Proposal for a Council Directive on Community measures for the control of Avian Influenza {SEC(2005)549}
Date: 2005-04-28
Institutions: European Commission
Subjects: animal disease, epidemiology, health control, poultry farming, veterinary inspection

COMMISSION OF THE EUROPEAN COMMUNITIES 

Brussels, 28.4.2005 
COM(2005) 171 final 

2005/0062 (CNS) 
2005/0063 (CNS) 

Proposal for a 

COUNCIL DIRECTIVE 

on Community measures for the control of Avian Influenza 

Proposal for a 

COUNCIL DECISION 

amending Council Decision 90/424/EEC on expenditure in the veterinary field 

(presented by the Commission) 

{SEC(2005)549} 

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EXPLANATORY MEMORANDUM 

1. 

Context of the proposal 

(cid:121) 

Grounds for and objectives of the proposal 

The  Commission  envisages  updating  current  Community  measures  on  Avian 
Influenza (AI) laid down in Council Directive 92/40/EEC, with the objective to 
achieve  better  prevention  and  control  of  outbreaks  and  to  reduce  the  health 
risks, the costs and losses and the negative impact to the whole of society due 
to this disease. The proposed changes in Community legislation on AI control 
should be made in parallel with amendments to Council Decision 90/424/EEC 
on Community expenditure in the veterinary field, to bring it in line with this 
proposal and ensure adequate financial support to the Member States (MSs) in 
relation to some of the newly envisaged control measures. 

(cid:121) 

General context 

AI is a serious, highly contagious disease of poultry and other birds caused by 
different  types  of  viruses  included  in  the  very  large  virus  family  called 
Influenzaviridae.  AI  viruses  may  also  spread  to  other  animals  and  humans, 
usually  following  direct  contact  with  infected  birds.  In  the  human  host,  the 
disease may vary from mild conjunctivitis to serious disease, sometimes fatal; 
during the still ongoing AI epidemic in certain Asian countries, the case fatality 
rate in humans has been very high. 

Due  to  continuous  genetic  changes  of  the  disease  agents  and  their  possible 
“adaptation” to newly infected animal or human hosts, the risks posed by the 
different AI viruses to animal and public health is variable and to a large extent 
unpredictable.  However,  current  knowledge  indicates  that  the  health  risks 
posed by the so-called Low Pathogenic AI (LPAI) viruses - are inferior to the 
one  posed  by  Highly  Pathogenic  AI  (HPAI)  viruses,  which  originate  from  a 
mutation of certain LPAI viruses, namely those of types H5 and H7, and which 
can cause a disease in poultry with a mortality rate as high as 90%. 

As regards public health, data available indicate that HPAI viruses of types H5 
and H7 have been responsible for the vast majority of the cases of AI reported 
in humans, and of all cases of human deaths due to AI viruses. 

In  general,  domestic  poultry  populations  are  free  from  AI  viruses.  However, 
certain wild birds (particularly migratory waterfowl, such as ducks and geese) 
act as a permanent “reservoir” of LPAI viruses, from which they occasionally 
spread  to  domestic  poultry.  No  measures  are  currently  available  or  can  be 
envisaged to stop or reduce virus circulation in wild birds living in nature; this 
means  that  there  is  a  permanent  risk  of  introduction  of  potentially  very 
dangerous  AI  viruses  from  wild  to  domestic  birds,  and  ultimately  to  other 
animals and humans. 

For unclear reasons, an increase of AI outbreaks has occurred in recent years. 
Serious  AI  outbreaks  (HPAI)  have  been  recently  reported  in  many  different 
species  of  birds  –  including  domestic  poultry,  kept  under  different  husbandry 

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and management practices - in several different areas of the world, and across 
all  continents.  These  outbreaks  have  caused  the  death  or  killing  for  disease 
control purposes of hundreds of millions of birds and very serious losses to the 
poultry industry worldwide. In connection with these outbreaks, several human 
cases of infection were also reported, some of them fatal. 

In  the  EU,  in  the  last  five  years,  major  outbreaks  of  HPAI  have  occurred  in 
Italy (1999-2000) and the Netherlands, with secondary spread to Belgium and 
Germany (2003). These outbreaks had devastating consequences on the poultry 
sector  and  a  negative  impact  on  the  society  as  a  whole  -  particularly  in  the 
Netherlands,  where  several  human  cases  of  disease  also  occurred.  This  was 
despite the draconian control measures applied by the MSs including massive 
killing and destruction of  poultry and other birds in the affected areas, which 
often went far beyond the minimum requirements of Directive 92/40/EEC. 

social,  economic  and  environmental 

After previous EU animal health crises, these outbreaks have prompted further 
criticisms  in  the  MSs  against  massive  slaughter  of  animals,  due  to  animal 
welfare,  ethical, 
reasons.  The 
implementation  of  this  measure  has  had  a  very  negative  impact  on  public 
opinion,  and  raised  serious  criticisms  in  particular  in  relation  to  special 
categories of birds, such as endangered species or breeds, or pets. The Court of 
Auditors has also often criticised the Commission due to the economic impact 
of massive slaughter on the Community budget. 

Scientists  deem  that  uncontrolled  AI  outbreaks,  particularly  those  caused  by 
certain virus types may, following transmission of the virus from birds or other 
animals into humans, eventually lead to the emergence of a virus fully adapted 
to humans and able to cause an Influenza pandemic, like the “Spanish flu” of 
1917-1919. Such a pandemic could cause millions of human deaths and major 
socio-economic consequences all over the world. 

Directive 92/40/EEC establishes compulsory disease control measures only in 
case of disease in poultry caused by HPAI. Lessons have been learnt during the 
recent epidemics. Outbreaks of AI caused by LPAI viruses of types H5 and H7, 
that  subsequently  mutated  into  HPAI  viruses  have  caused  devastating 
consequences.  Once  mutation  has  occurred, the virus is extremely difficult to 
control. 

In view of the increased knowledge on the risks for human health posed by AI 
viruses,  the  opinions  of  the  Scientific  Committee  (SC)  and  the  most  recent 
knowledge  on  the  pathogenesis,  the  epidemiology  and  the  distribution  of  AI, 
there is now a clear need to revise and update current legislation to reflect these 
new advances and experience and to improve disease control of both LPAI and 
HPAI  in  future.  This  will  be  of  direct  benefit  to  animal  health  and  indirectly 
also human health. 

(cid:121) 

Existing provisions in the area of the proposal 

Council  Directive  92/40/EEC;  Commission  Decision  2002/649/EC; 
Commission  Decision  2002/673/EC;  By  means  of  Commission  Decision 
2002/649/EC guidelines were laid down for EC-wide surveys for AI in poultry 

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and  wild  birds.  By  Commission  Decisions  2002/673/EC  and  2004/630/EC 
MSs'  programmes  for  surveys  in  poultry  and  wild  birds  have  been  approved 
and are currently ongoing.  

Decision  90/424/EEC  on  expenditure  in  the  veterinary  field  establishes  that 
MSs may receive a financial contribution from the Community for some of the 
measures implemented to control and eradicate AI (HPAI). 

(cid:121) 

Consistency with other policies 

Since live poultry is listed in Annex I of 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 to ensure the development of 
this  sector.  Furthermore,  a  high  level  of  human  health  protection  is  to  be 
ensured  in  the  definition  and  implementation  of  all  Community  policies  and 
activities. 

2. 

Consultation of interested parties and impact assessment 

(cid:121) 

Consultation of interested parties 

Consultation with MSs in working groups and in electronic exchange on a draft 
proposal has taken place in July/October 2004. 

In October 2004 European NGOs have been consulted on a draft proposal. 

As a result of the consultation suggestions on improving of some Articles and 
Annexes of the draft proposal have been taken into account. 

(cid:121) 

Collection and use of expertise 

1. 

In 2000 the SC delivered an opinion on AI and recommended to amend 
the  definition  laid  down  in  Directive  92/40/EEC  so  that  disease  control 
measures  are  also  adopted  in  case  of  infection  with  AI  virus  strains  of 
low pathogenicity.  

2. 

In  2003  another  scientific  opinion  has  been  issued  on  the  most  recent 
diagnostic techniques and the use of vaccination against AI.  

3. 

The opinions of the SC are published on: 

http//europa.eu.int/comm/food/fs/sc/scah/outcome_en.html. 

The opinions have been considered in the drafting of the proposal. 

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(cid:121) 

Impact assessment 

The three policy options identified by the SC in its report of 2000 have been 
assessed and an impact assessment has been laid down1. 

The result can be summarised as follows: 

Option 1: 

not to change the definition of AI and the control measures laid 
down in Directive 92/40/EEC, with a recommendation that MSs impose 
restrictions to limit the spread of LPAI: 

To maintain the status quo would not reduce the risk for the Community 
of future HPAI outbreaks due to uncontrolled circulation of LPAI viruses 
in  poultry  farms.  The  simple  recommendation  to  MSs  to  adopt  national 
measures  for  LPAI  control  would  not  give  sufficient  guarantees  for 
improved  disease  control  and  a  reduction  of  the  related  health  risks, 
taking also into account the resistance of operators against stricter control 
measures which may not be equally imposed to their competitors in other 
MSs.  The  implementation  of  national  measures  for  LPAI  surveillance 
and control by each individual MS may thus lead to serious disturbance 
to  trade  in  poultry  and  poultry  products  and  to  unfair  competition 
between poultry producers in a market where competition is very high. 

Option 2: 

to change the current definition of AI to also include LPAI, thus 

establishing the same disease control measures for LPAI and HPAI: 

To apply the current HPAI control measures also in case of LPAI would 
be disproportionate to the risks posed by LPAI to both animal and public 
health; this could also result in massive killings of animals - with a major 
negative  impact  on  animal  welfare  -  and  very  high  costs  for  disease 
control, in circumstances where such massive killings and costs may not 
be justified nor sustainable. In the case of LPAI, the implementation of a 
compulsory  and  systematic  stamping  out  policy,  which  would  lead  to 
massive  killing  and  destruction  of  animals,  does  not  appear  necessary, 
although in certain cases it can still be a valid option, taking into account 
its  costs  and  risks  vs.  its  benefits.  Furthermore,  several  other  ancillary 
disease control measures that are necessary for HPAI, should be applied 
in a more flexible manner in the case of LPAI. 

Option 3: 

to  change  the  definition  of  AI  to  also  include  LPAI,  but  to 
foresee  control  measures  taking  into  account  the  different  type  of  virus 
and animal host involved: 

The major benefit expected from option 3 would be to reduce the risk of 
HPAI outbreaks in  poultry  and other birds by means of  a  better  control 
on LPAI, and by building on an approach that is proportionate to the risk 
posed by the two conditions. Furthermore, this approach would only be 
the one which would match the new Chapter of the O.I.E. Code, which is 

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SEC(2005)549 

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expected to be finally adopted in May 2005 and this would prevent EC 
disease control measures having a negative impact on international trade. 

3. 

Legal elements of the proposal 

(cid:121) 

Summary of the proposed action 

Directive  92/40/EEC  would  be  replaced  by  a  new  Directive  updating  the 
existing provisions, with the aim of ensuring a better control of AI, taking into 
account the need to reduce as much as possible the need for massive slaughter 
of birds. 

In accordance with option 3, the following main changes would be introduced 
to current provisions on AI control: 

1. 

Change  in  the  definition  of  AI  to  extend  the  scope  of  the  control 
measures also to those LPAI viruses which could potentially mutate into 
HPAI  viruses,  however  it  would  make  a  distinction  between  the  two 
conditions  so  that  specific  control  measures  can  then  be  applied  in 
relation to the different risks posed by these viruses. 

2. 

Introduction of compulsory surveillance for LPAI in all MSs. 

3.  New and more flexible provisions on vaccination. 

4.  New  and  flexible  provisions  for  the  control  of  LPAI  and  HPAI  in 
domestic  birds  other  than  poultry,  such  as  those  kept  in  zoos  or 
endangered species. 

5.  New  provisions  to  ensure  co-operation  between  MSs  veterinary  and 
public  health  authorities  in  case  of  detection  of  AI,  with  the  view  of 
protecting human health. 

6.  Attribution to the Commission, through Comitology procedures, to adopt 
further  and  more  specific  AI  control  measures  and  to  establish  an  AI 
vaccine bank. 

(cid:121) 

Legal basis 

Article 37 of the Treaty establishing the European Community. 

(cid:121) 

Subsidiarity principle 

The animal health measures laid down in this proposal falls under the exclusive 
regulatory competence of the Community. There are very few measures which 
are linked to public health, which are in line with the subsidiarity principle, as 
MSs  are  given  the  full  responsibility  for  example  to  establish  disease 
prevention  measures  for  staff  exposed  to  poultry  infected  or  suspected  to  be 
infected with AI. 

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(cid:121) 

Proportionality Principle 

The proposal sets out the minimum measures to be applied in the event of an 
outbreak of AI in poultry and other birds. MSs are free to take more stringent 
administrative  and  sanitary  action  in  the  field  covered  by  the  proposed 
Directive.  Furthermore,  provisions  are  laid  down  to  allow  MSs  authorities  to 
apply measures proportionate to the different disease situations. 

(cid:121) 

Choice of instruments 

The proposed instrument is a Directive. 

Other means would not be adequate for the following reasons: 

Experiences  since  1964  with  Community  harmonized  veterinary  legislation 
have  shown  that  a  Directive  gives  sufficient  flexibility  for  the  MSs  to  apply 
legislation in the frame of their systems of legislation and administration. See 
also the comments on proportionality above.  

4. 

Budget Implications 

The budgetary implications of this proposal and of the associated proposal to amend 
Decision 90/424/EEC are indicated in the impact assessment and can be summarised 
as follows: 

The  annual  additional  cost  for  the  Community  budget  related  to  the  adoption  and 
implementation  of  the  measures  indicated  above  would  be  3-8  M€,  that  means 
~5.5M€ on average. These costs should be largely balanced by the savings related to 
the  reduced  risks  for  future  HPAI  epidemics.  Of  course,  it  cannot  be  precisely 
indicated to what extent the new legislation would lead to a decrease in the number 
of future HPAI epidemics, the occurrence of which is still largely unpredictable and 
can never be totally excluded, given the nature of the risk in question. However, if 
these measures had been already in place and implemented in the EU in the last five 
years, one of the two major epidemics which have occurred in the Community would 
have been most likely prevented. Based on this, it may therefore be estimated that the 
implementation  of  the  proposed  measures  could  successfully  prevent  two  major 
epidemics of HPAI in the next ten years. 

The  expenditure  incurred  by  the  MSs  concerned  for  compensating  farmers,  for 
stamping  out  measures  and  for  cleansing  and  disinfection  (expenditure  that  are  in 
principle  eligible  for  a  50%  Community  co-financing  in  accordance  with  current 
provisions  of  Decision  90/424/EEC)  in  relation  to  the  two  major  epidemics  which 
recently occurred in the EU has been between 101 and 174 M€. It can therefore be 
estimated that at the current costs the prevention of two major epidemics would lead 
to savings for the Community budget of 100M€ or more over a ten year period. This 
would largely outweigh the additional costs foreseen for the new LPAI surveillance 
and control measures (~55 M€ in ten years). 

Furthermore,  thanks  to  the  adoption  of  other  control  measures  envisaged  under  the 
current  proposal,  including  vaccination,  other  savings  should  result  from  the 
expected reduced size of future AI epidemics. It is, however, extremely difficult to 

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quantify these savings. 

5. 

Additional Information 

(cid:121) 

Repeal of existing legislation 

The adoption of the proposal will lead to the repeal of existing legislation. 

(cid:121) 

European Economic Area 

The proposed act concerns an EEA matter and should therefore extend to the 
EEA. 

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2005/0062 (CNS) 

Proposal for a 

COUNCIL DIRECTIVE 

on Community measures for the control of Avian Influenza 

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 Commission2, 

Having regard to the opinion of the European Parliament3, 

Having regard to the opinion of the European Economic and Social Committee4, 

Having regard to the opinion of the Committee of the Regions5, 

Whereas: 

(1) 

(2) 

(3) 

(4) 

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3 
4 
5 
6 

Avian  influenza  is  a  serious,  highly  contagious  disease  of  poultry  and  other  birds 
caused  by  different  types  of  influenza  viruses.  Those  viruses  may  also  spread  to 
mammals, including pigs and humans. 

Since live poultry is listed in Annex I of 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. 

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  influenza6,  in  order  to  ensure  the  protection  of  animal  health  and 
contribute to the development of the poultry sector. 

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.  

OJ C , , p. . 
OJ C , , p. . 
OJ C , , p. . 
OJ C , , p. . 
OJ L 167, 22.6.1992, p. 1. Directive as last amended by the 2003 Act of Acession. 

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(5) 

(6) 

(7) 

(8) 

(9) 

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 the 
changes  in  the  Terrestrial  Animal  Health  Code  and  the  Manual  of  Diagnostic  Tests 
and  Vaccines  for  Terrestrial  Animals  of  the  World  Organization  for  Animal  Health 
(O.I.E.) on avian influenza.  

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. 

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. Avian influenza viruses may also affect humans and may 
pose a serious risk to public health. 

Current  knowledge  indicates  that  the  health  risks  posed  by  the  so-called  low 
pathogenic avian influenza viruses are inferior to the one posed by highly pathogenic 
avian  influenza  viruses,  which  originate  from  a  mutation  of  certain  low  pathogenic 
viruses. 

Community legislation for the control of avian influenza should give the possibility for 
the  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.  

(10)  With a view to preventing and anticipating the public health problems which may be 
posed by avian influenza, effective communication and close co-operation should  be 
sought  between  the  animal  and  public  health  services  in  the  Member  States,  so  that 
appropriate  measures  to  safeguard  human  health  can  also  be  taken  by  the  competent 
authorities, whenever necessary. 

(11) 

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  measures  which  should  include  a  system  of  active  surveillance  to  be 
carried  out  by  Member  States.  That  surveillance  should  follow  general  guidelines 
which  should  be  adapted  in  the  light  of  further  knowledge  and  developments  in  this 
field. 

(12)  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. Those measures 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.  

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(13) 

In the case of detection of infection with low pathogenic avian influenza virus, or in 
the case of serological evidence of infection, where the presence of the virus cannot be 
confirmed  by  virus  isolation  tests,  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.  

(14)  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. 

(15) 

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  disinfection  of  the  infected  premises,  by  establishing 
protection  and  surveillance  zones  around  the  outbreak  and,  if  necessary,  by 
vaccination.  

(16)  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.  

(17)  Vaccination  against  avian  influenza  can  be  an  effective  tool  to  supplement  disease 
control  measures  and  to  avoid  massive  killing  and  destruction  of  poultry  and  birds. 
Current  knowledge  suggests  that  vaccination  may  be  useful  not  only  in  emergencies 
but  also  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 protective vaccination.  

(18)  Vaccinated  poultry  although  protected  against  the  clinical  signs  of  disease,  may 
become  infected  and  may  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.  

(19)  The  Community  and  the  Member  States  should  also  have  the  possibility  to  establish 
reserves  of  vaccine  against  avian  influenza  to  be  used  in  poultry  and  other  birds  in 
case of an emergency. 

(20)  Provisions should be made 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 the Member States. 

(21)  Provisions should be made to ensure the necessary level of preparation by the Member 
States to effectively tackle emergency situations caused by one or more outbreaks of 
avian influenza, in particular by drawing up contingency plans and setting up control 
centres. Such contingency plans should take account of the public health risk posed by 
avian influenza to poultry workers and other personnel.  

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(22) 

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  quarantine7,  it  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 Community8, in 
cases of outbreaks in Member States would not be appropriate.  

(23)  Cleansing  and  disinfection  should  be  an  integrated  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 market9.  

(24)  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  consumption10  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. It is necessary to provide for the 
adoption by comitology of specific, additional or different measures where necessary 
to enhance further avian influenza control measures. 

(25)  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  origin11  and 
Regulation  (EC)  No  852/2004  of  the  European  Parliament  and  of  the  Council  of 
29 April 2004 on the hygiene of foodstuffs12 may be applied under certain conditions 
to eggs originating from holdings where poultry suspected of being infected with avian 
influenza is kept. 

(26)  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 
must be effective, proportionate and dissuasive. 

(27)  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. 

(28)  Taking into account the unpredictability of influenza viruses, it is necessary 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, other birds or 

7 

8 

9 

10 

11 
12 

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  1822/2003  (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 668/2004 
(OJ L 112, 19.4.2004, p. 1). 
OJ L 226, 25.6.2004, p. 22. 
OJ L 139, 30.4.2004, p. 7. 

EN 

12 

   EN 

 
                                                 
other animals caused by any avian influenza viruses posing a serious threat to animal 
or public health, whenever such measures are necessary. 

(29)  This Directive sets out the minimum control measures to be applied in the event of an 
outbreak  of  avian  influenza  in  poultry  and  other  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 provides that Member States authorities may 
apply measures proportionate to the health risk posed by different disease situations. 

(30) 

In accordance with the principal of proportionality, it is necessary and appropriate for 
the  achievement  of  the  basic  objective  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. 

(31)  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 Commission13.  

(32) 

In  the  interests  of  clarity  and  rationality  of  Community  legislation,  Directive 
92/40/EEC should be repealed and replaced by this Directive. 

HAS ADOPTED THIS DIRECTIVE: 

CHAPTER I 

SUBJECT MATTER, SCOPE AND DEFINITIONS 

Article 1 
Subject matter and scope  

1. 

This Directive sets out: 

(a) 

(b) 

(c) 

certain preventative measures aimed at the surveillance and the early detection 
of avian influenza and increasing the level of awareness and preparation of the 
competent authorities and the farming community to the risks of that disease; 

the  minimum  control  measures  to  be  applied  in  the  event  of  an  outbreak  of 
avian  influenza  in  poultry  and  other  birds  and  a  possible  spread  of  avian 
influenza viruses to mammals;  

other measures to be applied where a serious threat to animal or public health is 
identified  in  relation  to  any  infection  of  birds  or  mammals  caused  by  any 
influenza  viruses  of  avian  origin  and  to  prevent  the  transmission  of  infection 
from those animals to humans. 

13 

OJ L 184, 17.7.1999, p. 23. 

EN 

13 

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2. 

Member States shall remain free to take more stringent measures in the field covered 
by this Directive.  

Article 2 
Definitions of avian influenza, highly pathogenic avian influenza and low pathogenic 
avian influenza 

For the purposes of this Directive, the following definitions shall apply: 

1. 

“avian  influenza”  means  an  infection  of  poultry  or  other  birds  caused  by  any 
influenza A virus: 

(a) 

of the subtypes H5 or H7; or  

(b)  with  an  intravenous  pathogenicity  index  in  six-week  old  chickens  greater 

than 1.2;  

2. 

“highly pathogenic avian  influenza (HPAI)”  means  an  infection  of  poultry  or  other 
birds caused by:  

(a) 

avian  influenza  viruses  of  the  subtypes  H5  and  H7  with  a  genome  sequences 
codifying  for  multiple  basic  amino  acids  at  the  cleavage  site  of  the 
haemagglutinin  molecule  similar  to  that  observed  for  other  HPAI  viruses, 
indicating  that  the  haemagglutinin  molecule  can  be  cleaved  by  a  host 
ubiquitous protease; or 

(b) 

avian  influenza  viruses  with  an  intravenous  pathogenicity  index  in  six-week-
old chickens greater than 1.2;  

3. 

“low pathogenic avian influenza (LPAI)” means an infection of poultry or other birds 
caused by avian influenza viruses of subtypes H5 and H7 that does not come within 
the definition in point (2).  

Article 3 
Other Definitions 

For the purpose of this Directive, the following definitions shall apply: 

1. 

2. 

3. 

‘poultry’  means  all  birds  that  are  reared  or  kept  in  captivity  for  the  production  of 
meat, hatching eggs and eggs for consumption, the production of other commercial 
products, for restocking supplies of game or for breeding these categories of birds;  

‘wild bird’ means a free-living bird which is not kept on any holding as defined in 
point 5; 

‘other  bird’  means  any  bird  other  than  poultry  that  is  kept  in  captivity  for  shows, 
races, exhibitions and competition, such as ornamental birds and racing pigeons, or 
for any reason other than those referred to in point 1;  

EN 

14 

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4. 

5. 

6. 

7. 

8. 

9. 

10. 

11. 

12. 

13. 

14. 

15. 

