EN    EN EN 
 
EN 1   EN  COMMISSION OF THE E UROPEAN COMMUNITIES 
Brussels, 5.11.2008 
SEC(2008) 2410 
  
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 
   
IMPACT ASSESSMENT  
{COM(2008) 543} 
{SEC(2008) 2411} 
 
EN 2   EN TABLE OF CONTENTS 
1. Executive summary...................................................................................................... 3 
2. Procedural issues and consulta tion of interested parties.............................................. 6 
3. Problem definition........................................................................................................ 9 4. Policy objectives ........................................................................................................ 28 5. Policy options............................................................................................................. 3 0 
6. Analysis of impacts.................................................................................................... 38 7. International situation................................................................................................. 58 8. Interaction with other eu ropean legislative acts......................................................... 61 
9. Comparing the options ............................................................................................... 64 10. Chosen options........................................................................................................... 83  
11. Monitoring and evaluation ......................................................................................... 86 12. Terminology............................................................................................................... 8 7 
13. Further information and feedback.............................................................................. 89 Annex ......................................................................................................................... ........... 90 
Literature ..................................................................................................................... ............. 92 
 
EN 3   EN 1. EXECUTIVE  SUMMARY 
This impact assessment analyses the impacts of  different policy options - including those put 
forward by stakeholders - for the revision of Directive 86 /609/EEC on the protection of 
animals used for experimental and other scientific  purposes. It is to a large extent based on an 
external study that was performed by Prognos AG for the European Commission, DG 
Environment, between January and December 20061.  
Directive 86/609/EEC is the central legislat ive act of the European Community which 
harmonises Member States' rules protecting animal s used for experimental and other scientific 
purposes. It was adopted in 1986 and has never been significantly  changed. It is the first time 
ever that an impact assessment has attempte d to identify, quantify and monetise impacts from 
policy changes in the area of expe rimental animals. Hardly any sc ientific litera ture about the 
impact of such policy changes on the welfare of animals and few official empirical cross-
national statistical data exist. Some aspects of  the assessments are therefore based on a cost 
model and on extrapolations from specific sample s as well as from the EU-statistics on use of 
animals in scientific procedures (experiments) in the EU-25 in 20052.  
Since the adoption of the Directive, significant progress in experimental  techniques has been 
achieved and new scientific knowle dge about the capacity of animals to feel pain, suffering or 
distress including their impact on scientific resu lts has become available. Furthermore, the 
ethical dimension of the use of an imals in scientific procedures is not sufficiently reflected in 
the current provisions of the Directive.  
To compensate for these weaknesses, a number of Member States have gone much further 
when adopting national measures. This has resulted in a highly diversified, unequal 
competitive environment for industry and the re search community within the EU, defeating 
the objective of the Directive to avoid fragmentat ion of the internal market. Furthermore, the 
wording of the Directive, closely followi ng that of an international Convention3, results in 
unclear provisions, inconsistencies and ambiguities, which in turn translate into transposition problems at Member State level. 
Finally, the Directive does not explicitly refer to, nor ensure the full a pplication of the Three 
Rs principle
4, even though it is now recognised as th e leading principle in this field by all 
stakeholders. These fundamental problems are the catalyst for this revision process. 
The problem analysis confirms indeed that four problems appear across 13 policy areas. 
These can be summarised as: 
                                                 
1 The information contained in the study was correct at the time the study was finalised. 
2 It should be noted that consistent data for Bulgar ia and Romania were not available because the current 
Directive foresees a reporting period of every 3 year s, and therefore the first systematic statistics from 
Bulgaria and Romania will only be available in 2009, covering the year 2008. This impact assessment 
therefore concentrated on data about the EU-25. 
3 Council of Europe Convention ETS 123 on “the protection of vertebrate animals used for experimental 
and other scientific purposes”. 
4 The Three Rs Principle (Replace, Reduce and Refine  the use of animals in experiments) is widely 
accepted as the guiding principles when using animal s 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. 
 
EN 4   EN a) Economic problems  affecting the internal market include competitive disadvantages for 
countries with high animal welf are standards resulting primarily from price differences (e.g. 
minimum requirements for housing), diverging re gulatory and authorisation procedures and 
criteria in the Member States leading to variable de lays and cost of pr ojects, unsatisfactory 
(working) conditions of researchers, obstacles to horizontal mobility and increasing activist criminality. Similar problems can be identified for the breeders and suppliers of experimental 
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 fr om a relatively high number of animals not 
protected by European  legislation. 
c) Scientific problems  concern low innovation and poor quality  science resulting from delays 
of projects, potentially unnecessa ry duplication of procedures, low incentive to develop and 
use alternative methods, risk of variable rese arch results due to non-consistent scrutiny of 
study design and implementation of refinement (l eading to higher stress levels for animals) 
and obstacles to free movement of researchers due to different requirements for education and 
training. 
d) Public/societal problems  occur due to the increasing disso ciation between weak legislation 
and strong public concern, evolving from change d ethical and societal values and increased 
public interest about the acceptability of animal te sting. This is further highlighted due to lack 
of transparency in the field. 
The economic problems are mainly related to a non-level playing field. These can be clearly 
demonstrated when observing differences in aver age delays for authorisation of a project due 
to significantly varying legal requirements and administrative pr ocedures; differences in the 
cost of housing and caring for animals; and diffe ring requirements for the level of training and 
education for personnel. The latte r problem also has a negative impact on the free movement 
of personnel when undertaking cr oss-border research projects . These problems are further 
exacerbated by differences in the scope of the na tional legislations; some animal species are 
not covered by legislation in some Member St ates, but even where covered there are big 
differences in administrative requirements l eading to varying processing times and cost 
structures. 
Animal welfare problems are caused by relativ ely weak provisions and ambiguities in the 
existing Directive and by unsystematic approach es among Member States. Together with 
scientific problems related to lower animal welf are standards, and a lack of transparency and 
accountability towards the public, combine to make a policy change necessary. 
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 scientific pro cedures, and further promoting the implementation 
of the Three Rs principle.  
Increased uptake of alternative methods will in return boost EU industry in accordance with 
the Lisbon Agenda. The revision of the Direct ive further strives to simplify the dispersed 
regulatory environment and ensure the competitive ness of EU research a nd industry. This will 
be achieved by harmonising the objectives an d minimum requirements at EU level, while 
 
EN 5   EN leaving the Member States considerable fl exibility to determine the most optimum 
mechanisms for their respective existing infrast ructure, which is fully in line with the 
principles of subsidiarity and proportionality. 
The assessment concludes that the identified problems will not improve autonomously or will 
further worsen over time if no action is taken. Four basic policy options for achieving the 
objectives have been screen ed: deregulation, no-policy-ch ange, self-regulation and 
reinforcement of the existing Directive. Only one  of these basic options proved viable, namely 
a significant upgrade of Directive 86/609/EEC. 
Within the basic option of upgrading Dire ctive 86/609/EEC, 25 specific options were 
analysed and evaluated, where possible in a quantified and monetised form. Benefits were 
assessed based on the four probl em dimensions, costs were ev aluated separate ly for user 
establishments and public authorities. In some cases, the original options were revised in the light of the results of  the external study.  
The most useful options to create a level pl aying field and improve  the good functioning of 
the internal market within the European Comm unity and to significantly increase animal 
welfare for all 12.2 million animals used  annually in the Community are:  
- Strengthening of the requireme nts for authorisation and ethical evaluation of projects – this 
would have a significant impact on levell ing the current economic differences between 
Member States; 
- Minimum housing and care standards – establ ishing harmonised compulsory housing and 
care standards would remove the current uneven competitive environment and prevent likely future problems related to an inconsistent im plementation of new standards agreed at Council 
of Europe level. This would not benefit onl y user establishments but also breeding and 
supplying establishments, at the same time havi ng a considerable impact on animal welfare; 
- Inspections – standardised inspections am ong Member States would expose non-compliant 
establishments, ensuring enforcement and di ssemination of best practises and improving 
public confidence. 
Total cost increase of all favoured options could be close to 143.7 million € per year but 
would be largely attributed to those options which in return al so provide the highest internal 
market and animal welfare benefits.  
These costs should be mirrored ag ainst the benefits to  animal welfare, innovation and science 
as well as society in terms of  increased public accountability and transparency Authorisation 
of groups of projects for regulato ry testing would reduce the av erage costs of this type of 
projects at the establishment level due to econo mies of scale. Positive impacts would also 
occur at the level of authorisati on bodies in Member States due to more flexible and efficient 
handling of the procedures. Furthermore, indus try and academia would benefit from specific 
deadlines for the authorisation decisions. 
Some simplification benefits have been ta ken into account, especially related to group 
authorisations which will greatly reduce the ad ministrative burden. Expect ed savings will be 
about 22 million € per year. Animal welfare bene fits are not easily quantifiable in monetary 
terms. The benefits from reduced administ rative costs and avoida ble unnecessary testing 
 
EN 6   EN alone were estimated in the order of 90 million € per year by the external study. These, 
however, are not reflected in the estimated annual cost. 
The cost increase also needs to be put into perspective with the following considerations: - The current total expenditure of all user establishments for animal experimentation in the 
EU-25 was calculated to be in the range of 2.9 billion € per year. This means that the cost 
increase of 143.7 million € per year that is likel y to be triggered through the revised Directive 
is relatively small (about 5%) in comparison to the current level of expe nditure in the sector. 
- While universities and other public  research institutes may need transitional periods to adapt 
to the new requirements, some industrial sectors may be able to cope with new standards 
much faster because animal care costs make up only a small share of their total investments, e.g. pharmaceutical companies for which the costs to develop a new product may amount to 1 Bio € over 10 years. 
- A significant share of these costs is due to the implementation of the revised guidelines for 
housing and care of experimental animals adopted  by the Council of Europe. As the European 
Community is a Party to the Convention, it woul d have to implement the revised Guidelines 
anyway (deadline was 15 June 2007). Therefore, a significant share of the cost increase is 
caused by international obligations  of the Community and cannot be  attributed solely to the 
revision of the Directive. 
- a 23 Mio € increase is attributed  to the authorisation of projects. This refl ects the scenario in 
which no Member State opts for the lighter aut horisation process for projects consisting of 
only "up to mild" procedures and not i nvolving the use of non-human primates.  
- The benefits from reduced administrative co sts and avoidable unnecessary procedures alone 
were estimated in the order of 90 million per year by the external study. These are not reflected in the estimated annual cost of 143.7 million. 
- For some options with a very  high potential to improve animal welf are, the corresponding 
benefits for science can be m onetised. If only a few percentages (1-3%) of the studies that 
currently suffer from a weak experimental de sign, inappropriate housi ng and care standards or 
not fully competent personnel could be improved, the benefits may be in the same order of 
magnitude as the financial costs of these options.  
2. PROCEDURAL
 ISSUES  AND  CONSULTATION  OF INTERESTED  PARTIES 
a) Scientific studies and policy documents 
Preparatory work for the revision of Directive 86/609/EEC started in 200 2 when the European 
Commission’s Directorate-Gene ral for Environment (DG ENV) requested an opinion on the 
welfare of non-human primates used in ex periments from the Commission’s Scientific 
Committee on Animal Health and Animal We lfare, SCAHAW. This Opinion, adopted by 
SCAHAW on 17 December 2002, is available at: 
http://europa.eu.int/comm/food/fs/aw/aw_scahaw_en.html .  
During the same period, the European Parliament drafted an own initiative report, with Jillian 
Evans as the rapporteur, calling for the Euro pean Commission to co me forward with a 
 
EN 7   EN proposal to revise Directiv e 86/609/EEC. The report was ad opted on 13 November 2002 and 
can be found at: 
http://ec.europa.eu/environment/chemi cals/lab_animals/pdf/evans_report.pdf   
In 2003, DG ENV convened a Technical Expert Working Group, TEWG, to collect scientific 
and technical background information for the re vision of the Directive. The experts from 
Member States, acceding countries (which ar e now Member States), industry, science and 
academia as well as from animal welfare organisations and other key stakeholders worked through a set of questions prepared by DG ENV.  The final reports, completed in November 
2003, can be found at: 
http://ec.europa.eu/environment/c hemicals/lab_animals/revision_en.htm
 
In 2004, the Animal Health and Animal Welfare Panel, AHAW, of the European Food Safety 
Authority (EFSA) was mandated to give a scie ntific opinion on four further questions in 
relation to the revision ; on the sentience of invertebrate species and foetal/embryonic forms, 
the criteria for and the species  that should be purpose bred a nd identification of the most 
humane methods of euthanasia for species most  commonly used in scientific procedures. The 
Opinion was published on 14 November 2005 and is available at: 
http://ec.europa.eu/environment/chemicals/lab_animals/scientific_en.htm  
In January 2006, the European Commission publis hed its Animal welfare Action Plan for the 
period 2006-2010. The European Parliament, in an own-initiative report drafted by Elisabeth 
Jeggle as the rapporteur, asked th e Commission to come forward w ith a proposal to revise the 
Directive 86/609/EEC before the end of th e year 2006. The resolution is available at: 
http://www.europarl.europa.eu/sides/ge tDoc.do?pubRef=-//EP //NONSGML+TA+P6-TA-
2006-0417+0+DOC+PDF+V0//EN&language=EN  
b) External study (Prognos report) 
The input from the TEWG, SCAHAW and the AHA W Panel has provided a broad basis for 
different policy options for the revision. DG ENV decided in 2005 to perform a voluntary 
Impact Assessment to be able to critically review and assess these policy options and their impacts, to test the conclusions and to provide  justifiable and (where  possible) quantitative 
indications as to the related benefits a nd costs. In December 2005, Prognos AG was assigned 
to carry out a study to provide input to the Co mmission’s Impact Asse ssment according to the 
revised Impact Assessment guidelines of the Commission’s Secretariat General 
(SEC(2005)791). 
The Prognos study followed a very systematic a pproach. In a first ste p, baseline data was 
gathered to substantiate the problem areas via stakeholder in terviews and two questionnaires, 
one to stakeholders and one to the nati onal contact points in 25 Member States.  
The stakeholder questionnaire was sent to all ma jor stakeholders includ ing representatives of 
private and public users of animals (e.g. industr y and academic institutes), industry, academic 
and professional associations, non-governmental organisations etc. The stakeholders were 
requested to forward the questionnaire freely to  any other experts. Fr om the 96 stakeholders 
who received the questionnaire, 66 filled it in and returned it.  
 
EN 8   EN DG Environment contacted the national authoritie s in the Member States that are responsible 
for the legislation concerning  experimental animals and the implementation of Directive 
86/609/EEC. From the 25 contact points that r eceived the questionnaire, 17 filled it in and 
returned it. 
The results of this survey were by far not as complete, detailed and fact-based as expected 
because many respondents were not able to pr ovide new facts and figures on the use of 
animals for scientific purposes  in their establishment or c ountry. As only relatively limited 
data was available, the contra ctor developed a model about be nefits and costs, and derived 
qualitative hypotheses from it about possi ble impacts of the respective options. 
The results of this firs t phase were presented to stakeholde rs in a public internet consultation 
which the Commission performed from 16 Ju ne to 18 August 2006. The main results and 
identified needs for further research fed into the second phase of the study and the results thereof into the final report of Prognos
5. 
c) Public Internet consultation 
The internet consultation was open to participatio n for a period of nine weeks and consisted of 
two separate questionnaires, one directed more to the general public an d one for experts and 
stakeholders in the field. However, no rest rictions for participation were imposed. 
The purpose of the consultation for the genera l public was to get an impression of public 
opinion in relation to the use of  animals for experimental and other scientific purposes. The 
results of this consultation were publis hed by the European Commission separately6 and are 
perhaps more interesting in political terms rather than of direct relevance to this staff impact 
assessment paper.  
With a total of 42,655 replies, th e citizens' consultati on received the third largest number of 
responses to a Commission intern et consultation ever. While the results of this consultation 
are not comparable to those obtained from representative surveys, such as Eurobarometer, the large participation gives a st rong indication of the public interest in this area.  
A large majority of respondents supports measures  at European level to  increase the welfare 
of animals. For instance, 93 % of  the respondents answ ered either "Yes, ce rtainly" or "Yes, 
probably" to the question "Do you believe that more needs to be done to improve the level of 
welfare/protection of animals used in experiments by action at EU level?". 
92% of the respondents were of the opinion th at the European Community should play a 
leadership role in promoting in  the international arena a greate r awareness of animal welfare 
and protection, in particular regard ing animals used in experiments. 
The expert questionnaire served to verify, co rrect and complete the preliminary findings of 
the assessment of the options to revise the existing Dir ective. The questionnaire was 
addressed to experts in the area of animal we lfare, animal testing, animal science, natural 
                                                
 
5 Published in September 2008 on the DG Environment Website under: 
http://ec.europa.eu/environment/c hemicals/lab_animals/ia_en.htm  
6 Published in December 2006 on the DG Environment Website under:  
http://ec.europa.eu/environment/chemicals/lab_animals/questionnaire2.htm  
 
EN 9   EN sciences (especially biology, medicine, pharm acology and toxicology), legal and economic 
affairs related to these areas and all those who were in a position to either confirm the identified impacts or provide factual, quantifiabl e information to the contrary. If experts did 
not support the preliminary findings, they were asked to provide further arguments 
accompanied by factual and quantitative data and if possible the source of their information.  
283 respondents took part in the expert consultati on, the vast majority of which were experts 
in the field of experimental animals. While th e consultation revealed a lot of support for the 
preliminary hypotheses on the impacts, they pr ovided only a limited amount of new facts or 
additional quantitative data.  
The results of the internet consultation were  published on the website of DG Environment in 
full. The main arguments and figures from the internet consultation regarding the preliminary 
hypotheses have been summarised in the exte rnal study as bullet points in grey boxes and 
have been taken into account  in the final report of th e external study. A number of 
conclusions have also fed into the legal drafting.  
Whilst this Commission staff pape r draws heavily on the Prognos study, it is also based on the 
much wider stakeholder and expe rt input over the last years. 
d) Inter-service group 
An informal inter-service group composed of re presentatives of various  Directorate-Generals 
of the European Commission was set up and me t several times in 2006  and 2007. Directorate-
Generals involved were Environment (lead), En terprise, Research, Joint Research Centre, 
Information Society and Media, Health and Consumer Affairs and in the later stages the Secretariat-General. Under the Commission rules, this Impact Assessment was performed voluntarily, thus no additional in ter-service steering group was re quired. Instead, the informal 
inter-service group discussed bot h issues related to policy- making and to the impact 
assessment in an integrated way.  
e) Commission Impact Assessment Board 
This Impact Assessment was reviewed in  March 2007 by the independent Commission 
Impact Assessment Board (IAB). The Boar d issued its Opinion on 16 March 2007 and 
emphasised the following positive elements about the Impact Assessment: The attempt to quantify and where possible monetise benefits and costs for each specific option, the inclusion of information about third country system s of experimental animal protection, the 
examination of links with other Community legi slation and the inclusion of a glossary of 
terms. In light of the Board's recommendations , the following sections have been further 
improved: internal market problems, the se ction on self-regul ation, the qualitative benefit 
dimension and the use of the standa rd model of administrative costs. 
3. PROBLEM
 DEFINITION 
Overview of the sector 
The number of vertebrate animals used annua lly for experimental and other scientific 
purposes in the EU-25 is about 12.2 million. Mo st of them are mice and rats but bigger 
 
EN 10   EN animals are also used in significant numbers (e.g. about  20.000 dogs and about 10.000 non-
human primates).  
No official aggregated data ar e available about many key data of  the sector but the external 
study performed by Prognos has estimated that a bout 1.330 establishments (industry, contract 
research laboratories and universities)  in the EU-25 perform animal tests7. The number of 
breeders and suppliers of animals for experiment al purposes is most likely in the range of 
several dozen only.  
To get an impression of the distribution of projects across types of establishments the 
disaggregated data from the UK in 20058 may be instructive, even though other Member 
States may have a different structure: 
- Universities: 68.0% of projects - Commercial organisa tions: 12.6% of projects 
- Government departments 3.6% of projects - Other public bodies 9.4% of projects - Non-profit organisatio ns 4.2% of projects 
- Hospitals: 1.2% of projects - Public health laborato ries 0.6% of projects 
In conclusion, most animal tests are performe d by universities and comm ercial organisations.  
Commercial organisations can be  further disaggregated into: 
- Companies doing research in-house for thei r own product development (e.g. pharmaceutical, 
chemical, pesticide, food and feed producers) . Even though only few of them complain 
openly about unfair competition from companies in  Member States with lower animal welfare 
standards, their cost structur e varies across Europe due to differences in the regulatory 
environment.  
- Contract research institutes performing anim al tests on behalf of other companies which 
have outsourced this task due to  cost or expertise reasons. These companies can be expected 
to benefit most from a more harmonised in ternal market and a level playing field. 
In addition, many universities are also affected by the functioning of the internal market in the 
area of animal experimentation, as they incr easingly competing for industry sponsoring for 
their research, are tende ring for public procurement (research)  contracts and sometimes create 
their own commercial off-springs or branches. 
                                                
 
7 Prognos report 2007, Chapter 7, page 55. 
8 See UK Home Office 2005: "Statistics of scientific procedures on living animal s, Great Britain 2005", 
pages 64 and 66. The report is available at: http://www.homeoffice.gov.uk/rds/pdfs06/spanimals05.pdf 
 
EN 11   EN About 9.300 new projects involving animal test s are annually starte d in the EU-25 which 
often last for several years. An average pr oject was estimated to cost about 300.000 Euros 
over three years9. However, it is clear that as a resu lt of differences in scope, application, 
housing and procedural requirements, the es timated average cost is likely to differ 
significantly between Member States.  
It should be noted that some Member States currently have a burdens ome regulatory structure 
in this field. The revision will provide an oppor tunity to streamline these based on the best 
practice and thus contribute to  simplification and at the same time close considerable 
loopholes in the existing Directive 86/609/EEC. 
There is no representative organisation of user establishments but experimental animal 
scientists have formed professional associations  in different Member States whose European 
organisation FELASA10 is well-recognised in the field. 
Problems identified  
An initial problem analysis has shown four ma in problem dimensions across the three areas 
mentioned in the Commission Impact Assessm ent guidelines (economic, social and 
environmental aspects). These main problem dimensions can be described as follows:  
a) Economic problems:  
Competitive disadvantages for countries with  high animal welfare standards resulting 
primarily from price differences (e.g. mini mum requirements for housing), diverging 
regulatory and authorisation proced ures and criteria in the Member  States leading to variable 
delays and cost of projects, uns atisfactory (working) conditions of researchers, obstacles to 
horizontal mobility, increasing activist criminalit y. Similarly, same problems can be identified 
for the breeders of experimental animals, especially in terms of  the cost of housing and care. 
b) Environmental problems/Animal welfare : 
Different levels of animal welfare resulting from a high number of animals not protected by 
the current Directive and from different stan dards that are in force. There are several 
arguments as to why current Community standards are insufficient: Most Member States have gone clearly beyond (some even far beyond) the cu rrent Directive which indicates that they 
consider the level of protection from the existing Directive as too low. The areas of variable 
legislative measures affecting animal welfare include requirements for ethical evaluation as 
well as housing and care standards. The Council  of Europe, with a unanimous support from 
the EU, adopted in 2006 higher housing and car e standards, clearly demonstrating its 
members' views on the necessity to increase these standards. Finally, the Commission regularly receives complaints from citizens about insufficient housing and care conditions and 
the related suffering of animals but these ca nnot be addressed by th e Commission because the 
existing Directive does not provide  even minimum requirements. 
                                                
 
9 Prognos report 2007, Chapter 7, p. 54. 
10 Federation of European Laborato ry Animal Science Associations. 
 
EN 12   EN c) Scientific problems:  
Low innovation / bad science resulting from dela ys of projects, potentially unnecessary 
testing and unnecessary duplication, low incenti ve to develop and use alternative methods, 
risk of variable research results due to non-consistent  scrutiny of study design and 
implementation of refinement (leading to higher stress levels for animals) and obstacles to 
free movement of researcher s due to different standard s for education and training. 
d) Public/societal problems:  
Increasing dissociation between weak legisla tion and strong public concern, evolving from 
changed ethical and societal values and increa sed public interest about the acceptability of 
animal testing.  
These four major problem dimensions and their sub-problems can be displayed in form of 
problem doughnut: 
 
Taking these problem-dimensions as a starting poi nt, a number of specific policy issues were 
identified in the course of the problem-analysis. These can be classified according to the following thirteen policy dimensions: 
I. Scope 
Current situation in Member States
 
Directive 86/609/EEC does not cove r animals used in basic rese arch, education and training 
and those that are merely bred and killed fo r using their tissues and organs. Neither does it 
cover any invertebrate species or  the life stages before birth or  hatching (embryonic and foetal 
forms), although for some of them there is scien tific evidence that they are sentient beings. 
 
EN 13   EN A significant number of animals are currently us ed in basic research within the European 
Community. Out of the total 12.2 million vertebra te animals used annually for scientific 
procedures in the EU-2511, approximately 4.1 million animals ( 35%) are used in this respect. 
These animals are mainly used by universities  and private research establishments. The 
external study has found that 80% of Member States have covered basic research under 
national regulation12. This means that around 500.000 animals used in basic research in the 
remaining five countries are not a fforded the same legal protection. 
Around 1.5% of all animals are used in the fiel ds of education and training. Their absolute 
number is about 200.000. 
Around 40% of Member States do not have legi slation in place which covers animals killed 
for their organs and tissue13. In most cases, euthanasia of animals for in vitro scientific work 
is not considered a scientific procedure. In some Member States, such as Sweden and the 
Netherlands, these animals are covered, whereas in some other Member States animals killed 
for in vitro experiments only have to be reported.  
The situation regarding the inclusion of sentient  invertebrates and foetal forms is even more 
diverse. The external study has found that at least 70% of Member States do not include these 
species and life stages14, whereas Germany fully includes both vertebrates and sentient 
invertebrates, though there is no obligation for authorisation/et hical evaluation of projects 
with invertebrates. 
Trends and implications  
During the last 20 years since the introduction of Directive 86/609/EEC, a shift from in-vivo 
to in-vitro experiments can be observed. This has led to an  increase in animals bred for the 
primary purpose to be killed for their organs and tissues. The use of foetal forms has also 
increased. The external study concluded th at around 175,000 foetal forms of mammalian 
species (at the stage of at least 2/3 of gesta tion) are used in the European Community per 
year. Due to the increasing accepta nce of the Three Rs principle15 a further shift into these 
directions can be expected.  
Problem dimension  
The scientific developments during the last 20 years since adoption of the Directive have led 
to efforts at national level aiming at improvi ng national legislation. However, these national 
legislative acts have resulted in a fragme nted regulatory environment in Europe and 
consequently to varying competitive frameworks between Member States. 
                                                 
11 The official EU statistics are fro m 2002 and cover the EU-15. However, an extrapolation allows an 
estimation on the corresponding figures for EU-25. The Commission report on the statistics of the year 
2005 is available at http://ec.europa.eu/envi ronment/chemicals/lab_animals/reports_en.htm. 
12 Prognos report 2007, p. 16. 
13 Prognos report 2007, p. 16. 
14 Member States where invertebrates are not covered:  Austria, (Belgium), Denmark, Estonia, Finland, 
France, Ireland, Spain, UK. Member  States where foetal and embryonic  forms are not covered: Austria, 
Belgium, Cyprus, Germany, Netherlands, Spain, (UK). Source: Prognos report 2007, p. 16. 
15 The Three Rs Principle (Replace, Reduce and Refine  the use of animals in experiments) is widely 
accepted as the guiding principles when using animal s in experiments both at national and international 
(e.g. OECD, OIE) level. It dates back to the fam ous book "The Principles of Humane Experimental 
Technique" by W.M.S. Russell and R.L. Burch in 1959. 
 
EN 14   EN The different levels of animal protection between Member States are undermining the 
objectives set out in the Protocol  to the EC Treaty which form ally recognises the welfare of 
animals as an element to be taken into acc ount in Community policy making. Even though 20 
Member States cover today basic research under their national le gislation, the area of 
application differs significantly. Whereas in severa l Member States all scientific work in basic 
research involving vertebrate animals is covere d, other Member States  exclude, for example, 
field studies and some  nutrition studies. 
The EFSA Opinion of 2005 recommends extendi ng the scope of the Directive to those 
invertebrates whose sentience is scientifically supported (c yclostomes, cephalopods and 
decapod crustaceans) and to foet al and embryonic forms from the last 1/3 of gestation until 
birth16.  
II. Authorisation of projects 
Current situation in Member States  
Authorisation procedures vary  across Europe, and are particularly long and demanding in 
some Member States. The external study found that currently 21 Member States, covering 
nearly 90 % of animal use, require so me form of authorisation of projects17. The regulatory 
setting for project authorisation in Europe is, however, complex. In most Member States, 
authorisation is primarily granted at a nationa l level but Germany, the Netherlands, Belgium, 
Finland, Greece and Spain having explicitly d ecentralised systems of authorisation. Most 
Member States have some form of authorisation system at the individual project level, mostly 
in combination with authorisa tion for establishments and personnel. Ethical evaluation of the 
project is often a prerequisite for authorisation. In some Memb er States the procedures to 
obtain the first authorisation are significantly di fferent from the procedures used for renewal 
of an existing authorisation18. 
Trends and implications  
Stakeholders estimated that their costs of au thorisation of projects make up approximately 3 
to 4% of the overall costs of a project using animals19. The variance between Member States 
is significant, with 0% in those Member States  without any project au thorisation requirement 
and up to two-digit % in at least one other (one  respondent in the expert internet consultation 
claimed up to 20%, although that figure seems t oo high because it would mean that in an 
average project of 300.000 €, about one full man-year of work would be spent on 
authorisation issues alone).  
Most stakeholders agree that well informed authorisation procedures are required for a good 
prior evaluation of a project’s pos sible negative consequences fo r animal welfare. Transparent 
and well informed authorisation procedures also  contribute to the qual ity of the results.  
                                                 
16 http://ec.europa.eu/environment/chemicals/lab_animals/scientific_en.htm 
17 Prognos report 2007, p. 17. 
18 It is important to note in this context that the terms "authorisation" and "ethical evaluation" are 
interlinked. This is especially important when discu ssing delays due to "authorisation". In the majority 
of cases, if not all, the authorisa tion process includes key elements of  ethical evaluation. Therefore the 
stated "delays due to authorisation" are considered to cover also delays due to ethical evaluation and 
these are both reported in this section.  
19 See Prognos report 2007, Chapter 7, p. 61. 
 
EN 15   EN Problem dimension  
Though it contains reference to the authorisati on or notification of projects, the current 
Directive does not require compulsory auth orisation of projects, nor does it require 
compulsory notification of  projects in all cases. 
The average delay of a project using animals du e to an authorisation in the Community is 
between 70 and 100 days in the EU-25, with sign ificant differences between Member States 
varying from 0 (no authorisation) up to 200 days . Even if these periods in some cases include 
already the time needed for the ethical evaluati on of the project, this variance results in an 
uneven playing field for user establ ishments in different countries.  
One of the main reasons for long delays is the lack of  transparent criteria and standards for the 
authorisation procedures. Most Member States´ authorities seem to have relatively unclear 
standards for the timing of these procedures an d often also the criteria for decision-making 
seem from the applicants' point of  view open to interpretation.  
III. Ethical Evaluation of projects 
Current situation in Member States  
Almost every Member State has some system fo r ethical evaluation in place. These systems, 
however, differ to a great extent. Differences can be seen as regards e.g. the legal status of the 
system, the level at which ethical evaluation is implemented and the elements that are 
integrated in the evaluation process. Differe nt combinations of these elements can be 
observed within the Member States.  
Ethical evaluation of a project is normally performed by an ethical evaluation committee. 
Although it is not a requirement of European law,  many Member States have installed ethical 
evaluation committees at establishment level. In  seven Member States ethical evaluation at 
establishment level is mandatory and laid down in  the legislation of the country. In countries 
with such a mandatory system, this  legal status is valued positively20. Eight other Member 
States have installed such co mmittees on a voluntary basis21. An additional two Member 
States have a mandatory system  at regional level installed.  
The external study has found that in 15 Member St ates, the Three Rs are part of the ethical 
evaluation, but the way this is implemented differs. In 13 Member States, harm-benefit 
analysis is part of the ethical evaluation22. 13 Member States have a severity classification 
system in place. The ways these systems are implemented again differ to a great extent. 
The external study has calculated the number of  experimental animals covered by compulsory 
ethical evaluation as 7.3 million in the EU-25 in 200523. This means that for the use of 4.9 
million animals, ethical evaluation of projects is not mandatory.  
                                                 
20 Stafleu, F.R and J. Vorstenbosch; Animal Welfar e Committees in the Europ ean Research Area, EC, 
2005, p. 79. available at: http://ec. europa.eu/research/science-society /pdf/animal_welfare_final_en.pdf. 
21 FELASA: Principles and Practice in Ethical Revi ew of Animal Experiment s across Europe; December 
2005. Available at http://www.f elasa.eu/recommendations.htm. 
22 Prognos report 2007, p. 20. 
23 Prognos report 2007, table on p. 20. 
 
EN 16   EN Trends and implications  
Ethical evaluation is frequently  mentioned as one of the key instruments to improve the 
scientific outcome and the welfare of experimental animals. Its main aim is to ensure that the use of animals is ethically justified. The benefi ts of ethical evaluation usually seem clear to 
those involved, but it is difficult to provide an objective (or quantitative) assessment of the 
value of the outcomes of the eval uation in practice. It is seen  as having a high potential for 
contributing to a substantial reduction of un necessary testing and for setting relevant 
incentives to increase the use of the concept of  the Three Rs. Most stakeholders agree that 
ethical evaluation procedures ar e required for a good prior eval uation of the project’s possible 
negative consequences on animal welfare. Tran sparent and well informed ethical evaluation 
also contributes to a high quality of scientific  results, as well as to  reducing animal numbers 
and animal suffering. 
Problem dimension
 
The current practice on ethical evaluation and the level of prot ection of experimental animals 
differs very much across the European Comm unity, making it difficult to compare the 
situation in the different Member States. Ethical  evaluation, as one of the main elements of 
the authorisation if one is requi red, has a strong impact on the variances in the authorisation 
delays from 0 (no authorisation)  up to 200 days. The users of anim als have to take this into 
account with their resource allocation. These diffe rences in national pro cedures result in the 
administrative burden varying significantly, cons equently exposing animal users in different 
Member States to an uneven competitive environment. 
It is clear that, if basic elements of ethica l evaluation are not suffici ently harmonised in the 
Directive, the opportunities for the full im plementation of the Three Rs cannot be 
exhaustively exploited and animal we lfare and good scie nce not optimised. 
Furthermore, it is also unclear how under the current structure, in which neither ethical 
evaluation nor authorisation is required by so me national legislation, compliance with the 
requirement of article 7(2) of the current Dire ctive to use an alternative replacement method if 
one is reasonably and practicably available, is ensured.  
IV. Permanent Ethical Review Body and National Animal Welfare and Ethics 
Committee 
Current situation in Member States  
Permanent ethical review bodies go beyond the eval uation of particular pr ojects. They aim at 
influencing the ethos of every establishment that  breeds, supplies and uses animals, creating a 
‘culture of care’ and ensuring proper consideration of ethical aspects and appl ication of the 
Three Rs in all areas. The level at which ethi cal review strategies are established differs 
across Member States. The most common system  within the European Community is based 
on committees at establishment level combined with a committee at a national level.  
The external study has found that 18 out of the 25 Member States have a mandatory national 
ethical review committee in place. The remit of these committees however differs24. 
                                                 
24 Prognos report 2007, p. 22. 
 
EN 17   EN According to the external study, in seven Memb er States establishment-based review is 
mandatory (by virtue of statut e or other binding requirement) and so all establishments in 
these countries carry out such local ethical reviews - though sometimes committees are shared 
between establishments. In the remaining countri es there is no legal or other administrative 
requirement for local ethical review (with the exception of Spain where three administrative 
regions require it and nationa lly all State research centr es are bound to perform it)25. 
Trends and implications  
The external study concluded that ethical review bodies are becoming more and more 
common in Member States and are increasingly c onsidered by a wide range of stakeholders as 
important instruments to improve the welfare of experimental animals.  
Problem dimension  
The existing, highly varied systems result in non -harmonised practices both within a country 
and between Member States. The highly diverse situation creates a non-le vel playing field in 
terms of resource requirements (staff, time) affe cting not only user es tablishments but also 
breeding and supplying establis hments. It leads to an imbalance of administrative burden 
between the different Member States and thus to an uneven competitive environment. It is also difficult to compare the national systems a nd to verify that animal welfare and the Three 
Rs are fully taken into account. 
V. Housing and care standards 
Current situation in Member States
 
Directive 86/609/EEC contains in its A nnex II, non-binding guidelines on accommodation 
and care of animals. Member States have im plemented them in a varying manner. In some 
Member States they are considered as compulsory minimum standards, in others they maintain the non-binding status of guidelines. 
Annex II of Directive 86/609/EEC is based on the corresponding text of the Council of 
Europe Convention ETS 123 for the protection of vertebrate animals used for experimental 
and other scientific purposes. This Conve ntion contains in its  Appendix A non-binding 
guidelines for the accommodation and care of anim als which have recently been revised to 
reflect the latest knowledge and scientific developments. The revised Council of Europe 
guidelines were adopted in June 2006 and Pa rties to the Conventi on are expected to 
implement them by June 2007.  
The European Community is Party to the Conve ntion and will therefore have to implement 
the revised guidelines. In addi tion, 13 Member States have ratified the Convention, covering 
91% of animal use in the EU-25
26.  
The revised guidelines foresee significant incr eases to the cage sizes and emphasise group 
housing and enrichment. The external study fo und that based on the factual feedback and 
                                                 
25 Prognos report 2007, p. 155. 
26 The following 13 Member States of the EU-25 have ratified the convention: Belgium, Cyprus, Czech 
Republic, Denmark, Finland, Fran ce, Germany, Greece, Netherlands,  Slovenia, Spain, Sweden and 
United Kingdom. Bulgaria and Romania also ratified before their accession. 
 
EN 18   EN estimations from users and keepers of animal s, at least 20% of both private and public 
establishments have already upgraded their faci lities to comply with the revised guidelines27.  
Trends and implications  
The revised Appendix A will apply to those c ountries who are parties to the Convention, 
currently only 12 out of the 25 Member States . However, the European Community will also 
need to update its guidelines in  Annex II of Directive 86/ 609/EEC. Therefore, even those 
Member States who are not Party to the Counc il of Europe Convention will need to promote 
the revised guidelines. 
Problem dimension  
Currently, some Member States consider these guidelines as compulsory minimum standards 
whereas others use them purely as guidance. The fact that these guidelines are interpreted differently from one Member State to anothe r places establishments (breeding, supply and 
user establishments) into a significantly differe nt cost environment, depending on the Member 
State in which they are located, consequently dist orting the internal market. This is unlikely to 
change without regulatory act ion at European level.  
Member States have confirmed that the im plementation of the revised housing and care 
standards as agreed at the Counc il of Europe will be considered in a similar manner as today, 
i.e. varying from non-binding to compulsory mi nimum. Due to the significant upgrading of 
these standards, this would suggest a strong possibi lity of further fragment ation of the internal 
market in the near future.  
Since the current guidelines in Annex II of the Directive are non-binding, there is no 
assurance for minimum animal welfare requir ements to be met, e.g. in terms of space 
allowance. This is not in li ne with the requirement to ta ke into account animal welfare 
requirements as per the Animal Welfare Protoc ol to the Treaty estab lishing the European 
Community.  
Inappropriate housing and care can lead to a number of physiological and behavioural 
changes in experimental animals that can heavily  interfere with the test results and undermine 
their reliability
28.  
VI. Transparency / Access to Information 
Current situation in Member States  
In most countries, public information about an imal tests is made av ailable through yearly 
statistical reports publis hed by the responsible ministry. As a minimum, these reports include 
basic statistical information required to be reported to the Comm ission. Several Member 
States make authorisation information availabl e to the public; few make essential parts of 
ethical evaluation reports public ly available. Some establishments publish more detailed 
information voluntarily in their annual reports. 
                                                 
27 Prognos report 2007, p. 205. 
28 See Annex of this document, EFSA 2005, p. 46 -53, and most recently Baldwin and Bekoff 2007. 
 
EN 19   EN Trends and implications  
The right of access to information is essential for a civilised society. If citizens are to exercise 
their democratic rights, and to make informed  choices, they must have access to political, 
social, scientific and economic information. A basic principle behind most freedom of 
information legislation is that the burden of  proof falls on the body asked for information, not 
the person asking for it. The requester does not usua lly have to give an explanation for his/her 
request, but if the information is not disclose d, a valid reason has to be given. In many 
countries, privacy or data pr otection laws may be part of the freedom of information 
legislation. 
Problem dimension  
Better regulation requires transp arency about regulations and economic actors' behaviour. The 
right of citizens to information about public policies at Community level has been recognised 
in Regulation (EC) 1049/2001 about access to info rmation. However, the current Directive 
86/609/EEC does not provide a le vel of transparency  called for by la rge proportion of 
stakeholders and the general public. It has been recognised by many companies and 
researchers that a consistent approach about transparency ac ross Europe would benefit all 
interested parties.  
A few countries such as Sweden, Denmark, and the Netherlands have implemented extensive 
public rights to information thr ough their freedom of informati on legislation. In principle, 
these rights would enable interested members of the public to access ex tensive information on 
projects, except for company and personal detail s. Intellectual property rights and other trade 
secrets are also considered as restricted info rmation and are not made available under freedom 
of information legislation.  
The external study concluded that a majority of stakeholders w ould expect the revision of the 
Directive to include more public rights/better access to information. On the other hand, they 
stressed that great caution should be exercised to  avoid that more transparency is used for 
political gain by animal rights extremists. It is also feared that this might lead to security 
issues for personnel. Many stakehol ders point out that increased le gislation in this area must 
be balanced against intellect ual property rights concerns. 
VII. Non-human primates (NHPs) 
Current situation in Member States  
Available data indicates that in 2002 about 9000 non-human prim ates (NHPs) were used in 
the 15 Member States which accounted for about 0.1%  of all the experimental animals used in 
that year29. The data shows that more NHPs were used in the United Kingdom, France and 
Germany than elsewhere in the Community. The to tal use of NHPs in the EU-25 is estimated 
to be close to 10,000 per year: 75-80% of these animals are "Old World monkeys" (mainly cynomolgus and rhesus monkeys); 20-25% ar e "New World monkeys" (mainly marmosets 
                                                
 
29 This impact assessment report has tried to use the extrapolations or EU statistics for the animal use of 
the EU-25 in 2005 wherever possible. However, for the NHP section, the reference year is often 2002 
because EU statistics had to be compared with CITES  statistics, and 2002 was the most recent year for 
which both statistics existed at the time of writing. 
 
EN 20   EN and some tamarins); and some Prosimians (mainly lemurs). Other species used counted for 
less than 3%. 
The use of Great Apes is ve ry limited, with 6 animals in 1999 and zero in 2002 and 2005. The 
use of Great Apes is banned in some Member States, a total ban in the Netherlands, Austria 
and UK (no further authorisations issued); a nd a partial ban in Sweden where they can be 
used only for research rela ting to their own species. 
Use and trends  
The main biomedical research areas using NHPs are safety testing of pharmaceuticals, quality 
control of vaccines, and funda mental and applied research. At present some scientific 
procedures require the use of NHPs e.g. for polio or Hepatitis C vaccine research, HIV 
research and investigations into higher cognitive function. A high proportion of NHPs (> 
70%) are used in applied studies and regulator y testing, therefore fu rther support for the 
development and implementation of alternativ e methods could be e ffective to reduce the 
number of animals used. Strategies are being developed in order to establish and maintain 
non-human primate tissue banks and primate-derived cell cult ure collections in order to 
optimise the use of this material but these ar e at present still inadequate to replace a 
substantial part of NHPs in biomedical research. 
There are insufficient data available to estima te whether the use of NHPs is decreasing in 
Europe. In the Netherlands the number of NH Ps decreased from about 400 in 2000 to about 
300 in 2004, but in the UK there was an increase from about 3700 to 4200 in this period.  
The USA, together with Japan, are the main us ers of NHPs in research and testing. Most 
recent statistics show that 52.279 NHPs where used  in research, testing and teaching in the 
USA in 2002. For Japan, no accurate figures are available as no mandatory reporting system 
is in place, but, based on data from CITES (2002), their use was estimated to be 6000-7000 
animals per year30. 
In 2002 about 75-80% of the NHPs used for scie ntific purposes in the EU were Old World 
monkeys. About 7000 of these animals were impor ted from outside the EU. Only a few were 
second or higher generation (F2+) purpose-bred31. 
The most frequently used NHPs in the European Community are macaques (cynomolgus and 
rhesus monkeys) and marmosets; in the UK th e ratio of Old to New World is about 3:1. The 
reproduction cycle for marmosets is 2-2.5 years (b reeding age reached at 1.5-2 years, with a 
4-month gestation period). One litter consists  of 2-3 progeny. The reproduction cycle for 
macaques is longer, approximately 4-5 years (b reeding age reached at 4 years, with a 5-6-
month gestation). A litter usuall y consists of only one progeny.  
Problem dimension  
Non-human primates are species with highly developed social sk ills and behavioural manners 
that are to some extent similar to those of human behaviour. Due to the similarities with 
human beings, the ethical justification of their us e is a sensitive issue an d a subject of serious 
                                                 
30 Prognos report 2007, p. 25. 
31 Prognos report 2007, p. 25. 
 
EN 21   EN debate. There is increasing (public) concern re garding their potential  use in scientific 
procedures and their welfare is not considered  sufficiently assured by the wording of the 
current Directive.  
A particular problem arises from the fact that  it has turned out to be difficult for several 
species to establish self-sustaining breeding colonies. Many NHPs are therefore caught in the wild and bred so that their fi rst generation offspring (F1) can be used for research. There is 
significant evidence that catching these highly aw are and social animals from the wild causes 
significant suffering and distre ss, both for themselves and for their remaining group and 
family members. The subsequent transport both in terms of distress and injuries add to these 
concerns. Several stakeholders have therefor e advocated to move to wards self-sustaining 
breeding colonies and only allow the use of second (F2) or higher generation captive-bred 
NHPs in scientific procedures. In that case, the need to catch NHPs in the wild would be 
significantly reduced. 
On the other hand, there is a clear need for NH Ps in biomedical research, due to the above 
mentioned similarities to the human species. For example, they are used to tackle severe diseases such as diabetes, AIDS, malaria, Parkinson’s, Alzheimer’s etc.
32. Furthermore, they 
are important for the development and quality control of vaccines, where Europe plays a 
leading role in the world (around 85% of the gl obal supply is produced in Europe) to which 
with the current scientif ic knowledge no alternatives are yet available. 
In their natural habitat, NHPs live in complex environments and the social dimension is vital 
for their well-being. If the physical and social environment is inadequate, the NHP is usually 
not a good model in research. Therefore, animal  welfare and quality of science are closely 
linked. As a consequence, research on NHPs is more cost-intensive than research on other 
mammalian species. Special consideration must be  paid to Great Apes where the discussion 
about NHPs is the most controversial. Their us e is quite rare, although some scientists are 
against a total ban because new emerging diseases  might make it necessary to use Great Apes 
for the development of v accines and treatments.  
VIII. Inspections 
Current situation in Member States  
All Member States have an infrastructure for periodic inspections. The frequency of 
inspections varies significantly fr om one Member State to another. 
Trends and implications  
Inspections are highlighted as one of the main  tools for ensuring compliance with legislation 
and minimum requirements. Some Member States  have over the recent years made specific 
investments to increase the tr aining of inspectors and the freque ncy of visits. In the UK for 
example, an establishment can have multiple inspections over a period of one year, many of which are unannounced. 
                                                
 
32 See also the Opinion of the Commission's Scientific Steering Committee about non-human primate use 
(2002): http://ec.europa.eu/food/fs/sc/ssc/out253_en.pdf. 
 
EN 22   EN Problem dimension  
The Directive does not specify any frequency of inspections apart from being periodic. Some 
Member States have therefore developed the practice of inspecting establishments several 
times per year whilst others do hardly any inspections at all. This situation creates a stricter regulatory environment in some Member States than in others and undermines trust in the 
proper enforcement of standards,  thereby itself creating incentiv es to deviate from official 
standards. This undermines the concept of a level playing field and legal certainty for 
breeders, suppliers and users.  
Since there are no effective Community wide mi nimum standards for inspections, there is a 
low public perception of levels of complia nce and enforcement by the authorities. 
Furthermore, if inspections are announced prior to the visit, it may result in providing an 
unrealistic picture of the day-to -day running of the establishmen t. In case full compliance is 
not assured, animal welfare may be comp romised. The Commission regularly receives 
complaints from citizens about alleged in fringements of the existing legislation
33. 
IX. Education and training 
Current situation in Member States  
The external study found that all Member States have set (minimum) legal requirements for 
the competence of personnel working with expe rimental animals. Several Member States 
referred to their system as being in accordance  with the FELASA guidelines for the education 
and training of persons (Belgium, Slovenia, th e Netherlands, Lithuani a (B and C category))34, 
while others have very different standards in place. 
Demonstrating/maintaining personnel competence how ever is required only in approx 35% of 
the Member States, covering approximately four million of total animal use in Europe. The other 65% of Member States do not ha ve specific requirements in place for 
demonstrating/maintaining competence
35. 
Trends and implications  
A “Code of conduct for education and training of  persons working with laboratory animals” 
of the European Convention ETS 123 was adopt ed by the Multilateral Consultation in 1993. 
Four categories of persons are de fined who must have had appropr iate education and training:  
Category A: Persons taking care of animals Category B: Persons carrying out procedures  Category C: Persons responsible for directing or desi gning procedures 
Category D: Laboratory anim al science specialists  
                                                
 
33 29 incorrect/non transposition and bad applications cases opened under Directive 86/609/EEC (11 
concerning transposition, 18 on bad applications). 15 of these were confirmed as infringements by the Commission. 
34 Prognos report 2007, p. 27. 
35 Prognos report 2007, p. 27. 
 
EN 23   EN Countries that ratified the Convention ETS 123 have agreed to ensure that these guidelines 
will be circulated among the persons responsible  for education and training of those working 
with experimental animals, to encourage thes e persons to follow these guidelines in their 
courses; and to encourage those responsible  for education and training to establish 
programmes to allow the fulfilm ent of the requirements of the Convention for all persons 
working with experimental animals. 
Problem dimension  
The current Directive does not specify the n ecessary competence of the personnel, nor how 
competence can be kept up-to-date and is dem onstrated. Staff qualifications determine to a 
great extent the costs of institutes and laborator ies. Differences in the levels of training and 
qualifications across Member States lead to differences in the cost of developing and 
performing a project. The differences in th e requirements for the personnel also make it 
difficult to participate in projects in anothe r Member State restricting their freedom of 
movement. 
Lack of competence can also seriously undermine animal welfare e.g. when performing a 
procedure or euthanasia on animals, as well as  having a deleterious eff ect on the scientific 
outcomes and their reliability. Qualified and well -trained personnel are th erefore essential for 
good animal welfare, good science,  and the human dimension of us e of animals in scientific 
procedures. People working with animals should be trained specifically to reduce suffering of 
animals during their whole lifetime. This is currently not ensured since the Directive does not give specific requirements for education a nd training or demonstrating competence.  
X. Avoiding unnecessary duplication 
Current situation in Member States
 
No systematic instruments apart from ethical  evaluation and authorisation are employed by 
Member States to avoid unnece ssary duplication of testing36. Retesting is a legal requirement 
with few exceptions for medical products for human and veterinary use which are imported 
from third countries. The only instruments possi bly contributing to a reduction of duplication 
in this area are Mutual R ecognition Agreements between exporting countries and the 
European Community. However these instruments only cover specific issues and are thus not 
able to abolish the requiremen t to test all products coming from that exporting country. For 
imported vaccines there is an option for Memb er States to retest, which 10 – 15 Member 
States actually use37.  
Trends and implications  
One of the leading principles of the Three Rs  is to avoid unnecessary testing on animals. 
However, due to the different laws, administra tive procedures in authorisation and inspection 
arrangements in the Member States, it cannot be excluded, that duplication of testing may 
                                                 
36 The new chemicals policy REACH is an exception in that respect because it foresees mandatory data-
sharing and prior evaluation of testing proposals by the new European Chemicals Agency. However, 
based on estimations produced by the Joint Research Centre of the Commission in 2003, REACH will only concern about 2-3% of all animals used for experimental and other scientific purposes per year, so 
relying on REACH mechanisms alone to address unnecessary duplication does  not seem sufficient. 
37 Prognos report 2007, p. 29. 
 
EN 24   EN occur. The external study ha s concluded that in Europe approximately 160.000 animals per 
year are subject to unnecessary duplication in regulatory testing38. There are no reliable data 
about unnecessary duplication in other areas (basic research, applied research) but little 
incentive may exist to knowingly duplicate scient ific procedures using animals on the same 
substance in applied research (e.g. due to ear ly patent protection of  active ingredients in 
pharmaceuticals). A similar disincen tive to duplicate exists in basi c research (e.g. due to strict 
scrutiny of any project proposals by funding bodies and peer reviews by scientific journals). 
Problem dimension  
Currently, there is no harmonised approach in Eu rope to ensure an effective exchange of 
relevant information and data regarding animal use in scientific proce dures. Authorisation and 
inspection bodies as well as researchers do not  have the necessary overview of objectives and 
results of all scientific proce dures carried out each year on more than 12 million animals in 
the EU-25 alone. Although it can be argued that scientists usually have an excellent overview 
of the literature within their respective fields  of specialisation, negati ve experimental results 
(although equally valuable), are often not reported.  
XI. Use of CO 2 for euthanasia  
Current situation in Member States  
The Commission has produced guidelines on humane methods of euthanasia39. Some Member 
States use these guidelines as such. The use of CO 2 is recommended for killing many 
common species of animals used  in scientific procedures. 
Trends and implications  
CO 2 is one of the most commonly used methods of euthanasia. It is the most convenient 
method for euthanasia of large numbers of rodents (quicker a nd less resource-intensive than 
alternatives). If used in optimal conditions, CO 2 may also be less stressful than manipulations 
required for injections or physical methods.  
Establishments do not use a single method of euth anasia but rather a co mbination of several 
methods according to the type of project or th e circumstances and the species in question. For 
example, if there is a necropsy (dissection of  the dead body to determine the cause of the 
death or changes produced by a di sease) at the end of  a toxicology study, the animal may be 
anesthetized with a suitable  method, and then exsanguinated.  If there is no necropsy, CO 2 is 
used (on conscious animals), or pentobarbital ove r-dosage, if less than 2-3 rodents (mice/rats) 
are to be killed at the same time.  
Problem dimension  
The Directive itself neither specifies nor give s any guidance as to the most appropriate 
methods of killing per type  of species. Applying CO 2 is a relatively cost effective way to kill 
certain species of animals whilst alternative gases are more expensive and pose different 
                                                 
38 Prognos report 2007, p. 29. 
39 See Close et al. 1996: Recommenda tions for the Euthanasia of expe rimental animals:  Part 1. In: 
Laboratory Animals, vol. 30, pages 293-316; Close et al. 1997: Recommendations for the Euthanasia of 
experimental animals: Part 2. In: Laboratory Animals, vol. 31, p. 1-32. 
 
EN 25   EN requirements for their use. If so me Member States are banning CO 2 as a method for 
euthanasia on welfare grounds for some or all species while other Me mber States do not, 
different cost structures for breeders and users occur across the community. This puts 
establishments in high standa rd countries in a different co st environment, distorting the 
internal market. 
In terms of animal welfare, recent research shows that CO 2 is aversive to all vertebrates, some 
species seem to find even low concentrations (10-20% by volume in air) aversive. However, 
there is insufficient scientific data yet availa ble on the aversiveness of alternative gases. The 
EFSA opinion recommended using CO 2 only when an animal is first rendered unconscious 
via another method40.  
XII. Statistical reporting 
Current situation in Member States  
The current Directive foresees that  MS have to report statistics at  least every three years to the 
Commission. To implement this, Member States  have voluntarily agreed to report on 8 
analytical categories:  
– species, numbers and origin of animals used, re-use  
– purpose of the experiments 
– toxicological or safety evaluati on for types of products/endpoints 
– animals used for studies of diseases 
– animals used in production and quality control 
– origin of regulatory requirements for animal s used in toxicological and other safety 
evaluations 
– animals used in toxicity test for toxi cological and other safety evaluations 
– type of toxicity test carried out for to xicological and other safety evaluations 
In addition, the external study found that nine Member States report on transgenic animals 
and seven report on animals killed for their tissue/organs separately in their national reporting
41.  
Trends and implications  
The current situation with statistical reporti ng in Europe is characterised by an increasing 
quality of data. Since 1991, the Commission has published statistical re ports on the use of 
animals in experiments in the European Co mmunity. The format for reporting data was 
harmonised in 1997 at European Community level. Based on this reporting system, both the 
                                                 
40 http://ec.europa.eu/environment/chemicals/lab_animals/scientific_en.htm 
41 Prognos report 2007, p. 31. 
 
EN 26   EN quality and coherence of data has constantly increased over the years. The 5th statistical 
report, covering the year 2005, contains  data from all 25 Member States. 
Problem dimension  
The availability of sound data  on the number of animals used for experimental and other 
scientific purposes is essential for public policy-makers working in the field of animal protection. To ensure a level of  confidence on the da ta, the basis for the data requirements 
should be uniform and enforceable. However, th e current basis is only secured by a voluntary 
agreement and thus not legally enforceable. Furthe rmore, the analysis of the statistical data 
currently available shows that th ere are central fields of politi cal and public interest which are 
not yet covered by the existing statistical report ing system. The use of genetically modified 
animals, which are increasingly used in scientific procedures are not specifically reported through the existing system, neither are animal s killed for their organs and tissues. The 
severity classes to which animals have b een subjected are not identified either. 
Finally, the current statistical  reporting system only focuses on overall numbers of animals 
used for experimental and other scientific pu rposes but there are no data available on how 
many projects per establishment category (public /private) are carried out in the European 
Community per year. This makes identificati on of trends and impacts of policy changes 
difficult and hinders good policy making. 
XIII. Promotion of alte rnative test methods 
Current situation in Member States
 
Directive 86/609/EEC in its Ar ticle 23 calls for the Commission and the Member States to 
encourage research into the development and validation of alternative methods. However, 
only a few Member States (e.g. Germany, Netherlands, Austria, UK) are known to have set up 
national centres to develop or validate alternative methods to animal tests42. Including 
laboratories, which could also serve such a pur pose, a maximum of 12 Member States have 
such national centres in place43. 
Trends and implications  
As a response to Article 23, the Commission set up in 1991 the European Centre for the 
Validation of Alternative Methods, ECVAM44. The concept of validatio n was not yet clear at 
the time and thus an extensive amount of work  was put into clarifying and optimising pre-
validation and validation procedures and criter ia, not only in EU but also internationally 
(ICCVAM, OECD). Today, the validation process is well established and increasing numbers 
of candidate methods are be ing proposed for validation.  
ECVAM is currently addressing th e potential validation of a si gnificant number of methods 
that are a result of a number of resear ch projects under the Community Framework 
Programme for Research. Not all test methods  may successfully pass pre-validation and 
                                                 
42 Information of ECVAM (European Centre for the Validation of Alternative Methods) and ZEBET 
(Zentralstelle zur Erfassung und Bewertung von Ersatz- und Ergänzungsmethoden zum Tierversuch in Germany; http://www.bfr.bund.de/cd/1433). 
43 Information by ECVAM. 
44 SEC(91) 1794, Communication of th e European Commission to Counc il and the European Parliament. 
 
EN 27   EN further validation. Nevertheless, the number of tests entering the pipeline has been increasing 
over the last few years and is not  expected to level off. Suitabl e methods need to be available 
to cover the requirements of the Cosmetics Di rective. REACH and new developments in the 
medical area may spark even a further increase.  
Problem dimension  
Even though the ECVAM structure and working me thods have now been established, several 
problems remain: 
1. The current infrastructure is not equipped to cope with this increasing demand and there is 
a lack of suitable methods but also available resources to carry out the required validation 
studies. It is important to note that the role of  ECVAM is to co-ordinate validation studies at 
the Community level, however, several participating laboratories are required for each 
validation study (inter-laborat ory validation in order to ensure reproducibility and 
transferability). 
2. Time delay is an additional bottle-neck to the process on ECVAM co-ordinated validation 
studies. Due to the requirements for transparen cy, the administrative pr ocedures to launch a 
validation study take an average one year  delaying the process significantly. 
3. Participating laboratories of ten have problems finding suppliers  or storing their chemicals 
in a purity that is necessary to perform effective validation studies45. 
Subsidiarity  
The European Community has the ri ght to act on the identified problems and is better placed 
than the Member States alone to tackle them:  
• The EC Treaty provides the European Community  in Article 95 with a legal base to adopt 
measures to approximate Member State pr ovisions laid down by law, regulation or 
administrative action, in order to ensure the functioning of the internal market.  
• The Protocol on protection and welfare of an imals annexed to the EC Treaty requires the 
European Community and the Member Stat es to pay full regard to the welfare 
requirements of animals in formulating and implementing the Community's agriculture, 
transport, internal market and research policies. 
• While most of the identified problems fa ll under a competence shared by the Community 
and the Member States, the problems cannot be  sufficiently solved by the Member States 
themselves because action or non-action by the Member States has created the problems of 
distortion of the internal market in the firs t place, as has been shown in detail above. 
                                                 
45 Information by ZEBET. 
 
EN 28   EN 4. POLICY  OBJECTIVES 
The overall, general and specifi c objectives for the revision of Directive 86/609/EEC are: 
Overall objective: Strengthen the Single  Market and reduce unfair competition  
Primary objective:  Strong convergence of standards that ensures a level playing field for 
industry, researchers, breeders and suppliers of experimental animals   
Specific objectives  
Reduce unfair competition and distortion of internal market for companies, research institutes 
and universities by  
• harmonising the minimum requirements in areas  such as scope, authorisation including 
ethical review, and minimum standards for housing and care in order to level the 
regulatory driven 
• cost and time factors for establishmen ts performing scien tific procedures 
involving the use of animals  
• cost for breeders and suppliers of experimental animals 
• stepping up enforcement of legislation by ensuring minimum inspections throughout the 
Member States 
• increasing transparency in line with better regulation principles 
• encouraging research into alternative appr oaches and improve conditions for innovation 
Secondary objective:  In line with the Animal Welfa re Protocol annexed to the EC 
Treaty, a significant improvement in animal  welfare and protection over the life time 
experience of experimental animals  
Specific objectives  
Improve animal welfare by ensuring a minimum scrutiny and standards of all animal keeping 
and use for experimental purposes by  
• Implementation of ethical evaluation of proj ects and permanent ethical review body in 
establishments to ensure full compliance with the Three Rs. 
• Minimum criteria for housing and care, and inspections 
• Ensure protection of all animals for which there is scientific evidence that they are sentient 
(including selected invertebrates, certain foet al and embryonic forms, animals used in basic 
research, those bred for tissue). 
 
EN 29   EN These objectives are in line with  the Lisbon Strategy calling for the internal market to be 
further harmonised, the regulato ry environment simplified a nd high-quality research and 
development fostered.  
The objectives also support the implementation of the 6th Environment Action Programme 
which foresees in Article 7(2)a) and b) that  the development and va lidation of alternative 
testing methods should be reinforced.  
 
EN 30   EN 5. POLICY  OPTIONS   
a) Four basic options 
In the course of the discussions with experts and stakeholders, four ba sic policy-options have 
been developed: 
1.) No Policy-Change:  
One option could be to keep the current si tuation unchanged. This would mean that the 
existing Directive 86/609/EEC would not be re vised and that the given standard of 
community legislation and national imp lementation would be continued.  
The problem descriptions in section 3 have pr esented a number of problems and trends of 
concern. The existing Directive will not be able to address these problems and trends 
effectively and no-policy-change is therefore not a vi able option. The Direct ive also needs to 
be adapted to scientific progress and new an imal techniques 20 years after its inception, and 
the opportunity should be used to review its e ffectiveness in the different areas and upgrade 
the standards where necessary. 
It has been suggested that the Commission could rather focus on implementation and better 
enforcement of the existing Directive instead  of upgrading it. However, given that the 
protection level provided by th e current Directive is not very ambitious and has many 
loopholes, there is little that the Commission c ould actually enforce before the Directive is 
revised. In view of the complaints about poor animal welfare and handling in establishments 
that the Commission receives, and the problems on correct transposition partly arising from 
the unclear legal wording and inconsistencies in the text46, it seems therefore better to first 
upgrade the existing Directive and then focus on  better implementation and enforcement in a 
second step. 
2.) Self-regulation  
A basic option that was discar ded for most policy dimensions  was self-regulation. Several 
reasons make such an approach impractical  across most of the policy dimensions:  
- Firstly, this in a way represen ts the status quo/busi ness as usual scenario where the problems 
mentioned above are not adequately addressed.  
- Secondly, there are no suitable Eu ropean or even national orga nisations of breeder, supplier 
or user establishments who could monitor or enforce a clear policy. For instance, while a US-based international self-regulation body for we lfare standards of experimental animals 
actually exists (AAALAC), to a large extent it just reinforces existin g national or European 
legislation and can therefore not serve as a su bstitute but only as an add-on to legislation. 
Currently only 29 out of an estimated 1,300 breed er, supplier and user es tablishments in the 
European Community are acc redited with AAALAC (mostly  national branches of 
multinational pharmaceutical companies).  
                                                
 
46 As an example, it is difficult to determine whether procedures entailing severe pain are allowed. Article 
8, paragraph 3; Article 10; and Article 12, paragraph 2, seem to contradict. 
 
