Proposal for a Directive of the European Parliament and of the Council on the protection of animals used for scientific purposes {SEC(2008) 2410} {SEC(2008) 2411}
Date: 2008-11-05
Institutions: European Commission
Subjects: European convention, animal experimentation, animal welfare

EN 

EN 

   EN 

 
COMMISSION OF THE EUROPEAN COMMUNITIES 

Brussels, 5.11.2008 
COM(2008) 543 final 

2008/0211 (COD) 

Proposal for a 

DIRECTIVE OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL  

on the protection of animals used for scientific purposes 

(presented by the Commission) 

{SEC(2008) 2410} 
{SEC(2008) 2411} 

EN 

   EN 

 
 
  
 
 
 
EXPLANATORY MEMORANDUM 

1) CONTEXT OF THE PROPOSAL 

Grounds for and objectives of the proposal 

Directive 86/609/EEC on the protection of animals used for experimental and other 
scientific  purposes  was  adopted  to  harmonise  practices  in  the  area  of  animal 
experimentation in the EU. However, due to a variety of weaknesses in the current 
Directive,  a  number  of  Member  States  have  established  considerably  more  far-
reaching  measures  in  their  national  implementation  whereas  others  apply  only 
minimum rules. The present uneven situation needs to be rectified to ensure that the 
objectives  of  the  internal  market  are  re-established.  The  current  proposal  aims  at 
ensuring  a  level  playing  field,  throughout  the  EU,  for  industry  and  the  research 
community,  at  the  same  time  strengthening  the  protection  of  animals  still  used  in 
scientific procedures in line with the EC Treaty's Protocol on Animal Welfare1. The 
proposal  supports  the  Commission’s  overall  strategy  on  animal  experimentation, 
including  enhanced  promotion  of  the  development,  validation,  acceptance  and 
implementation  of  alternative  methods  and  provides  a  solid  basis  for  a  full 
implementation  of  the  principles  of  the  Three  Rs2  -  Replacement,  Reduction  and 
Refinement of animals in experiments. 

General context 

Around 12 million animals are used on a yearly basis in scientific procedures in the 
EU-273.  All  efforts  should  be  made  to  reduce  the  numbers  of  animals  used  in 
experiments  to  a  minimum.  The  most  pragmatic  approach  to  reducing  experiments 
on  animals  is  through  the  introduction  of  alternative  methods,  as  with  current 
scientific  knowledge,  a  complete  phase-out  of  animal  experimentation  is  not  yet 
achievable4. Therefore, it is imperative to ensure that those animals that are still used 
for legitimate reasons receive the highest protection and welfare consistent with the 
aims of the experiment. 

The scientific grounds on which Directive 86/609/EEC was founded dates back over 
20 years. A number of provisions are out of date and the Directive therefore does not 
cater  for  modern  techniques  in  the  field  of  animal  experimentation,  nor  does  it 
incorporate the latest advancements in the field of animal welfare. Furthermore, the 
wording  of  the  Directive  follows  that  of  an  international  Convention;  the  style  of 
some  provisions  is  thus  more  political  than  regulatory.  A  significant  number  of 
provisions are open to interpretation and provide guidance rather than harmonisation.  

1 
2 

3 

4 

OJ C 340, 10.11.1997, p. 110. 
Three  Rs  Principles  by  Russel,  Burch  1959  which  today  is  a  commonly  accepted  principle  among 
scientists, academia and industry internationally when using animals in scientific procedures. 
12.1 million animals in 2005 in EU-25, Commission Report on the statistics on the number of animals 
used  for  experimental  and  other  scientific  purposes  in  the  Member  States  of  the  European  Union  - 
COM(2007) 675. 
See: A. P. Worth, M. Balls (ed.), alternative (Non-animal) Methods for chemicals testing: Current status 
and Future Prospects – A report prepared by ECVAM and the ECVAM Working Group on chemicals. 
ATLA 30, Supplement 1, July 2002; and CSTEE Opinion of 8 January 2004 (Opinion on the BUAV-
ECEAE report on "The way forward – action to end animal toxicity testing"). 

EN 

2 

   EN 

                                                 
Contrary to the objectives of the Directive, the afore-mentioned factors have resulted 
in  a  distortion  of  the  internal  market,  with  significant  differences  in  the  level  of 
regulation  between  Member  States.  Moreover,  the  current  provisions  contain 
ambiguities and inconsistencies, leading to transposition and compliance problems. 

The importance attached to animal welfare is evolving in terms of ethical concerns 
and this has become a “cultural attitude” for European society. This is acknowledged 
by the EC Treaty’s Protocol on Protection and Welfare of Animals which recognises 
animals as sentient beings. It requires the Community, and the Member States, to pay 
full  regard  to  animal  welfare.  However,  the  current  provisions  of  the  Directive  no 
longer meet this obligation. 

There  is  an  increasing  awareness  of  and  concern  for  animal  welfare  in  the  public 
arena.  The  participation  in  recent  opinion  polls  and  public  consultations  gives  a 
strong indication of the public interest in this area – two of the three largest public 
consultations ever launched by the European Commission amongst any of its various 
policy activities addressed the subject of animal welfare5. The existing measures do 
not  sufficiently  mirror  these  expectations  and  fail  to  provide  a  sufficient  level  of 
transparency in this highly controversial field. 

Other Community policies and legislative measures, such as REACH,6 may have as a 
temporary negative effect  an  increased use of animals in regulatory  testing,  despite 
the  provisions  already  taken  to  avoid  unnecessary  tests.  In  light  of  this  and  the 
provisions  of  the  Cosmetics  Directive,7  the  necessity  to  reduce  our  dependency  on 
animal experimentation is compelling. The ultimate goal should be to replace the use 
of animal experiments all together. In addition to animal welfare benefits, alternative 
methods  also  have  the  potential  to  provide  robust  information  through  quality-
controlled,  state-of-the-art  tests  which  could  be  faster  and  less  cost-intensive  than 
classical animal-based tests.  

Directive  86/609/EEC  has  encouraged  the  development  of  alternatives  to  animal 
testing.  For  example,  in  1991  the  Commission  created  the  European  Centre  for 
Validation  of  Alternative  Testing  Methods  (ECVAM)8  within  the  Commission’s 
Joint Research Centre. To move forward to the next level, the proposal has a specific 
emphasis  on  complementing  this  structure  by  introducing  a  number  of  measures  to 
promote alternative approaches, though recognising that the identification and setting 
of  regulatory  testing  needs  is  done  and  should  be  done  through  the  use  of  other 
pieces of legislation. The measures to promote alternative approaches range from a 
general requirement to use alternative methods as soon as they become available, to 
further concrete measures to promote their development, validation and acceptance, 
also at international level. Generally the proposal requires that the principles of the 
Three  Rs  are  fully  taken  into  account  when  developing  Community  measures  to 
protect the health and safety of human beings, animals and the environment. 

5 

6 

7 
8 

The  consultation  on  the  regulation  on  origin  marking  ("made  in")  received  166,680  replies,  the 
consultation on the Community Action Plan on Animal Welfare and Protection 44,514 replies and the 
one about the Revision of Directive 86/609/EEC received 42,655 replies. 
Regulation (EC) No 1907/2006 concerning the Registration, Evaluation, Authorisation and Restriction 
of Chemicals. 
Directive 76/768/EEC and its 7th Amendment through Directive 2003/15/EC. 
SEC(91) 1794. 

EN 

3 

   EN 

                                                 
The use of animals in scientific procedures today, however, still remains essential for 
ensuring a level of safety for human beings, animals and the environment and for the 
advancement  of  knowledge  which  will  lead  to  improvements  in  human  and  animal 
health  and  welfare9,10.  There  are  strong  arguments  for  differentiating  the  use  of 
animals with respect to the species, in particular in relation to their genetic proximity 
to  human  beings.  Although  the  proximity  of  non-human  primates  makes  some  of 
these species the only suitable ones for certain types of testing, this differentiation is 
supported by science and should be respected. 

Therefore,  and  in  line  with  earlier  commitments11,  specific  provisions  have  been 
incorporated  to  reduce  the  use  of  non-human  primates  to  an  absolute  minimum.  A 
strict  case-by-case scrutiny is imposed in cases where non-human primates are still 
the  only  suitable  species.  The  proposal  limits  the  use  of  non-human  primates  by 
prohibiting  the  use  of  Great  Apes  and  restricting  the  use  of  other  species  of  non-
human  primate  to  only  specific  fields  of  application.  Furthermore,  there  are 
ambitious  requirements  on  the  origins  of  the  animals  and  specific  monitoring 
mechanisms  are  foreseen  to  ensure  the  effectiveness  of  the  proposed  measures, 
ultimately facilitating the move towards abolishing the use of non-human primates in 
scientific  procedures.  It  is  recognised,  however,  that  current  scientific  knowledge 
will not allow us to achieve this goal in the near future12. 

In  its  role  as  guardian  of  the  EC  Treaties,  the  Commission  is  also  responsible  for 
ensuring  that  Community  legislation  is  properly  implemented  and  enforced.  The 
current  Directive  has  faced  criticism  linked  to  its  enforcement,  transparency  and 
public  accountability.  To  remedy  the  situation,  the  proposal  foresees  tightening  of 
national  inspections,  not  only to ensure compliance, but as a means to promote the 
exchange  of  best  practices  and  implementation  of  the  principles  of  the  Three  Rs. 
Furthermore,  the  Commission  can  play  a  constructive  role  in  assisting  where 
appropriate the national inspection systems in fulfilling their role. 

Existing provisions in the area of the proposal 

The  proposal  builds  on  the  current  provisions  of  Directive  86/609/EEC.  It  seeks  to 
tighten the loopholes, remove ambiguities, make the provisions coherent and align it 
with the better regulation standards of the Community. The existing provisions that 
have  had  the  most  pronounced  impact  on  the  distortion  of  the  internal  market, 
namely  authorisation  and  accommodation  and  care  requirements,  have  been  further 
developed to specifically ensure harmonised objectives and minimum standards can 
be applied throughout the EU. 

9 

10 

11 

12 

a  Non-animal  Testing  Approach", 

Opinion  of  The  Scientific  Committee  on  Toxicity,  Ecotoxicity  and  the  Environment  (CSTEE)  on  the 
BUAV-ECEAE  Report  on  "The  way  forward  –  Action  to  end  animal  toxicity  testing",  adopted  on  8 
January 2004 - http://ec.europa.eu/health/ph_risk/committees/sct/documents/out217_en.pdf. 
The  Scientific  Committee  on  Health  and  Environmental  Risks  opinion  on  "Endocrine  Disrupting 
- 
Chemicals: 
http://ec.europa.eu/health/ph_risk/committees/04_scher/docs/scher_o_015.pdf. 
Council Decision 1999/575/EC of 23 March 1998 concerning the conclusion by the Community of the 
European Convention for the protection of vertebrate animals used for experimental and other scientific 
purposes; whereas 3 and 4. 
The  Scientific  Steering  Committee:  "The  need  for  non-human  primates  in  biomedical  research", 
statement adopted 4-5 April 2002. http://europa.eu.int/comm/food/fs/sc/ssc/out253_en.pdf. 

25  November 

adopted 

2005 

on 

EN 

4 

   EN 

                                                 
The  accommodation  and  care  guidelines  annexed  to  the  Council  of  Europe 
Convention  (ETS  123)  were  fully  revised  in  June  2006,  with  the  support  of  the 
Community. In line with the Community's international obligations to implement the 
revised  guidelines,  parts  of  these  guidelines  will  be  implemented  as  minimum 
standards through this proposal. 

Consistency with other policies and objectives of the Union 

EU context 

This  proposal,  which  aims  at  harmonising  and  levelling  the  practices  for  the 
breeding,  keeping  and  use  of  animals  in  scientific  procedures  in  the  EU,  is  in  line 
with the objectives of Article 95 of the EC Treaty. It is specifically designed to take 
account  of  the  diversity  of  infrastructures  in  different  Member  States  by  leaving 
sufficient  scope  for  implementing  measures  at  a  national  level,  in  line  with  the 
principle of subsidiarity of the Community. Optimum implementation at the national 
level  through  the  use  of  identified  best  practices  will  provide  ample  opportunity  to 
reduce unnecessary red-tape and administrative costs. 

In  accordance  with  the  Lisbon  Agenda  objectives,  the  proposal  is  based  on  an 
analysis of the potential benefits and costs of action or lack of action as well as the 
respect  of  the  economic  and  social  development  of  the  Community  as  a  whole. 
Moreover,  specific  measures  have  been  included  to  allow  smooth  administrative 
procedures in support of the objectives of the Lisbon Agenda. The proposal strikes a 
balance in promoting European research and competitiveness while at the same time 
being at the forefront in ensuring that full regard is paid to animal welfare. 

The  proposal  ensures  that  the  necessary  harmonised  framework  is  put  in  place  to 
facilitate EU wide research projects, especially in terms of the mobility of research 
personnel  via  establishment  of  minimum  training  standards.  At  the  same  time,  the 
Community Framework Programmes for Research have put an increasing emphasis 
on  the  development  and  validation  of  alternative  approaches  which  are  echoed 
strongly in the proposal. 

In  addition,  the  Commission  has  an  important  responsibility  to  ensure  that  new 
legislation  regarding  animal  welfare  standards  is  based  on  evolving  scientific 
knowledge  and  current  best  practice.  As  part  of  this  policy,  the  European  Food 
Safety Authority (EFSA),13 established in 2002, serves as an independent scientific 
source  of  risk  assessment  and  advice,  information  and  risk  communication  to  the 
European  Commission.  Scientific  questions  on  animal  welfare  fall  also  under  the 
remit  of  EFSA  and  these  are  tackled  by  the  Panel  on  Animal  Health  and  Animal 
Welfare 
the 
recommendations  provided  by  AHAW.  The  incorporation  of  the  latest  scientific 
knowledge  will  be  facilitated  through  requirements  for  regular  review  of  these 
provisions. 

(AHAW).  A  number  of  specific  measures  are  based  on 

The  proposal  incorporates  fully  the  principles  of  the  Three  Rs  in  line  with  other 
Community  policies.  The  requirement  to  replace,  reduce  and  refine  the  use  of 
animals  in  scientific  procedures  is  highlighted  in  a  number  of  other  pieces  of 

13 

Council Regulation (EC) No 178/2002 establishing the European Food Safety Authority. 

EN 

5 

   EN 

                                                 
Community  legislation  such  as  Directive  98/8/EC  on  biocidal  products,  Directive 
1999/45/EC  on  dangerous  preparations,  7th  Amendment  to  Directive  76/768/EEC 
and most recently in Regulation (EC) No 1907/2006 (REACH)14,15,16,17. 

In  the  area  of  alternative  methods,  the  proposal  further  facilitates  the  aims  of  the 
European Partnership on Alternative Approaches to Animal Testing, EPAA18 which 
was launched in 2006 between the Commission and industry to promote alternative 
approaches to animal testing. 

Finally,  the  proposal  is  fully  in  line  with  the  recent  Community  Action  Plan  on 
Animal  Welfare19  which  included  this  proposal  as  part  of  its  specific  actions.  The 
European Parliament reiterated its call for the Commission to come forward as soon 
as possible with a proposal to revise Directive 86/609/EEC20. 

2) CONSULTATION OF INTERESTED PARTIES AND IMPACT ASSESSMENT 

Consultation of interested parties 

Consultation methods, main sectors targeted and general profile of respondents 

Stakeholder  groups  have  been  extensively  involved  in  the  development  of  this 
proposal  from  the  beginning  through  a  Technical  Expert  Working  Group  (TEWG) 
convened  by  the  Commission,  bilateral  consultations  with  different  stakeholder 
groups  as  well  as  through  public  internet  consultations.  The  documents  distributed 
for the TEWG were also widely distributed to the research community and industry 
to  allow  maximum  input.  In  2006,  the  Commission  carried  out  a  public  Internet 
consultation directed at the general public and experts and stakeholders in the field21. 

Summary of responses and how they have been taken into account 

The  results  of  the  citizens'  consultation  are  based  on  the  responses  of  citizens  who 
were  interested  in  the  subject  and  took  the  initiative  to  fill  in  the  questionnaire. 
Therefore,  the  results  are  not  comparable  to  those  obtained  from  surveys,  such  as 
Eurobarometer. However, the high level of participation gives a strong indication of 
the public interest in this area. A large majority of the respondents supports measures 
at EU level to increase the welfare of animals. 

The expert consultation received over 12,000 comments on the different options for 
the revision. These have been analysed in detail and taken into account in the legal 
drafting as well as in modifying and updating the Commission Impact Assessment. 

14 
15 
16 
17 
18 
19 

20 
21 

OJ L 123, 24.4.1998, p. 1. 
OJ L 200, 30.7.1999, p. 1. 
Directive 2003/15/EC, OJ L 66, 11.3.2003, p. 26. 
OJ L 396, 30.12.2006, p. 1. 
http://ec.europa.eu/enterprise/epaa/index_en.htm 
Communication  from  the  Commission  to  the  European  Parliament  and  the  Council  on  a  Community 
Action Plan on the Protection and Welfare of Animals 2006-2010 - COM(2006) 13, 23.1.2006. 
EP-Resolution 2006/2046(INI). 
Published in December 2006 on the DG Environment Website under:   
http://ec.europa.eu/environment/chemicals/lab_animals/background_en.htm 

EN 

6 

   EN 

                                                 
Collection and use of expertise 

Domains of scientific expertise concerned 

Experts in the area of animal testing and experimentation, laboratory animal science, 
natural  sciences  (especially  biology,  medicine,  pharmacology,  toxicology  and 
ecotoxicology),  animal  welfare,  ethics,  laboratory  animal  breeders,  technicians  and 
veterinarians, animal behaviourists, and experts in legal and economic affairs related 
to these areas were asked for and provided input. 

Methodology used 

The proposal is based on the best available scientific and technical knowledge. Such 
expertise  has  been  gathered  through  the  comprehensive  stakeholder  consultations 
including  the  TEWG,  a  public  internet  consultation  and  by  contracting  an  outside 
study  to  assess  the  socioeconomic  and  animal  welfare  impacts  of  the  measures 
proposed.  In  addition,  specific  scientific  questions  were  addressed  to  the  Panel  on 
Animal Health and Animal Welfare of the European Food Safety Authority and to its 
predecessor  Scientific  Committee  on  Animal  Health  and  Animal  Welfare 
(SCAHAW).  

Main organisations/experts consulted 

The  consultation  included  national  administrations,  industry  associations,  animal 
institutes, 
welfare  organisations,  patient  organisations,  science  and  research 
organisations in the field of the principles of the Three Rs and alternative methods, 
the  European  Medicines  Agency,  the  Joint  Research  Centre  and  other  Commission 
services,  national  administrations  and  breeders  of  laboratory  animals  in  third 
countries as well as many other associations which had European coverage. 

Summary of advice received and used 

There  is  a  broad  consensus  that  the  current  Directive  is  outdated  and  has  led  to 
distortion of the internal market. The technical-scientific advice was used as the basis 
for a preliminary set of foreseen measures. These measures were then presented for a 
wide consultation during which they received clear support from stakeholders.  

Among  the  options  that  were  abandoned  as  a  result  of  feedback  received,  was  a 
requirement  for  publication  of  ethical  evaluations  and  systematic  retrospective 
assessments of all projects using animals. These were replaced by a requirement for 
non-technical  summaries  to  be  produced  by  the  applicant  and  retrospective 
assessment  based on case-by-case analysis of its necessity. Furthermore, the option 
to  have  an  EU  wide  database  as  a  means  to  combat  unnecessary  duplication  of 
testing was discarded. 

Throughout  the  consultation,  stakeholders  supported  the  approach  to  ensure  a 
flexible mechanism that allows implementation to be determined at a national level. 

There was a broad consensus that the current Directive should be revised to include 
the  main  elements  presented  establishing  common  objectives  and  principles 
throughout  the  EU,  leaving  to  Member  States  the  adoption  of  detailed  measures  at 
the appropriate administrative level. 

