EN    EN EN 
EN 1   EN  COMMISSION OF THE E UROPEAN 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 us ed for scientific purposes 
   
SUMMARY OF THE IMPACT ASSESSMENT  
{COM(2008) 543} 
{SEC(2008) 2410} 
EN 2   EN SUMMARY 
1. What are the problems? 
Directive 86/609/EEC is the central legislativ e act of the European Community aiming at 
harmonising Member States' rules protecting animals used for experimental and other 
scientific purposes. It was a dopted 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 th e capacity of animals to feel pain and 
suffering has become available. Furthermore, th e 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 principle
1, 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 comm unity, 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 f our 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 authorisa tion procedures and criteria in the Member States leading to 
variable cost of projects and delays, unsatis factory (working) conditions of researchers, 
obstacles to horizontal mobility and increasing  activist criminality. Similar problems can be 
identified for the breeders and suppliers of anim als, especially in term s 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 fr om 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 expe riments, low incentive to develop and use 
alternative methods, risk of va riable research results due to  non-consistent scrutiny of study 
design and implementation of refinement, and ob stacles to free movement of researchers. 
d) Public/societal problems  occur due to the increasing dissociation between weak legislation 
and strong public concern, evolving from change d ethical and societal values and increased 
public interest in the acceptability of  animal testing.  
                                                 
1 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 na tional 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. 
EN 3   EN 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 increa sing 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 re gulatory environment and ensure the competitiveness of EU 
research and industry. 
3. What are the policy options? 
Four basic policy options for achieving the obj ectives 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 th e 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 orga ns 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 indi vidual 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 ethica l 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 retrospe ctive assessment of all projects 
EN 4   EN 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 we lfare and ethics committee 
Option 2: Permanent ethical review body in each establishment 
V. Housing and care standards 
The Directive could incorporate elements of th e Council of Europe’s re vised Appendix A to 
Convention ETS 123 as compulsory minimum standards.  
Option 1: Compliance with the revised Appendi x 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 inform ation 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 gene rations of purpose-bred NHPs coul d be desirable. The use of 
Great Apes could be highly restricted.  
Option 1: Shift to only use of F2 and s ubsequent 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 requi rements for annual inspections to two (one 
unannounced). A system of European Community  inspections could also be envisaged. 
Option 1: Minimum twice-yearly inspectio ns by national author ities (one unannounced) 
Option 2: EC inspections 
IX. Education and training 
The revised Directive could incorporate mini mum training requirements for personnel and set 
requirements for demonstrating and maintainin g competence over time, to reduce different 
cost environments. 
EN 5   EN Option 1: Requirement for competence and mi nimum 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 CO 2 for euthanasia 
The Directive could detail humane methods of euthanasia to remove cost advantages for 
establishments due to method choice. The use of CO 2 could be prohibited unless the animal is 
unconscious prior to its exposure.  
Option 1: Prohibit use of CO 2 unless animals are first render ed 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 genetical ly 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 classification
2 of the experiments 
XIII. Promotion of alte rnative 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. 
EN 6   EN 4. What are the impacts of the specific options? 
The 25 specific options were analysed and ev aluated, 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 pe rformed by contractor, 
Prognos AG.  
 BENEFITS  
(quantified where possible)
 COSTS   
(monetised where possible)  
Animal welfare ++ 500.000 
animals Costs for public 
authorities - 80,000 € 
Control +++  Costs due to 
authorisation -- 4 Mio € 
Costs due to ethical 
evaluation -- 2.6 Mio € I Scope – 
Option 1 – 
Basic research 
 
Delays due to 
authorisation and 
ethical evaluation -  
Animal welfare +++ 1.8 Mio 
animals Cost of 
experiments using tissue and organs -  
I Scope – 
Option 2 - 
Tissues 
Public 
accountability and 
transparency +++  Cost to public 
authorities - 320,000 € 
Animal welfare ++ Animals 
used in 1000 
experiments Costs for public 
authorities -  I Scope - 
Option 3 - 
invertebrates 
Control ++  Costs for user 
establishments ---  
Animal welfare (++) 175.000 
mammalian 
animals 
alone Costs for public 
authorities  - 12.6 Mio € I Scope - 
Option 4 - 
foetal forms 
Control +++  Cost for user 
establishments - 845.000 € 
Animal welfare ++ 199.000 
animals Costs for public 
authorities - 35.000 € I Scope - 
Option 5 - 
Education & 
Training Control +++  Cost for user 
establishments - 1.4 Mio € 
 
EN 7   EN  
Animal welfare 
Animal welfare 
(additional) ++ 
+++ 950.000 
animals Costs for MS 
without project 
authorisation  - - 57,000 € 
Control and 
transparency  ++  Costs for MS with 
project-
authorisation + 11,500 € 
Control and 
transparency (additional) +  Cost for user 
establishments in MS without project 
author. - 11 Mio € II 
Authorisation - 
Option 1 - 
individual 
Competitiveness  +++  Cost for user 
establishments in MS without project 
author - 12.6 Mio € 
Costs for users / 
Competitiveness SMEs/research +++ reduction of 
21.2 Mio € Public image -  
II 
Authorisation - 
Option 2 - 
group Costs for public 
authorities ++ 1.9 Mio € 
(reduction of 
700,000 €) Animal welfare 0  
 
Animal welfare +++ 11.7 Mio 
animals / 
371,000 
animals Administrative 
costs to enterprises - -  9 Mio € (7 Mio 
€) 
Awareness and work satisfaction 
researchers ++  Competitiveness - -  
Quality of science ++ up to 70 Mio 
€ Costs for public 
authorities - -   III Ethical 
Review (A) - 
Option 1 
Level playing 
field ++  Delay of projects -  
Transparency ++ 12.1 Mio 
animals Cost to 
establishments  - - revised option  
4 Mio € III Ethical 
Review (A) - 
Option 2 
Quality of science ++  Costs to national 
authorities  - -  
EN 8   EN  
Transparency ++ 12.1 Mio 
animals  Costs infrastructure   -  IV Ethical 
Review (B) - 
Option 1 Public 
accountability   +  Costs infrastructure 
for Member States  -  
Animal welfare +++ 12.1 Mio 
animals Costs for 
establishments - -   IV Ethical 
Review (B) - 
Option 2 Ethical discussion 
and awareness ++   
 
Animal welfare  +++ 12.1 Mio 
animals Upgrading costs for 
smaller animals -  
Science ++  Upgrading costs for 
larger animals - - -  V Housing & 
Care - Option 
1 - ETS 123 
Level playing 
field ++  Yearly Costs for 
user establishments  37 Mio € 
 
Public 
accountability and 
transparency ++  Cost to 
establishments --- revised option: 
520,000 € VI 
Transparency - 
Option 1 
Image of research and animal 
experimentation +  Costs for Member 
States -  
 
Animal welfare +/- +++ for 1300 
animals,  
-- for 12.000 
animals Costs for 
establishments --  
Public concern ++  Scientific need ---  VII Non-
human 
primates -  
Options 1  
Biodiversity +/0  Outsourcing/ 
Competitiveness --  
Animal welfare ++  Research -  VII Non-
human 
primates Opt 2 Public concern ++  Central Facility for 
future demand---  
EN 9   EN  
Animal welfare ++ 12.1 Mio. 
animals  Impact for 
establishments  - 0.9 Mio € VIII 
Inspections - 
Option 1 - 
national Accountability 
and transparency +++  Costs for Member 
States  -- 3.1 Mio. € / 
2.5 Mio. € 
(Animal welfare) (++) 12.1 Mio 
animals Costs for 
establishments  -  VIII 
Inspections - 
Option 2 - EU 
inspections (Accountability 
and transparency) (+++)  Costs to EU   --- 4.2 Mio € 
(revised option 
2.7 to 3.3 Mio) 
 