‘officially registered rare breeds of poultry or other birds’ means any poultry or other 
birds  that  the  competent  authority  has  officially  recognised  as  such  within  their 
contingency plan provided for in Article 63; 

‘holding’  means  any  agricultural  or  other  premises,  such  as  hatcheries,  circuses, 
zoos,  pet  bird  shops,  bird  markets,  and  aviaries,  where  poultry  or  other  birds  are 
being bred or kept on a permanent or temporary basis, except: 

(a) 

(b) 

slaughterhouses,  means  of  transport,  quarantine  facilities  and  centres,  border 
inspection posts and laboratories; and  

living  areas  for  humans  on  such  premises  for  the  purposes  of  the  second 
subparagraph  of  Article11(9),  point  (e)  of  Article  19,  point  (f)  of  Article  30, 
point (g) of Article 39 (5) and point (h) of Article 44 (1) unless poultry or other 
birds are kept on a permanent basis therein; 

‘commercial poultry holding’ means a holding where poultry is kept for commercial 
purposes; 

‘non-commercial  holding/pet  bird  holding’  mean  a  holding  where  poultry  or  other 
birds are kept by their owners: 

(a) 

for their own consumption of the poultry or other birds or their products; or 

(b) 

as pets;  

‘poultry  compartment’  or  ‘other  birds  compartment’  means  one  or  more  poultry 
holdings  or  other  birds  holdings  under  a  common  biosecurity  management  system 
containing a poultry or other birds sub-population with a distinct health status with 
respect  to  avian  influenza  subjected  to  appropriate  surveillance,  control  and 
biosecurity measures;  

‘flock’ means all poultry or other birds within a single production unit;  

‘production unit’ means a unit in a holding where the official veterinarian is satisfied 
that it is completely independent of any other unit in the same holding in terms of its 
location and day-to-day management of the poultry or other birds kept there,  

‘ready-to-lay-poultry’ means poultry prior to the laying stage; 

'hatching eggs' means eggs for incubation, laid by poultry;  

'day-old  chicks'  means  all  poultry  less  than  72  hours  old,  not  yet  fed;  however, 
muscovy ducks (Cairina moschata) or their crosses may be fed; 

‘diagnostic manual’ means the diagnostic manual provided for in Article 51(1); 

‘infected poultry’ and ‘infected other birds’ means any poultry or other birds:  

(a) 

in  which  the  presence  of  avian  influenza  has  been  confirmed  in  accordance 
with the diagnostic manual; or  

EN 

15 

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(b) 

in the case of second and subsequent outbreaks of avian influenza, any poultry 
or  other  birds  in  which  clinical  signs,  post-mortem  lesions  or  reactions  to 
laboratory tests carried out in laboratories approved in accordance with the first 
subparagraph  of  Article 51  (3)  (‘approved  laboratory')  are  consistent  with  the 
diagnosis of avian influenza in accordance with the diagnostic manual; 

‘poultry or other birds suspected of being infected’ means any poultry or other birds 
exhibiting  clinical  signs  or  showing  post-mortem  lesions  or  reactions  to  laboratory 
tests which are such that the presence of avian influenza cannot be excluded;  

‘incubation period’ means a maximum period of 21 days that takes place between the 
probable date of infection and the occurrence of clinical signs of avian influenza;  

‘owner’ means any natural or legal person who owns or keeps or who is otherwise 
responsible for poultry or other birds, whether or not for financial reward; 

‘competent authority’ means the authority of a Member State competent to carry out 
veterinary  checks  or  administrative  action  in  accordance  with  this  Directive  or  any 
authority to which such competence has been delegated;  

'veterinary check' means any physical check and/or administrative formality carried 
out by the competent authority;  

‘official veterinarian’ means the veterinarian designated by the competent authority;  

‘official  surveillance’  means  the  action  of  careful  watching  of  a  health  situation 
concerning  avian  influenza  by  the  competent  authority  which  may  lead  to  further 
investigations by it;  

‘official  supervision’  means  the  actions  taken  by  the  competent  authority  to  check 
and  verify  that  a  person  is  complying  with  or  has  complied  with  the  instructions 
concerning avian influenza received from that authority;  

‘killing’ means any procedure other than slaughter causing the death of an animal or 
bird;  

‘slaughter’ means any procedure causing the death of an animal or bird by bleeding; 

‘disposing of’ means the act of collecting, transporting, storing, handling, processing 
and using or disposing of animal by-products in accordance with: 

(a)  Regulation (EC) No 1774/2002; or  

(b) 

the detailed rules provided for in Article 64(1)of this Directive; 

16. 

17. 

18. 

19. 

20. 

21. 

22. 

23. 

24. 

25. 

26. 

EN 

16 

   EN 

 
27. 

28. 

29. 

30. 

31. 

32. 

33. 

34. 

35. 

‘Community  vaccine  bank’  means  appropriate  premises  designated  in  accordance 
with Article 59(1) of this Directive for the storage of Community reserves of avian 
influenza  vaccines  authorised  in  accordance  with  Directive  2001/82/EC  of  the 
European Parliament and of the Council14 and Regulation (EC) No 726/2004 of the 
European Parliament and of the Council15;  

‘contact holding’ means a holding where avian influenza could have been introduced 
as a result of its location, the movement of persons, poultry or other birds, vehicles or 
in any other way;  

‘suspected  outbreak’  means  a  holding  containing  poultry  or  other  birds  where  the 
competent authority suspects the presence of avian influenza;  

‘outbreak’  means  a  holding,  where  avian  influenza  has  been  confirmed  by  the 
competent authority;  

‘primary outbreak’ means an outbreak not epidemiologically linked with a previous 
outbreak  in  the  same  region  of  a  Member  State,  as  defined  in  Article  2  of  Council 
Directive  64/432/EEC16,  or  the  first  outbreak  in  a  different  region  of  the  same 
Member State;  

‘differentiating  infected  from  vaccinated  animal  (DIVA  strategy)’  means  a 
vaccination  strategy  which  enables  the  differentiation  between  vaccinated/infected 
and  vaccinated/non-infected  animals  through  the  application  of  a  diagnostic  test 
designed  to  detect  antibodies  against  the  field  virus  and  the  use  of  non-vaccinated 
sentinel birds; 

‘depopulation’  means  the  removal  of  all  poultry  or  other  birds  from  a  holding,  a 
poultry compartment or other birds compartment, or a production unit; 

‘mammal’ means an animal of the class Mammalia; 

‘carcasses’ means poultry or other birds which have died or have been killed. 

CHAPTER II 

SURVEILLANCE, NOTIFICATIONS AND EPIDIOMIOLOGICAL INQUIRIES  

Article 4 
Annual surveillance programmes  

Member  States  shall  ensure  that  surveillance  programmes  complying  with  Annex  I 
are adopted each year in order to: 

OJ L 311, 28.11.2001, p. 1. Directive as last amended by Directive 2004/28/EC. 
OJ L 136, 30.4.2004, p. 1. 
OJ 121, 29.7.1964, p. 1977. as last amended by Regulation (EC) No 1/2005 (OJ L 3, 5.1.2005, p. 1). 

1. 

14 
15 
16 

EN 

17 

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2. 

3. 

1. 

2. 

(a) 

(b) 

detect the prevalence of infections with avian influenza virus subtypes H5 and 
H7 in different species of poultry  

contribute to the knowledge on the threats posed by wildlife in relation to any 
influenza virus in birds of avian origin. 

Member States shall submit the annual surveillance programmes to the Commission 
for approval by 15 June 2007 and thereafter by 15 June each year in accordance with 
the procedure referred to in Article 65(2).  

Member  States  shall  report  to  the  Commission  each  year  on  the  implementation  of 
the  annual  surveillance  programmes  by  15  March  of 
the  year  following 
implementation. 

Article 5 
Reporting and notifications  

Member States shall provide for the immediate reporting to the competent authority 
of  any  cases  of  infected  poultry,  infected  other  birds  or  poultry  or  other  birds 
suspected being infected.  

In addition to the requirements provided for in Community legislation on notification 
of  outbreaks  of  animal  diseases,  Member  States  shall  notify  the  Commission  in 
accordance with Annex II of: 

(a) 

(b) 

(c) 

any positive findings of avian influenza which are confirmed by the competent 
authority  in  slaughterhouses,  means  of  transport,  border  inspection  posts,  and 
other  places  at  Community  borders  and  quarantine  facilities  or  centers 
operating  in  accordance with Community legislation on imports of poultry or 
other birds;  

the results of any official surveillance for avian influenza carried out in poultry, 
other birds or other animals, including positive findings in wild birds; and 

any infection of poultry, other birds or other animals caused by any influenza 
virus of avian origin other than those referred to in point 1 of Article 2 which 
may pose a serious threat to animal or public health.  

Article 6 
Epidemiological inquiry 

1. 

Member States shall ensure that epidemiological inquiries are carried out on the basis 
of  questionnaires,  established  within  the  framework  of  the  contingency  plans 
provided for in Article 63.  

2. 

The epidemiological inquiry shall deal with the following: 

(a) 

the length of time during which avian influenza may have been present on the 
holding or other premises or means of transport; 

EN 

18 

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(b) 

the possible origin of avian influenza on the holding, in the slaughterhouse or 
means of transport; 

(c) 

the identification of any contact holding; 

(d) 

the  movements  of  poultry  or  other  birds,  persons,  vehicles or  any  material  or 
substance likely to have caused the spread of avian influenza virus. 

3. 

The competent authority shall take account of the epidemiological inquiry when: 

(a) 

deciding  whether  additional  disease  control  measures,  as  provided  for  in  this 
Directive need to be applied; and 

(b)  granting derogations as provided for in this Directive. 

4. 

If the epidemiological inquiry suggests that avian influenza may have spread from or 
to  other  Member  States,  the  Commission  and  the  other  Member  States  concerned 
shall be immediately informed of the results of all findings of the inquiry. 

CHAPTER III 

MEASURES TO BE APPLIED IN CASES OF SUSPECTED OUTBREAKS  

Article 7 
Measures to be applied on holdings 

1. 

2. 

In the case of a suspected outbreak, the competent authority shall immediately set in 
motion  an  investigation  to  confirm  or  exclude  the  presence  of  avian  influenza  and 
place  the  holding  under  official  surveillance.  The  competent  authority  shall  also 
ensure that the measures provided for in paragraphs 2 and 3 are complied with. 

The competent authority shall ensure that the following measures are applied on the 
holding: 

(a) 

(b) 

poultry and other birds and all mammals of domestic species are counted or, if 
appropriate, estimated following their relevant category;  

a list is compiled of the approximate number of poultry and other birds and all 
mammals of domestic species already sick, dead or likely to be infected in each 
category  on  the  holding;  that  list  shall  be  updated  daily  to  take  account  of 
hatchings and deaths throughout the period of the suspected outbreak and shall 
be produced on request to the competent authority; 

(c) 

poultry and other birds must be restricted to their living quarters or be confined 
in some other place where they can be isolated to prevent contacts with other 
poultry, other birds or wild birds;  

(d)  no poultry and other birds may enter or leave the holding ;  

EN 

19 

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(e) 

(f) 

(g) 

(h) 

no carcasses, poultry or other birds meat including offal (‘meat’), animal feed, 
utensils, materials, waste, droppings, poultry or other birds manure (‘manure’), 
used litter or anything likely to transmit avian influenza may leave the holding 
without an authorisation from the competent authority; 

no eggs may leave the holding, with the exception of eggs including hatching 
eggs  authorised  by  the  competent  authority  to  be  sent  directly  to  an 
establishment  for  the  manufacture  of  egg  products,  as  set  out  in  Chapter  II 
Section X of Annex III to Regulation (EC) No 853/2004 and to be handled and 
treated  in  accordance  with  Chapter  IX  of  Annex  II  to  Regulation  (EC) 
No 852/2004;  where  the  competent  authority  issues  such  an  authorisation  it 
shall be subject to the conditions set out in Annex III to this Directive; 

the  movement  of  persons,  mammals  of  domestic  species,  vehicles  and 
equipment to or from the holding is subject to the conditions and authorisation 
of the competent authority;  

appropriate  means  of  disinfection  are  used  at  the  entrances  and  exits  of 
buildings  housing  poultry  and  other  birds  and  of  the  holding  itself  in 
accordance with the instructions of the competent authority. 

3. 

The competent authority shall ensure that an epidemiological inquiry is carried out in 
accordance with Article 6 (‘the epidemiological inquiry’). 

Article 8 
Derogations from certain measures to be applied on holdings  

The competent authority may grant derogations from the measures provided for in points (c) 
to (f) of Article 7(2) on the basis of a risk assessment and taking into account the precautions 
taken and the destination of the birds and products to be moved. 

Article 9 
Duration of the measures to be applied on holdings 

The  measures  to  be  applied  on  holdings  in  cases  of  suspected  outbreaks,  as  provided  for  in 
Article 7, shall continue to be applied until the presence of avian influenza has been excluded 
by the competent authority. 

Article 10 
Additional measures based on the epidemiological inquiry 

1. 

2. 

Based  on  the  preliminary  results  of  the  epidemiological  inquiry,  the  competent 
authority may apply the measures provided for in paragraphs 2, 3 and 4 in particular 
if the holding is located in an area with a high density of poultry.  

A temporary restriction may be introduced on the movements of poultry, other birds 
and eggs and the movement of vehicles related to the poultry sector in a large area or 
in the whole of the Member State.  

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20 

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That restriction may be extended to movements of mammals of domestic species, but 
shall not exceed 72 hours, unless justified by exceptional circumstances. 

3. 

The measures provided for in Article 11 may be applied to the holding. 

However, if conditions permit, the application of those measures may be limited only 
to the poultry suspected of being infected and their production units.  

Samples shall be taken from the poultry or other birds when they are killed in order 
that  the  risk  of  a  suspected  outbreak  can  be  confirmed  or  excluded,  in  accordance 
with the diagnostic manual.  

4. 

A temporary control zone around the holding may be established and some or all of 
the  measures  provided  for  in  Article  7  (2)  shall  be  applied  as  necessary  to  the 
holdings within that zone.  

CHAPTER IV 

MEASURES TO BE APPLIED IN CASES OF AN OUTBREAK OF HIGHLY 
PATHOGENIC AVIAN INFLUENZA (HPAI) 

SECTION 1 
MEASURES TO BE APPLIED ON HOLDINGS 

Article 11 
Measures to be applied by the competent authority 

1. 

2. 

In  case  of  an  outbreak  of  HPAI,  the  competent  authority  shall  ensure  that  the 
measures provided for in Article 7(2) and (3) and paragraphs 2 to 10 of this Article 
are applied. 

All poultry and other birds of the species in which HPAI has been confirmed on the 
holding shall be killed without delay under official supervision. The killing shall be 
carried  out  in  such  a  way  as  to  avoid  the  risk  of  spread  of  avian  influenza,  in 
particular  during  transport  or  killing  and  in  accordance  with  Council  Directive 
93/119/EEC17. 

That killing may be extended to other species of birds on the holding, on the basis of 
a risk assessment concerning further spread of avian influenza. 

3. 

Poultry and other birds which have died or have been killed and hatching and table 
eggs on the holding shall be disposed of under official supervision.  

17 

OJ  L  340,  31.12.1993,  p.  21.  Directive  amended  by  Regulation  (EC)  No 806/2003  (OJ  L  122, 
16.5.2003, p. 1). 

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21 

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4. 

5. 

6. 

7. 

8. 

9. 

Poultry  already  hatched  from  eggs  collected  from  the  holding  during  the  period 
between the probable date of introduction of HPAI on the holding and the application 
of  the  measures  provided  for  in  Article  7(2),  shall  be  placed  under  official 
supervision and investigations shall be carried out in accordance with the diagnostic 
manual. 

Meat of poultry slaughtered and hatching and table eggs collected from the holding 
during the period between the probable date of introduction of HPAI on the holding 
and  the  application  of  the  measures  provided  for  in  Article  7(2)  shall,  wherever 
possible, be traced and disposed of under official supervision.  

However, the competent authority may grant authorisations for table eggs to be sent 
directly  to  an  establishment  for  the  manufacture  of  egg  products  as  set  out  in 
Chapter II  of  Section  X  of  Annex  III  to  Regulation  (EC)  No  853/2004  and  to  be 
handled and treated in accordance with Chapter XI of Annex II to Regulation (EC) 
No  852/2004.  Any  such  authorisations  shall  be  subject  to  the  conditions  set  out  in 
Annex III to this Directive.  

All  substances  and  waste  likely  to  be  contaminated,  such  as  poultry  feed  (‘feed’), 
shall  be  destroyed  or  subjected  to  a  treatment  ensuring  the  destruction  of  the  avian 
influenza virus, in accordance with the instructions of the official veterinarian.  

Manure, slurry and bedding likely to be contaminated shall be treated in accordance 
with Article 49. 

Following  the  disposal  of  carcasses,  the  buildings  used  for  housing  them,  the 
equipment  likely  to  be  contaminated  and  the  vehicles  used  for  transporting  the 
poultry or other birds, carcasses, meat, feed, manure, slurry, bedding and of any other 
material or substance likely be contaminated shall be cleansed, disinfected or treated 
in accordance with Article 49.  

Other  domestic  birds  or  mammals  of  domestic  species  shall  not  enter  or  leave  the 
holding without the authorisation of the competent authority.  

That restriction shall not apply to mammals of domestic species which have access 
only to the living areas for humans. 

10. 

In  the  case  of  a  primary  outbreak,  the  virus  isolate  shall  be  subjected  to  the 
laboratory procedure in accordance with the diagnostic manual to identify the genetic 
subtype.  

That  virus  isolate  shall  be  submitted  to  the  Community  reference  laboratory,  as 
provided for in Article 52 (1) as soon as possible.  

Article 12 
Derogations from certain measures to be applied on holdings 

1. 

Member States shall draw up detailed rules for granting derogations, as provided for 
in Articles 13 and 14, including alternative appropriate measures and conditions.  

EN 

22 

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2. 

3. 

4. 

1. 

Member States shall immediately notify the Commission of any derogation granted 
in accordance with Article 13(1) and Article 14. 

Where a derogation has been granted, as provided for in Article 13(1) and Article 14, 
the  Commission  shall  immediately  review  the  situation  with  the  Member State 
concerned  and  in  the  Standing  Committee  on  the  Food  Chain  and  Animal  Health 
(‘the Committee’) as soon as possible.  

Taking  account  of  any  derogation  granted,  as  provided  for  in  Article  13(1)  and 
Article  14,  measures  to  prevent  the  spread  of  avian  influenza  may  be  adopted  in 
accordance with the procedure referred to in Article 65(3) 

Article 13 
Derogations concerning certain holdings 

The  competent  authority  may  grant  derogations  from  the  measures  provided  for  in 
the  first  subparagraph  of  Article  11  (2)  in  cases  of  an  outbreak  of  HPAI  in  a  non-
commercial holding/pet bird holding, a circus, a zoo, a pet bird shop, a wild life park, 
a fenced area where poultry or other birds are kept for scientific purposes or purposes 
related to the conservation of endangered species or officially registered rare breeds 
of  poultry  or  other  birds,  provided  that  such  derogations  do  not  endanger  disease 
control and basic Community interests.  

2. 

The competent authority shall ensure that where a derogation is granted, as provided 
for in paragraph 1, the poultry and other birds concerned by the derogation: 

(a) 

are  kept  completely  isolated  from  other  poultry  or  other  birds  and  where 
appropriate from wild birds;  

(b)  must  be  subjected  to  further  surveillance  and  testing  in  accordance  with  the 
diagnostic manual until the laboratory tests have indicated that they no longer 
pose a significant risk of further spread of HPAI; and  

(c) 

are  not  to  be  moved  from  their  holding  of  origin,  except  for  slaughter  or  to 
another holding: 

(i) 

located in the same Member State, in accordance with the instructions of 
the competent authority; or 

(ii) 

in another Member State, subject to the agreement of the Member State 
of destination. 

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SECTION 2 
MEASURES TO BE APPLIED IN SEPARATE PRODUCTION UNITS AND CONTACT 
HOLDINGS 

Article 14 
Measures to be applied in cases of outbreaks of HPAI in separate production units 

In  cases  of  an  outbreak  of  HPAI  in  a  holding  which  consists  of  two  or  more  separate 
production units, the competent authority may grant derogations from the measures provided 
for  in  the  firs  subparagraph  of  Article  11(2)  for  production  units  containing  healthy  poultry 
provided  that  such  derogations  do  not  endanger  disease  control  measures  and  basic 
Community interests.  

Such  derogations  shall  only  be  granted  in  respect  of  two  or  more  separate  production  units 
where  the  official  veterinarian,  taking  account  of  the  structure,  size,  operation,  type  of 
housing, feeding, water source, equipment, staff and visitors to the premises, is satisfied that 
they are completely independent of other production units in terms of location and day-to-day 
management of the poultry kept there.  

Article 15 
Measures to be applied in contact holdings  

1. 

Based  on  the  epidemiological  inquiry,  the  competent  authority  shall  decide  if  a 
holding is to be considered as a contact holding.  

The competent authority shall ensure that the measures provided for in Article 7(2) 
are  applied  to  contact  holdings  until  the  presence  of  HPAI  has  been  excluded  in 
accordance with the diagnostic manual.  

Based  on  the  epidemiological  inquiry,  the  competent  authority  shall  apply  the 
measures  provided  for  in  Article  11  to  contact  holdings  and  in  particular  if  the 
contact holding is located in an area with a high density of poultry.  

The main criteria to be considered for the application of the measures provided for in 
Article 11 in contact holdings are set out in Annex IV.  

The competent authority shall ensure that samples are taken from the poultry when 
they  are  killed  in  order  to  confirm  or  exclude  the  presence  of  HPAI  virus  in  those 
contact holdings in accordance with the diagnostic manual.  

2. 

3. 

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SECTION 3 
PROTECTION AND SURVEILLANCE ZONES AND FURTHER RESTRICTED ZONES  

Article 16 
Establishment of protection and surveillance zones and further restricted zones in cases 
of outbreaks of HPAI  

1. 

Immediately following an outbreak of HPAI, the competent authority shall establish: 

(a) 

a protection zone with a radius of at least three kilometres around the holding;  

(b) 

a surveillance zone with a radius of at least 10 kilometres around the holding, 
including the protection zone. 

2. 

When establishing protection and surveillance zones, as provided for in paragraph 1, 
the competent authority shall at least take account of the following criteria: 

(a) 

the epidemiological inquiry;  

(b) 

the geographical situation, particularly natural boundaries; 

(c) 

the location and proximity of holdings; 

(d)  patterns of movements and trade in poultry and other birds and the availability 

of slaughterhouses; 

(e) 

the  facilities  and  personnel  available  to  control  any  movement  within  the 
protection  and  surveillance  zones  of  poultry  and  other  birds,  their  carcasses, 
manure, bedding or used litter, in particular if the poultry or other birds to be 
killed and disposed of have to be moved from their holding of origin. 

3. 

4. 

The competent authority may establish further restricted zones around or adjacent to 
the protection and surveillance zones, taking account of the criteria provided for in 
paragraph 2.  

If  a  protection,  surveillance  or  further  restricted  zone  covers  the  territories  of 
different Member States, the competent authorities of the Member States concerned 
shall collaborate to establish the zone.  

Article 17 
Measures to be applied in the protection and surveillance zones 

1. 

The competent authority shall ensure that the following measures are applied within 
the protection and surveillance zones:  

(a) 

arrangements  are  put  in  place  which  permit  the  tracing  of  the  movements  of 
poultry or other birds, meat, eggs, carcasses and feed; 

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(b)  owners  are  to  provide  the  competent  authority,  on  request,  with  any  relevant 
information concerning the poultry or other birds and eggs entering or leaving 
the holding . 

2. 

The  competent  authority  shall  ensure  that  all  persons  concerned  are  fully  aware  of 
the restrictions in place in the protection and surveillance zones.  

That information may be conveyed through warning notices, media resources such as 
the press and television or any other appropriate means. 

SECTION 4 
MEASURES TO BE APPLIED IN THE PROTECTION ZONE 

Article 18 
Census and visits by the official veterinarian and surveillance  

The  competent  authority  shall  ensure  that  the  following  measures  are  applied  in 
protection zones: 

(a) 

(b) 

(c) 

a census of all the holdings is made as soon as possible;  

all holdings are visited by an official veterinarian within seven days of the date of the 
establishment  of  the  protection  zone  for  a  clinical  examination  of  the  poultry  and 
other birds; and, if necessary, the collection of samples for laboratory tests; a record 
of such visits and the findings thereof shall be kept; 

additional  surveillance  is  immediately  implemented  in  accordance  with  the 
diagnostic  manual  in  order  to  identify  any  further  spread  of  avian  influenza  in  the 
holdings located in the protection zone. 

Article 19 
Measures to be applied on holdings  

The competent authority shall ensure that the following measures are applied on holdings in 
protection zones:  

(a) 

(b) 

(c) 

poultry  and  other  birds  must  be  restricted  to  their  living  quarters  or  be  confined  in 
some other place where they can be isolated to prevent contacts with other poultry, 
other birds or wild birds;  

carcasses are disposed of; 

vehicles  and  equipment  used  for  transporting  live  poultry  or  other  birds  and  meat, 
feed, manure, slurry and bedding, and any other material or substances likely to be 
contaminated  are  cleansed,  disinfected  or  treated  as  soon  as  possible  after 
contamination, in accordance with Article 49;  

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(d) 

(e) 

(f) 

(g) 

(h) 

all  vehicles  used  by  staff  or  other  persons  which  enter  or  leave  holdings  and  are 
likely to have become contaminated are cleansed, disinfected or treated immediately 
after contamination, in accordance with Article 49; 

no poultry, other birds or other domestic animals may enter or leave a holding where 
poultry is kept without authorisation of the competent authority; this restriction shall 
not apply to animals which have access only to the living areas for humans on such 
holdings and when any contact with poultry or other birds can be excluded; 

any  increased  morbidity  or  mortality  or  significant  drop  in  production  data  in 
holdings  is  immediately  reported  to  the  competent  authority,  which  shall  carry  out 
appropriate investigations in accordance with the diagnostic manual;  

any  person  entering  or  leaving  holdings  observes  appropriate  biosecurity  measures 
aimed at preventing the spread of avian influenza;  

records  of  all  persons  visiting  holdings  are  kept  by  the  owner  in  order  to  facilitate 
disease  surveillance  and  control  and  must  be  made  available  upon  request  by  the 
competent authority. 

Article 20 
Prohibition on the removal or spreading of used litter or manure from holdings  

The competent authority shall ensure that the removal or spreading of used litter or manure 
from holdings in protection zones are prohibited, unless authorised by it. 

