meat with central nervous system tissue. A sampling plan using an appropriate laboratory test to detect central nervous system tissue shall be in place to verify that the measures to reduce contamination are properly implemented. Member States using this derogation shall inform the Commission and the other Member States in the framework of the Standing Committee of the Food Chain and Animal Health of their control system and the results of the sampling.
If the harvesting is performed without removing the bovine head from the conveyor or hooks, points 8.1 and 8.2 shall not apply.
By way of derogation from point 8, Member States may decide to allow the harvesting of head meat from bovine in cutting plants specifically authorised for this purpose and provided that the following conditions are complied with:
the heads intended for transport to the cutting plant shall be suspended on a rack during the storing period and the transport from the slaughterhouse to the cutting plant;
the frontal shot hole and the foramen magnum shall be properly sealed with an impermeable and durable stopper before being moved from the conveyor or hooks to the racks. Where the brainstem is sampled for laboratory testing for BSE, the foramen magnum shall be sealed immediately after that sampling;
the heads which have not been properly sealed in accordance with point (b), where the eyes are damaged or lost immediately prior to or after slaughter or which were otherwise damaged in a way which might result in contamination of the head meat with central nervous tissue shall be excluded from transport to the specifically authorised cutting plants;
a sampling plan for the slaughterhouse using an appropriate laboratory test to detect central nervous system tissue shall be in place to verify the proper implementation of the measures to reduce contamination;
the harvesting of head meat shall be carried out in accordance with a control system, recognized by the competent authority, to ensure the prevention of possible contamination of head meat. The system shall include at least:
all heads shall be visually checked for signs of contamination or damage and proper sealing before the harvesting of the head meat begins;
head meat shall not be harvested from heads which have not been properly sealed, where the eyes are damaged or which were otherwise damaged in a way which might result in contamination of the head meat with central nervous tissue. Head meat shall also not be harvested from any head where contamination from such heads is suspected;
without prejudice to general rules on hygiene, specific working instructions shall be in place to prevent contamination of the head meat during transport and harvesting, in particular where the seal is lost or the eyes damaged during the activity;
a sampling plan for the cutting plant using an appropriate laboratory test to detect central nervous system tissue shall be in place to verify that the measures to reduce contamination are properly implemented.
Member States may allow dispatch of heads or of un-split carcasses containing specified risk material to another Member State only after that Member State has agreed to receive the material and has approved the conditions of dispatch and transport.
By way of derogation from point 10.1, carcasses, half carcasses or half carcasses cut into no more than three wholesale cuts, and quarters containing no specified risk material other than the vertebral column, including dorsal root ganglia, may be dispatched from one Member State to another without the latter's prior agreement.
Exports outside the Community of heads and of fresh meat of bovine, ovine or caprine animals containing specified risk materials shall be prohibited.
Member States shall carry out frequent official controls to verify the correct application of this Annex and shall ensure that measures are taken to avoid any contamination, particularly in slaughterhouses, cutting plants or other places where specified risk material is removed, such as butcher shops or establishments referred in point 4.1 (c).
Member States shall in particular set up a system to ensure and check that specified risk material is handled and disposed of in accordance with Regulation (EC) No 999/2001 and Regulation (EC) No 1774/2002.
when removal of the vertebral column is not required, carcasses or wholesale cuts of carcasses of bovine animals containing vertebral column shall be identified by a clearly visible blue stripe on the label referred to in Regulation (EC) No 1760/2000;
specific information on the number of bovine carcasses or wholesale cuts of carcasses, from which removal of the vertebral column is required as well as the number where removal of the vertebral column is not required, shall be added on the commercial document relating to consignments of meat. When applicable, the specific information shall be added to the document referred to in Article 2(1) of Commission Regulation (EC) No 136/2004
butcher shops shall keep, for at least one year, the commercial documents referred to in (b).
The use of ruminant material for the production of the following products of animal origin is prohibited as referred to in Article 9(1):
mechanically recovered meat;
dicalcium phosphate intended as feedingstuffs for livestock;
gelatine, unless it is produced from ruminant hides;
derivatives made from rendered ruminant fat;
rendered ruminant fat, unless it was produced from:
discrete adipose tissue declared fit for human consumption;
raw materials which were processed in accordance with the standards referred to in Directive 90/667/EEC.
in the case of bovine animals:
all other ruminants on the holding of the animal in which the disease was confirmed,
where the disease was confirmed in a female animal, its progeny born within two years prior to, or after, clinical onset of the disease,
all animals of the cohort of the animal in which the disease was confirmed,
the possible origin of the disease,
other animals on the holding of the animal in which the disease was confirmed or on other holdings 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, of other material or any other means of transmission, which may have transmitted the TSE agent to or from the holding in question;
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,
in so far as they are identifiable, the parents, and in the case of females all embryos, ova and the last progeny of the female 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 referred to in the second indent,
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 TSE agent to or from the holding in question.
In the case of confirmation of BSE in a bovine animal, the killing and complete destruction of bovine animals identified by the inquiry referred to in the second and third indents of point 1(a); however, the Member State may decide:
not to kill and destroy animals of the cohort referred to in the third indent of point 1(a) if evidence has been provided that such animals did not have access to the same feed as the affected animal,
to defer the killing and destruction of animals in the cohort referred to in the third indent of point 1(a) until the end of their productive life, provided that they are bulls continuously kept at a semen collection centre and it can be ensured that they are completely destroyed following death.
