Commission staff working document - Annex to the: Report from the Commission to the Council and the European Parliament - Fifth Report on the Statistics on the Number of Animals used for Experimental and other Scientific Purposes in the Member States of the European Union - Part II {COM (2007) 675 final}
Date: 2007-11-05
Institutions: European Commission
Subjects: EU statistics, animal experimentation, animal welfare, impact study, report, scientific research

COMMISSION OF THE EUROPEAN COMMUNITIES 

Brussels, 5.11.2007 
SEC(2007) 1455 

PART II 

COMMISSION STAFF WORKING DOCUMENT 

Annex to the:  

REPORT FROM THE COMMISSION TO THE COUNCIL AND THE EUROPEAN 
PARLIAMENT  

Fifth 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 final}

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Important notice 

This Report is a document of the Commission services and cannot be considered binding to 
this institution in any way.

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PART B I: DATA AND SUMMARY OF THE COMMENTS SUBMITTED BY THE 
MEMBER STATES

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TABLE OF CONTENTS 

AUSTRIA ...................................................................................................................................5 

BELGIUM ................................................................................................................................20 

CYPRUS ...................................................................................................................................34 

CZECH REPUBLIC .................................................................................................................40 

DENMARK ..............................................................................................................................51 

GERMANY ..............................................................................................................................60 

ESTONIA .................................................................................................................................71 

GREECE ...................................................................................................................................76 

SPAIN .......................................................................................................................................86 

FRANCE...................................................................................................................................95 

HUNGARY ............................................................................................................................104 

IRELAND ...............................................................................................................................115 

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AUSTRIA 

Statistical data submitted 

The statistical data have been submitted by the “Bundesministerien für Gesundheit und Frauen- Land 
und  Forstwirtshaft,  Umwelt  und  Wasserwirtschaft  –  Wirtschaft  und  Arbeit  -  Bildung,  Wissenschaft 
und  Kultur”  (Federal  Ministries  for  Health  and  Women  -Agriculture  Forestry,  the  Environment  and 
Water Mangement – Economic Affairs and Labour - Education, Science and Culture). 

Comments from the Austrian authorities 

In accordance with Directive 86/609/EEC regarding the protection of animals used for experimental 
and other scientific purposes, animal experiments in Austria are regulated by the Tierversuchsgesetz 
(Animal  Experiments  Act)  (Federal  Law  of  27  September  1989  on  experiments  using  live  animals, 
Federal Law Gesetz, (BGBL. No 501/1989, as most recently amended by Federal Law No.162/2005. 
Responsibility for enforcing the Animal Experiments Act in Austria rests with the Federal Minister for 
Health and Women, the Federal Minister for Economic affairs and Labour, the Federal Minister for 
Agriculture,  Forestry,  the  Environment  and  Water  Management  and  the  Federal  Minister  for 
Education, Science and Culture. 

Animal  experiments  are  permitted  in  Austria  only  if  the  stringent  requirements  of  the  Animal 
Experiments Act are met and only for one of the following reasons: 

a) 

b) 

c) 

d) 

e) 

f) 

for research and development 

for vocational training 

for medical diagnosis and therapy 

for testing natural or synthetic materials, preparations or products 

for detecting environmental risks 

for obtaining materials 

Animal experiments may only be carried out providing that 

1. 

There is a justified interest in carrying out the experiment, i.e. 

a) for preventing, detecting or curing diseases in human beings or animals,  

b) for detecting or influencing physiological conditions or functions in human beings or animals, 

c) for securing scientific knowledge 

d) for providing vocational training or,  

e) for obviating environmental risks, and providing that 

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2. 
The objectives pursued by the experiments cannot be achieved by other methods or procedures 
(alternative  techniques)  or,  in  the  case  of  vocational  training,  by  using  other  teaching  aids,  in 
particular films or other audiovisual media. 

Experiments on animals are never permitted, 

if the results of a similar experiment are de facto and de jure accessible and no justified doubts 

a) 
exist as to the accuracy and meaningfulness of the said results,  

b) 

c) 

if no further or new knowledge is likely to come from the experiment,  

if the experiment is not necessary, even for control purposes, or  

d) 
if the results of an animal experiment carried out in Austria or abroad are de facto or de jure 
accessible,  no  justified  doubts  exist  regarding  the  accuracy  and  meaningfulness  of  those  results  and 
they are officially recognised in Austria on the basis of the relevant statutory provisions. 

In  addition  to  the  above,  the  competent  Federal  Ministers  can  issue  regulations  determining  which 
methods  are  no  longer  permitted  for  animal  experiments  since  they  are  outdated  in  the  light  of 
scientific progress achieved. By way of example, the "LD-50" test has been banned in Austria since 
1992.  

The Animal Experiments Act directly prohibits the following:  

- 

- 

animal experiments for cosmetic purposes (since 1999), and 

animal experiments involving the Great Apes (since 1. 1. 2006). 

Guiding principles 

The  Animal  Experiments  Act  also  contains  guiding  principles  for  all  scientists  and  other  personnel 
involved  in  animal  experiments  and  these  are  binding,  also  on  the  competent  authorities.  Particular 
features of these are that: 

Animal  experiments  must  be  consistent  with  the  principles  of  scientific  research  and  the  hypothesis 
being  tested  and  the  procedure  selected  must  be  reasonable  in  the  light  of  acknowledged  scientific 
progress. Animal experiments are to be conducted with a view to obtaining as much new knowledge 
as possible. 

The  meaningfulness  and  practicability  of  model  animal  experiments  are  to  be  continuously  and 
critically assessed with a view to reducing the number of animal experiments and increasing the 
use of alternative techniques, adapting them to reflect acknowledged scientific progress. Results 
obtained from behavioural research and animal experiments as well as developments in measurement 
and  laboratory  techniques  are  to  be  taken  into  account  in  order  to  minimize  the  stress  that 
experimental animals undergo. 

All  persons  involved  in  carrying  out  animal  experiments  are  responsible  in  ethical  and  scientific 
terms  for  the  tasks  they  are  required  to  undertake.  It  is  the  duty  of  every  scientist  to  assess  the 
necessity and appropriateness  of  the  animal experiment that  he  has planned,  headed  and  completed, 
weighing them against the stress to which the animals are subjected. 

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Accordingly,  Austria's  Animal  Experiments  Act  has  express  provision,  as  a  legal  requirement,  for 
applying the principles of the '3 Rs' (reduction, refinement, replacement). 

As  regards  the  keeping  of  experimental  animals  (caring  for  and  housing  the  animals)  Austria's 
legislation on animal experiments has not only fully transposed the guidelines set out in Annex II to 
Article 5 of Directive 86/609/EEC by law and regulation, but in the interests of animal welfare and of 
considerably  improving  the  standards  of  animal  husbandry,  it  has  also  made  these  provisions 
legally binding. 

Promoting alternatives to animal experiments as a legal obligation 

The Federal Ministers responsible for enforcing the Animal Experiments Act (see above) are required 
by  law  (the  Animal  Experiments  Act)  to  promote  the  development  of  alternative  methods  and 
procedures  that  do  not  involve  animal  experiments  (see  above)  in  line  with  the  relevant  Federal 
financial legislation and progress in science and to promote alternative methods and procedures. The 
aim is to develop alternative methods that are scientifically meaningful and which make it possible to 
reduce the number of experimental animals and the stress to which they are exposed or even to make 
animal experiments wholly redundant. 

Promoting  the  objective  of  the  3Rs  is  thus  an  express  component  of  Austria's  Animal  Experiments 
Act,  the  aim  being  to  improve  the  protection  of  animals.  Over  the  last  decade  more  than  EUR 2.5 
million has been spent on researching and developing alternatives to animal experiments, in particular 
on  the  part  of  the  Federal  Ministry  for  Education,  Science  and  Culture.  Austria  also  supports, 
wherever  possible,  the  development,  validation  and  use  of  alternatives  to  animal  experiments  at 
international level, in particular in the context of the EU and the OECD. 

It  should  also  be  remembered  in  this  connection  that  conferences  on  animal  experiments  and 
alternative methods have in the past been organised under Austrian Presidency. By way of example, in 
November  1998  a  conference  was  organised  in  conjunction  with  the  European  Commission  on  the 
subject of "Implementation of the 3 Rs – Objectives for the EU and for science and industry“. The aim 
of this symposium was to promote the implementation of the 3Rs also at EU level. The symposium 
was attended by the competent authorities from all EU Member States as well as, for the first time, 
representatives  of  the  third  countries  that  have  meanwhile  become  EU  Member  States.  One  of  the 
resolutions adopted at this symposium was forwarded to the Council of Ministers of the EU and to the 
European  Commission  for  further  action.  At  the  beginning  of  July  2006  the  13th  Congress  on 
Alternatives to Animal Testing (meanwhile a tradition) was held in Linz under the patronage of the 
Austrian  EU  Presidency  offering  a  much-acclaimed  scientific  programme  on  alternatives  to  animal 
experiments.  

During its EU Presidency in the first half of 2006 Austria sought, in addition to the above, to secure a 
decision  of  the  Council  on  the  position  of  the  European  Community  with  regard  to  the  proposal  to 
amend  Annex A  of  the  European  Convention  on  protecting  animals  used  for  experiments  and  other 
scientific  purposes  (see  Council  of  the  European  Union  7643/06  Legislative  Acts  and  other  legal 
instruments, adopted by the Council on 10 April 2006). As a result, it was possible to ensure that at 
the fourth multilateral hearing of the parties to this European Convention the European Commission, 
on behalf of the European Community, was able to support and adopt this revised Appendix A of the 
Convention that contained guidelines for the housing and care of such animals. 

Statistics on animal experiments 

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Statistics  on  animal  experiments  in  Austria  are produced  in  accordance  with  Article 13  of  Directive 
86/609/EEC pursuant to § 16 of the Animal Experiments Act and the Regulation on Statistics relating 
to  Animal  Experiments  (Tierversuchsstatistik-Verordnung),  which  is  based  on  it  (BGBl. II 
No 199/2000), and sets out the standardised statistics for animal experiments which are to be produced 
annually and be of a binding nature. No later than 1 March every year persons responsible for carrying 
out animal experiments must submit to the ministry responsible for enforcing the Animal Experiments 
Act their statistical data relating to their animal experiments during the previous year. The following 
information is to be provided: 

the  number  and  type  of  experimental  animals  used  overall  plus  the  origin  and  number,  with 

a) 
breakdown, of the animals used, 

b) 

c) 

d) 

the number and types of animals used (types of experimental animals, with breakdown), 

the number and types of experimental animals used for toxicological and other safety tests, 

the number and types of experimental animals used for tests on human and animal diseases, 

e) 
the number and types of experimental animals used in the manufacture and quality control of 
products  and  equipment  for  human  medicine,  dentistry  and  veterinary  medicine  including,  where 
appropriate, an indication of the relevant statutory provisions, 

f) 
the  number  and  types  of  animals  used  for  toxicological  and  other  safety  tests,  where 
appropriate  with  an  indication  of  the  relevant  statutory  provisions  as  well  as  the  type  of  test 
(technique) and products or materials (types of products or materials). 

The Federal Ministers responsible for enforcing the Animal Experiments Act are required to produce, 
by 30 June of every  year,  a  summary  report on animal experiment statistics  relating  to the  previous 
year and publish it in Austria's Official Journal (Amtsblatt zur Wiener Zeitung). 

Statistics on animal experiments for 2005 

Compared with the previous year there were 10% fewer animal experiments 

Compared with other countries there were few animal experiments 

As shown in Austria's Official Journal dated 29 June 2006, the 2005 animal experiment statistics show 
that in 2005 a total of 167,312 animals were used in experiments. This is the lowest figure since 2001. 

Compared with earlier years, this indicates a further reduction in the number of animal experiments in 
Austria as a whole within the "fluctuating" numbers of the past few years (ranging from 160,000 to 
200,000). The number of experimental animals is therefore again significantly lower than those for the 
previous years; for example, in 1996 the number totalled was 203,825, in 1993 it was 272,371 and in 
1992  it  was  304,308.  Compared  with  1991  (the  first  year  of  statistical  coverage)  the  number  of 
animals used has remained low (at less than 35%). In that year there were 482,166 animals used for 
experiments, in other words numbers have dropped since then by more than 65%. 

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500.000

450.000

400.000

350.000

300.000

250.000

200.000

150.000

100.000

50.000

0

1990 1991 1992 1993 1994 1995 1996 1997 1998 1999 2000 2001 2002 2003 2004 2005

The  full  statistics  on  animal  experiments  with  all  tables  produced  by  the  Federal  Ministries 
responsible  for  enforcing  the  Animal  Experiments  Act,  namely  the  Federal  Ministry  for  Health  and 
Women, the Federal Ministry for Economic affairs and Labour, the Federal Ministry for Agriculture, 
Forestry,  the  Environment  and  Water  Management  and  the  Federal  Ministry  for  Education,  Science 
and  Culture,  can  be  found  on  the  home  page  of  the  Federal  Ministry  for  Education,  Science  and 
Culture using the following link http://www.bmbwk.gv.at/tierversuche/statistik2005  

Animal experiments for human beings and animals 

The figures for animal experiments in 2005 – primarily on mice and rats – can be explained in general 
terms by an increase in biomedical research and a rise in the number of biomedical and bioscientific 
as  well  as  pharmaceutical  firms  conducting  research,  in  particular  research  and  development  of 
products  for  human  and  veterinary  medicine,  along  with  the  manufacture  and  quality  control  of 
vaccines  that  are  manufactured  for  the  world  market  to  control  major  diseases,  primarily  cancer, 
leukaemia, diseases of the heart and circulation and AIDS. Cancer research concentrates primarily on 
the development of improved and more effective therapies that are less stressful for patients.  

The  figures  for  animal  experiments  in  the  field  covered  by  the  Federal  Ministry  for  Health  and 
Women  have  their  origin  in  an  increase  in  the  number  of  samples  taken  for  the  (required)  quality 
control  as  well  as  the  establishment  of  new  standards  for  pharmaceutical  products  undergoing 
development  and  new  research  projects,  for  example  the  development  and  production  of  human 
vaccines  and  therapeutic  products. The  greater  emphasis  placed  on  the  development  of  medical  and 
pharmaceutical  medicaments  means  that  despite  every  effort  to  find  alternative  methods,  animal 
experiments  are,  with  a  view  to  protecting  the  health  and  safety  of  human  beings  and  animals, 
indispensable as a preliminary stage prior to any decision on clinical trials on humans.  

Lastly,  animal  experiments  are  necessary  for  the  animal  health  as  such,  i.e.  for  the  development  of 
pharmaceutical products for animals by means of clinical tests on and for animals and this has meant 
that  slightly  more  dogs  and  cats  have  been  used.  Animal  experiments  are  also  necessary  for  the 
development of diagnostic and therapeutic measures for animals as well, examples being procedures 

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for  the  early  detection  of  cardiac  insufficiency  in  cats  or  clinical  studies  on  vaccines  to  control 
infectious diseases in dogs. 

Rats and Mice are the primary experimental animals 

In 2005 of the 167 312 animals that were used for experiments in Austria, 140 554 (compared with 
158 361 in 2004 and 148.382 in 2003) were rats and mice,  

3 140 (2004: 4 158 and 2003: 4 958) were guinea pigs; 18 439 (2004: 20 654 and  

2003: 13 928) were rabbits, 1 664 were useful domestic farm animals, (sheep, goats, pigs, and cattle 
etc.), 1 011 were birds, 992 were fish, 865 were amphibians, 85 were dogs (2004: 155 and 2003: 139) 
and 12 (2004: 18 and 2003: 22) were cats. 

No animal experiments for cosmetics 

The  statutory  ban  on  the  use  of  animals  for  experiments  for  cosmetics  that  has  been  in  place  since 
1999 has meant that in accordance with §(5) of the Animal Experiments Act it goes without saying 
that  no  animal  experiments  were  conducted  in  Austria  for  cosmetics.  Austria  is  in  this  respect 
particularly committed to protecting Europe's animals. 

No primates for experimental purposes 

Statutory ban on experiments on or involving primates. 

It  can  happily  be  reported  that  in  2005  Austria  continued  to  forgo  the  use  of  primates  for  animal 
experiments. This is consistent with the pan-European call for restricting such animal experiments as 
far  as  possible  and  replacing  them  totally  in  line  with  "scientific  progress".  In  2005  the  Federal 
Ministry for Education Science and Culture resubmitted – on the basis of a Resolution of the National 
Council of December 2004 and following a general examination – a Parliamentary Bill to the National 
Council for a statutory ban on animal experiments involving primates, which it adopted in December 
2005. The provision entered into force on 1 January 2006. 

Austria's figures for animal experiments are comparatively low in international terms 

With  a  total  of  167.312  experimental  animals  (primarily  mice  and  rats)  used  in  2005,  Austria  had 
significantly fewer animal experiments in international terms as well as in terms of the animals used 
for  such  experiments.  By  way  of  example,  neighbouring  Switzerland  used  550  000  animals  for 
experimental purposes in 2005. 

These comparatively low figures for the animals used in animal experiments – accounting for a 65% 
drop  since  1991  –  can  be  explained  by  at  least  two  inter-related  lines  of  development  in  relation  to 
animal experiments: 

1.) The Three "Rs" 

Firstly,  'Reduction,  Refinement,  Replacement'  in  relation  to  animal  experiments  conducted  by 
scientists,  researchers  and  practical  scientists  themselves  as  well  as  ensuring,  as  far  as  possible,  the 
availability  of  alternative  methods  to  replace  animal  experiments  as  this  is  expressly  required  by 
Austria's Animal Experiments Act. 

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2)  Restrictions  on  the  authorization  of  animal  experiments  and  the  promotion  of  alternative 
techniques 

Secondly,  a  more  restrictive  approach  on  the  part  of  all  of  the  competent  authorities  to  the 
authorisation  of  animal  experiments  in  line  with  the  strict  requirements  of  the  Animal  Experiments 
Act,  which  has  undergone  further  improvement  since  1999/2000,  as  have  animal  experiment 
regulations  in  Austria,  in  accordance  with  which  animal  experiments  are  only  permitted  subject  to 
very  severe  restrictions  and  can  be  expressly  authorised  only  if  the  objectives  pursued  in  the 
experiment cannot be achieved by other methods or procedures (alternative techniques). 

Last but not least, it is the public motivation prompted by the award of national prizes or promoting 
research  projects  for  alternative  techniques  as  well  as  propagating  at  national  and  international 
level  the  use  of  alternatives  to  animal  experiments  that  has  led  to  an  enhanced  awareness  of 
responsibility  on  the  part  of  the  general  public  with  regard  to  science/research  involving  animal 
experiments.  

Greater effort to promote the development of alternatives to animal experiments 

In September of last year the Federal Ministry for Education, Science and Culture in agreement with 
all  the  other  Federal  Ministries  responsible  for  enforcing  the  Animal  Experiments  Act  (Federal 
Ministries for Health and Women, for Economic Affairs and Labour and for Agriculture and Forestry, 
the Environment and Water) renewed its public call for the submission of research projects targeting 
alternatives to animal experiments, the aim of which is to provide greater support for alternatives to 
animal experiments which will be determined ultimately by the number and scale of the projects that 
are submitted. 

It was only last year that the public call for projects by the Federal Ministry for Education Science and 
Culture was again used to award a national prize for alternatives to animal experiments, in other 
words particular recognition by the State of scientific results already achieved.  

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TABLE 1:  NUMBER OF ANIMALS USED IN RELATION TO THEIR PLACE OF ORIGIN 

1.1 
Species 

Origin versus species 

1.2  
Total 

1.3 
Animals coming from registered 
breeding or supplying 
establishments within the reporting 
country 

1.4 
Animals coming from 
elsewhere in the EC 

1.6 
Animals coming from 
other origins 

1.7 
Re-used animals 

1.5 
Animals coming from 
Member Countries of the 
Council of Europe which are 
parties to the Convention ETS 
123 (excluding EC Member 
States) 

Rats (Rattus norvegicus) 
Guinea-Pigs (Cavia porcellus) 
Hamsters (Mesocricetus ) 
Other Rodents (other Rodentia) 
Rabbits (Oryctolagus cuniculus) 
Cats (Felis catus) 
Dogs (Canis familiaris) 
Ferrets (Mustela putorius furo) 
Other Carnivores (other Carnivora) 
Horses, donkeys and cross breds (Equidae) 
Pigs (Sus) 

1.a.  Mice (Mus musculus) 
1.b. 
1.c. 
1.d. 
1.e. 
1.f. 
1.g. 
1.h. 
1.i. 
1.j. 
1.k. 
1.l. 
1.m.  Goats (Capra) 
1.n. 
1.o. 
1.p. 
1.q. 
1.r. 
1.s. 
1.t. 
1.u. 
1.v. 
1.w. 
1.x. 
1.y. 
1.z. 

Sheep (Ovis) 
Cattle (Bos) 
Prosimians (Prosimia) 
New World Monkeys (Ceboidea) 
Old World Monkeys (Cercopithecoidea) 
Apes (Hominoidea) 
Other Mammals (other Mammalia) 
Quail (Coturnix coturnix) 
Other birds (other Aves) 
Reptiles (Reptilia) 
Amphibians (Amphibia) 
Fish (Pisces) 
TOTAL 

128 634 
11 920 
3 149 
117 
107 
18 439 
12 
85 
0 
0 
71 
818 
44 
195 
536 
0 
0 
56 
0 
0 
14 
1 011 
40 
865 
1 199 
167 312 

28 469 
5 278 
340 
0 
60 
11 165 
0 
67 
0 
0 
21 
594 
20 
127 
352 
0 
0 
56 
0 
0 
14 
352 
0 
62 
192 
47 169 

99 702 
6 642 
2 809 
117 
25 
7 253 
2 
0 
0 
0 
0 
61 
0 
20 
16 
0 
0 
0 
0 
0 
0 
300 
0 
40 
4 
116 991 

184 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
184 

279 
0 
0 
0 
22 
21 
10 
18 
0 
0 
50 
163 
24 
48 
168 
0 
0 
0 
0 
0 
0 
359 
40 
763 
1 003 
2 968 

59 
47 
0 
0 
0 
41 
10 
7 
0 
0 
12 
41 
3 
34 
9 
0 
0 
41 
0 
0 
0 
22 
0 
0 
0 
326 

Note 1:  Column 1.5 concerns only those Member countries of the Council of Europe which, at the beginning of the reporting period, are Parties to the Convention ETS 123. Thus an updated list of 

those countries has to be used when filling in this column. 

Note 2:  Only the white boxes need to be completed. 

Note 3: 

The number of re-used animals in column 1.7 should be excluded from the total in the column 1.2 

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TABLE 2:  NUMBER OF ANIMALS USED IN EXPERIMENTS FOR SELECTED PURPOSES 

2.1 
Species 

2.2  
Biological 
studies of a 
fundamenta
l nature 

Purpose versus species 

2.4 
Production and 
quality control of 
products and 
devices for 
human medicine 
and dentistry 

2.5 
Production and 
quality control of 
products and 
devices for 
veterinary 
medicine 

2.6 
Toxicological 
and other safety 
evaluations 
(including 
safety 
evaluation of 
products and 
devices for 
human 
medicine and 
dentistry and 
for veterinary 
medicine) 

2.3 
Research and 
development of 
products and 
devices for human 
medicine and 
dentistry and for 
veterinary 
medicine 
(excluding 
toxicological and 
other safety 
evaluations 
counted in column 
2.6) 

2.7 
Diagnosis of 
disease 

2.8 
Education and 
training 

2.9 
Other 

2.10 
Total 

2.a.  Mice 
Rats 
2.b. 
Guinea-Pigs 
2.c. 
Hamsters 
2.d. 
Other Rodents 
2.e. 
Rabbits 
2.f. 
Cats 
2.g. 
Dogs 
2.h. 
Ferrets 
2.i. 
Other Carnivores 
2.j. 
Horses,  donkeys  and  cross 
2.k. 
breds 
Pigs 

2.l. 
2.m.  Goats 
Sheep 
2.n. 
Cattle 
2.o. 
Prosimians 
2.p. 
New World Monkeys 
2.q. 
Old World Monkeys 
2.r. 
Apes 
2.s. 
Other Mammals 
2.t. 
Quail 
2.u. 
Other birds 
2.v. 
Reptiles 
2.w. 
Amphibians 
2.x. 
Fish 
2.y. 
TOTAL 
2.z. 

25 313 
5 019 
24 
0 
47 
344 
0 
6 
0 
0 
33 

265 
0 
20 
333 
0 
0 
0 
0 
0 
14 
725 
40 
860 
876 
33 919 

74 677 
2 949 
548 
117 
0 
75 
2 
56 
0 
0 
10 

255 
4 
50 
0 
0 
0 
56 
0 
0 
0 
151 
0 
0 
180 
79 130 

20 884 
131 
1 411 
0 
0 
17 019 
0 
0 
0 
0 
0 

73 
0 
1 
0 
0 
0 
0 
0 
0 
0 
4 
0 
0 
0 
39 523 

EN 

2 956 
3 167 
967 
0 
0 
928 
0 
0 
0 
0 
0 

0 
0 
12 
3 
0 
0 
0 
0 
0 
0 
0 
0 
0 
143 
8 176 

1 296 
0 
0 
0 
0 
0 
10 
0 
0 
0 
22 

0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
60 
0 
0 
0 
1 388 

106 
422 
2 
0 
0 
8 
0 
12 
0 
0 
2 

189 
40 
70 
140 
0 
0 
0 
0 
0 
0 
71 
0 
5 
0 
1 067 

3 225 
0 
0 
0 
60 
42 
0 
11 
0 
0 
4 

36 
0 
0 
48 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
3 426 

128 634 
11 920 
3 149 
117 
107 
18 439 
12 
85 
0 
0 
71 

818 
44 
195 
536 
0 
0 
56 
0 
0 
14 
1 011 
40 
865 
1 199 
167 312 

177 
232 
197 
0 
0 
23 
0 
0 
0 
0 
0 

0 
0 
42 
12 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
683 

13 

EN 

 
  
TABLE 3:  NUMBER OF ANIMALS USED IN TOXICOLOGICAL AND OTHER SAFETY EVALUATIONS 

Products versus species 

3.1 
Species 

3.2  
Products/ 
substances or 
devices for 
human 
medicine and 
dentistry and 
for veterinary 
medicine 

3.3 
Products/ 
substances 
used or 
intended to 
be used 
mainly in 
agriculture 

3.4 
Products/ 
substances 
used or 
intended to 
be used 
mainly in 
industry 

3.5 
Products/ 
substances 
used or 
intended to 
be used 
mainly in 
the 
household 

3.6 
Products/ 
substances 
used or 
intended to 
be used 
mainly as 
cosmetics 
or toiletries 

3.a.  Mice 
Rats 
3.b. 
Guinea-Pigs 
3.c. 
Hamsters 
3.d. 
Other Rodents 
3.e. 
Rabbits 
3.f. 
Cats 
3.g. 
Dogs 
3.h. 
Ferrets 
3.i. 
Other Carnivores 
3.j. 
Horses, donkeys and cross breds 
3.k. 
3.l. 
Pigs 
3.m.  Goats 
Sheep 
3.n. 
Cattle 
3.o. 
Prosimians 
3.p. 
New World Monkeys 
3.q. 
Old World Monkeys 
3.r. 
Apes 
3.s. 
Other Mammals 
3.t. 
Quail 
3.u. 
Other birds 
3.v. 
Reptiles 
3.w. 
Amphibians 
3.x. 
Fish 
3.y. 
TOTAL 
3.z. 

2 026 
1 415 
279 
0 
0 
715 
0 
0 
0 
0 
0 
0 
0 
0 
3 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
4 438 

0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 

0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 

0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 

0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 

3.7 
Products/ 
substances 
used or 
intended to be 
used mainly 
as additives in 
food for 
human 
consumption 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 

3.8 
Products/ 
substances 
used or 
intended to be 
used mainly 
as additives in 
food for 
animal 
consumption 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 

3.11 
Total 

3.10 
Other 
toxicological 
or safety 
evaluations 

3.9 
Potential or 
actual 
contaminants in 
the general 
environment 
which do not 
appear in other 
columns 

0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 

930 
1 752 
688 
0 
0 
213 
0 
0 
0 
0 
0 
0 
0 
12 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
143 
3 738 

2 956 
3 167 
967 
0 
0 
928 
0 
0 
0 
0 
0 
0 
0 
12 
3 
0 
0 
0 
0 
0 
0 
0 
0 
0 
143 
8 176 

EN 

14 

EN 

 
  
TABLE 4:  NUMBER OF ANIMALS USED IN EXPERIMENTS FOR STUDIES ON HUMAN AND ANIMAL DISEASES 

4.1 
Species 

4.2  
Human cardiovascular 
diseases 

4.3 
Human nervous and 
mental disorders 

4.4 
Human cancer (excluding 
evaluations of carcinogenic 
hazards or risks) 

4.5 
Other human diseases 

4.6 
Studies specific to animal 
diseases 

4.7 
Total 

Main categories versus species 

4.a.  Mice 
Rats 
4.b. 
Guinea-Pigs 
4.c. 
Hamsters 
4.d. 
Other Rodents 
4.e. 
Rabbits 
4.f. 
Cats 
4.g. 
Dogs 
4.h. 
Ferrets 
4.i. 
Other Carnivores 
4.j. 
Horses, donkeys and cross breds 
4.k. 
4.l. 
Pigs 
4.m.  Goats 
Sheep 
4.n. 
Cattle 
4.o. 
Prosimians 
4.p. 
New World Monkeys 
4.q. 
Old World Monkeys 
4.r. 
Apes 
4.s. 
Other Mammals 
4.t. 
Quail 
4.u. 
Other birds 
4.v. 
Reptiles 
4.w. 
Amphibians 
4.x. 
Fish 
4.y. 
TOTAL 
4.z. 

1 275 
506 
0 
0 
0 
53 
0 
0 
0 
0 
0 
106 
0 
2 
0 
0 
0 
0 
0 
0 
0 
54 
0 
25 
0 
2 021 

3 407 
1 777 
0 
0 
0 
31 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
25 
0 
5 240 

15 919 
609 
0 
0 
0 
89 
0 
0 
0 
0 
0 
0 
0 
12 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
16 629 

45 266 
4 919 
905 
117 
0 
294 
0 
0 
0 
0 
0 
292 
4 
26 
0 
0 
0 
56 
0 
0 
0 
6 
0 
12 
0 
51 897 

95 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
95 

65 962 
7 811 
905 
117 
0 
467 
0 
0 
0 
0 
0 
398 
4 
40 
0 
0 
0 
56 
0 
0 
0 
60 
0 
62 
0 
75 882 

EN 

15 

EN 

 
  
TABLE 5:  NUMBER OF ANIMALS USED IN PRODUCTION AND QUALITY CONTROL OF PRODUCTS AND DEVICES FOR HUMAN 
MEDICINE AND DENTISTRY AND FOR VETERINARY MEDICINE 

5.1 
Species 

5.2  
National legislation 
specific to a single EC 
Member State 
1) 

5.3 
EC legislation 
including European 
Pharmacopoeia 
(requirements) 

5.4 
Member Country of Council 
of Europe (but not EC) 
legislation 
2) 

5.5 
Other legislation 

5.6 
Any combination of  
5.2/ 5.3/ 5.4/ 5.5 

5.7 
No regulatory 
requirements 

5.8 
Total 

Regulatory requirements versus species 

5.a.  Mice 
Rats 
5.b. 
Guinea-Pigs 
5.c. 
Hamsters 
5.d. 
Other Rodents 
5.e. 
Rabbits 
5.f. 
Cats 
5.g. 
Dogs 
5.h. 
Ferrets 
5.i. 
Other Carnivores 
5.j. 
Horses, donkeys and cross breds 
5.k. 
5.l. 
Pigs 
5.m.  Goats 
Sheep 
5.n. 
Cattle 
5.o. 
Prosimians 
5.p. 
New World Monkeys 
5.q. 
Old World Monkeys 
5.r. 
Apes 
5.s. 
Other Mammals 
5.t. 
Quail 
5.u. 
Other birds 
5.v. 
Reptiles 
5.w. 
Amphibians 
5.x. 
Fish 
5.y. 
5.z. 
TOTAL 
Examples: 

177 
131 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
21 
12 
0 
0 
0 
0 
0 
0 
4 
0 
0 
0 
345 

887 
0 
636 
0 
0 
12 884 
0 
0 
0 
0 
0 
0 
0 
22 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
14 429 

0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 

88 
0 
0 
0 
0 
145 
0 
0 
0 
0 
0 
73 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
306 
columns 5.2 - 5.5 refer to the legislation imposing that the test be carried out and 
not to the body which has issued the actual test method, guideline or protocol. 

19 909 
0 
775 
0 
0 
3 981 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
24 665 

0 
232 
197 
0 
0 
32 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
461 

21 061 
363 
1 608 
0 
0 
17 042 
0 
0 
0 
0 
0 
73 
0 
43 
12 
0 
0 
0 
0 
0 
0 
4 
0 
0 
0 
40 206 

5.2 – France is testing due to a UK (or FR) specific requirement 
5.3 - UK is testing according to EC legislation 
5.4 – Spain is testing due to a Hungarian requirement 
5.5 – Sweden is testing due to a US specific requirement 
5.6  –  Germany  is  testing  due  to  a  Czech  requirement  (also  an  EC 
requirement) 
1)  EC Member States: Austria, Belgium, Denmark, Finland, France, Germany, Greece, Ireland, Italy, Luxembourg, Netherlands, Portugal, Spain, Sweden, United Kingdom 
2)  Member  Countries  of  Council  of  Europe  (non-EC):  Albania,  Andorra,  Bulgaria,  Croatia,  Cyprus,  Czech  Rep.,  Estonia,  Hungary,  Iceland,  Latvia,  Liechtenstein,  Lithuania, 

ISO protocol must be coded as a national (FR) legislative requirement and be 
entered into column 5.2 in the tables submitted by Belgium. 

Example:  a test required by French legislation and carried out in Belgium according to an 

Note: 

Malta, Moldova, Norway, Poland, Romania, Russia, San Marino, Slovakia, Slovenia, Switzerland, ‘the former Yugoslav Rep. of Macedonia’, Turkey, Ukraine 

16 

EN 

Footnotes: 

EN 

 
  
 
 
 
 
 
 
 
 
TABLE 6:  NUMBER OF ANIMALS USED IN TOXICOLOGICAL AND OTHER SAFETY EVALUATIONS 

6.1 
Species 

6.2  
National legislation 
specific to a single EC 
Member State 
1) 

6.3 
EC legislation 
including European 
Pharmacopoeia 
(requirements) 

6.4 
Member Country of Council 
of Europe (but not EC) 
legislation 
2) 

6.5 
Other legislation 

6.6 
Any combination of  
6.2/ 6.3/ 6.4/ 6.5 

6.7 
No regulatory 
requirements 

6.8 
Total 

Regulatory requirements versus species 

6.a.  Mice 
Rats 
6.b. 
Guinea-Pigs 
6.c. 
Hamsters 
6.d. 
Other Rodents 
6.e. 
Rabbits 
6.f. 
Cats 
6.g. 
Dogs 
6.h. 
Ferrets 
6.i. 
Other Carnivores 
6.j. 
Horses, donkeys and cross breds 
6.k. 
6.l. 
Pigs 
6.m.  Goats 
Sheep 
6.n. 
Cattle 
6.o. 
Prosimians 
6.p. 
New World Monkeys 
6.q. 
Old World Monkeys 
6.r. 
Apes 
6.s. 
Other Mammals 
6.t. 
Quail 
6.u. 
Other birds 
6.v. 
Reptiles 
6.w. 
Amphibians 
6.x. 
Fish 
6.y. 
6.z. 
TOTAL 
Examples: 

0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 

1 595 
210 
204 
0 
0 
595 
0 
0 
0 
0 
0 
0 
0 
0 
3 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
2 607 

0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 

241 
287 
0 
0 
0 
43 
0 
0 
0 
0 
0 
0 
0 
12 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
583 
columns 6.2 - 6.5 refer to the legislation imposing that the test be carried out and 
not to the body which has issued the actual test method, guideline or protocol. 

