COMMISSION STAFF WORKING DOCUMENT EXECUTIVE SUMMARY OF THE 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) 160 final 

COMMISSION STAFF WORKING DOCUMENT 

EXECUTIVE SUMMARY OF THE 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) 161 final} 

EN 

   EN 

 
 
 
 
  
 
 
1.  Problems identified 

Background 

1.  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.  The  value  of  livestock  farming  output  in  the  EU  is 
€149 billion  annually.  Animals  are  also  pa rt  of  aquaculture,  are  companion 
animals,  are  farmed  for  fur,  and  are  used  in  or  form  part  of  various  other 
activities such as experimentation, zoos, circuses, entertainment and sporting 
pursuits.  

2.  EU intervention is currently focused primarily on the prevention and control 
of  transmissible  diseases  that  can  have  significant  health  and  economic 
impacts. The impacts of an animal disease outbreak can vary widely, usually 
posing a direct risk to animal and often public health. However, there can also 
be  other  negative  indirect  impacts,  such  as  economic  or  social  effects, 
including  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. 

3.  The current EU animal health legislative framework involves around 50 basic 
directives  and  regulations,  some  of  them  adopted  as  early  as  1964.  The 
veterinary acquis communautaire now covers more than 400 acts. 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  and  the  Common 
Agricultural Policy.  

Consideration of current policy and problems identified 

4. 

In  2004,  the  Commission  launched  an  independent  evaluation  to  assess  the 
performance  of  the  Community  Animal  Health  Policy  (CAHP)  over  the 
previous  decade.  The  EU  Animal  Health  Strategy  2007-2013  (AHS)  was 
developed  as  a  result  of  the  outcome  of  this  exercise.  Stakeholders  and 
competent authorities of the Member States were asked to identify problems 
with  current  legislation  on  animal  health  as  part  of  the  Animal  Health  Law 
Steering  Group.  The  CAHP  Evaluation  and  the  stakeholders'  consultation 
broadly agreed that the current system functioned well, however a number of 
issues were identified that need improvement.  

5.  The  main  problems 

identified  during 

the 
stakeholders  were:  the  high complexity of the current CAHP; the lack of an 
overall animal health strategy; and an insufficient focus on disease prevention 
(with  a  particular  focus  on  the  need  for  increased  biosecurity).  A  specific 
policy issue was also identified related to intra-EU trade in live animals. Each 
of these is explained in greater detail below.  

the  CAHP  evaluation  by 

6.  Both the need for simplification and the need for changes in policy proposed 

in this exercise were identified and emphasised by the stakeholders. 

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High complexity of current policy 

legal  experts.  Second, 

responsibilities  without  consulting 

7.  The  current  CAHP  is  highly  complex  in  a  number  of  ways.  First,  the  large 
number  of  pieces  of  animal  health  legislation  means  that  it  is  difficult  for 
those directly affected (such as farmers and other stakeholders) to understand 
the 
their 
responsibilities and obligations of animal keepers are not always clear. Some 
existing  responsibilities  are  not  consistent  across  different  pieces  of 
legislation,  and  some  are  interpreted  differently  in  different  Member  States. 
This could potentially lead to problems if the legislation does not adequately 
reflect the roles and needs of animal keepers. In addition, differences across 
Member States can lead to an uneven playing field for animal keepers when it 
comes  to  complying  with  their  legal  duties.  Third,  the  rules  for  commercial 
farming  do  not  always  apply  in  a  proportionate  manner  to  non-commercial 
animal  keeping.  Non-commercial  animal  keeping  (such  as  that  in  hobby  or 
backyard  holdings)  usually  entails  a  different  kind  and  level  of  disease  risk 
compared  to  industrial  farming  and  the  administrative  burdens  imposed  on 
non-commercial  animal  keeping are not always  proportionate  to  the level  of 
disease  risk.  Fourth,  the  definition  of  the  role  of  the  veterinary  services  has 
aspects  of  legal  uncertainty  that  need  to  be  rectified  to  ensure  that 
veterinarians  are  clear  about  their  legal  duties,  to  avoid  conflicts  of  interest, 
and to encourage the development of better veterinary networks. Fifth, there 
is currently a lack of rules on the professional qualifications and training for 
official  and  approved  veterinarians,  which  can  lead  to  differences  between 
levels of health protection across Member States and within the single market. 
Sixth,  specific  animal  health  conditions  relating  to  imports  are  difficult  to 
understand and apply. This creates complexity and administrative burden for 
competent authorities, importers and third countries who may find it difficult 
to understand their legal duties.  