If a TSE is suspected in an ovine or caprine animal on a holding in a Member State, all other ovine and caprine animals from that holding shall be placed under official movement restriction until the results of the examination are available. If there is evidence that the holding where the animal was present when the TSE was suspected is not likely to be the holding where the animal could have been exposed to a TSE, the competent authority may decide that other holdings or only the holding of exposure shall be placed under official control depending on the epidemiological information available.
In the case of confirmation of TSE in an ovine or caprine animal:
if BSE cannot be excluded after the results of a ring trial carried out in accordance with the procedure set out in Annex X, Chapter C, point 3.2(c), the killing and complete destruction of all animals, embryos and ova identified by the inquiry referred to in the second to fifth indents of point 1(b);
if BSE is excluded in accordance with the procedure set out in Annex X, Chapter C, point 3.2(c), pursuant to the decision of the competent authority:
either
the killing and complete destruction of all animals, embryos and ova identified by the inquiry referred to in the second and third indents of point 1(b). The conditions set out in point 3 shall apply to the holding;
or
the killing and complete destruction of all animals, embryos and ova identified by the inquiry referred to in the second and third indents of point 1(b), with the exception of:
breeding rams of the ARR/ARR genotype,
breeding ewes carrying at least one ARR allele and no VRQ allele and, where such breeding ewes are pregnant at the time of the inquiry, the lambs subsequently born, if their genotype meets the requirements of this subparagraph,
sheep carrying at least one ARR allele which are intended solely for slaughter,
if the competent authority so decides, sheep and goats less than three months old which are intended solely for slaughter.
The conditions set out in point 3 shall apply to the holding;
or
a Member State may decide not to kill and destroy the animals, identified by the inquiry referred to in the second and third indents of point 1(b) where it is difficult to obtain replacement ovine animals of a known genotype or where the frequency of the ARR allele within the breed or holding is low, or where it is deemed necessary in order to avoid inbreeding, or based on a reasoned consideration of all the epidemiological factors. The conditions set out in point 4 shall apply to the holding;
by way of derogation from the measures set out in point (b), and only where the TSE case confirmed on a holding is an atypical scrapie case, the Member State may decide to apply the measures laid down in point 5.
Member States may decide:
to replace the killing and complete destruction of all animals referred to in b(i) by slaughtering for human consumption;
to replace the killing and complete destruction of animals referred to in b(ii) by slaughtering for human consumption;
provided that:
the animals are slaughtered within the territory of the concerned Member State,
all animals which are over 18 months of age or have more than two permanent incisors erupted through the gum and are slaughtered for human consumption shall be tested for the presence of TSE in accordance with the laboratory methods set out in Annex X, Chapter C, point 3.2(b);
the prion protein genotype of ovine animals, up to a maximum of 50, killed and destroyed or slaughtered for human consumption in accordance with points (b)(i) and (iii) shall be determined
If the infected animal has been introduced from another holding, a Member State may decide, based on the history of the case, to apply eradication measures in the holding of origin in addition to, or instead of, the holding in which the infection was confirmed; in the case of land used for common grazing by more than one flock, Member States may decide to limit the application of those measures to a single flock, based on a reasoned consideration of all the epidemiological factors; where more than one flock is kept on a single holding, Member States may decide to limit the application of the measures to the flock in which the TSE has been confirmed, provided it has been verified that the flocks have been kept isolated from each other and that the spread of infection between the flocks through either direct or indirect contact is unlikely.
Only the following animals may be introduced to the holding(s):
male sheep of the ARR/ARR genotype;
female sheep carrying at least one ARR allele and no VRQ allele;
caprine animals, provided that:
no ovine animals for breeding other than those of the genotypes referred to in points (a) and (b) are present on the holding;
thorough cleaning and disinfection of all animal housing on the premises has been carried out following destocking.
Only the following ovine germinal products may be used in the holding(s):
semen from rams of the ARR/ARR genotype;
embryos carrying at least one ARR allele and no VRQ allele.
Movement of the animals from the holding shall be subject to the following conditions:
movement of ARR/ARR sheep from the holding shall not be subject to any restriction;
sheep carrying only one ARR allele may be moved from the holding only to go directly for slaughter for human consumption or for the purposes of destruction; however,
ewes carrying one ARR allele and no VRQ allele may be moved to other holdings which are restricted following the application of measures in accordance with point 2.3(b)(ii) or 4,
if the competent authority so decides, lambs and kids may be moved to one other holding solely for the purposes of fattening prior to slaughter; the holding of destination shall not contain any ovine or caprine animals other than those being fattened prior to slaughter, and shall not dispatch live ovine or caprine animals to other holdings, except for direct slaughter;
caprine animals may be moved provided that the holding is subjected to intensified TSE monitoring, including the testing of all caprine animals which are over the age of 18 months and:
are slaughtered for human consumption at the end of their productive lives; or
have died or been killed on the holding, and meet the conditions set out to in Annex III, Chapter A, Part II, point 3;
if the Member State so decides, lambs and kids less than three months old may be moved from the holding to go directly for slaughter for human consumption.
