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

• (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

• (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 (⁷) or Directive 90/425/EEC (⁸);

• (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

• — 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.

1a. 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.

1b. After consultation of the appropriate scientific committee, the age laid down in paragraph 1a(a) and (c) may be adapted according to scientific progress in accordance with the procedure referred to in Article 24(3).

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.

4a. Based on a favourable risk assessment taking into account at least the amount and possible source of contamination and the final destination of the consignment, a decision may be taken in accordance with the procedure referred to in Article 24(3) to introduce a tolerance level for insignificant amounts of animal proteins in feedingstuffs caused through adventitious and technically unavoidable contamination.

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 (¹⁴), 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

• (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

• (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.

• (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

SPECIFIC DEFINITIONS

• 1. 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 (¹⁵), Commission Regulation (EU) No 142/2011 (¹⁶), Regulation (EC) No 178/2002 of the European Parliament and of the Council (¹⁷), Regulation (EC) No 767/2009 of the European Parliament and of the Council (¹⁸), Council Directive 2006/88/EC (¹⁹) and Regulation (EU) 2016/1012 of the European Parliament and of the Council (²⁰) shall apply:

• (a) the definition of ‘farmed animal’ in Article 3(6) of Regulation (EC) No 1069/2009;

• (b) the following definitions in Annex I to Regulation (EU) No 142/2011:
• (i) ‘fur animals’ in point 1;
• (ii) ‘blood products’ in point 4;
• (iii) ‘processed animal protein’ in point 5;
• (iv) ‘fishmeal’ in point 7;
• (v) ‘collagen’ in point 11;
• (vi) ‘gelatine’ in point 12;
• (vii) ‘hydrolysed proteins’ in point 14;
• (viii) ‘canned petfood’ in point 16;
• (ix) ‘petfood’ in point 19;
• (x) ‘processed petfood’ in point 20;

• (c) the definition of ‘feed’ in Article 3(4) of Regulation (EC) No 178/2002;

• (d) Regulation (EC) No 767/2009:
• (i) ‘feed materials’ in Article 3(2)(g);
• (ii) ‘compound feed’ in Article 3(2)(h);
• (iii) ‘complete feed’ in Article 3(2)(i);
• (iv) ‘label’ in Article 3(2)(t);

• (e) Directive 2006/88/EC:
• (i) ‘aquaculture animal’ in Article 3(1)(b);
• (ii) ‘aquatic animal’ in Article 3(1)(e);

• (f) the definition of ‘endangered breed’ in Article 2(24) of Regulation (EU) 2016/1012.

• 1. For the purpose of this Regulation, the following definitions shall also apply:

• (a) ‘BSE indigenous case’ means a case of bovine spongiform encephalopathy which has not been clearly demonstrated to be due to infection prior to importation as a live animal;

• (b) ‘cohort’ means a group of bovine animals which includes both:
• (i) animals born in the same herd as the affected bovine animal, and within 12 months preceding or following the date of birth of the affected bovine animal; and
• (ii) animals which at any time during the first year of their lives were reared together with the affected bovine animal during the first year of its life;

• (c) ‘index case’ means the first animal on a holding, or in an epidemiologically defined group, in which a TSE infection is confirmed;

• (d) ‘TSE in small ruminants’ means a transmissible spongiform encephalopathy case detected in an ovine or caprine animal following a confirmatory test for abnormal PrP protein;

• (e) ‘scrapie case’ means a transmissible spongiform encephalopathy confirmed case in an ovine or caprine animal where a diagnosis of BSE has been excluded in accordance with the criteria laid down in the European Union reference laboratory’s technical handbook on TSE strain characterisation in small ruminants (²¹);

• (f) ‘classical scrapie case’ means a scrapie confirmed case classified as classical in accordance with the criteria laid down in the European Union reference laboratory’s technical handbook on TSE strain characterisation in small ruminants;

• (g) ‘atypical scrapie case’ means a scrapie confirmed case which is distinguishable from classical scrapie in accordance with the criteria laid down in the European Union reference laboratory’s technical handbook on TSE strain characterisation in small ruminants;

• (h) ‘Prion protein genotype’ in ovine animals means a combination of two alleles as described in point 1 of Annex I to Commission Decision 2002/1003/EC (²²);

• (i) ‘BSE case’ means a case of BSE confirmed in a national reference laboratory according to the methods and protocols in point 3.1.(a) and (b) of Chapter C of Annex X;

• (j) ‘classical BSE case’ means a BSE case classified as such in accordance with the criteria laid down in the European Union reference laboratory’s method for the classification of bovine TSE isolates (²³);

• (k) ‘atypical BSE case’ means a BSE case which cannot be classified as a classical BSE case in accordance with the criteria laid down in the European Union reference laboratory’s method for the classification of bovine TSE isolates;