EN 

7 

   EN 

Impact assessment 

The following broad options, from less to more prescriptive, have been considered: 

(1) Deregulation 

(2) Maintaining status quo 

(3) Strengthening the current legislation 

(4) Voluntary agreements as an alternative to legislation 

The Commission carried out an Impact Assessment, which sets out in more detail the 
findings as regards the socio-economic impacts and impacts on animal welfare linked 
to this proposal and the more detailed options therein.  

The  current  situation  in  the  European  Community  is  characterised  by  a  highly 
diversified,  unequal  competitive  environment  for  industry  and  the  research 
community.  The  main  economic  actors  affected  by  the  functioning  of  the  internal 
market are: 

-  Contract  research  institutes  performing  animal  tests  on  behalf  of  other  companies 
for cost or expertise reasons.  

-  Companies  doing  product  development  research  in-house  (e.g.  pharmaceutical, 
chemical producers). Their cost structure varies across Europe due to differences in 
the regulatory environment.  

Universities are also affected by the functioning of the internal market in the area of 
animal  experimentation,  as  they  compete  for  industry  sponsorship  for  research,  are 
tendering  for  public  procurement  contracts  and  sometimes  create  their  own 
commercial off-spring or branches. 

The  Impact  Assessment  was  reviewed  in  March  2007  by  the  independent 
Commission Impact Assessment Board. The Board issued its Opinion on 16 March 
2007  and  emphasised  the  following  positive  elements:  The  attempt  to  quantify  and 
where possible monetise benefits and costs for each specific option, the inclusion of 
information  about  third  country  systems  of  laboratory  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 option of self-regulation, 
the qualitative benefit dimension and the use of the standard model of administrative 
costs. 

The increase in annual costs is estimated to be about 143.7 million € for the EU-25. 
This  figure  includes  additional  administrative  costs  of  about  45  million  €  annually 
mainly from increased scrutiny of project applications, covering more animals, more 
inspections and improved statistics. 

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 

EN 

8 

   EN 

the average costs of this type of project 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. 
Industry and academia would benefit from deadlines for 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. The benefits from reduced administrative 
costs and avoidable unnecessary testing alone were estimated to be 90 million € per 
year. These, however, are not reflected in the estimated annual cost. 

EN 

9 

   EN 

3) LEGAL ELEMENTS OF THE PROPOSAL 

Summary of the proposed action 

- 

the proposed Directive includes requirements for: 

–  the  acquisition,  breeding,  marking  and  keeping  of  animals,  including  their 

accommodation and care requirements;  

–  the authorisation  and functioning of  establishments breeding,  supplying or using 

animals and inspections of these establishments; 

–  the  authorisation  of  persons  using  or  caring  for  animals,  supervising  or 

responsible for designing projects using animals; 

–  the  evaluation  and  authorisation  of  projects  using  animals,  including  their 

retrospective assessment; 

–  the choice of procedures and their conduct; 

–  the  development,  validation,  regulatory  acceptance  and  implementation  of 

alternative approaches; 

–  transparency  through  publication  of  non-technical  information  on  projects, 
reporting  on 

rules  and  guidelines  as  well  as 

national 
implementation and statistics. 

implementing 

The  basis  of  the  specific  measures  is  anchored  in  the  globally  acknowledged 
principles of the Three Rs (Replacement, Reduction and Refinement). 'Replacement' 
means the attempt to replace procedures involving live animals by alternatives which 
do  not  use  live  animals;  'reduction'  means  the  attempt  to  reduce  the  number  of 
animals  used  in  procedures  to  the  minimum  necessary  without  compromising  the 
quality of scientific results; 'refinement' means the employment of methods to ensure 
that any possible pain and suffering by the animals are reduced to the minimum, as 
well as to improve the care, treatment and living conditions of the animals to enhance 
their well-being, taking into consideration the life-time experience of the animals.  

Community context 

There  is  Community  legislation  in  place  to  evaluate  and  manage  potential  risks  of 
products and substances for health and safety reasons. In some cases, it is necessary 
to resort to animal testing to evaluate these risks. The areas include pharmaceuticals, 
chemicals,  pesticides  as  well  as  food  and  feed  safety.  It  is  therefore  necessary  that 
animal  welfare  considerations  are  taken  into  account,  while  being  balanced  against 
the  potentially  serious  threats  to  human  and  animal  health,  and  the  environment 
which need to be tested.  

EN 

10 

   EN 

Legal basis 

The provisions of this Directive relate to the harmonisation of the internal market in 
the  field  of  breeding,  supplying  and  use  of  animals  and  consequently  Article  95  of 
the EC Treaty was kept as the legal basis. 

Subsidiarity principle 

For the following reasons the proposal complies with the subsidiarity principle: 

•  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 
the 
Community's internal market and research policies. 

in  formulating  and 

implementing 

•  While  some  of  the  identified  problems  fall  under  a  competence  shared  by  the 
Community  and  the  Member  States,  problems  such  as  those  resulting  from 
diversified  requirements  for  authorisation  and  ethical  evaluation  as  well  as  for 
accommodation and care of animals, 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.  Without 
regulatory  action  at  European  level,  the  distortion  of  the  internal  market  will 
persist and possibly worsen. 

Without  Community  action  to  underpin  the  efforts  at  national  level,  the  current 
situation  has  created  an  uneven  playing  field  for  industry  and  the  research 
community. 

As a result there are competitive disadvantages for establishments in countries with 
high  animal  welfare  standards  resulting  primarily  from  price  differences,  diverging 
regulatory and authorisation procedures and criteria in the Member States leading to 
variable  delays  and  cost  of  projects,  unsatisfactory  conditions  for  researchers  and 
obstacles to horizontal mobility and between academia and the private sector. Similar 
problems can be identified for the breeders and suppliers of experimental animals. 

The  proposal  aims  at  achieving  common  principles,  objectives  and  actions  for  all 
Member States to ensure a fair and level playing field in the future. 

Proportionality principle 

The proposal complies with the proportionality principle for the following reasons: 

The proposed Directive would establish a set of measures to harmonise the practices 
for  the  use  and  the  care  of  animals  used  or  intended  to  be  used  in  scientific 
procedures, in line with the animal welfare protocol of the EC Treaty. Much scope is 
left to the Member States to identify the most suitable specific measures at the most 
appropriate administrative level and the respective administrative infrastructure. This 

EN 

11 

   EN 

will  ensure  that  the  regional  and  local  specificities  as  regards  socio-economic  and 
ethical aspects can be properly taken into account. 

The practical implementing measures are to be decided by Member States, allowing 
for  an  efficient  use  and  further  development  of  national  administrative  capabilities 
which may also be best suited to support the local industry and research community. 
As demonstrated by the Impact Assessment, the benefits of the proposed measures to 
the  internal  market  as  well  as  to  animal  welfare  outweigh  the  costs.  The  final 
measures have been refined to secure a balance between the need for harmonisation, 
the costs and flexibility for local implementation. 

The Member States will be entitled to take more stringent measures than those laid 
down in the proposed Directive, where they satisfy the requirements of Article 95(4) 
EC. 

Choice of instrument 

Proposed instrument: Directive. 

Other means would not be adequate for the following reason: 

A  more  prescriptive  instrument,  such  as  a  Regulation,  would  be  too  rigid  to 
encompass  all  the  existing  regulatory  systems  that  have  developed  over  the  last  20 
years  in  the  Member  States.  Deregulation  or  a  non-binding  instrument  would  not 
address the problems identified with the current Directive and could not prevent the 
further distortion of the internal market. 

4) BUDGETARY IMPLICATION 

The proposal has no implication for the Community budget. 

5) ADDITIONAL INFORMATION 

Review/revision/sunset clause 

The proposal includes a review clause. 

Correlation table 

The  Member  States  are  required  to  communicate  to  the  Commission  the  text  of 
national  provisions  transposing  the  Directive  as  well  as  a  correlation  table  between 
those provisions and this Directive. 

European Economic Area 

The  proposed  act  concerns  an  EEA  matter  and  should  therefore  extend  to  the 
European Economic Area. 

EN 

12 

   EN 

2008/0211 (COD) 

Proposal for a 

DIRECTIVE OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL  

on the protection of animals used for scientific purposes 

(Text with EEA relevance) 

THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE EUROPEAN UNION, 

Having regard to the Treaty establishing the European Community, and in particular Article 
95 thereof, 

Having regard to the proposal from the Commission22, 

Having regard to the opinion of the European Economic and Social Committee23, 

Having regard to the opinion of the Committee of the Regions24, 

Acting in accordance with the procedure laid down in Article 251 of the Treaty25, 

Whereas: 

(1) 

(2) 

(3) 

22 
23 
24 
25 
26 
27 

Animal  welfare  is  a  Community  value  that  is  enshrined  in  the  Protocol  on  the 
protection and welfare of animals annexed to the Treaty.  

On  23  March  1998  the  Council  adopted  Decision  1999/575/EC  concerning  the 
conclusion  by  the  Community  of  the  European  Convention  for  the  protection  of 
vertebrate animals used for experimental and other scientific purposes26. By becoming 
a  Party  to  that  Convention,  the  Community  acknowledged  the  importance  of  the 
protection and welfare of animals used for scientific purposes at international level. 

On  24  November  1986  the  Council  adopted  Directive  86/609/EEC27  in  order  to 
eliminate  disparities  between  laws,  regulations  and  administrative  provisions  of  the 
Member  States  regarding  the  protection  of  animals  used  for  experimental  and  other 
scientific  purposes.  Since  the  adoption  of  that  Directive,  further  disparities  between 
Member  States  have  emerged.  Certain  Member  States  have  adopted  national 
implementing  measures  that  ensure  a  high  level  of  protection  of  animals  used  for 
scientific  purposes  while  others  only  apply  the  minimum  requirements  laid  down  in 
Directive  86/609/EEC.  Accordingly,  this  Directive  should  provide  for  more  detailed 

OJ C […], […], p. […]. 
OJ C […], […], p. […]. 
OJ C […], […], p. […]. 
OJ C […], […], p. […]. 
OJ L 222, 24.8.1999, p. 29. 
OJ L 358, 18.12.1986, p. 1. Directive as amended by Directive 2003/65/EC of the European Parliament 
and of the Council (OJ L 230, 16.9.2003, p. 32). 

EN 

13 

   EN 

                                                 
(4) 

(5) 

(6) 

(7) 

rules  in  order  to  reduce  such  disparities  and  to  ensure  a  proper  functioning  of  the 
internal market. 

The European Parliament in its report of [5 December] 2002 on Directive 86/609/EEC 
called  for  the  Commission  to  come  forward  with  a  proposal  for  a  revision  of  that 
Directive  with  more  stringent  and  transparent  measures  in  the  area  of  animal 
experimentation.  

New scientific knowledge is available on factors influencing animal welfare as well as 
the  capacity  of  the  animals  to  sense  and  express  pain,  suffering,  distress  and  lasting 
harm.  It  is  therefore  necessary  to  improve  the  welfare  of  animals  used  in  scientific 
procedures  by  raising  the  minimum  standards  for  the  protection  of  those  animals  in 
line with the latest scientific developments. 

It  is  necessary  to  include  specific  invertebrate  species  within  the  scope  of  this 
Directive,  as  there  is  scientific  evidence  of  the  potential  ability  of  such  species  to 
experience pain, suffering, distress and lasting harm.  

This Directive should also cover embryonic and foetal forms of vertebrate animals, as 
there  is  scientific  evidence  showing  that  such  forms  in  the  last  third  of  their 
development have an increased risk of experiencing pain, suffering and distress, which 
may also affect negatively their subsequent development. Scientific evidence has also 
shown  that  procedures  on  embryonic  and  foetal  forms  at  an  earlier  stage  of 
development  could  result  in  pain,  suffering,  distress  or  lasting  harm,  should  the 
developmental  forms  be  allowed  to  live  beyond  the  first  two  thirds  of  their 
development. 

(8)  While it is desirable to replace the use of live animals in procedures by other methods 
not entailing the use of live animals, the use of live animals continues to be necessary 
to protect human and animal health and the environment. 

(9) 

The care and use of live animals for scientific purposes is governed by internationally 
established  principles  of  replacement,  reduction  and  refinement.  To  ensure  that  the 
way in which animals are bred, cared for and used in procedures in the Community is 
in  line  with  that  of  the  other  international  and  national  standards  outside  the 
Community,  the  replacement,  reduction  and  refinement  should  be  considered 
systematically when implementing this Directive. 

(10)  Animals have an intrinsic value in themselves which must be respected. There are also 
ethical  concerns  of  the  general  public  as  regards  the  use  of  animals  in  procedures. 
Therefore, the animals should always be treated as sentient creatures and their use in 
scientific  procedures  should  be  restricted  to  areas  which  advance  science  and 
ultimately  benefit  human  or  animal  health,  or  the  environment.  Use  of  animals  for 
scientific  procedures  in  other  areas  under  Community  competence  should  be 
prohibited. 

(11)  The  principles  of  replacement,  reduction  and  refinement  should  be  implemented 
through  a  strict  hierarchy  of  the  requirement  to  use  alternative  methods.  Where  no 
alternative method is recognised by Community legislation, numbers of animals may 
be  reduced  by  resorting  to  other  methods  which  are  reasonably  and  practically 
available,  and  by  implementing  testing  strategies,  such  as  use  of  in  vitro  and  other 
methods that would reduce and refine the use of animals.  

EN 

14 

   EN 

(12)  The  choice  of  methods  and  the  species  to  be  used  have  a  direct  impact  on  both  the 
numbers  of  animals  used  and  their  welfare.  The  choice  of  methods  should  therefore 
ensure  the  selection  of  the  method  that  is  able  to  provide  most  adequate  results  and 
likely to cause the minimum pain, suffering or distress. Such selected methods should 
use  the  minimum  number  of  animals  that  would  provide  statistically  reliable  results 
and  choose  the  species  with  the  lowest  degree  of  neurophysiological  sensitivity  that 
are optimal for the extrapolation into target species. 

(13)  The  methods  selected  should  avoid,  as  far  as  possible,  death  as  an  end-point  due  to 
severe  suffering  caused  by  the  approaching  death.  Where  possible,  it  should  be 
substituted  by  more  humane  end-points  using  clinical  signs  that  determine  the 
impending death thereby allowing the animal to be killed by a humane method without 
any further suffering. 

(14)  The  use  of  inappropriate  methods  for  killing  an  animal  can  cause  significant  pain, 
distress  and  suffering  to  the  animal.  The  level  of  competence  of  the  person  carrying 
out this operation is equally important. Animals should therefore be killed only by an 
authorised person with a humane method that is considered appropriate to the species. 

(15) 

It is necessary to ensure that the use of animals in procedures does not pose a threat to 
biodiversity. Therefore, the use of endangered species in procedures should be limited 
to a strict minimum to cover essential biomedical reasons as well as research aimed at 
the preservation of those species. 

(16)  With  current  scientific  knowledge  the  use  of  non-human  primates  in  scientific 
procedures is still necessary in biomedical research. Due to their genetic proximity to 
human  beings  and  to  their  highly  developed  social  skills,  the  use  of  non-human 
primates in scientific procedures raises specific ethical and practical problems in terms 
of  meeting  their  behavioural,  environmental  and  social  needs  in  a  laboratory 
environment. Furthermore, the use of non-human primates is of the highest concern to 
the public. Therefore the use of non-human primates should only be allowed in those 
essential  biomedical  areas  for  the  benefit  of  human  beings  for  which  no  other 
replacement  alternative  methods  are  yet  available  and  only  in  cases  where  the 
procedures are carried out in relation to clinical conditions having a substantial impact 
on  patients’  day-today  functioning  as  being  either  life-threatening  or  debilitating,  or 
for  the  preservation  of  the  respective  non-human  primate  species.  Fundamental 
research  in  some  areas  of  the  biomedical  sciences  can  provide  important  new 
information relevant to many life-threatening and debilitating human conditions. The 
is  established 
life-threatening  or  debilitating  clinical  conditions 
reference 
terminology  in  EC  legislation  as  reflected  in  Regulation  141/2000/EC,  in  Directive 
2001/20/EC, Regulation 726/2004/EC and Commission Regulation 507/2006/EC. 

to 

(17)  The use of great apes, as the closest species to human beings with the most advanced 
social  and  behavioural  skills,  should  only  be  allowed  in  research  aimed  at  the 
preservation  of  those  species  and  where  action  in  relation  to  a  life-threatening, 
debilitating condition endangering human beings is warranted, and no other species or 
alternative  method  could  suffice  for  the  aims  of  the  procedure.  The  Member  State 
claiming such a need should provide the necessary information for the Commission to 
take a decision. 

EN 

15 

   EN 

(18)  The capture  of non-human  primates  from the wild  is highly stressful for the animals 
and increases the risk of injury and suffering during capture and transport. In order to 
gradually  end  the  capturing  of  animals  from  the  wild  for  breeding  purposes,  only 
animals that are the offspring of an animal which has been bred in captivity should be 
made  available  for  use  in  scientific  procedures  as  soon  as  possible.  Establishments 
breeding and supplying non-human primates should therefore have a strategy in place 
to support and facilitate the progressive move towards that goal.  

(19)  There is a need for certain species of vertebrate animals used in procedures to be bred 
specifically  for  use  in  procedures  so  that  their  genetic,  biological  and  behavioural 
background  is  well-known  to  persons  undertaking  the  procedures.  Such  knowledge 
both  increases  the  scientific  quality  and  reliability  of  the  results  and  decreases  the 
variability,  ultimately  resulting  in  fewer  procedures  and  reduced  animal  use. 
Furthermore, for reasons of animal welfare and conservation, the use of animals taken 
from the wild in procedures should be limited only to cases where the purpose of the 
procedures cannot be achieved using animals bred specifically for use in procedures. 

(20)  Since the background of stray and feral animals of domestic species is not known, and 
capture  and  placement  into  establishments  increases  distress  for  those  animals,  they 
should not be used in procedures. 

(21)  To  enhance  transparency,  facilitate  the  project  authorisation  and  provide  tools  for 
monitoring compliance, a severity classification of procedures should be introduced on 
the basis of estimated level of pain, suffering, distress and lasting harm that is inflicted 
on  the  animals.  To  give  precision  how  severity  classes  should  be  assigned,  the 
Commission  should  develop  criteria  with  stakeholder  input  using  existing  severity 
classification  schemes  in  place  in  Member  States  as  well  as  those  promoted  by 
international organisations as basis. 

(22)  From  the  ethical  standpoint,  there  should  be  an  upper  limit  of  pain,  suffering  and 
distress,  above which animals should never be subjected in scientific procedures. To 
that  effect,  the  performance  of  procedures  that  result  in  severe  pain,  suffering  or 
distress and which is likely to be prolonged, should be prohibited. When developing a 
common format for reporting purposes, instead of the predicted severity at the time of 
the ethical  evaluation,  the  actual severity experienced by the  animal  should be  taken 
into account. 

(23)  The number of animals used in procedures could be reduced by performing procedures 
on animals more than once, where this does not detract from the scientific objective or 
result in poor animal welfare. However, the re-use of animals should be judged against 
minimising  any  adverse  affects  on  their  welfare,  taking  into  account  the  lifetime 
experience of the individual animal. As a result of this potential conflict, the re-use of 
animals  should  be  considered  on  a  case-by-case  basis  and  limited  only  to  those 
procedures where pain, distress and suffering are significantly reduced. 

(24)  At the end of the procedure, the most appropriate decision should be taken as regards 
the  future  of  the  animal  on  the  basis  of  animal  welfare  and  potential  risks  to  the 
environment.  The  animals  whose  welfare  would  be  compromised  should  be  killed 
using a humane method. In some cases, animals should be set free or animals such as 
dogs and cats should be allowed to be re-homed in families as there is a high public 
concern as to the fate of those animals. Should establishments allow re-homing, it is 

EN 

16 

   EN 

essential  that  there  is  a  scheme  in  place  to  provide  the  appropriate  socialisation  to 
those animals in order to ensure successful re-homing as well as to avoid unnecessary 
distress to the animals and to guarantee public safety. 