Lack of single overall animal health strategy 

8.  There is a lack of a single overall animal health strategy. The final report of 
the CAHP evaluation highlighted the lack of a single general approach behind 
the  CAHP.  Instead,  the  CAHP  is  perceived  to  be  a  patchwork  of  specific 
measures  and  actions,  with  inconsistent  objectives  and  an  unclear  overall 
direction.  Resources,  personnel  and  management  attention  have  tended  to 
follow animal health crises with a subsequent tendency to reduce focus on the 
definition and achievement of longer-term strategic objectives. There are four 
main  problems  here.  First,  the  lack  of  categorisation  and  prioritisation  of 
animal  disease  policy  measures.  This  has  often  led  to  a  tactical  rather  than 
strategic, and therefore (in the long term) sub-optimal allocation of resources 
for disease control. Second, there is still poor co-ordination of animal disease 
surveillance  with  various  surveillance  systems  and  actors  not  working 
together  in  the  most  effective  ways  possible.  A  better  co-ordination  effort 
could  reduce  the  risk  and  impact  of  disease  outbreaks.  Third,  there  is 
insufficient  harmonisation  of  EU  legislation  with  agreed  international  (OIE, 
the  World  Organisation  for  Animal  Health)  standards.  Greater  convergence 
would  lead  to  improved  competitiveness  in  international  markets  and  would 
avoid  trade  disputes  (whilst  respecting  the  need  to  retain  the  high  health 
standards  expected  in  the  EU).  Fourth,  a  long-term  view  of  emerging,  re-
emerging  and  exotic  diseases  is  not  sufficiently  taken  in  current  EU 

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legislation.  There  is  a  need  to  promote  a  more  strategic  outlook  in  order  to 
respond to, control and monitor future disease threats.  

Prevention rather than cure 

9.  Lastly, there is an insufficient focus in the current EU framework on disease 
prevention  rather  than  cure.  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 
the  WHO  (World  Health  Organisation),  OIE  (World 
developed  by 
Organisation  for  Animal  Health)  and  FAO  (Food  and  Agriculture 
Organisation).  Its  importance  is  not  limited  to  the  rural  economy  but  has  an 
impact on the whole of society. 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. This deficit manifests itself 
in poor co-ordination of animal disease surveillance and monitoring, as noted 
above;  the  lack  of  EU  level  promotion  of  biosecurity  measures  on-farm  to 
prevent  disease  outbreaks;  the  absence  of  a  vaccination  strategy  to  better 
prevent  and  control  animal  diseases;  and  the  inconsistent  provisions  on 
training in animal health for those dealing with animals.  

Intra-EU trade in live animals 

10.  Whilst the previously described problems fit under the thematic headings, the 
CAHP  evaluation  steering  group  and  the  wide  public  consultation  both 
highlighted  problems  with  intra-EU  trade  that  fell  under  several  of  these 
different  categories.  First,  the  current  animal  health  rules  for  intra-EU  trade 
are not always proportionate to the animal health risks posed by movements. 
In  particular,  some  low-risk  movements  are required to comply  with  stricter 
requirements  than  necessary.  Second,  in  many  cases,  there  is  replication  of 
procedures  which  adds  to  the  administrative  burden  associated  with 
movements.  Third,  the  concept  of  compartmentalisation  has  been  used 
successfully in some areas, but not yet extended to other appropriate parts of 
EU animal health law, and could be in the future.  

2.  Analysis  of  Subsidiarity:  is  EU  action  justified  on  grounds  of 

subsidiarity?  

11.  Articles  43,  114  and  168  of  the  Treaty  on  the  Functioning  of  the  European 
Union  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.  

12.  The need for action passes the 'necessity test' and the 'added value test'. The 
objectives  of  animal  health  policy  cannot  be  achieved  by  Member  States 
acting alone, and can be better achieved by the EU acting in harmony. In very 
general  terms,  good  animal  health  gives  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  and  trans-
boundary  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.  Therefore,  both  in  'peace  time'  and  in  the  case  of  an  outbreak,  the 

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cost  of  not  having  action  at  an  EU  level  is  potentially  much  greater  than 
working together.  

13.  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.  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.  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 Member States on the international scene. 

14.  Trans-boundary spread of animal diseases is a permanent threat for livestock 
keepers  and  Member  States  as  it  can  have  major  economic  implications  for 
both the private and public sectors. Many diseases 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 
Member  States  (for  example,  classical  swine  fever  in  wild  boar  posing  a 
potential  threat  to  farmed  pigs).  For  this  reason  control  measures  and 
harmonised surveillance systems are needed at EU level. 

15.  Given  the  above,  the  future  legislation  should  confirm  the  high  degree  of 
competence already attributed to the EU in this area during the last decades, 
which is well accepted by the Member States and stakeholders alike. 