1 060 
2 094 
763 
0 
0 
213 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
143 
4 273 

60 
576 
0 
0 
0 
77 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
713 

2 956 
3 167 
967 
0 
0 
928 
0 
0 
0 
0 
0 
0 
0 
12 
3 
0 
0 
0 
0 
0 
0 
0 
0 
0 
143 
8 176 

6.2 – France is testing due to a UK (or FR) specific requirement 
6.3 - UK is testing according to EC legislation 
6.4 – Spain is testing due to a Hungarian requirement 
6.5 – Sweden is testing due to a US specific requirement 
6.6  –  Germany  is  testing  due  to  a  Czech  requirement  (also  an  EC 
requirement) 
1)  EC Member States: Austria, Belgium, Denmark, Finland, France, Germany, Greece, Ireland, Italy, Luxembourg, Netherlands, Portugal, Spain, Sweden, United Kingdom 
2)  Member Countries of Council of Europe (non-EC): Albania, Andorra, Bulgaria, Croatia, Cyprus, Czech Rep., Estonia, Hungary, Iceland, Latvia, Liechtenstein, Lithuania, Malta, 

ISO protocol must be coded as a national (FR) legislative requirement and be 
entered into column 6.2 in the tables submitted by Belgium. 

Example:  a test required by French legislation and carried out in Belgium according to an 

Note: 

Moldova, Norway, Poland, Romania, Russia, San Marino, Slovakia, Slovenia, Switzerland, ‘the former Yugoslav Rep. of Macedonia’, Turkey, Ukraine 

17 

EN 

Footnotes: 

EN 

 
  
 
 
 
 
 
 
 
 
TABLE 7:  NUMBER OF ANIMALS USED IN TOXICOLOGICAL AND OTHER SAFETY EVALUATIONS 

7.1 
Species 

7.2 
Acute and sub-acute toxicity testing methods 
(including limit test) 

7.3 
Skin 
irritation 

7.4 
Skin 
sensitisatio
n 

7.5 
Eye 
irritation 

7.6 
Sub- 
chronic and 
chronic 
toxicity 

7.7 
Carcino- 
genicity 

7.8 
Develop- 
mental 
toxicity 

7.9 
Muta- 
genicit
y 

7.10 
Repro-
ductive 
toxicity 

Types of tests versus species 

7.12 
Other 

7.13 
Total 

7.11 
Toxicity 
to aquatic 
vertebra-
tes not 
included 
in other 
columns 

7.a.  Mice 
Rats 
7.b. 
Guinea-Pigs 
7.c. 
Hamsters 
7.d. 
Other Rodents 
7.e. 
Rabbits 
7.f. 
Cats 
7.g. 
Dogs 
7.h. 
Ferrets 
7.i. 
Other Carnivores 
7.j. 
Horses,  donkeys  and  cross 
7.k. 
breds 
Pigs 

7.l. 
7.m.  Goats 
Sheep 
7.n. 
Cattle 
7.o. 
Prosimians 
7.p. 
New World Monkeys 
7.q. 
Old World Monkeys 
7.r. 
Apes 
7.s. 
Other Mammals 
7.t. 
Quail 
7.u. 
Other birds 
7.v. 
Reptiles 
7.w. 
Amphibians 
7.x. 
Fish 
7.y. 
TOTAL 
7.z. 

7.2.1. 
LD50, 
LC50 

7.2.2 
Other lethal 
methods 

7.2.3 
Non lethal 
clinical signs 
methods 

0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 

0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 

293 
726 
0 
0 
0 
0 
0 
0 
0 
0 
0 

0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
143 
1 162 

1 580 
229 
119 
0 
0 
70 
0 
0 
0 
0 
0 

0 
0 
0 
3 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
2 001 

0 
104 
0 
0 
0 
123 
0 
0 
0 
0 
0 

0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
227 

EN 

784 
0 
688 
0 
0 
0 
0 
0 
0 
0 
0 

0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
1 472 

18 

0 
0 
0 
0 
0 
88 
0 
0 
0 
0 
0 

0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
88 

0 
1 596 
0 
0 
0 
0 
0 
0 
0 
0 
0 

0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
1 596 

0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 

0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 

0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 

0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 

154 
12 
0 
0 
0 
0 
0 
0 
0 
0 
0 

0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
166 

0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 

0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 

0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 

0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 

145 
500 
160 
0 
0 
647 
0 
0 
0 
0 
0 

0 
0 
12 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
1 464 

2 956 
3 167 
967 
0 
0 
928 
0 
0 
0 
0 
0 

0 
0 
12 
3 
0 
0 
0 
0 
0 
0 
0 
0 
0 
143 
8 176 

EN 

 
  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
TABLE 8:  NUMBER OF ANIMALS USED IN TOXICOLOGICAL AND OTHER SAFETY EVALUATIONS 

8.1 
Products 

8.2 
Acute and sub-acute toxicity testing 
methods (including limit test) 

8.3 
Skin 
irritation 

8.4 
Skin 
sensitisatio
n 

8.5 
Eye 
irritation 

Types of tests versus products 

8.7 
Carcino 
genicity 

8.8 
Develop- 
mental 
toxicity 

8.9 
Muta- 
genicit
y 

8.10 
Repro-
ductive 
toxicity 

8.6 
Sub- 
chronic 
and 
chronic 
toxicity 

8.12 
Other 

8.13 
Total 

8.11 
Toxicity 
to aquatic 
vertebra-
tes not 
included 
in other 
columns 

8.2.1. 
LD50, 
LC50 

8.2.2 
Other lethal 
methods 

8.2.3 
Non lethal 
clinical signs 
methods 

381 

2 001 

62 

8.a. 

8.b. 

8.c. 

8.d. 

8.e. 

8.f. 

8.g. 

8.h. 

Products/substances  or  devices 
for 
human  medicine  and  dentistry  and  for 
veterinary medicine 
Products/substances used or intended to 
be used mainly in agriculture 
Products/substances used or intended to 
be used mainly in industry 
Products/substances used or intended to 
be used mainly in the household 
Products/substances used or intended to 
be  used  mainly  as  cosmetics  or 
toiletries 
Products/substances used or intended to 
be used mainly as additives in food for 
human consumption 
Products/substances used or intended to 
be used mainly as additives in food for 
animal consumption 
Potential  or  actual  contaminants  in  the 
general  environment  which  do  not 
appear in other columns 
toxicological 

safety 

or 

8.i.  Other 

evaluations 
TOTAL 

8.j. 

0 

0 

0 

0 

0 

0 

0 

0 

0 

0 

0 

0 

0 

0 

0 

0 

0 

0 

0 

0 

0 

0 

0 

0 

781 

0 

0 

0 

0 

0 

0 

0 

0 

1 162 

2 001 

8 

0 

0 

0 

0 

0 

0 

0 

0 

0 

0 

0 

0 

0 

0 

0 

662 

0 

0 

0 

0 

0 

0 

0 

165 

227 

1 464 

1 472 

88 

88 

934 

1 596 

EN 

19 

0 

0 

0 

0 

0 

0 

0 

0 

0 

0 

0 

0 

0 

0 

0 

0 

0 

0 

0 

0 

6 

0 

0 

0 

0 

0 

0 

0 

160 

166 

0 

0 

0 

0 

0 

0 

0 

0 

0 

0 

0 

1 318 

4 438 

0 

0 

0 

0 

0 

0 

0 

0 

0 

0 

0 

0 

0 

0 

0 

0 

0 

0 

0 

0 

0 

0 

0 

146 

3 738 

1 464 

8 176 

EN 

 
  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
BELGIUM 

Statistical data submitted 

The  statistical  data  have  been  submitted  by  the  “SPF  Santé  Publique,  Sécurité  de  la  Chaine 
Alimentaire  et  Environnement”  (Federal  Public  Service  of  Public  Health,  Food  Chain  Safety  and 
Environment).  

Comments of the Belgian authorities 

ANIMALS USED FOR EXPERIMENTAL PURPOSES 

STATISTICS ON USE IN BELGIUM IN 2005 

1. Laboratories 

At  the  end  of  2005,  there  were  390  approved  laboratories  in  operation  which,  pursuant  to  Article  15  of  the 
Royal Decree of 14 November 1993 on the protection of animals used for experimental purposes, provided data 
on their use of animals for experiments. As in previous years, 25% of laboratories used no animals. 

In 2005, four laboratory approvals were withdrawn at the request of the head of the laboratory because it had 
ceased  operations;  five  new  approvals  were  issued  for  laboratories  and  one  for  a  supplier  of  animals  for 
experimental purposes. 

2. Number of animals used in experiments 

In  all  718  976  animals  were  used.  Of  the  various  species  used,  rodents  and  rabbits  accounted  for  92%,  fish, 
reptiles and amphibians accounted for 6% and birds for 2% of the total. 

Dogs,  cats  and  primates  accounted  respectively  for  0.19%,  0.01%  and  0.06%  of  the  animals  used  in  2005 
(Figure 1: Breakdown of species used in experiments). 

Animaux agricoles - 
Landbouw  dieren
0,49%

Primates - Apen
0,06%

Autres animaux à sang 
chaud - Andere w armbloed 
dieren
0,03%

Chiens/Chats - 
Honden/Katten
0,19%

Lapins - Konijnen
3%

Oiseaux - Vogels
2%

Animaux à sang froid - 
Koudbloed dieren
6%

Rongeurs - Knaagdieren
89%

EN 

20 

   EN 

 
 
Figure 1:Breakdown of species used in experiments 

Animaux agricoles – agricultural animals; Primates – primates; Autres animaux à sang chaud – other 
warm-blooded animals; Oiseaux – birds; Animaux à sang froid – cold-blooded animals; Rongeurs – 
rodents; Lapins – rabbits; Chiens/chats – dogs/cats 

A comparison of the figures for 2005 with those for previous years (Table 1: Trend in the number of 
animals used in experiments), shows an increase in the total number of animals of 1.44% over 2004. 
That increase was due mainly to greater use of fish (+ 13 391, 65%), birds (+ 2 849, 26%), mice (+ 5 
315, 1.1%) and, to a lesser extent, dogs (+ 201, 27%) and ferrets (+ 52, 51%). There was a substantial 
drop in the number of monkeys (- 137, 23%), rats (- 12 710, 11%), other rodents (- 1 661, 42%) and 
cats (- 103, 56%). 

Table 1: 

Trend in the number of animals used in experiments 

2005 

2004 

2003 

2002 

2001 

Mice
Rats
Guinea pigs
Hamsters
Other rodents
Rabbits
Total rodents and rabbits
Cats
Dogs
Ferrets
Other carnivores
Total carnivores
Horses, donkeys and cross-breds
Pigs
Goats
Sheep
Cattle
Total ungulates 
Prosimians
New world monkeys
Old world monkeys
Apes
Total primates 
Other mammals 
Total mammals 
Quails
Other birds
Total birds 
Reptiles
Amphibians
Fish
Total cold-blooded animals

488125
106483
39530
1874
2260
21159
659431
81
1295
154
0
1530
108
1876
157
445
944
3530
0
0
449
0
449
59
664999
425
13266
13691
144
6177
33965
40286
718976

482810
119193
38781
1688
3921
18577
664970
184
1014
102
0
1300
65
2272
125
495
982
3939
0
7
579
0
586
44
670839
350
10492
10842
129
6362
20574
27065
708746

430251 
128284 
40510 
2590 
11332 
18714 
631681 
90 
1000 
36 
0 
1126 
93 
2637 
114 
339 
1055 
4238 
0 
7 
281 
0 
288 
22 
637355 
514 
12499 
13013 
30 
1803 
24363 
26196 
676564 

460487
116340
34305
2645
16670
10805
641252
100
1071
20
0
1191
138
3587
102
524
1135
5486
0
20
547
0
567
8
648504
326
20026
20352
15
1601
24619
26235
695.091

436266
112040
40204
3163
12693
14631
618997
75
1036
20
0
1131
102
4079
217
492
714
5604
0
21
689
0
710
0
626442
134
8711
8845
95
2460
17375
19930
655.217

TOTAL ANIMALS 

EN 

21 

   EN 

 
 
The following graph (Figure 2: Trend in the number of animals used since 1997) clearly shows that 
the  number  of  animals  used  in  Belgian  laboratories  fell  between  1997  and  2005  (by  16%),  even 
though there were some unrepresentative annual fluctuations. 

859.620

837.560

790.089

651.504

655.217

695.091

676.564

708.746

718.976

1000000

900000

800000

700000

600000

500000

400000

300000

200000

100000

0

19 9 7

19 9 8

19 9 9

2 0 0 0

2 0 0 1

2 0 0 2

2 0 0 3

2 0 0 4

2 0 0 5

Figure 2: Trend in the number of animals used since 1997 

3. Experiments carried out 

In descending order, animals were used mainly for research and to develop products and devices used 
in human and veterinary medicine (33% of the animals used), basic research studies (29%) and tests 
on the production and quality control of such products and devices (24%) (Figure 3: Breakdown of the 
experimental fields). There has been a steady rise in the number of animals used for basic research and 
the figure in 2005 was the highest ever for this category. As regards  production and quality control 
tests  and  toxicology  tests,  98%  and  90%  respectively  of  the  animals  were  used  to  meet  legal 
requirements.  

EN 

22 

   EN 

 
 
Diagnostic - Diagnose
2%

Formation - Opleiding
2%

Toxicologie
9%

QC
24%

Autres - Overige
1%

Biol.fond. - Fund. Biol.
29%

R&D
33%

Figure 3: 

Breakdown of the experimental fields 

Diagnostic – diagnostics; Formation –training; Autres – other; Biol. Fond. – basic biology; R&D – research and 
development; QC – quality control; Toxicologie – toxicology 

The following diagram (Figure 4: Breakdown of experimental fields by the animals most used) shows 
that, of the animals most used, rats and mice are used mainly for basic research and the development 
of products and material for medicine (65%) and for safety tests (22%). 

250000

200000

150000

100000

50000

0

i

l

B
o
o
g
e

i

R
&
D

Q
C

f

o
n
d
a
m
e
n
a
e

t

l

i

T
o
x
c
o
o
g
e

l

i

i

D
a
g
n
o
s
t
i
c

Rongeurs
Oiseaux
Animaux à sang froid

Lapins

A
u
t
r
e
s

F
o
r
m
a

t
i

o
n

EN 

23 

   EN 

 
 
 
 
Figure 4: Breakdown of experimental fields by the animals most used  

Biologie  fondamentale  –  basic  biology;  R&D  –  research  and  development;  QC  –  quality  control; 
Toxicologie  –  toxicology;  Diagnostic  –  diagnostics;  Formation  –  training;  Autres  –  other;  Lapins  – 
rabbits; Animaux à sang froid – cold-blooded animals; Oiseaux – birds; Rongeurs – rodents. 

As  regards  the  other  species,  92%  of  primates  and  78%  of  dogs  were  used  in  toxicology  tests  for 
safety. 

The  use  of  primates  is  still  linked  to  the  World  Health  Organisation  programme  to  eradicate 
poliomyelitis  worldwide,  a  programme  for  which  the  bulk  of  the  oral  polio  vaccine  is  produced  in 
Belgium. Primates have not been used to produce the vaccine since 2003 and neurovirulence tests on 
types  of  vaccine  strain  are  now  carried  out  solely  on  mice  rather  then  primates,  a  method  which 
recently became part of international law. 

The  fields  where  use  has  increased  significantly  since  2004  are  training  (by  5  166,  71%),  medical 
diagnosis (by 7 475, 88%) and toxicology tests (by 15 026, 31%). 

Toxicology and safety tests account for 9% of the animals used in experiments in 2005; 90% of the 
animals used in toxicology tests were used in safety trials required by laws and regulations (Figure 5: 
Proportion of quality control and toxicology tests imposed by law). 

100,00%

75,00%

50,00%

25,00%

0,00%

v
e
r
p

l
i

c
h
t

L
e
g
a
e

l

L
é
g
a
e
/

l

O
b

l
i

g
a
t
i
o
n

v
e
r
p

l
i

c
h
t

/

i

N
e
t

o
b

l
i

g
a
t
o
i
r
e

N
o
n

v
e
r
p

l
i

c
h
t

L
e
g
a
e

l

L
é
g
a
e
/

l

O
b

l
i

g
a
t
i
o
n

v
e
r
p

l
i

c
h
t

/

i

N
e
t

o
b

l
i

g
a
t
o
i
r
e

N
o
n

Qualité Contrôle /
Kw aliteit Controle

Toxicologie

Figure 5: Proportion of quality control and toxicology tests imposed by law  

Obligation légale – legal requirement; Non obligatoire – not compulsory; Qualité Contrôle – quality 
control; Toxicologie –toxicology. 

4. Origin of animals used in experiments 

The Royal Decree of 14 November 1993 on the protection of animals used for experimental purposes 
lays down the list of animals which must come from specifically approved suppliers. In 2005, 91% of 
the animals used in experiments were on that list. Of these, 96% came from approved suppliers in 
Belgium, other countries of the European Union and members of the Council of Europe. 

EN 

24 

   EN 

 
 
 
 
 
 
Animals belonging to agricultural species and other animals, including cold-blooded animals, do not 
appear on the list in the Royal Decree of 14 November 1993. They come from suppliers which meet 
the conditions laid down by the legislation in force for such establishments. 

700000

600000

500000

400000

300000

200000

100000

0

Elevage
spécifique -
Specifiek
fokkerij

Animaux
agricoles -
Landbouw
dieren

Autres -
Andere

Réutilisés -
Hergebruikt

B+UE+CdE -
B+EG+RvE

Autre -
Andere

Utilisation / Gebruik

Origine / Herkomst

Figure 6: 

Origin of animals used in experiments 

Elevage spécifique – specially bred; Animaux agricoles – agricultural animals; Autres – other; Réutilisés – re-
used; B+UE+CdE – B+EU+CoE; Utilsiation – use; Origine – origin  

EN 

25 

   EN 

 
 
TABLE 1:  NUMBER OF ANIMALS USED IN RELATION TO THEIR PLACE OF ORIGIN 

1.1 
Species 

Origin versus species 

1.2  
Total 

1.3 
Animals coming from registered 
breeding or supplying 
establishments within the reporting 
country 

1.4 
Animals coming from 
elsewhere in the EC 

1.6 
Animals coming from 
other origins 

1.7 
Re-used animals 

1.5 
Animals coming from 
Member Countries of the 
Council of Europe which are 
parties to the Convention ETS 
123 (excluding EC Member 
States) 

Rats (Rattus norvegicus) 
Guinea-Pigs (Cavia porcellus) 
Hamsters (Mesocricetus ) 
Other Rodents (other Rodentia) 
Rabbits (Oryctolagus cuniculus) 
Cats (Felis catus) 
Dogs (Canis familiaris) 
Ferrets (Mustela putorius furo) 
Other Carnivores (other Carnivora) 
Horses, donkeys and cross breds (Equidae) 
Pigs (Sus) 

1.a.  Mice (Mus musculus) 
1.b. 
1.c. 
1.d. 
1.e. 
1.f. 
1.g. 
1.h. 
1.i. 
1.j. 
1.k. 
1.l. 
1.m.  Goats (Capra) 
1.n. 
1.o. 
1.p. 
1.q. 
1.r. 
1.s. 
1.t. 
1.u. 
1.v. 
1.w. 
1.x. 
1.y. 
1.z. 

Sheep (Ovis) 
Cattle (Bos) 
Prosimians (Prosimia) 
New World Monkeys (Ceboidea) 
Old World Monkeys (Cercopithecoidea) 
Apes (Hominoidea) 
Other Mammals (other Mammalia) 
Quail (Coturnix coturnix) 
Other birds (other Aves) 
Reptiles (Reptilia) 
Amphibians (Amphibia) 
Fish (Pisces) 
TOTAL 

166973 
19125 
5352 
69 

18347 
49 
82 
0 

0 
0 
0 
0 

421 

298054 
80233 
34178 
1773 

2806 
32 
898 
154 

0 
0 
37 
0 

0 

1079 
6535 
0 
0 

0 
0 
23 
0 

0 
0 
0 
0 

0 

22019 
590 
0 
32 

6 
0 
292 
0 

0 
0 
412 
0 

4 

536 
78 
475 
0 

0 
7 
22 
0 

488125 
106483 
39530 
1874 
2260 
21159 
81 
1295 
154 
0 
108 
1876 
157 
445 
944 
0 
0 
449 
0 
59 
425 
13266 
144 
6177 
33965 
718976 

Note 1:  Column 1.5 concerns only those Member Countries of the Council of Europe which, at the beginning of the reporting period, are Parties to the Convention ETS 123. Thus an updated list of 

those countries has to be used when filling in this column. 

Note 2:  Only the white boxes need to be completed. 

Note 3: 

The number of re-used animals in column 1.7 should be excluded from the total in the column 1.2 

EN 

26 

EN 

 
  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
TABLE 2:  NUMBER OF ANIMALS USED IN EXPERIMENTS FOR SELECTED PURPOSES 

2.1 
Species 

2.2  
Biological 
studies of a 
fundamenta
l nature 

2.a.  Mice 
Rats 
2.b. 
Guinea-Pigs 
2.c. 
Hamsters 
2.d. 
Other Rodents 
2.e. 
Rabbits 
2.f. 
Cats 
2.g. 
Dogs 
2.h. 
Ferrets 
2.i. 
Other Carnivores 
2.j. 
Horses,  donkeys  and  cross 
2.k. 
breds 
Pigs 

2.l. 
2.m.  Goats 
Sheep 
2.n. 
Cattle 
2.o. 
Prosimians 
2.p. 
New World Monkeys 
2.q. 
Old World Monkeys 
2.r. 
Apes 
2.s. 
Other Mammals 
2.t. 
Quail 
2.u. 
Other birds 
2.v. 
Reptiles 
2.w. 
Amphibians 
2.x. 
Fish 
2.y. 
TOTAL 
2.z. 

142620 
20078 
247 
131 
411 
1326 
49 
115 
0 
0 
28 

1197 
26 
177 
97 
0 
0 
37 
0 
28 
421 
11546 
144 
5071 
25466 
209215 

2.3 
Research and 
development of 
products and 
devices for human 
medicine and 
dentistry and for 
veterinary 
medicine 
(excluding 
toxicological and 
other safety 
evaluations 
counted in column 
2.6) 

168987 
56836 
5497 
1 
1697 
3888 
0 
104 
154 
0 
27 

144 
54 
123 
136 
0 
0 
0 
0 
31 
0 
1269 
0 
0 
0 
238948 

EN 

2.7 
Diagnosis of 
disease 

2.8 
Education and 
training 

2.9 
Other 

2.10 
Total 

Purpose versus species 

2.4 
Production and 
quality control of 
products and 
devices for 
human medicine 
and dentistry 

2.5 
Production and 
quality control of 
products and 
devices for 
veterinary 
medicine 

2.6 
Toxicological 
and other safety 
evaluations 
(including 
safety 
evaluation of 
products and 
devices for 
human 
medicine and 
dentistry and 
for veterinary 
medicine) 

31740 
12960 
14190 
0 
142 
1095 
0 
1018 
0 
0 
0 

95 
0 
24 
15 
0 
0 
412 
0 
0 
0 
238 
0 
0 
1769 
63698 

15303 
487 
26 
0 
0 
0 
0 
7 
0 
0 
1 

16 
0 
0 
83 
0 
0 
0 
0 
0 
0 
0 
0 
30 
0 
15953 

5518 
1843 
525 
34 
0 
84 
0 
13 
0 
0 
31 

113 
32 
2 
17 
0 
0 
0 
0 
0 
4 
2 
0 
1076 
3130 
12424 

3035 
550 
0 
48 
10 
161 
0 
0 
0 
0 
4 

103 
5 
85 
112 
0 
0 
0 
0 
0 
0 
10 
0 
0 
3600 
7723 

488125 
106483 
39530 
1874 
2260 
21159 
81 
1295 
154 
0 
108 

1876 
157 
445 
944 
0 
0 
449 
0 
59 
425 
13266 
144 
6177 
33965 
718976 

114435 
13598 
18039 
0 
0 
14276 
0 
0 
0 
0 
15 

21 
0 
0 
0 
0 
0 
0 
0 
0 
0 
165 
0 
0 
0 
160549 

6487 
131 
1006 
1660 
0 
329 
32 
38 
0 
0 
2 

187 
40 
34 
484 
0 
0 
0 
0 
0 
0 
36 
0 
0 
0 
10466 

27 

EN 

 
  
TABLE 3:  NUMBER OF ANIMALS USED IN TOXICOLOGICAL AND OTHER SAFETY EVALUATIONS 

Products versus species 

3.1 
Species 

3.2  
Products/ 
substances or 
devices for 
human 
medicine and 
dentistry and 
for veterinary 
medicine 

3.3 
Products/ 
substances 
used or 
intended to 
be used 
mainly in 
agriculture 

3.4 
Products/ 
substances 
used or 
intended to 
be used 
mainly in 
industry 

3.5 
Products/ 
substances 
used or 
intended to 
be used 
mainly in 
the 
household 

3.6 
Products/ 
substances 
used or 
intended to 
be used 
mainly as 
cosmetics 
or toiletries 

3.a.  Mice 
Rats 
3.b. 
Guinea-Pigs 
3.c. 
Hamsters 
3.d. 
Other Rodents 
3.e. 
Rabbits 
3.f. 
Cats 
3.g. 
Dogs 
3.h. 
Ferrets 
3.i. 
Other Carnivores 
3.j. 
Horses, donkeys and cross breds 
3.k. 
3.l. 
Pigs 
3.m.  Goats 
Sheep 
3.n. 
Cattle 
3.o. 
Prosimians 
3.p. 
New World Monkeys 
3.q. 
Old World Monkeys 
3.r. 
Apes 
3.s. 
Other Mammals 
3.t. 
Quail 
3.u. 
Other birds 
3.v. 
Reptiles 
3.w. 
Amphibians 
3.x. 
Fish 
3.y. 
TOTAL 
3.z. 

30371 
12260 
14190 
0 
0 
1095 
0 
1018 
0 
0 
0 
80 
0 
24 
0 
0 
0 
412 
0 
0 
0 
118 
0 
0 
275 
59843 

50 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
510 
560 

50 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
50 

0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 

0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 

3.7 
Products/ 
substances 
used or 
intended to be 
used mainly 
as additives in 
food for 
human 
consumption 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 

3.8 
Products/ 
substances 
used or 
intended to be 
used mainly 
as additives in 
food for 
animal 
consumption 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 

3.11 
Total 

3.10 
Other toxico- 
logical or 
safety 
evaluations 

3.9 
Potential or 
actual contami- 
nents in the 
general envi- 
ronment which 
do not appear in 
other columns 

1254 
0 
0 
0 
142 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
120 
0 
0 
444 
1960 

15 
700 
0 
0 
0 
0 
0 
0 
0 
0 
0 
15 
0 
0 
15 
0 
0 
0 
0 
0 
0 
0 
0 
0 
540 
1285 

31740 
12960 
14190 
0 
142 
1095 
0 
1018 
0 
0 
0 
95 
0 
24 
15 
0 
0 
412 
0 
0 
0 
238 
0 
0 
1769 
63698 

EN 

28 

EN 

 
  
TABLE 4:  NUMBER OF ANIMALS USED IN EXPERIMENTS FOR STUDIES ON HUMAN AND ANIMAL DISEASES 

4.1 
Species 

4.2  
Human cardiovascular 
diseases 

4.3 
Human nervous and 
mental disorders 

4.4 
Human cancer (excluding 
evaluations of carcinogenic 
hazards or risks) 

4.5 
Other human diseases 

4.6 
Studies specific to animal 
diseases 

4.7 
Total 

Main categories versus species 

4.a.  Mice 
Rats 
4.b. 
Guinea-Pigs 
4.c. 
Hamsters 
4.d. 
Other Rodents 
4.e. 
Rabbits 
4.f. 
Cats 
4.g. 
Dogs 
4.h. 
Ferrets 
4.i. 
Other Carnivores 
4.j. 
Horses, donkeys and cross breds 
4.k. 
4.l. 
Pigs 
4.m.  Goats 
Sheep 
4.n. 
Cattle 
4.o. 
Prosimians 
4.p. 
New World Monkeys 
4.q. 
Old World Monkeys 
4.r. 
Apes 
4.s. 
Other Mammals 
4.t. 
Quail 
4.u. 
Other birds 
4.v. 
Reptiles 
4.w. 
Amphibians 
4.x. 
Fish 
4.y. 
TOTAL 
4.z. 

5754 
1845 
233 
0 
36 
260 
0 
56 
0 
0 
0 
71 
0 
39 
4 
0 
0 
0 
0 
6 
0 
0 
0 
9 
0 
8313 

62251 
29488 
2134 
0 
585 
5 
0 
16 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
94479 

46356 
2602 
0 
0 
0 
18 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
3 
0 
0 
0 
0 
0 
48979 

193220 
41694 
15491 
70 
846 
219 
0 
121 
154 
0 
0 
116 
60 
75 
0 
0 
0 
25 
0 
25 
0 
211 
0 
3 
0 
252330 

9749 
119 
5 
0 
198 
321 
0 
2 
0 
0 
28 
286 
0 
0 
136 
0 
0 
0 
0 
0 
0 
1724 
0 
0 
1000 
13568 

317330 
75748 
17863 
70 
1665 
823 
0 
195 
154 
0 
28 
473 
60 
114 
140 
0 
0 
25 
0 
34 
0 
1935 
0 
12 
1000 
417669 

EN 

29 

EN 

 
  
TABLE 5:  NUMBER OF ANIMALS USED IN PRODUCTION AND QUALITY CONTROL OF PRODUCTS AND DEVICES FOR HUMAN 
MEDICINE AND DENTISTRY AND FOR VETERINARY MEDICINE 

5.1 
Species 

5.2  
National legislation 
specific to a single EC 
Member State 
1) 

5.3 
EC legislation 
including European 
Pharmacopoeia 
(requirements) 

5.4 
Member Country of Council 
of Europe (but not EC) 
legislation 
2) 

5.5 
Other legislation 

5.6 
Any combination of  
5.2/ 5.3/ 5.4/ 5.5 

5.7 
No regulatory 
requirements 

5.8 
Total 

Regulatory requirements versus species 

5.a.  Mice 
Rats 
5.b. 
Guinea-Pigs 
5.c. 
Hamsters 
5.d. 
Other Rodents 
5.e. 
Rabbits 
5.f. 
Cats 
5.g. 
Dogs 
5.h. 
Ferrets 
5.i. 
Other Carnivores 
5.j. 
Horses, donkeys and cross breds 
5.k. 
5.l. 
Pigs 
5.m.  Goats 
Sheep 
5.n. 
Cattle 
5.o. 
Prosimians 
5.p. 
New World Monkeys 
5.q. 
Old World Monkeys 
5.r. 
Apes 
5.s. 
Other Mammals 
5.t. 
Quail 
5.u. 
Other birds 
5.v. 
Reptiles 
5.w. 
Amphibians 
5.x. 
Fish 
5.y. 
5.z. 
TOTAL 
Examples: 

0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 

26663 
294 
2534 
840 
0 
81 
26 
22 
0 
0 
0 
82 
0 
2 
484 
0 
0 
0 
0 
0 
0 
201 
0 
0 
0 
31229 

0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 

1003 
2429 
9 
0 
0 
24 
0 
0 
0 
0 
15 
21 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
3501 
columns 5.2 - 5.5 refer to the legislation imposing that the test be carried out and 
not to the body which has issued the actual test method, guideline or protocol. 

83891 
9621 
12410 
820 
0 
14281 
6 
16 
0 
0 
0 
105 
40 
32 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
121222 

9365 
1385 
4092 
0 
0 
219 
0 
0 
0 
0 
2 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
15063 

120922 
13729 
19045 
1660 
0 
14605 
32 
38 
0 
0 
17 
208 
40 
34 
484 
0 
0 
0 
0 
0 
0 
201 
0 
0 
0 
171015 

5.2 – France is testing due to a UK (or FR) specific requirement 
5.3 - UK is testing according to EC legislation 
5.4 – Spain is testing due to a Hungarian requirement 
5.5 – Sweden is testing due to a US specific requirement 
5.6  –  Germany  is  testing  due  to  a  Czech  requirement  (also  an  EC 
requirement) 
1)  EC Member States: Austria, Belgium, Denmark, Finland, France, Germany, Greece, Ireland, Italy, Luxembourg, Netherlands, Portugal, Spain, Sweden, United Kingdom 
2)  Member  Countries  of  Council  of  Europe  (non-EC):  Albania,  Andorra,  Bulgaria,  Croatia,  Cyprus,  Czech  Rep.,  Estonia,  Hungary,  Iceland,  Latvia,  Liechtenstein,  Lithuania, 

ISO protocol must be coded as a national (FR) legislative requirement and be 
entered into column 5.2 in the tables submitted by Belgium. 

Example:  a test required by French legislation and carried out in Belgium according to an 

Note: 

Malta, Moldova, Norway, Poland, Romania, Russia, San Marino, Slovakia, Slovenia, Switzerland, ‘the former Yugoslav Rep. of Macedonia’, Turkey, Ukraine 

30 

EN 

Footnotes: 

EN 

 
  
 
 
 
 
 
 
 
 
TABLE 6:  NUMBER OF ANIMALS USED IN TOXICOLOGICAL AND OTHER SAFETY EVALUATIONS 

6.1 
Species 

6.2  
National legislation 
specific to a single EC 
Member State 
1) 

6.3 
EC legislation 
including European 
Pharmacopoeia 
(requirements) 

6.4 
Member Country of Council 
of Europe (but not EC) 
legislation 
2) 

6.5 
Other legislation 

6.6 
Any combination of  
6.2/ 6.3/ 6.4/ 6.5 

6.7 
No regulatory 
requirements 

6.8 
Total 

Regulatory requirements versus species 

6.a.  Mice 
Rats 
6.b. 
Guinea-Pigs 
6.c. 
Hamsters 
6.d. 
Other Rodents 
6.e. 
Rabbits 
6.f. 
Cats 
6.g. 
Dogs 
6.h. 
Ferrets 
6.i. 
Other Carnivores 
6.j. 
Horses, donkeys and cross breds 
6.k. 
6.l. 
Pigs 
6.m.  Goats 
Sheep 
6.n. 
Cattle 
6.o. 
Prosimians 
6.p. 
New World Monkeys 
6.q. 
Old World Monkeys 
6.r. 
Apes 
6.s. 
Other Mammals 
6.t. 
Quail 
6.u. 
Other birds 
6.v. 
Reptiles 
6.w. 
Amphibians 
6.x. 
Fish 
6.y. 
6.z. 
TOTAL 
Examples: 

0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
230 
230 

3234 
0 
40 
0 
0 
12 
0 
0 
0 
0 
0 
80 
0 
24 
0 
0 
0 
0 
0 
0 
0 
82 
0 
0 
0 
3472 

0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 

4184 
819 
0 
0 
142 
14 
0 
0 
0 
0 
0 
15 
0 
0 
0 
0 
0 
0 
0 
0 
0 
156 
0 
0 
674 
6004 
columns 6.2 - 6.5 refer to the legislation imposing that the test be carried out and 
not to the body which has issued the actual test method, guideline or protocol. 

21142 
11501 
13747 
0 
0 
1069 
0 
1018 
0 
0 
0 
0 
0 
0 
0 
0 
0 
412 
0 
0 
0 
0 
0 
0 
275 
49164 

3180 
640 
403 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
15 
0 
0 
0 
0 
0 
0 
0 
0 
0 
590 
4828 

31740 
12960 
14190 
0 
142 
1095 
0 
1018 
0 
0 
0 
95 
0 
24 
15 
0 
0 
412 
0 
0 
0 
238 
0 
0 
1769 
63698 

6.2 – France is testing due to a UK (or FR) specific requirement 
6.3 - UK is testing according to EC legislation 
6.4 – Spain is testing due to a Hungarian requirement 
6.5 – Sweden is testing due to a US specific requirement 
6.6  –  Germany  is  testing  due  to  a  Czech  requirement  (also  an  EC 
requirement) 
1)  EC Member States: Austria, Belgium, Denmark, Finland, France, Germany, Greece, Ireland, Italy, Luxembourg, Netherlands, Portugal, Spain, Sweden, United Kingdom 
2)  Member Countries of Council of Europe (non-EC): Albania, Andorra, Bulgaria, Croatia, Cyprus, Czech Rep., Estonia, Hungary, Iceland, Latvia, Liechtenstein, Lithuania, Malta, 

ISO protocol must be coded as a national (FR) legislative requirement and be 
entered into column 6.2 in the tables submitted by Belgium. 