(25)  Animal  tissue  and  organs  are  used  for  the  development  of  in  vitro  methods.  To 
implement the principle of reduction, Member States should establish programmes for 
sharing the organs and tissue of animals that are killed using humane methods. 

(26)  The welfare of the animals used in procedures is highly dependent on the quality and 
professional competence of the personnel supervising procedures, as well as of those 
performing procedures or supervising those taking care of the animals on a daily basis. 
In  order  to  secure  an  adequate  degree  of  competence  of  the  persons  dealing  with 
animals  and  with  procedures  involving  animals,  those  activities  should  only  be 
performed by persons authorised by the competent authorities. The main focus should 
be  on  obtaining  and  maintaining  an  adequate  level  of  competence  which  should  be 
demonstrated before authorising those persons or renewing their authorisation. 

(27)  Establishments should have adequate installations and equipment in place to meet the 
accommodation  requirements  of  the  animal  species  concerned  and  to  allow  the 
procedures to be performed efficiently and with the least distress to the animals. The 
establishments should operate only if they are authorised by the competent authorities. 

(28)  To  ensure  the  on-going  monitoring  of  animal  welfare  needs,  appropriate  veterinary 
care should be available at all times and a staff member should be made responsible 
for the care and welfare of animals in each establishment.  

(29)  Animal  welfare  considerations  should  be  given  the  highest  priority  in  the  context  of 
animal  keeping,  breeding  and  use.  Each  establishment  should  therefore  have  an 
independent permanent ethical review body in place with the primary task of focusing 
on ethical debate at establishment level, fostering a climate of care and providing tools 
for  practical  application  and  timely  implementation  of  the  recent  technical  and 
scientific  developments  in  relation  to  the  principles  of  replacement,  reduction  and 
refinement  to  enhance  the  life-time  experience  of  the  animals.  The  decisions  of  the 
permanent  ethical  review  body  should  be  properly  documented  and  open  to  scrutiny 
during inspections. 

(30) 

In order to enable the competent authorities to monitor compliance with this Directive, 
each establishment should maintain accurate records on the numbers of animals, their 
origins and fate. 

(31)  Non-human  primates  with  highly  developed  social  skills  should  have  a  personal 
history file from birth covering their lifetimes in order to be able to receive the care, 
accommodation and treatment that meet their individual needs and characteristics. 

(32)  The accommodation and care of the animals should be based on the specific needs and 

characteristics of each species. 

(33)  On  15  June  2006  the  Fourth  Multilateral  Consultation  of  Parties  to  the  European 
Convention  for  the  protection  of  vertebrate  animals  used  for  experimental  and  other 
scientific  purposes  adopted  a  revised  Appendix  A  which  sets  out  guidelines  for 
accommodation  and  care  of  experimental  animals.  Commission  Recommendation 
2007/526/EC  of  18  June  2007  on  guidelines  for  the  accommodation  and  care  of 

EN 

17 

   EN 

animals  used  for  experimental  and  other  scientific  purposes28  incorporated  those 
guidelines. 

(34)  There are differences in the requirements for the accommodation and care of animals 
between  Member  States,  which  contribute  to  the  distortion  of  the  internal  market. 
Furthermore, some of those requirements no longer reflect the most recent knowledge 
on the impacts of accommodation and care conditions on both the animal welfare and 
the  scientific  results  of  procedures.  It  is  therefore  necessary  to  establish  in  this 
Directive the minimum requirements on accommodation and care. 

(35)  To  monitor  compliance  with  this  Directive,  Member  States  should  carry  out  at  least 
two  inspections  annually  in  each  establishment.  To  ensure  public  confidence  and 
promote  transparency  at  least  one  inspection  a  year  must  be  unannounced. 
Programmes for joint inspections by Member States should be established to foster an 
environment of sharing good practice and expertise. 

(36)  To assist the Member States in the enforcement of this Directive and on the basis of 
the findings in the reports on the operation of the national inspections, the Commission 
should,  where  appropriate,  carry  out  controls  of  the  national  inspection  systems. 
Member  States  should  address  any  weaknesses  identified  in  the  findings  of  these 
controls. 

(37)  Comprehensive ethical evaluation of projects using animals, which forms the core of 
the project authorisation, should ensure implementation of principles of replacement, 
reduction and refinement in those projects.  

(38) 

(39) 

It  is  also  essential  to  ensure  both  on  moral  and  scientific  grounds  that  each  use  of 
animals is carefully evaluated on the scientific validity, usefulness and relevance of the 
expected result of that use. The likely harm to the animals should be balanced against 
the  expected  benefits  of  the  project.  Therefore,  an  independent  ethical  evaluation 
should be carried out as part of the authorisation process of projects involving the use 
of  live  animals.  Effective  implementation  of  an  ethical  evaluation  should  also  allow 
for an appropriate assessment of the use of any new scientific experimental techniques 
as they emerge. 

In  certain  cases,  due  to  the  nature  of  the  project,  the  type  of  species  used  and  the 
likelihood of achieving the desired objectives of the project, it is necessary to carry out 
a  retrospective  assessment.  Since  projects  may  vary  significantly  in  terms  of 
complexity,  length,  as  well  as  the  delay  for  obtaining  the  results,  it  is  necessary  that 
the decision as to whether retrospective assessment should be carried out takes those 
aspects fully into account. 

(40)  To ensure that the public is informed, it is important that objective information on the 
projects using live animals is made publicly available. The format of that information 
should  not  violate  proprietary  rights  or  expose  confidential  information.  Therefore, 
user  establishments  should  provide  anonymous  non-technical  summaries  of  those 
projects,  including  the  results  of  any  retrospective  assessments,  and  make  those 
summaries publicly available. 

28 

OJ L 197, 30.7.2007, p. 1. 

EN 

18 

   EN 

                                                 
(41)  To  manage  risks  to  human  and  animal  health  and  the  environment,  Community 
legislation  provides  that  substances  and  products  can  only  be  marketed  after 
appropriate safety and efficacy data have been submitted. Some of those requirements 
can  be  fulfilled  only  by  resorting  to  animal  testing,  hereinafter  referred  to  as 
“regulatory testing”. It is necessary to introduce specific measures in order to increase 
the  use  of  alternative  approaches  and  to  eliminate  unnecessary  duplication  of 
regulatory  testing.  For  that  purpose  Member  States  should  recognise  the  validity  of 
test data produced using test methods provided for in Community legislation.  

(42)  To reduce the unnecessary administrative workload and enhance the competitiveness 
of  Community  research  and  industry,  it  should  be  possible  to  authorise  multiple 
regulatory testing procedures under one group authorisation, albeit without exempting 
those procedures from ethical evaluation. 

(43)  To  ensure  effective  examination  of  authorisation  applications  and  to  enhance  the 
competitiveness  of  Community  research  and  industry,  a  time-limit  should  be  set  for 
the  competent  authorities  to  evaluate  project  proposals  and  take  decisions  on 
authorisation  of  those  projects.  In  order  not  to  compromise  the  quality  of  the  ethical 
evaluation, additional time may be required for more complex project proposals due to 
the  number  of  disciplines  involved,  the  novel  characteristics  and  more  complex 
techniques  of  the  proposed  project.  However,  extension  of  deadlines  for  ethical 
evaluation should remain an exception. 

(44)  The  availability  of  alternative  methods  is  highly  dependent  on  the  progress  of  the 
research for the development of alternatives. The Community Framework Programmes 
for  Research  and  Technological  Development  have  provided  increasing  funding  for 
projects  which  aim  to  replace,  reduce  and  refine  the  use  of  animals  in  procedures. 
Therefore,  in  order  to  increase  competitiveness  of  research  and  industry  in  the 
Community,  the  Commission  and  the  Member  States  should  contribute  to  the 
development and validation of alternative approaches. 

(45)  The European Centre for the Validation of Alternative Methods is established within 
the  Joint  Research  Centre  of  the  Commission  and  coordinates  the  validation  of 
alternative  approaches  in  the  Community.  However,  there  is  an  increasing  need  for 
new methods to be developed and proposed for validation. To provide the necessary 
mechanisms  at  Member  State  level,  a  reference  laboratory  for  the  validation  of 
alternative  methods  should  be  designated  by  each  Member  State.  Member  States 
should  designate  reference  laboratories  which  are  accredited  in  accordance  with 
Directive 2004/10/EC of the European Parliament and of the Council of 11 February 
2004 on the harmonisation of laws, regulations and administrative provisions relating 
to the application of the principles of good laboratory practice and the verification of 
their  applications  for  tests  on  chemical  substances29  in  order  to  ensure  coherent  and 
comparable quality of the results. 

(46)  There is a need to ensure a coherent approach to ethical evaluation and ethical review 
strategies  at  national  level.  Member  States  should  establish  national  animal  welfare 
and  ethics  committees  to  give  advice  to  the  competent  authorities  and  permanent 
ethical  review  bodies  of  establishments  in  order  to  promote  the  principles  of 

29 

OJ L 50, 20.2.2004, p. 44. 

EN 

19 

   EN 

                                                 
replacement,  reduction  and  refinement.  Therefore,  the  network  of  national  animal 
welfare  and  ethics  committees  should  play  a  role  in  the  exchange  of  best  practice  at 
Community level. 

(47)  The technical and scientific advancements in biomedical research can be rapid as can 
the  increase  in  knowledge  of  factors  influencing  animal  welfare.  It  is  therefore 
necessary  to  provide  for  review  of  this  Directive.  Such  a  review  should  examine 
possible replacement of the use of animals, and in particular non-human primates, as a 
matter of priority where it is possible, taking into account the advancement of science. 

(48)  The measures necessary for the implementation of this Directive should be adopted in 
accordance  with  Council  Decision  1999/468/EC  of  28  June  1999  laying  down  the 
procedures for the exercise of implementing powers conferred on the Commission30.  

(49) 

In  particular,  power  should  be  conferred  on  the  Commission  to  establish  the  criteria 
for  classification  of  procedures  and  to  adapt  Annexes  II  to  VII  to  scientific  and 
technical  progress.  Since  those  measures  are  of  general  scope  and  are  designed  to 
amend  non-essential  elements  of  this  Directive,  inter  alia  by  supplementing  it  with 
new  non-essential  elements,  they  must  be  adopted  in  accordance  with  the  regulatory 
procedure with scrutiny provided for in Article 5a of Decision 1999/468/EC. 

(50)  Member States should lay down rules on penalties applicable to infringements of the 
provisions  of  this  Directive  and  ensure  that  they  are  implemented.  Those  penalties 
should be effective, proportionate and dissuasive. 

(51)  Directive 86/609/EEC should therefore be repealed. 

(52)  Benefits to animal welfare from applying project authorisation retrospectively, and the 
related  administrative  costs,  can  only  be  justified  for  long  term  on-going  projects. 
Therefore,  it  is  necessary  to  include  transitional  measures  for  on-going  short  and 
medium  term  projects  to  avoid  the  need  for  a  retrospective  authorisation  with  only 
limited benefits. 

(53)  Since the objectives of the action to be taken - the harmonisation of legislation on use 
of  animals  for  scientific  purposes  -  cannot  be  sufficiently  achieved  by  the  Member 
States  and  can  therefore,  by  reason  of  scale  and  effects,  be  better  achieved  at 
Community  level,  the  Community  may  adopt  measures,  in  accordance  with  the 
principle  of subsidiarity  as  set  out  in  Article 5 of the Treaty.  In accordance with the 
principle  of  proportionality,  as  set  out  in  that  Article,  this  Directive  does  not  go 
beyond what is necessary in order to achieve those objectives. 

30 

OJ L 184, 17.7.1999, p. 23. Decision as amended by Decision 2006/512/EC (OJ L 200, 22.7.2006, p. 
11). 

EN 

20 

   EN 

                                                 
HAS ADOPTED THIS DIRECTIVE: 

CHAPTER I 
 GENERAL PROVISIONS 

Article 1 
Subject matter 

This Directive establishes measures for the protection of animals used or intended to be used 
for scientific purposes. 

To that end, it lays down rules on the following: 

(1) 

(2) 

(3) 

(4) 

the  replacement  and  reduction  of  the  use  of  animals  in  procedures  and  the 
refinement  of  the  breeding,  accommodation,  care  and  use  of  animals  in 
procedures;  

the origin, breeding, marking, care and accommodation of animals; 

the functioning of breeding, supplying or user establishments;  

the  evaluation  and  authorisation  of  projects  involving  the  use  of  animals  in 
procedures. 

Article 2 
Scope 

1. 

This  Directive  shall  apply  where  animals  are  used  or  intended  to  be  used  in 
procedures, or where they are bred specifically so that their organs or tissues may be 
used for scientific purposes.  

The elimination of pain, suffering, distress or lasting harm by the successful use of 
anaesthesia,  analgesia  or  other  methods  shall  not  exclude  the  use  of  an  animal  in 
procedures from the scope of this Directive. 

2. 

This Directive shall apply to the following animals: 

(a) 

(b) 

live  non-human  vertebrate  animals,  including  independently  feeding 
larval  forms  and  embryonic  or  foetal  forms  as  from  the  last  third  of 
their normal development; 

live  invertebrate  animals,  including  independently  feeding  larval 
forms, of those species listed in Annex I. 

3. 

This Directive shall apply to animals used in procedures, which are at an earlier stage 
of development than that referred to in point (a) of paragraph 2, if the animal is to be 
allowed  to  live  beyond  that  stage  of  development  and  is  likely  to  experience  pain, 
suffering, distress or lasting harm after it has reached that stage of development.  

EN 

21 

   EN 

4. 

This Directive shall not apply to the following: 

(a) 

(b) 

(c) 

non-experimental,  agricultural  or  clinical  veterinary  practices  and 
trials; 

practices undertaken for the purposes of recognised animal husbandry; 

practices undertaken for the primary purpose of marking an animal. 

(d) 

practices that are not invasive 

5. 

This Directive shall apply without prejudice to Council Directive 76/768/EEC on the 
approximation of the laws of the Member States relating to cosmetic products. 

For the purposes of this Directive the following definitions shall apply: 

Article 3 
Definitions 

(1) 

(2) 

(3) 

(4) 

(5) 

(6) 

'procedure'  means  any  use  of  an  animal  for  experimental  or  other  scientific 
purposes,  with  known  or  unknown  outcome,  which  may  cause  the  animal 
pain,  suffering  distress  or  lasting  harm,  including  any  course  of  action 
intended, or liable, to result in the birth of an animal in any such condition or 
in the creation of a new genetically modified animal line; 

'project'  means  a  programme  of  work  having  a  defined  scientific  objective 
and involving one or more procedures;  

'establishment'  means  any  installation,  building,  group  of  buildings  or  other 
premises and may include a place that is not wholly enclosed or covered and 
mobile facilities; 

'breeding  establishment'  means  any  establishment  where  animals  are  bred 
with a view to their use in procedures or for the use of their tissue or organs 
for scientific purposes;  

'supplying  establishment'  means  any  establishment,  other  than  a  breeding 
establishment,  from  which  animals  are  supplied  with  a  view  to  their  use  in 
procedures or for the use of their tissue or organs for scientific purposes; 

'user  establishment'  means  any  establishment  where  animals  are  used  in 
procedures. 

Article 4 
Replacement, reduction and refinement  

Where a method of testing not involving the use of animals exists and may be used in 
place of a procedure, Member States shall ensure that the alternative method is used. 

Member States shall ensure that the number of animals used in projects is reduced to 
the minimum without compromising the objectives of the project. 

22 

   EN 

1. 

2. 

EN 

3. 

Member States shall ensure refinement of breeding, accommodation and care, and of 
methods  used  in  procedures,  eliminating  or  reducing  to  the  minimum  any  possible 
pain, suffering, distress or lasting harm to the animals. 

Article 5 
Purposes of procedures 

Procedures may be carried out for the following purposes only: 

(1) 

basic research for the advancement of knowledge in biological or behavioural 
sciences; 

(2) 

translational or applied research with either of the following aims: 

(a) 

(b) 

the avoidance, prevention, diagnosis or treatment of disease, ill-health 
or  other  abnormality  or  their  effects  in  human  beings,  animals  or 
plants;  

the assessment, detection, regulation or modification of physiological 
conditions in human beings, animals or plants;  

(3) 

(4) 

the  development,  manufacture  or  testing  of  the  quality,  effectiveness  and 
safety of drugs, food- and feed-stuffs and other substances or products having 
either of the aims referred to in point (2); 

the  protection  of  the  natural  environment  in  the  interests  of  the  health  or 
welfare of human beings or animals; 

(5) 

research aimed at preservation of the species; 

(6) 

higher education or training;  

(7) 

forensic inquiries. 

Article 6 
Humane methods of killing 

1. 

2. 

3. 

Member States shall ensure that animals are killed in an authorised establishment, by 
an  authorised  person  and  with  a  minimum  of  pain,  suffering  and  distress  and,  in 
relation to the species included in Annex V, using the appropriate humane method of 
killing as set out in that Annex.  

However, in case of a field study an animal may be killed outside of an authorised 
establishment. 

Competent  authorities  may  grant  exemptions  from  paragraph  1  on  the  basis  of 
scientific  justification  that  the  purpose  of  the  procedure  cannot  be  achieved  by  the 
use of a humane method of killing. 

Paragraph  1  shall  not  apply  where  an  animal  has  to  be  killed  in  emergency 
circumstances for animal welfare reasons. 

EN 

23 

   EN 

Member States shall determine the emergency circumstances referred to in the first 
subparagraph. 

CHAPTER II  
PROVISIONS ON THE USE OF CERTAIN ANIMALS IN 
PROCEDURES 

Article 7 
Endangered species other than non-human primates 

1. 

Endangered species listed in Annex A to Council Regulation (EC) No 338/9731 shall 
not  be  used  in  procedures,  with  the  exception  of  those  procedures  meeting  the 
following conditions: 

(a) 

(b) 

the procedure has one of the purposes referred to in points (2)(a), (3) 
or (5) of Article 5;  

there  is  a  scientific  justification  that  the  purpose  of  the  procedure 
cannot be achieved by the use of species other than those listed in that 
Annex.  

2. 

This article shall not apply to any species of non-human primates. 

Article 8 

Non-human primates 

1. 

Non-human  primates  shall  not  be  used  in  procedures,  with  the  exception  of  those 
procedures meeting the following conditions: 

(a) 

(b) 

the procedure has one of the purposes referred to in points (1), (2)(a), 
(3)  and  is  undertaken  with  a  view  to  the  avoidance,  prevention, 
diagnosis  or  treatment  of  life-threatening  or  debilitating  clinical 
conditions in human beings or the purpose referred to in point (5) of 
Article 5; 

there  is  a  scientific  justification  that  the  purpose  of  the  procedure 
cannot  be  achieved  by  the  use  of  other  species  than  non-human 
primates. 

2. 

Notwithstanding paragraph 1, great apes shall not be used in procedures, subject to 
the use of the safeguard clause in Article 50. 

31 

OJ L 61, 3.3.1997, p. 1. 

EN 

24 

   EN 

                                                 
Article 9 
Animals taken from the wild 

1. 

2. 

1. 

Animals taken from the wild shall not be used in procedures.  

Competent  authorities  may  grant  exemptions  from  paragraph  1  on  the  basis  of 
scientific  justification  that  the  purpose  of  the  procedure  cannot  be  achieved  by  the 
use of an animal which has been bred for use in procedures. 

Article 10 
Animals bred for use in procedures 

Member States shall ensure that animals belonging to the species listed in Annex II 
may  only  be  used  in  procedures  where  those  animals  have  been  bred  for  use  in 
procedures. 

However,  as  from  the  dates  set  out  in  Annex  III,  Member  States  shall  ensure  that 
non-human primates listed in that Annex may only be used in procedures where they 
are the offspring of non-human primates which have been bred in captivity.  

2. 

Competent  authorities  may  grant  exemptions  from  paragraph  1  on  the  basis  of  a 
scientific justification. 

Article 11 
Stray and feral animals of domestic species  

Stray and feral animals of domestic species shall not be used in procedures. 