3.  Objectives of EU initiative: What are the main policy objectives? 

16.  The  EU  as  a  whole  is  working  towards  the  objectives  of  the  Europe  20201 
strategy.  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 and thus contributing to smart, 
inclusive and sustainable growth. 

17.  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  wider 
agricultural and environmental issues such as invasive alien species.  

1 

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

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18.  The general objectives of EU animal health policy are as outlined in the EU 

Animal Health Strategy 2007-2013, and are:  

Goal 1 

− 

− 

− 

− 

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  threats  and  minimise  environmental  impacts  in  support  of 
the EU Sustainable Development Strategy.  

19.  Animal  welfare  in  particular  has  close  links  with  animal  health  and  any 
objectives  for  animal  health  need  to  pay  full  regard  to  the  welfare 
requirements  of  animals,  in  accordance  with  Article  13  of  the  Treaty  on  the 
Functioning of the European Union (TFEU).  

20.  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.  

21.  The  scope  of  this  exercise  is  to  build  a  simplified  and  more  coherent 
legislative  framework  for  animal  health,  based  on  good  governance  and 
compliant with international (e.g. OIE) standards.  

22.  The  report  outlines  the  specific  and  operational  objectives  of  the  Animal 

Health Law in more detail.  

4.  Policy Options 

23.  In  order  to  solve  the  problems  identified  and  achieve  the  above-mentioned 
operational objectives, we have considered the 5 policy options below.  

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

25.  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. 
Changes  would  only  be  made  as  circumstances  required,  and  in  order  to 
comply with the Lisbon Treaty.  

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26.  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  (self-regulation  is 
defined by the Commission as "voluntary agreements between private bodies 
to solve problems by taking commitments between themselves").  

27.  Option 4: A new simplified flexible general legislative framework on animal 
health issues, based on achieving certain animal health outcomes. Under this 
option,  a  new  simplified  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  Member  States  to  apply  EU  rules  as  appropriate  in  accordance  with 
local circumstances to achieve the desired outcomes. 

28.  Option 5: A new prescriptive legislative framework on animal health issues, 
based  on  setting  specific  processes  and  standards  for  animal  health  policy. 
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  Member  States,  with  little  flexibility  for  Member  States  to  adapt  the 
rules to their differing circumstances. 

5.  Assessment of impacts 

Option 1 – No Change 

29.  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.  

30.  The  no  change  option  has  already  been  rejected  by  both  the  impact 
assessment  for  the  Animal  Health  Strategy  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 the report.  

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

31.  This  option  assumes  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 objectives and 
developments set out in the AHS.  

32.  Animal  health  policy  would  not  change  materially;  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 and duplications avoided.  

33.  However,  the  existing  legislation  has  no  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  aquis,  really  achieving  very  little  in  the  way  of 
genuine simplification, so the objectives set out in the AHS will not be met.  

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Option 3 – Existing legal framework with more self-regulation  

34.  This option is 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 
Member  States  either  developing  guidance  and  best  practice  to  improve 
animal  health  measures  or  encouraging  stakeholders  to  do  so.  These  would 
complement  the  existing  animal  health  legal  framework  and  would  aim  to 
achieve  better  prevention  of  animal  diseases.  Legislation  would  be  updated 
individually as necessary to comply with new requirements (such as the new 
decision-making  processes  following  the  introduction  of  the  Lisbon  Treaty), 
or with technological developments. 

35.  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  the  animal  disease  risks 
and responsibilities of 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. 

36.  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. 

Option 4 – flexible general legislative framework for animal health issues 

37.  The economic and public health impacts of option 4 are expected to be largely 
positive. First, there are the benefits expected from reduced disease instance. 
Overall,  resources  will  be  better  targeted  according  to  risk,  saving  time  and 
money. A strategy to make the best possible use of vaccines will be developed 
and  may  have  positive  economic  impacts  in the reduction of the instance of 
animal disease and all the associated positive impacts.  

38.  Undoubtedly  there  would  be  some  initial  impact  from  the  need  for 
familiarisation  with  the  new  legislative  framework  for  farmers  and  other 
animal  keepers  as  well  as  competent  authorities.  Nevertheless  this  initiative 
aims to simplify existing legislation, so it is considered that any burden will 
actually  be  very  limited,  and  derogations  introduced  where  appropriate. 
Where new measures might be introduced, such as for biosecurity, they will 
be  based  on  giving  possibilities  and  incentives  to  improve  rather  than 
introducing  compulsory  measures.  This  means  e.g.  that  the  additional 
familiarisation and implementation will be the farmer's or operator's choice to 
create  positive  (economic  and  animal  health)  benefits.  As  due  to  the  very 
nature of animal diseases, regular updates of valid rules are already a standard 
procedure;  one-off  familiarisation  costs  are  likely  to  be  integrated  into 
business-as-usual  costs.  In  the  long  term,  the  simplified,  more  coherent 
strategic framework should benefit all, and in particular, make more sense to 

8

 
 
those learning about their obligations for the first time (for example, for new 
entrants to farming).  