The restrictions set out in points 3.1, 3.2 and 3.3 shall continue to apply to the holding for a period of two years from:
the date of attainment of ARR/ARR status by all ovine animals on the holding; or
the last date when any ovine or caprine animal was kept on the premises; or
the date when the intensified TSE monitoring set out in 3.3(c) commenced; or
the date when all breeding rams on the holding are of ARR/ARR genotype and all breeding ewes carry at least one ARR allele and no VRQ allele, provided that during the two-year period, negative results are obtained from TSE testing of the following animals over the age of 18 months:
an annual sample of ovine animals slaughtered for human consumption at the end of their productive lives in accordance with the sample size referred to in the Table in Annex III, Chapter A, Part II, point 5, and
all ovine animals referred to in Annex III, Chapter A, Part II, point 3 which have died or been killed on the holding.
all ovine and caprine animals on the holding shall be identified;
all ovine and caprine animals on the holding may be moved only within the territory of the concerned Member State for slaughter for human consumption or for the purposes of destruction; all animals over the age of 18 months slaughtered for human consumption shall be tested for the presence of TSE in accordance with the laboratory methods laid down in Annex X, Chapter C, point 3.2(b);
the competent authority shall ensure that embryos and ova are not dispatched from the holding;
only the semen from rams of the ARR/ARR genotype and embryos carrying at least one ARR allele and no VRQ allele may be used in the holding;
all ovine and caprine animals which are over the age of 18 months which have died or been killed on the holding shall be subject to TSE testing;
only male sheep of the ARR/ARR genotype and female ovine animals from holdings where no TSE cases have been detected or from flocks fulfilling the conditions set out in point 3.4 may be introduced in the holding;
only caprine animals from holdings where no TSE cases have been detected or from flocks fulfilling the conditions of point 3.4 may be introduced in the holding;
All ovine and caprine animals in the holding shall be subject to common grazing restrictions to be determined by the competent authority, based on a reasoned consideration of all the epidemiological factors;
by way of derogation of point (b) if the competent authority so decides, lambs and kids may be moved to another holding within the same Member State solely for the purposes of fattening prior to slaughter; provided that the holding of destination shall not contain any ovine or caprine animals other than those being fattened prior to slaughter, and shall not dispatch live ovine or caprine animals to other holdings, except for direct slaughter.
either the killing and complete destruction of all animals, embryos and ova identified by the inquiry referred to in the second and third indents of point 1(b). Member States may decide to determine the prion protein genotype of ovine animals which have been killed and destroyed;
or, for a period of two breeding years following the detection of the last TSE case, at least the following measures:
all ovine and caprine animals in the holding shall be identified;
the holding must be subject to intensified TSE monitoring for a two years period, including the testing of all ovine and caprine animals which are over the age of 18 months and slaughtered for human consumption and all ovine and caprine animals over the age of 18 which have died or been killed on the holding;
the competent authority shall ensure that live ovine and caprine animals, embryos and ova from the holding are not dispatched to other Member States or third countries.
Member States applying the measures set out in point 2.3(b)(iii) or the derogations provided for in points 2.3(c) and (d) shall notify to the Commission an account of the conditions and criteria used for granting them. Where additional TSE cases are detected in flocks where derogations are applied, the conditions for granting such derogations shall be reassessed.
The breeding programme shall concentrate on flocks of high genetic merit.
the identity, breed and number of animals in all flocks participating in the breeding programme;
the identification of the individual animals sampled under the breeding programme;
the results of any genotyping tests.
A system of uniform certification shall be established in which the genotype of each animal sampled under the breeding programme is certified by reference to its individual identification number.
A system for the identification of animals and samples, the processing of samples and the delivery of results shall be established which minimises the possibility of human error. The effectiveness of that system shall be subject to regular random checking.
Genotyping of blood or other tissues collected for the purposes of the breeding programme shall be carried out in laboratories that have been approved under that programme.
The competent authority of the Member State may assist breed societies, to establish genetic banks consisting of semen, ova and/or embryos representative of prion protein genotypes which are likely to become rare as a result of the breeding programme.
frequencies of the different alleles within the breed;
rarity of the breed;
avoidance of inbreeding or genetic drift.
The breeding programme shall be aimed at increasing the frequency of the ARR allele within the sheep flock, while reducing the prevalence of those alleles which have been shown to contribute to susceptibility to TSEs.
all animals in the flock that are to be genotyped shall be individually identified using secure means;
all rams intended for breeding within the flock to shall be genotyped before being used for breeding;
any male animal carrying the VRQ allele shall be slaughtered or castrated, within six months following the determination of its genotype; any such animal shall not leave the holding except for slaughter;
female animals that are known to carry the VRQ allele shall not leave the holding except for slaughter;
male animals, including semen donors used for artificial insemination, other than those certified under the breeding programme, shall not be used for breeding within the flock.
Member States may decide to grant derogations from the requirements set out in point 2(c) and (d) for the purposes of protection of breeds and production traits.
Member States shall inform the Commission of derogations granted under point 3 and of the criteria used.
This recognition shall be granted on at least the following two levels:
level I flocks shall be flocks composed entirely of sheep of the ARR/ARR genotype;
level II flocks shall be flocks whose progeny have been sired exclusively by rams of the ARR/ARR genotype.
Member States may decide to grant recognition on further levels to suit national requirements.
on the farm or at the slaughterhouse to verify their genotype;
in the case of level I flocks, in animals over 18 months of age at the slaughterhouse, for TSE testing in accordance with Annex III.
Member States introducing national breeding programmes to select for resistance to TSE in their ovine populations shall notify to the Commission the requirements for such programmes and shall provide an annual report on their progress. The report for each calendar year shall be submitted at the latest by 31 March of the following year.
The following conditions shall apply to trade in ovine and caprine animals:
until 30 June 2007:
it is subject to regular official veterinary checks,
the animals are marked,
no case of scrapie has been confirmed,
checking by sampling of old female animals intended for slaughter is carried out,
females, with the exception of sheep of the ARR/ARR prion protein genotype, are introduced into the holding only if they come from a holding which complies with the same requirements.