CHAPTER III  
PROCEDURES 

Article 12 
Procedures  

1. 

Member  States  shall  ensure  that  procedures  are  always  carried  out  in  user 
establishments.  

The competent authority may grant an exemption from the first subparagraph on the 
basis of scientific justification.  

2. 

Procedures may be carried out only within the framework of a project. 

Article 13 
Methods used in procedures  

1. 

Member States shall ensure that a procedure is not carried out if another scientifically 
satisfactory method or testing strategy of obtaining the result sought, not entailing the 

EN 

25 

   EN 

use of an animal, is recognised by Community legislation. In the absence of such a 
method, a procedure may not be carried out if a scientifically satisfactory method or 
testing  strategy  for  obtaining  the  result  sought,  including  computer  supported,  in 
vitro and other methodologies, not entailing the use of an animal, is reasonably and 
practicably available. 

In a choice between procedures, those which use the minimum number of animals, 
involve  animals  with  the  lowest  degree  of  neurophysiological  sensitivity,  cause  the 
least  pain,  suffering,  distress  or  lasting  harm  and  which  are  most  likely  to  provide 
satisfactory results shall be selected. 

Death as the end-point in a procedure shall be avoided as far as possible and replaced 
by  early  and  humane  end-points.  If  death  as  the  end-point  is  unavoidable,  the 
procedure  shall  be  designed  so  as  to  result  in  the  deaths  of  as  few  animals  as 
possible. 

Article 14 
Anaesthesia 

Member States shall ensure that all procedures are carried out under general or local 
anaesthesia. 

By  way  of  derogation  from  paragraph  1,  procedures  may  be  carried  out  without 
anaesthesia in the following conditions: 

(c) 

(d) 

where  anaesthesia  is  judged  to  be  more  traumatic  to  the  animal  than 
the procedure itself; 

where  anaesthesia  is  incompatible  with  the  purpose  of  the  procedure 
unless  the  procedure  involves  serious  injuries  that  may  cause  severe 
pain. 

If  the  procedure  is  carried  out  without  anaesthesia,  analgesics  or  other  appropriate 
methods shall be used to ensure that unavoidable pain, suffering and distress are kept 
to a minimum. 

Member  States  shall  ensure  that  animals  are  not  given  any  drug  to  stop  or  restrict 
them from showing pain without an adequate level of anaesthesia or analgesia. 

In those cases, a scientific justification shall be provided, accompanied by the details 
of the anaesthetic or analgesic regime. 

An animal, which may suffer considerable pain once anaesthesia has worn off, shall 
be treated with pre-emptive and post-operative analgesics or other appropriate pain-
relieving methods, provided that it is compatible with the purpose of the procedure. 
Where the treatment with analgesics is not possible, the animal shall be immediately 
killed by a humane method. 

2. 

3. 

1. 

2. 

3. 

4. 

5. 

EN 

26 

   EN 

Article 15 
Classification of severity of procedures 

1. 

2. 

3. 

Member  States  shall  ensure  that  all  procedures  are  classified  as  'up  to  mild', 
'moderate',  'severe'  or  'non-recovery'  on  the  basis  of  the  duration  and  intensity  of 
potential pain, suffering, distress and lasting harm, the frequency of intervention, the 
deprivation of ethological needs and the use of anaesthesia or analgesia or both.  

Member  States  shall  ensure  that  the  procedures  classified  as  "severe"  are  not 
performed if the pain, suffering or distress is likely to be prolonged. 

Procedures performed under general anaesthesia, at the end of which and without a 
possibility to recover consciousness the animal is killed using humane method, shall 
be classified as "non-recovery". 

4. 

The Commission shall establish the criteria for classification of procedures.  

Those  measures,  designed  to  amend  non-essential  elements  of  this  Directive  by 
supplementing  it,  shall  by  [within  18  months  from  the  entry  into  force  of  this 
Directive]  be  adopted  in  accordance  with  the  regulatory  procedure  with  scrutiny 
referred to in Article 51(3). 

Article 16 
Re-use 

1. 

2. 

1. 

Member  States  shall  ensure  that  an  animal  already  used  in  a  procedure,  when  a 
different animal on which no procedure has previously been carried out could also be 
used, may be re-used in a new procedure only when all of the following conditions 
are met: 

(a) 

(b) 

the previous procedure was classified as 'up to mild'; 

it  is  demonstrated  that  its  general  state  of  health  and  well-being  has 
been fully restored; 

(c) 

the further procedure is classified as 'up to mild' or 'non-recovery'. 

By  way  of  derogation  from  paragraph  1,  the  competent  authority,  on  the  basis  of 
scientific  justification,  may  allow  re-use  of  an  animal  as  long  as  the  animal  is  not 
used  more  than  once  after  having  undergone  a  procedure  entailing  severe  pain, 
distress or equivalent suffering and the further procedure is classified as 'up to mild' 
or as 'non-recovery'. 

Article 17 
End of the procedure 

A procedure shall be deemed to end when no further observations are to be made for 
that  procedure  or,  as  regards  new  genetically  modified  animal  lines,  when  lack  of 
adverse effects to animals can be scientifically demonstrated.  

EN 

27 

   EN 

2. 

3. 

4. 

At the end of a procedure, a decision shall be taken by a veterinarian or by another 
competent  person  on  whether  the  animal  shall  be  kept  alive  or  killed  by  a  humane 
method.  

An animal shall be killed by a humane method when it is likely to remain in lasting 
pain or distress.  

Where  an  animal  is  to  be  kept  alive,  it  shall  receive  the  care  and  accommodation 
appropriate to its state of health and be placed under the supervision of a veterinarian 
or another competent person. 

Article 18 
Sharing organs and tissues 

Member  States  shall  establish  programmes  for  the  sharing  of  organs  and  tissues  of  animals 
killed by a humane method. 

Article 19 
Setting free of animals and re-homing 

Member States may allow animals used or intended to be used in procedures to be set free or 
re-homed provided that the following conditions are met: 

(a) 

(b) 

(c) 

the state of health of the animal allows it; 

there is no danger to public health or the environment;  

the maximum possible care has been taken to safeguard the well-being 
of the animal. 

CHAPTER IV  
AUTHORISATION 

Section 1 
Authorisation of persons 

Article 20 
Authorisation of persons  

1. 

Member  States  shall  ensure  that  persons  are  authorised  by  the  competent  authority 
before they carry out any of the following functions: 

(a) 

the carrying out of procedures on animals, including their killing by a 
humane method; 

EN 

28 

   EN 

(b) 

(c) 

the supervision or design of procedures and projects; 

the supervision of those taking care of animals. 

Member  States  shall  ensure  that,  for  the  purposes  of  the  authorisation,  the  persons 
referred  to  in  paragraph  1  have  the  appropriate  education  and  training  and  have 
demonstrated the requisite competence. 

Persons carrying out the functions referred to in point (b) of paragraph 1 shall have 
received  instruction  in  a  scientific  discipline  relevant to  the  work  being  undertaken 
and shall be capable of handling and taking care of the species concerned. 

All  authorisations  of  persons  shall  be  granted  for  a  limited  period  of  time,  not 
exceeding five years. Member States shall ensure that the renewal of an authorisation 
of persons is only granted on the basis of demonstration of the requisite competence. 

Member  States  shall  publish,  on  the  basis  of  the  elements  set  out  in  Annex  VI, 
minimum  requirements  with  regard  to  education,  training  and  requirements  for 
obtaining, maintaining and demonstrating requisite competence. 

Section 2 
Requirements for establishments 

Article 21 
Authorisation of establishments  

Member States shall ensure that all breeding, supplying and user establishments are 
authorised by and registered with the competent authority.  

An authorisation shall be given to an establishment only if it has been inspected by 
the competent authority and found to comply with the requirements of this Directive. 

The authorisation shall specify the type of establishment and the person responsible 
for the establishment and for compliance with the provisions of this Directive.  

Article 22 
Suspension and withdrawal of authorisation  

Where  an  establishment  no  longer  complies  with  requirements  set  out  in  this 
Directive, the competent authority shall suspend or withdraw its authorisation.  

Member States shall ensure that, where the authorisation is suspended or withdrawn, 
the welfare of the animals housed in the establishment is not adversely affected. 

2. 

3. 

4. 

1. 

2. 

1. 

2. 

EN 

29 

   EN 

Article 23 
Requirements for installations and equipment 

1. 

2. 

Member States shall ensure that all breeding, supplying and user establishments have 
installations  and  equipment  suited  to  the  species  of  animals  housed  and,  where 
procedures are carried out, to the performance of the procedures. 

The  design,  construction  and  method  of  functioning  of  the  installations  and 
equipment referred to in paragraph 1 shall ensure that the procedures are carried out 
as effectively as possible, obtaining consistent results with the minimum number of 
animals and the minimum degree of pain, suffering, distress or lasting harm. 

Article 24 
Requirements for personnel in establishments  

Each breeding, supplying and user establishment shall have sufficient trained staff, including 
as a minimum: 

(1) 

persons responsible on site for the welfare and care of the animals bred, kept 
or used in the establishment, who shall ensure the following:  

(a) 

(b) 

(c) 

(d) 

the staff dealing with animals have access to the information specific 
to the species housed in the establishment; 

the  projects  are  carried  out 
authorisation; 

in  accordance  with 

the  project 

any procedure in the course of which any unnecessary distress, pain or 
suffering is being inflicted on an animal is stopped; 

in  the  event  of  non-compliance  with  the  project  authorisation,  the 
appropriate  measures  to  rectify  the  non-compliance  are  taken, 
recorded and reported to the permanent ethical review body. 

(2) 

a  designated  veterinarian  with  expertise  in  laboratory  animal  medicine 
charged with advisory duties in relation to the well-being and treatment of the 
animals. 

Article 25 
Permanent ethical review body  

1. 

2. 

Member States shall ensure that each breeding, supplying and user establishment sets 
up a permanent ethical review body. 

The  permanent  ethical  review  body  shall  include  the  designated  veterinarian,  the 
person(s)  responsible  for  the  welfare  and  care  of  the  animals  in  the  establishment 
and, in the case of a user establishment, a scientific member. 

EN 

30 

   EN 

Article 26 
Tasks of permanent ethical review body 

1. 

The permanent ethical review body shall fulfil the following tasks: 

(a) 

(b) 

(c) 

(d) 

(e) 

(f) 

provide  ethical  advice  to  the  staff  dealing  with  animals  on  matters 
related  to  the  welfare  of  animals  in  relation  to  their  acquisition, 
accommodation, care and use; 

advise  the  staff  of  the  establishment  on  the  application  of  the 
requirement  of  replacement,  reduction  and  refinement  and  keep  it 
informed  on  the  latest  technical  and  scientific  developments  on  the 
application of those requirements; 

establish  and  review  internal  operational  processes  as  regards 
monitoring,  reporting  and  follow  up  in  relation  to  the  welfare  of 
animals housed or used in the establishment; 

review  annually  all  projects  which  are  of  more  than  12  months 
duration, focusing in particular on: 

– 

– 

– 

the  numbers,  species  and  life  stages  of  animals  used  in  the 
preceding year; 

the  justification  for  the  numbers,  species  and  life  stages  of 
animals needed for the subsequent year;  

the  use  of  humane  methods  of  killing  and  how  new 
developments  in  relation  to  the  use  of  animals  in  procedures 
have been taken into account; 

based  on  the  review  referred  to  in  point  (d)  or,  in  the  case  of 
deviations from the project authorisation, examine whether the project 
authorisation needs to be submitted for amendment or renewal; 

advise  on  re-homing  schemes,  in  particular  in  relation  to  the 
appropriate socialisation of the animals to be re-homed. 

2. 

1. 

Member States shall ensure that the records of any advice given to the establishment 
by the permanent ethical review body and decisions taken regarding that advice are 
kept.  

The records shall be submitted to the competent authority upon request. 

Article 27 
Breeding strategy for non-human primates 

Member  States  shall  ensure  that  breeding  and  supplying  establishments  of  non-
human primates have a strategy in place for increasing the proportion of animals that 
are the offspring of non-human primates that have been bred in captivity. 

EN 

31 

   EN 

2. 

Establishments  acquiring  non-human  primates  shall  supply  proof  to  the  competent 
authority, on request, that the establishment from which animals have been acquired 
have a breeding strategy in place. 

Article 28 
Re-homing scheme 

Where Member States allow re-homing as referred to in Article 19, the breeding, supplying 
and  user  establishments  from  which  animals  are  intended  to  be  re-homed  shall  have  a  re-
homing scheme in place that ensures socialisation of the animals that are re-homed. 

Article 29 
Records on animals 

1. 

Member States shall ensure that all breeding, supplying and user establishments keep 
records of the following: 

(a) 

(b) 

(c) 

(d) 

(e) 

(f) 

the  number  and  the  species  of  animals  bred,  acquired,  supplied, 
released or re-homed; 

the  origin  of  the  animals,  including  whether  they  are  bred  for  use  in 
procedures; 

the dates on which the animals are acquired, supplied, released or re-
homed; 

the name and address of  the supplying establishment and the date of 
their arrival; 

the name and address of the recipient of animals; 

the  number  and  species  of  animals  which  have  died  or  have  been 
killed using a humane method in the establishment. 

2. 

1. 

The records referred to in paragraph 1 shall be kept for a minimum of three years and 
shall be submitted to the competent authority upon request.  

Article 30 
Information on dogs, cats and non-human primates  

Member States shall ensure that all breeding, supplying and user establishments keep 
the following information on each dog, cat and non-human primate: 

(a) 

identity; 

(b) 

place of birth; 

(c) 

whether it is bred for use in procedures; 

EN 

32 

   EN 

(d) 

in the case of a non-human primate, whether it is the offspring of non-
human primates that have been bred in captivity. 

Each  non-human  primate  shall  have  an  individual  history  file,  which  follows  the 
animal throughout its life.  

The  file  shall  be  established  at  birth  and  shall  cover  detailed  reproductive,  medical 
and social information on the individual animal. 

The information referred to in paragraph 1 shall be kept for a minimum of three years 
after the death of the animal and shall be submitted to the competent authority upon 
request. 

Article 31 
Marking 

Each  dog,  cat  or  non-human  primate  in  any  breeding,  supplying  or  user 
establishment  shall,  except  in  the  cases  referred  to  in  paragraph  2,  be  provided, 
before it is weaned, with an individual identification mark in the least painful manner 
possible. 

Where  a  dog,  cat  or  non-human  primate  is  transferred  from  one  establishment  to 
another  before  it  is  weaned,  and  it  is  not  practicable  to  mark  it  beforehand,  a  full 
documentary  record,  specifying  in  particular  its  mother,  must  be  maintained  by  the 
receiving establishment until it is so marked. 

Where an unmarked dog, cat or non-human primate is taken into an establishment for 
the first time it shall be marked as soon as possible. 

The establishment shall provide, on request by the competent authority, reasons for 
the animal being unmarked. 

2. 

3. 

1. 

2. 

3. 

4. 

Article 32 
Care and accommodation 

1. 

Member States shall, as far as the care and accommodation of animals is concerned, 
ensure the following: 

(a) 

(b) 

(c) 

all animals are provided with accommodation, an environment, at least 
some  freedom  of  movement,  food,  water  and  care  which  are 
appropriate to their health and well-being; 

any  restrictions  on  the  extent  to  which  an  animal  can  satisfy  its 
physiological and ethological needs are limited to a minimum; 

the environmental conditions in which animals are bred, kept or used 
are checked daily; 

EN 

33 

   EN 

(d) 

(e) 

the  well-being  and  state  of  health  of  animals  are  observed  by  a 
competent  person  to  prevent  pain  or  avoidable  suffering,  distress  or 
lasting harm; 

arrangements  are  made  to  ensure  that  any  defect  or  suffering 
discovered is eliminated as quickly as possible. 

2. 

For the purposes of points (a) and (b) of paragraph 1, Member States shall apply the 
care and accommodation standards set out in Annex IV as from the dates provided 
for in that Annex. 

3. 

Member States may allow exemptions to paragraph 2 for animal welfare reasons. 

Section 3 
Inspections 

Article 33 
National inspections 

1. 

2. 

3. 

4. 

5. 

6. 

1. 

2. 

Member States shall ensure that all breeding, supplying and user establishments are 
subject to inspections on the compliance of those establishments with this Directive. 

National inspections shall be carried out by the competent authority at least twice a 
year. 

At least one of the inspections shall be unannounced. 

Member  States  shall  ensure  that  the  frequency  and  the  extent  of  inspections  are 
adequate to the number and species of animals housed, to the compliance record of 
the establishment  with  this  Directive and,  in the  case of user establishments, to the 
number and types of projects carried out in those establishments. 

Records of all inspections shall be kept for at least five years. 

Member States shall ensure that an appropriate infrastructure with sufficient numbers 
of trained inspectors is in place to carry out inspections. 

Member States shall establish programmes for joint inspections by Member States. 

Article 34 
Controls of national inspections 

The  Commission  may  undertake  controls  of  the  infrastructure  and  operation  of 
national inspections in Member States. 

The Member State in the territory of which the control is being carried out shall give 
all necessary assistance to the experts of the Commission in carrying out their duties. 

EN 

34 

   EN 

The  Commission  shall  inform  the  competent  authority  of  the  Member  State 
concerned of the results of the control. 

3. 

The competent authority of the Member State concerned shall take measures to take 
account of the results of the control. 

Section 4 
Requirements for projects 

Article 35 
Authorisation of projects 

1. 

2. 

Member  States  shall  ensure  that  projects  are  not  carried  out  without  a  prior 
authorisation by the competent authority. 

Granting  of  authorisation  shall  be  subject  to  favourable  ethical  evaluation  by  the 
competent authority. 

Article 36 
Application for the project authorisation 

1. 

The  user  establishment  shall  submit  an  application  for  the  project  authorisation, 
which shall include the following:  

(a) 

project proposal; 

(b) 

non-technical project summary; 

(c) 

information on the elements set out in Annex VII. 

2. 

Member  States  may  waive  the  requirement  in  paragraph  1(b)  and  permit  the  user 
establishment  to  submit  a  reduced  project  proposal  covering  only  the  ethical 
evaluation  and  elements  listed  in  Article  41(2),  provided  that  the  project  involves 
only procedures classified as "up to mild" and does not use non-human primates. 

Article 37 
Ethical evaluation 

1. 

The ethical evaluation shall verify that the project meets the following criteria: 

(a) 

(b) 

(c) 

the project is scientifically justified or required by law; 

the purposes of the project justify the use of animals; 

the project is designed so as to enable procedures to be carried out in 
the most humane and environmentally sensitive manner. 

EN 

35 

   EN 

2. 

The ethical evaluation shall consider in particular the following: 

(a) 

(b) 

(c) 

(d) 

an evaluation of the objectives of the project, the predicted scientific 
benefits or educational value; 

an  assessment  of  compliance  of  the  project  with  the  requirement  of 
replacement, reduction and refinement; 

an assessment of the classification of the severity of procedures; 

a  harm-benefit  analysis  of  the  project,  to  assess  whether  the  harm  to 
the  animals  in  terms  of  suffering,  pain  and  distress,  and  to  the 
the  expected 
environment,  where  appropriate, 
advancement  of  science  that  ultimately  benefits  human  beings, 
animals or the environment; 

justified  by 

is 

(e) 

an assessment of any scientific justification referred to in Articles 6, 7, 
8, 9, 10, 12, 14 and 16. 

3. 

The competent authority carrying out the ethical evaluation shall consider experts in 
particular in the following areas: 

(a) 

(b) 

(c) 

(d) 

(e) 

the areas of scientific use for which animals will be used; 

experimental design, including statistics where appropriate; 

veterinary practice in laboratory animal science or wildlife veterinary 
practice where appropriate; 

animal husbandry and care, in relation to the species that are intended 
to be used; 

practical application of the requirement of replacement, reduction and 
refinement; 

(f) 

applied ethics; 

(g) 

environmental science, where appropriate. 

4. 

Ethical  evaluation  shall  be  performed  in  a  transparent  manner,  by  integrating  the 
opinion of independent parties. 

