COMMISSION STAFF WORKING DOCUMENT IMPACT ASSESSMENT Accompanying the document Proposal for a REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL on Animal Health
Date: 2013-05-06
Institutions: European Commission
Subjects: animal breeding, animal health, disease prevention, food safety, health control, import (EU), infectious disease, marketing standard, transport of animals, veterinary inspection

EUROPEAN 
COMMISSION 

Brussels, 6.5.2013 
SWD(2013) 161 final 

COMMISSION STAFF WORKING DOCUMENT 

IMPACT ASSESSMENT 

Accompanying the document 

Proposal for a 

REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL 

on Animal Health 

{COM(2013) 260 final} 
{SWD(2013) 160 final} 

EN 

   EN 

 
 
 
 
  
 
 
1.  PROCEDURAL ISSUES AND CONSULTATION OF INTERESTED PARTIES. 4 

1.1. 

1.2. 

1.3. 

1.4. 

1.5. 

1.6. 

1.7. 

1.8. 

Consultation of Member States' Experts .............................................................................................. 5 

Animal Health Advisory Committee..................................................................................................... 5 

Animal Health Law Stakeholder Steering Group................................................................................ 6 

Inter-Service Steering Group (ISSG).................................................................................................... 6 

General on-line consultation .................................................................................................................. 6 

Consultation of competent authorities of MS and the industry on administrative burdens ............ 7 

Other opportunities used for consultation............................................................................................ 7 

IAB opinion ............................................................................................................................................. 7 

2.  POLICY CONTEXT, PROBLEMS IDENTIFIED, AND SUBSIDIARITY ............ 11 

2.1. 

Background and context ...................................................................................................................... 11 
2.1.1.  Nature and size of the sectors concerned ........................................................................................... 11 
2.1.2.  Overview of legislative framework and ongoing developments........................................................ 13 

2.2. 

Problem definition ................................................................................................................................ 14 
2.2.1.  High Complexity of the current CAHP.............................................................................................. 15 
2.2.2.  Lack of a single overall strategy ........................................................................................................ 21 
2.2.3. 
Insufficient focus on disease prevention ............................................................................................ 24 
2.2.4.  Rules for intra-EU trade of live terrestrial animals are sub-optimal .................................................. 27 

2.3.  Who is affected by the current policy?................................................................................................ 30 

2.4. 

The right and justification for EU action............................................................................................ 30 
2.4.1.  Treaty basis ........................................................................................................................................ 30 
2.4.2.  Subsidiarity test.................................................................................................................................. 30 

3.  OBJECTIVES.................................................................................................... 34 

3.1. 

3.2. 

3.3. 

General objectives................................................................................................................................. 34 

Specific objectives ................................................................................................................................. 35 

Operational objectives:......................................................................................................................... 35 

4.  OPTIONS .......................................................................................................... 36 

4.1. 

4.2. 

4.3. 

4.4. 

4.5. 

Option 1 - Do nothing ........................................................................................................................... 36 

Option 2 – Simplification of existing legislation with no major content or policy changes ............ 36 

Option 3 – Existing legal framework with more self-regulation....................................................... 36 

Option 4 - Flexible general legislative framework on animal health issues (AHL)......................... 37 

Option 5 - Prescriptive general legislative framework on animal health issues (AHL).................. 37 

2

 
 
 
4.6. 

Key elements of the different options.................................................................................................. 37 

5. 

IMPACT ANALYSIS.......................................................................................... 41 

5.1. 

5.2. 

Option 1 – No Change .......................................................................................................................... 41 

Option 2 – Simplification of existing legal framework with no significant policy change.............. 43 

5.3. 

Option 3 – Existing legal framework with more self-regulation....................................................... 43 
5.3.1.  Economic impacts.............................................................................................................................. 45 
5.3.2.  Social Impacts.................................................................................................................................... 46 
5.3.3.  Environmental impacts ...................................................................................................................... 46 

5.4. 

Option 4 – flexible general legislative framework for animal health issues..................................... 46 
5.4.1.  Economic impacts.............................................................................................................................. 47 
5.4.2.  Social Impacts.................................................................................................................................... 50 
5.4.3.  Environmental impacts ...................................................................................................................... 50 

5.5. 

Option 5 – prescriptive general legislative framework for animal health issues............................. 51 
5.5.1.  Economic impacts.............................................................................................................................. 51 
5.5.2.  Social impacts .................................................................................................................................... 53 
5.5.3.  Environmental impacts ...................................................................................................................... 53 

6.  HOW DO THE OPTIONS COMPARE?............................................................. 54 

7.  HOW WILL THE OPTION IMPLEMENTED BE ASSESSED? ......................... 56 

ANNEX I 

GLOSSARY OF TECHNICAL TERMS AND ABBREVIATIONS........ 58 

ANNEX II  KEY MESSAGES FROM THE EVALUATION OF THE COMMUNITY 
ANIMAL HEALTH POLICY (CAHP) ........................................................................ 60 

ANNEX III  SUMMARY OF CHRONOLOGY OF MAIN EXCHANGES WITH 
REPRESENTATIVES OF SPECIFIC SECTORS LIKELY TO BE AFFECTED BY 
THE NEW AH LAW.................................................................................................. 62 

ANNEX IV  SUMMARY DOCUMENT OF THE STAKEHOLDERS' STEERING 
GROUP: "PROBLEM IDENTIFICATION DURING THE CREATION OF THE 
ANIMAL HEALTH LAW" ......................................................................................... 64 

ANNEX V   SUMMARY OF CONSULTATION RESPONSES ............................... 73 

ANNEX VI  SUMMARY OF THE QUESTIONNAIRE ON ARTIFICIAL 
INSEMINATION AND RELATED ISSUES............................................................. 110 

ANNEX VII 

VACCINATION POLICY ............................................................... 122 

ANNEX VIII 

ADDITIONAL ASSESSMENT ON INTRA-EU TRADE ................. 151 

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ANNEX IX  KEY ELEMENTS OF THE NEW ANIMAL HEALTH LAW, INCLUDING 
INDICATIVE LIST OF EXISTING LEGISLATION AFFECTED.............................. 162 

ANNEX X  PRELIMINARY STRUCTURE OF THE LEGISLATIVE PROPOSAL – 
OPTIONS 4 AND 5................................................................................................. 172 

ANNEX XI 

 ADDITIONAL ASSESSMENT ON BIOSECURITY.......................... 173 

4

 
 
 
 
1. 

Procedural  issues  and  consultation  of  interested 
parties 

The  proposal  for  action  on  the  EU  animal  health  policy  is  the  result  of  a  long  series  of 
considered analyses.  

In 2004, the Commission launched an independent evaluation to assess the performance of the 
Community Animal Health Policy (CAHP)1 over the previous decade and its coherence with 
other EU policy interventions. The aim was to identify elements of the CAHP which could be 
further improved and to propose options to achieve these improvements. The summary of the 
key messages of the CAHP evaluation is attached at Annex II, and also discussed in further 
detail below.  

Among  other  things,  the  CAHP  evaluation  recommended  that  a  single  strategy  for  animal 
health  be  developed  to  prevent  piecemeal  and  crisis-driven  development  of  policy.  The  EU 
Animal Health Strategy 2007-2013 (AHS) "Prevention is better than cure" was the result2. 

The AHS provides for the adoption of a "single regulatory framework for animal health with a 
greater focus on incentives than penalties, consistent with other EU policies and converging to 
international  standards"  and  which  will  "define  and  integrate  common  principles  and 
requirements of existing legislation". In their reaction to the Commission Communication on 
the  new  Strategy,  the  European  Parliament3,  the  Council4  and  the  European  Economic  and 
Social  Committee5  welcomed  this  initiative.  Subsequently,  the  Action  Plan  for  the 
implementation  of  the  Strategy6  confirmed  that  "the  main  objective  of  the  Strategy  is  the 
development of an EU Animal Health Law (AHL)". 

From  the  very  start  of  the  process,  key  stakeholders,  Member  States  (MS)  Competent 
Authorities (CA), international organisations and trading partners have been closely involved 
and have played a crucial role in the discussion. In addition, economic and social stakeholders 
such as European associations with an interest in animal health and welfare and the interested 
public have been consulted on a number of occasions in accordance with the Commission’s 
standards for consultation.  

This  exercise  represents  a  considerable  contribution  to  the  so-called  "fitness  check"  of  the 
food safety and health policy and legislation.   

At  the  same  time,  it  reflects  the  priorities  of  Smart  Regulation7  by  aiming  to  simplify  the 
reducing 
legal 
existing 
administrative burdens.  

reflecting  stakeholders'  expectations 

framework  while 

in 

And  finally,  it  reflects  Commission  priorities  such  as  the  smart  growth  objective  of  the 
Europe 2020 strategy8 by helping the sector to become more resilient due to active prevention 
measures and risk management. 

http://ec.europa.eu/food/animal/diseases/strategy/cahpeval_en.htm 
http://ec.europa.eu/food/animal/diseases/strategy/index_en.htm 

1 
2 
3  EP Resolution 2007/2260(INI) 
4  Doc.15481/07 ADD 1 
5  NAT/376 – EU Animal Health Strategy 
6  COM (2008) 545 final, http://ec.europa.eu/food/animal/diseases/strategy/documents_en.htm 
7 COM(2010) 543 final "Smart Regulation in the European Union" 
8 COM(2010) 2020 "Europe 2020 - A strategy for smart, sustainable and inclusive growth" 

5

 
 
                                                 
This Impact Assessment (IA) follows the structure given in the Commission’s IA guidelines9. 
It  aims  to  consider  the  economic,  social  and  environmental  aspects  of  EU  policy  on  animal 
health in an integrated and proportionate way. 

1.1. 

Consultation of Member States' Experts 

CA of the MS have been involved in the preparation of this initiative from an early stage. 

Preparatory  work  started  in  the  frame  of  the  expert  working  group  meetings  of  the  Chief 
Veterinary Officers of the MS (CVOs). Several working groups were created (in the so-called 
Adelbrecht process) in order to obtain guidance from the CVOs on the implementation of the 
new AHS. Commission officials also participated in the working groups. The conclusions of 
the  various  working  groups  on  issues  such  as  prioritization  of  EU  intervention  and 
categorization of animal diseases, biosecurity and the use of the veterinary fund are publicly 
available.10 

As  a  continuation  of  this  work,  several  seminars  were  organised  by  the  EU  presidencies  to 
discuss major issues related to the AHL proposal. These led to the adoption of the set of CVO 
Conclusions  on  biosecurity  and  incentives  for  prevention  (October  2009)11  and  on  animal 
disease surveillance systems (April 2010)12.  

Furthermore,  as  explained  in  greater  detail  under  point  1.3,  representatives  of  several  MS 
formed part of the AHL Steering Group.  

MS have been updated regularly by the Commission on the development of the AHL during 
both  the  Council  and  Commission  CVO  meetings  and  the  Standing  Committee  of  the  Food 
Chain and Animal Health (SCOFCAH).  

1.2. 

Animal Health Advisory Committee 

The  Animal  Health  Advisory  Committee  was  created  as  a  working  group  of  the  Advisory 
Group  on  the  Food  Chain  and  Animal  and  Plant  Health13.  It  is  chaired  by  a  Commission 
representative, with the special participation of three representatives of CVOs from three MS 
(the  past,  present  and  future  Presidencies).  The  list  of  other  key  stakeholders  is  publicly 
available14 as are the agendas, the presentations, the summaries and the participants for each 
meeting15. 

A  consultation  and  regular  update  on  the  progress  of  the  work  was  provided  at  numerous 
meetings  of  this  Committee16  in  order  to  ascertain  stakeholders’  perceptions  of  the  issues 
identified,  to  collect  views  about  the  possible  options  to  solve  them  and  to  sound  out 
stakeholders on the likely acceptability of the various options.  

SEC(2009)92 of 15 January 2009 

9 
10  http://ec.europa.eu/food/animal/diseases/strategy/pillars/action_en.htm,  under  point  3.1,  5  and  17 

respectively 

11  15000/2/09 REV2, http://register.consilium.europa.eu/pdf/en/09/st15/st15000-re02.en09.pdf 
12  9547/10, http://register.consilium.europa.eu/pdf/en/10/st09/st09547.en10.pdf 
13  Article 4.2 of Commission Decision 2004/613/EC of 6 August 2004 
14  http://ec.europa.eu/food/animal/diseases/strategy/participants_en.htm 
15  http://ec.europa.eu/food/animal/diseases/strategy/animal_health_advisory_committee_en.htm 
16  19  May  2008,  3  November  2008,  6  March,  15  June,  29  September  2009,  8  February,  18  June  2010,  14 

February 2011 

6

 
 
                                                 
Ad hoc bilateral meetings were held with the representatives of the specific sectors likely to 
be  affected,  including  key  associations  (see  summary  of  chronology  of  main  exchanges  in 
Annex III).  

1.3. 

Animal Health Law Stakeholder Steering Group 

An AHL Stakeholder Steering Group was set up to assist the Commission Services during the 
impact  assessment  process.  Its  assistance  was  particularly  important  in  the  definition  of 
problems. 

This group comprised experts from national veterinary authorities, experts from international 
organizations and other interested stakeholders. 

In particular,  delegates from the  national veterinary authorities of Germany,  Italy,  Hungary, 
Denmark,  the  United  Kingdom,  Belgium,  Sweden,  Slovenia,  Lithuania,  Finland,  the 
Netherlands,  France  and  Switzerland  participated,  as  well  as  delegates  from  the  following 
international,  economic  or  non-governmental  organisations:  COPA-COGECA  (European 
farmers  and  European  agri-cooperatives),  OIE  (World  Organization  for  Animal  Health), 
UECBV (European Livestock and Meat Trading Union), FVE (Federation of Veterinarians of 
Europe),  FESASS  (European  Federation  for  Animal  Health  and  Sanitary  Security),  IFAH-
Europe (International Federation for Animal Health Europe), FEAP (Federation of European 
Aquaculture Producers), AVEC (Association of Poultry Processors and Poultry Trade in the 
EU countries), Vier Pfoten (Four Paws international).  

The  steering  group  had  4  meetings  during  the  first  part  of  2009,  and  working  papers  were 
used  during  the  meetings  to  focus  on  and  consider  particular  factors.17    The  work  of  the 
steering  group  is  summarised  in  a  document  entitled  "Problem  identification  during  the 
creation of the AHL" which can be found in Annex IV. 

1.4. 

Inter-Service Steering Group (ISSG) 

Given  the  crosscutting  nature  of  the  issues  concerned,  the  Commission  set  up  an  ISSG  to 
provide specialised input and to bring a wider perspective to the process.  

Five meetings of the ISSG were held (31 October 2008, 10 February 2009, 9 July 2009, 5 July 
2010, 14 April 2011) in order to obtain other services’ views about the issues identified, the 
possible options and likely impacts in addition to a formal 'Consultation Inter-Service' (CIS) 
on the AHL consultation document in August / September 2009. 

The  following  services  were  invited:  SG,  SJ,  AGRI,  COMP,  ENTR,  ENV,  RTD,  MARKT, 
MARE,  OLAF,  TRADE,  RELEX,  ELARG.  As  far  as  possible,  the  comments  expressed  by 
the  various  DGs  represented  at  the  five  meetings  have  been  taken  into  account  in  this 
document.  

1.5. 

General on-line consultation 

A general consultation addressed to the general public, stakeholders, MS and third countries 
was  carried  out  from  23  October  to  31  December  2009  via  an  online  Interactive  Policy 

17  http://ec.europa.eu/food/animal/diseases/strategy/pillars/action_steering_group_en.htm. Meetings held on 18 

February, 25 March, 19 May and 3 July.  

7

 
 
                                                 
Making tool.18 The outcome of this consultation was used as part of the analysis of impacts. 
The statistics and a summary of the main findings are available at Annex V. 

1.6. 

Consultation  of  competent  authorities  of  MS  and 
administrative burdens 

the 

industry  on 

Two questionnaires were developed in order to collect readily available data on administrative 
burdens  and  administrative  costs  for  the  competent  authorities  and  the  operators.19  Data  on 
compliance  costs  incurred  by  operators  when  implementing  current  EU  animal  health 
legislation  and  data  concerning  the  expected  potential  impact  of  the  proposal  on 
administrative  burdens  for  enterprises  and  competent  authorities  were  also  requested  in  the 
questionnaires.  

Where relevant, the results of this consultation have been used to analyse the impacts of the 
different proposed options and to identify opportunities for cost reduction.  

1.7. 

Other opportunities used for consultation 

EU  producers  of  semen,  ova  and  embryos  were  the  target  of  a  separate  questionnaire  for 
gathering  data  to  compare  possible  options  for  animal  health  rules  for  intra-EU  trade.  The 
submitted data was used to assess the impacts of the different options identified. An ad-hoc 
meeting  between  the  Commission  services  and  the  RepVet  group  of  COPA-COGECA  was 
organised  to  explain  the  different  possible  options  in  order  to  facilitate  answering  the 
questionnaire. The results of that questionnaire can be found in Annex VI. 

A task force of experts assisted the Commission in the development of an expert paper20 on 
EU  vaccine/antigen  banks  for  major  animal  diseases  (such  as  foot  and  mouth  disease, 
classical  swine  fever  etc.).  Based  on  that  work  a  questionnaire  on  emergency  vaccination 
policy prepared by Commission services was addressed to the EU CVOs. The analysis of the 
replies can be found in Annex VII (part 2).21  

In  addition  to  the  discussions  at  CVO  level,  special  emphasis  was  given  to  the  concept  of 
surveillance and its introduction in the new AHL during the Task Force for Animal Disease 
Surveillance  (TFADS).  This  Task  Force  was  created  in  November  2008  to  support  the  MS 
and the Commission services. Two meetings of this expert group, which took place on 16-17 
December 2009 and 17-18 May 2010, reflected on the ways in which surveillance should be 
introduced  in  the  new  AHL.  This  provided  expertise  and  experience  on  animal  disease 
surveillance in the context of animal disease management, and summaries of the meetings can 
In 
found  here:  http://ec.europa.eu/food/animal/diseases/surveillance/index_en.htm. 
be 
addition, the Spanish Presidency held a seminar on animal disease surveillance as part of the 
Working Party of Chief Veterinary Officers.  

1.8. 

IAB opinion 

The draft IA report was discussed at the meeting of the IAB on 13 July 2011. Following this 
meeting  the  board  issued  an  opinion  on  the  draft  IA  emphasising  four  main  points  to  be 
addressed in the final version of the IA report. 

18  http://ec.europa.eu/food/animal/diseases/strategy/pillars/consultation_process_en.htm 
19  http://ec.europa.eu/food/animal/diseases/strategy/pillars/consultation_process_en.htm.  Addressees  had  the 

possibility to respond from 19 December 2009 to 15 March 2010 

20  http://ec.europa.eu/food/animal/diseases/strategy/pillars/antigen-vaccine-banks-task-force_en.htm 
21  SANCO/7117/2010 

8

 
 
                                                 
These four main points have been addressed in this revised version of the IA as follows: 

(1) Strengthen the evidence regarding the seriousness of problems: 

−  The  background  of  evaluation  of  existing  law  and  development  of  strategy  is  now 

more clearly explained in the first paragraph to the IA.  

−  More extensive explanations are now given on the problems generated by the lack of a 

single and fully coherent EU legal framework. 

−  A summary of the key findings of the CAHP evaluation has now been annexed to the 
IA  (new  Annex  II)  to  better  explain  the  background  to  the  development  of  the  AH 
strategy,  the  thinking  behind  the  AHL  and  the  stakeholders  views  collected  in  this 
exercise.  

−  The summary of the main findings of the stakeholder consultation is now annexed to 

the IA rather than a reference made to a web-link (new Annex V).  

−  The results from the stakeholder consultation have now also been referred to in each 
relevant problem identified; including showing how many would support a change in 
the  existing  legislation.  Examples  have  also  been  added  of  particular  problems 
highlighted by the AHL steering group.  

− 

In  Point  2.2.1.,  a  paragraph  has  now  been  added  to  explain  who  is  affected  by 
regulatory over-complexity and how.  

(2) Clarify what each option involves and add a simplification only option: 

−  A  new  'simplification  only'  option  2  has  been  added  in  sections  4  and  5  and 

explanations are given for why this is not a viable option.  

−  A  new  point  4.6  has  been  introduced  to  explain  more  clearly  the  new  elements  that 

would be introduced by each option.  

−  Changes  have  been  made  to  the  legislation  table  (now  Annex  IX),  to  outline  more 
precisely  the  changes  planned  in  the  new  legislation.  In  this  new  Annex  IX  an 
introductory chapter has also been added to explain the key new elements of the future 
AHL, in accordance with options 4 and 5.  Some details are also provided to outline 
the  elements  of  the  existing  legislation and  map  them  onto  the  new  AHL  and/or  the 
delegated and implementing acts that should follow it, although full details cannot be 
provided at this stage.  

−  A  new  Annex  X  has  been  introduced  showing  the  structure  of  the  new  AHL  in 

accordance with options 4 and 5. 

(3) Present adequate information regarding vaccination issues: 

−  The current EU approach to vaccination has been explained and assessed in new Part 1 

of Annex VII. 

−  The conclusions of this assessment are presented in the main text of the IA. 

9

 
 
(4) Properly assess administrative burden arising from familiarisation activities: 

− 

In  point  5.4.1.  and  5.5.1.,  a  short  explanation  has  been  provided  why  familiarisation 
costs for the new AH framework law have not been quantified by the Standard Cost 
Model  (SCM)  but  rather  identified  as  being  part  of  the  business-as-usual  costs  for 
business and competent authorities alike, given the individual and different natures of 
animal diseases and subsequent frequent adaptations of the legal framework. 

The IA executive summary has been changed accordingly to reflect the changes of the main 
report. In addition, this version of the IA includes several improvements to better respond to 
the IA Quality Checklist for IAB Opinion. 

The  Impact  Assessment  was  re-submitted  to  the  IAB  in  September  2011  with  these 
amendments  made.  Some  further  changes  were  requested  by  the  IAB  and  have  been 
addressed as follows:  

(1)  Clarify  what  the  preferred  option  involves  in  terms  of  non-commercial  actors, 
biosecurity and future Impact Assessments.  

- More analysis has been made in section 5.4.1 of the impact of option 4 on non-commercial 
actors, particularly in economic impacts.  

- Option labels in the Annex XI on biosecurity have been changed for clarity, and the options 
linked back specifically to options in the main text.  

-  A  set  of  sub-options  in  table  4.1  has  been  removed  where  its  impacts  have  not  been 
separately analysed.  

-  A  paragraph  has  been  added  at  the  start  of  Annex  IX  to  give  examples  of  where  further 
impact assessments might be required.  

(2) Present further evidence regarding the seriousness of particular problems.  

-  An  FVE  report  has  been  cited  as  evidence  around  the  lack  of  consistency  in  training  for 
veterinarians in section 2.2.1.5.  

- Some more explanation of the problems faced in regulatory over-complexity has been made 
in section 2.2.1.6, using Food and Veterinary Office (FVO) reports as evidence.  

(3) Consistently describe vaccination options 

-  The  main  text  of  the  report  has  been  linked  more  explicitly  to  Annex  VII  on  vaccination, 
particularly in table 4.1 in section 1.   

- The option labels in Annex VII have been changed to provide more clarity and for ease of 
linkage with the main text.  

- Annex VII has more analysis of stakeholder views and the need for subsidiarity.  

(4) Better explain administrative burden analysis 

-  The  impacts  of  new  information  obligations  have  been  covered  more  explicitly  in  section 
5.4.1 in examining the analysis of economic impacts of the preferred option 4.  

10

 
 
 
(D) Procedure and presentation 

- A sentence has been added at the end of section 7 to cover the proposed evaluation 
timetable. 

11

 
 
 
 
2. 

2.1. 

Policy context, problems identified, and subsidiarity 

Background and context 

2.1.1.  Nature and size of the sectors concerned 

Across the EU, the farming sector is the largest user of animals with at least 2 billion birds 
(chickens, laying hens, turkeys, etc.) and 334 million mammals (pigs, sheep, goats, cattle, fur 
animals, etc.). There are 13.7 million animal holdings in the EU.22 

The value of livestock farming output in the EU is €149 billion 23 of which pigs and poultry 
(subject  to  specific  EU  provisions)  represent  38%  (i.e.  €57.6  billion).  Animal  output  value 
represents 41% of the overall agricultural output (€363 billion in 2008).  

According to Eurostat, total aquaculture production in the European Union (EU-27) in 2005 
was  1,272,455  tonnes  (live  weight).  This  includes  production  of  crustaceans,  molluscs,  and 
finfish24. The total value of production is estimated as €3,159bn.  

Pet  animals  represent  the  second  largest  type  or  usage  of  animals,  by  number,  in  the  EU. 
There  are  around  120  million  dogs  and  cats,  and  approximately  35  million  pet  birds.  The 
annual  value  of  cat  and  dog  sales  in  the  EU  is  estimated  at  €1.3  billi on  and  the  sector  is 
estimated to generate direct employment of 300,000 persons, including 32,000 dog breeders.  

Many  fewer  animals  are  used  for  experimentation  (pharmaceutical  and  cosmetic  industries 
and public research bodies): around 12 million animals in the EU, of which most are rodents. 
There are between 2,000 and 3,000 zoos in the EU and there are an estimated 800,000 captive 
wild  animals.  The  fur  farming  sector  also  farms  a  significant  number  of  animals,  covering 
about 7,200 farmers and producing around 32 million pelts per year25. No reliable data could 
be obtained for circuses or other activities such as animals used in sports, shows, etc. 

EU  intervention  is  currently  focused  primarily  on  the  prevention  and  control  of  major 
transmissible  diseases  that  can  have  significant  health  and  economic  impacts  at  EU  level. 
Animal  diseases  do  not  recognize  borders  and  present  a  constant  threat  to  all  of  the  sectors 
above.  They  pose  a  direct  risk  to  animal  and  often  public  health,  but  also  can  have  other 
negative  but  indirect  impacts,  such  as  economic  or  social  effects.  The  unpredictable 
occurrence and behaviour of animal disease epidemics and the still insufficient reliability of 
modelling  studies,  despite  the  recent  progress  made  in  this  field,  makes  forecasting  their 
frequency and impact very difficult. 

The  impacts  of  an  animal  disease  outbreak  can  vary  widely  due  to  a  variety  of  factors 
including  the  epidemiological  characteristics  of  the  disease,  the  structure  of  the  sectors 
affected and the nature of the control measures imposed. These impacts can include negative 
effects  for  animal  and  human  health,  costs  to  livestock  farmers  and  related  industries  of 
dealing  with  disease  and  of  business  disruption,  public  sector  costs  of  eradication  and 
monitoring,  and  changes  in  consumption  patterns.  Often,  disease  outbreaks  also  have 
significant  impacts  on  international  trade  of  animals  and  animal  products.    Finally,  many 

22  Data  from  Eurostat  2007,  Number  of  farms  and  heads  by  economic  size  of  farm  (ESU):. 

http://epp.eurostat.ec.europa.eu/cache/ITY_OFFPUB/KS-AF-07-001/EN/KS-AF-07-001-EN.PDF 

23  Data 2008 from the evaluation report. 
24  Finfish is the aggregate term for freshwater, diadromous and marine fish 
25  Data from European Fur Breeders Association, Annual Report 2010 

12

 
 
                                                 
animal  diseases  also  affect  wild  animals,  and  may  have  detrimental  effects  on  wild  animal 
populations.  Thus  they  can  have  a  negative  environmental  impact,  for  example,  on 
biodiversity.  

Some of the consequence of past animal health crises have been used to illustrate the potential 
scale of the impacts of animal disease outbreaks. 

(cid:131)  BSE (1996-1997): for UK only, GBP£3.5 billion (0.5% of GDP). The disease also caused 
a  serious  fall  in  consumer  confidence  across  the  whole  EU  and  the  deaths  of  more  than 
200 people in the last 15 years. 

(cid:131)  FMD (2001-2002): for UK only, GBP£10-12 billion (1.2% of GDP) mainly in agriculture 

/ food chain (30%) and tourism (50%).  

(cid:131)  SARS  (2003):  (cost  of  lost  GDP:  US$18bn  in  East  and  Southeast  Asia  (0.6%  of  GDP) 
(Asian  Development  Bank);  estimated  global  economic  impact  US$30bn  (World  Health 
Organisation, 2003). Around 800 people ultimately died from the illness. 

(cid:131)  Avian flu in the Netherlands (2003): 30 million birds and direct economic costs of more 

than €150 million. A veterinarian died due to this disease. 

The  EU  emergency  fund26  makes  financial  contributions  to  MS  during  animal  disease 
outbreaks27. It would usually make a contribution of 50% (with the remaining 50% covered 
by  the  MS)  of  the  direct  costs  to  animal  keepers  for  certain  specified  diseases.  Table  1.1 
below sets out contributions since 2000. As shown, the total amount paid since 2000 is just 
over €1 billion. However, it should  be noted that of this, €664 million (63% of total) was paid 
between 2002-2005 in relation to Foot and Mouth outbreaks in 2001. 

Table 1.1: EU Emergency Fund Payments by Disease from 2000-2010 

Payments in €m 

Year of 
Payment 

Avian 
Influenza  

Bluetongue 
- disease, 
surveillance 
& 
vaccination 

Classical 
swine 
fever  

FMD 

Newcastle 
disease 

Other 
Diseases 

Grand 
Total 

2000 
2001 
2002 
2003 
2004 
2005 
2006 
2007 

13.79 
17.00 

4.76 
55.92 
18.23 
0.05 
1.00 

0.73
11.46
0.47
4.14
2.65
0.10
4.27

47.05
6.28
11.42
1.78
8.92
4.16
1.63
5.00

400.44
67.82
78.73
119.96

0.42 

0.57 

1.00 
0.65 

0.22 

1.20 

60.84
24.01
424.32
74.84
148.71
145.64
1.78
11.69

26  2009/470/EC: Council Decision of 25 May 2009 on expenditure in the veterinary field (Codified version), 

OJ L 155, 18.6.2009, p. 30–45 

27  The way  the  EU  supports  the  control  and  eradication of  animal  disease  outbreaks  is not  addressed  in  this 

document as it is the subject of a separate piece of work to revise Council Decision 2009/470/EC.  

13

 
 
 
 
  
  
 
  
  
  
  
  
  
  
 
  
  
 
                                                 
2008 
2009 
2010 
Grand 
Total 

8.65 
3.90 
1.27 

51.00
36.36
31.75

3.32
0.04
0.02

0.46

0.72

0.14 
0.36 

63.56
40.66
50.94

17.18 

124.57 

142.93

89.63

668.14

2.79 

18.95  1,046.99

Animals  must  fulfil  specific  animal  health  conditions  when  they are moved between MS or 
imported  from  third  countries.  Indeed  there  are  areas  within  the  EU  with  different  health 
statuses  (for  example,  freedom  from  certain  animal  diseases).  These  conditions  ensure  that 
animals do not pose any risk during movement and they are moved only to an area of equal or 
lower health status than their place of origin. The conditions are attested by official veterinary 
certificates  accompanying  the  consignment  of  the  animals  from  their  origin  to  their 
destination. 

These specific rules for movements are sometimes considered burdensome, especially in the 
case  of  frequent  cross-border  movements  between  two  adjacent  MSs  with  a  similar  or 
identical health status. The most often cited examples of movements of this kind are those of 
pigs and poultry between Germany and the Netherlands; cattle between France, Belgium and 
Luxembourg; animals for slaughter between Austria and Germany; and cattle, pigs and sheep 
between Ireland and Northern Ireland (in the UK). More detailed analysis (along with some 
assessment of policy options referred to in Section 4 later) is available in Annex VIII.  

2.1.2.  Overview of legislative framework and ongoing developments 

The current EU animal health legislative framework involves almost 50 basic directives and 
regulations,  some  of  them  adopted  as  early  as  1964.  The  veterinary  acquis  communautaire 
now covers more than 400 acts: 

−  c.  50  basic  acts  that  lay  down  horizontal  and  vertical  principles  of  animal  health  which 
apply  to  intra-Community  trade,  imports,  disease  eradication,  veterinary  controls, 
notification  of  diseases  and  financial  support  of  terrestrial  and  aquatic  animal.  A 
provisional  list  of  legislation  expected  to  be  affected  by  the  new  legal  framework  is 
attached in Annex IX; 

−  c. 200 acts of general application that lay down implementing rules such as the ones that 

specify lists of third countries, or the rules on veterinary certification; 

−  c. 200 acts of special application that lay down more specific provisions such as rules on 

protection or transitional measures.  

This  set  of  animal  health  legislation  interacts  with  the  current  legal  framework  on  animal 
welfare,  food  safety,  public  health,  animal  nutrition,  veterinary  medicinal  products, 
environmental  protection,  official  controls,  the  Common  Fisheries  Policy  (CFP)  and  the 
Common  Agricultural  Policy  (CAP).  A  new  proposal  would  need  to  successfully  interlink 
with  all  these  sets  of  legislation,  especially  with  Regulation  (EC)  No.  882/200428,  so  as  to 
increase consistency for official controls (checks) related to animal health.  

28  On official  controls  to  ensure  the  verification of  compliance  with  inter alia  animal  health  rules, OJ  No L 

165, 1 p. 30.04.2004 

14

 
 
  
 
  
  
 
                                                 
For the aquatic sector, Directive 2006/88/EC was adopted in 2006, bringing together disease 
control and trade provisions (intra-EU movements and import). This amalgamation was a new 
concept,  which  has  proven  to  work  fairly  successfully,  so  no  policy  changes  are  being 
proposed in this area. Therefore, this Impact Assessment largely focuses on policies relating 
to terrestrial animals.  

2.2. 

Problem definition 

As  noted  in  Section  1  above,  problems  with  the  existing  animal  health  framework  and 
suggestions  for  improvements  to  it  have  been  identified  in  a  number  of  fora.  Subsequent  to 
the  evaluation  of  the  CAHP  and  the  development  of  the  EU  AHS  2007-2013,  stakeholders 
and competent authorities of the MS were then further asked to identify problems with current 
legislation on animal health in the scope of the AHL Steering Group. The replies served as a 
basis  to  develop  the  "Annotated  agenda  for  a  wide  stakeholder  consultation"  in  which 
stakeholders were asked to raise any issues of concern as regards current legislation on animal 
health. The summary of this consultation is available at Annex V.  

The  CAHP  Evaluation  and  the  stakeholders'  consultation  broadly  agreed  that  the  current 
system functioned well, however a number of issues were identified that could be improved. 
Some  relate  to  the  general  policy  approach  whilst  others  relate  to  specific  legal  acts  or 
diseases.  Some  of  these  issues  should  be  addressed  by  stakeholders  as  part  of  their 
responsibility  to  prevent  animal  diseases,  but  others  relate  to  the  responsibilities  of  the  EU 
and of CA. 

As the AHS recommends that the AHL should be a general horizontal legislative framework, 
this  impact  assessment  focuses  on  the  main  problems  identified  in  the  general  policy 
approach.  Some  of  the  more  specific  problems  identified  during  the  wide  stakeholders' 
consultation have been used in this impact assessment as examples of the general problems. 
Others  will  be  addressed,  if  needed,  in  subsequent  legislative  proposals  and  impact 
assessments – see Annex IX for more details. 

As  noted  above,  a  summary  of  the  key  messages  from  the  CAHP  is  available  at  Annex  II; 
however the main thematic issues identified during the CAHP evaluation were: 

−  The high complexity of the current CAHP 

−  The lack of an overall strategy 

−  An  insufficient  focus  on  disease  prevention,  with  a  particular  focus  on  the  need  for 

increased biosecurity. 

A specific policy issue was also identified both in the evaluation and in the consultation with 
stakeholders in the framework of the AHL preparatory work:  

−  Issues related to intra-EU trade in live animals. 

These trade issues cut across the general problems identified in the first three bullets. As such, 
further  more  specific  analysis  was  carried  out  on  intra-EU  trade,  which  is  presented  in 
overview in section 5 and in detail in Annex VIII. 

15

 
 
2.2.1.  High Complexity of the current CAHP 

As  described  above,  current  EU  animal  health  legislation  is  very  complex,  with  over 
400 pieces of legislation, but no single horizontal law containing the overarching principles, 
main objectives and tools of animal health policy. This means that legal measures are spread 
among  very  many  different  pieces  of  legislation  with  different  subject  matters,  including  a 
mixture  of  horizontal  and  vertical  issues,  trade  (intra-EU  and  international),  disease  control 
measures and specific safeguard measures. 

Within the current framework there are not always clear links to other relevant legislation, and 
there can be a lack of consistency and transparency across the various existing animal health 
legislation. The existing veterinary legislation and policies were widely perceived to be very 
complex by stakeholders across the board during the evaluation of the CAHP.  

The high complexity of the current system means it can be difficult for stakeholders (whether 
CA,  veterinary  professionals  or  farmers  and  operators  'on  the  ground')  to  understand  their 
roles  and  responsibilities.  Since  this  complexity  and  lack  of  clarity  are  caused  by  the 
shortcomings of the existing legal framework, they cannot be adequately mitigated by means 
of training or other familiarisation exercises only. Consequently, the current complexity has 
the potential to jeopardise the achievement of the EU's animal health objectives.  

All the specific problems identified below within the overall problem of 'high complexity of 
the current CAHP' relate to the implementation of the current legislation, with the exception 
of  the  lack  of  rules  on  professional  qualifications  and  training  for  official  veterinarians  (see 
2.2.1.5), which relates to a lack of legislation.  

2.2.1.1.  Large number of pieces of EU animal health legislation 

Driver: Large number of pieces of EU animal health legislation but no single horizontal law. 

Problem: Potential high administrative burden for stakeholders to understand legislation. 

The  absence  of  a  single  horizontal  act  containing  the  overarching  principles  means  that 
obligations are scattered in different legal acts. This can mean that the rules can be unclear or 
difficult  to  comprehend  for  animal  keepers  and  owners.  They  may  need  to  consult  many 
different  pieces  of  legislation  or  consult  a  specialist  before  they  can  fulfil  their  obligations. 
Some obligations are laid down in legislation dealing with disease outbreaks which could be 
outside  their  day-to-day  areas  of  activity.  There  can  also  be  a  lack  of  clarity  about  the 
relationship  between  animal  health  legislation  and  other  pillars  of  legislation.  So  it  can 
potentially be difficult for stakeholders to fully comprehend their roles and responsibilities in 
the  current  animal  health  framework.  Nevertheless,  this  situation  can  vary  between  MS 
according  to  the  manner  in  which  they  have  transposed  directives,  with  some  potentially 
offering more coherence than others.  

Nevertheless,  it  is  clear  that  the  time  spent  by  animal  keepers  and  operators  familiarising 
themselves with their statutory obligations represents an administrative burden. This could be 
through  the  time  spent  by  operators  reading  legislation  (or  more  likely  guidance  about  the 
legislation),  or  the  cost  of  consulting  legal  experts.  When  aggregated  across  the  several 
million  animal  keepers,  operators  and  related  business  operators  in  the  EU,  this  is  clearly  a 
considerable administrative burden.  

16

 
 
2.2.1.2.  Responsibilities  and  obligations  of  animal  keepers  and  owners  are  not  always 

clearly spelled out 

Driver: Existing roles and responsibilities differ across existing legislation and in many cases 
are not clearly laid down and consequently interpreted differently in different MS. 

Problems:  Animal  keepers'  legal  responsibilities  as  they  are  expressed  in  the  current  legal 
framework  do  not  reflect  the  totality  of  the  role  of  keepers  and  operators  in  animal  disease 
prevention and management. Differences in responsibilities between MS may lead to varying 
costs of complying with obligations between keepers in different MS. 

Animal keepers and owners, especially farmers, are well placed to prevent and detect animal 
diseases, but they can also contribute to the frequency and scale of disease outbreaks. Current 
EU and/or national legislation already sets certain obligations for animal keepers and owners, 
such as:  

−  notifying the keeping or possession of animals, 

−  notifying  the  relevant  authority  of  the  presence  or  suspected  presence  of  certain  diseases 

without delay, 

−  providing regular care for and supervision of the animals, 

−  handling animals with a certain standard of care, 

−  reporting the dispatch and/or arrival of animal consignments, 

−  keeping  records  and  registers  and  providing  for  the  identification  and  traceability  of 

animals, 

−  having a baseline knowledge of animal diseases and how to prevent them. 

Most of these obligations are laid down in Directives and Decisions which are then transposed 
by MS, but some others are not regulated at EU level. For example, there are currently very 
few mechanisms at EU level which actively involve animal keepers in the rapid notification 
of  suspected  animal  disease  or  on-farm  preventive  measures,  but  many  of  these  types  of 
mechanism exist at national or regional levels. 

The current framework creates a particular problem. Because many of the obligations are in 
Directives, they can be transposed into MS legislation differently. MS sometimes interpret the 
obligations in different ways so there are disparities in obligations related to animal health for 
animal  keepers  and  owners  between  MS.  These  inconsistencies  between  MS  mean  that  the 
responsibilities of animal keepers vary across the EU, which can alter the costs of complying 
with legislation. This in turn leads to an uneven playing field for livestock keepers in different 
MS in relation to the cost and responsibilities of national animal health requirements.  

the  stakeholder  consultation, 

these 
During 
responsibilities, with 78.4% of respondents replying 'agree' or 'strongly agree' to the proposal 
to  clearly  setting  out  obligations  of  animal  keepers/owners/operators.  In  particular  many  of 
the stakeholders stressed the need to establish obligations for operators as well as for animal 
keepers. The impacts on small farmers have to be taken into consideration. Furthermore, the 

there  was  wide  support  for  clarifying 

17

 
 
third  countries  replying  to  the  questionnaire  stressed  that  these  obligations  should  not  be 
imposed on third country operators. 

2.2.1.3  Rules for commercial farming do not always apply in a proportionate manner to 

non-commercial animal keeping 

Driver:  To  establish  better  consistency  and  proportionality  to  address  risk  posed  by  non-
commercial animal keeping. 

Problem: Non-commercial animal keeping usually entails a different kind and level of disease 
risk  compared  to  industrial  farming  and  the  administrative  burdens  imposed  on  non-
commercial animal keeping is not always proportionate to the level of disease risk.  

During the consultations, concerns were raised that surveillance and disease control measures 
are applied identically to both commercial and non-commercial holdings (such as hobby and 
backyard holdings). The necessity of the current application of measures to non-commercial 
farming  (such  as  for  example  the  obligation  to identify  and  register  certain  animals  and  the 
holding registration), was questioned, given the different levels of risk that they pose.  

To  ensure  appropriate  animal  health  in  the  EU  and  for  effective  prevention  and  control  of 
animal disease, at least a basic level of control measures need to be applied to both categories 
of holdings as they can both be affected by disease and become a source of wider infection. In 
some  circumstances,  non-commercial  holdings  can  pose  a  lower  risk  of  spreading  diseases 
compared to industrial holdings: for example, because of fewer movements, less contact with 
other  animals  (especially  with  industrially  farmed  animals),  animals  being  kept  in  smaller 
groups and more contact between the keepers and the animals (see studies on  the spread of 
Avian  Influenza).  On  the  other  hand  there  are  circumstances  where  high  numbers  of  small 
non-commercial  holdings  can  present  a  potentially  major  risk  of  spreading  diseases  to 
industrial  farming.  An  example  of  this  might  be  small-scale  pig  production.  The  risk  of 
disease can arise from potentially lower biosecurity levels in such holdings such as increased 
wildlife  contact,  less  supervised  movement  control,  swill  feeding,  uncontrolled  disposal  of 
carcasses, etc.  

Current practices also raise some questions about intra-EU movements, specifically whether 
different conditions should be applied to commercial and non-commercial movements. Some 
species of animals are considered not to represent a high risk for spreading animal diseases, or 
are  kept  or  bred  in  certain  particular  and  well  controlled  biologically  secure  conditions  (for 
example, laboratories, zoos, circuses etc.). Pet animals are often moved in a different context, 
that is to say, they move in accompanying their owners on their journeys. So they have little 
contact with farmed (or in fact any other) animals and the risk of spreading disease is much 
lower. However, the movements do need to be somewhat traceable and controllable in case of 
disease outbreaks posing risks to animal or human health. 

The stakeholder consultation showed a high level of support for the Commission's approach 
for  differentiated  rules  for  commercial  and  non-commercial  movements,  providing 
possibilities for risk based exemptions on a case-by case basis (74.5% of respondents agreed 
or strongly agreed with the suggested approach). However, a certain extent of uneasiness was 
observed  as  a  significant  percentage  of  respondents  argued  that  changes  could  lead  to  an 
increased  risk  of  animal  disease  spread  and  possible  outbreaks.  (for  full  details  see  2.8  in 
Annex V). 

18

 
 
2.2.1.4.  Unclear definition of the role of veterinary services including the tasks and duties 

of official veterinarians, and other veterinary practitioners. 

Driver: Inconsistency in the role of veterinary services across existing EU legislation. 

Problems:  Legal  uncertainty  about roles  of  veterinary  services,  possible  conflicts  of  interest 
and limits to the development of veterinary networks. 

EU  legislation  (such  as  Council  Directive  90/425/EEC,  Regulation  (EC)  No  882/2004, 
Council Directive 64/432/EEC, and Regulation (EC) 854/2004) gives different definitions of 
‘competent  authority’,  ‘official  veterinarian’,  ‘approved  veterinarian’  and  'official  auxiliary'. 
This  lack  of  legal  clarity  has  paved  the  way  for  different  interpretations  by  the  MS,  and  an 
uncertainty  about  the  roles  of  the  various  segments  of  veterinary  services  during  animal 
disease outbreaks. 

For  example,  the  majority  of  MSs'  veterinary  practitioners  or  technicians  are  authorised  to 
perform a range of official veterinary activities, including sampling (for example, in the cases 
of  brucellosis,  tuberculosis,  Aujeszky’s  disease  and  the  tuberculosis  skin  test),  vaccination 
(for  example,  for  Bluetongue)  and  also  some  clear-cut  official  controls,  such  as  regular 
hygiene checks on dairy farms, or health checks of animals prior to intra-EU trade dispatch. 
In other MS, official tasks such as these are only performed by official veterinarians.  

The steering group consultation also raised concerns that a veterinary practitioner might face a 
‘conflict  of  interest’  when  certifying  animals  in  his  or  her  care;  for  example  if  carrying  out 
work as an official veterinarian but also undertaking private veterinary work, perhaps for the 
same client.  

Different roles for veterinary services across the EU could limit veterinary coordination and 
the  development  of  networks  for  the  surveillance,  prevention,  early  detection,  control  and 
notification of disease. 

At the same time, all MS are members of the World Organisation for Animal Health (OIE). 
The OIE Terrestrial and Aquatic Animal Health Codes provide existing frameworks to which 
EU rules should be aligned in order to ensure that MS are fulfilling their obligations as OIE 
members,  which,  amongst  other  positive  benefits,  facilitates  trade  with  third  countries.  The 
Terrestrial  Animal  Health  Code  defines  the  concept  of  ‘Veterinary  Services’  as  the 
governmental and non-governmental organisations that implement animal health and welfare 
measures and other standards and recommendations in the two OIE codes in the territory. The 
Veterinary  Services  are  under  the  overall  control  and  direction  of  the  Veterinary  Authority. 
Private sector veterinary organisations, veterinarians, veterinary paraprofessionals or aquatic 
animal  health  professionals  are  therefore  included  in  Veterinary  Services  and  they  are 
normally  accredited  or  approved  by  the  Veterinary  Authority  to  deliver  the  delegated 
functions.  The  tasks  of  veterinary  services  include  many  programming  and  management 
activities,  including  international  certification,  and  particularly  the  organisation  of  a 
veterinary  network  for  the  prevention,  control  and  notification  of  disease  outbreaks. 
International  trade  in  animals,  animal  products  and  products  of  animal  origin  is  based  on 
international  (OIE)  standards,  where  the  first  step  in  fulfilling  import  conditions  is  a 
successful  evaluation  of  the  veterinary  services  in  a  given  potential  exporting  country. 
Without that evaluation, health certification is not reliable and export is therefore not possible 
under OIE rules.  

19

 
 
However, it has to be noted that in aquaculture, apiculture and some other animal categories 
(such as animals used in scientific experiments) control activities may be carried out not only 
by veterinarians but by other professions and services. In this regard, international standards 
and  recommendations  set  in  the  OIE  Terrestrial  and  Aquatic  Codes  have  to  be  taken  into 
account. 

This  variety  in  the  structure  of  differing  veterinary  services,  their  relationships  nationally, 
intra-EU and internationally, and the differences in their roles and responsibilities, adds to the 
complexity of the current context. During the stakeholder consultation, 81.7% of respondents 
agreed  with  the  suggestion  to  clarify  the  tasks  and  duties  of  official  veterinarians  and 
veterinary practitioners (for full details see 2.3 in Annex V). Stakeholders are of the view that 
there is a need to clarify and harmonise certain veterinary tasks EU-wide. This is in particular 
valid for "export certification" and international trade. 

2.2.1.5.  Lack  of  rules  on  the  professional  qualifications  and  training  for  official  and 

approved veterinarians  

Driver:  Diverging national standards for  qualification and training for official  and  approved 
veterinarians. 

Problem: Differences between levels of health protection across MS due to the differences in 
veterinary qualifications, ongoing training and professional development.  

Official,  approved  and  authorised  veterinarians  need  in-depth  and  regularly  updated 
knowledge  and  skills  to  perform  official  tasks  and  official  controls  adequately.  This 
knowledge  will  be  gained  first  through  undergraduate  veterinary  education  and  then  by 
postgraduate  studies  and/or  vocational  training.  Differences  in  these  qualifications  between 
MS  mean  that  there  can  be  differing  levels  of  health  protection  and  impartiality  throughout 
the EU.  

The  Federation  of  Veterinarians  of  Europe  (FVE)  and  the  European  Association  of 
Establishments  for  Veterinary  Education  (EAEVE)  run  an  evaluation  system  of  veterinary 
schools  in  MSs  with  a  view  to  providing  an  independent  and  fair  accreditation  system.  The 
latest published evaluation, in 2009, concluded that while many veterinary schools in the EU 
are  world-class,  some  16%  are  at  one  or  more  points  inadequate29.  This  variability  in 
education can lead to inconsistency in the knowledge of those who qualify as vets.  

Regulation  (EC)  No  882/2004  already  envisages  appropriate  and,  as  necessary,  additional 
training for staff performing official control tasks. In addition, there are specific provisions on 
the  professional  qualifications  and  continuing  education  of  official  veterinarians,  but  this  is 
limited to those responsible for fresh meat controls in establishments covered by Regulation 
(EC) No 854/2004. These provisions may need to be extended to other areas of competence of 
official  veterinarians  to  ensure  that  official  tasks  are  performed  in  an  adequate  and  uniform 
way throughout the EU. At the same time it has to be noted that in aquaculture, apiculture and 
some other animal categories (i.e. experimental animals), control activities may be carried out 
not only by veterinarians but by other professions and services. This would have to be taken 
into  account  as  necessary  in  defining  the  required  qualifications  and  ongoing  professional 
development.  

29 

http://www.fve.org/news/position_papers/education/060_oie_education%20_conference_october_2009_pres
entation_jvaarten.pdf  

20

 
 
                                                 
During  the  stakeholder  consultation,  there  was  wide  support  for  extending  the  requirements 
for professional qualification and for veterinary training for officials veterinarians in all areas, 
and to those authorised to perform official tasks in the field of animal health, with 81.0% of 
respondents  replying  'agree'  or  'strongly  agree'.  Many  supported  a  broader  harmonised  EU 
approach for all those that perform official tasks; this includes not only veterinarians but also 
other  professionals.  On  the  other  hand,  others  warn  that  MS  already  have  continuous 
professional developments for veterinarians in place and that additional regulation at EU level 
is  unnecessary.  If  training  is  to  be  introduced,  it  should  be  output  /  target  oriented  towards 
proper  enforcement  and  should  not  generate  unnecessary  costs.  (for  full  details  see  2.4  in 
Annex V). 

2.2.1.6.  Specific  animal  health  conditions  relating  to  imports  are  difficult  to  understand, 

and apply 

Driver: Animal health conditions on imports are unclear and difficult to apply. 

Problem:  Administrative  burden  for  third  countries,  importers  and  competent  authorities  to 
understand and comply with conditions. 

Animal health import requirements for live animals, animal products and products of animal 
origin are based on the need to prevent the introduction of animal diseases into the EU. These 
specific requirements are scattered in different pieces of legislation and sometimes within the 
texts of import certificates instead of the legal act itself. 

