Commission staff working paper accompanying the proposal for a directive of the European Parliament and of the Council on the protection of animals used for scientific purposes - Impact assessment {COM(2008) 543} {SEC(2008) 2411}
Date: 2008-11-05
Institutions: European Commission
Subjects: European convention, animal experimentation, animal welfare

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COMMISSION OF THE EUROPEAN COMMUNITIES 

Brussels, 5.11.2008 
SEC(2008) 2410 

COMMISSION STAFF WORKING PAPER 

accompanying the 

Proposal for a 

DIRECTIVE OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL 

on the protection of animals used for scientific purposes 

IMPACT ASSESSMENT 

{COM(2008) 543} 
{SEC(2008) 2411} 

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TABLE OF CONTENTS 

1. 

2. 

3. 

4. 

5. 

6. 

7. 

8. 

9. 

10. 

11. 

12. 

13. 

Executive summary...................................................................................................... 3 

Procedural issues and consultation of interested parties .............................................. 6 

Problem definition........................................................................................................ 9 

Policy objectives ........................................................................................................ 28 

Policy options............................................................................................................. 30 

Analysis of impacts .................................................................................................... 38 

International situation................................................................................................. 58 

Interaction with other european legislative acts......................................................... 61 

Comparing the options ............................................................................................... 64 

Chosen options ........................................................................................................... 83 

Monitoring and evaluation ......................................................................................... 86 

Terminology............................................................................................................... 87 

Further information and feedback.............................................................................. 89 

Annex 

.................................................................................................................................... 90 

Literature .................................................................................................................................. 92 

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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  legislative  act  of  the  European  Community  which 
harmonises Member States' rules protecting animals 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 attempted to identify, quantify and monetise impacts from 
policy changes in the area of experimental animals. Hardly any scientific literature 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 samples 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 knowledge about the capacity of animals to feel pain, suffering or 
distress  including  their  impact  on  scientific  results  has  become  available.  Furthermore,  the 
ethical dimension of the use of animals 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  research  community  within  the  EU,  defeating 
the objective of the Directive to avoid fragmentation of the internal market. Furthermore, the 
wording  of  the  Directive,  closely  following  that  of  an  international  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 application of the Three 
Rs  principle4,  even  though  it  is  now  recognised  as  the  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: 

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4 

The information contained in the study was correct at the time the study was finalised. 
It should be noted that consistent data for Bulgaria and Romania were not available because the current 
Directive foresees a reporting period of every 3 years, 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. 
Council of Europe Convention ETS 123 on “the protection of vertebrate animals used for experimental 
and other scientific purposes”. 
The  Three  Rs  Principle  (Replace,  Reduce  and  Refine  the  use  of  animals  in  experiments)  is  widely 
accepted as the guiding principles when using animals in experiments both at national and international 
(e.g. OECD, OIE) level. It dates back to the book "The Principles of Humane Experimental Technique" 
by W.M.S. Russell and R.L. Burch in 1959. 

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a)  Economic  problems  affecting  the  internal  market  include  competitive  disadvantages  for 
countries with high animal welfare standards resulting primarily from price differences (e.g. 
minimum  requirements  for  housing),  diverging  regulatory  and  authorisation  procedures  and 
criteria  in  the  Member  States  leading  to  variable  delays  and  cost  of  projects,  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  from  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 unnecessary duplication of procedures, low incentive  to develop and 
use  alternative  methods,  risk  of  variable  research  results  due  to  non-consistent  scrutiny  of 
study  design  and  implementation  of  refinement  (leading  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 dissociation between weak legislation 
and  strong  public  concern,  evolving  from  changed  ethical  and  societal  values and increased 
public interest about the acceptability of animal testing. 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 average delays for authorisation of a project due 
to  significantly  varying  legal requirements  and  administrative  procedures;  differences  in  the 
cost of housing and caring for animals; and differing requirements for the level of training and 
education for personnel. The latter problem also has a negative impact on the free movement 
of  personnel  when  undertaking  cross-border  research  projects.  These  problems  are  further 
exacerbated by differences in the scope of the national legislations; some animal species are 
not  covered  by  legislation  in  some  Member  States,  but  even  where  covered  there  are  big 
differences  in  administrative  requirements  leading  to  varying  processing  times  and  cost 
structures. 

Animal  welfare  problems  are  caused  by  relatively  weak  provisions  and  ambiguities  in  the 
existing  Directive  and  by  unsystematic  approaches  among  Member  States.  Together  with 
scientific problems related to lower animal welfare 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  increasing  the  level  of  welfare  and 
protection of animals used in scientific procedures, 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  Directive  further  strives  to  simplify  the  dispersed 
regulatory environment and ensure the competitiveness of EU research and industry. This will 
be  achieved  by  harmonising  the  objectives  and  minimum  requirements  at  EU  level,  while 

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leaving  the  Member  States  considerable  flexibility  to  determine  the  most  optimum 
mechanisms  for  their  respective  existing  infrastructure,  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  screened:  deregulation,  no-policy-change,  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  Directive  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  problem  dimensions,  costs  were  evaluated  separately  for  user 
establishments and public authorities. In some cases, the original options were revised in the 
light of the results of the external study.  

The most useful options to create a level playing field and improve the good functioning of 
the  internal  market  within  the  European  Community  and  to  significantly  increase  animal 
welfare for all 12.2 million animals used annually in the Community are:  

- Strengthening of the requirements for authorisation and ethical evaluation of projects – this 
would  have  a  significant  impact  on  levelling  the  current  economic  differences  between 
Member States; 

-  Minimum  housing  and  care  standards  –  establishing  harmonised  compulsory  housing  and 
care standards would remove the current uneven competitive environment and prevent likely 
future problems related to an inconsistent implementation of new standards agreed at Council 
of  Europe  level.  This  would  not  benefit  only  user  establishments  but  also  breeding  and 
supplying establishments, at the same time having a considerable impact on animal welfare; 

- Inspections – standardised inspections among Member States would expose non-compliant 
establishments,  ensuring  enforcement  and  dissemination  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 also provide the highest internal 
market and animal welfare benefits.  

These costs should be mirrored against 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  regulatory  testing  would  reduce  the  average  costs  of  this  type  of 
projects  at  the  establishment  level  due  to  economies  of  scale.  Positive  impacts  would  also 
occur at the level of authorisation bodies in Member States due to more flexible and efficient 
handling of the procedures. Furthermore, industry and academia would benefit from specific 
deadlines for the authorisation decisions. 

Some  simplification  benefits  have  been  taken  into  account,  especially  related  to  group 
authorisations which will greatly reduce the administrative burden. Expected savings will be 
about 22 million € per year. Animal welfare bene fits are not easily quantifiable in monetary 
terms.  The  benefits  from  reduced  administrative  costs  and  avoidable  unnecessary  testing 

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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 expenditure 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 would 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 reflects the scenario in 
which  no  Member  State  opts  for  the  lighter  authorisation  process  for  projects  consisting  of 
only "up to mild" procedures and not involving the use of non-human primates.  

- The benefits from reduced administrative costs 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 welfare, the corresponding 
benefits  for  science  can  be  monetised.  If  only  a  few  percentages  (1-3%)  of  the  studies  that 
currently suffer from a weak experimental design, inappropriate housing and care standards or 
not fully competent  personnel  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 2002 when the European 
Commission’s Directorate-General for Environment (DG ENV) requested an opinion on the 
welfare  of  non-human  primates  used  in  experiments  from  the  Commission’s  Scientific 
Committee  on  Animal  Health  and  Animal  Welfare,  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  European  Commission  to  come  forward  with  a 

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proposal to revise Directive 86/609/EEC. The report was adopted on 13 November 2002 and 
can be found at: 

http://ec.europa.eu/environment/chemicals/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  revision  of  the  Directive.  The  experts  from 
Member  States,  acceding  countries  (which  are  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/chemicals/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  scientific  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  and  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 published 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 the Commission to come forward with a proposal to revise the 
Directive 86/609/EEC before the end of the year 2006. The resolution is available at: 

http://www.europarl.europa.eu/sides/getDoc.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 AHAW 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 and costs. In December 2005, Prognos AG was assigned 
to carry out a study to provide input to the Commission’s Impact Assessment according to the 
revised 
the  Commission’s  Secretariat  General 
(SEC(2005)791). 

Impact  Assessment  guidelines  of 

The  Prognos  study  followed  a  very  systematic  approach.  In  a  first  step,  baseline  data  was 
gathered to substantiate the problem areas via stakeholder interviews and two questionnaires, 
one to stakeholders and one to the national contact points in 25 Member States.  

The stakeholder questionnaire was sent to all major stakeholders including representatives of 
private and public users of animals (e.g. industry 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. From the 96 stakeholders 
who received the questionnaire, 66 filled it in and returned it.  

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DG Environment contacted the national authorities 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  received  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  provide  new  facts  and  figures  on  the  use  of 
animals  for  scientific  purposes  in  their  establishment  or  country.  As  only  relatively  limited 
data  was  available,  the  contractor  developed  a  model  about  benefits  and  costs,  and  derived 
qualitative hypotheses from it about possible impacts of the respective options. 

The results of this first phase were presented to stakeholders in a public internet consultation 
which  the  Commission  performed  from  16  June  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 Prognos5. 

c) Public Internet consultation 

The internet consultation was open to participation for a period of nine weeks and consisted of 
two separate questionnaires, one directed more to the general public and one for experts and 
stakeholders in the field. However, no restrictions for participation were imposed. 

The  purpose  of  the  consultation  for  the  general  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 published 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, the citizens' consultation received the third largest number of 
responses  to  a  Commission  internet  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 strong 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 answered either "Yes, certainly" 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  that  the  European  Community  should  play  a 
leadership role in promoting in the international arena a greater awareness of animal welfare 
and protection, in particular regarding animals used in experiments. 

The  expert  questionnaire  served  to  verify,  correct  and  complete  the  preliminary  findings  of 
the  assessment  of  the  options  to  revise  the  existing  Directive.  The  questionnaire  was 
addressed  to  experts  in  the  area  of  animal  welfare,  animal  testing,  animal  science,  natural 

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September 

Published 
http://ec.europa.eu/environment/chemicals/lab_animals/ia_en.htm 
Published in December 2006 on the DG Environment Website under:   
http://ec.europa.eu/environment/chemicals/lab_animals/questionnaire2.htm 

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sciences  (especially  biology,  medicine,  pharmacology  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, quantifiable 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 consultation, the vast majority of which were experts 
in the field of experimental animals. While the consultation revealed a lot of support for the 
preliminary hypotheses on the impacts, they provided 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  external  study  as  bullet  points  in  grey  boxes  and 
have  been  taken  into  account  in  the  final  report  of  the  external  study.  A  number  of 
conclusions have also fed into the legal drafting.  

Whilst this Commission staff paper draws heavily on the Prognos study, it is also based on the 
much wider stakeholder and expert input over the last years. 

d) Inter-service group 

An informal inter-service group composed of representatives of various Directorate-Generals 
of the European Commission was set up and met several times in 2006 and 2007. Directorate-
Generals  involved  were  Environment  (lead),  Enterprise,  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 inter-service steering group was required. Instead, the informal 
inter-service  group  discussed  both  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  Board  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  systems  of  experimental  animal  protection,  the 
examination  of  links  with  other  Community  legislation  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  section  on  self-regulation,  the  qualitative  benefit 
dimension and the use of the standard model of administrative costs. 

3. 

PROBLEM DEFINITION 

Overview of the sector 

The  number  of  vertebrate  animals  used  annually  for  experimental  and  other  scientific 
purposes  in  the  EU-25  is  about  12.2  million.  Most  of  them  are  mice  and  rats  but  bigger 

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animals are also used in significant numbers (e.g. about 20.000 dogs and about 10.000 non-
human primates).  

No official aggregated data are available about many key data of the sector but the external 
study performed by Prognos has estimated that about 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  experimental  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 organisations: 12.6% of projects 

- Government departments 3.6% of projects 

- Other public bodies 9.4% of projects 

- Non-profit organisations 4.2% of projects 

- Hospitals: 1.2% of projects 

- Public health laboratories 0.6% of projects 

In conclusion, most animal tests are performed by universities and commercial organisations.  

Commercial organisations can be further disaggregated into: 

- Companies doing research in-house for their 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  structure  varies  across  Europe  due  to  differences  in  the  regulatory 
environment.  

-  Contract  research  institutes  performing  animal  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 internal 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  increasingly  competing  for  industry  sponsoring  for 
their research, are tendering for public procurement (research) contracts and sometimes create 
their own commercial off-springs or branches. 

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Prognos report 2007, Chapter 7, page 55. 
See UK Home Office 2005: "Statistics of scientific procedures on living animals, Great Britain 2005", 
pages 64 and 66. The report is available at: http://www.homeoffice.gov.uk/rds/pdfs06/spanimals05.pdf 

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About  9.300  new  projects  involving  animal  tests  are  annually  started  in  the  EU-25  which 
often  last  for  several  years.  An  average  project  was  estimated  to  cost  about  300.000  Euros 
over  three  years9.  However,  it  is  clear  that  as  a  result  of  differences  in  scope,  application, 
housing  and  procedural  requirements,  the  estimated  average  cost  is  likely  to  differ 
significantly between Member States.  