However,  the  movement  of  manure  may  be  authorised  from  holdings  under  biosecurity 
measures  to  a  designated  plant  for  treatment  or  for  intermediate  storage  for  subsequent 
treatment  to  destroy  the  possible  presence  of  avian  influenza  viruses  in  accordance  with 
Regulation (EC) No 1774/2002 or with the specific rules referred to in Article 64 (1). 

Article 21 
Fairs, markets or other gatherings and restocking of game  

The competent authority shall ensure that fairs, markets, shows or other gatherings of poultry 
or other birds are prohibited in protection zones. 

The competent authority shall ensure that poultry or other birds for restocking of game shall 
not be released in protection zones.  

Article 22 
Prohibition on the movement and transport of poultry and other birds and eggs  

The  competent  authority  shall  ensure  that  within  protection  zones,  the  movement  and 
transport on roads, excluding private service roads of holdings, or by rail, of poultry and other 
birds,  ready-to-lay  poultry,  day-old  chicks,  hatching  and  table  eggs  and  carcasses  are 
prohibited.  

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However,  that  prohibition  shall  not  apply  to  transit  through  the  protection  zone  on  roads  or 
rail without unloading or stopping. 

Article 23 
Derogations for the direct transport of poultry for immediate slaughter 

By  way  of  derogation  from  Article  22,  the  competent  authority  may  authorise  the  direct 
transport of poultry for immediate slaughter, subject to the following conditions: 

(a) 

(b) 

(c) 

(d) 

(e) 

(f) 

(g) 

(h) 

a  clinical  examination  of  the  poultry  on  the  holding  of  origin  is  carried  out  by  the 
official  veterinarian  in  order  to  prevent  that  any  poultry,  in  which  clinical  signs  of 
HPAI have been detected, is sent for slaughter;  

where appropriate, laboratory tests have been carried out on poultry on the holding of 
origin in accordance with the diagnostic manual, with favourable results;  

the  poultry  are  transported  in  vehicles  sealed  by  the  competent  authority  to  a 
slaughterhouse  designated  by 
(‘the  designated 
slaughterhouse’), located within the protection or surveillance zone or in exceptional 
cases outside those zones; 

the  competent  authority 

the  competent  authority  responsible  for  the  designated  slaughterhouse  is  informed 
before  the  dispatch  of  the  poultry  and  that  competent  authority  informs  the 
competent authority responsible for the place of dispatch of the arrival of the poultry 
at the designated slaughterhouse; 

at  the  designated  slaughterhouse,  the  poultry  from  the  protection  zone  are  kept 
separately  from  other  poultry  and  are  slaughtered  separately  or  at  different  times 
from other poultry, preferably at the end of a working day; subsequent cleansing and 
disinfection shall be completed before other poultry are slaughtered; 

the official veterinarian takes account of any signs relating to the presence of avian 
influenza  during  ante-mortem  and  post-mortem  inspections  carried  out  at  the 
designated slaughterhouse;  

the  meat  does  not  enter  into  intra-Community  or  international  trade  and  bears  the 
health  mark  for  fresh  meat  provided  for  in  Annex  II  to  Directive  2002/99/EC18, 
unless  otherwise  decided  in  accordance  with  the  procedure  referred  to  in 
Article 65(3) of this Directive;  

the  meat  is  obtained,  cut,  transported  and  stored  separately  from  meat  intended  for 
intra-Community  and  international  trade  and  is  used  in  such  a  way  as  to  avoid  it 
being  introduced  into  meat  products  intended  for  intra-Community  or  international 
trade, unless: 

(i) 

it has undergone a treatment set out in Annex III to Directive 2002/99/EC; or 

18 

OJ L 18, 23.1.2003, p. 11. 

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1. 

2. 

(ii) 

it  is  otherwise  decided  in  accordance  with  the  procedure  referred  to  in 
Article 65(3).  

Article 24 
Derogations for the direct transport of day-old-chicks  

By  way  of  derogation  from  Article  22,  the  competent  authority  may  authorise  the 
direct  transport  of  day-old-chicks  to  a  holding  or  shed  of  that  holding  in  the  same 
Member  State  in  which  there  is  no  other  poultry,  preferably  located  outside  the 
protection and the surveillance zones, subject to the following conditions:  

(a) 

they are transported in vehicles sealed by the competent authority;  

(b) 

(c) 

appropriate  biosecurity  measures  are  applied  during  transport  and  at  the 
holding of destination; 

the  holding  of  destination  is  placed  under  official  surveillance  following  the 
arrival of the day-old-chicks. 

By  way  of  derogation  from  Article  22,  the  competent  authority  may  authorise  the 
direct  transport  of  day-old-chicks  hatched  from  hatching  eggs  originating  from 
holdings located outside the protection and surveillance zones to any other holding in 
the  same  Member  State,  provided  that  the  hatchery  of  dispatch  can  ensure  by  its 
logistics and by its hygienic working conditions that no contact has occurred between 
those  eggs  and  any  other  hatching  eggs  or  day-old-chicks  originating  from  poultry 
flocks in such zones and which are therefore of a different health status 

Article 25 
Derogations for the direct transport of ready-to-lay poultry 

By  way  of  derogation  from  Article  22,  the  competent  authority  may  authorise  the  direct 
transport of ready-to-lay poultry to a holding or shed of that holding within the protection or 
the surveillance zone in which there is no other poultry, subject to the following conditions:  

(a) 

(b) 

(c) 

(d) 

a clinical examination of the poultry and other birds in the holding of origin and in 
particular of those to be moved is carried out by the official veterinarian;  

where appropriate, laboratory tests have been carried out on poultry in the holding of 
origin in accordance with the diagnostic manual with favourable results;  

the ready-to-lay poultry is transported in vehicles sealed by the competent authority; 

the holding or shed of destination is placed under official surveillance following the 
arrival of the ready-to-lay poultry.  

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29 

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Article 26 
Derogation for the direct transport of hatching and table eggs 

1. 

By  way  of  derogation  from  Article  22,  the  competent  authority  may  authorise  the 
direct transport of hatching eggs to a hatchery designated by the competent authority 
(‘the  designated  hatchery’),  preferably  located  within  the  protection  or  surveillance 
zone, subject to the following conditions: 

(a) 

(b) 

the  parent  flocks  from  which  the  hatching  eggs  are  derived  have  been 
examined in accordance with the diagnostic manual with favourable results; 

the  hatching eggs and their packaging are disinfected  before dispatch and  the 
tracing back of these eggs can be ensured; 

(c) 

the hatching eggs are transported in vehicles sealed by the competent authority;  

(d)  biosecurity measures are applied in the designated hatchery in accordance with 

the instructions of the competent authority.  

2. 

By  way  of  derogation  from  Article  22,  the  competent  authority  may  authorise  the 
direct  transport  of  table  eggs  to  a  packing  centre  designated  by  the  competent 
authority  (‘the  designated  packing  centre’),  provided  that  they  are  packed  in 
disposable  packaging  and  that  all  biosecurity  measures  required  by  the  competent 
authority are applied.  

Article 27 
Derogation for the direct transport of poultry or other birds which have died 

By  way  of  derogation  from  Article  22,  the  competent  authority  may  authorise  the  direct 
transport  of  poultry  or  other  birds  which  have  died  provided  that  they  are  transported  for 
disposing of.  

Article 28 
Cleansing and disinfecting of means of transport 

1. 

2. 

The  competent  authority  shall  ensure  that  the  vehicles  and  equipment  used  for  the 
transport as provided for in Articles 23 to 27 or in the transport of meat are cleansed 
and  disinfected  as  soon  as  possible  following  the  transport,  in  accordance  with 
Article 49. 

The competent authority shall ensure that biosecurity measures are applied to prevent 
the  spread  of  avian  influenza  by  means  of  movements  of  vehicles  to  and  from 
holdings located within the protection zone, particularly vehicles transporting feed. 

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Article 29 
Duration of measures  

1. 

2. 

The  measures  provided  for  in  this  Section  shall  be  maintained  at  least  21 days 
following  the  date  of  completion  of  preliminary  cleansing  and  disinfection  on  the 
infected holding in accordance with Article 49 and until all poultry and other birds 
on holdings located in the protection zone have undergone laboratory tests in order to 
detect  the  eventual  presence  of  avian  influenza  in  accordance  with  the  diagnostic 
manual. 

When  the  measures  referred  to  in  this  Section  are  no  longer  to  be  maintained,  as 
provided for in paragraph 1 of this Article, the measures laid down in Article 30 shall 
apply  in  the  former  protection  zone,  until  they  are  no  longer  to  be  applied  as 
provided for in Article 31. 

SECTION 5 
MEASURES TO BE APPLIED IN THE SURVEILLANCE ZONE 

Article 30 
Measures to be applied in the surveillance zone  

The competent authority shall ensure that the following measures are applied in surveillance 
zones: 

(a) 

(b) 

(c) 

a census of all poultry holdings is made as soon as possible;  

the  movement  of  poultry,  ready-to-lay  poultry,  day-old  chicks,  hatching  and  table 
eggs within the surveillance zone is prohibited unless authorisation is granted by the 
competent authority, which ensures that appropriate biosecurity measures are applied 
to  prevent  the  spread  of  avian  influenza;  this  prohibition  shall  not  apply  to  transit 
thorough the surveillance zone on road or rail, without unloading or stopping; 

the movement of poultry, ready-to-lay poultry, day-old chicks and hatching and table 
eggs to holdings, slaughterhouses or packing centres located outside the surveillance 
zone  is  prohibited;  however,  the  competent  authority  may  authorise  the  direct 
transport of:  

(i) 

(ii) 

poultry  for  slaughter  to  a  designated  slaughterhouse,  for  the  purpose  of 
immediate slaughter subject to point (a) of Article 23; 

ready-to-lay poultry to a holding in which there is no other poultry in the same 
Member  State;  that  holding  shall  be  placed  under  official  surveillance 
following the arrival of the ready-to-lay poultry; 

(iii)  day-old-chicks: 

– 

to a holding or shed of such holding in the same Member State in which 
there is no other poultry provided that appropriate  biosecurity measures 
are  applied  and  the  holding  is  placed  under  official  surveillance 
following the transport, or 

EN 

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– 

if hatched from hatching eggs originating from poultry holdings located 
outside  the  protection  and  surveillance  zones,  to  any  other  holding, 
provided  that  the  hatchery  of  dispatch  can  ensure  by  its  logistics  and 
biosecurity  working  conditions  that  no  contact  has  occurred  between 
these  eggs  and  any  other  hatching  eggs  or  day-old-chicks  originating 
from poultry flocks in those zones and which are therefore of a different 
health status; 

(iv)  hatching eggs to a designated hatchery; the eggs and their packaging shall be 
disinfected before dispatch and the tracing back of these eggs must be ensured; 

(v) 

table  eggs  to  a  designated  packing  centre,  provided  that  they  are  packed  in 
disposable packaging by applying biosecurity measures in accordance with the 
instructions of the competent authority; 

any person entering or leaving holdings in the surveillance zone observes appropriate 
biosecurity measures aimed at preventing the spread of avian influenza;  

vehicles  and  equipment  used  for  transporting  live  poultry  or  other  birds,  carcasses, 
feed, manure, slurry and bedding, and any other material or substances likely to be 
contaminated, are cleansed and disinfected as soon as possible after contamination in 
accordance with Article 49; 

no poultry, other birds or other domestic animals may enter or leave a holding where 
poultry is kept without authorisation of the competent authority; this restriction shall 
not apply to animals which have access only to the living areas for humans on such 
holdings and when any contact to poultry or other birds can be excluded; 

any  increased  morbidity  or  mortality  or  significant  drop  in  production  data  in 
holdings  is  immediately  reported  to  the  competent  authority,  which  shall  carry  out 
appropriate investigations in accordance with the diagnostic manual;  

the removal or spreading of used litter or manure is prohibited unless authorised by 
the competent authority; the movement of manure may be authorised from a holding 
situated in the surveillance zone under biosecurity measures to a designated plant for 
treatment or for intermediate storage for subsequent treatment to destroy the possible 
presence  of  avian 
in  accordance  with  Regulation  (EC) 
No 1774/2002 or with the specific rules referred to in Article 64 (1); 

influenza  viruses, 

fairs, markets, shows or other gatherings of poultry or other birds are prohibited;  

poultry for restocking of game are not released. 

(d) 

(e) 

(f) 

(g) 

(h) 

(i) 

(j) 

Article 31 
Duration of measures 

The measures provided for in this Section shall be maintained at least 30 days following the 
date  of  completion  of  preliminary  cleansing  and  disinfection  on  the  infected  holding  in 
accordance with Article 49 and until laboratory tests in accordance with the diagnostic manual 
in order to detect the eventual presence of avian influenza have been carried out on holdings 
located within the surveillance zone.  

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SECTION 6 
MEASURES TO BE APPLIED IN FURTHER RESTICTED ZONES 

Article 32 
Measures to be applied in further restricted zones  

The competent authority may provide that some or all the measures provided for in 
Sections  4  and  5  shall  apply  inside  the  further  restricted  zones  provided  for  in 
Article 16 (3) (‘the further restricted zones’).  

The  competent  authority  may  provide  that  preventative  depopulation,  either  by 
slaughtering or killing of poultry or other birds, in accordance with Council Directive 
93/119/EEC, is applied in holdings and areas at risk located in the further restricted 
zones. 

The restocking of those holdings shall take place in accordance with the instructions 
of the competent authority.  

Member  States  applying  the  measures  provided  for  in  paragraphs  1  and  2  shall 
immediately informthe Commission thereof. 

The Commission shall review the situation with the Member States concerned and in 
the Committee as soon as possible. 

Without  prejudice  to  decisions  to  be  adopted  pursuant  to  Council  Decision 
90/424/EEC,  further  surveillance,  biosecurity  and  control  measures  to  prevent  the 
spreading  of  avian  influenza  may  be  adopted  in  accordance  with  the  procedure 
referred to in Article 65 (3). 

SECTION 7 
DEROGATIONS AND BIOSECURITY MEASURES 

Article 33 
Derogations  

The competent authority may, based on a risk assessment, grant derogations from the 
measures  provided  in  Sections  4  and  5  in  cases  of  confirmation  of  HPAI  in  a 
hatchery. 

The  competent  authority  may  grant  derogations  from  the  measures  provided  for  in 
points (b) and (c) of Article 18, Article 22 and points (b), (c) and (f) of Article 30 in 
cases of an outbreak of HPAI in a non-commercial holding/pet bird holding, a circus, 
a  zoo,  a  wild  life  park,  a  fenced  area  where  poultry  or  other  birds  are  kept  for 
scientific purposes or purposes related to the conservation of endangered species or 
officially registered rare breeds of poultry or other birds. 

1. 

2. 

3. 

4. 

5. 

1. 

2. 

3. 

By way of derogation from of Sections 4 and 5, in cases of outbreaks of HPAI the 
Member  States  may,  based  on  a  risk  assessment,  introduce  specific  measures  on 

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4. 

5. 

6. 

1. 

2. 

3. 

4. 

movements  of  racing  pigeons  into,  from  and  within  the  protection  and  surveillance 
zones. 

The derogations provided for in paragraphs 1, 2 and 3 shall only be granted provided 
that  such  derogations  do  not  endanger  disease  control  and  basic  Community 
interests.  

Member  States  granting  derogations  provided  for  in  paragraphs  1,  2  and  3  shall 
immediately inform the Commission thereof. 

The  Commission  shall  in  all  cases  review  the  situation  with  the  Member State 
concerned and in the Committee as soon as possible.  

Taking account of any derogation granted, as provided for in paragraphs 1, 2 and 3, 
measures to prevent the spread of avian influenza may be adopted in accordance with 
the procedure referred to in Article 65 (3). 

Article 34 
Biosecurity measures 

In  order  to  prevent  the  spread  of  avian  influenza,  the  competent  authority  may,  in 
addition  to  the  measures  provided  for  in  Sections  4,  5  and  6,  order  the 
implementation of additional biosecurity measures in holdings in the protection and 
surveillance  zones  and in the further restricted zones, as well as in specific poultry 
compartments and other birds compartments in the Member State concerned.  

Those  measures  may  include  restrictions  on  movements  of  vehicles  or  persons  for 
feed supply, egg collection, the transport to slaughterhouses of poultry, the collection 
for  disposing  of  carcasses  and  other  movements  of  personnel,  veterinarians  or 
persons supplying farm equipment.  

Member  States  which  adopt  measures,  as  provided  for  in  paragraph  1,  shall 
immediately inform the Commission thereof. 

The Commission shall review the situation with the Member State concerned and in 
the Committee as soon as possible. 

Without  prejudice  to  decisions  to  be  adopted  pursuant  to  Decision  90/424/EEC, 
further surveillance, biosecurity and control measures to prevent the spread of avian 
influenza  may  be  adopted  in  accordance  with  the  procedure  referred  to  in 
Article 65 (3). 

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SECTION 8 
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 certain premises other than holdings and 
in means of transport 

Where there is suspicion or confirmation of the presence of HPAI in slaughterhouses, means 
of  transport  or  border  inspection  posts,  the  competent  authority  shall  immediately  set  in 
motion an investigation to confirm or exclude its presence in accordance with the diagnostic 
manual. 

1. 

2. 

1. 

Article 36 
Measures to be applied in slaughterhouses 

The  competent  authority  shall  ensure,  where  HPAI  is  suspected  or  confirmed  in  a 
slaughterhouse,  that,  on  the  basis  of  a  risk  assessment,  all  poultry  present  in  the 
slaughterhouse  is  either  killed  or  slaughtered  as  soon  as  possible  under  official 
supervision.  

Where  the  poultry  is  slaughtered,  their  meat  shall  be  kept  separately  under  official 
supervision until further investigations to confirm or exclude the presence of HPAI 
are completed, in addition to the investigations provided for in Article 35.  

If  HPAI  is  confirmed,  the  meat  of  the  infected  poultry  or  other  birds  and  the  meat 
likely to be contaminated shall be disposed of under official supervision. 

Article 37 
Measures to be applied in border inspection posts or means of transport 

The  competent  authority  shall  ensure,  where  HPAI  is  suspected  or  confirmed  in 
border inspection posts or means of transport, that, on the basis of a risk assessment, 
all  poultry  and  other  birds  present  in  the  border  inspection  post  or  in  the  means  of 
transport are conveyed to an appropriate place to be killed or slaughtered as soon as 
possible under official supervision.  

However, the competent authority may decide not to kill or slaughter those poultry 
and  other  birds  present  in  the  border  inspection  post  that  have  not  been  in  contact 
with the poultry or other birds suspected of being infected.  

Where  the  poultry  is  slaughtered,  their  meat  shall  be  kept  separately  under  official 
supervision until further investigations to confirm or exclude the presence of HPAI 
are completed, in addition to the investigations provided for in Article 35.  

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2. 

If  HPAI  is  confirmed,  the  carcasses  of  the  infected  poultry  or  other  birds  and  the 
meat likely to be contaminated shall be disposed of as soon as possible under official 
supervision. 

Article 38 
Additional Measures to be applied to slaughterhouses, border inspection posts or means 
of transport 

The competent authority shall ensure that the following additional measures are applied where 
HPAI  is  suspected  or  confirmed  in  a  slaughterhouse,  border  inspection  post  or  means  of 
transport:  

(a) 

(b) 

(c) 

(d) 

(e) 

(f) 

no poultry or other birds are introduced into the slaughterhouse, the border inspection 
post  or  the  means  of  transport  until  at  least  24  hours  after  the  cleansing  and 
disinfection as provided for in point (b) are completed in accordance with Article 49; 
in  the  case  of  border  inspection  posts,  the  prohibition  on  introduction  may  be 
extended to other animals;  

the cleansing and disinfection of buildings, equipment and vehicles takes place under 
the supervision of the official veterinarian in accordance with Article 49; 

an epidemiological inquiry is carried out; 

the measures provided for in Article 7(2) are applied in the holding of origin of the 
infected poultry or carcasses and in contact holdings; 

unless  otherwise  indicated  by  the  epidemiological  inquiry  and  the  further 
investigations, as provided for in Article 35, the measures provided for in Article 11 
are applied in the holding of origin; 

the avian influenza virus isolate is subjected to the laboratory procedure in order to 
identify the subtype of the virus, in accordance with the diagnostic manual.  

CHAPTER V 

MEASURES TO BE APPLIED IN CASES OF AN OUTBREAK OF LOW 
PATHOGENIC AVIAN INFLUENZA (LPAI) 

SECTION 1 
MEASURES TO BE APPLIED ON HOLDINGS 

Article 39 
Measures to be applied by the competent authority  

1. 

Without prejudice to the measures provided to in points (a), (b), (c), (e), (g) and (h) 
of  Article  7  (2),  the  competent  authority  shall  ensure  that  in  cases  of  outbreaks  of 
LPAI, the measures provided for in paragraphs 2 to 6 of this Article are taken on the 

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basis  of  a  risk  assessment  and  taking  account  of  at  least  the  criteria  set  out  in 
Annex V. 

2. 

The  competent  authority  shall  ensure  that  all  poultry  on  the  holding  and  all  other 
birds of the species in which LPAI has been confirmed are depopulated under official 
supervision in such a way as to prevent the spread of avian influenza. 

The  depopulation  may  be  extended  to  other  birds  on  the  holding  based  on  the  risk 
that they pose as regards further spread of avian influenza and to other holdings that 
may be considered as contact holdings, based on the epidemiological inquiry. 

Before depopulation, no poultry or other birds shall enter or leave the holding, unless 
authorised by the competent authority. 

3. 

For the purpose of paragraph 2, the depopulation shall be carried out in accordance 
with Directive 93/119/EEC and the competent authority shall decide that the poultry 
or other birds are: 

(a) 

killed as soon as possible, or 

(b) 

slaughtered 
measures are applied. 

in  a  designated  slaughterhouse,  provided 

that  bio-security 

4. 

The competent authority shall ensure that the following are disposed of under official 
supervision: 

(a) 

carcasses, and 

(b)  hatching eggs on the holding. 

5. 

The competent authority shall ensure that the following measures are taken: 

(a) 

hatching  eggs  collected  from  the  holding  during  the  period  between  the 
probable introduction of LPAI into the holding and the taking of the measures 
provided for in this Directive, are wherever possible traced and hatched under 
official surveillance;  

(b)  poultry already hatched from eggs collected from the holding during the period 
between the probable introduction of LPAI into the holding and the taking of 
the  measures  provided  for  in  this  Directive,  are  placed  under  official 
surveillance  and  investigations  are  carried  out  in  accordance  with  the 
diagnostic manual; 

(c) 

table  eggs  present  on  the  holding  and  further  produced  in  the  holding  before 
depopulation,  as  provided  for  in  paragraph  2,  are  either  transported  to  a 
designated packing centre, treated or disposed of;  

(d) 

any  material  or  substance  likely  to  be  contaminated  are  either  treated  in 
accordance with the instructions of the official veterinarian or disposed of;  

(e)  manure, slurry and bedding likely to be contaminated are treated in accordance 

with Article 49;  

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(f) 

after depopulation, the buildings used for housing the poultry and other birds, 
the equipment likely to be contaminated and the vehicles used for transporting 
carcasses, feed, manure, slurry, and bedding or any other material or substance 
likely  to  be  contaminated  are  cleansed,  disinfected  or  treated  in  accordance 
with Article 49 as soon as possible;  

(g)  domestic animals, other than those which have only access to the living areas 
for  humans  do  not  enter  or  leave  the  holding without the authorisation of the 
competent authority;  

(h) 

in the case of a primary outbreak of LPAI, the virus isolate is subjected to the 
laboratory  tests  to  identify  the  subtype  of  virus  in  accordance  with  the 
diagnostic  manual;  the  virus  isolate  shall  be  submitted  to  the  Community 
reference laboratory, as provided for in Article 52(1), as soon as possible; 

(i) 

the epidemiological inquiry is completed. 

The competent authority may take additional precautionary measures to prevent the 
spread of LPAI, including specifying the destiny and treatment of the eggs and the 
treatments of the meat obtained provided that the procedure referred to in point (b) of 
paragraph 3 is followed.  

Member  States  applying  the  measures  provided  for  in  paragraphs  2,  4  and  5  shall 
inform the Commission thereof. 

Article 40 
Derogations for certain premises 

The  competent  authority  may  grant  derogations  from  the  measures  provided  for  in 
Article 39(2) and point (b) of Article 39(4) in cases of an outbreak of LPAI in a non-
commercial holding/pet bird holding, a circus, a zoo, a pet bird shop, a wild life park, 
a fenced area where poultry or other birds are kept for scientific purposes or purposes 
related to the conservation of endangered species or officially registered rare breeds 
of  poultry  or  other  birds,  provided  that  such  derogations  do  not  endanger  disease 
control and basic Community interests. 

6. 

7. 

1. 

2. 

The competent authority shall ensure that where a derogation is granted, as provided 
for in paragraph 1, the poultry and other birds concerned by the derogation: 

(a) 

are  kept  completely  isolated  from  other  poultry  or  other  birds  and  where 
appropriate from wild birds;  

(b)  must  be  subjected  to  further  surveillance  and  testing  in  accordance  with  the 
diagnostic manual until the laboratory tests have indicated that they no longer 
pose a significant risk of further spread of LPAI; and  

(c) 

are  not  to  be  moved  from  their  holding  of  origin,  except  for  slaughter  or  to 
another holding: 

(i) 

located in the same Member State, in accordance with the instructions of 
the competent authority; or 

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(ii) 

in another Member State, subject to the agreement of the Member State 
of destination. 

The competent authority may in cases of outbreaks of LPAI in hatcheries, based on a 
risk assessment, grant derogations from some or all of the measures provided for in 
Article 39. 