This makes the rules difficult to understand and apply for competent authorities and business 
operators in MS and third countries. For example, the Food and Veterinary Office (FVO) has 
regularly made recommendations to MS to improve their import controls. Many of the issues 
causing the recommendations appear to arise from misunderstandings due to a lack of clarity 
rather  than  wilful  disregard.  In  addition,  the  complexity  adds  an  administrative  burden  to 
operators, who can find it difficult to establish what the requirements for import actually are. 
The  introduction  of  basic  animal  health  requirements  would  reduce  the  administrative 
familiarisation  burden  on  operators  who  are  running  import  businesses,  and  grant  more 
consistency in import policy. 

The  time  spent  by  the  concerned  parties  understanding  animal  health  import  conditions 
represents an administrative burden for business operators and competent authorities in both 
MS  and  third  countries  which  has  the  potential  to  be  reduced  through  simplification, 
harmonisation of the controls, and the introduction of electronic forms.  

During the stakeholder consultation, 75.1% of respondents replied 'agree' or 'strongly agree' to 
the  proposals  to  make  the  import  conditions  clearer  and  simpler.  For  full  details  of  the 
proposals  see  2.12  and  2.9  in  Annex  V.  Stakeholders  especially  highlighted  the  issue  of 
competitiveness:  they  are  of  the  view  that  EU  operators  face  stricter  standards  than 
international  standards.  Imports  of  special  animal  categories  also  have  to  be  considered 
carefully,  and  exemptions  only  granted  taking  into  consideration  the  risks  involved  (e.g. 
protected  and  endangered  species,  wild  animals,  etc).  They  emphasised  the  need  for  clear 
definitions to avoid misunderstanding in import conditions (for example, llamas should not be 
considered as ruminants).  

21

 
 
2.2.2.  Lack of a single overall strategy 

The  final  report  of  the  CAHP  evaluation  highlighted  the  lack  of  a  single  general  approach 
behind the CAHP measures. Instead, the CAHP was perceived to be a patchwork of specific 
measures and actions, with insufficient clarity in its overall direction. The setting of priorities 
for  the  CAHP  has  consisted  of  a  mixture  of  longer-term  components  such  as  eradication 
programmes or contingency planning but also of short-term or crisis-driven elements. 

Resources,  personnel  and  management  attention  have  tended  to  follow  animal  health  crises 
with a reducing focus on the definition and achievement of longer-term strategic objectives. 
Consequently, this apparent lack of a clear long-term strategy and prioritisation system could 
lead to sub-optimal prioritisation and allocation of resources. 

All of the problems identified below which relate to the lack of a single overall strategy are 
areas  where  EU  law  exists  only  in  piecemeal  fashion  (for  example,  relating  only  to  certain 
diseases); or where there is no existing law.  

2.2.2.1.  Lack of categorisation and prioritisation of animal disease policy 

Driver: Lack of prioritisation of different animal disease control and policy measures. 

Problem: Sub-optimal allocation of resources for disease control. 

As  described  above,  the  CAHP  evaluation  highlighted  the  absence  of  a  clear  system  for 
prioritising resources for animal health policy interventions, such as categorisation of animal 
diseases  and  animal-related  threats,  (or  reliable  scientific  grounds  for  such  categorisation). 
This  means  that  resources  have  sometimes  been  allocated  on  short-term,  political  or  crisis-
driven grounds, which do not fully reflect evidence based on scientific risk assessments and 
cost-benefit  analysis.  The  management  of  less  high-profile  diseases  might  therefore  be  de-
prioritised  as  a  consequence.  This  sub-optimal  allocation  of  resources  for  disease  control 
under  the  current  system  could  lead  to  more  negative  impacts  of  animal  diseases  than  if 
resource allocation were optimally prioritised.  

In  many  cases,  the  existing  legal  framework  is  too  rigid  and  cannot  adapt  to  new 
developments,  including  new  scientific  developments.  The  AHL  Steering  Group  mentioned 
certain examples of these problems in their discussions in July 2009, for example: the rules on 
swine vesicular disease, which they felt to be disproportionate to the risks the disease poses; 
and protective measures for Newcastle Disease, which they felt to be outdated.  

A  bluetongue  case  study  is  outlined  in  the  box  below  to  illustrate  a  short  term  crisis-driven 
allocation of resources.  

Bluetongue disease  

Bluetongue is an insect-transmitted disease which appeared in North-Western Europe for the 
first  time  ever  in  summer  2006  when  a  virus  strain,  probably  originating  in  sub-Saharan 
Africa, appeared in the Netherlands. That summer was exceptionally warm and these unusual 
climatic conditions may have exacerbated the conditions for the virus to flourish. That year 
2,000 farms were affected, and in the following year 60,000 farms were affected, from the UK 
to the Czech Republic. Infections caused high mortality in sheep and goat populations.  

In Belgium it is estimated that the mortality rate in 2007 amounted to one sixth of the national 
sheep  and  goat  population.  Economic  losses  in  the  Netherlands  were  estimated  at 

22

 
 
€130 million in 2006 and 2007. In 2007, a BTV-8 outbreak in France was estimated to cost 
€1.1 billion . Losses there were largely due to the inability to trade cattle on the international 
market.  

In the EU in 2008, a total of 45,000 outbreaks were reported. That number dropped to 1,118 
in 2009 and only 120 in 2010. The success is credited primarily to the vaccination campaigns 
in  the  MS.  A  co-financed  EU  programme  was  adopted,  initially  funded  by  the  "emergency 
fund", and later by annual programmes in all affected areas. This appears to be the main factor 
leading to the near-disappearance of the disease in the EU in 2010.  

It  has  been  argued  that  a  more  preventative  approach  to  Bluetongue  could  have  prevented 
much of the mortality and costs of the disease that the emergency measures required.  

2.2.2.2.  Poor coordination of animal disease surveillance  

Driver: Lack of coordination between different surveillance systems and actors. 

Problem: Sub-optimal use of surveillance to reduce the risk and impact of disease outbreaks. 

Animal  health  surveillance  is  an  essential  tool  to  detect  and  control  animal  diseases,  to 
monitor  disease  trends,  to  support  claims  for  freedom  from  disease  or  infection,  to  provide 
data for use in risk analysis, for animal and/or public health purposes, and to substantiate the 
rationale for sanitary measures. Therefore, surveillance is a key element of any animal health 
policy that gives priority to a preventive approach, early detection and quick response. 

Animal  disease  surveillance  is  one  of  the  cornerstones  of  Pillar  3  of  the  AHS  2007-2013. 
Several activities  (as  noted  above in section 1.7) have  been carried  out  to  identify  the  main 
challenges for surveillance and how they could be addressed: 

−  The  current  picture  of  animal  disease  surveillance  in  the  EU  is  rather  complex  and  the 
purposes or objectives of surveillance systems are not always sufficiently clear in current 
legislation (for example, there are surveillance systems which are EU harmonised vs. those 
not harmonised; compulsory vs. voluntary; surveillance in free areas vs. monitoring in not-
free areas; EU co-financed vs. not EU co-financed; active vs. passive; farmed animals vs. 
wildlife and so on). It can therefore be difficult for stakeholders and competent authorities 
to understand their roles and responsibilities.  

−  The current surveillance systems may not be sustainable, as they do not necessarily make 
best  use  of  available  resources,  nor  optimally  set  priorities;  so  the  affordability, 
sustainability and communication of surveillance activities need to be addressed. Support 
and  engagement  of  the  veterinary  authorities  and  stakeholders,  in  particular  farmers  and 
trading partners, is essential and should be actively sought.  

During the stakeholder consultation, 67.3% of respondents replied 'agree' or 'strongly agree' to 
the proposals to improve animal health surveillance. Full details are in part 2.6 of Annex V. 
Stakeholders  suggested  that  the  surveillance  should  be  developed  in  partnership  with  them. 
Some have asked for a cautious approach in introducing surveillance network in order not to 
be too prescriptive.  

23

 
 
 
2.2.2.3.  Insufficient harmonisation of EU legislation with international standards  

Driver: All MS are members of the OIE, so EU legislation should aim to better align with the 
existing  OIE  Health  Codes  for  the  sake  of  consistency  with  international  trade  rules  and 
competitiveness of the EU farming industry. 

Problem:  In  certain  respects,  convergence  of  standards  represents  a  trade-off  with  animal 
health  standards,  but  lack  of  convergence  may  lead  to  lack  of  competitiveness  and  even 
international trade disputes.  

MS are members of the OIE and as a result should align their rules to the existing OIE Code. 
As such the standards of the OIE Health Codes should be reflected in EU legislation. Some 
current differences in EU legislation and OIE standards are set out in the box below.  

The potential problem that arises from these differences is in the difficulty of achieving the 
optimal balance  between aligning with OIE standards and  maintaining EU health standards. 
This  amounts  to  a  trade-off  between  maintaining  good  relations  with  third  countries,  hence 
maintaining  the  competitiveness  of  the  EU  farming  industry  and  avoiding  potential  trade 
disputes; and maintaining current animal health standards within the EU. 

During the stakeholder consultation, 82.3% of respondents replied 'agree' or 'strongly agree' to 
the  proposals  to  aligning  EU  standards  with  international  standards  (while  not  lowering  EU 
standards) and to promoting EU standards in international fora, particularly the OIE.  

Whilst EU trade and import legislation generally reflects OIE standards, sometimes there are 
differences. For example: 

−  The  OIE  only  carries  out  a  paper  evaluation  as  the  basis  for  determining  disease-free 
countries or zones.  The  EU does  not  consider this  sufficient and generally  carries out  its 
own on-the-spot inspections before granting its trading partners this status. 

−  The  EU  has  its  own  level  of  protection  for  certain  imports,  based  on  scientific  risk 
assessment, which is often higher than that which can be achieved solely by applying OIE 
standards or guidelines. An example is that the EU does not accept that the import of bone-
in  beef  from  a  country  carrying  out  vaccinations  against  foot  and  mouth  disease  is  safe, 
whereas under certain conditions this would be possible under the OIE code. 

−  The EU can act faster and indeed can be more flexible than the OIE in certain instances, 
such  as  in  recognising  different  regions  of  a  country  or  reinstating  disease-free  status 
following a satisfactory outcome of an inspection by the Food and Veterinary Office. 

−  The  definition  of  certain  disease  incubation  periods  or  other  time  intervals  and  the 
approaches  to  evaluating  competent  authorities  for  animal  health  is  different  in  OIE  and 
EU standards. 

−  There are differences in veterinary roles and standards as highlighted earlier. 

−  Diagnostic  tests  in  EU  legislation  do  not  always  mirror  the  prescribed  tests  in  the  OIE 

manual. 

24

 
 
 
2.2.2.4.  Emerging,  re-emerging  and  exotic  diseases  are  not  duly  considered  in  current 

legislation  

Driver: Lack of flexibility and appropriate tools to respond to, control and monitor emerging 
and exotic animal diseases. 

Problem: Potential for larger scale and more frequent exotic disease outbreaks. 

Public  authorities  and  animal  keepers  know  less  about  diseases  which  are  not  commonly 
present  in  the  EU  (typically  known  as  exotic  diseases)  or  are  currently  unknown  (emerging 
diseases), than about diseases which are endemic in the EU. This means that MS and the EU 
have lower preparedness for dealing with outbreaks of exotic or emerging diseases. This can 
contribute to larger scale outbreaks of exotic diseases than if there was more adequate crisis-
preparedness. 

General  EU  measures  for  the  control  of  certain  animal  diseases  are  laid  down  in  Directive 
92/119/EEC but these measures refer only to a limited list of emerging and/or exotic diseases 
for the  EU  and  some of these measures do not prescribe the right tools to deal with certain 
exotic diseases. The rigidity of current rules limits the possibilities for the EU to play a more 
proactive role to prevent the spread and introduction of such diseases or to react in the event 
of  a  new  animal  disease.  This  could  lead  to  delays  in  taking  the  appropriate  measures  to 
control them. In addition, past crises have shown the need to put in place clear and flexible 
rules for controlling and monitoring animal diseases that can be adapted to every conceivable 
situation  and  to  varying  regional  factors.  A  good  example  is  that  of  bluetongue,  which  was 
outlined  in  2.2.2.1  above.  Other  examples  were  highlighted  by  the  AHL  Steering  Group  in 
their meeting in July 2009 for which they felt the existing legislation is too rigid and the EU 
relatively  unprepared.  These  included  Rift  Valley  Fever,  and  the  rules  for  African  Horse 
Sickness.  

During the stakeholder consultation, 86.1% of respondents replied 'agree' or 'strongly agree' to 
the  proposals  to  reflect  emerging  diseases  in  the  AHL  and  to  update  certain  disease  control 
directives that are outdated or disproportionate. Full details are available in 2.10 of Annex V.  

2.2.3. 

Insufficient focus on disease prevention 

Freedom from animal diseases is widely considered to be a global public good, as it protects 
the  health  of  animals  and  public  health  as  highlighted  in  the  "One  World  –  One  Health" 
concept developed by the WHO (World Health Organisation), OIE (World Organisation for 
Animal Health) and FAO (Food and Agriculture Organisation)30. Its importance is not limited 
to the rural economy but impacts on the whole of society. Animal diseases and related control 
measures can be costly to the livestock sector, and to competent authorities which currently 
cover most of the costs of crisis response. Additionally, freedom from certain animal diseases 
is a necessary condition for animals and animal products before they are traded within the EU 
and with third countries. 

While  animal  health  crises  will  always  occur,  the  CAHP  evaluation  highlighted  the  need  to 
focus more on disease prevention and rapid and effective risk management in order to reduce 
the incidence and scale of animal disease outbreaks. Recent work to put in practice the "One 
World  –  One  Health"  concept  clearly  show  that  the  emphasis  is  shifting  away  from  crisis 

30  See  Contributing  to  One  World,  One  Health,  A  Strategic  Framework  for  Reducing  Risks  of  Infectious 

Diseases at the Animal–Human–Ecosystems Interface, at:  
http://www.oie.int/downld/AVIAN%20INFLUENZA/OWOH/OWOH_14Oct08.pdf. 

25

 
 
                                                 
response  to  building  the  systems  and  capacity  to  prevent  and  respond  more  effectively  to 
future outbreaks of diseases. 

The  issues  identified  below  are  all  problems  caused  by  a  mixture  of  both  the  content  and 
implementation  of  existing  legal  powers;  and  because  legal  powers  to  provide  an  overall 
coherent view of all animal diseases are lacking.  

2.2.3.1.  Poor coordination of animal disease surveillance and monitoring 

Driver: Lack of coordination between different surveillance systems and actors. 

Problem:  Sub-optimal  use  of  surveillance  to  reduce  the  risk  and  impact  of  animal  disease 
outbreaks.  

As  noted  above  in  2.2.2.2,  surveillance  is  an  essential  tool  to  detect  and  control  animal 
diseases.  Its  present  sub-optimal  use  means  the  EU's  ability  to  prevent  disease  outbreaks 
before  they  occur  is  not  at  its  full  potential.  The  improvement  of  surveillance  systems  is 
widely supported by stakeholders, as noted above.  

2.2.3.2.  Insufficient  on-farm  biosecurity  measures  to  prevent  outbreaks  on  farms  and  in 

the farming industry  

Driver:  Lack  of  comprehensive  rules  on  farm  biosecurity  measures  to  reduce  impact  of 
disease outbreaks. 

Problem: Inefficient use of biosecurity on-farm and in the farming industry, and increased risk 
of disease outbreaks. 

Farmers  (animal  keepers  in  general)  are  often  the  best  placed  persons  to  prevent  and  detect 
animal  diseases.  Currently,  very  few  mechanisms  exist  at  EU  level  that  actively  encourage 
animal  keepers  to  take  preventive  disease  measures.  Mechanisms  to  achieve  on-farm 
biosecurity at other levels within the EU are mainly voluntary or industry-led schemes, which 
typically achieve a lower uptake than statutory measures. 

The lack of biosecurity measures is driven by two factors: 

−  Many farmers and animal keepers lack sufficient information about biosecurity measures 
they  could  implement.  In  particular  they  are  unlikely  to  be  aware  of  the  costs  of 
implementing  biosecurity  measures  compared  to  the  benefits  of  reduced  animal  diseases. 
This  can  lead  to  farmers  implementing  fewer  biosecurity  measures  than  would  be 
beneficial to them (because the on-farm benefits would exceed the implementation costs). 
This can lead to a lower level of biosecurity than is optimal and a higher risk of on-farm 
disease outbreaks. 

−  With optional or voluntary biosecurity schemes, farmers can choose the level of on-farm 
biosecurity they implement. Without specific mandates or incentives to take into account 
the wider benefits (public benefits) of  their biosecurity  measures, farmers  are unlikely to 
implement  additional  measures  above  those  that  benefit  them  directly  (private  benefits). 
For example, certain measures might reduce the likelihood of disease outbreaks spreading 
to other farms and therefore lead to an overall lower cost of disease to society as a whole. 
So  farmers  implement  on-farm  biosecurity  measures  based  on  the  private  benefits  they 
receive  on  their  farm,  not  fully  taking  into  account  public  benefits  to  others  or  to  wider 

26

 
 
society. This also leads to a lower level of biosecurity than is socially optimal and a higher 
risk of on-farm disease outbreaks spreading to other farms. 

Still very few mechanisms, regulatory or not, exist to rate holdings with respect to their level 
of biosecurity within the EU. Those mechanisms that do exist do not recognise or assist those 
who  wish  to  achieve  higher  than  minimum  (additional)  standards  (and  may  even  create  an 
uneven  playing  field  for  them).  More  data  and  analysis  on  this  issue  are  available  in 
Annex XI. 

During the stakeholder consultation, 75.8% of respondents replied 'agree' or 'strongly agree' to 
the proposal of a legal framework introducing voluntary biosecurity on farms, and a minimum 
criteria for biosecurity measures (adapted to local circumstances). Detailed stakeholder views 
and conclusions are presented in Points 2.5. and 3.5 of Annex V.   

2.2.3.3.  Applicability  and  acceptability  of  the  current  vaccination  strategy  for  control  of 

animal diseases  

Driver: The willingness of MS and stakeholders to use vaccination as a tool to control animal 
disease  outbreaks,  which  is  often  linked  to  the  availability  and  reliability  of  vaccines  and 
differentiating diagnostic tests. 

Problem:  Sub-optimal  level  of  use  of  vaccination  for  major  animal  diseases,  increasing  the 
impact of animal disease outbreaks, when they occur. 

The use of vaccination to control major epidemic diseases has been the subject of very intense 
debate  in  the  EU  in  the  last  twenty  years.  The  main  reasons  why  vaccination  is  not  often 
applied  by  MS  are  the  poor  availability  of  certain  vaccines  and  associated  DIVA31  tests; 
concern  over  potential  trade  blocks  (of  imports  of  vaccinated  animals  and/or  products  of 
vaccinated animals) by third countries; and consumer perception in the EU. 

Nevertheless, it is widely agreed that in many cases vaccination could be used as a means of 
preventing animal diseases. But more importantly, vaccination could also be the best means 
of  preventing  and  minimising  negative  impacts  of  animal  diseases  once  they  occur  by 
preventing  further  spread  of  disease.  The  principle  'vaccination  is  better  than  unnecessary 
culling' was agreed during the creation of the AHS and its Action Plan.32 In order to address 
the  issue  of  availability  of  vaccines,  a  task  force  of  experts  was  created  to  assist  the 
Commission in the development of an expert policy paper33 on EU vaccine/antigen banks for 
major animal diseases. The main conclusions reached in this process were: 

−  For  most  of  the  relevant  infectious  diseases,  existing  legislation  regarding  emerging 
vaccination  should  be  amended  so  that  vaccination  becomes  a  more  realistic  and  viable 
option in the event of a crisis.  

31  Differentiating Infected from Vaccinated Animals 
32  The  European  Parliament  (EP  Resolution  2007/2260(INI)),  the  Council  (Doc.15481/07  ADD  1)  and  the 
European Economic and Social Committee (NAT/376 – EU Animal Health Strategy) and stakeholders 
33  The  summary  of  the  paper  produced  by  this  group  of  experts  was  presented  to  the  delegates  of  Member 

States during the SCFCAH meeting on 3 May 2010. 
http://ec.europa.eu/food/animal/diseases/strategy/pillars/antigen-vaccine-banks-task-force_en.htm 
DG SANCO consulted the Chief Veterinary Officers of the EU Member States in charge of implementing 
animal health legislation on the use of vaccination as a control tool for major epidemic diseases.   

27

 
 
                                                 
 
 
−  The  mechanisms  of  accessing  the  vaccines/diagnostics  have  to  be  clarified.  A  procedure 

should be established to assure guaranteed supply. 

A  detailed  analysis  of  vaccination  policy  and  further  data  are  presented  in  Part  1  of 
Annex VII. Stakeholders' views concerning vaccination are collated in Point 2.15 of Annex V. 
As  referred  to  previously,  the  questionnaire  and  a  summary  of  the  outcome  of  this 
consultation with the CVOs can be found in Part 2 of Annex VII to this document. 

This approach is widely supported by stakeholders – there is wide agreement that vaccination 
should  be  used  in  a  flexible  way,  taking  into  account  its  advantages  and  disadvantages  and 
encouraged where it is strategically sensible to do so.  

2.2.3.4.  No  consistent  provisions  for  training  on  animal  health  for  people  dealing  with 

animals  

Driver:  Animal  keepers  often  have  a  lack  of  access  to  information  and  training  on  animal 
health. 

Problem:  Potential  for  sub-optimal  on-farm  animal  health  measures  to  prevent  and  control 
animal diseases, with increased potential for disease outbreaks. 

Current  EU  legislation  focuses  on  training  for  people  dealing  with  or  handling  animals  in 
dealers’  premises,  assembly  centres  and  during  transport.  However,  there  are  no  provisions 
for training of people dealing with animals at farm level in order to achieve a higher level of 
awareness of the potential health, social and economical impacts that animal diseases might 
have  and  the  measures  that  they  themselves  can  implement  to  prevent  them.  This  potential 
lack of awareness can lead to poor implementation of the rules, and the risk of animal health 
and welfare problems, such as late reporting of animal disease outbreaks. This can result in 
measures for controlling the diseases being delayed and therefore have an increased impact. 

During the stakeholder consultation, a voluntary approach to better training was regarded as 
the  most  adequate  solution  by  the  majority  of  stakeholders  (see  Point  2.2.  in  Annex  V). 
However,  a  significant  share  preferred  that  training  should  be  compulsory  in  the  AHL, 
expressing  at  the  same  time  concerns  on  funding.  The  importance  of  flexibility  to  adapt 
provisions to differing circumstances was highlighted by a majority of stakeholders.  

2.2.4.  Rules for intra-EU trade of live terrestrial animals are sub-optimal 

Whilst the previously described problems fit under the thematic headings, the steering group 
highlighted problems with intra-EU trade that fell under several of these different categories. 
Therefore  rather  than  addressing  these  thematically,  the  issues  related  to  trade  have  been 
grouped  together.  The  issues  here  are  areas  where  the  existing  law  is  not  optimal,  but  any 
proposals for better coherence would not necessarily expand the EU's powers further.  

2.2.4.1.  Current animal health rules for intra-EU trade 

Driver:  Current  animal  health  rules  for  intra-EU  trade  for  live  terrestrial  animals  are  not 
always proportionate to the animal health risks posed by movements. 

Problem:  Current  rules  limit  the  single  market  for  live  terrestrial  animals,  and  the 
administrative burden for traders and competent authorities is not always proportionate to the 
level of animal health risk posed by different types of movements. 

28

 
 
Current  animal  health  provisions  for  commercial  movements  of  live  terrestrial  animals 
between MS are largely based on the "intra-EU trade" concept. Under this approach, before 
live  terrestrial  animals  are  moved  between  MS  they  must  fulfil  certain  animal  health 
requirements  established  in  the  EU  legislation.  Veterinary  checks  and  examination  are 
required to ensure the animal meets these requirements and a certificate is issued before the 
movement is allowed. A notification of the movement must be made in national identification 
and registration databases and into the TRACES34 system. 

The current EU legislation allows MS to maintain, to a certain extent, animal health rules on 
national  movements  in  live  animals,  provided  that  these  national  rules  comply  with  the 
relevant provisions on the control of diseases that are regulated at EU level. 

The current system with different requirements for movements within the MS to that across 
MS does not fit well with the concept of the single market. Although border veterinary checks 
between MS were abolished long ago and certain certification rules for the EU movements are 
more straightforward than those for international trade; the movements system still contains 
different market approaches to trade within MS than for trade across MS. 

Furthermore,  this  system  was  criticised  during  the  CAHP  evaluation  for  being  complicated, 
expensive for operators and burdensome from an administrative perspective for operators and 
competent  authorities,  and  because  this  administrative  burden  was  not  proportionate  to  the 
health  risks  posed  by  such  movements.  This  is  most  obviously  the  case  for  movements  of 
animals  between  two  MS  with  an  identical  health  status  (in  an  extreme  example,  even 
movements  across  a  border  between  holdings  of  the  same  owner,  or  cross-border 
transhumance) and movements of animals for direct slaughter. These are largely known in the 
EU, for example between Germany and the Netherlands; Belgium and Luxembourg; Austria 
and Germany; in the island of Ireland; Slovenia and Austria; France and Italy; the special case 
of  moving  reindeer  between  Finland  and  Sweden;  and  many  others.  In  these  cases,  an 
argument can be made that the health status guarantees for the relevant animals may not need 
to be so demanding.  

However, in some cases the measures may be proportionate to the animal health risk posed, 
for  example  when  animals  or  their  products  are  moved  between  holdings  or  zones  of  a 
different  health  status,  or  for  specific  categories  of  animals,  where  a  health  status  is  of 
particular or specific relevance and where appropriate health guarantees have to be provided.  

A balanced solution ought to be sought for the health risks involved in a particular movement, 
reducing  some  complexity  of  the  procedures  and  costs  attached  to  it  and  preserving  a 
transparent  and  simple  system  that  can  be  easily  applied  in  practice.  More  data,  a  special 
analysis and examples on this issue are available in Annex VIII. 

2.2.4.2.  Duplication of procedures and electronic certification 

Driver: Lack of harmonisation of procedures and certification for intra-EU movements. 

Problem: Current system is difficult to use and unclear, with a high administrative burden for 
users through duplication of procedures.  

34  TRACES  is  the  intra-trade  system  for  cross-border  trade  in  animals.  TRACES  allows  the  competent 
authorities  of  the  different  Member  States  to  inform  each  other  of  cross-border  movements  of  animal 
submitted to veterinary certification. 

29

 
 
                                                 
The  diverse  information  systems  on  animal  health  within  the  EU  and  in  the  international 
framework  (TRACES  and  ADNS  in  the  EU;  WAHIS-WAHID  for  the  OIE;  and  national 
databases for animal identification and registration) sometimes create multiplication of effort 
for MS, as the same notification has to be entered in several databases. In addition, despite the 
high number of information systems, they do not provide information fit for purpose for EU 
and  MS  risk  managers  to  support  decision  making  on  disease  prevention  and  control 
measures.  

Furthermore, electronic certification could be considered as an option to simplify veterinary 
procedures greatly. The TRACES system could enable electronic certification and so simplify 
the process, but a legal basis for doing this is currently lacking.  

The  collection,  processing  and  use  of  information  on  animal  health  does  not  function 
optimally and does not deliver its full potential value. 

For  example,  the  CAHP  evaluation  recommended  exploring  further  the  possibility  of 
developing integrated electronic systems that could lead to better traceability and a reduction 
of administrative burdens for operators. However, there would be considerable technical and 
other difficulties to be overcome. Prior to proceeding, such integration efforts would have to 
be  subject  of  a  detailed  technical  feasibility  study/impact  assessment,  as  there  are  risks  in 
integrating the electronic systems for EU procedures applied in animal movement (e.g. data 
overload, security issues) that require further technical analysis.  

2.2.4.3.  Concept of compartmentalisation is not widely recognised in EU law 

Driver: Compartments used in some production systems are not widely recognised in EU law. 

Problem:  Legislation  does  not 
compartmentalisation is not well incentivised in the current legal framework. 

lower  disease 

reflect 

risks  of  compartments,  so 

In the context of better biosecurity a new concept of "compartmentalisation" was developed at 
international level and described in the OIE Health Codes. A compartment is a group of one 
or  more  animal  establishments  which  are  subject  to  a  common  biosecurity  management 
system,  with  a  distinct  health  status  for  a  specific  disease  or  diseases  which  require 
surveillance.  These  control  and  biosecurity  measures  are  usually  applied  to  facilitate 
international trade. 

In  practical  terms  this  implies  that  a  compartment  might  be  considered  as  a  homogeneous 
production  unit  with  respect  to  health  status,  veterinary  control  measures  and  trade,  as  all 
establishments in the compartment have the same distinct status, which is known throughout 
the compartment.  

This concept has not been introduced into the EU legislation except in Directive 2005/94/EC 
related to the measures for Avian Influenza, and Directive 2006/88/EC related to aquaculture 
animals. It could also be extended to other diseases and used by the MS for the purposes of 
international and intra-EU trade, and for better control and eradication of animal diseases.  

There  is  currently  a  lack  of  legal  powers  to  provide  an  overall  coherent  approach  for 
compartmentalisation for all relevant diseases.  

30

 
 
2.3.  Who is affected by the current policy? 

The  current  policy  and  the  issues  associated  with  it  as  identified  above  particularly  affect 
stakeholders involved in keeping live animals and in the production of, trade in, and import or 
export  of  live  animals,  animal  products  and  products  of  animal  origin.  Non-commercial 
animal keepers and holdings such as pet owners, zoos, backyard farmers, and hobby farmers 
are also affected.  

Under present legislation, animal keepers have a degree of responsibility for prevention and 
control of animal diseases. In general, non-professional animal keepers usually have a lower 
level of biosecurity and awareness of hazardous practices compared to the professional sector.  

Competent  authorities  in  the  MS  in  charge  of  implementing  and  controlling  the 
implementation of animal health rules are also a set of key stakeholders.  

Trading partners and competent authorities in third countries are affected by the EU's import 
conditions for live animals, animal products and products of animal origin. 

Veterinarians,  both  official  (state)  or  private,  other  veterinary  professionals,  technicians  and 
the wider veterinary industries also play a key role in the delivery of EU animal health policy. 

2.4. 

The right and justification for EU action 

2.4.1.  Treaty basis 

Articles  43,  114  and  168  of  the  Treaty  on  the  Functioning  of  the  European  Union  (TFEU) 
provide  the  legal  basis  for  the  EU  legislative  measures  on  animal  health,  as  they  are  an 
essential  part  of  EU  agricultural,  public  health  and  consumer  protection,  trade  and  single 
market policy.  

−  Article 43 provides the basis for the EU legislative measures on the Common Agricultural 
Policy.  This  article  also  became  the  basis  for  veterinary  legislation  as  the  CAHP  is 
considered  from  a  legal  perspective  to  be  part  of  the  Common  Agricultural  Policy,  so 
adopting the same legislative and administrative procedures.  

−  Article 114 provides the legal basis for the establishment and functioning of the internal 
market  and  the  approximation  of  provisions  laid  down  by  the  law,  regulation  or 
administrative actions in this respect.  

−  Article 168 on health protection refers to the protection of human health from all causes 
that may damage it, including those related to animal health. The legal basis for veterinary 
and  plant  health  measures  directly  aimed  at  protecting  public  health  were  adopted  under 
the co-decision procedure as a result of this article.  

2.4.2.  Subsidiarity test  

Necessity test - Why can the objectives not be achieved by MS? 

In very general terms, good animal health generates not only private benefits for the particular 
animal  keepers  and  owners  concerned  with  individual  animals,  but  is  a  public  good  with 
wider  societal  benefits.  The  transmissible  nature  of  many  animal  diseases  means  that  a 
common  approach,  rather  than  a  series  of  individual  actions,  is  likely  to  have  the  greatest 
overall benefits.  

31

 
 
The  value  of  a  harmonised  EU  approach  to  the  control  of  major  transmissible  diseases  has 
been confirmed by judgements of the Court of Justice and by reports of the Court of Auditors, 
the  farming,  agricultural  and  food  industries,  the  European  Parliament,  and  other 
stakeholders;  with  the  Commission's  role  in  policy  making  becoming  increasingly  accepted 
both within the EU and internationally. 

Veterinary legislation at EU level has led to harmonised rules which apply to all MS and has 
replaced  a  complex  web  of  national  and  regional  rules.  This  harmonisation  has  helped  to 
reduce  the  administrative  burden  for  operators,  traders,  veterinarians  and  veterinary-related 
industries. 

A  harmonised  animal  health  policy  has  played  a  key  role  in  the  establishment  of  the  single 
market, facilitating intra-EU trade in animals and animal products (meat, milk, etc.) by setting 
up  harmonised  animal  health  conditions  and  promoting  the  success  of  the  CAP.  The 
development  of  harmonised  EU  animal  health  standards  has  progressed  in  parallel  with  the 
development of intra-EU trade and trade with third countries.  

The  necessity  of  continued  EU  level  action  is  demonstrated  by  the  fact  that  if  MS  were  to 
introduce  national  rules  including  possible  restrictive  measures  in  the  event  of  an  animal 
disease outbreak, serious disruption would likely occur to trade in animals,  animal products 
and products of animal origin as well as to related agricultural and industrial activities such as 
farming and slaughter. This could also have consequent effects on exports of live animals due 
to the credibility of EU measures in third countries being jeopardised, while in the long run 
the EU would lose the power to negotiate at international level. 

Animal disease outbreaks that have occurred in the past have shown that MS may be subject 
to internal pressures which might not allow them to adopt the most effective disease control 
measures. This problem occurs particularly when certain outbreak scenarios are not provided 
for in EU legislation. In this situation, there could be increased spread of animal disease and 
additional costs and losses for the farming, agricultural and food industries as well as costs for 
MS and the EU.  

Added value test - Can objectives be better achieved by the EU? 

The  benefits  of  harmonised  rules  for  the  prevention,  notification,  control  and  eradication  of 
animal diseases at EU level have been demonstrated during animal disease outbreaks in recent 
times. The response to these crises showed the EU's capability to react quickly, limiting the 
spread  of  diseases  and  minimising  their  impacts.  This  was  largely  due  to  the  harmonised 
approach  to  disease  control,  including  providing  financial  compensation  for  the  losses  on 
farms due to disease eradication measures. The current system also enables the development 
of sustainable surveillance and monitoring programmes by providing co-financing at the EU 
level.  In  the  past,  the  EU  harmonised  approach  to  disease  control  has  enabled  the  EU  to 
defend the interests of its MSs on the international scene. For example, the EU has been able 
to  negotiate  the  regionalisation  approach  for  disease  control  measures  with  several  third 
countries on many occasions. This approach looks at the evidence for where diseases actually 
occur, treating regions individually according to risk, not simply a single country or territory 
as a disease-ridden or disease-free block. This has meant that in the case of a disease outbreak 
in  a  part  of  the  EU,  other  parts  of  the  EU  have  been  able  to  continue  to  trade  without 
restrictions  with  third  countries.  These  benefits  of  these  negotiations  could  not  have  been 
achieved without the EU acting as a coherent block.    

The main tools that have enabled the achievement of the benefits mentioned above are:  

32

 
 
• 

• 

• 

The establishment of an enhanced system for animal identification and traceability and 
of TRACES, 

The functioning of the Animal Disease Notification System (ADNS),  

Veterinary Fund expenditure. 

Furthermore, the AHL envisages the introduction of a disease categorisation and prioritisation 
exercise for evaluating the value of EU intervention in relation to animal diseases and related 
threats.  This  exercise  would  categorise  animal  diseases  according  to  their  impact  on  the 
economy,  trade,  human  health,  society,  animal  welfare  and  the  environment.  It  would  also 
take into account the feasibility of implementing successful control measures. Categorisation 
is a risk management exercise which would be compulsory prior to determining: 

−  whether a disease should be dealt with at the EU level, by MS and/or at the private level; 

−  if at EU level, the nature of EU intervention (such as legislation, enforcement regulation, 

eradication, awareness, training, cooperation or research). 

The AHL aims to establish a general framework for the prevention, control and eradication of 
animal  diseases.  This  framework  will  be  built  on  outcome-based  rules,  avoiding  over-
prescriptiveness, and leaving room for MS to regulate or set more detailed legislation when 
necessary,  so  providing  for  the  flexibility  to  adapt  the  rules  to  national,  regional  or  local 
circumstances.  

On the other hand, rules on trade must necessarily have a certain level of detail and precision 
to  reduce  the  risk  of  different  implementation  practices  by  operators  and  competent 
authorities and subsequent distortion of competition and possible reduction in the coherence 
of the approach to tackling disease. 

Boundary test - Impact on other geographical areas and other policy areas 

Trans-boundary animal diseases are a permanent threat for livestock keepers and MS as they 
can have major economic implications for both the private and public sectors. They can easily 
spread  from  one  country  to  another  and  can  reach  pandemic  proportions.  Wild  animals  can 
play  an  important  epidemiological  role  in  the  transmission  of  animal  diseases  and  their 
movements are extremely difficult to control or restrict between MS (for example, the spread 
of  avian  influenza  through  wild  birds).  Global  trade  and  movements  of  people  and  goods 
increase  the  risk  of  rapid  disease  spread  over  greater  distances.  For  this  reason  control 
measures and harmonised surveillance systems are needed at EU level. Past evidence of cases 
where  MS  failed  to  control  the  spread  of  the  disease  (in  the  absence  of  an  EU-wide 
framework)  show  that  such  cases  may  lead  to  significant  cross-border  impacts  in  terms  of 
animal health and possibly also public health. 

The EU, as the largest global importer of food and animal feed, needs to protect itself against 
the possible introduction of exotic animal diseases and public health risks through the trade in 
live animals and animal products. The EU has harmonised rules for imports of live animals 
and animal products. Their objective is to make sure that the same principles for import are 
applied  in  all  MS  in  order  to  prevent  animals  carrying  transmissible  diseases  that  are 
dangerous for livestock or humans from entering EU territory.  

33

 
 
All  types  of  micro-organisms  (viruses,  bacteria,  parasites)  causing  animal  diseases  are 
covered  by  this  impact  assessment.  Invasive  alien  species  other  than  micro-organisms,  but 
also causing diseases are not covered by this impact assessment. This issue is currently being 
assessed by DG Environment and will be addressed separately to the envisaged animal health 
law's  scope  of  animal  health  and  pathogens.  DG  Sanco  has  worked  closely  with  DG 
Environment to ensure a joined-up approach.  

The  new  AHS  for  the  EU  endorses  the  concept  of  the  OIE  and  the  World  Bank  of  animal 
health as a "global public good", which means that good animal health benefits everyone. It 
accepts that the functioning of animal health services should be a public investment priority. 
The  implementation  of  the  strategy  requires  public  authorities  in  the  EU  to  take  a  common 
approach.  Furthermore,  the  roles  and  responsibilities  of  all  actors  have  to  be  clear  and 
consistently enforced throughout the EU for the sake of better prevention of animal diseases.  

In light of these different elements, EU action is justified, as it is clear that MS cannot achieve 
this  satisfactorily  acting  alone  and  that  the  EU  would  achieve  a  consistent  approach  more 
effectively and efficiently. 

34

 
 
3.  Objectives 

Having established in section 2 above that there are a number of aspects of EU animal health 
policy that could be improved, and that the EU has both the basis to act and can add value by 
doing  so,  we  now  turn  to  the  objectives  of  what  animal  health  policy  is  actually  trying  to 
achieve.  

The EU as a whole is working towards the agreed objectives of Europe 202035. Animal health 
objectives  should  uphold  these  crucial  overarching  objectives  by  reducing  the  risk  of  the 
negative economic, social (including public health) and environmental impacts of poor animal 
health or animal disease outbreaks; and consequently by supporting the economic security and 
success of animal keepers, particularly farmers. 

It is worth reiterating here that animal health objectives do not stand in isolation. Good animal 
health is a critical factor in ensuring the viability and sustainability of the internal market; and 
particularly of the food sector, which is the largest single economic sector in the EU. There is 
inevitably  overlap  and  interaction  with  other  areas  of  policy,  such  as  animal  welfare,  food 
safety,  animal  nutrition,  veterinary  medicines,  and  official  controls,  but  also  with  wider 
agricultural and environmental issues.  

3.1. 

General objectives  

The  general  objectives  of  EU  animal  health  policy  are  outlined  in  the  EU  AHS  2007-2013, 
and are:  

−  to  ensure  a  high  level  of  public  health  and  food  safety  by  minimising  the  incidence  of 

biological and chemical risks to humans; 

−  to promote animal health by preventing/reducing the incidence of animal diseases, and in 

this way to support farming and the rural economy; 

−  to  improve  economic  growth/cohesion/competitiveness  assuring  free  circulation  of  goods 

and proportionate animal movements; 

−  to  promote  farming  practices  and  animal  welfare  which  prevent  animal  health  related 
the  EU  Sustainable 

in  support  of 

impacts 

threats  and  minimise  environmental 
Development Strategy.  

These  general  objectives  demonstrate  that  the  basis  for  EU  action  is  wider  than  simply 
preventing public or animal health problems from arising or ensuring the economic security 
of  farmers.  The  scope  of  any  new  measures  will  need  to  encompass  not  just  kept  animals 
(including production animals, animals used for work, sport, recreation or display, companion 
animals and animals used in research); but also, to an extent, wild animals, where their poor 
health has the potential to jeopardise any of these objectives.  

35  http://ec.europa.eu/europe2020/index_en.htm 

35

 
 
                                                 
3.2. 

Specific objectives  

The specific objectives of the new legislation are: 

−  to  establish  a  single,  simplified,  transparent  and  clear  regulatory  framework  that  sets  out 
systematically the objectives, scope and principles of the regulatory intervention; based on 
good governance and compliant with international (e.g. OIE) standards; focusing on long-
term preventative measures and working together with all relevant stakeholders; 

−  to introduce overarching general principles allowing a simplified legal framework in order 
to  be  prepared  for  the  new  challenges,  i.e.  to  enable  quick  reaction  in  case  of  emerging 
diseases; whilst ensuring the same quality of reaction as provided for in current legislation. 

−  to  ensure  consistency  amongst  the  horizontal  principles  of  the  legislation  in  the  field  of 
animal health, animal welfare and food safety policies as well as broader EU policies on 
climate change and sustainability; 

- 

- 

to  reduce  the  economic  and  social  impact  of  animal  diseases  on  public  health,  animal 
welfare,  economy  and  society  as  far  as  possible  by  enhancing  disease  awareness, 
preparedness, surveillance and emergency response systems at national and EU level;  

to ensure the smooth functioning of the internal market of animals and animal products, 
with  a  high  level  of  protection  of  animal  health  and  public  health  and  supporting  the 
objectives of Europe 2020. 

3.3. 

Operational objectives:  

- 

- 

- 

- 

- 

- 

- 

- 

to  integrate  the  new  prevention-driven  and  incentive-oriented  approach  into  the  core  of 
animal health policy; 

to  provide  for  a  clear  and  balanced  distribution  of  roles  and  responsibilities  between 
competent authorities, EU institutions, the farming sector, animal owners and others; 

to introduce disease categorization as the basis for EU intervention; 

to provide for effective mechanisms for a rapid response to disease events, including new 
challenges, such as emerging diseases; 

to ensure effective emergency preparedness and early response to animal diseases threats 
and zoonoses, including use of vaccines as appropriate; 

to  introduce  simplified  procedures,  wherever  possible  for  technical  and  other  reasons, 
taking into account the specificity of small farmers and micro businesses; 

to ensure that the new legal framework provides enough flexibility to adapt smoothly to 
future scientific and technological developments; 

to reduce the risk of trade disruption by seeking an appropriate level of convergence with 
relevant  international  standards,  while  ensuring  a  firm  commitment  to  high  standards  of 
animal health. 

36

 
 
 
4.  Options 

In  order  to  solve  the  problems  identified  and  achieve  the  above-mentioned  operational 
objectives,  we  have  considered  four  policy  options  below.  It  is  worth  noting  here  that  the 
development  of  any  new  measures  will  need  to  have  taken  evidence  into  account  (where  it 
exists), particularly scientific evidence; but also social, economic and ethical considerations.  

Option 1: Do nothing (i.e: continue with current policy) 

Option 2: Simplification of existing legislation with no major content or policy changes 

Option 3: Existing legal framework with more self-regulation 

Option  4:  A  new  flexible  general  legislative  framework  on  animal  health  issues,  based  on 
achieving certain animal health outcomes 

Option 5: A new prescriptive legislative framework on animal health issues, based on setting 
specific processes and standards for animal health policy. 

4.1. 

Option 1 - Do nothing  

Current  animal  health  rules  would  remain,  with  technical  updates  and  adaptations  made  as 
necessary but without a horizontal framework establishing overall strategic objectives. Where 
possible, existing regulatory tools would be used to tackle problems identified.  

4.2. 

Option 2 – Simplification of existing legislation with no major content or policy 
changes 

This option would enable the bringing together of all the existing Animal Health Legislation 
into one large piece of legislation, but would not make any significant changes to the content 
of the legislation itself. Minor changes would only be made as circumstances required, and in 
order  to  comply  with  the  Lisbon  Treaty.  This  would  slightly  improve  clarity  of  the  legal 
framework but would not solve the problems highlighted in the AHS and in Section 2 of this 
document. 

4.3. 

Option 3 – Existing legal framework with more self-regulation  

This option would complement the current animal health policy and existing legislation with 
additional initiatives of a non-regulatory nature. Under this option, the use of self-regulation 
tools36  such  as  the  drafting  of  guidelines  by  the  Commission,  or  by  stakeholders  with  the 
Commission and/or MS acting as facilitators, would be envisaged in order to cover some of 
the  gaps  and  inefficiencies  of  the  current  animal  health  legislation.  These  guidelines  would 
focus  on  different  aspects  of  day-to-day  management  at  the  farm  level  that  may  be 
challenging  and  would  encourage  best  practice.  They  would  take  into  account  the  risks 
associated  with  certain  types  of  production  and  would  explain  how  to  contribute  to  disease 
prevention and implement more effective biosecurity and surveillance measures. As now, MS 
would  have  the  ability  to  regulate  certain  issues  at  national  level.  Legislation  would  be 
updated  individually  as  necessary  to  comply  with  new  requirements  (such  as  the  new 

36  Self regulation is defined in the Commission's publication "Better Regulation: Simply Explained" (2006) as 
"voluntary  agreements  between  private  bodies  to  solve  problems  by  taking  commitments  between 
themselves". 

37

 
 
                                                 
decision-making  processes  following  the  introduction  of  the  Lisbon  Treaty),  or  with 
technological developments.  

4.4. 

Option  4  -  Flexible  general  legislative  framework  on  animal  health  issues 
(AHL) 

Under  this  option,  a  new  legal  framework  would  set  out  the  principles  and  objectives  for 
animal  health  policy  required  to  achieve  desired  outcomes.  The  outcomes,  such  as  certain 
animal health and linked public health standards, would be agreed at EU level. However, the 
framework would be flexible to allow MS to set their own specific rules in certain cases to 
achieve  these  outcomes.  It  envisages  that  these  specific  rules  would  be  based  on  veterinary 
risk assessment and cost benefit analysis to best suit particular situations in MS. 

This  general  legislative  framework  of  the  AHL  would  not  include  detailed  and  specific 
legislative  provisions  such  as  particular  disease  control  measures  for  specific  diseases, 
specific identification and registration rules for each animal species, or specific measures on 
movements within the EU for particular species and so on. These specific measures would be 
laid  down  at  a  later  stage  by  means  of  delegated  or  implementing  acts  under  the  procedure 
foreseen  in  Articles  290  and  291  of  the  TFEU.  These  acts  would  be  subject  to  an  Impact 
Assessment where appropriate. 

4.5. 

Option  5  -  Prescriptive  general  legislative  framework  on  animal  health  issues 
(AHL) 

Under  this  option,  a  new  comprehensive  legal  framework  would  set  out  the  principles  and 
objectives  of  animal  health.  This  framework  would  set  specific  standards  for  animal  health 
rules  and procedures which  would  be required across  MS,  with little  flexibility for MS to 
adapt  the  rules  to  their  differing  circumstances.  In  this  case  the  legal  framework  would  be 
much more prescriptive and detailed but would cover more or less the same or similar content 
as the previous option.  

Like  option  4,  this  general  legislative  framework  of  AHL  would  likely  not  contain  detailed 
and specific legislative provisions. These rules would be laid down at a later stage by means 
of delegated or implementing acts under the procedure foreseen in Articles 290 and 291 of the 
TFEU and subject to an impact assessment where appropriate. A more detailed overview of 
what  could  be  included  in  delegated  or  implementing  acts  can  be  found  in  table  IX.1 
presented in Annex IX. 

4.6. 

Key elements of the different options 

Table 4.1 below shows in more detail how various elements of animal health policy would be 
implemented  under  each  of  options  3,  4  and  5.  Options  1  and  2  are  not  considered  as  they 
would not entail changes in policy or approach, and so there would be no substantive changes 
to these aspects of policy.   

Separately, the new elements of a legislative framework under both options 4 and 5 are set out 
in more detail in Annex IX. The possible structure of the AHL and its empowering provisions 
is also schematically presented in Annex X. 

Under option 4  the  legislative framework would set out the  desired animal health outcomes 
with  flexibility  for  MS  to  set  rules  and  standards  appropriate  to  their  situations.  Under 
option 5  the  legislative  framework  would  set  out  the  desired  animal  health  standards  for 
animal health policy, which MS will be required to implement. 

38

 
 
Table 4.1: Aspects of animal health policy in relation to options 3-5  

Aspect of Animal 
Health Policy 

Option 3 

Option 4 

Option 5 

Clarification of owners' 
obligations 

Guidelines clarifying 
keepers' obligations in 
existing legislation 

Training for animal 
keepers 

Guidelines about training 
for keepers 

Clarify vets' 
responsibilities 

Guidelines about vet 
responsibilities for 
different types of vet 

Vet training 

Guidelines about training 
of vets performing official 
controls 

On-farm biosecurity 
(also see Annex XI) 

Prioritise surveillance 

Guidelines about best 
on-farm biosecurity 
practices, incl. 
information about costs 
and benefits of each 
practice 

Develop non-legislative 
surveillance 
strategy/principles for 
surveillance priority - 
encourage stakeholders 
to follow them. 

Set framework of animal 
health outcomes for which 
the keepers' obligations 
have to be set 
All keepers must be able 
to provide a particular 
level of animal health 
protection, with training if 
necessary 
Vet responsibilities 
clarified under the basis 
of not having conflict of 
interest in light of national 
organisational structures 
Requirement for training 
for all veterinarians 
performing official tasks 
ensures same quality of 
animal health protection 
throughout EU 
All keepers must 
introduce a certain level 
of biosecurity measures 
to ensure the health of 
their animals as 
appropriate for their type 
of farming and local 
circumstances.  
Set basic principles and 
increase co-ordination of 
surveillance based on 
risks and ensuring 
particular level of animal 
health protection. 
Encourage surveillance 
networks to develop along 
these principles 

All keepers have the 
same obligations - set to 
maintain higher health 
standards 

All keepers must 
undertake training to 
achieve a particular level

All vets have the same 
responsibilities across 
EU 

All vets undertake 
identical training for 
official tasks 

All keepers must 
introduce a certain 
defined set of on-farm 
biosecurity measures 

Develop EU-wide 
surveillance system and 
harmonised surveillance 
networks 

39

 
 
Option 3 

Option 4 

Option 5 

Aspect of Animal 
Health Policy 

Intra-EU trade 

Exotic and emerging 
diseases 

Categorisation of 
diseases  

Principles for animal 
health import 
requirements 

Compartmentalisation 

No change without 
altering the legislation. 
Possible clarification 
about the use of 
assembly centres 

Guidelines about best 
practice for exotic 
disease controls, 
develop non-legislative 
tools to improve disease 
preparedness and 
encourage exotic 
disease research 
Encourage national CAs 
and stakeholders to use 
results of disease 
categorisation tool to 
prioritise resources 
between diseases not 
covered by EU 
legislation 

Guidelines for importers 
and TCs clarifying 
requirements and best 
practice for imported 
products 

Improve information 
about potential for 
compartments under 
existing legislation 
(poultry for AI, 
aquaculture) 

Align with OIE 
standards 

Possible only with small 
/partial modifications in 
current legislation  

Non-commercial 
farming 

Encourage best-practice 
amongst non-
commercial farming and 
develop guidelines for 
these 

Allow derogations for 
certain types of Intra-EU 
movements in live 
terrestrial animals based 
on risk and economic 
analysis 

Develop legislative tools 
to improve preparedness 
and react quickly to exotic 
disease outbreaks; 
flexibility for MS to adapt 
tools to their own 
conditions 

Move to placing on the 
market concept for Intra-
EU trade in live 
terrestrial animals 

Develop tools to deal 
and to react to exotic 
diseases - the same 
obligations across EU 

Categorise diseases (for 
intervention) at EU and 
MS level and fix the tool 
which is used to 
categorise diseases 

Consolidation of criteria 
into a single transparent 
document. Allow for 
higher standards than 
the international based 
on risk assessment 

Extend compartments to 
more animal diseases 
and species - 
compartments must 
comply with defined 
animal health measures

Align EU legislation to 
OIE framework where it 
doesn't compromise 
health standards 

Definition and rules set 
for non-commercial 
farms harmonised for 
the EU 

Categorise diseases (for 
intervention) at EU level 

Legislation consolidates 
and defines animal health 
standards for imported 
commodities 

Extend compartments to 
more animal diseases 
and species - 
compartments have 
flexibility over which 
measures they implement 
as long as an EU defined 
health status is achieved.
Alignment where 
possible, higher 
standards in EU 
legislation only allowed on 
risk and CBA evidence 
base 
Definition and principles 
for non-commercial 
farming based on risk 
outcomes and flexible for 
MS conditions. 
Derogations from 
registration/ movement/ 
identification 
requirements for 
commercial farms where 
low risk to anima/human 
health.  