Example:  a test required by French legislation and carried out in Belgium according to an 

Note: 

Moldova, Norway, Poland, Romania, Russia, San Marino, Slovakia, Slovenia, Switzerland, ‘the former Yugoslav Rep. of Macedonia’, Turkey, Ukraine 

31 

EN 

Footnotes: 

EN 

 
  
 
 
 
 
 
 
 
 
TABLE 7:  NUMBER OF ANIMALS USED IN TOXICOLOGICAL AND OTHER SAFETY EVALUATIONS 

7.1 
Species 

7.2 
Acute and sub-acute toxicity testing methods 
(including limit test) 

7.3 
Skin 
irritation 

7.4 
Skin 
sensitisatio
n 

7.5 
Eye 
irritation 

7.6 
Sub- 
chronic and 
chronic 
toxicity 

7.7 
Carcino- 
genicity 

7.8 
Develop- 
mental 
toxicity 

7.9 
Muta- 
genicit
y 

7.10 
Repro-
ductive 
toxicity 

Types of tests versus species 

7.12 
Other 

7.13 
Total 

7.11 
Toxicity 
to aquatic 
vertebra-
tes not 
included 
in other 
columns 

7.2.1. 
LD50, 
LC50 

7.2.2 
Other lethal 
methods 

7.2.3 
Non lethal 
clinical signs 
methods 

7.a.  Mice 
Rats 
7.b. 
Guinea-Pigs 
7.c. 
Hamsters 
7.d. 
Other Rodents 
7.e. 
Rabbits 
7.f. 
Cats 
7.g. 
Dogs 
7.h. 
Ferrets 
7.i. 
Other Carnivores 
7.j. 
Horses,  donkeys  and  cross 
7.k. 
breds 
Pigs 

7.l. 
7.m.  Goats 
Sheep 
7.n. 
Cattle 
7.o. 
Prosimians 
7.p. 
New World Monkeys 
7.q. 
Old World Monkeys 
7.r. 
Apes 
7.s. 
Other Mammals 
7.t. 
Quail 
7.u. 
Other birds 
7.v. 
Reptiles 
7.w. 
Amphibians 
7.x. 
Fish 
7.y. 
TOTAL 
7.z. 

1534 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 

0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
1298 
2832 

15 
60 
0 
0 
142 
0 
0 
0 
0 
0 
0 

0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
100 
0 
0 
0 
317 

24673 
5297 
14030 
0 
0 
169 
0 
474 
0 
0 
0 

0 
0 
0 
0 
0 
0 
412 
0 
0 
0 
0 
0 
0 
0 
45055 

0 
0 
0 
0 
0 
18 
0 
0 
0 
0 
0 

0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
18 

EN 

0 
0 
160 
0 
0 
9 
0 
0 
0 
0 
0 

0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
169 

32 

0 
0 
0 
0 
0 
12 
0 
0 
0 
0 
0 

0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
12 

1720 
1718 
0 
0 
0 
0 
0 
215 
0 
0 
0 

0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
76 
3729 

854 
1604 
0 
0 
0 
0 
0 
0 
0 
0 
0 

0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
2458 

457 
1657 
0 
0 
0 
814 
0 
0 
0 
0 
0 

0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
2928 

1611 
531 
0 
0 
0 
0 
0 
0 
0 
0 
0 

0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
2142 

100 
326 
0 
0 
0 
0 
0 
0 
0 
0 
0 

0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
426 

0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 

0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 

776 
1767 
0 
0 
0 
73 
0 
329 
0 
0 
0 

95 
0 
24 
15 
0 
0 
0 
0 
0 
0 
138 
0 
0 
395 
3612 

31740 
12960 
14190 
0 
142 
1095 
0 
1018 
0 
0 
0 

95 
0 
24 
15 
0 
0 
412 
0 
0 
0 
238 
0 
0 
1769 
63698 

EN 

 
  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
TABLE 8:  NUMBER OF ANIMALS USED IN TOXICOLOGICAL AND OTHER SAFETY EVALUATIONS 

8.1 
Products 

8.2 
Acute and sub-acute toxicity testing 
methods (including limit test) 

8.3 
Skin 
irritation 

8.4 
Skin 
sensitisatio
n 

8.5 
Eye 
irritation 

Types of tests versus products 

8.7 
Carcino 
genicity 

8.8 
Develop- 
mental 
toxicity 

8.9 
Muta- 
genicit
y 

8.10 
Repro-
ductive 
toxicity 

8.6 
Sub- 
chronic 
and 
chronic 
toxicity 

8.12 
Other 

8.13 
Total 

8.11 
Toxicity 
to aquatic 
vertebra-
tes not 
included 
in other 
columns 

8.2.1. 
LD50, 
LC50 

8.2.2 
Other lethal 
methods 

8.2.3 
Non lethal 
clinical signs 
methods 

43801 

18 

169 

12 

3013 

2458 

2622 

2142 

426 

1669 

1788 

59652 

8.a. 

8.b. 

8.c. 

8.d. 

8.e. 

8.f. 

8.g. 

8.h. 

Products/substances  or  devices 
for 
human  medicine  and  dentistry  and  for 
veterinary medicine 
Products/substances used or intended to 
be used mainly in agriculture 
Products/substances used or intended to 
be used mainly in industry 
Products/substances used or intended to 
be used mainly in the household 
Products/substances used or intended to 
be  used  mainly  as  cosmetics  or 
toiletries 
Products/substances used or intended to 
be used mainly as additives in food for 
human consumption 
Products/substances used or intended to 
be used mainly as additives in food for 
animal consumption 
Potential  or  actual  contaminants  in  the 
general  environment  which  do  not 
appear in other columns 
toxicological 

safety 

or 

1534 

390 

0 

0 

0 

0 

0 

0 

0 

0 

0 

0 

0 

0 

368 

317 

0 

0 

0 

0 

0 

0 

0 

0 

0 

0 

0 

0 

0 

0 

0 

0 

0 

0 

0 

0 

0 

0 

0 

0 

0 

0 

0 

0 

0 

0 

0 

0 

0 

0 

0 

0 

0 

76 

640 

0 

0 

0 

0 

0 

0 

0 

0 

0 

0 

0 

0 

0 

0 

0 

306 

0 

0 

0 

0 

0 

0 

0 

0 

0 

0 

0 

0 

0 

0 

0 

0 

0 

0 

0 

0 

0 

0 

0 

0 

0 

0 

0 

0 

390 

0 

0 

0 

0 

0 

0 

155 

916 

0 

0 

2740 

8.i.  Other 

540 

0 

1254 

evaluations 
TOTAL 

8.j. 

2832 

317 

45055 

18 

169 

12 

3729 

2458 

2928 

2142 

426 

1669 

1943 

63698 

EN 

33 

EN 

 
  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
CYPRUS 

Statistical data submitted 

The statistical data have been submitted by “Veterinary Services of the Republic of Cyprus”. 

Remark: data are reported in table 1, 2 and 4 only. 

Comments of the Cyprus authorities 

The  Director  of  the  Veterinary  Services  of  the  Republic  of  Cyprus  is  empowered  by  Law  to  regulate  all 
activities that relate to the use of experimental animals. At present, within the areas under the control of the 
Republic, only rodents (mice) are used in animal experimentation. These primarily include genetic models 
for  various  diseases  or  processes  with  main  emphasis  on  Central  Nervous  System  complications  and 
development. 

These  activities  began  to  take  place  in  Cyprus  in  March  2003  and  are  all  carried  out  in  one  research 
establishment, the Cyprus Institute of Neurology and Genetics (www.cing.ac.cy). 

The Veterinary Services are satisfied that the animals are kept in a very rigorously monitored, pathogen-free 
environment  (monitored  according  to  FELASA  guidelines).  No  outbreak  of  all  pathogens  tested  has  been 
observed. We are also satisfied that the principles of the three Rs are duly adhered to. 

Dr. Giorgos Neophytou 

Director of Veterinary Services 

EN 

34 

   EN 

 
TABLE 1:  NUMBER OF ANIMALS USED IN RELATION TO THEIR PLACE OF ORIGIN 

1.1 
Species 

Origin versus species 

1.2  
Total 

1.3 
Animals coming from registered 
breeding or supplying 
establishments within the reporting 
country 

1.4 
Animals coming from 
elsewhere in the EC 

1.6 
Animals coming from 
other origins 

1.7 
Re-used animals 

1.5 
Animals coming from 
Member Countries of the 
Council of Europe which are 
parties to the Convention ETS 
123 (excluding EC Member 
States) 

Rats (Rattus norvegicus) 
Guinea-Pigs (Cavia porcellus) 
Hamsters (Mesocricetus ) 
Other Rodents (other Rodentia) 
Rabbits (Oryctolagus cuniculus) 
Cats (Felis catus) 
Dogs (Canis familiaris) 
Ferrets (Mustela putorius furo) 
Other Carnivores (other Carnivora) 
Horses, donkeys and cross breds (Equidae) 
Pigs (Sus) 

1.a.  Mice (Mus musculus) 
1.b. 
1.c. 
1.d. 
1.e. 
1.f. 
1.g. 
1.h. 
1.i. 
1.j. 
1.k. 
1.l. 
1.m.  Goats (Capra) 
1.n. 
1.o. 
1.p. 
1.q. 
1.r. 
1.s. 
1.t. 
1.u. 
1.v. 
1.w. 
1.x. 
1.y. 
1.z. 

Sheep (Ovis) 
Cattle (Bos) 
Prosimians (Prosimia) 
New World Monkeys (Ceboidea) 
Old World Monkeys (Cercopithecoidea) 
Apes (Hominoidea) 
Other Mammals (other Mammalia) 
Quail (Coturnix coturnix) 
Other birds (other Aves) 
Reptiles (Reptilia) 
Amphibians (Amphibia) 
Fish (Pisces) 
TOTAL 

930 

12 

25 

967 
0 
0 
0 

0 
0 
0 
0 

0 
0 
0 
0 

0 

967 

Note 1:  Column  1.5  concerns  only  those  Member  Countries  of  the  Council  of  Europe  which,  at  the  beginning  of  the  reporting  period,  are  Parties  to  the  Convention  ETS  123.  Thus  an 

updated list of those countries has to be used when filling in this column. 

Note 2:  Only the white boxes need to be completed. 

Note 3: 

The number of re-used animals in column 1.7 should be excluded from the total in the column 1.2 

EN 

35 

EN 

 
  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
EN 

36 

EN 

 
  
TABLE 2:  NUMBER OF ANIMALS USED IN EXPERIMENTS FOR SELECTED PURPOSES 

2.1 
Species 

2.2  
Biological 
studies of a 
fundamenta
l nature 

Purpose versus species 

2.4 
Production and 
quality control of 
products and 
devices for 
human medicine 
and dentistry 

2.5 
Production and 
quality control of 
products and 
devices for 
veterinary 
medicine 

2.6 
Toxicological 
and other safety 
evaluations 
(including 
safety 
evaluation of 
products and 
devices for 
human 
medicine and 
dentistry and 
for veterinary 
medicine) 

2.3 
Research and 
development of 
products and 
devices for human 
medicine and 
dentistry and for 
veterinary 
medicine 
(excluding 
toxicological and 
other safety 
evaluations 
counted in column 
2.6) 

2.7 
Diagnosis of 
disease 

2.8 
Education and 
training 

2.9 
Other 

2.10 
Total 

822 

145 

2.a.  Mice 
Rats 
2.b. 
Guinea-Pigs 
2.c. 
Hamsters 
2.d. 
Other Rodents 
2.e. 
Rabbits 
2.f. 
Cats 
2.g. 
Dogs 
2.h. 
Ferrets 
2.i. 
Other Carnivores 
2.j. 
Horses,  donkeys  and  cross 
2.k. 
breds 
Pigs 

2.l. 
2.m.  Goats 
Sheep 
2.n. 
Cattle 
2.o. 
Prosimians 
2.p. 
New World Monkeys 
2.q. 
Old World Monkeys 
2.r. 
Apes 
2.s. 
Other Mammals 
2.t. 
Quail 
2.u. 
Other birds 
2.v. 
Reptiles 
2.w. 
Amphibians 
2.x. 
Fish 
2.y. 

967 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 

0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 

EN 

37 

EN 

 
  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
2.z. 

TOTAL 

822 

0 

0 

0 

0 

0 

145 

0 

967 

EN 

38 

EN 

 
  
 TABLE 4:  NUMBER OF ANIMALS USED IN EXPERIMENTS FOR STUDIES ON HUMAN AND ANIMAL DISEASES 

4.1 
Species 

4.2  
Human cardiovascular 
diseases 

4.3 
Human nervous and 
mental disorders 

4.4 
Human cancer (excluding 
evaluations of carcinogenic 
hazards or risks) 

4.5 
Other human diseases 

4.6 
Studies specific to animal 
diseases 

4.7 
Total 

Main categories versus species 

4.a.  Mice 
Rats 
4.b. 
Guinea-Pigs 
4.c. 
Hamsters 
4.d. 
Other Rodents 
4.e. 
Rabbits 
4.f. 
Cats 
4.g. 
Dogs 
4.h. 
Ferrets 
4.i. 
Other Carnivores 
4.j. 
Horses, donkeys and cross breds 
4.k. 
4.l. 
Pigs 
4.m.  Goats 
Sheep 
4.n. 
Cattle 
4.o. 
Prosimians 
4.p. 
New World Monkeys 
4.q. 
Old World Monkeys 
4.r. 
Apes 
4.s. 
Other Mammals 
4.t. 
Quail 
4.u. 
Other birds 
4.v. 
Reptiles 
4.w. 
Amphibians 
4.x. 
Fish 
4.y. 
TOTAL 
4.z. 

792 

175 

0 

792 

0 

175 

0 

967 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
967 

EN 

39 

EN 

 
  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
CZECH REPUBLIC 

Statistical data submitted 

The statistical data have been submitted by the “Central Commission for Animal Welfare (Ústřední 
komise pro ochranu zvířat)”. 

Comments of the Czech authorities 

National comments for the preparation of the 5th Statistical report on the use of experimental 
animals - Czech Republic 

Protection of animals and animal welfare in the Czech Republic is the responsibility of the Ministry 
of Agriculture, which provides the organisation background necessary for the activities performed by 
the  Central  Commission  for  Animal  Welfare  (Ústřední  komise  pro  ochranu  zvířat).  The  animal 
welfare activities  are  implemented pursuant to Act No. 246/1992 Coll., on the protection of  animals 
against  cruelty,  as  amended.  The supervision  over  these  matters  has  been  the  responsibility  of  the 
Regional  Veterinary  Administrations’  inspectors  in  13  regions  of  the  Czech  Republic  and  the 
Municipal Veterinary Administration in Prague. 

There were 93 inspections conducted in laboratory animal breeding establishments involving 120 067 
animals,  corrective  measures  were  imposed  in  3  cases  and  administrative  procedure  was  initiated 
twice. 

In 2005 a total of 330 933 animals were used for experimental and other scientific purposes in the CR. 
It shall be pointed out that 36.99 % of it is represented by ringed birds (122 422 birds) since pursuant 
to the relevant Czech legislation even bird ringing is an experiment. 

Of  the  remaining  208 511  animals  used  for  experimental  and  scientific  purposes  only  0.01 %  were 
cats  (29  cats),  0.13 %  dogs  (264  dogs),  0.02 %  monkeys  (51  monkeys),  while  no  apes  were  used. 
Rodents and rabbits (62.16 %, i.e. 129 615 animals) and fish (33.29 %, i.e. 69 418 fish) represent the 
prevailing majority of animals used. 

In the last couple of years the number of experimental animals used in the CR was approximately the 
same  (approximately  220 000  animals  excluding  ringed  birds).  Fluctuations  in  numbers,  if  any,  are 
caused by experiments using fish and poultry because these experiments are usually conducted on a 
large group of animals (a flock in houses or stock in water reservoirs). 

The use of alternative methods to experiments on animals has been pushed through in the CR. Persons 
who  manage,  control  and  conduct  experiments  on  animals  are  obliged  to  seek  in  the  registers  of 
validated  alternative  methods  such  methods  which  are  applicable  to  their  experiment.  In  the 
experimental project the applicant shall declare in writing that no validated alternative method can be 
applied for the given purpose. 

The training courses for persons who manage, control and conduct experiments on animals comprise 
also teaching of alternative methods to experiments on animals. 

Doc. MVDr. Richard S O V J Á K, CSc. 

Chairman 

EN 

40 

   EN 

 
TABLE 1:  NUMBER OF ANIMALS USED IN RELATION TO THEIR PLACE OF ORIGIN 

1.1 
Species 

Origin versus species 

1.2  
Total 

1.3 
Animals coming from registered 
breeding or supplying 
establishments within the reporting 
country 

1.4 
Animals coming from 
elsewhere in the EC 

1.6 
Animals coming from 
other origins 

1.7 
Re-used animals 

1.5 
Animals coming from 
Member Countries of the 
Council of Europe which are 
parties to the Convention ETS 
123 (excluding EC Member 
States) 

Rats (Rattus norvegicus) 
Guinea-Pigs (Cavia porcellus) 
Hamsters (Mesocricetus ) 
Other Rodents (other Rodentia) 
Rabbits (Oryctolagus cuniculus) 
Cats (Felis catus) 
Dogs (Canis familiaris) 
Ferrets (Mustela putorius furo) 
Other Carnivores (other Carnivora) 
Horses, donkeys and cross breds (Equidae) 
Pigs (Sus) 

1.a.  Mice (Mus musculus) 
1.b. 
1.c. 
1.d. 
1.e. 
1.f. 
1.g. 
1.h. 
1.i. 
1.j. 
1.k. 
1.l. 
1.m.  Goats (Capra) 
1.n. 
1.o. 
1.p. 
1.q. 
1.r. 
1.s. 
1.t. 
1.u. 
1.v. 
1.w. 
1.x. 
1.y. 
1.z. 

Sheep (Ovis) 
Cattle (Bos) 
Prosimians (Prosimia) 
New World Monkeys (Ceboidea) 
Old World Monkeys (Cercopithecoidea) 
Apes (Hominoidea) 
Other Mammals (other Mammalia) 
Quail (Coturnix coturnix) 
Other birds (other Aves) 
Reptiles (Reptilia) 
Amphibians (Amphibia) 
Fish (Pisces) 
TOTAL 

4708 
1087 

2071 
240 

452 

26 

119 

24 

30 

75473 
29924 
4075 
220 

5567 
3 
264 
159 

51 

30 

82252 
31703 
4075 
220 
5798 
5567 
29 
264 
159 
7 
314 
1392 
56 
720 
711 
0 
0 
51 
0 
188 
30 
126211 
1475 
293 
69418 
330933 

Note 1:  Column  1.5  concerns  only  those  Member  Countries  of  the  Council  of  Europe  which,  at  the  beginning  of  the  reporting  period,  are  Parties  to  the  Convention  ETS  123.  Thus  an 

updated list of those countries has to be used when filling in this column. 

Note 2:  Only the white boxes need to be completed. 

Note 3: 

The number of re-used animals in column 1.7 should be excluded from the total in the column 1.2 

EN 

41 

EN 

 
  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
TABLE 2:  NUMBER OF ANIMALS USED IN EXPERIMENTS FOR SELECTED PURPOSES 

Purpose versus species 

2.7 
Diagnosis of 
disease 

2.8 
Education and 
training 

2.9 
Other 

2.10 
Total 

2.3 
Research and 
development of 
products and 
devices for human 
medicine and 
dentistry and for 
veterinary 
medicine 
(excluding 
toxicological and 
other safety 
evaluations 
counted in column 
2.6) 

4698 
2462 
4 

16 

126 

241 

2.4 
Production and 
quality control of 
products and 
devices for 
human medicine 
and dentistry 

2.5 
Production and 
quality control of 
products and 
devices for 
veterinary 
medicine 

8962 
146 
1575 
55 

1351 

10 
7 

14401 
920 
1048 
40 
187 
2962 
26 
100 

208 

569 

51 
40 

42 

2556 

2.6 
Toxicological 
and other safety 
evaluations 
(including 
safety 
evaluation of 
products and 
devices for 
human 
medicine and 
dentistry and 
for veterinary 
medicine) 

2673 
911 
527 

448 

145 

51 

30 

2.1 
Species 

2.2  
Biological 
studies of a 
fundamenta
l nature 

2.a.  Mice 
Rats 
2.b. 
Guinea-Pigs 
2.c. 
Hamsters 
2.d. 
Other Rodents 
2.e. 
Rabbits 
2.f. 
Cats 
2.g. 
Dogs 
2.h. 
Ferrets 
2.i. 
Other Carnivores 
2.j. 
Horses,  donkeys  and  cross 
2.k. 
breds 
Pigs 

2.l. 
2.m.  Goats 
Sheep 
2.n. 
Cattle 
2.o. 
Prosimians 
2.p. 
New World Monkeys 
2.q. 
Old World Monkeys 
2.r. 
Apes 
2.s. 
Other Mammals 
2.t. 
Quail 
2.u. 
Other birds 
2.v. 
Reptiles 
2.w. 
Amphibians 
2.x. 
Fish 
2.y. 

33319 
25532 
433 
115 
5449 
352 
3 
4 

7 

502 
56 
83 
152 

188 

122422 
755 
208 
26935 

EN 

1422 

26693 

870 

42 

9320 
77 
457 
10 

344 

5 
6 

85 

12 

6 

3338 
1655 
31 

162 
83 

20 

100 

236 

19 
84 

5541 

11 

6 

567 
182 

585 
720 
85 
11866 

600 

1632 

82252 
31703 
4075 
220 
5798 
5567 
29 
264 
159 
7 
314 

1392 
56 
720 
711 
0 
0 
51 
0 
188 
30 
126211 
1475 
293 
69418 

EN 

 
  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
2.z. 

TOTAL 

216515 

7547 

12148 

24530 

31478 

11192 

18984 

8539 

330933 

EN 

43 

EN 

 
  
TABLE 3:  NUMBER OF ANIMALS USED IN TOXICOLOGICAL AND OTHER SAFETY EVALUATIONS 

3.1 
Species 

3.2  
Products/ 
substances or 
devices for 
human 
medicine and 
dentistry and 
for veterinary 
medicine 

3.3 
Products/ 
substances 
used or 
intended to 
be used 
mainly in 
agriculture 

3.4 
Products/ 
substances 
used or 
intended to 
be used 
mainly in 
industry 

Products versus species 

3.5 
Products/ 
substances 
used or 
intended to 
be used 
mainly in 
the 
household 

3.6 
Products/ 
substances 
used or 
intended to 
be used 
mainly as 
cosmetics 
or toiletries 

3.7 
Products/ 
substances 
used or 
intended to be 
used mainly 
as additives in 
food for 
human 
consumption 

3.8 
Products/ 
substances 
used or 
intended to be 
used mainly 
as additives in 
food for 
animal 
consumption 
600 
150 

3.11 
Total 

3.10 
Other toxico- 
logical or 
safety 
evaluations 

3.9 
Potential or 
actual contami- 
nents in the 
general envi- 
ronment which 
do not appear in 
other columns 

405 
200 

25 

25 

68 
248 
471 

26 

4 

174 

2300 
663 
30 

245 

145 

51 

1468 
4902 

90 
120 

2676 
3637 

0 

0 

0 

750 

19523 
20178 

1891 
1891 

3373 
1261 
527 
0 
0 
448 
0 
145 
0 
0 
0 
0 
0 
0 
0 
0 
0 
51 
0 
0 
25 
0 
0 
0 
25648 
31478 

3.a.  Mice 
Rats 
3.b. 
Guinea-Pigs 
3.c. 
Hamsters 
3.d. 
Other Rodents 
3.e. 
Rabbits 
3.f. 
Cats 
3.g. 
Dogs 
3.h. 
Ferrets 
3.i. 
Other Carnivores 
3.j. 
Horses, donkeys and cross breds 
3.k. 
3.l. 
Pigs 
3.m.  Goats 
Sheep 
3.n. 
Cattle 
3.o. 
Prosimians 
3.p. 
New World Monkeys 
3.q. 
Old World Monkeys 
3.r. 
Apes 
3.s. 
Other Mammals 
3.t. 
Quail 
3.u. 
Other birds 
3.v. 
Reptiles 
3.w. 
Amphibians 
3.x. 
Fish 
3.y. 
TOTAL 
3.z. 

EN 

44 

EN 

 
  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
TABLE 4:  NUMBER OF ANIMALS USED IN EXPERIMENTS FOR STUDIES ON HUMAN AND ANIMAL DISEASES 

4.1 
Species 

4.2  
Human cardiovascular 
diseases 

4.3 
Human nervous and 
mental disorders 

4.4 
Human cancer (excluding 
evaluations of carcinogenic 
hazards or risks) 

4.5 
Other human diseases 

4.6 
Studies specific to animal 
diseases 

4.7 
Total 

Main categories versus species 

4.a.  Mice 
Rats 
4.b. 
Guinea-Pigs 
4.c. 
Hamsters 
4.d. 
Other Rodents 
4.e. 
Rabbits 
4.f. 
Cats 
4.g. 
Dogs 
4.h. 
Ferrets 
4.i. 
Other Carnivores 
4.j. 
Horses, donkeys and cross breds 
4.k. 
4.l. 
Pigs 
4.m.  Goats 
Sheep 
4.n. 
Cattle 
4.o. 
Prosimians 
4.p. 
New World Monkeys 
4.q. 
Old World Monkeys 
4.r. 
Apes 
4.s. 
Other Mammals 
4.t. 
Quail 
4.u. 
Other birds 
4.v. 
Reptiles 
4.w. 
Amphibians 
4.x. 
Fish 
4.y. 
TOTAL 
4.z. 

1230 
2896 

1473 
5697 
10 

167 
3 
2 
126 

31 

29 

9036 
694 

3 

30 

15146 
6104 
13 
10 

161 

6 

188 

5 
111 

7538 

4126 

9763 

21744 

4672 
136 
6 
20 
361 
72 

40 
56 
28 
17 

1093 

1430 
7931 

31557 
15527 
29 
30 
361 
403 
3 
2 
132 
0 
0 
289 
56 
57 
17 
0 
0 
0 
0 
0 
5 
1204 
0 
0 
1430 
51102 

EN 

45 

EN 

 
  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
TABLE 5:  NUMBER OF ANIMALS USED IN PRODUCTION AND QUALITY CONTROL OF PRODUCTS AND DEVICES FOR 
HUMAN MEDICINE AND DENTISTRY AND FOR VETERINARY MEDICINE 

5.1 
Species 

Regulatory requirements versus species 

5.2  
National legislation 
specific to a single EC 
Member State 
1) 

5.3 
EC legislation 
including European 
Pharmacopoeia 
(requirements) 

5.4 
Member Country of Council 
of Europe (but not EC) 
legislation 
2) 

5.5 
Other legislation 

5.6 
Any combination of  
5.2/ 5.3/ 5.4/ 5.5 

5.7 
No regulatory 
requirements 

5.8 
Total 

5.a.  Mice 
Rats 
5.b. 
Guinea-Pigs 
5.c. 
Hamsters 
5.d. 
Other Rodents 
5.e. 
Rabbits 
5.f. 
Cats 
5.g. 
Dogs 
5.h. 
Ferrets 
5.i. 
Other Carnivores 
5.j. 
Horses, donkeys and cross breds 
5.k. 
Pigs 
5.l. 
5.m.  Goats 
Sheep 
5.n. 
Cattle 
5.o. 
Prosimians 
5.p. 
New World Monkeys 
5.q. 
Old World Monkeys 
5.r. 
Apes 
5.s. 
Other Mammals 
5.t. 
Quail 
5.u. 
Other birds 
5.v. 
Reptiles 
5.w. 
Amphibians 
5.x. 
Fish 
5.y. 
5.z. 
TOTAL 
Examples: 

Footnotes: 

EN 

4422 
211 
3 

483 

205 

1222 
6546 

17623 
880 
2620 
95 

3433 
26 
110 
7 

3 
556 

51 
40 

2543 

27987 

8 

11 

187 

1368 
117 

386 

13 

55 

23413 
1216 
2623 
95 
187 
4313 
26 
110 
7 
0 
208 
569 
0 
51 
40 
0 
0 
0 
0 
0 
0 
2598 
0 
0 
1222 
36678 

5.2 – France is testing due to a UK (or FR) specific requirement 
5.3 - UK is testing according to EC legislation 
5.4 – Spain is testing due to a Hungarian requirement 
5.5 – Sweden is testing due to a US specific requirement 
5.6  –  Germany  is  testing  due  to  a  Czech  requirement  (also  an  EC 
requirement) 
1)  EC Member States: Austria, Belgium, Denmark, Finland, France, Germany, Greece, Ireland, Italy, Luxembourg, Netherlands, Portugal, Spain, Sweden, United Kingdom 

ISO protocol must be coded as a national (FR) legislative requirement and be 
entered into column 5.2 in the tables submitted by Belgium. 

Example:  a test required by French legislation and carried out in Belgium according to an 

1939 
columns 5.2 - 5.5 refer to the legislation imposing that the test be carried out and 
not to the body which has issued the actual test method, guideline or protocol. 

Note: 

187 

19 

0 

46 

EN 

 
  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
2)  Member  Countries  of  Council  of  Europe  (non-EC):  Albania,  Andorra,  Bulgaria,  Croatia,  Cyprus,  Czech  Rep.,  Estonia,  Hungary,  Iceland,  Latvia,  Liechtenstein,  Lithuania, 

Malta, Moldova, Norway, Poland, Romania, Russia, San Marino, Slovakia, Slovenia, Switzerland, ‘the former Yugoslav Rep. of Macedonia’, Turkey, Ukraine 

EN 

47 

EN 

 
  
 
TABLE 6:  NUMBER OF ANIMALS USED IN TOXICOLOGICAL AND OTHER SAFETY EVALUATIONS 

Regulatory requirements versus species 

6.1 
Species 

6.2  
National legislation 
specific to a single EC 
Member State 
1) 

6.3 
EC legislation 
including European 
Pharmacopoeia 
(requirements) 

6.4 
Member Country of Council 
of Europe (but not EC) 
legislation 
2) 

6.5 
Other legislation 

6.6 
Any combination of  
6.2/ 6.3/ 6.4/ 6.5 

6.7 
No regulatory 
requirements 

6.8 
Total 

6.a.  Mice 
Rats 
6.b. 
Guinea-Pigs 
6.c. 
Hamsters 
6.d. 
Other Rodents 
6.e. 
Rabbits 
6.f. 
Cats 
6.g. 
Dogs 
6.h. 
Ferrets 
6.i. 
Other Carnivores 
6.j. 
Horses, donkeys and cross breds 
6.k. 
6.l. 
Pigs 
6.m.  Goats 
Sheep 
6.n. 
Cattle 
6.o. 
Prosimians 
6.p. 
New World Monkeys 
6.q. 
Old World Monkeys 
6.r. 
Apes 
6.s. 
Other Mammals 
6.t. 
Quail 
6.u. 
Other birds 
6.v. 
Reptiles 
6.w. 
Amphibians 
6.x. 
Fish 
6.y. 
6.z. 
TOTAL 
Examples: 

278 
224 
351 

182 

2170 
663 
106 

257 

145 

51 

6476 
7511 

15055 
18447 

24 
70 

9 

225 

25 

2673 
911 
527 
0 
0 
448 
0 
145 
0 
0 
0 
0 
0 
0 
0 
0 
0 
51 
0 
0 
25 
0 
0 
0 
26698 
31478 

6.2 – France is testing due to a UK (or FR) specific requirement 
6.3 - UK is testing according to EC legislation 
6.4 – Spain is testing due to a Hungarian requirement 
6.5 – Sweden is testing due to a US specific requirement 
6.6  –  Germany  is  testing  due  to  a  Czech  requirement  (also  an  EC 
requirement) 
1)  EC Member States: Austria, Belgium, Denmark, Finland, France, Germany, Greece, Ireland, Italy, Luxembourg, Netherlands, Portugal, Spain, Sweden, United Kingdom 
2)  Member Countries of Council of Europe (non-EC): Albania, Andorra, Bulgaria, Croatia, Cyprus, Czech Rep., Estonia, Hungary, Iceland, Latvia, Liechtenstein, Lithuania, Malta, 

ISO protocol must be coded as a national (FR) legislative requirement and be 
entered into column 6.2 in the tables submitted by Belgium. 

Example:  a test required by French legislation and carried out in Belgium according to an 

Note: 

312 
415 

4855 
5105 
columns 6.2 - 6.5 refer to the legislation imposing that the test be carried out and 
not to the body which has issued the actual test method, guideline or protocol. 

0 

0 

Moldova, Norway, Poland, Romania, Russia, San Marino, Slovakia, Slovenia, Switzerland, ‘the former Yugoslav Rep. of Macedonia’, Turkey, Ukraine 

48 

EN 

Footnotes: 

EN 

 
  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
TABLE 7:  NUMBER OF ANIMALS USED IN TOXICOLOGICAL AND OTHER SAFETY EVALUATIONS 

7.1 
Species 

7.2 
Acute and sub-acute toxicity testing methods 
(including limit test) 

7.3 
Skin 
irritation 

7.4 
Skin 
sensitisatio
n 

7.5 
Eye 
irritation 

7.6 
Sub- 
chronic and 
chronic 
toxicity 

7.7 
Carcino- 
genicity 

7.8 
Develop- 
mental 
toxicity 

7.9 
Muta- 
genicit
y 

7.10 
Repro-
ductive 
toxicity 

Types of tests versus species 

7.12 
Other 

7.13 
Total 

7.11 
Toxicity 
to aquatic 
vertebra-
tes not 
included 
in other 
columns 

7.a.  Mice 
Rats 
7.b. 
Guinea-Pigs 
7.c. 
Hamsters 
7.d. 
Other Rodents 
7.e. 
Rabbits 
7.f. 
Cats 
7.g. 
Dogs 
7.h. 
Ferrets 
7.i. 
Other Carnivores 
7.j. 
Horses,  donkeys  and  cross 
7.k. 
breds 
Pigs 

7.l. 
7.m.  Goats 
Sheep 
7.n. 
Cattle 
7.o. 
Prosimians 
7.p. 
New World Monkeys 
7.q. 
Old World Monkeys 
7.r. 
Apes 
7.s. 
Other Mammals 
7.t. 
Quail 
7.u. 
Other birds 
7.v. 
Reptiles 
7.w. 
Amphibians 
7.x. 
Fish 
7.y. 
TOTAL 
7.z. 

7.2.1. 
LD50, 
LC50 

7.2.2 
Other lethal 
methods 

7.2.3 
Non lethal 
clinical signs 
methods 

1055 
298 

68 

487 

40 

259 

164 

120 

90 

225 

25 

1115 
613 

145 

51 

25 

22501 
23854 

0 

25 

299 

555 

164 

155 
2079 

0 

120 

25 

1600 
1690 

2442 
2442 

225 

EN 

49 

2673 
911 
527 
0 
0 
448 
0 
145 
0 
0 
0 

0 
0 
0 
0 
0 
0 
51 
0 
0 
25 
0 
0 
0 
26698 
31478 

EN 

 
  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
TABLE 8:  NUMBER OF ANIMALS USED IN TOXICOLOGICAL AND OTHER SAFETY EVALUATIONS 

8.1 
Products 

Types of tests versus products 

8.2 
Acute and sub-acute toxicity testing 
methods (including limit test) 

8.3 
Skin 
irritation 

8.4 
Skin 
sensitisatio
n 

8.5 
Eye 
irritation 

8.7 
Carcino 
genicity 

8.8 
Develop- 
mental 
toxicity 

8.9 
Muta- 
genicit
y 

8.10 
Repro-
ductive 
toxicity 

8.6 
Sub- 
chronic 
and 
chronic 
toxicity 

8.12 
Other 

8.13 
Total 

8.11 
Toxicity 
to aquatic 
vertebra-
tes not 
included 
in other 
columns 

8.2.1. 
LD50, 
LC50 

8.2.2 
Other lethal 
methods 

8.2.3 
Non lethal 
clinical signs 
methods 

8.a. 

8.b. 

8.c. 

8.d. 

8.e. 

8.f. 

8.g. 

8.h. 

for 
Products/substances  or  devices 
human  medicine  and  dentistry  and  for 
veterinary medicine 
Products/substances used or intended to 
be used mainly in agriculture 
Products/substances used or intended to 
be used mainly in industry 
Products/substances used or intended to 
be used mainly in the household 
Products/substances used or intended to 
be  used  mainly  as  cosmetics  or 
toiletries 
Products/substances used or intended to 
be used mainly as additives in food for 
human consumption 
Products/substances used or intended to 
be used mainly as additives in food for 
animal consumption 
Potential  or  actual  contaminants  in  the 
general  environment  which  do  not 
appear in other columns 
toxicological 

safety 

or 

8.i.  Other 

1213 

90 

1450 

19510 

591 

145 

30 

100 

1924 

12 

142 

18 

507 

64 

100 

1374 

3412 

120 

3637 

0 

0 

0 

0 

25 

120 

25 

90 

1068 

20838 

2655 

225 

3471 

evaluations 
TOTAL 

8.j. 