It should be noted that some Member States currently have a burdensome regulatory structure 
in  this  field.  The  revision  will  provide  an  opportunity  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 main problem dimensions across the three areas 
mentioned  in  the  Commission  Impact  Assessment  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.  minimum  requirements  for  housing),  diverging 
regulatory and authorisation procedures and criteria in the Member States leading to variable 
delays  and  cost  of  projects,  unsatisfactory  (working)  conditions  of  researchers,  obstacles  to 
horizontal mobility, increasing activist criminality. 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  standards  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 current 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  care  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 cannot be addressed by the Commission because the 
existing Directive does not provide even minimum requirements. 

9 
10 

Prognos report 2007, Chapter 7, p. 54. 
Federation of European Laboratory Animal Science Associations. 

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c) Scientific problems: 

Low  innovation  /  bad  science  resulting  from  delays  of  projects,  potentially  unnecessary 
testing  and  unnecessary  duplication,  low  incentive  to  develop  and  use  alternative  methods, 
risk  of  variable  research  results  due  to  non-consistent  scrutiny  of  study  design  and 
implementation  of  refinement  (leading  to  higher  stress  levels  for  animals)  and  obstacles  to 
free movement of researchers due to different standards for education and training. 

d) Public/societal problems: 

Increasing  dissociation  between  weak  legislation  and  strong  public  concern,  evolving  from 
changed  ethical  and  societal  values  and  increased  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 point, 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 cover animals used in basic research, education and training 
and  those  that  are  merely  bred  and  killed  for  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 scientific evidence that they are sentient beings. 

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A  significant  number  of  animals  are  currently  used  in  basic  research  within  the  European 
Community.  Out  of  the  total  12.2  million  vertebrate  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 afforded the same legal protection. 

Around  1.5%  of  all  animals  are  used  in  the  fields  of  education  and  training.  Their  absolute 
number is about 200.000. 

Around 40% of Member States do not have legislation 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/ethical  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  that  around  175,000  foetal  forms  of  mammalian 
species  (at  the  stage  of  at  least  2/3  of  gestation)  are  used  in  the  European  Community  per 
year.  Due  to  the  increasing  acceptance  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 improving national legislation. However, these national 
legislative  acts  have  resulted  in  a  fragmented  regulatory  environment  in  Europe  and 
consequently to varying competitive frameworks between Member States. 

11 

12 
13 
14 

15 

The  official  EU  statistics  are  from  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/environment/chemicals/lab_animals/reports_en.htm. 
Prognos report 2007, p. 16. 
Prognos report 2007, p. 16. 
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. 
The  Three  Rs  Principle  (Replace,  Reduce  and  Refine  the  use  of  animals  in  experiments)  is  widely 
accepted as the guiding principles when using animals in experiments both at national and international 
(e.g.  OECD,  OIE)  level.  It  dates  back  to  the  famous  book  "The  Principles  of  Humane  Experimental 
Technique" by W.M.S. Russell and R.L. Burch in 1959. 

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The  different  levels  of  animal  protection  between  Member  States  are  undermining  the 
objectives set out in the Protocol to the EC Treaty which formally recognises the welfare of 
animals as an element to be taken into account in Community policy making. Even though 20 
Member  States  cover  today  basic  research  under  their  national  legislation,  the  area  of 
application differs significantly. Whereas in several Member States all scientific work in basic 
research involving vertebrate animals is covered, other Member States exclude, for example, 
field studies and some nutrition studies. 

The  EFSA  Opinion  of  2005  recommends  extending  the  scope  of  the  Directive  to  those 
invertebrates  whose  sentience  is  scientifically  supported  (cyclostomes,  cephalopods  and 
decapod  crustaceans) and  to  foetal  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 some 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 national level but Germany, the Netherlands, Belgium, 
Finland,  Greece  and  Spain  having  explicitly  decentralised  systems  of  authorisation.  Most 
Member States have some form of authorisation system at the individual project level, mostly 
in combination with authorisation for establishments and personnel. Ethical evaluation of the 
project  is  often  a  prerequisite  for  authorisation.  In  some  Member  States  the  procedures  to 
obtain the first authorisation are significantly different from the procedures used for renewal 
of an existing authorisation18. 

Trends and implications 

Stakeholders estimated that their costs of authorisation 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 authorisation 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  too  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 possible negative consequences for animal welfare. Transparent 
and well informed authorisation procedures also contribute to the quality of the results.  

16 
17 
18 

19 

http://ec.europa.eu/environment/chemicals/lab_animals/scientific_en.htm 
Prognos report 2007, p. 17. 
It  is  important  to  note  in  this  context  that  the  terms  "authorisation"  and  "ethical  evaluation"  are 
interlinked. This is especially important when discussing delays due to "authorisation". In the majority 
of cases, if not all, the authorisation 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.  
See Prognos report 2007, Chapter 7, p. 61. 

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Problem dimension 

Though  it  contains  reference  to  the  authorisation  or  notification  of  projects,  the  current 
Directive  does  not  require  compulsory  authorisation  of  projects,  nor  does  it  require 
compulsory notification of projects in all cases. 

The  average  delay  of  a  project  using  animals  due  to  an  authorisation  in  the  Community  is 
between 70 and 100 days in the EU-25, with significant 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  evaluation  of  the  project,  this  variance  results  in  an 
uneven playing field for user establishments 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  and  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 for 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.  Different  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  committees  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 States, 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 

21 

22 
23 

Stafleu,  F.R  and  J.  Vorstenbosch;  Animal  Welfare  Committees  in  the  European  Research  Area,  EC, 
2005, p. 79. available at: http://ec.europa.eu/research/science-society/pdf/animal_welfare_final_en.pdf. 
FELASA: Principles and Practice in Ethical Review of Animal Experiments across Europe; December 
2005. Available at http://www.felasa.eu/recommendations.htm. 
Prognos report 2007, p. 20. 
Prognos report 2007, table on p. 20. 

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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 benefits 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 evaluation in practice. It is seen as having a high potential for 
contributing  to  a  substantial  reduction  of  unnecessary  testing  and  for  setting  relevant 
incentives  to  increase  the  use  of  the  concept  of  the  Three  Rs.  Most  stakeholders  agree  that 
ethical evaluation procedures are required for a good prior evaluation of the project’s possible 
negative consequences on  animal welfare. Transparent 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 protection of experimental animals 
differs  very  much  across  the  European  Community,  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 required, has a strong impact on the variances in the authorisation 
delays from 0 (no authorisation) up to 200 days. The users of animals have to take this into 
account with their resource allocation. These differences in national procedures result in the 
administrative burden varying significantly, consequently exposing animal users in different 
Member States to an uneven competitive environment. 

It is clear that, if basic elements of ethical evaluation are not sufficiently harmonised in the 
Directive,  the  opportunities  for  the  full  implementation  of  the  Three  Rs  cannot  be 
exhaustively exploited and animal welfare and good science not optimised. 

Furthermore,  it  is  also  unclear  how  under  the  current  structure,  in  which  neither  ethical 
evaluation  nor  authorisation  is  required  by  some  national  legislation,  compliance  with  the 
requirement of article 7(2) of the current Directive 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 evaluation of particular projects. 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  application  of  the 
Three  Rs  in  all  areas.  The  level  at  which  ethical  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. 

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According  to  the  external  study,  in  seven  Member  States  establishment-based  review  is 
mandatory  (by  virtue  of  statute  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  countries  there  is  no  legal  or  other  administrative 
requirement for local ethical review (with the exception of Spain where three administrative 
regions require it and nationally all State research centres 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 considered 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-level playing field in 
terms  of  resource  requirements  (staff,  time)  affecting  not  only  user  establishments  but  also 
breeding  and  supplying  establishments.  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 and 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  Annex  II,  non-binding  guidelines  on  accommodation 
and  care  of  animals.  Member  States  have  implemented  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  Convention  contains  in  its  Appendix  A  non-binding 
guidelines  for  the  accommodation  and  care  of  animals  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  Parties  to  the  Convention  are  expected  to 
implement them by June 2007.  

The  European  Community  is  Party  to  the  Convention  and  will  therefore  have  to  implement 
the revised guidelines. In addition, 13 Member States have ratified the Convention, covering 
91% of animal use in the EU-2526.  

The  revised  guidelines  foresee  significant  increases  to  the  cage  sizes  and  emphasise  group 
housing  and  enrichment.  The  external  study  found  that  based  on  the  factual  feedback  and 

25 
26 

Prognos report 2007, p. 155. 
The following 13 Member States of the EU-25 have ratified the convention: Belgium, Cyprus, Czech 
Republic,  Denmark,  Finland,  France,  Germany,  Greece,  Netherlands,  Slovenia,  Spain,  Sweden  and 
United Kingdom. Bulgaria and Romania also ratified before their accession. 

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estimations  from  users  and  keepers  of  animals,  at  least  20%  of  both  private  and  public 
establishments have already upgraded their facilities to comply with the revised guidelines27.  

Trends and implications  

The  revised  Appendix  A  will  apply  to  those  countries  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 Council 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  another  places  establishments  (breeding,  supply  and 
user establishments) into a significantly different cost environment, depending on the Member 
State in which they are located, consequently distorting the internal market. This is unlikely to 
change without regulatory action at European level.  

Member  States  have  confirmed  that  the  implementation  of  the  revised  housing  and  care 
standards as agreed at the Council of Europe will be considered in a similar manner as today, 
i.e.  varying  from  non-binding  to  compulsory  minimum.  Due  to  the  significant  upgrading  of 
these standards, this would suggest a strong possibility of further fragmentation 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  requirements  to  be  met,  e.g.  in  terms  of  space 
allowance.  This  is  not  in  line  with  the  requirement  to  take  into  account  animal  welfare 
requirements  as  per  the  Animal  Welfare  Protocol  to  the  Treaty  establishing  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 reliability28.  

VI. Transparency / Access to Information 

Current situation in Member States 

In  most  countries,  public  information  about  animal  tests  is  made  available  through  yearly 
statistical reports published by the responsible ministry. As a minimum, these reports include 
basic  statistical  information  required  to  be  reported  to  the  Commission.  Several  Member 
States  make  authorisation  information  available  to  the  public;  few  make  essential  parts  of 
ethical  evaluation  reports  publicly  available.  Some  establishments  publish  more  detailed 
information voluntarily in their annual reports. 

27 
28 

Prognos report 2007, p. 205. 
See Annex of this document, EFSA 2005, p. 46-53, and most recently Baldwin and Bekoff 2007. 

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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 usually have to give an explanation for his/her 
request,  but  if  the  information  is  not  disclosed,  a  valid  reason  has  to  be  given.  In  many 
countries,  privacy  or  data  protection  laws  may  be  part  of  the  freedom  of  information 
legislation. 

Problem dimension 

Better regulation requires transparency 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  information.  However,  the  current  Directive 
86/609/EEC  does  not  provide  a  level  of  transparency  called  for  by  large  proportion  of 
stakeholders  and  the  general  public.  It  has  been  recognised  by  many  companies  and 
researchers  that  a  consistent  approach  about  transparency  across  Europe  would  benefit  all 
interested parties.  

A few countries such as Sweden, Denmark, and the Netherlands have implemented extensive 
public  rights  to  information  through  their  freedom  of  information  legislation.  In  principle, 
these rights would enable interested members of the public to access extensive information on 
projects, except for company and personal details. Intellectual property rights and other trade 
secrets are also considered as restricted information and are not made available under freedom 
of information legislation.  

The external study concluded that a majority of stakeholders would 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 stakeholders point out that increased legislation in this area must 
be balanced against intellectual property rights concerns. 

VII. Non-human primates (NHPs) 

Current situation in Member States 

Available  data  indicates  that  in  2002  about  9000  non-human  primates  (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 total 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%  are  "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. 

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and  some  tamarins);  and  some  Prosimians  (mainly  lemurs).  Other  species  used  counted  for 
less than 3%. 

The use of Great Apes is very 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);  and  a  partial  ban  in  Sweden  where  they  can  be 
used only for research relating to their own species. 

Use and trends  

The main biomedical research areas using NHPs are safety testing of pharmaceuticals, quality 
control  of  vaccines,  and  fundamental  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  regulatory  testing,  therefore  further  support  for  the 
development  and  implementation  of  alternative  methods  could  be  effective  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  culture  collections  in  order  to 
optimise  the  use  of  this  material  but  these  are  at  present  still  inadequate  to  replace  a 
substantial part of NHPs in biomedical research. 

There  are  insufficient  data  available  to  estimate  whether  the  use  of  NHPs  is  decreasing  in 
Europe. In the Netherlands the number of NHPs 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  users  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 scientific purposes in the EU were Old World 
monkeys. About 7000 of these animals were imported 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 the ratio of Old to New World is about 3:1. The 
reproduction cycle for marmosets is 2-2.5 years (breeding 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  (breeding  age  reached  at  4  years,  with  a  5-6-
month gestation). A litter usually consists of only one progeny.  

Problem dimension 

Non-human primates are species with highly developed social skills 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 use is a sensitive issue and a subject of serious 

30 
31 

Prognos report 2007, p. 25. 
Prognos report 2007, p. 25. 

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debate.  There  is  increasing  (public)  concern  regarding  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 first generation offspring (F1) can be used for research. There is 
significant evidence that catching these highly aware and social animals from the wild causes 
significant  suffering  and  distress,  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  therefore  advocated  to  move  towards  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 NHPs 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 global supply is produced in Europe) to which 
with the current scientific 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  use  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 vaccines and treatments.  

VIII. Inspections 

Current situation in Member States 

All  Member  States  have  an  infrastructure  for  periodic  inspections.  The  frequency  of 
inspections varies significantly from 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 training of inspectors and the frequency 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. 

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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  incentives  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 minimum standards for inspections, there is a 
low  public  perception  of  levels  of  compliance  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 establishment. In case full compliance is 
not  assured,  animal  welfare  may  be  compromised.  The  Commission  regularly  receives 
complaints from citizens about alleged infringements of the existing legislation33. 

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  experimental  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, the Netherlands, Lithuania (B and C category))34, 
while others have very different standards in place. 

Demonstrating/maintaining personnel competence however is required only in approx 35% of 
the  Member  States,  covering  approximately  four  million  of  total  animal  use  in  Europe.  The 
in  place  for 
other  65%  of  Member  States  do  not  have  specific  requirements 
demonstrating/maintaining competence35. 

Trends and implications 

A “Code of conduct for education and training of persons working with laboratory animals” 
of the European Convention ETS 123 was adopted by the Multilateral Consultation in 1993. 
Four categories of persons are defined who must have had appropriate education and training:  

Category A:  Persons taking care of animals 

Category B:  Persons carrying out procedures  

Category C:  Persons responsible for directing or designing procedures 

Category D:  Laboratory animal science specialists  

33 

34 
35 

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. 
Prognos report 2007, p. 27. 
Prognos report 2007, p. 27. 

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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  these  persons  to  follow  these  guidelines  in  their 
courses;  and  to  encourage  those  responsible  for  education  and  training  to  establish 
programmes  to  allow  the  fulfilment  of  the  requirements  of  the  Convention  for  all  persons 
working with experimental animals. 

Problem dimension 

The current Directive  does  not  specify the necessary competence  of the personnel, nor how 
competence  can  be  kept  up-to-date  and  is  demonstrated.  Staff  qualifications  determine  to  a 
great extent the costs of institutes and laboratories. 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  the  requirements  for  the  personnel  also  make  it 
difficult  to  participate  in  projects  in  another  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  effect  on  the  scientific 
outcomes and their reliability. Qualified and well-trained personnel are therefore essential for 
good animal welfare, good science, and the human dimension of use 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 and 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 unnecessary 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 possibly contributing to a reduction of duplication 
in  this  area  are  Mutual  Recognition  Agreements  between  exporting  countries  and  the 
European Community. However these instruments only cover specific issues and are thus not 
able to abolish the requirement to test all products coming from that exporting country. For 
imported  vaccines  there  is  an  option  for  Member  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, administrative procedures in authorisation and inspection 
arrangements  in  the  Member  States,  it  cannot  be  excluded,  that  duplication  of  testing  may 

36 

37 

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. 
Prognos report 2007, p. 29. 

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occur.  The  external  study  has  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 scientific procedures using  animals on the same 
substance  in  applied  research  (e.g.  due  to  early  patent  protection  of  active  ingredients  in 
pharmaceuticals). A similar disincentive to duplicate exists in basic 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  Europe  to  ensure  an  effective  exchange  of 
relevant information and data regarding animal use in scientific procedures. Authorisation and 
inspection bodies as well as researchers do not have the necessary overview of objectives and 
results of all scientific procedures 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, negative experimental results 
(although equally valuable), are often not reported.  

XI. Use of CO2 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  CO2  is  recommended  for  killing  many 
common species of animals used in scientific procedures. 

Trends and implications  

CO2  is  one  of  the  most  commonly  used  methods  of  euthanasia.  It  is  the  most  convenient 
method for euthanasia of large numbers of rodents (quicker and less resource-intensive than 
alternatives). If used in optimal conditions, CO2 may also be less stressful than manipulations 
required for injections or physical methods.  

Establishments do not use a single method of euthanasia but rather a combination of several 
methods according to the type of project or the 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 disease) at the end of a toxicology study, the animal may be 
anesthetized with a suitable method, and then exsanguinated. If there is no necropsy, CO2 is 
used (on conscious animals), or pentobarbital over-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  gives  any  guidance  as  to  the  most  appropriate 
methods of killing per type of species. Applying CO2 is a relatively cost effective way to kill 
certain  species  of  animals  whilst  alternative  gases  are  more  expensive  and  pose  different 

38 
39 

Prognos report 2007, p. 29. 
See  Close  et  al.  1996:  Recommendations  for  the  Euthanasia  of  experimental  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. 

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24 

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requirements  for  their  use.  If  some  Member  States  are  banning  CO2  as  a  method  for 
euthanasia  on  welfare  grounds  for  some  or  all  species  while  other  Member  States  do  not, 
different  cost  structures  for  breeders  and  users  occur  across  the  community.  This  puts 
establishments  in  high  standard  countries  in  a  different  cost  environment,  distorting  the 
internal market. 

In terms of animal welfare, recent research shows that CO2 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 available on the aversiveness of alternative gases. The 
EFSA  opinion  recommended  using  CO2  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 evaluation for types of products/endpoints 

–  animals used for studies of diseases 

–  animals used in production and quality control 

–  origin  of  regulatory  requirements  for  animals  used  in  toxicological  and  other  safety 

evaluations 

–  animals used in toxicity test for toxicological and other safety evaluations 

–  type of toxicity test carried out for toxicological 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 
reporting41.  

Trends and implications  

The  current  situation  with  statistical  reporting  in  Europe  is  characterised  by  an  increasing 
quality  of  data.  Since  1991,  the  Commission  has  published  statistical  reports  on  the  use  of 
animals  in  experiments  in  the  European  Community.  The  format  for  reporting  data  was 
harmonised in 1997 at European Community level. Based on this reporting system, both the 

40 
41 

http://ec.europa.eu/environment/chemicals/lab_animals/scientific_en.htm 
Prognos report 2007, p. 31. 

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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  data,  the  basis  for  the  data  requirements 
should be uniform and enforceable. However, the current basis is only secured by a voluntary 
agreement  and  thus  not  legally  enforceable.  Furthermore,  the  analysis  of  the  statistical  data 
currently available shows that there are central fields of political and public interest which are 
not yet covered by the existing statistical reporting  system. The use of genetically  modified 
animals,  which  are  increasingly  used  in  scientific  procedures  are  not  specifically  reported 
through  the  existing  system,  neither  are  animals  killed  for  their  organs  and  tissues.  The 
severity classes to which animals have been subjected are not identified either. 

Finally,  the  current  statistical  reporting  system  only  focuses  on  overall  numbers  of  animals 
used  for  experimental  and  other  scientific  purposes  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  identification  of  trends  and  impacts  of  policy  changes 
difficult and hinders good policy making. 

XIII. Promotion of alternative test methods 

Current situation in Member States 

Directive  86/609/EEC  in  its  Article  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 purpose, 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 validation 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  criteria,  not  only  in  EU  but  also  internationally 
(ICCVAM, OECD). Today, the validation process is well established and increasing numbers 
of candidate methods are being proposed for validation.  

ECVAM is currently addressing the potential validation of a significant number of methods 
that  are  a  result  of  a  number  of  research  projects  under  the  Community  Framework 
Programme  for  Research.  Not  all  test  methods  may  successfully  pass  pre-validation  and 

42 

43 
44 

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). 
Information by ECVAM. 
SEC(91) 1794, Communication of the European Commission to Council and the European Parliament. 

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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. Suitable methods need to be available 
to cover the requirements of the Cosmetics Directive. REACH and new developments in the 
medical area may spark even a further increase.  

Problem dimension 

Even though the ECVAM structure and working methods 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-laboratory  validation 
to  ensure  reproducibility  and 
transferability). 

in  order 

2. Time delay is an additional bottle-neck to the process on ECVAM co-ordinated validation 
studies. Due to the requirements for transparency, the administrative procedures to launch a 
validation study take an average one year delaying the process significantly. 

3. Participating laboratories often 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 right 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  provisions  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 animals annexed to the EC Treaty requires the 
European  Community  and  the  Member  States  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 fall 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 first place, as has been shown in detail above. 

45 

Information by ZEBET. 

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4. 

POLICY OBJECTIVES 

The overall, general and specific 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  establishments  performing  scientific  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 approaches and improve conditions for innovation 

Secondary  objective:  In  line  with  the  Animal  Welfare  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  projects  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 foetal and embryonic forms, animals used in basic 
research, those bred for tissue). 

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These  objectives  are  in  line  with  the  Lisbon  Strategy  calling  for  the  internal  market  to  be 
further  harmonised,  the  regulatory  environment  simplified  and  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  validation  of  alternative 
testing methods should be reinforced.  

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5. 

POLICY OPTIONS  

a) Four basic options 

In the course of the discussions with experts and stakeholders, four basic policy-options have 
been developed: 

1.) No Policy-Change: 

One  option  could  be  to  keep  the  current  situation  unchanged.  This  would  mean  that  the 
existing  Directive  86/609/EEC  would  not  be  revised  and  that  the  given  standard  of 
community legislation and national implementation would be continued.  

The  problem  descriptions  in  section  3  have  presented  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 viable option. The Directive also needs to 
be adapted to scientific progress and new animal techniques 20 years after its inception, and 
the opportunity should be used to review its effectiveness 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  the  current  Directive  is  not  very  ambitious  and  has  many 
loopholes,  there  is  little  that  the  Commission  could  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  discarded  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 represents the status quo/business as usual scenario where the problems 
mentioned above are not adequately addressed.  

- Secondly, there are no suitable European or even national organisations 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  welfare  standards  of  experimental  animals 
actually  exists  (AAALAC), to a large  extent it just reinforces existing national or European 
legislation  and  can  therefore  not  serve  as  a  substitute  but  only  as  an  add-on  to  legislation. 
Currently only 29 out of an estimated 1,300 breeder, supplier and user establishments in the 
European  Community  are  accredited  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. 

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- Thirdly, using ethical evaluation as an example that clearly demonstrate how some existing 
national legislations go much further than others, creating an uneven playing field especially 
in terms of administrative delays and resource requirements. Such 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 with voluntary agreements has not always been 
very good, as can for example be seen when examining the voluntary agreement of European 
car  producers  to  reduce  their  CO2  emissions  which  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  Commission  may  not  be  very  credible.  The  main 
problem industry fears concerning voluntary agreements are free-riders whose market access 
may  be  difficult  to  control  without  state  action.  A  recent  call  for  legislation  instead  of 
voluntary  agreements  in  the  energy  efficiency  area  was  issued  by  the  white  goods  industry 
association Ceced47.  

3.) Deregulation: 

In  theory,  the  existing  Directive  could  be  repelled  and  the  regulatory  competence  fully 
transferred to the Member States, with the European Community level remaining to provide 
only  recommendations  and  playing  an  active  part  in  exchanging  information  on  good 
practices and alternative methods.  

This option of deregulation was not pursued further because all Member States have existing 
national  legislation  that  implements  the  original  Directive.  Most  Member  States  exceed  the 
requirements  of  the  Directive.  Also,  deregulation  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  the  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  current  Directive  is  necessary.  Finally,  deregulation  is  clearly  not 
advisable  in  view  of  the  international  commitments  (Council  of  Europe)  of  the  European 
Community. The question therefore is not whether 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  considerably  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 could 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  relevant  policy  dimensions,  such  as  scope, 
education and training, authorisation or housing and care, the absence of a level playing field 
leads to unfair competition and distortion of internal market for companies, research institutes 

47 

See ENDS Europe Daily, 22 March 2007. 

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31 

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and  universities.  Good  practice  examples  of  selected  Member  States  could  be  used  as  a 
starting  point  to  develop  a  higher  level  of  legal  and  procedural  convergence  throughout 
Europe.  

This option is also justified by the fact that both the scientific context and the policy-problems 
have significantly changed since 1986. Although, for instance, the level of animal protection 
in  Europe  has  increased  in  recent  years,  the  statistics  are  showing  an  increase  of  the  total 
number of animals used per year in most Member States. 

b) Choice of legal instrument 

Based on the reflections about the four basic options, the fourth basic option (reinforcement of 
the EC legislation) was developed further. In this 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 simplifying 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  developed  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 develop a good system suitable for their national or 
regional  administrative  system  as  long  as  certain  minimum  standards  are  set  at  European 
level. Moreover, the Protocol on Animal Welfare annexed to the EC Treaty foresees explicitly 
that "the legislative or administrative provisions and customs of the Member States relating in 
particular  to  religious  rites,  cultural  traditions  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  considers  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  States  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 the 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 cover animals used in basic research 

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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  euthanasia  if  it  is  performed  by  competent 
person using a method appropriate to the species) 

Option  3:  Extend  the  scope  to  cover  selected  invertebrates  species  (Cyclostomes, 
Cephalopods and Decapod crustaceans) 

Option 4: Extend the scope to cover foetal and embryonic forms from the last third of 
gestation until birth 

Option 5: Extend the scope to cover animals used in education and training 

II. Authorisation of projects 

In  view  of  the  large  differences  in  authorisation  practices  in  Europe,  a  level  playing-field 
should be established to guarantee comparable minimum requirements for the authorisation of 
projects while ensuring a smooth processing of applications to safeguard the competitiveness 
of  Europe  as  a  research  place  in  line  with  the  Lisbon  Strategy.  The  introduction  of 
compulsory  authorisation  for  individual  projects  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 individual projects with compliance check 

Option 2: Authorisation of a group 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 element of authorisation requirements in order to harmonise the 
internal market and ensure minimum standards of animal welfare.  

(1) An important option for the revision of the Directive could be to make ethical evaluation 
of  projects  mandatory.  The  revised  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  framework  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-stages of animals with justification 

•  Demonstration of lack of alternative methods 

•  Demonstration of competence of persons involved in the project 

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•  Use of anaesthesia, analgesia and other pain relieving methods 

•  Reduction, avoidance and alleviation of any other 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  categorising  the  procedures  by  the 
level  of  physical  pain,  physiological  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 beneficial to give practical guidance for this 
severity assessment.  

(iii) Harm-benefit analysis at a project level aims 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-ordination 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 implementation of ethical review requirements, 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 national 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. 

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34 

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Option  1:  Introduction  of  a  national  animal  welfare  and  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  incorporate  elements  of  the  Council  of  Europe’s  revised 
Appendix  A  to  Convention  ETS  123  as  compulsory  minimum  standards  with  appropriate 
transitional  periods  for  implementation.  This  would  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 knowledge 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 incorporate minimum requirements on transparency and 
public  accountability  by  requiring  non-confidential  information  on  ethical  evaluations  and 
project authorisation decisions to be made publicly available. 

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

VII. Non-human Primates (NHPs) 

The revised Directive could 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 biodiversity. The use of Great Apes could be highly restricted.  

Option 1: 

Shift to only use of F2 and subsequent generations of purpose bred NHP 

Option 2: 

Ban of the use of Great Apes with very limited exceptions 

VIII. Inspections 

The  revision  of  the  Directive  could  harmonise  the  minimum  requirements  for  annual 
inspections at the level of two, one of which could be unannounced, to reduce 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 

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VIX. Education and training 

The  revised  Directive  could  incorporate  some  minimum  training  requirements  for  the 
different  categories  of  personnel  and  set  requirements  for  demonstrating  and  maintaining 
competence  over  time,  to  reduce  different  cost  environments  that  establishments  find  in 
different Member States. 

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

X. Avoiding unnecessary duplication 

A  significant  reduction  of  duplication  in  regulatory  testing  would  require  changes  in 
numerous  legislative  requirements  at  Member  State  level.  This  policy  approach,  however, 
cannot  be  addressed  by  a  revision  of  the  given  horizontal  Directive.  However,  compulsory 
authorisation and ethical evaluation of projects would partly address this problem.  

In view of this situation, the general approach of a revised Directive regarding the reduction 
of  unnecessary  duplication  could  be  setting-up  a  centralised  European  Community-wide 
database collecting information on project authorisation and scientific results in each Member 
State. 

The database could also provide a discussion platform where scientists and inspectors could 
exchange their experiences, problems and good practices. As far as possible, information on 
practices  in  third  countries  could  also  be  collected.  This  could  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 CO2 for euthanasia 

The revised Directive could incorporate a list of humane methods 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 not yet banned. Within such a common list of 
methods, the use of CO2 could be prohibited unless the animal is rendered unconscious prior 
to its exposure to the CO2. 

Option 1: Prohibition to use CO2 unless the animals are first rendered unconscious by 
exposure to anaesthetic gases such as halothane  

XII. Statistical Reporting 

The revised Directive could increase 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  and  of  certain  invertebrate  species  and  foetal 
and embryonic forms (excluding larvae) from the last third of development 

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36 

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- 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 procedures to which animals have been subjected 

XIII. Promotion of alternative test methods 

The revised Directive could foresee that every Member State designates a national reference 
laboratory  to  contribute  to  the  validation  of  alternative  methods.  These  laboratories  could 
specialise  in  a  specific  area  of  expertise  (e.g.  development  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. 

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37 

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6. 

ANALYSIS OF IMPACTS  

a) Methodology and structure of this chapter 

to 

the 

The  impacts  have  been  assessed  across  all  13  policy  dimensions  with  benefits  assessed 
according 
(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. 

four  problem  dimensions 

The basic benefit and cost model is based on the methodology of the external study, normally 
assessing  the  impacts  against  existing  Member  State  legislation.  The  relative  strength  of  an 
impact  is  qualified  as  "slight",  "moderate"  and  "high"  according  to  the  feedback  from 
stakeholders. It is clear that these qualifications 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, two 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  were  made  in  line  with  the  European  animal 
use statistics and the external study49: 

- 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 animals in EU-25 per year: about 12.2 million 

- Number of personnel working with animal 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 project in EU-25: 300.000 € over three years 

It  will  be  indicated  if  an  option  has  been  discarded  or  revised  in  the  light  of  the  impact 
assessment or comments received in the expert internet consultation. 

It  should  be  noted  that  potential  environmental  impacts  of  the  revision  (e.g.  resulting  from 
upgraded housing or waste after animal testing) turned out to be negligible. A serious aspect 
that  was  scrutinised  was  the  assertion  by  some  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 species used in large numbers for 
research. Research plays an insignificant role for biodiversity in comparison to the destruction 
of habitats, e.g. of tropical forests, that should be urgently addressed via conservation policies.  

49 

Prognos report 2007, Chapter 7. 

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38 

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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 regulatory 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 competitive level playing field in this respect. 

Option 1: Extend the scope to cover 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  universities  in  high  standard  countries  which  already  had  to  comply 
with strict obligations while their 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  research  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 basic research in the EU-25 in the year 2005) 
in the five Member States not currently covering basic research. Two thirds of the respondents 
to the internet consultation supported this general assessment. 

The extension would have a moderate positive impact on animal welfare and a strong positive 
impact  on  the  control  of  the  use  of  these  animals.  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 evaluation. Costs for public authorities in these 
five Member States would increase slightly between 80.000 € and 160.000 € per year. 

It should be noted that the impacts identified for this particular option are already covered in 
sections  II  to  XII  within  the  aggregate  figures50.  However,  for  transparency  reasons  and  to 
enable  a  targeted  impact  analysis,  these  figures  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 that 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 that one must carefully distinguish 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 statistics on animal use in 2002 or 2005. The EU statistics 
already  include  the  number  of  animals  used  for  basic  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, selected invertebrates and foetal forms because their number is not yet 
included in the EU statistics and therefore, impacts from an extension of the scope to cover them are not 
yet included in sections II to XII. 

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39 

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Option 2: Extend the scope to cover animals bred for the primary purpose of their tissue 
and organs to be used in experiments or other scientific purposes with an exemption for 
authorisation  if  euthanasia  is  performed  by  a  competent  person  using  a  method 
appropriate to the species 

This option would approximate the legislative provisions of the Member States because some 
currently cover these animals in their legislation 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 bred for the primary purpose of their tissue and 
organs  would  significantly  improve  the  welfare  of  about  1.8  million  animals  in  the  EU-25, 
due  to  better  breeding,  housing,  care  and  euthanasia.  While  the  preliminary  finding  of  a 
“significant” improvement of animal welfare was 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  would  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  scientific  reliability  of  in  vitro  test  results  depends  on  high-
quality tissues that can better be ensured by a strictly controlled environment.  

Option  3:  Extend  the  scope  to  cover  selected  invertebrates  species  (Cyclostomes, 
Cephalopods and Decapod crustaceans) 

This option would have a small but positive impact on the harmonisation of Member States' 
rules and regulations and therefore benefit the internal market.  

The  extension  of  the  scope  to  cover  selected  invertebrates  species  as  recommended  by 
EFSA51 would improve the welfare of the animals involved. The preliminary assumption of a 
significant increase in animal welfare was not supported by one third of the respondents in the 
expert internet consultation, but a general improvement was not contested. The costs to public 
authorities  and  additional  administrative  burden  for  user  establishments  are  estimated  to  be 
moderate, due to their low share in total project costs, but cannot be quantified.  

The  question  whether  the  inclusion  of  selected  invertebrates  into  the  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  for  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 within a class of invertebrates 
because that could shift the demand to closely related species. This may be the reason why in 
the UK, not a single octopus vulgaris was used since this species was protected in 1995 but 
why other cephalopods continue to be used in neurological research.  

51 

See http://ec.europa.eu/environment/chemicals/lab_animals/scientific_en.htm 

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40 

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Discarded option: 

The  suggestion  to  include  all  invertebrate  species  into  the  scope  of  the  Directive  was 
discarded  at  a  very  early  stage  because  the  potential  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 forms 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  agree  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 would be low with an 
estimated total increase by about 846.000 € per year.  

It  is  expected  that  the  costs  from  extending  the  scope  of  the  Directive  to  non-mammalian 
foetal  and  embryonic  forms  in  the  last  third  of  development  will  be  negligible.  While  the 
vaccines industry is using large amounts of chicken embryos, these do not normally reach the 
threshold  of  the  last  third  of  development  before  the  scientific  procedure  is  carried  out.  It 
should also be noted that some Member States (e.g. the United Kingdom) protect foetal and 
embryonic  forms  from  half-way  through  development.  The  more  conservative  approach 
foreseen in the proposal for the revised Directive 86/609/EEC should therefore not disturb the 
research and production of vaccines. 

Option 5: Extend the scope to cover animals used in education and training 

This option would put institutions of higher education like universities which are increasingly 
competing  for  EU  research  money  onto  a  level  playing  field  and  contribute  both  to  the 
internal market and the European Research Area. 

It would also moderately improve the welfare of the about 200.000 animals annually used for 
education  and  training  in  the  EU-25.  Around  60%  of  the  respondents  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 year55. 
These low figures are based on the assumption that only 158 additional projects would come 
under the scope and that average costs per project in education and training are lower than for 
standard projects.  

52 
53 
54 
55 

See http://ec.europa.eu/environment/chemicals/lab_animals/scientific_en.htm 
Prognos report 2007, p. 97 and 101. 
Prognos report 2007, p. 103 and 106. 
Prognos report 2007 p. 107. 

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41 

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It should be noted that the impacts identified for this particular option are already covered in 
sections  II  to  XII  within  the  aggregate  figures56.  However,  for  transparency  reasons  and  to 
enable  a  targeted  impact  analysis,  these  figures  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 harmonisation of the authorisation procedures covered 
by the Directive. The aim is to introduce comparable minimum requirements for authorisation 
and thereby to establish a level playing-field in Europe.  

Option 1: Authorisation of individual projects with compliance check 

This option has a high potential to contribute to a level playing field in Europe because many 
of  the  time  and  cost  factors  affecting  user  establishments  relate  to  differing  authorisation 
systems  across  Member  States  and  the  internal  market  is  further  distorted  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  authorisation  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  legal  requirements  are  met  by  the  applicants.  No 
increase in project delays is to be expected if the authorisation procedure is implemented in an 
efficient  way  and  if  the  objectives  are  harmonised  throughout  the  Member  States.  Around 
60% of the experts consulted supported this preliminary assumption. 

The  implementation  of  project  authorisation  in  the  four  countries  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 authorities of Member States are estimated to be increased by about 
450.000 Euro. It is important to note that 23 Mio €  attributed to the authorisation 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 that 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 that one must carefully distinguish 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 statistics on animal use in 2002 or 2005. The EU statistics 
already  include  the  number  of  animals  used  for  basic  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, selected invertebrates and foetal forms because their number is not yet 
included in the EU statistics and therefore, impacts from an extension of the scope to cover them are not 
yet included in sections II to XII. 

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project  consisting  of  only  "up  to  mild"  procedures  and  not  involving  the  use  of  non-human 
primates.  

It should also be noted that in the current authorisation systems some duplication of activities 
may occur which creates avoidable costs that could be saved if the systems were restructured 
along the lines of best practice.  

Any authorisation fees that may be passed on from 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 user establishments induced by the requirement to 
prepare an application for authorisation.  

Option 2: Authorisation of a group of projects for regulatory testing  

As some Member States have already some sort of group authorisation or "thematic licensing" 
in place, this option could harmonise the requirements to the benefit of all user establishments 
across the Community and improve their competitiveness. 

Authorisation of groups of projects for regulatory testing would reduce the average costs of 
this  type  of  projects  at  the  establishment  level,  due  to  economies  of  scale.  Positive  impacts 
would  also  occur  for  authorisation  bodies  of  the  Member  States,  due  to  more  flexible  and 
efficient handling of the administrative procedures. Around 60% of the experts supported this 
analysis, around 15% did not agree. 

