CHAPTER I
SUBJECT MATTER, SCOPE AND DEFINITIONS
Article 1
Subject matter and scope
Article 2
Definitions
CHAPTER II
PREVENTIVE BIOSECURITY, SURVEILLANCE, NOTIFICATIONS AND EPIDEMIOLOGICAL INQUIRIES
Article 3
Preventive biosecurity measures
Article 4
Surveillance programmes
Article 5
Notification
Article 6
Epidemiological inquiry
CHAPTER III
SUSPECTED OUTBREAKS
Article 7
Measures to be applied on holdings where outbreaks are suspected
Article 8
Derogations from certain measures to be applied on holdings where outbreaks are suspected
Article 9
Duration of the measures to be applied on holdings where outbreaks are suspected
Article 10
Additional measures based on an epidemiological inquiry
CHAPTER IV
HIGHLY PATHOGENIC AVIAN INFLUENZA (HPAI)
SECTION 1
Holdings, separate production units and contact holdings
Article 11
Measures to be applied on holdings where outbreaks are confirmed
Article 12
Derogations
Article 13
Derogations concerning certain holdings
Article 14
Measures to be applied in cases of outbreaks of HPAI in separate production units
Article 15
Measures to be applied in contact holdings
SECTION 2
Protection, surveillance and further restricted zones
Article 16
Establishment of protection, surveillance and further restricted zones in cases of outbreaks of HPAI
Article 17
Measures to be applied both in the protection and in the surveillance zones
SECTION 3
Measures to be applied in protection zones
Article 18
Census and visits by the official veterinarian and surveillance
Article 19
Measures to be applied on holdings in protection zones
Article 20
Prohibition on the removal or spreading of used litter, manure or slurry from holdings
Article 21
Fairs, markets or other gatherings and restocking of game
Article 22
Prohibition on the movement and transport of birds, eggs, poultry meat and carcases
Article 23
Derogations for the direct transport of poultry for immediate slaughter and the movement or treatment of poultry meat
Article 24
Derogations for the direct transport of day-old chicks
Article 25
Derogations for the direct transport of ready to lay poultry
Article 26
Derogation for the direct transport of hatching and table eggs
Article 27
Derogation for the direct transport of carcases
Article 28
Cleansing and disinfecting of means of transport
Article 29
Duration of measures
SECTION 4
Measures to be applied in the surveillance zones
Article 30
Measures to be applied in the surveillance zones
Article 31
Duration of measures
SECTION 5
Measures to be applied in further restricted zones
Article 32
Measures to be applied in further restricted zones
SECTION 6
Derogations and additional biosecurity measures
Article 33
Derogations
Article 34
Additional biosecurity measures
SECTION 7
Measures to be applied in cases of suspicion and confirmation of highly pathogenic Avian Influenza (HPAI) in certain premises other than holdings and in means of transport
Article 35
Investigation of suspected presence of HPAI in slaughterhouses and in means of transport
Article 36
Measures to be applied in slaughterhouses
Article 37
Measures to be applied in border inspection posts or means of transport
Article 38
Additional measures to be applied to slaughterhouses, border inspection posts or means of transport
CHAPTER V
LOW PATHOGENIC AVIAN INFLUENZA (LPAI)
SECTION 1
Measures to be applied on holdings where outbreaks are confirmed
Article 39
Measures to be applied
Article 40
Derogations for certain holdings
SECTION 2
Separate production units and contact holdings
Article 41
Measures to be applied in cases of outbreaks of LPAI in separate production units
Article 42
Measures to be applied in contact holdings
SECTION 3
Establishment of restricted zones
Article 43
Establishment of restricted zones in cases of outbreaks of LPAI
Article 44
Measures to be applied in the restricted zone
Article 45
Duration of measures
Article 46
Derogations
CHAPTER VI
MEASURES AIMED AT AVOIDING THE SPREAD OF INFLUENZA VIRUSES OF AVIAN ORIGIN TO OTHER SPECIES
Article 47
Laboratory tests and other measures concerning pigs and other species
CHAPTER VII
CLEANSING, DISINFECTION AND RE-POPULATION