Vaccination strategy 
(also see Annex VII) 

Raise awareness about 
the safety of vaccinated 

Legal strategy to 
harmonise the use of 

EU level vaccination 
strategy, same approach 

40

 
 
Aspect of Animal 
Health Policy 

Option 3 

Option 4 

Option 5 

meat and alter market 
perception of vaccinated 
meat (affect the demand 
side of vaccine 
disconnect).  

vaccines based on their 
impact on disease control. 
Options B.i. (providing 
flexible approach for 
different diseases of 
Union concern with EU 
vaccine bank) and B.ii 
(without EU vaccine bank) 
in Annex VII  

for use of vaccines 
across the EU. Options 
A.i (providing a single 
vaccination policy for all 
diseases with EU 
vaccine bank) and A.ii 
(without EU vaccine 
bank) in Annex VII.  

Of  course,  elements  of  the  options  could  be  combined  for  different  policy  aspects.  For 
example,  a  flexible  legislative  framework  could  be  introduced  (option  4)  but  with 
encouragement  for  self-regulation  for,  say,  improved  biosecurity  measures  (following  the 
principle of option 3) and perhaps some specific detailed rules on the face of the law for, say, 
animal  trade  and  movements  (in  accordance  with  the  principle  of  option  5).  Other 
combinations are of course possible.  

41

 
 
 
5. 

Impact analysis 

The analysis below sets out the impacts of the different options. Options 1 (no change) and 2 
(simplification  only)  are  briefly  analysed  and  related  back  to  the  existing  problems  already 
identified  in  Chapter  2.  The  reduction  in  the  instance  of  animal  disease  is  such  a  crucial 
outcome that a short introduction on the overall impact on the reduction of animal disease is 
necessary for each of the options 3-5. The analysis will then look at the economic, social and 
environmental impacts of each option. As mentioned above, additional analysis on intra-EU 
trade is also available in Annex VIII, and on biosecurity in Annex XI. The potential effects of 
changes were felt to be so potentially wide-ranging in these areas that some further scrutiny of 
the possible impacts was felt necessary.  

5.1. 

Option 1 – No Change 

To  allow  for  a  proper  comparison  of  the  options,  Option  1,  continuing  with  current  animal 
health policy, is being used as the policy baseline and the impacts of the other options will be 
assessed in relation to it.  

The no change option has already been specifically rejected by both the impact assessment for 
the AHS and the CAHP assessment, and would therefore be extremely difficult to justify. No 
change will mean a continuation of the current EU level approach to tackling animal health 
issues and the problems identified in Chapter 2.2.  

Some illustrations of the possible consequences of 'no change' are set out below and add to 
the evidence that option 1 is not a desirable approach because of the potentially high-impact 
consequences  of  continuing  with  the  current  framework.  Choosing  this  option  would  mean 
accepting  the  lack  of  a  coherent,  comprehensive  approach  to  the  EU’s  work  in  the  field  of 
animal health. The major objectives and principles of the CAHP, including the protection of 
animal health and also the associated public health aims would not be achieved. The roles and 
responsibilities of all actors involved in animal health will continue to lack clarity and there 
will  be  an  insufficient  focus  on  disease  prevention.  The  EU  will  have  to  face  the  new 
challenges  for  animal  and  public  health  described  in  Chapter  2  with  the  current  legal  and 
financial  instruments  that  would  not  necessarily  be  fit  for  purpose.  This  option  will  not 
provide  sufficient  incentives  for  farmers  and  animal  keepers  to  take  optimal  preventative 
disease measures. This in turn could lower public opinion of the EU farming industries, which 
has already been dented in recent crises.  

Furthermore, an adaptation of basic acts to the new regulatory procedure on the execution of 
powers based on the Treaty of Lisbon is necessary. This fact in itself requires at least certain 
legislative  changes  in  the  current  animal  health  legislation  and  therefore  doesn't  support  the 
no-change scenario. 

In  the  boxes  below  we  use  some  hypothetical  examples  to  illustrate  the  potential  impact  of 
this option. The option doesn't promote a effective and pro-active approach to emerging and 
exotic  diseases,  or  encourage  the  optimal  preventive  approaches  or  categorization  of  risks. 
There would be impacts on public health, on consumption, and on trade, as well as economic 
costs. 

42

 
 
 
 
Possible  consequences  of  a  human  influenza  pandemic  caused  by  a  virus  of  avian  or 
mammal origin 

Influenza viruses are a large family of viruses able to infect many species of birds and mammals, 
including humans. Wild aquatic birds are the main reservoir of influenza viruses. These viruses 
may also spread to mammals and adapt to the new hosts. When a new influenza virus able to be 
transmitted  between  humans  emerges,  it  may  rapidly  spread  throughout  the  world  causing  a 
human pandemic.  

During previous pandemics, great variations have been seen in mortality rates, severity of illness, 
and  patterns  of  spread.  The  mortality  of  the  previous  century’s  three  pandemics  varied 
enormously, from less than 1 million to some 50 million deaths. One consistent feature reported 
in  all  cases,  nonetheless,  was  the  rapid  surge  in  the  number  of  fatalities  and  their  exponential 
increase over a very brief time, often measured in weeks. Most recent estimates indicate that the 
“Spanish”  flu  outbreak  of  1918  that  was  caused  by  a  virus  of  avian  origin  could  have  been 
responsible for the death of 50 million people, or 2.5% of the global population of the time. 

The  recent  fears  of  a  devastating  incoming  pandemic  originated  from  the  emergence  of  a  new 
avian  influenza  virus  type  H5N1  in  south-east  Asia  in  the  mid  1990s  which  was  capable  of 
infecting  and  causing  disease  not  only  in  birds  but  also  in  humans  (due  to  bird-to-human 
transmission).  From  2003  this  virus  began  spreading  westwards  to  more  than  50  countries  in 
Asia, Europe and Africa. According to data from the WHO, by 3 June 2011, a total of 556 human 
cases of H5N1 avian influenza had been reported, causing a total of 325 deaths. This represents a 
high case-fatality rate of 58%. 

Several incursions of this virus, mainly due to the spread via migratory birds, also occurred in the 
EU  in  2006-2010,  in  poultry  and  other  birds.  However,  the  disease  was  successfully  contained 
and  eradicated,  thanks  to  enhanced  surveillance  and  control  measures,  and  no  human  cases 
occurred. 

However,  while  the  scientific  community  was  mainly  focussing  on  the  potential  pandemic  risk 
posed by the H5N1 virus, in 2009 the 'swine 'flu' pandemic caused by the H1N1 influenza virus, 
which included genes of bird, human and pig origin, emerged in Mexico and then spread all over 
the  world  (human-to-human  transmission).  Eventually  the  pandemic  caused  by  this  virus  was 
much  less  serious  than  feared  at  first,  although  it  caused  at  least  18,000  deaths,  with  a  case 
fatality rate of 0.03%.  

Recently, the H5N1 virus circulating in Egypt – where 145 human cases have been reported in 
the last years - showed increased ability to bind to human cells, which may indicate an increased 
pandemic  potential.  Scientists  continue  to  recommend  closely  following  the  evolution  of  this 
virus and to intensify the efforts to eradicate it from birds in those countries in Asia and Africa 
where it is currently endemic. 

Pandemics,  like  the  viruses  that  cause  them,  are  largely  unpredictable  and  it  is  therefore 
impossible to predict with any accuracy the origin of the next pandemic and its impact. However, 
all  estimates,  from  the  best-case  to  the  worst-case  scenario,  show  that  losses  would  be  very 
extensive. These consequences might be prevented or their impacts diminished by more effective 
preventive mechanisms and better tools for rapid response to emerging risks. 

43

 
 
 
Examples of impact of disease outbreaks on trade 

•  The  UK  had  developed  a  significant  export  trade  in  beef  and  live  cattle  during  the  early 
1990s. By 1995, annual exports of beef of 300,000 tonnes were worth almost £600 million. 
There was also a substantial trade in live calves from the British dairy herd to the rest of 
Europe,  worth  some  £70  million  per  year.  This  trade  completely  collapsed  when  the 
European Union imposed a ban on all UK exports worldwide as a consequence of the BSE 
crisis. (Source: DEFRA) 

• 

In  2003  Classical  Swine  Fever  (CSF)  outbreaks  in  the  Netherlands,  Belgium,  Germany, 
France  and  Spain  resulted  in  a  drop  of  15%  in  live  animal  exports  (Source:  Europa- 
Agriculture Trade Statistics). 

5.2. 

Option 2 – Simplification of existing legal framework with no significant policy 
change 

Option  2  assumes  that  there  would  be  a  simplification  of  the  existing  legal  framework,  by 
bringing together the several pieces of existing legislation into one overall piece of legislation 
but without addressing policy options and developments set out in the AHS.  

The  benefits  associated  with  this  option  are  solely  those  from  the  simplification  of  the 
legislation.  By  bringing  together  all  the  existing  legislation  into  one  place,  there  would  be 
some improved simplicity for those stakeholders searching for legislation who weren't already 
aware where it would be.  

However,  it  is  difficult  to  see  how  this  would  actually  work  in  practice.  The  existing 
legislation has no single set of principles of overarching coherence and so to put everything in 
one piece of legislation would lead to a long list of the existing acquis, really achieving very 
little in the way of genuine simplification.  

If  option  2  is  chosen  the  EU  would  run  a  reputational  risk  as  a  key  opportunity  would  be 
missed to address the deficiencies in the current legislation which have been widely criticised, 
and  the  problems  due  to  the  lack  of  a  single  overall  policy  (Section  2.2.2.),  the  insufficient 
focus  on  disease  prevention  (Section  2.2.3.)  and  the  shortcomings  of  the  current  rules  on 
intra-EU trade (Section 2.2.4.). Even the problem of the large number of pieces of legislation 
and  complexity  of  the  current  legal  framework  discussed  in  Section  2.2.1.  would  not  be 
solved,  as  any  new  piece  of  law  is  not  by  definition  more  coherent  unless  work  is  done  to 
identify and set out the principles of the animal health policy and create a new, overarching 
legal framework.  

The  approach  of  option  2  would  not  solve  the  problems  that  have  emerged  during  the 
evaluation of the CAHP and highlighted by the stakeholders during the recent consultations. 

5.3. 

Option 3 – Existing legal framework with more self-regulation  

Self-regulation  is  defined  by  the  Commission  as  "voluntary  agreements  between  private 
bodies  to  solve  problems  by  taking  commitments  between  themselves".  This  option  is 

44

 
 
 
 
 
composed  mainly  of  non-regulatory  actions  that  will  be  carried  out  with  the  resources 
currently available and will not create additional administrative burdens. These actions would 
include the Commission and/or MS either developing guidance and best practice to improve 
animal health measures or encouraging stakeholders to do so. These would be complementary 
to the existing animal health legal framework and would aim to achieve better prevention of 
animal diseases. 

In general terms, offering guidance and promoting best practices for animal health measures 
will  make  animal  keepers  and  other  actors  in  the  food  chain  better  informed  about  animal 
health measures and disease risks and so take more responsibility for their actions. If animal 
keepers  are  more  aware  of  best  practices  for  preventing  diseases,  they  are  more  likely  to 
implement  measures,  such  as  biosecurity  and  surveillance,  which  would  be  worthwhile  for 
them in terms of reducing the frequency and impact of animal diseases. 

However, these actions will not be mandated. They rely on the willingness of stakeholders to 
develop  guidance  in  the  first  place;  and  the  co-operation  of  animal  keepers  in  voluntarily 
following  this  guidance,  under  circumstances  where  it  may  not  always  be  in  their  direct 
interest  to  do  so.  Therefore  the  actual  effects  of  this  option  being  put into  practice  are  very 
uncertain, ranging from no change at all at one end to a potentially fairly positive impact at 
the  other.  Nevertheless,  even  if  some  significantly  positive  self-regulatory  schemes  were  to 
get  successfully  underway,  working  within  the  existing  legal  framework  would  be  likely  to 
prove challenging.  

As part of this option, we can assume that certain legislative changes would be necessary (for 
example, to align with the new co-decision requirements as agreed under the Lisbon Treaty, 
or because of technological developments). However, these would be carried out individually 
for  each  piece  of  legislation  rather  than  trying  to  coherently  combine  them  into  a  new 
overarching framework as envisaged in options 4 and 5.  

If we assume that some change takes place under option 3, there should be a reduction in the 
scale and frequency of animal disease outbreaks. This is largely because increased guidance 
and  information  is  likely  to  improve  understanding  and  take-up  of  preventative  disease 
measures.  

The likely reduction in the scale and frequency of animal disease outbreaks is due to:  

•  The clarification of owners' obligations – keepers are more likely to understand their 

obligations and comply with them.  

•  The increased likelihood of additional training being taken by animal keepers.  

•  The  increase  in  understanding  of  biosecurity  and  keepers'  likely  take-up  of  best 

practice in biosecurity.  

•  The increase in understanding of the importance of surveillance and better individual 

surveillance measures being taken.  

•  Better  information  sharing  about  emerging  and  exotic  diseases  and  their  possible 

impacts.  

•  Encouraging  better  information-sharing  and  best  practice  among  non-commercial 

farmers.  

45

 
 
• 

Increased take-up of vaccination where appropriate.  

However,  as  mentioned  above,  under  self-regulation  there  would  be  no  mandates  or 
incentives  for  stakeholders  to  implement  best  practices  recommended  in  guidelines  (if 
guidelines are developed at all). This means that each stakeholder is only likely to improve his 
animal  health  practices  when  it  is  worthwhile  for  him  as  an  individual  to  do  so  –  i.e.  the 
projected reduction in the costs of animal disease to the individual stakeholder is higher than 
the  costs  of  implementing  preventative  measures.  They  have  no  incentive  to  consider  the 
wider  benefits  of  reduction  in  animal  disease,  for  example  benefits  to  other  stakeholders, 
competent authorities, consumers and rural economies. Therefore, the improvement in animal 
health practices would be lower than required to reduce the impact of animal diseases by the 
socially  optimal  amount,  and  there  is  a  smaller  reduction  in  animal  diseases  compared  to 
using mandates or incentives. 

It  is  very  difficult  to  accurately  quantify  this  reduction  in  animal  disease  outbreaks,  as  the 
scale and frequency of disease outbreaks depend on an extremely complex set of factors, on 
top of the aforementioned uncertainties inherent in this option.  

Furthermore it needs to be mentioned that an adaptation of basic acts to the new regulatory 
procedure on the execution of powers based on the Treaty of Lisbon is necessary. This fact in 
itself requires at least certain legislative changes to the current animal health legislation. 

5.3.1.  Economic impacts 

Assuming  that  some  action  towards  self-regulation  does  happen,  the  possible  economic 
impacts of option 3 divide into two aspects:  

• 

• 

the impacts on farming and the rural economy; and  

the impact on the promotion of growth and cohesion within the EU.  

Of these, the first (the impacts on farming and the rural economy) would largely be positive 
impacts. The reduction in the scale and frequency of animal disease outbreaks that option 3 
could be expected to deliver will have positive ramifications in several areas. It is impossible 
to quantify these savings but there will be benefits to:  

•  The farming sector, through:  

o  Direct financial benefits of reduced disease instance 

o  Benefits  through  simplification  of  administrative  burdens  (although  this  is 
initially  partially  offset  by  extra  costs  of  adjusting  to  any  new  system  and 
developing guidance) 

o  Development of new, more efficient practices 

•  Wider food chain stakeholders, particularly assembly centres; transporters and dealers; 

slaughterhouses; and food processing companies.  

•  The  rural  economy,  particularly  through  possible  improved  rural  employment 
opportunities and benefits to rural tourism (or rather, fewer disbenefits because of the 
lack of movement restrictions or other stigma associated with disease outbreaks).  

46

 
 
With  respect  to  the  promotion  of  growth  and  cohesion  within  the  EU,  there  might  be  some 
positive impacts from clarifying the use of assembly centres for live movements, which may 
enhance  intra-EU  trade.  However,  there  will  be  some  initial  negative  impacts  from 
familiarising  and  implementing  any  new  guidelines.  Because  of  the  uncertainty  of  whether 
and  how  these  factors  would  be  implemented  under  self-regulation,  and  their  complex 
interaction, it is difficult to say whether the overall positive economic impact of any measures 
would outweigh the familiarisation and implementation costs.  

5.3.2.  Social Impacts 

The  social  impacts  of  any  positive  self-regulation  measures  stem  directly  from  the 
aforementioned  potential  reduction  in  animal  disease  instances.  Any  reduction  in  animal 
disease would consequently reduce any associated public health risks. So the impact (if any) 
is positive, but indirect and impossible to quantify.  

5.3.3.  Environmental impacts 

First, the best practice guidelines envisaged in option 3 are likely to include aspects related to 
appropriate environmental management of the farm, especially regarding the use of veterinary 
medicinal  products  and  better  hygiene  (management  of  slurry,  etc)  to  minimise  the 
environmental  impact  of  farming  practices.  Therefore,  if  these  guidelines  are  in  fact 
developed,  we  can  assume  a  positive  environmental  impact  from  the  effects  of  improved 
environmental management.  

Assuming  that  there  is  a  reduced  instance  of  animal  disease  outbreaks,  we  can  extrapolate 
several  other  positive  environmental  impacts.  However,  as  noted  previously,  this  is  an 
assumption  that  is  uncertain  and  impossible  to  quantify.  Nevertheless,  the  likely  positive 
impacts include the below.  

Animal diseases found in kept animals can have negative  impacts  on  wildlife (for  example, 
the impact of avian flu on wild birds). Thus reducing the incidence of such diseases should 
have a two-fold beneficial effect; both in the reduction of wildlife disease and the protection 
of  biodiversity,  and  subsequent  reduction  of  the  risk  of  diseased  wildlife  re-infecting  kept 
animals  and  even  humans.  Guidelines  on  best  practices  should  also  help  farmers  to  better 
understand  the  importance  of  their  role  in  interacting  with  and  protecting  wildlife  and 
biodiversity. 

Reduced  animal  disease  instance  would  also  lead  to  fewer  health-related  welfare  problems, 
thereby overall improving animal welfare. In addition, if new guidelines promote better use of 
vaccination,  this  will  also  have  a  preventative  effect  on  both  animal  diseases  and  also  the 
associated welfare problems.  

We  can  also  assume  that  biosecurity  guidelines  would  be  included  in  any  self-regulatory 
guidance scheme. It is very difficult to predict what the environmental impacts of improved 
biosecurity  measures  would  be.  On  the  one  hand,  we  have  already  identified  the  positive 
environmental  impacts  from  the  lower  instance  of  animal  disease  outbreaks.  On  the  other 
hand,  increased  biosecurity  measures  might  include  the  increased  use  of  disinfectants  or 
chemicals which could potentially have harmful effects on the surrounding environment. 

5.4. 

Option 4 – flexible general legislative framework for animal health issues 

Option 4 covers a new flexible general legislative framework as envisaged in the AHS. This is 
expected  to  have  more  definite  and  deeper  impacts  than  option  3  because  it  will  enable 

47

 
 
legislative  changes  in  animal  health  policy,  which  option  3  cannot  bring  about.  It  will  also 
mandate  certain  aspects  of  animal  health  policy  which  option  3  only  makes  voluntary.  And 
although  it  potentially  has  similar  outcomes  to  option  5  in  terms  of  animal  health;  it  offers 
greater  flexibility  and  subsequently  a  potentially  lower  administrative  burden.  As  noted 
previously,  Table  4.1  and  Annex  IX  show  in  more  detail  which  measures  option  4  would 
specifically entail. However, the longer-term impacts of option 4 cannot be fully quantified at 
present because many of the specific rules of a general framework law on animal health will 
be  developed  subsequent  to  the  law's  introduction.  Nevertheless,  some  general  points  about 
the overall direction of travel, and whether its effects are likely to be positive or negative, can 
be made in respect of its economic, social and environmental impacts.  

5.4.1.  Economic impacts 

The economic impacts of option 4 are expected to be largely positive.  

First,  there  are  the  benefits  expected  from  reduced  disease  instance.  These  are  much  as 
outlined in 5.3.1, but because option 4 would have more definite and deeper outcomes, and is 
expected to have a greater impact in any case, we can say that the impacts from prevention of 
animal diseases would be of a similar nature, but more pronounced. However, for the reasons 
outlined above, it is very difficult to quantify them any further than in relative terms.  

Overall,  resources  will  be  better  targeted  according  to  risk,  saving  time  and  money.  This  is 
true of surveillance, where a more risk-based approach will be encouraged; and contingency 
planning and categorisation/prioritisation of diseases where legislative tools will be developed 
to improve readiness for disease outbreaks in accordance with their risk of actually occurring.  

A  vaccination  strategy  will  be  developed  to  harmonise  the  use  of  vaccines  based  on  their 
impact  on  disease  control.  The  safety  of  products  of  animal  origin  from  vaccinated  animals 
could be emphasised to encourage the industry to increase use of vaccines, when relevant and 
possible. This would likely have positive economic impacts in the reduction of the instance of 
animal disease and all the associated impacts mentioned elsewhere in this analysis. However, 
there would still exist certain barriers to trade with countries who do not wish to import meat 
from  vaccinated  animals  due  to  negative  consumer  perception  and/or  associated  risks  of 
spreading disease, so this may have a negative economic impact.  

An  impact  of  option  4  which  needs  some  further  analysis  is  that  of  administrative  burden. 
Undoubtedly there would be some negative economic impact from the initial administrative 
burden  of  familiarisation  with  the  new  legislative  framework  for  farmers  and  other  animal 
keepers as well as competent authorities. However, due to the very nature of animal disease, 
regular updates of valid rules are standard procedure which means that one-off familiarisation 
costs  are  likely  to  be  limited  and  integrated  into  business-as-usual  costs  (see  feature  box 
below).  

As  regards  to  the  costs  of  familiarisation  with  new  legislation,  due  to  the  very  nature  of 
animal  diseases  and  continuously  evolving  legislation,  these  are  largely  part  of  business-as-
usual  costs.  However,  a  special  effort  might  be  needed  for  CA  to  adequately  manage  the 
implementation of new legislation. In order to support MS in this task, while generating EU 
added value by fostering experience exchange, the Commission services maintain the 'Better 
Training for Safer Food' initiative37 to train and advice officials in MS and third countries on 
EU requirements.  

37 Council Regulation (EC) No 882/2004 Art. 51 

48

 
 
                                                 
A  practical  example  is  the  training  on  zoonoses  which  was  provided  in  2009  and  2010  for 
more than 300 Member States' officials, focusing on microbiological criteria and the control 
of zoonoses, with a total cost of just over €2m for the two years. 

Ongoing training activities should only be adapted to the needs deriving from the adoption of 
the new legislative framework. 

Nevertheless,  in  the  long  term,  the  more  coherent  strategic  framework  should  make  more 
sense to those learning about their obligations for the first time (for example, for new entrants 
to  farming).  Overall  and  in  the  long  term,  it  is  fair  to  assume  that  a  flexible  and  outcome-
based framework will impose a lower administrative burden on farming and related industries 
and animal keepers than the prescriptive framework of option 5. This is because its inherent 
flexibility  means  obligations  and  requirements  could  be  tailored  to  national  or  regional 
circumstances,  enabling  MSs  to  adapt  any  administrative  obligations  to  that  which  is  only 
strictly necessary according to a reasonable assessment of risk.  

However, this could lead to them setting lighter touch regulation, or fewer requirements than 
at  EU  level,  because  they  do  not  wish  to  impose  higher  burdens  than  other  MSs  thereby 
placing  their  livestock  industry  at  a  competitive  disadvantage.  In  addition,  they  might  not 
fully consider the impacts of diseases on other MS when deciding level of controls – so they 
implement fewer controls that would be optimal for the EU as a whole (taking into account 
the full costs of disease spread).  

There  are  two  examples  that  were  felt  particularly  important  to  analyse  in  more  detail: 
biosecurity and trade. With respect to biosecurity, a questionnaire was carried out to seek the 
views  of  relevant  stakeholders  about  the  level  of  burden  that  the  possible  introduction  of 
biosecurity plans would bring. The results are shown in detail in Annex XI and demonstrate 
mixed views. While many stakeholders thought that biosecurity plans would represent overall 
cost  savings,  others  thought  that  they  would  impose  too  many  costs.  These  mixed  views 
suggest  that  the  possibility  of  option  4,  allowing  MSs  to  introduce  biosecurity  plans  if  they 
felt it beneficial, would be the best option for all parties. More will be said about this in the 
analysis relating to option 5 below.  

Intra-EU  trade  in  animals  was  the  other  issue  to  be  looked  at  in  more  detail,  as  it  might  be 
particularly  affected.  Under  option  4,  possible  derogations  to  remove  the  burden  of  health 
certification could be introduced in a combination of the AHL itself and secondary legislation. 
Nevertheless, derogations would refer  to specific sectors or  types of  movements, and so for 
each category of movement which is allowed derogation, a full individual risk and economic 
assessment would need to be carried out. 

However, it is possible to estimate the unit saving per consignment if a particular derogation 
for health certification was introduced. The overview of the administrative burden at present 
is available in Annex VIII. The unit reduction in administrative burden is set out in Table 5.2 
below  following  the  Standard  Cost  Model  template.  The  administrative  burden  saving  to 
operators  is  estimated  to  be  €120  per  consig nment  sent,  and  the  saving  to  the  competent 
authority  estimated  at  €128.  These  are  based  on  the  time  estimates  received  from  the 
administrative burden questionnaires during the consultation period and are estimates of the 
savings related to removing certification for particular procedures which are considered low 
risk, for example, moving animals for slaughter.  

For illustrative purposes, the following table applies the unit cost saving to different types of 
movements to illustrate the potential annual reduction in administrative burden that could be 

49

 
 
realised  if  various  derogations  were  introduced.  They  are  based  on  the  annual  number  of 
consignments sent between MS from information in TRACES. As derogations would usually 
be  introduced  in  a  secondary  level  of  legislation  these  benefits  would  not  be  immediately 
realised  when  the  AHL  was  adopted,  but  they  are  indicative  of  the  direction  of  travel 
proposed. 

Table 5.2: Illustrative reduction in administrative burden saving for different categories 
of movements, based on movement figures in 2009. Savings figures represent estimated 
annual cost savings. 

Number of 
Consignments 

Savings to 
Operator 

Savings to 
Competent 
Authority 

Total 
Savings 

Bovine - direct to 
slaughter 
Bovine - all slaughter 
Bovine - all movements 
w/out assembly centre 

All species - movements 
less than 3 hours 

All species - less than 
3 hours and to slaughter 

All movements to 
slaughter 

Of which: 

Bovine 
Equine 
Goats 
Poultry 
Sheep 
Swine 

16,939
28,314

2,036,068 €
3,403,343 €

2,170, 733 € 
3,628,439 € 

4,206,801 €
7,031,782 €

92,618

11,132,684 €

11,868,997 € 

23,001,680 €

115,726

13,910,265 €

14,830,287 € 

28,740,552 €

68,052

8,179,850 €

8,720,864 € 

16,900,714 €

321,838
28,314
3,537
621
52,364
8,721
78,691

38,684,928 €
3,403,343 €
425,147 €
74,644 €
6,294,153 €
1,048,264 €
9,458,658 €

41,243,540 € 
3,628,439 € 
453,267 € 
79,581 € 
6,710,447 € 
1,117,596 € 
10,084,252 € 

79,928,467 €
7,031,782 €
878,414 €
154,225 €
13,004,599 €
2,165,860 €
19,542,910 €

There would also be other economic impacts. The law would introduce some obligations to 
acquire  particular  knowledge  for  all  veterinarians  performing  official  tasks  across  the  EU. 
Therefore it would be easier for vets to move around between MS to perform official tasks. 
This  has  both  economic  and  social  impacts,  as  it  would  improve  the  flexibility  of  the  vet 
labour market in responding to supply and demand peaks and troughs (especially in times of 
animal  disease  outbreaks,  when  a  great  deal  of  veterinary  resource  may  be  needed  in  a 
particular place).  

Unpublished data from the Federation of Veterinarians of Europe (FVE)38 in 2010 shows that 
the total number of veterinarians in the 27 EU MS is 187,175. Of this number, around 25,000 
work in the public veterinary services. However, it is worth noting that a large proportion of 
veterinarians  working  in  private  or  general  practice  (around  112,000)  also  carry  out  some 
official  public  tasks  as  official  or  authorised  veterinarians.  All  these  categories  of 
veterinarians will be affected to some extent by the changes described above. 

The  obligation  to  have  a  basic  knowledge  of  animal  health  matters  would  not  generally  be 
over  and  above  what  is  expected  in  good  practice.  Therefore,  veterinarians  and  the  vast 

38  FVE: Interim report on veterinary demography, 2010 - unpublished 

50

 
 
 
 
  
 
  
  
  
  
  
 
                                                 
majority of commercial farmers would not expect to be affected by this requirement, as their 
training and education, working experience and/or acquired knowledge would be sufficient to 
meet the basic requirements. These measures will concentrate on improving the knowledge of 
those  carrying  out  activities  which  represent  a  higher  health  risk  (such  as  assembly 
operations),  and  new  entrants.  It  should  also  require  those  (relatively  few)  individuals  who 
present health  risks through lack of knowledge and bad practice to improve  their standards. 
Those who would be affected are exactly those who pose the most risk, so this obligation is 
proportionate and sensible for disease prevention.  

It is not envisaged that this measure would impose significant or disproportionate economic 
impacts on non-commercial farmers or other keepers of animals. While they will be required 
to have some basic knowledge about animal health where appropriate, it will not be over and 
above  what  good  practice  would  dictate.  In  line  with  the  risk-based  approach  of  the 
framework,  pet  animals  are  proposed  to  be  exempt  from  the  requirements  for  registration, 
approval, 
their 
movements  are  non-commercial;  and  in  some  cases,  the  requirements  for  import  into  the 
Union. As well as pets, other small-scale and low-risk situations would or could be granted 
derogations  from  requirements  such  as  registration  of  premises,  movement  certification  and 
identification  requirements.  In  some  cases,  MS  would  be  able  to  decide  at  what  level  these 
derogations would apply, ensuring that local contexts were taken into account.  

register-keeping;  movement  certification  where 

record-keeping  and 

Thus  this  option  aims  to  achieve  the  optimum  balance  between  reducing  disease  risk,  but 
minimising costs and adapting to local circumstances.  

5.4.2.  Social Impacts 

As noted above, there should be a slightly positive social effect with respect to the flexibility 
of the veterinary labour market and in particular, some benefits from achieving a consistently 
safe standard across the EU in animals and animal products.  

5.4.3.  Environmental impacts 

Assuming  that  there  is  a  reduced  instance  of  animal  disease  outbreaks,  we  can  extrapolate 
several  other  positive  environmental  impacts.  However,  as  noted  previously,  this  is  an 
assumption that is uncertain and impossible to quantify. We can nevertheless assume that the 
flexible  AHL  will  have  a  greater  impact  on  animal  disease  than  option  3,  and  the  likely 
positive impacts include the below.  

First,  a  better  structured  vaccination  policy,  setting  up  a  flexible  legal  framework  for 
vaccination,  will  provide  the  possibility  of  different  approaches  to  be  used  for  different 
diseases under different circumstances. The AHL will give the possibility to animal keepers to 
use  vaccination  for  all  diseases,  and  promote  the  vaccination  option  whenever  feasible.  For 
diseases relevant for Union intervention the AHL will take a flexible approach by choosing 
the  best  option  to  address  a  particular  disease in  particular  circumstances  on  a  case  by  case 
basis;  for  example,  by  allowing  either  a  general  preventive  vaccination,  introducing 
compulsory vaccination, or providing for emergency vaccination only, etc). For more details 
see Annex VII. 

Reduced  animal  disease  instance  would  also  lead  to  fewer  health-related  welfare  problems, 
thereby  in  overall  terms  improving  animal  welfare.  In  addition,  if  new  guidelines  promote 
better use of vaccination, this will also have a preventative effect on both animal diseases but 
also the associated welfare problems.  

51

 
 
We  can  also  assume  that  improved  biosecurity  would  be  encouraged  in  some  form  in  a 
flexible  manner.  It  is  very  difficult  to  predict  what  the  environmental  impacts  of  improved 
biosecurity  measures  would  be.  On  the  one  hand,  we  have  already  identified  the  positive 
environmental  impacts  from  the  lower  instance  of  animal  disease  outbreaks.  On  the  other 
hand,  increased  biosecurity  measures  might  include  the  increased  use  of  disinfectants  or 
chemicals which could have harmful effects on the surrounding environment. More stringent 
biosecurity  measures  can,  however,  have  negative  impacts  on  animal  welfare.  For  example, 
housing pigs or poultry indoors all year round could have negative welfare impacts.  

All the above could also result in better overall health of animals, which would contribute to 
the reduced use of antimicrobial agents in animals and thus indirectly, reducing the level of 
antimicrobial resistant microorganisms in animals. 

As  with  option  3,  the  reduction  of  the  incidence  of  animal  disease  should  have  a  two-fold 
beneficial  effect  on  wildlife,  through  the  reduction  in  animal  disease  in  wildlife,  the 
associated health and welfare benefits and the protection of biodiversity; and the subsequent 
reduction of the risk of diseased wildlife re-infecting kept animals and even humans.  

5.5. 

Option 5 – prescriptive general legislative framework for animal health issues 

Option 5 is a prescriptive legal framework setting out specific requirements for animal health. 
More details about the measures that option 5 would entail are available in Table 4.1 above.  

Analysis of the impacts of option 5 does come up against some of the same problems as with 
the  other  options;  namely,  that it  is  a  wide-ranging  legislative  proposal  with  many  different 
aspects.  Most  of  the  details  will  be  covered  in  delegated  or  implementing  legislation  and 
cannot be fully described in this impact assessment. Those specific proposals with significant 
anticipated  impacts  are  likely  to  undergo  their  own  specific  impact  assessment  before 
introduction. In this assessment, while the general direction of travel can be extrapolated, the 
specific  levels  at  which  certain  requirements  would  be  set  are  as  yet  impossible  to  develop 
and assess.  

Option 5 is likely to lead to a significant reduction in the instance of animal disease in the EU. 
This  has  the  associated  benefits  already  described  in  options  3  and  4.  However,  option  5  is 
likely  to  have  a  significant  administrative  burden.  In  addition,  more  prescriptive  rules  are 
liable to become obsolete much more quickly with environmental and technological changes 
as  they  are  less  flexible.  The  main  focus  in  the  assessment  of  this  option  is  to  determine 
whether  the  projected  reduction  in  disease  is  worth  the  associated  implementation  and 
ongoing costs, including the potential administrative burden. 

5.5.1.  Economic impacts 

Option  5  should  entail  a  reduction  in  animal  disease,  but  as  for  the  other  options,  this  is 
extremely difficult to quantify. It is difficult to assert with any confidence that requiring the 
same standards across the board, as in option 5, will have a better or worse effect than a well-
executed risk-based approach, as in option 4. It depends at what level resources are applied 
and standards are set. However, one could assert that (assuming the same level of resources 
applied to each option) a good risk-based application of resources, with riskier areas assigned 
more time and attention; will have a more beneficial effect than a uniform standard applied 
across the board, with riskier and less risky areas assigned a similar level of resources.  

52

 
 
As  with  option  4,  if  option  5  were  to  be  introduced,  there  would  be  a  transitional 
administrative burden associated with animal keepers and competent authorities familiarising 
themselves with the new legislation. However, and as for option 4, due to the very nature of 
animal disease, regular updates of valid rules are standard procedure, which means that one-
off familiarisation costs are likely to be negligible and integrated into business-as-usual costs. 
Also, over time, and particularly for those new to animal keeping, a more coherent framework 
should be easier to understand compared with option 1 (no change).  

Nevertheless,  option  5  envisages  very  comprehensive  training  for  farmers,  even  those  who 
have  many  years  of  experience.  This  would  be  an  enormous  administrative  burden  for  the 
farmers themselves. If the MSs were obliged to provide or source the training, it would also 
be a massive burden for them.  

We can very roughly extrapolate a range for the potential administrative burden of providing 
training. 

We  will  assume  that  training  is  required  by  many  farm  personnel  working  with  animals. 
There are 16.4m persons who work regularly on farm holdings (Eurostat). If we assume that 
45-55%  of  these  farmers  work  with  animals  at  some  point,  we  get  a  figure  of  7.4-9.0m 
persons. Of these farm personnel working with animals, we might assume that 20-40% would 
be  exempted  because  of  previous  education,  professional  development  or  training,  or 
'grandfather  rights'.  This  would  leave  a  range  of  4.4m  -  7.2m  people  requiring  training.  We 
will also assume that every person will have one day's training and we can assume that a day's 
training costs €200-400 per person to put on.  

So total administrative burden (number of people x cost per person) is estimated to be in the 
 lost labour to those taking the training, 
range of €886m - €2.89bn. This ignores the costs of
and the cost of developing it and setting it up.  

So even if it were possible to use existing mechanisms for training delivery such as the Farm 
Advisory Service39, this is an enormous sum and would be very difficult to justify imposing 
on MSs unless there were very significant benefits expected. As it is, although some benefits 
would likely arise, it is virtually impossible to demonstrate that the added value of this extent 
of training would be in the region of billions of euros.  

In  addition,  the  lack  of  flexibility  in  the  ability  of  animal  keepers  to  implement  differing 
measures for differing circumstances would likely mean that in many cases, keepers would be 
implementing measures very unlikely to benefit them or their neighbours, perhaps measures 
altogether  unnecessary.  Some  animal  keepers  such  as  'hobby'  or  backyard  keepers,  and 
perhaps even those with family pets, would also have to accept a new administrative burden.  

The administrative burden for MSs is potentially very large with this option. The size of the 
burden  would  depend  on  exactly  how  it  were  to  be  implemented,  but  if  there  were 
requirements  for  MSs  to  provide  training  for  animal  keepers;  as  well  as  developing, 
administering and enforcing new animal health measures in biosecurity and surveillance; the 
burdens  would  be  very  significant.  For  example,  the  specific  analysis  of  the  possible 
administrative burden on MSs with respect to possible biosecurity requirements was carried 
out through a questionnaire to the MSs, as mentioned above, and the full results can be seen 

39  As  outlined  in  Art  12  of  Council  Regulation  (EC)  No  73/2009  of  19  January  2009  establishing  common 
rules for direct support schemes for farmers under the common agricultural policy and establishing certain 
support schemes for farmers 

53

 
 
                                                 
in  Annex  XI.  The  questionnaire  results  show  mixed  opinions  among  stakeholders.  While 
some felt that biosecurity plans would be beneficial overall, others felt that the costs involved 
would  be  disproportionate.  Therefore,  on  the  basis  of  these  results,  it  would  be  difficult  to 
justify imposing biosecurity plans as an obligatory requirement for all relevant holdings and 
operators in all MSs.  

On the positive side, the new prescriptive law would likely remove some of the obstacles to 
animal  movements,  promoting  a  more  harmonised  single  market.  However,  with  a 
prescriptive  and  comprehensive  system  of  movements  there  are  likely  to  be  'winners'  and 
'losers' among those who are differently affected by the new requirements, some of whom will 
benefit  economically,  but  some  who  will  bear  additional  costs  (see  also  Table  VIII.2  and 
Figure  VIII.2  of  Annex  VIII).  There  will  also  be  a  positive  economic  impact  from  a  more 
harmonised veterinary expertise. If vets are required to undergo identical training for official 
tasks, this will promote their free movement and, as with option 4, enable the supply of vets to 
better  follow  peaks  and  troughs  in  demand  according  to  circumstances  such  as  disease 
outbreaks. More detail on this is below in the social impacts.  

5.5.2.  Social impacts 

The prescriptive legislative framework will set out the knowledge and skills which must be 
attained in the professional qualifications and training for official and approved veterinarians 
at EU level.  Ensuring that veterinarians have the same  knowledge and skills throughout the 
EU  will  make  it  easier  for  official  and  approved  veterinarians  to  work  in  other  MS  without 
compromising  health  standards.  Additionally,  as  these  veterinarians  all  acquire  more 
comparable knowledge and skills, this will improve the functioning of the veterinary labour 
market as it will reduce the barriers to veterinarians moving between MS. As noted in option 
4, most veterinarians would be affected to some degree, and a large proportion of them work 
full time in public veterinary services or do some public veterinary work. 

5.5.3.  Environmental impacts 

There should largely be positive health and environmental impacts from the implementation 
of  option  5,  very  similar  to  those  outlined  in  option  4.  On  the  one  hand,  more  mandated 
actions  might  be  expected  to  produce  more  positive  environmental  impacts  of  the  kind 
outlined  in  relation  to  option  4.  However,  the  increased  rigidity  of  option  5  may  mean  that 
measures  are  less  adaptable  to  particular  environmental  circumstances,  perhaps  leading  to 
some negative environmental impacts. It is very difficult to assess even the relative direction 
of travel here, let alone to quantify the expected impacts. 

This  is  also  relevant  for  possible  vaccination  policy  options,  which  would  in  this  option 
envisage  a  single  vaccination  policy  for  all  diseases.  This  option  is  considered  in  a  detailed 
evaluation in Annex VII and assessed as not realistic.   

54

 
 
6. 

How do the options compare?  

Below  in  Table  6.1  is  a  general  summary  analysis  of  options  3-5  against  the  suggested 
assessment  criteria  of  effectiveness,  efficiency,  and  coherence  with  overarching  EU 
objectives, strategies and priorities. Options 1 and 2 are not considered here because they self-
evidently do not meet the objectives set out in Section 3.  

Table 6.1: Comparison of Options 3-5 

Objectives 
Effectiveness  Option 3 has a range of 

Option 3 

outcomes from no 
change compared to the 
baseline, to a relatively 
significant self-
regulatory system. Its 
effectiveness in relation 
to achieving the 
objectives is therefore 
more likely to be 
positive than negative.  
+ 
Its efficiency depends 
on the amount of 
resources devoted to 
getting a self-regulatory 
system up and running. 
However, it will not 
require time consuming 
regulatory change. 

Efficiency 

Coherence 
with EU 
objectives 

+/- 
It would not achieve the 
objectives set out in the 
EU AHS of bringing 
together all AH 
legislation under one 
framework. 

Option 4 

Option 4 is likely to be 
effective in achieving or 
working towards these 
objectives. 

Option 5 

Option 5 is likely to be 
effective in achieving or 
working towards these 
objectives, but may be less 
likely to maintain this 
effectiveness in the long 
term because of its lack of 
flexibility. 

+ 
The flexible framework will 
require limited 
familiarisation costs; 
because this will mainly be 
undertaken within already 
existing training networks 
(e.g. BTSF, etc).It is likely 
to be more understandable 
and efficient in the longer 
term for stakeholders, both 
animal keepers and MS. 

+ 
Option 5 is likely to require 
more administrative burden 
to familiarise and 
implement. While it will 
allow for more coherence in 
the legislation and may lead 
to an overall benefit, the 
lack of flexibility means 
that as circumstances 
change, more resource will 
be required to change the 
legislation. 

++ 
Would achieve the EU AH 
strategy goal of bringing 
together all AH legislation 
into a coherent and flexible 
framework. Is in line with 
flexible approach taken 
elsewhere and is most likely 
to achieve the operational 
objectives in section 3.  

+ 
Would achieve the EU AH 
strategy goal of a single 
legislative framework but 
the lack of flexibility means 
it is less likely to achieve 
some of the operational 
objectives as it is less able 
to be adapted to changing 
circumstances in the future.  

- 

++ 

+ 

Overall, option 4 seems to be the option most likely to deliver a good level of effectiveness, 
efficiency  and  coherence  with  EU  objectives.  It  should  achieve  the  main  objectives  of 
delivering  the  clarity  and  coherence  of  an  overall  strategy  and  framework,  but  leaving 
flexibility  to  allow  for  particular  circumstances in  particular  MS  or  regions,  and  to  adapt  to 

55

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
rapidly  changing  circumstances.  Therefore,  it  is  also  the  option  which  best  respects  the 
principles of subsidiarity and proportionality. Option 3, while offering more continuity with 
the present context, simply lacks any guarantee of positive outcomes, and retains the existing 
confusing  myriad  of  legislation.  Option  5  would  deliver  the  objective  of  simplicity  with  an 
overarching  strategy  and  framework,  but  is  likely  to  be  too  rigid  to  adapt  successfully  to 
differing  circumstances  across  the  Union  and  changes  in  the  long  term,  so  potentially 
undermining its own objectives.  

The beauty of option 4 is in its flexibility. As noted previously, the nature of the overarching 
enabling framework means that it is possible for certain specific policy measures to use the 
tools outlined in general terms in options 3 or 5. The tools of option 3 (some self-regulatory 
schemes  or  elements)  could  be  introduced  or  encouraged  if  a  particular  issue  was  felt  to  be 
unnecessary  or  inappropriate  to  be  specifically  covered  in  legislation  The  more  prescriptive 
legislative framework described in option 5 could be introduced for particular issues, species 
or  diseases  under  delegated  or  implementing  legislation  under  the  flexible  legislative 
framework if more detailed measures were necessary or appropriate.  

56

 
 
7. 
How will the option implemented be assessed?  
The option implemented will need to achieve, or clearly work positively towards achieving, 
the objectives set out in Section 3.  

The  AHS  sums  up  the  purpose  of  performance  indicators  well:  "Simple  and  reliable 
performance  indicators  will  help  to  measure  progress  towards  the  strategy’s  goals,  guide 
policy, inform priorities, target resources and focus discussion […] They will cover both hard 
indicators of animal health (e.g. disease prevalence, number of animals culled due to disease) 
and  softer  indicators  tracking  the  confidence,  expectations  and  perceptions  of  European 
citizens.  It  must  be  recognised  that  uncertainties  and  unforeseeable  events  may  affect 
achievement of the performance indicators." 

It is very difficult to prescribe a set of precise indicators here that will definitively show that 
such  a  wide-ranging  initiative  such  as  the  AHL  has  succeeded  in  its  objectives;  and 
additionally that any improvement in the indicators is directly attributable to the AHL. This is 
partly  because  of  the  complexity  of  the  interlinked  measures  and  their  effects;  and  partly 
because  the  objectives  could  be  completely  undermined  by  external  events  out  of  the  direct 
control of the EU or its MSs. Not only are there peaks and troughs in certain indicators (such 
as animal disease outbreaks) that might not be indicative of the direct effects of the AH Law; 
there are also other wider factors (for example, political or economic issues either within or 
outside the EU) that may affect the general direction of travel in some indicators.  

Nevertheless,  a  series  of  measurements  over  a  fairly  generous  timeframe  should  give  an 
indication of the general direction  of  travel. Those indicators  could be, as the strategy says, 
hard indicators or soft indicators. Examples of hard indicators of success are:  

−  the  proportion  of  EU  veterinary  expenditure  for  eradication  and  monitoring  measures 

compared to costs of emergency measures (data from emergency veterinary fund); 

−  restrictions  (number  of  areas  x  length  of  restrictions)  due  to  outbreaks  of  regulated 

notifiable diseases (data from ADNS/ADIS); 

−  the  number  of  large  scale  disease  outbreaks  and  of  animals  culled  due  to  eradication 

measures (data from emergency veterinary fund); 

−  overall costs and losses for the EU, MS and farmers and other stakeholders due to animal 

disease outbreaks  

−  animal consignments moved across borders under the simplified regime; 

−  the number of training sessions taken up by animal keepers, especially farmers.  

Several  'soft'  perception  indicators  could  be  developed  around  the  objectives  outlined  in 
section 3, particularly the operational objectives. These would need to cover the perceptions 
of the relevant stakeholders about the success or otherwise of each objective – sometimes a 
wide  range  of  stakeholders,  sometimes  more  narrow.  For  a  genuinely  useful  indicator,  a 
baseline would need to be taken either before or at the moment that the AHL is implemented, 
and comparisons in perceptions taken at future points in time.  

57

 
 
As  noted  above,  this  impact  assessment  is  necessarily  a  wide-ranging  overview.  When 
specific secondary legislative measures are introduced, more specific impact assessments will 
need to be completed, and as part of this, much more specific indicators for each measure.  

It is envisaged that an evaluation should take place around five years after the implementation 
of the AHL, and the results will be made available for future decision-making. 

58

 
 
 
 
ANNEX I  Glossary of technical terms and abbreviations 

Animal Disease Information System 

Animal Disease Notification System 

EU Commission's Directorate General  for Agriculture and Rural Development 

Animal Health Advisory Committee 

Animal Health Law 

Animal Health Strategy 2007-2013 

Avian Influenza 

African Swine Fever 

ADIS 

ADNS 

AGRI 

AHAC 

AHL 

AHS 

AI 

ASF 

AVEC 

Association of Poultry Processors and Poultry Trade in the EU countries 

BSE 

BT 

CA 

CAP 

CAHP 

CBA 

Bovine Spongiform Encephalopathy 

Bluetongue disease 

Competent Authority  

Common Agricultural Policy 

Community Animal Health Policy 

Cost Benefit Analysis 

CLITRAVI 

Liaison Centre for the Meat Processing Industry in the European Union 

Compartment 

COPA-
COGECA 

CSF 

CVO 

an animal subpopulation contained in one or more establishments under a common 
biosecurity management system with a distinct health status with respect to a specific disease 
or diseases for which required surveillance, control and biosecurity measures have been 
applied for the purpose of international trade 

European farmer and agri-cooperatives organisation 

Classical Swine Fever 

Chief Veterinary Officer 

DEFRA 

Department for Environment, Food and Rural Affairs, United Kingdom 

DG 

EAZA 

EFBA 

EFSA 

EMA 

ENTR 

ENV 

Directorate General 

European Association of Zoos and Aquaria 

European Fur Breeders' Association 

European Food Safety Authority  

European Medicines Agency 

EU Commission's Directorate General  for Enterprise and Industry 

EU Commission's Directorate General  for Environment 

EUROSTAT 

The statistical office of the European Union 

FAO 

FEAP 

Food and Agriculture Organisation  

Federation of European Aquaculture Producers 

FEDIAF 

European Pet Food Industry Federation 

59

 
 
 
FESASS 

European Federation for Animal Health and Sanitary Security 

FMD 

FVE 

FVO 

HPAI 

IA 

IAB 

Foot and Mouth Disease 

Federation of Veterinarians of Europe 

Food and Veterinary Office 

Highly Pathogenic Avian Influenza 

Impact Assessment 

Impact Assessment Board 

IFAH - Europe 

International Federation for Animal health Europe 

Intra-EU trade  Movements of animal and products between EU Member States 

ISSG 

LPAI 

LS /SJ 

MS 

NCD 

OIE 

Inter-Service Steering Group 

Low Pathogenic Avian Influenza 

The European Commission’s Legal Service 

Member State / Member States  

 Newcastle Disease 

World Organisation for Animal Health  

OIE PVS 

The OIE Tool for the Evaluation of Performance of Veterinary Services 

OLAF 

European Anti-Fraud Office 

RepVet group 

Veterinarians representing  sectors of artificial insemination of their respective MS  (in the 
framework of COPA-COGECA) 

RTD 

EU Commission's Directorate General  for Research and Innovation 

SANCO 

EU Commission's Directorate General  for Health and Consumers 

SARS 

Severe Acute Respiratory Syndrome caused by Corona virus 

SCFCAH 

Standing Committee of the Food Chain and Animal Health 

SG 

SVD 

TFADS 

TFEU 

TRADE 

European Commission Secretariat-General  

Swine Vesicular Disease 

Task Force for Animal Disease Surveillance 

Treaty on the Functioning of the European Union  

EU Commission's Directorate General  for Trade 

TRACES 

Trade Control and Expert System of the EU 

The Treaty  

Treaty on European Union  

UECBV 

The European Livestock And Meat Trading Union 

Vier Pfoten 

For Paws international 

WAHIS-WAHID  World Animal Health Information System and World Animal Health Information Database 

WHO 

WTO 

World Health Organisation 

World Trade Organisation 

WTO-SPS 

World Trade Organisation - Sanitary & Phytosanitary Agreement 

60

 
 
 
ANNEX II  Key Messages from the evaluation of the Community 
Animal Health Policy (CAHP) 

The following key points have emerged from this evaluation: 

1.  Over  the  time  period  reviewed  by  this  evaluation  (1995-2004),  the  Community 
Animal  Health  Policy  (CAHP)  has  become  increasingly  successful  in  terms  of 
achieving  the  outcomes  it  is  seeking  to  pursue.  Although  policy  improvements  were 
mainly  stimulated  by  the  need  to  respond  to  some  major  crises  that  occurred  in  the 
Community  during  this  period,  the  results  can  be  considered  to  have  been  positive. 
Thus, for example, there has been a considerable reduction over time in the prevalence 
of  a  significant  number  of  animal  diseases  and  a  considerably  better  structured 
response  to  crises.  Following  the  CSF,  FMD  and  AI  crises  all  relevant  "vertical" 
legislation  on  the  control  of  these  diseases  was  revised  and  updated,  taking  into 
account the lessons learnt, including those on vaccination and contingency planning. It 
is also an achievement that over time the Commission’s role in respect of the policy 
has come to be increasingly widely accepted both within the EU and internationally. 

