(1)
Annex II to Regulation (EC) No 999/2001 is replaced by the following:
ANNEX IIDETERMINATION OF BSE STATUS
CHAPTER AU.K.Criteria
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)
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;
(b)
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;
(c)
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;
(d)
an obligation to notify and investigate all bovine animals showing clinical signs consistent with BSE is in force;
(e)
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.
CHAPTER BU.K.Risk analysis
1.Structure of the risk analysisU.K.
The risk analyses shall comprise a release assessment and an exposure assessment.
2.Release assessment (external challenge)U.K.
2.1.The release assessment shall consist of assessing the likelihood that the BSE agent has either been introduced into the country or region via commodities potentially contaminated with a BSE agent, or is already present in the country or region.U.K.
The following risk factors shall be taken into account:
(a)
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;
(b)
the production of meat-and-bone meal or greaves from the BSE indigenous ruminant population;
(c)
imported meat-and-bone meal or greaves;
(d)
imported bovine and ovine and caprine animals;
(e)
imported animal feed and feed ingredients;
(f)
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;
(g)
imported products of ruminant origin for in vivo use in bovine animals.
2.2.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.U.K.
3.Exposure assessmentU.K.
The exposure assessment shall consist of assessing the likelihood of exposure of bovine animals to the BSE agent, through a consideration of the following:
(a)
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;
(b)
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;
(c)
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;
(d)
the level of surveillance for BSE conducted on the bovine animals population to that time and the results of that surveillance.
CHAPTER CU.K.Definition of categories
I.COUNTRY OR REGION WITH A NEGLIGIBLE BSE RISKU.K.
A country or region:
(1)
where a risk analysis in accordance with Chapter B has been conducted in order to identify the historical and existing risk factors;
(2)
which has demonstrated that appropriate specific measures have been taken for the relevant period of time defined below to manage each identified risk;
(3)
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
(4)
which is:
(a)
either in the following situation:
(i)
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;
(ii)
the criteria in points (c), (d) and (e) of Chapter A of this Annex have been complied with for at least seven years; and
(iii)
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;
(b)
or in the following situation:
(i)
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;
(ii)
the criteria in points (c), (d) and (e) of Chapter A have been complied with for at least seven years;
(iii)
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;
(iv)
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.
II.COUNTRY OR REGION WITH A CONTROLLED BSE RISKU.K.
A country or region
(1)
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;
(2)
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;
(3)
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
(4)
which is:
(a)
either in the following situation:
(i)
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;
(ii)
the criteria in points (c), (d) and (e) of Chapter A have been complied with for a period shorter than seven years; and/or
(iii)
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;
(b)
or in the following situation:
(i)
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;
(ii)
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
(iii)
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;
(iv)
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.
III.COUNTRY OR REGION WITH UNDETERMINED BSE RISKU.K.
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.
CHAPTER DU.K.Minimal surveillance requirements
1.Surveillance typesU.K.
For the purpose of this Annex, the following definitions shall apply:
(a)
Type A surveillance
The application of Type A surveillance will allow the detection of BSE at a design prevalence() of at least one case per 100 000 in the adult bovine animals population in the country or region of concern, at a confidence level of 95 %;
(b)
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:
(a)
bovine animals over 30 months of age displaying behavioural or clinical signs consistent with BSE (clinical suspects);
(b)
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);
(c)
bovine animals over 30 months of age which are found dead or killed on farm, during transport or at an abattoir (fallen stock);
(d)
bovine animals over 36 months of age at routine slaughter.
2.Surveillance strategyU.K.
2.1.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.U.K.
2.2.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.U.K.
3.Points values and point targetsU.K.
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.
Table 1
Surveillance point values for samples collected from animals in the given sub-population and age category
|
|
|
|
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 |
Table 2
Points targets for different adult bovine animals population sizes in a country or region
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 |
4.Specific targetingU.K.
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.
5.BSE surveillance modelU.K.
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.
6.Maintenance surveillanceU.K.
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.”