From 1 July 2004 at the latest, the holding or holdings shall begin to satisfy the following additional requirements:
all animals referred to in Annex III, Chapter A, Part II, point 3 over the age of 18 months which have died or been killed on the holding shall be examined for scrapie in accordance with the laboratory methods laid down in Annex X, Chapter C, point 3.2(b), and
ovine and caprine animals, with the exception of sheep of the ARR/ARR prion protein genotype, shall be introduced into the holding only if they come from a holding which complies with the same requirements.
from 1 July 2007:
it is subject to regular official veterinary checks,
the animals are identified in conformity with Community legislation,
no case of scrapie has been confirmed,
all animals referred to in Annex III, Chapter A, Part II, point 3 over the age of 18 months which have died or been killed on the holding have been examined for scrapie in accordance with the laboratory methods laid down in Annex X, Chapter C, point 3.2(b),
ovine and caprine animals, with the exception of sheep of the ARR/ARR prion protein genotype, are introduced into the holding only if they come from a holding which complies with the same requirements.
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) or (c), ovine and caprine animals for breeding shall comply with the additional guarantees, general or specific, which have been defined in accordance with the procedure referred to in Article 24(2).
a Member State which has a compulsory or voluntary national scrapie control program for all or part of its territory:
may submit the said program to the Commission, outlining in particular:
the distribution of the disease in the Member State,
the reasons for the program, taking into consideration the importance of the disease and the cost/benefit ratio,
the geographical area in which the program will be implemented,
the status categories defined for holdings and the standards which must be attained in each such category,
the test procedures to be used,
the program 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 program are positive,
the program referred to in point (i) may be approved if it complies with the criteria laid down in that point, in accordance with the procedure referred to in Article 24(2). 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 program in accordance with the procedure referred to in Article 24(2). Such guarantees must not exceed those which the Member State implements nationally,
amendments or additions to the programmes submitted by Member States may be approved in accordance with the procedure referred to in Article 24(2). Amendments to the guarantees which have been defined in accordance with point (ii) may be approved in accordance with that procedure,
where a Member State considers that its territory or part of its territory is free from scrapie:
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,
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,
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)
be collected from animals which have been kept continuously since birth or for the last three years of their life on a holding or holdings which have satisfied the requirements of subparagraph (a)(i) or, as appropriate, (a)(ii) for three years or
in the case of ovine semen, be collected from male animals of the ARR/ARR prion protein genotype as defined in Annex I to Commission Decision 2002/1003/EC
in the case of ovine embryos, be of the ARR/ARR prion protein genotype as defined in Annex I to Decision 2002/1003/EC.
The United Kingdom shall ensure that bovine animals born or reared on its territory before 1 August 1996 are not dispatched from its territory to other Member States or third countries.
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.
The following products of animal origin are exempt from the prohibition referred to in Article 16(3), provided that they are derived from bovine, ovine and caprine animals that satisfy the requirements of Section B:
fresh meat,
minced meat,
meat preparations,
meat products.
The products referred to in Section A must satisfy the following requirements:
the animals from which the products of bovine, ovine and caprine animal origin were derived have not been fed meat-and-bone meal or greaves derived from ruminants and passed ante-mortem and post-mortem inspections;
the animals from which the products of bovine, ovine and caprine animal origin were derived 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;
the products of bovine, ovine and caprine animal origin are not derived from:
specified risk material as defined in Annex V;
nervous and lymphatic tissues exposed during the deboning process; and
mechanically separated meat obtained from bones of bovine, ovine or caprine animals.
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.
Imports of bovine animals from a country or a region with a negligible BSE risk shall be subject to the presentation of an animal health certificate attesting that:
the animals were born and continuously reared in a country or region classified in accordance with Article 5(2) of Regulation (EC) No 999/2001 as a country or region posing a negligible BSE risk;
the animals are identified by a permanent identification system enabling them to be traced back to the dam and herd of origin, and are not exposed bovine animals as described in Chapter C, part I, point (4) (b) (iv) of Annex II; and
if there have been BSE indigenous cases in the country concerned, the animals were born after the date from which the ban on the feeding of ruminants with meat-and-bone meal and greaves derived from ruminants had been effectively enforced or after the date of birth of the last BSE indigenous case if born after the date of the feed ban.
Imports of bovine animals from a country or a region with a controlled BSE risk shall be subject to the presentation of an animal health certificate attesting that:
the country or region is classified in accordance with Article 5(2) of Regulation (EC) No 999/2001 as a country or region posing a controlled BSE risk;
the animals are identified by a permanent identification system enabling them to be traced back to the dam and herd of origin, and are not exposed bovine animals as described in Chapter C, Part II, point (4)(b)(iv) of Annex II;
the animals were born after the date from which the ban on the feeding of ruminants with meat-and-bone meal and greaves derived from ruminants had been effectively enforced or after the date of birth of the last BSE indigenous case if born after the date of the feed ban.
Imports of bovine animals from a country or a region with an undetermined BSE risk shall be subject to the presentation of an animal health certificate attesting that:
the country or region has not been categorized in accordance with Article 5(2) of Regulation (EC) No 999/2001 or has been categorized as a country or region with undetermined BSE risk;
the animals are identified by a permanent identification system enabling them to be traced back to the dam and herd of origin, and are not exposed bovine animals as described in Chapter C, Part II, point (4)(b)(iv) of Annex II;
the animals were born at least two years after the date from which the ban on the feeding of ruminants with meat-and-bone meal and greaves derived from ruminants had been effectively enforced or after the date of birth of the last BSE indigenous case if born after the date of the feed ban.