Member States shall draw up detailed rules for applying the derogations provided for 
in paragraphs 1 and 3, taking account of the animal health guarantees which may be 
obtained and shall provide for alternative appropriate measures. 

Member States shall immediately inform the Commission of any derogation granted 
in accordance with paragraphs 1 and 3. 

The Commission shall review the situation with the Member State concerned and in 
the Committee as soon as possible.  

Taking account of any derogation granted, as provided for in paragraph 1, measures 
to  prevent  the  spread  of  avian  influenza  may  be  adopted  in  accordance  with  the 
procedure referred to in Article 65 (3).  

SECTION 2 
MEASURES TO BE APPLIED IN CASES OF OUTBREAK OF LPAI IN SEPARATE 
PRODUCTION UNITS AND CONTACT HOLDINGS 

Article 41 
Measures to be applied in cases of outbreaks of LPAI in separate production units 

In cases of an outbreak of LPAI in a holding which consists of two or more separate 
production units, the competent authority may grant derogations from the measures 
provided  for  in  Article  39(2),  for  production  units  containing  healthy  poultry 
provided that such derogations do not endanger disease control and basic Community 
interests.  

Member States shall draw up detailed rules for applying the derogations provided for 
in  paragraph  1,  taking  account  of  the  animal  health  guarantees  which  may  be 
obtained and shall provide for alternative appropriate measures. 

Member States shall immediately inform the Commission of any derogations granted 
in accordance with paragraph 1. 

The Commission shall review the situation with the Member State concerned and in 
the Committee as soon as possible.  

Taking account of any derogation granted, as provided for in paragraph 1, measures 
to  prevent  the  spread  of  avian  influenza  may  be  adopted  in  accordance  with  the 
procedure referred to in Article 67(3). 

3. 

4. 

5. 

6. 

7. 

1. 

2. 

3. 

4. 

5. 

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Article 42 
Measures to be applied in contact holdings  

1. 

Based  on  the  epidemiological  inquiry,  the  competent  authority  shall  decide  if  a 
holding is to be considered as a contact holding.  

The competent authority shall ensure that the measures provided for in Article 7(2) 
are  applied  to  contact  holdings  until  the  presence  of  LPAI  has  been  excluded  in 
accordance with the diagnostic manual.  

Based  on  the  epidemiological  inquiry,  the  competent  authority  shall  apply  the 
measures  provided  for  in  Article  39  to  contact  holdings  and  in  particular  if  the 
contact holding is located in an area with a high density of poultry.  

The main criteria to be considered for the application of the measures provided for in 
Article 39 in contact holdings are set out in Annex IV.  

The competent authority shall ensure that samples are taken from the poultry when 
they are killed in order to confirm or exclude the presence of the LPAI virus in those 
contact holdings in accordance with the diagnostic manual.  

2. 

3. 

SECTION 3 
ESTABLISHMENT OF RESTRICTED ZONES 

Article 43 
Establishment of restricted zones in cases of outbreaks of LPAI  

Immediately  following  an  outbreak  of  LPAI,  the  competent  authority  shall  establish  a 
restricted zone with a radius of at least three kilometres around the holding. 

Article 44 
Measures to be applied in the restricted zone 

1. 

The competent authority shall ensure that the following measures are applied in the 
restricted zone: 

(a) 

a census of all poultry holdings is made as soon as possible; 

(b) 

(c) 

laboratory  tests are carried out on poultry  holdings within a  radius of at  least 
one kilometre around the holding in accordance with the diagnostic manual.  

all movements of poultry and other birds, ready-to-lay poultry, day-old chicks 
and  hatching  and  table  eggs  within  the  restricted  zone  are  subjected  to 
authorisation  and  to  other  control  measures  deemed  appropriate  by  the 
competent  authority;  this  restriction  shall  not  apply  to  the  transit  through  the 
restricted zone on road or rail without unloading or stopping;  

(d) 

the movement of poultry and other birds, ready-to-lay poultry, day-old chicks 

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40 

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and hatching and table eggs from the restricted zone are prohibited during the 
first  15 days  following  the  establishment  of  the  zone,  unless  the  competent 
authority authorises the direct transport of: 

(i) 

poultry for slaughter to a slaughterhouse in the same Member State; 

(ii) 

ready-to-lay poultry to a holding under official surveillance in the same 
Member  State  in  which  there  is  no  other  poultry;  that  holding  shall  be 
placed under official surveillance following the arrival of the ready-to-lay 
poultry; 

(iii)  day-old-chicks: 

– 

– 

to a holding or shed of such holding in the same Member State in 
which  there  is  no  other  poultry,  provided  that  appropriate 
biosecurity  measures  are  applied  and  the  holding  is  placed  under 
official surveillance following the transport; or 

if  hatched  from  hatching  eggs  originating  from  poultry  holdings 
located outside of the restricted zone to any other holding provided 
that the hatchery can ensure by its logistics and biosecurity working 
conditions that any contact is excluded with hatching eggs or day-
old-chicks originating from poultry flocks in the restricted zone and 
which are therefore of a different health status; 

(iv)  hatching  eggs  to  a  designated  hatchery;  the  eggs  and  their  packaging 
shall  be  disinfected  before  dispatch  and  the  tracing  back  of  these  eggs 
must be ensured; 

(v) 

table eggs to a packing centre provided that they are packed in disposable 
packaging by the application of biosecurity measures in accordance with 
the instructions of the competent authority;  

(e) 

carcasses shall be disposed of; 

(f) 

any  person  entering  or  leaving  holdings  in  the  restricted  zone  observes 
appropriate  biosecurity  measures  aimed  at  preventing  the  spread  of  avian 
influenza;  

(g)  vehicles and equipment used for transporting live poultry or other birds, feed, 
manure,  slurry  and  bedding  and  any  other  material  or  substances  likely  to  be 
contaminated  are  cleansed  and  disinfected  as  soon  as  possible  after 
contamination, in accordance with Article 49;  

(h)  no poultry, other birds or mammals of domestic species may enter or leave a 
holding where poultry is kept without authorisation of the competent authority; 
this  restriction  shall  not  apply  to  mammals  of  domestic  species  which  have 
only  access  to  the  living  areas  for  humans  on  such  holdings  and  when  any 
contact to poultry or other birds can be excluded; 

(i) 

any increased morbidity or mortality or significant drop in production data in 
holdings is immediately reported to the competent authority, which shall carry 

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41 

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out appropriate investigations in accordance with the diagnostic manual;  

(j) 

the  removal  or  spreading  of  used  litter  or  manure  is  prohibited,  unless 
authorised  by  the  competent  authority;  the  movement  of  manure  may  be 
authorised  from  a  holding  situated  in  the  restricted  zone  under  biosecurity 
measures  to  a  designated  plant  for  treatment  or  for  intermediate  storage  for 
subsequent  treatment  to  destroy  the  possible  presence  of  avian  influenza 
viruses in accordance with Regulation (EC) No 1774/2002 or with the specific 
rules referred to in Article 64 (1); 

(k) 

fairs,  markets,  shows  or  other  gatherings  of  poultry  or  other  birds  are 
prohibited, unless authorised by the competent authority;  

(l) 

poultry or other birds for restocking of game are not be released. 

2. 

3. 

The competent authority may, based on a risk assessment, introduce further measures 
in  addition  to  the  measures  provided  for  in  this  Section  and  shall  inform  the 
Commission thereof.  

Taking account of the measures referred to in paragraph 2, further measures may be 
adopted  to  prevent  the  spread  of  avian  influenza  in  accordance  with  the  procedure 
referred to in Article 65(3).  

Article 45 
Duration of measures  

The measures provided for in this Section shall be maintained either: 

(a) 

(b) 

1. 

2. 

at  least  21  days  following  the  date  of  completion  of  preliminary  cleansing  and 
disinfection  of  the  infected  holding  in  accordance  with  Article  49  and  until  the 
competent authorities, based on the investigations and laboratory tests carried out in 
the restricted zone in accordance with the diagnostic manual and a risk assessment, 
consider that the risk of spread of LPAI is negligible; or 

at  least  42  days  following  the  date  of  confirmation  of  the  outbreak  and  until  the 
competent authorities, based on the investigations and laboratory tests carried out in 
the restricted zone in accordance with the diagnostic manual and a risk assessment, 
consider that the risk of spread of LPAI is negligible. 

Article 46 
Derogations  

Where  LPAI  is  confirmed  in  a  hatchery,  the  competent  authority  may,  based  on  a 
risk  assessment,  derogate  from  some  or  all  of  the  measures  provided  for  in 
Articles 43 and 44.  

The  competent  authority  may  grant  derogations  from  the  measures  provided  for  in 
Article  43  and  points  (c),  (d),  (h)  and  (i)  of  Article  44  in  cases  of  an  outbreak  of 
LPAI in a non-commercial holding/pet bird holding, a circus, a zoo, a pet bird shop, 
a  wild  life  park,  a  fenced  area  where  poultry  or  other  birds  are  kept  for  scientific 

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3. 

4. 

5. 

1. 

2. 

3. 

4. 

1. 

purposes or purposes related to the conservation of endangered species or officially 
registered rare breeds of poultry or other birds, provided that such derogations do not 
endanger disease control and basic Community interests. 

Member  States  granting  the  derogation  provided  for  in  paragraphs  1  and  2  shall 
immediately inform the Commission thereof. 

The Commission shall review the situation with the Member State concerned and in 
the Committee as soon as possible.  

Taking  account  of  any  derogation  granted,  as  provided  for  in  paragraphs  1  and  2, 
measures to prevent the spread of avian influenza may be adopted in accordance with 
the procedure referred to in Article 65(3).  

CHAPTER VI 

MEASURES CONCERNING PUBLIC HEALTH AND ANIMALS OTHER THAN 
POULTRY OR OTHER BIRDS  

Article 47 
Public health measures 

Member States shall ensure that in cases  of outbreaks or  confirmation of  any other 
finding  of  influenza  viruses  of  avian  origin  in  poultry  and  other  birds  or  mammals 
which  may  pose  a  risk  to  public  health,  the  competent  authority  shall  contact  the 
relevant national public health authority as soon as possible in order to decide on the 
early  adoption  of  appropriate  precautionary  measures  aiming  at  the  prevention  of 
influenza infections in poultry workers and other persons at risk.  

Where a risk to public health is identified, as referred to in paragraph 1, the Member 
State  concerned  shall  immediately  inform  the  Commission  and  the  other  Member 
States thereof. 

The  situation  shall  be  reviewed  in  the  framework  of  the  Committee  as  soon  as 
possible.  

Additional  animal  health  measures  to  prevent  the  spread  of  avian  influenza  from 
poultry, other birds or mammals to humans may be adopted in accordance with the 
procedure referred in Article 65 (3).  

Article 48 
Laboratory tests and other measures concerning pigs and other animals  

The competent authority shall ensure that following an outbreak, laboratory tests are 
carried out on pigs present on the holding to confirm or exclude the presence of avian 
influenza.  

No pigs shall be moved from the holding pending the results of those tests. 

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2. 

3. 

4. 

5. 

6. 

7. 

Where the laboratory tests provided for in paragraph 1 confirm positive findings for 
avian influenza viruses in pigs, the competent authority may authorize the movement 
of  those  pigs  to  other  pig  holdings  or  to  designated  slaughterhouses,  provided  that 
subsequent appropriate tests have shown that the risk of spread of avian influenza is 
negligible.  

The competent authority shall ensure that where the laboratory tests provided for in 
paragraph  1  confirm  a  serious  health  threat,  the  pigs  are  killed  as  soon  as  possible 
under  official  supervision  and  in  such  a  way  as  to  prevent  the  spread  of  avian 
influenza,  in  particular  during  transport,  and  in  accordance  with  Directive 
93/119/EEC.  

The  competent  authority  may,  following  an  outbreak  or  confirmation  of  a  positive 
finding of avian influenza in pigs on a holding, and based on a risk assessment, apply 
the measures provided for in paragraphs 1, 2 and 3 to any other animals present on 
the holding and may extend those measures to contact holdings 

Member States shall inform the Commission within the framework of the Committee 
of the results of the tests and measures applied pursuant to paragraphs 1 to 4.  

Additional  measures  to  prevent  the  spread  of  avian  influenza  in  pigs  and  other 
animals,  may  be  adopted  in  accordance  with  the  procedure  referred  to  in 
Article 65 (3)  

Rules  for  the  application  of  this  Article  may  be  adopted  in  accordance  with  the 
procedures referred to in Article 65 (2). 

CHAPTER VII 

CLEANSING, DISINFECTION AND RE-POPULATION 

Article 49 
Cleansing, disinfection and treatment  

Member States shall ensure that: 

(a) 

the  cleansing,  disinfection  and  treatment  of  places,  vehicles  and  any  materials  or 
substances  contaminated  or  likely  to  be  contaminated  with  avian  influenza  viruses 
are carried out under official supervision in accordance with: 

(i) 

the instructions of the official veterinarian; and 

(ii) 

the principles and procedures for cleansing, disinfecting and treatment set out 
in Annex VI. 

(b) 

the disinfectants to be used and their concentrations are approved by the competent 
authority; 

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1. 

2. 

3. 

4. 

5. 

6. 

Article 50 
Re-population of holdings  

Member States shall ensure that paragraphs 2 to 6 of this Article are complied with, 
following the application of the measures provided for in Articles 11 and 39. 

The re-population of poultry in a commercial poultry holding shall not take place for 
a  period  of  21  days  following  the  date  of  completion  of  the  final  cleansing  and 
disinfection as provided for in Article 49.  

The following measures shall be performed during a period of 21 days following the 
date of the re-population of the commercial poultry holdings: 

(a) 

the poultry undergoes a weekly clinical examination carried out by the official 
veterinarian; 

(b) 

laboratory tests are carried out in accordance with the diagnostic manual;  

(c) 

(d) 

(e) 

(f) 

(g) 

poultry  that  die  during  the  re-population  phase  are  tested  in  accordance  with 
the diagnostic manual;  

any person entering or leaving the commercial poultry holding complies with 
appropriate  biosecurity  measures  aimed  at  preventing  the  spread  of  avian 
influenza;  

during  the  re-population  phase  no  poultry  leaves  the  commercial  poultry 
holding without the authorisation of the competent authority; 

the  owner  keeps  a  record  on  the  production  data,  which  must  be  updated 
regularly; 

any significant change in production data, as referred to in point (f), and other 
abnormalities are immediately reported to the competent authority.  

The  re-population  of  poultry  or  other  birds  in  non-commercial  holding/pet  bird 
holding, a circus, a zoo, a pet bird shop, a bird market, an aviary, a wild life park, or 
a fenced area where poultry or other birds are kept for scientific purposes or purposes 
related to the conservation of endangered species or officially registered rare breeds 
of  poultry  or  other  birds  shall  take  place  in  accordance  with  the  instructions  of  the 
competent authority. 

The  re-repopulation  of  poultry  in  contact  holdings  shall  take  place  in  accordance 
with the instructions of the competent authority. 

Based  on  a  risk  assessment,  the  competent  authority  may  order  that  the  procedures 
provided  for  in  paragraph  3  be  applied  to  other  holdings  than  commercial  poultry 
holdings. 

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CHAPTER VIII 

DIAGNOSTIC PROCEDURES, DIAGNOSTIC MANUAL AND REFERENCE 
LABORATORIES  

Article 51 
 Diagnostic procedures and diagnostic manual 

1. 

The Member States shall ensure that diagnostic procedures, sampling and laboratory 
testing  to  detect  the  presence  of  avian  influenza  are  carried  out  in  accordance  with 
the  diagnostic  manual  in  order  to  ensure  uniform  procedures  for  the  diagnosis  of 
avian influenza.  

That  manual  shall  be  adopted  in  accordance  with  the  procedure  referred  to 
Article 65 (2)  within six months from the date of entry into force  of  this  Directive. 
Any subsequent amendment to the  manual  shall be  adopted  in  accordance with  the 
same procedure  

2. 

The  diagnostic  manual  provided  for  in  paragraph  1  shall  establish  at  least  the 
following: 

(a)  minimum biosecurity requirements and quality standards: 

(i) 

to  be  observed  by  approved  laboratories  carrying  out  tests  for  the 
diagnosis of avian influenza; and  

(ii) 

for the transport of samples; 

(b) 

(c) 

criteria  and  procedures  to  be  followed  when  clinical  or  post-mortem 
examinations  are  carried  out  to  confirm  or  exclude  the  presence  of  avian 
influenza; 

criteria  and  procedures  to  be  followed  for  the  collection  of  samples  from 
poultry or other birds for laboratory tests to confirm or exclude the presence of 
avian  influenza;  including  sampling  methods  for  serological  or  virological 
screenings carried out in accordance with this Directive; 

(d) 

laboratory tests to be used for the diagnosis of avian influenza, including: 

(i) 

tests for the differential diagnosis; 

(ii) 

tests to distinguish HPAI and LPAI viruses; 

(iii)  suitable tests to distinguish between birds vaccinated and those infected 

with the field strain of avian influenza;  

(iv)  criteria for the evaluation of the results of the laboratory tests; 

(e) 

laboratory techniques for the typing of avian influenza virus isolates. 

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3. 

1. 

2. 

Member States shall ensure that avian influenza viruses, their genome and antigens, 
and vaccines for research, diagnosis or manufacture of vaccine shall be manipulated 
or  used  only  in  places,  establishments  or  laboratories  approved  by  the  competent 
authority where the appropriate biosecurity requirements are guaranteed. 

The  list  of  approved  places,  establishments  or  laboratories  shall  be  transmitted  to 
the Commission by 1 July 2006 and kept up-to-date.  

Article 52 
Reference laboratories 

The laboratory set out in Annex VII shall be the Community reference laboratory for 
avian influenza (‘the Community reference laboratory’).  

Without  prejudice  to  Decision  90/424/EEC,  the  Community  reference  laboratory 
shall carry out the functions and duties listed in Part 2 of that Annex.  

The  laboratories  listed  in  Part  1  of  Annex  VIII  shall  be  the  national  reference 
laboratories for avian influenza (‘the national reference laboratories’).  

Member States shall communicate to the Commission and other Member States any 
changes  concerning  their  national  reference  laboratories  as  listed  in  Part  1  of  that 
Annex . 

3. 

Member States shall ensure that the national reference laboratories: 

(a) 

carry out the functions and duties set out in Part 2 of Annex VIII; 

(b) 

are  responsible  for  co-ordinating  standards  and  methods  of  diagnosis  in  each 
Member State in accordance with Annex VIII and liasing with the Community 
reference laboratory. 

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CHAPTER IX 

VACCINATION 

SECTION 1 
GENERAL PROHIBITION OF VACCINATION 

Article 53 
Manufacture, sale and use of avian influenza vaccines 

1. 

Member States shall ensure that: 

(a) 

(b) 

(c) 

vaccination  against  avian  influenza  is  prohibited  on  their  territory,  except  as 
provided for in Sections 2 and 3; 

the  handling,  manufacture,  storage,  supply,  distribution  and  sale  of  avian 
influenza vaccines on their territory are carried out under official supervision; 

only  vaccines  authorised  in  accordance  with  Directive  2001/82/EC  and 
Regulation No 726/2004 are used. 

2. 

Rules  relating  to  the  conditions  of  supply  and  storage  of  stocks  of  avian  influenza 
vaccines  in  the  Community  may  be  adopted  in  accordance  with  the  procedure 
referred to in Article 65(2).  

SECTION 2 
EMERGENCY VACCINATION 

Article 54 
 Emergency vaccination in poultry or other birds 

1. 

2. 

Member  States  may  introduce  emergency  vaccination  in  poultry  or  other  birds,  in 
accordance  with  this  Section,  where  there  is  an  outbreak  and  a  risk  that  avian 
influenza may spread.  

Where a Member State intends to introduce emergency vaccination, as provided for 
in paragraph 1, it shall submit an emergency vaccination plan to the Commission for 
its approval.  

That  plan  shall  be  in  accordance  with  a  DIVA  strategy  and  contain  at  least  the 
following information: 

(a) 

the  disease  situation  which  has  led  to  the  application  for  emergency 
vaccination; 

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(b) 

(c) 

the geographical area in which emergency vaccination is to be carried out and 
the number of holdings in that area; 

the  species  and  categories  of  poultry  or  other  birds  or,  if  appropriate,  the 
poultry or other birds compartment to be vaccinated; 

(d) 

the approximate number of poultry or other birds to be vaccinated; 

(e) 

the summary of the vaccine characteristics; 

(f) 

the envisaged duration of the emergency vaccination campaign; 

(g)  measures  for  movements  of  poultry  or  other  birds  and  their  products  in 
accordance  with  the  general  requirements  set  out  in  Annex  IX,  except  where 
the Member State concerned provides justification for measures differing from 
those general requirements; 

(h) 

the  criteria  for  deciding  if  emergency  vaccination  is  to  be  applied  in  contact 
holdings; 

(i) 

the record keeping and registration of the vaccinated poultry and other birds; 

(j) 

clinical and laboratory tests to be carried out in the holdings where emergency 
vaccination is to be carried out and in other holdings located in the emergency 
vaccination  area  in  order  to  monitor  the  epidemiological  situation,  the 
effectiveness  of  the  emergency  vaccination  campaign  and  the  control  of 
movements of vaccinated poultry and other birds. 

3. 

Detailed rules for emergency vaccination may be established in accordance with the 
procedure referred to in Article 65 (2). 

Article 55 
Approval of emergency vaccination plans  

1. 

2. 

The  Commission  shall  immediately  examine  the  emergency  vaccination  plan,  as 
provided  for  in  Article  54(2),  together  with  the  Member  State  concerned  and  shall 
review the situation in the Committee as soon as possible. 

The emergency vaccination plan shall be approved in accordance with the procedure 
referred to in Article 65(3). 

The approval of the emergency vaccination plan may include measures restricting the 
movements of poultry or other birds and their products. Those measures may include 
restrictions concerning specific poultry compartments and other birds compartments 
and the establishment of restricted zones.  

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Article 56 
Derogations 

1. 

By  way  of  derogation  from  Article  54,  Member  States  may  apply  emergency 
vaccination around the outbreak before approval of the emergency vaccination plan, 
subject to the following conditions: 

2. 

3. 

1. 

2. 

(a) 

(b) 

(c) 

the  emergency  vaccination  plan  and  the  decision  to  apply  emergency 
vaccination  are  notified  to  the  Commission  before  the  commencement  of  the 
emergency vaccination; 

the  Member  State  concerned  applies  the  general  requirements  for  movements 
of poultry and poultry products set out in Annex IX;  

the decision to apply emergency vaccination does not endanger disease control 
and basic Community interests. 

When a Member State applies the derogation provided for in paragraph 1, the disease 
situation and the emergency vaccination plan shall be reviewed in the Committee as 
soon as possible.  

Additional measures may be adopted in accordance with the procedure referred to in 
Article 65 (3).  

SECTION 3 
PROTECTIVE VACCINATION 

Article 57 
Protective vaccination in poultry or other birds 

Member  States  may  introduce  protective  vaccination  in  poultry  or  other  birds,  in 
accordance  with  this  Section,  where  they  deem  that  certain  areas  of  their  territory, 
certain characteristics of their poultry production or certain categories of poultry or 
other  birds  are  at  a  particular  high  risk  of  the  introduction  and  spread  of  avian 
influenza.  

Where a Member State intends to introduce protective vaccination, as provided for in 
paragraph 1, it shall submit a protective vaccination plan to the Commission for its 
approval.  

That  plan  shall  be  in  accordance  with  a  DIVA  strategy  and  contain  at  least  the 
following information: 

(a) 

(b) 

a clear description of the reasons for the protective vaccination, including the 
disease history; 

the  geographical  area  in  which  the  protective  vaccination  is  to  be  carried  out 
and the number of holdings in that area; 

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(c) 

the  species  and  categories  of  poultry  or  other  birds  or,  if  appropriate,  the 
poultry or other birds compartment to be vaccinated; 

(d) 

the approximate number of poultry or other birds to be vaccinated; 

(e) 

the summary of the vaccine characteristics; 

(f) 

the envisaged duration of the protective vaccination campaign; 

(g) 

the specific provisions on the movements of vaccinated poultry and other birds 
without  prejudice  to  the  measures  provided  for  in  Sections  4,  5  and  6  of 
Chapter IV and Section 3 of Chapter V; 

(h) 

the record keeping and registration of the vaccinated poultry and other birds; 

(i) 

the  laboratory  tests  to  be  carried  out  in  the  holdings  where  protective 
vaccination is to be carried out and such tests in other holdings located in the 
vaccination  area  in  order  to  monitor  the  epidemiological  situation,  the 
effectiveness  of  the  protective  vaccination  campaign  and  the  control  of 
movements of vaccinated poultry and other birds. 

Detailed rules for protective vaccination may be established in accordance with the 
procedure referred to in Article 65(2). 

Article 58 
Approval of protective vaccination plan 

The Commission shall immediately examine the protective vaccination plan provided 
for in Article 57(2), together with the Member State concerned and shall review the 
situation in the Committee as soon as possible. 

The protective vaccination plan shall be approved in accordance with the procedure 
referred to in Article 65(3).  

The approval of the protective vaccination plan may include measures restricting the 
movements of poultry or other birds and their products. Those measures may include 
restrictions concerning specific poultry compartments and other birds compartments 
and the establishment of restricted zones.  

3. 

1. 

2. 

SECTION 4 
VACCINE BANKS 

Article 59 
Community vaccine bank  

1. 

A  Community  vaccine  bank  may  be  established  in  accordance  with  the  procedure 
referred in Article 65(2). 