2.  This  having  been  said,  until  now  the  policy  has  consisted  of  a  series  of  interrelated 
policy  actions/actors  at  institutional  and  civil  society  level  operating  under  a  large 
umbrella  of  legislation  and  formal/informal  networks  but  without  a  definition  of 
strategy for the whole and limited assessment of the success of actions taken in terms 
of review and feedback on performance. The evaluation has demonstrated the need to 
develop  a  clear  and  transparent  strategy  accompanied  by  a  communication  strategy 
which  improves  stakeholder  engagement  and  involvement  in  decision-making.  In 
addition,  future  actions  need  to  be  informed  by  a  review  of  the  achievement  of 
outcomes in relation to past actions. 

3.  The evaluation has highlighted the many linkages inherent in the policy e.g. between 
what  happens  in  third  countries,  what  happens  at  EU  borders  and  what  actions  are 
taken  to  secure  animal  health  status  within  the  EU.  In  future  better  consistency 
between  actions  to  improve  animal  health  and  welfare  in  the  EU  and  international 
competitiveness could be achieved by pursuing simplified rules and better regulation 
and carrying out impact assessments before introducing new legislation. 

4.  Subsidiarity  aspects  have  been  a  key  theme  underlying  the  various  policy  areas 
covered  by  this  evaluation.  With  principles  and  rules  laid  down  at  EU  level  but 
implemented  by  Member  States,  enforcement  issues  have  often  been  identified  as  a 
key  parameter 
the 
in  allowing  flexibility  at  MS/regional/local 
Commission’s role is crucial in guaranteeing that a common approach and standards 
apply across the Community.  

level  while 

5.  In terms of strategic focus, while it is clear that crises will always recur, the evaluation 
has highlighted the need to move towards a policy which is more focused on effective 
risk  management/disease  prevention.  This  can  be  achieved  via  better  risk  based 
targeting of funding (using cost effectiveness and cost benefit analysis), measures and 
incentives at all levels as well as early detection of exotic and new/emerging disease 
threats. This involves better prioritisation of actions relating to disease eradication and 
surveillance,  research  and  development,  controls  on  illegal  entry  of  potentially  risk 

61

 
 
 
 
 
 
 
 
carrying materials but also more generally creating a stronger culture of bio-security at 
all levels. 

6.  Following  analysis  undertaken  in  particular  under  Part  II  of  this  evaluation,  a  key 
component in the creation of such a culture of bio-security would be the introduction 
of  a  harmonised  framework  for  cost  and  responsibility  sharing.  This  could  be 
structured so as to allow implementation in line with subsidiarity at Member State and 
regional level. A key component of such a cost and responsibility sharing framework 
as well as the idea of better overall prioritisation of actions would be the introduction 
of  a  disease  classification  system.  This  would  allow  greater  focus  on  those  diseases 
which  can  be  considered  to  have  high  ‘EU  relevance’  in  terms  of  the  need  for 
coordinated  action  at  EU  level  due  to  their  potential  impact  on  human  health  and 
potential supra-national/supra-regional economic impact. 

7.  More specific actions which could be considered for the future would include: 

(cid:131)  Further alignment of EU rules more closely with OIE guidelines and standards; 
(cid:131)  A  gradual  move  towards  integrated  electronic  identification  and  certification 

procedures for intra-Community trade; 

(cid:131)  The streamlining of texts going through the Standing Committee procedures; 
(cid:131)  Providing  specific  support  for  bio-security  measures  at  farm  level  via  existing 

funds; 

(cid:131)  Providing  specific  support  to  third  countries  to  assist  them  in  upgrading  their 

animal health status to meet EU and international (OIE) requirements; 

(cid:131)  Negotiating export conditions at Community level; 
(cid:131)  Targeting illegal (commercial) imports/fraud. 

A preliminary assessment of the advantages/disadvantages, feasibility, stakeholder acceptance 
and needs for further assessment has also been undertaken for each of these actions. 

full  CAHP 

documents 
The 
http://ec.europa.eu/food/animal/diseases/strategy/final_report_en.htm   

supporting 

evaluation 

and 

are 

available 

at: 

62

 
 
 
 
 
 
ANNEX III  Summary of chronology of main exchanges with 
representatives of specific sectors likely to be affected by the new 
AH Law 

Stakeholders' Steering group (1st meeting)  

Action 

Time 
18 February 2009 

No 
(1)   

(2)   

(3)   

(4)   

(5)   

(6)   

(7)   

(8)   

(9)   

(11)  

(12)  

(13)  

(14)  

(15)  

(16)  

(17)  

(18)  

(19)  

(20)  

(21)  

Animal Health Advisory Committee meeting 

Stakeholders' Steering group (2nd  meeting) 

Stakeholders' Steering group (3rd  meeting) 

FESSAS (Fédération Européenne pour la Santé Animale et 
la Sécurité Sanitaire) general assembly 

Animal Health Advisory Committee meeting 

Stakeholders' Steering group (4th  meeting) 

CVO meeting  

Special Advisory Committee meeting (Consultation kick-off) 

6 March 2009 

25 March 2009 

19 May 2009 

12 June 2009 

15 June 2009  

3 July 2009 

3 September 2009 

29 September 
2009 

21-23 October 
2009 

9 November 2009 

10 November 2009 

(10)  

Informal CVO meeting, Jonkoping, Sweden 

Animal Health Advisory Committee meeting 

CVO meeting 

Thorough  stakeholders  consultation  in  the  frame  of  the 
preparation of the impact assessment 

23 October to 
31December 2009 

FVE  (Federation  of  Veterinarians  of  Europe)  -  General 
Assembly 

13 November 2009 

DG AGRI – Advisory group on beekeeping 

Administrative 
cost 
questionnaires for CA and operators – informal consultation 
with the members of ISSG 

burden/costs 

compliance 

and 

18 November 2009 

20 November to 3 
December 

Meeting: Veterinary education – DG Markt, DG EAC 

23 November 2009 

Administrative 
burden/costs 
questionnaires – sent to the MS and stakeholders  

compliance 

and 

cost 

5 December 2009 

CVO meeting  

8 December 2009 

Fédération Nationale des groupements de défense sanitaire 

9 December 2009 

organisations 
COPA–COGECA 
professionnelles  agricoles  -  Confédération  générale  de  la 
coopération  agricole)  working  party  on  animal  health  and 
welfare 

(Comité 

des 

9 December 2009 

(22)  

Task  Force  Animal  Disease  Surveillance:  surveillance  in 
general  

17 December 2009 

63

 
 
 
(23)  

(24)  

(25)  

(26)  

(27)  

(28)  

(29)  

(30)  

(31)  

(32)  

(33)  

(34)  

(35)  

(36)  

(37)  

(38)  

(39)  

(40)  

(41)  

(42)  

(43)  

(44)  

(45)  

(46)  

(47)  

CVO meeting 

Animal  Health  Advisory  Committee  meeting  (if  and  as 
necessary, depending on progress) 

14 January 2010 

8 February 2010 

Rencontre avec les éleveurs de l'Aisne 02, France 

15 January 2010 

Meeting veterinary education: EAC 

DG AGRI - Simplification WG with MS experts 

Informal CVO meeting – Sevilla, Spain 

Meeting FESSAS 

Intra-SANCO meeting 

Task Force Animal Disease Surveillance: surveillance in the  
EU AHL  

15 February 2010 

23 March 2010 

13-15 April, 2010 

22 April 2010 

10 May 2010 

17-18 May 2010 

COPA–COGECA  working  party  on  animal  health  and 
welfare 

19 May 2010 

COPA –COGECA RepVet meeting 

CVO meeting 

Inter-Service steering group meeting  

Animal Health Advisory Committee meeting  

Rep Vet meeting and EU AI Vets conference 

COPA-COGECA – Export working group 

Meeting  COPA-COGECA  working  party  on  animal  health 
and welfare 

19 May 2010 

16 June 2010 

5 July 2010 

18 June 2010 

15-16 September 
2010 

10 October 2010 

4 November 2010 

AHL  WG  meeting  with  EU  MS,  Switzerland,  Norway  and 
Iceland 

10 December 2010 

Council WG on bee health 

AHL  WG  meeting  with  EU  MS,  Switzerland,  Norway  and 
Iceland 

Animal Health Advisory Committee meeting 

CVO meeting 

AHL  WG  meeting  with  EU  MS,  Switzerland,  Norway  and 
Iceland 

1 February 2011 

4 February 2011 

17 February 2011 

18 February 2011 

4 March 2011 

Commission CVO meeting  

22 March 2011 

COPA-COGECA working party on animal health and welfare 

30 March 2011 

Minutes of these meeting, consultation results, summaries, conclusions and presentations 
used to steer the discussions are available upon request.  

64

 
 
 
ANNEX IV  Summary document of the stakeholders' steering group: 
"Problem identification during the creation of the animal health law" 

EUROPEAN COMMISSION 
HEALTH & CONSUMERS DIRECTORATE-GENERAL 

Directorate D – Animal Health and Welfare 
D1 - Animal Health and Standing Committees 

Brussels 03/07/2009 

WORKING DOCUMENT 

on 

PROBLEM IDENTIFICATION 
DURING THE CREATION OF THE ANIMAL HEALTH LAW 
(point 4 of the Programming document40  
of the Animal Health Strategy 2007-2013) 

Steering Group on the EU Animal Health Law 
Brussels, 3 July 2009 

This document does not necessarily represent the views of the Commission Services 

40  http://ec.europa.eu/food/animal/diseases/strategy/pillars/action_en.htm 

65

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
                                                 
Problem 
identification 
(group) 

Complexity of the 
legislation 

Burdensome 
implementation 

Problem definition 

Objectives/Solutions (following the 
discussion of the SG) 

Relevance for the 
AHL/Remarks 

Current legislation is composed of 60 basic legal acts 
and more than 400 implementing acts and safeguard 
rules. 

In the absence of a horizontal legal act the legislation 
is  scattered  among  many  legal  measures  with  a 
different  subject-matter,  a  mixture  of  horizontal  and 
vertical  issues  including  trade  (intra-Community  and 
international), disease control measures and specific 
safeguard measures. 
Identification,  Registration  and  Traceability  systems 
are often perceived as too burdensome, costly 

establish 

act 
a 
To 
containing the general principles, main 
objectives, and tools. 

horizontal 

Yes 

To  merge 
scattered through different Directives  

common 

provisions 

To clarify links with other legislation 

To establish a reliable system for food 
producing  animals  based  on  the  risks 
for  human  and  animal  health  and  not 
only on grounds of costs  

Yes 
No 
for 
provisions  

detailed 

Bovine  identification  system  is  too  complex  and 
resource-demanding 
obligations, 
documents, finances). 

(notification 

livestock  owners 

Costs  borne  by  all  beneficiaries  not 
(measures 
only 
considered as Global Public Good). 
Bovine identification simplification 

Disease  control  and  preventive  measures  currently 
applied to hobby and /or backyard farms might be too 
restrictive  but  on  the  other  hand,  these  measures 
might be necessary in order to address risks. 

Current  animal  health  rules  for  zoo's  and  circus' 
animals  require  the  registration  of  the  movements  of 
these animals inside a country. 

To clarify a need for the differentiation 
or  unification  of  disease  control 
measures  on  commercial  and  non-
commercial farming to address risks in 
a proper way.  
the  rules  of 
To  clarify 
identification and registration of certain 
categories of animals 

the  scope 

AHS  Action  plan: 
Steering  group  on 
electronic 
identification 
bovine animals. 
Yes 

of 

Yes 

66

 
 
 
 
 
 
 
 
 
 
 
Problem 
identification 
(group) 

Problem definition 

Objectives/Solutions (following the 
discussion of the SG) 

Relevance for the 
AHL/Remarks 

There  are 
several  existing  databases  and 
computerised  systems  (TRACES,  I+R,  ADNS)  which 
require  different 
are  not 
notification  processes,  which  often 
to 
duplications and unnecessary burden.  

interconnected  and 

leads 

Need  for  alignment  of  ADIS  with  the 
OIE  database  -  WAHIS/WAHID  as 
Regional Core System. 
Integration  national 
and TRACES. 

I&R  databases 

No  unified 
originating from ANIMO and SHIFT). 

legal  basis 

for  TRACES  (outdated, 

Need to modernise and simplify certification  

Responsibilities  of  the  competent  authorities  not 
always clear (control obligations) 

Unclear 
responsibilities 

linked 

To  verify  the  possibilities  for  unified 
I&R  system  (EU  27),  and  possible 
links 
the  animal  health 
to 
information system (long term). 
To  provide  for  an  appropriate  legal 
base 
for  TRACES  and  TRACES 
procedures. 
Electronic  certificates  possibly 
TRACES 
To  simplify  wording  in  the  certificates 
as far as possible. 
To clarify the roles and responsibilities 
of  different  actors  as  regards  official 
controls  and  other  supervision  or 
testing  activities  not  directly  linked  to 
the  verification  of  compliance  with  the 
existing legislation. 

in 

The role and the tasks of the approved veterinarians 
need  to  be  to  be  clarified  in  relation  to  the  official 
controls (Regulation (EC) No. 882/2004). 

Clarify  and  adjust  the  roles  of  official 
veterinarians,  approved  veterinarians 
and  other  official  control  bodies 
covering  the  full  scope  of  the  animal 
health law.   

67

Yes  
Steering  group  on 
ADIS 
Steering  group  on  
Electronic 
certification and Inter-
operability  of  bovine 
databases 

for  detailed 

Yes 
No 
- 
provisions. 
Yes  
AHS  Action  plan: 
Steering  group  on 
electronic certification 
Yes  
(see  also  part  on 
convergence 
with 
international 
standards:  Veterinary 
be 
services 
considered 
a 
Global Public Good). 
Yes 

as 

to 

 
 
 
 
 
  
 
 
 
 
 
 
Problem 
identification 
(group) 

Problem definition 

Objectives/Solutions (following the 
discussion of the SG) 

Relevance for the 
AHL/Remarks 

Need  for  a  better  and  clearer  coordination  between 
different surveillance systems and actors. 

of 

animal 

responsibilities 
The 
keepers/farmers/owners/operators/animal 
transporters/dealers and veterinarians are not clear. 
The  role  of  NGOs  and  farmers  associations  is  not 
clear.  
EFSA's role is not clear as regards animal health and 
welfare.  

Legislation  is  too  rigid  to  be  adapted  to  scientific 
developments and new circumstances. 
Flexibility  for  appropriate  urgent  response  in  case  of 
disease outbreaks has to be at least maintained. 

Provisions  of  the  bluetongue  directive  do  not  reflect 
the  current  health  situation  and  this  result  in  spread 
of the disease. 
Rules 
disproportionate to the risk. 

Vesicular  Disease 

Swine 

are 

on 

Protective measures for  NCD are outdated (Directive 
92/66/EEC) 
Procedure  for  standardisation  of  used  laboratory 
tests is too complicated. 

Rigidity of 
legislation to adapt 
to new 
circumstances and 
developments, 
including scientific 
developments 

in  order 

To  establish  a  better  surveillance 
network  where  the  roles  of  all  actors 
are  clear 
to  achieve  an 
effective  preparedness  for  control  and 
eradication of animal diseases. 
The  roles  and  responsibilities  of  all 
actors need to be clarified. 

To  clarify  the  role  of  NGOs,  industry 
associations. 
To  define  EFSA's  role  as  regards 
animal  health  and  welfare 
risk 
analysis. 
to  establish 
Legislative 
general  principles 
to  be  directly 
applicable,  while  specific  control  rules 
should 
modifiable 
be 
(comitology). 
Revision  of  the  rules  for  control  and 
eradication o bluetongue. 

instrument 

easily 

Yes 

Yes 

Yes 

Yes 

Yes 
No 
- 
provisions. 

for  detailed 

- 

Yes 
provisions. 

for  general 

Set proportionate rules for SVD. 

Set new and updated rules for NCD 

simplify 

procedures 

To 
for 
standardisation as far as possible, use 
of  diagnostic  manuals  and 
ISO 
references  OIE  and  Codex  (CCMAS) 
references. 

for  general 

Yes  – 
provisions. 
Prioritisation exercise 
Yes 
for  general 
provisions 
 Yes  – 
provisions 

for  general 

- 

Certain rules for intra-Community trade are inflexible  Trade 

facilitation  mechanisms  and  Yes 

68

 
 
Problem 
identification 
(group) 

Problem definition 

Objectives/Solutions (following the 
discussion of the SG) 

Relevance for the 
AHL/Remarks 

and difficult to implement.   

There  is  a  need  to  clarify  the  use  of  bilateral 
agreements  for  intra-Community  trade  in  order  to 
ensure a proper functioning of the Single Market. 
Need  of  import  certificate  for  animals  accompanying 
their  owners  and  for  certain  products  for  personal 
consumption in all cases even if they do not pose any 
risk. 

Directive 92/65/EEC is "unworkable": trade conditions 
for  many  animal  species  are  not  clear  or  not  useful 
and create unnecessary administrative burden. 
Current  legislation  does  not  recognize  Veterinary 
services  as  a  public  good  in  line  with  the  OIE 
provisions 

Limited 
convergence with 
the international 
standards (See also 
part on "Unclear 
responsibilities") 

Duplications,  
overlaps, 
inconsistencies with  
other policy areas 

Need  to  review  the  categories  of  animals  for  intra-
Community  trade  (especially  Bov,  Ov,  Sus  and 
equidae)  as  they  are  not  consistent  with  the  import 
rules (and the OIE).  
The concept of what is considered as" trade" and the 
definition  of  "non-commercial  movement"  are  not 
clear.  

69

facilitation: 

same 
to 

cross-border 
reduced 
controls  for  trade  between  territories 
status, 
with 
the 
possibilities 
certain 
categories  of  animals  cross-border, 
surveillance, I+R rules, biosecurity. 
Clarification  of  the  use  of  bilateral 
agreements. 

health 
supply 

Yes 

The  obligations  for  import  certificates 
and  possibilities  for  derogation  to  the 
general rule to be set in the AHL.  

Directive  92/65/EEC  to  be  improved 
radically. 

To set provisions on: 
-  Staff resources 
-  Coordination/cooperation  between 

the CA 

-  Training  or  guidelines 

for  vet. 

Services 

-  Definition  and  distribution  of 

responsibilities 

To review the categories of animals for 
intra-Community  trade  to  make  them 
consistent  with  the  international  trade 
rules and standards where relevant.  
"non-
Concepts  as 
commercial" movement to be clarified. 

"trade"  and 

for  general 

Yes  – 
provisions  
Directives 
2002/99/EC 
92/65/EEC 
Yes    -  for  general 
provisions 

and 

Yes  
OIE  Chapter  3.1., 
3.2.,  OIE  PVS  Tool 
(Evaluation 
of 
veterinary services).  

Yes 
No  – 
provisions 

for  detailed 

Yes 

 
 
 
 
 
 
 
 
Problem 
identification 
(group) 
exist 
(such as zoonoses, 
animal nutrition, 
animal welfare, 
official control 
regulation.) 

Problem definition 

Provisions  for  intra-Community  trade  and  import  of 
equidae are inconsistent. (Directive 90/426/EEC). 

Rules  for  movements  of  pet  animals  younger  than  3 
months are not harmonised 
There are no rules for pet animals others than dogs, 
cats and birds 
Biosecurity  needs to be applied as a preventive tool 
and not only when an outbreak occurs 

Need  to  provide  incentives  for  prevention  of  animal 
diseases. 

is  currently  only 
The  concept  of  compartment 
applicable  to  the  poultry  sector  as  regards  Avian 
influenza. 

Prevention-driven 
approach  

Early  detection  of  animal  diseases  and  the  current 
surveillance network needs to be improved 

70

Objectives/Solutions (following the 
discussion of the SG) 

Relevance for the 
AHL/Remarks 

Amend 
Community 
equidae.  

the  provisions 
trade  and 

for 

intra-
imports  of 

Yes 
No  – 
provisions 

for  detailed 

Revision of the rules for the movement 
of pet animals to better adapt them to 
the risks.  

No  
Regulation  (EC)  No. 
998/2003 

Yes 

Yes 

Yes 

Yes 

-  Possible  application  of  HACCP  - 
principles  system  for  biosecurity 
on-farms  

-  Biosecurity guidelines on EU level  
-  To  encourage 
the  drafting  and 
biosecurity 
of 
application 
guidelines  at  MS/regional/other 
levels. 

To  provide  incentives  for  the  adoption 
of  biosecurity  and  other  preventive 
measures,  financial  incentives,  trade 
incentives, 
of 
controls. 
Introduction  of 
compartment 
diseases/species. 

concept  of 
other 

reduced 

number 

the 

for 

(including  hobby 
Animal  keepers 
keepers) need to be registered and to 
implement 
preventive  measures 
including  surveillance  adapted  to  their 
activities. 
Compulsory  veterinary  supervision  of 
holdings/herds. 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Problem 
identification 
(group) 

Problem definition 

Objectives/Solutions (following the 
discussion of the SG) 

Relevance for the 
AHL/Remarks 

Need to put in place a clear vaccination strategy for 
the different diseases.  

-  Vaccination as a possible tool 
- 
-  exit strategies 

vaccination strategies  

Yes (general 
principles)  
Remark: Task force 
on the reinforcement 
of the EU 
antigen/vaccine 
banks 

Sufficient  rendering  capacity  is  not  always  available 
for crisis events  

Epidemiological unit and the definition of holding are 
not clearly set in the EU legislation. 

Current  legislation  allows  moving  around  sick  bee-
colonies. 
Emerging  diseases  not  properly  addressed  –  in 
particular  Rift  Valley  Fever  (Directive  92/119/EEC) 
and rules for AHS. 
Other  diseases  as  PRRS,  E.  multilocularis, 
Gyrodactilus  salaries  are  not  properly  addressed  in 
the current rules for control and eradication.  

Ensure  sufficient  rendering  capacity 
for crisis events, so that dead animals 
are  not  buried  or  burned,  in  order  to 
efficiently  prevent 
the  spread  of 
diseases. 
Epidemiological  unit 
defined 
to 
definition) 
To  amend  rules  in  order  to  prevent 
further spread of bees' diseases  
Emerging diseases should be reflected Yes 

to  be  clearly 
the  OIE  Code 

  (align 

To  assess  the  need  to  address  other 
diseases.  

The re-grouping of animals in assembly centres may 
pose a threat for the spread of animal diseases.  

To explore options in order to address 
this potential risk.  

The system of identification of companion animals is 
not harmonised and is not compulsory for all species 
and  this  might  lead  to  animal  health  and  welfare 

relevance  of 

identification  of 
The 
companion  animals  needs 
to  be 
highlighted  from  different  perspectives 

71

No 
Provision  included  in 
regulatory 
the  new 
proposal 
for  animal 
by-products 
Yes 

- 

Yes 
provisions 

for  general 

- 

for  general 

provisions 
Prioritisation exercise 
the 
–  with 
No 
exception  of  general 
principles. 
Prioritisation 
diseases 
Yes  
No  – 
provisions 
Yes 

for  detailed 

of 

 
 
 
Problem 
identification 
(group) 

Problem definition 

Objectives/Solutions (following the 
discussion of the SG) 

Relevance for the 
AHL/Remarks 

threats (including illegal trade). 

Provisions  for  the  certification  of  game  birds  are 
unclear,  disease  surveillance  programmes  for  some 
of  the  diseases  need  to  be  evaluated  (Directive 
90/539/EEC). 
Need  to  minimize  opportunities  for  mistakes  and 
fraud in the certification process. 

Un-availability  of  Veterinary  medicines 
insufficient markets (minor uses/ minor species) 

  due 

to 

Public 
diagnostic tools 

interest  of  having  reliable  vaccines  and 

(animal  health,  animal  welfare,  public 
health and illegal trade). 

Provisions  of  Directive  90/539/EEC  to 
be revised 

Certificates  reflecting  clearly  the  trade 
conditions  and  clear  adequate  items 
that  could  be  honestly  signed  by  a 
veterinarian  
DG ENTR 

Yes  
No  – 
provisions 

for  detailed 

Yes  
No  – 
provisions 

for  detailed 

No 
(DG ENTR) 

Need for DIVA vaccines to deal with different animal 
diseases  
Misuse  of  veterinary  medicines  can 
appearance/spread 
antimicrobial 
organisms.  
Rules  for  imports  of  pathogens  including  aquatic 
animals' pathogens are not harmonised. 

the 
resistant 

trigger 

of 

for 

imports  and 

Rules 
reptiles  and 
amphibians  and  trade  of  deer/  other  ruminants  are 
not harmonized. (Directive 92/65). 

trade  of 

72

Promoting 
antimicrobials 

responsible 

use 

of 

Yes 

To harmonize provisions for imports of 
pathogens. Directive 92/118/EEC 

Review  provisions  of  to  better  adapt 
them to risks.  

Yes 
No  – 
provisions 

for  detailed 

Yes 
No  – 
provisions 

for  detailed 

 
 
 
 
 
 
 
 
 
 
Problem 
identification 
(group) 

Problem definition 

There are no common horizontal rules and standards 
on  basic  knowledge  on  animal  health  for  people 
dealing with animals. 

Objectives/Solutions (following the 
discussion of the SG) 

Relevance for the 
AHL/Remarks 

To  establish  rules  or  training  for  the 
persons involved with animals. 
To promote/encourage training 
To  raise  awareness  of  the  need  to 
have appropriate training programmes. 

Yes 
For  official  control 
staff: 882/2004 
For 
veterinarians: 
Decision 90/424/EEC 

set 

rules 

governing 

To 
the 
qualifications of official veterinarians in 
the  field  of  animal  health  /  animal 
those  already 
to 
welfare  similar 
existing  in  the  Regulation  (EC)  No. 
854/2004 

Yes 

Others 

No  specific  provisions  on  the  qualifications  of  official 
and/or  approved  veterinarians  in  the  field  of  animal 
health / animal welfare 
the  qualifications  of  official 
 (Rules  governing 
veterinarians already exist in the Regulation (EC) No. 
854/2004 for the veterinary public health) 

73

 
 
 
 
 
 
 
ANNEX V   Summary of Consultation Responses 

EUROPEAN COMMISSION 
HEALTH AND CONSUMERS DIRECTORATE-GENERAL 

Animal health and welfare 
Animal health and standing committees 

Working document 
on the 

"Annotated agenda 

for stakeholders’ consultation" 

Summary of the consultation questionnaire on the new EU Animal Health Law 
Brussels, March 2010 

This document does not necessarily represent the views of the Commission Services 

Please note that this document has been established for information and consultation purposes only. It 
has not been adopted or in any way approved by the European Commission and should not be 
regarded as representative of the Commission Services either. The European Commission does not 
guarantee the accuracy of the information provided, nor does it accept responsibility for any use made 
thereof. 

-  - 
74

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
1.  Introduction 

The  wide  stakeholders'  consultation  on  possible  approaches  for  the  new  Animal  Health 
Law (AHL) included 14 major issues that were collected by the Commission in previous 
discussions with the AHL Stakeholders' steering group.  

The  consultation  document  "Annotated  agenda  for  wide  Stakeholders'  consultation  was 
presented to the Animal Health Advisory Committee on 29 September, 2009. 

This document was published on the Commission website and was available through the 
Commission's IPM tool (Interactive Policy Making) as of 23 October 2010 until the end of 
2009. The consultation was concluded at the end of 2009 / beginning of 2010. 

During  this  period  the  Commission  received  153  responses.  Structure  of  responding 
entities is presented in Table 1. 

Comments presented below are summarised regardless of the fact whether they were made 
by  the  participants  of  the  consultation  that  have  supported  Commission's  preliminary 
approach or rejected it.  

Status of submitting entity: -single choice reply- (compulsory)  

   An economic/business operator 

 An organisation 
 Other (please specify) 

Number of 
requested 
records 

Requested 
records 
(153)  

17 

110 

26 

% of total 
number records 
(153)  
(11.1%) 

(11.1%) 

(71.9%) 

(17%) 

(71.9%) 

(17%) 

 If an organisation, nature thereof: -single choice reply- (compulsory)  
Requested 
records 
(110)  
(6.4%) 

Number of 
requested 
records 
7 

% of total 
number records 
(153)  

   EU national veterinary authority 
   Other national veterinary authority 

International organisation 

Industry organisation on EU level 

Industry organisation on national level 
   Non-governmental organisation EU level 
   Non-govt. organisation national level 
 Other organisation (please specify) 

(4.6%) 

(3.9%) 

(2.6%) 

(8.5%) 

(15%) 

(7.8%) 

(18.3%) 

(11.1%) 

6 

4 

13 

23 

12 

(5.5%) 

(3.6%) 

(11.8%) 

(20.9%) 

(10.9%) 

28 

17 

(25.5%) 

(15.5%) 

-  - 
75

 
 
 
 
 
 
 
  
  
 
 
 
 
 
  
  
  
  
  
 
2.  Results of the consultation 

Results and summary of different questions are presented in the following points 

2.1. Responsibilities and obligations of animal keepers and owners 

(cid:190)  Proposed approach for comments 

The Community Animal Health Law would clearly set out the obligations of animal 
keepers/owners/operators and those would be applied equally in all Member States.  

(cid:190)  Statistics 

Do you support this preliminary approach? -single choice reply- (compulsory)  

Number of 
requested 
records 
45 

Requested 
records 
(153)  
(29.4%) 

% of total 
number records
(153)  
(29.4%) 

75 

9 

15 

4 

1 

4 

(49%) 

(5.9%) 

(9.8%) 

(2.6%) 

(0.7%) 

(2.6%) 

(49%) 

(5.9%) 

(9.8%) 

(2.6%) 

(0.7%) 

(2.6%) 

   Strongly agree 
   Agree 
   Neutral 
   Disagree 
   Strongly disagree 
   Not relevant 
   No opinion 

(cid:190)  Comments  

Rules: 

•  To establish  the roles and responsibilities of the operators in a Regulation would allow 
for  more  clear  and  practical  rules,  will  help  to  limit/prevent  actions  under  political 
pressure  and  will  establish  a  level  of  playing  field  for  operators  in  the  EU  ensuring  a 
smooth  functioning  of  the  internal  market  as  the  animal  health  policy  will  be 
implemented in a uniform way across the EU. 

•  A  Directive  establishing  general  principles  to  be  applied  equally  in  the  MS  would  be 
better option as it provides for greater flexibility to adapt it to different circumstances in 
the Member States (different species and production systems, economic needs, territorial 
needs need for quick action in case of emerging threats). 

•  This  issue  should  be  left  to  be  regulated  by  the  MS  so  they  can  agree  the  roles  and 
responsibilities  in  conjunction  with  their  livestock  industry.  To  lay  down  the  roles  and 
responsibilities of the operators at EU level will create an inflexible system. 

•  The  EU  should  only  regulate  the  aspects  that  could  have  an  impact  at  EU  level  (e.g.: 
trans-boundary animal diseases). MS should be able to set higher standards than the EU 
ones. 

-  - 
76

 
 
 
 
 
 
 
 
 
 
  
  
 
 
 
•  There is no need for establishing these rules as current legislation sets clear obligations 

for operators. 

•  A  licensing  system  for  farmers  accredited  by  experts  should  be  established  (linked  to 

knowledge, training, etc). 

•  Transitional period needs to be provided. 

•  Responsibilities  of  operators  other  than  animal  keepers  such  as  transport  operators, 

handlers of animals and trader must be defined as well.  

•  Roles  and  responsibilities  should  be  defined  for  all  animal  owners/keepers  (keepers  of 

wild animals, hobby-keepers, etc.)  

•  Obligations  should  be  output  based  and  not  prescriptive.  They  should  be  practical, 
proportionate,  and  science-based,  adapted  to  different  situations  in  the  Member  States 
and should avoid disproportionate burden.  

•  The roles and responsibilities should be linked to EU compensation after animal disease 

outbreaks.  

•  Some disease incursions are out of control of the farmers (e.g. bluetongue virus). 

•  Animals  registered  in  the  national  databases  should  always  be  linked  to  a  responsible 

person (owner, keeper).  

•  When establishing roles and responsibilities of operators it should be specified how they 
need  to  liaise  with  the  veterinarians.  Operators  should  be  obliged  to  take  appropriate 
professional advice to manage risks. 

•  Should  be  clear  that  notification  of  an  outbreak  will  not  have  negative  consequences: 

encourage early reporting. 

•  Animal health and animal welfare rules should be separate. 

•  Coherence with food law needs to be ensured.  

•  The rules for use and availability of veterinary medicines are also important. Roles and 
responsibilities  should  be  laid  down  together  with  obligations  and  privileges  emerging 
from  them  and  linked  with  setting  the  right  conditions  to  fulfil  these  responsibilities 
(scale and intensity of the production, level of biosecurity, disease status and self control 
measures) 

•  Third countries replying to the questionnaire highlighted that these obligations should not 
be imposed to third country operators exporting animals and animal products to the EU.  

Impacts:  

-  - 
77

 
 
 
 
 
 
•  The  Member  States  should  be  responsible  for  ensuring  and  demonstrating  full 
implementation  (including  control  of  the  system  and  sanctions  in  case  of  non-
compliance).This  could  generate  administrative  burdens  and  have  negative  impact  in 
other controls due to lack of resources.  

•  The  consequences  for  small  farmers  should  be  taken  into  account.  Traceability 
requirements should be adapted to them and simplified, if not they risk disappearing and 
they  play  a  crucial  social  role  in  rural  areas.  Same  considerations  apply  for  hobby 
holdings. 

•  The  impact  would  depend  on  the  current  situation  in  the  Member  States  and  on  the 
different  sectors,  on  new  obligations  been  introduced  or  just  a  clarifying  the  current 
ones and also is the fulfilment of these roles and responsibilities would be linked to the 
EU financial compensation after animal disease outbreaks. 

•  To clarify the roles and responsibilities of the operators will benefit animal welfare and 

animal disease control. 

Specific sector concerns: Zoos 

•  The  specialized  and  unique  role  of  zoos  must be considered in the  AHL (zoo animals 
are not part of the food chain but part of breeding-conservation programmes). There is a 
need to clarify when animals kept in zoos would fall under the definition of the animal 
health  law.  Implementation  of  AH  legislation  for  these  animals  varies  considerably 
amongst the MS and this makes the movement within the EU difficult (transport is rare 
and  not  as  risky  as  farmed  animals,  part  of  breeding  and  conservations  programmes). 
Knowledge  of  applicability  at  customs  level  and  local  level  is  poor.  Negative 
consequence to these specificities are not taken into account. 

2.2. Training on animal health and welfare for people dealing with animals 

(cid:190)  Proposed approach for comments 

The animal health law could introduce the possibility of training people dealing with animals, 
and give incentives and tools (guidelines) to the Member States for such training. Increased 
awareness of potential threats related to animal diseases among staff dealing with animals is 
one of the basic pillars of effective and efficient early detection systems.  

(cid:190)  Statistics 

Do you support this preliminary approach? -single choice reply- (compulsory)  

   Strongly agree 
   Agree 
   Neutral 
   Disagree 
   Strongly disagree 
   Not relevant 
   No opinion 

Number of 
requested 
records 
26 

Requested 
records 
(153)  
(17%) 

% of total 
number records
(153)  
(17%) 

88 

9 

18 

6 

1 

5 

(57.5%) 

(5.9%) 

(11.8%) 

(3.9%) 

(0.7%) 

(3.3%) 

(57.5%) 

(5.9%) 

(11.8%) 

(3.9%) 

(0.7%) 

(3.3%) 

-  - 
78

 
 
 
 
 
 
 
 
  
  
(cid:190)  Comments  

Financial issues:  

•  The impact of training provisions would depend on its funding. The Rural Development 
Fund is used for this purpose in some MSs. The use of funds from the Better Training 
for Safer Food programme should be considered.  

•  Funding and training centres are needed in the MSs. 

•  Training requirements should be linked to compensation after animal disease outbreaks. 

•  There  should  be  a  compensation  of  business  hours  lost  due  to  training  for  animal 

keepers.  

•  Training at  work should be possible. 

•  Cost-effective means to provide training should be explored (webpages, etc) 

•  There will be no big impacts in the MSs as training systems are already in place.  

•  An  assessment  of  the  availability  and  quality  of  training  in  the  Member  States  (MSs) 

will need to be carried out.  

Target group 

•  Low motivation of farmers for attending training could be an issue, especially for those 

with "worst" preventive behaviour. 

•  Training is needed mainly for non-commercial activities and extensive farming.  

• 

It's necessary to take into account the knowledge that they already have (different level 
of  knowledge,  experience  and  education  of  the  farmers).  Experience  and  "learning  by 
doing" should be recognized.  

•  Accessibility of training to small farmers, in remote areas needs to be guaranteed (not to 
discourage them from quitting the activity). Negative social and economic impacts are 
expected if training requirements and access to training are not adapted to them.  

•  An important target group for training is the staff working in abattoirs (early detection 

of animal diseases).  

•  How to ensure and control training of pet owners, temporary staff? 

•  Training is needed especially for new farmers.  

•  Zoo staff is very experienced and qualified. Training is already available for them but 

more harmonization will be welcomed.  

-  - 
79

 
 
 
 
 
 
 
 
•  Stricter rules on training should apply for professional keepers than for non-professional 

ones. 

•  Target-groups  for  training  are  too  large:  only  for  commercial  activities.  Better  not  to 

include animal welfare. 

Compulsory Vs voluntary. Level at which training should be regulated.  

•  Training  needs  are  too  specific  (depending  on  the  activity,  the  experience  and 
knowledge of the animal keepers) to be addressed at EU or MS level; it will be better 
done by the industry.  

•  Training should be compulsory to ensure equal implementation in the MSs. 

•  Training  should  be  voluntarily  in  the  first  place  and  after  a  transitional  period  should 

become compulsory.  

•  Training should be a requisite in order to obtain a compulsory licence to keep animals. 
Training should be part of a farm assurance scheme including farm visitation scheme. 

•  Combination of options is suggested: compulsory training plus incentives provided.  

•  Obligatory  provision  should  be  basic  and  relevant  level  of  awareness  (not  to  detailed 

obligations). 

•  Training should be laid down just as an objective in the Animal Health Law and then 

the MSs will choose the means to attain it. 

•  The EU should lay down the minimum content of training and then the MSs will decide 

for whom it will be compulsory. 

•  Training should be voluntary to allow for flexibility to integrate existing mechanisms.  

Content 

•  An  important  aspect  would  be  the  quality  and  relevance  of  the  training  provided  as  it 

has to be adapted to the type of activity. 

•  Farmers need to be aware of the legislative developments and their obligations and of 

the economic consequences of animal diseases (epidemic and endemic). 

•  There  is  a  need  to  reinforce  the  links/confidence  between  animal  keepers  and 

veterinarians. 

•  Competence  and  training  are  two  different  things.  The  frequency  of  the  training  and 

continuous training are important issues to be considered.  

•  Guidelines should be provided to the MSs. 

•  Training is not output-based, is expensive and cumbersome. The key issue is to have a 
well functioning veterinary services and laboratory infrastructure at reasonable prices. 

-  - 
80

 
 
 
 
 
•  All  training  requirements  should  be  coordinated  so  that  animal  keepers  can  combine 

(animal welfare, animal health…). 

2.3. The role of  the veterinary services - clarifying the tasks and duties of official 

veterinarians and private veterinary practitioners  

(cid:190)  Proposed approach for comments 

The  basic  tasks  and  responsibilities  of  official  and/or  approved  veterinarians  should  be  laid 
down  in  Regulation  (EC)  No  882/2004,  while  specific  provisions  could  be  regulated  in  the 
animal health law.  
The  new  legal  framework  should  make  clear  what  specific  tasks  and  duties  in  the  field  of 
animal  health  a  veterinary  practitioner  can  undertake  as  an  official/designated/approved 
veterinarian and under what conditions. This system should be comparable and should not vary 
between the Member States.  

EU legislation should take into account the internationally recognised (OIE) standards for these 
specific  tasks  and  duties,  which  enable  the  EU  Member  States’  international  trade  to  flow 
smoothly. 

(cid:190)  Statistics  

Do you support this preliminary approach? -single choice reply- (compulsory)  

   Strongly agree 
   Agree 
   Neutral 
   Disagree 
   Strongly disagree 
   Not relevant 
   No opinion 

(cid:190)  Comments  

Number of 
requested 
records 
24 

Requested 
records 
(153)  
(15.7%) 

% of total 
number records
(153)  
(15.7%) 

101 

9 

11 

2 

1 

5 

(66%) 

(5.9%) 

(7.2%) 

(1.3%) 

(0.7%) 

(3.3%) 

(66%) 

(5.9%) 

(7.2%) 

(1.3%) 

(0.7%) 

(3.3%) 

•  There  is  a  widely  perceived  need  to  harmonise  and  clarify  certain  veterinary  tasks 
EU-wide. This is valid in particular for the "export certification". In general certain 
tasks  are  perceived  as  purely  official,  while  the  others  have  a  certain  official 
character  (need  to  remain  under  authority  control)  but  can  be  performed  by 
veterinary practitioners.  

•  Conflict  of  interest  shall  be  avoided.  However,  opinions  diverge  on  whether  one 
should achieve that through professional standards and conduct or through the EU or 
national legislation. 

•  Certain  perceive  that  MS  should  have  more  freedom  to  organise  their  services  as 
they wish (principle of subsidiarity). The focus should be given towards an output 
based and not prescriptive approach. 

-  - 
81

 
 
 
 
 
 
 
  
  
 
•  Quality standards of the veterinary services should be set - especially in relation to 

certification scheme. 

•  Veterinarians are not always perceived to be best placed responsible persons for all 
animals, especially aquatic animals and apiculture. In addition, certain roles can be 
trusted to other staff such as technicians, animal keepers. 

•  One  should  avoid  higher  administrative  and  compliance  costs.  Higher  number  of 
official veterinarians is unlikely; therefore we should aim for an optimal use of all 
available resources in order to achieve best possible results and ensure the coverage 
of all areas (including remote areas) with the veterinary services. System should be 
able to adapt to rural production, small farms. 

•  New system should take into account possible public-private partnerships as Animal 

Health Services, which are lately being developed in some countries.  

•  For international trade compliance with the OIE standards is very important. 

2.4. Professional qualifications and training for official and approved veterinarians 

(cid:190)  Proposed approach for comments 

The Animal Health Law would extend the requirements for professional qualifications and for 
veterinary training to official veterinarians in all areas and to those authorised to perform 
official tasks in the field of animal health, similar to the existing provisions of Regulation (EC) 
No 854/2004. Additionally it could provide basic requirements for Continuing Professional 
Development (CPD) for veterinarians  

(cid:190)  Statistics 

Do you support this preliminary approach? -single choice reply- (compulsory)  

   Strongly agree 
   Agree 
   Neutral 
   Disagree 
   Strongly disagree 
   Not relevant 
   No opinion 

(cid:190)  Comments: 

Number of 
requested 
records 
34 

Requested 
records 
(153)  
(22.2%) 

% of total 
number records
(153)  
(22.2%) 

90 

13 

4 

2 

1 

9 

(58.8%) 

(58.8%) 

(8.5%) 

(2.6%) 

(1.3%) 

(0.7%) 

(5.9%) 

(8.5%) 

(2.6%) 

(1.3%) 

(0.7%) 

(5.9%) 

•  Education and training for veterinarians are very important but should be adapted to 
the  level  of  public  tasks  assigned  to  a  professional;  for  example  approved 
veterinarians don't need the same level of training as the official veterinarians. The 

-  - 
82

 
 
 
 
 
 
 
 
  
  
 
trainings  should  therefore  be  output  /  target  oriented  towards  proper  enforcement 
and shouldn't generate unnecessary costs. 

•  Basic requirements of the AHL should secure the quality of the veterinary services 

and acting of veterinary professionals. 

•  We  should  aim  to  establish  a  harmonised  EU  approach  for  all  those  that  perform 
official  tasks  and  these  include  besides  veterinarians  some  other  professionals, 
especially  linked  to  certain  working  areas,  as  for  example  aquaculture,  apiculture, 
etc. Training programmes should be flexible and adjusted to specific needs. 

•  A  need  for  an  EU-wide  minimum  requirements (which should not  be  too low) for 
undergraduate  and  post-graduate  training  was  expressed.  However,  MS  shall  have 
the possibility to deliver this output, and keep the flexibility for its organisation and 
financing. 

•  Many  MS  already  have  continuous  professional  developments  of  veterinarians  put 
in place and for those it seems that the additional regulation at the EU level would 
be redundant. 

•  Some are of the view that it is necessary to regulate all steps of veterinary education, 

including accreditation of the veterinary schools. 

•  Many  participants  emphasised  that  good  qualifications  of  veterinarians  are  well 
perceived by the farmers and this strengthens the public opinion on food safety. 

2.5. Biosecurity measures to prevent outbreaks on farms and not only deal with them 

when they occur 

(cid:190)  Proposed approach for comments:  

The Animal Health Strategy aims for preventive and incentive-oriented approaches. Therefore a 
legal  framework  should  aim  for  the  voluntary  introduction  of  biosecurity  measures  at  farms. 
The  implementation  of  these  measures  could  be  encouraged  by  providing  incentives  such  as 
trade-facilitation  mechanisms  and  reducing  the  number  of  controls.  The  animal  health  law 
would set the minimum criteria for biosecurity measures, allowing them to be adapted to local 
circumstances. 

(cid:190)  Statistics: 

Do you support this preliminary approach? -single choice reply- (compulsory)  

   Strongly agree 
   Agree 
   Neutral 
   Disagree 
   Strongly disagree 
   Not relevant 

Number of 
requested 
records 
25 

Requested 
records 
(153)  
(16.3%) 

% of total 
number records
(153)  
(16.3%) 

91 

12 

16 

3 

0 

(59.5%) 

(7.8%) 

(10.5%) 

(2%) 

(0%) 

(59.5%) 

(7.8%) 

(10.5%) 

(2%) 

(0%) 

-  - 
83

 
 
 
 
 
 
 
  
  
   No opinion 

6 

(3.9%) 

(3.9%) 

(cid:190)  Comments: 

Controls 

•  Reductions of controls plus trade-facilitation mechanisms lead to increased risks. 

•  Controls should be maintained: to ensure implementation of biosecurity measures. 

•  Controls need to be reviewed in order to simplify, check of they provide added-value or 

if they are obsolete and duplicated. 

Scope 

•  Biosecurity should also be applied on transport and holdings other than farms. 

• 

It  is  also  important  to  manage  and  reduce  the  risk  at  Member  States  level  (import 
controls strengthened, animal disease eradication programmes, etc.) 

•  Large  commercial  farms  should  apply  maximum  biosecurity  standards  and  incentives 
will  be  provided  to  them,  while  small  farms  and  hobby  farms  should  apply  minimum 
standards adapted to their circumstances.  

•  Small holdings with poor biosecurity represent a high risk. 

•  These  options  are  not  applicable  for  zoos  and  aquariums  (different  risks  also:  low 
density,  animals  do  not  enter  the  food  chain:  different  measures  needed:  ex:  visitors). 
Directive  92/65  is  not  properly  implemented  and  therefore  there  are  no  incentives  for 
zoos applying biosecurity measures.  

• 

Interaction of animals kept on zoos and wild animals are not covered by the Directive 
92/65. 

•  Special status for genetically important livestock (indigenous breeds) should be granted.   

Incentives 

•  At  MS 

level,  sanitary  actors 

(veterinarians,  administration  and  professional 
organizations)  should  encourage  and  motivate  farmers  for  the  adoption  of  biosecurity 
measures,  for  example  by  linking  biosecurity  measures  to  increased  farm  profitability 
and better animal health.  

• 

Incentives such as access to markets are important to ensure effective and wide-spread 
implementation of minimum standards.  

•  The objective should be to discourage the transport of animals, not to increase it as this 
represents a risk for animal health and welfare. Reward should be granted to farms with 
they  avoid  animal  movements.  Specialization  and 
close-production  cycles  as 
intensification  of  farms:  increases  the  development  of  fast  spreading  disease  (highly 
pathogen virus) 

-  - 
84

 
 
 
 
 
 
• 

Incentives  must  be  conditioned  to  risk  analysis  carried  out  after  biosecurity  measures 
are in place. 

•  An  important  incentive  for  the  implementation  of  biosecurity  measures  would  be  to 
exempt  from  certain  restrictions  farmers  with  excellent  biosecurity  measures  in  a 
restricted  zone  if  they  did  not  get  the  disease.  It  is  also  important  to  grant  financial 
compensation for farms in surveillance/ restricted zones. 

•  Trade  facilitation  mechanisms  and  reduced  controls  can  only  be  granted  if  the 
Competent  Authorities  have  certainty  of  the  correct  implementation  of  biosecurity 
measures.  This  will  imply  reporting  requirements  from  farmers  to  the  competent 
authorities (increased administrative burden for farmers that has to be compensated with 
less costs due to reduced controls and saving in acquisition of trade-certificates). 

•  Financial  support  from  the  EU  would  be  needed  to  implement  biosecurity  measures. 
Need  also  for  denial  or  reduction  of  compensation  in  case  of  disease  outbreaks  to 
holdings where biosecurity measures are not adhere to. 

Impact 

•  Rules  on  biosecurity  measure  should  be  designed  in  partnership  with  the  industry  to 

allow for adaptation to their own circumstances and minimize costs. 

• 

• 

Implementation  of  biosecurity  measures  would  be  an  economic  burden  for  farmers. 
Therefore, rules should be science-based, cost-effective, easy to implement  

Investments  will  depend  on  sector/  MS  and  of  the  farm  status-quo  but  will  be 
compensated through better animal health and welfare. 

•  Balance  between  costs  of  diseases  and  investment  costs  needs  to  be  calculated  before 

implementing biosecurity measures. 

• 

• 

Implementation of biosecurity measures would have benefits day to day and also when 
outbreaks occur.  

Implementation  of  biosecurity  measures  would  be  a  challenge  for  several  structures 
(veterinary services, farmers) but they are crucial for future development. 

Rules 

•  Efficacy  would  depend  on  the  definition  and  content  of  biosecurity  measures  (avoid 

inconsistent, highly variable definitions and insufficient controls).  

•  Quarantine,  testing  before  introduction  of  new  animals,  vectors  control  are  important 

measures.  

•  Rules should be outcome-based and not prescriptive. 

•  Same rules should apply for third country imports. 

•  Biosecurity measures have to be equally implemented to be effective. 

-  - 
85

 
 
 
 
 
•  Role  of  the  veterinary  surgeon  (advice,  recommend  which  biosecurity  measures  are 

more suitable for each holding) should be recognized.  

• 

Important to link with financial issues. 

•  Biosecurity should not be introduced at the costs of animal welfare (free-range, outdoor 

keeping, more sterile environment and less contact animal keeper-animals). 

•  Biosecurity measures should be measurable in order to be able to assess compliance. 

•  Role of veterinary practitioners should be officially recognized.  

