LegalizeRegulation (EC) No 999/2001 of the European Parliament and of the Council of 22 May 2001 laying down rules for the prevention, control and eradication of certain transmissible spongiform encephalopathies
REGULATION (EC) No 999/2001 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 22 May 2001 laying down rules for the prevention, control and eradication of certain transmissible spongiform encephalopathies
CHAPTER I
GENERAL PROVISIONS
Article 1
Scope
This Regulation shall not apply to:
(a) cosmetic or medicinal products or medical devices, or to their starting materials or intermediate products;
(b) products which are not intended for use in human food, animal feed or fertilisers, or to their starting materials or intermediate products;
(c) products of animal origin intended for exhibition, teaching, scientific research, special studies or analysis, provided those products are not eventually consumed or used by humans or by animals other than those kept for the research projects concerned;
(d) live animals used in or intended for research.
Article 2
Separation of live animals and of products of animal origin
In order to avoid cross-contamination or substitution between the live animals or of the products of animal origin referred to in Article 1(1) and the products of animal origin referred to in Article 1(2)(a), (b) and (c), or the live animals referred to in Article 1(2)(d), they shall be kept separate at all times unless such live animals or products of animal origin are produced under at least the same conditions of health protection in respect of TSEs.
Rules for the implementation of this Article shall be adopted in accordance with the procedure referred to in Article 24(2).
Article 3
Definitions
For the purposes of this Regulation the following definitions shall apply:
(a) TSEs: all transmissible spongiform encephalopathies with the exception of those occurring in humans;
(b) placing on the market: any operation the purpose of which is to sell live animals or products of animal origin covered by this Regulation to a third party in the Community, or any other form of supply against payment or free of charge to such a third party or storage with a view to supply to such a third party;
(c) products of animal origin: any product derived from or containing a product derived from any animal covered by the provisions of Directive 89/662/EEC (1) or Directive 90/425/EEC (2);
(d) starting materials: raw materials or any other product of animal origin out of which, or with the help of which, the products referred to in Article 1(2)(a) and (b) are produced;
(e) competent authority: the central authority of a Member State competent to ensure compliance with the requirements of this Regulation or any authority to which that central authority has delegated that competence, in particular for the control of feedingstuffs; it shall also include, where appropriate, the corresponding authority of a third country;
(f) category: one of the classification categories referred to in Chapter C of Annex II;
(g) specified risk material: the tissues specified in Annex V; unless otherwise indicated, it does not include products containing or derived from those tissues;
(h) animal suspected of being infected by a TSE: live, slaughtered or dead animals, which show or have shown neurological or behavioural disorders or a progressive deterioration of the general condition linked to impairment of the central nervous system and for which the information gathered on the basis of a clinical examination, response to treatment, a post-mortem examination or an ante or post-mortem laboratory analysis do not allow an alternative diagnosis to be established. Bovine spongiform encephalopathies (BSE) shall be suspected in bovine animals which have produced a positive result from a rapid test specifically for BSE;
(i) holding: any place in which animals covered by this Regulation are held, kept, bred, handled or shown to the public;
(j) sampling: the taking of samples, ensuring a statistically correct representation, from animals or their environment, or from products of animal origin, for the purpose of establishing a disease diagnosis, familial relationships, for health surveillance, or for the monitoring of the absence of microbiological agents or of certain materials in products of animal origin;
(k) fertilisers: any substance containing products of animal origin utilised on land to enhance growth of vegetation; it may include digestion residues from bio-gas production or composting;
(l) rapid tests: the screening methods listed in Annex X, for which the results are known within 24 hours;
(m) alternative test: the tests referred to in Article 8(2) which are used as an alternative to the withdrawal of specified risk material;
(n) mechanically separated meat or ‘MSM’: the product obtained by removing meat from flesh-bearing bones after boning, using mechanical means resulting in the loss or modification of the muscle fibre structure;
(o) passive surveillance: the reporting of all animals suspected of being infected by a TSE and, where TSE cannot be excluded by clinical investigation, the laboratory testing of such animals;
(p) active surveillance: the testing of animals not reported as suspected of being infected by a TSE, such as emergency slaughtered animals, animals with observations at ante mortem inspection, fallen stock, healthy slaughtered animals and animals culled in connection with a TSE case, in particular in order to determine the evolution and prevalence of TSE in a country or region thereof.
Article 4
Safeguard measures
CHAPTER II
DETERMINATION OF BSE STATUS
Article 5
Classification
The BSE status of Member States or third countries or regions thereof (hereinafter referred to as ‘countries or regions’) shall be determined by classification into one of the following three categories:
— negligible BSE risk as defined in Annex II,
— controlled BSE risk as defined in Annex II,
— undetermined BSE risk as defined in Annex II.
The BSE status of countries or regions may be determined only on the basis of the criteria set out in Annex II, Chapter A. These criteria shall include the outcome of a risk analysis on the basis of all the potential factors for the appearance of bovine spongiform encephalopathy as defined in Annex II, Chapter B, and their development over time, as well as comprehensive active and passive surveillance measures taking into account the risk category of the country or region.
Member States, and third countries wishing to be retained on the list of third countries approved for the export to the Community of the live animals or of the products covered by this Regulation, shall submit to the Commission an application for their BSE status to be determined, accompanied by the relevant information on the criteria set out in Annex II, Chapter A, and on the potential risk factors specified in Annex II, Chapter B, and their development over time.
This decision shall be taken within six months of the submission of the application and of the relevant information referred to in the second subparagraph of paragraph 1. If the Commission finds that the supporting evidence does not include the information laid down in Annex II, Chapters A and B, it shall ask for additional information to be provided within a period to be specified. The final decision shall then be taken within six months of the submission of all information.
After the International Office of Epizootic Diseases (OIE) has established a procedure for the classification of countries by category and if it has placed the applicant country in one of those categories, a re-assessment of the Community categorisation of the country concerned in accordance with the first subparagraph of this paragraph may be decided, if appropriate, in accordance with the procedure referred to in Article 24(2).
Such a risk analysis must include a conclusive statistical survey of the epidemiological situation regarding TSEs in the applicant Member State or third country, on the basis of the use, in a screening procedure, of rapid tests. The Commission shall take into account the classification criteria used by the OIE.
The rapid tests shall be approved for that purpose in accordance with the regulatory procedure with scrutiny referred to in Article 24(3) and entered on a list set out in Annex X, Chapter C, point 4.
Such screening procedure may also be used by Member States or third countries which wish to have the classification they carried out on that basis approved by the Commission — in accordance with the procedure laid down in Article 24(2).
The cost of such screening procedure shall be borne by the Member State or third country concerned.
The eligibility of third countries to export to the Community live animals, or products of animal origin for which this Regulation provides specific rules, under conditions based on their category as established by the Commission, shall be conditional upon their undertaking to notify the latter in writing as soon as possible of any epidemiological or other evidence which might lead to a change in BSE status.