EN 

22854 

0 

25 

299 

555 

164 

2024 

0 

120 

25 

90 

5097 

225 

31478 

50 

EN 

 
  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
DENMARK  

Statistical data submitted 

The  statistical  data  have  been  submitted  by  the  “Dyreforsøgstilsynet”  (Animal 
Experiments Inspectorate). 

Comments of Danish authorities  

None 

EN 

51 

   EN

 
TABLE 1:  NUMBER OF ANIMALS USED IN RELATION TO THEIR PLACE OF ORIGIN 

1.1 
Species 

Origin versus species 

1.2  
Total 

1.3 
Animals coming from registered 
breeding or supplying 
establishments within the reporting 
country 

1.4 
Animals coming from 
elsewhere in the EC 

1.6 
Animals coming from 
other origins 

1.7 
Re-used animals 

1.5 
Animals coming from 
Member Countries of the 
Council of Europe which are 
parties to the Convention ETS 
123 (excluding EC Member 
States) 

Rats (Rattus norvegicus) 
Guinea-Pigs (Cavia porcellus) 
Hamsters (Mesocricetus ) 
Other Rodents (other Rodentia) 
Rabbits (Oryctolagus cuniculus) 
Cats (Felis catus) 
Dogs (Canis familiaris) 
Ferrets (Mustela putorius furo) 
Other Carnivores (other Carnivora) 
Horses, donkeys and cross breds (Equidae) 
Pigs (Sus) 

1.a.  Mice (Mus musculus) 
1.b. 
1.c. 
1.d. 
1.e. 
1.f. 
1.g. 
1.h. 
1.i. 
1.j. 
1.k. 
1.l. 
1.m.  Goats (Capra) 
1.n. 
1.o. 
1.p. 
1.q. 
1.r. 
1.s. 
1.t. 
1.u. 
1.v. 
1.w. 
1.x. 
1.y. 
1.z. 

Sheep (Ovis) 
Cattle (Bos) 
Prosimians (Prosimia) 
New World Monkeys (Ceboidea) 
Old World Monkeys (Cercopithecoidea) 
Apes (Hominoidea) 
Other Mammals (other Mammalia) 
Quail (Coturnix coturnix) 
Other birds (other Aves) 
Reptiles (Reptilia) 
Amphibians (Amphibia) 
Fish (Pisces) 
TOTAL 

208375 
85664 
5046 
402 
6381 
5805 
16 
566 
19 
242 
62 
7697 
199 
156 
489 
0 
0 
0 
0 
185 
0 
7784 
54 
840 
35958 
365940 

109300 
45960 
1204 
402 
0 
4288 
4 
10 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 

96573 
37649 
3838 
0 
0 
1359 
0 
514 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 

0 
725 
0 
0 
0 
18 
4 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 

2502 
1330 
4 
0 
0 
140 
8 
42 
19 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 

145 
71 
2 
0 
0 
739 
0 
84 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 

Note 1:  Column 1.5 concerns only those Member Countries of the Council of Europe which, at the beginning of the reporting period, are Parties to the Convention ETS 123. Thus an updated list of 

those countries has to be used when filling in this column. 

Note 2:  Only the white boxes need to be completed. 

Note 3: 

The number of re-used animals in column 1.7 should be excluded from the total in the column 1.2 

EN 

52 

EN 

 
  
TABLE 2:  NUMBER OF ANIMALS USED IN EXPERIMENTS FOR SELECTED PURPOSES 

2.1 
Species 

2.2  
Biological 
studies of a 
fundamenta
l nature 

2.a.  Mice 
Rats 
2.b. 
Guinea-Pigs 
2.c. 
Hamsters 
2.d. 
Other Rodents 
2.e. 
Rabbits 
2.f. 
Cats 
2.g. 
Dogs 
2.h. 
Ferrets 
2.i. 
Other Carnivores 
2.j. 
Horses,  donkeys  and  cross 
2.k. 
breds 
Pigs 

2.l. 
2.m.  Goats 
Sheep 
2.n. 
Cattle 
2.o. 
Prosimians 
2.p. 
New World Monkeys 
2.q. 
Old World Monkeys 
2.r. 
Apes 
2.s. 
Other Mammals 
2.t. 
Quail 
2.u. 
Other birds 
2.v. 
Reptiles 
2.w. 
Amphibians 
2.x. 
Fish 
2.y. 
TOTAL 
2.z. 

50339 
18795 
393 
338 
0 
247 
12 
46 
19 
242 
39 

3992 
26 
125 
444 
0 
0 
0 
0 
137 
0 
2695 
54 
597 
10284 
88824 

2.3 
Research and 
development of 
products and 
devices for human 
medicine and 
dentistry and for 
veterinary 
medicine 
(excluding 
toxicological and 
other safety 
evaluations 
counted in column 
2.6) 

128153 
54087 
850 
0 
6343 
700 
0 
109 
0 
0 
0 

1807 
3 
27 
30 
0 
0 
0 
0 
48 
0 
0 
0 
93 
23710 
215960 

EN 

2.7 
Diagnosis of 
disease 

2.8 
Education and 
training 

2.9 
Other 

2.10 
Total 

Purpose versus species 

2.4 
Production and 
quality control of 
products and 
devices for 
human medicine 
and dentistry 

2.5 
Production and 
quality control of 
products and 
devices for 
veterinary 
medicine 

2.6 
Toxicological 
and other safety 
evaluations 
(including 
safety 
evaluation of 
products and 
devices for 
human 
medicine and 
dentistry and 
for veterinary 
medicine) 

3742 
8786 
2303 
64 
0 
556 
0 
407 
0 
0 
0 

581 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
1480 
17919 

2524 
703 
66 
0 
38 
3232 
0 
0 
0 
0 
0 

483 
163 
0 
0 
0 
0 
0 
0 
0 
0 
5087 
0 
0 
0 
12296 

1441 
1984 
0 
0 
0 
104 
4 
4 
0 
0 
11 

350 
1 
0 
13 
0 
0 
0 
0 
0 
0 
0 
0 
150 
84 
4146 

8169 
449 
0 
0 
0 
2 
0 
0 
0 
0 
0 

435 
6 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
400 
9461 

208375 
85664 
5046 
402 
6381 
5805 
16 
566 
19 
242 
62 

7697 
199 
156 
489 
0 
0 
0 
0 
185 
0 
7784 
54 
840 
35958 
365940 

13842 
860 
1434 
0 
0 
882 
0 
0 
0 
0 
12 

20 
0 
4 
0 
0 
0 
0 
0 
0 
0 
2 
0 
0 
0 
17056 

165 
0 
0 
0 
0 
82 
0 
0 
0 
0 
0 

29 
0 
0 
2 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
278 

53 

EN 

 
  
TABLE 3:  NUMBER OF ANIMALS USED IN TOXICOLOGICAL AND OTHER SAFETY EVALUATIONS 

Products versus species 

3.1 
Species 

3.2  
Products/ 
substances or 
devices for 
human 
medicine and 
dentistry and 
for veterinary 
medicine 

3.3 
Products/ 
substances 
used or 
intended to 
be used 
mainly in 
agriculture 

3.4 
Products/ 
substances 
used or 
intended to 
be used 
mainly in 
industry 

3.5 
Products/ 
substances 
used or 
intended to 
be used 
mainly in 
the 
household 

3.6 
Products/ 
substances 
used or 
intended to 
be used 
mainly as 
cosmetics 
or toiletries 

3.a.  Mice 
Rats 
3.b. 
Guinea-Pigs 
3.c. 
Hamsters 
3.d. 
Other Rodents 
3.e. 
Rabbits 
3.f. 
Cats 
3.g. 
Dogs 
3.h. 
Ferrets 
3.i. 
Other Carnivores 
3.j. 
Horses, donkeys and cross breds 
3.k. 
3.l. 
Pigs 
3.m.  Goats 
Sheep 
3.n. 
Cattle 
3.o. 
Prosimians 
3.p. 
New World Monkeys 
3.q. 
Old World Monkeys 
3.r. 
Apes 
3.s. 
Other Mammals 
3.t. 
Quail 
3.u. 
Other birds 
3.v. 
Reptiles 
3.w. 
Amphibians 
3.x. 
Fish 
3.y. 
TOTAL 
3.z. 

2733 
5453 
2102 
64 
0 
407 
0 
407 
0 
0 
0 
581 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
11747 

0 
2138 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
2138 

556 
355 
45 
0 
0 
9 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
1080 
2045 

51 
134 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
185 

0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 

3.7 
Products/ 
substances 
used or 
intended to be 
used mainly 
as additives in 
food for 
human 
consumption 
0 
33 
0 
0 
0 
135 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
168 

3.8 
Products/ 
substances 
used or 
intended to be 
used mainly 
as additives in 
food for 
animal 
consumption 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 

3.11 
Total 

3.10 
Other toxico- 
logical or 
safety 
evaluations 

3.9 
Potential or 
actual contami- 
nents in the 
general envi- 
ronment which 
do not appear in 
other columns 

25 
561 
156 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
400 
1142 

377 
112 
0 
0 
0 
5 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
494 

3742 
8786 
2303 
64 
0 
556 
0 
407 
0 
0 
0 
581 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
1480 
17919 

EN 

54 

EN 

 
  
TABLE 4:  NUMBER OF ANIMALS USED IN EXPERIMENTS FOR STUDIES ON HUMAN AND ANIMAL DISEASES 

4.1 
Species 

4.2  
Human cardiovascular 
diseases 

4.3 
Human nervous and 
mental disorders 

4.4 
Human cancer (excluding 
evaluations of carcinogenic 
hazards or risks) 

4.5 
Other human diseases 

4.6 
Studies specific to animal 
diseases 

4.7 
Total 

Main categories versus species 

4.a.  Mice 
Rats 
4.b. 
Guinea-Pigs 
4.c. 
Hamsters 
4.d. 
Other Rodents 
4.e. 
Rabbits 
4.f. 
Cats 
4.g. 
Dogs 
4.h. 
Ferrets 
4.i. 
Other Carnivores 
4.j. 
Horses, donkeys and cross breds 
4.k. 
4.l. 
Pigs 
4.m.  Goats 
Sheep 
4.n. 
Cattle 
4.o. 
Prosimians 
4.p. 
New World Monkeys 
4.q. 
Old World Monkeys 
4.r. 
Apes 
4.s. 
Other Mammals 
4.t. 
Quail 
4.u. 
Other birds 
4.v. 
Reptiles 
4.w. 
Amphibians 
4.x. 
Fish 
4.y. 
TOTAL 
4.z. 

1902 
3072 
65 
171 
0 
142 
0 
0 
0 
0 
0 
254 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
5606 

92293 
35360 
629 
0 
5923 
8 
12 
17 
19 
0 
0 
172 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
127 
0 
134560 

20255 
332 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
20587 

30999 
27760 
281 
0 
420 
740 
0 
92 
0 
0 
0 
1616 
29 
50 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
61987 

716 
96 
24 
0 
0 
2 
0 
42 
0 
102 
26 
665 
0 
0 
10 
0 
0 
0 
0 
0 
0 
3714 
0 
0 
2800 
8197 

146165 
66620 
999 
171 
6343 
892 
12 
151 
19 
102 
26 
2707 
29 
50 
10 
0 
0 
0 
0 
0 
0 
3714 
0 
127 
2800 
230937 

EN 

55 

EN 

 
  
TABLE 5:  NUMBER OF ANIMALS USED IN PRODUCTION AND QUALITY CONTROL OF PRODUCTS AND DEVICES FOR HUMAN 
MEDICINE AND DENTISTRY AND FOR VETERINARY MEDICINE 

5.1 
Species 

5.2  
National legislation 
specific to a single EC 
Member State 
1) 

5.3 
EC legislation 
including European 
Pharmacopoeia 
(requirements) 

5.4 
Member Country of Council 
of Europe (but not EC) 
legislation 
2) 

5.5 
Other legislation 

5.6 
Any combination of  
5.2/ 5.3/ 5.4/ 5.5 

5.7 
No regulatory 
requirements 

5.8 
Total 

Regulatory requirements versus species 

5.a.  Mice 
Rats 
5.b. 
Guinea-Pigs 
5.c. 
Hamsters 
5.d. 
Other Rodents 
5.e. 
Rabbits 
5.f. 
Cats 
5.g. 
Dogs 
5.h. 
Ferrets 
5.i. 
Other Carnivores 
5.j. 
Horses, donkeys and cross breds 
5.k. 
5.l. 
Pigs 
5.m.  Goats 
Sheep 
5.n. 
Cattle 
5.o. 
Prosimians 
5.p. 
New World Monkeys 
5.q. 
Old World Monkeys 
5.r. 
Apes 
5.s. 
Other Mammals 
5.t. 
Quail 
5.u. 
Other birds 
5.v. 
Reptiles 
5.w. 
Amphibians 
5.x. 
Fish 
5.y. 
5.z. 
TOTAL 
Examples: 

86 
96 
0 
0 
0 
7 
0 
0 
0 
0 
0 
25 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
214 

517 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
517 

0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 

522 
0 
102 
0 
0 
530 
0 
0 
0 
0 
12 
0 
0 
4 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
1170 
columns 5.2 - 5.5 refer to the legislation imposing that the test be carried out and 
not to the body which has issued the actual test method, guideline or protocol. 

12882 
764 
1332 
0 
0 
397 
0 
0 
0 
0 
0 
24 
0 
0 
2 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
15401 

0 
0 
0 
0 
0 
30 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
2 
0 
0 
0 
32 

14007 
860 
1434 
0 
0 
964 
0 
0 
0 
0 
12 
49 
0 
4 
2 
0 
0 
0 
0 
0 
0 
2 
0 
0 
0 
17334 

5.2 – France is testing due to a UK (or FR) specific requirement 
5.3 - UK is testing according to EC legislation 
5.4 – Spain is testing due to a Hungarian requirement 
5.5 – Sweden is testing due to a US specific requirement 
5.6  –  Germany  is  testing  due  to  a  Czech  requirement  (also  an  EC 
requirement) 
1)  EC Member States: Austria, Belgium, Denmark, Finland, France, Germany, Greece, Ireland, Italy, Luxembourg, Netherlands, Portugal, Spain, Sweden, United Kingdom 
2)  Member  Countries  of  Council  of  Europe  (non-EC):  Albania,  Andorra,  Bulgaria,  Croatia,  Cyprus,  Czech  Rep.,  Estonia,  Hungary,  Iceland,  Latvia,  Liechtenstein,  Lithuania, 

ISO protocol must be coded as a national (FR) legislative requirement and be 
entered into column 5.2 in the tables submitted by Belgium. 

Example:  a test required by French legislation and carried out in Belgium according to an 

Note: 

Malta, Moldova, Norway, Poland, Romania, Russia, San Marino, Slovakia, Slovenia, Switzerland, ‘the former Yugoslav Rep. of Macedonia’, Turkey, Ukraine 

56 

EN 

Footnotes: 

EN 

 
  
 
 
 
 
 
 
 
 
TABLE 6:  NUMBER OF ANIMALS USED IN TOXICOLOGICAL AND OTHER SAFETY EVALUATIONS 

6.1 
Species 

6.2  
National legislation 
specific to a single EC 
Member State 
1) 

6.3 
EC legislation 
including European 
Pharmacopoeia 
(requirements) 

6.4 
Member Country of Council 
of Europe (but not EC) 
legislation 
2) 

6.5 
Other legislation 

6.6 
Any combination of  
6.2/ 6.3/ 6.4/ 6.5 

6.7 
No regulatory 
requirements 

6.8 
Total 

Regulatory requirements versus species 

6.a.  Mice 
Rats 
6.b. 
Guinea-Pigs 
6.c. 
Hamsters 
6.d. 
Other Rodents 
6.e. 
Rabbits 
6.f. 
Cats 
6.g. 
Dogs 
6.h. 
Ferrets 
6.i. 
Other Carnivores 
6.j. 
Horses, donkeys and cross breds 
6.k. 
6.l. 
Pigs 
6.m.  Goats 
Sheep 
6.n. 
Cattle 
6.o. 
Prosimians 
6.p. 
New World Monkeys 
6.q. 
Old World Monkeys 
6.r. 
Apes 
6.s. 
Other Mammals 
6.t. 
Quail 
6.u. 
Other birds 
6.v. 
Reptiles 
6.w. 
Amphibians 
6.x. 
Fish 
6.y. 
6.z. 
TOTAL 
Examples: 

223 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
223 

0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 

0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 

1329 
2936 
191 
0 
0 
140 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
400 
4996 
columns 6.2 - 6.5 refer to the legislation imposing that the test be carried out and 
not to the body which has issued the actual test method, guideline or protocol. 

2190 
5850 
2112 
64 
0 
416 
0 
407 
0 
0 
0 
581 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
11620 

0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
1080 
1080 

3742 
8786 
2303 
64 
0 
556 
0 
407 
0 
0 
0 
581 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
1480 
17919 

6.2 – France is testing due to a UK (or FR) specific requirement 
6.3 - UK is testing according to EC legislation 
6.4 – Spain is testing due to a Hungarian requirement 
6.5 – Sweden is testing due to a US specific requirement 
6.6  –  Germany  is  testing  due  to  a  Czech  requirement  (also  an  EC 
requirement) 
1)  EC Member States: Austria, Belgium, Denmark, Finland, France, Germany, Greece, Ireland, Italy, Luxembourg, Netherlands, Portugal, Spain, Sweden, United Kingdom 
2)  Member Countries of Council of Europe (non-EC): Albania, Andorra, Bulgaria, Croatia, Cyprus, Czech Rep., Estonia, Hungary, Iceland, Latvia, Liechtenstein, Lithuania, Malta, 

ISO protocol must be coded as a national (FR) legislative requirement and be 
entered into column 6.2 in the tables submitted by Belgium. 

Example:  a test required by French legislation and carried out in Belgium according to an 

Note: 

Moldova, Norway, Poland, Romania, Russia, San Marino, Slovakia, Slovenia, Switzerland, ‘the former Yugoslav Rep. of Macedonia’, Turkey, Ukraine 

57 

EN 

Footnotes: 

EN 

 
  
 
 
 
 
 
 
 
 
TABLE 7:  NUMBER OF ANIMALS USED IN TOXICOLOGICAL AND OTHER SAFETY EVALUATIONS 

7.1 
Species 

7.2 
Acute and sub-acute toxicity testing methods 
(including limit test) 

7.3 
Skin 
irritation 

7.4 
Skin 
sensitisatio
n 

7.5 
Eye 
irritation 

7.6 
Sub- 
chronic and 
chronic 
toxicity 

7.7 
Carcino- 
genicity 

7.8 
Develop- 
mental 
toxicity 

7.9 
Muta- 
genicit
y 

7.10 
Repro-
ductive 
toxicity 

Types of tests versus species 

7.12 
Other 

7.13 
Total 

7.11 
Toxicity 
to aquatic 
vertebra-
tes not 
included 
in other 
columns 

7.2.1. 
LD50, 
LC50 

7.2.2 
Other lethal 
methods 

7.2.3 
Non lethal 
clinical signs 
methods 

7.a.  Mice 
Rats 
7.b. 
Guinea-Pigs 
7.c. 
Hamsters 
7.d. 
Other Rodents 
7.e. 
Rabbits 
7.f. 
Cats 
7.g. 
Dogs 
7.h. 
Ferrets 
7.i. 
Other Carnivores 
7.j. 
Horses,  donkeys  and  cross 
7.k. 
breds 
Pigs 

7.l. 
7.m.  Goats 
Sheep 
7.n. 
Cattle 
7.o. 
Prosimians 
7.p. 
New World Monkeys 
7.q. 
Old World Monkeys 
7.r. 
Apes 
7.s. 
Other Mammals 
7.t. 
Quail 
7.u. 
Other birds 
7.v. 
Reptiles 
7.w. 
Amphibians 
7.x. 
Fish 
7.y. 
TOTAL 
7.z. 

0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 

0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
1080 
1080 

0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 

0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 

2363 
1244 
1177 
28 
0 
0 
0 
20 
0 
0 
0 

0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
4832 

0 
0 
0 
0 
0 
53 
0 
0 
0 
0 
0 

8 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
61 

EN 

30 
0 
801 
0 
0 
0 
0 
0 
0 
0 
0 

0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
831 

58 

0 
0 
0 
0 
0 
5 
0 
0 
0 
0 
0 

0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
5 

216 
4585 
169 
36 
0 
294 
0 
381 
0 
0 
0 

473 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
6154 

0 
3 
0 
0 
0 
0 
0 
0 
0 
0 
0 

0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
3 

0 
116 
0 
0 
0 
0 
0 
0 
0 
0 
0 

0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
116 

325 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 

0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
325 

14 
2612 
0 
0 
0 
0 
0 
0 
0 
0 
0 

100 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
2726 

0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 

0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
400 
400 

794 
226 
156 
0 
0 
204 
0 
6 
0 
0 
0 

0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
1386 

3742 
8786 
2303 
64 
0 
556 
0 
407 
0 
0 
0 

581 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
1480 
17919 

EN 

 
  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
TABLE 8:  NUMBER OF ANIMALS USED IN TOXICOLOGICAL AND OTHER SAFETY EVALUATIONS 

8.1 
Products 

8.2 
Acute and sub-acute toxicity testing 
methods (including limit test) 

8.3 
Skin 
irritation 

8.4 
Skin 
sensitisatio
n 

8.5 
Eye 
irritation 

Types of tests versus products 

8.7 
Carcino 
genicity 

8.8 
Develop- 
mental 
toxicity 

8.9 
Muta- 
genicit
y 

8.10 
Repro-
ductive 
toxicity 

8.6 
Sub- 
chronic 
and 
chronic 
toxicity 

8.12 
Other 

8.13 
Total 

8.11 
Toxicity 
to aquatic 
vertebra-
tes not 
included 
in other 
columns 

8.a. 

8.b. 

8.c. 

8.d. 

8.e. 

8.f. 

8.g. 

8.h. 

Products/substances  or  devices 
for 
human  medicine  and  dentistry  and  for 
veterinary medicine 
Products/substances used or intended to 
be used mainly in agriculture 
Products/substances used or intended to 
be used mainly in industry 
Products/substances used or intended to 
be used mainly in the household 
Products/substances used or intended to 
be  used  mainly  as  cosmetics  or 
toiletries 
Products/substances used or intended to 
be used mainly as additives in food for 
human consumption 
Products/substances used or intended to 
be used mainly as additives in food for 
animal consumption 
Potential  or  actual  contaminants  in  the 
general  environment  which  do  not 
appear in other columns 
toxicological 

safety 

or 

8.i.  Other 

evaluations 
TOTAL 

8.j. 

8.2.1. 
LD50, 
LC50 

8.2.2 
Other lethal 
methods 

8.2.3 
Non lethal 
clinical signs 
methods 

0 

0 

1080 

0 

0 

0 

0 

0 

0 

1080 

0 

0 

0 

0 

0 

0 

0 

0 

0 

0 

4654 

43 

786 

0 

105 

0 

0 

34 

0 

0 

8 

8 

9 

0 

0 

0 

0 

0 

0 

0 

45 

0 

0 

0 

0 

0 

0 

4801 

60 

831 

5 

0 

0 

0 

0 

0 

0 

0 

0 

5 

5739 

0 

350 

8 

0 

0 

0 

0 

88 

6185 

0 

0 

0 

3 

0 

0 

0 

0 

0 

3 

116 

48 

100 

0 

320 

11811 

0 

0 

0 

0 

0 

0 

0 

0 

0 

51 

0 

0 

0 

0 

2051 

0 

14 

2073 

0 

0 

0 

0 

0 

400 

456 

2445 

0 

0 

123 

185 

0 

0 

0 

135 

169 

0 

0 

0 

561 

0 

181 

742 

0 

226 

14 

0 

158 

494 

116 

325 

2726 

400 

1387 

17919 

EN 

59 

EN 

 
  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
GERMANY  

Statistical data submitted 

The  statistical  data  have  been  submitted  by 
für 
Verbraucherschutz, Ernährung und Landwirtschaft" (Federal Ministry for Consumer 
protection, Food and Agriculture).  

the  "Bundesministerium 

Comments of German authorities  

Further  to  the  German Government's  communications  of  27 July 2006  regarding 
statistical information on the use of animals for experimental purposes, I now inform 
you of the following: 

The  German Government  seeks  to  reduce  animal  experiments  and  to  support  the 
development of alternative methods (point 8.6 paragraph 3 of the 11 November 2005 
coalition  agreement).  For  example,  the  volume  of  assistance  for  the  support  priority 
"methods  to  replace  animal  experiments"  has  been  increased  from  €3.4 million  in 
2005 to €4 million in 2006 - an increase of almost 18%. Furthermore, for many years 
the  Federal  Ministry  of  Food,  Agriculture  and  Consumer  Protection  has  been 
awarding  a  "research  prize  to  support  work  on  methods  aimed  at  restricting  and 
replacing  animal  experiments";  the  prize  carries  an  award  of  €15 000.  In  2006  the 
25th animal protection research prize will be awarded. 

Based  at  the  Federal  Institute  for  Risk  Assessment,  the  Central  Office  for  recording 
and assessing methods to replace animal experiments was established in 1989 as the 
first  institution  of  its  kind  in  the  world.  Its  task  is  to  promote  potentially  successful 
approaches  to  developing  and  validating  replacement  and  complementary  methods. 
The  Central  Office's  budget  for  doing  so  was  almost  doubled  between  1990 
(€204 200)  and  2005  (€375 000).  High  priority  is  accorded  to  replacing  animal 
experiments  in  official  registration  and  authorisation  procedures  in  which  animal 
experiments are stipulated. The scientists at the Federal Institute for Risk Assessment 
also undertake successful research work themselves. For example, the Central Office 
is  heavily  involved  in  EU  research  projects,  undertakes  research  projects  as  part  of 
major joint projects and takes part in validation studies and collaborative tests within 
the  EU.  Furthermore,  for  many  years  a  database  on  methods  to  replace  animal 
experiments  has  been  maintained  at  the  Federal  Institute  for  Risk  Assessment;  the 
database is available free of charge to scientists from the research world and industry 
at http://www.dimdi.de/static/en/db/dbinfo/dbkurz/zt00.htm. 

In 2005 in Germany 1 822 424 animals were used for experiments and other scientific 
purposes. That represents an increase of 20 971 animals or 1.2% compared with the 
previous year. 

As in previous years, rodents are the largest group at 1 573 074 animals or 86%. It is 
striking  that  up  to  2005  their  share  continually  increased  from  75%  in  2001.  The 
number of dogs and cats has increased by 581 and 395 respectively compared with the 

EN 

60 

   EN

 
previous  year.  The  number  of  farm  animals  used  has  remained  constant  at  around 
20 000 a year. 

Apes have not been used. In the case of old-world monkeys, new-world monkeys and 
prosimians,  there  has  been  an  increase  of  338  animals  compared  with  the  previous 
year.  That  is  the  second  highest  figure  since  2000.  Apes  were  last  reported  in 
Germany in 1991. 

The decline by 92 270 or 59% in the number of fish used is encouraging. In particular, 
there has been a reduction by 64 083 fish within basic research and by 15 463 fish in 
toxicological tests to identify environmental risks. 

Within biological basic research there has been a reduction by 42 014 animals (5.5%) 
and within toxicological investigations and tests by 1 562 (1.0%). 

No  uniform  trend  is  discernible  in  the  case  of  animals  used  in  the  diagnosis  of 
diseases;  while  their  number  rose  by  158%  to  39 013  in  2004  compared  with  the 
previous year, it fell again to 13 661 in 2005 and was therefore lower than in 2004. 

With regard to products or equipment for medicine, dentistry or veterinary medicine, 
their  research  and  development  saw  a  marked  increase  by  13 869  animals  and  their 
manufacture or quality control by 101 535 animals. 

Of those animals, 58% were used to research diseases in humans or animals. 

For legally stipulated experiments for the manufacture or quality control of products 
for medicine, dentistry or veterinary medicine, or for toxicological safety tests, 24.9% 
of the animals were used. 

On behalf of the ministry, 

Dr Polten 

EN 

61 

   EN

 
TABLE 1:  NUMBER OF ANIMALS USED IN RELATION TO THEIR PLACE OF ORIGIN 

1.1 
Species 

Origin versus species 

1.2  
Total 

1.3 
Animals coming from registered 
breeding or supplying 
establishments within the reporting 
country 

1.4 
Animals coming from 
elsewhere in the EC 

Rats (Rattus norvegicus) 
Guinea-Pigs (Cavia porcellus) 
Hamsters (Mesocricetus ) 
Other Rodents (other Rodentia) 
Rabbits (Oryctolagus cuniculus) 
Cats (Felis catus) 
Dogs (Canis familiaris) 
Ferrets (Mustela putorius furo) 
Other Carnivores (other Carnivora) 
Horses, donkeys and cross breds (Equidae) 
Pigs (Sus) 

1.a.  Mice (Mus musculus) 
1.b. 
1.c. 
1.d. 
1.e. 
1.f. 
1.g. 
1.h. 
1.i. 
1.j. 
1.k. 
1.l. 
1.m.  Goats (Capra) 
1.n. 
1.o. 
1.p. 
1.q. 
1.r. 
1.s. 
1.t. 
1.u. 
1.v. 
1.w. 
1.x. 
1.y. 
1.z. 

Sheep (Ovis) 
Cattle (Bos) 
Prosimians (Prosimia) 
New World Monkeys (Ceboidea) 
Old World Monkeys (Cercopithecoidea) 
Apes (Hominoidea) 
Other Mammals (other Mammalia) 
Quail (Coturnix coturnix) 
Other birds (other Aves) 
Reptiles (Reptilia) 
Amphibians (Amphibia) 
Fish (Pisces) 
TOTAL 

921 971 
339 626 
37 372 
6 965 

101 939 
569 
2 923 
131 

0 
347 
120 
0 

2 457 

141 721 
90 339 
389 
861 

1 354 
316 
671 
4 

99 
61 
247 
0 

0 

1 084 358 
435 417 
37 761 
7 916 
7 622 
103 329 
1 023 
4 868 
560 
235 
755 
13 166 
275 
3 517 
2 909 
99 
408 
1 579 
0 
115 
2 457 
39 150 
136 
10 432 
64 337 
1 822 424 

1.5 
Animals coming from 
Member Countries of the 
Council of Europe which are 
parties to the Convention ETS 
123 (excluding EC Member 
States) 

18 197 
3 516 
0 
13 

4 
0 
0 
0 

0 
0 
0 
0 

0 

1.6 
Animals coming from 
other origins 

1.7 
Re-used animals 

2 469 
1 936 
0 
77 

32 
138 
1 274 
425 

0 
0 
1 212 
0 

0 

6 532 
262 
1 056 
4 

81 
67 
327 
0 

Note 1:  Column 1.5 concerns only those Member Countries of the Council of Europe which, at the beginning of the reporting period, are Parties to the Convention ETS 123. Thus an 

updated list of those countries has to be used when filling in this column. 

Note 2:  Only the white boxes need to be completed. 

Note 3: 

The number of re-used animals in column 1.7 should be excluded from the total in the column 1.2 

EN 

62 

EN 

 
  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
TABLE 2:  NUMBER OF ANIMALS USED IN EXPERIMENTS FOR SELECTED PURPOSES 

2.1 
Species 

Purpose versus species 

2.2  
Biological 
studies of a 
fundamenta
l nature 

2.3 
Research and 
development of 
products and devices 
for human medicine 
and dentistry and for 
veterinary medicine 
(excluding 
toxicological and other 
safety evaluations 
counted in column 2.6) 

2.4 
Production and 
quality control of 
products and 
devices for human 
medicine and 
dentistry 

2.5 
Production and 
quality control 
of products and 
devices for 
veterinary 
medicine 

2.6 
Toxicological and 
other safety 
evaluations 
(including safety 
evaluation of 
products and 
devices for human 
medicine and 
dentistry and for 
veterinary 
medicine) 

2.7 
Diagnosis of 
disease 

2.8 
Education 
and training 

2.9 
Other 

2.10 
Total 

2.a.  Mice 
Rats 
2.b. 
Guinea-Pigs 
2.c. 
Hamsters 
2.d. 
Other Rodents 
2.e. 
Rabbits 
2.f. 
Cats 
2.g. 
Dogs 
2.h. 
Ferrets 
2.i. 
Other Carnivores 
2.j. 
Horses,  donkeys  and  cross 
2.k. 
breds 
Pigs 

2.l. 
2.m.  Goats 
Sheep 
2.n. 
Cattle 
2.o. 
Prosimians 
2.p. 
New World Monkeys 
2.q. 
Old World Monkeys 
2.r. 
Apes 
2.s. 
Other Mammals 
2.t. 
Quail 
2.u. 
Other birds 
2.v. 
Reptiles 
2.w. 
Amphibians 
2.x. 
Fish 
2.y. 
TOTAL 
2.z. 

548 649 
101 199 
1 907 
3 583 
3 161 
2 600 
293 
410 
4 
27 
385 

3 140 
151 
882 
435 
2 
196 
51 
0 
107 
0 
9 089 
114 
8 836 
30 135 
715 356 

277 287 
195 642 
4 999 
2 227 
3 901 
7 083 
490 
1 568 
542 
0 
202 

4 845 
43 
583 
1 159 
0 
89 
158 
0 
7 
0 
10 329 
13 
0 
0 
511 167 

EN 

106 512 
47 486 
14 251 
3 
0 
81 097 
35 
34 
0 
0 
0 

32 
7 
54 
0 
0 
0 
0 
0 
0 
0 
690 
0 
0 
0 
250 201 

42 650 
11 683 
5 921 
1 195 
0 
5 204 
38 
245 
0 
202 
2 

985 
1 
101 
147 
0 
0 
0 
0 
0 
0 
13 117 
0 
0 
825 
82 316 

63 

50 280 
62 982 
9 755 
56 
0 
4 568 
128 
2 422 
0 
0 
10 

327 
2 
2 
91 
97 
122 
1 299 
0 
0 
2 447 
1 644 
0 
0 
23 180 
159 412 

4 411 
885 
11 
6 
6 
1 188 
3 
63 
0 
0 
54 

925 
3 
359 
734 
0 
0 
0 
0 
0 
0 
857 
0 
0 
4 156 
13 661 

16 146 
13 472 
402 
307 
186 
194 
13 
89 
0 
0 
102 

1 978 
55 
104 
161 
0 
0 
8 
0 
1 
0 
1 271 
9 
1 596 
2 177 
38 271 

38 423 
2 068 
515 
539 
368 
1 395 
23 
37 
14 
6 
0 

934 
13 
1 432 
182 
0 
1 
63 
0 
0 
10 
2 153 
0 
0 
3 864 
52 040 

1 084 358 
435 417 
37 761 
7 916 
7 622 
103 329 
1 023 
4 868 
560 
235 
755 

13 166 
275 
3 517 
2 909 
99 
408 
1 579 
0 
115 
2 457 
39 150 
136 
10 432 
64 337 
1 822 424 

EN 

 
  
TABLE 3:  NUMBER OF ANIMALS USED IN TOXICOLOGICAL AND OTHER SAFETY EVALUATIONS 

Products versus species 

3.1 
Species 

3.2  
Products/ 
substances or 
devices for 
human 
medicine and 
dentistry and 
for veterinary 
medicine 

3.3 
Products/ 
substances 
used or 
intended to 
be used 
mainly in 
agriculture 

3.4 
Products/ 
substances 
used or 
intended to 
be used 
mainly in 
industry 

3.5 
Products/ 
substances 
used or 
intended to 
be used 
mainly in 
the 
household 

3.6 
Products/ 
substances 
used or 
intended to 
be used 
mainly as 
cosmetics 
or toiletries 

3.a.  Mice 
Rats 
3.b. 
Guinea-Pigs 
3.c. 
Hamsters 
3.d. 
Other Rodents 
3.e. 
Rabbits 
3.f. 
Cats 
3.g. 
Dogs 
3.h. 
Ferrets 
3.i. 
Other Carnivores 
3.j. 
Horses, donkeys and cross breds 
3.k. 
3.l. 
Pigs 
3.m.  Goats 
Sheep 
3.n. 
Cattle 
3.o. 
Prosimians 
3.p. 
New World Monkeys 
3.q. 
Old World Monkeys 
3.r. 
Apes 
3.s. 
Other Mammals 
3.t. 
Quail 
3.u. 
Other birds 
3.v. 
Reptiles 
3.w. 
Amphibians 
3.x. 
Fish 
3.y. 
TOTAL 
3.z. 