Total costs of project authorisation for user establishments and public authorities 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 per establishment  would  be reduced to five per 
year.  This  compares  favourably  to  the  normal  scenario  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  requirements  for  ethical  evaluation  as  part  of  the 
authorisation  of  projects.  Retrospective  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 question of whether all researchers and companies in Europe have a 
similar chance to get their animal projects approved or not, while the current situation leads to 
different access to using animals across the European Community. 

The introduction of a compulsory ethical evaluation of projects would have positive impacts 
due to its high potential to improve both animal welfare (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  innovate  according  to  the  concept  of  the  Three  Rs. 
Almost  two  thirds  of  the  respondents  supported  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 

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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  substantial  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  which  do  not  yet  have  fully  implemented  ethical 
evaluation systems. This would concern 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 should 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 administrative 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 consequence, 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  system  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 prior to the research, retrospective assessment 
would  be  done  after  the  research  has  been  finalised,  to  evaluate  the  results  and  compare  it 
with the predicted harm and benefits. Retrospective assessment gives the opportunity to learn 
from  the  past  in  order  to  improve  future  research  projects  and  may  provide  more  accurate 
information.  It  also  has  the  potential  to  verify  in  the  long  term  which  types  of  animal  tests 
have  really  been  useful  for  the  progress  of  science  and  which  have  been  rather  unreliable. 
This can help to increase animal welfare slightly60 in the short-term but also drive innovation 
to areas where animal tests could be relatively 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 increase in costs in the short and medium term 

57 
58 

59 
60 

Prognos report 2007, p. 164. 
No  reliable  quantitative  data  exist  about  the  percentage  of  studies  that  are  performed  but  are  useless 
because of a bad experimental design. 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  Nature,  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 number RM04/JH18/IR), available at 
www.pcpoh.bham.ac.uk/publichealth/nccrm/publications.htm. Hence, 3% is a conservative estimate.  
Prognos report 2007, p. 164. 
Prognos report 2007, p. 175/176. 

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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  respondents  supported  this 
general assessment. 

Introduction of retrospective assessment for all projects would lead to an increase 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 Directive 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 primates). Retrospective assessment 
can be expected to be most beneficial 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 ensure 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 has 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  and  ethics  committee  with  a 
minimum harmonised remit 

The  introduction  of  a  national  animal  welfare  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  guidelines  are  set  for  all  establishment-based  ethical 
review strategies. This facilitates compliance across the Community 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 body 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. 

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The  introduction  of  a  compulsory  ethical  review  body  at  establishment  level  has  a  high 
potential of increasing the level of animal welfare and has the potential to be beneficial to the 
debate  about  ethical  aspects  within  and  maybe  even  between  different  establishments  (if 
provisions are made for the exchange of information 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  positive  impacts  on  the  work  satisfaction  of  personnel 
due  to  a  more  constructive  and  animal  friendly  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 animals used for experimental 
and other scientific  purposes (ETS  123) to become  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  guidelines  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 different environment of requirements for physical 
investments,  depending  on  their  location.  It  would  prevent  further  fragmentation  of  the 
internal market in the near future which would otherwise be highly likely 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 mental 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 benefits in all Member States would be in the 
range of 90 million €. 

62 

63 

Stafleu,  F.R  and  J.  Vorstenbosch:  Animal  Welfare  Committees  in  the  European  Research  Area,  EC 
2005, p. 79. 
Prognos report 2007, p. 200. 

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Many  of  the  general  provisions  and  recommendations  of  the  revised  guidelines  for  health, 
transport,  quarantine,  acclimatisation,  isolation,  watering,  feeding,  cleaning,  records  and 
identification are already in place in many establishments, as these are integral parts of good 
scientific/laboratory  practice  to  obtain  reliable  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, nesting material and for some species elevated 
platforms) and the mandatory group housing and socialising of animals. 

Based  on  data  from  university  facilities  run  under  full-cost  recovery  schemes,  the  external 
study has estimated that yearly costs will increase by about 37 million €. This figure includes 
additional  cage  costs  depreciated  over  5  years  as  well  as  additional  care  costs  and  is 
equivalent  to  about  6%  of  project  costs  (about  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 their facilities to the new standards.  

Revised option: 

In the light of the arguments and data presented above and supported by many experts in the 
internet  consultation,  the  Commission  proposal  for  revising  Directive  86/609/EEC  foresees 
staggered transitional periods, dependent 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 large breeding establishments indicated that they 
would  most  probably  require  up  to  10  years  from  now  because  they  normally  use  close  to 
100% of their facilities (need to plan, obtain permits 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 scientific purposes. However, increased openness in 
this  area  must  be  balanced  against  concerns  about  intellectual  property  rights  and  safety  of 
personnel and property.  

Option  1:  Relevant,  non-confidential  information  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  considered,  direct  and  indirect  costs  for  user 
establishments  and  authorities  should  be  low.  While  around  44%  of  the  respondents  of  the 
expert consultation supported this analysis, about one third questioned the effectiveness and 
feasibility of this option. Some stakeholders pointed 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  summaries  of  projects  produced  by  the  applicant  for  project 
authorisation. 

64 

Prognos report 2007, p. 205. 

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Revised option: 

In the light of the arguments presented above and supported by several experts in the internet 
consultation, the Commission proposal for revising Directive 86/609/EEC foresees a system 
based on the publication of non-technical summaries of projects produced by the applicant for 
project authorisation.  

Making  such  non-technical  summaries  publicly  available  would  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  carried  out  and  how  it  is 
justified. Personal safety issues and intellectual property rights would be adequately addressed 
as the author of the summary would be the animal user. 

Direct and indirect costs for user establishments and authorities would be low. The external 
study has calculated that the annual costs for the 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  breeding,  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  other  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 current practice in the EU-25 where for many species, 
first-generation captive-bred animals (F1) are often used and the breeding stock is constantly 
renewed by catching new animals from the wild.  

This assessment takes place against a serious debate about whether 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  nevertheless  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 subsequent 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.  For  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  breeding  centres  in  the  European 

65 

Prognos report 2007 p. 215. 

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Community  and  elsewhere  have  successfully  started  to  breed  very  small  numbers  of  F2+ 
macaques.  

For some other species such as marmosets no transitional period would be needed since they 
have  been  breeding  well  in  captivity  in  the  European  Community  for  several  years  or  even 
decades.  

Animal welfare impacts  

On  the  one  hand,  high  animal  welfare  impacts  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  mortality during capture and 
transport, distress due to change of environment 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  would  happen  to  the  about  800  male  surplus  whose 
female counterparts are used for replenishing the breeding stock.  

It is also not clear what would happen to the 1300 animals currently caught in the wild and 
used for breeding F1 animals for the European market. In some countries of origin, they are 
considered as imported pests which tend to destroy 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 breeders would in the short run easily be able to 
sell the same amount of F1 animals to countries 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 experimental animal welfare in the context of the 
OIE (World Organisation for Animal Health), prospects for an international 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 notice, the impacts on science and 
competitiveness would be highly negative.  

Even with a suitable transitional period, a requirement 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  costs  from  maintaining  a  significantly  larger 
breeding colony.  

The  move  to  F2  animals  via  a  transitional  period  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. 

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the  European  Community  to  other  countries.  Both  the  United  States  and  China  have  been 
mentioned in this respect.  

Revised option  

In  the  light  of  the  arguments  presented  above  and  supported  by  experts  in  the  internet 
consultation, the Commission proposal for revising Directive 86/609/EEC foresees a system 
differentiating  between  different  types  of  species,  in  line  with  their  reproductive  behaviour 
and patterns of use: 

•  For marmosets, no transitional period is necessary. 

•  For  macaques,  a  reasonable  transitional  period  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  possible  new  information  about  the  supply,  demand  and  welfare 
implications for lesser used species. For rarely used NHP species, an F2+ requirement may 
turn  out  not  to  benefit  animal  welfare  at  all,  as  this  might  require  setting  up  breeding 
colonies  for  these  species  where  none  exist  today.  Surplus  may  easily  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. However, 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 perform scientific procedures with Great Apes may 
be the development of treatments for new devastating diseases that might occur in the future. 

Discarded option: 

Some  stakeholders  have  suggested  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 need for such research in Europe.  

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-  Secondly,  one  limited  but  well  equipped  centralised  facility  at  global  level  would  be 
sufficient  for  this  purpose,  but  several  third  countries  including  the  United  States  already 
maintain such facilities, so there is currently no need to establish an additional one in Europe.  

- Thirdly it should be noted that the costs would 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  housing  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 ensuring compliance with legislation and minimum 
standards.  A  harmonisation  of  the  requirements  for  inspections  could  help  to  create  a  level 
playing field in the European Community.  

Option 1: Minimum of two inspections per year by competent authorities of which one 
unannounced 

The proposed  system of  inspections would have positive impacts for animal welfare, public 
perception  and transparency. The costs for Member States would  increase  moderately when 
intensifying the level of inspections. Nearly half of the respondents in the expert consultation 
supported this analysis, whereas 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  about  3.1  million  €.  If  all  Member  States  had  a 
fully decentralised inspections system, costs would be lower due to reduced 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 consultation, the Commission proposal to revise 
Directive 86/609/EEC includes a minimum of two inspections and a reference 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 with decentralised or 
local systems this information currently does not get passed on from the inspector. 

Option 2: European Community inspections 

European Community inspections could further contribute to ensuring a level playing filed for 
all breeder, supplier and user establishments in the European Community.  

However,  they  would  not  result  in  a  significant  increase  in  animal  welfare  unless 
disproportionately  high  resources  were  spent  to  render  these  inspections  effective  and 

67 

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sufficiently  frequent.  A  majority  of  around  65%  of  participants  in  the  internet  consultation 
supported this analysis, and only around 7% did not agree. 

A stand-alone Community inspection system to inspect 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  Community  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  European  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  three  years,  including  discussions  with  public 
officials  in  the  Member  States  and  a  selected  number  of  on-the-spot  checks  in  user 
establishments. 

The  Commission  proposal  for  the  revision  of  Directive  86/609/EEC  also  foresees  that 
Member States should set up programmes for joint inspections between national inspectors of 
one  country  and  senior  experts  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 essential for good animal welfare, good science and 
the  human  dimension  of  scientific  procedures  using  animals.  It  is  therefore  essential  to 
include  in  the  revised  Directive  the  key  elements  that  should  be  included  in  the  training 
requirements  for  obtaining  initial  and  maintaining  competence  over  the  entire  professional 
life, appropriate for the different categories of personnel.  

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

Harmonised  education  and  training  would  substantially  decrease  existing  obstacles  to 
horizontal mobility of researchers in the European Community. 

Appropriate education and training would also improve the implementation of the Three Rs 
and  ensure  respect  of  their  welfare  requirements  of  animals  before,  during  and  after 
procedures. Almost 80% of the respondents to the expert internet consultation supported this 
analysis, only about 1% disagreed. 

The welfare of 12.1 million animals concerned would increase significantly and would lead to 
a  higher  job  satisfaction  of  those  having  direct  contact  with  animals  on  a  daily  basis  as 
confirmed during the internet consultation. 

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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  results  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 Member States would be in the range of 90 million 
€. 

Total costs for a system of a mandatory refreshment 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  authorisation  are  employed  to 
reduce unnecessary duplication of testing. However, in vertical legislation such as REACH68, 
several tools are foreseen such as mandatory data sharing, requirements for the recognition of 
data  generated  elsewhere  and  mutual  acceptance  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 collecting information on project authorisation 
and  scientific  results  in  every  Member  State.  It  should  be  noted,  however,  that  not  all 
duplication  of  procedures  is  unnecessary,  one  may  even  argue  that  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 comprehensive 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 general database covering only a minor share of 
relevant information in an unsystematic way (regulatory 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 decrease 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 development costs (e.g. IUCLID70 database at around 2 million Euro). 

68 

69 
70 

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). 
Prognos report 2007, p. 277. 
International Unified ChemicaL Information Database. 

EN 

53 

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Discarded option: 

In  light  of  the  arguments  presented  above,  a  general  EU  database  would  not  substantially 
address  the  issue  of  unnecessary  duplication  of  animal  procedures,  if  any.  In  view  of  the 
significant costs of a database, this option has not been included in the Commission proposal 
for the revision of Directive 86/609/EEC. 

Revised option: 

However,  the  Commission  is  planning  to  prevent  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 international level to adopt mutual recognition agreements 

XI. Use of CO2 for euthanasia 

The revision of the Directive could incorporate a list of humane methods for euthanasia to be 
used for experimental animals. This would contribute 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 CO2 unless the animal is rendered unconscious prior to its 
use 

The  prohibition  to  use  CO2  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  CO2  with  regard  to  their 
aversiveness. 

Discarded option: 

Because  the  effect  on  animal  welfare  cannot  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 revise Directive 86/609/EEC.  

71 

Prognos report 2007, p. 284. 

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54 

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Revised option:  

An  alternative  option  that  can  be  implemented  relatively  cheaply  while  awaiting  further 
research results on available alternatives would be to prohibit exposing animals to pre-filled 
chambers of CO2 . This option will have no significant 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 available shows that there are central fields of political 
and public interest which are not yet covered by the existing statistical reporting system.  