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2. 

3. 

1. 

2. 

Member States shall have access to the Community vaccine bank on request to the 
Commission. 

Where it is in the interest of the Community, the Commission may supply vaccines 
to third countries.  

Without  prejudice  to  agreements  concluded  between  the  Community  and  third 
countries,  the  access  of  third  countries  to  the  Community  vaccine  bank  shall  be 
authorised in accordance with the procedure referred to in Article 65 (3), subject to 
detailed arrangements between the Commission and the third country concerned on 
the  financial  and  technical  co-operation  to  be  adopted  in  accordance  with  that 
procedure. 

Article 60 
National vaccine banks 

Member  States may,  within the framework  of the contingency plan provided for in 
Article  63,  establish  or  maintain  a  national  vaccine  bank  for  storage  of  reserves  of 
avian  influenza  vaccines  authorised  in  accordance  with  Article  5  to  Article  15  of 
Directive 2001/82/EC, to be used for emergency or protective vaccination. 

Member States maintaining a national vaccine bank shall inform the Commission of 
the quantities and types of the stored vaccines. 

CHAPTER X 

COMMUNITY CONTROLS, PENALTIES AND CONTINGENCY PLANS  

Article 61 
Community controls 

Commission  experts  may  make  on-the-spot  checks  in  cooperation  with  the  competent 
authority,  in  so  far  as  it  is  necessary  to  ensure  uniform  application  of  this  Directive  in 
accordance  with  Commission  Decision  98/139/EC19  and  Article  45  of  Regulation  (EC) 
No 882/2004 of the European Parliament and of the Council20. 

Article 62 
Penalties 

Member States shall lay down the rules on penalties applicable to infringements of national 
provisions adopted pursuant to this Directive and shall take all measures necessary to ensure 
that  they  are  implemented.  The  penalties  provided  for  must  be  effective,  proportionate  and 
dissuasive.  The  Member  States  shall  notify  those  provisions  to  the  Commission  by 

19 
20 

OJ L 38, 12.2.1998, p. 10. 
OJ L 165, 30.4.2004, p. 1. 

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31 December  2006  at  the  latest  and  shall  notify  it  without  delay  of  any  subsequent 
amendment affecting them. 

1. 

2. 

3. 

4. 

5. 

Article 63 
Contingency plans 

Member  States  shall  draw  up  a  contingency  plan  in  accordance  with  Annex  X 
specifying the national measures to be implemented in the event of an outbreak and 
submit that plan to the Commission for approval.  

The  contingency  plan  shall  allow  access  to  facilities,  equipment,  personnel  and  all 
other  appropriate  materials  necessary  for  the  rapid  and  efficient  eradication  of  the 
outbreak. It shall give a precise indication of the number, location and census of all 
commercial  poultry  holdings  and  vaccine  requirements,  which  each  Member  State 
concerned considers it needs in the event of emergency vaccination. 

The Commission shall examine the contingency plans in order to determine whether 
they permit the desired objective to be attained and shall suggest to the Member State 
concerned any amendments required, in particular to ensure that they are compatible 
with those of the other Member States.  

The contingency plans shall be approved in accordance with the procedure referred 
to  in  Article  65(2).  Any  subsequent  amendments  to  that  plan  shall  be  adopted  in 
accordance with the same procedure. 

Member State shall update the contingency plan at least every five year and submit it 
to  the  Commission  for  approval  in  accordance  with  the  procedure  referred  to  in 
Article 65(2). 

In addition to the measures provided for paragraphs 1 to 4, further rules to ensure a 
rapid  and  efficient  eradication  of  avian  influenza,  including  provisions  on  disease 
control  centers,  expert  groups  and  real-time  alert  exercises,  may  be  adopted  in 
accordance with the procedure referred to in Article 65(2).  

CHAPTER XI 

IMPLEMENATING POWERS AND COMMITTEE PROCEDURE 

Article 64 
Implementing powers 

1. 

Detailed rules necessary for the implementation of this Directive shall be adopted in 
accordance with the procedure referred to in Article 65(2) and in particular specific 
rules concerning: 

(a) 

the disposal of carcasses, and  

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2. 

3. 

4. 

1. 

2. 

3. 

(b) 

the  movement  and  treatment  of  feed,  bedding,  used  litter,  manure  and  slurry 
contaminated or suspected to be contaminated. 

Any amendments to the annexes to take account of scientific and technical progress 
shall be decided in accordance with the procedure referred to in Article 65(2). 

Detailed rules required by the epidemiological situation to supplement the minimum 
control measures provided for in this Directive shall be adopted in accordance with 
the procedure referred to in Article 65(3). 

Without  prejudice  to  the  safeguard  measures  provided  for  in  Article  9  of  Council 
Directive 89/662/EEC21 or Article 10 of Council Directive 90/425/EEC22, temporary 
emergency  measures  required  due  to  a  serious  health  threat  caused  by  influenza 
viruses  of  avian  origin  other  than  those  referred  to  in  point  1  of  Article  2,  shall  be 
adopted in accordance with the procedure referred to in Article 65(3). 

Article 65 
Committee procedure 

The Commission shall be assisted by the Committee. 

Where  reference  is  made  to  this  paragraph,  Articles  5  and  7  of  Decision 
1999/468/EC shall apply. 

The period laid down in Article 5 (6) of Decision 1999/468/EC shall be set at three 
months. 

Where  reference  is  made  to  this  paragraph,  Articles  5  and  7  of  Decision 
1999/468/EC shall apply. 

The period laid down in Article 5 (6) of that Decision shall be set at 15 days. 

4. 

The Committee shall adopt its Rules of Procedure. 

CHAPTER XII 

TRANSITIONAL AND FINAL PROVISIONS 

Article 66 
Repeals 

Directive  92/40/EEC  is  repealed  as  from  31  December  2006.  References  to  Directive 
92/40/EEC shall be construed as references to this Directive and shall be read in accordance 
with the correlation table set out in Annex XI. 

21 
22 

OJ L 395, 30.12.1989, p. 13. as amended by Directive 2004/41/EC (OJ L 157, 30.4.2004, p. 33). 
OJ L 224, 18.8.1990, p. 29. as last amended by Directive 2002/33/EC (OJ L 315, 19.11.2002, p. 14). 

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1. 

2. 

1. 

Article 67 
Transitional provisions 

Contingency  plans  for  the  control  of  avian  influenza  approved  in  accordance  with 
Article  17(4)  of  Directive  92/40/EEC  and  in  force  at  31  December  2006  shall 
continue to apply for the purpose of this Directive. 

However, before 31 December 2006 Member States shall submit to the Commission 
amendments to those contingency plans, to bring them in line with this Directive. 

Those amended plans shall be approved in accordance with the procedure referred to 
in Article 65(2). 

Pending  the  application  of  this  Directive,  further  transitional  provisions  on  the 
control of avian influenza may be adopted in accordance with the procedure referred 
to in Article 65(2). 

Article 68 
Transposition  

Member States shall adopt and publish by 31 December 2006 at the latest, the laws, 
regulations  and  administrative  provisions  necessary  to  comply  with  this  Directive. 
They  shall  forthwith  communicate  to  the  Commission  the  text  of  those  provisions 
and a correlation table between those provisions and this Directive. 

They shall apply those provisions from 1 January 2007. 

When  Member  States  adopt  those  provisions,  they  shall  contain  a  reference  to  this 
Directive  or  be  accompanied  by  such  a  reference  on  the  occasion  of  their  official 
publication. Member States shall determine how such reference is to be made. 

2. 

Member States shall communicate to the Commission the text of the main provisions 
of national law which they adopt in the field covered by this Directive. 

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Article 69 
Entry into force 

This Directive shall enter into force on the twentieth day following that of its publication in 
the Official Journal of the European Union. 

Article 70 
Addressees 

This Directive is addressed to the Member States. 

Done at Brussels, 

For the Council 
The President 

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ANNEX I as referred to in Article 4(1) 

REQUIREMENTS FOR ANNUAL SURVEILLANCE PROGRAMMES FOR AVIAN 
INFLUENZA IN POULTRY AND OTHER BIRDS 

A. 

GENERAL REQUIREMENTS FOR SURVEYS IN POULTRY 

1. 

2. 

Sampling  shall  cover  the  winter  period  as  in  many  Member  States  a  large 
slaughter of poultry, in particular turkeys and geese, takes place in December- 
January. 

Testing of samples shall be carried out at the national reference laboratories for 
avian  influenza  in  Member  States  or  by  other  laboratories  approved  by  the 
competent  authorities  and  under  the  supervision  of  the  national  reference 
laboratory. 

3.  All  results,  both  serological  and  virological,  shall  be  sent  to  the  Community 
reference  laboratory  for  collation.  The  Community  reference  laboratory  shall 
provide technical support and keep an enlarged stock of diagnostic reagents. 

4.  All  avian  influenza  virus  isolates  shall  be  submitted  to  the  Community 
reference laboratory. Viruses of subtypes H5 and H7 shall be subjected to the 
characterisation tests, in accordance with the diagnostic manual. 

5.  All  positive  findings  shall  be  retrospectively  tested  at  the  holding  and  the 
conclusions of the test shall be reported to the Commission and the Community 
reference laboratory. 

6. 

7. 

8. 

9. 

Specific protocols shall accompany the sending of material to the Community 
reference laboratory. 

Collection of survey data shall be in accordance with the tables provided by the 
Community reference laboratory. In those tables the laboratory testing methods 
used shall be indicated. 

Blood  samples  for  serological  tests  shall  be  collected  from  all  species  of 
poultry, from at least 5 to 10 birds, except ducks and geese, per holding, and 
from the different sheds, if there is more than one shed on a holding. 

Sampling  shall  be  stratified  throughout  the  whole  Member  State,  so  that 
samples  can  be  considered  as  representative  for  the  whole  Member  State, 
taking into account: 

(a) 

the number of holdings to be sampled; that number shall be defined so as 
to  ensure  the  identification  of  at  least  one  infected  holding  if  the 
prevalence  of  infected  holdings  is  at  least  5%,  with  a  95%  confidence 
interval, in accordance with tables 1 and 2, and 

(b) 

the number of birds sampled from each holding shall be defined so as to 
ensure  95%  probability  of  identifying  at  least  one  positive  bird  if  the 
prevalence of seropositive birds is ≥ 30%. 

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10.  The sampling design shall also consider: 

(a) 

the  types  of  production  and  their  specific  risks,  such  as  free  range, 
outdoor  keeping,  multi  age  layers,  use  of  surface  water,  a  relatively 
longer  life  span,  and  the  presence  of  more  than  one  species  on  the 
holding; 

(b) 

the number of turkey holdings to be sampled, which shall be defined to 
ensure the identification of at least one infected holding if the prevalence 
of infected holdings is at least 5%, with a 99% confidence interval; 

(c)  where  holdings  producing  ratites  and  quails  are  present  in  a  Member 
State they shall be included in the annual surveillance programme; 

(d) 

the  time  period;  where  appropriate,  sampling  shall  be  adapted  to 
identified periods, during which the presence of other poultry hosts on a 
holding might pose a greater risk for disease introduction; 

(e)  Member  States  that  must  carry  out  sampling  for  Newcastle  disease  to 
maintain  their  status  as  Newcastle  disease  non-vaccinating  countries 
(Commission  Decision  94/327/EC23)  may  utilise  these  samples  from 
breeding flocks for the surveillance of H5/H7 antibodies. 

Table 1: Number of holdings to be sampled of each poultry category 
(except turkey holdings) 

Number of holdings per 
poultry category (except 
turkey holdings) 

Number of holdings to be 
sampled 

Up to 34 

35-50 

51-80 

81-250 

>250 

All 

35 

42 

53 

60 

23 

OJ L 146, 11.6.1994, p. 17. 

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Table 2: Number of turkey holdings to be sampled 

Number of turkey 
holdings 

Number of holdings to be 
sampled 

Up to 46 

47-60 

61-100 

101-350 

>350 

All 

47 

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80 

90 

B. 

SPECIFIC  REQUIREMENTS  FOR  DETECTION  OF  INFECTIONS  WITH 
H5/H7 SUBTYPES OF AVIAN INFLUENZA IN DUCKS AND GEESE 

1. 

2. 

Blood  samples  for  serological  testing  shall  be  taken  preferably  from  birds 
which are kept outside in fields. 

From each selected holding 40-50 blood samples shall be taken for serological 
testing. 

C. 

SPECIFIC REQUIREMENTS FOR DETECTION OF INFECTION IN WILD 
BIRDS 

Survey design and implementation 

1. 

2. 

3. 

4. 

5. 

In  order  to  ensure  a  proper  designing  and  implementation  of  sampling,  the 
Member  States  shall  ensure  co-operation  between  veterinary  authorities,  wild 
life biologists, bird-watching and -ringing organisations and hunters. 

Sampling  shall  focus  on  the  wild  birds  migrating  south  during  autumn  and 
early winter. 

Sampling procedures, storage and transport of samples 

Cloacal  swabs  for  virological  tests  shall  be  taken,  particularly  from  those 
species  with  high  susceptibility  and  increased  contact  with  poultry,  such  as 
Mallard ducks. 

The distribution between the different species shall, if possible, be as follows: 
70% waterfowl; 20% shorebirds; 10% other free-living birds. 

Swabs containing faeces, or carefully collected fresh faeces shall be taken from 
wild birds trapped, hunted and found freshly dead. 

6. 

Pooling of up to five samples from the same species shall be possible. 

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7. 

Specific  care  shall  be  taken  for  the  storage  and  transport  of  samples.  If  rapid 
transport within 48 hours to the laboratory, in transport medium at 4° Celsius, 
is not guaranteed, samples shall be stored and then transported in dry ice at -
70° Celsius. 

D. 

LABORATORY TESTING 

Laboratory  tests  shall  be  carried  out  in  accordance  with  the  diagnostic  manual. 
However, Member States wishing to adopt different tests, shall provide the relevant 
validation data to the Commission and the Community reference laboratory. 

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ANNEX II as referred to in Article 5(2) 

NOTIFICATION OF DISEASE AND FURTHER EPIDEMIOLOGICAL 
INFORMATION TO BE PROVIDED BY THE MEMBER STATES  

1. 

Within 24 hours of the confirmation of any primary outbreak, or detection of avian 
influenza  in  a  slaughterhouse  or  means  of  transport  the  Member  State  concerned 
shall  notify  in  accordance  with  the  procedure  referred  to  in  Article  5  of  Directive 
82/894/EEC: 

(a) 

the date of notification; 

(b) 

the time of notification; 

(c) 

the name of the Member State concerned; 

(d) 

the name of the disease;  

(e) 

the  number  of  the  outbreak  or  positive  finding  of  avian  influenza  in  a 
slaughterhouse or means of transport;  

(f) 

the date on which the disease was first suspected; 

(g) 

the date of confirmation; 

(h) 

the methods used for confirmation; 

(i)  whether the disease has been confirmed in a holding, slaughterhouse or means 

of transport; 

(j) 

the geographical location of the outbreak or positive finding of avian influenza 
in a slaughterhouse or means of transport; 

(k) 

the disease control measures applied.  

2. 

In  the  case  of  positive  findings  for  avian  influenza  in  slaughterhouses  or  means  of 
transport,  the  Member  State  concerned  must  forward  the  following  information  in 
addition to the data referred to in paragraph 1: 

(a) 

(b) 

(c) 

(d) 

the number of susceptible poultry or other birds in the slaughterhouse or means 
of transport; 

the  number  of  dead  poultry  or  other  birds  of  each  category  in  the 
slaughterhouse or means of transport; 

for each poultry or other bird category, the identified morbidity and the number 
of poultry in which avian influenza has been confirmed; 

the number of poultry or other birds killed or slaughtered in the slaughterhouse 
or means of transport; 

(e) 

the number of poultry or other birds disposed of; 

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(f) 

(g) 

in case of a slaughterhouse, the distance from the nearest poultry or other bird 
holding; 

the  location  of  the  holding  or  holdings  of  origin  of  the  infected  poultry  or 
carcasses. 

In the case of secondary outbreaks, the information referred to in paragraph 1 and 2 
must be forwarded within the time-limits laid down in the first paragraph of Article 4 
of Directive 82/894/EEC. 

The  Member  State  concerned  shall  ensure  that  the  information  to  be  provided  in 
accordance with paragraph 1, 2 and 3, in relation to any outbreak or positive finding 
of avian influenza in a slaughterhouse or means of transport is followed as soon as 
possible  by  a  written  report  to  the  Commission  and  the  other  Member  States 
including at least: 

(a) 

(b) 

(c) 

(d) 

the date on which the poultry or other birds on the holding, slaughterhouse or 
means of transport were killed and their carcasses disposed of or slaughtered; 

any information relating to the possible origin of that disease or, if ascertained, 
its actual origin; 

information  on  the  control  system  established  to  ensure  that  the  measures  in 
place for the control of animal movements are effectively implemented; 

in  the  case  of  detection  of  avian  influenza  in  a  slaughterhouse  or  means  of 
transport, the genetic type of virus responsible; 

(e)  where poultry or other birds have been killed or slaughtered in contact holdings 
or  in  holdings  containing  poultry  or  other  birds  suspected  of  being  infected 
with avian influenza virus, information on: 

(i) 

(ii) 

the  date  of  killing  or  slaughtering  and  the  number  of  poultry  or  other 
birds of each category killed or slaughtered in each holding; 

the epidemiological link between the source of infection and each contact 
holding  or  the  other  reasons  that  have  induced  the  suspicion  that  avian 
influenza is present in each suspected holding; 

(iii)  where poultry or other birds in contact holdings have not been killed or 
slaughtered, information must be provided concerning the reasons for the 
decision not to kill or slaughter them. 

In case of confirmation of avian influenza in live poultry or poultry products being 
imported  or  introduced  at  Community  borders,  in  border  inspection  posts  or  in 
quarantine facilities or centres operating in accordance  with Community  legislation 
on  imports,  the  competent  authority  must  notify  this  finding  to  the  Commission 
without delay and report on the measures taken. 

The  results  of  any  surveillance  for  avian  influenza  carried  out  in  poultry  or  other 
birds must be notified yearly to the Commission. However, the Commission and the 

3. 

4. 

5. 

6. 

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other  Member  States  must  be  notified  within  24  hours  where  a  serious  animal  or 
public health threat is identified due to the surveillance. 

7. 

Any positive result of laboratory tests for influenza viruses of avian origin other than 
those  referred  to  in  point  1  of  Article  2,  which  have  been  carried  out  in  poultry  or 
other  birds,  must  be  notified  yearly  to  the  Commission.  However,  the  Commission 
and the other Member States must be notified within 24 hours where a serious animal 
or public health threat is identified due to the testing. 

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ANNEX III as referred to in Articles 7(2) and 11(5)  

AUTHORISATION TO REMOVE TABLE EGGS FROM A HOLDING IN 
ACCORDANCE WITH POINT (f) OF ARTICLE 7 (2) and ARTICLE 11 (5) 

The  competent  authority  may  authorise  the  transport  of  eggs  from  a  holding  subject  to  the 
provisions of point (f) of Article 7(2) and Article 11(5) of this Directive to an establishment 
approved for the manufacture of egg products in accordance with the provisions of Regulation 
(EC) No 853/2004 (‘the designated establishment’), subject to the following conditions: 

1. 

in order to be allowed to be removed from the holding of origin, the eggs must: 

(a) 

comply  with  the  requirements  laid  down  in  Section  X  of  Annex  III  to 
Regulation (EC) No 853/2004; 

(b)  be  sent  directly  from  the  suspected  holding  to  the  designated  establishment; 
each  consignment  must  be  sealed  before  dispatch  by  the  official  veterinarian 
responsible  for  the  suspected  holding  and  must  remain  sealed  throughout 
transport to the designated establishment; 

2. 

3. 

the official veterinarian responsible for the holding of origin of the eggs shall inform 
the competent authority of the designated establishment of the intention to send the 
eggs to it; 

the  competent  authority  responsible  for  the  designated  establishment  shall  ensure 
that: 

(a) 

the eggs referred to in 1(b) are kept isolated from other eggs from the time they 
arrive until they are processed; 

(b) 

the shells of such eggs are disposed of; 

(c) 

the packaging used for the eggs is either destroyed or cleansed and disinfected 
in such a way as to destroy all avian influenza viruses; 

(d) 

the eggs referred to in 1(b) are transported in cleansed and disinfected vehicles.  

EN 

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ANNEX IV as referred to in Article 15(2) and Article 42 (2) 

MAIN CRITERIA AND RISK FACTORS FOR THE DECISION TO KILL POULTRY 
IN CONTACT HOLDINGS OR HOLDINGS AT RISK 

The  competent  authority  shall  consider  the  following  criteria  when  deciding  whether  to  kill 
poultry in contact holdings or holdings at risk:  

Criteria 

Decision 

For killing 

Against killing 

signs 
influenza 

Clinical 
avian 
holdings 

suggesting 
in  contact 

High 
predominant poultry species 

susceptibility 

of 

Movement of poultry or other 
birds  from  the  outbreak  to 
contact  holdings  after 
the 
likely time of introduction of 
virus in the infected holding 

Location  of  contact  holdings 
in an area with a high density 
of poultry 

Likely  spreading  of  virus 
the  outbreak  before 
from 
application  of 
eradication 
measures 

Location  of  contact  holdings 
within  500  meters(1)  from  the 
outbreak 

Proximity of contact holdings 
to more than one outbreak 

Number  of  poultry  or  other 
birds  in  the  outbreak  and/or 
in contact holdings 

Yes 

Yes 

Yes 

Yes 

No 

No 

No 

No 

Massive/unknown 

Limited 

Yes 

Yes 

High 

No 

No 

Low 

(1) 

In case with a very high density of poultry, a longer distance must be considered. 

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ANNEX V as referred to in Article 39(1) 

CRITERIA FOR THE DECISION FOR THE DESTINY OF EGGS AND 
DEPOPULATION OF HOLDINGS IN RELATION TO LPAI 

When  deciding  on  the  destiny  of  eggs  and  on  depopulation  of  holdings  in  accordance  with 
Article 39(1) the competent authority shall at least consider the following criteria: 

(a) 

(b) 

(c) 

(d) 

(e) 

(f) 

(g) 

(h) 

(i) 

species in question; 

virus type and risk of its mutation; 

density of holdings; 

location of slaughterhouses and packing centres; 

transport route; 

evidence of spread; 

public health risk, if any; 

further treatments of the products in question; 

socio-economic impact and other impacts. 

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ANNEX VI as referred to in Article 49 

PRINCIPLES AND PROCEDURES FOR CLEANSING, DISINFECTION AND 
TREATMENT  

1. 

The  following  general  principles  and  procedures  shall  be  applied  for  the  cleaning, 
disinfection and treatment provided for in Article 49: 

(a) 

(b) 

(c) 

(d) 

(e) 

the  cleansing  and  disinfection  and,  where  necessary,  the  measures  to  destroy 
rodents  and  insects  must  be  carried  out  under  official  supervision  and  in 
accordance with the instructions given by the official veterinarian; 

the  disinfectants  to  be  used  and  their  concentrations  must  be  officially 
approved  by  the  competent  authority  to  ensure  destruction  of  avian  influenza 
virus; 

the  efficacy  of  disinfectants  must  be  checked  before  use,  as  the  efficacy  of 
certain disinfectants is diminished by prolonged storage; 

the  choice  of  disinfectants  and  of  procedures  for  disinfection  must  be  made 
taking into account the nature of the premises, vehicles and objects which are 
to be treated; 

the conditions under which degreasing agents and disinfectants are used must 
ensure  that  their  efficacy  is  not  impaired;  in  particular  technical  parameters 
indicated  by  the  manufacturer,  such  as  pressure,  minimum  temperature  and 
required contact time must be observed; 

(f) 

irrespective  of  the  disinfectant  used,  the  following  general  rules  shall  be 
applied: 

(i) 

a thorough soaking of bedding and litter, as well as faecal matter with the 
disinfectant; 

(ii)  washing and cleansing by careful brushing and scrubbing of the ground, 
floors,  ramps  and  walls  following  the  removal  or  dismantling,  where 
possible, of equipment or installations otherwise impairing the effective 
cleansing and disinfection procedures; 

(iii) 

then,  further  application  of  disinfectant  for  a  minimum  contact  time  as 
stipulated in the manufacturer’s recommendations; 

(g)  where  washing 

is  carried  out  with 

liquids  applied  under  pressure 

re-contamination of the previously cleansed parts must be avoided; 

(h)  washing,  disinfecting  or  destroying  of  equipment,  installations,  articles  or 

compartments likely to be contaminated must be included; 

(i) 

following the disinfection procedures re-contamination must be avoided; 

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(j) 

cleansing and disinfection as required in the framework of this Directive must 
be documented in the holding or vehicle register and, where official approval is 
required, be certified by the supervising official veterinarian; 

(k) 

cleansing and disinfection of vehicles used for transport and by staff. 

2. 