• (l) ‘ovine and caprine animals over 18 months of age’ means ovine and caprine animals:
• (i) whose age is confirmed by the registers or movement documents referred to in point 1(b), (c) and (d) of Article 3 of Council Regulation (EC) No 21/2004 (²⁴), or
• (ii) which have more than two permanent incisors erupted through the gum;

• (m) ‘farmed insects’ means farmed animals, as defined in Article 3(6)(a) of Regulation (EC) No 1069/2009, of those insect species which are authorised for the production of processed animal protein in accordance with point 2 of Part A of Section 1 of Chapter II of Annex X to Regulation (EU) No 142/2011;

• (n) ‘home compounders’ means livestock farmers who mix compound feed for the exclusive use on their own holding;

• (o) ‘farmed and captive cervids’ means animals of the family Cervidae which are kept by humans in an enclosed territory;

• (p) ‘wild cervids’ means animals of the family Cervidae which are not kept by humans;

• (q) ‘semi-domesticated cervids’ means animals of the family Cervidae which are kept by humans although not in an enclosed territory.

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

1. Structure of the risk analysis

The risk analyses shall comprise an entry assessment and an exposure assessment.

2. Entry assessment (external challenge)

• 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.

3. Exposure 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

I. COUNTRY OR REGION WITH A NEGLIGIBLE BSE RISK

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 RISK

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 RISK

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

1. Surveillance types

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 (²⁵) 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 strategy

• 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.

3. Points values and point targets

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	Surveillance sub-population	Surveillance sub-population	Surveillance sub-population
Routine slaughter 1	Fallen stock 2	Casualty slaughter 3	Clinical suspect 4
Age ≥ 1 year and < 2 years	Age ≥ 1 year and < 2 years	Age ≥ 1 year and < 2 years	Age ≥ 1 year and < 2 years
0,01	0,2	0,4	N/A
Age ≥ 2 years and < 4 years (young adult)	Age ≥ 2 years and < 4 years (young adult)	Age ≥ 2 years and < 4 years (young adult)	Age ≥ 2 years and < 4 years (young adult)
0,1	0,2	0,4	260
Age ≥ 4 years and < 7 years (middle adult)	Age ≥ 4 years and < 7 years (middle adult)	Age ≥ 4 years and < 7 years (middle adult)	Age ≥ 4 years and < 7 years (middle adult)
0,2	0,9	1,6	750
Age ≥ 7 years and < 9 years (older adult)	Age ≥ 7 years and < 9 years (older adult)	Age ≥ 7 years and < 9 years (older adult)	Age ≥ 7 years and < 9 years (older adult)
0,1	0,4	0,7	220
Age ≥ 9 years (aged)	Age ≥ 9 years (aged)	Age ≥ 9 years (aged)	Age ≥ 9 years (aged)
0,0	0,1	0,2	45

Bovine animals over 36 months of age at routine slaughter.

Bovine animals over 30 months of age which are found dead or killed on farm, during transport or at an abattoir (fallen stock).

Bovine animals over 30 months of age that are non-ambulatory, recumbent, unable to rise or to walk without assistance; bovine animals over 30 months of age sent for emergency slaughter or with abnormal observations at ante-mortem inspection (casualty or emergency slaughter).

Bovine animals over 30 months of age displaying behavioural or clinical signs consistent with BSE (clinical suspects).

Table 2

Points targets for different adult bovine animals population sizes in a country or region

Points targets for country or region	Points targets for country or region	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

4. Specific targeting

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 model

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 surveillance

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

MONITORING SYSTEM

CHAPTER A

I. MONITORING IN BOVINE ANIMALS

1. General

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. Monitoring in animals slaughtered for human consumption

• 2.1. All bovine animals over 24 months of age shall be tested for BSE where they have undergone:

• — emergency slaughter in accordance with point 1 of Chapter VI of Section I of Annex III to Regulation (EC) No 853/2004 (²⁶), or

• — an ante mortem inspection with observations concerning accidents, or serious physiological and functional problems, or signs in accordance with point 2 of Part B of Chapter II of Section I of Annex I to Regulation (EC) No 854/2004 (²⁷).

• 2.2. All healthy bovine animals over 30 months of age slaughtered normally for human consumption shall be tested for BSE.

3. Monitoring in animals not slaughtered for human consumption

• 3.1. All bovine animals over 24 months of age which have died or been killed but which were not:

• — killed for destruction pursuant to Commission Regulation (EC) No 716/96 (²⁸),

• — killed in the framework of an epidemic, such as foot-and-mouth disease,

• — slaughtered for human consumption,

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.

4. Monitoring in animals purchased for destruction pursuant to Regulation (EC) No 716/96

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.

5. Monitoring in other animals

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. Measures following testing

• 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.

7. Revision of the annual monitoring programmes concerning BSE (BSE monitoring programmes), as provided for in Article 6(1b)

7.1.   Member States’ applications

Applications submitted to the Commission by Member States for revision of their annual BSE monitoring programme shall include at least the following: