Commission staff working paper accompanying the proposal for a directive of the European Parliament and of the Council on the protection of animals used for scientific purposes - Summary of the impact assessment {COM(2008) 543} {SEC(2008) 2410}
Date: 2008-11-05
Institutions: European Commission
Subjects: European convention, animal experimentation, animal welfare

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COMMISSION OF THE EUROPEAN COMMUNITIES 

Brussels, 5.11.2008 
SEC(2008) 2411 

COMMISSION STAFF WORKING PAPER 

accompanying the 

Proposal for a 

DIRECTIVE OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL 

on the protection of animals used for scientific purposes 

SUMMARY OF THE IMPACT ASSESSMENT 

{COM(2008) 543} 
{SEC(2008) 2410} 

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SUMMARY 

1. What are the problems? 

Directive  86/609/EEC  is  the  central  legislative  act  of  the  European  Community  aiming  at 
harmonising  Member  States'  rules  protecting  animals  used  for  experimental  and  other 
scientific purposes. It was adopted in 1986 and has never been significantly changed. Since 
the  adoption  of  the  Directive,  significant  progress  in  experimental  techniques  has  been 
achieved  and  new  scientific  knowledge  about  the  capacity  of  animals  to  feel  pain  and 
suffering has become available. Furthermore, the ethical dimension of the use of animals for 
experiments  is  not  sufficiently  reflected  in  the  current  provisions  of  the  Directive.  The 
Directive  does  not  explicitly  refer  to,  nor  ensure  the  full  application  of  the  Three  Rs 
principle1,  even  though  it  is  now  recognised  as  the  leading  principle  in  this  field  by  all 
stakeholders. 

To  compensate  for  these  weaknesses,  a  number  of  Member  States  have  gone  further  when 
adopting  national  measures.  This  has  resulted  in  a  highly  diversified,  unequal  competitive 
environment for industry and the research community, defeating the objective of the Directive 
to  avoid  fragmentation  of  the  internal  market.  Furthermore,  the  wording  of  the  Directive, 
closely  following  that  of  an  international  Convention,  results  in  unclear  provisions, 
inconsistencies and ambiguities, causing transposition problems. 

The problem analysis confirmed that four problems appear across 12 policy areas: 

a)  Economic  problems  affecting  the  internal  market  include  competitive  disadvantages  for 
countries  with  high  animal  welfare  standards  resulting  primarily  from  price  differences, 
diverging regulatory and authorisation procedures and criteria in the Member States leading to 
variable  cost  of  projects  and  delays,  unsatisfactory  (working)  conditions  of  researchers, 
obstacles to horizontal mobility and increasing activist  criminality. Similar problems can  be 
identified for the breeders and suppliers of animals, especially in terms of the cost of housing 
and care. 

b)  Animal  welfare  problems  relate  to  different  levels  of  animal  welfare  resulting  from 
different  standards  that  are  in  force  and  from  a  relatively  high  number  of  animals  not 
protected by national legislation. 

c) Scientific problems concern low innovation and poor quality science resulting from project 
delays, potentially unnecessary duplication of experiments, low incentive to develop and use 
alternative methods, risk of variable research results  due  to non-consistent scrutiny of  study 
design and implementation of refinement, and obstacles to free movement of researchers. 

d) Public/societal problems occur due to the increasing dissociation between weak legislation 
and  strong  public  concern,  evolving  from  changed  ethical  and  societal  values  and  increased 
public interest in the acceptability of animal testing.  

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The  Three  Rs  Principle  (Replace,  Reduce  and  Refine  the  use  of  animals  in  experiments)  is  widely 
accepted as the guiding principles when using animals in experiments both at national and international 
(e.g. OECD, OIE) level. It dates back to the book "The Principles of Humane Experimental Technique" 
by W.M.S. Russell and R.L. Burch in 1959. 

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2. What are the policy objectives? 

The main objective of the European Commission in this field is to create a level playing field 
for  researchers  and  industry.  At  the  same  time,  in  line  with  the  Animal  Welfare  Protocol 
annexed  to  the  EC  Treaty,  the  proposal  will  aim  at  increasing  the  level  of  welfare  and 
protection of animals used in experiments. 

Increased uptake of alternative methods will boost EU industry. The revision of the Directive 
also  strives  to  simplify  the  regulatory  environment  and  ensure  the  competitiveness  of  EU 
research and industry. 

3. What are the policy options? 

Four basic policy options for achieving the objectives have been screened: deregulation, no-
policy-change, self-regulation and reinforcement of the existing Directive. Only an upgrade of 
Directive 86/609/EEC proved viable. 