CHAPTER III
PREVENTION OF TSE
Article 6
Monitoring system
Rapid tests shall be approved for that purpose in accordance with the procedure referred to in Article 24(3) and listed in Annex X.
The annual monitoring programme referred to in paragraph 1 shall cover as a minimum the following subpopulations:
(a) all bovine animals above 24 months of age sent for emergency slaughter or with observations at ante mortem inspections;
(b) all bovine animals above 30 months of age slaughtered normally for human consumption;
(c) all bovine animals above 24 months of age not slaughtered for human consumption, which have died or been killed on the farm, during transport or in an abattoir (fallen stock).
Member States may decide to derogate from the provision under point (c) in remote areas with a low animal density, where no collection of dead animals is organised. Member States making use of this possibility shall inform the Commission and submit a list of the areas concerned together with a justification for the derogation. The derogation shall not cover more than 10 % of the bovine population in a Member State.
At the request of a Member State which can demonstrate the improvement of the epidemiological situation of the country, according to certain criteria to be laid down in accordance with the procedure referred to in Article 24(3), the annual monitoring programmes for that particular Member State may be revised.
The Member State concerned shall provide proof of its capability to determine the effectiveness of the measures in place and ensure protection of human and animal health based on a comprehensive risk analysis. In particular, the Member State shall demonstrate:
(a) a clearly declining or consistently low BSE prevalence, based on up-to-date testing results;
(b) that it has implemented and enforced for at least six years a full BSE testing scheme (Community legislation on traceability and identification of live animals and BSE surveillance);
(c) that it has implemented and enforced for at least six years Community legislation on total feed ban for farmed animals.
Article 6a
Breeding Programmes
Article 7
Prohibitions concerning animal feeding
The Commission may decide in accordance with the procedure referred to in Article 24(3), based on a scientific assessment of the dietary needs of young ruminants and subject to the rules adopted for the implementation of this Article provided for in paragraph 5 of this Article, and following an assessment of the control aspects of this derogation, to allow the feeding of young animals of ruminant species with proteins derived from fish.
Third countries, or regions thereof, with an undetermined BSE risk shall not be permitted to export to the Community feed intended for farmed animals which contains protein derived from mammals or feed intended for mammals, except feed for dogs, cats and fur animals, which contains processed protein derived from mammals.
At the request of a Member State or third country a decision in accordance with the procedure referred to in Article 24(2) may be taken, following detailed criteria to be laid down in accordance with the procedure referred to in Article 24(3), to grant individual exemptions from the restrictions in this paragraph. Any exemption shall take account of the provisions provided for in paragraph 3 of this Article.
Article 8
Specified risk material
The Member States which authorise the use of an alternative test pursuant to this paragraph shall inform the other Member States and the Commission.
Article 9
Products of animal origin derived from or containing ruminant material
The Commission shall thereupon present a communication to the European Parliament and the Council on the future necessity and use of MSM in the Community, including the information policy towards consumers.
Article 10
Education programmes
CHAPTER IV
CONTROL AND ERADICATION OF TSEs
Article 11
Notification
Without prejudice to Directive 82/894/EEC (8), the Member States shall ensure that any animal suspected of being infected by a TSE is notified immediately to the competent authorities.
Member States shall regularly inform each other and the Commission of the cases of TSE notified.
The competent authority shall without delay take the measures laid down in Article 12 of this Regulation, together with any other necessary measures.
Article 12
Measures with respect to suspect animals
If a TSE is officially suspected in a bovine animal at a holding in a Member State, all other bovine animals at that holding shall be placed under an official movement restriction until the results of the examination are available. If a TSE is officially suspected in an ovine or caprine animal at a holding in a Member State, all other ovine and caprine animals at that holding shall be placed under an official movement restriction until the results are available.
However, if there is evidence that the holding where the animal was present when the TSE was suspected is unlikely to be the holding where the animal could have been exposed to the TSE, the competent authority may decide that only the animal suspected of being infected shall be placed under an official movement restriction.
If considered necessary, the competent authority may also decide that other holdings or only the holding of exposure shall be placed under official control depending on the epidemiological information available.
In accordance with the procedure referred to in Article 24(2) and by way of derogation from the official movement restrictions provided for in this paragraph, a Member State may be exempted from implementing such restrictions if it applies measures offering equivalent safeguards based on an appropriate assessment of the possible risks for human and animal health.
Article 13
Measures following confirmation of the presence of a TSE
When the presence of a TSE has been officially confirmed, the following measures shall be applied as soon as possible:
(a) all parts of the body of the animal shall be disposed of in accordance with Regulation (EC) No 1774/2002 except for material retained for records in accordance with Annex III, Chapter B, of this Regulation.
(b) an inquiry shall be carried out to identify all animals at risk in accordance with Annex VII, point 1;
(c) all animals and products thereof at risk, as listed in Annex VII, point 2, of this Regulation, identified by the inquiry referred to in point (b) of this paragraph shall be killed and disposed of in accordance with Regulation (EC) No 1774/2002.
At the request of a Member State and based on a favourable risk assessment taking particularly into account the control measures in that Member State, a decision may be taken in accordance with the procedure referred to in Article 24(2) to allow the use of bovine animals referred to in this paragraph until the end of their productive lives.
By way of derogation from this paragraph, a Member State may apply other measures offering an equivalent level of protection based on a favourable risk assessment pursuant to Articles 24a and 25, taking particularly into account the control measures in that Member State, if those measures have been approved for that Member State in accordance with the regulatory procedure referred to in Article 24(2).
If there is evidence that the holding where the affected animal was present when the TSE was confirmed is not likely to be the holding where the animal was exposed to the TSE, the competent authority may decide that both holdings or only the holding of exposure shall be placed under official control.
Article 14
Contingency plan
CHAPTER V
PLACING ON THE MARKET AND EXPORT
Article 15
Live animals, their semen, embryos and ova
Article 16
Placing on the market of products of animal origin
The following products of animal origin derived from healthy ruminants shall not be subject to restrictions on placing on the market or, if need be, export pursuant to this Article, to Annex VIII, Chapters C and D, and to Annex IX, Chapters A, C, F and G:
(a) products of animal origin covered by Article 15, in particular semen, embryos and ova;
(b) milk and dairy products, hides and skins, and gelatine and collagen derived from hides and skins.
Food products of animal origin containing material obtained from bovine animals originating in a country or region with an undetermined BSE risk shall not be placed on the market unless they come from animals which:
(a) were born eight years after the date from which the prohibition on the feeding to ruminants of animal protein derived from mammals was effectively enforced; and
(b) were born, raised and have stayed in herds with a certified history of freedom from BSE for at least seven years.
Furthermore, food products of ruminant origin shall not be dispatched from a Member State or a region thereof with an undetermined BSE risk to another Member State or be imported from a third country with an undetermined BSE risk.
This prohibition shall not apply to products of animal origin listed in Annex VIII, Chapter C, and fulfilling the requirements of Annex VIII, Chapter C.