32 474 
36 143 
5 364 
36 
0 
3 182 
128 
2 135 
0 
0 
10 
303 
0 
2 
91 
97 
122 
1 299 
0 
0 
0 
60 
0 
0 
313 
81 759 

6 930 
10 131 
2 290 
20 
0 
851 
0 
184 
0 
0 
0 
0 
2 
0 
0 
0 
0 
0 
0 
0 
2 447 
1 084 
0 
0 
8 521 
32 460 

10 388 
15 018 
2 061 
0 
0 
501 
0 
103 
0 
0 
0 
8 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
2 664 
30 743 

0 
113 
0 
0 
0 
4 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
117 

0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 

3.7 
Products/ 
substances 
used or 
intended to be 
used mainly 
as additives in 
food for 
human 
consumption 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 

3.8 
Products/ 
substances 
used or 
intended to be 
used mainly 
as additives in 
food for 
animal 
consumption 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
480 
0 
0 
0 
480 

3.11 
Total 

3.10 
Other toxico- 
logical or 
safety 
evaluations 

3.9 
Potential or 
actual contami- 
nents in the 
general envi- 
ronment which 
do not appear in 
other columns 

10 
451 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
20 
0 
0 
9 744 
10 225 

478 
1 126 
40 
0 
0 
30 
0 
0 
0 
0 
0 
16 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
1 938 
3 628 

50 280 
62 982 
9 755 
56 
0 
4 568 
128 
2 422 
0 
0 
10 
327 
2 
2 
91 
97 
122 
1 299 
0 
0 
2 447 
1 644 
0 
0 
23 180 
159 412 

EN 

64 

EN 

 
  
TABLE 4:  NUMBER OF ANIMALS USED IN EXPERIMENTS FOR STUDIES ON HUMAN AND ANIMAL DISEASES 

4.1 
Species 

4.2  
Human cardiovascular 
diseases 

4.3 
Human nervous and 
mental disorders 

4.4 
Human cancer (excluding 
evaluations of carcinogenic 
hazards or risks) 

4.5 
Other human diseases 

4.6 
Studies specific to animal 
diseases 

4.7 
Total 

Main categories versus species 

4.a.  Mice 
Rats 
4.b. 
Guinea-Pigs 
4.c. 
Hamsters 
4.d. 
Other Rodents 
4.e. 
Rabbits 
4.f. 
Cats 
4.g. 
Dogs 
4.h. 
Ferrets 
4.i. 
Other Carnivores 
4.j. 
Horses, donkeys and cross breds 
4.k. 
4.l. 
Pigs 
4.m.  Goats 
Sheep 
4.n. 
Cattle 
4.o. 
Prosimians 
4.p. 
New World Monkeys 
4.q. 
Old World Monkeys 
4.r. 
Apes 
4.s. 
Other Mammals 
4.t. 
Quail 
4.u. 
Other birds 
4.v. 
Reptiles 
4.w. 
Amphibians 
4.x. 
Fish 
4.y. 
TOTAL 
4.z. 

53 032 
45 836 
614 
661 
10 
4 559 
0 
543 
0 
0 
0 
2 156 
15 
375 
0 
0 
16 
3 
0 
0 
0 
0 
13 
561 
300 
108 694 

131 336 
110 443 
289 
1 783 
1 006 
221 
60 
3 
0 
0 
0 
172 
1 
9 
43 
0 
105 
18 
0 
7 
0 
8 
0 
131 
593 
246 228 

161 390 
9 632 
37 
182 
362 
124 
0 
28 
0 
0 
8 
118 
3 
0 
0 
0 
2 
2 
0 
0 
0 
0 
0 
16 
0 
171 904 

361 742 
110 670 
4 777 
2 426 
3 615 
2 725 
28 
195 
533 
0 
16 
1 677 
6 
253 
142 
0 
129 
96 
0 
42 
0 
915 
12 
239 
2 000 
492 238 

3 918 
289 
144 
0 
634 
480 
360 
955 
0 
0 
451 
2 368 
12 
933 
1 884 
0 
0 
0 
0 
0 
0 
10 965 
78 
0 
6 756 
30 227 

711 418 
276 870 
5 861 
5 052 
5 627 
8 109 
448 
1 724 
533 
0 
475 
6 491 
37 
1 570 
2 069 
0 
252 
119 
0 
49 
0 
11 888 
103 
947 
9 649 
1 049 291 

EN 

65 

EN 

 
  
TABLE 5:  NUMBER OF ANIMALS USED IN PRODUCTION AND QUALITY CONTROL OF PRODUCTS AND DEVICES FOR 
HUMAN MEDICINE AND DENTISTRY AND FOR VETERINARY MEDICINE 

Regulatory requirements versus species 

5.1 
Species 

5.2  
National legislation 
specific to a single EC 
Member State 
1) 

5.3 
EC legislation 
including European 
Pharmacopoeia 
(requirements) 

5.4 
Member Country of Council 
of Europe (but not EC) 
legislation 
2) 

5.5 
Other legislation 

5.6 
Any combination of  
5.2/ 5.3/ 5.4/ 5.5 

5.7 
No regulatory 
requirements 

5.8 
Total 

5.a.  Mice 
Rats 
5.b. 
Guinea-Pigs 
5.c. 
Hamsters 
5.d. 
Other Rodents 
5.e. 
Rabbits 
5.f. 
Cats 
5.g. 
Dogs 
5.h. 
Ferrets 
5.i. 
Other Carnivores 
5.j. 
Horses, donkeys and cross breds 
5.k. 
Pigs 
5.l. 
5.m.  Goats 
Sheep 
5.n. 
Cattle 
5.o. 
Prosimians 
5.p. 
New World Monkeys 
5.q. 
Old World Monkeys 
5.r. 
Apes 
5.s. 
Other Mammals 
5.t. 
Quail 
5.u. 
Other birds 
5.v. 
Reptiles 
5.w. 
Amphibians 
5.x. 
Fish 
5.y. 
5.z. 
TOTAL 
Examples: 

Footnotes: 

EN 

391 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
15 
0 
0 
0 
0 
0 
0 
0 
0 
0 
863 
0 
0 
0 
1 269 

110 626 
52 998 
16 475 
859 
0 
52 271 
73 
245 
0 
202 
2 
948 
4 
15 
128 
0 
0 
0 
0 
0 
0 
1 931 
0 
0 
825 
237 602 

0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 

3 663 
297 
136 
64 
0 
25 738 
0 
0 
0 
0 
0 
54 
3 
61 
2 
0 
0 
0 
0 
0 
0 
50 
0 
0 
0 
30 068 
columns 5.2 - 5.5 refer to the legislation imposing that the test be carried out and 
not to the body which has issued the actual test method, guideline or protocol. 

33 610 
5 874 
3 125 
275 
0 
8 292 
0 
34 
0 
0 
0 
0 
1 
79 
17 
0 
0 
0 
0 
0 
0 
10 963 
0 
0 
0 
62 270 

872 
0 
436 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
1 308 

149 162 
59 169 
20 172 
1 198 
0 
86 301 
73 
279 
0 
202 
2 
1 017 
8 
155 
147 
0 
0 
0 
0 
0 
0 
13 807 
0 
0 
825 
332 517 

5.2 – France is testing due to a UK (or FR) specific requirement 
5.3 - UK is testing according to EC legislation 
5.4 – Spain is testing due to a Hungarian requirement 
5.5 – Sweden is testing due to a US specific requirement 
5.6  –  Germany  is  testing  due  to  a  Czech  requirement  (also  an  EC 
requirement) 
1)  EC Member States: Austria, Belgium, Denmark, Finland, France, Germany, Greece, Ireland, Italy, Luxembourg, Netherlands, Portugal, Spain, Sweden, United Kingdom 

ISO protocol must be coded as a national (FR) legislative requirement and be 
entered into column 5.2 in the tables submitted by Belgium. 

Example:  a test required by French legislation and carried out in Belgium according to an 

Note: 

66 

EN 

 
  
 
 
 
 
 
 
 
2)  Member  Countries  of  Council  of  Europe  (non-EC):  Albania,  Andorra,  Bulgaria,  Croatia,  Cyprus,  Czech  Rep.,  Estonia,  Hungary,  Iceland,  Latvia,  Liechtenstein,  Lithuania, 

Malta, Moldova, Norway, Poland, Romania, Russia, San Marino, Slovakia, Slovenia, Switzerland, ‘the former Yugoslav Rep. of Macedonia’, Turkey, Ukraine 

EN 

67 

EN 

 
  
 
TABLE 6:  NUMBER OF ANIMALS USED IN TOXICOLOGICAL AND OTHER SAFETY EVALUATIONS 

Regulatory requirements versus species 

6.1 
Species 

6.2  
National legislation 
specific to a single EC 
Member State 
1) 

6.3 
EC legislation 
including European 
Pharmacopoeia 
(requirements) 

6.4 
Member Country of Council 
of Europe (but not EC) 
legislation 
2) 

6.5 
Other legislation 

6.6 
Any combination of  
6.2/ 6.3/ 6.4/ 6.5 

6.7 
No regulatory 
requirements 

6.8 
Total 

6.a.  Mice 
Rats 
6.b. 
Guinea-Pigs 
6.c. 
Hamsters 
6.d. 
Other Rodents 
6.e. 
Rabbits 
6.f. 
Cats 
6.g. 
Dogs 
6.h. 
Ferrets 
6.i. 
Other Carnivores 
6.j. 
Horses, donkeys and cross breds 
6.k. 
6.l. 
Pigs 
6.m.  Goats 
Sheep 
6.n. 
Cattle 
6.o. 
Prosimians 
6.p. 
New World Monkeys 
6.q. 
Old World Monkeys 
6.r. 
Apes 
6.s. 
Other Mammals 
6.t. 
Quail 
6.u. 
Other birds 
6.v. 
Reptiles 
6.w. 
Amphibians 
6.x. 
Fish 
6.y. 
6.z. 
TOTAL 
Examples: 

0 
374 
0 
0 
0 
0 
102 
64 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
4 770 
5 310 

33 677 
35 528 
7 055 
56 
0 
3 484 
22 
999 
0 
0 
0 
139 
2 
2 
91 
97 
0 
0 
0 
0 
1 562 
1 213 
0 
0 
5 653 
89 580 

0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 

1 621 
2 374 
193 
0 
0 
50 
0 
12 
0 
0 
10 
16 
0 
0 
0 
0 
0 
0 
0 
0 
0 
80 
0 
0 
2 892 
7 248 
columns 6.2 - 6.5 refer to the legislation imposing that the test be carried out and 
not to the body which has issued the actual test method, guideline or protocol. 

10 625 
24 122 
2 487 
0 
0 
1 034 
4 
1 347 
0 
0 
0 
172 
0 
0 
0 
0 
122 
1 299 
0 
0 
885 
351 
0 
0 
9 865 
52 313 

4 357 
584 
20 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
4 961 

50 280 
62 982 
9 755 
56 
0 
4 568 
128 
2 422 
0 
0 
10 
327 
2 
2 
91 
97 
122 
1 299 
0 
0 
2 447 
1 644 
0 
0 
23 180 
159 412 

6.2 – France is testing due to a UK (or FR) specific requirement 
6.3 - UK is testing according to EC legislation 
6.4 – Spain is testing due to a Hungarian requirement 
6.5 – Sweden is testing due to a US specific requirement 
6.6  –  Germany  is  testing  due  to  a  Czech  requirement  (also  an  EC 
requirement) 
1)  EC Member States: Austria, Belgium, Denmark, Finland, France, Germany, Greece, Ireland, Italy, Luxembourg, Netherlands, Portugal, Spain, Sweden, United Kingdom 
2)  Member Countries of Council of Europe (non-EC): Albania, Andorra, Bulgaria, Croatia, Cyprus, Czech Rep., Estonia, Hungary, Iceland, Latvia, Liechtenstein, Lithuania, Malta, 

ISO protocol must be coded as a national (FR) legislative requirement and be 
entered into column 6.2 in the tables submitted by Belgium. 

Example:  a test required by French legislation and carried out in Belgium according to an 

Note: 

Moldova, Norway, Poland, Romania, Russia, San Marino, Slovakia, Slovenia, Switzerland, ‘the former Yugoslav Rep. of Macedonia’, Turkey, Ukraine 

68 

EN 

Footnotes: 

EN 

 
  
 
 
 
 
 
 
 
 
TABLE 7:  NUMBER OF ANIMALS USED IN TOXICOLOGICAL AND OTHER SAFETY EVALUATIONS 

7.1 
Species 

7.2 
Acute and sub-acute toxicity testing methods 
(including limit test) 

7.3 
Skin 
irritation 

7.4 
Skin 
sensitisatio
n 

7.5 
Eye 
irritation 

7.6 
Sub- 
chronic and 
chronic 
toxicity 

7.7 
Carcino- 
genicity 

7.8 
Develop- 
mental 
toxicity 

7.9 
Muta- 
genicit
y 

7.10 
Repro-
ductive 
toxicity 

Types of tests versus species 

7.2.1. 
LD50, 
LC50 

7.2.2 
Other lethal 
methods 

7.2.3 
Non lethal 
clinical signs 
methods 

7.a.  Mice 
Rats 
7.b. 
Guinea-Pigs 
7.c. 
Hamsters 
7.d. 
Other Rodents 
7.e. 
Rabbits 
7.f. 
Cats 
7.g. 
Dogs 
7.h. 
Ferrets 
7.i. 
Other Carnivores 
7.j. 
Horses,  donkeys  and  cross 
7.k. 
breds 
Pigs 

7.l. 
7.m.  Goats 
Sheep 
7.n. 
Cattle 
7.o. 
Prosimians 
7.p. 
New World Monkeys 
7.q. 
Old World Monkeys 
7.r. 
Apes 
7.s. 
Other Mammals 
7.t. 
Quail 
7.u. 
Other birds 
7.v. 
Reptiles 
7.w. 
Amphibians 
7.x. 
Fish 
7.y. 
TOTAL 
7.z. 

0 
374 
0 
0 
0 
0 
102 
64 
0 
0 
0 

0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
4 770 
5 310 

33 677 
35 528 
7 055 
56 
0 
3 484 
22 
999 
0 
0 
0 

139 
2 
2 
91 
97 
0 
0 
0 
0 
1 562 
1 213 
0 
0 
5 653 
89 580 

EN 

1 621 
2 374 
193 
0 
0 
50 
0 
12 
0 
0 
10 

16 
0 
0 
0 
0 
0 
0 
0 
0 
0 
80 
0 
0 
2 892 
7 248 

50 280 
62 982 
9 755 
56 
0 
4 568 
128 
2 422 
0 
0 
10 

327 
2 
2 
91 
97 
122 
1 299 
0 
0 
2 447 
1 644 
0 
0 
23 180 
159 412 

0 
374 
0 
0 
0 
0 
102 
64 
0 
0 
0 

0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
4 770 
5 310 

33 677 
35 528 
7 055 
56 
0 
3 484 
22 
999 
0 
0 
0 

139 
2 
2 
91 
97 
0 
0 
0 
0 
1 562 
1 213 
0 
0 
5 653 
89 580 

0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 

0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 

4 357 
584 
20 
0 
0 
0 
0 
0 
0 
0 
0 

0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
4 961 

0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 

0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 

4 357 
584 
20 
0 
0 
0 
0 
0 
0 
0 
0 

0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
4 961 

10 625 
24 122 
2 487 
0 
0 
1 034 
4 
1 347 
0 
0 
0 

172 
0 
0 
0 
0 
122 
1 299 
0 
0 
885 
351 
0 
0 
9 865 
52 313 

69 

7.11 
Toxicity 
to aquatic 
vertebra-
tes not 
included 
in other 
columns 

10 625 
24 122 
2 487 
0 
0 
1 034 
4 
1 347 
0 
0 
0 

172 
0 
0 
0 
0 
122 
1 299 
0 
0 
885 
351 
0 
0 
9 865 
52 313 

7.12 
Other 

7.13 
Total 

1 621 
2 374 
193 
0 
0 
50 
0 
12 
0 
0 
10 

16 
0 
0 
0 
0 
0 
0 
0 
0 
0 
80 
0 
0 
2 892 
7 248 

50 280 
62 982 
9 755 
56 
0 
4 568 
128 
2 422 
0 
0 
10 

327 
2 
2 
91 
97 
122 
1 299 
0 
0 
2 447 
1 644 
0 
0 
23 180 
159 412 

EN 

 
  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
TABLE 8:  NUMBER OF ANIMALS USED IN TOXICOLOGICAL AND OTHER SAFETY EVALUATIONS 

8.1 
Products 

Types of tests versus products 

8.2 
Acute and sub-acute toxicity testing 
methods (including limit test) 

8.3 
Skin 
irritation 

8.4 
Skin 
sensitisatio
n 

8.5 
Eye 
irritation 

8.7 
Carcino 
genicity 

8.8 
Develop- 
mental 
toxicity 

8.9 
Muta- 
genicit
y 

8.10 
Repro-
ductive 
toxicity 

8.6 
Sub- 
chronic 
and 
chronic 
toxicity 

8.11 
Toxicity 
to aquatic 
vertebra-
tes not 
included 
in other 
columns 

8.12 
Other 

8.13 
Total 

8.2.1. 
LD50, 
LC50 

8.2.2 
Other lethal 
methods 

8.2.3 
Non lethal 
clinical signs 
methods 

0 

33 677 

374 

35 528 

0 

0 

0 

0 

7 055 

56 

0 

3 484 

102 

22 

64 

999 

0 

0 

0 

0 

0 

0 

0 

0 

0 

0 

0 

0 

0 

0 

8.a. 

8.b. 

8.c. 

8.d. 

8.e. 

8.f. 

8.g. 

8.h. 

for 
Products/substances  or  devices 
human  medicine  and  dentistry  and  for 
veterinary medicine 
Products/substances used or intended to 
be used mainly in agriculture 
Products/substances used or intended to 
be used mainly in industry 
Products/substances used or intended to 
be used mainly in the household 
Products/substances used or intended to 
be  used  mainly  as  cosmetics  or 
toiletries 
Products/substances used or intended to 
be used mainly as additives in food for 
human consumption 
Products/substances used or intended to 
be used mainly as additives in food for 
animal consumption 
Potential  or  actual  contaminants  in  the 
general  environment  which  do  not 
appear in other columns 
toxicological 

safety 

or 

8.i.  Other 

evaluations 
TOTAL 

8.j. 

EN 

4 357 

10 625 

1 621 

50 280 

0 

33 677 

0 

4 357 

10 625 

1 621 

50 280 

584 

24 122 

2 374 

62 982 

374 

35 528 

20 

2 487 

193 

9 755 

0 

0 

0 

0 

56 

0 

1 034 

50 

4 568 

0 

0 

0 

0 

7 055 

56 

0 

3 484 

4 

0 

128 

102 

22 

1 347 

12 

2 422 

64 

999 

0 

0 

0 

0 

0 

0 

0 

0 

0 

0 

0 

0 

0 

0 

0 

0 

0 

70 

0 

0 

0 

0 

0 

0 

0 

0 

0 

584 

24 122 

2 374 

62 982 

20 

2 487 

193 

9 755 

0 

0 

0 

0 

0 

0 

0 

0 

0 

0 

0 

56 

0 

1 034 

50 

4 568 

4 

0 

128 

1 347 

12 

2 422 

0 

0 

0 

0 

0 

0 

EN 

 
  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
ESTONIA 

Statistical data submitted 

The statistical data have been submitted by anneli.harmson@agri.ee 

Remark: data were reported in table 1, 2 and 4 only. 

Comments of Estonian authorities 

None 

EN 

71 

EN 

 
  
TABLE 1:  NUMBER OF ANIMALS USED IN RELATION TO THEIR PLACE OF ORIGIN 

1.1 
Species 

Origin versus species 

1.2  
Total 

1.3 
Animals coming from registered 
breeding or supplying 
establishments within the reporting 
country 

1.4 
Animals coming from 
elsewhere in the EC 

1.6 
Animals coming from 
other origins 

1.7 
Re-used animals 

1.5 
Animals coming from 
Member Countries of the 
Council of Europe which are 
parties to the Convention ETS 
123 (excluding EC Member 
States) 

Rats (Rattus norvegicus) 
Guinea-Pigs (Cavia porcellus) 
Hamsters (Mesocricetus ) 
Other Rodents (other Rodentia) 
Rabbits (Oryctolagus cuniculus) 
Cats (Felis catus) 
Dogs (Canis familiaris) 
Ferrets (Mustela putorius furo) 
Other Carnivores (other Carnivora) 
Horses, donkeys and cross breds (Equidae) 
Pigs (Sus) 

1.a.  Mice (Mus musculus) 
1.b. 
1.c. 
1.d. 
1.e. 
1.f. 
1.g. 
1.h. 
1.i. 
1.j. 
1.k. 
1.l. 
1.m.  Goats (Capra) 
1.n. 
1.o. 
1.p. 
1.q. 
1.r. 
1.s. 
1.t. 
1.u. 
1.v. 
1.w. 
1.x. 
1.y. 
1.z. 

Sheep (Ovis) 
Cattle (Bos) 
Prosimians (Prosimia) 
New World Monkeys (Ceboidea) 
Old World Monkeys (Cercopithecoidea) 
Apes (Hominoidea) 
Other Mammals (other Mammalia) 
Quail (Coturnix coturnix) 
Other birds (other Aves) 
Reptiles (Reptilia) 
Amphibians (Amphibia) 
Fish (Pisces) 
TOTAL 

510 
0 

0 

3460 
484 

66 

0 
0 

0 

380 
0 

0 

0 

4350 
484 
0 
0 
0 
66 
0 
0 
0 
0 
0 

0 

0 
0 
0 
0 
0 

0 

4900 

Note 1:  Column  1.5  concerns  only  those  Member  Countries  of  the  Council  of  Europe  which,  at  the  beginning  of  the  reporting  period,  are  Parties  to  the  Convention  ETS  123.  Thus  an 

updated list of those countries has to be used when filling in this column. 

Note 2:  Only the white boxes need to be completed. 

Note 3: 

The number of re-used animals in column 1.7 should be excluded from the total in the column 1.2 

EN 

72 

EN 

 
  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
TABLE 2:  NUMBER OF ANIMALS USED IN EXPERIMENTS FOR SELECTED PURPOSES 

2.1 
Species 

2.2  
Biological 
studies of a 
fundamenta
l nature 

200 

2.a.  Mice 
Rats 
2.b. 
Guinea-Pigs 
2.c. 
Hamsters 
2.d. 
Other Rodents 
2.e. 
Rabbits 
2.f. 
Cats 
2.g. 
Dogs 
2.h. 
Ferrets 
2.i. 
Other Carnivores 
2.j. 
Horses,  donkeys  and  cross 
2.k. 
breds 
Pigs 

2.l. 
2.m.  Goats 
Sheep 
2.n. 
Cattle 
2.o. 
Prosimians 
2.p. 
New World Monkeys 
2.q. 
Old World Monkeys 
2.r. 
Apes 
2.s. 
Other Mammals 
2.t. 
Quail 
2.u. 
Other birds 
2.v. 
Reptiles 
2.w. 
Amphibians 
2.x. 
Fish 
2.y. 

2.7 
Diagnosis of 
disease 

2.8 
Education and 
training 

2.9 
Other 

2.10 
Total 

Purpose versus species 

2.4 
Production and 
quality control of 
products and 
devices for 
human medicine 
and dentistry 

2.5 
Production and 
quality control of 
products and 
devices for 
veterinary 
medicine 

2.6 
Toxicological 
and other safety 
evaluations 
(including 
safety 
evaluation of 
products and 
devices for 
human 
medicine and 
dentistry and 
for veterinary 
medicine) 

2.3 
Research and 
development of 
products and 
devices for human 
medicine and 
dentistry and for 
veterinary 
medicine 
(excluding 
toxicological and 
other safety 
evaluations 
counted in column 
2.6) 

4150 
484 

66 

4350 
484 
0 
0 
0 
66 
0 
0 
0 
0 
0 

0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 

EN 

73 

EN 

 
  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
2.z. 

TOTAL 

200 

4700 

0 

0 

0 

0 

0 

0 

4900 

EN 

74 

EN 

 
  
 TABLE 4:  NUMBER OF ANIMALS USED IN EXPERIMENTS FOR STUDIES ON HUMAN AND ANIMAL DISEASES 

Main categories versus species 

4.1 
Species 

4.2  
Human cardiovascular 
diseases 

4.3 
Human nervous and 
mental disorders 

4.4 
Human cancer (excluding 
evaluations of carcinogenic 
hazards or risks) 

1070 

4.5 
Other human diseases 

4.6 
Studies specific to animal 
diseases 

4.7 
Total 

640 
150 

2300 
320 

340 
14 

66 

4.a.  Mice 
Rats 
4.b. 
Guinea-Pigs 
4.c. 
Hamsters 
4.d. 
Other Rodents 
4.e. 
Rabbits 
4.f. 
Cats 
4.g. 
Dogs 
4.h. 
Ferrets 
4.i. 
Other Carnivores 
4.j. 
Horses, donkeys and cross breds 
4.k. 
4.l. 
Pigs 
4.m.  Goats 
Sheep 
4.n. 
Cattle 
4.o. 
Prosimians 
4.p. 
New World Monkeys 
4.q. 
Old World Monkeys 
4.r. 
Apes 
4.s. 
Other Mammals 
4.t. 
Quail 
4.u. 
Other birds 
4.v. 
Reptiles 
4.w. 
Amphibians 
4.x. 
Fish 
4.y. 
TOTAL 
4.z. 

4350 
484 
0 
0 
0 
66 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
4900 

420 

2620 

1070 

790 

0 

EN 

75 

EN 

 
  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
GREECE  

Statistical data submitted 

The statistical data have been submitted by the “ΥΠΟΥΡΓΕΙΟ ΓΕΩΡΓΙΑΣ ΓΕΝΙΚΗ Δ/ΝΣΗ 
ΚΤΗΝΙΑΤΡΙΚΗΣ”  (Ministry  of  Rural  Development  and  Food,  Directorate  for  Veterinary 
Care, Drugs & Practice). 

Comments of Greek authorities  

The legal basis for the collection of statistics on the number and use of vertebrate animals for 
experimental and other scientific purposes in Greece is provided by: 

- Presidential Decree No 160/91 (Government Gazette I 64) on the protection of animals used 
for  experimental  and  other  scientific  purposes,  in  accordance  with  Council  Directive 
86/609/EEC, and  

-  Law  No  2015/92  (Government  Gazette  I  30)  approving  the  European  Convention  on  the 
protection of animals used for experimental and other scientific purposes. 

For the collection of statistics relating to the year 2005, the tables, data and glossary of terms 
set out in European Commission document EL/11/97/04100000 W00 of 24.6.1997 were used. 
The  Ministry  of  Rural  Development  and  Food,  Directorate-General  for  Veterinary  Affairs, 
Directorate  for  Veterinary  Care,  Drugs  &  Practice  sent  them  directly  to  the  educational 
establishments  (universities  and 
technological  colleges),  research  centres,  healthcare 
institutions  and  businesses  and  pharmaceutical  companies  which  use  vertebrate  animals  for 
experimental  and  other  scientific  purposes.  These  documents  were  not  sent  to  cosmetics 
manufacturers  for  the  year  in  question,  as  our  department  was  informed  that  no  cosmetics 
company uses animals for experimental purposes in Greece.  

The total number of animals used in experiments in Greece in 2005 was 926 094. 

Of  these,  97.32%  (901º300  animals)  were  fish,  of  which  0.14%  were  used  to  study 
fundamental biological characteristics and 99.86% for research and development of medical, 
dental and veterinary products and appliances (not including toxicological studies). 

A  further  2.374%  (21 978  animals)  were  rodents  (15 340  mice  –  accounting  for  69.79%, 
6 024  rats  -  accounting  for  27.4%,  574  guinea  pigs  –  accounting  for  2.61%  and  40  other 
rodents – accounting for 0.18%), 36.95% of which were used to study fundamental biological 
characteristics,  18.48%  for  research  and  development  of  medical,  dental  and  veterinary 
products  and  appliances,  0.59%  to  control  the  production  and  quality  of  medical  and  dental 
products and appliances, 25.2% for toxicological and other safety studies (exclusively rats in 
this  case),  14.84%  for  diagnosing  illnesses,  0.01%  for  education  and  training  purposes  and, 
finally, 0.019% for other purposes. 

Rabbits accounted for 0.13% of the animals used: (1 255 animals, of which 10 had already 
been  used  to  take  blood  samples  for  the  purpose  of  isolating  platelets  for  further  laboratory 
trials) 48.44% were used to study fundamental biological characteristics, 2.78% for research 
and development of medical, dental and veterinary products and appliances, 1.59% to control 
the  production  and  quality  of  medical  and  dental  products  and  appliances,  9.32%  to  control 

EN 

76 

   EN 

 
 
the production and quality of veterinary products and appliances, 0.95% for toxicological and 
other safety studies, 2.23% for the diagnosis of illnesses, 16.09% for education and training 
purposes and, finally, 18.56% for other purposes. 

Dogs  accounted  for  0.0015%  (14  animals),  of  which  71.42%  were  used  for  research  and 
development  of  medical,  dental  and  veterinary  products  and  appliances  and  28.58%  for 
education and training purposes. 

Pigs accounted for 0.048% of the animals used (448 animals), of which 25.67% were used to 
study  fundamental  biological  characteristics,  11.16%  for  research  and  development  of 
medical,  dental  and  veterinary  products  and  appliances,  59.37%  for  education  and  training 
purposes and, finally, 3.79% for other purposes. 

Sheep accounted for 0.001% of the animals used (99 animals), of which 20.2% were used to 
study  fundamental  biological  characteristics,  54.54%  for  the  diagnosis  of  illnesses,  24.24% 
for education and training purposes and 1.01% for other purposes. 

Three  Old  World  Apes  were  used  to  study  fundamental  biological  characteristics,  of  which 
two can be reused according to the research institution’s statement. 

Hens  accounted  for  0.002%  (21  animals),  of  which  71.42%  were  used  for  the  diagnosis  of 
diseases and 28.58% for education and training purposes. 

Amphibians  accounted  for  0.105%  (975  animals),  of  which  100%  were  used  for  education 
and training purposes. 

Finally, only one (1) equid was used for education and training purposes. 

It is apparent from the above data that the two main categories of experiments conducted in 
Greece  are  on  the  one  hand,  research  and  development  of  medical,  dental  and  veterinary 
products and appliances and on the other, the study of fundamental biological characteristics.  

More specifically, vertebrate animals are principally used: 

- 
for  research  programmes  in  Greece's  Higher  Education  Institutions  and  research 
centres.  In  particular,  a  high  percentage  of  fish  endemic  to  the  waters  of  the  Mediterranean 
Sea are used (the main source of the large number of fish referred to above). 

to study each species' fundamental biological characteristics, for which mainly rodents 

- 
(mice and rats) and rabbits are used. 

HEAD OF THE DIRECTORATE FOR VETERINARY CARE, DRUGS & PRACTICE 

I. PAPADOPOULOS 

EN 

77 

   EN 

 
TABLE 1:  NUMBER OF ANIMALS USED IN RELATION TO THEIR PLACE OF ORIGIN 

1.1 
Species 

Origin versus species 

1.2  
Total 

1.3 
Animals coming from registered 
breeding or supplying 
establishments within the reporting 
country 

1.4 
Animals coming from 
elsewhere in the EC 

Rats (Rattus norvegicus) 
Guinea-Pigs (Cavia porcellus) 
Hamsters (Mesocricetus ) 
Other Rodents (other Rodentia) 
Rabbits (Oryctolagus cuniculus) 
Cats (Felis catus) 
Dogs (Canis familiaris) 
Ferrets (Mustela putorius furo) 
Other Carnivores (other Carnivora) 
Horses, donkeys and cross breds (Equidae) 
Pigs (Sus) 

1.a.  Mice (Mus musculus) 
1.b. 
1.c. 
1.d. 
1.e. 
1.f. 
1.g. 
1.h. 
1.i. 
1.j. 
1.k. 
1.l. 
1.m.  Goats (Capra) 
1.n. 
1.o. 
1.p. 
1.q. 
1.r. 
1.s. 
1.t. 
1.u. 
1.v. 
1.w. 
1.x. 
1.y. 
1.z. 

Sheep (Ovis) 
Cattle (Bos) 
Prosimians (Prosimia) 
New World Monkeys (Ceboidea) 
Old World Monkeys (Cercopithecoidea) 
Apes (Hominoidea) 
Other Mammals (other Mammalia) 
Quail (Coturnix coturnix) 
Other birds (other Aves) 
Reptiles (Reptilia) 
Amphibians (Amphibia) 
Fish (Pisces) 
TOTAL 

14050 
5892 
324 

1255 

6 

80 

8 

1 

15340 
6024 
574 
0 
40 
1255 
0 
14 
0 

1 
448 

99 

0 
0 
1 
0 

0 
21 

975 
901300 
926092 

1.6 
Animals coming from 
other origins 

1.7 
Re-used animals 

1.5 
Animals coming from 
Member Countries of the 
Council of Europe which are 
parties to the Convention ETS 
123 (excluding EC Member 
States) 

1210 
132 
250 

10 

2 

Note 1:  Column 1.5 concerns only those Member Countries of the Council of Europe which, at the beginning of the reporting period, are Parties to the Convention ETS 123. Thus an updated list of 

those countries has to be used when filling in this column. 

Note 2:  Only the white boxes need to be completed. 

Note 3: 

The number of re-used animals in column 1.7 should be excluded from the total in the column 1.2 

EN 

78 

EN 

 
  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
2.1 
Species 

2.2  
Biological 
studies of a 
fundamenta
l nature 

TABLE 2:  NUMBER OF ANIMALS USED IN EXPERIMENTS FOR SELECTED PURPOSES 

2.3 
Research and 
development of 
products and 
devices for human 
medicine and 
dentistry and for 
veterinary 
medicine 
(excluding 
toxicological and 
other safety 
evaluations 
counted in column 
2.6) 

3382 
641 

40 
35 

10 

50 

3279 
4629 
215 

608 

115 

20 

1 

2.7 
Diagnosis of 
disease 

2.8 
Education and 
training 

2.9 
Other 

2.10 
Total 

Purpose versus species 

2.4 
Production and 
quality control of 
products and 
devices for 
human medicine 
and dentistry 

2.5 
Production and 
quality control of 
products and 
devices for 
veterinary 
medicine 

2.6 
Toxicological 
and other safety 
evaluations 
(including 
safety 
evaluation of 
products and 
devices for 
human 
medicine and 
dentistry and 
for veterinary 
medicine) 

50 
80 

20 

5324 
144 
85 

2956 
37 
270 

138 
280 
4 

211 
213 

117 

12 

28 

202 

233 

17 

1 

4 

1 

266 

24 

6 

975 

54 

15 

15340 
6024 
574 
0 
40 
1255 
0 
14 
0 
0 
1 

448 
0 
99 
0 
0 
0 
1 
0 
0 
0 
21 
0 
975 
901300 
926092 

1300 
10167 

900000 
904158 

150 

117 

5565 

3360 

1900 

675 

2.a.  Mice 
Rats 
2.b. 
Guinea-Pigs 
2.c. 
Hamsters 
2.d. 
Other Rodents 
2.e. 
Rabbits 
2.f. 
Cats 
2.g. 
Dogs 
2.h. 
Ferrets 
2.i. 
Other Carnivores 
2.j. 
Horses,  donkeys  and  cross 
2.k. 
breds 
Pigs 

2.l. 
2.m.  Goats 
Sheep 
2.n. 
Cattle 
2.o. 
Prosimians 
2.p. 
New World Monkeys 
2.q. 
Old World Monkeys 
2.r. 
Apes 
2.s. 
Other Mammals 
2.t. 
Quail 
2.u. 
Other birds 
2.v. 
Reptiles 
2.w. 
Amphibians 
2.x. 
Fish 
2.y. 
TOTAL 
2.z. 

EN 

79 

EN 

 
  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
TABLE 3:  NUMBER OF ANIMALS USED IN TOXICOLOGICAL AND OTHER SAFETY EVALUATIONS 

3.1 
Species 

3.a.  Mice 
Rats 
3.b. 
Guinea-Pigs 
3.c. 
Hamsters 
3.d. 
Other Rodents 
3.e. 
Rabbits 
3.f. 
Cats 
3.g. 
Dogs 
3.h. 
Ferrets 
3.i. 
Other Carnivores 
3.j. 
Horses, donkeys and cross breds 
3.k. 
3.l. 
Pigs 
3.m.  Goats 
Sheep 
3.n. 
Cattle 
3.o. 
Prosimians 
3.p. 
New World Monkeys 
3.q. 
Old World Monkeys 
3.r. 
Apes 
3.s. 
Other Mammals 
3.t. 
Quail 
3.u. 
Other birds 
3.v. 
Reptiles 
3.w. 
Amphibians 
3.x. 
Fish 
3.y. 
TOTAL 
3.z. 