25 specific options were analysed:  

I. Scope 

The options include extending the scope of animals and procedures covered under the current 
Directive 86/609/EEC to cover: 

Option 1: animals used in basic research 

Option  2:  animals  bred  for  their  tissue  and  organs  to  be  used  in  experiments  or  for  other 
scientific purposes  

Option 3: selected invertebrates species 

Option 4: embryonic and foetal forms from the last third of gestation until birth 

Option 5: animals used in education and training 

II. Authorisation of projects 

A  level  playing-field  should  be  established  to  guarantee  minimum  requirements  for  the 
authorisation of projects, while safeguarding competitiveness in the field of research: 

Option 1: Authorisation of individual projects within 30 days 
Option 2: Authorisation of a group of projects for regulatory testing 

III. Ethical Evaluation of projects  

The  revised  Directive  could  make  an  ethical  evaluation  of  all  projects  using  animals 
mandatory and set out minimum requirements. 

Option 1: Compulsory ethical evaluation of projects with minimum requirements 

Option 2: Introduction of retrospective assessment of all projects 

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IV.  Permanent  Ethical  Review  Body  and  National  Animal  Welfare  and  Ethics 
Committee 

A  combination  of  a  national  animal  welfare  and  ethics  committee  for  ethical  review  co-
ordination  and  an  ethical  review  body  at  establishment  level  could  ensure  consistent  ethical 
review. 

Option 1: National animal welfare and ethics committee 

Option 2: Permanent ethical review body in each establishment 

V. Housing and care standards 

The Directive could incorporate elements of the Council of Europe’s revised Appendix A to 
Convention ETS 123 as compulsory minimum standards.  

Option 1: Compliance with the revised Appendix A to the Council of Europe Convention ETS 
123 

VI. Transparency / Access to information 

The  Directive  could  incorporate  minimum  requirements  on  transparency  and  public 
accountability  by  requiring  non-confidential  information  on  ethical  evaluations  and  project 
authorisation to be made publicly available. 

Option  1:  Non-confidential  information  from  the  ethical  evaluation  reports  and  project 
authorisation decisions to be made publicly available 

VII. Non-human Primates (NHP) 

The  revised  Directive  could  reinforce  the  ban  on  wild-caught  NHPs  and  further  restrict  the 
research  areas  in  which  NHP  can  be  used.  A  gradual  switch  to  permitting  use  of  second-
generation (F2) and higher generations of purpose-bred NHPs could be desirable. The use of 
Great Apes could be highly restricted.  

Option 1: Shift to only use of F2 and subsequent generations of purpose bred NHP 
Option 2: Ban of the use of Great Apes with very limited exceptions 

VIII. Inspections 

The Directive could harmonise the minimum requirements for annual inspections to two (one 
unannounced). A system of European Community inspections could also be envisaged. 

Option 1: Minimum twice-yearly inspections by national authorities (one unannounced) 

Option 2: EC inspections 

IX. Education and training 

The revised Directive could incorporate minimum training requirements for personnel and set 
requirements  for  demonstrating  and  maintaining  competence  over  time,  to  reduce  different 
cost environments. 

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Option 1: Requirement for competence and minimum elements for education and training 

X. Avoiding duplication of animal experiments 

A  centralised  Community-wide  database  for  information  on  project  authorisation  and 
scientific  results  could  be  established.  This  could  allow  knowledge  sharing,  and  provide 
transparency on results. 

Option 1: Establishing a centralised database 

XI. Use of CO2 for euthanasia 

The  Directive  could  detail  humane  methods  of  euthanasia  to  remove  cost  advantages  for 
establishments due to method choice. The use of CO2 could be prohibited unless the animal is 
unconscious prior to its exposure.  

Option 1: Prohibit use of CO2 unless animals are first rendered unconscious by exposure to 
anaesthetic gases 

XII. Statistical Reporting 

The  revised  Directive  could  increase  the  quality  of  annual  statistical  reporting  of  Member 
States by introducing the following elements: 

Option  1:  Number  of  genetically  modified  animals,  certain  invertebrate  species  and 
embryonic and foetal forms (excluding larvae) in the last third of their development 

Option  2:  Numbers  of  animals  killed  for  use  of  their  organs  and  tissues  in  scientific 
procedures 

Option 3: Numbers of projects and types of establishments 

Option 4: Severity classification2 of the experiments 

XIII. Promotion of alternative test methods 

Every Member State could designate a national reference laboratory to speed up the validation 
of animal testing alternatives. 