Article 48
Cleansing, disinfection and procedures for eliminating avian influenza virus
Article 49
Re-population of holdings
CHAPTER VIII
DIAGNOSTIC PROCEDURES, DIAGNOSTIC MANUAL AND REFERENCE LABORATORIES
Article 50
Diagnostic procedures and diagnostic manual
Article 51
Reference laboratories
CHAPTER IX
VACCINATION
SECTION 1
General prohibition of vaccination
Article 52
Manufacture, sale and use of avian influenza vaccines
SECTION 2
Emergency vaccination
Article 53
Emergency vaccination in poultry or other captive birds
Article 54
Approval of emergency vaccination plans
Article 55
Derogations
SECTION 3
Preventive vaccination
Article 56
Preventive vaccination in poultry or other captive birds
Article 57
Approval of preventive vaccination plan
SECTION 4
Vaccine banks
Article 58
Community vaccine bank
Article 59
National vaccine banks
CHAPTER X
COMMUNITY CONTROLS, PENALTIES AND CONTINGENCY PLANS
Article 60
Community controls
Article 61
Penalties
Article 62
Contingency plan
CHAPTER XI
IMPLEMENTING POWERS AND COMMITTEE PROCEDURE
Article 63
Implementing powers
Article 64
Committee procedure
CHAPTER XII
TRANSITIONAL AND FINAL PROVISIONS
Article 65
Repeal
Article 66
Transitional provisions
Article 67
Transposition
Article 68
Entry into force
Article 69
Addressees
ANNEX I
(referred to in Article 2)
Definition of avian influenza
1.
‘avian influenza’ means an infection of poultry or other captive...
2.
‘highly pathogenic avian influenza (HPAI)’ means an infection of poultry...
3.
‘low pathogenic avian influenza (LPAI)’ means an infection of poultry...
ANNEX II
(referred to in Article 5(2))
Notification of disease and further epidemiological information to be provided...
1.
Within 24 hours of the confirmation of any primary outbreak...
2.
In the case of positive findings for avian influenza in...
3.
In the case of secondary outbreaks, the information referred to...
4.
The Member State concerned shall ensure that the information to...
5.
In the case of confirmation of avian influenza in live...
6.
The Commission and the other Member States must be notified...
ANNEX III
(referred to in Articles 8(3) and 13(3))
Authorisation to remove eggs from a holding in accordance with...
ANNEX IV
(referred to in Article 15(2), Article 32(2) and Article 42(2))
ANNEX V
(referred to in Article 39(1))
Criteria for the Decision to apply measures to holdings in...
ANNEX VI
(referred to in Article 48)
Principles and procedures for cleansing, disinfection and treatment of holdings...
1.
The following general principles and procedures shall be applied for...
2.
Cleansing and disinfection of infected holdings shall be carried out...
3.
Disinfection of contaminated bedding, manure and slurry shall be carried...
4.
However, by way of derogation from paragraphs 1 and 2,...
5.
Without prejudice to Article 48(b), if the competent authority is...
ANNEX VII
(referred to in Article 51(1))
Community reference laboratory for avian influenza
1.
The European Union reference laboratory for avian influenza is:
2.
The functions and duties of the Community reference laboratory shall...
ANNEX VIII
(referred to in Article 51(3))
Function and duties of the national reference laboratories
1.
The national reference laboratories shall be responsible for ensuring that...
2.
The national reference laboratories shall submit isolates of influenza virus...
3.
The national reference laboratory in each Member State shall be...
ANNEX IX
(referred in Article 55(1) point (b))
Requirements for movements of poultry or other captive birds and...
1.
Member States shall ensure that movement controls on poultry or...
2.
Any vehicles or means of transport and equipment used for...
3.
The following provisions shall apply to the movements of live...
4.
The following provisions shall apply to the movements of live...
5.
The following provisions shall apply to movements of live poultry...
6.
For meat obtained from poultry kept within the vaccination area...
7.
The competent authority may authorise the movement of carcases or...
8.
No further restrictions shall apply to movements of eggs packed...
9.