Article 38 
Retrospective assessment 

1. 

The  ethical  evaluation  shall  determine,  on  the  basis  of  the  harm-benefit  analysis 
referred to in point (d) of Article 37(2), whether the project should, once it has been 
completed, be assessed retrospectively by the competent authority. 

EN 

36 

   EN 

If  a  retrospective  assessment  is  deemed  appropriate,  the  ethical  evaluation  shall 
determine,  in  relation  to  the  project  concerned,  the  deadline  by  which  the 
retrospective assessment is to take place. 

2. 

Retrospective assessment shall evaluate the following: 

(a) 

(b) 

(c) 

whether the objectives of the project were achieved; 

harm  inflicted  on  animals  including  the  numbers  and  species  of 
animals used and the severity of the procedures; 

elements  that  may  contribute  to  the  further  implementation  of  the 
requirement of replacement, reduction and refinement. 

All projects using non-human primates shall undergo a retrospective assessment.  

Without prejudice to paragraph 3, all projects involving only procedures classified as 
"up to mild" shall be exempted from the requirement for a retrospective assessment. 

Article 39 
Records of ethical evaluation  

The  establishment  shall  keep  records  of  ethical  evaluation  for  at  least  three  years 
from the expiry date of authorisation of the project and shall submit those records to 
the competent authority upon request. 

However,  records  of  ethical  evaluation  for  projects  which  have  to  undergo 
retrospective  assessment  shall  be  kept  until  the  retrospective  assessment  has  been 
completed. 

3. 

4. 

1. 

2. 

Article 40 
Non-technical project summaries  

1. 

Subject to safeguarding confidential information, the non-technical project summary 
shall provide the following: 

(a) 

(b) 

information  on  the  objectives  of  the  project,  including  the  likelihood 
of achieving them, the potential harm, and details of the number and 
types of animals to be used;  

a  demonstration  of  compliance  with  the  requirement  of  replacement, 
reduction and refinement. 

2. 

3. 

On  the  basis  of  the  results  of  the  ethical  evaluation,  the  user  establishment  shall 
specify  in  the  non-technical  project  summary  whether  a  project  is  to  undergo  a 
retrospective assessment and by which deadline. 

The  user  establishment  shall  update  the  non-technical  project  summary  with  the 
results of retrospective assessment. 

EN 

37 

   EN 

4. 

1. 

Member States shall make publicly available the non-technical project summaries of 
authorised projects and any updates to them. 

Article 41 
Granting of project authorisation 

The project authorisation shall be limited to the procedures which have been subject 
to  an  ethical  evaluation  and  to  the  severity  classifications  assigned  to  those 
procedures. 

2. 

The project authorisation shall identify the following: 

(a) 

(b) 

(c) 

in 
the  persons 
implementation of the project; 

the  establishment  responsible  for 

the  overall 

the user establishments in which the project will be undertaken; 

in the case of field studies, the user establishment which is responsible 
for the project; 

(d) 

at least one person demonstrating species specific knowledge. 

Project authorisations shall be granted for a period not exceeding four years. 

Member States may allow the authorisation of multiple projects when those projects 
are required by law. 

User establishments shall keep records of all project authorisations for at least three 
years from the expiry date of the authorisation and shall submit those records to the 
authority upon request. 

Article 42 
Amendment, renewal and withdrawal of a project authorisation 

The  competent  authority  may  amend  or  renew  the  project  authorisation  on  the 
request of the user establishment. 

Any  amendment  or  renewal  of  a  project  authorisation  shall  be  subject  to  a  further 
favourable ethical evaluation. 

The competent authority may withdraw the project authorisation where the project is 
not carried out in accordance with the project authorisation. 

Where  a  project  authorisation  is  withdrawn,  the  welfare  of  the  animals  used  or 
intended to be used in the project shall not be adversely affected. 

Member  States  shall  establish  and  publish  detailed  conditions  for  amendment  and 
renewal of project authorisations. 

3. 

4. 

5. 

1. 

2. 

3. 

4. 

5. 

EN 

38 

   EN 

1. 

2. 

1. 

2. 

Article 43 
Authorisation decisions  

Member  States  shall  ensure  that  the  decision  to  grant  an  authorisation  is  taken  and 
communicated  to  the  user  establishment  at  the  latest  within  30  days  from  the 
submission of the application. Should the Member State fail to take a decision within 
that period, the authorisation shall be deemed to have been granted, where the project 
concerned  involves  only  procedures  classified  as  "up  to  mild"  and  non-human 
primates are not used. In all other cases, no such presumption shall apply. 

Notwithstanding paragraph 1, in exceptional circumstances and where the project is 
non-routine, multi-disciplinary and innovative, the decision to grant an authorisation 
shall be taken and communicated to the user establishment within 60 days from the 
submission of the application. 

CHAPTER V 
AVOIDANCE OF DUPLICATION AND ALTERNATIVE 
APPROACHES 

Article 44 
Unnecessary duplication of procedures 

Each  Member  State  shall  accept  data  that  are  required  by  law  and  generated  by 
procedures recognised by Community legislation from another Member State, unless 
further  procedures  need  to  be  carried  out  regarding  that  data  for  the  protection  of 
public health, safety or the environment. 

Outside  the  area  of  testing  required  by  law,  subject  to  safeguarding  confidential 
information,  the  Member  States  shall  ensure  the  sharing  of  data  generated  by 
procedures. 

Article 45 
Alternative approaches 

The  Commission  and  Member  States  shall  contribute  to  the  development  and 
validation  of  alternative  approaches  that  could  provide  the  same  or  higher  level  of 
information as that obtained in procedures using animals but that do not involve the 
use of animals or use fewer animals or that entail less painful procedures and shall 
take such other steps as they consider appropriate to encourage research in this field. 

Article 46 
National reference laboratories for alternative methods 

1. 

Each  Member  State  shall,  by  [one  year  after  entry  into  force  of  this  Directive], 
designate  a  national  reference  laboratory  for  the  validation  of  alternative  methods 
replacing, reducing and refining the use of animals.  

EN 

39 

   EN 

2. 

3. 

Member  States  may  only  designate  as  national  reference  laboratories  those  that  are 
accredited in accordance with Directive 2004/10/EC. 

The national reference laboratories shall fulfil the following requirements:  

(a) 

(b) 

(c) 

(d) 

they  shall  have  suitably  qualified  staff  with  adequate  training  in 
alternative  methods  and  validation  process  and  techniques  applied  in 
their area of competence; 

they shall possess the equipment and products needed to carry out the 
tasks assigned to them; 

they shall have an appropriate administrative infrastructure; 

they shall ensure that their staff respect the rules on confidentiality. 

4. 

The national reference laboratories shall perform the following functions: 

(a) 

(b) 

(c) 

(d) 

(e) 

cooperate with the Commission in their area of competence;  

participate  in  pre-validation  and  validation  of  alternative  methods 
under the co-ordination of the Commission; 

communicate  information  on  the  availability  and  application  of 
alternative  methods  received  from  the  Commission  to  the  relevant 
authorities of the Member State; 

provide scientific and technical assistance to the relevant authorities of 
the  Member  States  for  the  acceptance  and  implementation  of 
alternative methods; 

provide training on the use of alternative methods to persons referred 
to in Article 20(1). 

5. 

6. 

7. 

1. 

National reference laboratories shall declare any conflict of interest on any task being 
undertaken. 

Each  Member  State  shall  communicate  the  name  and  address  of  their  reference 
laboratory to the Commission. The Commission shall make publicly available the list 
of national reference laboratories. 

After  consulting  the  national  reference  laboratories,  the  Commission  shall  set  the 
priorities for the validation studies and allocate the tasks between those laboratories 
for carrying out those studies. 

Article 47 
National animal welfare and ethics committee  

Each  Member  State  shall  establish  a  national  animal  welfare  and  ethics  committee 
that  shall  advise  the  competent  authorities  and  permanent  ethical  review  bodies  in 
matters  dealing  with  the  acquisition,  breeding,  accommodation,  care  and  use  of 
animals in procedures and ensure sharing of best practices.  

EN 

40 

   EN 

2. 

The national animal welfare and ethics committees shall exchange information on the 
operation  of  permanent  ethical  review  bodies  and  ethical  evaluation  and  share  best 
practices within the Community. 

CHAPTER VI 
FINAL PROVISIONS 

Article 48 
Adaptation of annexes to technical progress 

The Commission may adapt Annexes II to VII to technical and scientific progress.  

Those measures, designed to amend non-essential elements of this Directive, shall be adopted 
in accordance with the regulatory procedure with scrutiny referred to in Article 51(4). 

Article 49 
Reporting 

1. 

2. 

3. 

1. 

Member  States  shall  by  [within  six  years  from  transposition  date],  and  every  five 
years thereafter, send the information on the implementation of this Directive and in 
particular Articles 10(1), 25 , 27, 33, 37, 38, 40 and 44 thereof to the Commission. 

Member  States  shall  collect  and  make  publicly  available,  on  an  annual  basis, 
statistical information on the use of animals in procedures, including information on 
the  actual  severity  of  the  procedures  and  on  the  origin  and  species  of  non-human 
primates used in procedures. 

Member States shall submit that statistical information to the Commission by [three 
years from transposition date] and every year thereafter. 

The  Commission  shall  by  [within  18  months  from  the  entry  into  force  of  this 
Directive]  establish  a  common  format  for  submitting  the  information  referred  to  in 
paragraph 2 in accordance with the regulatory procedure referred to in Article 51(2). 

Article 50 
Safeguard clause 

Where  a  Member  State  has  justifiable  grounds  for  believing  that  action  is  essential 
for the preservation of the species or in relation to an unexpected outbreak of a life-
threatening  or  debilitating  clinical  condition  in  human  beings,  it  may  authorise  the 
use  of  great  apes  in  procedures  having  one  of  the  purposes  referred  to  in  Article 
5(2)(a), (3) or 5; provided that the purpose of the procedure cannot be achieved by 
the  use  of  other  species  than  great  apes  or  by  the  use  of  alternative  methods. 
However, the reference to Article 5(2)(a) shall not be taken to include the reference 
to animals or plants. 

EN 

41 

   EN 

2. 

3. 

1. 

2. 

3. 

4. 

1. 

2. 

The Member State shall immediately inform the Commission and the other Member 
States thereof, giving reasons for its decision and submitting evidence of the situation 
as described in paragraph 1 on which the provisional measure is based.  

The Commission shall take a decision in accordance with the procedure referred to in 
Article  51(2)  within  60  days  of  receipt  of  the  information  from  the  Member  State. 
This decision shall either: 

(a) 

authorise  the  provisional  measure  for  a  time  period  defined  in  the 
decision; or 

(b) 

require the Member State to revoke the provisional measure. 

Article 51 
Committee 

The Commission shall be assisted by a Committee. 

Where  reference  is  made  to  this  paragraph,  Articles  5  and  7  of  Decision 
1999/468/EC shall apply, having regard to the provisions of Article 8 thereof. 

The period laid down in Article 5(6) of Decision 1999/468/EC shall be set at three 
months. 

Where  reference  is  made  to  this  paragraph,  Article  5a(1)  to  (4)  and  Article  7  of 
Decision  1999/468/EC  shall  apply,  having  regard  to  the  provisions  of  Article  8 
thereof. 

Article 52 
Commission report 

By  [seven  years  after  transposition  date]  and  every  five  years  thereafter  ,  the 
Commission shall, based on the information received from the Member States under 
Article  49(1),  submit  to  the  European  Parliament  and  the  Council  a  report  on  the 
implementation of this Directive.  

By  [seven  years  after  transposition  date]  and  every  three  years  thereafter  the 
Commission shall, based on the statistical information submitted by Member States 
under Article 49(2), submit to the European Parliament and the Council a summary 
report on that information. 

Article 53 
Review 

The Commission shall review this Directive by [10 years after the date of entry into force] 
taking into account advancement in development of alternative methods not entailing the use 
of  animals,  and  in  particular  of  non-human  primates,  and  propose  any  amendments,  where 
appropriate. 

EN 

42 

   EN 

Article 54 
Competent authorities 

1. 

Each Member State shall designate one or more competent authorities responsible for 
the implementation of this Directive. 

Member  States  may  designate  bodies  other  than  public  authorities  for  the 
implementation  of  this  Directive.  Bodies  thus  designated  shall  be  considered 
competent authorities for the purposes of this Directive.  

2. 

Member  States  shall  inform  the  Commission  of  the  names  and  addresses  of  the 
competent  authorities by [three months after Entry into Force of this Directive], at 
the latest. Member States shall inform the Commission of any changes to the names 
and addresses of the competent authorities.  

The Commission shall make publicly available the list of the competent authorities. 

Article 55 
Penalties 

The Member  States  shall  lay  down  the  rules on penalties  applicable to  infringements  of the 
national provisions adopted pursuant to this Directive and shall take all measures necessary to 
ensure that they are implemented. The penalties provided for must be effective, proportionate 
and dissuasive. The Member States shall notify those provisions to the Commission by [(the 
date specified in Article 56)] at the latest and shall notify the Commission without delay of 
any subsequent amendment affecting them. 

Article 56 
Transposition 

1. 

Member States shall adopt and publish, by [18 months from the Entry into Force of 
this  Directive]  at  the  latest,  the  laws,  regulations  and  administrative  provisions 
necessary  to  comply  with  this  Directive.  They  shall  forthwith  communicate  to  the 
Commission  the  text  of  those  provisions  and  a  correlation  table  between  those 
provisions and this Directive. 

They shall apply those provisions from [1 January of the year following the date of 
transposition as specified in the first subparagraph]. 

When  Member  States  adopt  those  provisions,  they  shall  contain  a  reference  to  this 
Directive  or  be  accompanied  by  such  a  reference  on  the  occasion  of  their  official 
publication. Member States shall determine how such reference is to be made. 

2. 

Member States shall communicate to the Commission the text of the main provisions 
of national law which they adopt in the field covered by this Directive. 

EN 

43 

   EN 

Article 57 
Repeal 

Directive  86/609/EEC  is  repealed  with  effect  from  [the  date  referred  to  in  the  second 
subparagraph of Article [56(1)]. 

References to the repealed Directive shall be construed as references to this Directive. 

Article 58 
Transitional provisions 

1. 

2. 

Member  States  shall  not  apply  laws;  regulations  and  administrative  provisions 
adopted  in  accordance  with  Articles  35  to  43  to  projects  which  have  been  started 
before  [the  date  referred  to  in  the  second  subparagraph  of  Article  [56(1)]  and  the 
duration of which does not extend beyond [three years after the date referred to in the 
second subparagraph of Article [56(1)]. 

Projects  which  have  been  started  before  [the  date  referred  to  in  the  second 
subparagraph  of  Article  [56(1)]  and  the  duration  of  which  extends  beyond  [three 
years  after  the  date  referred  to  in  the  second  subparagraph  of  Article  [56(1)]  shall 
obtain  project  authorisation  by  [three  years  after  the  date  referred  to  in  the  second 
subparagraph of Article [56(1)]. 

Article 59 
Entry into force 

This Directive shall enter into force on the twentieth day following that of its publication in 
the Official Journal of the European Union. 

Article 60 
Addressees 

This Directive is addressed to the Member States. 

Done at Brussels,  

For the European Parliament 
The President 

For the Council 
The President 

EN 

44 

   EN 

ANNEX I 

Invertebrate Species referred to in Article 2(2) 

•  Cyclostomes 

•  Cephalopods 

•  Decapod crustaceans 

EN 

45 

   EN 

ANNEX II 

List of animals referred to in Article 10 

Frog (Xenopus (laevis, tropicalis), Rana (temporaria, pipiens)) 

Mouse (Mus musculus) 

Rat (Rattus norvegicus) 

Guinea Pig (Cavia porcellus) 

Syrian (Golden) Hamster (Mesocricetus auratus) 

Chinese Hamster (Cricetulus griseus) 

Mongolian gerbil (Meriones unguiculatus) 

Rabbit (Oryctolagus cuniculus) 

Dog (Canis familiaris) 

Cat (Felis catus) 

All species of non-human primate  

1. 

2. 

3. 

4. 

5. 

6. 

7. 

8. 

9. 

10. 

11. 

EN 

46 

   EN 

ANNEX III 

list of non-human primates and dates referred to in the second subparagraph of Article 
10(1) 

Species 

Dates  

Marmoset (Callithrix jacchus) 

[date of application referred to in the second 
subparagraph  of  the  first  paragraph  Article 
on transposition] 

Cynomolgus monkey (Macaca fascicularis) 

[7 years after transposition of Directive] 

Rhesus monkey (Macace mulatta) 

[7 years after transposition of Directive] 

Other species of non-human primates 

[10 years after transposition of Directive] 

EN 

47 

   EN 

ANNEX IV 

Care and accomodation standards referred to in Article 32 

SECTION A: GENERAL SECTION 

1. 

THE PHYSICAL FACILITIES 

1.1. 

Functions and general design  

a) 
All facilities shall be constructed so as to provide an environment which takes into account the 
physiological  and  ethological  needs  of  the  species  kept  in  them.  Facilities  shall  also  be  designed  and 
managed to prevent access by unauthorised persons and the ingress or escape of animals. 

Establishments shall have an active maintenance programme to prevent and remedy any defect 

b) 
of buildings or equipment. 

1.2. 

Holding rooms  

Establishments  shall  have  a  regular  and  efficient  cleaning  schedule  of  the  rooms  and  the 

a) 
maintenance of satisfactory hygienic standards. 

b) 
Where the animals are allowed to run freely, walls and floors shall be surfaced with a material 
resistant to the heavy wear and tear caused by the animals and the cleaning process. The material shall 
not be detrimental to the health of the animals and shall be such that the animals cannot hurt themselves. 
Additional protection shall be given to any equipment or fixtures so that they are not damaged by the 
animals or injure the animals themselves. 

c) 
Species  that  are  incompatible,  for  example  predator  and  prey,  or  animals  requiring  different 
environmental conditions, shall not be housed in the same room nor, in the case of predator and prey, 
within sight, smell or sound. 

1.3. 

General and special purpose procedure rooms  

All  establishments  shall  have  available  laboratory  facilities  for  the  carrying  out  of  simple 
a) 
diagnostic tests, post-mortem examinations, and/or the collection of samples that are to be subjected to 
more extensive laboratory investigations elsewhere. 

Facilities  shall  be  provided  to  enable  newly-acquired  animals  to  be  isolated  until  their  health 

b) 
status can be determined and the potential health risk to established animals assessed and minimised. 

c) 

There shall be accommodation for separate housing of sick or injured animals. 

1.4. 

Service rooms  

a) 
Storerooms shall be designed, used and maintained to safeguard the quality of food and bedding. 
These rooms shall be vermin and insect-proof. Other materials, which may be contaminated or present a 
hazard to animals or staff, shall be stored separately. 

b) 
The  cleaning  and  washing  areas  shall  be  large  enough  to  accommodate  the  installations 
necessary to decontaminate and clean used equipment. The cleaning process shall be arranged so as to 
separate  the  flow  of  clean  and  dirty  equipment  to  prevent  the  contamination  of  newly-cleaned 
equipment. 

EN 

48 

   EN 

c) 
Establishments  shall  provide  for  the  hygienic  storage  and  disposal  of  carcasses  and  animal 
waste.  Establishment  shall  have  specific  measures  in  place  to  handle,  store  and  dispose  of  toxic, 
radioactive or infectious waste. 

2. 

THE ENVIRONMENT AND ITS CONTROL 

2.1. 

Ventilation 

Ventilation  shall  be  provided  in  the  holding  room  and  the  animal  enclosures  to  satisfy  the 

a) 
requirements of the species housed. 

b) 

c) 

d) 

The air in the room shall be renewed at frequent intervals. 

The ventilation system shall be designed so as to avoid harmful draughts and noise disturbance. 

Smoking in rooms where there are animals shall be forbidden. 

2.2. 

Temperature 

Temperature  in  the  holding  rooms  shall  be  adapted  to  the  species  housed.  Temperature  in  the 

a) 
holding rooms shall be measured and logged on a daily basis. 