Option 1: National reference laboratories 

2 

The severity of an experiment is classified based on the duration, intensity and frequency of potential 
pain, suffering or distress caused to an animal. 

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4. What are the impacts of the specific options? 

The  25  specific  options  were  analysed  and  evaluated,  where  possible  in  a  quantified  and 
monetised  form.  Benefits  were  assessed  based  on  the  four  problem  dimensions,  costs  were 
evaluated separately for user establishments and public authorities. In some cases, the original 
options were revised in the light of the results of an external study performed by contractor, 
Prognos AG.  

– 
Scope 
I 
Option  1  – 
Basic research 

BENEFITS  

COSTS  

(quantified where possible) 

(monetised where possible) 

Animal welfare 

++ 

500.000 
animals 

for  public 

Costs 
authorities 

- 

80,000 € 

Control 

+++ 

Costs 
due 
authorisation 

to 

-- 

4 Mio € 

Costs due to ethical 
evaluation 

-- 

2.6 Mio € 

due 
Delays 
authorisation 
ethical evaluation 

to 
and 

Scope 
I 
Option  2 
Tissues 

– 
- 

Animal welfare 

+++ 

1.8 
animals 

Mio 

of 
Cost 
experiments  using 
tissue and organs 

- 

- 

Public 
accountability and 
transparency 

+++ 

Animal welfare 

++ 

Control 

++ 

Animal welfare 

(++) 

to 
Cost 
authorities 

public 

- 

320,000 € 

Animals 
used  in  1000 
experiments 

for  public 

Costs 
authorities 

- 

Costs 
establishments 

for 

user 

--- 

for  public 

Costs 
authorities  

- 

12.6 Mio € 

175.000 
mammalian 
animals 
alone 

Control 

+++ 

Cost 
establishments 

for 

user 

- 

845.000 € 

Animal welfare 

++ 

199.000 
animals 

for  public 

Costs 
authorities 

- 

35.000 € 

Control 

+++ 

Cost 
establishments 

for 

user 

- 

1.4 Mio € 

Scope 
I 
Option  3 
invertebrates 

- 
- 

I 
Scope 
Option  4 
foetal forms 

- 
- 

- 
I 
Scope 
Option  5 
- 
Education  & 
Training 

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II 
Authorisation - 
Option  1 
- 
individual 

Animal welfare 

++ 

Animal  welfare 
(additional) 

+++ 

950.000 
animals 

Costs 
without 
authorisation  

for  MS 
project 

- - 

57,000 € 

Control 
transparency  

and 

++ 

and 

+ 

Control 
transparency 
(additional) 

Competitiveness  

+++ 

+ 

11,500 € 

- 

11 Mio € 

- 

12.6 Mio € 

Costs  for  MS  with 
project-
authorisation 

for 

user 
Cost 
establishments 
in 
MS without project 
author. 

for 

user 
Cost 
establishments 
in 
MS without project 
author 

II 
Authorisation - 
- 
Option  2 
group 

Costs  for  users  / 
Competitiveness 
SMEs/research 

+++ 

reduction  of 
21.2 Mio € 

Public image 

- 

Costs  for  public 
authorities 

++ 

1.9  Mio 
€ 
(reduction  of 
700,000 €) 

Animal welfare 

0 

Animal welfare 

+++ 

Ethical 
III 
Review  (A)  - 
Option 1 

11.7 
animals 
371,000 
animals 

Mio 
/ 

Administrative 
costs to enterprises 

- -  

9 Mio € (7 Mio 
€) 

and 
Awareness 
work  satisfaction 
researchers 

++ 

Quality of science  ++ 

Competitiveness 

- - 

up to 70 Mio 
€ 

for  public 

Costs 
authorities 

- -  

Level 
field 

playing 

++ 

Delay of projects 

- 

III 
Ethical 
Review  (A)  - 
Option 2 

Transparency 

++ 

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animals 

Mio 

Cost 
establishments  

to 

- - 

revised option  

4 Mio € 

Quality of science  ++ 

to  national 

Costs 
authorities  

- - 

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IV 
Ethical 
Review  (B)  - 
Option 1 