EN 31   EN - Thirdly, using ethical evaluation as an example that clearly demonstrate how some existing 
national legislations go much further than othe rs, creating an uneven playing field especially 
in terms of administrative dela ys and resource requirements. Su ch variance in administrative 
delays, which can have direct implications for competitiveness, is unlikely to be addressed successfully through self-regulation.  
- Fourthly, the experience of the Commission w ith voluntary agreements has not always been 
very good, as can for example be seen when ex amining the voluntary ag reement of European 
car producers to reduce their CO2 emissions wh ich is likely to fail to deliver the agreed 
results. 
- Finally, there seems to be a move away from  voluntary agreements in industry as well so 
that any voluntary scheme set up by the Comm ission may not be very credible. The main 
problem industry fears concerni ng voluntary agreements are fr ee-riders whose market access 
may be difficult to control without state ac tion. A recent call for le gislation instead of 
voluntary agreements in the energy efficien cy area was issued by the white goods industry 
association Ceced
47.  
3.) Deregulation:  
In theory, the existing Directive could be repelled and the regulatory competence fully 
transferred to the Member States, with the Eu ropean Community level remaining to provide 
only recommendations and playing an activ e part in exchangi ng information on good 
practices and alternative methods.  
This option of deregulation was not pursued furt her because all Member States have existing 
national legislation that implem ents the original Directive. Most Member States exceed the 
requirements of the Directive. Also, deregula tion would naturally lead  to an even more 
uneven playing field and more acute problems with the Single Market. Furthermore, the 
impact of deregulation would fail to address th e calls from experts, stakeholders, Member 
States and policy makers who have reached a broad consensus during the last few years on the fact that a revision of the curre nt Directive is necessary. Fina lly, deregulation is clearly not 
advisable in view of the international commitm ents (Council of Eur ope) of the European 
Community. The question therefore is not whet her the EC should regulate but how it should 
regulate.  
4.) Reinforcement of the existing European Community legislation:
 
A fourth option could be to reinforce the European Community regulation by revising the 
existing Directive. This would mean that in  specific areas, where evidence shows that a 
Community wide harmonisation could consider ably contribute to a reduction of existing 
obstacles to the functioning of the internal market and to the enhancement of the welfare of experimental animals, a revised Directive coul d set clearer and more harmonized standards.  
This option is justified by the fact that  Directive 86/609/EEC has not succeeded in 
harmonising the internal market. In many re levant policy dimensions, such as scope, 
education and training, authorisation or housing a nd care, the absence of a level playing field 
leads to unfair competition and distortion of intern al market for companies, research institutes 
                                                
 
47 See ENDS Europe Daily, 22 March 2007. 
 
EN 32   EN and universities. Good pract ice examples of selected Member  States could be used as a 
starting point to develop a hi gher level of legal and pro cedural convergence throughout 
Europe.  
This option is also justified by  the fact that both the scientif ic context and the policy-problems 
have significantly changed since 1986. Although, fo r instance, the level of animal protection 
in Europe has increased in recent years, the st atistics are showing an increase of the total 
number of animals used per ye ar in most Member States. 
b) Choice of legal instrument 
Based on the reflections about the four basic op tions, the fourth basic option (reinforcement of 
the EC legislation) was developed further. In th is context, the question of the legal instrument 
was discussed in relation to the subsidiarity principle. In theory, both a Regulation or a 
Directive would be possible to address the problems and trends of concern.  
A Regulation  would have the advantage of simplifyi ng the regulatory environment in Europe 
and may be the better instrument to ensure a level playing field for all establishments, 
regardless of their location. On the other hand, a Regulation may be too rigid to encompass all 
the existing regulatory systems that have deve loped over the last 20 years in the Member 
States, and changing these completely would be a significant cost factor. Finally and most 
importantly, the principle of subsidiarity would caution against using a Regulation in this 
field. Member States can be expected to deve lop a good system suitable for their national or 
regional administrative system as long as certain minimum st andards are set at European 
level. Moreover, the Protocol on Animal Welfare annexed to the EC Treaty foresees explicitly 
that "the legislative or admini strative provisions and customs of the Member States relating in 
particular to religious rites, cultural traditi ons and regional heritage " shall be respected. A 
Regulation would not seem an appropriate instrument in such a sensitive area. 
In view of these arguments, the Commission cons iders that a Directive is a more suitable 
instrument in this field and proposes to  revise the existing Directive 86/609.  
c) Subsidiarity 
The analysis of these basic policy options has shown that the proposed policy objectives 
cannot be sufficiently achieved by the Member St ates alone and can be better achieved at 
Community level. 
Specific options for each policy dimension have been defined and are outlined in the next 
section. 
d) Specific policy options 
I. Scope  
The options include extending th e scope of animals and procedures covered under the current 
Directive to create a uniform regulatory environment within the European Community. This 
would result in a more competitive level playing field in this respect and protect at least 4.1 
million additional animals currently not covered by the Directive.  
Option 1: Extend the scope to cove r animals used in basic research 
 
EN 33   EN Option 2: Extend the scope to cover animals bred for the primary purpose of their tissue 
and organs to be used in experiments or for other scientific purposes (but without 
requiring a project authorisation for the euth anasia if it is performed by competent 
person using a method appropriate to the species) 
Option 3: Extend the scope to cover sel ected invertebrates species (Cyclostomes, 
Cephalopods and Decapod crustaceans) 
Option 4: Extend the scope to cover foetal and embryonic fo rms from the last third of 
gestation until birth 
Option 5: Extend the scope to cover an imals used in education and training 
II. Authorisation of projects  
In view of the large differences in authorisat ion practices in Europe , a level playing-field 
should be established to guarant ee comparable minimum requirements for the authorisation of 
projects while ensuring a smooth processing of a pplications to safeguard the competitiveness 
of Europe as a research pl ace in line with the Lisbon Strategy. The introduction of 
compulsory authorisation for individual proj ects with a maximum deadline of 30 days for 
public authorities to decide on applications could be a highly effective instrument to 
harmonise the internal market and enhance animal welfare.  
Option 1: Authorisation of indivi dual projects with compliance check 
Option 2: Authorisation of a gro up of projects for regulatory testing 
III. Ethical evaluation of projects  
An effective ethical evaluation for scientific uses of animals could be mandatory in every 
European country as a central el ement of authorisation requirements in order to harmonise the 
internal market and ensure minimu m standards of animal welfare.  
(1) An important option for the revision of the Directive could be to make ethical evaluation 
of projects mandatory. The revi sed Directive could contain a list of minimum requirements 
for ethical evaluation such as: 
(i) Implementation of the Three Rs in which every project has to be critically evaluated to see 
if the concepts within the Three Rs framewor k have been sufficiently taken into account. 
Minimum elements could include: 
• Justification of the scientific objectives 
• Justification of the proposed use of animals and procedures 
• Origin, numbers, species and life-stag es of animals with justification 
• Demonstration of lack of alternative methods 
• Demonstration of competence of persons involved in the project 
 
EN 34   EN • Use of anaesthesia, analgesia a nd other pain relieving methods 
• Reduction, avoidance and alleviation of any othe r form of animal suffering from birth to 
death 
• Housing, husbandry and care conditions  in the context of procedures 
• Use of early and humane endpoints 
• Experimental strategy and statistical design to minimise animal numbers and animal 
suffering 
• Assessment of life time experience, including the re-use of animals 
• Avoidance of unnecessary duplication of procedures 
(ii) Severity classification of  procedures which aims at cat egorising the procedures by the 
level of physical pain, physio logical perturbation, or mental  distress the procedures may 
inflict on an animal, and their duration.  
Whereas some Member States systematically apply severity classification, most Member 
States have little or no experience in this area. Consideration could therefore be given to 
minimum requirements. In addition, it could be be neficial to give pract ical guidance for this 
severity assessment.  
(iii) Harm-benefit analysis at a project level ai ms at quantifying, not in mathematical terms, 
the harm to the individual animal in terms of suffering, pain, distress etc and the likely benefit 
to humans, animals and the environment.  
(2) An additional option would be to require retrospective assessment of the benefits and 
harms in all projects. 
Option 1: Compulsory ethical evaluation  of projects with minimum requirements 
Option 2: Introduction of retrospective assessment of all projects to record deviations 
and evaluate factual harm and realized benefit 
IV. Permanent Ethical Review Body and National Animal Welfare and Ethics 
Committee  
A combination of a national committee for co-ord ination of ethical review matters within the 
Member States and a local ethical review body at  an establishment level may be useful to 
ensure a consistent implementa tion of ethical review requireme nts, creating an improved level 
playing field for research and industry, and at  the same time aiming at improved welfare for 
animals. The tasks of a nati onal committee could include:  
Establishment and publication of requirements for ethical evaluation of projects and local 
ethical review body. 
Promotion and co-ordination of Three Rs approach at a national level to help ensure good 
animal welfare and good science. 
 
EN 35   EN Option 1: Introduction of a national animal welfare a nd ethics committee with a 
minimum harmonised remit 
Option 2: Introduction of a permanent ethical review body in each establishment V. Housing and care standards
 
The revised Directive could in corporate elements of the Council of Europe’s revised 
Appendix A to Convention ETS 123 as compul sory minimum standards with appropriate 
transitional periods for implementation. This w ould create a competitive level playing field 
within the European Community (and between Member States and non-Member States who are Parties to the Convention), avoid further distortion of the internal market and bring the 
Directive in line with current scientific and technical knowledg e to increase animal welfare. 
Option 1: Requiring as a minimum standard  compliance with the revised Appendix A to 
the Council of Europe Convention ETS 123 
VI. Transparency / Access to information
 
The revision of the Directive could incorpor ate minimum requirements on transparency and 
public accountability by requiring non-confidentia l information on ethical evaluations and 
project authorisation decisions to be made publicly available. 
Option 1: Relevant, non-confidential inform ation from the ethical evaluation reports 
and project authorisation decisions to be made publicly available 
VII. Non-human Primates (NHPs)  
The revised Directive co uld reinforce the ban on wild-caught  NHPs and could further restrict 
the research areas in which NHP can be used. A gradual switch to only allowing use of F2 
(second-generation) and higher generations of purpose-bred  NHPs could be desirable 
regarding animal welfare and bi odiversity. 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 revision of the Directive could harm onise the minimum requirements for annual 
inspections at the level of tw o, one of which could be unannounced, to re duce distortions in 
the internal market caused by varying levels of  enforcement across Member States. A system 
of European Community inspections could also be envisaged to increase public confidence. 
Option 1: Minimum twice yearly inspections by national authorities of which at least 
one unannounced 
Option 2: European Community inspections 
 
EN 36   EN VIX. Education and training  
The revised Directive could incorporate so me minimum training requirements for the 
different categories of personnel and set requ irements for demonstrating and maintaining 
competence over time, to reduce different cost environments that establishments find in 
different Member States. 
Option 1: Requirement for competence combin ed with minimum elements for education 
and training 
X. Avoiding unnecessary duplication  
A significant reduction of dup lication in regulatory testi ng would require changes in 
numerous legislative requirements at Member State level. This polic y approach, however, 
cannot be addressed by a revision of the give n horizontal Directive. However, compulsory 
authorisation and ethical eval uation of projects would part ly address this problem.  
In view of this situation, the general appro ach of a revised Directive regarding the reduction 
of unnecessary duplication could be setting- up a centralised European Community-wide 
database collecting information on project authoris ation and scientific results in each Member 
State. 
The database could also provide a discussion pl atform where scientists and inspectors could 
exchange their experiences, prob lems and good practices. As fa r as possible, information on 
practices in third countries coul d also be collected. This coul d contribute to increasing the 
knowledge, especially in basic research, and provide more transparency on results, not 
systematically published so far. 
Option 1: Setting up a centralised European Community-wide database 
XI. Use of CO 2 for euthanasia  
The revised Directive coul d incorporate a list of humane met hods of euthanasia to be used for 
experimental animals to ensure that no cost advantages occur for establishments in Member States where inhumane methods of killing are no t yet banned. Within su ch a common list of 
methods, the use of CO
2 could be prohibited unless the animal is rendered unconscious prior 
to its exposure to the CO 2. 
Option 1: Prohibition to use CO 2 unless the animals are firs t rendered unconscious by 
exposure to anaesthetic gases such as halothane  
XII. Statistical Reporting  
The revised Directive could increa se the quality and usability of annual statistical reporting of 
the Member States by introducing the following elements so that future revisions of the 
legislation can be based on improved data: 
- the number of genetically modified animals a nd of certain invertebra te species and foetal 
and embryonic forms (excluding larvae) from the last third of development 
 
EN 37   EN - numbers of animals killed for the primary purpose of their organs and tissues to be used in 
scientific procedures 
- numbers of projects and types of establishments - severity classes of the scientific proce dures to which animals have been subjected 
XIII. Promotion of alte rnative test methods
 
The revised Directive could foresee that every Member State designates  a national reference 
laboratory to contribute to the validation of alternative met hods. These laboratories could 
specialise in a specific area  of expertise (e.g. developm ent toxicology, carcinogenicity, 
biologicals, etc.) and also contribute to hands- on training of scientists  in the validation of 
alternative methods48. 
Option 1: National reference laboratories 
                                                 
48 Proposal by ZEBET. 
 
EN 38   EN 6. ANALYSIS  OF IMPACTS   
a) Methodology and structure of this chapter  
The impacts have been assessed across all 13 policy dimensions with benefits assessed 
according to the four problem dimensi ons (Economic problems, Environmental 
problems/Animal welfare, Scientific problems , Public/societal problems) and costs were 
assessed according to whether they occur for user, breeder or supplier establishments or for public authorities. 
The basic benefit and cost model is based on the methodology of the external study, normally 
assessing the impacts against existing Member St ate legislation. The relative strength of an 
impact is qualified as "slight", "moderate" an d "high" according to the feedback from 
stakeholders. It is clear that these qualifica tions express subjective views because many of the 
impacts are very difficult or impossible to measure in absolute figures. The strength of animal welfare impacts is expressed in terms of one, tw o or three pluses (+, ++ or +++) in the tables 
on page 62-68 and is summarised in  the overview table on page 69.  
The following assumptions and extrapolations we re made in line with the European animal 
use statistics and the external study
49: 
- Number of establishments in the EU-25: about 1.330 - Number of newly started projects  in the EU-25 per year: about 9.300  
- Number of newly used vertebrate anim als in EU-25 per year: about 12.2 million 
- Number of personnel working with an imal tests in the EU-25: about 150.000 
- Average hourly wage for researchers and public officials in the EU-25: about 35 € 
- Average cost and length of a proj ect in EU-25: 300.000 € over three years 
It will be indicated if an option has been discarded or re vised in the light  of the impact 
assessment or comments received in  the expert internet consultation. 
It should be noted that potenti al environmental impacts of the revision (e.g. resulting from 
upgraded housing or waste after an imal testing) turned out to be  negligible. A serious aspect 
that was scrutinised was the assertion by so me stakeholders that biodiversity will be 
endangered when continuing to use non-human primates for research. The Commission has 
found no indication that this is really a problem for those speci es used in large numbers for 
research. Research plays an insignificant role for biodiversity in comparison to the destruction 
of habitats, e.g. of tropical forest s, that should be urge ntly addressed via conservation policies.  
                                                
 
49 Prognos report 2007, Chapter 7. 
 
EN 39   EN b) Impacts per option  
I. Scope  
This section assesses the extension of the scope  of animals and procedures covered under the 
current Directive to create a uniform regulator y environment within the European Community 
for at least 2.7 million animals currently not covered by the Directive. This would consequently result in a more competitiv e level playing field in this respect. 
Option 1: Extend the scope to cove r animals used in basic research 
This option would create a level playing field for all user establishments in the EU. The main 
beneficiaries would be universi ties in high standard countrie s which already had to comply 
with strict obligations while thei r scientific colleagues in other countries did not have to spend 
resources on high animal welfare. The option would put establishments like universities 
which are increasingly competing for EU res earch money into a level playing field and 
contribute both to the internal market and the European Research Area.  
The extension of the scope to cover animals used  in basic research would improve the welfare 
of 500,000 animals (15% of all animals used for ba sic research in the EU -25 in the year 2005) 
in the five Member States not currently coveri ng basic research. Two thirds of the respondents 
to the internet cons ultation supported this general assessment. 
The extension would have a mode rate positive impact on animal welfare and a strong positive 
impact on the control of the use of these animal s. For establishments in these five Member 
States, moderate costs between 6.6 million € and 10.0 million € per year would occur due to the requirement for authorisation and ethical ev aluation. Costs for public authorities in these 
five Member States would increase s lightly between 80.000 € and 160.000 € per year. 
It should be noted that the impacts identified fo r this particular option are already covered in 
sections II to XII with in the aggregate figures
50. However, for transparency reasons and to 
enable a targeted impact analysis, these fi gures are specified in section I, again in 
disaggregated form. Care needs to be taken however not to double-count the benefits and 
costs indicated here.  
                                                 
50 This section about scope is special in the sense th at almost all impacts identified will only occur if the 
other options (introduction of Authorisation, Ethical evaluation, Inspections, etc) are taken up in the revision of the Directive 86/609/EEC. This means th at one must carefully di stinguish between impacts 
that are already
 identified in the subsequent sections (II to XII) and those which occur in addition  due to 
an extension of the scope. Actually, only the impacts identified for scope options 2, 3 and 4 are additional impacts beyond those identified in sections II to XII. The reason for this is that the 
calculations in sections II to XII are based on the five models explained in Chapter 7 of the Prognos 
report and these in turn are based on the EU statis tics on animal use in 2002 or 2005. The EU statistics 
already include the number of animals used for basi c research and for education and training even 
though these animals are not yet protected under Directive 86/609/EEC. The situation is different for animals killed for their tissues, sel ected invertebrates and foetal form s because their number is not yet 
included in the EU statistics and therefore, impacts fro m an extension of the scop e to cover them are not 
yet included in sections II to XII. 
 
EN 40   EN Option 2: Extend the scope to cover animals bred for the primary purpose of their tissue 
and organs to be used in experiments or othe r scientific purposes with an exemption for 
authorisation if euthanasia is performe d by a competent person using a method 
appropriate to the species  
This option would approximate the legislative pr ovisions of the Member States because some 
currently cover these animals in their legislati on whilst others do not which leads to differing 
cost structures for experiments using such tissues and organs. 
The extension of the scope to cover animals br ed for the primary purpose of their tissue and 
organs would significantly improve the welf are of about 1.8 million animals in the EU-25, 
due to better breeding, housing, care and euthan asia. While the preliminary finding of a 
“significant” improvement of animal welfare wa s contested by over 40% of the respondents to 
the expert internet consultation, the general idea of the option was broadly accepted. Only 
minor additional costs for establishments wo uld occur if, as suggested by this option, 
euthanasia is performed by a competent person and therefore does not need authorisation.  
It is contested why animals bred for their tissue and organs to be  used for in vitro tests should 
receive better protection than those bred for their tissue to be used for food or fur. The main 
counter argument is that the sc ientific reliability of in vitro test re sults depends on high-
quality tissues that can bette r be ensured by a strictly controlled environment.  
Option 3: Extend the scope to cover sel ected invertebrates species (Cyclostomes, 
Cephalopods and Decapod crustaceans) 
This option would have a small but positive im pact on the harmonisation of Member States' 
rules and regulations an d therefore benefit the internal market.  
The extension of the scope to cover select ed invertebrates species as recommended by 
EFSA51 would improve the welfare of the animals involved. The preliminary assumption of a 
significant increase in animal we lfare was not supported by one th ird of the resp ondents in the 
expert internet consultation, but a general impr ovement was not contested. The costs to public 
authorities and additional admini strative burden for user establis hments are estimated to be 
moderate, due to their low share in total project costs, but ca nnot be quantified.  
The question whether the inclusion of selected  invertebrates into th e scope would boost the 
demand for tests with vertebrates is relevant. In theory, a relative price increase of using invertebrates in comparison to using vertebrates could lead to a higher demand for using 
vertebrates. Because a possible price increase fo r using invertebrates can not be quantified, 
the question whether the demand for vertebrates would be boosted cannot  be answered. What 
seems important however is not to  protect only a single species w ithin a class of invertebrates 
because that could shift the demand to closely re lated species. This may be the reason why in 
the UK, not a single octopus vul garis was used since this species was pr otected in 1995 but 
why other cephalopods continue to be used in neurological research.  
                                                
 
51 See http://ec.europa.eu/environment/c hemicals/lab_animals/scientific_en.htm 
 
EN 41   EN Discarded option: 
The suggestion to include all invertebrate sp ecies into the scope of the Directive was 
discarded at a very early stage because the poten tial animal welfare benefits due to lack of 
scientific supportive evidence would not have been proportionate to the costs.  
Option 4: Extend the scope to cover foetal and embryonic fo rms from the last third of 
gestation until birth 
This option would put research establishments like universities which are increasingly 
competing for EU research money for new technologies onto a level playing field and 
contribute both to the internal market and the European Research Area. 
The extension of the scope to include foetal and embryonic forms from the last third of 
gestation as recommended by EFSA52 would probably improve moderately the welfare of the 
175.000 mammalian foetal forms involved in the EU -25, given that about one third of the 
experts in the internet consultation did not ag ree with the assumption of a high increase in 
animal welfare53. The cost increase for user establishments for mammalian foetal forms is 
estimated to be 12.6 million € per year. The costs for public authorities w ould be low with an 
estimated total increase by about 846.000 € per year.  
It is expected that the costs from extendi ng the scope of the Directive to non-mammalian 
foetal and embryonic forms in th e last third of development wi ll be negligible. While the 
vaccines industry is using large amounts of ch icken embryos, these do not normally reach the 
threshold of the last third of development befo re the scientific procedure is carried out. It 
should also be noted that some Member Stat es (e.g. the United Kingdom) protect foetal and 
embryonic forms from half-way through devel opment. The more conservative approach 
foreseen in the proposal for the revised Dir ective 86/609/EEC should therefore not disturb the 
research and production of vaccines. 
Option 5: Extend the scope to cover an imals used in education and training 
This option would put institutions of higher educ ation like universities which are increasingly 
competing for EU research money onto a leve l playing field and contribute both to the 
internal market and the European Research Area. 
It would also moderately improve the welfar e of the about 200.000 animals annually used for 
education and training in the EU-25. Around 60% of the re spondents to the expert 
consultation supported this analysis54. The costs increase is estimated to be minor. The 
external study concluded that for user establishments, the costs increase will be in the range of 1.4 million € per year, for public authorities it  is likely to be around 35.000 Euro per year
55. 
These low figures are based on the assumption th at only 158 additional projects would come 
under the scope and that average co sts per project in education a nd training are lower than for 
standard projects.  
                                                 
52 See http://ec.europa.eu/environment/c hemicals/lab_animals/scientific_en.htm 
53 Prognos report 2007, p. 97 and 101. 
54 Prognos report 2007, p. 103 and 106. 
55 Prognos report 2007 p. 107. 
 
EN 42   EN It should be noted that the impacts identified fo r this particular option are already covered in 
sections II to XII with in the aggregate figures56. However, for transparency reasons and to 
enable a targeted impact analysis, these fi gures are specified in section I, again in 
disaggregated form. Care needs to be taken however not to double-count the benefits and 
costs indicated here. 
II. Authorisation  
This section assesses the impacts from harmonisa tion of the authorisation procedures covered 
by the Directive. The aim is to introduce comp arable minimum requirements for authorisation 
and thereby to establish a leve l playing-field in Europe.  
Option 1: Authorisation of indivi dual projects with compliance check 
This option has a high potential to  contribute to a le vel playing field in Europe because many 
of the time and cost factors affecting user es tablishments relate to differing authorisation 
systems across Member States and the internal  market is further di storted because some 
Member States do not require  authorisation at all. 
Authorisation of individual projects would significantly increase welfare for about 950.000 
animals in the four Member States which do not yet have any auth orisation system for 
projects. This impact would occur due to the assurance that minimum legal requirements are met by the applicants. A reduction of unnecessary  scientific procedures using animals can 
also take place. The welfare of  the remaining 11.2 million animals can be slightly increased as 
well, due to an assurance that minimum lega l requirements are met by the applicants. No 
increase in project delays is to be expected if  the authorisation procedur e is implemented in an 
efficient way and if the obj ectives are harmonised through out the Member States. Around 
60% of the experts consulted suppo rted this preliminary assumption. 
The implementation of project authorisation in the four c ountries combined with the 
introduction of a compliance check in all 25 Member States would lead to an increase in costs 
for user establishments of about 23 million €. The cost increase for public authorities would 
be 58.000 € per year for the four Member Stat es, while the introduction of the compliance 
check in all 25 Member States would lead to  a cost increase of up to 390.000 € per year. 
Yearly costs for public authoriti es of Member States are esti mated to be increased by about 
450.000 Euro. It is important to note that 23 Mio € attributed to the auth orisation of projects 
reflects the scenario in which no Member State opts for the lighter authorisation process for 
                                                
 
56 This section about scope is special in the sense th at almost all impacts identified will only occur if the 
other options (introduction of Authorisation, Ethical evaluation, Inspections, etc) are taken up in the revision of the Directive 86/609/EEC. This means th at one must carefully di stinguish between impacts 
that are already
 identified in the subsequent sections (II to XII) and those which occur in addition  due to 
an extension of the scope. Actually, only the impacts identified for scope options 2, 3 and 4 are additional impacts beyond those identified in sections II to XII. The reason for this is that the 
calculations in sections II to XII are based on the five models explained in chapter 7 of the Prognos 
report and these in turn are based on the EU statis tics on animal use in 2002 or 2005. The EU statistics 
already include the number of animals used for basi c research and for education and training even 
though these animals are not yet protected under Directive 86/609/EEC. The situation is different for animals killed for their tissues, sel ected invertebrates and foetal form s because their number is not yet 
included in the EU statistics and therefore, impacts fro m an extension of the scop e to cover them are not 
yet included in sections II to XII. 
 
EN 43   EN project consisting of only "up to mild" pro cedures and not involving the use of non-human 
primates.  
It should also be noted that in  the current authorisation system s some duplication of activities 
may occur which creates avoidable costs that coul d be saved if the systems were restructured 
along the lines of best practice.  
Any authorisation fees that may be passed on fro m public authorities to user establishments 
via a full cost recovery scheme may vary from Member State to Member State. But these will 
be negligible in comparison to the costs for us er establishments induced  by the requirement to 
prepare an applicati on for authorisation.  
Option 2: Authorisation of a group of projects for regulatory testing  
As some Member States have al ready some sort of group authoris ation or "thematic licensing" 
in place, this option could harmonise the requireme nts to the benefit of all user establishments 
across the Community and improve their competitiveness. 
Authorisation of groups of proj ects for regulatory testing woul d reduce the average costs of 
this type of projects at the establishment leve l, due to economies of scale. Positive impacts 
would also occur for authorisation bodies of th e Member States, due to more flexible and 
efficient handling of the administrative proced ures. Around 60% of the e xperts supported this 
analysis, around 15% did not agree. 
Total costs of project au thorisation for user establishments and public authorit ies in the EU-25 
would be reduced to 92 million € per year if groups  of projects could be authorised so that the 
average number of authorisation procedures pe r establishment would be reduced to five per 
year. This compares favourably to the normal s cenario where all projects would have to be 
authorised one by one. Given that the total cost for user establishments and public authorities 
in the EU-25 would under the normal scenario  be about 114 million € per year, the savings 
would be around 21.9 million € per year.  
III. Ethical Evaluation of projects  
The revised Directive could set minimum require ments for ethical evaluation as part of the 
authorisation of projects. Retros pective assessment of the benefits and harm in all projects 
would have provided a further option. 
Option 1: Compulsory ethical evaluation  of projects with minimum requirements 
This option addresses the questi on of whether all researchers a nd companies in Europe have a 
similar chance to get their animal projects approv ed or not, while the curre nt situation leads to 
different access to using animals across the European Community. 
The introduction of a compulsory ethical eval uation of projects would have positive impacts 
due to its high potential to impr ove both animal welfar e (via the Three Rs) and the quality of 
science (via a prior evaluation of the research design). Such a requirement would also provide 
an incentive to science and industry to innova te according to the concept of the Three Rs. 
Almost two thirds of the respondents suppor ted this general assessment. Although the 
introduction of a severity classification system  would be time consuming for countries that do 
not have such a system in place, the benefits  are likely to outweigh these costs. Severity 
 
EN 44   EN classification would improve and speed up the harm  benefit analysis after the initial work of 
setting it up.  
Model calculations by Prognos have shown a subs tantial positive effect for animal welfare 
due to the potential for a European Community -wide reduction of animal use by up to 8 % of 
animals used in the 12 Member States whic h do not yet have full y implemented ethical 
evaluation systems. This would c oncern about 371.000 animals per year)57. 
The benefits for science can be monetised. If one assumes that 3% of the animal studies 
performed are of such a low quality that they sh ould rather not have been performed and that 
this would have been detected via the scrutiny of the experimental design within the improved 
ethical evaluation, the annual benefits in the 25 Member States would be in the range of 90 
million €58.  
Introducing a harm-benefit analysis  would increase the administra tive burden for the Member 
States which do not yet have such a system in  place. Yet, the overall  assessment is positive 
due to the important impact that harm-benefit analyses can have on the reduction of suffering 
of animals, as well as their numbers. In conse quence, animal research may become more cost-
effective.  
Based on an extrapolation using data from the Netherlands, Prognos has calculated that total 
yearly costs for setting up a complete syst em would amount to about 9 million € in the 
Member States which currently do not yet have a compulsory ethical evaluation of projects in 
place. It would lead to savings in the range of  70 million € per year in the medium-term, due 
to a reduction of animal use59. 
Option 2: Introduction of retrospective assessment of all projects to record deviations 
and evaluate factual harm and realized benefit 
Whereas harm-benefit analysis would be done pr ior to the research, re trospective assessment 
would be done after the research has been finalised, to evaluate the results and compare it with the predicted harm and be nefits. Retrospective assessment gives the opportunity to learn 
from the past in order to improve future rese arch projects and may provide more accurate 
information. It also has the poten tial to verify in the long term which types of animal tests 
have really been useful for th e progress of science and which have been rather unreliable. 
This can help to increase animal welfare slightly
60 in the short-term but also drive innovation 
to areas where animal tests could be relati vely easily replaced in the medium-term.  
On the cost side, the preliminary assessment indicated that introduction of retrospective 
assessment for all projects would lead to a high in crease in costs in the short and medium term 
                                                 
57 Prognos report 2007, p. 164. 
58 No reliable quantitative data exist about the percentage of studies that are performed but are useless 
because of a bad experimental desi gn. However, a recent publication found out via six case studies and 
meta-reviews of scientific literature that the experimental design of animal studies is often of 
surprisingly poor quality. See Na ture, 21 December 2006, p. 981, and a related study by Prof. Ian 
Roberts (London School of Hygiene and Tropical Medicine) 2006: Testing treatment on animals: 
Relevance to humans (project numb er RM04/JH18/IR), available at  
www.pcpoh.bham.ac.uk/publichealth/nccrm/publications.htm. Hence, 3% is a conservative estimate.  
59 Prognos report 2007, p. 164. 
60 Prognos report 2007, p. 175/176. 
 
EN 45   EN while it is yet uncertain if the objectives of  "learning from mistakes" and achieving more 
accurate data collection on severity  and benefits are met. Potential benefits can be expected to 
become visible only after several years. A small majority of re spondents supported this 
general assessment. 
Introduction of retrospective assessm ent for all projects would lead  to an increas e in costs of 
about 20 million € per year in the sh ort and medium term in the EU-25. 
Revised option: 
In the light of the arguments presented above and supported by many experts during the 
internet consultation, the Commission proposal  for a revised Direc tive 86/609/EEC now only 
foresees a retrospective assessment for selected  types of projects (e.g. those of highest 
predicted severity class and those involving non-human primat es). Retrospective assessment 
can be expected to be most bene ficial in these cases and costs can be expected to be reduced 
to about 4 million € per year.  
IV. Permanent Ethical Review Body and National Animal Welfare and Ethics 
Committee  
An ethical review body goes beyond the evaluation of a particular project. It aims at creating a 
‘culture of care’ in each establishment to en sure proper consideration of ethical aspects and 
the implementation of the Three R principle in all areas of animal breeding, housing and use. 
While the ongoing ethical review ha s to take place in the vicinity  of the establishment in order 
to understand its internal decision-making, an additional national body could be useful to set guidelines. 
Option 1: Introduction of a national animal welfare a nd ethics committee with a 
minimum harmonised remit 
The introduction of a national animal welfar e and ethics committee with a minimum 
harmonised remit could increase consistency of  implementation of the Directive as well as 
transparency, due to an assurance that guidelin es are set for all establishment-based ethical 
review strategies. This facil itates compliance across the Commun ity and has at least slightly 
positive impacts on animal welfare (they could be substantial in case this option would be 
combined with mandatory ethical evaluation of all projects)
61.  
There would be additional costs for Member States when setting up such a committee or 
aligning their system to the possible new European requirements but these costs were estimated to be low.  
Option 2: Introduction of a compulsory ethical review body in each establishment 
Minimum requirements for an ethical review bod y would have a moderate benefit on working 
towards a level playing field. A less diverse competitive environment between the EU Member States would be the result.  
                                                
 
61 Prognos report 2007, p. 183. 
 
EN 46   EN The introduction of a compulsory ethical re view body at establishment level has a high 
potential of increasing the level of  animal welfare and has the poten tial to be beneficial to the 
debate about ethical as pects within and maybe even between different establishments (if 
provisions are made for the exchange of inform ation between local and national frameworks). 
A compulsory system is valued positive since it provides the mechanism with the legal status 
that is often needed to be accepted and respected  by other staff members of the establishment. 
In countries were establishment-based committees  do not have such a formal status, this can 
be a serious drawback in terms of  legitimisation towards stakeholders62. Only a compulsory 
system guarantees that minimum requirements are implemented.  
Furthermore, there would be slightly positiv e impacts on the work satisfaction of personnel 
due to a more constructive and animal frie ndly atmosphere with an ongoing focus on the 
Three Rs and good science.  
V. Housing and Care  
The revision of the Directive could envisage  elements of the revised Appendix A to the 
Council of Europe Convention for the protection of vertebrate an imals used for experimental 
and other scientific purposes (ETS 123) to b ecome a minimum standard, with a transitional 
period for implementation. This would create a competitive level playing field within the 
European Community and at the same time increase animal welfare. 
Option 1: Compliance with ETS 123 
Making elements of the revised guideline s of ETS 123 mandatory would significantly 
approximate Member States' rules and regulations  which differ significantly and put breeder, 
user and supplier establishments in a very di fferent environment of requirements for physical 
investments, depending on thei r location. It would prevent further fragmentation of the 
internal market in the near future which woul d otherwise be highly like ly given that several 
Member States have announced that they will  implement parts or all of the new housing and 
care standards agreed at the Council of Europe in different binding ways while some Member 
States would leave them completely non-binding.  
A significant increase in the welfare of all 12.1 million animals used annually in the EU-25 
through better housing and care standards could also be expected63. This will lead to more 
reliable scientific results and improve the ment al well-being of personnel.  More than half of 
the respondents of the expert  consultation supported this analysis, only around 17% did not 
agree. 
The benefits for science can be monetised. If  one assumes that currently only 3% of the 
animal studies performed in all 25 Member States  yield unreliable results due to inconsistent 
or unsuitable housing and care conditions and that  this would not happen if the revised ETS 
123 standards had been mandatory, the annual benef its in all Member Stat es would be in the 
range of 90 million €. 
                                                 
62 Stafleu, F.R and J. Vorstenbosch: Animal Welfar e Committees in the Europ ean Research Area, EC 
2005, p. 79. 
63 Prognos report 2007, p. 200. 
 
EN 47   EN Many of the general provisions and recommenda tions of the revised guidelines for health, 
transport, quarantine, acclimatisation, isol ation, watering, feedi ng, cleaning, records and 
identification are already in place in many estab lishments, as these are integral parts of good 
scientific/laboratory practice to obtain reliabl e and reproducible scientific results. Major 
changes required are mostly related to the new cage sizes, the mandatory use of 
environmental enrichment (e.g. floor covering, ne sting material and for some species elevated 
platforms) and the mandatory group hous ing and socialising of animals. 
Based on data from university facilities run unde r full-cost recovery schemes, the external 
study has estimated that yearly costs will incr ease by about 37 million €. This figure includes 
additional cage costs deprecia ted over 5 years as well as additional care costs and is 
equivalent to about 6% of project costs (a bout 1.3% of total animal research costs). 
Preliminary findings indicate that 35% of establishments in the private sector and 20% in the 
public sector have already adapted thei r facilities to the new standards.  
Revised option: 
In the light of the arguments and data presented above and s upported by many experts in the 
internet consultation, the Comm ission proposal for revising Directive 86/609/EEC foresees 
staggered transitional periods, de pendent on the type of species.  Facilities for smaller species 
(mice, rats, other small rodents)  will need to be given only a transitional period of five years 
from now, while bigger ones (especially dogs and non-human primates) will require about 10 
years from now to spread the costs. A few larg e breeding establishments  indicated that they 
would most probably require up to 10 years fr om now because they normally use close to 
100% of their facilities (need to plan, obtain pe rmits and build new premises to accommodate 
bigger space allowances per animal)64. However, some other large breeders as well as many 
of the smaller breeding establishments can be expected to be able to cope with the new 
requirements earlier.  
VI. Transparency / Access to information  
This section assesses the impact of extending the rights of the public to better access to 
information about the use of animals for scie ntific purposes. However,  increased openness in 
this area must be balanced against concerns about intellectual propert y rights and safety of 
personnel and property.  
Option 1: Relevant, non-confidential inform ation from the ethical evaluation reports 
and project authorisation decisions to be made publicly available 
Making non-confidential information publicly  available would substantially improve 
accountability and the public image of the sector. Provided that personal safety issues and 
intellectual property rights are adequately cons idered, direct and indirect costs for user 
establishments and authorities should be low. While around 44% of the respondents of the 
expert consultation sup ported this analysis, ab out one third questioned the effectiveness and 
feasibility of this option. Some stakeholders po inted out that this option was tried in the UK 
and turned out too expensive. Therefore, the UK has introduced a system based on the 
publication of non-technical su mmaries of projects produced by the applicant for project 
authorisation. 
                                                 
64 Prognos report 2007, p. 205. 
 
EN 48   EN Revised option: 
In the light of the arguments presented above and supported by several experts in the internet 
consultation, the Commission proposal for revi sing Directive 86/609/EEC foresees a system 
based on the publication of non-technical summarie s of projects produced  by the applicant for 
project authorisation.  
Making such non-technical summa ries publicly available w ould substantially improve 
accountability and the public image of the sector and would contribute to the need to increase 
understanding of the public as to why animal experimentation is carr ied out and how it is 
justified. Personal safety issues and intellectual property rights would be  adequately addressed 
as the author of the summar y would be the animal user. 
Direct and indirect costs for user establishmen ts and authorities would be low. The external 
study has calculated that the annual costs for th e implementation of such a system in the EU-
25 would amount to 520.000 €65. 
VII. Non-human primates (NHP)  
Introducing minimum standards for the breed ing, using and care of non-human primates 
would prevent future distortions of the internal  market which may arise from different policies 
pursued at Member State level, including the potential that policies that benefit user 
establishments in one country (e.g. the requirement to move to F2+ animals) could divert 
resources away from breeding and keeping up the supply of F1 animals from breeders in third 
countries to user establishments in othe r Member States. A coordinated medium-term 
approach at EU level will  therefore be beneficial. 
The assessments in this section focuses on impacts in case the use of non-human primates 
would be restricted to  second and higher generation captive- bred animals (F2+). This would 
require a significant change from the curren t practice in the EU-25 where for many species, 
first-generation captive-bred animals (F1) are of ten used and the breedin g stock is constantly 
renewed by catching new animals from the wild.  
This assessment takes place agai nst a serious debate about whethe r it is ethically  justified at 
all to use non-human primates in scientific procedures. Although their use is important and 
cannot be substituted in some areas, it is ne vertheless controversial whether their high 
sensitivity and awareness makes them a good scientific model under current breeding, 
housing and care conditions. 
Option 1: Shift to only use of F2 and s ubsequent generations of purpose bred NHP 
Biological background The species most concerned by a requirement to shift F2+ are macaques because they have so 
far not been bred extensively in captivity. Fo r macaques, the shortest possible transitional 
period would be about 7 years from now but it is  very unclear when breeding colonies could 
achieve self-sustainability in practice, even though a few breed ing centres in the European 
                                                
 
65 Prognos report 2007 p. 215. 
 
EN 49   EN Community and elsewhere have successfully st arted to breed very small numbers of F2+ 
macaques.  
For some other species such as marmosets no tr ansitional period would be  needed since they 
have been breeding well in captivity in the Eu ropean Community for several years or even 
decades.  
Animal welfare impacts  
On the one hand, high animal welfare impact s can be expected for an estimated 1300 
macaques which are currently caught from the wild annually in Mauritius and other Asian 
countries which causes them suffering in terms of injuries and morta lity during capture and 
transport, distress due to change of envi ronment including breaking up of family ties66.  
On the other hand, the move to F2+ animals would increase the required breeding population 
by at least 10.000 animals, leading to a moderate  negative animal welfare impact for these 
additional animals. It is not clear what w ould happen to the about 800 male surplus whose 
female counterparts are used for replenishing the breeding stock.  
It is also not clear what woul d happen to the 1300 animals cu rrently caught in the wild and 
used for breeding F1 animals for the European ma rket. In some countries of origin, they are 
considered as imported pests which tend to de stroy agricultural fields and endogenous wild-
life (e.g. in Mauritius). It is therefore likely that  they would either be killed or still be caught 
in the wild and used for breeding for the US and other markets outside the European 
Community.  
Most experts agree that there is currently  a higher world demand than world supply for 
macaques to be used in research. Therefore bree ders would in the short run easily be able to 
sell the same amount of F1 animals to countr ies outside the European Community than they 
currently export to the European  Community. Such a supply shift could only be prevented by 
a global move to use only F2+ animals. While the Commission would be happy to encourage more international activities in the area of expe rimental animal welfare in the context of the 
OIE (World Organisation for Animal Health), pr ospects for an interna tional agreement about 
the use of F2+ are currently dim. 
Impacts for users and science 
If a shift to use only F2+ NHPs was required at very short noti ce, the impacts on science and 
competitiveness would be highly negative.  
Even with a suitable transitional period, a requirem ent to shift to F2+ animals would lead to a 
price increase for about 7.000 macaques annually  imported into the European Community 
because of longer breeding cycles and higher co sts from maintaining a significantly larger 
breeding colony.  
The move to F2 animals via a transitional pe riod could also decrease annual supply of F1 
animals by about 10% during this period, leading to a reduction/outsourcing of research from 
                                                
 
66 Prognos report 2007, p. 224. 
 
EN 50   EN the European Community to other countries. Bo th the United States and China have been 
mentioned in this respect.  
Revised option  
In the light of the arguments presented a bove and supported by experts in the internet 
consultation, the Commission proposal for revi sing Directive 86/609/EEC foresees a system 
differentiating between different types of speci es, in line with their reproductive behaviour 
and patterns of use: 
• For marmosets, no transitional period is necessary. 
• For macaques, a reasonable transitional peri od of 7 years from now for the transition to 
F2+ is set. The progress and suitability of this deadline should be closely monitored.  
• For all other NHP species, a transitional period of 10 years from now is envisaged with a 
review clause to assess po ssible new information about the supply, demand and welfare 
implications for lesser used species. For rare ly used NHP species, an F2+ requirement may 
turn out not to benefit animal welfare at al l, as this might require setting up breeding 
colonies for these species where none exis t today. Surplus may eas ily be produced and 
would need to be killed and/or incentives would be created to increase the use of these species, once the offspring is available which would have negative impact on animal 
welfare as a whole.  
Option 2: Ban of the use of Great Apes with very limited exceptions 
A ban on the use of Great Apes has in theory a highly positive effect on animal welfare, Great 
Apes being our closest ancestors  with highly developed social  capacities. In practice, the 
animal welfare benefit in the EU may be only minor because no such animals have been used 
in experiments in the EU since at least 1999. Ho wever, such a ban may inspire other countries 
to pursue a stricter Great Ape policy and could indirectly have  a high animal welfare benefit 
in third countries.  
The negative impact on research in Europe would be low as already at this stage, the number 
of Great Apes used is zero. The impact on the level playing field would be minor but positive, 
due to increased legal certainty. 
The only realistic scenario for a need to perfor m scientific procedures with Great Apes may 
be the development of treatments for new devasta ting diseases that might occur in the future. 
Discarded option: 
Some stakeholders have sugge sted that a central breeding facility should be set up at 
European level to continue to breed Great Apes  for research purposes, just in case they would 
ever be needed for such emergencies.  
However, this option was not pursued further in view of three arguments: 
- First of all, there is no current n eed for such research in Europe.  
 
EN 51   EN - Secondly, one limited but well equipped centra lised facility at global level would be 
sufficient for this purpose, but several thir d countries including the United States already 
maintain such facilities, so ther e is currently no need to establis h an additional one in Europe.  
- Thirdly it should be noted that the costs woul d be significant and divert public funding away 
from more immediately useful biomedical research. The United States have a moratorium on 
breeding Chimpanzee's since 199767, for the same ethical reasons as mentioned above and to 
avoid further significant costs (daily housi ng and care costs for a single Chimpanzee was 
reported to be in the range of 30-40 US$ in the internet consultation). 
VIII. Inspections  
Inspections are one of the main tools for en suring compliance with le gislation and minimum 
standards. A harmonisation of the requirements fo r inspections could help to create a level 
playing field in the European Community.  
Option 1: Minimum of two inspections per ye ar by competent authorities of which one 
unannounced 
The proposed system of inspections would have  positive impacts for an imal welfare, public 
perception and transparency. The costs for Memb er States would increase moderately when 
intensifying the level of inspections. Nearly half  of the respondents in the expert consultation 
supported this analysis, wh ereas about 23% disagreed. 
The new standard of inspections would lead to a moderate increase in animal welfare for the 
12.1 million animals concerned. The cost increase for establishments is relatively low with 
922.000 € per year, confined to the day of insp ection. Costs for all 25 Member States could 
amount to a maximum of 3.1 million € per year. If  all Member States had a fully centralised 
inspections system, annual costs would be a bout 3.1 million €. If all Member States had a 
fully decentralised inspections system, costs woul d be lower due to redu ced travel distances, 
travel times and ticket costs and would be in the range of 2.5 million. € per year. 
Revised option: 
In the light of expert responses  in the internet cons ultation, the Commissi on proposal to revise 
Directive 86/609/EEC includes a minimum of two inspections and a refere nce to a risk-based 
approach to inspections. A further proposal is to make sure that inspection reports actually get 
passed on from the inspectors to national authorities . In some countries w ith decentralised or 
local systems this information currently doe s not get passed on from the inspector. 
Option 2: European Community inspections 
European Community inspections could further c ontribute to ensuring a level playing filed for 
all breeder, supplier and user establis hments in the European Community.  
However, they would not result in a sign ificant increase in animal welfare unless 
disproportionately high resour ces were spent to render thes e inspections effective and 
                                                 
67 Source: http://www.sciencemag.org/cgi/content/full/315/5811/450  
 
EN 52   EN sufficiently frequent. A majority  of around 65% of participants in the internet consultation 
supported this analysis, and onl y around 7% did not agree. 
A stand-alone Community inspection system to in spect all user establishments twice per year 
by a centralised European inspectorate would lead  to total costs of 4.2 million. € per year to 
be paid from the Community budget.  This seems disproportionate.  
Revised option: 
One could instead model the European Commun ity inspections after the audit-oriented 
inspections system currently maintained already by the Commission’s Food and Veterinary 
Office (FVO) in Dublin in the area of food safety  and farm animal welfare. In that case, costs 
would amount to 240.000 € per year in addition to the costs of national inspections. Total 
inspection costs for Member States and Eur opean Community together would then be 
between 3.33 million € (if all Member States ha d centralised inspection systems) and 2.73 
million € (if all had Member States had decentralised inspection systems). 
The audit-oriented inspections system of the FVO relies on inspections mainly by competent 
authorities in the Member States but performs  an audit of each Member State’s inspections 
and enforcement system on average every thr ee years, including discussions with public 
officials in the Member States and a select ed number of on-the-spot checks in user 
establishments. 
The Commission proposal for th e revision of Directive 86/ 609/EEC also foresees that 
Member States should set up programmes for join t inspections between national inspectors of 
one country and senior expert s from another country. Member  States could second their 
senior experts for a mission in another Member State. 
IX. Education and Training  
Qualified and well-trained personnel are essent ial for good animal welfare, good science and 
the human dimension of scientif ic procedures using animals. It is therefore essential to 
include in the revised Directive the key elem ents that should be in cluded in the training 
requirements for obtaining initial and maintain ing competence over the entire professional 
life, appropriate for the differe nt categories of personnel.  
Option 1: Requirement for competence combin ed with minimum elements for education 
and training  
Harmonised education and training would subs tantially decrease existing obstacles to 
horizontal mobility of research ers in the European Community. 
Appropriate education and trai ning would also improve the im plementation of the Three Rs 
and ensure respect of their welfare requir ements of animals before, during and after 
procedures. Almost 80% of the respondents to th e expert internet cons ultation supported this 
analysis, only about 1% disagreed. 
The welfare of 12.1 million animals concerned w ould increase significantly and would lead to 
a higher job satisfaction of those having direct contact w ith animals on a daily basis as 
confirmed during the internet consultation. 
 
EN 53   EN The benefits for science can be monetised. If one assumes that currently 3% of the animal 
studies performed in all 25 Member States yield unreliable result s due to incompetent 
handling by not ideally trained personnel and that  that this would not happen if all personnel 
had been properly trained and had been required to  participate in a refresher course at least 
every five years, the annual benefits in all Me mber States would be in the range of 90 million 
€. 
Total costs for a system of a mandatory refr eshment course of 40 hours for personnel every 
five years in the EU-25 would amount to 38 million. € per year (on average 28.000 € per 
establishment per year.  
X. Avoiding unnecessary duplication  
No specific instruments apart from ethical evaluation and authoris ation are employed to 
reduce unnecessary duplicat ion of testing. However, in vert ical legislation such as REACH68, 
several tools are foreseen such as mandatory data sharing, requirements for the recognition of 
data generated elsewhere and mutual acceptan ce agreements. The general approach of a 
revised Directive could nevertheless have been to set up a centralised Community-wide database to avoid unnecessary duplication by co llecting information on project authorisation 
and scientific results in every Member State.  It should be noted, ho wever, that not all 
duplication of procedures is unn ecessary, one may even argue th at replication of scientific 
procedures to verify if the results  can be reproduced is  an essential part of  science, especially 
when developing and validating new test methods. 
Option 1: Setting up a centralised European Community-wide database 
A centralised Community-wide database may help  to prevent some duplication of regulatory 
testing by providing neutral, timely and compre hensive information about all non-confidential 
aspects of authorised projects in Europe. However, the resource required to establish, 
administer and maintain such a database would be very high and casts doubts about the 
efficiency of this option. About 40% of the respondents to the expert  consultation supported 
this analysis, 23% disagreed.  
A minor improvement for animals used in basic research could be expected due to a lower 
risk of unnecessary duplication. However, a gene ral database covering only a minor share of 
relevant information in an unsystematic way (r egulatory testing has a share of about 22% of 
all animal use) would hardly contribute to a general improvement in animal welfare. But it 
would introduce unnecessary bureaucracy and decr ease the scientific competitiveness of the 
European Community. 
The external study has calculated that total yearly costs for maintaining and using a 
Community-wide database would amount to 6. 5 million Euro and that one-off development 
and installation costs would be about 30.000 €
69. However, these costs could be too optimistic 
in view of the fact that other international databases related to test results have incurred considerably higher deve lopment costs (e.g. IUCLID
70 database at around 2 million Euro).  
                                                 
68 Regulation (EC) No 1907/2006 concerning the Registration, Evaluation, Authorisation and Restriction 
of Chemicals; Official Journal of the European Union (OJ L 396, 30.12.2006, p. 1). 
69 Prognos report 2007, p. 277. 
70 International Unified ChemicaL Information Database. 
 
EN 54   EN Discarded option: 
In light of the arguments presented above, a general EU database would not substantially 
address the issue of unnecessary duplication of animal procedur es, if any. In view of the 
significant costs of a database, this option has not been includ ed in the Commission proposal 
for the revision of Directive 86/609/EEC. 
Revised option: 
However, the Commission is planning to prev ent any potential problems of unnecessary 
duplication without recourse  to a new central database in this  horizontal Directive. More cost-
effective measures could be: 
• to promote integration of smaller databases into vertical legislation such as REACH 
• to identify which vertical European Community  legislation could be changed to create an 
incentive to decrease the overall level of regulatory testing with potential unnecessary 
duplication  
• to reinforce activities at in ternational level to adopt mu tual recognition agreements 
XI. Use of CO 2 for euthanasia  
The revision of the Directive could incorporate a list of humane methods for euthanasia to be 
used for experimental animals. This would contri bute to fair conditions in the internal market 
because higher costs of euthanasia in some countries disadvantage them in comparison to 
users in Member States with lower standards.  
Option 1: Prohibition to use CO 2 unless the animal is rendered unconscious prior to its 
use 
The prohibition to use CO 2 without rendering the animal unconscious by another method 
before would increase animal welfare. Such a requirement would entail higher costs. This 
preliminary finding was supported by around 30%  of the respondents in the expert 
consultation. The external study has calculated that the total cost increase for all establishments in the European Community  would amount to at least 46 million €
71. In 
addition, there is a lack of studied  alternatives to the use of CO 2 with regard to their 
aversiveness. 
Discarded option: 
Because the effect on animal welfare canno t be quantified, the lack of non-aversive 
alternatives and the costs that would be significant, this option was not further pursued in the 
Commission proposal to revi se Directive 86/609/EEC.  
                                                 
71 Prognos report 2007, p. 284. 
 
EN 55   EN Revised option:  
An alternative option that can be implemente d relatively cheaply while awaiting further 
research results on available alternatives would be to prohibit exposing animals to pre-filled 
chambers of CO 2 . This option will have no signifi cant cost implications to the users. 
XII. Statistical Reporting  
The availability of sound data  on the number of animals used for experimental and other 
scientific purposes is essential for policy-makers as well as for other interested actors. The analysis of the statistical data currently availabl e shows that there are central fields of political 
and public interest which are not yet covered by the existing statisti cal reporting system.  
Option 1: Inclusion of genetically altere d animals, some invertebrate species and 
embryonic and foetal forms (excluding larvae) in the statistical reporting 
Although there is no direct impact on animal we lfare, a better statis tical reporting system 
would highly contribute to be tter informed policy-making both at European Community and 
national level. It would also increase transparen cy and thus provide better information for the 
general public and in some cases provide an opportunity  to improve the image of the research 
community. More than half of the respondents to the expert consultation supported this 
analysis, whereas around 23% did not agree with  it, mainly fearing that new statistical 
categories might lead to misunderstandings by giving the impression that the number of used 
animals has significantly increased, alt hough no change has occurred in reality. 
The external study has calculated that an inclus ion of genetically altered animals, selected 
invertebrates and embryonic and foetal forms wo uld provide more detail ed information on 2.4 
million animals (2.3 million genetically altered animals and 175.000 foetal forms of mammalian species) in the EU-25 and would thus be  highly beneficial to a better monitoring 
of their use at Member States and Community  level. Consequently, a moderately positive 
impact on the enhancement of national and Eu ropean policy-making can be expected. Prognos 
has calculated that total costs for user establishments from a requirement to report statistics on transgenic animals and foetal forms of mamm alian species would amount to 7.4 million € per 
year
72.  
Option 2: Inclusion of animal s killed for the primary purpo se of their organs and tissue 
to be used in experiments 
Although there is no direct impact on animal we lfare, a better statis tical reporting system 
would moderately contribute to better info rmed policy-making both at Community and 
national level. It would also increase transparen cy and thus provide better information for the 
general public and in some cases provide an opportunity  to improve the image of the research 
community. Around 53% of the respondents to the expert consultation supported this analysis, 
while around 17% disagreed.  
                                                 
72 Prognos report 2007, p. 290. 
 
EN 56   EN The external study has estimated that total cost s for user establishments from reporting on the 
1.8 million animals killed annually for their organs  and tissue would amount to 4 million € per 
year73. 
Option 3: Inclusion of numbers of projects an d types of establishments in the statistical 
reporting 
Inclusion of numbers of proj ects and types of establishments would provide a more 
comprehensive picture on the overall number a nd structure of animal experimentation in 
Europe, thus contributing to a better monitori ng at Member State and Community level. The 
associated costs would be negligible. 
Option 4: Inclusion of severity classes to which animals have been subjected to in the 
statistical reporting 
Although there is no direct impact on animal welf are, an improved statis tical reporting system 
would lead to better informed policy-making both at European Community and national level. 
It would also increase transpar ency and thus provide better in formation for the general public 
and in this case provide an opportunity to improve the imag e of the resear ch community. 
Almost 60% of the respondents to the expert co nsultation supported this overall analysis, and 
only around 12% disagreed.  
The external study has found that few user establishments and Member States have 
experience in this field and that a cost  quantification is therefore not possible74.  
XIII. Promotion of alte rnative test methods  
Option 1: National Reference laboratories 
It is assumed that 20 additional Member Stat es would have to set up national reference 
laboratories and each one would participate w ith in 2-3 validation studies per year. In 
addition, they may contribute sign ificantly to the development of  alternative test approaches. 
Benefits 
There will be several layers of benefits: 
1. Time saving of almost two years seem po ssible for the validati on of individual methods75. 
This could significantly speed up innovation in this field.  
2. Reductions in animal numbers are possible:  - In the context of the new European chemical s policy REACH, it has been estimated that a 
substantial amount of animal use under REACH could be reduced by alternative approaches, 
in particular regarding te sts for reprotoxic properties
76.  
                                                 
73 Prognos report 2007, p. 292. 
74 Prognos report 2007, p. 306. 
75 Information by ZEBET (Zentralstelle zu r Erfassung und Bewertung von Ersatz- und 
Ergänzungsmethoden zum Tierversuch in Germany). 
76 Information by ECVAM (European Centre for the Validation of Alternative Methods). 
 
EN 57   EN - As an example, based on the past experien ce, the following alternative methods, validated 
by ECVAM have had a positive impact: 
- Pyrogenicity: About 200.000 rabbits per year coul d be saved in Europe by the use of five 
blood cell methods for monitoring side effect s such as fever reac tions arising from 
contaminants of injectable drugs77. 
- Acute aquatic toxicity: The number of fish used  in acute aquatic toxicity testing for hazard 
classification could probably be reduced by 65% if an "Upper threshold level concentration" 
(UTC) approach is used78. 
Costs 
a) One–off costs  
One-off infrastructure costs to upgrade an ex isting public laboratory to  a national reference 
laboratory would be in the range of 100.000 €,  based on data from ECVAM. If 20 Member 
States would have to up grade existing public laborat ories to be able to perform the function as 
national reference laboratory, the one-off cost would be about 2 million €.  
ZEBET79 suggested that at least five of the nati onal reference laborator ies should be equipped 
with material that allows them to apply stan dard techniques of mo lecular biology. Assuming 
that this may cost an additional 500.000 € in fi ve cases, the total one-off cost would be about 
4-5 million €. 
These costs do not include training co sts for personnel or building costs. 
b) Ongoing costs  
Annual costs for a full validation study (3 GLP laboratories over 3 year s) per laboratory is 
estimated to be in the range  of 40.000 to 100.000 € or about 0.5 to 1 full-time equivalent of 
researchers depending on the t ype of method under validation a nd whether additional animal 
tests are necessary in case of  reduction/refinement alternativ es. Total on-going annual costs 
for 25 Member States together would (under the assumption of 50% overhead costs) be 
around 1.5 -3 million €. 
Part of the costs could potentially be recouped if the national referen ce laboratory would offer 
training seminars for hands-on training of indus try and other experts at a significantly high 
price.  
Industry and public authorities (in future resear ch budgets) may be able to save some current 
costs in the medium term if certain alternative tests turn out to be cheaper than the current 
standard animal tests.  
                                                 
77 See http://ecvam.jrc.it  click 'news events and meetings' then 'press releases'. 
78 See ESAC Statement of 20-21 March 2006. 
79 Zentralstelle zur Erfassung und Bewertung von Ersatz- und Ergänzungsmethoden zum Tierversuch 
(ZEBET) in Germany; http://www.bfr.bund.de/cd/1433 . 
 
EN 58   EN 7. INTERNATIONAL  SITUATION 
a) Third countries Even though the revised Directive will reinfor ce the international lead ership role of the 
European Community in the area of animal welf are, it should be noted that a number of third 
countries have several of the opt ions discussed in this impact  assessment already in place. 
Australia As of 1st September 2005, the Animal Research  Regulation 2005 came into effect, replacing 
the 1995 Regulation under the Animal Research  Act of 1985. Australia has also recently 
(2004) upgraded its animal welfare code of practice including a strong emphasis on ethical 
evaluation. In addition, Queensland protec ts cephalopods and some crustaceans. 
Canada Canada is likely to review their guidelines on non-human primates in the coming years. There 
is currently no prohibition to use F1 or wild caught non-huma n primates and implications 
from moving towards F2 have not been studied. With regard to the revised Council of Europe 
guidelines on housing and care, the document will serve as one of the do cuments for the basis 
of discussion when revising space allowances for different species. The work has already 
started for rats. 
China 
Not much is known about the level of experimental  animal welfare in China, therefore for the 
time being, the welfare level can be assumed as low. However, China is planning to expand 
its role in global animal research and is we ll aware that this will require a significant 
upgrading of its standards. The Chinese authori ties seem very interest ed in cooperating with 
European authorities on how to improve its welfare standards a nd how to establish a reliable 
documentation and inspection system.  
India India protects all species (including all, not onl y selected, invertebrate s) and requires approval 
of projects by a national committee. It legi slation dates back to 1960 but has been 
supplemented in 1998. 
New Zealand The range of animals protected by legislation in  New Zealand has been widened to include all 
animals that are capable of f eeling pain. The definition of animals under the Act therefore 
includes mammals, birds, reptiles, amphibians,  fish, crabs, crayfish, squid and octopus. 
Norway The legislation for animal experimentation in No rway applies to live mammals, birds, toads, 
frogs, salamanders (newts), reptiles, fish, and crustaceans thus including also some 
invertebrate species. 
 
EN 59   EN Switzerland 
Switzerland has a very strict animal welfare legislation, wh ich was last amended in 2001. 
There is a specific emphasis on education an d training requirement s as well as on both 
prospective and retrospective assessment of scientific projects using animals. 
United States The US system is largely built on self-ass essment but foresees establishment-based 
“Institutional Care and Use Committees” (IUCAC s). These are obligatory and should perform 
an ethical evaluation of projec ts and provide for a permanent ethical review body in case an 
establishment receives a research grant from the National Institute of Health (NIH), which is 
often the case. While normally mice, rats a nd birds are not protected by the US Animal 
Welfare Act, they have to be appropriately car ed for in case grants are accepted from the 
National Institute of Health (NIH). 
b) Council of Europe 
The Council of Europe Conventions ETS 123 has inspired Directive 86/609/EEC at its 
inception in the early 1980s and its recently up dated Housing and Care Standards will likely 
be similarly influential. Currently 13 Member  States are Parties to the Convention ETS 123, 
with two new ones becoming a Party in summ er 2007, as well as Switzerland and Norway. 
The Council of Europe has also adopted a numbe r of other Conventions dealing with animal 
welfare matters. These Conventions cover areas such as:  
• transport of animals 
• animals kept for farming purposes 
• protection of animals for slaughter 
• protection of pet animals 
The Community is a party to the farming Conve ntion. However, severa l pieces of Community 
legislation exist in the areas of transport of animals and slaughter. 
c) World Organisation for Animal Health (OIE) 
The World Organisation for Animal Health (OIE) has recently begun to discuss whether 
experimental animal welfare should be addressed at global level. While it may still take a long 
time until the first global guidelines on experi mental animal welfare may be adopted and 
implemented, the Commission is planning to step up its activities in this area with OIE. A natural starting point for global harmonisation could be to try to  agree to make some of the 
new housing and care guidelines developed by the Council of Europe a global standard. 
 
EN 60   EN d) Outsourcing/European Community competitiveness 
The external study has established via its stakeh older questionnaire that scientific procedures 
using animals are sometimes outsourced from th e European Community to third countries but 
that this is more likely due to wage differentials and specialist expertise sought for than due to 
the stringency of animal welfare legislation80. The section which included this finding was 
supported by about 50% of the experts who part icipated in the intern et consultation while 
about 25% did not agree.  
                                                 
80 Prognos report 2007, p. 18. 
 
EN 61   EN 8. INTERACTION  WITH  OTHER  EUROPEAN  LEGISLATIVE  ACTS 
Directive 86/609/EEC is a horizontal direct ive providing for minimum standards when 
animals are needed in scientif ic procedures. The pieces of Co mmunity legislation referred to 
below are mainly sector related, whose focus is on gathering information, which sometimes 
needs to be fulfilled by performing tests on animal s, to reduce risks for the safety and health 
of humans and the environment. It is therefor e clear that elements such as housing and care 
standards, ethical evaluation, a permanent ethical review body and education and training are 
not addressed in this other legislation. 
Also it should be born in mind th at the regulatory use of animal s as required by the legislation 
referred to below, covers only 22 % of the anim al use in the European Community. The vast 
majority of animals are used in the areas of basic, translational and applied research (including early product development stages). 
In line with the Lisbon Agenda to ensure the competitiveness of the EU  industry, two specific 
measures have been foreseen to ensure fa st handling of authoris ation requests under the 
revised 86/609/EEC.  
Firstly, the proposal foresees a possibility to request a group authorisation when the purpose 
of the project is to fulfil regulatory require ments. This will not only reduce the processing 
times but also the resource and manpower re quirements arising from the authorisation. 
Secondly, the proposal includes a deadline for the au thorities to deliver their decision within 
30 days (in exceptional cases with in 60 days). As explained in section 3.II in this document, 
the current uneven playing field varies from  zero to 200 days but averaging to 70-100 days. 
a) REACH (Regulation (EC) No 1907/2006) 
The REACH (Registration, Evaluation, Author isation and Restriction of Chemicals) 
Regulation is the only European legislative act requiring propos als for animals tests to be 
approved at European level (by the European Chemicals Agency) before new tests can be 
carried out. This raises the question of how  the REACH approval requirement at European 
level and the new authorisation requirements proposed for the revised Directive 86/609/EEC 
for national or regional level can be coordinate d in a way that they reinforce each other's 
objectives without overlap.  
It is important to note that the objectives of th ese authorisations are ve ry different. On the one 
hand the proposal for the revised Directive 86/ 609/EEC aims at ensuri ng full implementation 
of the Three Rs, the competence of the people involved and that the pr oject is supported by 
harm-benefit analysis. On the other hand, for REAC H, the main objectives are to ensure that 
the proposed test is necessary and scientifically  the most appropriate for the purpose and that 
it fulfils the information requirements to support the risk assessment to protect workers, consumers and the environment. 
There is still ample opportunity within the Agency to streamlin e administrative procedures to 
ensure efficient operation between the two pieces of legislation to their mutual benefit. The 
same applies to the revised Directive, as sufficient room for manoeuvre is left to the Member States for optimum implementation. 
 
EN 62   EN In terms of practical functioning of REACH an d the proposed revised Directive, two areas 
have been identified requir ing closer attention:  
• most importantly, the time delay that coul d occur for the producer /importer to perform 
tests. 
• the potential contradictory decision to approve  a test method using animals by the Agency 
and the authorisation decision made under revised Directive. 
There are two types of appr oval decisions under REACH: 
1. The testing plans are proposed by the pr oducer/importer to the Agency (in which 
case there is no time limit to carry out th e tests). The Agency has 180 days (and in 
case of phase-in substances be tween 2 and 4 years) to appr ove the tests to be carried 
out. The Agency also has to subject the te sting plan to a 45 day public consultation 
period. 
As the authorisation decision under this Di rective is taken much earlier, within 30 
(max 60) days, additional delays will not result from the implementation of this 
Directive. Moreover, the ethical evaluati on under the proposed Directive may allow 
additional benefits to be gained by furt her facilitating the review by the Agency. 
2. REACH foresees that the Agency ma y impose binding decisions on testing 
requirements for substances during evalua tion. In the case of non compliance with 
information requirements or the identification of further information needs, the Agency can require a company to perform a specific test in a given time period.  
To ensure that authorisation under Direc tive 86/609/EEC would not  contradict other 
regulatory decision making bodies, specific wording to accommodate this has been 
foreseen in the proposal. 
Finally, concerning time delay and the dead line imposed by the Agency for the tests 
in the second case, the specific provisions  foreseen in the proposal requiring the 
authorisation decision to be communicated within 30 (maximum 60) days would 
ensure that no additional dela ys arise from the application. These deadlines can be 
further accommodated by the Agency when establishing internal administrative and 
operational procedures. 
b) Other sectoral legislations  
The revised Directive will apply equally to all other regulator y testing (e.g. for cosmetics, 
pharmaceuticals, food and feed, pesticides, toys, et c.). The costs and benefits of revising the 
Directive 86/609/EEC have already been assesse d in this impact assessment. It can be 
assumed that significant animal welfare benefi ts will occur while th e additional costs are 
acceptable.  
No significant coordination problems between hori zontal and sectoral legislation are likely to 
occur because both the revised Dire ctive and the sectoral legislati on consists of Directives and 
allow Member States to find suitable arrangeme nts without overlaps in national legislation. 
None of the other sectoral legislation foresees a prior approval of anim al tests at Community 
level, therefore no contradictory decisi ons at different levels can occur.  
 
EN 63   EN c) GLP (Directives 2004/9/EC and 2004/10/EC) 
Good Laboratory Practice (GLP) is a quality assurance system ba sed on very careful planning 
and documentation of scientific procedures and thus has very different objectives to those 
mentioned before. It increases confidence in  the test results and should therefore be 
mandatory for all regulatory tests involving an imals. It can also significantly reduce the 
inspection workload of compet ent authorities because of the careful documentation and 
because GLP inspections are already performed regularly and can be seen as complementary 
to any inspections system set up by the revised Directive.  
 
EN 64   EN 9. COMPARING  THE  OPTIONS 
a) Overview table showing the benefits and costs per option81  
 BENEFITS   
(quantified where possible) COSTS   
(monetarised where possible) 
Animal 
welfare  ++  500.000 
animals Costs for public 
authorities  -  80,000 € 
Control  +++  Costs due to 
authorisation  - -  4 million € 
Delays due to 
authorisation  - -  
Costs due to 
ethical evaluation  - -  2.6 million 
€ I Scope – 
Option 1 – 
Basic 
research 
 
Delays due to 
ethical evaluation  -  
 
Animal 
welfare  +++ 1.8 million 
animals Cost of 
experiments using tissue and organs -  
Use of 
alternatives  +  Cost to public 
authorities - 320,000 € I Scope – 
Option 2 – 
Tissues 
Public 
accountability and transparency  +++   
 
I Scope - 
Option 3 - 
invertebrates Animal 
welfare  ++ Animals 
used in 1000 scientific Costs for public 
authorities  -  
                                                 
81 Mainly based on Prognos report 2007, p. 305-312. 
 
EN 65   EN procedures  
Control  ++  Costs for user 
establishments  - - 
-  
 
Animal 
welfare  (++) 175.000 
mammalian animals alone Costs for public 
authorities  - 12.6 million 
€ 
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 million 
€ 
 
 BENEFITS  
(quantified where possible) COSTS   
(monetarised where possible) 
Animal welfare 
Animal welfare 
(additional) ++  
+++ 950.000 
animals Costs for MS 
without system of project authorisation  - - 57,000 € 
Control and 
transparency  ++  Costs for MS 
with system of project authorisation + 11,500 € 
Control and 
transparency (additional) +  Cost for user 
establishments in MS without project autho - 11 million €
Competitiveness 
private sector +++  Cost for user 
establishments in MS without project author - 12.6 million 
€ II 
Authorisation 
- Option 1 – 
individual 
Competitiveness ++   
 
EN 66   EN public sector 
Accountability 
and transparency  ++  
 
Costs for users  +++ reduction 
of 21.2 million € Public image -  
Competitiveness 
and SMEs  ++  Animal welfare 0  
Competitiveness 
and research ++  Duplication of 
testing 0  
Competitiveness 
of industry and innovation +++  
Administrative 
costs for users ++  II 
Authorisation 
- Option 2 – 
group 
Costs for public 
authorities ++ 1.9 million 
€ (reduction of 700,000 €)  
 
 
EN 67   EN  
 BENEFITS   
(quantified where possible) COSTS   
(monetarised where possible) 
Animal 
welfare +++ 11.7 
million animals/ 371,000 animals Administrative 
costs to enterprises - -  9 million € 
(7 million €) 
Transparency +++  Competitiveness - -  
Reducing animal suffering +++  Costs for public 
authorities - -   
Awareness and 
work satisfaction researchers ++  Delay of 
projects -  
Reduction of 
animal numbers ++ 371,000 
animals 
Quality of science  ++ up to 70 
million € 
Level playing field ++  
Innovations ++  III Ethical 
Review (A) - 
Option 1 
Societal 
impacts (ethical approach):  +   
 
Transparency  ++ 12.1 
million animals Cost to 
establishments  - - 20 million € 
(revised option  
4 million €) III Ethical 
Review (A) - 
Option 2 
Quality of 
science ++  Costs to 
national - -  
 
EN 68   EN authorities  
Reduction of 
animals +  Competitiveness -   
Reduction of 
animal suffering  +  
Duplication of 
scientific procedures using animals  +   
 
Transparency ++ 12.1 
million animals  Costs 
infrastructure in relation to overall research costs  -  
IV Ethical 
Review (B) - 
Option 1 
Public 
accountability 
and objectivity  +  Costs 
infrastructure 
for Member 
States  -  
 
Animal 
welfare +++ 12.1 
million animals Costs for 
establishments - -   
Increase level 
ethical discuss./ awareness  ++  IV Ethical 
Review (B) - 
Option 2 
Work 
satisfaction +   
 
 BENEFITS   
(quantified where possible) COSTS   
(monetarised where possible) 
V Housing & 
Care - Option 
1 – ETS 123 Animal welfare  +++ 12.1 
million 
animals Upgrading costs 
for 
establishments 
regarding -  
 
EN 69   EN smaller animals  
Science  ++  Upgrading costs 
for establishments regarding larger animals  - - 
-  
Societal 
concerns  +  Length of 
transitional period  0  
Level playing 
field  ++  Yearly costs for 
user establishments  37 million € 
Public 
accountability and ethical concerns  +++     
 
Public 
accountability 
and transparency  ++  Cost to 
establishments  --- 26 million € 
(revised 
option: 520,000 €) 
Image of research and animal experimentation  +  Costs for 
Member States  -  
   Fear of 
extremist activity  -  VI 
Transparency 
- Option 1 
   Competitiveness  -  
 
Animal Welfare +/- +++ for 
1,300 animals,  
-- for 
12,000 animals Costs for 
establishments --  
VII Non-
human 
primates -  
Option 1 
Public Concern ++  Scientific need ---  
 
EN 70   EN Biodiversity +/0  Outsourcing/ 
Competitiveness --  
 
Animal Welfare ++  Research -  VII Non-
human 
primates 
Option 2 Public Concern ++  Central Facility 
to cope with future demand ---  
 
 BENEFITS   
(quantified where possible) COSTS   
(monetarised where possible) 
Animal welfare ++ 12.1 
million animals  Impact for 
establishments  - 0.9 million 
€ VIII 
Inspections - 
Option 1 - 
national 
Accountability 
and transparency +++  Costs for 
Member States  -- 3.1 million 
€ / 2.5 million. € 
 
(Animal 
welfare) (++) 12.1 
million 
animals Costs for 
establishments  -  
(Accountability 
and transparency) (+++)  Efficiency --  
   Costs to MS -  VIII 
Inspections - 
Option 2 - EU 
inspections 
   Costs to EU  --- 4.2 million 
€ (revised option between 
2.7 million 
€ and 3.3 million €) 
 
IX Education 
and Training Animal welfare +++ 12.1 
million Additional costs 
to national -  
 
EN 71   EN animals authorities 
Quality of 
science +++  Additional costs 
to establishments  -- 38 million € 
Free movement 
of people/workers  +++  - Option 1 
Job satisfaction 
of personnel +++   
 
Animal welfare 
– basic research (+) slight 
positive effect Administrative 
burden - - 
-  
Animal welfare 
– regulatory testing 0  Cost to 
establishments - - 
- 6.2 million 
€ 
Ethical concerns – basic research (+)  Administrative 
costs for Member States - - 173,000 € 
Ethical 
concerns – regulatory testing 0  Resource 
requirements at an EU-level - - 
- 30,000 € 
one-time costs, 105,000 € yearly costs X Duplication 
- Option 1  
Cost reductions 
for Member States +   
 
 
EN 72   EN  
 BENEFITS  
(quantified where possible) COSTS  
(monetarised where possible) 
XI CO2 - 
Option 1 Animal 
welfare  ? 
  Impacts to 
establishments  - - 
- 46.2 million 
€ 
 
Monitoring and public accountability +++  Administrative 
burden - 7.4 million €
Image of 
research and industry +     XII Statistical 
Reporting - 
Option 1  
Policy making ++     
 
Monitoring 
and public accountability  +++  Administrative 
burden to users  - 4 million € 
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 - -  
 
XII Statistical 
Reporting - 
Option 4 Monitoring 
and policy making / transparency  +++  Administrative 
burden to users  --  
 
EN 73   EN Public 
awareness  +++  Administrative 
burden to Member States  - -  
 Administrative 
burden to Member States (impact distribution)  - -  
 
Animal 
welfare increase through Reduction in animal use or method refinement +++  Costs to 
Member States - One-off 
costs 4-5 million € 
 Annual 
costs 1,5 – 3 million € 
Promotion of innovation 
 +++  Costs to 
industry ++ Some 
alternative tests may allow cost savings XIII 
Promotion of 
alternative 
methods – 
Option 1 
Public 
awareness  ++  Efficiency gains 
for public research budgets + Some 
alternative tests may allow cost savings 
 
b) Analysis of the options 
ba) Options in the order of capacity to im prove harmonisation of the internal market 
- Authorisation Option 1 and 2 – Authorisation of individual projects  including a compliance 
check and ethical evaluation with decisions to  be taken within 30 days, but allowing group 
authorisations in the ar ea of regulatory testing 
- Housing and Care - Minimum housing and care standards along the lines of the ETS 123 
Appendix 
- Inspections Option 1 – Two inspections pe r year of which at least one unannounced 
- Education and training Op tion 1 – Minimum standards 
 
EN 74   EN - Introduction of a compulsory ethical review body in each establishment 
- Ethical Review Option 1 – National body to issue guidance 
bb) Options in the order of c apacity to enhance competitiveness 
Education and Training – Option 1 - Invest ment in top scientists, higher mobility 
Promotion of alternative methods – Option 1: Investment in re search and innovation 
Authorisation - Option 1: Projec t authorisation within 30 days 
Authorisation - Option 2: Group au thorisation saves money and time 
Ethical Evaluation - Option 1: Potentia l to save animal lives and costs 
Promotion of alternatives – Option 1: Po tential to save current testing costs  
Transparency - Option 1: Summaries explain research to public Avoiding Duplication – Option 1: Data base can save more than it costs 
It should be noted that all m easures improving the internal ma rket (see above under letter ba) 
also contribute to competitiveness. 
It should also be noted that a consistent a pproach at EU level will allow the European 
Community to take credible initiatives at inte rnational level (e.g. in the context of the World 
organisation for Animal Health – IOE) to mo ve towards establishing  global standards for 
animal welfare which would not only improve an imal lives globally but also contribute to 
European competitiveness. 
bc) Options in the order of annual animal welfare benefits 
Ethical Review Option 2 – Permanent Body: 12.2 million animals +++ 
Education and Training – Option 1: 12.2 million animals +++ Housing and Care Option 1 – Standards: 12.2 million animals +++ Scope Option 2 – Tissues: 1.8 million animals +++ Inspections Option 1 – Minimum 2: 12.2 million animals ++ Ethical Evaluation Option 1 – Ethical evaluation 0.37 million animals +++, 11.7 million 
animals ++ 
Author. Option 1 – Project authorisat ion: 0.95 million animals +++, 11.2 million + 
Ethical Evaluation – Retrospective: 12.2 million animals + Scope Option 1 – Basic Research: 0.5 million animals ++ Ethical Review Option 1 – National body: 12.2 million animals + 
 
EN 75   EN NHP Option 1 – Move to F2+: 1300 highly sensitive animals +++, 12.000 – 
NHP Option 2 – No use of Great Apes: +++ in theory, but none used since 1999  Scope Option 3 – Invertebrates: 1000 scientific procedures ++ 
Scope Option 4 – Immature forms: 0.17 million mammalian animals ++ Scope Option 5 – Education: 0.20 million animals ++ Avoiding Duplication – Option 1: 0.16 million animals (+) Promotion of alternatives – Option 1: No t quantifiable, but can be significant  
bd) Options ordered according to the annual monetary costs 
Cost increases: 
Housing and Care Option 1 – Standards: 37 million € annually  
Education and Training – Option 1: 38 million € 
CO
2 – Option 1 – Full ban: 46.2 million € one-off  
Author. Option 1 – Project authorisation: 23 million € Ethical Evaluation Option 1 – Ethical evaluation: 9 million € 
Ethical Evaluation – Retrospective: 4 million € Scope Option 4 – Immature forms: 13.5 million € Statistics Option 1 – Invertebrates etc.: 7.4 million € Scope Option 1 – Basic Research: 6.6 million €*** 
Avoiding Duplication – Option 1: 6.5 million € 
Inspections Option 2 – EC Inspections: up to 5.1 million €  Inspections Option 1 – Minimum 2 national: up to 4.0 million € Statistics Option 2 – Tissue animals: 4 million € Promotion of alternatives – Option 1: up to 3 million € annually, plus 4-5 million € one-off  
Scope Option 5 – Education: 1.4 million €*** Transparency Option 1 – Public summaries: 0.52 million € Scope Option 2 – Tissues: 0.32 million € 
 
EN 76   EN Cost savings: 
Authorisation Option 2 – Group authorisation: -21.9 million € 
Ethical Evaluation – Option 1 : -70 million € Promotion of alternatives – Option 1: Not quantifiable  Further cost savings are likely to realise throug h the lighter authorisation process for project 
consisting of only "up to mild" procedures a nd not involving the use of non-human primates. 
However, these have not been quantified. 
*** It should be noted that th e impacts identified for Scope  Options 1 and 5 are already 
covered in those covered by th e other options, especially fo r Authorisati on and Ethical 
Evaluation. However, for transparency reasons, these figures are specif ied in this section 
again in disaggregated form. Ca re needs to be taken however not to double-count the benefits 
and costs indicated here. 
c) Administrative costs 
The Commission Impact Assessment Guidelines c ontain an Administrati ve Cost Model which 
recommends presenting the administrative costs for each option. It should be noted that this 
section does not specify additional costs beyond t hose identified in the previous chapters but 
simply presents them in a different format.  
It should also be noted that the assessment pr ovided in this section c oncerns only the changes 
(in plus or in minus) of the administrative cost s as compared to the cu rrent status. It does not 
provide a baseline assessment of the current administrative costs that already occur due to the 
existing legislation currently in place in the Member States. 
 Will it entail "administrative 
costs" for public authorities? Will it entail "administrative 
costs" for breeders, suppliers and users? 
Extending the scope of the directive to cover further species/immature forms/ animals killed for their tissues  Yes: Will entail additional 
Authorisation decisions and Ethical review (1.2 million €)
82 Yes: will entail additional 
authorisation a pplications and 
proposal submission for ethical review (12.6 million €)
83 
 No: Housing and care 
standards (if any additional costs occur in this respect at 
                                                 
82 It should be noted that the impacts identified for scope options 1 and 5 are already covered in those 
covered by the other options, especially for Authorisation and Ethical Evaluation, therefore only the 
additional costs for scope options 2, 3 and 4 were included here.  
83 Same remark as in the previous footnote. 
 
EN 77   EN all) 
Authorisation of projects Ye s: Authorisation decisions 
(0.06 million €)  
 Yes: Authorisation 
applications (23.6 million € cost increase for Option 1, but 21.2 million € cost savings for Option 2) 
Ethical evaluation Yes, but small effect is 
negligible  Yes: proposal submission for 
ethical evaluation and maintenance of infrastructure (committee members etc) to perform the ethical evaluation (9 million €, but reduces animal testing costs by 70 million €)  
Housing and care No No 
Retrospective ethical evaluation Yes, about 2 million € 
(revised option). Yes, about 2 million € 
(revised option). 
Transparency/Access to information Yes, but small effect is 
negligible  Yes (0.52 million €) 
Special rules for non-human 
primates Yes, but small effect is 
negligible  Yes, but small effect is 
negligible 
Inspections Yes (3.1 million €) Yes (0.62 million €) 
Education and Training Yes, but small effect is 
negligible Yes, but small effect is 
negligible 
Database to avoid duplication Yes (0.1 million €) Yes (6.2 million €) 
 
Using CO2 to kill animals Yes, but small effect is 
negligible No 
Extending statistical 
reporting obligations Yes, but small effect is 
negligible Yes (7.4 million € for Option 
1, 4 million € for Option 2)  
Promotion of alternatives Yes, but small effect is 
negligible No 
Marking of the animal  Yes, but small effect is 
negligible because these obligations are close to the 
existing Directive Yes, but small effect is 
negligible because these obligations are close to the 
existing Directive 
 
EN 78   EN Record keeping  Probably not because record 
keeping simplifies the work of inspectors. However, the small effect is probably negligible because record keeping is already now obligatory Yes, but small effect is 
negligible because record keeping is already now obligatory and only slightly increased for new documents 
 
EN 79   EN Revision of Directive 86/609/EEC 
One part of the proposed new Di rective transposes the revised 
Council of Europe Guidelines on Housing an Care Tariff 
(€ per hour)*  
Time  (hour) Price
(per action or equip)* Freq 
(per year) Nbr  
of  entities Total nbr
of  actions Total cost Regulatory 
origin (%) 
No. Ass
. Art.   Type of 
obligation Description of 
required action(s) Target 
group i e i e           In
t E
U N
at R
eg 
1 Art. 
3(1)(a)   Application for 
individual authorisation (mammalian foetal forms) Processing 
additional project applications Public 
authorities 
38    5    190  165
84 27  4455  0.9m €85   X     
2 Art. 
3(1)(a)   Application for 
individual authorisation (mammalian foetal forms) Filing forms and 
tables certain 
user establishments 43    83
    3550
86  5,3  67087
  3550  12.6m €   X     
3 Art. 
31   Application for 
individual Processing 
additional Public 
authorities 38    6    228  6388
  4  252  0.06m €   X     
                                                 
84 Average per Member State if 3 50 0 projects are distributed equally. 
85 Without costs for animals killed for their tissues. 
86 Based on weighed average of the data presented by Prognos in report, page 102 (costs per project public/private). 
87 Assuming that no institute is only killing animals for tissues and that only 50% of establishments using live animals also kil l animals for their tissues. 
88 Assuming that no institute is only killing animals for tissues and that only 50% of establishments using live animals also kil l animals for their tissues. 
 
EN 80   EN authorisation  applications for 
individual authorisation 
4 Art. 
31   Application for 
individual authorisation  Filing forms and 
tables some user 
establishments 43    19
0    8180 7  187  1309  9.7m €   X     
5 Art 
31  More 
demanding application due to compliance check Filing forms and 
tables all user 
establishments 43  35  1493 7 1339 9305 14.0 
million €     
6 Art. 
36 (4)   Application for 
group authorisation  Reduced number 
of applications to be processed Public 
authorities 38    6    228  min
us 100 
89  27  minus 
2700  minus 
0.7m €   X     
7 Art. 
36(4)   Application for 
group authorisation Filing forms and 
tables certain 
user establishments 43    19
0   8180 min
us 4 670
90
  minus 
2680  minus 
21.1m €   X     
8 Art 
32   Ethical 
evaluation Preparing 
document justifying animal all user 
establishm 43    45
    1918  7 670
91 4590 9m €   X     
                                                 
89 Average number of avoided project applications per Member State in the 27 Member States, based on 5 project authorisations per  establishment per year (instead of 
7 without group authorisation) and 1339 establishments. 
90 Based on the assumption that regulatory testing projects are performed by 50% of all establishments. 
91 Based on extrapolations of number of establishments (Prognos report 2007, p. 55). 
 
EN 81   EN testing ents 
9 Art 
35   Non-technical 
project summaries for publication Writing and 
submitting them for Ethical Evaluation all user 
establishments 43    1,
5    60  7 1339
  9300  0.52m €   X     
10 Art 
29   Two inspections 
per year Inspection of 
breeder, user and supplier establishments Public 
authorities 58
92    20
    1158 2  1339
  2678 3.1m €   X     
11 Art 
29   Two inspections 
per year Inspection of 
breeder, user and supplier establishments all 
breeder, user and supplier establishments 43    8    344  2  1339
  2678 0.92m €   X     
12 Art 
33  Retrospective 
ethical evaluation Filing forms and 
tables User 
establishments 43  35
93  1505 2 670 1340 2m €   X   
13 Art 
33  Retrospective 
ethical evaluation Processing 
additional submissions Public 
authorities 38  35
94  1505 2 670 1340 2m €  X   
                                                 
92 Includes travel costs. 
93 Estimation based on Prognos report 2007, p. 176. 
94 More conservative estimate than Prognos report 2007, p. 176. 
 