Cleansing  and  disinfection  of  infected  holdings  shall  be  carried  out  in  accordance 
with the following principles and procedures: 

(a) 

preliminary cleansing and disinfection: 

(i) 

during  the  killing  of  the  poultry  and  other  birds  all  necessary  measures 
must  be  taken  to  avoid  or  minimise  the  dispersion  of  avian  influenza 
virus;  those  measures  must  include  inter  alia  the  installation  of 
temporary  disinfection  equipment,  supply  of  protective  clothing, 
showers,  decontamination  of  used  equipment,  instruments  and  facilities 
and the interruption of power supply to the ventilation; 

(ii)  killed poultry or other birds must be sprayed with disinfectant; 

(iii) 

if the killed poultry or other birds have to be removed from the holding 
for disposing of, covered and leak proof containers must be used; 

(iv)  as  soon  as  the  killed  poultry  or  other  birds  have  been  removed  to  be 
disposed  of,  those  parts  of  the  holding  in  which  they  were  housed  and 
any parts of other buildings, yards etc. contaminated during the killing, or 
the  post-mortem  examination  must  be  sprayed  with  disinfectants 
approved in accordance with Article 49; 

(v) 

any  tissue  or  blood  spilled  during  the  killing  or  slaughter  or  the 
post-mortem  or  gross  contamination  of  buildings,  yards,  utensils  etc. 
must  be  carefully  collected  and  disposed  of  with  the  killed  poultry  or 
other birds; 

(vi) 

the disinfectant must remain on the surface for at least 24 hours; 

(b) 

final cleansing and disinfection: 

(i)  manure  and  used  beddings  must  be  removed  and  treated  as  provided 

in paragraph 3(a); 

(ii)  grease and dirt must be removed from all surfaces by the application of a 

degreasing agent and the surfaces washed with water; 

(iii)  after washing with cold water, further spraying with disinfectant must be 

applied; 

(iv)  after  seven  days  the  premises  must  be  treated  with  a  degreasing  agent, 
rinsed with water, sprayed with disinfectant and rinsed again with water; 

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3. 

Disinfection  of  contaminated  bedding,  manure  and  slurry  shall  be  carried  out  in 
accordance with the following principles and procedures: 

(a)  manure and used bedding shall either: 

(i) 

undergo a steam treatment at a temperature of at least 70° C;  

(ii)  be destroyed by burning;  

(iii)  be buried deep enough to prevent access by wild birds and other animals; 

or 

(iv)  be stacked to heat, sprayed with disinfectant and left for at least 42 days; 

(b) 

slurry  must  be  stored  for  at  least  60  days  after  the  last  addition  of  infective 
material, unless  the competent  authorities authorises a reduced storage period 
for slurry which has been effectively treated in accordance with the instructions 
of the official veterinarian so as to ensure the destruction of the virus. 

The  competent  authority  may  authorise  the  transportation  of  manure,  litter  and 
bedding  likely  to  be  contaminated  to  either  an  approved  plant  for  treatment  of  the 
manure where a treatment ensuring the destruction of any influenza virus is carried 
out  or  for  intermediate  storage  before  destruction  or  treatment,  in  accordance  with 
Regulation (EC) No 1774/2002 or with the specific rules referred to in Article 64(1). 
Such transport shall be carried out in closed, leak proof vehicles or containers under 
official supervision in such a way as to prevent the spread of avian influenza virus.  

4. 

However,  by  way  of  derogation  from  paragraphs  1  and  2,  in  the  case  of  holdings, 
where  birds  are  kept  in  the  open,  the  competent  authority  may  establish  specific 
procedures for cleansing and disinfection, taking into account the type of holding and 
the climatic conditions. 

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ANNEX VII as referred to in Article 52 (1) 

COMMUNITY REFERENCE LABORATORY FOR AVIAN INFLUENZA 

1. 

The Community reference laboratory for avian influenza is: 

Veterinary Laboratories Agency (VLA), New Haw, Weybridge, Surrey KT 15 3NB, 
United Kingdom. 

2. 

The functions and duties of the Community reference laboratory shall be: 

(a) 

to co-ordinate, in consultation with the Commission, the methods employed in 
the Member States for diagnosing avian influenza, specifically by; 

(i) 

(ii) 

typing,  storing  and  supplying  strains  of  avian  influenza  virus  for 
serological tests and the preparation of antisera; 

supplying  standard  sera  and  other  reference  reagents  to  the  national 
reference laboratories in order to standardise the tests and reagents used 
in the Member States; 

(iii)  building up and retaining a collection of avian influenza virus strains and 

isolates; 

(iv)  organising  periodical  comparative  tests  of  diagnostic  procedures  at 

Community level; 

(v) 

collecting and collating data and information on the methods of diagnosis 
used and the results of tests carried out in the Community; 

(vi)  characterising isolates of avian influenza viruses by the most up-to-date 
methods available to allow greater understanding of the epidemiology of 
avian influenza and to gain an insight into the epidemiology of the virus 
and  the  emergence  of  highly  pathogenic  and  potentially  pathogenic 
strains; 

(vii)  keeping  abreast  of  developments  in  avian  influenza  surveillance, 

epidemiology and prevention worldwide; 

(viii)  retaining expertise on avian influenza virus and other pertinent viruses to 

enable rapid differential diagnosis; 

(ix)  acquiring  a  thorough  knowledge  of  the  preparation  and  use  of  the 
products  of  veterinary  immunology  used  to  eradicate  and  control  avian 
influenza; 

(b) 

to actively assist in the diagnosis of outbreaks in the Community by receiving 
isolates  of  influenza  viruses  of  avian  origin  for  confirmatory  diagnosis, 
characterisation  and  epidemiological  studies  and  to  obtain  virus  isolates  from 
primary  outbreaks  to  be  submitted  from  third countries  authorised  for  the 
importation  of  live  poultry  and  meat  into  the  Community  pursuant  to  the 

EN 

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relevant Community legislation; on the virus isolates received, the Community 
reference laboratory shall in particular carry out the following: 

(i) 

nucleotide  sequencing  analysis  to  allow  determination  of  the  deduced 
amino acid sequence at the cleavage site of the haemagglutinin molecule;  

(ii)  determination of the intravenous pathogenicity index (IVPI); 

(iii)  antigenic typing; 

(iv)  phylogenetic analysis to assist in epidemiological investigations; 

(c) 

to facilitate the training or retraining of experts in laboratory diagnosis with a 
view to the harmonisation of techniques throughout the Community; 

(d)  prepare  the  programme  and  working  documents  for  the  Annual  Meeting  of 

National Reference Laboratories;  

(e) 

(f) 

assist in the conduction of avian influenza surveys in poultry and wild birds to 
be carried out in the Member States by supplying antigens in the framework of 
the  programme  and  the  approved  testing  procedures  and  prepare  a  summary 
report on the results of the surveys; 

keep  under  review  the  possible  zoonotic  impact  arising  from  avian  influenza 
viruses  and  collaborate  with  internationally  recognized  human  influenza 
laboratories. 

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ANNEX VIII as referred to in Article 52(2 

LIST OF NATIONAL REFERENCE LABORATORIES FOR AVIAN INFLUENZA 
AND THEIR FUNCTIONS AND DUTIES 

1. 

The national reference laboratories for avian influenza are as follows: 

Belgium & 
Luxembourg:  Centrum  voor  Onderzoek  in  Diergeneeskunde  en  Agrochemie

Czech 
Republic: 

Denmark: 

Germany: 

Estonia: 

Greece: 

Spain: 

France: 

(CODA) 
Centre d’Etudes et de Recherches Vétérinaires et Agrochimiques,
(CERVA) 
Groeselenbergstraat 99/ 99, Rue Groeselenberg 
B-1180 Brussel/Bruxelles 

National Reference Laboratory for Newcastle Disease and highly
pathogenic 
Avian Influenza, Statni veterinarni ustav Praha 
Sidlistni 136/24 
165 03 Praha 6-Lysolaje 

Statens Veterinære Serumlaboratorium 
Hangøvej 2 
DK-8200 Århus N. 

Friedrich-Löffler-Institut, 
Tiergesundheit (FLI) 
Boddenblick 5a 
D-17493 Greifswald - Insel Riems 

Bundesforschungsanstalt 

für

Estonian Veterinary and Food Laboratory, Tallinn laboratory 
Väike-Paala 3 
11415 Tallinn 

National  Reference  Laboratory,  (NRL)  Center  of  Veterinary
Institutes 
80, 26th October Str 
GR-54627 Thessaloniki 

Laboratorio Central de Veterinaria (L.C.V.) 
Carretera de Algete, Km. 8 
E-28110 Algete, Madrid 

Laboratoire d'Etudes de Recherches Avicoles et Porcines 
B.P. 53,  AFFSA  Ploufragan  (Agence  Française  de  Securité
Sanitaire 
des Aliments) 
F-22440 Ploufragan 

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Ireland: 

Poultry Virology, Veterinary Research Laboratory 
Abbotstown, Castleknock 
Dublin 15 

Italy&  
San Marino: 

Cyprus: 

Latvia: 

Lithuania: 

Hungary: 

Malta: 

Istituto Zooprofilattico Sperimentale delle Venezie (IZS-VE) 
Via Romea 14/A 
I-35020-Legnaro – Padova 

Veterinary Services, National Reference Laboratory for Newcastle
Disease 
and Avian Influenza 
1417 Nicosia  

State Veterinary Medicine Diagnostic Centre (SVMDC) 
Lejupes str. 3 
LV-1076 Riga 

National Veterinary Laboratory 
J.Kairiukscio 10 
LT-2021 Vilnius 

Central Veterinary Institute 
Tábornok u.2 
149 Budapest 

Food and Veterinary Division 
Laboratory Civil Abbatoir 
Albertown 

Netherlands: 

CIDC-Lelystad,  Central  Institute  for  Animal  Disease  Control,
Lelystad 
Postbox 2004 
NL-8203 AA Lelystad 

Austria: 

Poland: 

Portugal: 

Österreichische Agentur für Gesundheit und Ernährungssicherheit
(AGES) 
Veterinärmedizinische  Untersuchungen  Mödling,  Robert  Koch
Gasse 17 
A-2340 Mödling 

State Veterinary Institute in Puławy- Poultry Disease Department 
Al. Partyzantów 57 
24-100 Puławy 

Laboratório Nacional de Investigação Veterinária (LNIV) 
Estrada de Bemfica 701 
P-1549-011 Lisboa 

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   EN 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Slovenia: 

Slovakia: 

Finland: 

Sweden: 

United 
Kingdom: 

National Veterinary Laboratory 
Gerbiceva 60 
1000 Ljubljana 

State  Veterinary  Institute,  Reference  Laboratory  for  Newcastle
Disease and Avian influenza 
Pod Dráhami 918 
96086 Zvolen  

Eläinlääkintä ja elintarviketutkimuslaitos (EELA) 
Helsinki, Anstalten för veterinärmedicin och livsmedel 
Helsingfors PL 45 
FIN-00581 Helsinki  

Statens Veterinärmedicinska Anstalt 
Uppsala (SVA) 
S-75189 Uppsala 

Veterinary Laboratory Agency (VLA) Weybridge 
Avian Virology, Woodham Lane 
New Haw, Addlestone 
Surrey KT 15 3NB 

Disease Surveillance and Investigation Department 
Veterinary Sciences Division 
Soney Road 
Belfast BT4 3SD 

2. 

The functions and duties of the national reference laboratories  

(a)  The  national  reference  laboratories  shall  be  responsible  for  ensuring  that  in 
each  Member  State  the  laboratory  testing  to  detect  the  presence  of  avian 
influenza and the identification of the genetic type of virus isolates are carried 
out in accordance with the diagnostic manual. For that purpose, they may make 
special  agreements  with  the  Community  reference  laboratory  or  with  other 
national laboratories. 

(b)  The  national  reference  laboratories  shall  submit  isolates  of  influenza  virus  of 
avian  origin  to  the  Community  reference  laboratory  without  delay  for  full 
characterisation: 

(i) 

from all primary outbreaks of avian influenza; 

(ii) 

in case of secondary outbreaks, from representative number of outbreaks; 

(iii) 

in  case  of  detection  of  influenza  viruses  other  than  those  referred  to  in 
point 1 of Article 2 (a) in poultry, other birds or other animals, posing a 
serious threat to animal or public health. 

(c)  The  national  reference  laboratory  in  each  Member  State  shall  be  responsible 
for co-ordinating the standards and diagnostic methods in each avian influenza 
diagnostic laboratory within that Member State. For that purpose: 

EN 

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(i) 

they may provide diagnostic reagents to individual laboratories; 

(ii) 

they  shall  control  the  quality  of  all  diagnostic  reagents  used  in  that 
Member State; 

(iii) 

they shall arrange comparative tests periodically; 

(iv) 

they  shall  hold  isolates  of  avian  influenza  virus  from  outbreaks  and  of 
any other influenza viruses of avian origin detected in that Member State; 

(v) 

they shall collaborate with the national human influenza laboratories.  

EN 

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ANNEX IX as referred in point (g) of Article 54 (2) and point (b) of Article 56 (1) 

GENERAL REQUIREMENTS ON MOVEMENTS OF POULTRY AND POULTRY 
PRODUCTS APPLICABLE IN RELATION TO EMERGENCY VACCINATION 

1. 

2. 

Member States shall ensure that movement controls of poultry and birds vaccinated 
in accordance with Articles 54 and 56 and of their products are applied as set out in 
paragraphs 2 to 7. 

For movements of live poultry, hatching and table eggs within the vaccination area 
the following provisions shall apply: 

(a) 

hatching eggs shall: 

(i) 

originate  from  a  vaccinated  or  unvaccinated  breeding  flock  which  has 
been regularly examined, with favourable results, in accordance with the 
monitoring provided for in point (j) of Article 54(2); 

(ii)  have  been  disinfected  before  dispatch  in  accordance  with  a  method 

approved by the competent authority; 

(iii)  be  transported  directly  to  the  hatchery  of  destination  in  disposable 
packaging or materials that can be effectively washed and disinfected; 

(iv)  be traced-back in the hatchery; 

(b)  day-old chicks shall: 

(i) 

originate from hatching eggs satisfying the conditions set out in (a); 

(ii)  be  transported  in  disposable  packaging  or  materials  that  can  be 

effectively washed and disinfected: 

(iii)  be placed in a poultry house or shed where: 

– 

– 

no poultry has been kept for at least three weeks; and 

cleansing and disinfection have been carried out in accordance with 
the instructions of the competent authority; 

(c) 

ready-to-lay poultry shall: 

(i) 

have been regularly vaccinated against avian influenza, if provided for in 
the vaccination programme; 

(ii)  have  been  regularly  examined,  with  favourable  results,  in  accordance 

with the monitoring provided for in point (j) of Article 54 (2); 

(iii)  be placed in a poultry house or shed where no poultry has been kept for 
at  least  three  weeks,  and  where  cleansing  and  disinfection  has  been 
carried out; 

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(d)  poultry for slaughter shall: 

(i) 

be  examined  with  favourable  results  before  loading  in  accordance  with 
the monitoring provided for in point (j) of Article 54 (2); 

(ii)  be sent directly to a slaughterhouse for immediate slaughter; 

(iii)  be  transported  in  vehicles  cleansed  and  disinfected  under  official 

supervision before and after each transport; 

(e) 

table eggs shall: 

(i) 

originate from a vaccinated or non-vaccinated layer flock which has been 
regularly  examined,  with  favourable  results,  in  accordance  with  the 
monitoring provided for in point (j) of Article 54 (2); 

(ii)  be sent directly to a packaging centre or a thermal-treatment plant; 

(iii)  be transported using disposable packaging material or materials that can 

be effectively washed and disinfected. 

3. 

For movements of live poultry, hatching eggs and table eggs originating from outside 
the vaccination area into the vaccination area the following provisions shall apply: 

(a) 

hatching eggs shall: 

(i) 

be  transported  directly  to  the  hatchery  of  destination  in  disposable 
packaging or materials that can be effectively washed and disinfected; 

(ii)  be traced-back in the hatchery; 

(b)  day-old chicks shall: 

(i) 

be transported in disposable packaging ; 

(ii)  be placed in a poultry house or shed where: 

– 

– 

no poultry has been kept for at least three weeks; and 

cleansing and disinfection have been carried out in accordance with 
the instructions of the competent authority; 

(c) 

ready-to-lay poultry shall: 

(i) 

be placed in a poultry house or shed where no poultry has been kept forat 
least three weeks, and cleansing and disinfection have been carried out; 

(ii)  be vaccinated at the farm of destination, if provided for in the vaccination 

programme; 

(d)  poultry for slaughter shall: 

(i) 

be sent directly to a slaughterhouse for immediate slaughter; 

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(ii)  be  transported  in  vehicles  cleansed  and  disinfected  under  official 

supervision before and after each transport; 

(e) 

table eggs shall: 

(i) 

be sent directly to a packing centre or a thermal treatment plant;  

(ii)  be  transported  using  disposable  packaging  or  materials  that  can  be 

effectively washed and disinfected. 

4. 

For movements of live poultry, hatching and table eggs originating and coming from 
the  vaccination  area  towards  outside  the  vaccination  area  the  following  provisions 
shall apply: 

(a) 

hatching eggs shall: 

(i) 

originate  from  a  vaccinated  or  unvaccinated  breeding  flock  which  has 
been regularly examined, with favourable results, in accordance with the 
monitoring provided for in point (j) of Article54(2) ; 

(ii)  have  been  disinfected  before  dispatch  in  accordance  with  a  method 

approved by the competent authority; 

(iii)  be  transported  directly  to  the  hatchery  of  destination  in  disposable 
packaging or materials that can be effectively washed and disinfected; 

(iv)  be traced-back in the hatchery; 

(b)  day-old chicks shall: 

(i) 

originate from hatching eggs satisfying the conditions set out in point (a) 
of paragraph 2, point (a) of paragraph 3 or point (a) of paragraph 4; 

(ii)  be transported in disposable packaging material, 

(iii)  be placed in a poultry house or shed where: 

– 

– 

no poultry has been kept for at least three weeks; and 

cleansing and disinfection have been carried out in accordance with 
the instructions of the competent authority; 

(c) 

ready-to-lay poultry shall: 

(i) 

not have been vaccinated; 

(ii)  have been regularly examined with favourable results, in accordance with 

the monitoring provided for in point (j) of Article 54(2); 

(iii)  be placed in a poultry-house or shed where no poultry has been kept for 
at  least  three  weeks,  and  where  cleansing  and  disinfection  has  been 
carried out; 

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(d)  poultry for slaughter shall: 

(i) 

be  examined  before  loading  with  favourable  results,  in  accordance  with 
the monitoring provided for in point (j) of Article54(2)  

(ii)  be sent directly to a slaughterhouse for immediate slaughter; 

(iii)  be  transported  in  vehicles  cleansed  and  disinfected  under  official 

supervision before and after each transport; 

(e) 

table eggs shall: 

(i) 

originate from a vaccinated or non-vaccinated layer flock which has been 
regularly  examined,  with  favourable  results,  in  accordance  with  the 
monitoring provided for in point (j) of Article54(2); 

(ii)  be sent directly to a packing centre or a thermal-treatment plant; 

(iii)  be  transported  using  disposable  packaging  or  packaging  material  which 

can be effectively washed and disinfected. 

5. 

For  meat  obtained  from  poultry  kept  within  the  vaccination  area  the  following 
provisions shall apply: 

(a) 

for meat obtained from vaccinated poultry, the poultry shall: 

(i) 

have been vaccinated with a heterologous subtype vaccine, 

(ii)  have  been  regularly  inspected  and  tested  with  negative  results  in 
accordance  with  the  provisions  in  the  vaccination  programme,  in  the 
framework of a DIVA strategy, 

(iii)  have been clinically inspected by an official veterinarian within 48 hours 
before  loading;  sentinel  birds  shall  have  been  inspected  with  particular 
attention, 

(iv)  have  been  sent  directly  to  a  designated  slaughterhouse  for  immediate 

slaughter; 

(b) 

for  meat  obtained  from  non-vaccinated  poultry,  the  poultry  must  undergo 
monitoring  in  accordance  with  the  monitoring  provided  for  in  point  (j)  of 
Article 54(2). 

The  cleansing  and  disinfection  referred  to  in  this  Annex  shall  be  carried  out  in 
accordance with the instructions of the competent authority. 

The testing requirements before loading as referred to in paragraphs (2), (3) und (4) 
shall be carried in accordance with the diagnostic manual. 

6. 

7. 

EN 

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   EN 

 
ANNEX X as referred to in point 1 of Article 63 

CRITERIA FOR CONTINGENCY PLANS  

Contingency plans shall meet at least the following criteria: 

1. 

2. 

3. 

4. 

5. 

6. 

7. 

8. 

9. 

10. 

11. 

The  establishment  of  a  crisis  centre  on  a  national  level,  which  shall  co-ordinate  all 
control measures in the Member State. 

A list shall be provided of local disease control centres with adequate facilities to co-
ordinate the disease control measures at a local level. 

Detailed  information  shall  be  given  about  the  staff  involved  in  control  measures, 
their  skills,  their  responsibilities  and  the  instructions  for  staff  taking  account  of  the 
need for personal protection and the potential risk for human health posed by avian 
influenza. 

Each  local  disease  control  centre  must  be  able  to  contact  rapidly  persons  and 
organisations which are directly or indirectly involved in an outbreak, s. 

Equipment and materials shall be available to carry out the disease control measures 
properly. 

Detailed  instructions  shall  be  provided  on  action  to  be  taken  on  suspicion  and 
confirmation of infection or contamination, including proposed means of disposal of 
carcasses.  

Training programmes shall be established to maintain and develop skills in field and 
administrative procedures. 

Diagnostic  laboratories  must  have  facilities  for  post-mortem  examination,  the 
necessary capacity for serology, histology etc. and must maintain the skills for rapid 
diagnosis. Arrangements must be made for rapid transportation of samples. 

Provisions  shall  be  in  place  in  case  vaccination  against  avian  influenza  shall  be 
carried  out  containing  different  scenarios  to  be  followed,  a  comprehensive 
vaccination  plan,  the  indication  of  which  populations  of  poultry  and  birds  to  be 
included into the scheme, the estimated quantity of vaccine required, the logistics of 
such  a  measure,  in  particular,  the  possible  vaccine  availability,  the  storage  and 
distribution capacities and the availability of manpower for the administration of the 
vaccine 

Provisions  shall  be  made  for  the  availability  of  data  on  registration  of  commercial 
poultry  holdings  on  their  territory,  without  prejudice  to  other  relevant  provisions 
established by Community legislation in this field. 

Provisions  shall  be  made  for  the  recognition  of  officially  registered  rare  breeds  of 
poultry and birds. 

12. 

Provisions shall be made for the identification of areas with a high density of poultry. 

EN 

80 

   EN 

 
13. 

14. 

Provisions  shall  be  in  place  for  a  close  co-operation  between  the  competent 
authorities of the veterinary, the public health and the environmental sector. 

Provisions shall be made to ensure the legal powers necessary for the implementation 
of the contingency plans. 

EN 

81 

   EN 

 
ANNEX XI 

CORRELATION TABLE  

This Directive 

Directive 92/40 EEC 

Article 1 (1)(a),(c) 

Article 1 (1)(b) 

Article 1 (2) 

Article 1 (3) 

Article 2 (1) 

Article 2 (2),(3) 

Article  3  (1)  to  (l4),  (17),  (18),  (20),  (22)  to 
(33)  

Article 3 (15) 

Article 3 (16) 

Article 3 (19) 

Article 3 (21) 

Article 4 

Article 5 (1) 

Article 5 (2) 

Article 6 (1) 

Article 6 (2)  

Article 6 (3) and (4) 

Article 7 (1)  

Article 7 (2)(a) and (b) 

Article 7 (2)(c) 

Article 7 (2)(d) 

Article 7 (2)(e) and (g) 

- 

Article 1, first subparagraph 

- 

Article 1, second subparagraph  

Annex III, third subparagraph 

- 

- 

Article 2 (a) 

Article 2 (b) 

Article 2 (d)- 

Article 2 (e)- 

- 

Article 3 

- 

- 

Article 7 (1) 

- 

Article 4 (1)  

Article 4 (2)(a) 

Article 4 (2)(b) 

Article 4 (2)(c) 

Article 4 (2)(d) 

EN 

82 

   EN 

 
Article 7 (2)(f) 

Article 7 (2)(h) 

Article 7 (3) 

Article 8 

Article 9 

Article 10 

Article 11 (1) 

Article 11 (2) and (3) 

Article 11 (4) 

Article 11 (5) 

Article 11 (6),(7) 

Article 11 (8) 

Article 11 (9) and (10) 

Article 12 

Article 13 

Article 14 

Article 15 

Article 4 (2)(e) 

Article 4 (2)(f) 

Article 4 (2)(g) 

- 

Article 4 (5) 

- 

Article 5 (1)(a) 

Article 5 (1)(d) 

Article 5 (1)(c) 

Article 5 (1)(b) 

Article 5 (1)(e) 

- 

- 

- 

Article 6 

Article 8 

Article 16 (1) and (2) 

Article 9 (1) 

Article 16 (3) 

Article 16 (4) 

Article 17 (1) 

Article 17 (2) 

Article 18 (a)  

Article 18 (b) 

Article 18 (c) 

Article 19 (a) 

- 

Article 9 (6) 

Article 10  

Article 13 

Article 9 (2)(a) 

Article 9 (2)(b) 

- 

Article 9 (2)(c) 

EN 

83 

   EN 

 
 
Article 19 (b),(c) and (d) 

Article 9 (2)(d) and (e) 

Article 19 (e) 

Article 9 (2)(f), first subparagraph 

Article 19 (f),(g) and (h) 

- 

Article 20 

Article 21 

Article 22 

Article 23  

Article 24 

Article 25 

Article 26 (1) 

Article 26 (2)  

Article 27 

Article 28 

Article 29  

Article 30 (a) 

Article 30 (b),(c) 

Article 9 (2)(g) 

Article 9 (2)(h) 

Article 9 (2)(e)  

Article 9 (2)(f)(i) 

Article 9 (2)(f)(ii) 

- 

Article 9 (2)(f)(iii) 

- 

Article 9(2)(e) 

- 

Article 9 (3) 

Article 9 (4)(a) 

Article 9 (4)(b),(c) and (d) 

Article 30 (d),(e),(g) and (j) 

- 

Article 30 (f) 

Article 30 (h) 

Article 30 (i) 

Article31 

Article 32 

Article 33 

Article 34 

Article 35 

Article 36 

EN 

Article 9 (4)(b) 

Article 9 (4)(e) 

Article 9 (4)(f) 

Article 9 (5) 

- 

- 

- 

- 

- 

84 

   EN 

 
Article 37 

Article 38 

Article 39 

Article 40 

Article 41 

Article 42 

Article 43 

Article 44 

Article 45 

Article 46 

Article 47 

Article 48 

Article 49 

Article 50 

Article 51 

Article 52 (1) 

Article 52 (2) and (3) 

Article 53 

Article 54 

Article 55 

Article 56 

Article 57 

Article 58 

Article 59 

Article 60 

Article 61 

EN 

- 

- 

- 

- 

- 

- 

- 

- 

- 

- 

- 

- 

Article 11 

- 

- 

Article 15  

Article 14  

- 

Article 16 (a), first subparagraph 

Article 16 (a), first subparagraph 

Article 16 (a), second subparagraph 

- 

- 

- 

- 

Article 18 

85 

   EN 

 
Article 62 

Article 63 

Article 64 (1),(2) and (4) 

Article 64 (3) 

Article 65 

Article 66 

Article 67 

Article 68 

Article 69 

Article 70 

Annex I  

Annex II 

Annex III 

Annex IV 

Annex V 

Annex VI 

Annex VII 

Annex VIII 

Annex IX 

Annex X 

Annex XI 

- 

Article 17 

- 

Article 20 

Article 21 

- 

- 

-Article 22 

- 

Article 23 

- 

- 

Annex I 

- 

- 

Annex II 

Annex V 

Annex IV 

- 

Annex VI 

- 

EN 

86 

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LEGISLATIVE FINANCIAL STATEMENT 

Policy area(s): Health and Consumers Protection 

Activity: Food safety, animal health, animal welfare and plant health  

TITLE  OF  ACTION:  PROPOSAL  FOR  A  COUNCIL  DIRECTIVE  ON  COMMUNITY  MEASURES  FOR 

THE CONTROL OF AVIAN INFLUENZA 

1. 