3.2  
Products/ 
substances or 
devices for 
human 
medicine and 
dentistry and 
for veterinary 
medicine 

105 

85 

Products versus species 

3.3 
Products/ 
substances 
used or 
intended to 
be used 
mainly in 
agriculture 

3.4 
Products/ 
substances 
used or 
intended to 
be used 
mainly in 
industry 

3.5 
Products/ 
substances 
used or 
intended to 
be used 
mainly in 
the 
household 

3.6 
Products/ 
substances 
used or 
intended to 
be used 
mainly as 
cosmetics 
or toiletries 

3.7 
Products/ 
substances 
used or 
intended to be 
used mainly 
as additives in 
food for 
human 
consumption 

3.8 
Products/ 
substances 
used or 
intended to be 
used mainly 
as additives in 
food for 
animal 
consumption 

3.9 
Potential or 
actual contami- 
nents in the 
general envi- 
ronment which 
do not appear in 
other columns 

3.11 
Total 

3.10 
Other toxico- 
logical or 
safety 
evaluations 

84 

60 

5219 

12 

190 

84 

60 

0 

0 

0 

0 

0 

5231 

5324 
144 
85 
0 
0 
12 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
5565 

EN 

80 

EN 

 
  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
TABLE 4:  NUMBER OF ANIMALS USED IN EXPERIMENTS FOR STUDIES ON HUMAN AND ANIMAL DISEASES 

4.1 
Species 

4.2  
Human cardiovascular 
diseases 

4.3 
Human nervous and 
mental disorders 

4.4 
Human cancer (excluding 
evaluations of carcinogenic 
hazards or risks) 

4.5 
Other human diseases 

4.6 
Studies specific to animal 
diseases 

4.7 
Total 

Main categories versus species 

4.a.  Mice 
Rats 
4.b. 
Guinea-Pigs 
4.c. 
Hamsters 
4.d. 
Other Rodents 
4.e. 
Rabbits 
4.f. 
Cats 
4.g. 
Dogs 
4.h. 
Ferrets 
4.i. 
Other Carnivores 
4.j. 
Horses, donkeys and cross breds 
4.k. 
4.l. 
Pigs 
4.m.  Goats 
Sheep 
4.n. 
Cattle 
4.o. 
Prosimians 
4.p. 
New World Monkeys 
4.q. 
Old World Monkeys 
4.r. 
Apes 
4.s. 
Other Mammals 
4.t. 
Quail 
4.u. 
Other birds 
4.v. 
Reptiles 
4.w. 
Amphibians 
4.x. 
Fish 
4.y. 
TOTAL 
4.z. 

1458 
102 

410 

40 

95 
65 

162 

36 

2950 
814 

321 

79 

358 

1560 

450 

4164 

300 

270 

28 

54 

15 

900000 
900667 

5213 
981 
270 
0 
40 
511 
0 
0 
0 
0 
0 
115 
0 
54 
0 
0 
0 
0 
0 
0 
0 
15 
0 
0 
900000 
907199 

EN 

81 

EN 

 
  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
TABLE 5:  NUMBER OF ANIMALS USED IN PRODUCTION AND QUALITY CONTROL OF PRODUCTS AND DEVICES FOR HUMAN 
MEDICINE AND DENTISTRY AND FOR VETERINARY MEDICINE 

5.1 
Species 

5.2  
National legislation 
specific to a single EC 
Member State 
1) 

5.3 
EC legislation 
including European 
Pharmacopoeia 
(requirements) 

5.4 
Member Country of Council 
of Europe (but not EC) 
legislation 
2) 

5.5 
Other legislation 

5.6 
Any combination of  
5.2/ 5.3/ 5.4/ 5.5 

5.7 
No regulatory 
requirements 

5.8 
Total 

Regulatory requirements versus species 

5.a.  Mice 
Rats 
5.b. 
Guinea-Pigs 
5.c. 
Hamsters 
5.d. 
Other Rodents 
5.e. 
Rabbits 
5.f. 
Cats 
5.g. 
Dogs 
5.h. 
Ferrets 
5.i. 
Other Carnivores 
5.j. 
Horses, donkeys and cross breds 
5.k. 
5.l. 
Pigs 
5.m.  Goats 
Sheep 
5.n. 
Cattle 
5.o. 
Prosimians 
5.p. 
New World Monkeys 
5.q. 
Old World Monkeys 
5.r. 
Apes 
5.s. 
Other Mammals 
5.t. 
Quail 
5.u. 
Other birds 
5.v. 
Reptiles 
5.w. 
Amphibians 
5.x. 
Fish 
5.y. 
5.z. 
TOTAL 
Examples: 

80 

117 

80 

117 

50 

20 

50 
80 
0 
0 
0 
137 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
267 

5.2 – France is testing due to a UK (or FR) specific requirement 
5.3 - UK is testing according to EC legislation 
5.4 – Spain is testing due to a Hungarian requirement 
5.5 – Sweden is testing due to a US specific requirement 
5.6  –  Germany  is  testing  due  to  a  Czech  requirement  (also  an  EC 
requirement) 
1)  EC Member States: Austria, Belgium, Denmark, Finland, France, Germany, Greece, Ireland, Italy, Luxembourg, Netherlands, Portugal, Spain, Sweden, United Kingdom 
2)  Member  Countries  of  Council  of  Europe  (non-EC):  Albania,  Andorra,  Bulgaria,  Croatia,  Cyprus,  Czech  Rep.,  Estonia,  Hungary,  Iceland,  Latvia,  Liechtenstein,  Lithuania, 

ISO protocol must be coded as a national (FR) legislative requirement and be 
entered into column 5.2 in the tables submitted by Belgium. 

Example:  a test required by French legislation and carried out in Belgium according to an 

70 
columns 5.2 - 5.5 refer to the legislation imposing that the test be carried out and 
not to the body which has issued the actual test method, guideline or protocol. 

Note: 

0 

0 

0 

Malta, Moldova, Norway, Poland, Romania, Russia, San Marino, Slovakia, Slovenia, Switzerland, ‘the former Yugoslav Rep. of Macedonia’, Turkey, Ukraine 

82 

EN 

Footnotes: 

EN 

 
  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
TABLE 6:  NUMBER OF ANIMALS USED IN TOXICOLOGICAL AND OTHER SAFETY EVALUATIONS 

6.1 
Species 

6.2  
National legislation 
specific to a single EC 
Member State 
1) 

6.3 
EC legislation 
including European 
Pharmacopoeia 
(requirements) 

6.4 
Member Country of Council 
of Europe (but not EC) 
legislation 
2) 

6.5 
Other legislation 

6.6 
Any combination of  
6.2/ 6.3/ 6.4/ 6.5 

6.7 
No regulatory 
requirements 

6.8 
Total 

Regulatory requirements versus species 

89 

105 
55 
85 

5219 

12 

6.a.  Mice 
Rats 
6.b. 
Guinea-Pigs 
6.c. 
Hamsters 
6.d. 
Other Rodents 
6.e. 
Rabbits 
6.f. 
Cats 
6.g. 
Dogs 
6.h. 
Ferrets 
6.i. 
Other Carnivores 
6.j. 
Horses, donkeys and cross breds 
6.k. 
6.l. 
Pigs 
6.m.  Goats 
Sheep 
6.n. 
Cattle 
6.o. 
Prosimians 
6.p. 
New World Monkeys 
6.q. 
Old World Monkeys 
6.r. 
Apes 
6.s. 
Other Mammals 
6.t. 
Quail 
6.u. 
Other birds 
6.v. 
Reptiles 
6.w. 
Amphibians 
6.x. 
Fish 
6.y. 
6.z. 
TOTAL 
Examples: 

5324 
144 
85 
0 
0 
12 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
5565 

89 

245 

6.2 – France is testing due to a UK (or FR) specific requirement 
6.3 - UK is testing according to EC legislation 
6.4 – Spain is testing due to a Hungarian requirement 
6.5 – Sweden is testing due to a US specific requirement 
6.6  –  Germany  is  testing  due  to  a  Czech  requirement  (also  an  EC 
requirement) 
1)  EC Member States: Austria, Belgium, Denmark, Finland, France, Germany, Greece, Ireland, Italy, Luxembourg, Netherlands, Portugal, Spain, Sweden, United Kingdom 
2)  Member Countries of Council of Europe (non-EC): Albania, Andorra, Bulgaria, Croatia, Cyprus, Czech Rep., Estonia, Hungary, Iceland, Latvia, Liechtenstein, Lithuania, Malta, 

ISO protocol must be coded as a national (FR) legislative requirement and be 
entered into column 6.2 in the tables submitted by Belgium. 

Example:  a test required by French legislation and carried out in Belgium according to an 

12 
columns 6.2 - 6.5 refer to the legislation imposing that the test be carried out and 
not to the body which has issued the actual test method, guideline or protocol. 

Note: 

5219 

0 

0 

Moldova, Norway, Poland, Romania, Russia, San Marino, Slovakia, Slovenia, Switzerland, ‘the former Yugoslav Rep. of Macedonia’, Turkey, Ukraine 

83 

EN 

Footnotes: 

EN 

 
  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
TABLE 7:  NUMBER OF ANIMALS USED IN TOXICOLOGICAL AND OTHER SAFETY EVALUATIONS 

7.1 
Species 

7.2 
Acute and sub-acute toxicity testing methods 
(including limit test) 

7.3 
Skin 
irritation 

7.4 
Skin 
sensitisatio
n 

7.5 
Eye 
irritation 

7.6 
Sub- 
chronic and 
chronic 
toxicity 

7.7 
Carcino- 
genicity 

7.8 
Develop- 
mental 
toxicity 

7.9 
Muta- 
genicit
y 

7.10 
Repro-
ductive 
toxicity 

Types of tests versus species 

7.12 
Other 

7.13 
Total 

7.11 
Toxicity 
to aquatic 
vertebra-
tes not 
included 
in other 
columns 

7.a.  Mice 
Rats 
7.b. 
Guinea-Pigs 
7.c. 
Hamsters 
7.d. 
Other Rodents 
7.e. 
Rabbits 
7.f. 
Cats 
7.g. 
Dogs 
7.h. 
Ferrets 
7.i. 
Other Carnivores 
7.j. 
Horses,  donkeys  and  cross 
7.k. 
breds 
Pigs 

7.l. 
7.m.  Goats 
Sheep 
7.n. 
Cattle 
7.o. 
Prosimians 
7.p. 
New World Monkeys 
7.q. 
Old World Monkeys 
7.r. 
Apes 
7.s. 
Other Mammals 
7.t. 
Quail 
7.u. 
Other birds 
7.v. 
Reptiles 
7.w. 
Amphibians 
7.x. 
Fish 
7.y. 
TOTAL 
7.z. 

7.2.1. 
LD50, 
LC50 

7.2.2 
Other lethal 
methods 

5219 

7.2.3 
Non lethal 
clinical signs 
methods 

34 

60 

50 

105 

85 

12 

0 

5219 

34 

0 

0 

0 

60 

0 

0 

50 

0 

0 

202 

5324 
144 
85 
0 
0 
12 
0 
0 
0 
0 
0 

0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
5565 

EN 

84 

EN 

 
  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
TABLE 8:  NUMBER OF ANIMALS USED IN TOXICOLOGICAL AND OTHER SAFETY EVALUATIONS 

8.1 
Products 

8.2 
Acute and sub-acute toxicity testing 
methods (including limit test) 

8.3 
Skin 
irritation 

8.4 
Skin 
sensitisatio
n 

8.5 
Eye 
irritation 

Types of tests versus products 

8.7 
Carcino 
genicity 

8.8 
Develop- 
mental 
toxicity 

8.9 
Muta- 
genicit
y 

8.10 
Repro-
ductive 
toxicity 

8.6 
Sub- 
chronic 
and 
chronic 
toxicity 

8.12 
Other 

8.13 
Total 

8.11 
Toxicity 
to aquatic 
vertebra-
tes not 
included 
in other 
columns 

8.a. 

8.b. 

8.c. 

8.d. 

8.e. 

8.f. 

8.g. 

8.h. 

Products/substances  or  devices 
for 
human  medicine  and  dentistry  and  for 
veterinary medicine 
Products/substances used or intended to 
be used mainly in agriculture 
Products/substances used or intended to 
be used mainly in industry 
Products/substances used or intended to 
be used mainly in the household 
Products/substances used or intended to 
be  used  mainly  as  cosmetics  or 
toiletries 
Products/substances used or intended to 
be used mainly as additives in food for 
human consumption 
Products/substances used or intended to 
be used mainly as additives in food for 
animal consumption 
Potential  or  actual  contaminants  in  the 
general  environment  which  do  not 
appear in other columns 
toxicological 

safety 

or 

8.i.  Other 

8.2.1. 
LD50, 
LC50 

8.2.2 
Other lethal 
methods 

8.2.3 
Non lethal 
clinical signs 
methods 

84 

60 

5219 

202 

202 

84 

60 

0 

0 

0 

0 

0 

5219 

evaluations 
TOTAL 

8.j. 

0 

5219 

84 

0 

0 

0 

60 

0 

0 

0 

0 

0 

202 

5565 

EN 

85 

EN 

 
  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
SPAIN  

Statistical data submitted 

The  Statistical  data  have  been  provided  by  the:  "Ministerio  de  Agricultura,  Pesca  y 
Alimentación,  Subdirección  General  de  Ordenacion  de  explotaciones"  (Ministry  of 
Agriculture, Fisheries and Food, Sub-directorate of Management of Developments). 

Comments of Spanish authorities  

None 

EN 

86 

   EN

 
TABLE 1:  NUMBER OF ANIMALS USED IN RELATION TO THEIR PLACE OF ORIGIN 

1.1 
Species 

Origin versus species 

1.2  
Total 

1.3 
Animals coming from registered 
breeding or supplying 
establishments within the reporting 
country 

1.4 
Animals coming from 
elsewhere in the EC 

1.6 
Animals coming from 
other origins 

1.7 
Re-used animals 

1.5 
Animals coming from 
Member Countries of the 
Council of Europe which are 
parties to the Convention ETS 
123 (excluding EC Member 
States) 

Rats (Rattus norvegicus) 
Guinea-Pigs (Cavia porcellus) 
Hamsters (Mesocricetus ) 
Other Rodents (other Rodentia) 
Rabbits (Oryctolagus cuniculus) 
Cats (Felis catus) 
Dogs (Canis familiaris) 
Ferrets (Mustela putorius furo) 
Other Carnivores (other Carnivora) 
Horses, donkeys and cross breds (Equidae) 
Pigs (Sus) 

1.a.  Mice (Mus musculus) 
1.b. 
1.c. 
1.d. 
1.e. 
1.f. 
1.g. 
1.h. 
1.i. 
1.j. 
1.k. 
1.l. 
1.m.  Goats (Capra) 
1.n. 
1.o. 
1.p. 
1.q. 
1.r. 
1.s. 
1.t. 
1.u. 
1.v. 
1.w. 
1.x. 
1.y. 
1.z. 

Sheep (Ovis) 
Cattle (Bos) 
Prosimians (Prosimia) 
New World Monkeys (Ceboidea) 
Old World Monkeys (Cercopithecoidea) 
Apes (Hominoidea) 
Other Mammals (other Mammalia) 
Quail (Coturnix coturnix) 
Other birds (other Aves) 
Reptiles (Reptilia) 
Amphibians (Amphibia) 
Fish (Pisces) 
TOTAL 

393217 
125754 
16780 
908 
294 
11878 
168 
685 
237 
0 
42 
4818 
119 
821 
294 
0 
1 
81 
2 
60 
1 
8424 
10 
419 
30584 
595597 

357390 
113623 
14321 
877 

11111 
84 
525 
155 

0 
0 
52 
2 

1 

31627 
10478 
2459 
31 

767 

151 
82 

0 
1 
29 
0 

0 

22 
0 
0 
0 

0 
0 
0 
0 

0 
0 
0 
0 

0 

4178 
1653 
0 
0 

0 
84 
9 
0 

0 
0 
0 
0 

0 

498141 

45625 

22 

5924 

0 
0 
0 
0 

0 
0 
0 
0 

0 

Note 1:  Column 1.5 concerns only those Member Countries of the Council of Europe which, at the beginning of the reporting period, are Parties to the Convention ETS 123. Thus an updated list of 

those countries has to be used when filling in this column. 

Note 2:  Only the white boxes need to be completed. 

Note 3: 

The number of re-used animals in column 1.7 should be excluded from the total in the column 1.2 

EN 

87 

EN 

 
  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
TABLE 2:  NUMBER OF ANIMALS USED IN EXPERIMENTS FOR SELECTED PURPOSES 

2.1 
Species 

2.2  
Biological 
studies of a 
fundamenta
l nature 

2.a.  Mice 
Rats 
2.b. 
Guinea-Pigs 
2.c. 
Hamsters 
2.d. 
Other Rodents 
2.e. 
Rabbits 
2.f. 
Cats 
2.g. 
Dogs 
2.h. 
Ferrets 
2.i. 
Other Carnivores 
2.j. 
Horses,  donkeys  and  cross 
2.k. 
breds 
Pigs 

2.l. 
2.m.  Goats 
Sheep 
2.n. 
Cattle 
2.o. 
Prosimians 
2.p. 
New World Monkeys 
2.q. 
Old World Monkeys 
2.r. 
Apes 
2.s. 
Other Mammals 
2.t. 
Quail 
2.u. 
Other birds 
2.v. 
Reptiles 
2.w. 
Amphibians 
2.x. 
Fish 
2.y. 
TOTAL 
2.z. 

130339 
51885 
342 
493 
100 
854 
76 
44 
17 
0 
0 

288 
16 
17 
0 
0 
1 
23 
2 
0 
1 
94 
10 
351 
28349 
213302 

2.3 
Research and 
development of 
products and 
devices for human 
medicine and 
dentistry and for 
veterinary 
medicine 
(excluding 
toxicological and 
other safety 
evaluations 
counted in column 
2.6) 

115641 
39077 
8343 
52 
166 
2674 
3 
81 
220 
0 
0 

1531 
7 
94 
104 
0 
0 
21 
0 
0 
0 
2682 
0 
0 
700 
171396 

EN 

2.7 
Diagnosis of 
disease 

2.8 
Education and 
training 

2.9 
Other 

2.10 
Total 

Purpose versus species 

2.4 
Production and 
quality control of 
products and 
devices for 
human medicine 
and dentistry 

2.5 
Production and 
quality control of 
products and 
devices for 
veterinary 
medicine 

2.6 
Toxicological 
and other safety 
evaluations 
(including 
safety 
evaluation of 
products and 
devices for 
human 
medicine and 
dentistry and 
for veterinary 
medicine) 

62528 
8379 
3510 
0 
0 
5026 
0 
272 
0 
0 
0 

368 
24 
62 
0 
0 
0 
37 
0 
0 
0 
40 
0 
0 
1269 
81515 

51405 
5252 
92 
87 
0 
51 
0 
5 
0 
0 
0 

40 
0 
0 
0 
0 
0 
0 
0 
0 
0 
15 
0 
0 
0 
56947 

8325 
5085 
28 
12 
28 
1008 
3 
18 
0 
0 
0 

1200 
0 
75 
0 
0 
0 
0 
0 
0 
0 
50 
0 
0 
266 
16098 

11300 
2843 
13 
0 
0 
90 
73 
0 
0 
0 
0 

387 
72 
2 
0 
0 
0 
0 
0 
0 
0 
1200 
0 
68 
0 
16048 

403817 
115535 
16780 
908 
294 
11839 
168 
426 
237 
0 
42 

4735 
119 
821 
294 
0 
1 
81 
2 
60 
1 
8424 
10 
419 
30584 
595597 

6680 
2204 
1142 
0 
0 
30 
13 
6 
0 
0 
0 

0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
10075 

17599 
810 
3310 
264 
0 
2106 
0 
0 
0 

42 

921 
0 
571 
190 
0 
0 
0 
0 
60 
0 
4343 
0 
0 
0 
30216 

88 

EN 

 
  
 
TABLE 3:  NUMBER OF ANIMALS USED IN TOXICOLOGICAL AND OTHER SAFETY EVALUATIONS 

Products versus species 

3.1 
Species 

3.2  
Products/ 
substances or 
devices for 
human 
medicine and 
dentistry and 
for veterinary 
medicine 

3.3 
Products/ 
substances 
used or 
intended to 
be used 
mainly in 
agriculture 

3.4 
Products/ 
substances 
used or 
intended to 
be used 
mainly in 
industry 

3.5 
Products/ 
substances 
used or 
intended to 
be used 
mainly in 
the 
household 

3.6 
Products/ 
substances 
used or 
intended to 
be used 
mainly as 
cosmetics 
or toiletries 

3.a.  Mice 
Rats 
3.b. 
Guinea-Pigs 
3.c. 
Hamsters 
3.d. 
Other Rodents 
3.e. 
Rabbits 
3.f. 
Cats 
3.g. 
Dogs 
3.h. 
Ferrets 
3.i. 
Other Carnivores 
3.j. 
Horses, donkeys and cross breds 
3.k. 
3.l. 
Pigs 
3.m.  Goats 
Sheep 
3.n. 
Cattle 
3.o. 
Prosimians 
3.p. 
New World Monkeys 
3.q. 
Old World Monkeys 
3.r. 
Apes 
3.s. 
Other Mammals 
3.t. 
Quail 
3.u. 
Other birds 
3.v. 
Reptiles 
3.w. 
Amphibians 
3.x. 
Fish 
3.y. 
TOTAL 
3.z. 

21400 
3870 
3287 
0 
0 
5187 
0 
179 
0 
0 
0 
251 
24 
62 
0 
0 
0 
37 
0 
0 
0 
40 
0 
0 
100 
34437 

24 
359 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
237 
620 

0 
768 
63 
0 
0 
111 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
942 

0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
560 
560 

0 
0 
0 
0 
0 
75 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
75 

3.7 
Products/ 
substances 
used or 
intended to be 
used mainly 
as additives in 
food for 
human 
consumption 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 

3.8 
Products/ 
substances 
used or 
intended to be 
used mainly 
as additives in 
food for 
animal 
consumption 
725 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
725 

3.11 
Total 

3.10 
Other toxico- 
logical or 
safety 
evaluations 

3.9 
Potential or 
actual contami- 
nents in the 
general envi- 
ronment which 
do not appear in 
other columns 

1285 
230 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
372 
1887 

40597 
1375 
160 
0 
0 
45 
0 
77 
0 
0 
0 
15 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
42269 

64031 
6602 
3510 
0 
0 
5418 
0 
256 
0 
0 
0 
266 
24 
62 
0 
0 
0 
37 
0 
0 
0 
40 
0 
0 
1269 
81515 

EN 

89 

EN 

 
  
TABLE 4:  NUMBER OF ANIMALS USED IN EXPERIMENTS FOR STUDIES ON HUMAN AND ANIMAL DISEASES 

4.1 
Species 

4.2  
Human cardiovascular 
diseases 

4.3 
Human nervous and 
mental disorders 

4.4 
Human cancer (excluding 
evaluations of carcinogenic 
hazards or risks) 

4.5 
Other human diseases 

4.6 
Studies specific to animal 
diseases 

4.7 
Total 

Main categories versus species 

4.a.  Mice 
Rats 
4.b. 
Guinea-Pigs 
4.c. 
Hamsters 
4.d. 
Other Rodents 
4.e. 
Rabbits 
4.f. 
Cats 
4.g. 
Dogs 
4.h. 
Ferrets 
4.i. 
Other Carnivores 
4.j. 
Horses, donkeys and cross breds 
4.k. 
4.l. 
Pigs 
4.m.  Goats 
Sheep 
4.n. 
Cattle 
4.o. 
Prosimians 
4.p. 
New World Monkeys 
4.q. 
Old World Monkeys 
4.r. 
Apes 
4.s. 
Other Mammals 
4.t. 
Quail 
4.u. 
Other birds 
4.v. 
Reptiles 
4.w. 
Amphibians 
4.x. 
Fish 
4.y. 
TOTAL 
4.z. 

5844 
5938 
44 
0 
0 
180 
0 
27 
0 
0 
0 
273 
40 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
12346 

13808 
15263 
286 
87 
120 
3 
18 
2 
0 
0 
17 
0 
24 
0 
0 
1 
3 
0 
0 
0 
57 
0 
45 
192 

29926 

87612 
1538 
110 
52 
0 
66 
0 
3 
0 
0 
0 
21 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
50 
200 
89652 

80515 
36055 
637 
46 
74 
803 
3 
135 
0 
0 
0 
468 
7 
45 
0 
0 
0 
28 
2 
0 
0 
0 
0 
50 
300 
119168 

3839 
579 
325 
143 
448 
474 
0 
12 
0 
0 
0 
420 
0 
55 
14 
0 
0 
0 
0 
0 
0 
1300 
0 
0 
3966 
11575 

191618 
59373 
1402 
328 
642 
1526 
21 
179 
0 
0 
17 
1182 
71 
100 
14 
1 
3 
28 
2 
0 
57 
1300 
45 
292 
4466 
262667 

EN 

90 

EN 

 
  
 
TABLE 5:  NUMBER OF ANIMALS USED IN PRODUCTION AND QUALITY CONTROL OF PRODUCTS AND DEVICES FOR HUMAN 
MEDICINE AND DENTISTRY AND FOR VETERINARY MEDICINE 

5.1 
Species 

5.2  
National legislation 
specific to a single EC 
Member State 
1) 

5.3 
EC legislation 
including European 
Pharmacopoeia 
(requirements) 

5.4 
Member Country of Council 
of Europe (but not EC) 
legislation 
2) 

5.5 
Other legislation 

5.6 
Any combination of  
5.2/ 5.3/ 5.4/ 5.5 

5.7 
No regulatory 
requirements 

5.8 
Total 

Regulatory requirements versus species 

5.a.  Mice 
Rats 
5.b. 
Guinea-Pigs 
5.c. 
Hamsters 
5.d. 
Other Rodents 
5.e. 
Rabbits 
5.f. 
Cats 
5.g. 
Dogs 
5.h. 
Ferrets 
5.i. 
Other Carnivores 
5.j. 
Horses, donkeys and cross breds 
5.k. 
5.l. 
Pigs 
5.m.  Goats 
Sheep 
5.n. 
Cattle 
5.o. 
Prosimians 
5.p. 
New World Monkeys 
5.q. 
Old World Monkeys 
5.r. 
Apes 
5.s. 
Other Mammals 
5.t. 
Quail 
5.u. 
Other birds 
5.v. 
Reptiles 
5.w. 
Amphibians 
5.x. 
Fish 
5.y. 
5.z. 
TOTAL 
Examples: 

66 
0 
0 
0 
0 
2 
0 
0 
0 
0 
0 
22 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
90 

21771 
1342 
3340 
0 
0 
1563 
0 
0 
0 
0 
42 
553 
0 
571 
190 
0 
0 
0 
0 
60 
0 
3349 
0 
0 
0 
32781 

0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 

2437 
0 
54 
264 
0 
571 
0 
6 
0 
0 
0 
326 
0 
0 
0 
0 
0 
0 
0 
0 
0 
313 
0 
0 
0 
3971 
columns 5.2 - 5.5 refer to the legislation imposing that the test be carried out and 
not to the body which has issued the actual test method, guideline or protocol. 

0 
1672 
1058 
0 
0 
0 
13 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
681 
0 
0 
0 
3424 

5 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
20 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
25 

24279 
3014 
4452 
264 
0 
2136 
13 
6 
0 
0 
42 
921 
0 
571 
190 
0 
0 
0 
0 
60 
0 
4343 
0 
0 
0 
40291 

5.2 – France is testing due to a UK (or FR) specific requirement 
5.3 - UK is testing according to EC legislation 
5.4 – Spain is testing due to a Hungarian requirement 
5.5 – Sweden is testing due to a US specific requirement 
5.6  –  Germany  is  testing  due  to  a  Czech  requirement  (also  an  EC 
requirement) 
1)  EC Member States: Austria, Belgium, Denmark, Finland, France, Germany, Greece, Ireland, Italy, Luxembourg, Netherlands, Portugal, Spain, Sweden, United Kingdom 
2)  Member  Countries  of  Council  of  Europe  (non-EC):  Albania,  Andorra,  Bulgaria,  Croatia,  Cyprus,  Czech  Rep.,  Estonia,  Hungary,  Iceland,  Latvia,  Liechtenstein,  Lithuania, 

ISO protocol must be coded as a national (FR) legislative requirement and be 
entered into column 5.2 in the tables submitted by Belgium. 

Example:  a test required by French legislation and carried out in Belgium according to an 

Note: 

Malta, Moldova, Norway, Poland, Romania, Russia, San Marino, Slovakia, Slovenia, Switzerland, ‘the former Yugoslav Rep. of Macedonia’, Turkey, Ukraine 

91 

EN 

Footnotes: 

EN 

 
  
 
 
 
 
 
 
 
 
TABLE 6:  NUMBER OF ANIMALS USED IN TOXICOLOGICAL AND OTHER SAFETY EVALUATIONS 

6.1 
Species 

6.2  
National legislation 
specific to a single EC 
Member State 
1) 

6.3 
EC legislation 
including European 
Pharmacopoeia 
(requirements) 

6.4 
Member Country of Council 
of Europe (but not EC) 
legislation 
2) 

6.5 
Other legislation 

6.6 
Any combination of  
6.2/ 6.3/ 6.4/ 6.5 

6.7 
No regulatory 
requirements 

6.8 
Total 

Regulatory requirements versus species 

6.a.  Mice 
Rats 
6.b. 
Guinea-Pigs 
6.c. 
Hamsters 
6.d. 
Other Rodents 
6.e. 
Rabbits 
6.f. 
Cats 
6.g. 
Dogs 
6.h. 
Ferrets 
6.i. 
Other Carnivores 
6.j. 
Horses, donkeys and cross breds 
6.k. 
6.l. 
Pigs 
6.m.  Goats 
Sheep 
6.n. 
Cattle 
6.o. 
Prosimians 
6.p. 
New World Monkeys 
6.q. 
Old World Monkeys 
6.r. 
Apes 
6.s. 
Other Mammals 
6.t. 
Quail 
6.u. 
Other birds 
6.v. 
Reptiles 
6.w. 
Amphibians 
6.x. 
Fish 
6.y. 
6.z. 
TOTAL 
Examples: 

308 
96 
41 
0 
0 
133 
0 
0 
0 
0 
0 
6 
0 
2 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
586 

13299 
1195 
703 
0 
0 
194 
0 
67 
0 
0 
0 
244 
24 
42 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
15768 

0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 

3602 
1411 
0 
0 
0 
156 
23 
0 
0 
0 
0 
0 
0 
18 
0 
0 
0 
5 
0 
0 
0 
40 
0 
0 
0 
5255 
columns 6.2 - 6.5 refer to the legislation imposing that the test be carried out and 
not to the body which has issued the actual test method, guideline or protocol. 

46381 
2391 
2479 
0 
0 
4760 
0 
156 
0 
0 
0 
16 
0 
0 
0 
0 
0 
32 
0 
0 
0 
0 
0 
0 
1197 
57412 

441 
1509 
287 
0 
0 
175 
0 
10 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
72 
2494 

64031 
6602 
3510 
0 
0 
5418 
23 
233 
0 
0 
0 
266 
24 
62 
0 
0 
0 
37 
0 
0 
0 
40 
0 
0 
1269 
81515 

6.2 – France is testing due to a UK (or FR) specific requirement 
6.3 - UK is testing according to EC legislation 
6.4 – Spain is testing due to a Hungarian requirement 
6.5 – Sweden is testing due to a US specific requirement 
6.6  –  Germany  is  testing  due  to  a  Czech  requirement  (also  an  EC 
requirement) 
1)  EC Member States: Austria, Belgium, Denmark, Finland, France, Germany, Greece, Ireland, Italy, Luxembourg, Netherlands, Portugal, Spain, Sweden, United Kingdom 
2)  Member Countries of Council of Europe (non-EC): Albania, Andorra, Bulgaria, Croatia, Cyprus, Czech Rep., Estonia, Hungary, Iceland, Latvia, Liechtenstein, Lithuania, Malta, 

ISO protocol must be coded as a national (FR) legislative requirement and be 
entered into column 6.2 in the tables submitted by Belgium. 

Example:  a test required by French legislation and carried out in Belgium according to an 

Note: 

Moldova, Norway, Poland, Romania, Russia, San Marino, Slovakia, Slovenia, Switzerland, ‘the former Yugoslav Rep. of Macedonia’, Turkey, Ukraine 

92 

EN 

Footnotes: 

EN 

 
  
 
 
 
 
 
 
 
 
TABLE 7:  NUMBER OF ANIMALS USED IN TOXICOLOGICAL AND OTHER SAFETY EVALUATIONS 

7.1 
Species 

7.2 
Acute and sub-acute toxicity testing methods 
(including limit test) 

7.3 
Skin 
irritation 

7.4 
Skin 
sensitisatio
n 

7.5 
Eye 
irritation 

7.6 
Sub- 
chronic and 
chronic 
toxicity 

7.7 
Carcino- 
genicity 

7.8 
Develop- 
mental 
toxicity 

7.9 
Muta- 
genicit
y 

7.10 
Repro-
ductive 
toxicity 

Types of tests versus species 

7.12 
Other 

7.13 
Total 

7.11 
Toxicity 
to aquatic 
vertebra-
tes not 
included 
in other 
columns 

7.2.1. 
LD50, 
LC50 

7.2.2 
Other lethal 
methods 

7.2.3 
Non lethal 
clinical signs 
methods 

7.a.  Mice 
Rats 
7.b. 
Guinea-Pigs 
7.c. 
Hamsters 
7.d. 
Other Rodents 
7.e. 
Rabbits 
7.f. 
Cats 
7.g. 
Dogs 
7.h. 
Ferrets 
7.i. 
Other Carnivores 
7.j. 
Horses,  donkeys  and  cross 
7.k. 
breds 
Pigs 

7.l. 
7.m.  Goats 
Sheep 
7.n. 
Cattle 
7.o. 
Prosimians 
7.p. 
New World Monkeys 
7.q. 
Old World Monkeys 
7.r. 
Apes 
7.s. 
Other Mammals 
7.t. 
Quail 
7.u. 
Other birds 
7.v. 
Reptiles 
7.w. 
Amphibians 
7.x. 
Fish 
7.y. 
TOTAL 
7.z. 

9430 
831 
0 
0 
0 
6 
0 
0 
0 
0 
0 

0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
287 
10554 

35486 
365 
399 
0 
0 
16 
0 
0 
0 
0 
0 

0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
36266 

1016 
601 
12 
0 
0 
24 
0 
0 
0 
0 
0 

0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
1653 

0 
135 
16 
0 
0 
282 
0 
0 
0 
0 
0 

0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
433 

EN 

40 
0 
463 
0 
0 
0 
0 
0 
0 
0 
0 

0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
503 

93 

0 
0 
0 
0 
0 
64 
0 
0 
0 
0 
0 

0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
64 

0 
1057 
0 
0 
0 
6 
0 
156 
0 
0 
0 

0 
0 
0 
0 
0 
0 
37 
0 
0 
0 
0 
0 
0 
860 
2116 

674 
96 
0 
0 
0 
0 
0 
0 
0 
0 
0 

0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
770 

0 
0 
0 
0 
0 
113 
0 
0 
0 
0 
0 

0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
50 
163 

24 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 

0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
24 

0 
567 
0 
0 
0 
0 
0 
0 
0 
0 
0 

0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
72 
639 

0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 

0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 

17361 
2956 
2614 
0 
0 
4907 
0 
100 
0 
0 
0 

266 
24 
62 
0 
0 
0 
0 
0 
0 
0 
40 
0 
0 
0 
28330 

64031 
6608 
3504 
0 
0 
5418 
0 
256 
0 
0 
0 

266 
24 
62 
0 
0 
0 
37 
0 
0 
0 
40 
0 
0 
1269 
81515 

EN 

 
  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
TABLE 8:  NUMBER OF ANIMALS USED IN TOXICOLOGICAL AND OTHER SAFETY EVALUATIONS 

8.1 
Products 

8.2 
Acute and sub-acute toxicity testing 
methods (including limit test) 

8.3 
Skin 
irritation 

8.4 
Skin 
sensitisatio
n 

8.5 
Eye 
irritation 

Types of tests versus products 

8.7 
Carcino 
genicity 

8.8 
Develop- 
mental 
toxicity 

8.9 
Muta- 
genicit
y 

8.10 
Repro-
ductive 
toxicity 

8.6 
Sub- 
chronic 
and 
chronic 
toxicity 

8.12 
Other 

8.13 
Total 

8.11 
Toxicity 
to aquatic 
vertebra-
tes not 
included 
in other 
columns 

8.a. 