The movement of poultry (including day-old chicks) or other captive...
ANNEX X
(referred to in Article 62(1))
Criteria for contingency plans
ANNEX XI
Council Directive 2005/94/EC
of 20 December 2005
on Community measures for the control of avian influenza and repealing Directive 92/40/EEC
THE COUNCIL OF THE EUROPEAN UNION,
Having regard to the Treaty establishing the European Community, and in particular Article 37 thereof,
Having regard to the proposal from the Commission,
Having regard to the Opinion of the European Parliament ,
Having regard to the Opinion of the European Economic and Social Committee ,
After consulting the Committee of the Regions,
Whereas:
(1)
Avian influenza is a serious, highly contagious disease of poultry and other captive birds caused by different types of influenza viruses. Those viruses may also spread to mammals, in particular pigs, and humans.
(2)
Since poultry is covered by live animals listed in Annex I to the Treaty, one of the Community's tasks in the veterinary field is to improve the health status of poultry, thereby facilitating trade in poultry and poultry products and ensuring the development of this sector. Furthermore, a high level of human health protection is to be ensured when defining and implementing Community policies and activities.
(3)
Influenza viruses include a large number of different virus strains. The level of risks posed by the different strains of influenza viruses for animal and public health is very variable and to some extent unpredictable, due to rapid virus mutation and possible re-assortment of the genetic material between different strains.
(4)
The infection with certain strains of influenza viruses of avian origin may trigger outbreaks in domestic birds of epizootic proportions, causing mortality and disturbances of poultry on a scale, which can threaten in particular the profitability of poultry farming as a whole.
(5)
Community measures for the control of avian influenza were established by Council Directive 92/40/EEC of 19 May 1992 introducing Community measures for the control of avian influenza , in order to ensure the protection of animal health and contribute to the development of the poultry sector.
(6)
The measures laid down in Directive 92/40/EEC should be fundamentally reviewed in the light of recent scientific knowledge on the risks of avian influenza for animal and public health, development of new laboratory tests and vaccines and the lessons learnt during recent outbreaks of this disease in the Community as well as in third countries.
(7)
The new Community measures should also take account of the most recent opinions delivered by the Scientific Committee on Animal Health and Animal Welfare and by the European Food Safety Authority (EFSA) and the changes in the Terrestrial Animal Health Code and the Manual of Diagnostic Tests and Vaccines for Terrestrial Animals of the International Office of Epizootics (O.I.E.) on avian influenza.
(8)
Certain influenza viruses of avian origin may in some circumstances affect humans and may then pose a serious risk to public health. The provisions of this Directive, which aim at fighting the disease in farmed animals, could indirectly contribute to preventing public health problems. However, it is, at this stage, chiefly for the Member States to tackle such problems.
(9)
At Community level, the human health risks posed by influenza viruses are primarily dealt with by other actions and legal acts. These concern in particular the European Centre for Disease Prevention and Control (hereinafter referred to as ‘ECDC’), established by Regulation (EC) No 851/2004 of the European Parliament and of the Council , the recommendations issued by the Commission on Community Influenza pandemic preparedness and response planning, the European Union Early Warning and Response System and the establishment of the European Influenza Surveillance Scheme.
(10)
It is appropriate, however, for the Commission to assess together with ECDC whether further public health or workers' health and safety measures, complementing the animal health provisions of this Directive are needed at Community level to address the risks posed by certain influenza viruses of avian origin to humans and in particular for workers in contact with infected animals and to present any necessary legislative proposals.
(11)
Current knowledge indicates that the health risks posed by the so-called low pathogenic avian influenza viruses are inferior to the risks posed by highly pathogenic avian influenza viruses, which originate from a mutation of certain low pathogenic viruses.
(12)
Community legislation for the control of avian influenza should enable Member States to adopt disease control measures in a proportionate and flexible manner, taking into account the various levels of risk posed by different virus strains, the likely social and economic impact of the measures in question on the agriculture sector and other sectors involved while at the same time ensuring that the measures taken for each specific disease scenario are the most appropriate.