•  HACCP should be applied for larger farms that will be audited (instead of trade-related 

controls) . 

•  Collection and transport of animals can only be done if they come from holdings with 

similar biosecurity status.  

•  Surveillance and controls should be risk-based. 

Compulsory/voluntary 

•  Combination  of  options  2  and  3  is  suggested  as  the  best  approach  by  various 

stakeholders. 

•  Biosecurity measures should be compulsory (EU minimum standards) and then Member 

States can impose higher requirements. 

•  Promoting implementation (soft-regulation) is the best option. 

•  Biosecurity  needs  to  be  adapted to  the  type  of  farm  (certain  level  of  biosecurity  to  be 
obligatory and equally applied in the EU; industry that wants to go further could do it 
through guidelines (and in this way participation of farmers will be encouraged). 

•  Assurance systems should be developed in order to ensure and control implementation. 

•  Training and guidance are better tools than Regulation.  

•  Should be responsibility of the Member States to develop a non-legislative framework. 

•  Minimum  standards  should  be  mandatory  and  on  top  of  that  voluntary  standards  with 

incentives provided. 

•  Compulsory  minimum  requirements  are  inflexible  for  adapting  them  to  different 

premises (example: laboratories). 

•  MS  should  introduce  long-term  health  management  plans,  regular  visitation  of 

veterinary practitioners for all livestock enterprises.  

•  Companion and hobby animals should also be taken into account. 

•  Biosecurity measures should be prerequisite for trade with animals and animal products. 

-  - 
86

 
 
 
 
 
• 

Implementing  a  legal  framework  with  few  exemptions  is  better  than  to  establish 
minimum criteria and unmanageable national guidelines. 

•  Minimum  requirements  should  be  laid  down  for  high-risk  holdings  (traders,  market 
shows, transport…) taking into account animal density, size of the enterprises or farms. 

2.6. Animal disease surveillance needs to be improved 

(cid:190)  Proposed approach for comments:  

Without  prejudice  to  Directive  2003/99/EC  as  regards  zoonoses,  the  best  way  to  improve 
animal  disease  surveillance  seems  to  be  to  extend  the  scope  and  purpose  of  surveillance 
networks as set out in Article 14 of Directive 64/432/EEC, which is currently envisaged only 
for  bovine  animals  and  pigs,  to  other  species  of  terrestrial  animals/diseases.  Animal  keepers 
(including hobby keepers) would be registered and preventive measures suited to their activities 
introduced, including surveillance. The new Animal Disease Information System would support 
this approach by clarifying and facilitating reporting. The introduction of surveillance networks 
will support the implementation of trade-facilitation mechanisms.  

(cid:190)  Statistics: 

Do you support this preliminary approach? -single choice reply- (compulsory)  

   Strongly agree 
   Agree 
   Neutral 
   Disagree 
   Strongly disagree 
   Not relevant 
   No opinion 

(cid:190)  Comments: 

Number of 
requested 
records 
19 

Requested 
records 
(153)  
(12.4%) 

% of total 
number records
(153)  
(12.4%) 

84 

19 

14 

9 

1 

7 

(54.9%) 

(12.4%) 

(9.2%) 

(5.9%) 

(0.7%) 

(4.6%) 

(54.9%) 

(12.4%) 

(9.2%) 

(5.9%) 

(0.7%) 

(4.6%) 

In some cases preliminary  approach  of the Commission to  strengthen  the  surveillance system 
was  supported,  but  on  the  other  hand  there  was  some  diversity  of  opinions  in  relation  to 
Commission's  option  3  (suggested  surveillance  network).  Many  of  those  supporting  the 
preliminary approach have, instead of option 3, rather chosen options 1 – EU wide compulsory 
surveillance  for  certain  diseases  (in  eleven  cases)  or  4  –  to  develop  soft  regulatory  approach 
"guidelines" (in nine cases). 
•  Proposed approach for surveillance network appears to be too prescriptive, detailed and to a 
certain  extent  too  authoritative.  What  we  should  aim  for  is  robust  disease  surveillance, 
providing solid grounds for early warning and detection of diseases. 

•  There  is  a  perception  of  a  limited  applicability  for  all  animal  species.  Specificities  of 
different  production  channels  and  production  types  should  be  taken  into  account,  i.e.  for 
hobby  farms,  backyards, horse keeping,  laboratory  animals, zoos,  fur animals, companion 
animals, wildlife, endangered species etc. 

-  - 
87

 
 
 
 
 
 
 
  
  
 
•  Specific  disease  situation  have  to  be  taken  into  account,  partnership  with  stakeholders 

established and appropriate consideration taken on the private surveillance. 

•  Surveillance should be structured in a way that it would provide minimum EU requirements 
on one hand and open the possibilities for additional provisions in the Member States (basic 
health statuses and additional health guarantees). 

•  The purpose and expected outcomes of surveillance should be clearly defined. 

•  Some consulted prefer to have a soft regulatory approach (option 4) 

•  Surveillance  system  should  be  cost  effective  and  linked  to  the  level  of  threat  of  a  certain 

disease (in particular zoonotic agents) 

2.7. Intra-Community trade / placing on the market concept 

(cid:190)  Proposed approach Option 1: 

Similarly to the approach already introduced for aquaculture animals in Directive 2006/88/EC, 
the concept of intra-Community trade in live terrestrial animals would be replaced by the 
concept ‘placing on the market’. 

1.  Proposed approach Option 2: 

Maintain  the  concept  of  intra-Community  trade  as  the  basis  for  regulating  commercial 
movements  of  terrestrial  animals  between  Member  States.  However,  the  implementation  of 
enhanced  biosecurity  measures  and  surveillance  schemes  and  subsequent  trade  facilitation 
mechanisms  should,  in  principle,  narrow  the  gaps  between  the  rules  governing  intra-
Community trade and those  on  national movements in live terrestrial animals, and eventually 
make  it  possible  in  the  long  term  to  move  towards  a  ‘placing  on  the  market’  system  for  live 
terrestrial animals, too.  

(cid:190)  Statistics: 

- Option 1 – placing on the market 

Do you support this preliminary approach? -single choice reply- (compulsory)  

   Strongly agree 
   Agree 
   Neutral 
   Disagree 
   Strongly disagree 
   Not relevant 
   No opinion 

Number of 
requested 
records 
13 

Requested 
records 
(153)  
(8.5%) 

% of total 
number records
(153)  
(8.5%) 

46 

16 

48 

10 

3 

17 

(30.1%) 

(10.5%) 

(31.4%) 

(6.5%) 

(2%) 

(30.1%) 

(10.5%) 

(31.4%) 

(6.5%) 

(2%) 

(11.1%) 

(11.1%) 

-  - 
88

 
 
 
 
 
 
 
 
  
  
 
- Option 2: Intra-Community trade 

Do you support this preliminary approach? -single choice reply- (compulsory)  

   Strongly agree 
   Agree 
   Neutral 
   Disagree 
   Strongly disagree 
   Not relevant 
   No opinion 

Number of 
requested 
records 
19 

Requested 
records 
(153)  
(12.4%) 

% of total 
number records
(153)  
(12.4%) 

53 

27 

25 

6 

4 

19 

(34.6%) 

(17.6%) 

(16.3%) 

(3.9%) 

(2.6%) 

(34.6%) 

(17.6%) 

(16.3%) 

(3.9%) 

(2.6%) 

(12.4%) 

(12.4%) 

Comments concerning statistics: 

The  results  from  the  IPM  tool  as  presented  above  show  separate  analysis  of  the  answers 
received for each of the two options presented in the consultation paper.  
However,  many  replied  on  both  questions  with  the  same  answer,  as  for  example:  neutral,  no 
opinion,  acceptable  or  unacceptable  in  both  cases.  Finally,  only  108  of  153  received  clearly 
expressed  their  view  for  one  or  another  option  and  of  those  65  opted  to  keep  the  Intra-
Community trade system and 43 chosen the introduction of placing of the market approach. 
From presented data it can be concluded that the views on both approaches are rather divided, 
but a tendency towards the Intra-Community trade concept.  

Additional remarks 

•  New EU AHL should pave a pathway towards the placing on the market concept but 

should not introduce it at this stage yet. 

•  Possible  introduction  of  HACCP-like  concepts  is  not  welcomed,  has  not  been 
proven  as  a  right  approach  for  small  holdings  and  it  brings  too  many  costs  for 
operators. 

•  Certain  categories  and/or  species  of  animals  are  perceived  as  low  risk  and  should 
therefore  in  view  of  consulting  parties  be  exempted  from  the  general  movement 
rules,  especially  when  these  animals  are  kept  in  controlled  environment  –  for 
example  laboratory  animals).  For  some  specific  rules  would  be  needed  (bees,  zoo 
animals, etc.) 

•  Differentiation for commercial and non-commercial movements is important.  

•  EU  legislation  should  lay  down  minimal  health  requirements  and  recognise 

initiatives for reaching higher biosecurtiy and health standards. 

On the placing on the market  

•  This concept is at this stage perceived as too risky, hazardous, and premature. The 
animals can not be compared to products of animal origin they involve more health 
risks.  

-  - 
89

 
 
 
 
 
  
  
 
 
•  There are doubts if the system is feasible for terrestrial animals.  

•  Problem in certification of specific health provisions especially in terms of export of 

animals are envisaged.  

•  Placing  on  the  market  concept  would  suit  only  certain  types  of  holdings  or  trade 
partners;  while  for  the  others  it  would  represent  a  big  additional  burden,  limiting 
them with the sourcing of animals and national movements.  

•  Suggested system appears too costly for the majority of holdings across the EU. 

• 

It would be more difficult to apply the placing on the market for terrestrial animals 
than  it  was  for  aquatic  animals.  Terrestrial  animals  involve,  which  consequently 
leads  to  more  diseases.  The  system  introduced  for  aquaculture,  has  already  shown 
deficiencies,  which  might  be  even  bigger  in  case  of  more  complex  situation  on 
terrestrial side. 

•  Placing on the market could be introduced by imposing animal health surveillance 
schemes (including regular veterinary visits on farms), recording, traceability, good 
hygiene practices and be strongly supported by regionalisation. 

• 

In  case  of  placing  on  the  market,  clear  provisions  should  be  set  for  movement  of 
animals from holdings with low health status to those with high health status. 

•  Placing on the market approach is perceived as beneficial as the holdings will need 
to  comply  with  higher  standards  that  will  bring  more  advantages  to  welfare  of 
animals. 

2.8. Differentiation or uniformity of trade rules and disease control measures on 

commercial and non-commercial farming 
(cid:190)  Proposed approach for comments:  

Diseases do not distinguish between different categories of holdings and all holdings might be 
at risk of getting and spreading disease. The optimal way forward seems to be to apply disease 
control measures and the same rules on movement for all holdings; however, opportunities for 
risk-based  exemptions  on  a  case-by-case  basis  might  be  achievable  for  certain  diseases  or 
animals. The Animal Health Law would need to provide for basic principles on when and how 
a  certain  category  of  animal  or  product  movement  can  be  exempted  from  the  general  rule. 
Detailed provisions should be set in subsequent legislation and made sufficiently flexible and 
controllable. 

(cid:190)  Statistics: 

Do you support this preliminary approach? -single choice reply- (compulsory)  

   Strongly agree 
   Agree 
   Neutral 
   Disagree 

Number of 
requested 
records 
30 

Requested 
records 
(153)  
(19.6%) 

% of total 
number records
(153)  
(19.6%) 

84 

15 

13 

(54.9%) 

(54.9%) 

(9.8%) 

(8.5%) 

(9.8%) 

(8.5%) 

-  - 
90

 
 
 
 
 
  
  
  
   Strongly disagree 
   Not relevant 
   No opinion 

(cid:190)  Comments: 

4 

0 

7 

(2.6%) 

(0%) 

(4.6%) 

(2.6%) 

(0%) 

(4.6%) 

•  EU legislation for these categories of animals should allow for stricter Member States rules. 

•  AHL  should  not  go  beyond  guidelines  and  basic  principles  on  when  and  how  a  certain 

category of animals/ products should be subjected to stricter rules. 

•  Harmonized EU approach is needed.  

•  This  issue  should  be  left  to  be  regulated  by  the  MSs  (hobby,  zoo,  etc).  Rules  have  to  be 

flexible to acknowledge local circumstances. 

•  Proportionality is vital. 

•  Definition of commercial and  hobby holdings needs to be established (any holding that is 
part of the food production chain should be considered as commercial). Definition should 
be sound and enforceable. 

•  An important issue is who will be responsible to grant the exemptions.   

•  Risk-evaluation  to  establish  exemptions  should  be  harmonized,  acknowledge  risk 

evaluating principles. 

•  Avoid having at the end a two-tier system.  

•  Requiring application of derogation case-by-case is too heavy administrative system. 

•  High administrative burden costs for small/hobby farms, cost beneficial at all levels in the 

long-run.  

• 

Impacts of differentiating rules: minimum risk for disease spreading, decrease bureaucracy. 

•  Exemption  should  be  generic,  based  on  the  size  of  the  holding,  no  case-by-case  basis, 

similar to hygiene package. 

•  Possible adaptation with regard to compartmentalization principle should be considered.  

•  The EU should clearly state those animals and diseases for which exemptions would apply.  

•  Specific rules for categories of animals different from farm animals should be provided. 

•  Certain category  of animals could be exempted if they apply self-imposed higher level of 

biosecurity and health status. 

•  Hobby-farmers,  pet  owners:  low  disease  awareness,  low  knowledge  on  biosecurity, 
important to find a relevant, realistic way to include these groups, avoid practical increasing 
of administrative burden for competent authorities and farmers. 

-  - 
91

 
 
 
 
 
 
•  The  new  Regulation  should  contain  tools  for  performing  risk-based  analysis  and 

surveillance schemes for movements of non-commercial farming. 

•  To give hobby holdings a formal status, that would place them under the general rules and 

allow for derogations. 

Arguments against differentiation of measures:  

•  AH rules should apply equally, regardless of whether the animals are kept for commercial 

or non-commercial purposes. 

•  Trans-boundary transport of pets can spread pathogens. 

•  No  animals  should  be  exempted  from  monitoring  and  surveillance.  Zoo,  circus  and  pet 

animals should be controlled when they are moved (at least randomly). 

•  Surveillance and monitoring also needed for wild animals.  

•  Outbreak and spreading of animal diseases in non-commercial holdings could have major 

implications for commercial ones (establishment of restricted and surveillance zones). 

•  To  differentiate  between  commercial  and  non-commercial  animals  is  difficult  (hobby 

farmers often engage in limited commercial activities. 

•  Horse transport should maintain strict health regulations. 

Arguments in favour of differentiation 

•  More flexible for zoos/hobby animals: not intended for the food chain.  

•  Ornamental fish, kept in home aquarium should be exempted for general rules. 

•  Exceptions should apply also to some specific traditional small farms (free-range, organic) 

in the poultry/eggs sector. 

•  Contact movements at non-commercial farms are far less than in commercial holdings.  

•  Laboratory animals represent minimum risk (not traded, confined). 

•  Differentiation animals for slaughter and other animals: limited risk, deserve to be treated 

differently.  

•  Diseases are normally concentrated in commercial holdings. 

•  Zoos  do  not  represent  a  risk  for  agricultural  holdings,  is  the  other  way  around,  they  are 
relatively  small  population  of  endangered  species  applying  already  strict  animal  health 
rules. Zoos usually do not exchange animals with agricultural holdings. 

•  Breeding programmes for endangered species are jeopardized by unclear legislation, lack of 
uniform  application  and  slow  decision-making  process:  animal  exchanges  are  difficult  or 

-  - 
92

 
 
 
 
 
 
even  impossible:  compromised  welfare  conditions  and  obstruction  of  conservation 
initiatives. 

•  All  holdings  do  not  pose  the  same  risks  for  animal  diseases  spreading  (hosts  specificity, 

opportunities for disease transmission, new animals, transport, stocking densities).  

•  Some  control  measures  are  not  suitable  for  zoo  animals  (compulsory  slaughter  is  not 

adequate; vaccination  and surveillance are better). 

• 

Indigenous  livestock  breeds  need  a  special  status  in  the  event  of  disease:  if  not,  negative 
impact in biodiversity, special breeds will disappear. 

2.9. Animal health requirements for trade and import for certain animal species under 

Directive 92/65/EC 

(cid:190)  Proposed approach for comments:  

The future Animal Health Law should establish clear general rules on trade for these "special" 
species  and  categories  of  animals,  and  clarify  which  species  could  be  exempted  by  special 
animal health rules, while leaving more specific provision to implementing rules. 

(cid:190)  Statistics: 

Do you support this preliminary approach? -single choice reply- (compulsory)  

Number of 
requested 
records 
41 

Requested 
records 
(153)  
(26.8%) 

% of total 
number records
(153)  
(26.8%) 

76 

12 

3 

2 

2 

17 

(49.7%) 

(7.8%) 

(2%) 

(1.3%) 

(1.3%) 

(49.7%) 

(7.8%) 

(2%) 

(1.3%) 

(1.3%) 

(11.1%) 

(11.1%) 

   Strongly agree 
   Agree 
   Neutral 
   Disagree 
   Strongly disagree 
   Not relevant 
   No opinion 

(cid:190)  Comments: 

General remarks: 

•  EU rules for these categories of animals should be consistent with the OIE standards. 

•  Transit of animals from third country to third country through the EU should be taken into 

account.  

•  Traceability of animal movements is a key issue. Use of TRACES for every type of animal 

movement should be required. 

•  We have to be careful that the new law does not encourage transport of wild/exotic animals. 

Conditions for transport should be taken into consideration as well. 

-  - 
93

 
 
 
 
 
 
 
  
  
 
•  Wild animals need sedation and special handling before moving them and this should also 

be taken into account when laying down rules.  

Risk of "special species" imports:  

•  A  risk-based  approach  should  be  followed  when  establishing  rules  for  these  categories  of 

animals.  

•  Basic rules should apply also for animals not entering the food-chain if they represent a risk 

to the health of food-producing animals or for food-safety. 

•  As  changes  in  ecosystems  can  lead  to  disease  risks,  a  clear  and  justified  need  should  be 

demonstrated for importation of "special species".  

• 

Imports of exotic animals may not have an immediate health risk, but in the long term could 
have huge consequences. 

•  Exemptions to the rules have to be as limited as possible: exotic species could be a major 
reservoir  of  exotic  pathogens  and  the  origin  of  epizootic  disease  in  the  EU  animal 
populations. 

•  Prevention aspects of animal health legislation should apply to all species.  

•  This review should not lead to a ban on imports from species already authorised. 

Degree of harmonization of the rules:  

•  Rules  should  be  completely  harmonized  for  these  species,  including  implementing  rules, 
otherwise is not possible to have a harmonized border control and intra-Community trade 
control system and to avoid market distortion.  

•  The EU should lay down minimum requirements for these categories of animals and the MS 

should be able to apply stricter rules based on their animal disease situation. 

•  Same  rules  should  apply  for  all  MS,  but  allowing  them  to  review  exemptions  for  certain 

species if they are considered to be an increased disease-threat. 

•  Directive  92/65  is  not  implemented  properly  by  the  Member  States  and  this  makes 
therefore  breeding/conservation 
movement  of  animals 
programmes  are  endangered.  This  legal  act  should  be  changed  from  Directive  to 
Regulation.  There  is  a  need  for  uniform  implementation  of  the  rules,  also  targeting 
movements of zoo animals across MS. 

impossible  sometimes  and 

•  Basic general rules should apply to all species. MSs starting to import new species should 
present and discuss this with the rest of the MS. Not only the species but also the conditions 
for importation should be specified.  

Specific sector remarks: 

• 

Important  to  establish  a  clear  definition  of  the  species  to  avoid  misunderstandings  (e.g.: 
llamas are not ruminants).  

-  - 
94

 
 
 
 
 
•  Wild  equidae  should  be  accommodated  into  Directive  92/65.  Some  species  such  as  the 
American  bison  are  kept  in  zoos  and  also  for  commercial  purposes.  Experts  should  be 
consulted before laying down rules to avoid problems. Legislation should reflect the correct 
taxonomy; to treat a whole taxonomic class as if they were domestic animals has no sense. 

•  Laboratory  animals  are  almost  always  maintained  at  a  very  high  health  status,  which  is 
closely  monitored  and  controlled  and  therefore  exemptions  from  restrictions  should  apply 
for those animals. 

•  Ornamental fish should have a different status than fish. 

•  Specific needs of the horse sector should be taken into account. Extent of horse movements 
is huge compared to exotic pets and zoo animals. All horses shouldn't be treated the same 
(wild  ponies,  slaughter  horses,  competition  horses),  they  have  hugely  varied  health  status 
and disease risks. 

•  The  possibility  for  bilateral  agreements  on  cross-border  movement  of  certain  species  as 
reindeer should however remain possible, but rules on traceability should be laid down to 
ensure rapid tracing in disease outbreaks. 

2.10. 

Emerging, re-emerging and exotic diseases 

(cid:190)  Proposed approach for comments:  

Emerging diseases should be reflected in the new Animal Health Law and linked to the ongoing 
exercise to set priorities for EU intervention and categorise diseases. Certain provisions of the 
current Directive 92/119/EEC can be considered as a basis for developing a solid and concise 
legal  framework  for  horizontal  control  principles  for  emerging,  re-emerging  and  exotic 
diseases,  taking  into  consideration  the  OIE  rules  on  notification.  The  provisions  of  certain 
disease control directives that are outdated, disproportionate, not flexible enough or not aligned 
with international standards should be revised and aligned with general principles to be set out 
in  the  Animal  Health  Law.  In  addition,  some  technical  adaptations  to  existing  rules  in  the 
chapter of simplification will be needed.  

(cid:190)  Statistics: 

Do you support this preliminary approach? -single choice reply- (compulsory)  

   Strongly agree 
   Agree 
   Neutral 
   Disagree 
   Strongly disagree 
   Not relevant 
   No opinion 

Number of 
requested 
records 
43 

Requested 
records 
(153)  
(28.1%) 

% of total 
number records
(153)  
(28.1%) 

89 

7 

3 

0 

0 

11 

(58.2%) 

(4.6%) 

(2%) 

(0%) 

(0%) 

(58.2%) 

(4.6%) 

(2%) 

(0%) 

(0%) 

(7.2%) 

(7.2%) 

-  - 
95

 
 
 
 
 
 
 
  
  
 
(cid:190)  Comments: 

•  Basic  EU  animal  health  legislation  is  too  rigid  (difficult  to  change)  to  accommodate  all 
emerging  and  re-emerging  diseases.  Detailed  provisions  should  be  flexible  and  should 
therefore  be  laid  down  in  lower  level  legislation.  Strategies  to  control  different  types 
diseases are different and this needs to be taken into account. Member States should have a 
possibility to introduce national measures for control of specific diseases. 

•  Framework AHL should provide general rules for different groups of diseases (like vector 
borne diseases, highly contagious diseases with direct transmission, etc.). It should take into 
consideration  wildlife  as  a  permanent  reservoir  of  disease  agents,  different  exotic  animal 
species and pet animals that might introduce new diseases especially zoonotic agents. 

•  Definition  of  emerging  diseases  should  be  constructed  carefully  and  can  include  non-

infectious diseases and antimicrobial resistance. 

•  AHL should include latest scientific knowledge and risk based measures within the EU and 

in imports. 

•  AHL disease control rules should align as far as possible with the OIE. Where scientifically 

justified a higher health status should be set.  

•  Vaccination  policy  should  be  less  restrictive  and  the  importance  of  vaccination 

strengthened. More emphasis should be given to vaccine development. 

• 

Innovation  is  important  for  the  animal  health  sector  in  particular  in  developing  new 
diagnostic kits, vaccines. EU should aim for latest diagnostic and vaccination technologies 
and should influence in this respect international organisations. 

•  Disease categorisation and prioritisation are very important tools and the result needs to be 

included in the AHL.   

•  OIE  disease  situation  information  should  be  introduced  into  the  TRACES  system,  which 
can be used as a proper control tool for preventing the introduction of exotic diseases into 
the EU.  

•  More passive surveillance should be used for diagnosis of emerging diseases. 

2.11. 

Review and simplification of current rules on identification and registration 

of animals 

(cid:190)  Proposed approach for comments: 

Current  provisions  would  be  essentially  confirmed,  without  lowering  current  traceability 
standards.  However,  basic  principles  and  objectives  for  identification  and  registration  of 
animals  would  be  clearly  laid  down  in  the  Animal  Health  Law,  while  specific  provisions  for 
different  species  or  categories  of  animals  would  be  established  by  Comitology.  This  would 
ensure  policy  coherence,  better  understanding  of  the  animal  owners  and  more  successful 
enforcement. In the meantime, current legislation would remain in place. 

-  - 
96

 
 
 
 
 
 
 
(cid:190)  Statistics 

Do you support this preliminary approach? -single choice reply- (compulsory)  

   Strongly agree 
   Agree 
   Neutral 
   Disagree 
   Strongly disagree 
   Not relevant 
   No opinion 

Number of 
requested 
records 
22 

Requested 
records 
(153)  
(14.4%) 

% of total 
number records
(153)  
(14.4%) 

92 

16 

7 

4 

1 

11 

(60.1%) 

(10.5%) 

(4.6%) 

(2.6%) 

(0.7%) 

(7.2%) 

(60.1%) 

(10.5%) 

(4.6%) 

(2.6%) 

(0.7%) 

(7.2%) 

(cid:190)  Comments: 

•  The  Commission's  approach  was  generally  supported.  However,  only  basic  principles, 
objectives and outcomes should be set in the AHL; excluding many detailed provisions or 
rules for identification. 

•  Traceability  is  perceived  as  an  imperative  but  it  can  be  achievable  with  different  means. 

Individual identification of all species is not always necessary. 

• 

• 

Identification  and  registration  of  pet  animals  was  largely  perceived  as  a  necessary  step 
further for animal health and welfare reasons.  

Identification of non-food animals is seen as necessary for these animals might represent a 
health threat for other animals and humans. 

•  All elements of identification and registration system (identification mark, documents, and 
database)  are  not  suitable  for  all  species  and  categories  of  animals.  Therefore  careful 
consideration  should  be  given  to  what  extent  these  provisions  would  apply  to  all  animals 
like fur animals, bees, aquatic animals, poultry, etc. 

•  Data collected for identification and registration should be used for other purposes and not 
only  traceability.  Identification  and  registration  databases  of  the  member  states  should  be 
connected within the EU. 

•  Specificity has to be recognised especially for equidae, where an existing system complying 
with  the  international  standards  for  registered  horses  is  already  in  place.  More  emphasis 
should be given to its implementation.  

•  AHL  should  give  consideration  to  special  animal  categories  like  zoo  animals,  where  an 
international approach has been created (ISIS system; ZIMS database). Special arrangement 
for domestic animals kept in zoos is suggested. 

•  A good balance of efficiency, feasibility and costs should be established. 

-  - 
97

 
 
 
 
 
  
  
 
 
2.12. 

Specific animal health conditions relating imports 

(cid:190)  Proposed approach 

Regulation (EC) No 882/2004 provides the legal framework for general import conditions and 
controls. These provisions would be supplemented by specific import conditions set out in the 
new animal health law. These rules are to allow appropriate flexibility, while all the technical 
provisions are to be set in subsequent legislation and in line with the OIE recommendations as 
far  as  possible.  Flexibility  and  tailor-made  rules  based  on  risk  assessment  should  ensure  the 
desired level of protection, while at the same time reducing the burden for operators.  
The  Animal  Health  Law  should  make  explicit  the  specific  principles  to  be  observed  when 
setting  import  conditions  based  on  animal  health  concerns  (i.e.  what  animal  health  grounds 
warrant the limitation of trade with non-EU countries) and the principle that import conditions 
must be risk-based and therefore adjustable to the level of risk.  
The  Animal  Health  Law  should  cross-refer  to  the  principles  and  procedures  laid  down  in 
Regulation 882/2004 for collecting information on the basis of which import conditions are set 
and the arrangements for setting general and specific import conditions by sectoral (delegated) 
legislation.  

(cid:190)  Statistics: 

Do you support this preliminary approach? -single choice reply- (compulsory)  

Number of 
requested 
records 
27 

Requested 
records 
(153)  
(17.6%) 

% of total 
number records
(153)  
(17.6%) 

88 

18 

6 

0 

0 

14 

(57.5%) 

(11.8%) 

(3.9%) 

(0%) 

(0%) 

(57.5%) 

(11.8%) 

(3.9%) 

(0%) 

(0%) 

(9.2%) 

(9.2%) 

   Strongly agree 
   Agree 
   Neutral 
   Disagree 
   Strongly disagree 
   Not relevant 
   No opinion 

(cid:190)  Comments: 

Rules 

•  Flexibility is required to allow Member States to apply additional conditions if necessary, 

based on a scientific risk analysis. 

•  Principles and procedures should all be the same for all MS and clear for all operators, to 

avoid delays in animal transport and problems. 

•  Details on import requirements to be established in bilateral agreements. 

•  Simplification  is  welcomed,  but  without  lowering  standards  while  increasing  rules  for  the 

EU operators. 

-  - 
98

 
 
 
 
 
 
 
  
  
 
•  All  import  requirements  (specific  rules  for  imports  and  controls)  should  be  laid  down  in 

Regulation 882/2004 to remain a coherent set. 

•  AHL  should  lay  down  main  requirements;  specific  requirements  should  be  left  for 

implementing rules.  

•  Harmonized procedures and intensity of controls should be the same across al MS. 

•  Good pre-import testing and monitoring are essential.  

•  Stakeholders and importers should be consulted to make sure that the conditions are easy to 
understand  and  accessible  and  not  "lost"  in  a  complicated  legal  act  dealing  with  very 
different range of issues. Simplification should not be only for Competent Authorities, but 
also for operators. 

•  List of risks by species and sector is a good start. 

•  Proper enforcement of the legislation is a key point. 

•  Efficient identification of imported animals is essential.  

• 

Imports of live animals and animal products are the biggest threat for animal health in the 
EU. 

•  Sanctions to MS not complying not implementing  the rules, not  supporting the veterinary 

services shall be defined and applied. 

•  EFSA should be consulted to carry out risk-assessment in relation to imports. 

Import conditions and competitiveness of EU business. 

•  Rules  on  general  import  condition  should  be  based  first  on  scientific  risk  assessment  and 

international standards. 

• 

Import  conditions  should  be  similar  to  the  requirements  imposed  to  EU  farmers  and  food 
business  operators  by  the  EU  legislation.  This  may  regard  the  registration,  training, 
surveillance  and  monitoring:  in  that  way  control  of  disease  risks  of  imports  will  be 
improved and will create a level of playing field. 

•  Community  standards  are  higher  than  international  ones:  this  means  higher  costs  for  EU 

producers. 

•  The concepts used for risk analysis in the EU and in third countries are not the same. 

• 

Imported  products  and  animals  should  comply  with  the  same  standards  as  the  EU  ones 
(animal welfare, animal health and food safety, environment). 

•  Third countries should apply regionalization as the EU does. 

•  Requirements  for  internal  movements  should  be  equal  to  import  conditions  (not  having 

higher standards for intra EU trade than for imports). 

-  - 
99

 
 
 
 
 
Impact 

•  Simplification  of  import  regulation  likely  to  facilitate  border  controls  and  improve  AH 

status in the Community.  

• 

Impact on bilateral trade between MS should be taken into account. 

Specific sector needs 

•  Specificities of the horse sector should be taken into account. 

•  Occasional  imports  of  zoo  animals  are  needed  to  ensure  long-term  genetic  variability 
(conservation/breeding  programmes  for  endangered  species).  Disease  risks  should  not  be 
extrapolated from domestic to wild animals, experts should be consulted. 

•  Genetically important livestock should have a special treatment, also in the OIE Code. 

2.13. 

Converegence of the EU legislation with international standards 

(cid:190)  Proposed approach 

In order both to achieve its desired level of protection in relation to imports and fulfil its 
international obligations the EU should:  

•  align the EU legislation with the international standards as far as possible (OIE, Codex) 
while  at  the  same  time  not  lowering  its  health  standards  which  have  already  been 
achieved; and  

•  promote its standards in the international fora and in particular the OIE, with the aim to 
ensure the maximum possible convergence between the EU and international standards.  

(cid:190)  Statistics: 

Do you support this preliminary approach? -single choice reply- (compulsory)  

   Strongly agree 
   Agree 
   Neutral 
   Disagree 
   Strongly disagree 
   Not relevant 
   No opinion 

Number of 
requested 
records 
43 

Requested 
records 
(153)  
(28.1%) 

% of total 
number records
(153)  
(28.1%) 

83 

13 

4 

2 

0 

8 

(54.2%) 

(54.2%) 

(8.5%) 

(2.6%) 

(1.3%) 

(0%) 

(5.2%) 

(8.5%) 

(2.6%) 

(1.3%) 

(0%) 

(5.2%) 

-  - 
100

 
 
 
 
 
 
 
 
  
  
 
(cid:190)  Comments: 

•  OIE convergence is by the majority welcomed. However, the current EU health standards 
should not be lowered where the EU has reached higher standard. Only few expressed the 
need to review current higher EU standards to see if they can be adjusted to a level provided 
for in international standards. 

•  When creating new measures, higher standards than the OIE can be introduced only after a 
risk  assessment.  In  these  cases  all  efforts  should  be  engaged  to  reach  the  consensus  to 
modify relevant international standards. 

•  Moreover some emphasise that the internal EU rules should not be more stringent than the 
import rules unless specifically justified (if possible with quantitative analysis). The goal of 
the subsequent requirements should be to minimize risk to acceptable level.  

•  OIE recommendations focus on outputs (achievements) rather than tools and EU legislation 

should follow this approach. 

•  The  ones  that  disagree  with  the  approach  mostly  stress  that  the  EU  has  achieved  higher 
health and quality standards in the past.  Their perception is that these standards should not 
be lowered and the EU position not weakened. 

•  EU  influence  in  the  international  forums  should  be  more  proactive  aiming  at  achieving 
higher standards at the international level. EU membership is perceived as a beneficial step 
forward.  However,  EU  can't  be  too  patronising  and  impose  so  high  standards,  which  can 
have negative effects for less developed countries. 

•  Concept  of  aligning  with  international  standards  should  not  limit  the  onset  of  private 

standards at a higher level.  

•  Definitions in the AHL should be in line with the OIE standards. 

• 

In terms of OIE animal welfare constitutes an important element of OIE convergence.. 

•  Emerging  diseases  presenting  threat  to  biodiversity  of  animal  species  are  an  important 
element.  OIE  already  follows  this  approach;  co-operation  with  other  international 
organisations should be considered.  

•  Responses  of  countries  in  case  of  disease  outbreaks  should  be  comparable;  EU  currently 
applies  much  more  reasonable  measures  towards  than  some  countries  apply  towards  the 
EU. 

2.14. 

The definition of 'epidemiological unit' and 'holding' in EU legislation 

(cid:190)  Proposed approach 

The  Animal  Health  Law  should  refine  existing  concepts  of  herd  and  holding  and  establish 
cross-links between them. he concept and definition of ‘epidemiological unit’ for animal health 
purposes  is  of  fundamental  importance  to  taking  all  measures  necessary  on  biosecurity, 
registration  of  animals  and  their  movements,  surveillance  and  definition  of  the  animal  health 
status of the relevant population and, as a consequence, granting incentives for prevention, as 
highlighted in several points in this document. Therefore, based on these concepts, the Animal 
Health Law should ensure a coherent and consistent definition of ’epidemiological unit’.  

-  - 
101

 
 
 
 
 
(cid:190)  Statistics: 

Do you support this preliminary approach? -single choice reply- (compulsory)  

   Strongly agree 
   Agree 
   Neutral 
   Disagree 
   Strongly disagree 
   Not relevant 
   No opinion 

Number of 
requested 
records 
27 

Requested 
records 
(153)  
(17.6%) 

% of total 
number records
(153)  
(17.6%) 

81 

20 

4 

0 

1 

20 

(52.9%) 

(13.1%) 

(2.6%) 

(0%) 

(0.7%) 

(52.9%) 

(13.1%) 

(2.6%) 

(0%) 

(0.7%) 

(13.1%) 

(13.1%) 

(cid:190)  Comments: 

•  Epidemiological unit has to be defined for each pathogen. 

•  The definition of epidemiological unit should be based on the OIE definition to be accepted 

internationally. 

•  Work in partnership with the OIE to agree on a definition that suits also EU purposes. 

•  There should be flexibility in the definition to adapt it to different systems/species. It would 
be  necessary  also  to  define  a  list  of  common  basic  criteria  in  order  to  adopt  similar 
approaches for each species, together with the definition of epidemiological unit.  

•  All  relevant  terms  describing  animal  populations  should  be  considered  when  defining 

epidemiological unit. 

•  A  clear  and  undisputable  definition  should  be  established  in  the  AHL  to  avoid 

misunderstandings and problems. 

•  The new definition should take into account already existing definitions and arrangements 

in the MS and their particularities.  

• 

It's too difficult to establish a definition that will fit in all cases, is better to rely on barriers 
to  slow  down  the  spreading  of  diseases  and  stand-still  requirements  that  are  easier  to 
standardise.  

•  The  consequences  of  establishing  this  definition  have  to  be  assessed  carefully  (e.g. 
implications for movement reporting burden that this could have).It is important to identify 
current patterns  of land  use within each MS and use this to assess the impacts of moving 
towards the use of a prescribed definition of a holding. 

•  To refine the definition of herd and holding is necessary but to define epidemiological unit 

at EU level is too complicated.  

•  Pet owners of small number of animals should be excluded from the scope of the definition; 

otherwise it would be extremely complicated. 

-  - 
102

 
 
 
 
 
 
  
  
 
•  Definition of approved areas in Directive 92/65 may help in order to establish a definition 

of epidemiological unit. 

•  Panel of internationally recognized scientists and epidemiologist to find what could be the 

best possible definition. 

•  Definition  for  pet  animals  is  easier  than  for  large  commercial  holdings  that  should  be 

registered.  

•  General rules to exempt certain parts of holdings from restrictions should be laid down in 
relation to the characteristics of each disease or disease group and specific implementation 
rules left to the MS.  

•  One herd per holding and holding becomes epidemiological unit. 

•  To define epidemiological unit will have no use for animal disease control purposes, as all 

animals in the holding will have to be killed in case of an outbreak.  

2.15. 

Is there any other issue that you would like to raise or that you feel that 
should be addressed by the Animal Health Law and that is not included in the 
document? 

General principles: 

•  A  new  "general  framework  law"  should  be  established,  with  the  aim  to  merge  animal 
health, animal welfare and food safety into a single framework. These three areas can't 
be separated. Therefore they need to be put together into the same legal text, since they 
address  the  same  actors  and  stakeholders  (animal  keepers,  traders,  veterinarians,  etc.). 
General food law shall be re-constructed for that purpose.  

•  AHL shall include general principles, similar to the ones set out in a general food law 

(Regulation (EC) No. 178/2002). 

•  AHL shall include veterinary checks regime and prevention principles through controls 

on permitted imports. 

•  AHL should contain budgetary / financial questions – emergency funding rules. 

•  A clear and reactive chain of command of veterinary services needs to be set. 

Coherence with other legislation and policies: 

•  Coherence between animal and public health legislation addressing primary production 
needs to be drawn up (coherence of animal health certification and providing food chain 
information). It shall establish a single sending of information and link databases.  

•  Relation  between  the  AHL,  food  and  feed  safety,  zoonoses  should  be  established. 
Monitoring and surveillance schemes in all areas should be adjusted to each other and 
be comparable.  

-  - 
103

 
 
 
 
 
 
•  AHL  should  integrate  with  other  Commission  activities  under  the  framework  of  DG 

AGRI, ENTR, and ENVI. 

Relation animal health animal welfare: 

•  Clear  reference  and  link  between  animal  health  and  animal  welfare  needs  to  be 

established in the AHL. 

•  Comprehensive definition of health and welfare should be set out: "freedom of diseases 
or  abnormality  and  state  of  wellbeing  by  meeting  physical,  physiological  and 
psychological elements. 

•  Link should be established to protection of laboratory animals. 

Focus on prevention: 

•  Disease  prevention  is  a  shared  effort  of  all  MS;  good  implementation  and  control  are 

needed. 

•  Focus on prevention should not take away need to focus on eradication. Eradication is a 
starting  point  for  prevention.  Prevention  and  biosecurity  should  be  promoted  as 
beneficial to farmer in day-to-day life.  

One health concept: 

• 

Include  "One  health"  concept  –  diseases  spread  from  animals  to  humans  and  from 
domestic  animals  to  wildlife  and  vice  versa.  This  needs  to  be  considered  in  the 
legislation.  

Vaccination: 

•  Vaccination policy should be clarified and vaccination should not be prohibited, when it 

is proved to be effective and it doesn't harm health. 

•  Vaccination of animals after outbreaks should be more protective; emergency measures 
and  special  marking  of  animal  products  remain  in  place  for  too  long  period  and 
influence  the  trade  with  products  of  vaccinated  animals.  This  causes  unjustifiable 
economic losses.  

•  Hobby  keepers  want  to  use  preventive  vaccination  to  protect  their  animals  and  this 

should be allowed. This same is valid for protection of rare breeds. 

•  Vaccination should be designated as a strong preventative tool.  

•  There  is  no  reason  for  products,  which  originate  from  vaccinated  animals  to  be 
distinguished with special labelling. These products don't constitute public health risks. 

•  There  are  considerable  differences  between  health  statuses  of  vaccinated  and  non-

vaccinated areas, which result in trade implications. 

•  A level of proving of disease freedom after vaccination for creation diseases is too high 

(for example 100% for FMD, which is un-realistic). 

-  - 
104

 
 
 
 
 
Wildlife: 

•  Wild animals present health  risk and the AHL shall provide the same approach to them 
as to the commercial animals, in particular in relation to disease control measures (TB 
testing) 

•  More  attention  should  be  given  to  wild  animals  and  non-commercial  categories  of 

animals.  

Horses: 

•  EU  animal  health  policy  is  unclear  about  the  status  of  the  horses  and  doesn't  reflect 

commercial, racing, breeding, sporting and leisure movements of horses. 

•  Distinction between breeding and registered horses is not needed; only slaughter horses 

need a different approach. 

•  Provisions of directive 90/426/EEC to be included into the bilateral trade or veterinary 
agreements,  which  would  reduce  day-to  day  practical  problems  and  costs,  facilitate 
exchanges and allow flexibility. 

Specific animal categories: 

•  Bees and beekeeping are special areas of expertise. The AHL should also provide legal 
framework  for  them,  but  allowing  specific  rules  at  a  higher  level  of  detail  as  a 
subsequent step. 

•  Zoo  animals  and  aquatic  animals  from  aquariums  need  modified  arrangements. 
Movements of those animals do not usually have the nature of commercial movements 
and animals don't end in food chain. Related to this protection of rare species need to be 
taken into the consideration. Furthermore, transport of these animals can't be considered 
as commercial operation. 

•  Some categories of animals presenting lover health risks per se and some of them leave 
in controlled environment, these elements should be taken into account accordingly (i.e. 
fur animals, laboratory animals). 

•  Amphybians  and  other  "exotic"  companion  animals  have  often  in  the  past  constituted 

health risks, especially for humans (salmonella infections) and other animals.  

Movements: 

•  All movements represent risks; therefore national movements should be included in the 

AHL. 

•  Animal  identification  and  registration  databases  should  be  connected  in  order  to 

facilitate animal movements across the EU.  

•  For animal health and welfare reasons movements of animals should be limited to only 

one assembly operation. 

-  - 
105

 
 
 
 
 
•  Rules  should  be  established  for  gathering  of  animals  at  international  level  like 

international exhibitions. 

Disease control measures: 

•  An  automatic  abolishment  of  emergency  measures  after  a  certain  period  elapses  after 

the outbreak should be introduced into legislation. 

•  Stand-still requirements for pigs in directive 91/119/EEC should be reviewed. 

•  The new law should replace detailed rules for disease control, especially those from the 
Regulation (EC) No. 2005/76, Directive 2005/94/E, 2003/85/EC, 200/75/EC with more 
general provisions, allowing more flexibility. 

•  Measures to control Rift Valley Fever have to be put in place. 

•  Rules for suppression of tuberculosis should be up-dated. 

Laboratories and tests: 

•  More  flexibility  should  be  introduced  for  tests  in  a  framework  of  directive  90/429  for 

porcine semen. 

•  AHL should include provisions to ensure quality of laboratory reagents. 

Audits and controls: 

• 

Internal audits should ensure harmonised application of EU rules in the MS. 

•  Better enforcement measures should be put in place in the AHL. 

•  More  flexibility  should  be  allowed  on  a  level  and  frequency  of  controls  (example 

Regulation (EC) No. 1082/2003 – controls on identification of bovine animals).  

VMPs and antimicrobial resistance: 

•  AHL  should  include  chapter  on  veterinary  medicinal  products  –  holistic  approach 

needed. 

•  Prevention  part  should  include  rules  for  use  of  antibiotics,  with  a  link  to  prevent 

developing of antimicrobial resistance. 

•  Availability of VMPs, vaccines and biocides should be regulated by the AHL. 

•  AMB  resistance:  status  of  MRSA  in  MS  differs.  Continuation  of  work  on  eradication 

and fighting diseases. Facilitating trade only adds to spreading.  

Import: 

• 

Import certificates for aquatic animals are too complicated. Signing authorities in third 
countries can't understand them. 

-  - 
106

 
 
 
 
 
Stakeholders: 

•  AHL should contain a chapter dealing with the relationship with stakeholders to ensure 
transparency, easier implementation of legislation across the EU). An instrument similar 
to the Animal Health Advisory Committee would be advisable.  

Private standards: 

•  New animal health legislation should give room for private quality systems. 

3. Conclusions 

3.1. Responsibilities and obligations of animal keepers and owners 

Results of the consultation show a general support of stakeholders on the proposed approach by 
the  Commission  to  clarify  roles  and  responsibilities  of  animal  keepers  and  owners.  However, 
some discrepancies on the degree of harmonisation of this subject were observed. The need to 
establish obligations also for operators other than animal keepers and owners was highlighted 
by several stakeholders.  

3.2. Training for people dealing with animals 

Although  the  voluntary  approach  was  regarded  as  the  most  adequate  one  by  the  majority  of 
stakeholders, a significant share would prefer that compulsory training for people dealing with 
animals  is  established  in  the  AHL.  Concerns  on  the  funding  for  training  activities  were 
expressed  by  some  stakeholders.  The  majority  of  stakeholders  highlighted  the  importance  to 
provide flexibility to adapt training provisions to specific circumstances.  

3.3. The role of the veterinary services - clarifying the tasks and duties of official 

veterinarians and private veterinary practitioners 

Consultation shows a need to clarify and harmonise certain veterinary tasks EU-wide. This is 
valid in particular for the "export certification" and international trade. Certain veterinary tasks 
are  perceived  as  purely  official,  while  the  others  have  a  certain  official  character  (need  to 
remain  under  authority's  control)  and  can  be  performed  by  veterinary  practitioners,  other 
experts, where relevant (i.e. for aquaculture, apiculture) or other staff, such as technicians. All 
resources should be used in an optimal way in order to ensure proper territorial coverage and a 
good quality of veterinary services in line with the OIE provisions. 

3.4. Professional qualifications and training for official and approved veterinarians 

Education and training for veterinarians are very important but should be flexible, adjusted to 
specific  needs  and  adapted  to  the  level  of  public  tasks  assigned  to  a  professional;  approved 
veterinarians don't need the same level of training as the official veterinarians. These trainings 
should therefore be output / target oriented towards proper enforcement and shouldn't generate 
unnecessary  costs.  Training  should  be  provided  also  to  other  professionals  responsible  for 
certain working areas with a lack of veterinarians, such as for example aquaculture, apiculture, 
etc.  Many  MS  already  have  already  introduced  continuous  professional  developments  of 

-  - 
107

 
 
 
 
 
 
 
 
 
 
 
 
 
veterinarians  and  for  those  it  seems  that  the  additional  regulation  at  the  EU  level  would  be 
redundant. 

3.5. Biosecurity measures to prevent outbreaks on farms and not only deal with them 

when they occur  

Although  the  voluntary  approach  was  regarded  as  the  most  adequate  one  by  the  majority  of 
stakeholders,  a  significant  share  would  prefer  that  compulsory  biosecurity  measures  are 
established in the AHL. A combination of options 2 and 3 was suggested as the best approach 
by various stakeholders. Some stakeholders are against providing trade-facilitation mechanisms 
as they consider that this would increase animal diseases risk. Discrepancies on the scope for 
implementation of biosecurity measures and on the level at which this should be regulated were 
observed.  

3.6. Surveillance 

There  is  a  substantial  support  towards  the  Commission's  approach  to  strengthen  the 
surveillance, however the views on the necessity to introduce surveillance network were more 
diverged.  It  seems  that  even  this  approach  would  largely  be  welcomed  but  should  aim  for  a 
robust system for disease surveillance that would be able to adjust to different production types 
and  different  diseases.  Room  for  additional  provisions  and  specific  solutions  at  the  level  of 
Member  States  should  be  preserved,  using  at  the  same  time,  where  possible  a  soft-regulatory 
approach. 

3.7. Intra-Community trade / placing on the market concept  

From presented statistical data it can be concluded that the views on both approaches are rather 
divided, but there is a tendency towards the keeping of Intra-EU trade concept.  
The overall feeling is that the new EU AHL should pave a pathway towards the placing on the 
market  but  should  not  yet  introduce  it  at  this  stage.  This  concept  is  perceived  as  too  risky, 
hazardous, and premature. The animals can not be compared to products of animal origin they 
involve more health risks.  There are doubts if the system is feasible for terrestrial animals as it 
already shows problems with aquaculture. In addition, it could create further problems related 
to inability of the certification of specific health provisions for export of animals. A fear exist 
that placing on the market would suit only certain types of holdings or trade partners; while for 
the others it would represent a big additional burden, limiting them with the sourcing of animals 
and  national  movements.  On  the  other  hand  the  concept  is  well  perceived  from  the  animal 
welfare perspective, expecting the farms to obtain better conditions for animals. 

3.8. Differentiation or uniformity of trade rules and disease control measures on 

commercial and non-commercial farming  

The  majority  of  the  replies  support  differentiation  of  measures  for  commercial  and  non-
commercial holdings. However, a significant percentage of the replies argue that this will imply 
an increased risk of animal disease outbreaks and spreading. Discrepancies were also observed 
on the risk attached to non-commercial farming activities.  

-  - 
108

 
 
 
 
 
 
 
 
 
  
 
 
 
3.9. Animal health requirements for trade and import for certain animal species under 

Directive 92/65/EC 

Results of the consultation show a general support of stakeholders on the proposed approach by 
the Commission, however discrepancies were observed on the risks attached to these "special 
species" imports and on the level at which the exemptions should be granted.  

3.10. 

Emerging, re-emerging and exotic diseases 

Framework  AHL  should  provide  general  rules  for  different  groups  of  diseases  (like  vector 
borne  diseases,  highly  contagious  diseases  with  direct  transmission,  etc.).  Basic  EU  animal 
health  legislation  is  too  rigid  (difficult  to  change)  to  accommodate  all  emerging  and  re-
emerging diseases. It should take into consideration wildlife as a permanent reservoir of disease 
agents,  different  exotic  animal  species  and  pet  animals  that  might  introduce  new  diseases 
especially zoonotic agents. Vaccination policy should be less restrictive and the importance of 
vaccination  strengthened.  More  emphasis  should  be  given  to  vaccine  development  and 
innovation. 

3.11. 

Review and simplification of current rules on identification and registration 

of animals 

The  Commission's  approach  was  generally  supported.  However,  only  basic  principles, 
objectives and outcomes should be set in the AHL; excluding detailed provisions or rules for 
identification. Traceability is perceived as an imperative but it can be achievable with different 
means;  individual  identification  is  not  always  necessary.  Specificity  of  species  should  be 
considered  and  a  good  balance  of  efficiency,  feasibility  and  costs  should  be  established. 
Identification  and  registration  of  pet  animals,  zoo  animals  and  some  others,  was  largely 
perceived as a necessary step further for animal health and/or welfare reasons.  

3.12. 

Convergence of the EU legislation with international standards 

OIE convergence is by the majority welcomed and should apply for animal health and welfare. 
However,  the  current  EU  health  standards  should  not  be  lowered  where  the  EU  has  reached 
higher standard. Only few expressed the need to review current higher EU standards to see if 
they  can  be  adjusted  to  a  level  provided  for  in  international  standards.  When  creating  new 
measures,  higher  standards  than  the  OIE  can  be  introduced  only  if  scientifically  justified.  In 
these cases the EU should take a proactive role and all efforts should be engaged to reach the 
consensus  to  modify  the  relevant  international  standards.  EU  membership  in  the  OIE  is 
perceived as a beneficial step forward. Concept of aligning with international standards should 
not limit the onset of private standards at a higher level.  