They must be accompanied by an animal health certificate issued by an official veterinarian certifying that they have been produced in conformity with this Regulation.
Article 17
Under the procedure referred to in Article 24(2), the health certificates referred to in Annex F to Directive 64/432/EEC, Models II and III in Annex E to Directive 91/68/EEC and the appropriate health certificates laid down by Community legislation relating to trade in the semen, embryos and ova of bovine, ovine or caprine animals shall be supplemented, where necessary, by a reference to the category specifying the classification of the Member State or region of origin given in accordance with Article 5.
Appropriate commercial documents relating to trade in products of animal origin shall be supplemented, where necessary, by a reference to the category of the Member State or region of origin given by the Commission in accordance with Article 5.
Article 18
The appropriate health certificates relating to imports provided for by Community legislation shall, under the procedure referred to in Article 24(2), be supplemented in respect of third countries classified in a category pursuant to Article 5 by the specific requirements laid down in Annex IX, as soon as that classification decision has been taken.
CHAPTER VI
REFERENCE LABORATORIES, SAMPLING, TESTING AND CONTROLS
Article 20
Sampling and laboratory methods
CHAPTER VII
TRANSITIONAL AND FINAL PROVISIONS
Article 22
Transitional measures concerning specified risk material
Article 23
Amendment of the annexes and transitional measures
After consultation of the appropriate scientific committee on any question which could have an impact on public health, the annexes shall be amended or supplemented and any appropriate transitional measures shall be adopted in accordance with the regulatory procedure with scrutiny referred to in Article 24(3).
In accordance with that procedure, transitional measures shall be adopted for a period ending on 1 July 2007 at the latest, to permit the change-over from the current arrangements to the arrangements established by this Regulation.
Article 23a
The following measures which are designed to amend non-essential elements of this Regulation, including by supplementing it, shall be adopted in accordance with the regulatory procedure with scrutiny referred to in Article 24(3):
(a) approval of the rapid tests referred to in Article 5(3) third subparagraph, Article 6(1), Article 8(2) and Article 9(3),
(b) adaptation of the age referred to in Article 6(1b),
(c) criteria to demonstrate improvement of the epidemiological situation referred to in Article 6(1b),
(d) decision to allow feeding of young animals of ruminant species with proteins derived from fish as referred to in Article 7(3),
(e) criteria for granting exemptions from the restrictions referred to in Article 7(4),
(f) decision to introduce a tolerance level as referred to in Article 7(4a),
(g) decision on age as referred to in Article 8(1),
(h) rules providing for exemptions from the requirement to remove and destroy specified risk material as referred to in Article 8(5),
(i) approval of production processes referred to in Article 9(1),
(j) decision to extend certain provisions to other animal species as referred to in Article 15(3),
(k) extension to other products of animal origin of the provisions of paragraphs 1 to 6 of Article 16,
(l) adoption of the method to confirm BSE in ovine and caprine animals referred to in Article 20(2),
(m) amendment or addition to the annexes and adoption of any appropriate transitional measures referred to in Article 23.
Article 24
Committees
The time-limits referred to in Article 5(6) of that Decision shall be three months and, in the case of safeguard measures referred to in Article 4(2) of this Regulation, 15 days.
Article 24a
Decisions to be adopted in accordance with one of the procedures referred to in Article 24 shall be based on an appropriate assessment of the possible risks for human and animal health and shall, taking into account existing scientific evidence, maintain, or if scientifically justified increase, the level of protection of human and animal health ensured in the Community.
Article 25
Consultation of the scientific committees
The appropriate scientific committees shall be consulted on any matter within the scope of this Regulation which could have an impact on public health.
Article 26
Entry into force
This Regulation shall enter into force on the day following its publication in the Official Journal of the European Communities.
It shall apply from 1 July 2001.
This Regulation shall be binding in its entirety and directly applicable in all Member States.
ANNEX I
For the purpose of this Regulation, the following definitions set out in Regulation (EC) No 1069/2009 of the European Parliament and of the Council (9), Commission Regulation (EU) No 142/2011 (10), Regulation (EC) No 178/2002 of the European Parliament and of the Council (11), Regulation (EC) No 767/2009 of the European Parliament and of the Council (12), Council Directive 2006/88/EC (13) and Regulation (EU) 2016/1012 of the European Parliament and of the Council (14) shall apply:
For the purpose of this Regulation, the following definitions shall also apply:
ANNEX II
DETERMINATION OF BSE STATUS
CHAPTER A
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). For the purpose of this Annex, ‘BSE’ excludes ‘atypical BSE’ as a condition believed to occur spontaneously in all cattle populations at a very low rate.
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 B
Risk analysis
The risk analyses shall comprise an entry assessment and an exposure assessment.
2.1.The entry 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.
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 ac-count in carrying out the entry 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:
(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 C
Definition of categories
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.
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.
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 D
Minimal surveillance requirements
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 (19) 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.
2.1.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.
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.
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 (1) | Fallen stock (2) | Casualty slaughter (3) | Clinical suspect (4) |
| 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 |
| (1) Bovine animals over 36 months of age at routine slaughter. (2) Bovine animals over 30 months of age which are found dead or killed on farm, during transport or at an abattoir (fallen stock). (3) 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). (4) Bovine animals over 30 months of age displaying behavioural or clinical signs consistent with BSE (clinical suspects). | |||
| Points targets for country or region | |||
| --- | --- | --- | |
| Adult bovine animals population size (24 months and older) | Type A surveillance | Type B surveillance | |
| > 1 000 000 | 300 000 | 150 000 | |
| 900 001 -1 000 000 | 214 600 | 107 300 | |
| 800 001 -900 000 | 190 700 | 95 350 | |
| 700 001 -800 000 | 166 900 | 83 450 | |
| 600 001 -700 000 | 143 000 | 71 500 | |
| 500 001 -600 000 | 119 200 | 59 600 | |
| 400 001 -500 000 | 95 400 | 47 700 | |
| 300 001 -400 000 | 71 500 | 35 750 | |
| 200 001 -300 000 | 47 700 | 23 850 | |
| 100 001 -200 000 | 22 100 | 11 500 | |
| 90 001 -100 000 | 19 900 | 9 950 | |
| 80 001 -90 000 | 17 700 | 8 850 | |
| 70 001 -80 000 | 15 500 | 7 750 | |
| 60 001 -70 000 | 13 000 | 6 650 | |
| 50 001 -60 000 | 11 000 | 5 500 | |
| 40 001 -50 000 | 8 800 | 4 400 | |
| 30 001 -40 000 | 6 600 | 3 300 | |
| 20 001 -30 000 | 4 400 | 2 200 | |
| 10 001 -20 000 | 2 100 | 1 050 | |
| 9 001 -10 000 | 1 900 | 950 | |
| 8 001 -9 000 | 1 600 | 800 | |
| 7 001 -8 000 | 1 400 | 700 | |
| 6 001 -7 000 | 1 200 | 600 | |
| 5 001 -6 000 | 1 000 | 500 | |
| 4 001 -5 000 | 800 | 400 | |
| 3 001 -4 000 | 600 | 300 | |
| 2 001 -3 000 | 400 | 200 | |
| 1 001 -2 000 | 200 | 100 |
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.