(13)
In view of the potential of low pathogenic avian influenza viruses to mutate into highly pathogenic avian influenza viruses, provision should be made for the early detection of infection in poultry aimed at a quick reaction and the adoption of appropriate and proportionate control and eradication measures which should include a system of active surveillance to be carried out by Member States. Such surveillance should follow general guidelines to be adapted in the light of further knowledge and developments in this field.
(14)
Any suspicion of avian influenza infection which may arise from clinical or laboratory investigations or any other reason that leads to the suspicion of the presence of infection should set in motion immediate official investigations so that prompt and effective action can be taken, as appropriate. Such action should be reinforced as soon as the presence of infection is confirmed to include depopulation of the holdings infected and of those which are at risk of infection.
(15)
In the case of detection of infection with low pathogenic avian influenza virus, control measures may differ from those which should apply in the case of detection of highly pathogenic avian influenza virus, taking into account the different levels of risk posed by these two conditions.
(16)
Disease control measures and in particular the establishment of restriction zones should also be modulated taking into account the density of the poultry population as well as other risk factors in the area in which the infection has been detected.
(17)
If an outbreak occurs, it is also necessary to prevent any further spread of infection by carefully monitoring and restricting movements of poultry and the use of products liable to be contaminated, by tightening biosecurity measures at all levels of poultry production, by cleansing and disinfecting the infected holding, by establishing protection and surveillance zones around the outbreak and, if necessary, by vaccination.
(18)
Community measures for the control of highly pathogenic avian influenza should be based first on the depopulation of the infected flocks, in accordance with Community legislation on animal welfare.
(19)
Council Directive 93/119/EC of 22 December 1993 on the protection of animals at the time of slaughter or killing sets out the minimum standards for the protection of animals at the time of slaughter or killing including for the purpose of disease control. Such rules apply fully to slaughter or killing pursuant to this Directive.
(20)
Vaccination against avian influenza can be an effective tool to supplement disease control measures and to avoid massive killing and destruction of poultry or other captive birds. Current knowledge suggests that vaccination may be useful not only as a short-term measure in emergencies but also as a long-term measure to prevent disease in situations of higher risk of introduction of avian influenza viruses from wild life or other sources. Provisions should therefore be established for both emergency and preventive vaccination.
(21)
Vaccinated poultry, although protected against the clinical signs of disease, may become infected and thus contribute to the further spread of the infection. Vaccination must therefore be accompanied by appropriate surveillance and restriction measures established at Community level. Therefore, the vaccination strategy should allow differentiation between infected and vaccinated animals. Products of vaccinated poultry, such as meat and table eggs, should be then placed on the market in accordance with the relevant Community legislation, including this Directive.
(22)
It should also be made possible for the Community and the Member States to establish reserves of vaccine against avian influenza to be used in poultry or other captive birds in the case of an emergency.
(23)
Provisions should be adopted to ensure that harmonised procedures and methods are used for the diagnosis of avian influenza, including the functioning of a Community reference laboratory as well as reference laboratories in Member States.
(24)
Provisions should be adopted to ensure the necessary level of preparation by Member States effectively to tackle emergency situations caused by one or more outbreaks of avian influenza, in particular by drawing up contingency plans and setting up control centres.
(25)
If avian influenza is detected during importation in a quarantine facility or centre, as provided for in Commission Decision 2000/666/EC of 16 October 2000 laying down the animal health requirements and the veterinary certification for the import of birds, other than poultry and the conditions for quarantine , this should be reported to the Commission. However, reporting as provided for by Council Directive 82/894/EEC of 21 December 1982 on the notification of animal diseases within the Community , in cases of outbreaks in Member States would not be appropriate.
(26)
Cleansing and disinfection should be an integral part of the Community control policy for avian influenza. Disinfectants should be used in compliance with Directive 98/8/EC of the European Parliament and of the Council of 16 February 1998 concerning the placing of biocidal products on the market .