8.b. 

8.c. 

8.d. 

8.e. 

8.f. 

8.g. 

8.h. 

Products/substances  or  devices 
for 
human  medicine  and  dentistry  and  for 
veterinary medicine 
Products/substances used or intended to 
be used mainly in agriculture 
Products/substances used or intended to 
be used mainly in industry 
Products/substances used or intended to 
be used mainly in the household 
Products/substances used or intended to 
be  used  mainly  as  cosmetics  or 
toiletries 
Products/substances used or intended to 
be used mainly as additives in food for 
human consumption 
Products/substances used or intended to 
be used mainly as additives in food for 
animal consumption 
Potential  or  actual  contaminants  in  the 
general  environment  which  do  not 
appear in other columns 
toxicological 

safety 

or 

8.i.  Other 

8.2.1. 
LD50, 
LC50 

8.2.2 
Other lethal 
methods 

8.2.3 
Non lethal 
clinical signs 
methods 

2563 

2749 

1633 

281 

445 

24 

897 

0 

96 

237 

601 

0 

0 

0 

0 

0 

71 

0 

0 

0 

725 

473 

812 

0 

0 

0 

0 

0 

0 

6 

6680 

33075 

14 

0 

90 

0 

56 

0 

0 

0 

6 

0 

58 

0 

0 

0 

0 

0 

0 

0 

21 

0 

19 

0 

0 

0 

0 

359 

560 

0 

0 

0 

300 

0 

evaluations 
TOTAL 

8.j. 

10554 

37432 

1653 

433 

503 

64 

2116 

0 

0 

0 

0 

0 

0 

0 

674 

770 

163 

0 

567 

0 

25115 

34437 

0 

0 

0 

0 

0 

0 

0 

0 

24 

0 

0 

0 

0 

0 

0 

0 

0 

0 

0 

0 

0 

0 

0 

0 

0 

0 

0 

0 

0 

5 

0 

0 

0 

0 

620 

942 

560 

75 

0 

725 

72 

0 

224 

1887 

0 

0 

1820 

42269 

163 

24 

639 

0 

27164 

81515 

EN 

94 

EN 

 
  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
FRANCE  

Statistical data submitted 

The  statistical  data  have  been  submitted  by  the  “Ministère  de  la  Recherche  et  des 
Nouvelles Technologies” (Ministry for Research and New Technologies).  

Comments of the French authorities 

This study was realized by the EFICOM Markétudes Company for the Research and 
University Education Ministry. 

The number of animals used in France since 1999 is steady and about 2.2 billion. It 
represents  a  decrease  of  40 %  in  comparison  with  the  figures  of  the  first  study  in 
1990. In 2004, a slight increasing tendency could have been observed which led the 
figures to their 1999 rounded values. Since 1999, the amount of rodents used is steady 
(2.1  billion);  and  even  if  some  animal  groups  are  more  often  used  (the  amount  of 
fishes and amphibian has doubled), there is a reversal tendency for other species (the 
amount of horses and oxen decreased by 50 %, and cats by 25 %). In return, the use of 
primates  becomes  more  and  more  significant  and  is  certainly  not  going  to  weak 
because of their scientific interests. 

Concerning the study results, when significant differences were revealed between the 
2001 and the 2004 figures,  some  verification were done in order to know what was 
the origin of these sudden evolutions. Each time these differences were explained by 
either new activity, for example  the obtainment of therapeutic antibodies for rabbits 
increased  by  74 %,  or  the  closure  of  laboratories.  They  could  be  explained  too  by 
mistakes typed in the 2001 study report (concerning reptiles for example). The other 
variations are not significant and support the figures provided by experimental centres 
and laboratories. 

This  study  allows  estimating  that  public  sector  uses  a  third  of  the  total  amount  of 
animals, of which 65 % is for basic research and education. On the other hand, private 
sector  uses  the  remaining  two  third,  of  which  37 %  are  dedicated  to  research  and 
development, 46 % to production and control, and 11 % to toxicological evaluations. 

This study allows showing too that centres for animal experimentation are about 450 
(it can vary depending on juridical conventions that link laboratories to these centres). 
It represents a third of the figure established in 1990. This decrease of the amount of 
experimental  centres  shows  that  henceforth  laboratories  are  regrouped  in  order  to 
dispose of centralized installations and competent staff. The « disappearance » of 900 
experimental  animal  houses  shows  the  pressure  brought  by  the  associations  and  the 
concerned  authorities  for  fifteen  years.  It  was  engendered  by  very  significant 
investments  to  come  up  to  the  current  sanitary,  ethic  and  scientific  expectances.  Of 
course, this diminution did not obviously drive to a decrease of the amount of animals 
with  the  same  proportion,  but  it  set  practices  that  assure  respect  and  well-being  to 
animals. 

EN 

95 

   EN

 
TABLE 1:  NUMBER OF ANIMALS USED IN RELATION TO THEIR PLACE OF ORIGIN 

1.1 
Species 

Origin versus species 

1.2  
Total 

1.3 
Animals coming from registered 
breeding or supplying 
establishments within the reporting 
country 

1.4 
Animals coming from 
elsewhere in the EC 

1.6 
Animals coming from 
other origins 

1.7 
Re-used animals 

1.5 
Animals coming from 
Member Countries of the 
Council of Europe which are 
parties to the Convention ETS 
123 (excluding EC Member 
States) 

Rats (Rattus norvegicus) 
Guinea-Pigs (Cavia porcellus) 
Hamsters (Mesocricetus ) 
Other Rodents (other Rodentia) 
Rabbits (Oryctolagus cuniculus) 
Cats (Felis catus) 
Dogs (Canis familiaris) 
Ferrets (Mustela putorius furo) 
Other Carnivores (other Carnivora) 
Horses, donkeys and cross breds (Equidae) 
Pigs (Sus) 

1.a.  Mice (Mus musculus) 
1.b. 
1.c. 
1.d. 
1.e. 
1.f. 
1.g. 
1.h. 
1.i. 
1.j. 
1.k. 
1.l. 
1.m.  Goats (Capra) 
1.n. 
1.o. 
1.p. 
1.q. 
1.r. 
1.s. 
1.t. 
1.u. 
1.v. 
1.w. 
1.x. 
1.y. 
1.z. 

Sheep (Ovis) 
Cattle (Bos) 
Prosimians (Prosimia) 
New World Monkeys (Ceboidea) 
Old World Monkeys (Cercopithecoidea) 
Apes (Hominoidea) 
Other Mammals (other Mammalia) 
Quail (Coturnix coturnix) 
Other birds (other Aves) 
Reptiles (Reptilia) 
Amphibians (Amphibia) 
Fish (Pisces) 
TOTAL 

1 409 076 
411 068 
56 862 
7 672 

92 897 
622 
3 662 
85 

578 
340 
809 
0 

3 983 

21 809 
2 128 
16 679 
75 

10 
9 
20 
0 

0 
20 
38 
0 

0 

2 383 
25 
0 
0 

0 
0 
0 
0 

0 
13 
0 
0 

0 

77 066 
11 166 
5 809 
944 

375 
682 
1 857 
70 

0 
60 
1 931 
0 

40 

1 542 
408 
690 
0 

30 
96 
427 
0 

0 

1 510 334 
424 387 
79 350 
8 691 
12 683 
93 282 
1 313 
5 539 
155 
0 
223 
6 587 
442 
4 992 
1 296 
578 
433 
2 778 
0 
0 
4 023 
102 240 
0 
15 675 
50 397 
2 325 398 

Note 1:  Column 1.5 concerns only those Member Countries of the Council of Europe which, at the beginning of the reporting period, are Parties to the Convention ETS 123. Thus an updated 

list of those countries has to be used when filling in this column. 

Note 2:  Only the white boxes need to be completed. 

Note 3: 

The number of re-used animals in column 1.7 should be excluded from the total in the column 1.2 

EN 

96 

EN 

 
  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
TABLE 2:  NUMBER OF ANIMALS USED IN EXPERIMENTS FOR SELECTED PURPOSES 

Purpose versus species 

2.1 
Species 

2.2  
Biological 
studies of a 
fundamenta
l nature 

2.a.  Mice 
Rats 
2.b. 
Guinea-Pigs 
2.c. 
Hamsters 
2.d. 
Other Rodents 
2.e. 
Rabbits 
2.f. 
Cats 
2.g. 
Dogs 
2.h. 
Ferrets 
2.i. 
Other Carnivores 
2.j. 
Horses,  donkeys  and  cross 
2.k. 
breds 
Pigs 

2.l. 
2.m.  Goats 
Sheep 
2.n. 
Cattle 
2.o. 
Prosimians 
2.p. 
New World Monkeys 
2.q. 
Old World Monkeys 
2.r. 
Apes 
2.s. 
Other Mammals 
2.t. 
Quail 
2.u. 
Other birds 
2.v. 
Reptiles 
2.w. 
Amphibians 
2.x. 
Fish 
2.y. 
TOTAL 
2.z. 

351 428 
73 253 
1 404 
2 043 
745 
1 246 
53 
106 
30 
0 
0 

159 
26 
731 
56 
382 
24 
238 
0 
0 
20 
3 768 
0 
4 760 
41 140 
481 612 

EN 

2.3 
Research and 
development of 
products and 
devices for human 
medicine and 
dentistry and for 
veterinary 
medicine 
(excluding 
toxicological and 
other safety 
evaluations 
counted in column 
2.6) 

404 603 
205 258 
6 127 
3 320 
10 645 
9 686 
396 
1 062 
55 
0 
21 

2 421 
106 
936 
461 
0 
121 
216 
0 
0 
0 
10 718 
0 
53 
0 
656 205 

2.6 
Toxicological 
and other safety 
evaluations 
(including 
safety 
evaluation of 
products and 
devices for 
human 
medicine and 
dentistry and 
for veterinary 
medicine) 

71 036 
69 933 
13 122 
144 
0 
10 328 
24 
3 427 
41 
0 
0 

1 002 
10 
10 
92 
0 
168 
1 874 
0 
0 
0 
36 332 
0 
500 
4 948 
212 991 

2.4 
Production and 
quality control of 
products and 
devices for 
human medicine 
and dentistry 

2.5 
Production and 
quality control of 
products and 
devices for 
veterinary 
medicine 

475 247 
19 913 
50 991 
151 
0 
61 349 
0 
148 
29 
0 
87 

4 
77 
3 062 
1 
0 
35 
326 
0 
0 
0 
10 857 
0 
0 
0 
622 277 

59 199 
14 031 
6 373 
2 103 
0 
3 334 
458 
491 
0 
0 
8 

1 407 
0 
0 
11 
0 
0 
0 
0 
0 
0 
37 069 
0 
0 
0 
124 484 

97 

2.7 
Diagnosis of 
disease 

2.8 
Education and 
training 

2.9 
Other 

2.10 
Total 

66 658 
497 
7 
910 
27 
1 123 
0 
0 
0 
0 
0 

1 
0 
26 
20 
0 
0 
0 
0 
0 
0 
435 
0 
0 
0 
69 704 

41 988 
15 714 
417 
12 
0 
1 689 
9 
32 
0 
0 
91 

350 
23 
111 
141 
0 
5 
29 
0 
0 
100 
1 209 
0 
9 362 
1 439 
72 721 

40 175 
25 788 
909 
8 
1 266 
4 527 
373 
273 
0 
0 
16 

1 243 
200 
116 
514 
196 
80 
95 
0 
0 
3 903 
1 852 
0 
1 000 
2 870 
85 404 

1 510 334 
424 387 
79 350 
8 691 
12 683 
93 282 
1 313 
5 539 
155 
0 
223 

6 587 
442 
4 992 
1 296 
578 
433 
2 778 
0 
0 
4 023 
102 240 
0 
15 675 
50 397 
2 325 398 

EN 

 
  
TABLE 3:  NUMBER OF ANIMALS USED IN TOXICOLOGICAL AND OTHER SAFETY EVALUATIONS 

Products versus species 

3.1 
Species 

3.2  
Products/ 
substances or 
devices for 
human 
medicine and 
dentistry and 
for veterinary 
medicine 

3.3 
Products/ 
substances 
used or 
intended to 
be used 
mainly in 
agriculture 

3.4 
Products/ 
substances 
used or 
intended to 
be used 
mainly in 
industry 

3.5 
Products/ 
substances 
used or 
intended to 
be used 
mainly in 
the 
household 

3.6 
Products/ 
substances 
used or 
intended to 
be used 
mainly as 
cosmetics 
or toiletries 

3.a.  Mice 
Rats 
3.b. 
Guinea-Pigs 
3.c. 
Hamsters 
3.d. 
Other Rodents 
3.e. 
Rabbits 
3.f. 
Cats 
3.g. 
Dogs 
3.h. 
Ferrets 
3.i. 
Other Carnivores 
3.j. 
Horses, donkeys and cross breds 
3.k. 
3.l. 
Pigs 
3.m.  Goats 
Sheep 
3.n. 
Cattle 
3.o. 
Prosimians 
3.p. 
New World Monkeys 
3.q. 
Old World Monkeys 
3.r. 
Apes 
3.s. 
Other Mammals 
3.t. 
Quail 
3.u. 
Other birds 
3.v. 
Reptiles 
3.w. 
Amphibians 
3.x. 
Fish 
3.y. 
TOTAL 
3.z. 

39 549 
44 318 
4 353 
142 
0 
4 796 
24 
2 623 
41 
0 
0 
303 
0 
0 
67 
0 
168 
970 
0 
0 
0 
262 
0 
0 
0 
97 616 

7 321 
3 177 
445 
0 
0 
696 
0 
134 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
400 
2 848 
15 021 

5 868 
5 693 
3 832 
2 
0 
1 319 
0 
108 
0 
0 
0 
39 
0 
0 
0 
0 
0 
6 
0 
0 
0 
98 
0 
0 
2 000 
18 965 

EN 

0 
16 
177 
0 
0 
106 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
299 

1 797 
2 226 
940 
0 
0 
533 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
5 496 

98 

3.7 
Products/ 
substances 
used or 
intended to be 
used mainly 
as additives in 
food for 
human 
consumption 
516 
229 
27 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
772 

3.8 
Products/ 
substances 
used or 
intended to be 
used mainly 
as additives in 
food for 
animal 
consumption 
123 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
444 
0 
10 
25 
0 
0 
0 
0 
0 
0 
30 519 
0 
100 
0 
31 221 

3.11 
Total 

3.10 
Other toxico- 
logical or 
safety 
evaluations 

3.9 
Potential or 
actual contami- 
nents in the 
general envi- 
ronment which 
do not appear in 
other columns 

2 438 
1 565 
0 
0 
0 
0 
0 
0 
0 
0 
0 
83 
10 
0 
0 
0 
0 
0 
0 
0 
0 
366 
0 
0 
100 
4 562 

13 424 
12 709 
3 348 
0 
0 
2 878 
0 
562 
0 
0 
0 
133 
0 
0 
0 
0 
0 
898 
0 
0 
0 
5 087 
0 
0 
0 
39 039 

71 036 
69 933 
13 122 
144 
0 
10 328 
24 
3 427 
41 
0 
0 
1 002 
10 
10 
92 
0 
168 
1 874 
0 
0 
0 
36 332 
0 
500 
4 948 
212 991 

EN 

 
  
TABLE 4:  NUMBER OF ANIMALS USED IN EXPERIMENTS FOR STUDIES ON HUMAN AND ANIMAL DISEASES 

4.1 
Species 

4.2  
Human cardiovascular 
diseases 

4.3 
Human nervous and 
mental disorders 

4.4 
Human cancer (excluding 
evaluations of carcinogenic 
hazards or risks) 

4.5 
Other human diseases 

4.6 
Studies specific to animal 
diseases 

4.7 
Total 

Main categories versus species 

4.a.  Mice 
Rats 
4.b. 
Guinea-Pigs 
4.c. 
Hamsters 
4.d. 
Other Rodents 
4.e. 
Rabbits 
4.f. 
Cats 
4.g. 
Dogs 
4.h. 
Ferrets 
4.i. 
Other Carnivores 
4.j. 
Horses, donkeys and cross breds 
4.k. 
4.l. 
Pigs 
4.m.  Goats 
Sheep 
4.n. 
Cattle 
4.o. 
Prosimians 
4.p. 
New World Monkeys 
4.q. 
Old World Monkeys 
4.r. 
Apes 
4.s. 
Other Mammals 
4.t. 
Quail 
4.u. 
Other birds 
4.v. 
Reptiles 
4.w. 
Amphibians 
4.x. 
Fish 
4.y. 
TOTAL 
4.z. 

69 470 
47 369 
1 719 
1 078 
0 
3 349 
0 
130 
0 
0 
0 
830 
9 
152 
1 
0 
9 
9 
0 
0 
0 
5 
0 
0 
0 
124 130 

226 646 
112 450 
924 
1 117 
10 633 
0 
14 
36 
0 
0 
0 
1 
0 
40 
0 
382 
29 
69 
0 
0 
0 
0 
0 
649 
0 
352 990 

154 806 
17 732 
149 
0 
0 
93 
0 
11 
0 
0 
0 
6 
0 
0 
0 
0 
0 
52 
0 
0 
0 
0 
0 
2 018 
0 
174 867 

307 007 
99 236 
2 980 
2 031 
114 
4 504 
127 
654 
85 
0 
0 
245 
1 
116 
0 
0 
107 
315 
0 
0 
20 
0 
0 
1 869 
32 809 
452 220 

64 760 
2 221 
1 766 
2 047 
670 
4 109 
308 
337 
0 
0 
21 
1 499 
122 
1 385 
536 
0 
0 
9 
0 
0 
0 
14 916 
0 
277 
8 331 
103 314 

822 689 
279 008 
7 538 
6 273 
11 417 
12 055 
449 
1 168 
85 
0 
21 
2 581 
132 
1 693 
537 
382 
145 
454 
0 
0 
20 
14 921 
0 
4 813 
41 140 
1 207 521 

EN 

99 

EN 

 
  
TABLE 5:  NUMBER OF ANIMALS USED IN PRODUCTION AND QUALITY CONTROL OF PRODUCTS AND DEVICES FOR HUMAN 
MEDICINE AND DENTISTRY AND FOR VETERINARY MEDICINE 

Regulatory requirements versus species 

5.1 
Species 

5.2  
National legislation 
specific to a single EC 
Member State 
1) 

5.3 
EC legislation 
including European 
Pharmacopoeia 
(requirements) 

5.4 
Member Country of Council 
of Europe (but not EC) 
legislation 
2) 

5.5 
Other legislation 

5.6 
Any combination of  
5.2/ 5.3/ 5.4/ 5.5 

5.7 
No regulatory 
requirements 

5.8 
Total 

5.a.  Mice 
Rats 
5.b. 
Guinea-Pigs 
5.c. 
Hamsters 
5.d. 
Other Rodents 
5.e. 
Rabbits 
5.f. 
Cats 
5.g. 
Dogs 
5.h. 
Ferrets 
5.i. 
Other Carnivores 
5.j. 
Horses, donkeys and cross breds 
5.k. 
5.l. 
Pigs 
5.m.  Goats 
Sheep 
5.n. 
Cattle 
5.o. 
Prosimians 
5.p. 
New World Monkeys 
5.q. 
Old World Monkeys 
5.r. 
Apes 
5.s. 
Other Mammals 
5.t. 
Quail 
5.u. 
Other birds 
5.v. 
Reptiles 
5.w. 
Amphibians 
5.x. 
Fish 
5.y. 
5.z. 
TOTAL 
Examples: 

5 219 
4 608 
0 
0 
0 
6 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
9 833 

92 021 
13 371 
9 411 
2 254 
0 
7 978 
458 
639 
23 
0 
0 
1 342 
0 
0 
11 
0 
35 
6 
0 
0 
0 
37 117 
0 
0 
0 
164 666 

0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
152 
0 
0 
0 
152 

8 082 
0 
6 
0 
0 
19 
0 
0 
0 
0 
0 
65 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
8 172 
columns 5.2 - 5.5 refer to the legislation imposing that the test be carried out and 
not to the body which has issued the actual test method, guideline or protocol. 

428 624 
1 027 
47 947 
0 
0 
56 680 
0 
0 
6 
0 
95 
4 
77 
3 062 
1 
0 
0 
320 
0 
0 
0 
10 657 
0 
0 
0 
548 500 

500 
14 938 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
15 438 

534 446 
33 944 
57 364 
2 254 
0 
64 683 
458 
639 
29 
0 
95 
1 411 
77 
3 062 
12 
0 
35 
326 
0 
0 
0 
47 926 
0 
0 
0 
746 761 

5.2 – France is testing due to a UK (or FR) specific requirement 
5.3 - UK is testing according to EC legislation 
5.4 – Spain is testing due to a Hungarian requirement 
5.5 – Sweden is testing due to a US specific requirement 
5.6  –  Germany  is  testing  due  to  a  Czech  requirement  (also  an  EC 
requirement) 
1)  EC Member States: Austria, Belgium, Denmark, Finland, France, Germany, Greece, Ireland, Italy, Luxembourg, Netherlands, Portugal, Spain, Sweden, United Kingdom 
2)  Member Countries of Council of Europe (non-EC): Albania, Andorra, Bulgaria, Croatia, Cyprus, Czech Rep., Estonia, Hungary, Iceland, Latvia, Liechtenstein, Lithuania, Malta, 

ISO protocol must be coded as a national (FR) legislative requirement and be 
entered into column 5.2 in the tables submitted by Belgium. 

Example:  a test required by French legislation and carried out in Belgium according to an 

Note: 

Moldova, Norway, Poland, Romania, Russia, San Marino, Slovakia, Slovenia, Switzerland, ‘the former Yugoslav Rep. of Macedonia’, Turkey, Ukraine 

100 

EN 

Footnotes: 

EN 

 
  
 
 
 
 
 
 
 
 
TABLE 6:  NUMBER OF ANIMALS USED IN TOXICOLOGICAL AND OTHER SAFETY EVALUATIONS 

Regulatory requirements versus species 

6.1 
Species 

6.2  
National legislation 
specific to a single EC 
Member State 
1) 

6.3 
EC legislation 
including European 
Pharmacopoeia 
(requirements) 

6.4 
Member Country of Council 
of Europe (but not EC) 
legislation 
2) 

6.5 
Other legislation 

6.6 
Any combination of  
6.2/ 6.3/ 6.4/ 6.5 

6.7 
No regulatory 
requirements 

6.8 
Total 

6.a.  Mice 
Rats 
6.b. 
Guinea-Pigs 
6.c. 
Hamsters 
6.d. 
Other Rodents 
6.e. 
Rabbits 
6.f. 
Cats 
6.g. 
Dogs 
6.h. 
Ferrets 
6.i. 
Other Carnivores 
6.j. 
Horses, donkeys and cross breds 
6.k. 
6.l. 
Pigs 
6.m.  Goats 
Sheep 
6.n. 
Cattle 
6.o. 
Prosimians 
6.p. 
New World Monkeys 
6.q. 
Old World Monkeys 
6.r. 
Apes 
6.s. 
Other Mammals 
6.t. 
Quail 
6.u. 
Other birds 
6.v. 
Reptiles 
6.w. 
Amphibians 
6.x. 
Fish 
6.y. 
6.z. 
TOTAL 
Examples: 

7 381 
568 
414 
0 
0 
502 
0 
0 
0 
0 
0 
31 
0 
0 
0 
0 
0 
0 
0 
0 
0 
629 
0 
500 
0 
10 025 

17 787 
8 729 
9 751 
78 
0 
1 631 
24 
231 
0 
0 
0 
187 
0 
0 
67 
0 
0 
253 
0 
0 
0 
98 
0 
0 
3 000 
41 836 

22 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
22 

7 803 
6 331 
527 
2 
0 
1 800 
0 
139 
0 
0 
0 
140 
10 
0 
0 
0 
0 
98 
0 
0 
0 
0 
0 
0 
1 915 
18 765 
columns 6.2 - 6.5 refer to the legislation imposing that the test be carried out and 
not to the body which has issued the actual test method, guideline or protocol. 

34 457 
48 339 
2 107 
64 
0 
4 669 
0 
2 547 
41 
0 
0 
512 
0 
10 
25 
0 
168 
1 035 
0 
0 
0 
35 605 
0 
0 
33 
129 612 

3 586 
5 966 
323 
0 
0 
1 726 
0 
510 
0 
0 
0 
132 
0 
0 
0 
0 
0 
488 
0 
0 
0 
0 
0 
0 
0 
12 731 

71 036 
69 933 
13 122 
144 
0 
10 328 
24 
3 427 
41 
0 
0 
1 002 
10 
10 
92 
0 
168 
1 874 
0 
0 
0 
36 332 
0 
500 
4 948 
212 991 

6.2 – France is testing due to a UK (or FR) specific requirement 
6.3 - UK is testing according to EC legislation 
6.4 – Spain is testing due to a Hungarian requirement 
6.5 – Sweden is testing due to a US specific requirement 
6.6  –  Germany  is  testing  due  to  a  Czech  requirement  (also  an  EC 
requirement) 
1)  EC Member States: Austria, Belgium, Denmark, Finland, France, Germany, Greece, Ireland, Italy, Luxembourg, Netherlands, Portugal, Spain, Sweden, United Kingdom 
2)  Member Countries of Council of Europe (non-EC): Albania, Andorra, Bulgaria, Croatia, Cyprus, Czech Rep., Estonia, Hungary, Iceland, Latvia, Liechtenstein, Lithuania, Malta, 

ISO protocol must be coded as a national (FR) legislative requirement and be 
entered into column 6.2 in the tables submitted by Belgium. 

Example:  a test required by French legislation and carried out in Belgium according to an 

Note: 

Moldova, Norway, Poland, Romania, Russia, San Marino, Slovakia, Slovenia, Switzerland, ‘the former Yugoslav Rep. of Macedonia’, Turkey, Ukraine 

101 

EN 

Footnotes: 

EN 

 
  
 
 
 
 
 
 
 
 
TABLE 7:  NUMBER OF ANIMALS USED IN TOXICOLOGICAL AND OTHER SAFETY EVALUATIONS 

7.1 
Species 

7.2 
Acute and sub-acute toxicity testing methods 
(including limit test) 

7.3 
Skin 
irritation 

7.4 
Skin 
sensitisatio
n 

7.5 
Eye 
irritation 

7.6 
Sub- 
chronic and 
chronic 
toxicity 

7.7 
Carcino- 
genicity 

7.8 
Develop- 
mental 
toxicity 

7.9 
Muta- 
genicit
y 

7.10 
Repro-
ductive 
toxicity 

Types of tests versus species 

7.12 
Other 

7.13 
Total 

7.11 
Toxicity 
to aquatic 
vertebra-
tes not 
included 
in other 
columns 

7.2.1. 
LD50, 
LC50 

7.2.2 
Other lethal 
methods 

7.2.3 
Non lethal 
clinical signs 
methods 

7.a.  Mice 
Rats 
7.b. 
Guinea-Pigs 
7.c. 
Hamsters 
7.d. 
Other Rodents 
7.e. 
Rabbits 
7.f. 
Cats 
7.g. 
Dogs 
7.h. 
Ferrets 
7.i. 
Other Carnivores 
7.j. 
Horses,  donkeys  and  cross 
7.k. 
breds 
Pigs 

7.l. 
7.m.  Goats 
Sheep 
7.n. 
Cattle 
7.o. 
Prosimians 
7.p. 
New World Monkeys 
7.q. 
Old World Monkeys 
7.r. 
Apes 
7.s. 
Other Mammals 
7.t. 
Quail 
7.u. 
Other birds 
7.v. 
Reptiles 
7.w. 
Amphibians 
7.x. 
Fish 
7.y. 
TOTAL 
7.z. 

2 005 
1 881 
0 
0 
0 
0 
0 
0 
0 
0 
0 

0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
1 178 
5 064 

17 724 
8 642 
92 
64 
0 
15 
0 
166 
0 
0 
0 

49 
0 
0 
0 
0 
72 
0 
0 
0 
0 
0 
0 
0 
0 
26 824 

9 119 
5 955 
282 
0 
0 
1 289 
0 
599 
41 
0 
0 

0 
0 
0 
0 
0 
78 
259 
0 
0 
0 
5 087 
0 
0 
1 000 
23 709 

2 493 
0 
1 919 
0 
0 
1 494 
0 
0 
0 
0 
0 

0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
5 906 

EN 

8 033 
0 
8 239 
0 
0 
0 
0 
0 
0 
0 
0 

0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
16 272 

102 

0 
142 
0 
0 
0 
1 647 
0 
0 
0 
0 
0 

0 
0 
0 
0 
0 
0 
33 
0 
0 
0 
0 
0 
0 
0 
1 822 

12 909 
20 645 
352 
2 
0 
1 026 
0 
2 429 
0 
0 
0 

262 
0 
0 
0 
0 
18 
1 556 
0 
0 
0 
98 
0 
0 
2 170 
41 467 

5 105 
6 386 
0 
0 
0 
0 
0 
0 
0 
0 
0 

0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
11 491 

912 
5 301 
0 
0 
0 
2 544 
0 
0 
0 
0 
0 

89 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
8 846 

1 001 
4 573 
0 
0 
0 
0 
0 
0 
0 
0 
0 

0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
5 574 

315 
6 247 
0 
0 
0 
1 254 
0 
0 
0 
0 
0 

0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
7 816 

0  11 420 
0  10 161 
2 238 
0 
78 
0 
0 
0 
1 059 
0 
24 
0 
233 
0 
0 
0 
0 
0 
0 
0 

602 
0 
10 
0 
10 
0 
92 
0 
0 
0 
0 
0 
26 
0 
0 
0 
0 
0 
0 
0 
0  31 147 
0 
0 
500 
0 
500 
100 
500  57 700 

71 036 
69 933 
13 122 
144 
0 
10 328 
24 
3 427 
41 
0 
0 

1 002 
10 
10 
92 
0 
168 
1 874 
0 
0 
0 
36 332 
0 
500 
4 948 
212 991 

EN 

 
  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
TABLE 8:  NUMBER OF ANIMALS USED IN TOXICOLOGICAL AND OTHER SAFETY EVALUATIONS 

8.1 
Products 

Types of tests versus products 

8.2 
Acute and sub-acute toxicity testing 
methods (including limit test) 

8.3 
Skin 
irritation 

8.4 
Skin 
sensitisatio
n 

8.5 
Eye 
irritation 

8.7 
Carcino 
genicity 

8.8 
Develop- 
mental 
toxicity 

8.9 
Muta- 
genicit
y 

8.10 
Repro-
ductive 
toxicity 

8.6 
Sub- 
chronic 
and 
chronic 
toxicity 

8.11 
Toxicity 
to aquatic 
vertebra-
tes not 
included 
in other 
columns 

8.12 
Other 

8.13 
Total 

8.2.1. 
LD50, 
LC50 

8.2.2 
Other lethal 
methods 

8.2.3 
Non lethal 
clinical signs 
methods 

2 016 

13 462 

15 447 

1 216 

6 197 

792 

18 681 

5 623 

3 485 

5 016 

5 643 

0  20 038 

97 616 

8.a. 

8.b. 

8.c. 

8.d. 

8.e. 

8.f. 

8.g. 

8.h. 

Products/substances  or  devices 
for 
human  medicine  and  dentistry  and  for 
veterinary medicine 
Products/substances used or intended to 
be used mainly in agriculture 
Products/substances used or intended to 
be used mainly in industry 
Products/substances used or intended to 
be used mainly in the household 
Products/substances used or intended to 
be  used  mainly  as  cosmetics  or 
toiletries 
Products/substances used or intended to 
be used mainly as additives in food for 
human consumption 
Products/substances used or intended to 
be used mainly as additives in food for 
animal consumption 
Potential  or  actual  contaminants  in  the 
general  environment  which  do  not 
appear in other columns 
toxicological 

safety 

or 

8.i.  Other 

evaluations 
TOTAL 

8.j. 

2 111 

1 683 

1 865 

102 

568 

1 080 

1 218 

2 455 

56 

5 896 

1 723 

119 

9 156 

2 488 

230 

972 

133 

0 

36 

67 

0 

684 

413 

2 222 

281 

966 

123 

185 

0 

0 

0 

19 

0 

0 

0 

0 

0 

467 

0 

24 

1 350 

0 

1 289 

287 

18 

349 

0 

0 

0 

0 

0 

0 

0 

0 

0 

0 

666 

873 

0 

0 

2 

0 

368 

213 

0 

0 

0 

8 

0 

0 

134 

555 

0 

15 021 

0 

0 

0 

0 

0 

0 

0 

0 

34 

18 965 

45 

299 

0 

5 496 

0 

155 

772 

0  31 012 

31 221 

592 

0 

1 044 

4 562 

409 

6 943 

1 779 

372 

2 096 

367 

18 251 

473 

2 298 

2 042 

1 180 

0 

2 829 

39 039 

5 104 

24 824 

21 588 

4 594 

11 869 

1 682 

54 767 

10 331 

7 690 

7 281 

7 549 

555  55 157 

212 991 

EN 

103 

EN 

 
  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
HUNGARY 

Statistical data submitted 

The statistical data have been submitted by the Ministry of Agriculture and Rural Development. 

Comments of the Hungarian authorities 

2005  was  the  first  year  when  Hungarian  user  establishments  furnished  data  on  the  number  of  animals 
used  for  experimental  and  other  scientific  purposes  in  the  harmonized  eight  table  version  of  statistical 
reporting format. Furthermore, the data in this format were supplied on a voluntary basis. (The Hungarian 
law  in  force  prescribes  the  use  of  the  former  5-table  version  for  statistical  reporting.)  This  situation 
resulted in two consequences. 

1. It is very difficult to compare the data of 2005 with those of the previous years when the former 5-table 
version had been in use. 

2. The novelty and unfamiliarity of the tables and lack of sufficient guidance on the meaning of the new 
columns may have had a negative impact on the accuracy and coherence of data. (For example, in Tables 
5  and  6  the  non  mutually  exclusive  classification  of  regulatory  requirements  may  have  corrupted  the 
precision of the breakdown of the total figures.)  

All the above circumstances warrant caution in interpreting the data.  

Comments relating to the number of animals used 

The  total  number  of  animals  used  for  experimental  and  other  scientific  purposes  in  2005  was  297.209 
which represents 19% decrease compared to the same figure of 2004. (It  is worth  to note  that  the total 
number  of  animals  had  been  relatively  stable  (365-377  thousand)  in  the  period  of  2001-2004).  The 
decrease was 25% in the number of mice, 7% in case of rats, 28% for guinea-pigs, 66% in other rodents 
and  47%  within  birds.  The  number  of  used  dogs  and  cats  practically  did  not  change.  In  contrast  to  the 
general  decreasing  tendency  the  use  of  fish  more  than  doubled  (+138%)  while  the  number  of  rabbits 
increased by 9%.  

Despite  the  considerable  reduction  in  the  number  of  rodents  from  year  2004  to  year  2005  (~59.000 
animals) this group kept its proportion (86.4%) within the total number of animals. Notable changes can 
be observed in the proportion of birds (a drop from 8.9% to 5.9%) and that of fish (an increase from 1.1% 
to 3%). 

Due to the limiting conditions described above, however, it cannot be fairly judged whether these changes 
represent the beginning of a longer-term tendency or just reflect natural variation of the data. 

When analysed by the purposes of the use of animals a slight increase can be observed in the fundamental 
biological  research  segment  (3.7%)  while  the  number  of  animals  substantially  decreased  in  education 
(51%), in diagnosis of disease and toxicological evaluations (32% each) and in the human and veterinary 
medicine  field  (21%)  including  research,  development,  production  and  quality  control.  However,  in 
absolute  numbers  the  latter  decrease  (48.671)  accounts  for  more  than  two  thirds  of  the  total  decrease 
(68.008).  

Compared to 2004 the proportion of fundamental research in overall usage augmented from 21% to 27% 
while that of medicine related use decreased from 62% to 60%. Toxicological and safety investigations 
form the third largest part (10%) of animal usage.  