ANNEX III
CHAPTER A
I. MONITORING IN BOVINE ANIMALS
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).
2.1. All bovine animals over 24 months of age shall be tested for BSE where they have undergone:
2.2. All healthy bovine animals over 30 months of age slaughtered normally for human consumption shall be tested for BSE.
3.1. All bovine animals over 24 months of age which have died or been killed but which were not: shall be tested for BSE.
3.2. 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.
6.1.Where an animal slaughtered for human consumption has been selected for testing for BSE, the health marking provided for in Chapter III of Section I of Annex I to Regulation (EC) No 854/2004 shall not be carried out on the carcase of that animal until a negative result to the rapid test has been obtained.
6.2.Member States may derogate from 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.
6.3.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 12(a) or (b) of Regulation (EC) No 1069/2009, or unless its fats are processed in accordance with Regulation (EU) No 142/2011 and used in accordance with Article 12(e) of Regulation (EC) No 1069/2009 or used for the manufacture of derived products referred to in Article 36 of that Regulation.
6.4.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 12(a) or (b) of Regulation (EC) No 1069/2009, apart from material to be retained in conjunction with the records provided for in Chapter B, Part III of this Annex, and apart from the fats obtained from such a body, provided that these fats are processed in accordance with Regulation (EU) No 142/2011 and used in accordance with Article 12(e) of Regulation (EC) No 1069/2009 or used for the manufacture of derived products referred to in Article 36 of that Regulation.
6.5.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 animal tested positive or inconclusive on the same slaughter line shall be destroyed in accordance with point 6.4.
By way of derogation from the first paragraph of this point, 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).
6.6.Member States may derogate from the provisions of point 6.5 where a system is in place in the slaughterhouse preventing contamination between carcases.
Applications submitted to the Commission by Member States for revision of their annual BSE monitoring programme shall include at least the following:
(a) information on the annual BSE monitoring system in place during the previous six-year period within the territory of the Member State, including detailed documentation proving compliance with the epidemiological criteria set out in point 7.2;
(b) information on the bovine identification and traceability system, as referred to in point (b) of the third subparagraph of Article 6(1b), in place during the previous six-year period within the territory of the Member State, including a detailed description of the functioning of the computerised database as referred to in Article 5 of Regulation (EC) No 1760/2000 of the European Parliament and of the Council (23);
(c) information on prohibitions concerning animal feeding during the previous six-year period within the territory of the Member State, including a detailed description of the enforcement of the feed ban for farmed animals, as referred to in point (c) of the third subparagraph of Article 6(1b), including the sampling plan and the number and type of infringements found and the follow-up results;
(d) a detailed description of the proposed revised BSE monitoring programme that includes the geographical area in which the programme is to be implemented and a description of subpopulations of bovine animals to be covered by the BSE revised monitoring programme, including indications of the age limits and the sample sizes for testing;
(e) the result of a comprehensive risk analysis showing that the revised BSE monitoring programme will ensure the protection of human and animal health. This risk analysis shall include a birth cohort analysis or other relevant studies aiming to demonstrate that the TSE risk reducing measures, including the feeding prohibitions as referred to in point (c) of the third subparagraph of Article 6(1b), have been implemented in an efficient way.
Applications for revision of a BSE monitoring programme may only be accepted if the Member State concerned can demonstrate that, in addition to the requirements laid down in points (a), (b) and (c) of the third subparagraph of Article 6(1b), the following epidemiological criteria are met within its territory:
(a) for a period of at least six consecutive years following the date of implementation of the Community BSE testing scheme as referred to in point (b) of the third subparagraph of Article 6(1b): either (i) the average decrease of the annual BSE incidence rate observed within the adult bovine animal population (over 24 months of age) was superior to 20 %, and the total number of BSE affected cattle born after the implementation of the Community total feed ban for farmed animals, as referred to in point (c) of the third subparagraph of Article 6(1b), did not exceed 5 % of the total number of confirmed BSE cases; or (ii) the annual observed BSE incidence rate within the adult bovine animal population (over 24 months of age) remained consistently less than 1/100 000 ; or (iii) as a further option for a Member State with an adult bovine animal population (over 24 months of age) of less than 1 000 000 animals, the cumulated number of confirmed BSE cases remained under five;
(b) following the six-year period referred to in point (a), there is no evidence that the BSE epidemiological situation is deteriorating.
II. MONITORING IN OVINE AND CAPRINE ANIMALS
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).
(a)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;
(b)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;
(c)A Member State may choose to replace a maximum of:
— 50 % of its minimum sample size of ovine and caprine animals slaughtered for human consumption set out in points (a) and (b) 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;
— 10 % of its minimum sample size set out in points (a) and (b) 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 (1) |
|---|---|
| > 750 000 | 10 000 |
| 100 000 -750 000 | 1 500 |
| 40 000 -100 000 | 100 % up to 500 |
| < 40 000 | 100 % up to 100 |
| (1) 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 (1) |
| --- | --- |
| > 750 000 | 10 000 |
| 250 000 -750 000 | 1 500 |
| 40 000 -250 000 | 100 % up to 500 |
| < 40 000 | 100 % up to 100 |
| (1) 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 which are killed for destruction in accordance with Annex VII, Chapter B, Part 2, point 2.2.1. and point 2.2.2.(b) or (c), shall be tested for the presence of TSE in accordance with the laboratory methods and protocols set out in Annex X, Chapter C, Part 3, point 3.2.(b), based on the selection of a simple random sample, in accordance with the sample size set out in the following table.
| Number of animals over 18 months of age 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.
7.1.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.
7.2.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.
7.3.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, unless they are disposed of in accordance with Article 12(a) or (b) of Regulation (EC) No 1069/2009, or unless its fats are processed in accordance with Regulation (EU) No 142/2011 and used in accordance with Article 12(e) of Regulation (EC) No 1069/2009 or used for the manufacture of derived products referred to in Article 36 of that Regulation.
7.4.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 12(a) or (b) of Regulation (EC) No 1069/2009, apart from the material to be retained in conjunction with the records provided for in Chapter B, Part III of this Annex, and apart from rendered fats derived from such a body provided that these rendered fats are processed in accordance with Regulation (EU) No 142/2011 and used in accordance with Article 12(e) of Regulation (EC) No 1069/2009 or used for the manufacture of derived products referred to in Article 36 of that Regulation.
8.1. 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 (A) on both alleles at codon 136, arginine (R) on both alleles at codon 154 and arginine (R) 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 also be determined.
8.2. The prion protein genotype for the codons 146 and 222 shall be determined for each positive TSE case in goats. TSE cases found in goats of genotypes which encode serine (S) or aspartic acid (D) on at least one allele at codon 146 and/or lysine (K) on at least one allele at codon 222, shall immediately be reported to the Commission.