3.13. 

Specific animal health conditions relating to imports  

General support to the Commissions' proposed approach was observed in the replies. Concerns 
were  expressed  on  the  fact  that  EU  operators  have  to  face  stricter  rules  than  international 
standards. Discrepancies on the level of detail of the legislation needed at EU level were also 
observed. 

-  - 
109

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
3.14. 

The definition of 'epidemiological unit' and 'holding' in EU legislation 

Although  there  was  a  general  agreement  to  the  proposed  approach  by  the  Commission,  the 
majority  of  replies  highlighted  the  difficulties  in  establishing  a  definition  of  epidemiological 
unit that could be adapted to all animal species and relevant diseases and the implications that 
this definition could have for movement registration and disease control measures.  

End  

-  - 
110

 
 
 
 
 
 
 
 
 
ANNEX VI  Summary of the questionnaire on artificial insemination 
and related issues 

EUROPEAN COMMISSION 
HEALTH AND CONSUMERS DIRECTORATE-GENERAL 

Directorate D - Animal health and welfare 
Unit D1 - Animal health and Standing Committees 

EU Animal Health Law – consultation process 

Commission staff working document 

Summary of the replies to Questionnaire on the potential impacts (economic and social) 
that the introduction of the "placing on the market" concept could have for semen 
collection and storage centres, embryo collection and production team 

Brussels, 10 September 2010 

This document does not necessarily represent the views of the Commission Services 

Please note that this document has been established for information and consultation purposes only. It 
has not been adopted or in any way approved by the European Commission and should not be regarded 
as representative of the Commission Services either. The European Commission does not guarantee the 
accuracy of the information provided, nor does it accept responsibility for any use made thereof. 

-  - 
111

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Summary of the replies to Questionnaire on the potential impacts (economic and social) 
that the introduction of the "placing on the market" concept could have for semen 
collection and storage centres, embryo collection and production teams 

The Commission, in the context of preparatory activities for the new EU Animal Health Law, launched 
a wide stakeholders' consultation, the so called "Annotated agenda for stakeholders' consultation". The 
intra-EU trade vs. the "placing on the market" concept was presented in this consultation with the aim to 
obtain the views of interested parties. 

A specific questionnaire addressed to producers of semen, ova and embryos was distributed to the Rep 
Vet group of COPA-COGECA. In this questionnaire operators were asked to express their views about 
the  "placing  on  the  market"  vs.  intra-EU  trade  question  and  to  provide  quantitative  data  that  would 
enable us to assess impacts of possible changes of the concepts to your respective sector. 

Replies  were  received  from  operators  of  several  Member  States  Belgium,  Czech  Republic,  France, 
Germany, Poland, Spain, Sweden, the Netherlands, Hungary and United Kingdom. Also operators from 
Norway and Switzerland replied to the questionnaire.  

Intra-EU trade / placing on the market concept 

(cid:190) 

Problem dimension 

Current  animal  health  provisions  for  commercial  movements  of  live  terrestrial  animals  and  control  of 
their diseases are largely based on the Intra-EU trade concept. This concept is based on fulfilment of the 
animal  health  requirements  established  in  the  EU  legislation  and  subsequent  certification  prior  to  the 
movement  of  live  animals  between  Member  States.  The  EU  legislation  allows  Member  States  to 
maintain, to a certain extent, animal health rules on national movements in live animals, provided that 
these national rules comply with the relevant provisions on the control of diseases that are regulated at 
EU level.  

The concept of intra-EU trade is different from the  one of ‘placing on the market’, which is currently 
used in food safety legislation for products of animal origin (hygiene package and for live aquaculture 
animals). In this case the general rule is that the products or animals in question have to comply with the 
same harmonised standards when placed on the market, regardless whether this is a national market or a 
market of another Member State(s). For example, Directive 2006/88/EC introduces certain prerequisites 
for  placing  on  the  market  animals  and  products  obtained  from  aquaculture  production,  such  as  an 
obligation to hold an authorisation, recording and traceability obligations and obligations to implement 
good hygiene practice, in addition to the animal health surveillance scheme.  

(cid:190) 

Potential solutions / options  

Option 1: 

Similarly  to  the  approach  already  introduced  for  aquaculture  animals  in  Directive  2006/88/EC,  the 
concept  of  intra-EU  trade  in  live  terrestrial  animals  would  be  replaced  by  the concept  ‘placing on  the 
market’. 

There are two important sets of requirements to be met to support this option: 

•  basic  standards  for  holding  of  origin,  and  prerequisites  for  authorisation  such  as  good  hygiene 
practices  (biosecurity)  and  surveillance  obligation  on  farms  regardless  of  the  destination  of  the 
animals being dispatched (within the same Member State or in another Member State), and 

• 

standards  for  accepting  animals  into  the  holding,  region,  or  zone  at  destination,  taking  into 
consideration  the  animal’s  health  status,  and  biosecurity  and  surveillance  information.  This 
approach would shift more responsibilities onto operators (animal keepers) and standards could be 
better met if a ‘HACCP approach’ were put in place in primary production, too. 

However,  flexibility  could  be  introduced  to  ensure  that  these  additional  standards  do  not  lead  to  an 
additional burden on those operators who move animals only locally. 

-  - 
112

 
 
 
 
 
 
Do you support this preliminary approach?  

-  Agree:   
-  Neutral: 
-  Strongly disagree: 
-  Not relevant :   

3 representatives (plus NO and CH) 
3 representatives 
2 representatives 
1 representative 

Option 2: 

Maintain the concept of intra-EU trade as the basis for regulating commercial movements of terrestrial 
animals between Member  States. However, the implementation of enhanced biosecurity measures  and 
surveillance schemes and subsequent trade facilitation mechanisms should, in principle, narrow the gaps 
between the rules governing intra-EU trade and those on national movements in live terrestrial animals, 
and eventually make it possible in the long term to move towards a ‘placing on the market’ system for 
live terrestrial animals, too.  

Do you support this preliminary approach?  

-  Agree:   
-  Neutral: 
-  Disagree: 

2 representatives 
4 representatives 
1 representative 

Comments:  

Representatives in favour of the first option are from Member States where same rules apply for intra-
EU trade and national trade. No changes are expected for national trade while for intra-EU trade they 
perceive simplification of procedures as an advantage.  

Opinions  against  the  first  option  are  based  on  the  difficulties  for  small  farms  to  make  the  necessary 
investments  for  complying  with  all  the requirements  to  be  authorised  for  intra-EU  trade.  Concerns  on 
the measures to be taken in case of an epidemic disease spread were also expressed.  

For  some,  current  situation  creates  unfair  competition  (different  requirements  for  trade  within  the 
Member States depending on the Member State).  

Can you specify the main differences between the national and EU approved centres (if relevant)? 

Member  States  applying  the  same  standards  are:  Czech  Republic,  France,  Germany  (almost,  certain 
differences  for  horses),  Poland,  Spain,  and  the  Netherlands  (but  for  the  Netherlands  representative  it 
would  be  unacceptable  to  apply  the  same  rules  to  storage  tanks  for  use  in  the  same  farm  where 
collected).  

Member States with different rules for intra EU trade and trade within the Member State are:  

- 

- 

Hungary:  different  requirements  for  black  and  white  areas.  For  them,  applying  intra-EU  trade 
rules  to  national  movements  would  imply  significant  investments  for  the  farms  that  cannot  be 
afforded, due to the low profitability of the activity. They estimate decrease on AI for pigs.  

UK: semen for national use is subjected to lower standards than semen for intra-EU trade. The 
use of semen collected and stored in the same holding is common practice and is not regulated.  

-  - 
113

 
 
 
 
 
 
 
Could you estimate the possible economic and social impacts of introducing the concept of placing 
on the market? (Meaning that in order to trade nationally the centres would have to comply with 
the same requirements as those for intra-EU trade?) 

Special rules would have to be provided for semen produced before the legislative changes. 

For  artificial  insemination  within  the  herd  or  farms  it  seems  disproportionate  to  apply  the  standards 
required for intra-EU trade but on the other hand full traceability has to be ensured.  

Questions on how additional guarantees will be applied in a credible way. 

Semen for exports to third countries will still be subjected to certification.  

Porcine: concerns were expressed on the use of antibiotics and PRRS positive boar stations. 

Conclusion:  

Placing  on  the  market  seems  more  feasible  for  bovine  and  porcine  semen.  However,  this  view  is  not 
shared  by  all  contributors,  as  in  certain  Member  States  placing  on  the  market  could  also  have  a 
considerable  impact  for  bovine  an  porcine  semen  use.  For  the  rest  of  the  species  negative  impacts  on 
society, the economy and biodiversity are expected due to the need for investments needed to change 
protocols  and  equipment  and  the  fact  that  valuable  genetic  material  will  be  lost  because  of  non-
compliance with EU standards.  

-  - 
114

 
 
 
 
 
 
 
 
 
 
 
 
 
DATA  

Estimate of the number of semen collection centres approved for intra-EU trade and the number 
of semen collection centres approved/authorised only for national trade within your Member State 

BELGIUM 

Species 

Intra-EU 

National 

Porcine 
Bovine 
Sheep 
Goats 
Rabbits 
Bees 
Equine 
Total 

CZECH REPUBLIC 

Species 

Intra-EU 

Porcine 
Bovine 
Sheep 
Goats 
Rabbits 
Bees 
Equine 
Total 

FRANCE 

Porcine 
Bovine 
Sheep 
Goats 
Rabbits 
Bees 
Others 
Total 

Species 

Intra-EU 

3
3   

16
22

20
8

5
33

23
32
11
2

68

National 

National 

GERMANY 

Species 

Intra-EU 

National 

Porcine 
Bovine 
Sheep 
Goats 
Rabbits 
Bees 
Equine 
Total 

38
37

2  

139
216

-  - 
115

30

1

102
133

20
8

5
33

23
32
11
2

68

11
4

92
107

 
 
 
 
 
 
 
 
  
  
  
  
  
  
  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
POLAND 

Porcine 
Bovine 
Sheep 
Goats 
Rabbits 
Bees 
Others 
Total 

SPAIN 

Porcine 
Bovine 
Sheep 
Goats 
Rabbits 
Bees 
Equine 
Total 

SWEDEN 

Porcine 
Bovine 
Sheep 
Goats 
Rabbits 
Bees 
Others 
Total 

Species 

Intra-EU 

National 

Species 

Intra-EU 

12  
10  

22

37
9
8
7

21
82

National 

Species 

Intra-EU 

National 

3  
2

5

THE NETHERLANDS 

Species 

Intra-EU 

National 

Porcine 
Bovine 
Sheep 
Goats 
Rabbits 
Bees 
Equine 
Total 

5
5
0  
0  
0  
0  
22
32

-  - 
116

1

1

0
0
0
0
0
0
0
0

1

1

0
0

80
80

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
HUNGARY 

Species 

Intra-EU 

National 

Porcine 
Bovine 
Sheep 
Goats 
Rabbits 
Bees 
Others 
Total 

UNITED KINGDOM 

6
3  
1  

1  
1  

12

Species 

Intra-EU 

National 

Porcine 
Bovine 
Sheep 
Goats 
Rabbits 
Bees 
Equine 
Total 

14
9
3  

22  
48

4

4

1
1

2

-  - 
117

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Estimate  of  the  number  of  semen  storage  centres  approved  for  intra-EU  trade  in  your  Member 
States  and  the  number  of  semen  storage  centres  approved/authorised  only  for  national  trade  in 
your Member State 

BELGIUM 

Species 

Intra-EU 

National 

Porcine 
Bovine 
Sheep 
Goats 
Rabbits 
Bees 
Equine 
Total 

CZECH REPUBLIC 

Species 

Intra-EU 

5
4

16
25

11

11

National 

41
5
1

80
127

11

11

67
11
2

80

Porcine 
Bovine 
Sheep 
Goats 
Rabbits 
Bees 
Others 
Total 

FRANCE 

Porcine 
Bovine 
Sheep 
Goats 
Rabbits 
Bees 
Others 
Total 

Species 

Intra-EU 

National 

23 more than 23 
67
11
2

103

GERMANY 

Species 

Intra-EU 

National 

Porcine 
Bovine 
Sheep 
Goats 
Rabbits 
Bees 
Others 
Total 

no data 
20 no data 
no data 
no data 
no data 
no data 
no data 
20 no data 

-  - 
118

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
POLAND 

Porcine 
Bovine 
Sheep 
Goats 
Rabbits 
Bees 
Others 
Total 

SPAIN 

Porcine 
Bovine 
Sheep 
Goats 
Rabbits 
Bees 
Equine 
Total 

SWEDEN 

Porcine 
Bovine 
Sheep 
Goats 
Rabbits 
Bees 
Others 
Total 

Species 

Intra-EU 

National 

Species 

Intra-EU 

Species 

Intra-EU 

National 

1

1

0

0
0

National 

all DYI + ai co-ops

12  
10  

22

21

1
22

4
7

11

THE NETHERLANDS 

Porcine 
Bovine 

Sheep 
Goats 
Rabbits 
Bees 
Others 
Total 

Species 

Intra-EU 

National 

1  

all inseminators and private 
farmers for DYS AI 

7
0  
0  
0  
0  

8  

-  - 
119

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
HUNGARY 

Species 

Intra-EU 

National 

Porcine 
Bovine 
Sheep 
Goats 
Rabbits 
Bees 
Others 
Total 

UNITED KINGDOM 

6  

6

Species 

Intra-EU 

National 

Porcine 
Bovine 
Sheep 
Goats 
Rabbits 
Bees 
Others 
Total 

4 no data 

10 4 (and on-farm) 

3 no data 

17

0

0

Estimate of the number of embryo collection and production teams approved for intra-EU trade 
in  your  Member  States  and  the  number  of  embryo  collection  and  production  teams 
approved/authorised only for national trade within your Member State 

BELGIUM 

Species 

Intra-EU 

National 

Porcine 
Bovine 
Sheep 
Goats 
Rabbits 
Bees 
Equine 
Total 

CZECH REPUBLIC 

4  

12  
16

Species 

Intra-EU 

National 

Porcine 
Bovine 
Sheep 
Goats 
Rabbits 
Bees 
Others 
Total 

3

3

-  - 
120

0

3

3

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
FRANCE 

Porcine 
Bovine 
Sheep 
Goats 
Rabbits 
Bees 
Others 
Total 

Species 

Intra-EU 

National 

1
37
2
2

42

GERMANY 

Species 

Intra-EU 

National 

Porcine 
Bovine 
Sheep 
Goats 
Rabbits 
Bees 
Equine 
Total 

POLAND 

Porcine 
Bovine 
Sheep 
Goats 
Rabbits 
Bees 
Others 
Total 

SPAIN 

Porcine 
Bovine 
Sheep 
Goats 
Rabbits 
Bees 
Equine 
Total 

2 no data 
40 no data 
6 no data 
no data 
no data 
no data 
10 no data 
58 no data 

Species 

Intra-EU 

National 

4  

4

13

2
15

National 

Species 

Intra-EU 

-  - 
121

1
37
2
2

42

0

0

0
0

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
SWEDEN 

Porcine 
Bovine 
Sheep 
Goats 
Rabbits 
Bees 
Others 
Total 

Species 

Intra-EU 

National 

research 
3 a couple 

THE NETHERLANDS 

Species 

Intra-EU 

Porcine 
Bovine 
Sheep 
Goats 
Rabbits 
Bees 
Equine 
Total 

HUNGARY 

National 

3

0
8

3
11

Species 

Intra-EU 

National 

Porcine 
Bovine 
Sheep 
Goats 
Rabbits 
Bees 
Equine 
Total 

UNITED KINGDOM 

2

2

Species 

Intra-EU 

National 

Porcine 
Bovine 
Sheep 
Goats 
Rabbits 
Bees 
Others 
Total 

23

23

-  - 
122

0

0
20

30
50

1

1

16

16

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
ANNEX VII Vaccination policy 

EU vaccination policies – background and additional assessment 

Part 1 

I. 

BACKGROUND OF THE ANIMAL VACCINATION POLICY WITHIN THE EU  

I.1 

Introduction 

The EU animal health policy has been developed progressively and supported by harmonised 
legislation since the early 1960s. This policy is fundamental to ensuring the health and welfare 
of animals, profitability for farmers, food safety, the functioning of the EU single market and 
the possibility of exporting animals and animal products. 

EU strategies for the control of major animal diseases of food producing animals often rely on 
strict surveillance and rapid containment of disease outbreaks. This is achieved by means of a 
'stamping out' policy consisting in the culling of the animals in the infected and other at-high 
risk farms. In this way the confirmed and possible sources of infection are eliminated and the 
disease  agent  is  eradicated.  This  strategy  is  suitable  for  diseases  which  occur  rather 
sporadically, but which are easily spread from  farm to farm and across state borders, such as 
classical swine fever (CSF), foot-and-mouth disease (FMD) and Avian Influenza (AI). By using 
the  stamping  out  policy,  the  affected  MS  can  quickly  regain  their  "disease  free  status".  For 
these diseases, the EU policy foresees only a rather limited use of vaccines, mainly in cases of 
emergency. In fact, the Commission has put in place vaccine banks for FMD and CSF, so that 
vaccines could be made rapidly available to MS in case of need. 

Conversely,  regular  vaccination  against  other  diseases  is  widely  applied  in  the  MS  in 
accordance  with  EU  disease  control  legislation.  For  example,  vaccination  against  Brucellosis 
has proven to be an effective tool not only to control and facilitate its eradication in livestock 
but also to protect human health, as the disease can be transmitted to humans. Another example 
is  the  substantial  investment  of  resources  in  the  vaccination  of  wildlife  against  rabies.  This 
significantly improved the rabies situation in Europe, reducing risk to human health and making 
travelling with pets easier.  

Vaccination is used in accordance with the EU legislation to control and eradicate diseases with 
large  production  losses,  such  as  Aujeszky's  Disease,  Infectious  Bovine  Rhinotracheitis  (IBR), 
etc.  

For  many  diseases,  vaccination  of  farmed,  sports  or  pet  animals  is  not  regulated  by  EU 
legislation and it is usually applied because of industry standards or veterinary recommendation 
e.g. equine influenza, equine herpes virus, parvovirosis for dogs, etc.. 

I.2.  The reasons behind the EU "non-vaccination" policy against major animal diseases 

Before the strategies against major animal diseases were established at EU level in the last few 
decades,  MS  routinely  using  vaccination  against  diseases  such  as  CSF  and  FMD  had  faced 
considerable  problems  in  trade  with  other  MSs  and  third  countries  which  were  not  applying 
vaccination  and  were  considered  as  "free  from  the  disease".  Trade  in  vaccinated  animals  and 
their products was considered unsafe, because vaccinated animals – although not showing signs 
of disease - can still become infected with the virus in the field, leading to a "masked infection".  

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In  the  late  '80s  EU  legislation  was  therefore  adopted  that  included  the  prohibition  of 
prophylactic vaccination against FMD and CSF. The Single Market  in cattle, pigs, sheep and 
goats  and  their  products  was  established  in  the  early  '90s  thanks  to  this  "non-vaccination" 
policy  and  to  the  improvement  in  the  disease  situation,  leading  to  the  achievement  of  the 
"disease  free  status"  across  the  EU  (except  the  areas  where  limited  outbreaks  of  disease 
occurred, which were however "regionalized"). In this way EU farmers could trade more easily 
and transparently not only within the EU but also with third countries, leading to considerable 
economic benefits. 

Resources  were  therefore  focused  on  the  prompt  eradication  of  new  introductions  of  diseases 
when  they  occurred,  rather  than  investing  in  very  extensive  and  expensive  vaccination 
campaigns and surveillance of vaccinated populations.  

I.3.  The impact of major animal health crises on the "non-vaccination" policy 

At the end of the '90s and beginning of the 2000s serious animal disease outbreaks in the EU 
(CSF in 1997-98 and 2001-02, FMD in 2001, AI in 1999 and 2003) resulted in the destruction 
of many millions of animals, many on the grounds of prevention of disease spread rather than 
because  they  were  infected,  in  accordance  with  the  'stamping  out'  policy.  This  raised  serious 
economic  and  ethical  concerns.  Those  crises  highlighted  the  need  to  review  disease  control 
policies, including the approach to vaccination. 

The serious problems encountered in controlling those outbreaks were caused by a combination 
of factors, including:  

- 

- 

- 

the  dramatic  raise  of  the  global  trade  (legal  and  illegal)  in  animals  and  their  products, 
resulting in an increased risk of introduction of diseases to the EU and their spread within 
the EU; 

the difficulty in controlling diseases in areas at higher risk due to a high density of animals 
and/or insufficient biosecurity measures at farm level; 

the presence of diseases in the wild fauna (e.g. CSF in wild boar, AI in wild birds) in the 
EU  and/or  in  many  neighbouring  countries,  combined  with  increased  contact  between 
wildlife and domestic animals; 

- 

insufficient disease preparedness in the MS. 

Several corrective actions have been taken in the last years to address these problems both at 
EU and MS level, including a more flexible approach to vaccination, with results that can be 
considered by and large positive. For example, as from the early 2000s the EU has supported 
the development of a vaccination strategy of wild boar against CSF, by means of legislation and 
funding. This strategy has led to a major improvement of the disease situation in Europe, both 
in wild and domestic pigs. 

Nevertheless, legislation adopted after 2000 (on BT in 2000, on CSF in 2001, FMD in 2003 and 
AI in 2005) confirmed that vaccination is not to be routinely used against these diseases, as the 
benefits would not justify the costs. However, there is now a wider possibility than in the past 
to  use  vaccines,  both  as  an  emergency  response  to  outbreaks  which  might  get  out  of  control 
and, for some diseases, namely AI and Bluetongue, also as a prevention tool.  

This revised approach was also made possible by technical developments such as better quality 
and purity of vaccines, new marker vaccines (which allow diagnostic tests to detect infection in 

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vaccinated  animals)  and  diagnostic  tests  allowing  more  effective  surveillance  in  vaccinated 
populations. At the same time, legislation on trade in vaccinated animals and their products has 
become  more  flexible  and  less  punishing  when  vaccination  is  used.  Indeed,  in  certain  cases, 
like  BT  (and  also  rabies),  vaccination  is  envisaged  by  the  legislation  as  a  tool  for  facilitating 
movement and trade of animals, if certain conditions are met.  

It  must  be  mentioned,  however,  that  despite  the  additional  flexibility  introduced  in  the 
legislation on the possible use of vaccines, there is still limited experience of their emergency 
use for some diseases (CSF, FMD, AI). This makes difficult or even prevents its use by MS. 
Fears  also  exist  that  other  MSs  will  not  accept  the  flexibility  of  legislation  allowing  the 
application of only minimal trade restrictions on products originating from vaccinated animals. 
In  this  regard,  some  MSs  have  traditionally  shown  a  quite  negative  attitude  vis-à-vis 
vaccination. Even if this is overcome, traders may still be cautious of possible trade restrictions 
from  third  countries,  while  retailers  may  refuse  to  buy  products  from  vaccinated  animals,  as 
they are also concerned about negative reactions of consumers (although these reactions would 
not  be  justified  by  the  scientific  evidence).  All  this  would  finally  affect  the  decision  (that  is 
largely up to the affected Member State(s)) to use or not vaccines in case of an emergency. This 
is true of CSF and FMD in particular. 

I.4. 

International standards and impact on international trade 

The Terrestrial Code of the World Organisation for Animal Health (OIE) is revised every year. 
With respect to vaccination, when an approved vaccine exists its use is permitted, and the code 
only requires that the health certificates accompanying animals contain the relevant information 
about any vaccinations. In some cases laboratory testing of animals is required and/or that the 
surveillance of the territory is adapted according to the vaccination policy adopted.  

EU legislation largely reflects OIE standards on vaccination and its effects on trade in animals 
and  animal  products.  However,  third  countries  may  be  very  reluctant  to  fully  accept  OIE 
standards,  even  when  the  OIE  (in  parallel  with  the  EU)  has  been  very  open  and  rapid  in 
adapting them to new technical developments.  

The  positions  of  trading  partner  countries  regarding  vaccination  policies  and  their  impact  on 
trade  are  widely  diverse,  depending  on  the  country  and  on  the  disease.  It  can  be  said  that 
vaccination  still  increases  the  risk  of  trade  barriers  being  applied  (even  if  unjustified).  The 
barriers  that  are  technically  justified  and  supported  by  EU  legislation  and  OIE  standards  are 
usually not insurmountable. However, in some circumstances they may be sufficiently severe to 
discourage vaccine use, particularly in MSs which have strong interests in export. 

II. ADVANTAGES AND DISADVANTAGES OF VACCINATION 

In  summary,  on  the  bases  of  the  lessons  learned  in  the  last  two  decades,  the  advantages  and 
disadvantages  of  vaccination  as  a  control  tool  against  major  epidemic  diseases  can  be 
summarised as follows: 

Advantages: 

a)  Reduction of clinical disease and mortality and associated losses; 

b)  Reduction of risk of infection; 

c)  Reduction of virus excretion from vaccinated animals and spread to other animals/farms; 

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d)  Possible reduced risk of disease outbreaks of major size, of massive killing of animals and 
of  direct  and  indirect  economic  losses  (although  the  limited  experience  in  the  emergency 
use of vaccines does not allow definite conclusions to be drawn). 

Disadvantages: 

a)  Vaccination may be technically challenging to administer and require several injections to 
build up immunity (e.g. cumbersome individual vaccination of large numbers of poultry or 
vaccination of dangerous animals);  

b)  The  immune  response  induced  by  vaccination  is  not  always  fully  satisfactory  so  it  is 

possible for some vaccinated animals to still get infected; 

c)  It may mask the occurrence of infection and thus delay its detection;  

d)  It may require vaccination of a high number of animals to establish sufficient protection of 

the population ('herd immunity'); 

e)  It  may  induce  a  false  sense  of  security  and  thus  encourage  relaxation  of  biosecurity  and 

surveillance measures; 

f)  The  vaccine  strain  may  not  always  match  the  virus  in  circulation  –  e.g.  there  are  several 
different FMD virus strains which will make vaccination expensive, when several vaccine 
strains are needed. 

g)  Where  vaccination  does  not  prevent  the  possibility  of  infection,  a  suitable  surveillance 

programme must be installed to prove absence of infection. 

III.  PRACTICAL  EXAMPLES  OF  THE  EU  POLICY  DEVELOPMENTS  ON 

VACCINATION  

The  examples  of  AI,  ND,  CSF,  FMD  and  BT  are  used  below  to  demonstrate  how  the  EU 
legislation  foresees  different  vaccination  possibilities  according  to  the  nature  of  the  disease 
agent,  available  vaccines,  acceptable  vaccination  policies  and  consequences  for  economy  and 
trade; and how this legislation has evolved in the last decade. 

III. 1.  Avian Influenza and Newcastle Disease 

The  approach  to  vaccination  against  AI  and  ND,  the  two  most  important  highly  contagious 
poultry diseases in the world, is entirely different. 

Vaccination against AI is used only very seldom. This is due to a number of factors  

i) until 2000, AI was a very rare disease in the EU and therefore a preventive vaccination 
had never been justified;  

ii)  AI  vaccination  prevents  the  disease  but  does  not  fully  protect  against  infection.  This 
could  lead  to  undetected  virus  spread;  therefore  costly  surveillance  is  required  to  detect 
infected animals in a vaccinated population;  

iii) vaccines that would allow an easy and cheap application are not yet available (currently 
injection of each individual bird is needed); and  

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iv) the use of a vaccine may lead trading partners to impose trade restrictions  

Preventive routine vaccination against ND is used widely and fully supported by the industry. 
This is due to a number of factors:  

i) several ND outbreaks occurred in various MS, causing serious losses;  

ii) the risk of continuous spill-over from wild birds into domestic poultry farms;  

iii) cheap, effective vaccines are available; and  

iv) the OIE Code does not establish significant trade restrictions in relation to vaccination. 

The different approach towards these two poultry diseases is reflected in the requirements for 
intra-EU trade and imports into the EU. 

III.2. Classical Swine Fever 

Following  the  CSF crises of 1997-98, the experience gained through oral vaccination of wild 
boars against CSF (mainly in Germany) and the development of marker vaccines for domestic 
pigs  allowed  more  flexibility  towards  vaccination  in  EU  legislation  (Council  Directive 
2001/89/EC). 

If  wild  boar  are  vaccinated  against  CSF,  EU  legislation  does  not  impose  trade  restrictions  on 
unvaccinated domestic pigs and their products in addition to the restrictions normally applied in 
an area where the disease occurs in the wild boar. Trade in pig meat is not restricted.  

As  regards  vaccination  of  domestic  pigs,  Directive  2001/89/EC  introduced  the  use  of  marker 
vaccines and a discriminatory test which were developed in the late 1990s/early 2000s. 

If  a  marker  vaccine  is  used,  which  allows  identification  of  infected  animals  in  a  vaccinated 
population; trade in pig meat from vaccinated animals may regularly take place, provided that 
the herd of origin is shown to be disease-free via discriminatory testing.  

III.3.  Foot and mouth disease (FMD) 

In the early '90s, after FMD was eradicated from Europe, the EU adopted a policy prohibiting 
prophylactic vaccination against FMD. For this disease, in addition to the policy considerations 
explained in chapter 1 above, the adoption of a policy of prophylactic vaccination posed (and 
still poses) serious technical problems, notably because  of  the  several  distinct  strains  of  virus 
existing outside Europe. This causes significant uncertainties as regards which vaccine strains 
ought to be used for such vaccination.  

For  these  reasons,  following  the  FMD  crisis  in  2001,  the  prohibition  of  prophylactic 
vaccination was confirmed, even though new FMD control legislation was adopted (Directive 
2003/85/EC) which moved emergency vaccination further to the forefront of the disease control 
measures.  MSs  had  to  review  their  contingency  plans  to  be  better  prepared  for  emergency 
vaccination. MS have retained a substantial degree of sovereignty over the decision whether to 
employ  vaccination  or  not;  however  they  now  have  the  legal  obligation  to  put  in  place  all 
necessary  arrangements  for  a  possible  emergency  vaccination  at  the  very  early  stage  of  an 
outbreak and not wait until it becomes evident that the outbreak is out of control. 

However, so far FMD emergency vaccination has not been used, e.g. during the UK 2007 FMD 
outbreak or the BG 2011 outbreak, as in both cases it was possible to successfully contain the 

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disease in small areas and then eradicate it by means of a limited stamping out of the infected 
animals and those at high risk.  

III.4. Bluetongue 

BT  is  an  insect  transmitted  disease  of  wild  and  domestic  ruminants;  its  expansion  in  the  EU 
follows  the  climate  changes  observed  over  the  last  years.  In  the  last  decade  this  disease  has 
shown  a  tendency  to  become  endemic  in  southern  Europe;  however,  it  is  also  able  to  cause 
major epidemics in central and even northern Europe, as observed in 2007-2008. 

Given that it is transmitted by insects this disease cannot be effectively controlled by stamping-
out. Vaccination is the most efficient veterinary measure that can be implemented in an infected 
territory, together with surveillance. The wide use of the vaccine is explicitly foreseen by EU 
legislation. Whether to use vaccines or not is in principle up to the MS. However, harmonised 
vaccination  programmes  are  preferred  and  if  EU  co-financing  is  requested,  a  harmonised 
approach is required. 

Vaccination can be used for the purpose of controlling the disease, to facilitate safe trade under 
certain  conditions  or  even  with  the  objective  of  eradicating  the  disease  from  limited  regions. 
Vaccination  is  currently  possible  after  virus  introduction  in  an  area,  while  it  is  forbidden  in 
disease-free  areas  because  of  the  safety  problems  posed  by  the  "live-attenuated"  vaccines. 
These  consist  in  live  although  attenuated  viruses  which  may  spread  from  vaccinated  to 
unvaccinated  animals  and  cause  undesired  side  effects.  Newly  developed  "inactivated  virus" 
vaccines  are  undoubtedly  safer  than  the  "live-attenuated"  ones  and  are  the  best  choice  when 
available. However, the availability of inactivated vaccines is for the moment limited to only a 
few serotypes of the BT virus. 

In  2010  the  Commission  proposed  a  change  in  legislation  to  facilitate  the  use  of  inactivated 
vaccines  and  also  make  their  use  possible  in  disease-free  areas.  The  proposal  is  still  under 
discussion in the European Parliament and Council. 

IV. FUTURE APPROACHES FOR THE AHL  

The  CAHP  evaluation  has  already  addressed  the  issues  of  vaccination  and  the  relevance  of 
vaccine banks. It also noticed that although significant funds were spent on this issue, MS very 
seldom  used  vaccination  during  crises.  The  AHS  has  clearly  emphasised  the  need  for  better 
preparedness  for  animal  disease  related  emergencies,  which  must  be  dealt  with  swiftly  and 
effectively  by  means  of  an  agreed  approach.  Taking  fast-track  decisions  by  the  Commission 
and MS for emergency action is of high value in limiting and controlling animal-related threats 
at EU level. 

In response to ethical concerns and the growing demand for improved animal welfare, the EU 
has  already  moved  to  a  more  flexible  approach  towards  vaccination,  as  well  as  improving  its 
policy to control major animal diseases. One of the objectives of the AHS is to reduce the risk 
of  massive  culling  and  destruction  of  animals.  However,  different  elements  (e.g.  vaccine 
availability  and  effectiveness,  demands  for  validated  tests  able  to  differentiate  infected  from 
vaccinated  animals,  OIE  international  guidelines  and  possible  trade  implications,  cost-
effectiveness  analysis,  possible  risks  related  to  the  use  of  vaccines)  have  to  be  considered 
before a decision is taken as regards the use of vaccines. This decision can therefore be taken 
only on a case-by-case basis, in line with the principles agreed at EU level. 

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In  line  with  the  AHS's  Action  Plan,  EU  vaccine  banks  for  emergency  situations  shall  be 
strengthened  in  addition  to  those  already  existing  for  FMD  and  CSF.  An  expert  group  has 
produced a "policy paper on the necessity of EU vaccine banks". It recommended EU vaccine 
banks  for  five  major  diseases,  namely  FMD,  AI,  CSF,  African  Horse  Sickness  and  BT.  An 
extensive  consultation  on  this  subject  with  the  CVOs  took  place  and  the  results  of  both 
activities are presented in Part 2 of this Annex. 

The  "added  value"  of  vaccine  banks  established  at  EU  level  is  widely  recognised  and  it  is 
therefore likely that follow-up to the recommendations of the policy paper will be welcomed by 
MS and other stakeholders.  

Objectives 

Following  the  commitments  of  the  AHS,  EU  legislation  must  establish  a  comprehensive  and 
flexible legal framework for vaccination policy and vaccine banks in the EU that could be used 
for  different  diseases  and  circumstances,  taking  into  account  the  following  aspects  for  each 
different disease: 

-  Nature  of  disease  agents  and  related  availability  and  reliability  of  vaccines,  including 

availability of valid tests to differentiate vaccinated from infected animals 

-  Susceptible animal species and their natural environment (domesticated, wild animals) 

-  Purpose of vaccination: preventive (prophylactic) or emergency vaccination 

-  Possible risks related to vaccine use 

-  Different approaches and control measures for endemic and exotic diseases, considering 

economic implications 

-  Relevance of the disease for EU intervention in terms of the importance of the disease 
(disease  categorisation)  or  animal  categories  (livestock,  farmed  animals  versus  pet 
animals and animals kept for hobby and sport / recreation) 

-  Emergency preparedness: need for vaccine bank at EU level 

-  Ethical considerations concerning stamping out eradication measures 

-  Consumers acceptance of products originating from vaccinated animals 

-  Cost-effectiveness analysis (including vaccination costs). 

Policy options on vaccination: 

A.i.  AHL  provides  a  single  vaccination  policy  for  all  diseases  and  provides  a  legal  basis  for 
vaccine banks. 

A.ii. AHL provides a single vaccination policy for all diseases and doesn't provide a legal basis 
for vaccine banks. 

Both options A.i. and A.ii. fit most comfortably into of option 5 in the main impact assessment 
– a prescriptive legal framework.  

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B.i. AHL sets up a flexible legal framework for vaccination, providing possibilities for different 
approaches to be used for different diseases under different circumstances and provides a legal 
basis for vaccine banks.  

B.ii.  AHL  sets  up  a  flexible  legal  framework  for  vaccination,  providing  possibilities  for 
different  approaches  to  be  used  for  different  diseases  under  different  circumstances  and  does 
not provide a legal basis for vaccine banks. 

Both  options  B.i.  and  B.ii.  are  possible  sub-sets  of  option  4  in  the  main  impact  assessment, 
providing a flexible legal framework.  

C. AHL shall not set the vaccination policy at all.   

Assessment of impacts: 

Options  A.i.  and  A.ii.  AHL  provides  a  single  vaccination  policy  for  all  diseases,  with  or 
without a legal basis for vaccine banks. 

Following the information, analysis and examples provided in sections 1 to 3 above it is very 
clear  that  a  single  vaccination  policy  valid  for  all  diseases  cannot  exist.  This  is  for  many 
reasons, for example; the differences amongst diseases and their appearance or absence in the 
EU,  vaccination  possibilities,  vaccine  development  and  availability,  the  relevance  of  diseases 
for EU intervention, different uses of animals, economic consequences, ethical considerations, 
and so on. To provide one single policy would be nonsense.  

B.i.  AHL  sets  up  a  flexible  legal  framework  for  vaccination,  providing  possibilities  for 
different approaches to be used for different diseases under different circumstances and 
provides a legal basis for vaccine banks 

EU legislation on vaccination should be rapidly adapted to new developments, including new 
scientific evidence and experience gained with disease control. Furthermore, the EU legislation 
would  take  into  account  the  divergence  of  situations  and  approaches  for  vaccination 
possibilities. Vaccination against major animal diseases shall remain flexible, giving the MS the 
clear possibility of vaccinating and the responsibility to decide to do so when it is feasible and 
desirable.  

EU  rules  must  also  foresee  the  possibility  for  a  rapid  adaption  to  take  account  of  technical 
developments  of  new  vaccines  and  diagnostic  tests.  An  inability  to  quickly  include  new 
available tools due to an inflexible and outdated legal framework would put the credibility of 
the EU in cases of emergencies at significant risk.  

As regards the lack of consumer acceptance of products from vaccinated animals, the EU legal 
framework cannot solve this issue, but can contribute to better understanding of the safety and 
benefits of a well-implemented vaccination policy. EU intervention should be limited to major 
diseases, taking into account disease categorisation.  

Emergency  preparedness  can  only  be  achieved  if  a  clear  legal  basis  for  vaccine  banks  is 
provided for the diseases on a case-by case basis, where this is considered necessary. 

B.ii.  AHL  sets  up  a  flexible  legal  framework  for  vaccination,  providing  possibilities  for 
different approaches to be used for different diseases under different circumstances and 
does not provide a legal basis for vaccine banks. 

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As for option B.i, the possibility of vaccination would be available, decisions on its use left to 
the MS, and a flexible approach is applied but no legal basis for vaccine banks is provided. This 
omission would compromise the EU emergency preparedness and ability to react quickly. 

C. AHL shall not set the framework for vaccination policy at all.   

To withdraw any kind of EU framework for vaccination policy would be extremely unpopular 
amongst the MS and other stakeholders. This option does not uphold the objectives of the AHS 
which confirmed the value of a coherent approach at EU level. 

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Table VII.1:    Pros and Cons of Options Considered 

Option C 

(cid:131)  No interference from legislation 
(cid:131)  Full flexibility for the MS and full 

freedom of choice for animal keepers 

Option B.i 
(cid:131)  EU approach ensured 
(cid:131)  Flexible legal framework for 
vaccination possibilities 
(cid:131)  Measures can be adjusted to 

changed circumstances, different 
diseases and vaccine 
developments 

(cid:131)  Flexibility for the MS ensured; 
quite broad freedom of choice 
ensured for animal keepers 
(cid:131)  Better emergency preparedness 
(cid:131)  Better availability of vaccines 
(cid:131)  Costs for the MS can be lower (no 
need for national vaccine banks) 

Option B.2 
(cid:131)  EU approach partially ensured 
(cid:131)  Flexible legal framework for 
vaccination possibilities 
(cid:131)  Measures can be adjusted to 
changed circumstances, 
different diseases and vaccine 
developments 

(cid:131)  Flexibility for the MS ensured; 
quite broad freedom of choice 
ensured for animal keepers 
(cid:131)  In short term lower cost for the 
reasons of absence of vaccine / 
antigen banks  

(cid:131)  Costs of vaccine banks at EU 
level (purchase, maintenance) 
(cid:131)  Freedom of choice for animal 
keepers is  limited to some 
diseases (harmonised EU 
intervention)  

(cid:131)  Difficult availability of 

vaccines 

(cid:131)  Weaker emergency 

(cid:131)  AHS objectives not met 
(cid:131)  Possible negative impact on health 

situation in the EU 

preparedness due to lack of  
vaccine banks 

(cid:131)  Consequential trade implications 
(confidence of trade partners) 

(cid:131)  Inability to react quickly, higher 

costs and negative welfare 
impacts if disease occurs and 
vaccine is not available 

Options A.i. and A.ii 

Pros 

(cid:131)  EU approach ensured  
(cid:131)  Health status harmonised 

Cons 

(cid:131)  Burdensome for animal keepers and 

veterinary services; it would affect all 
vaccinations of all animals and all 
diseases with substantial practical 
problems 

(cid:131)  No freedom of choice for animal 
keepers and MS (no subsidiarity) 

(cid:131)  High costs 
(cid:131)  Non-flexible, rigid 
(cid:131)  Loss of prioritisation  possibly leading 

to waste of resources 

(cid:131)  Unrealistic due to: 

(cid:131) 

(cid:131) 

different animal species, 
different uses and relevance for 
the EU intervention 
variety of diseases, disease 
agents, development / 
availability of vaccines, 
vaccination options,  trade 
impacts 

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V. CONCLUSIONS 

1.  The EU policy on vaccination against animal diseases only concerns a limited number of 
diseases of major importance because of their tendency to spread irrespective of national 
borders and of their trade impact. There is no proposal to address vaccination for diseases 
other than this limited set.  

2.  In order to avoid large-scale killing  of animals  as a disease control measure as much as 
possible,  in  the  last  decade  EU  legislation  has  already  included  several  elements  of 
flexibility to facilitate the use of vaccines both as a preventative and an emergency tool, as 
shown during the recent epidemics of highly pathogenic avian influenza H5N1 and BT. 

3.  The  EU  policy  and  legislation,  however,  must  duly  consider  the  technical  specifications 
and  limits  of  the  available  vaccines  and  accompanying  diagnostic  tests,  as  well  as  the 
practical feasibility of vaccination and its costs.  

4.  In  reality,  there  are  obstacles  and  limitations  to  the  use  of  vaccines  against  some  major 

diseases (CSF, FMD, AI) that are not dependent on legislation. 

5.  Inappropriate  use  of  vaccines  may  pose  additional  risks  and  jeopardise  disease  control, 
have a negative impact on safe trade from areas in which the vaccine has been used and 
ultimately make large-scale killing of animals inevitable. 

6.  Subsidiarity is important to maintain because of particular local contexts and the need for 

MS to develop their own particular rules on vaccination accordingly.  

7.  However,  EU  legislation  must  also  allow  for  the  possibility  of  rapidly  assessing  and 
permitting  the  use  of  vaccination  for  newly  developed  vaccines  and  accompanying 
diagnostic tests. 

8.  In  addition,  quick  availability  of  reliable  vaccines  in  case  of  emergencies  is  essential. 
Therefore, future policy has to continue to make use of these concepts and promote them 
in order to avoid massive killing of animals as much as possible.  

9.  The legal basis for the MS and the farmers has to mirror this strategy. Only option B.i (the 
preferred  option)  fulfils  all  elements  and  addresses  the  concerns  raised  in  the  CAHP 
evaluation,  AHS  and  stakeholders'  consultation  (see  "Vaccination"  under  Point  2.15  of 
Annex V).  

10. This option B.i is also the one most in line with the risk-based preferred option (option 4) 
for  the  AHL  as  a  whole:  a  coherent  and  flexible  EU  approach  providing  proportionality 
and subsidiarity, but with support at EU level (through the vaccine bank) providing added 
value over and above what MS can achieve by themselves 

11. However, the future EU law cannot resolve issues such as a lack of consumer acceptance 
of  products  from  vaccinated  animals  (this is  a  task  for  a  good  communication  strategy), 
but can contribute to better understanding of the safety and benefits of a well-implemented 
vaccination strategy.  

-  - 
133

 
 
 
 
 
Questionnaire to EU CVOs on emergency vaccination policy and an 
analysis of the replies 

Part 2 

EUROPEAN COMMISSION 
HEALTH & CONSUMERS DIRECTORATE-GENERAL  

Directorate D — Animal Health and Welfare 
D1-Animal Health and Standing Committees 

              Brussels, 30 June 2010 

SANCO/7117/2010 

Results of the 

QUESTIONNAIRE 

for Chief Veterinary Officers of the EU Member States and Norway 
to collect information and opinions on: 

VACCINE AND/OR DIAGNOSTIC BANKS FOR MAJOR ANIMAL DISEASE 

(point 24 of the Programming document41  
for the Animal Health Strategy 2007-2013) 

This document does not necessarily represent the views of the Commission Services 

Please note that this document has been established for information and consultation purposes only. It 
has  not  been  adopted  or  in  any  way  approved  by  the  European  Commission  and  should  not  be 
regarded  as  representative  of  the  Commission  Services  either.  The  European  Commission  does  not 
guarantee the accuracy of the information provided, nor does it accept responsibility for any use made 
thereof. 

41  http://ec.europa.eu/food/animal/diseases/strategy/pillars/action_en.htm. 

-  - 
134

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
                                                 
I. 

Introduction 

The European Commission launched an external evaluation to review its animal health policy 
in  2005.  Based  on  the  results  of  this  evaluation,  strategic  aims  and  objectives  for  animal 
health  were  set  out  in  the  Commission  Communication  on  the  new  EU  Animal  Health 
Strategy where ‘Prevention is better than cure’. 

Identifying problems before they emerge while being ready to manage major animal disease 
outbreaks  and  crises  is  one  of  the  expected  outcomes  of  the  Animal  Health  Strategy.  It  is 
widely agreed that in many cases, the best means of combating animal diseases once they 
occur is in accordance with the principle that ‘vaccination is better than unnecessary culling’. 

The recently published "Expert Opinion on Vaccine and/or diagnostic Banks for major Animal 
diseases  has  been  presented  to  the  Member  States  during  the  SCFCAH  meeting  in  May 
2010.  
It can be found on the SANCO web page:  
http://ec.europa.eu/food/animal/diseases/strategy/pillars/antigen-vaccine-banks-task-
force_en.htm 

Based on the above-mentioned document questions arose. Therefore DG SANCO Unit D1 
wished to consult the Chief Veterinary Officers of the EU Member States (and Norway, as an 
agreement is in place between the EU and Norway in relation to the EU animal diseases 
vaccine banks)  in charge of implementing animal health legislation on those questions.  

23 Member States and Norway responded to this questionnaire, resulting in a response rate 
of 86%. In the following document the opinions and have been gathered and are presented 
in both graphical and descriptive form.   

The information and opinions given serve as valuable base for the discussion between 
Commission and Member States. Moreover, they will be used by the Commission Services 
as inputs to finalise a policy paper on possible options for the reinforcement of the EU 
antigen and vaccine banks and on the establishment of EU reserves for essential diagnostics 
for certain diseases.  

Following this introduction the second part presents the key messages of the paper produced 
by  a  group  of  experts  (see  page  3).  In  the  third  part  the  answers  to  all  questions  will  be 
analysed separately (see pages 4–17). The fourth part attempts to summarize the opinion of 
all participating countries in form of 12 conclusions (see page 18).  

Thank you for your participation and for your valuable contribution to this process! 

-  - 
135

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
II. 

Key Messages Of The Expert Opinion 

The key messages of the "Expert Opinion on Vaccine and/or diagnostic Banks for major 
Animal Diseases" are as agreed among the experts: 

1.  Vaccination  is  a  fundamental  tool  in  a  strategy  to  control  and  eradicate  major 

emerging diseases. 

2.  Emergency  vaccination  has  to  be  considered  as  one  tool  in  a  whole  range  of 
measures  as  a  part  of  a  complex  strategy  to  control  and  eradicate  major  animal 
diseases. 

3.  Emergency  vaccination  for  most  relevant  infectious  diseases  should  in  general  be 
seen  in  a  new  light,  directly  linked  to  the  availability  of  effective  diagnostic  tools 
substantiating  that  vaccinated  animals,  or  meat  and  other  products  obtained  from 
vaccinated animals, are free from pathogens and can be traded safely. 

4.  Emergency  vaccination  has  to  be  understood  as  vaccinate-to-live,  meaning  that 
vaccinated  animals  are  kept  to  the  end  of  a  normal  production  cycle,  and  that  their 
meat and other products can be marketed. 

5.  Diagnostic  banks  for  particular  infectious  diseases  are  necessary  to  supplement 

vaccine banks to enable a holistic strategy of disease control and eradication. 

6.  The establishment and maintenance of vaccine and diagnostic banks must be part of 

a strategic plan prepared during ‘peace time’, ready for an emergency. 

7.  The  issue  of  vaccine  and  diagnostic  banks  can  only  be  treated  in  the  context  of  a 
control  and  eradication  strategy  specific  to  each  major  animal  disease  (e.g.  FMD, 
CSF, AI) and various outbreak scenarios. 

8.  For  most  of  the  relevant  infectious diseases,  existing  legislation  regarding  emerging 
vaccination should be amended so that vaccination becomes a realistic option in the 
event of a crisis.  

9.  Trade issues regarding vaccinated animals or fresh meat and meat products obtained 

from vaccinated animals should be resolved. 

10. Relevant  legislation  regarding  veterinary  medicinal  products  is  not  well  suited  to 

approve the use of vaccines in emergency situations. 

11. The current review of legislation dealing with veterinary medicinal products is an ideal 
opportunity  to  introduce  a  mechanism  to  approve  vaccines  for  emergency  use  at 
European level. 

12. Proposals  to  be  considered  could  include  alternatives  to  vaccine  banks,  such  as 
vaccine master seed stocks and ‘mock up’ authorisations for particular vaccines. 

13. Vaccination and testing should replace unnecessary culling. 

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136

 
 
 
 
 
 
 
 
 
III. 

 RESULTS OF THE QUESTIONNAIRE  

1.  SUPPORT OF NATIONAL LEGISLATION 

Do  your  national 
legislation  and  contingency  plans 
support the use of an EU vaccine bank in your strategy to 
control and eradicate major emerging diseases? 

In 20 (83%) of the responses of participating countries it was 
stated that the use of an EU vaccine bank is supported by their 
national legislation and contingency plans, even though the 
term "EU vaccine bank" is not specifically mentioned yet. 
However, stamping out policy was still mentioned as the first 
option by two Member States.  

• 

• 

Q1 - Result

No; 
17%

Yes; 
83%

In  general,  the  option  of  emergency  vaccination  is  already  included  in  the  contingency 
plans of the respective countries for a variable number of diseases; so do some countries 
currently  consider  vaccination  only  for  FMD,  others  list  up  to  four  out  of  the  following 
diseases: FMD, AI, CSF, ASF and BT.    

•  One out of four countries where present national legislation does not include provisions 
for the use of an EU vaccine bank stated that amendments of national legislation and of 
contingency plans are possible, whenever required. 

2.  VACCINATION IN A NEW LIGHT, LINKED TO DIAGNOSTICS 

Do you think that emergency vaccination for most of the 
relevant infectious diseases should in general be seen in 
a  new  light,  directly  linked  to  the  availability  of  effective 
diagnostic tools?  

•  23 (96%) responses share the opinion that vaccination has to 
be seen in a new light, (Q2 was not answered by one country, 
4%). The availability to effective and safe diagnostic tools that 
help to distinguish between vaccinated and infected animals 
or detect possible carriers in vaccinated animals are seen as 
absolute prerequisite. 

Q2 - Result

n.a.; 
4%

Yes; 
96%

n.a.: not answered 

•  This change of view is not only linked to the availability of effective diagnostic tools, but 

also technical, economical, commercial, societal issues and the global strategy of disease 
control have to be kept in mind. Tradability has to be granted. 