Option  1:  Inclusion  of  genetically  altered  animals,  some  invertebrate  species  and 
embryonic and foetal forms (excluding larvae) in the statistical reporting 

Although  there  is  no  direct  impact  on  animal  welfare,  a  better  statistical  reporting  system 
would highly contribute to better informed policy-making both at European Community and 
national level. It would also increase transparency 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, although no change has occurred in reality. 

The  external  study  has  calculated  that  an  inclusion  of  genetically  altered  animals,  selected 
invertebrates and embryonic and foetal forms would provide more detailed 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 European 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 mammalian species would amount to 7.4 million € per 
year72.  

Option 2: Inclusion of animals killed for the primary purpose of their organs and tissue 
to be used in experiments 

Although  there  is  no  direct  impact  on  animal  welfare,  a  better  statistical  reporting  system 
would  moderately  contribute  to  better  informed  policy-making  both  at  Community  and 
national level. It would also increase transparency 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 

55 

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The external study has estimated that total costs 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 and types of establishments in the statistical 
reporting 

Inclusion  of  numbers  of  projects  and  types  of  establishments  would  provide  a  more 
comprehensive  picture  on  the  overall  number  and  structure  of  animal  experimentation  in 
Europe, thus contributing to a better monitoring 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 welfare, an improved statistical reporting system 
would lead to better informed policy-making both at European Community and national level. 
It would also increase transparency and thus provide better information for the general public 
and  in  this  case  provide  an  opportunity  to  improve  the  image  of  the  research  community. 
Almost 60% of the respondents to the expert consultation 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 alternative test methods 

Option 1: National Reference laboratories 

It  is  assumed  that  20  additional  Member  States  would  have  to  set  up  national  reference 
laboratories  and  each  one  would  participate  with  in  2-3  validation  studies  per  year.  In 
addition, they may contribute significantly to the development of alternative test approaches. 

Benefits 

There will be several layers of benefits: 

1. Time saving of almost two years seem possible for the validation 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 chemicals policy REACH, it has been estimated that a 
substantial amount of animal use under REACH could be reduced by alternative approaches, 
in particular regarding tests for reprotoxic properties76.  

73 
74 
75 

76 

Prognos report 2007, p. 292. 
Prognos report 2007, p. 306. 
Information  by  ZEBET 
Ergänzungsmethoden zum Tierversuch in Germany). 
Information by ECVAM (European Centre for the Validation of Alternative Methods). 

(Zentralstelle  zur  Erfassung  und  Bewertung  von  Ersatz-  und 

EN 

56 

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- As an example, based on the past experience, the following alternative methods, validated 
by ECVAM have had a positive impact: 

- Pyrogenicity: About 200.000 rabbits per year could be saved in Europe by the use of five 
blood  cell  methods  for  monitoring  side  effects  such  as  fever  reactions  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  existing  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 upgrade existing public laboratories 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 national reference laboratories should be equipped 
with material that allows them to apply standard techniques of molecular 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 costs for personnel or building costs. 

b) Ongoing costs 

Annual  costs  for  a  full  validation  study  (3  GLP  laboratories  over  3  years)  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 type of method under validation and whether additional animal 
tests  are  necessary  in  case  of  reduction/refinement  alternatives.  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 reference laboratory would offer 
training  seminars  for  hands-on  training  of  industry  and  other  experts  at  a  significantly  high 
price.  

Industry and public authorities (in future research 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 
78 
79 

See http://ecvam.jrc.it click 'news events and meetings' then 'press releases'. 
See ESAC Statement of 20-21 March 2006. 
Zentralstelle  zur  Erfassung  und  Bewertung  von  Ersatz-  und  Ergänzungsmethoden  zum  Tierversuch 
(ZEBET) in Germany; http://www.bfr.bund.de/cd/1433. 

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7. 

INTERNATIONAL SITUATION 

a) Third countries 

Even  though  the  revised  Directive  will  reinforce  the  international  leadership  role  of  the 
European Community in the area of animal welfare, it should be noted that a number of third 
countries have several of the options 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 protects 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-human  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 documents 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  well  aware  that  this  will  require  a  significant 
upgrading of its standards. The Chinese authorities seem very interested in cooperating with 
European authorities on how to improve its welfare standards and how to establish a reliable 
documentation and inspection system.  

India 

India protects all species (including all, not only selected, invertebrates) and requires approval 
of  projects  by  a  national  committee.  It  legislation  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  feeling  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 Norway applies to live mammals, birds, toads, 
frogs,  salamanders  (newts),  reptiles,  fish,  and  crustaceans  thus  including  also  some 
invertebrate species. 

EN 

58 

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Switzerland 

Switzerland  has  a  very  strict  animal  welfare  legislation,  which  was  last  amended  in  2001. 
There  is  a  specific  emphasis  on  education  and  training  requirements  as  well  as  on  both 
prospective and retrospective assessment of scientific projects using animals. 

United States 

The  US  system  is  largely  built  on  self-assessment  but  foresees  establishment-based 
“Institutional Care and Use Committees” (IUCACs). These are obligatory and should perform 
an ethical evaluation of projects 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  and  birds  are  not  protected  by  the  US  Animal 
Welfare  Act,  they  have  to  be  appropriately  cared  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 updated 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 summer 2007, as well as Switzerland and Norway. 

The Council of Europe has also adopted a number 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 Convention. However, several 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  experimental  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 

59 

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d) Outsourcing/European Community competitiveness 

The external study has established via its stakeholder questionnaire that scientific procedures 
using animals are sometimes outsourced from the 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  participated  in  the  internet  consultation  while 
about 25% did not agree.  

80 

Prognos report 2007, p. 18. 

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60 

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8. 

INTERACTION WITH OTHER EUROPEAN LEGISLATIVE ACTS 

Directive  86/609/EEC  is  a  horizontal  directive  providing  for  minimum  standards  when 
animals are needed in scientific procedures. The pieces of Community legislation referred to 
below are mainly sector related, whose focus is on gathering information, which sometimes 
needs to be fulfilled by performing tests on animals, to reduce risks for the safety and health 
of humans and the environment. It is therefore 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 that the regulatory use of animals as required by the legislation 
referred to below, covers only 22 % of the animal 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  fast  handling  of  authorisation  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  requirements.  This  will  not  only  reduce  the  processing 
times  but  also  the  resource  and  manpower  requirements  arising  from  the  authorisation. 
Secondly, the proposal includes a deadline for the authorities to deliver their decision within 
30 days (in exceptional cases within 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,  Authorisation  and  Restriction  of  Chemicals) 
Regulation  is  the  only  European  legislative  act  requiring  proposals  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  coordinated  in  a  way  that  they  reinforce  each  other's 
objectives without overlap.  

It is important to note that the objectives of these authorisations are very different. On the one 
hand the proposal for the revised Directive 86/609/EEC aims at ensuring full implementation 
of the Three Rs, the competence of the people involved and that the project is supported by 
harm-benefit analysis. On the other hand, for REACH, 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 streamline 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 

61 

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In  terms  of  practical  functioning  of  REACH  and  the  proposed  revised  Directive,  two  areas 
have been identified requiring closer attention:  

•  most  importantly,  the  time  delay  that  could  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 approval decisions under REACH: 

1. 

2. 

The  testing  plans  are  proposed  by  the  producer/importer  to  the  Agency  (in  which 
case there is no time limit to carry out the tests). The Agency has 180 days (and in 
case of phase-in substances between 2 and 4 years) to approve the tests to be carried 
out. The Agency also has to subject the testing plan to a 45 day public consultation 
period. 

As  the  authorisation  decision  under  this  Directive  is  taken  much  earlier,  within  30 
(max  60)  days,  additional  delays  will  not  result  from  the  implementation  of  this 
Directive. Moreover, the ethical evaluation under the proposed Directive may allow 
additional benefits to be gained by further facilitating the review by the Agency. 

REACH  foresees  that  the  Agency  may  impose  binding  decisions  on  testing 
requirements  for  substances  during  evaluation.  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 Directive 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 deadline 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  delays  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  regulatory  testing  (e.g.  for  cosmetics, 
pharmaceuticals, food and feed, pesticides, toys, etc.). The costs and benefits of revising the 
Directive  86/609/EEC  have  already  been  assessed  in  this  impact  assessment.  It  can  be 
assumed  that  significant  animal  welfare  benefits  will  occur  while  the  additional  costs  are 
acceptable.  

No significant coordination problems between horizontal and sectoral legislation are likely to 
occur because both the revised Directive and the sectoral legislation consists of Directives and 
allow  Member  States  to  find  suitable  arrangements  without  overlaps  in  national  legislation. 
None of the other sectoral legislation foresees a prior approval of animal tests at Community 
level, therefore no contradictory decisions at different levels can occur.  

EN 

62 

   EN 

 
c) GLP (Directives 2004/9/EC and 2004/10/EC) 

Good Laboratory Practice (GLP) is a quality assurance system based 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  animals.  It  can  also  significantly  reduce  the 
inspection  workload  of  competent  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 

63 

   EN 

 
9. 

COMPARING THE OPTIONS 

a) Overview table showing the benefits and costs per option81  

BENEFITS  

COSTS  

I  Scope 
– 
Option  1  – 
Basic 
research 

(quantified where possible) 

(monetarised where possible) 

Animal 
welfare  

++  

500.000 
animals 

Costs  for  public 
authorities  

-  

80,000 € 

Control  

+++ 

Costs  due 
authorisation  

to 

- -   4 million € 

Delays  due  to 
authorisation  

- - 

Costs  due 
ethical 
evaluation  

to 

- -   2.6  million 

€ 

Delays  due  to 
ethical 
evaluation  

of 

Cost 
experiments 
using  tissue  and 
organs 

Cost  to  public 
authorities 

- 

- 

- 

320,000 € 

I  Scope 
– 
Option  2  – 
Tissues 

Animal 
welfare  

+++ 

1.8  million 
animals 

Use 
alternatives  

of 

+ 

+++ 

Public 
accountability 
and 
transparency  

- 
I 
Scope 
Option  3 
- 
invertebrates 

Animal 
welfare  

++ 

Animals 
used 
1000 
scientific 

Costs  for  public 
authorities  

- 

in 

81 

Mainly based on Prognos report 2007, p. 305-312. 

EN 

64 

   EN 

 
 
 
 
 
 
 
 
 
 
 
 
 
                                                 
procedures  

Control  

++ 

Costs  for  user 
establishments  

-  - 
- 

I 
Scope 
Option  4 
foetal forms 

- 
- 

Animal 
welfare  

(++) 

175.000 
mammalian 
animals 
alone 

Costs  for  public 
authorities  

- 

12.6  million 
€ 

Control  

+++ 

Cost 
for  user 
establishments  

- 

845.000 € 

- 
I 
Scope 
Option  5 
- 
Education  & 
Training 

Animal 
welfare  

++ 

199.000 
animals 

Costs  for  public 
authorities  

Control  

+++ 

Cost 
for  user 
establishments  

- 

- 

35.000 € 

1.4  million 
€ 

BENEFITS  

COSTS  

(quantified where possible) 

(monetarised where possible) 

II 
Authorisation 
-  Option  1  – 
individual 

Animal welfare 

++  

Animal  welfare 
(additional) 

+++ 

950.000 
animals 

Control 
transparency  

and 

++ 

and 

Control 
transparency 
(additional) 

+ 

Competitiveness 
private sector 

+++ 

Competitiveness  ++ 

Costs  for  MS 
without  system 
of 
project 
authorisation  

Costs  for  MS 
with  system  of 
project 
authorisation 

for  user 

Cost 
establishments 
in  MS  without 
project autho 

for  user 

Cost 
establishments 
in  MS  without 
project author 

- - 

57,000 € 

+ 

11,500 € 

- 

11 million €

- 

12.6 million 
€ 

EN 

65 

   EN 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
public sector 

Accountability 
and 
transparency  

++ 

II 
Authorisation 
-  Option  2  – 
group 

Costs for users   +++ 

Public image 

- 

reduction 
of 
million € 

21.2 

Animal welfare  0 

Duplication  of 
testing 

0 

Competitiveness 
and SMEs  

++ 

Competitiveness 
and research 

++ 

Competitiveness 
of  industry  and 
innovation 

+++ 

Administrative 
costs for users 

++ 

Costs  for  public 
authorities 

++ 

1.9  million 
€ 
(reduction 
of  700,000 
€) 

EN 

66 

   EN 

 
 
 
 
 
 
 
 
 
 
 
 
BENEFITS  

COSTS  

(quantified where possible) 

(monetarised where possible) 

III 
Ethical 
Review  (A)  - 
Option 1 

Animal 
welfare 

+++ 

11.7 
million 
animals/ 
371,000 
animals 

Administrative 
costs 
enterprises 

to 

- -   9  million  € 
(7 million €) 