Animals shall not be restricted to outdoor areas under climatic conditions which may cause them 

b) 
distress. 

2.3. 

Humidity 

Humidity levels in the holding rooms shall be adapted to the species housed. 

2.4. 

Lighting 

a) 
Where natural light does not provide an appropriate light/dark cycle, controlled lighting shall be 
provided  to  satisfy  the  biological  requirements  of  the  animals  and  to  provide  a  satisfactory  working 
environment. 

Illumination shall satisfy the needs for the performance of husbandry procedures and inspection 

b) 
of the animals. 

c) 

Regular photoperiods and intensity of light adapted to the species shall be provided. 

When keeping albino animals, the lighting shall be adjusted to take into account their sensitivity 

d) 
to light. 

2.5. 

Noise 

Noise  levels  within  the  hearing  ranges  of  animals,  including  ultrasound,  shall  be  minimised 

a) 
particularly during their resting phase. 

Establishments  shall  have  alarm  systems  that  sound  outside  the  sensitive  hearing  range  of  the 

b) 
animals, where this does not conflict with their audibility to human beings. 

c) 

Holding rooms shall be provided with noise insulation and absorption materials. 

EN 

49 

   EN 

2.6. 

Alarm systems 

a) 
Establishments  relying  on  electrical  or  mechanical  equipment  for  environmental  control  and 
protection, shall have a stand-by system to maintain essential services and emergency lighting systems as 
well as to ensure that alarm systems themselves do not fail to operate; 

b) 

c) 

3. 

Heating and ventilation systems shall be equipped with monitoring devices and alarms; 

Clear instructions on emergency procedures shall be prominently displayed. 

CARE 

3.1. 

Health  

a) 
Establishments  shall  have  a  strategy  in  place  to  ensure  that  a  health  status  of  the  animals  is 
maintained  that  safeguards  animal  welfare  and  meets  scientific  requirements.  This  strategy  shall 
include a microbiological surveillance programme, plans for dealing with health breakdowns and shall 
define health parameters and procedures for the introduction of new animals. 

b) 
Inspections of the animals shall be made at least daily by the person responsible on site for the 
welfare  and  care  of  the  animals.  Inspections  shall  include  the  health  monitoring  of  the  animals  and 
ensure that all sick or injured animals are identified and appropriate action taken. 

3.2. 

Capture from the wild  

a) 
When animals need to be captured from the wild, it shall be done by humane methods and by 
persons competent to apply them. The impact of the capturing procedures on the remaining wildlife and 
habitats shall be minimised. 

b) 
Any  animal  found,  at  or  after  capture,  to  be  injured  or  in  poor  health  shall  be  examined  by  a 
competent person as soon as possible and action taken to minimise the suffering of the animals, having 
as first priority to restore the health of the animal. 

Transport containers and means of transport adapted to the species concerned shall be available 

c) 
at capture sites, in case animals need to be moved for examination or treatment. 

Special  measures  shall  be  taken  for  the  acclimatisation,  quarantine,  housing,  husbandry  and 

d) 
care of wild caught animals. 

3.3. 

Housing and enrichment 

a) 

Housing 

Animals,  except  those  which  are  naturally  solitary,  shall  be  socially  housed  in  stable  groups  of 
compatible individuals. In cases where single housing is allowed on the basis of exceptional scientific 
and/or welfare justification supported by a favourable ethical evaluation, the duration shall be limited 
to  the  minimum  period  necessary  and  visual,  auditory,  olfactory  and/or  tactile  contact  shall  be 
maintained.  The  introduction  or  re-introduction  of  animals  to  established  groups  shall  be  carefully 
monitored to avoid problems of incompatibility and disrupted social relationships. 

b) 

Enrichment 

All animals shall be provided with space of sufficient complexity to allow expression of a wide range of 
normal behaviour. They shall be given a degree of control and choice over their environment to reduce 
stress-induced  behaviour.  Establishments  shall  have  appropriate  enrichment  techniques  in  place,  to 

EN 

50 

   EN 

extend  the  range  of  activities  available  to  the  animal  and  increase  their  coping  activities  including 
physical  exercise,  foraging,  manipulative  and  cognitive  activities,  as  appropriate  to  the  species. 
Environmental enrichment in animal enclosures shall be adapted to the species and individual needs of 
the  animals  concerned.  The  enrichment  strategies  in  establishments  shall  be  regularly  reviewed  and 
updated. 

c) 

Animal enclosures 

Animal  enclosures  shall  not  be  made  out  of  materials  detrimental  to  the  health  of  the  animals.  Their 
design and construction shall be such that no injury to the animals is caused. Unless they are disposable, 
they  shall  be  made  from  materials  that  will  withstand  cleaning  and  decontamination  techniques.  The 
design of animal enclosure floors shall be adapted to the species and age of the animals and be designed 
to facilitate the removal of excreta. 

3.4. 

Feeding  

The form, content and presentation of the diet shall meet the nutritional and behavioural needs of 

a) 
the animal.  

b) 
The  animals’  diet  shall  be  palatable  and  non-contaminated.  In  the  selection  of  raw  materials, 
production,  preparation  and  presentation  of  feed,  establishments  shall  take  measures  to  minimise 
chemical, physical and microbiological contamination. 

c) 
Packing,  transport  and  storage  shall  be  such  as  to  avoid  contamination,  deterioration  or 
destruction. All feed hoppers, troughs or other utensils used for feeding shall be regularly cleaned and, if 
necessary, sterilised.  

Each  animal  shall  be  able  to  access  the  food,  with  sufficient  feeding  space  provided  to  limit 

d) 
competition.  

3.5.  Watering 

a) 

Uncontaminated drinking water shall always be available to all animals. 

b) 
When  automatic  watering  systems  are  used,  their  functioning  shall  be  regularly  checked, 
serviced and flushed to avoid accidents. If solid-bottomed cages are used, care shall be taken to minimise 
the risk of flooding. 

Provision  shall  be  made  to  adapt  the  water  supply  for  aquaria  and  tanks  to  the  needs  and 

c) 
tolerance limits of the individual fish, amphibian and reptile species. 

3.6. 

Flooring, substrate, litter, bedding and nesting material 

Bedding  materials  or  sleeping  structures  adapted  to  the  species  shall  always  be  provided, 

a) 
including nesting materials or structures for breeding animals. 

Within the animal enclosure, the flooring shall provide a solid, comfortable resting area for all 

b) 
animals. All sleeping areas shall be kept clean and dry.  

3.7. 

Handling  

Establishments  shall  set  up  training  programmes  for  co-operation  of  animals  during  procedures.  The 
training programmes shall be adapted to the species  and their origin, the procedures and length of the 
project. Social contact with human beings shall be made a priority and adapted to the species and their 
origin, the procedures and length of the project.  

EN 

51 

   EN 

SECTION B: SPECIES-SPECIFIC SECTION 

1. Mice, rats, gerbils, hamsters and guinea pigs 

In  this  and  subsequent  tables  for  mice,  rats,  gerbils,  hamsters  and  guinea  pigs,  “enclosure  height” 
means  the  vertical  distance  between  the  enclosure  floor  and  the top  of  the  enclosure  and  this  height 
applies over more than 50% of the minimum enclosure floor area prior to the addition of enrichment 
devices. 

When  designing  procedures,  consideration  shall  be  given  to  the  potential  growth  of  the  animals  to 
ensure  adequate  space  is  provided  (as  detailed  in  Tables  1.1.  to  1.5)  for  the  duration  of  the  study. 
Table 1.1. Mice  

Body weight 

Minimum enclosure size 

Floor area 

(g) 

(cm2) 

per animal 

Minimum 
enclosure 
height 

referred 
in  Article 

Date 
to 
32(2)  

stock 

In 
during 
procedures 

and 

up to 20 

over 20 to 25 

over 25 to 30 

over 30 

Breeding 

330 

330 

330 

330 

330 

[Jan 2012] 

(cm2) 

(cm) 

60 

70 

80 

100 

12 

12 

12 

12 

12 

For  a  monogamous  pair 
(outbred/inbred)  or  a 
trio 
(inbred). For each additional 
female  plus  litter  180  cm2 
shall be added. 

at 

less than 20 

950 

40 

12 

Stock 
breeders* 

Enclosure size 

950 cm² 

Enclosure size 

less than 20 

1500 

30 

12 

1500 cm² 

* Post-weaned mice may be kept at these higher stocking densities, for the short period after weaning until issue, provided 
that  the  animals  are  housed  in  larger  enclosures  with  adequate  enrichment.  These  housing  conditions  shall  not  cause  any 
welfare  deficit  such  as:  increased  levels  of  aggression,  morbidity  or  mortality,  stereotypes  and  other  behavioural  deficits, 
weight loss, or other physiological or behavioural stress responses. 

EN 

52 

   EN 

 
Table 1.2. Rats 

Body weight 

Minimum enclosure size 

Floor area 

(g) 

(cm2) 

per animal 

(cm2) 

referred 
in  Article 

Date 
to 
32(2) 

Minimu
m 
enclosur
e  height 
(cm) 

stock 

In 
during 
procedures* 

and 

up to 200 

over 200 to 300 

over 300 to 400 

over 400 to 600 

over 600 

Breeding 

800 

800 

800 

800 

1500 

800 

Mother  and  litter.  For  each 
additional 
animal 
permanently  added  to  the 
enclosure add 400 cm2 

adult 

Stock at breeders**

Enclosure size  
1500 cm² 

up to 50 

1500 

over 50 to 100 

1500 

over 100 to 150 

1500 

over 150 to 200 

1500 

Stock 
breeders** 

at 

up to 100 

2500 

Enclosure 
2500 cm² 

size  

over 100 to 150 

2500 

over 150 to 200 

2500 

200 

250 

350 

450 

600 

100 

125 

150 

175 

100 

125 

150 

18 

18 

18 

18 

18 

18 

18 

18 

18 

18 

18 

18 

18 

[Jan 2012] 

* In lifetime studies, animals shall be provided with enclosures of a suitable size to enable the animals to be socially housed. 
Where space allowances per individual animal fall below those indicated above, priority shall be given to maintaining stable 
social structures. 

** Post-weaned rats may be kept at these stocking densities, for the short period after weaning until issue, provided that the 
animals  are  housed  in  larger  enclosures  with  adequate  enrichment.  These  housing  conditions  shall  not  cause  any  welfare 
deficit such as: increased levels of aggression, morbidity or mortality, stereotypes and other behavioural deficits, weight loss, 
or other physiological or behavioural stress responses. 

Table 1.3. Gerbils 

Body weight 

Minimum enclosure size 

Floor area 

Minimum 

(g) 

(cm2) 

per animal 

(cm2) 

enclosure 
height 

(cm) 

Date 
referred 
to 
in  Article 
32(2) 

EN 

53 

   EN 

 
 
 
 
 
 
 
 
 
 
 
 
In  stock  and 
during 
procedures 

up to 40 

over 40 

Breeding 

1200 

1200 

1200 

[Jan 2012] 

150 

250 

18 

18 

18 

Monogamous  pair  or  trio 
with offspring 

EN 

54 

   EN 

 
 
Table 1.4. Hamsters 

Body weight 

Minimum enclosure size 

Floor area 

Minimum 

(g) 

(cm2) 

per animal 

enclosure 
height (cm) 

(cm2) 

150 

200 

250 

14 

14 

14 

14 

In  stock  and 
during 
procedures 

up to 60 

800 

over 60 to 100 

800 

over 100 

800 

800 

Mother  or  monogamous 
pair with litter 

Breeding 

Stock 
breeders* 

at 

less than 60 

1500 

100 

14 

Date 
referred 
to 
in  Article 
32(2) 

[Jan 2012] 

* Post-weaned hamsters may be kept at these stocking densities, for the short period after weaning until issue, provided that 
the animals are housed in larger enclosures with adequate enrichment. These housing conditions shall not cause any welfare 
deficit such as: increased levels of aggression, morbidity or mortality, stereotypes and other behavioural deficits, weight loss, 
or other physiological or behavioural stress responses. 

Table 1.5. Guinea pigs 

Body weight 

Minimum enclosure size 

Floor area 

Minimum 

(g) 

(cm2) 

per animal 

(cm2) 

enclosure 
height (cm) 

In  stock  and 
during 
procedures 

up to 200 

1800 

over 200 to 300 

1800 

over 300 to 450 

1800 

over 450 to 700 

2500 

over 700 

Breeding 

2500 

2500 

200 

350 

500 

700 

900 

23 

23 

23 

23 

23 

23 

Pair  with  litter.  For  each 
additional  breeding  female 
add 1000 cm2 

Date 
referred 
to 
in  Article 
32(2) 

[Jan 2012] 

2. Rabbits  

A raised area shall be provided within the enclosure. This raised area must allow the animal to lie and 
sit  and  easily  move  underneath,  and  shall  not  cover  more  than  40%  of  the  floor  space.  When  for 
exceptional scientific or veterinary reasons a shelf cannot be used, the enclosure shall be 33% larger 
for a single rabbit and 60% larger for two rabbits. Where a raised area is provided for rabbits of less 

EN 

55 

   EN 

 
 
 
 
 
 
 
 
than 10 weeks of age, the size of the raised area shall be at least of 55x25 cm and the height above the 
floor shall be such that the animals can make use of it.  

EN 

56 

   EN 

Table 2.1. Rabbits over 10 weeks of age 

Table 2.1 is to be used for both cages and pens. The additional floor area is as a minimum 3000 cm2 
per rabbit for the third, the fourth, the fifth and the sixth rabbit, while 2500 cm2 as a minimum shall be 
added for each additional rabbit above a number of six. 

Final body weight (kg) 

Minimum  floor  area  for  one  or  two 
socially harmonious animals 

Minimum height 

less than 3 

from 3 to 5 

over 5 

(cm2) 

3500 

4200 

5400 

Table 2.2. Doe plus litter 

Doe weight 

(kg) 

Minimum  enclosure  size 
(cm2) 

less than 3 

3500 

from 3 to 5 

4200 

over 5 

5400 

(cm) 

45 

45 

60 

Addition for nestboxes 

Minimum height 

(cm2) 

1000 

1200 

1400 

(cm) 

45 

45 

60 

Date 
referred 
to 
in  Article 
32(2) 

[Jan 2012] 

Date 
referred 
to 
in  Article 
32(2) 

[Jan 2012] 

Table 2.3. Rabbits less than 10 weeks of age 

Table 2.3 is to be used for both cages and pens. 

Age 

Minimum 
enclosure 
(cm2) 

Weaning to 7 weeks 

4000 

From 7 to 10 weeks 

4000 

Minimum 
per animal 

size 

floor  area 

Minimum height 

(cm²) 

800 

1200 

(cm) 

40 

40 

Table  2.4.  Rabbits:  Optima  dimensions  for  raised  areas  for  enclosures  having  the  dimensions 
indicated in Table 2.1.  

Age in 

Weeks 

over 10 

3. Cats 

EN 

Final body weight 

Optimum size 

(kg) 

(cm x cm) 

height 
Optimum 
from  the  enclosure 
floor (cm) 

referred 
in  Article 

Date 
to 
32(2) 

less than 3 

from 3 to 5 

over 5 

55 x 25 

55 x 30 

60 x 35 

57 

[Jan 2012] 

25 

25 

30 

   EN 

 
 
Table 3.1. Cats 

The minimum space in which a queen and litter may be held is the space for a single cat, which shall 
be gradually increased so that by four months of age litters have been re-housed to follow the space 
requirements for adults.  

Areas  for  feeding  and  for  litter  trays  shall  not  be  less  than  0.5  metres  apart  and  shall  not  be 
interchanged. 

Floor* 

Shelves 

(m²) 

1.5 

Minimum 
adult animal 

for  one 

For  each  additional 
animal add 

0.75 

Note: * Floor area excluding shelves. 

4. Dogs 

(m²) 

0. 5 

0.25 

Date  referred 
to  in  Article 
32(2) 

[Jan 2017] 

Height 

(m) 

2 

– 

The internal enclosure shall represent at least 50% of the minimum space to be made available to the 
dogs, as detailed in Table 4.1. 

The space allowances detailed below are based on the requirements of beagles, but giant breeds such 
as St Bernards or Irish wolfhounds shall be provided with allowances significantly in excess of those 
detailed in Table 4.1. For breeds other than the laboratory beagle, space allowances shall be decided in 
consultation with veterinary staff. 

Table 4.1. Dogs 

Dogs that are pair or group housed may each be constrained to half the total space provided (2 m² for a 
dog under 20 kg, 4 m² for a dog over 20 kg) while they are undergoing procedures as defined in this 
Directive, if this separation is essential for scientific purposes.  

A nursing bitch and litter shall have the same space allowance as a single bitch of equivalent weight. 
The whelping pen shall be designed so that the bitch can move to an additional compartment or raised 
area away from the puppies. 

Weight  

(kg) 

up to 20 

over 20 

Minimum 
enclosure size 

(m²) 

4 

8 

floor 
Minimum 
area  for  one  or 
two animals 

each 
For 
additional  animal 
add  a  minimum 
of (m²) 

(m²) 

4 

8 

2 

4 

Minimum 
height 

Date 
referred to in 
Article 32(2) 

(m) 

2 

2 

[Jan 2017] 

EN 

58 

   EN 

 
 
Table 4.2. Dogs - post-weaned stock  

Weight of dog 

Minimum 
size 

enclosure 

Minimum 
area/animal 

floor 

Minimum height 

(m²) 

4 

4 

4 

4 

8 

(kg) 

up to 5 

over 5 to 10 

over 10 to 15 

over 15 to 20 

over 20 

5. Ferrets 

Table 5. Ferrets 

(m2) 

0.5 

1.0 

1.5 

2 

4 

(m) 

2 

2 

2 

2 

2 

Minimum 
size 

enclosure 

Minimum 
per animal 

floor  area 

Minimum height 

(cm²) 

Animals up to 600g  

4500 

Animals over 600g 

4500 

Adult males 

Jill and litter 

6000 

5400 

6. Non-human primates 

Table 6.1. Marmosets and Tamarins  

(cm²) 

1500 

3000 

6000 

5400 

(cm) 

50 

50 

50 

50 

Date  referred 
to  in  Article 
32(2) 

[Jan 2017] 

Date  referred 
to  in  Article 
32(2) 

[Jan 2012] 

Minimum floor area of enclosures 
for 1* or 2 animals plus offspring 
up to 5 months old (m2) 

Minimum volume per 
additional 
animal 
over 5 months (m 3) 

Minimum 
enclosure 
height (m) ** 

referred 
in  Article 

Date 
to 
32(2) 

Marmosets 

0.5 

Tamarins 

1.5 

0.2 

0.2 

[Jan 2017] 

1.5 

1.5 

* Animals shall only be kept singly under exceptional circumstances.  
** The top of the enclosure shall be at least 1.8m from the floor. 

EN 

59 

   EN 

 
 
Table 6.2. Squirrel Monkeys  

Minimum floor area for 

1* or 2 animals (m2) 

Minimum  volume  per  additional 
animal over 6 months of age (m3) 

Minimum  enclosure 
height (m) 

referred 
in  Article 

Date 
to 
32(2) 

2.0 

0.5 

1.8 

[Jan 2017] 

* Animals shall only be kept singly under exceptional circumstances.  

Table 6.3. Macaques and vervets *  

Minimum 
enclosure  size 
(m2) 

Minimum 
enclosure 
volume (m3) 

Minimum 
volume 
animal (m3) 

per 

Minimum 
enclosure  height 
(m) 

Date  referred 
to  in  Article 
32(2) 

Animals 
less 
than  3  yrs  of 
age ** 

2.0 

Animals  from  3 
yrs of age *** 

2.0 

Animals held for 
breeding 
purposes**** 

[Jan 2017] 

3.6 

3.6 

1.0 

1.8 

3.5 

1.8 

1.8 

2.0 

* Animals shall only be kept singly under exceptional circumstances. 
** An enclosure of minimum dimensions may hold up to three animals. 
*** An enclosure of minimum dimensions may hold up to two animals. 
**** In breeding colonies no additional space/volume allowance is required for young animals up to 2 years of age housed 
with their mother. 