•  DIVA vaccines are specifically mentioned as pre-requirement for a change in control 

strategies. One opposing response clearly expressed reservation against the use of DIVA 
vaccines, but promoted the strategy of prior testing in combination with a well established 
surveillance system.  

•  The importance to share practical experience gained from successful vaccination 

campaigns to support decision making was mentioned. Furthermore, more research 
should be done in this area.  

-  - 
137

 
 
 
 
 
 
 
 
 
 
3.  DISEASES TO BE CONSIDERED 

Do  you  consider  that  the  list  of  infectious  diseases 
identified  in  the  expert  paper  for  which  vaccine  and 
diagnostic  banks  should  be  available  in  the  EU  in  the 
near future is appropriate (or correctly identified)? 
Note:  the  expert  paper  lists  the  following  diseases:  FMD,  AI, 
CSF, AHS, BT and ASF. 

Q3 - Result

No; 
17%

•  20 (83%) responses agreed with the list of infectious diseases 
identified in the expert paper. One response stressed the need 
to concentrate efforts and resources on the major diseases listed and not to include 
others (at the moment). 

Yes; 
83%

•  4 (17%) responses proposed to add one or more of the following diseases: Rabies, Peste 
des Petits Ruminants, Rift Valley Fever, Sheep Pox, Aujeszky's Disease, Crimean-Congo 
haemorrhagic fever and zoonoses in general.  

•  The stored vaccines / diagnostics should be timely available both to prevent spread of an 
"old" re-introduced disease (as Rabies) and of "new" diseases that might be introduced in 
future.   

• 

In addition it was pointed out that certain vector-borne diseases might have a higher 
probability to occur in future due to climate change and that for such emerging diseases 
sufficient diagnostic knowledge should be made available. Furthermore, terrorist threats 
should be considered.  

4.  VACCINATION TO COMPLEMENT / REPLACE CULLING 

the  principle 

that  emergency 
Do  you  agree  with 
vaccination in combination with testing, at least in cases 
where  vaccination  does  not  prevent  infection,  should 
complement or wherever possible replace culling (except 
the infected herd)?  

•  21  (87%)  responses  support  the  principle  that  emergency 
vaccination  can  be  part  of  a  control  strategy  if  the  disease 
status of vaccinated animals can be assessed unambiguously. 

Q4 - Result

No; 
13%

Yes; 
87%

•  The  opposing  3  (13%)  responses  stress  that  vaccination  can  complement  but  not 
necessarily replace culling. The latter issue was also mentioned by countries which agree 
with the principle; emergency vaccination must be always part of measures which prevent 
spreading  of  the  disease  and/or  pathogen,  ensure  safe  animal  products  and  protect 
public health. 

•  Decision  has  to  be  taken  case  by  case  (country  specific  decision  according  to 
epidemiological situation, density of susceptible population, disease specific factors, etc.) 

•  Costs and benefits of vaccination and culling should be compared. 

-  - 
138

 
 
 
 
 
 
 
 
 
 
 
5.  EMERGENCY VACCINATION FOR VACCINATE-TO-LIVE 

Do  you  agree  that  emergency  vaccination,  except  where 
specifically  carried  out  as  suppressive  vaccination  to 
damp down virus shedding from infected animals, should 
be  understood  as  vaccinate-to-live,  meaning 
that 
vaccinated  animals  are  kept  to  the  end  of  a  normal 
production  cycle,  and 
from 
vaccinated  animals  can  be  marketed  without  additional 
requirements?  

that  products  derived 

Q5 - Result

No; 
21%

other
4%

Yes; 
75%

• 

In 18 (75%) responses consented that emergency vaccination should be understood as 
vaccinate-to-live  in  the  above  mentioned  sense.  A  Vaccinate-to-live  strategy  also 
complies with a sustainable food production cycle. 

•  Sound  diagnostic  regime  constitutes  the  pre-requisite  so  that  a  specified  degree  of 

freedom from infectious agent can be granted.  

• 

International trading partners have to be included into the debate. 

•  However, for certain diseases countries additional requirements and / or restrictions are 
preferred;  specifically  for  FMD  or  zoonotic  agents  as  AI.  One  possible  restriction 
mentioned was that trade of vaccinated animals should only take place between countries 
with the same disease status.  

• 

It  has  to  be  assured  that  no  public  health  issues  arise  (residues  of  vaccine  or  vaccine 
components)   

6.  LEGISLATION AS OBSTACLE 

Do  you  consider  that  for  most  of  the  relevant  infectious 
diseases,  some  of  the  existing  legislation  regarding 
emergency  vaccination  is  an  obstacle  for  vaccination-to-
live and therefore should be amended?  

•  15 

(63%) 

responses 

the  existing 
legislation,  specifically  restrictions  on  the  trade  in  vaccinated 
animals and products thereof in combination with the duration 
of the restrictions.  

report  obstacles  of 

Q6 - Result

No; 
38%

Yes; 
62%

•  The remaining 9 (38%) responses think believe that legislation gives enough flexibility to 
apply  vaccination-to-live  approach.  However,  limited  acceptance  of  the  market  is  still  a 
major problem. 

• 

It  has  been  proposed  to  amend  legislation  as  a  first  step  to  make  vaccination-to-live  a 
reasonable  option  for  the  Member  States.  In  a  second  step  trade  issues  regarding 
vaccinated  animals  or  fresh  meat  and  meat  products  obtained  from  vaccinated  animals 
should be resolved. 

•  FMD, CSF and AI legislation are in particular concerned. 

•  The  BT  history  was  mentioned  as  a  positive  example  for  the  changed  way  of  thinking 

regarding vaccination. 

-  - 
139

 
 
 
 
 
 
 
 
 
 
 
7.  USE OF EU BANKS IN EMERGENCY SITUATION 

In  case  of  an  emergency  situation  would  you  consider 
the use of vaccines and/or diagnostics from EU banks if 
there  is  no  immediate  alternative  and/or  by  bridging  the 
period  until  you  can  obtain  vaccines  and  diagnostic 
tests through your own budget?  

•  All  except  one  response  (23;  96%)  consider  the  use  of 
vaccines  and  /  or  diagnostics  under  certain  circumstances 
and if a range of pre-requisites are met. 

Q7 - Result

No; 
4%

Yes; 
96%

•  Following pre-requisites were pointed out:  

>  A quick decision about the availability in case of an emergency has to be taken 

(“chain of command” at EC level); 

>  National marketing authorisation of vaccine is obtained; diagnostics would have to be 

OIE recognised or equivalent;  

>  Quality and quantity: vaccines must be effective and available in large enough 

amounts to be successfully applied in high-risk areas; 

>  National laboratories must be familiar with the handling of used diagnostics; 
>  Sufficient financial resources can be dedicated by the Member State for this purpose. 

•  Reported situations where the use of vaccines and / or diagnostics from EU banks would 

be considered are:  
>  The outbreak already has spread beyond the primary outbreak; occurrence in different 

parts of the country; 

>  If national vaccine / diagnostics reserves do not protect against outbreak strain or if an 

exotic disease has to be dealt with; 

>  The use of vaccine depends on disease: a clear yes for FMD, but as well for CSF and 

AI; 

>  If the products are not immediately commercially available at an affordable price. 

8.  NATIONAL BANK VS. EU BANK 

Would  you  consider  giving  up  a  national  vaccine  or 
diagnostic  bank  in  favour  of  a  centralised  EU  bank  if 
legislation on contingency planning so allows?  

•  This  question  is  not  applicable  to  7  (29%)  countries  as  they 
responded not  to  have a  national  vaccine  and /  or  diagnostic 
bank. 

Q8 - Result

not 
appli-
cable 
29%

No; 
8%

Yes; 
63%

•  15  (63%)  of  the  remaining  17  responses  take  the  closure  of 

their national banks in consideration, for 2 (8%) countries this is no option. 

•  Centralised  banks  appear  to  be  reasonable  from  an  economical  point  of  view  (e.g. 
reduction of spoilage due to the short shelf-life); nevertheless an economical evaluation 
should  be  undertaken  to  describe  costs  of  establishment  and  maintenance  of  a 
centralised bank for the single participating country and the EU. 

•  Moreover,  aspects  such  as  management  and  technical  support  are  probably  favourable 

compared to national banks. 

-  - 
140

 
 
 
 
 
 
 
 
 
 
•  Agreement  exists  on  the  need  of  clear  criteria  how  vaccines  and  diagnostics  can  be 
assessed, particularly in the case when more than one Member State is affected by or at 
risk of introduction of a disease. 

•  As regards of diagnostics, several countries consent that these should remain within the 
responsibility  of  national  reference  laboratories.  An  adequate  amount  of  diagnostics 
should be available both for routine and for emergency situations. 

•  Several of those countries witch currently hold vaccine banks point out that the quantity of 
stored vaccines will be a crucial factor – national vaccine banks could only be closed if a 
centralised  bank  can  provide  enough  vaccine  in  a  short  amount  of  time.  Another 
influential  factor  will  be  the  effectiveness  of  the  EU  bank.  So  far  no  experience  is 
available on this point. 

9.  MASTER SEED STOCKS AND ‘MOCK UP’ AUTHORISATION 

For  which  diseases  do  you  consider  that  master  seed  stocks  and  ‘mock  up’ 
authorisations would be appropriate (instead of ready to use vaccines):  

Q9 - Diseases for which master seed stocks and 
‘mock up’ authorisations would be appropriate

AHS

BT

AI

CSF

FMD

17

17

13

10

15

4

4

11

8

5

3

3

3

3

4

0%

10%

20%

30%

40%

50%

60%

70%

80%

90%

100%

Yes

No

Depends, see comments

−  Favour for master seed stocks depends on:   

>  How long production and distribution of vaccines would take in case of emergency; 
>  Serotypes (AI and BT). 

−  Possibilities for master seed stocks to be tested in line with the European Pharmacopoeia 
should be examined with scrutiny. Moreover, discussion has to be started on who will be 
and 
in 

availability 

charge 

control 

quality 

seeds.   

the 

the 

of 

of 

−  Several  countries  agree  that  for  FMD  ready  to  use  vaccine  should  be  available  in  the 
vaccine bank as emergency vaccination might be required in a very short period of time; 
serotypes A & O are specifically indicated. For the more rarely occurring serotypes seed 
stock is seen as a good option. 

− 
−  Other diseases for which master seed stocks and mock-up authorisations are mentioned 

as desirable: oral vaccines for CSF and Rabies. 

-  - 
141

 
 
 
 
 
 
 
 
 
 
 
 
10. RAPID DECISION ON DISTRIBUTION OF VACCINE 

Do  you  agree  that  the  Commission  should  be  fully 
empowered to make rapid decisions on the distribution of 
the vaccines available in stock after consultation with the 
Member States concerned or at direct risk because of an 
outbreak?  

•  18  (75%)  responses  agree  to  fully  empower  the  Commission 
to  take  decisions  as  long  as  concerned  Member  States  are 
consulted. 

Q10 - Result

No; 
25%

Yes; 
75%

•  6  (25%)  responses  request  that  not  only  the  directly  concerned  but  all  Member  States 
should be consulted before decisions are taken. This could be done via SCoFCAH and / 
or a CVO meeting. To assure that rapid decisions can be taken teleconferences or written 
procedures  were  mentioned  as  an  alternative  to  a  live  meeting.  Besides  SCoFCAH 
consideration of the epidemiological situation was mentioned as second axis to come to a 
decision. 

•  Several responses claimed that irrespective of any outbreak scenario procedures on how 
to distribute vaccines or tests between Member States must be agreed on in advance.  

11. EURL TO SUPPLEMENT VACCINE BANKS 

Do  you  think  diagnostic  banks  for  particular  infectious 
diseases  should  be  within  the  remit  of  the  EURL  to 
supplement  vaccine  banks,  if  diagnostic  kits  are  not 
commercially available?  

•  23  (96%)  responses  agree  that  the  EURL  is  the  appropriate 
institution to ensure that diagnostic kits for particular infectious 
diseases are made accessible if not commercially available. 

Q11 - Result

No; 
4%

Yes; 
96%

•  Additionally,  it  was  pointed  out  that  it  is  mandatory  that  all  Member  States  have  an 
effective diagnostic capability for the diseases that are considered of importance for the 
EU.  Therefore,  other  national  laboratories  could  be  entitled to  cooperate  with  EURL,  on 
the basis of documented expertise and capacity. 

•  The reason given for the opposition of one country (4%) is that the primary function of the 

EURL should remain to provide expertise. 

12. GUARANTEES FOR SAFE TRADE 

Do  you  think  that  vaccinated  animals  and  their  products 
could  be  traded  safely  if  appropriate  diagnostic  tool  and 
surveillance  schemes  were  available  and  used  properly, 
so that this surveillance gives the appropriate guarantees 
that those animals and products are not infected?  

Q12 - Result

other 
8%

No; 
13%

Yes; 
79%

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142

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
•  The  opinion  was  shared  in  19  (79%)  responses  that  a  combination  of  appropriate 
diagnostic  tools  with  surveillance  schemes  offers  the  possibility  that  vaccinated  animals 
and their products could be traded safely.  

•  Conditions: 

>  Clearly defined rules for movement of animals and animal products in the framework 

of eradication measures;  

>  Dependent from disease, vaccine (DIVA, live), international acceptance, availability of 

approved tests;  

>  Traceability is indispensable for every vaccinated animal. 

•  3  (13%)  responses  did  not  agree,  2  (8%)  responses  could  only  envisage  trade  of 

products, but not of live animals.   

•  BT  and  AHS  were  examples  given  for  current  legislation  that  already  allows  vaccinated 

animals and their products to be traded safely. 

13. AUTHORISATION OF VACCINES 

In  your  view  vaccination-to-live  with  vaccines  from  an  EU  vaccine  bank  and 
subsequent  intra-EU  trade  in  vaccinated  animals  and  their  products  could  only 
take  place  provided  that  vaccines  used  have  received  the  following  authorisation 
for being placed on the market:  

Q13 - Authorisation for vaccines being placed on the market 
from an EU vaccine bank

Provisional by a MS

5

15

2

2

National, in at least 2 MS

National, in at least 1 MS

4

4

EMA

13

15

22

4

3

1

4

2

0% 10% 20% 30% 40% 50% 60% 70% 80% 90% 100%

Yes

No

Depends, see comment

Not answered

•  A large majority of responses (22; 92%) shares the opinion that EMA authorisations could 
ensure  the  required  standards.  In  addition,  international  acceptance  was  deemed  to  be 
more  forthcoming  following  an  EMA  authorisation  rather  than  any  of  the  other  three 
options.   

•  Besides  this  positive  reputation  of  EMA  opinions  vary    considerably:  whereas  several 
Member State only opt for EMA authorisation other Member States have the opinion that 
in  an  emergency  situation  any  authorisation  is  welcome  if  a  minimum  of  guarantees 
regarding quality and safety of the vaccines can be assured. The national authorisation in 
the  case  of  BT  has  shown  that  the  system  worked  excellently;  an  EMA  authorisation  is 
deemed as not absolutely necessary. 

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143

 
 
 
 
 
 
 
 
 
 
 
14. MOVEMENT WITHIN NATIONAL MARKET 

Would  you  in  general  accept  moving  vaccinated  animals 
or products obtained from vaccinated animals within your 
national market?  

•  18  (75%)  responses  report  general  acceptance  of  movement 

of vaccinated animals or their products.  

•  Conditions quoted are: 

>  If tested with approved tests and with an appropriate 

Q14 - Result

other 
8%

No; 
17%

Yes; 
75%

surveillance scheme in place, giving a guarantee of freedom (of infectious agent) and 
safety of products; 

>  After discussion with stakeholders; 
>  No negative implications for international trade. 

•  Comments in those 6 responses (25%) which would not accept such movement include 
the  need  for  additional  guarantees  for  absence  of  virus  circulation  in  the  country.  This 
should be decided on the disease in question. In case of BT vaccinated animals could be 
placed on the market. 

•  One  response  emphasized  that  moving  of  products  would  be  acceptable  but  not  of  live 
animals  as  important  trading  partners  request  for  non-vaccinated  animals.  Furthermore, 
special conditions for products and live animals were claimed with regard to FMD 

15. UNSOLVED TRADE ISSUES 

Please  explain  briefly  which  are  in  your  opinion  the  main  still  unsolved  trade 
issues related to vaccination by disease and problem (maximum 3). 

• 

In total 51 comments were made in relation to trade in all 24 responses. The comments 
quoted both  
>  already existing and  
>  possible future trade hindrances if vaccination would be applied.  

•  As several levels of trade-related issues were addressed they were summarized in three 
categorical levels in Table 1: 1.) technical level, 2.) legislative level and 3.) customer (or 
user-end)  level.  This  structured  form  should  highlight  the different  stages  which  have  to 
be taken in consideration. 

•  Procedure  of  categorisation:  One  category  was  selected  for  every  comment.  In  case  a 
comment addressed more than one trade issues it was grouped into the category which 
mentions the cause, i.e. not the consequence.    
Example:    "a  safe  vaccine  to  enhance  international  trade"  would  be  categorised  as     
"1a.)  safe  vaccine  and  diagnostics"  as  "to  enhance  international  trade"  is  the 
consequence. 

•  This categorisation is only indicative.  

•  Comments given in relation to specific diseases are listed separately below Table 1. 

-  - 
144

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
    
 
Table 1: Summary of trade-related comments 

Level 

Description 

1.) Technical level 

a.) General comment made 
b.) Safe vaccine and diagnostics   
Vaccines have a high protective efficacy and matching 
diagnostics are highly sensitive and specific. Movement 
of vaccinated animals can be allowed given that vaccine 
and diagnostics properly applied and according 
surveillance scheme is in place. 
c.) Distinguishability  
Applied vaccines and / or diagnostics allow 
distinguishing between infected and non-infected 
animals despite vaccination.  
d.) Identification and traceability 
Identification and registration of vaccinated animals, 
products are traceable.  

Number of 
quotations 

Sum:    21

1

9

8

3

2.) Legislative level 

Sum:      7

a.) Acceptance and authorisation 
Vaccinated animals are accepted as safe in the 
legislation, vaccines have received authorisation 
accordingly. 
b.) Discrimination 
Vaccinated animals have comparable conditions in 
relation to trade as non-vaccinated animals originating 
from the regions which share the same disease status. 

4

3

3.) Customer level 

Sum:    21

a.) General comment made 
b.) Consumer 
c.) Industry / retail 
d.) EU – wide market 
Trade of vaccinated animals and their products between 
Member States 
e.) Trade with third countries 
Trade of vaccinated animals and their products with third 
countries 

Specific 
case 

i.) Loss of "disease-free" status for 
EU/MS 
EU/MS may lose its/their “disease-free” 
status if vaccinated animals/products were 
traded within the EU, thus resulting in 
disadvantages in the trade with third 
countries as third countries may consider 
the EU as one economic and 
epidemiological entity. 

5
3
2

1

8

2

-  - 
145

 
 
 
 
 
 
 
 
 
 
 
 
ADDITION: TRADE-RELATED ISSUES MENTIONED BY DISEASE 

•  FMD:  

•  AI:   

•  CSF:  

Vaccination and DIVA testing on farm level;  
Carrier status. 

Trade issues in relation to meat;  
Lack of acceptance of regionalisation by third countries.  

Absence of DIVA vaccine; traceability and transparency still open questions;  
Trade of meat products from free compartments from countries not free;  
Time period till permission of trade of live pigs is regained when vaccination is 
applied. 

•  ASF:  

Trade of meat products from free compartments from countries not free;  

•  BT:  

No  individual  records  about  vaccinated  animals  if  traded  between  Member 
States;  
Vertical transmission;  
Trade of live animals in absence of effective surveillance. 

•  AHS:  

Vertical transmission; 
No DIVA capability. 

16. MOVEMENT BETWEEN MEMBER STATES 

Would  you  in  general  accept  vaccinated  animals  or 
products  obtained  from  vaccinated  animals  originating 
from  other  Member  States  into  your  national  market 
where this is not expressively forbidden by OIE rules?  

Q16 - Result

other 
8%

No; 
25%

•  Out  of  the  18  responses  (see  Q14)  that  in  general  would 
accept  the  nation-wide  trade  of  animals  plus  products  which 
were  vaccinated  in  their  own  country  16  (67%)  also  consider 
the possibility to accept animals or products thereof that were 
vaccinated  in  another  Member  State.  It  has  to  be  highlighted  that  only  2  responses 
express their preference to act differently depending on the outbreak location. 

Yes; 
67%

• 

It  was  pointed  out  that  it  has  to  be  distinguished  between  preventive  vaccination  and 
emergency  vaccination  –  for  emergency  vaccination  a  clearly  stipulated  system  of 
movement and processing has to be defined case by case, disease by disease.  

•  Furthermore Member States with a similar disease status should fulfil similar conditions to 

be able to move animals and their products between Member States.   

• 

In  addition  to  the  conditions  listed  under  Q14  it  would  be  welcomed  if  a  certain  time 
period  would  be  determined  after  which  trade  can  be  allowed  to  obtain  guarantees  that 
there  is  no  virus  circulation  at  the  place  of  origin.  Also  the  vaccination  of  live  animals 
should  be  made  traceable  (as  by  recording  in  TRACES  and  in  a  central  register),  see 
present BT legislation as an example.  

•  The  position  that  trade  of  live  animals  should  be  limited  to  regions  following  the  same 
vaccination  policy  is  among  those  responses  which  do  not  favour  trade  of  vaccinated 
animals between Member States. 

-  - 
146

 
 
 
 
 
 
 
 
 
 
 
 
17. NECESSITY OF MITIGATING MEASURES 

Do  you  believe  that  mitigating  measures  applied  to  the 
product (e.g. deboning and maturation and/or removal of 
the head from the food chain) are needed to market meat 
from vaccinated animals?  

•  15  (63%)  responses  state  not  to  believe  that  additional 
mitigation  measures  are  needed  to  be  able  to  market  meat 
from vaccinated animals. 

•  Again this will depend largely on the disease in question and 

Q17 - Result

other 
8%

Yes; 
21%

No; 
62%

the animal health status of the affected country. So it was proposed that a differentiation 
could be made between vaccinated animals from countries which are free of the disease 
after  containing  the  disease  with  a  good  vaccination  plan  and  a  surveillance  scheme  in 
place and countries where the disease is still present.  

•  Exception:  several  countries  think  that  for  FMD  deboning  and  maturation  is  certainly 

necessary. 

•  Scientific  evidence  on  the  animal  health  safety  of  products  derived  from  vaccinated 

animals still has to be provided in many cases.  

18. FURTHER COMMENTS 

Do you have any further comments on the issue of vaccine and/or diagnostic 
banks for major animal diseases? 

•  The following sections present a summary of concerns (18.1) and open questions (18.2) 
which were not specifically addressed by an earlier question and/or mentioned as a 
further comment under this open question.  

•  Furthermore a collection of factors which are deemed important to take the decision for 

vaccination is listed up (18.3); this list tries to grasp the essential points mentioned in the 
participating countries' comments.  

•  Numerous actions to be undertaken by the Commission, Member States and scientific 
and industry partners were highlighted in the questionnaires. In 18.4. an attempt was 
made to assign these tasks to the specific group. It has to be kept in mind that these lists 
are not indicative and make no claim to be complete. 

•  All  comments  made  under  this  point  and  all  numerous  comments  made  under  the 

remaining question shall be summarized in the following four categories: 
>  18.1  Concerns 
>  18.2  Open questions 
>  18.3 
>  18.4  Action needed 

Factors important to take decision for vaccination 

-  - 
147

 
 
 
 
 
 
 
 
 
 
 
 
18.1  CONCERNS 

•  Vaccinate-to-live could be connected with an excessive additional administrative burden. 

• 

Insufficient data available convincing scientific evidences with vaccinate-to-live strategy. 

•  Safe  trade  if  appropriate  diagnostic  tool  and  surveillance  schemes  were  available: 
surveillance systems do have limitations. Therefore the risk is always present, but it may 
be considered as reduced enough to accept this trade. 

•  A  centralised  EU  decision  process  may  risk  paying  less  attention  to  local  national 

conditions. 

•  The financial consequences for a bank of this size (30-40 million doses) are likely to be 

high and the likelihood of it being used low. 

CONCERNS RELATED TO SPECIFIC DISEASE 

•  FMD: With the numerous strains of this disease even a well stocked bank may not hold 

the right antigen to vaccinate against the field strain seen in an outbreak. 

•  AI:  vaccinated  birds  would  still  be  capable  of  spreading  disease.  Mutation  of  influenza 
viruses could render a vaccine less useful. Furthermore practical issues around delivering 
vaccine by injection to individual birds have to be considered; another matter of concern 
was the length of time until immunity would be developed after vaccination.  

18.2  OPEN QUESTIONS 

•  Which subtypes for vaccine and for diagnostic purpose should be stored? Is it necessary 

to keep all serotypes (e.g. for BT)? 

•  How  quickly  can  Member  States  gain  access  to  vaccine?  Where  would  the  banks  be 
located?  How  much  time  is  needed  to  make  up  vaccine?  How  can  the  issue  be  solved 
when  more  than  one  Member  State  demand  vaccines  or  diagnostics?  How  quickly  can 
the vaccines provide immunity?   

•  How  will  the  master  seed  stock  be  accessible?  Which  producers  are  empowered  to 

process antigens to vaccine?  

•  How  will  the  EU  banks  work  in  relation  to  banks  that  are  held  by  individual  member 

states? 

•  How to organize re-stocking of vaccines and diagnostic kits?  

•  Can  master  seed  be  tested  in  should  in  accordance  with  the  European  Pharmacopoeia 
already when laid down? Who will be in charge of the availability and quality control of the 
master seed? 

•  What costs arise for the Member States as a user of the EU banks? How can a practical 
financing  system  look  like?  Where  does  the  funding  come  from  if  EURL  supplements 
vaccine bank with diagnostics that are not available commercially? 

-  - 
148

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
18.3  FACTORS  IMPORTANT TO TAKE DECISION FOR VACCINATION  

•  Epidemiological situation 

>  One single infected premise (culling) vs. more extensive outbreak (vaccination) 
>  High animal density vs. low animal density 
>  Phase of the outbreak: acute stage where vaccination could lower risk of spread vs. 

later stage when outbreak is under control and the focus lies on regaining disease free 
status to support trade. 

>  Endemicity of disease or new outbreak 

•  Type of vaccine 

>  DIVA / marker vaccine 
>  Live vs. attenuated vaccine 
>  Quality of vaccine / it's ability to prevent both infection and disease  

•  Matching validated diagnostic tests 

>  Sensitivity and specificity to differentiate between infected and non-infected animals 
>  User-friendliness: a high number of samples can be analysed in a reasonable time 

period 

>  Availability in big enough quantities at reasonable price 

•  Effective surveillance scheme in place 

•  Disease 

>  For BT generally accepted.  

•  Risk – benefit calculation 

•  Assuring conditions 

>  If tradability is granted 
>  If disease / pathogen spread can be prevented 
>  If safe animal products can be ensured to protect public health 

18.4  ACTION NEEDED 

18.4.1  ACTION OF MEMBER STATES AND EUROPEAN COMMISSION NEEDED 

• 

If vaccination is applied rules have to be set up for animal products, animal by products, 
foodstuffs and feeding stuffs. 

•  The proposal for the vaccine and diagnostic bank has to be clearly defined:  

>  which subtypes of virus should be part of the stock;  
>  the source of the virus and amendment of the storage subtypes;  
>  which diagnostics the national laboratories need to be familiar with;  
>  an optimal balance between vaccine, “mock up” authorisations and vaccine 

alternatives has to be developed and evaluated;  

>  how to assure that the bank is arranged in an effective, dynamic (e. g. dimension and 

updating) and cost saving way, as regards the priority of diseases. 

•  A cost/benefit analyses for setting up the banks is needed. 

•  The mechanisms of accessing the vaccines/diagnostics have to be clarified. 

• 

It  has  to  be  agreed  on  how  quick  decision  about  the  availability  of  vaccines  and 
diagnostics in case of an emergency can be taken (“chain of command” at EC level) 

-  - 
149

 
 
 
 
 
 
 
 
 
 
•  Prior  to  trade  clear  requirements  have  to  be  set  up  for  a  specified  degree  of  “freedom 

from infectious agent”, i.e. introduction of a “disease free” status with vaccination.  

•  Additional  rules  for  Identification  &  Registration  and  movement  control  of  vaccinated 

animals have to be adopted. 

•  Risk mitigating measures should be defined for animals and products if a vaccinate-to-live 

strategy is applied. 

• 

If  such  rules  are  defined  for  vaccinate-to-live,  standards  for  the  vaccinate-to-kill  policy 
should also be set up. 

18.4.2  ACTION OF MEMBER STATES NEEDED 

•  The  Member  States  should  prepare  contingency  plans  with  their  vaccination  strategy 
during peacetime and share them with the other Member States and the Commission to 
make  their  principles  of  vaccination  and  testing  during  an  emergency  situation 
transparent to all Member States.  

•  The  effective  operation  of  the  vaccine  bank  and  the  allocation  of  vaccines  should  be 

tested in simulation exercises. 

18.4.3  INVOLVEMENT OF SCIENCE (AND INDUSTRY) 

•  Science / industry should be motivated as safe vaccines are required.  

•  Scientific  institutions  must  be  able  to  provide  support  service  (risk  assessments, 
epidemiological  information,  tracing,  etc.)  so  that  decisions  can  be  taken  on  a  sound 
basis. 

•  Specifically,  the  risk  of  virus  transmission  through  vaccinated  animals  and  the  role  of 

products in the spread of the disease should be assessed. 

•  Wider social and economic consequences of vaccination should be considered.   

-  - 
150

 
 
 
 
 
 
 
 
 
 
 
 
 
 
IV.  DRAFT CONCLUSIONS FROM THE QUESTIONNAIRE  

The following 12 conclusions were drawn from the information and opinions gathered from all 
participating countries: 

•  Vaccine and diagnostic banks should be set up in a manner that best storing standards of 

stored equipment can be guaranteed / should be strived for. 

•  Vaccination should be understood to complement and not replace current disease control 

strategies. 

•  Vaccines need to be safe; spread of disease by vaccinated animals will jeopardize 

reliability of the whole strategy. 

•  Vaccines and / or matching diagnostics must allow distinguishing between infected and 

non-infected animals in a reliable manner.  

•  National and international acceptance should be improved in a way that vaccinated 

animals and products obtained from vaccinated animals can be traded at comparable / 
similar conditions as non-vaccinated animals and their products. 

•  Authorisation of vaccine should be done by EMA procedure; this has to go hand in hand 

with quick availability in emergency situations. 

•  Decision to vaccinate should be taken case by case. 

•  Third countries and stakeholders have to be involved in the discussion at an early stage.  

• 

If emergency vaccination is conceived as vaccinate-for-live, a realistic exit strategy 
should be outlined, taking in consideration international trade and additional resources 
needed.  

•  The mechanisms of accessing the vaccines/diagnostics have to be clarified. A procedure 

should be established to assure guaranteed supply.  

•  Requirements for vaccination in context with FMD have to be discussed separately from 

other infectious diseases due to the special role of this disease. 

•  An evaluation of EU banks has to be undertaken in relation to its cost - effectiveness; a 

financing plan has to be set up. 

-  - 
151

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
ANNEX VIII 

Additional assessment on Intra-EU trade 

Background 

The  concept  of  free  movement  applies  in  theory  to  almost  all  aspects  of  life  in  the  EU. 
However, for reasons of protecting both animal and human health, movement within the EU 
is not considered possible for live animals and their products without fulfilling certain health 
requirements.  Current  animal  health  regulations  require  specific  health  obligations  to  be 
respected when animals and their products are moved between the MS (which vary dependent 
on the context, but might include, for example, certification by an official veterinarian at place 
of origin, notification of the movement or provision of relevant data to the relevant authority 
and/or non-discriminatory checks at the destination). This is due to disease control provisions 
which  aim  to  reduce  the  risk  of  those  movements  spreading  diseases  and  the  according 
consequences for the health of other animals and/or humans in other countries or territories. 
Some of the most common routes of transmission for infectious agents are direct animal-to-
animal contact and indirect contact through equipment, persons, transporters, etc. This is most 
often  caused  by  the  movement  of  infected  animals  towards  with  non-infected  animals,  and 
being in close physical or indirect contact. Economic forces can lead to animals being moved 
over large distances, and this increases the possibility of the geographical spread of disease. 
Besides  the  health  and  welfare  considerations  themselves,  disease  outbreaks  or  poor  animal 
(or  human)  health  can  have  significant  negative  impacts  on  international  trade  and  national 
economies.  

This current concept of 'Intra-Community Trade' is therefore used for movement of animals 
and  products  and  it  retains  certain  international  trade  rules  for  movements  within  the  EU 
(although  border  checks  have  long  since  been  abolished).  The  legislation  allows  MS  to 
develop their own animal health and movement rules and requirements in their own territories 
to a large extent, and does not interfere with them unless there is a financial contribution from 
the  EU  for  surveillance  and  eradication  programmes,  there  is  an  EU  level  eradication 
programme, or if the animals may be traded across borders within the EU at a later stage. The 
current  system  has  been  widely  criticised  as  being  too  prescriptive  and  somewhat  outdated, 
most  notably  in  the  CAHP  evaluation  in  2006.  Nevertheless,  the  current  system  has  proven 
itself  to  be  very  useful,  successful  and  relatively  safe,  for  example,  enabling  the  near-
eradication of brucellosis, bovine leucosis, and bovine tuberculosis in some areas of the EU.  

The current system for the movement of terrestrial animals is very different from the 'placing 
on the market' concept. This concept was introduced in general feed and food law for products 
of  animal  origin,  and  later  also  for  aquatic  animals  and  animal  by-products  for  reasons  of 
animal health. The current system for terrestrial animals of 'Intra-Community Trade' uses MS 
as  the  basic  geographical  unit  for  deciding  on  certification  requirements.  'Placing  on  the 
market' for aquatic animals instead specifies 'zones' with similar health statuses, which may or 
may  not  be  based  around  MSs'  borders.  Animals  moving  within  a  zone,  independent  of 
whether it is within the same MS, do not need certification (although the movement does need 
to be notified to TRACES if crossing a national border). There are certain guarantees required 
when  moving  from  one  type  of  zone  to  another.  This  means  that  the  administrative  burden 
required  with  a  particular  movement  could  be  more  in  proportion  with  the  health  risk  it 
potentially poses.  However, certification is required for movements within a MS if an animal 
is moving to a different health zone.  

-  - 
152

 
 
 
 
 
 
 
 
 
 
Current Intra-EU trade in live terrestrial animals: evidence 

Trade in live terrestrial animals has increased in the EU since the creation of the single market 
(1993).  The  enlargement  of  the  EU  has  provided  further  opportunities  for  such  trade. 
According to TRACES, trade in live terrestrial animals within the EU increased on average by 
9% per year between 2005 and 2009. However, part of this expansion can be explained by the 
progressive development of the TRACES system since its start in 2004. 

In 2009, 36 million farm animals (28 million swine, 4 million cattle, 0.08 million equine, 4 
million  sheep  and  0.1  million  goats)  and  731  million  poultry  were  transported  between  EU 
MSs (see Figure VI.1) 

Figure VIII.1 

Intra-EU trade of live terrestrial animals (in heads, 
excluding poultry) in 2009

Sheep
12%

Goats
0%

Equine
0%

Bovine
10%

Swine
78%

Source: TRACES 

According to TRACES, 46% of farm animals and 51% of poultry transported within the EU 
in  2009  were  intended  for  slaughter.  Of  consignments  of  bovine  animals  destined  for 
slaughter in 2009, 56% went directly to slaughter whilst the remaining 44% passed through at 
least  one  Assembly  Centre  operation.  In  2005  75%  of  bovine  consignments  destined  for 
slaughter went directly there, but the proportion has decreased since then. 

-  - 
153

 
 
 
 
 
 
 
 
 
 
Table VIII.1 
Intra-EU trade in animals destined for slaughter (heads of animals) in 2009 
Equine  Bovine 
Sheep  Goats 
57,058  652,193 12,669,820 2,941,629 81,403 377,511,981 393,914,084 
As a percentage of total intra-EU trade: 

Poultry 

Swine 

Total 

Total excl poultry
16,402,103 

72% 

18% 

46% 

69% 

78% 

52% 

51% 

46% 

Source: TRACES 

For this analysis, we will largely focus on the number of consignments sent and received for 
intra-EU trade in live terrestrial animals. This is because European policy on intra-EU trade in 
live terrestrial animals is based on consignments rather than animals. 

Trade  in  live  terrestrial  animals  takes  place  in  order  to  exploit  the  price  differentials  which 
exist between livestock markets. Both buyers in recipient MS and sellers in producing MS can 
benefit  financially  from  this  trade.  The  table  below  shows  selected  MS  that  were  the  main 
senders and recipients of intra-EU consignments (for all species) during 2009. Interestingly, 
some  of  these  MS  have  a  large  trade  deficit  (Italy)  or  surplus  (France  and  Denmark).  Yet 
other MS both sent and received a similarly large number of consignments, leading their net 
figure to be relatively small (Spain).    

Table VIII.2  
Total number of consignments of animals sent and received by certain MSs in 2009 

Consignments sent 
Consignments received 
Net consignments sent 
Source: TRACES 

BE 

16,040 
40,515 
-24,475 

DE 
50,074
83,057
-32,983

DK 
31,684
240
31,444

ES 
18,500
21,208
-2,708

FR 
74,047 
9,589 
64,458 

IT 

NL 

2,536  74,193
65,693  44,483
-63,157  29,710

Together these 7 MS were involved in approximately ¾ of all consignments sent and ¾ of all 
consignments received in 2009. The high degree of concentration of movements in these MSs 
was true for all the different movement purposes of all species. 

MS  which  send  a  high  proportion  of  consignments  do  not  necessarily  represent  the  nations 
with  the  largest  livestock  sectors.  This  is  shown  in  the  chart  below,  where  the  size  of  the 
circles represents the number of consignments sent by each MS. 

-  - 
154

 
 
 
 
 
 
 
 
 
 
 
 
Figure  VIII.2:  Total  number  of  consignments  originating  from  each  MS,  displayed 
depending on the number of holdings and value of production in the MS (2007) 

16000

14000

12000

10000

8000

6000

4000

2000

)
s
e
c
i
r
p

0
1000

-2000

-4000

7
0
0
2

€,

n
o

i
l
l
i

m

(

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e
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r
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f
o
e
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a
V

l

10000

100000

1000000

10000000

Number of Holdings

Net recipients of live animals Net senders of live animals

Source: Eurostat and TRACES 

As comprehensive national internal movement data is very time consuming to consolidate, the 
size of livestock sectors has been used as a rough proxy for the total amount of movements, 
both  national  and  intra-EU.  It  is  reasonable  to  expect  that  MS  with  larger  livestock  sectors 
would,  on  average,  have  a  larger  volume  of  movements  of  live  terrestrial  animals  than  MS 
with  smaller  livestock  sectors.  From  the  chart  above,  we  can  see  that  there  are  some  MS 
which  have  a  relatively  large  livestock  sector  but  a  relatively  small  level  of  intra-EU 
movements. We could infer therefore that these MS have a relatively large level of national 
movements, compared to their intra-EU movements. 

Movements over short distances are particularly highlighted when discussing intra-EU trade 
in  live  terrestrial  animals.  In  2008,  116,000  bovine,  swine  and  poultry  consignments  made 
journeys of less than 3 hours. This accounts for 38% of all consignments of these species. Of 
these short movements, 59% of them (68,000) were destined for slaughter. 

However, these proportions vary when you look at different species, as illustrated in the chart 
below.  A  higher  proportion  of  poultry  movements  last  for  less  than  3  hours  than  the 
proportion for other species – 63% of poultry consignments compared to 30% of bovine and 
32% of swine consignments in 2008. 

-  - 
155

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Figure VIII.3: Proportion of bovine, swine and poultry consignments in 2008 separated 
by type of movement and journey time 

)
8
0
0
2

s
t
n
e
m
n
g
i
s
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%

100%

90%

80%

70%

60%

50%

40%

30%

20%

10%

0%

Bovine

Swine

Poultry

Slaughter, < 3 hours

Slaughter, > 3 hours

Fattening and breeding, > 3 hours

Fattening and breeding, < 3 hours

Source: TRACES 

Examples of notable movements between adjacent MS are those of pigs and poultry between 
Germany and the Netherlands, cattle between France and Italy, and sheep between Ireland and 
the  United  Kingdom  (particularly  Northern  Ireland).  As  shown  in  the  table  below,  these 
movements  account  for  a  large  proportion  of  an  individual  MS's  trade  in  live  terrestrial 
animals, for a particular species. 

Table VIII.3 Particular examples of high density cross-border movements 

% of all 
EU 
movements 
of this 
species 

% of total 
movements 
of this 
species 
from this 
MS 

% of total 
movements 
of this 
species to 
this MS 

From: 
Netherlands 

To: 
Germany 

Germany  

Netherlands 

France 

Italy 

United Kingdom 

Ireland 

Source: TRACES 

Total no. 
sent (2009) 

7,122,498 

Species 
Pigs 
No. Consignments  33,660 
No. Animals 
Poultry 
No. Consignments  21,635 
No. Animals 
Bovine 
No. Consignments  34,591 
No. Animals 
Sheep 
No. Consignments  1,282 
No. Animals 

970,058 

347,845 

27% 
26% 

27% 
26% 

10% 
8% 

27% 
164,389,846  22% 

69% 
62% 

89% 
85% 

73% 
75% 

83% 
84% 

55% 
50% 

90% 
89% 

68% 
67% 

100% 
100% 

-  - 
156

 
 
 
 
 
 
 
 
 
 
 
 
  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Questions  about  intra-EU  trade  and  the  'placing  on  the  market'  concepts  in  relation  to 
germinal products were asked in the questionnaire for operators in various MSs and its results 
are presented in Annex V above.  

Problem definition: 

Intra-Community  trade  approach  for  animals  and  animal  products  is  criticised  by 
stakeholders and MSs as being too burdensome and outdated 

The current system of Intra-Community trade has often been criticised as being outdated and 
putting too many burdens on animal keepers and operators.   

The different rules for animals and products within a particular MS and between MSs do not 
fit  well  with  the  concept  of  the  EU  single  market.  Though  veterinary  checks  at  borders 
between MS were abolished long ago, and certain certification rules for movements have been 
eased;  to  a  certain  extent  the  system  still  supports  different  market  approaches  in  different 
MSs. Furthermore, it has been criticised as too burdensome for both the competent authorities 
and  animal  keepers  to  implement  systematically  and  for  individual  animal  movements.  For 
example,  there  is  an  obligation  for  the  animal  to  have  a  veterinary  check  and  examination 
before  it  is  moved  to  comply  with  animal  health  and  welfare  provisions;  there  is  also  an 
obligation to have a health certificate in each particular case of movement; and a requirement 
to notify the movement to both the national identification and registration databases and to the 
TRACES system. This procedure is perceived as complicated, expensive and administratively 
burdensome  for  both  operators  and  competent  authorities.  In  addition,  the  system  doesn't 
differentiate  in  what  burdens  it  imposes  according  to  the  level  of  health  risk  of  a  particular 
type of movement. 

In  many  cases,  those  measures  which  can  be  perceived  as  burdensome  may  be  justified, 
especially when animals or their products are moved between holdings or zones with different 
health  statuses.  In  these  cases  it  is  appropriate  that  health  status  guarantees  are  provided  to 
prevent  the  spread  of  disease  and  protect  animal  and  human  health.  On  the  other  hand,  in 
many  cases  the  level  of  bureaucracy  associated  with  the  movements  cannot  be  said  to  be 
proportionate  to  the  risk  involved.  For  example,  there  are  cases  of  movements  of  animals 
between  two  adjacent  holdings  in  neighbouring  MS  with  the  same  health  status  (or  even 
owned by the same person) which pose extremely low risk of disease spread. Movements of 
animals  between  MSs  of  the  same  health  status  for  direct  slaughter  is  also  very  low  risk 
because  of  the  low  likelihood  of  contact  with  live  animals  at  destination.  Table  VI.1  shows 
that  a  high  proportion  of  intra-EU  animal  movements  (with  the  exception  of  bovine 
movements)  are  for  direct  slaughter.  Many  of  the  high  density  cross-border  movements 
highlighted in Table VII.3 also fall into these low-risk categories.  

Policy Options:  

1.  Keep Intra-EU Trade regime unchanged 

2.  Keep  Intra-EU  Trade  regime  but  introduce  some  facilitation  mechanisms  (such  as 
derogations from the requirement for health certification) for low risk movements such 
as for slaughter or between adjacent zones of two MS of the same health status, with 
the possible use of bilateral agreements.  

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157

 
 
 
 
 
 
 
 
 
 
 
 
 
 
3.  Introduce  Intra-EU  movements  regime,  retaining  certain  elements  of  the  current 
certification  requirements  for  movements  between  MSs  but  introducing  some 
facilitation  mechanisms  (such  as  derogations  from  the  requirement  for  health 
certification) for low risk movements. These could include movements for slaughter, 
for certain low-risk products such as bovine semen, hatching eggs or day-old chicks, 
or between adjacent zones of two MS of the same health status (such as through the 
introduction of cross-border zones), without the possibility of bilateral agreements.  

4.  Introduce 'placing on the market' concept to live animal movements.   

Assessment of impacts: 

Option 1: Keep Intra-EU trade regime unchanged 

The Intra-Community Trade concept has been in past years proven to be relatively effective in 
ensuring that, as far as possible, only animals with the appropriate level of health are moved. 
It has therefore provided industry and authorities with sufficient health guarantees for those 
animals which are moved, and so avoided many preventable diseases outbreaks in the EU.   

On  the  other  hand,  as  we  have  seen,  certain  burdens  of  administration  and  certification  are 
imposed for some low-risk movements which are difficult to justify on the basis of upholding 
health  standards.  As  an  example,  the  same  health  certification  requirements  would  be 
necessary for animals being moved from one side of the EU to the other, from one MS with a 
very  different  health  status  from  the  destination  MS;  as  for  animals  being  moved  to  an 
adjacent holding, perhaps even owned by the same person, but which happens to be across a 
national border.  

Option  2:  Keep  Intra-EU  Trade  regime  but  introduce  some  facilitation  mechanisms 
(such  as  derogations  from  the  requirement  for  health  certification)  for  low  risk 
movements  such  as  for  slaughter  or  between  adjacent  zones  of  two  MS  of  the  same 
health status, with the possible use of bilateral agreements.  

This option would retain Intra-EU Trade provisions (as described and assessed in Option 1) 
but  would  aim  to  enable  MS  to  resolve  cross-border  issues  with  the  use  of  bilateral 
arrangements (agreements or other measures).  

In addition, exemptions, derogations or simpler procedures could be permitted for movement 
of  animals  for  direct  slaughter.  However,  even  if  the  health  certification  requirements  were 
removed,  there  would  still  be  obligations  for  veterinary  checks  at  origin  because  of  animal 
welfare requirements.   

This system would lead to bilateral solutions where there is felt by MSs to be a particular need 
(where  there  is  a  lot  of  low-risk  cross-border  trade,  including  much  of  that  shown  in  Table 
VI.3). While this might facilitate those particular movements, it would likely entail different 
approaches from each pair of MSs concerned, with limited transparency of these agreements 
and  the  movements  concerned  to  the  EU.  It  could  also  lead  to  complicated  solutions  to 
specific problems, with possible impacts on the single market.  

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158

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Option  3:  Introduce  Intra-EU  movements  regime,  retaining  certain  elements  of  the 
current  certification  requirements  but  introducing  some  facilitation  mechanisms  (such 
as  derogations  from  the  requirement  for  health  certification)  for  low  risk  movements 
such  as  for  slaughter  or  between  adjacent  zones  of  two  MS  of  the  same  health  status 
(such as through the introduction of cross-border compartments), without the possibility 
of bi-lateral agreements.  

This  option  would  set  some  basic  principles  for  all  cross-border  movements;  keeping 
certification  as  a  baseline  requirement,  but  applying  it  in  a  much  more  risk-based  manner. 
This  baseline  requirement  would  ensure  that  movement  controls  are  retained  where  it  is 
important  to  do  so,  thus  retaining  the  low  level  of  risk  of  animal  disease  outbreaks  as  at 
present.  

More  derogations  would  be  introduced  for  low-risk  movements.  Examples  of  low-risk 
movements which could be released from the certification obligations could include animals 
moved directly to slaughter and the movement of bovine semen, hatching eggs, and day-old 
chicks,  which  all  pose  very  minimal  health  risks.  There  might  also  be  the  possibility  of 
removing  certain  cross-border  administrative  burdens  where  there  is  a  high  frequency  of 
certain  low-risk  trade  patterns  by  introducing  cross-border  compartments.  Examples  will 
include many of those high-density cross-border movements shown in Table VI.3.  

Subsidiarity  would  largely  be  retained  for  national  movements,  allowing  MSs  to  maintain 
their  own  specific  requirements  where  particular  issues  are  concerned.  Exceptions  would 
include identification and registration requirements, traceability and registration of holdings. 
Certification  would  also  be  retained  for  welfare  certification,  in  line  with  current 
requirements.  

In  addition,  certain  elements  of  the  'placing  on  the  market'  concept  could  be  introduced  for 
operators entering quality assurance schemes. For example, a farm (or other operator such as 
an  assembly  centre)  which  is  participating  in  a  quality  assurance  scheme  might  be  able  to 
obtain a 'licence' which would enable it to guarantee (with a 'stamp') any products it exports, 
rather  than  getting  individual  certification  guarantees  for  every  consignment.  Their  health 
status and compliance with the relevant scheme would need to be guaranteed through regular 
inspection.  

Option 4: Change to 'placing on the market' 

The 'placing on the market' concept was introduced in general feed and food law for products 
of  animal  origin  and  in  the  animal  health  area  for  aquatic  animals  and  animal  by-products. 
This  concept  doesn't  require  animal  health  certification  for  each  consignment,  but  (for 
aquaculture  animals)  their  health  status  is  defined  by  which  'zone'  they  originate  in.  For 
foodstuffs,  health  marking  is  used  which  is  based  on  systematic  surveillance  and  control  of 
the  Competent  Authority,  and  not  linked  to  individual  cases  or  consignments.  These  zones 
may or may not align with national borders. In practice, to guarantee the status of a particular 
zone, this means compliance with higher standards for all animals and products in all cases 
unless  there  are  possibilities  for  exemptions.  So,  movements  are  within  or  between  health 
zones rather than cross-border; and no particular guarantees or certification are required other 
than verification of the origin.  

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159

 
 
 
 
 
 
 
 
 
 
 
 
This system was developed with the aim of protecting consumers and ensuring the same level 
of protection and the same quality of products across the EU. This is fairly straightforward to 
achieve with products, which undergo certain production or treatment processes and remain in 
a controlled environment. It is less straightforward but still possible with aquaculture animals 
which are often kept and particularly transported in an isolated environment, and this concept 
was  indeed  introduced  for  aquaculture  animals  in  Directive  2006/88/EC.  This  Directive 
regulates  specific  areas  of  aquaculture  businesses,  which  are  on  the  whole  more  uniformly 
industrialised  and  business-focused  than  terrestrial  farms.  But  even  in  this  case,  certain 
certification  requirements  and  TRACES  notifications  have  been  preserved  for  movements 
between zones with different health statuses.  

If this were to be introduced for terrestrial animals, it would enable a much more risk-based 
approach to be taken to movements. Health zones would be established which would set out 
which  areas  were  high  or  low  risk  for  particular  diseases.  Animals  making  a  low  risk 
movement  would  then  have  a  lower  burden  of  proof  of  status.  Rather  than  rigid  rules  for 
crossing national borders, administrative requirements would be genuinely based on the risk 
that  a  particular  movement  posed  of  spreading  disease.  However,  there  would  be  additional 
certification  requirements  for  certain  national  movements,  when  moving  between  different 
health zones.  

However, this approach is felt by stakeholders (see consultation on artificial insemination and 
related  issues  in  Annex  V)  to  be  inapplicable  to  terrestrial  animals.  This  is  partly  because 
terrestrial  animals  are  in  constant  contact  and  interaction  with  their  natural  environment, 
including both wild fauna and flora. So, it is much more challenging to isolate them from their 
environment  and  guarantee  the  health  status  of  a  particular  geographical  area.  But  it  is  also 
because the overall context is much more complex in terms of the large number of species and 
their  interactions,  more  varied  production  types,  complexity  of  different  diseases  and  their 
epidemiology,  the  current  system  of  disease  free  statuses,  etc.  The  health  zones  for  each 
disease  for  each  animal  would  be  different,  leading  to  a  complicated  multi-layered  map  of 
different health zones. The picture would also be constantly changing. In addition, the burden 
of understanding the requirements when moving animals is on the operator, rather than on the 
certifying veterinarian, as at present. This has the potential to introduce an unnecessarily large 
administrative burden on animal keepers and dealers.  