Transparency 

+++ 

Competitiveness  - - 

Costs  for  public 
authorities 

- -  

Delay 
projects 

of 

- 

+++ 

++ 

Reducing 
animal 
suffering 

Awareness and 
work 
satisfaction 
researchers 

Reduction  of 
animal 
numbers 

++ 

371,000 
animals 

Quality 
science  

of 

++ 

to  70 

up 
million € 

Level  playing 
field 

++ 

Innovations 

++ 

+ 

Societal 
impacts 
(ethical 
approach):  

III 
Ethical 
Review  (A)  - 
Option 2 

Transparency  

++ 

12.1 
million 
animals 

Cost 
establishments  

to 

- - 

20  million  € 
(revised 
option  

4 million €) 

Quality 
science 

of 

++ 

Costs 
national 

to 

- - 

EN 

67 

   EN 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
authorities  

Competitiveness  -  

 - 

 - 

Costs 
infrastructure  in 
relation 
to 
overall  research 
costs 

Costs 
infrastructure 
for 
States 

Member 

Costs 
establishments 

for 

- -  

+ 

+ 

+ 

Reduction  of 
animals 

Reduction  of 
animal 
suffering  

Duplication  of 
scientific 
procedures 
using animals  

IV 
Ethical 
Review  (B)  - 
Option 1 

Transparency 

++ 

12.1 
million 
animals  

Public 
accountability 
and objectivity 

 + 

IV 
Ethical 
Review  (B)  - 
Option 2 

Animal 
welfare 

level 

Increase 
ethical 
discuss./ 
awareness  

12.1 
million 
animals 

+++ 

++ 

Work 
satisfaction 

+ 

BENEFITS  

COSTS  

(quantified where possible) 

(monetarised where possible) 

V  Housing  & 
Care - Option 
1 – ETS 123 

Animal welfare   +++ 

12.1 
million 
animals 

- 

Upgrading  costs 
for 
establishments 
regarding 

EN 

68 

   EN 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
smaller animals  

Upgrading  costs 
for 
establishments 
regarding  larger 
animals  

-  - 
- 

of 

0 

Length 
transitional 
period  

Yearly  costs  for 
user 
establishments 

37 million € 

Science  

++ 

Societal 
concerns  

+ 

Level  playing 
field  

++ 

+++ 

Public 
accountability 
and 
concerns  

ethical 

VI 
Transparency 
- Option 1 

Public 
accountability 
and 
transparency  

++ 

Cost 
establishments  

to 

---  26 million € 
(revised 
option: 
520,000 €) 

Costs 
for 
Member States  

- 

of 

- 

Fear 
extremist 
activity  

Competitiveness   - 

Costs 
establishments 

for 

-- 

+ 

of 
and 

Image 
research 
animal 
experimentation  

Animal Welfare  +/- 

for 

+++ 
1,300 
animals,  

for 

-- 
12,000 
animals 

VII 
human 
primates 
Option 1 

Non-

-  

Public Concern  ++ 

Scientific need 

--- 

EN 

69 

   EN 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Biodiversity 

+/0 

Outsourcing/ 
Competitiveness 

-- 

Non-

VII 
human 
primates 
Option 2 

Animal Welfare  ++ 

Research 

Public Concern  ++ 

Central  Facility 
to  cope  with 
future demand 

- 

--- 

BENEFITS  

COSTS  

(quantified where possible) 

(monetarised where possible) 

VIII 
Inspections  - 
Option  1 
- 
national 

Animal welfare  ++ 

12.1 
million 
animals  

Impact 
for 
establishments  

- 

0.9  million 
€ 

Accountability 
and 
transparency 

+++ 

Costs 
for 
Member States  

-- 

3.1  million 
2.5 
/ 
€ 
million. € 

VIII 
Inspections  - 
Option 2 - EU 
inspections 

(Animal 
welfare) 

(Accountability 
and 
transparency) 

(++) 

12.1 
million 
animals 

Costs 
for 
establishments  

- 

(+++) 

Efficiency 

-- 

Costs to MS 

- 

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 
national 
to 

- 

EN 

70 

   EN 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
- Option 1 

animals 

authorities 

Additional costs 
to 
establishments  

-- 

38 million € 

Quality 
science 

of 

+++ 

Free movement 
of 
people/workers

+++ 

Job satisfaction 
of personnel 

+++ 

X Duplication 
- Option 1  

Animal welfare 
– 
basic 
research 

(+) 

slight 
positive 
effect 

Administrative 
burden 

-  - 
- 

Animal welfare 
– 
regulatory 
testing 

0 

Ethical 
concerns 
basic research 

– 

(+) 

0 

– 

Ethical 
concerns 
regulatory 
testing 

Cost reductions 
for  Member 
States 

+ 

Cost 
establishments 

to 

-  - 
- 

6.2  million 
€ 

Administrative 
costs 
Member States 

for 

- - 

173,000 € 

Resource 
requirements  at 
an EU-level 

-  - 
- 

€ 

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

EN 

71 

   EN 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
BENEFITS  

COSTS  

(quantified where possible) 

(monetarised where possible) 

XI  CO2 
Option 1 

- 

Animal 
welfare  

? 

Impacts 
to 
establishments  

-  - 
- 

46.2  million 
€ 

XII  Statistical 
Reporting 
- 
Option 1  

Monitoring 
and 
accountability 

public 

+++ 

Administrative 
burden 

- 

7.4 million €

Image 
research 
industry 

+ 

of 
and 

Policy making  ++ 

XII  Statistical 
Reporting 
- 
Option 2 

Monitoring 
and 
public 
accountability  

+++ 

Administrative 
burden to users  

- 

4 million € 

Image 
research 
industry  

+ 

of 
and 

Policy making   +++ 

XII  Statistical 
- 
Reporting 
Option 3 

Monitoring 
and 
making  

policy 

++ 

Transparency  

++ 

XII  Statistical 
Reporting 
- 
Option 4 

+++ 

Monitoring 
and 
making 
transparency  

policy 
/ 

Administrative 
burden 
to 
Member States  

- - 

Administrative 
burden to users  

-  

Administrative 
burden 
Member States 

to 

- - 

Administrative 
burden to users  

-- 

EN 

72 

   EN 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Public 
awareness  

+++ 

XIII 
Promotion  of 
alternative 
methods 
Option 1 

– 

+++ 

Animal 
welfare 
increase 
through 
Reduction 
in 
animal  use  or 
method 
refinement 

- - 

- - 

Administrative 
burden 
to 
Member States  

Administrative 
burden 
to 
Member  States 
(impact 
distribution)  

Costs 
Member States 

to 

- 

One-off 
costs 
million € 

4-5 

Promotion  of 
innovation 

+++ 

Costs 
industry 

Public 
awareness  

++ 

Efficiency  gains 
public 
for 
research budgets 

+ 

Annual 
costs 1,5 – 3 
million € 

to 

++  Some 

alternative 
tests  may 
allow 
cost 
savings 

Some 
alternative 
tests  may 
allow 
cost 
savings 

b) Analysis of the options 

ba) Options in the order of capacity to improve 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 area of regulatory testing 

-  Housing  and  Care  -  Minimum  housing  and  care  standards  along  the  lines  of  the  ETS  123 
Appendix 

- Inspections Option 1 – Two inspections per year of which at least one unannounced 

- Education and training Option 1 – Minimum standards 

EN 

73 

   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 capacity to enhance competitiveness 

Education and Training – Option 1 - Investment in top scientists, higher mobility 

Promotion of alternative methods – Option 1: Investment in research and innovation 

Authorisation - Option 1: Project authorisation within 30 days 

Authorisation - Option 2: Group authorisation saves money and time 

Ethical Evaluation - Option 1: Potential to save animal lives and costs 

Promotion of alternatives – Option 1: Potential to save current testing costs  

Transparency - Option 1: Summaries explain research to public 

Avoiding Duplication – Option 1: Database can save more than it costs 

It should be noted that all measures improving the internal market (see above under letter ba) 
also contribute to competitiveness. 

It  should  also  be  noted  that  a  consistent  approach  at  EU  level  will  allow  the  European 
Community to take credible initiatives at international level (e.g. in the context of the World 
organisation  for  Animal  Health  –  IOE)  to  move  towards  establishing  global  standards  for 
animal  welfare  which  would  not  only  improve  animal  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 authorisation: 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 

74 

   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: Not 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 € 

CO2 – 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 

75 

   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 through the lighter authorisation process for project 
consisting of only "up to mild" procedures and not involving the use of non-human primates. 
However, these have not been quantified. 

***  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.  However,  for  transparency  reasons,  these  figures  are  specified  in  this  section 
again in disaggregated form. Care needs to be taken however not to double-count the benefits 
and costs indicated here. 

c) Administrative costs 

The Commission Impact Assessment Guidelines contain an Administrative Cost Model which 
recommends presenting the administrative costs for each option. It should be noted that this 
section does not specify additional costs beyond those identified in the previous chapters but 
simply presents them in a different format.  

It should also be noted that the assessment provided in this section concerns only the changes 
(in plus or in minus) of the administrative costs as compared to the current 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? 

Extending  the  scope  of  the 
further 
directive 
to  cover 
forms/ 
species/immature 
their 
animals  killed 
tissues  

for 

Yes:  Will  entail  additional 
Authorisation  decisions  and 
Ethical  review  (1.2  million 
€) 82 

Will  it  entail  "administrative 
costs"  for  breeders,  suppliers 
and users? 

Yes:  will  entail  additional 
authorisation applications and 
proposal 
for 
ethical  review  (12.6  million 
€) 83 

submission 

No:  Housing 
care 
standards  (if  any  additional 
costs  occur  in  this  respect  at 

and 

82 

83 

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.  
Same remark as in the previous footnote. 

EN 

76 

   EN 

 
 
 
                                                 
Authorisation of projects 

Yes:  Authorisation  decisions 
(0.06 million €)  

Ethical evaluation 

Yes,  but  small  effect 
negligible  

is 

all) 

Authorisation 

Yes: 
applications  (23.6  million  € 
cost  increase  for  Option  1, 
but  21.2  million 
savings for Option 2) 

€  cost 

evaluation 

Yes: proposal submission  for 
ethical 
and 
maintenance  of  infrastructure 
(committee  members  etc)  to 
perform 
ethical 
the 
evaluation  (9  million  €,  but 
reduces  animal  testing  costs 
by 70 million €)  

Housing and care 

No 

No 

Retrospective 
evaluation 

ethical 

Yes,  about  2  million 
(revised option). 

€ 

Yes,  about  2  million 
(revised option). 

€ 

Transparency/Access 
information 

to 

Yes,  but  small  effect 
negligible  

is 

Yes (0.52 million €) 

Special  rules  for  non-human 
primates 

Yes,  but  small  effect 
negligible  

is 

Yes,  but  small  effect 
negligible 

is 

Inspections 

Yes (3.1 million €) 

Yes (0.62 million €) 

Education and Training 

Yes,  but  small  effect 
negligible 

is 

Yes,  but  small  effect 
negligible 

is 

Database to avoid duplication  Yes (0.1 million €) 

Yes (6.2 million €) 

Using CO2 to kill animals 

Yes,  but  small  effect 
negligible 

is 

No 

Extending 
reporting obligations 

statistical 

Yes,  but  small  effect 
negligible 

is 

Yes (7.4 million € for Option 
1, 4 million € for Option 2)  

Promotion of alternatives 

Yes,  but  small  effect 
negligible 

is 

No 

Marking of the animal  

is 
Yes,  but  small  effect 
negligible 
these 
obligations  are  close  to  the 
existing Directive 

because 

is 
Yes,  but  small  effect 
negligible 
these 
obligations  are  close  to  the 
existing Directive 

because 

EN 

77 

   EN 

 
 
 
Record keeping  

Probably  not  because  record 
keeping  simplifies  the  work 
of  inspectors.  However,  the 
is  probably 
small  effect 
negligible  because 
record 
keeping 
already  now 
obligatory 

is 

is 
Yes,  but  small  effect 
record 
negligible  because 
keeping 
already  now 
obligatory  and  only  slightly 
increased for new documents 

is 

EN 

78 

   EN 

 
Revision of Directive 86/609/EEC 

One  part  of  the  proposed  new  Directive  transposes  the  revised 
Council of Europe Guidelines on Housing an Care 

Tariff 
(€ 
hour)* 

per 

Time  
(hour) 

Price
(per 
actio
n  or 
equip
)* 

Freq 
(per 
year
) 

Nbr  
of  
entiti
es 

Total  nbr
of  
actions 

Total cost 

Regulatory 
origin 
(%) 

No
. 

1 

2 

3 

84 
85 
86 
87 
88 

Ass
. 
Art. 

Art. 
3(1)
(a) 

Art. 
3(1)
(a) 

Art. 
31 

Type 
obligation 

of 

Description 
required 
action(s) 

of 

Target 
group 

i 

e 

i 

e 

In
t 

E
U 

N
at 

R
eg 

Application  for 
individual 
authorisation 
(mammalian 
foetal forms) 

Application  for 
individual 
authorisation 
(mammalian 
foetal forms) 

Processing 
additional project 
applications 

Filing  forms  and 
tables 

   Application  for 
individual 

Processing 
additional 

Public 
authorities 

certain 
user 
establishm
ents 

Public 
authorities 

38  

5  

190  

165
84 

27  

4455  

0.9m € 85 

   X 

43  

83

3550
86  

67087

5,3  

3550  

12.6m € 

   X 

38  

6  

228  

6388

4  

252  

0.06m € 

   X 

Average per Member State if 3 500 projects are distributed equally. 
Without costs for animals killed for their tissues. 
Based on weighed average of the data presented by Prognos in report, page 102 (costs per project public/private). 
Assuming that no institute is only killing animals for tissues and that only 50% of establishments using live animals also kill animals for their tissues. 
Assuming that no institute is only killing animals for tissues and that only 50% of establishments using live animals also kill animals for their tissues. 