Table 6.4. Baboons* 

Minimum 
enclosure  size 
(m2) 

Minimum 
enclosure 
volume (m3) 

Minimum 
volume 
animal (m3) 

per 

Minimum 
enclosure  height 
(m) 

Date referred to 
in Article 32(2) 

Animals** 
less 
than 4 yrs of age 

4.0 

Animals**  from 
4 yrs of age 

7.0 

held 
breeding 

Animals 
for 
purposes*** 

7.2 

12.6 

3.0 

6.0 

12.0 

1.8 

1.8 

2.0 

[Jan 2017] 

* Animals shall only be kept singly under exceptional circumstances. 
** An enclosure of minimum dimensions may hold up to 2 animals. 
*** In breeding colonies no additional space/volume allowance is required for young animals up to 2 years of age housed 
with their mother. 

EN 

60 

   EN 

 
 
 
 
 
 
referred 
in  Article 

Date 
to 
32(2) 

[Jan 2017] 

7. Farm animals 

Table 7.1. Cattle 

Body weight 

(kg) 

Minimum 
enclosure  size 
(m2) 

Minimum  floor 
area/animal 

(m2/animal) 

Trough space for 

Trough space for 

ad-libitum  feeding  of 
polled 
cattle 
(m/animal) 

restricted  feeding  of 
polled 
cattle 
(m/animal) 

up to 100 

2.50 

over  100  to 
200 

4.25 

over  200  to 
400 

6.00 

over  400  to 
600 

9.00 

over  600  to 
800 

11.00 

2.30 

3.40 

0.10 

0.15 

4.80 

0.18 

7.50 

0.21 

8.75 

0.24 

over 800 

16.00 

10.00 

0.30 

Table 7.2. Sheep and Goats 

0.30 

0.50 

0.60 

0.70 

0.80 

1.00 

Body weight 

(kg) 

Minimum 
enclosure  size 
(m2)  

Minimum 
area/animal 

floor 

(m2/ animal) 

Minimum 
partition 
height 

space 
Trough 
for  ad-libitum 
feeding 
(m/animal) 

space 
restricted 

Trough 
for 
feeding 
(m/animal) 

Date 
referred to in 
Article 32(2)

less than 20 

1.0 

over 20 to 35  1.5 

over 35 to 60  2.0 

over 60 

3.0 

0.7 

1.0 

1.5 

1.8 

Table 7.3. Pigs and Minipigs 

(m) 

1.0 

1.2 

1.2 

1.5 

0.10 

0.10 

0.12 

0.12 

0.25 

0.30 

0.40 

0.50 

[Jan 2017] 

Liveweight (kg) 

Minimum 
enclosure size* 

Minimum  floor 
area per animal 

(m2) 

(m2/animal) 

lying 
Minimum 
space per animal (in, 
thermoneutral 
conditions) 
(m2/animal) 

Date  referred  to  in 
Article 32(2) 

Up to 5 

over 5 to 10 

2.0 

2.0 

EN 

0.20 

0.25 

61 

0.10 

0.11 

[Jan 2017] 

   EN 

over 10 to 20 

over 20 to 30 

over 30 to 50 

over 50 to 70 

over 70 to 100 

over 100 to 150 

over 150 

2.0 

2.0 

2.0 

3.0 

3.0 

4.0 

5.0 

Adult (conventional) boars  7.5 

0.35 

0.50 

0.70 

0.80 

1.00 

1.35 

2.50 

0.18 

0.24 

0.33 

0.41 

0.53 

0.70 

0.95 

1.30 

* Pigs may be confined in smaller enclosures for short periods of time, for example by partitioning the main enclosure using 
dividers, when justified on veterinary or experimental grounds, for example where individual food consumption is required. 

Table 7.4. Equines 

The shortest side shall be a minimum of 1.5 x the wither height of the animal. The height of indoor 
enclosures shall allow animals to rear to their full height. 

Wither height  

Minimum floor area/animal 

(m) 

(m2/animal) 

For  each  animal 
held  singly  or  in 
groups  of  up  to  3 
animals 

For  each  animal 
held  in  groups  of 
4 or more animals

Foaling  box 
mare with foal 

/ 

Minimum 
enclosure 
height (m) 

Date  referred  to  in 
Article 32(2) 

[Jan 2017] 

1.00 to 1.40 

9.0 

over 1.40 to 1.60  12.0 

6.0 

9.0 

over 1.60 

16.0 

(2 x WH)2 * 

16 

20 

20 

3.00 

3.00 

3.00 

*  To  ensure  adequate  space  is  provided,  space  allowances  for  each  individual  animal  shall  be  based  on  height  to  withers 
(WH) 

8. Birds 

Table 8.1. Domestic fowl 

Where these minimum enclosures sizes cannot be provided for scientific reasons, the duration of the 
confinement  shall  be  justified  by  the  experimenter  in  consultation  with  veterinary  staff.  In  such 
circumstances, birds can be housed in smaller enclosures containing appropriate enrichment and with a 
minimum floor area of 0.75 m2. 

Body mass (g) 

Minimum 
enclosure 
(m2) 

size 

Minimum 
area 
bird (m2) 

per 

Minimum 
height (cm) 

Minimum 
length  of  feed 
trough  per  bird 
(cm) 

referred 
in  Article 

Date 
to 
32(2) 

EN 

62 

   EN 

 
[Jan 2012] 

Up to 200 

1.00 

1.00 

over 200 to 300 

over 300 to 600 

1.00 

over 600 to 1200 

2.00 

over 1200 to 1800 

2.00 

over 1800 to 2400 

2.00 

over 2400 

2.00 

Table 8.2. Domestic Turkey 

0.025 

0.03 

0.05 

0.09 

0.11 

0.13 

0.21 

30 

30 

40 

50 

75 

75 

75 

3 

3 

7 

15 

15 

15 

15 

All  enclosure  sides  shall  be  at  least  1.5  m  long.  Where  these  minimum  enclosures  sizes  cannot  be 
provided for scientific reasons, the duration of the confinement shall be justified by the experimenter 
in consultation with veterinary staff. In such circumstances, birds can be housed in smaller enclosures 
containing appropriate enrichment and with a minimum floor area of 0.75 m2 and a minimum height of 
50 cm for birds below 0.6 kg, 75 cm for birds below 4 kg, and 100 cm for birds over 4 kg. These can 
be used to house small groups of birds in accordance with the space allowances given in table 8.2.  

Minimum 
area per bird 

Minimum 
height (cm) 

Minimum 
length 
of  feed  trough  per 
bird (cm) 

Date  referred  to  in 
Article 32(2) 

Body mass (kg)  Minimum 
enclosure 
size 

Up to 0.3 

(m2) 

2.00 

over 0.3 to 0.6 

2.00 

over 0.6 to 1 

2.00 

over 1 to 4 

over 4 to 8 

2.00 

2.00 

over 8 to 12 

2.00 

over 12 to 16 

2.00 

over 16 to 20 

2.00 

over 20 

3.00 

Table 8.3. Quail 

(m2) 

0.13 

0.17 

0.30 

0.35 

0.40 

0.50 

0.55 

0.60 

1.00 

[Jan 2012] 

50 

50 

100 

100 

100 

150 

150 

150 

150 

3 

7 

15 

15 

15 

20 

20 

20 

20 

Body 
mass 
(g) 

Minimum 
enclosure 
size 

Area  per  bird 
pair-housed 
(m2) 

Area 
per 
additional  bird 
group-housed 
(m2) 

Minimum 
height (cm) 

Minimum 
length 
of  trough  per  bird 
(cm) 

Date 
referred 
to 
in  Article 
32(2) 

EN 

63 

   EN 

(m2) 

to 

1.00 

0.5 

1.00 

0.6 

Up 
150 

Over 
150  

Table 8.4. Ducks and geese 

0.10 

0.15 

20 

30 

4 

4 

[Jan 2012] 

Where these minimum enclosures sizes cannot be provided for scientific reasons, the duration of the 
confinement  shall  be  justified  by  the  experimenter  in  consultation  with  veterinary  staff.  In  such 
circumstances, birds can be housed in smaller enclosures containing appropriate enrichment and with a 
minimum floor area of 0.75 m2. These can be used to house small groups of birds in accordance with 
the space allowances given in table 8.4. 

Body mass (g) 

Minimum 
enclosure 
size 

(m2) 

Ducks 

Up to 300 

2.00 

Over 300 to 1200** 

2.00 

Over 1200 to 3500 

2.00 

Over 3500 

2.00 

Geese 

Up to 500 

2.00 

Over 500 to 2000 

2.00 

Over 2000 

2.00 

Area  per  bird 
(m2)* 

Minimum 
height (cm) 

Minimum  length  of 
feed  trough  per  bird 
(cm) 

Date  referred  to 
in Article 32(2) 

[Jan 2012] 

0.10 

0.20 

0.25 

0.50 

0.20 

0.33 

0.50 

50 

200 

200 

200 

200 

200 

200 

10 

10 

15 

15 

10 

15 

15 

*  This  shall  include  a  pond  of  minimum  area  0.5  m2  per  2m2  enclosure  with  a  minimum  depth  of  30cm.  The  pond  may 
contribute up to 50% of the minimum enclosure size.  
** Pre-fledged birds may be held in enclosures with a minimum height of 75 cm.  

Table 8.5. Ducks and geese: Minimum pond sizes* 

Ducks 

Geese 

Area (m2) 

Depth (cm) 

0.5 

0.5 

30 

from 10 to 30 

* Pond sizes are per 2 m2 enclosure. The pond may contribute up to 50% of the minimum enclosure size. 

Table 8.6. Pigeons 

Enclosures  shall  be  long and  narrow  (for  example  2  m  by  1  m)  rather  than  square  to  allow  birds  to 
perform short flights.  

EN 

64 

   EN 

 
 
 
Group size 

Minimum 
enclosure 
size (m2) 

Minimum 
height (cm) 

Minimum 
of 
length 
food 
trough 
per bird (cm) 

Minimum 
length  of  perch 
per bird (cm) 

Date  referred  to 
in Article 32(2) 

Up to 6 

 from 7 to 12  

2 

3 

200 

200 

For  each  additional  bird 
above 12 

0.15 

Table 8.7. Zebra Finch 

[Jan 2012] 

5 

5 

5 

30 

30 

30 

Enclosures shall be long and narrow (for example, 2 m by 1 m) to enable birds to perform short flights. 
For  breeding  studies,  pairs  may  be  housed  in  smaller  enclosures  containing  appropriate  enrichment 
with a minimum floor area of 0.5 m2 and a minimum height of 40 cm. The duration of the confinement 
shall be justified by the experimenter in consultation with veterinary staff.  

Group size 

Up to 6 

 7 to 12 

13 to 20 

Minimum  enclosure 
size (m2) 

Minimum 
(cm) 

height 

Minimum  number 
of feeders 

Date  referred  to 
in Article 32(2) 

1.0 

1.5 

2.0 

100 

200 

200 

[Jan 2012] 

2 

2 

3 

1 per 6 birds 

for each additional bird 
above 20 

0.05 

9. Amphibians 

Table 9.1. Aquatic urodele 

Body 
length*(cm) 

Minimum water 
surface area (cm2) 

Minimum 
water depth 
(cm) 

Optimal 
temperature 

Relative 
humidity 

Date  referred  to 
in Article 32(2) 

Minimum 
water surface 
area for each 
additional 
animal in 
group-holding 
(cm2) 

15ºC-22٥C  100% 

[Jan 2012] 

Up to 10 

262.5 

over 10 to 15 

525 

over 15 to 20 

875 

over 20 to 30 

1837.5 

Over 30 

3150 

* measured from snout to vent 

50 

110 

200 

440 

800 

13 

13 

15 

15 

20 

EN 

65 

   EN 

 
 
Table 9.2. Aquatic anurans* 

Body 
length**(cm) 

Minimum water 
surface area (cm2) 

Minimum 
water depth 
(cm) 

Optimal 
temperatur
e 

Relative 
humidity 

Date  referred  to 
in Article 32(2) 

Minimum 
water surface 
area for each 
additional 
animal in 
group-holding 
(cm2) 

Less than 6 

from 6 to 9 

over 9 to 12 

over 12  

160 

300 

600 

920 

40 

75 

150 

230 

6 

8 

10 

12.5 

18ºC-22٥C  100% 

[Jan 2012] 

* these conditions apply to holding (i.e., husbandry) tanks but not to those tanks used for natural mating and super-ovulation 
for reasons of efficiency, as the latter procedures require smaller individual tanks. Space requirements determined for adults 
in the indicated size categories; juveniles and tadpoles shall either be excluded, or dimensions altered according to the scaling 
principle 
** measured from snout to vent 

Table 9.3. Semi-aquatic anurans 

Body length* 

(cm) 

Minimum 
enclosure 
size** (cm2) 

Minimum 
area  for  each 
additional 
animal 
group 
holding 
(cm2) 

in 

up to 5.0 

1500 

over 5.0 to 7.5 

3500 

Over 7.5 

4000 

200 

500 

700 

20 

30 

30 

Minimum 
enclosure 
height*** 
(cm) 

Minimum 
water 
depth 

Optimal 
temperatu
re 

Relati
ve 
humid
ity  

Date referred to 
in Article 32(2) 

(cm) 

10 

10 

15 

10ºC-
15ºC 

50-
80% 

[Jan 2012] 

* measured from snout to vent 
** one third land division, two thirds water division sufficient for animals to submerge 
*** measured from the surface of the land division up to the inner part of the top of the terrarium; furthermore, the height of 
the enclosures shall be adapted to the interior design  

Table 9.4. Semi-terrestrial anurans 

Body length* 

(cm) 

Minimum 
enclosure 
size** 

Minimum  area  for  each 
additional 
in 
animal 
group-holding (cm2) 

(cm2) 

Relative 
humidity 

Date  referred 
to  in  Article 
32(2) 

Minimum 
water 
depth 

(cm) 

Optim
al 
tempe
rature 

Minim
um 
enclos
ure 
height
*** 
(cm) 

Up to 5.0 

1500 

over 5.0 to 7.5 

3500 

200 

500 

20 

30 

10 

10 

50-80% 

[Jan 2012] 

23ºC-
27ºC 

EN 

66 

   EN 

over 7.5 

4000 

700 

30 

15 

* measured from snout to vent 
** two-thirds land division, one-third water division sufficient for animals to submerge 
*** measured from the surface of the land division up to the inner part of the top of the terrarium; furthermore, the height of 
the enclosures shall be adapted to the interior design 

Table 9.5. Arboreal anurans 

Body length* 

(cm) 

up to 3.0 

Over 3.0  

Minimum 
enclosure size** 

(cm2) 

900 

1500 

area 
Minimum 
each 
for 
additional animal 
in  group-holding 
(cm2) 

100 

200 

Minimum 
enclosure 
height*** 

Optimal 
temperatu
re 

Relative 
humidity  

Date referred to 
in Article 32(2) 

(cm) 

30 

30 

18ºC-
25ºC 

50-70% 

[Jan 2012] 

* measured from snout to vent 
** two-thirds land division, one-third pool division sufficient for animals to submerge 
*** measured from the surface of the land division up to the inner part of the top of the terrarium; furthermore, the height of 
the enclosures shall be adapted to the interior design. 

10. Reptiles  

Table 10.1. Aquatic chelonians 

Body length*) 

(cm) 

Minimum 
surface area 

water 

(cm2) 

Minimum  water 
surface  area 
for 
additional 
each 
animal 
in  group 
holding (cm2) 

up to 5 

600 

Over 5 to 10 

1600 

Over 10 to 15 

3500 

Over 15 to 20 

6000 

Over 20 to 30 

10000 

Over 30 

20000 

100 

300 

600 

1200 

2000 

5000 

Minimum 
water depth 

Optimal 
tempera
ture 

Relative 
humidit
y  

Date referred to in 
Article 32(2) 

20ºC-
25ºC 

80-70%  [Jan 2012] 

(cm) 

10 

15 

20 

30 

35 

40 

*) measured in a straight line from the front edge to the back edge of the shell 

Table 10.2. Terrestrial snakes 

Body length*) 

(cm) 

Minimum 
area 

floor 

(cm2) 

Minimum  area  for 
additional 
each 
animal 
in 
group-holding (cm2) 

Minimum 
enclosure 
height **) 

Optimal 
temperat
ure 

Relative 
humidity 

Date  referred  to 
in Article 32(2) 

up to30 

300 

Over 30 to 40 

400 

150 

200 

(cm) 

10 

12 

22ºC-
27ºC 

60-80% 

[Jan 2012] 

EN 

67 

   EN 

Over 40 to 50 

600 

Over 50 to 75 

1200 

Over 75 

2500 

300 

600 

1200 

15 

20 

28 

*) measured from snout to tail 
**) measured from the surface of the land division up to the inner part of the top of the terrarium; furthermore, the height of 
the enclosure shall be adapted to the interior design. 

EN 

68 

   EN 

ANNEX V 

Humane Methods of Killing animals 

Table 1 – Humane methods of killing fish, including gnathostomes and cyclostomes 

Agent 

Rapidity  Efficacy 

Ease 
of 

use 

Operator

Aesthetic 

Overall 

Remarks 

safety 

value 

rating 

(1-5) 

Anaesthetic 
overdose  

++ 

++ 

++ 

+ to ++ 

++ 

4 to 5* 

Electrical 
stunning 

++ 

+ 

+ 

+ 

++ 

4 

Maceration 

++ 

++ 

++ 

++ 

Concussion 

++ 

+ 

+ 

++ 

+ 

- 

4 

3 

May  be  used  with 
prior  sedation  of  the 
animal.  

*Some  anaesthetics 
may 
skin 
cause 
irritation  when  used 
on fish. 

Specialised 
equipment required. 

or 

To  be  followed  by 
immediate 
exsanguination, 
immediate 
destruction  of 
the 
brain,  or  death  to  be 
ensured  by  another 
method. 

Only  for  fish 
than 2 cm in length  

less 

or 

To  be  followed  by 
immediate 
exsanguination, 
immediate 
destruction  of 
the 
brain,  or  death  to  be 
ensured  by  another 
method. 

Cervical 
dislocation 

++ 

++ 

+ 

++ 

- 

2 - if animal 
conscious 

5 - if animal 
unconscious 

in 
To 

Not  used 
>500g. 
followed 
destruction  of 
brain. 

fish 
be 
by 
the 

Other  methods  may  be  used  on  unconscious  fish,  providing  the  animal  does  not  regain 
consciousness before death. 

Rapidity:  ++  very  rapid,  +  rapid,  -  slow.  Efficacy:  ++  very  effective,  +  effective,  -  not 
effective.  Ease  of  use:  ++  easy  to  use,  +  requires  expertise,  -  requires  specialist  training. 

EN 

69 

   EN 

 
 
 
 
 
 
Operator  safety:  ++  no  danger,  +  little  danger,  -  dangerous.  Aesthetic  value:  ++  good 
aesthetically, + acceptable for most people, - unacceptable for many people. Rating: 1-5 with 
5 as most satisfactory. 

EN 

70 

   EN 

Table 2 - Humane methods of killing amphibians 

Agent 

Rapidity  Efficacy 

Ease 
of 

use 

Operator

Aesthetic

Overall

Remarks 

safety 

value 

rating 

(1-5) 

Anaesthetic 
overdose  

++ 

++ 

++ 

++ 

++ 

5 

May be used with prior 
sedation of the animal.  

Concussion 

++ 

++ 

+ 

++ 

- 

3 

NMB/ 
anaesthetic 
mixtures*) 

Microwave 
irradiation 

Electrical 
stunning 

+ 

++ 

++ 

++ 

- 

- 

+ 

+ 

+ 

3 

++ 

3 

+ 

+ 

+ 

- 

- 

2 

followed  by 

To  be 
immediate 
exsanguination, 
or 
immediate  destruction 
of the brain, or death to 
be  ensured  by  another 
method. 

be 

To 
intravenously, 
therefore 
expertise. 

injected 

requires 

Specialised  equipment 
required. 