The following products of bovine, ovine and caprine animal origin, as defined by Regulation (EC) No 853/2004 of the European Parliament and of the Council
fresh meat,
minced meat and meat preparations,
meat products,
treated intestines,
rendered animal fats,
greaves, and
gelatine.
Imports of products of bovine, ovine and caprine animal origin referred to in Section A from a country or a region with a negligible BSE risk shall be subject to the presentation of an animal health certificate attesting that:
the country or region is classified in accordance with Article 5(2) of Regulation (EC) No 999/2001 as a country or region posing a negligible BSE risk;
the animals from which the products of bovine, ovine and caprine animal origin were derived were born, continuously reared and slaughtered in the country with negligible BSE risk and passed ante-mortem and post-mortem inspections;
if in the country or region there have been BSE indigenous cases:
the animals were born after the date from which the ban on the feeding of ruminants with meat-and-bone meal and greaves derived from ruminants had been enforced; or
the products of bovine, ovine and caprine animal origin do not contain and are not derived from specified risk material as defined in Annex V to Regulation (EC) No 999/2001, or mechanically separated meat obtained from bones of bovine, ovine or caprine animals.
the country or region is classified in accordance with Article 5(2) of Regulation (EC) No 999/2001 as a country or region posing a controlled BSE risk;
the animals from which the products of bovine, ovine and caprine animal origin were derived passed ante-mortem and post-mortem inspections;
animals from which the products of bovine, ovine and caprine animal origin destined for export were derived 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;
the products of bovine, ovine and caprine animal origin do not contain and are not derived from specified risk material as defined in Annex V to Regulation (EC) No 999/2001, or mechanically separated meat obtained from bones of bovine, ovine or caprine animals.
By way of derogation from point 1(d) carcasses, half carcasses or half carcasses cut into no more than three wholesale cuts, and quarters containing no specified risk material other than the vertebral column, including dorsal root ganglia, may be imported.
When removal of the vertebral column is not required, carcasses or wholesale cuts of carcasses of bovine animals containing vertebral column, shall be identified by a blue stripe on the label referred to in Regulation (EC) No 1760/2000.
The number of bovine carcasses or wholesale cuts of carcasses, from which removal of the vertebral column is required as well as he number where removal of the vertebral column is not required shall be added to the document referred to in Article 2(1) of Regulation (EC) No 136/2004 in case of imports.
the country or region is classified in accordance with Article 5(2) as a country or region posing a controlled BSE risk;
the animals from which the products of bovine, ovine and caprine animal origin were derived were born, continuously reared and slaughtered in the country or region with a negligible BSE risk and passed ante-mortem and post-mortem inspections;
if the intestines are sourced from a country or region where there have been BSE indigenous cases:
the animals were born after the date from which the ban on the feeding of ruminants with meat-and-bone meal and greaves derived from ruminants had been enforced; or
the products of bovine, ovine and caprine animal origin do not contain and are not derived from specified risk material as defined in Annex V.
the animals from which the products of bovine, ovine and caprine animal origin were derived have not been fed meat-and-bone meal or greaves derived from ruminants and passed ante-mortem and post-mortem inspections;
the animals from which the products of bovine, ovine and caprine animal origin were derived 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;
the products of bovine, ovine and caprine animal origin are not derived from:
specified risk material as defined in Annex V;
nervous and lymphatic tissues exposed during the deboning process;
mechanically separated meat obtained from bones of bovine, ovine or caprine animals.
By way of derogation from point 1(c), carcasses, half carcasses or half carcasses cut into no more than three wholesale cuts, and quarters containing no specified risk material other than the vertebral column, including dorsal root ganglia, may be imported.
When removal of the vertebral column is not required, carcasses or wholesale cuts of carcasses of bovine animals containing vertebral column, shall be identified by a clearly visible blue stripe on the label referred to in Regulation (EC) No 1760/2000.
Specific information on the number of bovine carcasses or wholesale cuts of carcasses, from which removal of the vertebral column is required and from which removal of the vertebral column is not required shall be added to the document referred to in Article 2(1) of Regulation (EC) No 136/2004 in case of imports.
the country or region is classified in accordance with Article 5(2) as a country or region posing an undetermined BSE risk;
the animals from which the products of bovine, ovine and caprine animal origin were derived were born, continuously reared and slaughtered in the country or region with a negligible BSE risk and passed ante-mortem and post-mortem inspections;
if the intestines are sourced from a country or region where there have been BSE indigenous cases:
the animals were born after the date from which the ban on the feeding of ruminants with meat-and-bone meal and greaves derived from ruminants had been enforced; or
the products of bovine, ovine and caprine animal origin do not contain and are not derived from specified risk material as defined in Annex V.
This Chapter shall apply to the following animal by-products and processed products derived therefrom from bovine, ovine and caprine animal origin as referred to in Regulation (EC) No 1774/2002:
rendered fats,
pet food,
blood products,
the processed animal protein,
bones and bone products,
category 3 material, and
gelatine.
Imports of the animal by-products processed products derived therefrom from bovine, ovine and caprine animal origin referred to in Section A. shall be subject to the presentation of an animal health certificate attesting that:
the animal by-product does not contain and is not derived from specified risk material as defined in Annex V or mechanically separated meat obtained from bones of bovine, ovine or caprine animals;
the animals from which this animal by-product is derived, 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 of central nervous tissue by means of an elongated rod-shaped instrument introduced into the cranial cavity,
or
the animal by-product does not contain and is not derived from bovine, ovine and caprine materials other than those derived from animals born, continuously reared and slaughtered in a country or region classified in accordance with Article 5(2) of Regulation (EC) No 999/2001 as a country or region posing a negligible BSE risk.