IV 
Ethical 
Review  (B)  - 
Option 2 

V  Housing  & 
Care  -  Option 
1 - ETS 123 

Transparency 

++ 

12.1 
animals  

Mio 

Costs infrastructure  

 - 

Public 
accountability  

 + 

Costs  infrastructure 
for Member States 

 - 

Animal welfare 

+++ 

12.1 
animals 

Mio 

Costs 
establishments 

for 

- -  

Ethical  discussion 
and awareness 

++ 

Animal welfare  

+++ 

12.1 
animals 

Mio 

Upgrading costs for 
smaller animals 

- 

Science 

++ 

Upgrading costs for 
larger animals 

- - - 

Level 
field 

playing 

++ 

for 
Yearly  Costs 
user establishments 

37 Mio € 

VI 
Transparency - 
Option 1 

Public 
accountability and 
transparency 

++ 

Image  of  research 
and 
animal 
experimentation 

+ 

Cost 
establishments 

to 

--- 

revised  option: 
520,000 € 

Costs  for  Member 
States 

- 

VII 
human 
primates 
Options 1  

Non-

Animal welfare 

+/- 

+++ for 1300 
animals,  

Costs 
establishments 

for 

-- 

-  

--  for  12.000 
animals 

Public concern 

++ 

Scientific need 

Biodiversity 

+/0 

Non-

Animal welfare 

VII 
human 
primates Opt 2  Public concern 

++ 

++ 

Outsourcing/ 
Competitiveness 

Research 

Central  Facility  for 
future demand

--- 

-- 

- 

--- 

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VIII 
Inspections 
Option  1 
national 

- 
- 

VIII 
- 
Inspections 
Option  2  -  EU 
inspections 

IX  Education 
and  Training  - 
Option 1 

Animal welfare 

++ 

12.1  Mio. 
animals  

Impact 
establishments  

for 

- 

0.9 Mio € 

Accountability 
and transparency 

+++ 

(Animal welfare) 

(++) 

(Accountability 
and transparency) 

(+++) 

Costs  for  Member 
States  

-- 

3.1  Mio.  €  / 
2.5 Mio. € 

12.1 
animals 

Mio 

Costs 
establishments  

for 

- 

Costs to EU  

--- 

4.2  Mio 
€ 
(revised  option 
2.7 to 3.3 Mio) 

Animal welfare 

+++ 

12.1 
animals 

Mio 

Additional  costs  to 
national authorities 

- 

Additional  costs  to 
establishments 

-- 

38 Mio € 

Quality of science  +++ 

Free movement of 
people/workers 

+++ 

Job satisfaction of 
personnel 

+++ 

X  Duplication 
- Option 1  

Animal  welfare  – 
basic research 

(+) 

slight 
positive 
effect 

Cost 
establishments 

to 

--- 

6.2 Mio € 

Animal  welfare  – 
regulatory testing 

0 

reductions 
Member 

+ 

Cost 
for 
States 

Administrative 
costs  for  Member 
States 

-- 

173,000 € 

Resource 
requirements  at  an 
EU-level 

--- 

30,000  €  one-
time 
105,000 
yearly costs 

costs, 

€ 

XI  CO2 
Option 1 

- 

Animal welfare 

+/- 

Impacts 
establishments 

to 

--- 

46.2 Mio € 

XII  Statistical 
Reporting 
- 
Option 1  

Monitoring 
accountability 

and 

+++ 

Policy making 

++ 

Administrative 
burden 

- 

7.4 Mio € 

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XII  Statistical 
- 
Reporting 
Option 2 

Monitoring 
accountability  

and 

+++ 

Image  of  research 
and industry 

+ 

Policy making  

+++ 

XII  Statistical 
Reporting 
- 
Option 3 

Monitoring 
policy making  

and 

++ 

Transparency  

++ 

XII  Statistical 
- 
Reporting 
Option 4 

Monitoring 
and 
policy  making  / 
transparency  

+++ 

Public awareness   +++ 

+++ 

XIII 
Promotion  of 
alternative 
methods 
Option 1 

– 

Animal  welfare 
through 
increase 
Reduction 
in 
animal  use  or 
method 
refinement 

Administrative 
burden to users 

Administrative 
burden  to  Member 
States 

Administrative 
burden to users 

Administrative 
burden  to  Member 
States 

Administrative 
burden to users 

Administrative 
burden  to  Member 
States  

- 

-- 

- 

-- 

-- 

-- 

to  Member 

- 

Costs 
States 

4 Mio € 

One-off 
costs 
4-5 
Mio  €,  plus 
annual  costs 
1,5  –  3  Mio 
€ 

Promotion 
innovation 

of 

+++ 

Costs to industry 

++ 

Public awareness 

++ 

Efficiency  gains  for 
research 
public 
budgets 

+ 

5. How do the options compare?  

The following are the most useful options to create a level playing field within the European 
Community  and  to  increase  the  welfare  for  all  12.2  million  animals  used  annually  in  the 
Community:  

•  Strengthening the authorisation and ethical evaluation of projects would have a significant 

impact on levelling economical differences between Member States; 

•  Minimum  housing  and  care  standards  would  remove  the  current  uneven  competitive 
environment for users and breeding and supplying establishments, whilst improving animal 
welfare; 
•  Standardised 

inspections  would  expose  non-compliant  establishments,  ensuring 

enforcement and improving public confidence. 