Animal welfare +++ 12.1 Mio 
animals Additional costs to 
national authorities -  
Quality of science +++  Additional costs to 
establishments  -- 38 Mio € 
Free movement of 
people/workers  +++  IX Education 
and Training - 
Option 1 
Job satisfaction of 
personnel +++   
 
Animal welfare – 
basic research (+) slight 
positive 
effect Cost to 
establishments --- 6.2 Mio € 
Animal welfare – 
regulatory testing 0  Administrative 
costs for Member States -- 173,000 € X Duplication 
- Option 1  
Cost reductions 
for Member 
States +  Resource 
requirements at an 
EU-level --- 30,000 € one-
time costs, 
105,000 € yearly costs 
 
XI CO2 - 
Option 1 Animal welfare +/- 
  Impacts to 
establishments --- 46.2 Mio € 
 
Monitoring and 
accountability +++  Administrative 
burden - 7.4 Mio € XII Statistical 
Reporting - 
Option 1  
 Policy making ++     
EN 10   EN Monitoring and 
accountability  +++  Administrative 
burden to users - 4 Mio € 
Image of research 
and industry +  Administrative 
burden to Member 
States --  XII Statistical 
Reporting - 
Option 2  
Policy making  +++     
Monitoring and 
policy making  ++  Administrative 
burden to users -  XII Statistical 
Reporting - 
Option 3  Transparency  ++  Administrative 
burden to Member 
States --  
Monitoring and 
policy making / 
transparency  +++  Administrative 
burden to users --  XII Statistical 
Reporting - 
Option 4  
Public awareness  +++  Administrative 
burden to Member 
States  --  
 
Animal welfare 
increase through Reduction in 
animal use or 
method refinement +++  Costs to Member 
States - One-off 
costs 4-5 Mio €, plus 
annual costs 
1,5 – 3 Mio € 
Promotion of 
innovation 
 +++  Costs to industry ++  XIII 
Promotion of 
alternative 
methods – 
Option 1 
Public awareness ++  Efficiency gains for 
public research 
budgets +  
 
5. How do the options compare?  
The following are the most useful options to cr eate 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 ev aluation of projects woul d 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 supplyi ng establishments, whilst improving animal 
welfare; 
• Standardised inspections would expose non-compliant establishments, ensuring 
enforcement and improving public confidence. 
EN 11   EN 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 (Housin g and Care standards, 
Education and Training standards) . However, inspections costs ar e relatively low and the cost 
for transparency in the form of non-tec hnical summaries is almost negligible. 
Only the option of banning CO2 seems to enta il costs that are out of proportion vis-à-vis 
benefits. The remaining policy options do not go fu rther than what is necessary to achieve the 
objectives of the revision (p rinciple of proportionality). 
Therefore the options th at are justified are: 
• Extending the scope to cover animals used in basic research, animals bred for their tissue 
and organs, selected invertebrates species, foet al 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 complian ce check and ethical evaluation 
with decisions to be taken within 30 (maximum 60) days, but allowing group 
authorisations in the area of regulatory testi ng and lighter authorisa tion process for projects 
consisting of only "up to mild" procedur es 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 al ong the lines of the ETS 123 standards; 
• Improving transparency and access to info rmation by publishing non-technical project 
summaries; 
• Improving welfare of non-human primates th rough 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 pe riod specific for certain types of species; 
• Banning the use of Great Apes with very limited exceptions; 
• Improving enforcement by twice yearly insp ections by national authorities (one 
unannounced); 
• Appropriate education an d training standards; 
• Specific conditions for CO 2 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 th at 23 Mio € attributed to the au thorisation of pr ojects reflects 
EN 12   EN the scenario in which no Member State opts for the lighter authorisation process for project 
consisting of only "up to mild" procedures a nd 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 indus trial 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 th e studies that currently suffer from a weak 
experimental design, inappropr iate housing and care standard s 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 ch eck that they pass the necessity test. They are 
necessary to fulfil the requirements of the Prot ocol annexed to the EC Treaty to pay full 
regard to animal welfare requirements in formula ting internal market and research policies. At 
the same time, they cannot be better carri ed out by Member States individually.