III. MONITORING IN CERVIDS
1.1.The Member States which have a wild and/or farmed and/or semi-domesticated population of moose and/or reindeer (Estonia, Finland, Latvia, Lithuania, Poland and Sweden) shall carry out a three-year monitoring programme for CWD in cervids, from 1 January 2018 to 31 December 2020. The TSE tests performed for the purpose of this monitoring programme shall take place between 1 January 2018 and 31 December 2020, however, the collection of samples for the purpose of the monitoring programme may, however, start in 2017.
1.2.The three-year CWD monitoring programme shall cover the following cervid species:
— Eurasian tundra reindeer (Rangifer tarandus tarandus);
— Finnish forest reindeer (Rangifer tarandus fennicus);
— Moose (Alces alces);
— Roe deer (Capreolus capreolus);
— White-tailed deer (Odocoileus virginianus);
— Red deer (Cervus elaphus).
1.3.By way of derogation from point 1.2, a Member State may, based on a documented risk assessment submitted to the European Commission, select for the three-year CWD monitoring programme a subset of the species listed in that point.
2.1.The Member States referred to in point 1.1 shall identify Primary Sampling Units (PSU), which shall cover all territories in which cervid populations are present, using at least the following elements:
(a) for farmed and captive cervids, each farm and each facility in which cervids are kept in an enclosed territory shall be considered as a PSU.
(b) for wild and semi-domesticated cervids, PSU shall be defined geographically based on the following criteria: (i) the areas in which wild and semi-domesticated animals of a species covered by the monitoring programme gather in at least a certain period of the year; (ii) if no gathering takes place for a species, the areas delimited by natural or artificial barriers in which animals of the species covered by the monitoring programme are present; (iii) the areas in which animals of the species covered by the monitoring programme are hunted and areas connected to other relevant activities related to the species covered by the monitoring programme.
2.2.The Member States referred to in point 1.1 shall select farmed, captive, wild and semi-domesticated cervids for TSE testing using the following two-stage sampling approach:
(a) in the first stage, those Member States shall: (i) for farmed and captive cervids: — select, on a random basis ensuring geographical representativeness, and if relevant taking into account relevant risk factors identified in a documented risk assessment carried out by the Member State, 100 PSU to be covered over the three-year period of the monitoring programme, or — if the Member State was unable to identify 100 PSU for farmed and captive cervids, select all PSU identified. (ii) For wild and semi-domesticated cervids: — select, on a random basis ensuring geographical representativeness, and if relevant taking into account relevant risk factors identified in a documented risk assessment carried out by the Member State, 100 PSU to be covered over the three-year period of the monitoring programme, or — if the Member State was unable to identify 100 PSU for wild and semi-domesticated cervids, select all PSU identified.
(b) in the second stage: (i) for farmed and captive cervids: — a Member State having selected 100 PSU shall, within every selected PSU, sample all animals belonging to the target groups listed under point 2.4.(a) over the three-year period until a target of 30 animals tested per PSU is reached. If however certain PSU are not be able to reach the target of 30 animals tested over the three-year period due to the limited size of their cervid population, the sampling of animals belonging to the target groups listed under point 2.4.(a) may continue in larger PSU even after having reached the target of 30 animals tested, with the objective of reaching a total number of up to 3 000 farmed and captive cervids, where possible, tested at national level over the three-year period of the monitoring programme; — a Member State having identified fewer than 100 PSU shall, within every PSU, sample all animals belonging to the target groups listed under point 2.4.(a) over the three-year period, with the objective of approaching a total number of up to 3 000 farmed and captive cervids, where possible, tested at national level over the three-year period of the monitoring programme. (ii) for wild and semi-domesticated cervids: — a Member State having selected 100 PSU shall, within every selected PSU, sample all animals belonging to the target groups listed under point 2.4.(b), over the three-year period until a target of 30 animals tested per PSU is reached, with the objective of reaching up to 3 000 wild and semi-domesticated cervids tested at national level over the three-year period; — a Member State having identified fewer than 100 PSU shall, within every PSU, sample all animals belonging to the target groups listed under point 2.4.(b) over the three-year period, with the objective of approaching a total number of 3 000 wild and semi-domesticated cervids tested at national level over the three-year period of the monitoring programme.
2.3.All cervids selected must be over 12 months of age. The age shall be estimated on the basis of dentition, obvious signs of maturity, or any other reliable information.
2.4.The cervids must be selected from the following target groups:
(a) for farmed and captive cervids: (i) fallen/culled farmed or captive cervids, defined as farmed or captive cervids found dead on the enclosed territory in which they are kept, during transport or at slaughterhouse, as well as farmed or captive cervids killed for health/age reasons; (ii) clinical/sick farmed or captive cervids, defined as farmed or captive cervids showing abnormal behavioural signs and/or locomotor disturbances and/or as being generally in poor condition; (iii) slaughtered farmed cervids which have been declared unfit for human consumption; (iv) slaughtered farmed cervids considered fit for human consumption if a Member State identifies fewer than 3 000 farmed and captive cervids from the groups (i) to (iii).
(b) for wild and semi-domesticated cervids: (i) fallen/culled wild or semi-domesticated cervids, defined as cervids found dead in the wild as well as semi-domesticated cervids found dead or killed for health/age reasons; (ii) road- or predator-injured or killed cervids, defined as wild or semi-domesticated cervids hit by road vehicles, by trains or attacked by predators; (iii) clinical/sick wild and semi-domesticated cervids, defined as wild and semi-domesticated cervids which are observed as showing abnormal behavioural signs and/or locomotor disturbances and/or as being generally in poor health condition; (iv) wild hunted cervids and slaughtered semi-domesticated cervids which have been declared unfit for human consumption; (v) hunted wild game and slaughtered semi-domesticated cervids considered fit for human consumption if a Member State identifies fewer than 3 000 wild and semi-domesticated cervids from the groups (i) to (iv).
2.5.In case of a positive finding of TSE in a cervid, the number of samples from cervids collected in the zone where the positive TSE case was found must be increased, based on an assessment carried out by the Member State concerned.
3.1.For each cervid selected in accordance with point 2, a sample of obex shall be collected and tested for TSEs.
In addition, where feasible, a sample of one of the following tissues shall be collected in the following order of preference:
(a) retropharyngeal lymph nodes;
(b) tonsils;
(c) other head lymph nodes.
For rapid testing a hemisection of obex shall be submitted in a fresh or frozen state. The remaining hemisection should be fixed. When collected, lymph nodes and tonsils should be fixed.
A portion of fresh tissue from each sample type shall be kept frozen until a negative result is obtained, in case bioassay is required.