39.  Overall and in the long term, it is fair to assume that a simplified, 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, 
low-risk  situations  where 
appropriate,  and  enabling  Member  States  to  tailor  any  administrative 
obligations to that which is only strictly necessary according to a reasonable 
assessment of risk.  

introducing  derogations  for 

40.  There  are  three  examples  that  were  felt  particularly  important  to  analyse  in 
more detail: biosecurity, trade and vaccination, which are set out in the report 
text  and  in  some  detail  in  the  accompanying  annexes  to  this  report.  An 
example  of  the  potential  impact  on  administrative  burden  is  summarised  in 
Table 5.2 of the main report.  

41.  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  the  same  standard  of  safety  of  animals  and  animal 
products.  

42.  Assuming that there is a reduced instance of animal disease outbreaks, we can 
extrapolate  several  other  positive  environmental  impacts.  Animal  diseases 
found  in  kept  animals  can  have  negative  impacts  on  wildlife  (for  example, 
avian flu, as wild birds may not only actively spread this disease to domestic 
poultry  but  also  be  infected  by  domestic  poultry).  Thus  reducing  their 
incidence should have an overall positive impact on wildlife. 

Option 5 – prescriptive general legislative framework for animal health issues 

43.  Option 5 is likely to lead to a significant reduction in the instance of animal 
disease in the EU, with all the associated economic, social and environmental 
benefits analysed in some detail in the report. However, option 5 is likely to 
have a significant administrative burden. In addition, more prescriptive rules 
are  likely  to  become  obsolete  much  more  quickly  with  environmental  and 
technological changes.  

44.  Option 5 should entail a reduction in animal disease, but 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  that  in  option  4.  It  depends at what level  resources are  applied 
and  standards  are  set.  One  could  assert  that  (assuming  the  same  level  of 
resources  applied  to  each  option)  a  good risk-based application  of resources 
will have a more beneficial effect than a uniform standard applied across the 
board. 

45.  The  administrative  burden  for  Member  States  is  potentially  very  large  with 
this  option.  The  size  of  the  burden  would  depend  on  exactly  how  it  was 
implemented,  but  if  there  were  requirements  for  Member  States  to  provide 
training  for  animal  keepers;  as  well  as  developing,  administering  and 

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enforcing  new  animal  health  measures  in  biosecurity  and  surveillance;  the 
burdens would be very significant. 

46.  The  prescriptive  legislative  framework  will  set  the  knowledge  and  skills 
which  much  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 is easier 
for  official  and  approved  veterinarians  to  work  in  other  Member  States 
without compromising health standards. 

47.  There  should 

impacts 

largely  be  positive  environmental 

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,  including  welfare  impacts.  It  is  very  difficult  to  assess  even 
the relative direction of travel here, let alone to quantify the expected impacts. 

from 

6.  Comparison of Options 

48.  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  Member  States  or  areas,  and  to  adapt  to  rapidly 
changing  circumstances.  Therefore,  it  is  also  the  option  which  best  respects 
the  principles  of  subsidiarity  and  proportionality.  Options  2  or  3,  while 
offering more continuity with the present context, simply lack any guarantee 
of positive outcomes, and retain 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, so potentially undermining its own 
objectives.  

49.  The  main  benefit  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 it was felt to be unnecessary 
or inappropriate to cover a specific issue 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.  

10

 
 
Table 6.1: Comparison of Options 3-5 

Option 3 

Objectives 
Effectiveness  Option 3 has a range 
of 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 
objectives 

EU 

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

Option 4 

Option 5 

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

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. 

++ 

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.  

+ 
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 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.  
+ 

- 

++ 

11

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
7.  Monitoring and Evaluation  

50.  Simple  and  reliable  performance  indicators  will  help  to  measure  progress. 
They should cover both hard indicators of animal health and softer indicators 
tracking the confidence, expectations and perceptions of European citizens.  

51.  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  Animal 
Health  Law  has  succeeded  in  its  objectives.  Nevertheless,  a  series  of 
measurements over a fairly generous timeframe should give an indication of 
the general direction of travel.  

52.  Examples of what the hard indicators of success are:  

− 

the  proportion  of  EU  veterinary  expenditure  for  eradication  and 
monitoring measures vs. emergency measures;  

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

regulated notifiable diseases;  

− 

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

−  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.  

53.  As  noted  above,  this  impact  assessment  is  necessarily  a  wide-ranging 
overview. When specific secondary legislative measures are introduced, more 
specific impact assessments will likely 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.  

12