EN 82   EN 14 Art 
39(2)   Statistical 
Reporting Collecting and 
submitting information User 
establishments 43    37
    1591 10  470
954700 7.4m €   X     
15 Art 
39(2)   Statistical 
Reporting Collecting and 
submitting information User 
establishments  43   14
    602 10  670
966700 4.0m €   X     
                   
          
   Total 
administrative costs: 45.08m Euro    
                   
 * It should be noted that the ex ternal study is based on a complex cost model that  takes into account th e wage differential acr oss the 25 Member 
States weighed according to the number of projects and establishmen ts estimated to be related to each of these Member States to  calculate the 
total costs. The cost per unit (1 hour of work) in this table has on the other hand been calculated via a simple linear equatio n to make this table 
consistent.
                                                
 
95 Based on the assumption of 3500 projects with foetal forms and 1200 projects with GM O animals per year (assumptions in the Pro gnos report 2007 on page 289 and 
290), on average 10 projects per user establishment obliged to re port such statistics, average le ngth of a foetal form project assumed only a few weeks but at high 
cost, standard model used for GMO animals and no overlap between GMO establishments and those using foetal and embryonic forms.  
96 Based on the assumption that 50% of curren t user establishments have on average 10 such projects involving killing animals for  in-vitro tests, that the average length 
of such a project is 3 years (assumption made in the Prognos report 2007 on page 89) and that the number of independent supplie rs is negligible. 
 
EN 83   EN 10. CHOSEN  OPTIONS   
In the light of the table above, it becomes clear that some of the options that provide for the 
highest animal welfare benefits  create also the highest costs (Housing and Care  standards, 
Education and Training standards) . On the other hand, inspections  costs are relatively low and 
the cost for transparency in the form of non-technical summaries is almost negligible. 
In terms of proportionality, only the option of ba nning CO2 seems to entail costs that are out 
of proportion in relation to its  unquantifiable animal welfare benefits. The remaining policy 
options do not go further than what is necessary  to achieve the objectives of the revision and 
are as simple as possible (principle of proportionality). 
Therefore the options th at are justified are: 
• Extending the scope to cover animals used in basic research, animals bred for the primary 
purpose of their tissue and organs, selected invertebrates species, foetal and embryonic 
forms in the last third of their 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 welfar e and ethics committee with a minimum 
harmonised remit 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 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 inspec tions by national authorities of which one 
unannounced; 
• Appropriate education an d training standards; 
• Specific conditions for the use of CO2; 
• Improving the data for policy-making via improved statistics. 
 
EN 84   EN • National reference laboratories. 
The total costs of these options is about 143.7 million € per year which may decrease over 
time as animal care staff gains more experien ce with the new housing and care standards. 
These costs are not evenly spread, but are higher in Member States with low current 
standards. The cost increases can be largely attributed to the three options which contribute most to the harmonisation of the internal market and also provi de the highest animal welfare 
benefits. Therefore, the benefits  in terms of Single Market and animal welfare outweigh these 
costs. 
The combination of these specific options combin es legal certainty with sufficient flexibility. 
The proposed options therefore represent a mix of best practices from around the world and 
enhance the European Community's internati onal leadership role on animal welfare.  
The cost increase from the chosen options needs to be put into perspective with the following 
considerations: 
- The current total expenditure of all user establishments for animal experimentation in the 
EU-25 was calculated to be in the range of 2.9 billion € per year. This means that the cost 
increase of 143.7 million € per year that is likel y to be triggered thr ough the revised Directive 
is relatively small (about 5%) in comparison to the current level of expe nditure in the sector. 
- While universities and other public research in stitutes may need transitional periods to adapt 
to the new requirements, and this has been catered  for, some industrial sectors may be able to 
cope with new standards much faster because animal care costs make up only a small share of 
their total investments, e.g. pharmaceutical companies for whic h the costs to develop a new 
product may amount to 1 billion € over 10 years. 
- A significant share of these costs is due to the implementation of the revised guidelines for 
housing and care of experimental animals adopted by the Council of Europe. As the European 
Community is a Party to the Convention, it had to implement the revised Guidelines anyway 
(Commission Recommendation 2007/526/EC of 18 J une 2007). Therefore, a significant share 
of the cost increase is caused  by international obligations of  the Community and cannot be 
attributed solely to the revision of the Directive. 
- It is important to note that 23 Mio € attribut ed to the authorisation of projects reflects the 
scenario in which no Member State opts for th e lighter authorisation process for project 
consisting of only "up to mild" procedures a nd not involving the use of non-human primates.  
- The benefits from reduced administrative co sts and avoided unnecessary  testing alone were 
estimated in the order of 90 million € per year by the external study. However, these have not 
been reflected in the total cost. 
- For some options with a very  high potential to improve animal welf are, the corresponding 
benefits for science can be m onetised. If only a few percentages (1-3%) of the studies that 
currently suffer from a weak experimental de sign, inappropriate housi ng and care standards or 
not fully competent personnel could 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 
 
EN 85   EN regard to animal welfare requirements in formul ating agriculture, transport, internal market 
and research policies. At the sa me time, they cannot be better carried out by Member States 
individually. 
 
EN 86   EN 11. MONITORING  AND  EVALUATION 
The Commission will monitor th e transposition of the Directive, any implementation and 
enforcement problems, together with the Member States. The final indicators to monitor and evaluate progress towards the objectives of the revision of  the Directive can only be 
established once the Directive is adopted. Ho wever, a preliminary list could include: 
Related to Objective 1
 - Strong convergence of standards th at ensures a level playing field for 
industry and the researcher community: 
Harmonising the minimum requirements in areas such as scope, authorisation and ethical 
review for carrying out scientif ic procedures using animals: number of complaints about 
non-level playing field.  
Levelling the administrative cost and time factor s of scientific procedures using animals: 
variance of administrative costs and time factors across the Member States; price 
differences of experimental animals and regulatory tests between different Member 
States.  
Related to Objective 2  - Significant improvement in animal  welfare and further promotion of 
the implementation of the Three Rs:  
Improve animal welfare by ensuring a minimu m scrutiny of animal experimentation by  
• Implementation of ethical evaluation of projects and an ethi cal review body in 
establishments to ensure full compliance with the Three Rs: retrospective assessment, 
non-technical summaries;  
• Minimum standards for housing and care: percentage of estab lishments who have 
upgraded by year until the end of the transitional period;  
• Minimum standards for inspections: numbers of inspections performed and number of 
infringements; numbers of joint insp ections; numbers of EC inspections;  
• Ensure protection of animals for which there is scientific evidence of their sentience 
(invertebrates, foetal forms, basic research, bred for tissue) number of new species/life-
stages protected by the scope, new speci es/life-stages intro duced by comitology;  
• Encouraging research into alternative appr oaches and improve conditions for innovation: 
number of methods developed and undergone validation per year, and regulatory 
approval of validated methods.  
Further general indicators:  
• numbers of animals used in scientific procedures 
• number of EC infringement cases registered 
• numbers and pattern of wild caught, F1, F2+ non-human primates used 
 
EN 87   EN 12. TERMINOLOGY 
Term Definition for the purposes of this impact assessment 
Alternative method A method that reduces the number of animals required for the 
same purpose (Reduction Alternative), refines the method to reduce pain, suffering and distress  and/or to enhance animal 
well-being (Refinement Alterna tive), and replaces the method 
with one not using live, sent ient animals (Replacement 
Alternative). 
Establishment Any installa tion, building, group of buildi ngs or other premises 
and may include a place which is not wholly enclosed or 
covered and mobile facilities;  
• "breeding establishment" means any establishment where 
animals are bred with a view to  their use, or for the primary 
purpose of using their tissue or organs, in procedures;  
• "supplying establishment" mean s any establishment, other 
than a breeding establishment, from which animals are 
supplied with a view to their use in procedures;  
• "user establishment" means any establishment where animals 
are used for procedures 
Ethical Evaluation A process of eval uating the justification, design and 
consequences to science, society, environment and animal welfare of a particular piece of research, for example a project 
proposal that can be carried ou t prior to, during, or after the 
lifetime of a project. 
Ethical Review Committee A specific mechan ism/strategy for carrying out an ethical 
evaluation or wider ethical review and whose members reflect a recognised skill base as well as representation. 
Ethical Review Body A broad concept with specific objectives to ensure that all 
production, keeping and use of an imals for experimental and 
other scientific purposes is car efully considered, adequately 
justified, carried out and followe d up so that the animals are 
treated as humanely as possibl e, incorporating the Three Rs 
principles throughout, as well as providing a forum for an on-
going, wider discussion on the us e of animals in scientific 
procedures. 
Experiment See scientific procedure 
Genetically 
altered/modified animal An animal in which the heritable DNA has been intentionally 
altered, or the progeny of such an animal(s), or of an animal 
with a mutation recognised as ha rmful. This includes animals 
 
EN 88   EN produced by genetic modification or by induced mutagenesis, or 
animals created by nuclear transfer procedures, as well as harmful mutant lines arising fr om spontaneous mutations. This 
definition excludes animals with ch anges that are not heritable, 
such as gene therapy interv entions or DNA immunisations. 
Harmonisation Applying the same legislat ive requirements in all European 
Community countries (or in some cases within a Member State).
Humane endpoint A biological or chemi cal response, that can predict pain, 
distress, suffering or impending de ath that is not necessary, to 
achieve the scientific objective. 
Humane killing A method of killing that causes no avoidable pain, distress or 
other suffering to the animal(s) concerned. 
In vitro Literally meaning in glass, an experimental technique that may 
involve animal organs, tissues  and cells taken from dead 
animals. 
In vivo Scientific procedures invol ving a living animal with its whole 
body systems intact in order to st udy what happens in the body 
itself. 
Project A coherent programme of work aimed at meeting a defined 
scientific objective or  objectives and involving a combination of 
one or more procedures. 
Regulatory testing Testing required by national, European or international 
legislation. 
Scientific Procedure A combination of one or more technical acts carried out on an 
animal for an experimental or other scientific purpose, with 
known or unknown outcome, and which may cause that animal pain, suffering, distress or lasting harm. 
Technique A technical act on one or mo re animals for an experimental or 
other scientific purpose and wh ich may cause that animal or 
those animals pain, suffering, distress or lasting harm. Examples of technical acts would be gavage , injection e.g. saline or other 
substance, laparotomy, withholdi ng of food/water, giving an 
anaesthetic. 
Three Rs Replacement  of scientific procedures by those not using live 
animals, Reduction  of animal use, Refinement  to lessen pain, 
suffering, distress and to enhance animal well-being. 
 
 
 
EN 89   EN 13. FURTHER  INFORMATION  AND  FEEDBACK 
The website of DG Environment contains useful  information about the revision, the existing 
legislation and future developments:  
http://europa.eu.int/comm/environment/c hemicals/lab_animals/revision_en.htm  
In case further factual information on this Imp act Assessment is available in quantified or 
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EN 90   EN ANNEX 
Inappropriate housing and care of experimental animals can lead to a number of physiological 
and behavioural changes that can heavily interf ere with the test results and undermine their 
reliability:97 
- Exposure to inappropr iate temperatures:  Some species are very sensitive to changes in 
temperature, and effects can be seen on beha viour, food and water c onsumption, and growth 
rates (Svendsen, 1994). Significant deviations from the thermo-n eutral zone can result in 
significant distress, morbidity and even death. 
- Exposure to inappropria te Relative Humidity:  Although many species will tolerate well 
variations in relative humidity, for some speci es extreme variations can adversely affect 
wellbeing, breeding performance, and, by affecting the rate of heat loss,  can affect activity 
and food intake (Stille et al., 1968; Clough, 1982; 1984). 
- Inadequate ventilation:  Poor air quality (e.g. elevated carbon dioxide or ammonia levels) 
can lead to abnormal behaviour and increased susceptibility to respiratory disease (Lipman and Perkins, 2002). 
- Exposure to inappropriate noise:  Loud, unexpected and unfamiliar sounds, including 
ultrasound, can disrupt breedi ng programmes and may cause behavioural disturbances 
(Gamble, 1982; Sales et al., 1994). 
- Lack of appropriate ne sting/bedding materials:  can increase neonatal mortality rates or 
cause abnormal/stereotypic behaviours (H ubrecht et al., 1992; Weidenmayer, 1997a; 
Reinhardt, 2004) 
- Inappropriate lighting: Too bright or too dark light or unsuitable ligh ting patterns over a 24h 
period can disrupt breeding cycles, and can cause  retinal changes (O’Steen et al., 1972).  
- Unsuitable diet can lead to  poor growth or obesity, nutrient  deficiencies or excesses and 
effects on breeding performance (Coates, 1999). 
- Lack of social and environmental enrichment:  Failure to provide an appropriate environment 
and social contact has been de monstrated in many species to lead to behavioural problems, 
stress and physiological abnormalities, including increased susceptibility to disease. Animals 
in enriched environments may be better able to  cope with novel and unexpected changes and 
thus show a more uniform response (Rose, 1994;  Baumans, 1997). In some areas of research; 
this has been shown to radically affect the scientific outcomes (Ros e, 2002 presented at the 
4th World Congress on Alternatives).  
For example, individual housing has frequently  been shown to be stressful for mice. 
Detrimental effects of individual housing in clude both, behaviou ral and physiological 
abnormalities usually referred to as 'isolation st ress' or 'isolation syndrome' (e.g. Baer, 1971; 
Brain, 1975; Haseman, 1994). There is evidence th at subordinate male mice prefer company 
to being housed individually, even if that companion is dominant (Van Loo and Baumans, 
                                                
 
97 See also EFSA 2005 Scientific Report, p. 46-53 -  
http://ec.europa.eu/environment/chemicals/lab_animals/scientific_en.htm . 
 
EN 91   EN 1998). Gerbils develop extensive stereotypic diggi ng if they are not given the chance to dig 
burrows, or if they are not provided with an artificial burrow (Wiedenmayer, 1997). There is 
evidence that hamsters housed in non-enriched cages are more  stressed than hamsters housed 
in enriched cages (Kuhnen, 1997) and that enclos ure size and stocking densities induce stress 
responses that may affect health and we lfare (e.g. Sørensen DB et al., 2005). 
- Inadequate breeding management  may lead to breeding immature animals; genetic 
abnormalities, early weaning losses a nd poor temperament (GV-SOLAS, 1999). 
- Inadequate health management and monitoring  can lead to overt clin ical disease and deaths 
(Poole and Evans 1982), reduction in growth rate and breeding performance (GV-SOLAS, 
1999; FELASA, 2002). 
A major source of variance in some animal st udies is contaminatio n or infection with 
microbial agents; elimination of these agents contributes to the standardization of scientific procedures using animals (Johnston and Neva lainen 2003). In experimental animals good 
health status not only means absence of clini cal disease, but also absence of numerous 
specified etiologic agents of disease (example  certain murine viruses which may enhance or 
compromise the immune response). For example, Gärtner (1990) showed that Mycoplasma pulmonis increased rat kidney we ight considerably. Consequen tly, when kidney weight was 
the scientific outcome measure, 5 times as many rats were required to  reveal a significant 
difference.  
- Genetic contamination  is a real risk even with proper colony management, and may go 
undetected unless genetic monitoring sc hemes are in place (Benavides, 1999).  
- Inappropriate handling of animals:  The influence of humans, for example during handling, 
may cause significant variance in results, and he nce should be subjected to stringent control 
(Davies and Balfour, 1992; ILAR, 2002). 
 
EN 92   EN LITERATURE98 
Baer H, 1971. Long-term isolation stress and its effects on drug respons e in rodents. Lab. 
Anim. Sci. 21, 341-349. 
Baldwin A. and Bekoff M., 2007. Too stressed to work. Scientists must provide lab animals 
with decent living conditions or accept that their results could be useless. New Scientist, 2 June 2007, p. 24.  
Baumans V, 1997. Environmental enrichment: practi cal applications. In: Animal Alternatives, 
Welfare and Ethics. Van Zutphen L.F.M. and Balls M. (eds.) , Elsevier, 187-197. 
Benavides FJ., 1999. Genetic Contamination of an  SJL/J Mouse Colony: Rapid Detection by 
PCR-based Microsatellite Analysis. Contemp Top Lab Anim Sci; 38:54-55 
Brain PF, 1975. What does individual housing mean  to a mouse? Life Sciences 16, 187-200 
Clough, G., 1982 Environmental effects on animals used in biomedical research. Biological 
Reviews 57, 487-523 
Clough, G., 1984. Environmental factors in relation to the comfort and well-being of 
Laboratory Animal Management. pp 7-24 Pr oceedings of a LASA/UFAW Symposium. 
Potters Bar: UFAW 
Coates M E, 1999. Nutrition and Feeding. In UFAW Handbook on the care and management 
of Laboratory Animals 7th Edition Editor Tr evor Poole Blackwell Science Volume 1 pp 45-
60 
Davies H. and Balfour D., 1992. The inevitable bond: examining sc ientist-animal interactions. 
Cambridge University Press. ISBN 0-521-40510-6. p. 399. 
EFSA (2005): The EFSA Journal 292, Opinion on the “Aspects of the biology and welfare of 
animals used for experimental and other scie ntific purposes”, p. 1-46, and Annex (Scientific 
Report - Aspects of the biology and welfare of  animals used for experimental and other 
scientific purposes, EFSA-Q-2004-105, p. 1-136,  http://ec.europa.eu/environment/chemicals/lab_animals/scientific_en.htm
 
European Commission (2005): Impact As sessment Guidelines; SEC (2005) 791, 
http://ec.europa.eu/govern ance/impact/docs/SEC2005_791_IA%20guidelines_annexes.pdf  
FELASA, 2002. (Federation of European Laborat ory Animal Science Associations Working 
Group on Health Monitoring of Rodent and Rabbit Colonies). Recommendations for the 
health monitoring of rodent and rabbit colonies in breedi ng and experimental units. Lab 
Anim.; 36:20-42 http://www.felasa.eu  
Gamble MR, 1982. Sound and its significance for laboratory animals. Biological Reviews 57, 
395-421 
                                                 
98 See also EFSA Scientific Report 2005, p. 123-128 -  
http://ec.europa.eu/environment/chemicals/lab_animals/scientific_en.htm  
 
EN 93   EN Gärtner K., 1990. A third component causing random variability beside environment and 
genotype. A reason for limited success of a 30 y ear long effort to standardize laboratory 
animals. Lab Anim; 24: 71-77 
GV-SOLAS Working Group Report on Hygiene, 1999. Implications of infectious agents on 
results of animal experiments Laboratory Animals 33 (Suppl.1) S1:39-S1:87 
Haseman JK, Bourbina J, Eustis SL, 1994.  Effect of individual housing and other 
experimental design factors on tumor incidenc e in B6C3F1 mice. Fundamental and Applied 
Toxicology 23, 44-52 
Hubrecht RC, Sepell JA, Poole T, 1992. Correlates of pen size and housing conditions on the 
behaviour of kennelled dogs. Applie d Animal Behaviour Science 34 365-383 
ILAR Journal, 2002. Institute of Laboratory Animal Resources (National Research Council) 
Implications of Human-Animal Interactions and Bonds in the Laboratory. Volume 43 Number 
1. ISSN 1084-2020 
Johnston NA, Nevalainen T. Impact of the biotic and abiotic environment on animal 
experiments, 2003 In: Hau J, Van Hoosier GL Jr, eds. Handbook of Laboratory Animal 
Science. 2. ed. Essential Principles and Pr actices, p. 311-325. Boca Raton: CRC Press. Vol. 1 
Kuhnen G, 1997. The effect of cage size and envi ronmental enrichment on the generation of 
fever in golden hamster. Ann.N.Y.Acad.Sci. 813, 398-400 
Lipman N. S. and Perkins, S. E., 2002. Factor s that may affect animal research pp 1143 - 
1184. In Laboratory Animal Medicine. Edited by Fox J.G., Anderson L.C ., Loew F. M. and 
Quimby F.Q. Academic Press 
O'Steen WK, Shear CR and A nderson KV, 1992. Retinal damage after prolonged exposure to 
visible light. Am. J. Anat. 134 5-22 
Poole T B, Evans R G, 1982. Repr oduction, infant survival and productivity of a colony of 
common marmosets (Callithrix jacch us jacchus). Lab. Anim. 16 88-97 
Prognos report 2007: Study on the impacts of di fferent options for the Revision of the 
Directive 86/609/EEC on the Protection of  Laboratory Animals. Berlin/Basel.  
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Reinhardt V, 2004. Common husbandry-related variab les in biomedical re search with animals 
Laboratory Animals 38 213-235 
Rose, M. A., 1994. Environmental factors likely to impact on an animal's well-being – an 
overview. In R. M. Baker et al. (Eds.), Improv ing the well-being of animals in the research 
environment. Proceedings of the ANZCCART conference (pp. 99 - 116) 
Russell W M S and Burch R L (1959): The Prin ciples of Humane E xperimental Technique, 
Methuen: London, UK 
Sales GD, Milligan SR, Khirnykh K, 1994. The acoustic environment and its effects on 
laboratory animals , Proceedings of the Fifth FELAS Symposium, RSM Press pp 60-64 
 
EN 94   EN SCAHAW (2002): The Welfare of  Non-Human Primates used in Research. Report of the 
Scientific Committee on Animal Health an d Animal Welfare, European Commission, 
http://ec.europa.eu/f ood/fs/sc/scah/out83_en.pdf  
Sørensen DB, Krohn T, Hansen HN, Ottesen JL & Hansen AK, 2005. An ethological 
approach to housing requirements of golden hams ters, Mongolian Gerbils and fat sand rats in 
the laboratory – A review. Applie d Animal Behaviour Science 181-195 
Stafleu Frans R., Vorstenbosch, Jan (2005): An imal Welfare Committees in the European 
Research Area, Ethics Institute Utrecht University, European Communities 
Stille, G., Brenzowsky, H., and Weike, W.H ., 1968. The Influence of the Weather on the 
Locomotor Activity of Mice. Arzneimittel-Forschung 18: 892-893 
Svendsen, P., 1994 Environmental impact on animal esperiments. In: Handbook of 
Laboratory Animal Science, Vol 1 (eds P. Svendsen & J Hau) Boca Raton: CRC Press). 
Van Loo PLP, Baumans V, 1998. Preference of  subordinate male mice for their dominant 
cage mate. Aktuelle Arbeiten zur Artgem ässen Tierhaltung. KTBLSchrift 380, 45-52 
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