The possibility here is that by introducing a system based on genuinely risk-based measures, a 
much  greater  degree  of  complexity  would  inevitably  (and  necessarily)  be  introduced.  This 
complexity  would  have  the  potential  to  totally  undermine  any  benefit  that  is  obtained  from 
attempting to introduce a more proportionate system.   

-  - 
160

 
 
 
 
 
 
 
 
Table VIII.4 Pros and Cons of Each Option Considered 

Pros 

(cid:131)  Safe, consistent and controllable 

(cid:131)  Would retain safety and health 

(cid:131)  Enables MS to maintain 

Option 1 

Option 2 

Option 3 

system 

(cid:131)  Animals and products checked before 

dispatch to verify health status 
(cid:131)  Low risk of disease transmission 
(cid:131)  Guarantees provided in certification 
serve for further assurance for third 
countries should the animals 
subsequently be moved out of the EU 

(cid:131)  Allows MSs flexibility to determine 
their own internal requirements 
concerning movements (should there 
be specific local circumstances such as 
lots of backyard or hobby keepers or 
less developed areas, etc) 

standards  

(cid:131)  Would resolve the administrative 
burden and expense problems of 
option 1 for low-risk short 
distance movements and 
movements for slaughter 

(cid:131)  Would not put health status of 

MSs at risk 

(cid:131)  Might discourage long distance 
movements which would have a 
positive impact on animal welfare 

specific solutions for particular 
issues 

(cid:131)  Facilitates movements by 

removing certain administrative 
burdens 

(cid:131)  Allows new options for sector 

development 

(cid:131)  Introduces a more modern 

approach towards the single 
market 

(cid:131)  Retains movement controls 
where important to do so, 
ensuring good health 
management 

(cid:131)  Provides a better and more 

proportionate risk-based system 

Option 4 
(cid:131)  Higher standards applied in all holdings 

and by all operators 

(cid:131)  Consistency: the same standards would 

apply across the EU  

(cid:131)  Would resolve some of the problems of 
Intra-Community Trade by providing a 
more proportionate risk-based system 

(cid:131)  Potentially less burdensome for 

movements between MS with the same 
health status 

(cid:131)  Potentially encourages movements 
(cid:131)  Good for big traders who often move 

animals across borders within the EU – 
potential reduction of administrative 
burden 

Cons 

(cid:131)  Often burdensome, sometimes 

unjustifiably so 

(cid:131)  Often expensive for MSs and 

stakeholders 

(cid:131)  Many notification duplications, such as 
for both the EU-wide TRACES system 
and national databases, increasing 
administrative burden and the 
likelihood of conflicting information 
being held 

(cid:131)  Not really necessary for short and low 

risk cross border movements and 
movements to slaughterhouses 

(cid:131)  Less consistent and controllable 
system (especially in the case of 
health problems such as a disease 
outbreak).  

(cid:131)  Opaque system in terms of its 

comprehensibility across the EU 

(cid:131)  Many potential bilateral 
agreements, causing 
inconsistency and confusion.  

(cid:131)  Possible problems of 

certification/guarantees not being 
available to other MSs and 
countries outside the EU if 
animals are subsequently moved. 

(cid:131)  Limitations of uses of the 

exemption for animal welfare 
reasons 

(cid:131)  Could be difficult to obtain an 

(cid:131)  Less understandable controllable 

overview if different movement 
rules for different types of 
movements  Reduction of 
administrative burden is 
somewhat limited because of 
the continued welfare 
obligations 

(cid:131)  Certification and therefore 
administrative burden still 
retained to a certain extent 
(cid:131)  Could increase the risk of 

limited control systems being in 
place and therefore increase the 
risk of lowering health status 

system 

(cid:131)  Could potentially lead to lower health 
statuses if certification is lifted for low-
risk movements 

(cid:131)  Veterinary checks for welfare purposes 

would still be required, so 
administrative burden is only partly 
lifted 

(cid:131)  Less flexibility for MS to decide on 
their own national requirements 

(cid:131)  Could be more burdensome for national 

movements if more certification 
required 

(cid:131)  Disadvantageous for small and medium 
average farms, which don't often move 
animals outside national territory, 
because increased administrative 
burden 

-  - 

161

 
 
 
 
 
 
 
Summary 

It is clear that the burden of certification is not appropriate in all current cases of movements. 
Our  goal  is  to  find  a  solution  that  eases  this  burden  and  simplifies  the  system  where 
appropriate,  without  introducing  an  overly  complex  and  confusing  system,  which  would 
undermine  the  goal  of  simplification.  While  no  option  is  entirely  without  its  disadvantages, 
option  3  seems  to  offer  us  the  most  appropriate  solution.  Option  1  offers  no  change  to  the 
status quo. Option 2, although easing some administrative burden, risks introducing a level of 
complexity  for  derogations  which  might  lead  to  confusion  at  EU  level  and  lack  of 
transparency  in  an  animal  health  emergency.  Option  4  moves  to  a  completely  risk-based 
system but introduces a vast degree of complexity in the assessment and understanding of risk 
which undermines the gains made from easing certification administrative burdens. However, 
option  3  would  allow  the  removal  or  easing  of  administrative  burden  in  low-risk  cases, 
without  introducing  the  opaqueness  of  option  2,  or  the  vast  complexity  that  option  4  would 
entail. Therefore, option 3 is the preferred option.  

Consultation:  

Consultation on this issue took place in the following forums: 

(cid:190)  within the Animal Health Law Steering group (January – July 2009) 
(cid:190)  in the framework of wide stakeholders' consultation (September – December 2009) 
(cid:190)  administrative  burden  and  administrative  costs  assessment 

including  special 
assessment  for  the  sector  for  production  of  germinal  products  (December  2009  – 
March 2010) 

(cid:190)  consultation of the sector for artificial insemination on Intra-EU trade and placing on 

the market concepts (May-September 2010) 
(cid:190)  Animal Health Advisory Committee (2008-2010) 
(cid:190)  Chief Veterinary Officers (2008-2010) 

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162

 
 
 
 
 
 
 
 
 
 
ANNEX IX  Key elements of the new Animal Health Law, including 
indicative list of existing legislation affected 

1. 

New key elements of the new AHL 

An overview of the new key elements of the new AHL, if options 4 and/or 5, as explained in 
chapter 4 of the Impact assessment is given below: 

−  Clarify and codify the obligations of animal keepers/owners/operators. 

− 

Introduce  an  obligation  to  obtain  knowledge  on  animal  health  for  animal  keepers, 
operators  and  staff  dealing  with  animals  in  order  to  increase  awareness  of  potential 
threats related to animal diseases. 

−  Clarify  and  enhance  farm  level  biosecurity  measures  to  reduce  the  risk  of  on-farm 

outbreaks.  

− 

Introduce  disease  categorisation  and  prioritisation  and  new  principles  for  the  EU 
intervention, to ensure a coherent approach to disease management. 

−  Clarify and simplify general disease control rules.  

−  Establish  an  efficient  legal  framework  to  facilitate  timely,  adequate  and  efficient 
response towards emerging and exotic diseases, in light of the disease categorisation 
and prioritisation exercise. 

− 

Introduce  a  new  regulatory  approach  concerning  EU-wide  surveillance,  to  enhance 
surveillance while ensuring that resources are used as efficiently as possible, including 
the further development of "surveillance networks". 

−  Clarify  and  codify  the  basic  principles  and  objectives  for  identification  and 

registration of animals.  

−  Clarify and simply the rules on movements of live terrestrial animals within the EU to 
better  reflect  the  actual  risk  of  disease  spread,  taking  into  account  the  burden  on 
operators  and  competent  authorities  related  to  the  movement  of  animals.  [Different 
options were considered and assessed in Annex VIII.] 

−  Clarify and codify the general animal health requirements for import of live animals 
and  products  thereof,  based  on  assessment  of  animal  health  risks  of  trade  with  third 
countries,  while  leaving  the  legal  framework  for  general  import  controls  and 
procedures to be provided by Regulation (EC) No 882/2004.  

−  Extend  the  concept  of  compartments  to  other  animal  species  and  diseases,  beyond 
existing  legislation  for  poultry  and  avian  influenza  and  aquaculture,  to  allow  for 
increased  flexibility  in  disease  control  and  encourage  the  enhancement  of  animal 
health standards. 

−  Align  the  EU  legislation  with  the  international  standards  as  far  as  appropriate  (OIE) 

without lowering EU health standards which have already been achieved. 

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163

 
 
 
 
 
 
 
2.  The  new  AHL  and  its  relationship  with  the  current  European  Animal  health 

legislation 

Currently, animal health issues are regulated in 49 different legal acts from the Council and 
European Parliament. Following a preliminary assessment, the issues covered by these legal 
the  AHL: 
acts  would 

following  manner 

dealt  with 

under 

the 

be 

in 

−  For 16 legal acts, the main provisions would be integrated in the AHL, while Annexes 
and  certain  specific  articles  would  be  integrated  in  delegated/implementing  acts  or 
subject to deregulation. 

−  For  11  legal  acts,  only  the  basic  principles  and  a  legal  basis  to  lay  down 
delegated/implementing acts would be included in the AHL, whereas the majority of 
the  provisions  would  be  included  in  delegated/implementing  acts  or  subject  to 
deregulation. 

−  For  7  legal  acts,  all  provisions  would  be  included  in  delegated/implementing  acts  or 
subject to deregulation. The AHL would only contain a legal basis to lay down those 
rules. 

−  For  3  legal  acts,  the  majority  of  the  provisions  would  be  included  in  the  general 
control framework regulation of Regulation (EC) No 882/2004 and the rest included in 
delegated or implementing acts. 

−  7 legal acts are obsolete and would be repealed. 

−  5  legal  acts  would  remain  unchanged  due  their  particular  nature,  but  the  main 
principles of the AHL will apply and they might be integrated with the AHL at a later 
stage. 

To summarise, following this exercise the AH acquis, which today consists of 49 basic legal 
acts, will be reduced to one single legal act (AHL) and 5 specific basic acts, which may also 
in the future be integrated into the AHL. In addition, an exercise will be initiated to establish a 
simplified and streamlined set of delegated and implementing acts replacing relevant parts of 
the above mentioned basic acts and the large body of current implementing acts. 

A  list  of  these  49  legal  acts,  indicating  their  relevance  for  the  AHL  or  its  subsequent 
legislation is reported below. 

-  - 
164

 
 
 
 
 
 
Table IX.1  Indicative list of existing legislation affected by the Animal 
Health Law 
Much  of  the  legislation  mentioned  below  will  simply  be  replaced  by  the  AHL.  However, 
some material changes to the legal framework are envisaged.  

A full list of proposed delegated and implementing acts to be prepared under the AHL has yet 
to be fully drawn up. Nevertheless, where material changes are envisaged to the current legal 
framework  and  their  impacts  have  not  specifically  been  assessed  in  this  impact  assessment, 
further  impact  assessments  would  be  prepared.  For  example,  impact  assessments  would  be 
needed if delegated powers are  used to significantly change the approach to  vaccination for 
particular diseases; if the requirements for electronic certification significantly changed; or if 
the  certification  and  identification  requirements  around  animal  movements  were  to  be 
considerably amended.  

No 

1. 

Celex 
number 

Title of the existing legislation 

Preliminary assessment: relevance 
for the AHL (basic act) or its 
subsequent legislation 

31964L0432  Council Directive 64/432/EEC of 26 June 
1964 on animal health problems affecting 
intra-Community trade in bovine animals 
and swine 

AHL: 

Articles 

health 
requirements  for  movements  and 
trade  principles  

setting 

Obsolete: 

Articles 

transitional 

provisions and amendments  

Delegated  or 

implementing  acts: 
Annexes;  detailed  health  provisions 
set out in certain articles  

Delegated and implementing acts 

2. 

31977L0391  Council Directive 77/391/EEC of 17 May 
1977 introducing Community measures 
for the eradication of brucellosis, 
tuberculosis and leucosis in cattle 

3. 

31978D0642  Council Decision 78/642/EEC of 25 July 

Obsolete, repeal needed  

1978 on health protection measures in 
respect of the Republic of Botswana 

4. 

31978L0052  Council Directive 78/52/EEC of 13 

Delegated and implementing acts 

December 1977 establishing the 
Community criteria for national plans for 
the accelerated eradication of 
brucellosis, tuberculosis and enzootic 
leukosis in cattle 

5. 

31979L0110  Council Directive 79/110/EEC of 24 
January 1979 authorizing the Italian 
Republic to postpone the notification and 
implementation of its national plans for 
the accelerated eradication of brucellosis 
and tuberculosis in cattle 

Obsolete, repeal needed 

6. 

31980L1095  Council Directive 80/1095/EEC of 11 

Delegated and implementing acts 

November 1980 laying down conditions 
designed to render and keep the territory 
of the Community free from classical 
swine fever 

-  - 
165

 
 
 
 
 
 
 
 
 
 
 
No 

Celex 
number 

Title of the existing legislation 

7. 

8. 

9. 

31981L0006  Council Directive 81/6/EEC of 1 January 
1981 authorizing the Hellenic Republic to 
communicate and to implement its 
national plans for the accelerated 
eradication of brucellosis and 
tuberculosis in cattle 
31982L0894  Council Directive 82/894/EEC of 21 

December 1982 on the notification of 
animal diseases within the Community 

31989D0455  Council Decision 89/455/EEC of 24 July 
1989 introducing Community measures 
to set up pilot projects for the control of 
rabies with a view to its eradication or 
prevention 

10.  31989L0556  Council Directive 89/556/EEC of 25 

September 1989 on animal health 
conditions governing intra-Community 
trade in and importation from third 
countries of embryos of domestic 
animals of the bovine species 

Preliminary assessment: relevance 
for the AHL (basic act) or its 
subsequent legislation 

Obsolete, repeal needed 

AHL: All articles  

Delegated  or 
Annexes  

implementing  acts: 

Obsolete, repeal needed 

AHL: 

Articles 

health 
requirements  for  movements  and 
trade  principles  

setting 

Delegated  or 

implementing  acts: 
Annexes;  detailed  health  provisions 
set out in certain articles  

11.  31189L0608  Council Directive 89/608/EEC of 21 

AHL: No.  

November 1989 on mutual assistance 
between the administrative authorities of 
the Member States and cooperation 
between that latter and the Commission 
to ensure the correct application of 
legislation on veterinary and zootechnical 
matters 

12.  31989L0662  Council Directive 89/662/EEC of 11 

December 1989 concerning veterinary 
checks in intra-Community trade with a 
view to the completion of the internal 
market 

13.  31990D0424 

Council Decision 90/424/EEC of 26 June 
1990 on expenditure in the veterinary 
field 

32009D0470 

Council Decision of 26 June 1990 on 
expenditure in the veterinary field 

Will be introduced in the new version of 
Regulation  (EC)  No.  882/2004  on 
official  controls  in  feed  and  food 
area  

Zootechnical  aspects  to  be  considered 

in zootechnical legislation 

AHL:  Article  9  -  Safeguard  provisions 
and  parts  of  Article  3  –  rules  for 
movements 

All  other  text  will  be  a  part  of  official 
controls  legislation  (new  Regulation 
882/04  and/or  delegated  act); 
certain parts in the AHL  

AHL: No 

A  separate 

legislative  proposal 

for 
financial rules (initiative following the 
AHL). 

14.  31990D0678  Council Decision 90/678/EEC of 13 

Obsolete, formal repeal needed 

December 1990 recognizing certain parts 
of the territory of the Community as being 
either officially swine fever free or swine 

-  - 
166

 
 
 
 
 
 
 
 
 
No 

Celex 
number 

Title of the existing legislation 

Preliminary assessment: relevance 
for the AHL (basic act) or its 
subsequent legislation 

15.  31990L0423  Council Directive 90/423/EEC of 26 June 

Obsolete, formal repeal needed 

fever free 

1990 amending Directive 85/511/EEC 
introducing Community measures for the 
control of foot-and-mouth disease, 
Directive 64/432/EEC on animal health 
problems affecting intra- Community 
trade in bovine animals and swine and 
Directive 72/462/EEC on health and 
veterinary inspection problems upon 
importation of bovine animals and swine 
and fresh meat or meat products from 
third countries 

16.  31990L0425  Council Directive 90/425/EEC of 26 June 

1990 concerning veterinary and 
zootechnical checks applicable in intra- 
Community trade in certain live animals 
and products with a view to the 
completion of the internal market 

AHL:  Article  10  -  Safeguard  provisions 
and  parts  of  Article  3  –  rules  for 
movements 

All  other  text  will  be  a  part  of  official 
controls  legislation  (new  Regulation 
882/04  and/or  delegated  act); 
certain parts in the AHL 

17.  31990L0426  Council Directive 90/426/EEC of 26 June 

1990 on animal health conditions 
governing the movement and import from 
third countries of equidae 

18.  31990L0429  Council Directive 90/429/EEC of 26 June 

1990 laying down the animal health 
requirements applicable to intra- 
Community trade in and imports of 
semen of domestic animals of the 
porcine species 

19.  32010L0158  Council Directive 2009/158/EC on animal 

health conditions governing intra-
Community trade in, and imports from 
third countries of, poultry and hatching 
eggs 

AHL: 

Articles 

health 
requirements  for  movements  and 
trade  principles  

setting 

Obsolete: 

Articles 

transitional 

provisions and amendments  

implementing  acts: 
Delegated  or 
Annexes 
health 
provisions laid down in some articles

detailed 

and 

AHL: 

Articles 

health 
requirements  for  movements  and 
trade  principles  

setting 

Delegated  or 

implementing  acts: 
Annexes;  detailed  health  provisions 
set out in certain articles 

Delegated  or 
implementing  acts: 
health 
Annexes 
provisions laid down in some articles

detailed 

and 

20.  31991D0666  Council Decision 91/666/EEC of 11 

Delegated or implementing acts  

December 1991 establishing Community 
reserves of foot-and-mouth disease 
vaccines 

21.  31991L0068  Council Directive 91/68/EEC of 28 

January 1991 on animal health 
conditions governing intra-Community 

-  - 
167

AHL: 

Articles 

health 
requirements  for  movements  and 

setting 

 
 
 
 
 
 
No 

Celex 
number 

Title of the existing legislation 

Preliminary assessment: relevance 
for the AHL (basic act) or its 
subsequent legislation 

trade in ovine and caprine animals 

trade  principles  

Obsolete: 

Articles 

transitional 

provisions and amendments  

implementing  acts: 
Delegated  or 
Annexes 
health 
provisions laid down in some articles

detailed 

and 

22.  31992D0438  Council Decision 92/438/EEC of 13 July 

AHL: No 

1992 on computerization of veterinary 
import procedures (Shift project), 
amending Directives 90/675/EEC, 
91/496/EEC, 91/628/EEC and Decision 
90/424/EEC, and repealing Decision 
88/192/EEC 

New  legal  basis  in  official  controls 
Regulation 

(new 

regulation 
882/2004) 

23.  31992L0035  Council Directive 92/35/EEC of 29 April 

AHL:  only  a  legal  basis  and  broad 

1992 laying down control rules and 
measures to combat African horse 
sickness 

outlay of the measures 

Delegated  act  and  implementing  acts: 
all  text  of  the  directive  including 
annexes 

24.  31992L0065  Council Directive 92/65/EEC of 13 July 

1992 laying down animal health 
requirements governing trade in and 
imports into the Community of animals, 
semen, ova and embryos not subject to 
animal health requirements laid down in 
specific Community rules referred to in 
Annex A (I) to Directive 90/425/EEC 

AHL: 

Articles 

health 
requirements  for  movements  and 
trade  principles  

setting 

Obsolete: 

Articles 

transitional 

provisions and amendments  

implementing  acts: 
Delegated  or 
Annexes 
health 
provisions laid down in some articles

detailed 

and 

25.  31992L0066  Council Directive 92/66/EEC of 14 July 
1992 introducing Community measures 
for the control of Newcastle disease 

AHL:  only  a  legal  basis  and  broad 
the  disease  control 

outlay  of 
measures 

Delegated  act  and  implementing  acts: 
all  text  of  the  directive  including 
annexes 

26.  31992L0102 

32008L0071 

Council Directive 92/102/EEC of 27 
November 1992 on the identification and 
registration of animals 

AHL: 

legal 

basis 

of 

identification, 
traceability  

registration 

animal 
and 

Council Directive 2008/71/EEC of 15 July 
2008 on the identification and registration
of pigs 

Delegated  and 

implementing  acts: 

Provisions of existing regulation  

Temporarily remains untouched 

27.  31992L0118  Council Directive 92/118/EEC of 17 
December 1992 laying down animal 

Delegated and implementing acts 

-  - 
168

 
 
 
 
 
 
 
 
 
No 

Celex 
number 

Title of the existing legislation 

Preliminary assessment: relevance 
for the AHL (basic act) or its 
subsequent legislation 

health and public health requirements 
governing trade in and imports into the 
Community of products not subject to the 
said requirements laid down in specific 
Community rules referred to in Annex A 
(I) to Directive 89/662/EEC and, as 
regards pathogens, to Directive 
90/425/EEC 

28.  31992L0119  Council Directive 92/119/EEC of 17 
December 1992 introducing general 
Community measures for the control of 
certain animal diseases and specific 
measures relating to swine vesicular 
disease 

AHL: basic principles of disease control 

set up in Articles  

Delegated  an 

implementing  acts: 
laid 

Annexes  and  detailed  rules 
down in articles 

29.  31995D0410  95/410/EC: Council Decision of 22 June 

Delegated and implementing acts  

1995 laying down the rules for the 
microbiological testing by sampling in the 
establishment of origin of poultry for 
slaughter intended for Finland and 
Sweden 

30.  31996L0093  Council Directive 96/93/EC of 17 

AHL: No 

December 1996 on the certification of 
animals and animal products 

31.  31997L0012  Council Directive 97/12/EC of 17 March 
1997 amending and updating Directive 
64/432/EEC on health problems affecting 
intra-Community trade in bovine animals 
and swine 
32.  31998L0099  Council Directive 98/99/EC of 14 

December 1998 amending Directive 
97/12/EC amending and updating 
Directive 64/432/EEC on health problems 
affecting intra-Community trade in bovine 
animals and swine 

Legal basis in new Regulation (EC) No 

882/2004 on official  

Same as  Directive 64/432/EEC  

Same as Directive 64/432/EEC  

33.  32000D0258  Council Decision 2000/258/EC of 20 

Delegated or Implementing acts  

March 2000 designating a specific 
institute responsible for establishing the 
criteria necessary for standardising the 
serological tests to monitor the 
effectiveness of rabies vaccines 

34.  32000L0075  Council Directive 2000/75/EC of 20 

November 2000 laying down specific 
provisions for the control and eradication 
of bluetongue 

AHL:  only  a  legal  basis  and  broad 
the  disease  control 

outlay  of 
measures 

Delegated  act  and  implementing  acts: 
all  text  of  the  directive  including 
annexes 

35.  32000R1760  Regulation (EC) No 1760/2000 of the 

AHL: 

legal 

basis 

of 

animal 

-  - 
169

 
 
 
 
 
 
 
 
No 

Celex 
number 

Title of the existing legislation 

European Parliament and of the Council 
of 17 July 2000 establishing a system for 
the identification and registration of 
bovine animals and regarding the 
labelling of beef and beef products and 
repealing Council Regulation (EC) No 
820/97 

36.  32001L0089  Council Directive 2001/89/EC of 23 

October 2001 on Community measures 
for the control of classical swine fever 
(Text with EEA relevance) 

Preliminary assessment: relevance 
for the AHL (basic act) or its 
subsequent legislation 

identification, 
traceability  

registration 

and 

Delegated  and 

implementing  acts: 

Provisions of existing regulation  

Remains untouched 

AHL:  only  a  legal  basis  and  broad 
the  disease  control 

outlay  of 
measures 

Delegated  act  and  implementing  acts: 
all  text  of  the  directive  including 
annexes 

37.  32009R0999  Regulation 999/2001/EC - laying down 

Remains untouched 

rules for the prevention, control and 
eradication of certain transmissible 
spongiform encephalophaties 

38.  32002L0060  Council Directive 2002/60/EC of 27 June 
2002 laying down specific provisions for 
the control of African swine fever and 
amending Directive 92/119/EEC as 
regards Teschen disease and African 
swine fever (Text with EEA relevance) 

39.  32002L0099  Council Directive 2002/99/EC of 16 

December 2002 laying down the animal 
health rules governing the production, 
processing, distribution and introduction 
of products of animal origin for human 
consumption 
40.  32003L0085  Council Directive 2003/85/EC of 29 
of September 2003 on Community 
measures for the control of foot-and-
mouth disease repealing Directive 
85/511/EEC and Decisions 89/531/EEC 
and 91/665/EEC and amending Directive 
92/46/EEC (Text with EEA relevance.) 

41.  32003R0998  Regulation (EC) No 998/2003 of the 

European Parliament and of the Council 
of 26 May 2003 on the animal health 
requirements applicable to the non-
commercial movement of pet animals 
and amending Council Directive 
92/65/EEC 

AHL:  only  a  legal  basis  and  broad 
the  disease  control 

outlay  of 
measures 

Delegated  act  and  implementing  acts: 
all  text  of  the  directive  including 
annexes  

AHL: Major part of the text of articles  

Delegated  and 
Annexes 

implementing  acts: 

AHL:  only  a  legal  basis  and  broad 
the  disease  control 

outlay  of 
measures 

Delegated  act  and  implementing  acts: 
all  text  of  the  directive  including 
annexes  

AHL:  Legal  basis 

for  movements, 

import  and disease control rules 

Delegated  and 

implementing  acts: 

Detailed rules and annexes 

42.  32004L0068  Council Directive 2004/68/EC of 26 April 
2004 laying down animal health rules for 

AHL: Major part of the text of articles  

-  - 
170

 
 
 
 
 
 
 
 
 
Preliminary assessment: relevance 
for the AHL (basic act) or its 
subsequent legislation 

Delegated  and 
Annexes 

implementing  acts: 

AHL: 

legal 

basis 

of 

identification, 
traceability  

registration 

animal 
and 

Delegated  and 

implementing  acts: 

Provisions of existing regulation  

Remains untouched 

AHL:  only  a  legal  basis  and  broad 
the  disease  control 

outlay  of 
measures 

Delegated  act  and  implementing  acts: 
all  text  of  the  directive  including 
annexes  

AHL:  articles  governing  aquaculture 
for 
diseases 

import, 

health 

rules 

production, 
movements, 
control rules.  

Delegated 

/ 

annexes 
provisions form articles 

and 

implementing 
some 

acts: 
detailed 

With  the  adoption  of  AHL:  obsolete  for 
the  articles  amending  animal  health 
directives.   

Remains 

in  place 

for 

the  Articles 

amending zootechnical legislation  

Remains untouched – a link in the AHL

No 

Celex 
number 

Title of the existing legislation 

the importation into and transit through 
the Community of certain live ungulate 
animals, amending Directives 
90/426/EEC and 92/65/EEC and 
repealing Directive 72/462/EEC (Text 
with EEA relevance.) 
43.  32004R0021  Council Regulation (EC) No 21/2004 of 

17 December 2003 establishing a system 
for the identification and registration of 
ovine and caprine animals and amending 
Regulation (EC) No 1782/2003 and 
Directives 92/102/EEC and 64/432/EEC 

44.  32005L0094  Council Directive 2005/94/EC of 20 

December 2005 on Community 
measures for the control of avian 
influenza and repealing Directive 
92/40/EEC 

45.  32006L0088  Council Directive 2006/88/EC of 

24 October 2006 on animal health 
requirements for aquaculture animals 
and products thereof, and on the 
prevention and control of certain 
diseases in aquatic animals 

46.  32008L0073  Council Directive 2008/73/EC of 15 July 

2008  
simplifying procedures of listing and 
publishing information in the veterinary 
and zootechnical fields and amending 
Directives 64/432/EEC, 77/504/EEC, 
88/407/EEC, 88/661/EEC, 89/361/EEC, 
89/556/EEC, 90/426/EEC, 90/427/EEC, 
90/428/EEC, 90/429/EEC, 90/539/EEC, 
91/68/EEC, 91/496/EEC, 92/35/EEC, 
92/65/EEC, 92/66/EEC, 92/119/EEC, 
94/28/EC, 2000/75/EC, Decision 
2000/258/EC and Directives 2001/89/EC, 
2002/60/EC and 2005/94/EC 

47.  32009R1069  Regulation (EC) No of the European 
Parliament and of the Council of 21 
October 2009 laying down health rules 
as regards animal by-products and 
derived products not intended for human 
consumption and repealing Regulation 
(EC) No. 1774/2002 (Animal by-products 
regulation) 

-  - 
171

 
 
 
 
 
 
 
No 

Celex 
number 

Title of the existing legislation 

48.  32003L0099  Directive of the European Parliament and 
of the Council 2003/99 on the monitoring 
of zoonoses and zoonotic agents 
amending Council Decision 90/424 and 
repealing Council Directive   92/117 

49.  32003R2160  Regulation of the European Parliament 
and of the Council (EC) No. 2160/2003 
on the control of salmonella and other 
specified food-borne zoonotic agents  

Preliminary assessment: relevance 
for the AHL (basic act) or its 
subsequent legislation 

Remains untouched 

Remains untouched 

-  - 
172

 
 
 
 
 
 
 
ANNEX X  Preliminary structure of the legislative proposal – 
options 4 and 5 

Part I General rules  

⎯  Subject matter scope etc. 
⎯  General principles 
⎯  General responsibilities 
⎯  Categorisation and prioritisation 

Part II Surveillance and disease freedom 

⎯  Surveillance general obligations (operators + MS) 
⎯  Notification (national + Union) 
⎯  Surveillance and eradication programmes 
⎯  Disease free Member States and zones 

Part III Disease prevention, control and eradication  

⎯  Disease preparedness (contingency plans, simulation, union vet experts) 
⎯  Vaccination 
⎯  Emergency measures 
⎯  Control measures A diseases 
⎯  Control measures B and C diseases 

Part IV Requirements concerning establishments, identification and registration of 
animals and movements  

Title 1 Terrestrial animals 

⎯  Registration, approval, traceability 
⎯  Movement within the Union 

Title 2 Aquatic animals 

⎯  Registration and approval 
⎯  Movement within the Union 

Title 3 Other animals 

⎯  Part 2 and 3 shall apply to extent relevant for species concerned for a disease of 

Union concern 

Part V Introduction and Export 

Part VI Transitional measures and final provisions 

-  - 
173

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
ANNEX XI   

Additional assessment on biosecurity 

Background 

Following the external evaluation of the Community Animal Health Policy, the vision of the 
AHS is to improve the prevention of animal health related problems before they happen: the 
principle  of  'prevention  is  better  than  cure'.  Biosecurity  and  systematic  surveillance  are  the 
main elements in putting this principle into practice. 

It is difficult to give a single definition of biosecurity, because of the wide use of the concept 
in many areas (human, animal, plant health) for different needs and objectives and using the 
differing  available  tools  and  resources.  Biosecurity  can  be  described  as  a  wide  set  of 
preventive and control measures, but can also be the prevention of the risk of spreading one 
specific pathogen by using only one tool, such as disinfection, for example. 

In  general,  biosecurity  is  a  set  of  precautions  taken  to  minimise  the  risk  of  the  introduction 
and  spread  of  diseases  to  humans,  animals  or  plants.  This  can  consist  of  management 
measures or physical and/or chemical measures and the measures used are often dependent on 
the nature of disease, its transmission methods and epidemiology, and climatic conditions.  
These measures could include:  

Management  measures  to  reduce  disease  risks  due  to  direct  and  indirect  contact  with 
potentially  disease-carrier  or  infected  animals,  vectors,  equipment,  means  of  transport, 
persons, or other objects such as:  

rules for movement within the different parts of the holding; 
rules and procedures for using equipment; 

-  procedures for entering / exiting the holding for persons, vehicles, animals; 
- 
- 
-  quarantine, isolation or separation of new animals;  
-  conditions for accepting the animals on holdings/farms including standstill; 
- 
- 
- 

isolation of sick animals;  
safe disposal of carcasses; 
in the case of aquatic animals, measures on water supply and discharge; 

Physical protection and hygiene barriers such as:  

-  Keeping indoors, fencing-in, providing cover for animals;  
-  cleaning and disinfection, de-infestation and pest control; 
- 

in the case of aquatic animals, natural or artificial barriers from surrounding water 
courses that prevent aquatic animals from entering or leaving the farm, including 
measures against  flooding or infiltration of water from surrounding water courses. 

Benefits of biosecurity:  

While  health  protection  benefits  from  biosecurity  measures  have  been  known  throughout 
history, it is not easy to measure their exact effect in terms of the reduction of risk of disease 
outbreaks occurring, or the reduction of the impact of a disease outbreak once it has occurred. 
Specific  case  studies  in  controlled  circumstances  would  be  extremely  difficult,  and  very 
costly to perform. Even if they were feasible, the results obtained could provide evidence only 
for a particular disease and species under certain specific climatic conditions and so could not 
be extrapolated very widely. 

-  - 
174

 
 
 
 
 
 
 
 
 
But  we  can  illustrate  the  effects  of  a  lack  of  effective  biosecurity  behaviours.  Widespread 
movements  of  animals  with  relatively  poor  biosecurity  management  measures  in  the  very 
early stages of FMD in the UK in 2001 led to the extensive spread of the disease in a very 
short time. The relevant movements are presented in a chart below.  

Chart  XI.1  Spread  of  foot  and  mouth  disease  by  livestock  moved  through  markets  before  23 
February 2001 Source: UK Department for Environment, Food and Rural Affairs (DEFRA)  

-  - 
175

 
 
 
 
 
 
In  addition,  we  can  demonstrate  that  a  lack  of  biosecurity  leading  to  the  rapid  spread  of 
disease  such  as  that  shown  above  can  lead  to  serious  economic  losses  for  the  agricultural 
industries, as well as potentially serious wider consequences. In section 5.1 of the report we 
show the economic effects of some serious outbreaks. Below is a further demonstration of the 
effects of the recent AI outbreak on poultry consumption.  

Impacts of recent Avian Influenza outbreaks on consumption (source: Eurostat) 
A special Eurobarometer survey conducted in March/April 2006 on consumers' responses in 
the  EU-  27  following  the  world  HPAI  (Highly  Pathogenic  Avian  Influenza)  outbreaks 
revealed that nearly a fifth of citizens had reduced their consumption of poultry meat (18% on 
average, with large country differences). Although three quarters of this group did so only on 
a  temporary  basis,  some  13%  intended  to  cut  down  on  consumption  permanently.  Sales  of 
poultry and eggs were reported in early 2006 to have fallen by 70% in Italy and by 20% in 
France,  following  announcements  of  AI  outbreaks  in  other  parts  of  Europe/the  world.  The 
Italian farmers' association estimated that the industry was losing €6m a day, and that it had 
lost a total of about €650m so far. 

Disadvantages of requiring more stringent biosecurity measures:  

to  Good  Hygiene  Practice  for 

Additional  costs  and  burdens  for  the  operators  are  the  main  reason  not  to  require  more 
stringent  biosecurity  measures.  These  costs  and  burdens  would  vary  across  the  agricultural 
sector, since many operators have already established well-developed biosecurity systems, but 
others  have  no  systematic  biosecurity  schemes.  The  schemes  in  highly  industrialised  food 
production and intensive farming, such as intensive poultry or pig production, are very well-
developed and require a high level of biosecurity  from  the  operator.  As  an  example  see  the 
the  Prevention  and  Control  of  Pathogenic 
'Guide 
Microorganisms with particular Reference to Salmonella in Gallus gallus (Broilers) reared for 
meat  -  on  farms'42,  or  the  examples  of  biosecurity  schemes  in  the  Danish  pig  industry,  as 
presented  at  the  CVO  seminar  in  Sweden  by  the  Danish  Agricultural  Council43.  These 
industrial  sectors  would  not  incur  much  additional  cost  or  have  large  adjustments  to  make. 
But on the other hand, much extensive animal production and particularly 'backyard' or small 
family holdings, might find it expensive, time-consuming and problematic to introduce new 
schemes. The benefits (including both the health benefits and wider economic benefits from 
reduced  disease  impact)  of  introducing  such  a  requirement  would  need  to  be  balanced  with 
the  additional  costs.  Therefore  this  issue  was  specifically  addressed  in  the  questionnaire 
addressed to operators and Competent Authorities. The results are presented below. 

Sometimes stringent biosecurity measures may have some negative consequences on animal 
welfare, for example, if animals are continually kept indoors.  

Biosecurity – data on administrative burdens and costs 

Biosecurity potential administrative burden – questionnaire results 

At  present,  few  biosecurity  rules  or  incentives  exist  at  EU  level,  and  there  are  a  variety  of 
biosecurity  guidelines  set  at  other  levels,  both  at  national  level  and  by  industry.  A 

42  http://www.avec-poultry.eu/Default.aspx?ID=4764 
43  http://www.agricultureandfood.dk/ 

-  - 
176

 
 
 
 
 
 
 
 
 
                                                 
questionnaire by the European Commission to collect information about on-farm biosecurity44 
found  that  many  biosecurity  guidelines  already  exist,  but  there  is  little  consistency  between 
guidelines in terms of their scope, coverage, degree of obligation, strength of the biosecurity 
measures and by whom they are organised. For example, the questionnaire found that current 
guidelines were mainly organised by national and local veterinary authorities and by industry, 
and  that  coverage  varied  for  different  species  and  production  systems.  Nearly  half  the 
guidelines  were  designed  to  cover  specific  animal  diseases,  but  many  also  covered  both 
infectious and non-infectious diseases and good husbandry more generally. 

Questionnaire results 

During the consultation period, questionnaires were issued to MS CA and Operators in MS to 
help provide estimates for any additional administrative burden following from the proposals 
in the AHL. The following section sets out the results of the questionnaire which are relevant 
to biosecurity. The biosecurity administrative burden calculation in the IA is based on these 
results.  

Competent Authority administrative burden 

Forty-two MS Competent Authorities responded to the questionnaire. Twenty-three of these 
were Central Authorities and the remaining respondents were at regional or local level. 

Competent  Authorities  estimated  the  average  time  (in  hours)  and  the  personnel  needed  for 
developing  protocols  or  guidelines  for  the  drafting  of  on-farm  biosecurity  plans.  For  all 
respondents,  time  to  develop  guidelines  ranged  from  16  hours  to  2,400  hours.  The  median 
time for central Competent Authorities was 200 hours. 

The  proposed  biosecurity  schemes  would  require  Competent  Authorities  to  assess  the 
biosecurity plans drafted by operators, as a desk exercise, and also perform a field inspection 
of the implementation  of  the  biosecurity plan. Responding Competent Authorities estimated 
that  on  average  each  plan  would  take  13  hours  to  assess.  On  average,  this  broke  down  as 
around  7  hours  of  official  veterinarian  time,  and  6  hours  of  policy  staff,  approved 
veterinarians,  technicians  and  others'  time.  For  the  field  inspection,  two  thirds  of  all 
respondents  thought  that  the  Competent  Authority  should  approve  biosecurity  plans. 
Estimates for the time to verify plans on the spot  ranged  from  30  minutes  to  40  hours.  The 
average time to verify the plans was 16 hours. 

All  respondents  to  the  Competent  Authority  questionnaire  thought  that  training  would  be 
necessary. They all thought that official veterinarians would need training, and the majority 
thought other types of personnel would also need training. All respondents wanted training to 
be organised at a national level, and nearly half also wanted training at regional or EU level. 
The questionnaire did not ask Competent Authorities to estimate the duration of training. 

Operators' administrative burden 

Forty-three  unique,  and  substantially  completed,  questionnaires  were  used  to  estimate  the 
administrative  burden  of  the  biosecurity  requirements.  Nearly  one  half  of  respondents  were 
animal  breeders  or  animal  producers;  the  remaining  respondents  covered  a  range  of 
stakeholder groups, including industry representatives, transporters, and zoos. Of course, this 
is a self-selecting group of respondents, so it cannot be claimed that this is representative of 
the EU as a whole. However, it gives an interesting indication of relevant views. 

44  Questionnaire to collect data on: "On-farm biosecurity guidelines for animal keepers" based on point 11.1 of 

the Programming document of the Animal Health Strategy.  
http://ec.europa.eu/food/animal/diseases/strategy/docs/draft_questionaire.pdf 

-  - 
177

 
 
 
 
 
                                                 
 
The  cost  of  drafting  a  plan  was,  on  average  €2,000,  although  a  large  range  of  costs  were 
estimated  and  varied  across  sectors.  There  was  a  positive  skew  in  the  responses  to  this 
question  –  most  results  were  clustered  around  low  drafting  costs  but  there  were  a  few 
estimates for much higher drafting costs. 

A similar pattern was observed with the estimated implementation costs, although the range 
of costs was much wider – from 'working time' only to a maximum of €365,000. The median 
implementation cost for all respondents was €10,750, although this varied between different 
sectors represented in the questionnaire. Several respondents also highlighted that there were 
likely to be ongoing costs of maintaining higher biosecurity standards. 

Chart XI.2: Median implementation cost of biosecurity plans by sector 

Median Implementation cost, by species sector

t
s
o
c

n
o

i
t
a
t
n
e
m
e
l

p
m

I

45000

40000

35000

30000

25000

20000

15000

10000

5000

0

All Respondents

Artificial Insemination
Aquaculture

Bovine

Industry Rep - multi species

Pigs

Poultry

Transport, Dealer, Assembly 

Zoo

Just over half of all respondents thought that biosecurity plans would represent cost savings. 
Those  that  thought  biosecurity  plans  would  represent  cost  savings  gave,  on  average,  lower 
and less varied costs of drafting and implementing plans. The two box plots below show how 
the drafting and implementation costs varied on whether operators believed biosecurity plans 
would represent a cost advantage: 

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178

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Charts XI.3 Distribution of drafting costs and implementation costs 

Distribution of drafting costs, 
depending on whether 
biosecurity plans represent a 
cost advantage

Distribution of implementation 
costs, depending on whether 
biosecurity plans are viewed 
as a cost advantage

25000

20000

15000

10000

g
n
i
t
f
a
r
d
f
o
t
s
o
C

5000

0

400000

350000

300000

250000

200000

n
o
i
t
a
t
n
e
m
e
p
m

l

i

f
o
t
s
o
C

150000

100000

50000

0

No

Yes

No

Yes

Do biosecurity plans represent a 
cost advantage?

Do biosecurity plans represent a 
cost advantage?

Operators  were  also  asked  whether  they  would  require  external  human  resources  help  or 
training to help fulfil the proposed biosecurity requirements. There was no overall consensus 
about  whether  these  would  be  required  in  order  to  draft  and  implement  biosecurity  plans. 
There  were  different  preferences  for  the  type  of  human  resources  and  training  required,  but 
many respondents stated that they would require assistance on several different levels. 

Incentives: 

Biosecurity  benefits  the  farming  industry  as  a  whole,  but  individual  farmers  do  not  always 
have  a  personal  incentive  to  optimise  their  biosecurity  measures.  We  discuss  this  in  some 
detail in the main text of the impact assessment.   

Options Considered: 

A.  Promote  existing  best  practices  for  biosecurity  at  EU  level,  and  encourage 
stakeholders  to  further  develop  these,  but  with  no  introduction  of  additional  legal 
measures. 

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179

 
 
 
 
 
 
 
 
 
 
 
 
 
 
B.  Establish a legal framework for the voluntary introduction of biosecurity measures at 
farms.  Encourage  implementation  by  providing  incentives  such  as  trade-facilitation 
mechanisms  and  reducing  the  number  of  controls.  Legislation  would  set  minimum 
criteria for biosecurity measures, allowing them to be adapted to local circumstances. 
Guidelines  at  EU/national  level  would  be  drafted  to  facilitate  compliance  with  this 
obligation.  

C.  Lay down the obligation to adopt biosecurity measures for all EU farms. Legislation to 
establish the minimum criteria for biosecurity measures, providing some flexibility to 
adapt them to local circumstances. Guidelines at EU/national level would be drafted to 
facilitate compliance with this obligation. 

Assessment of options: 

Option  A:  Promote  existing  best  practices  for  biosecurity  at  EU  level,  and  encourage 
stakeholders to further develop these, but with no introduction of additional legal measures.  

This option would not impose any additional burdens or costs to the food production sector 
EU-wide other than those which they voluntarily incur, but would not meet the objectives of 
the  AHS  nor  meet  the  expectations  of  the  industry.  Above  all,  it  would  not  fit  with  the 
prevention principle, and would retain existing animal disease risks.  

This option is a sub-set of option 3 in the main impact assessment text – using the existing 
legal framework but promoting best practice guidelines.  

Option B: Establish a legal framework for the voluntary introduction of biosecurity measures 
at  farms.  Encourage  implementation  by  providing  incentives  such  as  trade-facilitation 
mechanisms and reducing the number of controls. Legislation would set minimum criteria for 
biosecurity  measures,  allowing  them  to  be  adapted  to  local  circumstances.  Guidelines  at 
EU/national level would be drafted to facilitate compliance with this obligation.  

This option aims at introducing basic biosecurity rules in order to protect against the risk of 
spreading diseases and to ensure farmers within the EU take their responsibilities seriously. It 
could be a flexible option adjusted to local circumstances in MS, and also be adjusted to the 
differing needs of specific sectors (poultry, pigs, bovines, semen collection centres, etc).  

It  would  also  promote  a  higher  level  of  biosecurity  for  those  who  wish  to  enter  quality 
assurance  schemes  and  benefit  from  incentives  such  as  easier  trade,  possible  additional 
financial and health benefits, lower production losses, and international trade advantages. This 
option would entail certain obligatory costs and burdens, but to a much lesser extent than for 
option  C  (see  below),  and  only  for  those  sectors  which  have  few  existing  biosecurity 
guidelines or requirements for primary production in animal health and food safety.  

The  flexibility  of  this  option  avoids  the  universal  implementation  of  potentially  large  costs 
that option C entails (see below). The decision about whether a higher level of biosecurity is 
economically  worthwhile  is  therefore  left  to  the  individual  farmer  or  manager,  and  will 
encourage the implementation of plans where benefits will be gained.  

This option is a sub-variant of option 4 in the main text of the Impact Assessment – a flexible 
framework.   

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180

 
 
 
 
 
 
 
 
 
 
 
 
 
 
Option  C:  Lay  the  down  the  obligation  to  adopt  biosecurity  measures  for  all  EU  farms. 
Legislation  to  establish  the  minimum  criteria  for  biosecurity  measures,  providing  some 
flexibility  to  adapt  them  to  local  circumstances.  Guidelines  at  EU/national  level  would  be 
drafted to facilitate compliance with this obligation. 

This option would likely reduce the risks of spreading animal diseases (assuming widespread 
compliance  with  the  legislation)  as  it  would  require  a  relatively  high  level  of  biosecurity 
(every  farm  or  holding  drafting  their  own  plan  as  envisaged  in  the  questionnaire  outlined 
above). Different production systems in  different geographical contexts entail very  different 
levels  of  biosecurity  risk,  and  therefore  an  appropriate  level  of  biosecurity  for  a  particular 
farm or holding can vary very significantly. The measures taken need to be adjusted to local 
circumstances.  

Nevertheless,  it  would  impose  very  significant  costs  and  administrative  burdens  in  some 
sectors, particularly those who do not currently have widespread biosecurity measures or self-
regulated  guidelines  or  plans.  It  is  difficult  to  extrapolate  exactly  the  administrative  burden 
associated with implementing this option EU wide. However, it is clear from the answers to 
the questionnaires above that many stakeholders consider that this would be an unnecessary 
and  burdensome  option.  Leaving  aside  the  need  for  Competent  Authorities  to  develop 
guidance, the average time needed by them to assess and verify each plan would on average 
be 29 hours. If the number of agricultural holdings across the EU is 7,310,00045, this amounts 
to 212,000,000 hours.  

The  cost  to  operators  is  more  difficult  to  assess  as  some  operators  will  already  have  quite 
significant  measures  in  place,  while  others  would  need  to  introduce  considerable  changes. 
Taking the average cost of drafting and implementing a plan as €12,750, this would represent 
a total cost of €93.2bn across EU farming. In  2009, the gross value added (GVA) at producer 
prices  of  all  EU  farming  amounted  to  €125  billion 45.  So,  the  estimated  costs  of  introducing 
biosecurity plans would represent some 75% of the total annual GVA of agricultural output. It 
would be extremely hard to demonstrate that the benefits of introducing universal biosecurity 
plans would generate anything like the total costs involved, so under these assumptions, these 
measures can be said to be completely disproportionate.  

Another  thing  to  consider  in  setting  a  very  high  regulatory  bar  is  the  serious  risk  of  non-
compliance. The potentially large costs involved in implementing biosecurity plans across the 
board risks a high level of non-compliance, thus undermining the objective of the legislation 
and the credibility of the EU.   

This  option  is  a  sub-set  of  the  strict  framework  of  option  5  in  the  main  text  of  the  impact 
assessment.  

45  Eurostat Pocketbooks Agricultural Statistics 2008/09 

http://epp.eurostat.ec.europa.eu/cache/ITY_OFFPUB/KS-ED-10-001/EN/KS-ED-10-001-EN.PDF  

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181

 
 
 
 
 
 
 
 
 
 
 
 
 
                                                 
 
Table XI.1: Options Compared 

Option A 

Pros  (cid:131)  no additional costs or 

burdens for farmers 

(cid:131)  does not entail the 

negative impacts of 
biosecurity measures on 
welfare (for example 
keeping animals 
continually indoors) 

Option C 
(cid:131)  harmonised biosecurity 
systems, preventive 
approach taken EU-
wide 

(cid:131)  higher protection 

against the risks of 
spreading disease and 
therefore lower 
expected incidence of 
disease 

(cid:131)  fewer diseases leading 
to fewer associated 
animal welfare 
problems 

(cid:131)  farmers taking more 

responsibility 

Option B 
(cid:131)  introduction of a basic 
level of protection 
against the risks of 
spreading diseases  
(cid:131)  farmers taking more 

responsibility 

(cid:131)  incentives for those who 
wish to develop more 
advanced systems 
(cid:131)  beneficial impacts on 
animal welfare, since 
fewer diseases 

(cid:131)  system more tailored to 
specific circumstances; 
subsidiarity respected 

(cid:131)  avoids imposing 

disproportionate burdens 
on  local farming 
practices and local 
economies 

Cons  (cid:131)  current risks of health 

(cid:131)  a certain level of 

threats persist  

(cid:131)  costs because of impacts 
of diseases, when they 
occur (direct and indirect 
costs for farmers) 
(cid:131)  negative impacts on 

animal welfare, when 
more animals are sick; 
necessity to cull animals 
in restricted zones due to 
welfare reasons, etc. 

additional costs and 
burdens introduced in 
many cases 

(cid:131)  possible negative 

impacts of biosecurity 
measures on welfare (for 
example: keeping 
animals indoors) 

(cid:131)  very high additional 
costs and/or burdens 
for many farmers EU-
wide 

(cid:131)  no incentives for those 
who wish to do more 
than the minimum 
required 

(cid:131)  rigid biosecurity 
measures may 
negatively impact 
animal welfare 

Summary  

Option B is clearly the most viable option. Option C is too administratively burdensome for 
many sectors, requiring them to make very large and potentially expensive changes which are 
not necessarily proportionate to the risk they bear. And to do nothing, as in option A, would 
mean continuing with the present situation, which, while not causing massive problems, could 
be  improved.  Option  B  offers  a  good  solution:  requiring  a  basic  level  of  biosecurity  which 
could be tailored to specific MSs, sectors, production methods, and other circumstances; but 
is  not  too  unnecessarily  administratively  burdensome.  It  would  also  encourage  those  who 
wish to introduce biosecurity measures at a higher level than the legal baseline.  

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182

 
 
 
 
 
 
 
 
 
 
 
 
 
Consultation 

Consultation on this issue took place in the following forums: 

(cid:190)  within the Animal Health Law Steering group (January – July 2009) 
(cid:190)  in the framework of wide stakeholders' consultation (September – December 2009) 
(cid:190)  administrative  burden  and  administrative  costs  assessment 

including  special 
assessment  for  the  sector  for  production  of  germinal  products  (December  2009  – 
March 2010) 

(cid:190)  Seminar on biosecurity; Chief Veterinary Officers (2009) 
(cid:190)  Animal Health Advisory Committee (2008-2010) 

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183