3.2.Until the publication of guidelines on TSE testing in cervids of the EU Reference Laboratory for TSE, the following laboratory method shall be used for the purpose of the CWD monitoring programme:
(a) rapid tests: Rapid tests as referred to in point 4 of Chapter C of Annex X used for TSE detection in obex of bovine or small ruminant animals are considered suitable for TSE detection in obex of cervids. Rapid tests as referred to in point 4 of Chapter C of Annex X used for TSE detection in the lymph nodes of bovine or small ruminant animals are considered suitable for TSE detection in lymph nodes of cervids. Member States may also use immunohistochemistry for screening purposes for which purpose they shall satisfy a proficiency test organised by the EU Reference Laboratory for TSE.
(b) confirmatory tests: When the result of the rapid test is inconclusive or positive, the sample shall be subjected to confirmatory examinations using at least one of the following methods and protocols as laid down in the latest edition of the Manual for diagnostic tests and vaccines for Terrestrial Animals of the World Organisation for Animal Health (OIE): — the immunohistochemical (IHC) method; — Western blot. Where a Member State is unable to confirm a positive rapid test result, it shall send adequate tissue to the EU Reference laboratory for confirmation.
(c) isolate characterisation: In the case of positive findings of TSE, further isolate characterisation should be undertaken, in consultation with the EU Reference Laboratory for TSE.
3.3.The prion protein genotype shall be determined for each positive finding of TSE in cervids.
In addition, for each cervid tested and found negative for TSE, either:
— the prion protein genotype of the animal tested and found negative for TSE is determined, or
— a sample of a tissue, which may be the obex, shall be kept frozen until at least 31 December 2021, to allow for genotyping if so decided.
Member States shall carry out additional monitoring for TSEs in cervids based on a risk assessment which may take into account the detection of a TSE in cervids in the same or neighbouring regions.
Member States other than those mentioned under point 1.1 of Part A may on a voluntary basis carry out monitoring for TSEs in cervids.
After the end of the three-year monitoring programme referred to in Part A, the Member States mentioned under point 1.1 may on a voluntary basis carry out monitoring for TSEs in cervids.
IV. MONITORING IN OTHER ANIMAL SPECIES
Member States may on a voluntary basis carry out monitoring for TSE in animal species other than bovine, ovine, caprine and cervid animals.
CHAPTER B
REPORTING AND RECORDING REQUIREMENTS
I. REQUIREMENTS ON MEMBER STATES
1.The number of suspected cases placed under official movement restrictions in accordance with Article 12(1), per animal species.
2.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, the age distribution of all tested animals. The age distribution should be grouped as follows: ‘below 24 months’, distribution per 12 months between 24 and 155 months, and ‘above 155 months’ of age.
3.The number of flocks where suspected cases in ovine and caprine animals have been reported and investigated pursuant to Article 12(1) and (2).
4.The number of bovine animals tested within each subpopulation referred to in Chapter A, Part I, points 2.1, 2.2, 3.1 and 5. The method of the sample selection, the results of the rapid and confirmatory tests and the age distribution of the tested animals grouped as set out in point 2 shall be provided.
5.The number of ovine and caprine animals and flocks tested within each subpopulation referred to in Chapter A, Part II, points 2, 3, 5 and 6 together with the method for sample selection and the results of the rapid and confirmatory tests.
6.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 shall be indicated. For scrapie cases, the results of the primary and secondary molecular testing, referred to in Annex X, Chapter C, point 3.2(c), shall be reported, where appropriate.
7.In animals other than bovine, ovine and caprine animals, as well as in cervids other than those covered by the three-year CWD monitoring programme referred to in Part III.A of Chapter A of this Annex, the number of samples and confirmed TSE cases per species.
8.The genotype, and, where possible, the breed, of each ovine and caprine animal found positive to TSE and sampled in accordance with Chapter A, Part II, point 8.
9.For Member States covered by the three-year CWD monitoring programme referred to in Part III.A of Chapter A of this Annex, the annual report for the years 2018, 2019 and 2020 shall include:
(a) The number of cervid samples submitted for testing, by target group according to the following criteria: — primary Sampling Unit (PSU) identifier, — species, — management system: farmed, captive, wild or semi-domesticated, — target group, — sex,
(b) The results of the rapid and confirmatory tests (number of positives and negatives) and, where applicable, of further isolate characterisation investigations, the tissue sampled and the rapid test and confirmatory technique used.
(c) The geographical location, including the country of origin if not the same as the reporting Member State, of positive cases of TSE.
(d) The genotype and species of each cervid found positive for TSE.
(e) Where tested, the genotype of cervids tested and found negative for TSE.
The compilation of reports containing the information referred to in Section A and submitted to the Commission (which shall send it to the European Food Safety Authority) on a monthly basis in the electronic format agreed between the Member States, the Commission and the European Food Safety Authority 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.
II. INFORMATION TO BE PRESENTED IN THE UNION SUMMARY REPORT
The Union summary shall be presented in a tabled format covering at least the information referred to in Part I.A for each Member State.
From 1 January 2016, the European Food Safety Authority shall analyse the information referred to in Part I and publish by the end of November a summary report on the trends and sources of Transmissible Spongiform Encephalopathies in the Union.
III. RECORDS
1.The competent authority shall keep, for 7 years, records of the information referred to in Part I.A.
2.The investigating laboratory shall keep, for 7 years, all records of testing, in particular laboratory workbooks and, where appropriate, paraffin blocks and photographs of western blots.
ANNEX IV
ANIMAL FEEDING
CHAPTER I
Extensions of the prohibition provided for in Article 7(1)
In accordance with Article 7(2), the prohibition provided for in Article 7(1) shall be extended to the feeding:
(a) to ruminants of dicalcium phosphate and tricalcium phosphate of animal origin and compound feed containing these products;
(b) to non-ruminant farmed animals, other than fur animals, of: (i) processed animal protein; (ii) blood products; (iii) hydrolysed protein of animal origin; (iv) dicalcium phosphate and tricalcium phosphate of animal origin; (v) feed containing the products listed in points (i) to (iv).