BUDGET LINE(S) + HEADING(S) 

17 01: Administrative expenditure of health and consumer protection policy area 

17 04 02: Other measures in the veterinary, animal welfare and public-health field 

17  04  03:  Emergency  fund  for  veterinary  complaints  and  other  animal

contaminations which are a risk to public health 

2. 

OVERALL FIGURES  

2.1. 

Total allocation for action (Part B): 18,810 € million for commitment 

2.2. 

Period of application: 

Action is open ended 

2.3. 

Overall multiannual estimate of expenditure: 

(a) 

Schedule  of  commitment  appropriations/payment  appropriations 
intervention) (see point 6.1.1) 

(financial 

€ million (to three decimal places) 

Year 
[2006] 

[n+1]

[n+2] 

[n+3] 

[n+4] 

Total 

[n+5 
and 
subs. 
Years
] 

Commitments 

Payments 

3.135 

3.135 3.135 

3.135 

3.135 

3.135 

18.810 

3.135 

3.135  3.135 

3.135 

3.135 

3.135 

18.810 

(b) 

Technical and administrative assistance and support expenditure (see point 6.1.2) 

Commitments 

0.000 

0.000 

0.000 

0.000 

0.000 

0.000 

Payments 

0.000 

0.000 

0.000 

0.000 

0.000 

0.000 

EN 

87 

   EN 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
Subtotal a+b 

Commitments 

Payments 

3.135 

3.135 

3.135 

3.135 

3.135 

3.135 

18.810 

3.135 

3.135 

3.135 

3.135 

3.135 

3.135 

18.810 

(c) 

Overall  financial  impact  of  human  resources  and  other  administrative  expenditure 
(see points 7.2 and 7.3) 

0.195 

0.195 

0.195 

0.195 

01195  01195  1.170 

Commitments/ 
payments 

TOTAL a+b+c 

Commitments 

3.330 

3.330 

3.330 

3.330 

3.330 

3.330 

19.980 

Payments 

3.330 

3.330 

3.330 

3.330 

3.330 

3.330 

19.980 

2.4. 

Compatibility with financial programming and financial perspective 

Proposal is compatible with existing financial programming. 

2.5. 

Financial impact on revenue:24 

Proposal  has  no  financial  implications  (involves  technical  aspects  regarding 

implementation of a measure) 

3. 

BUDGET CHARACTERISTICS 

Type of expenditure 

New 

EFTA 
contribution 

Contributions 
form applicant 
countries 

Heading in 
financial 
perspective 

Comp 

Non-diff 

NO 

NO 

NO 

No 5 – 1a 

4. 

LEGAL BASIS  

Council Decision 90/424/EEC 

24 

For further information, see separate explanatory note. 

EN 

88 

   EN 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
                                                 
5. 

DESCRIPTION AND GROUNDS 

5.1. 

Need for Community intervention 25 

5.1.1.  Objectives pursued 

It  is  envisaged  to  update  current  Community  legislation  on  avian  influenza  laid  down  in 
Council Directive 92/40/EEC, with the objective to achieve better prevention and control of 
outbreaks and to reduce the health risks, the costs and losses and the negative impact to the 
whole of society due to Avian Influenza.  

Since  live  poultry  is  listed  in  Annex  II  of  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  to  ensure  the  development  of  this  sector.  Furthermore,  a  high  level  of 
human  health  protection  is  to  be  ensured  in  the  definition  and  implementation  of  all 
Community policies and activities.  

Furthermore,  thanks  to  the  adoption  of  other  disease  control  measures  envisaged  under  the 
current proposal, including vaccination, other savings should result from the expected reduced 
size of future AI epidemics. It is, however, extremely difficult to quantify these savings. 

Results would be achieved by means of surveillance and control measures targeted to the low 
pathogenic  form  of  disease  -  to  prevent  virus  mutation  into  its  highly  pathogenic  form-  by 
means of vaccination where appropriate and by other measures that take into account the most 
recent  scientific  knowledge  on  this  disease,  the  lessons  learned  during  recent  outbreaks  and 
the  need  to  avoid  massive  killing  and  destruction  of  animals  as  much  as  possible.  As 
mentioned already, these actions as such have no financial implications for the EU-budget. 

However,  in  combination  with  Council  Decision  90/424/EC  the  following  actions,  as  it  is 
already the case with existing avian influenza legislation, have financial consequences: 

Objective 1: emergency fund eradication of the disease 

Objective 2: surveillance 

Objective 3: establishment of a vaccine bank 

Objective 4: establishment of a Community Reference Laboratory for avian influenza  

5.1.2.  Measures taken in connection with ex ante evaluation  

In  view  of  the  increased  knowledge  on  the  risks  for  human  health  posed  by  AI 
viruses, (which, particularly in the context of the ongoing outbreak in certain Asian 
countries,  have  prompted  several  actions  by  International  organisations  such  the 
FAO, the WHO and the OIE), the opinions of the Scientific Committee and the most 
recent knowledge on the pathogenesis, the epidemiology and the distribution of AI, 
there is now a clear need to revise and update current legislation to reflect these new 
advances and experience and to improve disease control of both LPAI and HPAI in 

25 

For further information, see separate explanatory note. 

EN 

89 

   EN 

 
 
                                                 
future.  This  will  be  of  direct  benefit  to  animal  health  and  indirectly  also  human 
health.26  

5.1.3.  Measures taken following ex post evaluation 

Not applicable 

5.2. 

Action envisaged and budget intervention arrangements 

Not applicable 

5.3.  Methods of implementation 

Not applicable 

6. 

FINANCIAL IMPACT 

6.1. 

Total financial impact on Part B - (over the entire programming period) 

(The method of calculating the total amounts set out in the table below must be explained by 
the breakdown in Table 6.2.) 

6.1.1.  Financial intervention 

Commitments (in € million to three decimal places) 

Breakdown 

[2006] 

[n+1] 

[n+2] 

[n+3] 

[n+4] 

Total 

[n+5 and 
subs. 
Years] 

Operational objective Nr 1 

It is impossible to predict when and where there will be an outbreak of the disease and the relative costs.. 
The impact assessment annexed to the proposal has considered various scenarios from which it results that 
the new disease eradication measures should not lead to higher costs than the current ones. 

Operational objective Nr 2 

1.500 

1.500 

1.500 

1.500 

1.500 

1.500 

9.000 

Operational objective Nr 3 

1.500 

1.500 

1.500 

1.500 

1.500 

1.500 

9.000 

Operational objective Nr 4 

0.135 

0.135 

0.135 

0.135 

0.135 

0.135 

0.810 

TOTAL  3.135 

3.135 

3.135 

3.135 

3.135 

3.135 

18.810 

26 

For minimum information requirements relating to new initiatives, see SEC 2000 (1051) 

EN 

90 

   EN 

 
                                                 
6.1.2.  Technical  and  administrative  assistance,  support  expenditure  and  IT  expenditure 

(commitment appropriations) 

[Year n] 

[n+1] 

[n+2] 

[n+3] 

[n+4] 

Total 

[n+5 and 
subs. 
years] 

1) 
administrative assistance 

Technical 

and 

Technical 

a) 
offices

assistance 

b)  Other 
administrative assistance: 

technical 

and 

- intra muros: 

- extra muros: 

of  which  for  construction 
and 
of 
maintenance 
computerised  management 
systems 

Subtotal 1 

2) Support expenditure 

a) Studies 

b) Meetings of experts 

c) Information and 
publications 

Subtotal 2 

TOTAL 

EN 

91 

   EN 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
6.2. 

Calculation  of  costs  by  measure  envisaged  in  Part  B  (over  the  entire 
programming period)27 

Breakdown  

Commitments (in € million to three decimal places) 

Type  
of outputs 
(projects, files ) 

Number of 
outputs 

Average unit 
cost 

(total for years 
1…n)  

Total cost 

(total for years 
1…n)  

1 

2 

3 

4=(2X3) 

Action 1 

- Measure 1 

- Measure 2  

Action 2 

- Measure 1 

- Measure 2 

- Measure 3 

etc. 

TOTAL COST 

7. 

IMPACT ON STAFF AND ADMINISTRATIVE EXPENDITURE  

7.1. 

Impact on human resources 

Types of post 

Staff to be assigned to management of the 
action using existing and/or additional 
resources 

Number of 
permanent posts 

Number of 
temporary posts 

Officials 
temporary staff 

or 

A 

B 

C 

Other human resources 

Total 

1 

- 

- 

1 

- 

- 

- 

- 

- 

Total 

1 

- 

- 

- 

1 

Description of tasks deriving from the 
action 

27 

For further information, see separate explanatory note. 

EN 

92 

   EN 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
                                                 
7.2. 

Overall financial impact of human resources 

Type of human resources 

Amount (€) 

Method of calculation *  

Officials 

Temporary staff 

Other human resources 

108,000 

1 full time official per year 

(specify budget line) 

Total 

108,000 

The amounts are total expenditure for twelve months. 

7.3. 

Other administrative expenditure deriving from the action 

Budget line 

Overall allocation (Title A7) 

1701021101 – Missions 

1701021102 – Meetings 
A07031 – Compulsory committees 1 
A07032 – Non-compulsory committees 1 

A07040 – Conferences 

A0705 – Studies and consultations 

Other expenditure (specify) 

Information systems (A-5001/A-4300) 

Other expenditure - Part A (specify) 

Amount € 

Method of calculation 

35,000 

- 

52,000 

- 

- 

- 

- 

- 

- 

Based  on  5  missions  per  year  at  an 
average of 7000 Euro per mission 

- 
1meeting of the Standing committee on 
Food Chain and Animal Health only on 
the subject of avian influenza  

- 

- 

- 

- 

- 

Total 

87,000 

The amounts are total expenditure for twelve months. 

1 Specify the type of committee and the group to which it belongs. 

I. 

II. 

Annual total (7.2 + 7.3) 

Duration of action 

III. 

Total cost of action (I x II) 

195,000 € 

6 years 

1,170,000 € 

8. 

FOLLOW-UP AND EVALUATION 

8.1. 

Follow-up arrangements 

The Commission will have at its disposal several ways to evaluate the impact of the proposal:  

–  the  occurrence  of  future  HPAI  epidemics  giving  an  overall  indication  on  the 

effectiveness of the new measures,  
–  results of the surveillance programmes, 
–  control measures on LPAI outbreaks. 

EN 

93 

   EN 

 
 
 
 
 
 
 
 
 
 
Already  at  this  stage  the  Commission  has  the  basic  tools  to  monitor,  such  as  the  Standing 
Committee for the Food Chain and animal health and the network of Community and national 
reference laboratories. 

8.2. 

Arrangements and schedule for the planned evaluation 

As  mentioned  above,  the  Commission  has  at  its  disposal  tools,  such  as  the  Standing 
Committee for the Food Chain and animal health and the network of Community and national 
reference laboratories; these instruments will allow 

9. 

ANTI-FRAUD MEASURES 

Not relevant 

EN 

94 

   EN 

 
EXPLANATORY MEMORANDUM 

1. 

Context of the proposal 

• 

Grounds for and objectives of the proposal 

– 

– 

The  Commission  envisages  updating  current  procedures  governing 
Community’s  financial  contribution  towards  veterinary  measures  laid 
down in Council Decision 90/424/EEC28 of 26 June 1990 on expenditure 
in the veterinary field. 

The  general  objective  is  to  better  achieve  the  targets  on  specific 
veterinary measures on Avian Influenza. 

• 

General context 

– 

– 

– 

The  current  proposal  of  the  amendment  of  Decision  90/424/EEC  is 
limited to avian influenza (AI). 

By  means  of  its  proposal  for  a  new  Council  Directive  on  Community 
measures  for  the  control  of  Avian  Influenza  (reference  to  the  COM 
document),  the  Commission  envisages  updating  current  measures  laid 
down  in  Council  Directive  92/40/EEC29,  with  the  objective  to  achieve 
better prevention and control of outbreaks and to reduce the health risks, 
the costs and losses and the negative impact to the whole of society due 
to Avian Influenza. This would be achieved by means of surveillance and 
control  measures  targeted  to  the  low  pathogenic  form  of  disease  -  to 
prevent  virus  mutation  into  its  highly  pathogenic  form  -  by  means  of 
vaccination  where  appropriate  and  by  other  measures  that  take  into 
account the most recent scientific knowledge of this disease, the lessons 
learned during recent outbreaks and the need to avoid massive killing and 
destruction of animals as much as possible. 

The proposed changes in Community legislation on AI control should be 
made  in  parallel  with  amendments  to  Council  Decision  90/424/EEC  on 
Community expenditure in the veterinary field to bring it in line with the 
new  Directive  and  ensure  adequate  financial  support  to  the  MSs  in 
relation to some of the newly envisaged AI control measures. 

28 

29 

OJ  L  224,  18.8.1990,  p.  19;  Decision  as  last  amended  by  Regulation  (EC)  No  806/2003  (OJ  L  122, 
16.5.2003, p. 1). 
OJ L 167, 22.6.1992, p. 1. 

EN 

95 

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– 

At  present,  Article  3  of  Council  Decision  90/424/EEC  provides  for  a 
Community  financial  contribution  (50%)  to  be  granted  to  the  MSs  for 
some of the expenditure which they may incur when eradicating HPAI30, 
namely  for  reimbursement  to  farmers  who  have  had  their  birds 
slaughtered  and  destroyed  to  eradicate  the  disease,  for  cleansing  and 
disinfection,  and  for  the  destruction  of  eggs,  feedingstuff  and  other 
materials likely to be contaminated. In accordance with the same Article, 
The Community may also reimburse 100% of vaccine costs and 50 % of 
the  costs  incurred  in  carrying  out  that  vaccination  (at  present  only 
emergency vaccination but not preventive vaccination may be allowed in 
accordance with Directive 92/40/EEC).  

• 

Consistency with other policies 

– 

– 

A debate about the prevention of and response to sanitary crises is now 
underway. The Commission has already produced a preliminary study31 
on  a  risk  financing  model  for  livestock  epidemics  in  the  EU  and  a 
complementary study is programmed for 2005. The Commission has also 
started a process of evaluation of the  whole Community Animal  Health 
Policy,  which  will  include  questions  on  the  cost/effectiveness  of  the 
current  financial  instruments  to  cope  with  animal  disease  surveillance, 
control  and  eradication  and  on  ways  in  which  producers  should  be 
induced  to  take  all  appropriate  measures  to  reduce  the  risk  of  disease 
introduction  onto  their  farms.  In  this  context  major  risk  factors  such  as 
density of animal populations and on-farm biohazards will be considered, 
together with mitigating measures and consequences on the EU budget. 

Based on the outcome of these studies and evaluation, alternatives to the 
current  way  Community  financial  support  is  granted  to  the  Member 
States might be proposed. Nevertheless, it has been deemed appropriate 
to  adopt  the  current  proposal  without  waiting  until  the  end  of  this 
process,  taking  into  account  the  urgent  need  of  revising  current 
legislation on this major health risk. 

2. 

Consultation of interested parties and impact assessment 

• 

Consultation of interested parties 

– 

On  the  Draft  Proposal  for  a  new  Council  Directive  on  Community 
measures  for  the  control  of  Avian  Influenza,  consultation  with  Member 
States  in  Commission  Working  Group  and  in  electronic  way  has  taken 
place in July/October 2004. In October 2004 European NGOs have been 
consulted  on  that  Draft  Proposal.  As  a  result  of  the  consultation, 
suggestions  on  improving  of  some  Articles  and  Annexes  of  the  Draft 
Proposal have been taken into account. 

30 
31 

Decision 90/424/EEC currently uses the very old terminology “avian plague” for HPAI. 
http://europa.eu.int/comm/food/animal/diseases/financial/risk_financing_model_10-04_en.pdf. 

EN 

96 

   EN 

 
                                                 
Collection and use of expertise 

– 

On AI: the newely envisaged measures have been taken into full account 
the  opinions  of  the  Scientific  Committee  on  AI  delivered  in  2000 
and 2003. 

• 

Impact assessment 

– 

– 

The  policy  options  identified  by  the  Scientific  Committee,  Section 
Animal  Health  and  Welfare  in  its  report  of  2000  "Definition  of  Avian 
Influenza  -  Use  of  Vaccination  against  Avian  Influenza"  have  been 
assessed. Three possible options for disease control have been examined 
and the option involving a change of the definition of AI to also include 
LPAI  and  to  foresee  control  measures  taking  into  account  the  different 
type of virus and animal has been considered most advantageous. 

An impact assessment of the newly envisaged AI control measures and of 
the amendments proposed by means of this proposal to Council Decision 
90/424/EEC has been produced (reference to the SEC document).  

3. 

Legal elements of the proposal 

• 

Summary of the proposed actions 

– 

The  current  proposal  primary  envisages  the  following  changes  to 
Decision 90/424/EEC: 

– 

– 

– 

to  foresee  a  financial  contribution  (up  to  50%)  for  the  Member 
States surveillance programmes to be implemented annually. 

to  foresee  a  financial  contribution  (30%)  to  MSs,  for  the  costs 
which they incurred in case of a stamping out policy being applied 
following  LPAI  outbreaks.  The  reduced  contribution  compared 
with HPAI outbreaks is justified by the fact that MSs should keep 
the option not to apply a stamping-out policy in case of LPAI, and 
a  higher  Community  contribution  might  induce  them  not  to  make 
adequate use of this option. On the other hand, the Community co-
financed  surveillance  programme  should  allow  the  detection  of 
LPAI in a timely manner and thus the need for extensive stamping 
out should be reduced, with a positive impact also on MSs budgets. 

as  regards  vaccination,  Community  financial  support  as  specified 
above  would  continue  to  be  granted  only  in  case  of  emergency 
vaccination. In a similar manner, no changes would be introduced 
to exisiting provisions on co-financing of HPAI control measures. 

Furthermore necessary adjustments and clarifications are foreseen. 

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• 

Legal basis 

– 

Treaty  establishing 
Article 37 thereof. 

• 

Subsidiarity principle 

the  European  Community,  and 

in  particular 

– 

The  measures  laid  down  in  this  proposal  falls  under  the  competence  of 
the Community.  

• 

Proportionality principle 

– 

The proposal sets out Community financial support to Member States of 
minimum  measures  to  be  applied  in  the  event  of  an  outbreak  of  Avian 
Influenza in poultry and other birds, and the minimum measures to allow 
a  multi-annual  effective  and  efficient  approach  for  eradication,  control 
and monitoring programmes for animal diseases and zoonoses.  

• 

Choice of instruments 

– 

The  proposed  instrument  is  a  Decision.  This  proposal  concerns 
amendments to existing provisions on expenditure in the veterinary field 
that are laid dwon in a Council Decision. The legal instrument choosen to 
amend those provisions is therefore another Council Decision. 

4. 

Budget implications 

The current proposal would entail additional costs for the MSs and the Community 
budget,  due  to  the  measures  being  introduced  for  the  surveillance  and  control  of 
LPAI.  The  approximate  costs  for  the  Community  budget  can  be  anticipated  as 
follows: 

(a)  LPAI surveillance: 1-2 M€ per year. These figures take into account the costs 
of the programmes for AI surveillance which have been put in place in the MSs 
in  2003  and  2004.  However,  it  is  envisaged  that  in  the  future  it  might  be 
appropriate to reinforce these programmes and this should lead to incremental 
costs; 

(b)  LPAI control by means of stamping out: ~1-4 M€ per year. This figure is based 

on: 

– 

– 

– 

the results of the surveillance for Avian Influenza carried out in the MSs 
in  2003  and  the  preliminary  data  available  on  the  LPAI  surveillance 
carried out in 2004; 

the  average  cost  of  any  single  AI  outbreak  for  which  a  stamping  out 
policy  has  been  applied  in  the  Community  in  recent  years  (~150,000  € 
per poultry farm); and  

the costs for the EU budget of these outbreaks (30% of co-financing, that 
is 50,000€ per farm). 

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Assuming ~80-320 LPAI outbreaks per year in the whole EU, it is envisaged that it 
will be necessary to apply a stamping out policy on 20-80 LPAI infected farms each 
year, that is on 25% of the farms in which LPAI would be detected. 

Furthermore, if the decision to establish an AI vaccine bank is finally taken, the 
establishment and maintenance of this bank would cost approximately 1-2 M€ 
per  year.  This  figure  has  been  estimated  taking  into  account  the  costs  of  the 
existing Foot and Mouth Disease antigen bank for the formulation of vaccine. 
However, in this regard it must be underlined that: 

– 

– 

in accordance with already exisiting provisions of Article 7 of Decision 
90/424/EEC,  Community  vaccine  banks  can  already  be  financed  by  the 
Community budget; 

the newly envisaged Directive does not oblige the Community to set up 
an AI vaccine bank, but only establish the legal base for the Community 
to do so. 

Therefore, the current proposal to amend Decision 90/424/EEC will not consider this 
particular  aspect.  As  explained  in  the  impact  assessment  accompanying  the  two 
Commission proposals on AI, the annual additional cost for the Community budget 
related  to  the  adoption  and  implementation  of  the  measures  indicated  above 
(including  the  possible  establishment  of  a  vaccine  bank)  would  be  ~3-8  M€,  that 
means ~5-6 M€ on average. 

However, it is expected that the above costs will be counterbalanced by the savings 
related  to  the  reduced  risks  for  future  HPAI  epidemics.  Of  course,  it  cannot  be 
precisely indicated to what extent the proposed measures would lead to a decrease in 
the  number  of  future  HPAI  epidemics,  the  occurrence  of  which  is  still  largely 
unpredictable  and  can  never  be  totally  excluded,  given  the  nature  of  the  risk  in 
question.  However,  if  the  envisaged  measures  had  been  already  in  place  and 
implemented in the EU in the last five years, one of the two major epidemics which 
have occurred in the Community would most likely have been prevented. Based on 
this, it may therefore be estimated that the implementation of the proposed measures 
could successfully prevent two major epidemics of HPAI in the next ten years. 

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2005/0063 (CNS) 

Proposal for a 

COUNCIL DECISION 

amending Council Decision 90/424/EEC on expenditure in the veterinary field 

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 Commission32, 

Having regard to the opinion of the European Parliament33 

Having regard to the opinion of the Economic and Social Committee34 

Whereas: 

(1) 

(2) 

(3) 

Avian influenza, previously called “avian plague”, is a very severe infection of birds 
that causes a very serious risk for animal health. Influenza virus of avian origin may 
also pose a risk for human health. 

Decision  90/424/EEC35  on  expenditure  in  the  veterinary  field  provides  for  the 
possibility of a financial contribution from the Community to the Member States for 
the  eradication  of  certain  animal  diseases.  Currently,  this  Decision  foresees  the 
possibility to grant such contribution for the eradication of avian influenza caused by 
the so-called “highly pathogenic” strains of virus. 

During  recent  avian  influenza  epidemics,  outbreaks  of  disease  caused  by  low 
pathogenic  avian  influenza  viruses  subsequently  mutated  into  highly  pathogenic 
viruses  causing  devastating  consequences  and  risks  for  public  health.  Once  mutation 
has occurred, the virus is extremely difficult to control. Directive xxx on Community 
measures  for  the  control  of  avian  influenza  establishes  compulsory  surveillance  and 
control measures36 also in relation with the low pathogenic viruses, so that outbreaks 
of highly pathogenic avian influenza can be prevented. 