(2)
Annex V is replaced by the following:
‘ANNEX VSPECIFIED RISK MATERIAL
1.Definition of specified risk materialU.K.
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:
(a)
as regards bovine animals:
(i)
the skull excluding the mandible and including the brain and eyes, and the spinal cord of animals aged over 12 months;
(ii)
the vertebral column excluding the vertebrae of the tail, the spinous and transverse processes of the cervical, thoracic and lumbar vertebrae and the median sacral crest and wings of the sacrum, but including the dorsal root ganglia of animals aged over 24 months; and
(iii)
the tonsils, the intestines from the duodenum to the rectum and the mesentery of animals of all ages.
(b)
as regards ovine and caprine animals
(i)
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
(ii)
the spleen and ileum of animals of all ages.
2.Derogation for Member StatesU.K.
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.
3.Marking and disposalU.K.
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.
4.Removal of specified risk materialU.K.
4.1.Specified risk material shall be removed at:U.K.
(a)
slaughterhouses, or, as appropriate, other places of slaughter;
(b)
cutting plants, in the case of vertebral column of bovine animals;
(c)
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.
4.2.By way of derogation from point 4.1, the use of an alternative test to the removal of specified risk material may be authorised under the following conditions:U.K.
(a)
tests must be carried out in slaughterhouses on all animals eligible for the removal of specified risk material;
(b)
no bovine, ovine or caprine product intended for human food or animal feed may leave the slaughterhouse before the competent authority has received and accepted the results of the tests on all slaughtered animals potentially contaminated if BSE has been confirmed in one of them;
(c)
when an alternative test gives a positive result, all bovine, ovine and caprine material which has been potentially contaminated in the slaughterhouse is destroyed in accordance with point 3, unless all parts of the body including the hide of the affected animal can be identified and kept separate.
4.3.By way of derogation from point 4.1, Member States may decide to allow:U.K.
(a)
the removal of spinal cord of ovine and caprine animals in cutting plants specifically authorised for this purpose;
(b)
the removal of bovine vertebral column from carcasses or parts of carcasses in butcher shops specifically authorised, monitored and registered for this purpose;
(c)
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.
4.4.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.U.K.
5.Measures concerning mechanically separated meatU.K.
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.
6.Measures concerning laceration of tissuesU.K.
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.
7.Harvesting of tongues from bovine animalsU.K.
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.
8.Harvesting of bovine head meatU.K.
8.1.Head meat of bovine animals above 12 months of age shall be harvested at slaughterhouses, in accordance with a control system, recognised by the competent authority, to ensure the prevention of possible contamination of head meat with central nervous system tissue. The system shall include at least the following provisions:U.K.
(a)
harvesting shall take place in a dedicated area, physically separated from the other parts of the slaughterline;
(b)
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;
(c)
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;
(d)
head meat shall not be harvested from heads which have not been properly sealed in accordance with the second indent;
(e)
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:
(f)
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.
8.2.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.U.K.
8.3.If the harvesting is performed without removing the bovine head from the conveyor or hooks, points 8.1 and 8.2 shall not apply.U.K.
9.Harvesting of bovine head meat in authorised cutting plantsU.K.
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:
(a)
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;
(b)
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;
(c)
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;
(d)
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;
(e)
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:
(i)
all heads shall be visually checked for signs of contamination or damage and proper sealing before the harvesting of the head meat begins;
(ii)
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;
(iii)
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;
(f)
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.
10.Rules on trade and exportU.K.
10.1.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.U.K.
10.2.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.U.K.
10.3.Exports outside the Community of heads and of fresh meat of bovine, ovine or caprine animals containing specified risk materials shall be prohibited.U.K.
11.ControlsU.K.
11.1.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).U.K.
11.2.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.U.K.
11.3.A control system shall be put in place for the removal of the vertebral column as specified in point 1(a). The system shall include at least the following measures:U.K.
(a)
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;
(b)
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() in the case of imports;
(c)
butcher shops shall keep, for at least one year, the commercial documents referred to in (b).”