CHAPTER II
Derogations from the prohibitions provided for in Article 7(1) and in Chapter I
In accordance with the first subparagraph of Article 7(3), the prohibitions provided for in Article 7(1) and in Chapter I shall not apply to the feeding to:
(a) ruminants of: (i) milk, milk-based products, milk-derived products, colostrum and colostrum products; (ii) eggs and egg products; (iii) collagen and gelatine derived from non-ruminants; (iv) hydrolysed proteins derived from: — parts of non-ruminants, or — ruminant hides and skins; (v) compound feed containing the products listed in points (i) to (iv) above;
(b) non-ruminant farmed animals of the following feed materials and compound feed: (i) hydrolysed proteins derived from parts of non-ruminants or from ruminant hides and skins; (ii) fishmeal and compound feed containing fishmeal which are produced, placed on the market and used in accordance with the general conditions laid down in Chapter III and the specific conditions laid down in Section A of Chapter IV; (iii) dicalcium phosphate and tricalcium phosphate of animal origin and compound feed containing such phosphates which are produced, placed on the market and used in accordance with the general conditions laid down in Chapter III and the specific conditions laid down in Section B of Chapter IV; (iv) blood products derived from non-ruminants and compound feed containing such blood products which are produced, placed on the market and used in accordance with the general conditions laid down in Chapter III and the specific conditions laid down in Section C of Chapter IV;
(c) aquaculture animals of the following feed materials and compound feed: (i) processed animal protein derived from non-ruminants, other than fishmeal and other than processed animal protein derived from farmed insects, and compound feed containing such processed animal protein, which are produced, placed on the market and used in accordance with the general conditions laid down in Chapter III and the specific conditions laid down in Section D of Chapter IV; (ii) processed animal protein derived from farmed insects, and compound feed containing such processed animal protein, which are produced, placed on the market and used in accordance with the general conditions laid down in Chapter III and the specific conditions laid down in Section F of Chapter IV;
(d) unweaned ruminants of milk replacers containing fishmeal and which are produced, placed on the market and used in accordance with specific conditions laid down in Section E of Chapter IV;
(e) farmed animals of feed materials of plant origin and compound feed containing such feed materials contaminated with insignificant amount of bone spicules derived from unauthorised animal species. Member States may only use this derogation if they have carried out a risk assessment beforehand which has confirmed there is a negligible risk for animal health. That risk assessment must take into account at least the following: (i) the level of the contamination; (ii) the nature and the source of the contamination; (iii) the intended use of the contaminated feed;
(f) poultry of the following feed materials and compound feed: (i) processed animal protein derived from porcine animals and compound feed containing such processed animal protein, which are produced, placed on the market and used in accordance with the general conditions laid down in Chapter III and the specific conditions laid down in Chapter IV, Section G; (ii) processed animal protein derived from farmed insects, and compound feed containing such processed animal protein, which are produced, placed on the market and used in accordance with the general conditions laid down in Chapter III and the specific conditions laid down in Chapter IV, Section F;
(g) porcine animals of the following feed materials and compound feed: (i) processed animal protein derived from poultry and compound feed containing such processed animal protein, which are produced, placed on the market and used in accordance with the general conditions laid down in Chapter III and the specific conditions laid down in Chapter IV, Section H; (ii) processed animal protein derived from farmed insects, and compound feed containing such processed animal protein, which are produced, placed on the market and used in accordance with the general conditions laid down in Chapter III and the specific conditions laid down in Chapter IV, Section F.
CHAPTER III
General conditions for the application of certain derogations provided for in Chapter II
1.The following products intended to be used for feeding non-ruminant farmed animals shall be transported in vehicles and containers and stored in storage facilities which are not used, respectively, for the transport or storage of feed intended for ruminants:
(a) bulk processed animal protein derived from non-ruminants, including fishmeal, processed animal protein derived from farmed insects, processed animal protein derived from porcine animals and processed animal protein derived from poultry;
(b) bulk dicalcium and tricalcium phosphate of animal origin;
(c) bulk blood products derived from non-ruminants;
(d) bulk compound feed containing the feed materials listed in (a), (b) and (c).
Records detailing the type of products that were transported or stored in a storage plant shall be kept available to the competent authority for a period of at least two years.
2.By way of derogation from point 1, vehicles, containers and storage facilities which have been previously used for the transport or storage of the products listed in that point, may be subsequently used for the transport or storage of feed intended for ruminants provided that they are cleaned beforehand in order to avoid cross-contamination, in accordance with a documented procedure which has been given prior authorisation by the competent authority.
Whenever such a procedure is used, a documented record of such use shall be kept available to the competent authority for a period of at least two years.
3.Storage plants storing in accordance with point 2 feed materials and compound feed listed in point 1 shall be authorised by the competent authority based on verification of their compliance with the requirements listed in point 2.
4.Bulk processed animal protein derived from porcine animals, and bulk compound feed containing such processed animal protein, shall be transported in vehicles and containers and stored in storage facilities which are not used, respectively, for the transport or storage of feed intended for non-ruminant farmed animals other than aquaculture animals and poultry.
5.By way of derogation from point 4, vehicles, containers and storage facilities which have been previously used for the transport or storage of bulk processed animal protein derived from porcine animals and bulk compound feed containing such processed animal protein may be subsequently used for the transport or storage of feed intended for non-ruminant farmed animals other than aquaculture animals and poultry provided that they are cleaned beforehand in order to avoid cross-contamination, in accordance with a documented procedure which has been given prior authorisation by the competent authority.
Whenever such a procedure is used, a documented record of such use shall be kept available to the competent authority for a period of at least two years.
6.Bulk processed animal protein derived from poultry, and bulk compound feed containing such processed animal protein, shall be transported in vehicles and containers and stored in storage facilities which are not used, respectively, for the transport or storage of feed intended for non-ruminant farmed animals other than aquaculture and porcine animals.
7.By way of derogation from point 6, vehicles, containers and storage facilities which have been previously used for the transport or storage of bulk processed animal protein derived from poultry and bulk compound feed containing such processed animal protein may be subsequently used for the transport or storage of feed intended for non-ruminant farmed animals other than aquaculture animals and porcine animals provided that they are cleaned beforehand in order to avoid cross-contamination, in accordance with a documented procedure which has been given prior authorisation by the competent authority.
Whenever such a procedure is used, a documented record of such use shall be kept available to the competent authority for a period of at least two years.
8.Bulk processed animal protein derived from farmed insects, and bulk compound feed containing such processed animal protein, shall be transported in vehicles and containers and stored in storage facilities which are not used, respectively, for the transport or storage of feed intended for non-ruminant farmed animals other than aquaculture, poultry and porcine animals.
9.By way of derogation from point 8, vehicles, containers and storage facilities which have been previously used for the transport or storage of bulk processed animal protein derived from farmed insects and bulk compound feed containing such processed animal protein may be subsequently used for the transport or storage of feed intended for non-ruminant farmed animals other than aquaculture animals, poultry and porcine animals provided that they are cleaned beforehand in order to avoid cross-contamination, in accordance with a documented procedure which has been given prior authorisation by the competent authority.
Whenever such a procedure is used, a documented record of such use shall be kept available to the competent authority for a period of at least two years.
10.Bulk processed animal protein derived from non-ruminants, excluding fishmeal and processed animal protein derived from poultry, porcine animals and farmed insects, and bulk compound feed containing such processed animal protein, shall be transported in vehicles and containers and stored in storage facilities which are not used, respectively, for the transport or storage of feed intended for non-ruminant farmed animals other than aquaculture animals.
11.By way of derogation from point 10, vehicles, containers and storage facilities which have been previously used for the transport or storage of the products referred to in that point may be subsequently used for the transport or storage of feed intended for non-ruminant farmed animals other than aquaculture animals provided that they are cleaned beforehand in order to avoid cross-contamination, in accordance with a documented procedure which has been given prior authorisation by the competent authority.
Whenever such a procedure is used, a documented record of such use shall be kept available to the competent authority for a period of at least two years.