Ovine and caprine animals imported into the Community after 1 October 2003 are to be subject to the presentation of an animal health certificate attesting that:
either they were born in and continuously reared on holdings in which a case of scrapie has never been diagnosed, and, in the case of ovine and caprine animals for breeding, they satisfy the requirements of subparagraph (i) of point (a) of Chapter A(I) of Annex VIII;
or they are sheep of the ARR/ARR prion protein genotype, as defined in Annex I to Commission Decision 2002/1003/EC, coming from a holding where no case of scrapie has been reported in the last six months.
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) or (c) of Chapter A(I) of Annex VIII, they shall comply with the additional guarantees, general or specific, which have been defined in accordance with the procedure referred to in Article 24(2).
This product contains or is derived exclusively from meat, excluding offal and spinal cord, of farmed cervid animals which have been examined for chronic wasting disease by histopathology, immunohistochemistry or other diagnostic method recognized by the competent authority with negative results and is not derived from animals coming from a herd where chronic wasting disease has been confirmed or is officially suspected.
This product contains or is derived exclusively from meat, excluding offal and spinal cord, of wild cervid animals which have been examined for chronic wasting disease by histopathology, immunohistochemistry or other diagnostic method recognized by the competent authority with negative results and is not derived from animals coming from a region where chronic wasting disease has been confirmed in the last three years or is officially suspected.
Semen and embryos of ovine and caprine animals imported into the Community from 1 January 2005 shall satisfy the requirements of Annex VIII, Chapter A(I)(d).
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;
verify diagnostic methods used in regional diagnostic laboratories;
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;
is to cooperate with the Community reference laboratory.
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.
Austria: | Österreichische Agentur für Gesundheit und Ernährungssicherheit GmbH, Institut für veterinärmedizinische Untersuchungen Mödling Robert Koch Gasse 17 A-2340 Mödling |
Belgium: | CERVA -CODA-VAR Centre d'Étude et de Recherches Vétérinaires et Agrochimiques Centrum voor Onderzoek in Diergeneeskunde en Agrochemie Veterinary and Agrochemical Research Centre Groeselenberg 99 B-1180 Bruxelles |
Национален диагностичен научноизследователски ветеринарномедицински институт ‘Проф. Д-р Георги Павлов’ Национална референтна лаборатория ‘Tрансмисивни спонгиформни енцефалопатии’ бул. ‘Пенчо Славейков’ София 1606 (National Diagnostic Veterinary Research Institute ‘Prof. Dr. Georgi Pavlov’ National Reference Laboratory for Transmissible Spongiform Encephalopathies 15, Pencho Slaveykov Blvd. 1606 Sofia) | |
Cyprus: | State Veterinary Laboratories Veterinary Services CY-1417 Athalassa Nicosia |
Czech Republic: | Státní veterinární ústav Jihlava Rantířovská 93 586 05 Jihlava |
Denmark: | Danmarks Fødevareforskning Bülowsvej 27 DK-1790 København V |
Estonia: | Veterinaar- ja Toidulaboratoorium Kreutzwaldi 30 Tartu 51006 |
Finland: | Eläinlääkintä- ja elintarvikelaitos Hämeentie 57 FIN-00550 Helsinki |
France: | Agence française de sécurité sanitaire des aliments Laboratoire de pathologie bovine 31, avenue Tony Garnier 69 364 LYON CEDEX 07 |
Germany: | Friedrich-Loeffler-Institut, Bundesforschungsinstitut für Tiergesundheit Anstaltsteil Insel Riems Boddenblick 5A D-17498 Insel Riems |
Greece: | Ministry of Agriculture — Veterinary Laboratory of Larisa 7th km of Larisa — Trikala Highway GR-411 10 Larisa |
Hungary: | Országos Állategészségügyi Intézet (OÁI) Pf. 2. Tábornok u. 2. H-1581 Budapest |
Ireland: | Central Veterinary Research Laboratory Young's Cross Celbridge Co. Kildare |
Italy: | Istituto Zooprofilattico Sperimentale del Piemonte, Liguria e Valle d’Aosta — CEA Via Bologna, 148 I-10154 Torino |
Latvia: | State Veterinary Medicine Diagnostic Centre Lejupes Str. 3 Riga LV 1076 |
Lithuania: | Nacionalinė veterinarijos laboratorija J. Kairiūkščio g. 10 LT-08409 Vilnius |
Luxembourg: | CERVA -CODA-VAR Centre d'Étude et de Recherches Vétérinaires et Agrochimiques Centrum voor Onderzoek in Diergeneeskunde en Agrochemie Veterinary and Agrochemical Research Centre Groeselenberg 99 B-1180 Bruxelles |
Malta: | National Veterinary Laboratory Albert Town Marsa |
Netherlands: | Centraal Instituut voor Dierziektecontrole-Lelystad Houtribweg 3g 8221 RA Lelystad Postbus 2004 8203 AA Lelystad |
Poland: | Państwowy Instytut Weterynaryjny (PIWet) 24-100 Puławy al. Partyzantów 57 |
Portugal: | Laboratório Nacional de Investigação Veterinária Estrada de Benfica 701 P-1500 Lisboa |
Institutul de Diagnostic și Sănătate Animală Strada Dr. Staicovici nr. 63, sector 5 codul 050557, București. | |
Slovakia: | State Veterinary Institute Zvolen Pod dráhami 918 SK-960 86, Zvolen |
Slovenia: | National Veterinary Institute Gerbičeva 60 1000 Ljubljana |
Spain: | Laboratorio Central de Veterinaria (Algete) Ctra. de Algete km. 8 28110 Algete (Madrid) |
Sweden: | National Veterinary Institute S-751 89 Uppsala |
United Kingdom: | Veterinary Laboratories Agency Woodham Lane New Haw Addlestone Surrey KT15 3NB |
The Veterinary Laboratories Agency
Woodham Lane
New Haw
Addlestone
Surrey KT15 3NB
United Kingdom
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;
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;
to facilitate the training or retraining of experts in laboratory diagnosis with a view to the harmonisation of diagnostic techniques throughout the Community.