For small amphibians. 

Specialised  equipment 
required.  

followed  by 

To  be 
immediate 
or 
exsanguination, 
immediate  destruction 
of the brain, or death to 
be  ensured  by  another 
method. 

*) Neuromuscular blocking agent, NMB 

Other methods may be used on unconscious amphibians, providing the animal does not regain 
consciousness before death. 

Rapidity:  ++  very  rapid,  +  rapid,  -  slow.  Efficacy:  ++  very  effective,  +  effective,  -  not 
effective.  Ease  of  use:  ++  easy  to  use,  +  requires  expertise,  -  requires  specialist  training. 
Operator  safety:  ++  no  danger,  +  little  danger,  -  dangerous.  Aesthetic  value:  ++  good 
aesthetically, + acceptable for most people, - unacceptable for many people. Rating: 1-5 with 
5 as most satisfactory. 

EN 

71 

   EN 

 
 
 
 
 
 
 
Table 3 - Humane methods of killing reptiles 

Agent 

Rapidity  Efficacy 

Ease of 

Operator

Aesthetic 

Overall

Remarks 

use 

safety 

value 

rating 

(1-5) 

Anaesthetic 
overdose  

++ 

++ 

++ 

+ 

++ 

5 

May be used with prior 
sedation of the animal.  

Captive bolt 

++ 

++ 

++ 

+ 

+ 

5 

For large reptiles. 

followed  by 

To  be 
immediate 
exsanguination, 
or 
immediate  destruction 
of the brain, or death to 
be  ensured  by  another 
method. 

Shooting 

++ 

++ 

++ 

- 

+ 

4 

Concussion 

+ 

+ 

+ 

++ 

- 

3 

be 

used 

To 
by 
experienced  marksman. 
May  need  a  method  to 
ensure  death.  To  be 
used in field conditions. 

followed  by 

To  be 
immediate 
or 
exsanguination, 
immediate  destruction 
of the brain, or death to 
be  ensured  by  another 
method. 

Other  methods  may  be  used  on  unconscious  reptiles,  providing  the  animal  does  not  regain 
consciousness before death. 

Rapidity:  ++  very  rapid,  +  rapid,  -  slow.  Efficacy:  ++  very  effective,  +  effective,  -  not 
effective.  Ease  of  use:  ++  easy  to  use,  +  requires  expertise,  -  requires  specialist  training. 
Operator  safety:  ++  no  danger,  +  little  danger,  -  dangerous.  Aesthetic  value:  ++  good 
aesthetically, + acceptable for most people, - unacceptable for many people. Rating: 1-5 with 
5 as most satisfactory. 

EN 

72 

   EN 

 
 
 
 
 
 
 
 
 
Table 4 - Humane methods of killing birds 

Agent 

Rapidity 

Efficacy 

Ease of 

Operator 

Aesthetic 

Overall 

Remarks 

Use 

safety 

value 

rating 

(1-5) 

NMB/ 
anaesthetic 
mixtures 

++ 

++ 

+ 

+ 

++ 

4 

Inert 
(Ar, N2) 

gases 

++ 

++ 

++ 

++ 

+ 

4 

Maceration 

++ 

++ 

++ 

++ 

Cervical 
dislocation 

++ 

++ 

- 

++ 

Microwave 
irradiation 

++ 

++ 

Concussion 

++ 

++ 

- 

- 

++ 

++ 

- 

- 

+ 

- 

To  be  injected 
intravenously, 
therefore 
requires 
expertise. 

To  be  followed 
by 
immediate 
exsanguination, 
immediate 
or 
destruction 
of 
the  brain,  or 
be 
death 
ensured 
by 
another method. 

to 

For chicks up to 
72 h old 

4 

if 

- 

1/3 
animal 
conscious 

For  small  and 
young 
birds 
(<250 g).  

5  -  if  animal 
unconscious 

3 

3 

To  be  followed 
by 
immediate 
exsanguination, 
immediate 
or 
destruction 
of 
the  brain,  or 
be 
death 
ensured 
by 
another method. 

to 

Specialised 
equipment 
required. 

To  be  followed 
by 
immediate 
exsanguination, 
or 
immediate 
of 
destruction 
the  brain,  or 
be 
death 
ensured 
by 
another method. 

to 

EN 

73 

   EN 

 
 
 
 
 
Electrical 
stunning 

++ 

++ 

+ 

- 

- 

3 

Carbon 
monoxide 

+ 

+ 

++ 

- 

- 

1 

Specialised 
equipment 
required. 

To  be  followed 
immediate 
by 
exsanguination, 
immediate 
or 
destruction 
of 
the  brain,  or 
be 
death 
ensured 
by 
another method. 

to 

Danger 
operator. 

to 

Other  methods  may  be  used  on  unconscious  birds,  providing  the  animal  does  not  regain 
consciousness before death. 

Rapidity:  ++  very  rapid,  +  rapid,  -  slow.  Efficacy:  ++  very  effective,  +  effective,  -  not 
effective.  Ease  of  use:  ++  easy  to  use,  +  requires  expertise,  -  requires  specialist  training. 
Operator  safety:  ++  no  danger,  +  little  danger,  -  dangerous.  Aesthetic  value:  ++  good 
aesthetically, + acceptable for most people, - unacceptable for many people. Rating: 1-5 with 
5 as most satisfactory. 

EN 

74 

   EN 

Table 5 - Humane methods of killing rodents  

Agent 

Rapidity  Efficacy 

Ease 
of 

use 

Operator 

Aesthetic 

Overall 

Remarks 

safety 

value 

rating 

(1-5) 

++ 

++ 

++ 

+ 

++ 

5 

May  be  used  with 
prior  sedation  of  the 
animal.  

Anaesthetic 
overdose  

NMB/ 
anaesthetic 
mixtures 

++ 

++ 

- 

+ 

++ 

Inert gases (Ar)  ++ 

+ 

++ 

+ 

+ 

4 

4 

Concussion 

++ 

++ 

+ 

++ 

- 

3 

be 

To 
intravenously, 
therefore 
expertise. 

injected 

requires 

To  be  followed  by 
immediate 
exsanguination, 
or 
immediate  destruction 
of  the  brain,  or  death 
to  be  ensured  by 
another listed method. 

For  rodents  under  1 
kg. To be followed by 
immediate 
exsanguination, 
or 
immediate  destruction 
of  the  brain,  or  death 
to  be  ensured  by 
another method. 

Cervical 
dislocation 

++ 

++ 

+ 

++ 

- 

- 

2/3 
animal 
conscious 

if 

For 
150g. 

rodents 

under 

Microwave 
irradiation 

++ 

++ 

Decapitation 

+ 

+ 

- 

+ 

++ 

++ 

+ 

- 

To  be  followed  by 
immediate 
or 
exsanguination, 
immediate  destruction 
of  the  brain,  or  death 
to  be  ensured  by 
another method. 

Specialised equipment 
required. 

5  -  if  animal 
unconscious 

3 

if 

- 

1/2 
animal 
conscious 

5  -  if  animal 
unconscious 

EN 

75 

   EN 

 
 
 
 
 
 
Carbon dioxide  + 

++ 

++ 

+ 

++ 

if  sole 

1  - 
agent 

To  be  used  in  gradual 
fill only.  

5  -  if  animal 
unconscious 

Carbon 
monoxide 

+ 

+ 

+ 

- 

++ 

1 

Danger to operator 

Other  methods  may  be  used  on  unconscious  rodents,  providing  the  animal  does  not  regain 
consciousness before death. 

Rapidity:  ++  very  rapid,  +  rapid,  -  slow.  Efficacy:  ++  very  effective,  +  effective,  -  not 
effective.  Ease  of  use:  ++  easy  to  use,  +  requires  expertise,  -  requires  specialist  training. 
Operator  safety:  ++  no  danger,  +  little  danger,  -  dangerous.  Aesthetic  value:  ++  good 
aesthetically, + acceptable for most people, - unacceptable for many people. Rating: 1-5 with 
5 as most satisfactory. 

EN 

76 

   EN 

Table 6 - Humane methods of killing rabbits  

Agent 

Rapidity 

Efficacy 

Ease of 

Operator 

Aesthetic 

Overall 

Remarks 

use 

safety 

value 

rating 

++ 

++ 

++ 

+ 

++ 

Anaesthetic 
overdose  

NMB/ 
anaesthetic 
mixtures 

++ 

++ 

- 

- 

+ 

+ 

++ 

+ 

Captive bolt 

++ 

++ 

Cervical 
dislocation 

++ 

++ 

- 

++ 

- 

(1-5) 

5 

4 

4 

if 

3 
- 
animal 
conscious 

if 

5 
- 
animal 
unconscio
us 

Concussion 

++ 

+ 

- 

++ 

- 

3 

Electrical 
stunning 

++ 

+ 

++ 

- 

+ 

3 

May be used with prior 
sedation of the animal.  

be 

To 
injected 
intravenously,  therefore 
requires expertise. 

followed  by 

To  be 
immediate 
or 
exsanguination, 
immediate  destruction 
of the brain, or death to 
be  ensured  by  another 
method. 

Acceptable  for  rabbits 
under 1 kg. 

followed  by 

To  be 
immediate 
exsanguination, 
or 
immediate  destruction 
of the brain, or death to 
be  ensured  by  another 
method. 

followed  by 

To  be 
immediate 
exsanguination, 
or 
immediate  destruction 
of the brain, or death to 
be  ensured  by  another 
method. 

Specialised  equipment 
required.  

followed  by 

To  be 
immediate 
or 
exsanguination, 
immediate  destruction 
of the brain, or death to 
be  ensured  by  another 
method. 

Microwave 

++ 

++ 

- 

++ 

+ 

3 

Specialised  equipment 

EN 

77 

   EN 

 
 
 
 
 
 
 
irradiation 

Decapitation 

+ 

+ 

+ 

- 

- 

if 

1 
- 
animal 
conscious 

if 

- 
5 
animal 
unconscio
us 

Carbon 
monoxide 

+ 

Rapid freezing 

+ 

+ 

+ 

++ 

- 

++ 

++ 

++ 

+ 

1 

1 

required. 

For rabbits under 1 kg. 

Danger to operator. 

be 

To 
foetuses under 4g 

used  with 

Other  methods  may  be  used  on  unconscious  rabbits,  providing  the  animal  does  not  regain 
consciousness before death. 

Rapidity:  ++  very  rapid,  +  rapid,  -  slow.  Efficacy:  ++  very  effective,  +  effective,  -  not 
effective.  Ease  of  use:  ++  easy  to  use,  +  requires  expertise,  -  requires  specialist  training. 
Operator  safety:  ++  no  danger,  +  little  danger,  -  dangerous.  Aesthetic  value:  ++  good 
aesthetically, + acceptable for most people, - unacceptable for many people. Rating: 1-5 with 
5 as most satisfactory. 

EN 

78 

   EN 

Table 7 - Humane methods of killing dogs, cats, ferrets and foxes 

Agent 

Rapidity  Efficacy

Ease 
of 

use 

Operator

Aesthetic

Overall 

Remarks 

safety 

value 

rating 

(1-5) 

Anaesthetic overdose  

++ 

++ 

- 

+ 

++ 

5 

NMB/ 
anaesthetic mixtures 

++ 

++ 

Shooting  with  a  free 
bullet  with  appropriate 
rifles, 
and 
guns 
ammunition 

++ 

++ 

- 

- 

+ 

- 

+ 

- 

4 

4 

Captive bolt 

++ 

++ 

- 

++ 

+ 

3 

Electrical stunning 

++ 

++ 

- 

- 

- 

3 

Concussion 

++ 

++ 

+ 

++ 

- 

2 

May  be  used  with 
prior  sedation  of 
the animal.  

injected 

To  be 
intravenously, 
therefore  requires 
expertise. 

To  be  used  by 
experienced 
marksman.  May 
need  a  method  to 
ensure death. 

To be followed by 
immediate 
exsanguination,  or 
immediate 
destruction  of  the 
brain,  or  death  to 
be 
by 
ensured 
another method. 

Specialised 
equipment 
required.  

To be followed by 
immediate 
exsanguination,  or 
immediate 
destruction  of  the 
brain,  or  death  to 
be 
by 
ensured 
another method. 

To  be  used  on 
neonates.  

To be followed by 
immediate 
exsanguination,  or 
immediate 
destruction  of  the 
brain,  or  death  to 
by 
ensured 
be 

EN 

79 

   EN 

 
 
 
 
 
 
 
 
another method. 

Other methods may be used on unconscious dogs, cats, ferrets or foxes, providing the animal 
does not regain consciousness before death. 

Rapidity:  ++  very  rapid,  +  rapid,  -  slow.  Efficacy:  ++  very  effective,  +  effective,  -  not 
effective.  Ease  of  use:  ++  easy  to  use,  +  requires  expertise,  -  requires  specialist  training. 
Operator  safety:  ++  no  danger,  +  little  danger,  -  dangerous.  Aesthetic  value:  ++  good 
aesthetically, + acceptable for most people, - unacceptable for many people. Rating: 1-5 with 
5 as most satisfactory. 

EN 

80 

   EN 

Table 8 - Humane methods of killing large mammals  

Agent 

Rapidity  Efficacy

Ease 
of 

use 

Operator

Aesthetic

Overall 

Remarks 

safety 

value 

rating 

(1-5) 

Anaesthetic overdose  

++ 

++ 

- 

+ 

++ 

5 

Captive bolt 

++ 

++ 

+ 

+ 

+ 

5 

Shooting  with  a  free 
bullet  with  appropriate 
rifles, 
and 
guns 
ammunition. 

++ 

++ 

+ 

- 

+ 

4 

NMB/ 
anaesthetic mixtures 

++ 

++ 

- 

+ 

++ 

4 

Inert gases (Ar) 

++ 

++ 

+ 

+ 

+ 

4 

Electrical stunning 

++ 

++ 

+ 

- 

- 

3 

May  be  used 
with 
prior 
sedation  of  the 
animal.  

To  be  followed 
immediate 
by 
exsanguination, 
immediate 
or 
destruction 
of 
the  brain,  or 
be 
death 
ensured 
by 
another method. 

to 

To  be  used  by 
experienced 
marksman.  May 
need  a  method 
to  ensure  death. 
To  be  used  in 
field conditions. 

To  be  injected 
intravenously, 
therefore 
requires 
expertise. 

To  be  followed 
by 
immediate 
exsanguination, 
immediate 
or 
destruction 
of 
the  brain,  or 
be 
death 
by 
ensured 
another method. 

to 

Acceptable 
pigs. 

for 

Specialised 
equipment 
required.  

To  be  followed 

EN 

81 

   EN 

 
 
 
 
 
 
Concussion 

++ 

+ 

- 

+ 

+ 

by 
immediate 
exsanguination, 
immediate 
or 
destruction 
of 
the  brain,  or 
death 
be 
by 
ensured 
another method. 

to 

To  be  followed 
immediate 
by 
exsanguination, 
immediate 
or 
destruction 
of 
the  brain,  or 
be 
death 
ensured 
by 
another method. 

to 

3 - if animal 
conscious 

5 - if animal 
unconscious 

Other methods may be used on other large unconscious mammals, providing the animal does 
not regain consciousness before death. 

Rapidity:  ++  very  rapid,  +  rapid,  -  slow.  Efficacy:  ++  very  effective,  +  effective,  -  not 
effective.  Ease  of  use:  ++  easy  to  use,  +  requires  expertise,  -  requires  specialist  training. 
Operator  safety:  ++  no  danger,  +  little  danger,  -  dangerous.  Aesthetic  value:  ++  good 
aesthetically, + acceptable for most people, - unacceptable for many people. Rating: 1-5 with 
5 as most satisfactory. 

EN 

82 

   EN 

 
Table 9 - Humane methods of killing non-human primates 

Agent 

Rapidity  Efficacy 

Ease 
of 

use 

Operator

Aesthetic 

Overall

Remarks 

safety 

value 

rating 

(1-5) 

Anaesthetic 
overdose  

++ 

++ 

- 

+ 

++ 

5 

May  be  used  with  prior 
sedation of the animal. 

Other methods may be used on unconscious non-human primates, providing the animal does 
not regain consciousness before death. 

Rapidity:  ++  very  rapid,  +  rapid,  -  slow.  Efficacy:  ++  very  effective,  +  effective,  -  not 
effective.  Ease  of  use:  ++  easy  to  use,  +  requires  expertise,  -  requires  specialist  training. 
Operator  safety:  ++  no  danger,  +  little  danger,  -  dangerous.  Aesthetic  value:  ++  good 
aesthetically, + acceptable for most people, - unacceptable for many people. Rating: 1-5 with 
5 as most satisfactory. 

EN 

83 

   EN 

 
 
 
 
 
 
 ANNEX VI  

List of elements referred to in Article 20(4) 

National  legislation  in  force  relevant  to  the  acquisition,  husbandry,  care  and  use  of 
animals in scientific procedures. 

Ethics in relation to human animal relationship, intrinsic value of life and arguments 
for and against the use of animals in scientific procedures. 

Basic biology in relation to anatomy, physiological features, breeding, genetics and 
genetic alteration. 

Animal behaviour, husbandry and enrichment. 

Animal health management and hygiene. 

Recognition  of  species  specific  distress,  pain  and  suffering  of  most  common 
laboratory species. 

Anaesthesia, pain relieving methods and euthanasia. 

Use of humane end-points. 

Requirement of replacement, reduction and refinement. 

1. 

2. 

3. 

4. 

5. 

6. 

7. 

8. 

9. 

EN 

84 

   EN 

ANNEX VII  
List of elements referred to in Point (3) of Article 36  

1. 

Relevance and justification of the following: 

(a) 

use of animals including their origin, estimated numbers, species and 
life stages; 

(f) 

procedures. 

Demonstration that existing methods to replace, reduce and refine the use of animals 
in procedures have been applied. 

Demonstration of competence of persons involved in the project. 

The planned use of anaesthesia, analgesia and other pain relieving methods. 

Reduction, avoidance and alleviation of  any form of animal suffering from birth to 
death. 

Housing, husbandry and care conditions of the animals. 

Use of early and humane end-points. 

Experimental  or  observational  strategy  and  statistical  design  to  minimise  animal 
numbers, suffering and environmental impact. 

Life time experience and re-use of animals. 

2. 

3. 

4. 

5. 

6. 

7. 

8. 

9. 

10. 

Avoidance of unnecessary duplication of procedures. 

EN 

85 

   EN 

LEGISLATIVE FINANCIAL STATEMENT FOR PROPOSALS HAVING A 
BUDGETARY IMPACT EXCLUSIVELY LIMITED TO THE REVENUE SIDE 

1. 

NAME OF THE PROPOSAL: 

Proposal  for  a  Directive  of  the  European  Parliament  and  of  the  Council  on  the 
protection  of  animals  used  for  scientific  purposes  and  repealing  Directive 
86/609/EEC on the protection of animals used for experimental and other scientific 
purposes 

2. 

BUDGET LINES: 

Chapter and Article: 

Amount budgeted for the year concerned: 

3. 

FINANCIAL IMPACT  

X 

Proposal has no financial implications 

(cid:133) 

Proposal has no financial impact on expenditure but has a financial impact on 
revenue – the effect is as follows: 

(€ million to one decimal place) 

Budget line 

Revenue32 

12 month period, 
starting dd/mm/yyyy

[Year n] 

Article … 

Impact on own resources 

Article … 

Impact on own resources 

Situation following action 

[n+1] 

[n+2] 

[n+3] 

[n+4] 

[n+5] 

32 

Regarding  traditional  own  resources  (agricultural  duties,  sugar  levies,  customs  duties)  the  amounts 
indicated must be net amounts, i.e. gross amounts after deduction of 25 % of collection costs. 

EN 

86 

   EN 

 
 
 
 
 
 
 
 
 
 
                                                 
Article … 

Article … 

4. 

5. 

ANTI-FRAUD MEASURES 

OTHER REMARKS 

EN 

87 

   EN