1.Compound feed intended to be used for feeding non-ruminant farmed animals and which contain the following feed materials, shall be produced in establishments which do not produce compound feed for ruminants, and which are authorised by the competent authority:
(a) fishmeal;
(b) dicalcium and tricalcium phosphate of animal origin;
(c) blood products derived from non-ruminants.
2.By way of derogation from point 1, the production of compound feed for ruminants, in establishments which also produce compound feed for non-ruminant farmed animals which contains the products listed in that point, may be authorised by the competent authority, following an on-site inspection by it, subject to compliance with the following conditions:
(a) compound feed intended for ruminants must be manufactured and kept, during storage, transport and packaging, in facilities that are physically separate from those facilities where compound feed for non-ruminants are manufactured and kept;
(b) records detailing the purchases and uses of the products listed in point 1 and the sales of compound feed containing those products must be kept available to the competent authority for a period of at least five years;
(c) regular sampling and analysis of the compound feed intended for ruminants must be carried out in order to verify the absence of unauthorised constituents of animal origin using the methods of analysis for the determination of constituents of animal origin for the control of feed set out in Annex VI to Commission Regulation (EC) No 152/2009 (24); the frequency of sampling and analysis shall be determined on the basis of a risk assessment carried out by the operator as part of its procedures based on hazard analysis and critical control points (HACCP) principles; the results of such sampling and analysis shall be kept available to the competent authority for a period of at least five years.
3.By way of derogation from point 1, a specific authorisation for the production of complete feed from compound feed containing the products listed in that point, shall not be required for home compounders subject to their compliance with the following conditions:
(a) they must be registered by the competent authority as producing complete feed from compound feed containing the products listed in point 1;
(b) they must keep only non-ruminant animals;
(c) any compound feed containing fishmeal used in the production of the complete feed must contain less than 50 % crude protein;
(d) any compound feed containing dicalcium and tricalcium phosphate of animal origin used in the production of the complete feed must contain less than 10 % total phosphorus;
(e) any compound feed containing blood products derived from non-ruminants used in the production of the complete feed must contain less than 50 % crude protein.
Before release for free circulation in the Union, importers shall ensure that each of the consignment of the following feed materials and compound feed, which are intended to be used for the feeding of non-ruminant farmed animals, other than fur animals, in accordance with Chapter II of this Annex, is analysed in accordance with the methods of analysis for the determination of constituents of animal origin for the control of feed set out Annex VI to Regulation (EC) No 152/2009 in order to verify the absence of unauthorised constituents of animal origin:
(a) processed animal protein derived from non-ruminants, including fishmeal, processed animal protein derived from farmed insects, processed animal protein derived from porcine animals and processed animal protein derived from poultry;
(b) blood products derived from non-ruminants;
(c) compound feed containing the feed materials listed in (a) and (b).
1.The use and storage of the following feed shall be prohibited on farms keeping farmed animal species for which such feed is not intended:
(a) processed animal protein derived from non-ruminants, including fishmeal, processed animal protein derived from farmed insects, processed animal protein derived from porcine animals and processed animal protein derived from poultry;
(b) dicalcium and tricalcium phosphate of animal origin;
(c) blood products derived from non-ruminants;
(d) compound feed containing the feed materials listed in (a) to (c).
2.By way of derogation from point 1, the competent authority may authorise the use and storage of compound feed referred to in point 1(d) in farms keeping farmed animal species for which the compound feed is not intended provided that on-farm measures are implemented to prevent such compound feed being fed to an animal species for which it is not intended.
CHAPTER IV
Specific conditions for the application of derogations provided for in Chapter II
The following specific conditions shall apply to the production and use of fishmeal and compound feed containing fishmeal intended to be used for the feeding of non-ruminant farmed animals other than fur animals:
(a) the fishmeal must be produced in processing plants dedicated exclusively to the production of products derived from: (i) aquatic animals, except sea mammals; (ii) farmed aquatic invertebrates other than those that fall within the definition of ‘aquatic animals’ provided for in Article 3(1)(e) of Directive 2006/88/EC; or (iii) starfish of the species Asterias rubens which are harvested in a production area as defined in Annex I point 2.5 of Regulation (EC) No 853/2004 and classified accordingly;
(b) The words ‘fishmeal — shall not be used in feed for ruminants except unweaned ruminants’ shall be clearly indicated on the accompanying commercial document or health certificate referred to in Article 21(2) of Regulation (EC) No 1069/2009, as appropriate, as well as on the label of fishmeal; The words ‘contains fishmeal — shall not be fed to ruminants’ shall be clearly indicated on the label of compound feed containing fishmeal intended for non-ruminant farmed animals other than fur animals.
(a) The words ‘di-/tricalcium phosphate of animal origin — shall not be used in feed for ruminants’ shall be clearly indicated on the accompanying commercial document or health certificate referred to in Article 21(2) of Regulation (EC) No 1069/2009, as appropriate, as well as on the label of dicalcium/tricalcium phosphate of animal origin;
(b) The words ‘contains dicalcium/tricalcium phosphate of animal origin — shall not be fed to ruminants’ shall be clearly indicated on the label of compound feed containing dicalcium/tricalcium phosphate of animal origin.
The following specific conditions shall apply to the production and use of blood products derived from non-ruminants and to compound feed containing such blood products, intended to be used for the feeding of non-ruminant farmed animals other than fur animals:
(a) The blood intended to be used for the production of blood products shall be derived from slaughterhouses which do not slaughter ruminants and which are registered by the competent authority as not slaughtering ruminants. By way of derogation from that specific condition, the competent authority may authorise the slaughter of ruminants in a slaughterhouse producing non-ruminant blood intended for the production of blood products for use in feed for non-ruminant farmed animals. That authorisation may be granted only where the competent authority is satisfied, following an inspection, concerning the effectiveness of measures aimed to prevent cross-contamination between ruminant and non-ruminant blood. Those measures shall include the following minimum requirements: (i) the slaughtering of non-ruminants must be carried out in lines that are physically separate from lines used for the slaughtering of ruminants; (ii) the collection, storage, transport and packaging facilities for blood of non-ruminant origin must be kept separate from those used for blood of ruminant origin; (iii) a regular sampling and analysis of blood of non-ruminant origin must be carried out to detect the presence of ruminant proteins. The method of analysis used must be scientifically validated for that purpose. The frequency of sampling and analysis must be determined on the basis of a risk assessment carried out by the operator as part of its procedures based on the HACCP principles.
(b) The blood intended to be used for the production of blood products for non-ruminants shall be transported to a processing plant in vehicles and containers dedicated exclusively for the transport of non-ruminant blood. By way of derogation from that specific condition, vehicles and containers which have been previously used for the transport of blood derived from ruminants may be used for the transport of non-ruminant blood provided that they have been thoroughly cleaned beforehand in order to avoid cross-contamination in accordance with a documented procedure which has been given prior authorisation by the competent authority. Whenever such a procedure is used, a documented trace of such use shall be kept available to the competent authority for a period of at least two years.
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