(4) 

In  the  light  of  the  adoption  of  Directive  xxx  it  is  appropriate  to  modify  Decision 
90/424/EEC  so  that  Community  financial  assistance  may  also  be  granted  for  those 

32 
33 
34 
35 

36 

OJ C […], […], p. […]. 
OJ C […], […], p. […]. 
OJ C […], […], p. […]. 
OJ L 224, 18.8.1990, p. 19; Decision as last amended by Directive 2003/99/EC (OJ L 325, 12.12.2003, 
p. 1). 
OJ L […], […], p. […] […] see accompanying draft proposal. 

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eradication measures carried out by the Member States to combat avian influenza virus 
strains of low pathogenicity that may mutate into highly pathogenic strains. 

(5) 

The  reference  to  Article  40  in  Article  3(4)  of  Council  Decision  90/424/EEC  is 
erroneous as the procedure which is referrred is mentioned in Article 41. 

HAS ADOPTED THIS DECISION: 

Article 1 

Council Decision 90/424/EEC is amended as follows: 

1. 

Article 3 is amended as follows: 

(a) 

in paragraph 1, the sixth indent is deleted; 

(b) 

in paragraph 2, the first indent is replaced by the following: 

– 

‘the  slaughter  of  animals  of  susceptible  species  which  are  affected  or 
contaminated  or  suspected  of  being  affected  or  contaminated,  and  their 
destruction, and, in the case of avian influenza, destruction of the eggs,’ 

(c) 

paragraph 4 is replaced by the following: 

‘If,  in  view  of  the  development  of  the  situation  in  the  Community,  it  proves 
necessary to continue the measures provided for in paragraph 2, a new decision 
concerning the financial contribution by the Community, which might exceed 
the figure of 50% laid down in the first indent of paragraph 5, may be adopted 
in accordance with the procedure laid down in Article 41. When this decision is 
adopted, any measures which the Member State concerned must take in order 
to  ensure  the  success  of  the  action  may  be  laid  down,  and  in  particular 
measures other than those mentioned in paragraph 2.’ 

2. 

The following Article 3a is inserted: 

“Article 3a 

1. 

2. 

This Article shall apply in the event of the occurrence of avian influenza in the 
territory of a Member State. 

The  Member  State  concerned  shall  obtain  a  financial  contribution  from  the 
Community  for  the  eradication  of  avian  influenza  if  the  minimum  control 
measures  provided  for  in  Directive  xxx  have  been  fully  and  efficiently 
implemented  in  compliance  with  relevant  Community  legislation  and,  in  the 
case  of  killing  of  animals  of  susceptible  species  which  are  affected  or 
contaminated or suspected of being affected or contaminated, livestock owners 
have been compensated swiftly and adequately. 

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3. 

The financial contribution by the Community, divided if necessary into several 
tranches, must be: 

– 

– 

in the case of highly pathogenic avian influenza 50% and in the case of 
low pathogenic avian influenza 30% of the following costs, incurred by 
the  Member  State  in  compensating  livestock  owners  for  the  killing,  the 
destruction  of  animals,  the  destruction  of  animal  products,  the  cleaning 
and  disinfection  of  holdings  and  equipment,  the  destruction  of  the 
contaminated  feedingstuffs  and  for  the  destruction  of  contaminated 
equipment, where such equipment cannot be disinfected, 

where  emergency  vaccination  is  decided  upon  in  accordance  with 
Article 55 of Directive xxx 100 % of the cost of supply of the vaccine and 
50 % of the costs incurred in carrying out that vaccination.”  

3. 

In the Annex, in Group 1, the following indent is added: 

– 

‘avian influenza .’ 

Article 2 

This Decision is addressed to the Member States. 

Done at Brussels 

For the Council 
The President 

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LEGISLATIVE FINANCIAL STATEMENT 

Policy area(s): Health and Consumers Protection 

Activity: Food safety, animal health, animal welfare and plant health  

TITLE  OF  ACTION:  PROPOSAL  FOR  A  COUNCIL  DECISION  AMENDING  COUNCIL  DECISION 

90/424/EEC ON EXPENDITURE IN THE VETERINARY FIELD 

1. 

BUDGET LINE(S) + HEADING(S) 

17 04 01: Animal disease eradication and monitoring programmes and monitoring of 
the  physical  conditions  of  animals  that  could  pose  a  public-health risk  linked to  an 
external factor 

17 04 02: Other measures in the veterinary, animal welfare and public-health field 

17  04  03:  Emergency  fund  for  veterinary  complaints  and  other  animal 
contaminations which are a risk to public health 

2. 

OVERALL FIGURES  

2.1. 

Total allocation for action (Part B): 33 € million for commitment 

2.2. 

Period of application: 

Action is open ended 

2.3. 

Overall multiannual estimate of expenditure: 

(a) 

Schedule  of  commitment  appropriations/payment  appropriations 
intervention) (see point 6.1.1) 

(financial 

€ million (to three decimal places) 

Year 
[2006] 

[n+1]

[n+2] 

[n+3] 

[n+4] 

Commitments 

Payments 

5.5 

5.5 

5.5 

5.5 

5.5 

5.5 

5.5 

5.5 

5.5 

5.5 

[n+5 
and 
subs. 
Years
] 

5.5 

5.5 

Total 

33.0 

33.0 

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(b) 

Technical and administrative assistance and support expenditure (see point 6.1.2) 

Commitments 

0.000 

0.000 

0.000 

0.000 

0.000 

0.000 

Payments 

0.000 

0.000 

0.000 

0.000 

0.000 

0.000 

Subtotal a+b 

Commitments 

Payments 

5.5 

5.5 

5.5 

5.5 

5.5 

5.5 

5.5 

5.5 

5.5 

5.5 

5.5 

5.5 

33.0 

33.0 

(c) 

Overall  financial  impact  of  human  resources  and  other  administrative  expenditure 
(see points 7.2 and 7.3) 

0.216 

0.216 

0.216 

0.216 

0.216 

0.216 

1.296 

Commitments/ 
payments 

TOTAL a+b+c 

Commitments 

5.716 

5.716 

5.716 

5.716 

5.716 

5.716 

34.296 

Payments 

5.716 

5.716 

5.716 

5.716 

5.716 

5.716 

34.296 

2.4. 

Compatibility with financial programming and financial perspective 

Proposal is compatible with existing financial programming. 

2.5. 

Financial impact on revenue:37 

Proposal  has  no  financial  implications  (involves  technical  aspects  regarding 
implementation of a measure) 

37 

For further information, see separate explanatory note. 

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3. 

BUDGET CHARACTERISTICS 

Type of expenditure 

New 

EFTA 
contribution 

Contributions 
form applicant 
countries 

Heading in 
financial 
perspective 

Comp 

Comp 

Comp 

Non-diff 

Non-diff 

Non-diff 

YES 

YES 

NO 

NO 

NO 

NO 

NO 

NO 

NO 

No 1a 

No 1a 

No 1a 

4. 

LEGAL BASIS  

Council Decision 90/424/EEC 

5. 

DESCRIPTION AND GROUNDS 

5.1. 

Need for Community intervention 38 

5.1.1.  Objectives pursued 

Objective 1: EXTENSION of the surveillance programmes to avian influenza 

Objective 2: EXTENSION of emergency measures (Article 3 of Decision 
90/424/EEC) to low pathogenic avian influenza stamping out 

Objective 3: POSSIBILITY to establish of an avian influenza vaccine bank 

ONLY  THE  REALIZATION  OF  OBJECTIVE  2  LEADS  TO  AN  ADDITIONAL 
DIRECT COST FOR THE EU-BUDGET. HOWEVER, THE STAMPING OUT OF 
LPAI  COULD,  COMPARED  TO  THE  EXISTING  SITUATION,  LEAD  TO  AN 
OVERALL  ECONOMY  BECAUSE  THE  AIM  IS  TO  PREVENT/REDUCE 
MUTATION FROM LPAI INTO HPAI.  

5.1.1.1. Compulsory surveillance and control measures for LPAI. 

Very  often  LPAI  viruses  do  not  cause  any  clinical  signs  in  domestic  poultry  and 
therefore  circulate  unnoticed  in  the  poultry  population,  due  to  direct  or  indirect 
contact between poultry farms or movements of poultry. Spread of LPAI viruses in 
domestic poultry is a major risk factor for their mutation into HPAI viruses, which 
then cause devastating disease outbreaks. The compulsory surveillance is needed so 
that disease control measures can be rapidly applied and mutation of LPAI into HPAI 
is prevented. The prevention of HPAI will protect the EU budget against high costs 
for its eradication. 

38 

For further information, see separate explanatory note. 

EN 

105 

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5.1.1.2. Possible establishment of an avian influenza vaccine bank 

In some cases, it might be necessary to proceed to a rapid vaccination which again 
will protect the EU budget against high costs for its eradication. 

5.1.2.  Measures taken in connection with ex ante evaluation 

AI  is  a  serious,  highly  contagious  disease  of  poultry  and  other  birds  caused  by 
different  types  of  viruses  included  in  the  very  large  virus  family  called 
Influenzaviridae. AI viruses may also spread to mammals, including humans, usually 
following direct contact with infected birds. In the human host, the disease may vary 
from mild conjunctivitis to serious disease, sometimes fatal; during the still ongoing 
AI epidemic in certain Asian countries, the case fatality rate in humans has been very 
high. 

Due  to  continuous  genetic  changes  of  the  disease  agents  and  their  possible 
“adaptation”  to  newly  infected  animal  or  human  hosts,  the  risks  posed  by  the 
different  AI  viruses  to  animal  and  public  health  is  variable  and  to  a  large  extent 
unpredictable.  However, current  knowledge indicates that the health risks  posed  by 
the  so-called  Low  Pathogenic  AI  (LPAI)  viruses  -  are  inferior  to  the  one  posed  by 
Highly  Pathogenic  AI  (HPAI)  viruses,  which  originate  from  a  mutation  of  certain 
LPAI viruses, namely those of types H5 and H7, and which can cause a disease in 
poultry with a mortality rate as high as 90%.  

As regards public health, data available indicate that HPAI viruses of types H5 and 
H7 have been responsible for the vast majority of the cases of AI reported in humans, 
and of all cases of human deaths due to AI viruses.  

In general, domestic poultry populations are free from AI viruses. However, certain 
wild  birds  (particularly  migratory  waterfowl,  such  as  ducks  and  geese)  act  as  a 
permanent  “reservoir”  of  LPAI  viruses,  from  which  they  occasionally  spread  to 
domestic poultry. No measures are currently available or can be envisaged to stop or 
reduce  virus  circulation  in  wild  birds  living  in  nature;  this  means  that  there  is  a 
permanent risk of introduction of potentially very dangerous AI viruses from wild to 
domestic birds, and ultimately to other animals and humans. 

For unclear reasons, an increase of AI outbreaks has occurred in recent years. Serious 
AI outbreaks (HPAI) have been recently reported in many different species of birds – 
including  domestic  poultry,  kept  under  different  husbandry  and  management 
practices  -  in  several  different  areas  of  the  world,  and  across  all  continents.  These 
outbreaks have caused the death or killing for disease control purposes of hundreds 
of  millions  of  birds  and  very  serious  losses  to  the  poultry  industry  worldwide.  In 
connection  with  these  outbreaks,  several  human  cases  of  infection  were  also 
reported, some of them fatal. 

In  the  EU,  in  the  last  five  years,  major  outbreaks  of  HPAI  have  occurred  in  Italy 
(1999-2000)  and  the  Netherlands,  with  secondary  spread  to  Belgium  and  Germany 
(2003).  These  outbreaks  had  devastating  consequences  on  the  poultry  sector  and  a 
negative  impact  on  the  society  as  a  whole  -  particularly  in  the  Netherlands,  where 
several human cases of disease also occurred. This was despite the draconian control 
measures  applied  by  the  Member  States  (MSs)  including  massive  killing  and 

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destruction  of  poultry  and  other  birds  in  the  affected  areas,  which  often  went  far 
beyond the minimum requirements of Council Directive 92/40/EEC on Community 
control measures for the control of AI. These outbreaks have also entailed significant 
costs  for  the  Community  budget,  in  the  framework  of  existing  rules  laid  down  in 
Council decision 90/424/EEC. 

After  previous  EU  animal  health  crises  (classical  swine  fever,  1997-1998;  foot  and 
mouth  disease,  2001)  these  outbreaks  have  prompted  further  criticisms  in  the  MSs 
against massive slaughter of animals, due to animal welfare, ethical, social, economic 
and  environmental  reasons.  The  implementation  of  this  measure  has  had  a  very 
negative  impact  on  public  opinion,  and  raised  serious  criticisms  in  particular  in 
relation to special categories of birds, such as endangered species or breeds, or pets. 
The Court of Auditors has also often criticised the Commission due to the economic 
impact of massive slaughter on the Community budget.  

Scientists deem that uncontrolled AI outbreaks, particularly those caused by certain 
virus types may, following transmission of the virus from birds or other animals into 
humans,  eventually  lead  to  the  emergence  of  a  virus  fully  adapted  to  humans  and 
able  to  cause  an  Influenza  pandemic,  like  the  “Spanish  flu”  of  1917-1919.  Such  a 
pandemic  could  cause  millions  of  human  deaths  and  major  socio-economic 
consequences all over the world. 

Directive  92/40/EEC  establishes  compulsory  disease  control  measures  only  in  case 
of  disease  in  poultry  caused  by  HPAI.  Lessons  have  been  learnt  during  the  recent 
epidemics.  Outbreaks  of  AI  caused  by  LPAI  viruses  of  types  H5  and  H7,  that 
subsequently  mutated  into  HPAI  viruses  have  caused  devastating  consequences. 
Once mutation has occurred, the virus is extremely difficult to control.  

Council  Decision  90/424/EEC  provides  for  a  Community  financial  contribution 
(50%) to be granted to the MSs for some of the expenditure which they may incur 
when  eradicating  HPAI  (Decision  90/424/EEC  currently  uses  the  old  terminology 
“avian plague” for HPAI), namely for reimbursement to farmers who have had their 
birds  slaughtered  and  destroyed  to  eradicate  the  disease,  for  cleansing  and 
disinfection, and for the destruction of eggs, feedingstuff and other materials likely to 
be contaminated. The Community may also reimburse 100% of vaccine costs. 

In  view  of  the  increased  knowledge  on  the  risks  for  human  health  posed  by  AI 
viruses, the opinions of the Scientific Committee and the most recent knowledge on 
the  pathogenesis,  the  epidemiology  and  the  distribution  of  AI,  there  is  now  a  clear 
need  to  revise  and  update  current  legislation  to  reflect  these  new  advances  and 
experience  and  to  improve  disease  control  of  both  LPAI  and  HPAI  in  future.  This 
will be of direct benefit to animal health and indirectly also human health. 

The current proposal envisages the following changes to Decision 90/424/EEC: 

– 

to  foresee  a  financial  contribution  (30%)  to  MSs,  for  the  costs  which  they 
incurred  in  case  of  a  stamping  out  policy  being  applied  following  LPAI 
outbreaks. The reduced contribution compared with HPAI outbreaks is justified 
by the fact that MSs should keep the option not to apply a stamping-out policy 
in case of LPAI, and a higher Community contribution might induce them not 
to  make  adequate  use  of  this  option.  On  the  other  hand,  the  Community  co-

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financed  surveillance  programme  should  allow  the  detection  of  LPAI  in  a 
timely manner and thus the need for extensive stamping out should be reduced, 
with a positive impact also on MSs budgets; 

– 

to  foresee  a  financial  contribution  (up  to  50%)  for  the  MSs  surveillance 
programmes to be implemented annually in accordance with the first proposal 
(see also footnote 8). 

The  current  proposal  would  therefore  entail  additional  costs  for  the  MSs  and  the 
Community  budget,  due  to  the  measures  being  introduced  for  the  surveillance  and 
control of LPAI. 

However, it is expected that the above costs will be counterbalanced by the savings 
related  to  the  reduced  risks  for  future  HPAI  epidemics.  Of  course,  it  cannot  be 
precisely indicated to what extent the proposed measures would lead to a decrease in 
the  number  of  future  HPAI  epidemics,  the  occurrence  of  which  is  still  largely 
unpredictable  and  can  never  be  totally  excluded,  given  the  nature  of  the  risk  in 
question.  However,  if  the  envisaged  measures  had  been  already  in  place  and 
implemented in the EU in the last five years, one of the two major epidemics which 
have occurred in the Community would have been most likely prevented. Based on 
this, it may therefore be estimated that the implementation of the proposed measures 
could successfully prevent two major epidemics of HPAI in the next ten years. 

The  expenditure  incurred  by  the  MSs  concerned  for  compensating  farmers,  for 
stamping  out  measures  and  for  cleansing  and  disinfection  (expenditure  that  are  in 
principle  eligible  for  a  50%  Community  co-financing  in  accordance  with  current 
provisions  of  Decision  90/424/EEC)  in  relation  to  the  two  major  epidemics  which 
recently occurred in the EU has been between 101 and 174 M€. It can therefore be 
estimated that at the current costs the prevention of two major epidemics would lead 
to savings for the Community budget of 100 M€ or more over a ten year period. This 
would largely outweigh the additional costs foreseen for the new LPAI surveillance 
and control measures (~50-60 M€ in ten years). 

As seen above in this document, a decrease in the AI risk in poultry and other birds 
in  the  Community  is  bound  to  indirectly  but  significantly  reduce  the  public  health 
risks  posed  by  AI  viruses,  including  the  one  of  an  Influenza  pandemic,  since  the 
circulation  of  AI  viruses  in  domestic  birds  is  the  main  source  of  the  AI  risk  for 
humans.  The  implementation  of  regular  surveillance  would  also  have  the  positive 
effect that circulation of any AI virus in domestic poultry having a potential impact 
on  public  health  could  be  rapidly  detected,  so  allowing  the  adoption  of  any 
appropriate preventive measures, by both animal and public health authorities. 

However,  it  is  not  possible  to  quantify  more  precisely  the  benefit  of  the  proposed 
measures on public health. 

As regards the prevention of an Influenza pandemic, this event may have its origin in 
any country in the world and may then spread into the Community due to human-to-
human  transmission  of  virus  via  movements  of  people.  In  this  case,  animal  health 
control  measures  in  place  in  the  Community  would  have  no  effect  in  reducing  that 
risk. However, the cost and the impact of an Influenza pandemic would be so serious 
that even a slight reduction of the overall risk stemming from the proposed measures 

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should  not  be  disregarded  in  the  overall  cost/benefit  evaluation  of  such  measures. 
Furthermore,  if  such  a  catastrophic  event  originated  in  the  EU  in  the  absence  of 
appropriate  and  scientifically  updated  Community  legislation  on  animal  health,  the 
Community, as well as MSs, would be exposed to very serious criticisms, probably 
not inferior to the ones made in the past in relation to the emergence and spread of 
Bovine Spongiform Encephalopathy.  

From all the data above, it emerges that both the Community as a whole and the MSs 
have  a  clear  interest  in  the  updating  of  Community  policy  on  AI  control,  and  to 
allocate appropriate resources for the prevention and control of disease. 

5.1.3.  Measures taken following ex post evaluation 

Not applicable 

5.2. 

Action envisaged and budget intervention arrangements 

Not applicable 

5.3.  Methods of implementation 

Not applicable 

6. 

FINANCIAL IMPACT 

6.1. 

Total financial impact on Part B - (over the entire programming period) 

(The method of calculating the total amounts set out in the table below must be explained by 
the breakdown in Table 6.2.) 

6.1.1.  Financial intervention 

Commitments (in € million to three decimal places) 

Breakdown 

[2006] 

[n+1] 

[n+2] 

[n+3] 

[n+4] 

Total 

[n+5 and 
subs. 
Years] 

Operational objective Nr 1 

1.500 

1.500 

1.500 

1.500 

1.500 

1.500 

9.000 

Operational objective Nr 2 

2.500 

2.500 

2.500 

2.500 

2.500 

2.500 

Operational objective Nr 3 

1.500 

1.500 

1.500 

1.500 

1.500 

1.500 

15.000 

9.000 

TOTAL  5.500 

5.500 

5.500 

5.500 

5.500 

5.500 

33.000 

EN 

109 

   EN 

 
6.1.2.  Technical  and  administrative  assistance,  support  expenditure  and  IT  expenditure 

(commitment appropriations) 

[Year n] 

[n+1] 

[n+2] 

[n+3] 

[n+4] 

Total 

[n+5 and 
subs. 
years] 

1) 
administrative assistance 

Technical 

and 

Technical 

a) 
offices

assistance 

b)  Other 
administrative assistance: 

technical 

and 

- intra muros: 

- extra muros: 

of  which  for  construction 
and 
of 
maintenance 
computerised  management 
systems 

Subtotal 1 

2) Support expenditure 

a) Studies 

b) Meetings of experts 

c) Information and 
publications 

Subtotal 2 

TOTAL 

EN 

110 

   EN 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
6.2. 

Calculation  of  costs  by  measure  envisaged  in  Part  B  (over  the  entire 
programming period)39 

Breakdown  

Commitments (in € million to three decimal places) 

Type  
of outputs 
(projects, files ) 

Number of 
outputs 

Average unit 
cost 

(total for years 
1…n)  

Total cost 

(total for years 
1…n)  

1 

2 

3 

4=(2X3) 

Action 1 

- Measure 1 

- Measure 2  

Action 2 

- Measure 1 

- Measure 2 

- Measure 3 

etc. 

TOTAL COST 

7. 

IMPACT ON STAFF AND ADMINISTRATIVE EXPENDITURE  

7.1. 

Impact on human resources 

Types of post 

Staff to be assigned to management of the 
action using existing and/or additional 
resources 

Number of 
permanent posts 

Number of 
temporary posts 

Officials 
temporary staff 

or 

A 

B 

C 

Other human resources 

Total 

2 

- 

- 

2 

- 

- 

- 

- 

- 

Total 

2 

- 

- 

- 

2 

Description of tasks deriving from the 
action 

39 

For further information, see separate explanatory note. 

EN 

111 

   EN 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
                                                 
7.2. 

Overall financial impact of human resources 

Type of human resources 

Amount (€) 

Method of calculation *  

Officials 

Temporary staff 

Other human resources 

216,000 

1 full time official per year 

(specify budget line) 

Total 

216,000 

The amounts are total expenditure for twelve months. 

7.3. 

Other administrative expenditure deriving from the action 

Amount € 

Method of calculation 

Budget line 

Overall allocation (Title A7) 

1701021101 – Missions 

1701021102 – Meetings 
A07031 – Compulsory committees 1 
A07032 – Non-compulsory committees 1 

A07040 – Conferences 

A0705 – Studies and consultations 

Other expenditure (specify) 

Information systems (A-5001/A-4300) 

Other expenditure - Part A (specify) 

Total 

The amounts are total expenditure for twelve months. 

1 Specify the type of committee and the group to which it belongs. 

I. 

II. 

Annual total (7.2 + 7.3) 

Duration of action 

III. 

Total cost of action (I x II) 

216,000 € 

6 years 

1,296,000 € 

8. 

FOLLOW-UP AND EVALUATION 

8.1. 

Follow-up arrangements 

The Commission will have at its disposal several ways to evaluate the future impact 
of the proposals: 

– 

from  the  occurrence  of  future  HPAI  epidemics  on  poultry,  it  will  be  evident 
whether  the  measures  put  in  place  have  been  effective  to  prevent  and  control 
those epidemics; 

EN 

112 

   EN 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
– 

– 

from  the  results  of  the  regular  LPAI  surveillance  programmes,  future 
programmes  could  be  better  modulated  to  ensure  that  the  resources  allocated 
are  proportionate  to  the  risks  posed  by  LPAI;  this  would  prevent  under-  or 
over-expenditure  both  for  the  Community  and  MSs  in  connection  with 
surveillance; 

from  the  control  measures  applied  by  the  MSs  in  relation  to  future  LPAI 
outbreaks  and  related  costs,  it  will  be  more  clear  what  the  real  impact  of  the 
new financial measures introduced in relation to LPAI control will be. 

The Commission has already in place the necessary basic tools to gather and analyse 
this information in the proper manner, such as the Standing Committee for the Food 
Chain and Animal Health, the inspectors of the Food and Veterinary Office and the 
network  of  Community  and  National  Reference  Laboratories,  whose  role  will  be 
confirmed  and  strengthened  by  the  current  proposal.  However,  in  the  future  new 
scientific  opinions  could  also  be  useful  to  assist  the  Commission  for  policy 
formulation  and  fine  tuning  of  legislation,  as  well  as  for  MSs  when  implementing 
disease control measures. 

The  Commission  has  also  started  a  process  of  evaluation  of  the  whole  Community 
Animal Health Policy, which will include questions on the cost/effectiveness of the 
current  financial  instruments  to  cope  with  animal  disease  surveillance,  control  and 
eradication and on ways in which producers should be induced to take all appropriate 
measures to reduce the risk of disease introduction onto their farms. In this context 
major risk factors such as density of animal populations and on-farm biohazards will 
be  considered,  together  with  mitigating  measures  and  consequences  on  the  EU 
budget.  Based  on  the  outcome  of  these  studies  and  evaluation,  alternatives  to  the 
current way Community financial support is granted to the MSs might be proposed. 

8.2. 

Arrangements and schedule for the planned evaluation 

As  mentioned  above,  the  Commission  has  at  its  disposal  tools,  such  as  the  Standing 
Committee for the Food Chain and animal health and the network of Community and national 
reference laboratories; these instruments will allow 

9. 

ANTI-FRAUD MEASURES 

Not relevant 

EN 

113 

   EN