Any samples intended to be examined for the presence of a TSE shall be collected using the methods and protocols laid down in the latest edition of the Manual for diagnostic tests and vaccines for Terrestrial Animals of the International Office for Epizooties (IOE/OIE) (the Manual). In addition, or in the absence, of OIE methods and protocols, and to ensure that sufficient material is available, the competent authority shall ensure the use of sampling methods and protocols in accordance with guidelines issued by the Community Reference Laboratory. In particular the competent authority shall collect the appropriate tissues, according to the available scientific advice and the guidelines of the Community Reference Laboratory, in order to ensure the detection of all known strains of TSE in small ruminants and shall keep at least half of the collected tissues fresh but not frozen until the result of the rapid test is negative. Where the result is positive or inconclusive the residual tissues must be processed in accordance with the Community reference laboratory guidelines.
The samples shall be correctly marked as to the identity of the sampled animal.
Any laboratory examination for TSE shall be carried out in laboratories approved for that purpose by the competent authority.
Samples from bovine animals sent for laboratory testing pursuant to the provisions of 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 Manual (immunocytochemistry, immuno-blotting or demonstration of characteristic fibrils by electron microscopy). However, rapid tests cannot be used for this purpose.
If the result of one of those examinations is positive, the animals shall be regarded a positive BSE case.
Samples from bovine animals sent for laboratory testing pursuant to the provisions of Annex III, Chapter A, Part I (Monitoring in bovine animals) shall be examined by a rapid test.
When the result of the rapid test is inconclusive or positive, the sample shall immediately be subject to confirmatory examinations in an official laboratory. The confirmatory examination shall start by 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 sample shall be subjected to an examination by one of the other diagnostic methods referred to in (a).
An animal shall be regarded a positive BSE case, if the result of the rapid test is positive or inconclusive, and either
the result of the subsequent histopathological examination is positive, or
the result of another diagnostic method referred to in (a) is positive.
Samples from ovine and caprine animals sent for laboratory testing pursuant to the provisions of 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 sample shall be subjected to an examination by immunocytochemistry, immuno-blotting or demonstration of characteristic fibrils by electron microscopy, as laid down in the Manual. However, rapid tests cannot be used for this purpose.
If the result of one of those examinations is positive, the animal shall be regarded a positive scrapie case.
Samples from ovine and caprine animals sent for laboratory testing pursuant to the provisions of Annex III, Chapter A, Part II (Monitoring in ovine and caprine animals) shall be examined by a rapid test using the appropriate methods and protocols, according to the available scientific advice and the guidelines of the Community Reference Laboratory, in order to ensure the detection of all known strains of TSE.
When the result of the rapid test is inconclusive or positive, the sampled tissues shall immediately be sent to an official laboratory for confirmatory examinations by immunocytochemistry, immuno-blotting or demonstration of characteristic fibrils by electron microscopy, as referred to in (a). If the result of the confirmatory examination is negative or inconclusive, additional confirmatory testing shall be carried out according the guidelines of the Community reference laboratory.
If the result of one of the confirmatory examination is positive, the animal shall be regarded a positive TSE case.
Primary molecular testing with a discriminatory immuno-blotting
Samples from clinical suspect cases and from animals tested in accordance with Annex III, Chapter A, Part II, points 2 and 3 which are regarded as positive scrapie cases following the examinations referred to in points (a) or (b), or which display characteristics which are deemed by the testing laboratory to merit investigation, shall be forwarded for further examination by a primary molecular typing method to:
Agence Française de Sécurité Sanitaire des Aliments, Laboratoire de pathologie bovine, 31, avenue Tony Garnier, BP 7033, F-69342, Lyon Cedex, France, or
Veterinary Laboratories Agency, Woodham Lane, New Haw, Addlestone, Surrey KT15 3NB, United Kingdom, or
to a laboratory, appointed by the competent authority, which has participated successfully in proficiency testing organised by the Community Reference Laboratory for the use of a molecular typing method, or
on a provisional basis until 1 May 2005, the laboratories approved for this purpose by the CRL panel of experts.
Ring trial with additional molecular testing methods
Samples from scrapie cases in which the presence of BSE cannot be excluded according to the guidelines issued by the Community Reference Laboratory by the primary molecular testing referred to in (i), shall be forwarded immediately to the laboratories listed in point (d) after consultation with the Community Reference Laboratory, and with all the relevant information available. They shall be submitted to a ring trial with at least:
a second discriminatory immuno-blotting,
a discriminatory immunocytochemistry, and
a discriminatory ELISA (Enzyme linked ImmunoSorbent Assay)
carried out in the laboratories approved for the relevant method as listed in point (d). Where samples are unsuitable for immunocytochemistry, the Community Reference Laboratory will direct appropriate alternative testing within the ring trial.