EN 

79 

EN 

 
  
 
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
                                                 
authorisation  

Application  for 
individual 
authorisation  

More 
demanding 
application  due 
compliance 
to 
check 

for 

applications 
individual 
authorisation 

Filing  forms  and 
tables 

Filing  forms  and 
tables 

Application  for 
group 
authorisation  

Reduced  number 
of applications to 
be processed 

some  user 
establishm
ents 

user 
all 
establishm
ents 

Public 
authorities 

43  

19
0  

8180  7  

187  

1309  

9.7m € 

   X 

43 

35 

1493  7 

1339  9305 

14.0 
million € 

38  

6  

228  

min
us 
100 
89  

27  

minus 
2700  

minus 
0.7m € 

   X 

Application  for 
group 
authorisation 

Filing  forms  and 
tables 

Ethical 
evaluation 

Preparing 
document 
justifying  animal 

certain 
user 
establishm
ents 

43  

all 
user 
establishm 43  

19
0 

45

8180 

min
us 4 

67090

minus 
2680  

minus 
21.1m € 

   X 

1918 

 7 

67091

 4590 

9m € 

   X 

Art. 
31 

Art 
31 

Art. 
36 
(4) 

Art. 
36(
4) 

Art 
32 

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. 
Based on the assumption that regulatory testing projects are performed by 50% of all establishments. 
Based on extrapolations of number of establishments (Prognos report 2007, p. 55). 

4 

5 

6 

7 

8 

89 

90 
91 

EN 

80 

EN 

 
  
  
  
  
  
  
 
 
 
 
 
 
 
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
                                                 
testing 

ents 

9 

Art 
35 

Non-technical 
project 
summaries 
publication 

for 

Writing 
and 
submitting  them 
Ethical 
for 
Evaluation 

all 
user 
establishm
ents 

43  

10 

Art 
29 

Two inspections 
per year 

Inspection 
of 
breeder, user and 
supplier 
establishments 

Public 
authorities  58
92  

1,
5  

20

60  

7 

1339

9300  

0.52m € 

   X 

1158  2  

1339

2678 

3.1m € 

   X 

11 

Art 
29 

Two inspections 
per year 

Inspection 
of 
breeder, user and 
supplier 
establishments 

and 

all 
breeder, 
user 
supplier 
establishm
ents 

43  

8  

344  

2  

1339

2678 

0.92m € 

   X 

12 

Art 
33 

13 

Art 
33 

Retrospective 
ethical 
evaluation 

Filing  forms  and 
tables 

Retrospective 
ethical 
evaluation 

Processing 
additional 
submissions 

User 
establishm
ents 

43 

Public 
authorities  38 

35
93 

35
94 

1505  2 

670 

1340 

2m €  

1505  2 

670 

1340 

2m € 

X 

X 

92 
93 
94 

Includes travel costs. 
Estimation based on Prognos report 2007, p. 176. 
More conservative estimate than Prognos report 2007, p. 176. 

EN 

81 

EN 

 
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
 
 
 
 
 
 
 
 
 
 
 
 
                                                 
14 

15 

Art 
39(
2) 

Art 
39(
2) 

Statistical 
Reporting 

Statistical 
Reporting 

and 

and 

Collecting 
submitting 
information 

Collecting 
submitting 
information 

User 
establishm
ents 

User 
establishm
ents 

43  

 43 

37

14

1591  10  

47095 4700 

7.4m € 

   X 

602 

10  

67096 6700 

4.0m € 

   X 

Total 
administr
ative 
costs: 

45.08m Euro 

* It should be noted that the external study is based on a complex cost model that takes into account the wage differential across the 25 Member 
States weighed according to the number of projects and establishments 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 equation to make this table 
consistent.

95 

96 

EN 

Based on the assumption of 3500 projects with foetal forms and 1200 projects with GMO animals per year (assumptions in the Prognos report 2007 on page 289 and 
290), on average 10 projects per user establishment obliged to report such statistics, average length 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. 
Based on the assumption that 50% of current 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 suppliers is negligible. 

82 

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

•  Introduction  of  a  national  animal  welfare  and  ethics  committee  with  a  minimum 

harmonised remit to issue guidance; 

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

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

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

summaries; 

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

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

•  Improving  enforcement  by  twice  yearly  inspections  by  national  authorities  of  which  one 

unannounced; 

•  Appropriate education and training standards; 

•  Specific conditions for the use of CO2; 

•  Improving the data for policy-making via improved statistics. 

EN 

83 

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•  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  experience  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 provide 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 combines 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 international 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 through the revised Directive 
is relatively small (about 5%) in comparison to the current level of expenditure in the sector. 

- While universities and other public research institutes 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 which 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 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. 

- 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  the  lighter  authorisation  process  for  project 
consisting of only "up to mild" procedures and not involving the use of non-human primates.  

- The benefits from reduced administrative costs 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 welfare, the corresponding 
benefits  for  science  can  be  monetised.  If  only  a  few  percentages  (1-3%)  of  the  studies  that 
currently suffer from a weak experimental design, inappropriate housing and care standards or 
not fully competent  personnel  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  check  that  they  pass  the  necessity  test.  They  are 
necessary  to  fulfil  the  requirements  of  the  Protocol  annexed  to  the  EC  Treaty  to  pay  full 

EN 

84 

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regard  to  animal  welfare  requirements  in  formulating  agriculture,  transport,  internal  market 
and research policies. At the same time, they cannot be better carried out by Member States 
individually. 

EN 

85 

   EN 

 
11. 

MONITORING AND EVALUATION 

The  Commission  will  monitor  the  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. However, a preliminary list could include: 

Related to Objective 1 - Strong convergence of standards that 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  scientific  procedures  using  animals:  number  of  complaints  about 
non-level playing field. 

Levelling  the  administrative  cost  and  time  factors  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 minimum scrutiny of animal experimentation by  

•  Implementation  of  ethical  evaluation  of  projects  and  an  ethical  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  establishments  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 inspections; 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 species/life-stages introduced by comitology; 

•  Encouraging  research  into  alternative  approaches  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 

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12. 

TERMINOLOGY 

Term 

Definition for the purposes of this impact assessment 

Alternative method 

Establishment 

Ethical Evaluation 

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  Alternative),  and  replaces  the  method 
with  one  not  using 
live,  sentient  animals  (Replacement 
Alternative). 

Any installation, building, group of buildings 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"  means  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 

A  process  of  evaluating 
justification,  design  and 
the 
consequences  to  science,  society,  environment  and  animal 
welfare of a particular piece of research, for example a project 
proposal  that  can  be  carried  out  prior  to,  during,  or  after  the 
lifetime of a project. 

Ethical Review Committee  A  specific  mechanism/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  animals  for  experimental  and 
other  scientific  purposes  is  carefully  considered,  adequately 
justified,  carried  out  and  followed  up  so  that  the  animals  are 
treated  as  humanely  as  possible,  incorporating  the  Three  Rs 
principles  throughout,  as  well  as  providing  a  forum  for  an  on-
going,  wider  discussion  on  the  use  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  harmful.  This  includes  animals 

EN 

87 

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produced by genetic modification or by induced mutagenesis, or 
animals  created  by  nuclear  transfer  procedures,  as  well  as 
harmful mutant lines arising from spontaneous mutations. This 
definition excludes animals with changes that are not heritable, 
such as gene therapy interventions or DNA immunisations. 

Applying  the  same  legislative  requirements  in  all  European 
Community countries (or in some cases within a Member State).

A  biological  or  chemical  response,  that  can  predict  pain, 
distress,  suffering  or  impending  death  that  is  not  necessary,  to 
achieve the scientific objective. 

Harmonisation 

Humane endpoint 

Humane killing 

A  method  of  killing  that  causes  no  avoidable  pain,  distress  or 
other suffering to the animal(s) concerned. 

In vitro 

In vivo 

Project 

Literally meaning in glass, an experimental technique that may 
involve  animal  organs,  tissues  and  cells  taken  from  dead 
animals. 

Scientific  procedures  involving  a  living  animal  with  its  whole 
body systems intact in order to study what happens in the body 
itself. 

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 
legislation. 

international 

Scientific Procedure 

Technique 

Three Rs 

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. 

A technical act on one or more animals for an experimental or 
other  scientific  purpose  and  which  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,  withholding  of  food/water,  giving  an 
anaesthetic. 

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 

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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/chemicals/lab_animals/revision_en.htm 

In  case  further  factual  information  on  this  Impact  Assessment  is  available  in  quantified  or 
monetised  form  and  with  the  source  of  the  information  indicated,  readers  are  requested  to 
send  this  information  to  the  following  functional  mailbox  with  the  keyword  “Impact 
Assessment” in the subject heading.  

env-laboratory-animals@ec.europa.eu 

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ANNEX 

Inappropriate housing and care of experimental animals can lead to a number of physiological 
and  behavioural  changes  that  can  heavily  interfere  with  the  test  results  and  undermine  their 
reliability:97 

-  Exposure  to  inappropriate  temperatures:  Some  species  are  very  sensitive  to  changes  in 
temperature, and effects can be seen on behaviour, food and water consumption, and growth 
rates  (Svendsen,  1994).  Significant  deviations  from  the  thermo-neutral  zone  can  result  in 
significant distress, morbidity and even death. 

-  Exposure  to  inappropriate  Relative  Humidity:  Although  many  species  will  tolerate  well 
variations  in  relative  humidity,  for  some  species  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  breeding  programmes  and  may  cause  behavioural  disturbances 
(Gamble, 1982; Sales et al., 1994). 

-  Lack  of  appropriate  nesting/bedding  materials:  can  increase  neonatal  mortality  rates  or 
cause  abnormal/stereotypic  behaviours  (Hubrecht  et  al.,  1992;  Weidenmayer,  1997a; 
Reinhardt, 2004) 

- Inappropriate lighting: Too bright or too dark light or unsuitable lighting 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  demonstrated  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  (Rose, 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  include  both,  behavioural  and  physiological 
abnormalities usually referred to as 'isolation stress' or 'isolation syndrome' (e.g. Baer, 1971; 
Brain, 1975; Haseman, 1994). There is evidence that 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. 

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1998). Gerbils develop extensive stereotypic digging 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 enclosure size and stocking densities induce stress 
responses that may affect health and welfare (e.g. Sørensen DB et al., 2005). 

-  Inadequate  breeding  management  may  lead  to  breeding  immature  animals;  genetic 
abnormalities, early weaning losses and poor temperament (GV-SOLAS, 1999). 

- Inadequate health management and monitoring can lead to overt clinical 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  studies  is  contamination  or  infection  with 
microbial  agents;  elimination  of  these  agents  contributes  to  the  standardization  of  scientific 
procedures  using  animals  (Johnston  and  Nevalainen  2003).  In  experimental  animals  good 
health  status  not  only  means  absence  of  clinical  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  weight  considerably.  Consequently,  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 schemes are in place (Benavides, 1999).  

- Inappropriate handling of animals: The influence of humans, for example during handling, 
may cause significant variance in results, and hence should be subjected to stringent control 
(Davies and Balfour, 1992; ILAR, 2002). 

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LITERATURE98 

Baer  H,  1971.  Long-term  isolation  stress  and  its  effects  on  drug  response  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: practical 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  Proceedings  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 Trevor Poole Blackwell Science Volume 1 pp 45-
60 

Davies H. and Balfour D., 1992. The inevitable bond: examining scientist-animal interactions. 
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EFSA (2005): The EFSA Journal 292, Opinion on the “Aspects of the biology and welfare of 
animals used for experimental and other scientific 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 
http://ec.europa.eu/governance/impact/docs/SEC2005_791_IA%20guidelines_annexes.pdf 

Impact  Assessment  Guidelines;  SEC 

(2005): 

(2005)  791, 

FELASA, 2002. (Federation of European Laboratory Animal Science Associations Working 
Group  on  Health  Monitoring  of  Rodent  and  Rabbit  Colonies).  Recommendations  for  the 
health  monitoring  of  rodent  and  rabbit  colonies  in  breeding  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 

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Gärtner  K.,  1990.  A  third  component  causing  random  variability  beside  environment  and 
genotype.  A  reason  for  limited  success  of  a  30  year  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 incidence 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. Applied 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 Practices, p. 311-325. Boca Raton: CRC Press. Vol. 1 

Kuhnen G, 1997. The effect of cage size and environmental 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.  Factors  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 Anderson KV, 1992. Retinal damage after prolonged exposure to 
visible light. Am. J. Anat. 134 5-22 

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