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6. Which options were finally chosen and what are their impacts? 

In the light of the table above, it becomes clear that some of the options that provide for the 
highest  animal  welfare  benefits  also  create  the  highest  costs  (Housing  and  Care  standards, 
Education and Training standards). However, inspections costs are relatively low and the cost 
for transparency in the form of non-technical summaries is almost negligible. 

Only  the  option  of  banning  CO2  seems  to  entail  costs  that  are  out  of  proportion  vis-à-vis 
benefits. The remaining policy options do not go further than what is necessary to achieve the 
objectives of the revision (principle of proportionality). 

Therefore the options that are justified are: 

•  Extending the scope to cover animals used in basic research, animals bred for their tissue 
and organs, selected invertebrates species, foetal and embryonic forms in the last third of 
development before birth or hatching and animals used in education and training; 

•  Authorisation  of  individual  projects  including  a  compliance  check  and  ethical  evaluation 
with  decisions  to  be  taken  within  30  (maximum  60)  days,  but  allowing  group 
authorisations in the area of regulatory testing and lighter authorisation process for projects 
consisting  of  only  "up  to  mild"  procedures  and  not  involving  the  use  of  non-human 
primates; 

•  Introduction of a national animal welfare and ethics committee to issue guidance; 

•  Introduction of a permanent ethical review body in each establishment; 

•  Minimum housing and care standards along the lines of the ETS 123 standards; 

•  Improving  transparency  and  access  to  information  by  publishing  non-technical  project 

summaries; 

•  Improving  welfare  of  non-human  primates  through  limiting  further  the  research  areas  in 
which  they  can  be  used  and  via  a  shift  to  use  only  F2  and  subsequent  generations  of 
purpose bred animals after a transitional period specific for certain types of species; 

•  Banning the use of Great Apes with very limited exceptions; 

•  Improving  enforcement  by  twice  yearly  inspections  by  national  authorities  (one 

unannounced); 

•  Appropriate education and training standards; 

•  Specific conditions for CO2 use; 

•  Improving statistical information; 

•  National reference laboratories. 

Total cost increase of favoured options could be 143.7 Mio € per year but would be largely 
attributed  to  those  three  options  which  in  return  also  provide  the  highest  animal  welfare 
benefits. It is important to note that 23 Mio € attributed to the au thorisation of projects reflects 

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the scenario in which no Member State opts for the lighter authorisation process for project 
consisting of only "up to mild" procedures and not involving the use of non-human primates. 
The cost increase has to be assessed against the total costs for animal experiments which were 
calculated  to  be  around  2.9  Bio  €  per  year  in 
the  EU-25.  However,  it  is  understood  that 
universities  and  public  research  institutes  may  need  transitional  periods  to  adapt  to  new 
requirements, whereas some industrial sectors may be able to cope with new standards much 
faster.  

The  benefits  from  reduced  administrative  costs  and  avoiding  unnecessary  testing  were 
estimated at around 90 Mio € per y ear. To calculate the net cost increase of the revision, one 
may subtract these 90 Mio € savings from the  143.7 Mio € gross costs increase. The net cost 
increase would then be about 51 Mio € per year. 

Further benefits/savings from improved science are not yet included. For some options with a 
very high potential to improve animal welfare, the corresponding benefits for science can be 
monetised. If only a few percentages (1-3%) of the studies that currently suffer from a weak 
experimental  design,  inappropriate  housing  and  care  standards  or  not  fully  competent 
personnel  can  be  improved,  the  benefits  may  be  in  the  same  order  of  magnitude  as  the 
financial costs of these options. 

All  of  the  actions  have  been  scrutinised  to  check  that  they  pass  the  necessity  test.  They  are 
necessary  to  fulfil  the  requirements  of  the  Protocol  annexed  to  the  EC  Treaty  to  pay  full 
regard to animal welfare requirements in formulating internal market and research policies. At 
the same time, they cannot be better carried out by Member States individually. 

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