(27)
Regulation (EC) No 1774/2002 of the European Parliament and of the Council of 3 October 2002 laying down health rules concerning animal by-products not intended for human consumption lays down the rules on the collection, transport, storage, handling, processing and use or disposal of animal by-products including animals killed to eradicate epizootic diseases, to prevent them from presenting a risk to animal and public health. That Regulation and its implementing measures provide for a general framework for the disposal of dead animals. Provision should be made for the adoption, by the committee procedure, of specific, additional or different measures where necessary to enhance further avian influenza control measures.
(28)
Regulation (EC) No 853/2004 of the European Parliament and of the Council of 29 April 2004 laying down specific hygiene rules for food of animal origin and Regulation (EC) No 852/2004 of the European Parliament and of the Council of 29 April 2004 on the hygiene of foodstuffs may be applied under certain conditions to eggs originating from holdings where poultry suspected of being infected with avian influenza is kept.
(29)
Member States should lay down rules on penalties applicable to infringements of the provisions of this Directive and ensure that they are implemented. Those penalties should be effective, proportionate and dissuasive.
(30)
Provision should be made for the possibility for amendments to be made to the Annexes to this Directive when necessary without delay in order to take account of developments in scientific and technical knowledge.
(31)
Taking into account the unpredictability of influenza viruses, it is appropriate to ensure that a swift procedure is also in place for a rapid adoption at Community level of additional or more specific measures to control any infection of poultry and other animal species whenever such measures are necessary.
(32)
This Directive should set out the minimum control measures to be applied in the event of an outbreak of avian influenza in poultry or other captive birds. However, Member States are free to take more stringent administrative and sanitary action in the field covered by this Directive. In addition, this Directive should provide for Member States' authorities to apply measures proportionate to the health risk posed by different disease situations.
(33)
In accordance with the principle of proportionality, it is necessary and appropriate for the achievement of the basic objectives of ensuring the development of the poultry sector and contributing to the protection of animal health, to lay down rules on specific measures and minimum measures aimed at the prevention and control of avian influenza. This Directive does not go beyond what is necessary in order to achieve the objectives pursued, in accordance with the third paragraph of Article 5 of the Treaty.
(34)
The measures necessary for the implementation of this Directive should be adopted in accordance with Council Decision 1999/468/EC of 28 June 1999 laying down the procedures for the exercise of implementing powers conferred on the Commission .
(35)
In the interests of clarity and rationality of Community legislation, Directive 92/40/EEC should be repealed and replaced by this Directive.
(36)
The Council, in accordance with point 34 of the Inter-Institutional Agreement on better law making , encourages Member States to draw up, for themselves and in the interest of the Community, their own tables illustrating, as far as possible, the correlation between this Directive and the transposition measures and to make them public,
HAS ADOPTED THIS DIRECTIVE:
Opinion delivered on 1 December 2005 (not yet published in the Official Journal).
Opinion delivered on 28 September 2005 (not yet published in the Official Journal).
OJ L 167, 22.6.1992, p. 1. Directive as last amended by the 2003 Act of Accession.
OJ L 142, 30.4.2004, p. 1.
OJ L 340, 31.12.1993, p. 21. Directive as last amended by Council Regulation (EC) No 1/2005 (OJ L 3, 5.1.2005, p. 1).
OJ L 278, 31.10.2000, p. 26. Decision as last amended by Decision 2002/279/EC (OJ L 99, 16.4.2002, p. 17).
OJ L 378, 31.12.1982, p. 58. Directive as last amended by Commission Decision 2004/216/EC (OJ L 67, 5.3.2004, p. 27).
OJ L 123, 24.4.1998, p. 1. Directive as last amended by Regulation (EC) No 1882/2003 (OJ L 284, 31.10.2003, p. 1).
OJ L 273, 10.10.2002, p. 1. Regulation as last amended by Commission Regulation (EC) No 416/2005 (OJ L 66, 12.3.2005, p. 10).
OJ L 139, 30.4.2004, p. 55. Corrected version in OJ L 226, 25.6.2004, p. 22.
OJ L 139, 30.4.2004, p. 1. Corrected version in OJ L 226, 25.6.2004, p. 3.
OJ L 184, 17.7.1999, p. 23.
OJ C 321, 31.12.2003, p. 1.