The results shall be interpreted by the Community Reference Laboratory assisted by a panel of experts including a representative of the relevant National Reference Laboratory. The Commission shall be informed immediately about the outcome of that interpretation. Samples indicative for BSE by three different methods and samples inconclusive in the ring trial shall be further analysed by a mouse bioassay for final confirmation.
The laboratories approved for further molecular typing are:
Agence Française de Sécurité Sanitaire des Aliments
Laboratoire de pathologie bovine
31, avenue Tony Garnier
BP 7033
F-69342 Lyon Cedex
Centre CEA Fontenay-aux-Roses, BP 6
F-92265 Fontenay-aux-Roses Cedex
Service de Pharmacologie et d’Immunologie
Centre CEA Saclay, bâtiment 136
F-91191 Gif-sur-Yvette Cedex
Veterinary Laboratories Agency
Woodham Lane
New Haw
Addlestone
Surrey KT15 3NB
United Kingdom
Where methods and protocols are established for tests carried out to confirm the suspected presence of a TSE in a species other than bovine, ovine and caprine, they shall include at least a histopathological examination of brain tissue. The competent authority may also require laboratory tests such as immunocytochemistry, immuno-blotting, demonstration of characteristic fibrils by electron microscopy or other methods designed to detect the disease associated form of the prion protein. In any case at least one other laboratory examination shall be carried out if the initial histopathological examination is negative or inconclusive. At least three different examinations shall be carried out in the event of the first appearance of the disease.
In particular, where BSE is suspected in a species other than bovine animals, samples shall be submitted for strain-typing, where possible.
For the purposes of carrying out the rapid tests in accordance with Articles 5(3) and 6(1), the following methods shall be used as rapid tests for the monitoring of BSE in bovine animals:
immuno-blotting test based on a Western blotting procedure for the detection of the Proteinase K-resistant fragment PrPRes (Prionics-Check Western test),
chemiluminescent ELISA test involving an extraction procedure and an ELISA technique, using an enhanced chemiluminescent reagent (Enfer test & Enfer TSE Kit version 2.0, automated sample preparation),
microplate-based immunoassay for the detection of PrPSc (Enfer TSE Version 3),
sandwich immunoassay for PrPRes carried out following denaturation and concentration steps (Bio-Rad Te-SeE test),
microplate-based immunoassay (ELISA) which detects Proteinase K-resistant PrPRes with monoclonal antibodies (Prionics-Check LIA test),
conformation-dependent immunoassay, BSE antigen test kit (Beckman Coulter InPro CDI kit),
chemiluminescent ELISA for qualitative determination of PrPSc (CediTect BSE test),
immunoassay using a chemical polymer for selective PrPSc capture and a monoclonal detection antibody directed against conserved regions of the PrP molecule (IDEXX HerdChek BSE Antigen Test Kit, EIA),
lateral-flow immunoassay using two different monoclonal antibodies to detect Proteinase K-resistant PrP fractions (Prionics Check PrioSTRIP),
two-sided immunoassay using two different monoclonal antibodies directed against two epitopes presented in a highly unfolded state of bovine PrPSc (Roboscreen Beta Prion BSE EIA Test Kit),
sandwich ELISA for the detection of Proteinase K-resistant PrPSc (Roche Applied Science PrionScreen),
antigen-capture ELISA using two different monoclonal antibodies to detect Proteinase K-resistant PrP fractions (Fujirebio FRELISA BSE post-mortem rapid BSE Test).
For the purposes of carrying out the rapid tests in accordance with Articles 5(3) and 6(1), the following methods shall be used as rapid tests for the monitoring of TSE in ovine and caprine animals:
conformation-dependent immunoassay, BSE antigen test kit (Beckman Coulter InPro CDI kit),
sandwich immunoassay for PrPRes carried out following denaturation and concentration steps (Bio-Rad Te-SeE test),
sandwich immunoassay for PrPRes carried out following denaturation and concentration steps (Bio-Rad Te-SeE Sheep/Goat test),
chemiluminescent ELISA test involving an extraction procedure and an ELISA technique, using an enhanced chemiluminescent reagent (Enfer TSE Kit version 2.0),
microplate-based immunoassay for the detection of PrPSc (Enfer TSE Version 3),
immunoassay using a chemical polymer for selective PrPSc capture and a monoclonal detection antibody directed against conserved regions of the PrP molecule (IDEXX HerdChek BSE-Scrapie Antigen Test Kit, EIA),
microplate-based chemiluminiscent immunoassay for the detection of PrPSc in ovine tissues (POURQUIER’S-LIA Scrapie),
immuno-blotting test based on a Western blotting procedure for the detection of the Proteinase K-resistant fragment PrPRes (Prionics-Check Western Small Ruminant test),
microplate-based chemiluminescent immunoassay for the detection of Proteinase K-resistant PrPSc (Prionics Check LIA Small Ruminants).
In all tests, sample tissue on which the test must be applied must comply with the manufacturer’s instructions for use.
Producers of rapid tests must have a quality assurance system in place that has been approved by the Community Reference Laboratory (CRL) and ensures that the test performance does not change. Producers must provide the CRL with the test protocols.
Changes to rapid tests and to test protocols may only be made after prior notification to the CRL and provided that the CRL finds that the change does not alter the sensitivity, specificity or reliability of the rapid test. That finding shall be communicated to the Commission and to the national reference laboratories.
(To be defined)
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