EN 

104 

   EN 

 
TABLE 1:  NUMBER OF ANIMALS USED IN RELATION TO THEIR PLACE OF ORIGIN 

1.1 
Species 

Origin versus species 

1.2  
Total 

1.3 
Animals coming from registered 
breeding or supplying 
establishments within the reporting 
country 

1.4 
Animals coming from 
elsewhere in the EC 

1.6 
Animals coming from 
other origins 

1.7 
Re-used animals 

1.5 
Animals coming from 
Member Countries of the 
Council of Europe which are 
parties to the Convention ETS 
123 (excluding EC Member 
States) 

Rats (Rattus norvegicus) 
Guinea-Pigs (Cavia porcellus) 
Hamsters (Mesocricetus ) 
Other Rodents (other Rodentia) 
Rabbits (Oryctolagus cuniculus) 
Cats (Felis catus) 
Dogs (Canis familiaris) 
Ferrets (Mustela putorius furo) 
Other Carnivores (other Carnivora) 
Horses, donkeys and cross breds (Equidae) 
Pigs (Sus) 

1.a.  Mice (Mus musculus) 
1.b. 
1.c. 
1.d. 
1.e. 
1.f. 
1.g. 
1.h. 
1.i. 
1.j. 
1.k. 
1.l. 
1.m.  Goats (Capra) 
1.n. 
1.o. 
1.p. 
1.q. 
1.r. 
1.s. 
1.t. 
1.u. 
1.v. 
1.w. 
1.x. 
1.y. 
1.z. 

Sheep (Ovis) 
Cattle (Bos) 
Prosimians (Prosimia) 
New World Monkeys (Ceboidea) 
Old World Monkeys (Cercopithecoidea) 
Apes (Hominoidea) 
Other Mammals (other Mammalia) 
Quail (Coturnix coturnix) 
Other birds (other Aves) 
Reptiles (Reptilia) 
Amphibians (Amphibia) 
Fish (Pisces) 
TOTAL 

106993 
102798 
4688 
137 

8640 
121 
966 
0 

0 
0 
3 
0 

93 

29067 
6681 
3672 
0 

0 
0 
104 
0 

0 
0 
0 
0 

0 

0 
0 
0 
0 

0 
0 
0 
0 

0 
0 
0 
0 

0 

2252 
0 
0 
0 

512 
3 
136 
0 

0 
0 
3 
0 

190 

0 
0 
0 
0 

0 
0 
0 
0 

138312 
109479 
8360 
137 
381 
9152 
124 
1206 
0 
0 
6 
882 
2 
381 
32 
0 
0 
6 
0 
0 
283 
17151 
25 
1709 
9581 
297209 

Note 1:  Column  1.5  concerns  only  those  Member  Countries  of  the  Council  of  Europe  which,  at  the  beginning  of  the  reporting  period,  are  Parties  to  the  Convention  ETS  123.  Thus  an 

updated list of those countries has to be used when filling in this column. 

Note 2:  Only the white boxes need to be completed. 

Note 3: 

The number of re-used animals in column 1.7 should be excluded from the total in the column 1.2 

EN 

105 

EN 

 
  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
TABLE 2:  NUMBER OF ANIMALS USED IN EXPERIMENTS FOR SELECTED PURPOSES 

2.1 
Species 

2.2  
Biological 
studies of a 
fundamenta
l nature 

Purpose versus species 

2.4 
Production and 
quality control of 
products and 
devices for 
human medicine 
and dentistry 

2.5 
Production and 
quality control of 
products and 
devices for 
veterinary 
medicine 

2.6 
Toxicological 
and other safety 
evaluations 
(including 
safety 
evaluation of 
products and 
devices for 
human 
medicine and 
dentistry and 
for veterinary 
medicine) 

2.3 
Research and 
development of 
products and 
devices for human 
medicine and 
dentistry and for 
veterinary 
medicine 
(excluding 
toxicological and 
other safety 
evaluations 
counted in column 
2.6) 

2.7 
Diagnosis of 
disease 

2.8 
Education and 
training 

2.9 
Other 

2.10 
Total 

2.a.  Mice 
Rats 
2.b. 
Guinea-Pigs 
2.c. 
Hamsters 
2.d. 
Other Rodents 
2.e. 
Rabbits 
2.f. 
Cats 
2.g. 
Dogs 
2.h. 
Ferrets 
2.i. 
Other Carnivores 
2.j. 
Horses,  donkeys  and  cross 
2.k. 
breds 
Pigs 

2.l. 
2.m.  Goats 
Sheep 
2.n. 
Cattle 
2.o. 
Prosimians 
2.p. 
New World Monkeys 
2.q. 
Old World Monkeys 
2.r. 
Apes 
2.s. 
Other Mammals 
2.t. 
Quail 
2.u. 
Other birds 
2.v. 
Reptiles 
2.w. 
Amphibians 
2.x. 
Fish 
2.y. 

31950 
35834 
771 
137 
0 
1146 
109 
273 
0 
0 
0 

173 
0 
19 
6 
0 
0 
6 
0 
0 
93 
3068 
25 
458 
5365 

67452 
64523 
2417 
0 
81 
3995 
0 
92 
0 
0 
0 

261 
0 
189 
12 
0 
0 
0 
0 
0 
0 
8070 
0 
0 
0 

22717 
0 
2562 
0 
0 
3011 
0 
0 
0 
0 
0 

0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
132 
0 
0 
0 

EN 

0 
0 
0 
0 
0 
24 
0 
0 
0 
0 
0 

0 
0 
24 
0 
0 
0 
0 
0 
0 
0 
3165 
0 
0 
0 

106 

8125 
7625 
2554 
0 
300 
702 
0 
633 
0 
0 
0 

26 
0 
4 
8 
0 
0 
0 
0 
0 
190 
2244 
0 
0 
3330 

7050 
0 
16 
0 
0 
105 
0 
0 
0 
0 
0 

55 
0 
3 
0 
0 
0 
0 
0 
0 
0 
360 
0 
0 
0 

988 
1497 
22 
0 
0 
167 
15 
208 
0 
0 
6 

82 
2 
2 
6 
0 
0 
0 
0 
0 
0 
109 
0 
1251 
386 

30 
0 
18 
0 
0 
2 
0 
0 
0 
0 
0 

285 
0 
140 
0 
0 
0 
0 
0 
0 
0 
3 
0 
0 
500 

138312 
109479 
8360 
137 
381 
9152 
124 
1206 
0 
0 
6 

882 
2 
381 
32 
0 
0 
6 
0 
0 
283 
17151 
25 
1709 
9581 

EN 

 
  
2.z. 

TOTAL 

79433 

147092 

28422 

3213 

25741 

7589 

4741 

978 

297209 

EN 

107 

EN 

 
  
TABLE 3:  NUMBER OF ANIMALS USED IN TOXICOLOGICAL AND OTHER SAFETY EVALUATIONS 

Products versus species 

3.1 
Species 

3.2  
Products/ 
substances or 
devices for 
human 
medicine and 
dentistry and 
for veterinary 
medicine 

3.3 
Products/ 
substances 
used or 
intended to 
be used 
mainly in 
agriculture 

3.4 
Products/ 
substances 
used or 
intended to 
be used 
mainly in 
industry 

3.5 
Products/ 
substances 
used or 
intended to 
be used 
mainly in 
the 
household 

3.6 
Products/ 
substances 
used or 
intended to 
be used 
mainly as 
cosmetics 
or toiletries 

3.a.  Mice 
Rats 
3.b. 
Guinea-Pigs 
3.c. 
Hamsters 
3.d. 
Other Rodents 
3.e. 
Rabbits 
3.f. 
Cats 
3.g. 
Dogs 
3.h. 
Ferrets 
3.i. 
Other Carnivores 
3.j. 
Horses, donkeys and cross breds 
3.k. 
3.l. 
Pigs 
3.m.  Goats 
Sheep 
3.n. 
Cattle 
3.o. 
Prosimians 
3.p. 
New World Monkeys 
3.q. 
Old World Monkeys 
3.r. 
Apes 
3.s. 
Other Mammals 
3.t. 
Quail 
3.u. 
Other birds 
3.v. 
Reptiles 
3.w. 
Amphibians 
3.x. 
Fish 
3.y. 
TOTAL 
3.z. 

2994 
1556 
208 
0 
300 
55 
0 
296 
0 
0 
0 
6 
0 
4 
8 
0 
0 
0 
0 
0 
0 
1444 
0 
0 
1000 
7871 

321 
1317 
2 
0 
0 
18 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
190 
0 
0 
0 
430 
2278 

0 
13 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
13 

0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 

0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 

3.7 
Products/ 
substances 
used or 
intended to be 
used mainly 
as additives in 
food for 
human 
consumption 
0 
52 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
52 

3.8 
Products/ 
substances 
used or 
intended to be 
used mainly 
as additives in 
food for 
animal 
consumption 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 

3.11 
Total 

3.10 
Other toxico- 
logical or 
safety 
evaluations 

3.9 
Potential or 
actual contami- 
nents in the 
general envi- 
ronment which 
do not appear in 
other columns 

556 
394 
0 
0 
0 
0 
0 
0 
0 
0 
0 
20 
0 
0 
0 
0 
0 
0 
0 
0 
0 
800 
0 
0 
1000 
2770 

4254 
4293 
2344 
0 
0 
629 
0 
337 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
900 
12757 

8125 
7625 
2554 
0 
300 
702 
0 
633 
0 
0 
0 
26 
0 
4 
8 
0 
0 
0 
0 
0 
190 
2244 
0 
0 
3330 
25741 

EN 

108 

EN 

 
  
TABLE 4:  NUMBER OF ANIMALS USED IN EXPERIMENTS FOR STUDIES ON HUMAN AND ANIMAL DISEASES 

4.1 
Species 

4.2  
Human cardiovascular 
diseases 

4.3 
Human nervous and 
mental disorders 

4.4 
Human cancer (excluding 
evaluations of carcinogenic 
hazards or risks) 

4.5 
Other human diseases 

4.6 
Studies specific to animal 
diseases 

4.7 
Total 

Main categories versus species 

4.a.  Mice 
Rats 
4.b. 
Guinea-Pigs 
4.c. 
Hamsters 
4.d. 
Other Rodents 
4.e. 
Rabbits 
4.f. 
Cats 
4.g. 
Dogs 
4.h. 
Ferrets 
4.i. 
Other Carnivores 
4.j. 
Horses, donkeys and cross breds 
4.k. 
4.l. 
Pigs 
4.m.  Goats 
Sheep 
4.n. 
Cattle 
4.o. 
Prosimians 
4.p. 
New World Monkeys 
4.q. 
Old World Monkeys 
4.r. 
Apes 
4.s. 
Other Mammals 
4.t. 
Quail 
4.u. 
Other birds 
4.v. 
Reptiles 
4.w. 
Amphibians 
4.x. 
Fish 
4.y. 
TOTAL 
4.z. 

2146 
3601 
59 
0 
0 
350 
0 
165 
0 
0 
0 
61 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
6382 

55622 
54589 
93 
0 
75 
2753 
0 
9 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
818 
0 
0 
0 
113959 

7607 
1003 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
8610 

13195 
6056 
2167 
0 
6 
196 
0 
18 
0 
0 
0 
14 
0 
3 
0 
0 
0 
0 
0 
0 
0 
10 
0 
0 
0 
21665 

5982 
15 
301 
0 
0 
707 
0 
43 
0 
0 
0 
189 
0 
277 
20 
0 
0 
0 
0 
0 
0 
9906 
0 
0 
300 
17740 

84552 
65264 
2620 
0 
81 
4006 
0 
235 
0 
0 
0 
264 
0 
280 
20 
0 
0 
0 
0 
0 
0 
10734 
0 
0 
300 
168356 

EN 

109 

EN 

 
  
TABLE 5:  NUMBER OF ANIMALS USED IN PRODUCTION AND QUALITY CONTROL OF PRODUCTS AND DEVICES FOR 
HUMAN MEDICINE AND DENTISTRY AND FOR VETERINARY MEDICINE 

5.1 
Species 

Regulatory requirements versus species 

5.2  
National legislation 
specific to a single EC 
Member State 
1) 

5.3 
EC legislation 
including European 
Pharmacopoeia 
(requirements) 

5.4 
Member Country of Council 
of Europe (but not EC) 
legislation 
2) 

5.5 
Other legislation 

5.6 
Any combination of  
5.2/ 5.3/ 5.4/ 5.5 

5.7 
No regulatory 
requirements 

5.8 
Total 

5.a.  Mice 
Rats 
5.b. 
Guinea-Pigs 
5.c. 
Hamsters 
5.d. 
Other Rodents 
5.e. 
Rabbits 
5.f. 
Cats 
5.g. 
Dogs 
5.h. 
Ferrets 
5.i. 
Other Carnivores 
5.j. 
Horses, donkeys and cross breds 
5.k. 
Pigs 
5.l. 
5.m.  Goats 
Sheep 
5.n. 
Cattle 
5.o. 
Prosimians 
5.p. 
New World Monkeys 
5.q. 
Old World Monkeys 
5.r. 
Apes 
5.s. 
Other Mammals 
5.t. 
Quail 
5.u. 
Other birds 
5.v. 
Reptiles 
5.w. 
Amphibians 
5.x. 
Fish 
5.y. 
5.z. 
TOTAL 
Examples: 

Footnotes: 

EN 

0 
0 
0 
0 
0 
24 
0 
0 
0 
0 
0 
0 
0 
24 
0 
0 
0 
0 
0 
0 
0 
100 
0 
0 
0 
148 

17952 
0 
1317 
0 
0 
2981 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
3065 
0 
0 
0 
25315 

0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 

425 
0 
88 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
2 
0 
0 
0 
515 
columns 5.2 - 5.5 refer to the legislation imposing that the test be carried out and 
not to the body which has issued the actual test method, guideline or protocol. 

4340 
0 
1157 
0 
0 
30 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
130 
0 
0 
0 
5657 

0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 

22717 
0 
2562 
0 
0 
3035 
0 
0 
0 
0 
0 
0 
0 
24 
0 
0 
0 
0 
0 
0 
0 
3297 
0 
0 
0 
31635 

5.2 – France is testing due to a UK (or FR) specific requirement 
5.3 - UK is testing according to EC legislation 
5.4 – Spain is testing due to a Hungarian requirement 
5.5 – Sweden is testing due to a US specific requirement 
5.6  –  Germany  is  testing  due  to  a  Czech  requirement  (also  an  EC 
requirement) 
1)  EC Member States: Austria, Belgium, Denmark, Finland, France, Germany, Greece, Ireland, Italy, Luxembourg, Netherlands, Portugal, Spain, Sweden, United Kingdom 

ISO protocol must be coded as a national (FR) legislative requirement and be 
entered into column 5.2 in the tables submitted by Belgium. 

Example:  a test required by French legislation and carried out in Belgium according to an 

Note: 

110 

EN 

 
  
 
 
 
 
 
 
 
2)  Member  Countries  of  Council  of  Europe  (non-EC):  Albania,  Andorra,  Bulgaria,  Croatia,  Cyprus,  Czech  Rep.,  Estonia,  Hungary,  Iceland,  Latvia,  Liechtenstein,  Lithuania, 

Malta, Moldova, Norway, Poland, Romania, Russia, San Marino, Slovakia, Slovenia, Switzerland, ‘the former Yugoslav Rep. of Macedonia’, Turkey, Ukraine 

EN 

111 

EN 

 
  
 
TABLE 6:  NUMBER OF ANIMALS USED IN TOXICOLOGICAL AND OTHER SAFETY EVALUATIONS 

Regulatory requirements versus species 

6.1 
Species 

6.2  
National legislation 
specific to a single EC 
Member State 
1) 

6.3 
EC legislation 
including European 
Pharmacopoeia 
(requirements) 

6.4 
Member Country of Council 
of Europe (but not EC) 
legislation 
2) 

6.5 
Other legislation 

6.6 
Any combination of  
6.2/ 6.3/ 6.4/ 6.5 

6.7 
No regulatory 
requirements 

6.8 
Total 

6.a.  Mice 
Rats 
6.b. 
Guinea-Pigs 
6.c. 
Hamsters 
6.d. 
Other Rodents 
6.e. 
Rabbits 
6.f. 
Cats 
6.g. 
Dogs 
6.h. 
Ferrets 
6.i. 
Other Carnivores 
6.j. 
Horses, donkeys and cross breds 
6.k. 
6.l. 
Pigs 
6.m.  Goats 
Sheep 
6.n. 
Cattle 
6.o. 
Prosimians 
6.p. 
New World Monkeys 
6.q. 
Old World Monkeys 
6.r. 
Apes 
6.s. 
Other Mammals 
6.t. 
Quail 
6.u. 
Other birds 
6.v. 
Reptiles 
6.w. 
Amphibians 
6.x. 
Fish 
6.y. 
6.z. 
TOTAL 
Examples: 

2779 
945 
0 
0 
0 
6 
0 
242 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
1000 
4972 

1839 
900 
946 
0 
300 
76 
0 
60 
0 
0 
0 
6 
0 
4 
8 
0 
0 
0 
0 
0 
190 
1182 
0 
0 
1430 
6941 

148 
646 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
794 

0 
13 
0 
0 
0 
0 
0 
0 
0 
0 
0 
20 
0 
0 
0 
0 
0 
0 
0 
0 
0 
1062 
0 
0 
0 
1095 
columns 6.2 - 6.5 refer to the legislation imposing that the test be carried out and 
not to the body which has issued the actual test method, guideline or protocol. 

3359 
5121 
1608 
0 
0 
620 
0 
331 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
900 
11939 

0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 

8125 
7625 
2554 
0 
300 
702 
0 
633 
0 
0 
0 
26 
0 
4 
8 
0 
0 
0 
0 
0 
190 
2244 
0 
0 
3330 
25741 

6.2 – France is testing due to a UK (or FR) specific requirement 
6.3 - UK is testing according to EC legislation 
6.4 – Spain is testing due to a Hungarian requirement 
6.5 – Sweden is testing due to a US specific requirement 
6.6  –  Germany  is  testing  due  to  a  Czech  requirement  (also  an  EC 
requirement) 
1)  EC Member States: Austria, Belgium, Denmark, Finland, France, Germany, Greece, Ireland, Italy, Luxembourg, Netherlands, Portugal, Spain, Sweden, United Kingdom 
2)  Member Countries of Council of Europe (non-EC): Albania, Andorra, Bulgaria, Croatia, Cyprus, Czech Rep., Estonia, Hungary, Iceland, Latvia, Liechtenstein, Lithuania, Malta, 

ISO protocol must be coded as a national (FR) legislative requirement and be 
entered into column 6.2 in the tables submitted by Belgium. 

Example:  a test required by French legislation and carried out in Belgium according to an 

Note: 

Moldova, Norway, Poland, Romania, Russia, San Marino, Slovakia, Slovenia, Switzerland, ‘the former Yugoslav Rep. of Macedonia’, Turkey, Ukraine 

112 

EN 

Footnotes: 

EN 

 
  
 
 
 
 
 
 
 
 
TABLE 7:  NUMBER OF ANIMALS USED IN TOXICOLOGICAL AND OTHER SAFETY EVALUATIONS 

7.1 
Species 

7.2 
Acute and sub-acute toxicity testing methods 
(including limit test) 

7.3 
Skin 
irritation 

7.4 
Skin 
sensitisatio
n 

7.5 
Eye 
irritation 

7.6 
Sub- 
chronic and 
chronic 
toxicity 

7.7 
Carcino- 
genicity 

7.8 
Develop- 
mental 
toxicity 

7.9 
Muta- 
genicit
y 

7.10 
Repro-
ductive 
toxicity 

Types of tests versus species 

7.2.1. 
LD50, 
LC50 

7.2.2 
Other lethal 
methods 

7.2.3 
Non lethal 
clinical signs 
methods 

7.a.  Mice 
Rats 
7.b. 
Guinea-Pigs 
7.c. 
Hamsters 
7.d. 
Other Rodents 
7.e. 
Rabbits 
7.f. 
Cats 
7.g. 
Dogs 
7.h. 
Ferrets 
7.i. 
Other Carnivores 
7.j. 
Horses,  donkeys  and  cross 
7.k. 
breds 
Pigs 

7.l. 
7.m.  Goats 
Sheep 
7.n. 
Cattle 
7.o. 
Prosimians 
7.p. 
New World Monkeys 
7.q. 
Old World Monkeys 
7.r. 
Apes 
7.s. 
Other Mammals 
7.t. 
Quail 
7.u. 
Other birds 
7.v. 
Reptiles 
7.w. 
Amphibians 
7.x. 
Fish 
7.y. 
TOTAL 
7.z. 

1781 
160 
368 
0 
0 
0 
0 
0 
0 
0 
0 

0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
2330 
4639 

427 
529 
0 
0 
0 
0 
0 
0 
0 
0 
0 

0 
0 
0 
0 
0 
0 
0 
0 
0 
110 
0 
0 
0 
0 
1066 

2282 
2915 
419 
0 
300 
64 
0 
311 
0 
0 
0 

6 
0 
4 
8 
0 
0 
0 
0 
0 
80 
1008 
0 
0 
900 
8297 

0 
0 
0 
0 
0 
143 
0 
0 
0 
0 
0 

0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
143 

EN 

0 
0 
0 
0 
0 
111 
0 
0 
0 
0 
0 

0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
111 

40 
1129 
0 
0 
0 
0 
0 
200 
0 
0 
0 

0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
1369 

0 
47 
0 
0 
0 
0 
0 
0 
0 
0 
0 

0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
47 

6 
6 
0 
0 
0 
0 
0 
0 
0 
0 
0 

0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
100 
112 

1068 
13 
0 
0 
0 
0 
0 
0 
0 
0 
0 

0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
1081 

0 
773 
0 
0 
0 
252 
0 
0 
0 
0 
0 

0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
1025 

0 
0 
1091 
0 
0 
0 
0 
0 
0 
0 
0 

0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
1091 

113 

7.12 
Other 

7.13 
Total 

7.11 
Toxicity 
to aquatic 
vertebra-
tes not 
included 
in other 
columns 

0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 

0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 

2521 
2053 
676 
0 
0 
132 
0 
122 
0 
0 
0 

20 
0 
0 
0 
0 
0 
0 
0 
0 
0 
1236 
0 
0 
0 
6760 

8125 
7625 
2554 
0 
300 
702 
0 
633 
0 
0 
0 

26 
0 
4 
8 
0 
0 
0 
0 
0 
190 
2244 
0 
0 
3330 
25741 

EN 

 
  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
TABLE 8:  NUMBER OF ANIMALS USED IN TOXICOLOGICAL AND OTHER SAFETY EVALUATIONS 

8.1 
Products 

Types of tests versus products 

8.2 
Acute and sub-acute toxicity testing 
methods (including limit test) 

8.3 
Skin 
irritation 

8.4 
Skin 
sensitisatio
n 

8.5 
Eye 
irritation 

8.7 
Carcino 
genicity 

8.8 
Develop- 
mental 
toxicity 

8.9 
Muta- 
genicit
y 

8.10 
Repro-
ductive 
toxicity 

8.6 
Sub- 
chronic 
and 
chronic 
toxicity 

8.12 
Other 

8.13 
Total 

8.11 
Toxicity 
to aquatic 
vertebra-
tes not 
included 
in other 
columns 

8.a. 

8.b. 

8.c. 

8.d. 

8.e. 

8.f. 

8.g. 

8.h. 

for 
Products/substances  or  devices 
human  medicine  and  dentistry  and  for 
veterinary medicine 
Products/substances used or intended to 
be used mainly in agriculture 
Products/substances used or intended to 
be used mainly in industry 
Products/substances used or intended to 
be used mainly in the household 
Products/substances used or intended to 
be  used  mainly  as  cosmetics  or 
toiletries 
Products/substances used or intended to 
be used mainly as additives in food for 
human consumption 
Products/substances used or intended to 
be used mainly as additives in food for 
animal consumption 
Potential  or  actual  contaminants  in  the 
general  environment  which  do  not 
appear in other columns 
toxicological 

safety 

or 

8.i.  Other 

evaluations 
TOTAL 

8.j. 

EN 

8.2.1. 
LD50, 
LC50 

8.2.2 
Other lethal 
methods 

8.2.3 
Non lethal 
clinical signs 
methods 

2778 

24 

2924 

9 

490 

110 

1425 

12 

0 

0 

0 

0 

0 

1000 

0 

0 

0 

0 

0 

0 

0 

0 

0 

52 

0 

760 

371 

932 

3136 

4639 

1066 

8297 

0 

0 

0 

0 

0 

0 

122 

143 

114 

0 

0 

0 

0 

0 

0 

0 

0 

1091 

0 

0 

111 

80 

0 

0 

0 

0 

0 

0 

0 

0 

0 

0 

0 

0 

0 

1289 

1091 

111 

1369 

0 

0 

0 

0 

0 

0 

0 

100 

0 

0 

0 

0 

0 

0 

0 

0 

13 

0 

0 

0 

0 

0 

0 

0 

0 

0 

0 

0 

0 

2036 

7871 

0 

0 

0 

0 

0 

0 

158 

2386 

0 

0 

0 

0 

0 

13 

0 

0 

52 

0 

47 

12 

0 

131 

0 

820 

2770 

0 

47 

0 

1068 

894 

112 

1081 

1025 

0 

0 

3746 

12649 

6760 

25741 

EN 

 
  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
IRELAND  

Statistical data submitted 

The statistical data for Ireland have been provided by the Department of Health and Children. 

Comments of Irish authorities  

General 

-A total of 37,940 animals were used. This represents a reduction of 27% compared to 2002 
(the last published figures). 

- There were 539 valid licences during the period 1 January 2005 – 31 December 2005. 

- 171 new licences were issued in 2005. This is an increase of 13% compared to 2002. 

- Rodents accounted for 67% of all animals used. 

- No primates were used. This was in accordance with Ireland’s policy not to licence for the 
use of primates. 

-  Of  the  animals  used,  39%  (14,779)  were  bred  in  registered  breeding  establishments  in 
Ireland. 

-  Universities  and  Colleges  accounted  for  76%  (28,904)  of  all  animals  used  in  scientific 
procedures. 

- 58% of all procedures (21,929) used no anaesthesia (Certificate A). Certificate A is granted 
where the anaesthesia  is  considered  to  be more traumatic to the animal than the experiment 
itself or where anaesthesia is incompatible with the object of the experiment. 

-  20%  of  animals  (7,557)  were  used  in  procedures  involving  anaesthesia  with  permitted 
recovery (Certificate B). 

-  3,336  genetically  modified  animals  were  used  in  experimental  activity.  This  represents 
approximately 9% of the total numbers used. 

Animals Used for Selected Purposes  

- 9% of animals (3,472) were involved in studies specific to animal diseases. 

-  Of  the  382  pigs  used  in  2005,  69%  (263)  were  involved  in  studies  on  human  and  animal 
diseases. 

- 119 cats were used, 64 of which were used in toxicology and other safety evaluations. 

- 167 dogs were used, a reduction of 14% since 2002. 

- Education and training accounted for 2% (688) of the animals used. 

- Of the 2,024 other birds, 95% (1,914) were used in behavioural studies. 

EN 

115 

   EN 

 
- 82% (313) of the rabbits used were for the study of human cardiovascular diseases. 

- 189 horses were used, an increase of 170 since 2002. 91% of the horses used were for EC 
legislation  including  European  Pharmacopoeia  requirements.  117  of  the  horses  were  used 
with a Certificate A. Certificate A is granted where the anaesthesia is considered to be more 
traumatic to the animal than the experiment itself or where anaesthesia is incompatible with 
the object of the experiment. 

Toxicological and other Safety Evaluations 

- No animals were used in the testing of cosmetic products. 

- Toxicological and other safety evaluations accounted for 18% (6,869) of animals used. 

- 98% of the animals used in toxicological and other safety evaluations were mice. 

- 875 mice were used in LD50 and LC50 testing, a reduction of 33% since 2002.  

EN 

116 

   EN 

 
TABLE 1:  NUMBER OF ANIMALS USED IN RELATION TO THEIR PLACE OF ORIGIN 

1.1 
Species 

Origin versus species 

1.2  
Total 

1.3 
Animals coming from registered 
breeding or supplying 
establishments within the reporting 
country 

1.4 
Animals coming from 
elsewhere in the EC 

Rats (Rattus norvegicus) 
Guinea-Pigs (Cavia porcellus) 
Hamsters (Mesocricetus ) 
Other Rodents (other Rodentia) 
Rabbits (Oryctolagus cuniculus) 
Cats (Felis catus) 
Dogs (Canis familiaris) 
Ferrets (Mustela putorius furo) 
Other Carnivores (other Carnivora) 
Horses, donkeys and cross breds (Equidae) 
Pigs (Sus) 

1.a.  Mice (Mus musculus) 
1.b. 
1.c. 
1.d. 
1.e. 
1.f. 
1.g. 
1.h. 
1.i. 
1.j. 
1.k. 
1.l. 
1.m.  Goats (Capra) 
1.n. 
1.o. 
1.p. 
1.q. 
1.r. 
1.s. 
1.t. 
1.u. 
1.v. 
1.w. 
1.x. 
1.y. 
1.z. 

Sheep (Ovis) 
Cattle (Bos) 
Prosimians (Prosimia) 
New World Monkeys (Ceboidea) 
Old World Monkeys (Cercopithecoidea) 
Apes (Hominoidea) 
Other Mammals (other Mammalia) 
Quail (Coturnix coturnix) 
Other birds (other Aves) 
Reptiles (Reptilia) 
Amphibians (Amphibia) 
Fish (Pisces) 
TOTAL 

8 767 
5 733 
4 

19 
119 
137 

8 532 
1 864 

360 

30 

17 776 
7 722 
4 
0 
0 
379 
119 
167 
0 
0 
189 
382 
0 
601 
2 109 
0 
0 
0 
0 
48 
0 
2024 
0 
0 
6 420 
37940 

1.6 
Animals coming from 
other origins 

1.7 
Re-used animals 

1.5 
Animals coming from 
Member Countries of the 
Council of Europe which are 
parties to the Convention ETS 
123 (excluding EC Member 
States) 

60 

477 
65 

60 
92 

Note 1:  Column 1.5 concerns only those Member Countries of the Council of Europe which, at the beginning of the reporting period, are Parties to the Convention ETS 123. Thus an updated list 

of those countries has to be used when filling in this column. 

Note 2:  Only the white boxes need to be completed. 

Note 3: 

The number of re-used animals in column 1.7 should be excluded from the total in the column 1.2 

EN 

117 

EN 

 
  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
TABLE 2:  NUMBER OF ANIMALS USED IN EXPERIMENTS FOR SELECTED PURPOSES 

2.1 
Species 

2.2  
Biological 
studies of a 
fundamenta
l nature 

Purpose versus species 

2.4 
Production and 
quality control of 
products and 
devices for 
human medicine 
and dentistry 

2.5 
Production and 
quality control of 
products and 
devices for 
veterinary 
medicine 

2.6 
Toxicological 
and other safety 
evaluations 
(including 
safety 
evaluation of 
products and 
devices for 
human 
medicine and 
dentistry and 
for veterinary 
medicine) 

2.3 
Research and 
development of 
products and 
devices for human 
medicine and 
dentistry and for 
veterinary 
medicine 
(excluding 
toxicological and 
other safety 
evaluations 
counted in column 
2.6) 

2.7 
Diagnosis of 
disease 

2.8 
Education and 
training 

2.9 
Other 

2.10 
Total 

2.a.  Mice 
Rats 
2.b. 
Guinea-Pigs 
2.c. 
Hamsters 
2.d. 
Other Rodents 
2.e. 
Rabbits 
2.f. 
Cats 
2.g. 
Dogs 
2.h. 
Ferrets 
2.i. 
Other Carnivores 
2.j. 
Horses,  donkeys  and  cross 
2.k. 
breds 
Pigs 

2.l. 
2.m.  Goats 
Sheep 
2.n. 
Cattle 
2.o. 
Prosimians 
2.p. 
New World Monkeys 
2.q. 
Old World Monkeys 
2.r. 
Apes 
2.s. 
Other Mammals 
2.t. 
Quail 
2.u. 
Other birds 
2.v. 
Reptiles 
2.w. 
Amphibians 
2.x. 
Fish 
2.y. 

9 922 
6 367 

61 

130 

62 
1417 

4 

6408 

603 
1209 
4 

304 
10 
38 

123 

1 
15 

44 

7 

6703 

158 
76 

15 
26 

45 
42 

64 
87 

15 

172 

72 
329 

10 

3 

5 

99 

463 
20 

375 
44 

14 

12 

20 

313 

110 

60 

1847 

12 

17776 
7722 
4 
0 
0 
379 
119 
167 
0 
0 
189 

382 
0 
601 
2109 
0 
0 
0 
0 
48 
0 
2024 
0 
0 
6420 

EN 

118 

EN 

 
  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
2.z. 

TOTAL 

24371 

2358 

87 

573 

6869 

357 

688 

2637 

37940 

EN 

119 

EN 

 
  
TABLE 3:  NUMBER OF ANIMALS USED IN TOXICOLOGICAL AND OTHER SAFETY EVALUATIONS 

3.1 
Species 

3.a.  Mice 
Rats 
3.b. 
Guinea-Pigs 
3.c. 
Hamsters 
3.d. 
Other Rodents 
3.e. 
Rabbits 
3.f. 
Cats 
3.g. 
Dogs 
3.h. 
Ferrets 
3.i. 
Other Carnivores 
3.j. 
Horses, donkeys and cross breds 
3.k. 
3.l. 
Pigs 
3.m.  Goats 
Sheep 
3.n. 
Cattle 
3.o. 
Prosimians 
3.p. 
New World Monkeys 
3.q. 
Old World Monkeys 
3.r. 
Apes 
3.s. 
Other Mammals 
3.t. 
Quail 
3.u. 
Other birds 
3.v. 
Reptiles 
3.w. 
Amphibians 
3.x. 
Fish 
3.y. 
TOTAL 
3.z. 

Products versus species 

3.2  
Products/ 
substances or 
devices for 
human 
medicine and 
dentistry and 
for veterinary 
medicine 

150 

3.3 
Products/ 
substances 
used or 
intended to 
be used 
mainly in 
agriculture 

3.4 
Products/ 
substances 
used or 
intended to 
be used 
mainly in 
industry 

3.5 
Products/ 
substances 
used or 
intended to 
be used 
mainly in 
the 
household 

3.6 
Products/ 
substances 
used or 
intended to 
be used 
mainly as 
cosmetics 
or toiletries 

3.7 
Products/ 
substances 
used or 
intended to be 
used mainly 
as additives in 
food for 
human 
consumption 

3.8 
Products/ 
substances 
used or 
intended to be 
used mainly 
as additives in 
food for 
animal 
consumption 

3.9 
Potential or 
actual contami- 
nents in the 
general envi- 
ronment which 
do not appear in 
other columns 

3.11 
Total 

3.10 
Other toxico- 
logical or 
safety 
evaluations 

6553 

64 
87 

15 

316 

0 

0 

0 

0 

0 

0 

0 

6553 

6703 
0 
0 
0 
0 
0 
64 
87 
0 
0 
0 
0 
0 
0 
15 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
6869 

EN 

120 

EN 

 
  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
TABLE 4:  NUMBER OF ANIMALS USED IN EXPERIMENTS FOR STUDIES ON HUMAN AND ANIMAL DISEASES 

Main categories versus species 

4.1 
Species 

4.2  
Human cardiovascular 
diseases 

4.3 
Human nervous and 
mental disorders 

4.5 
Other human diseases 

4.6 
Studies specific to animal 
diseases 

4.7 
Total 

4.a.  Mice 
Rats 
4.b. 
Guinea-Pigs 
4.c. 
Hamsters 
4.d. 
Other Rodents 
4.e. 
Rabbits 
4.f. 
Cats 
4.g. 
Dogs 
4.h. 
Ferrets 
4.i. 
Other Carnivores 
4.j. 
Horses, donkeys and cross breds 
4.k. 
4.l. 
Pigs 
4.m.  Goats 
Sheep 
4.n. 
Cattle 
4.o. 
Prosimians 
4.p. 
New World Monkeys 
4.q. 
Old World Monkeys 
4.r. 
Apes 
4.s. 
Other Mammals 
4.t. 
Quail 
4.u. 
Other birds 
4.v. 
Reptiles 
4.w. 
Amphibians 
4.x. 
Fish 
4.y. 
TOTAL 
4.z. 

675 
1386 

313 
10 

101 

1 

4 

7 

2497 

4.4 
Human cancer (excluding 
evaluations of carcinogenic 
hazards or risks) 

1155 

1927 
5379 
4 

2 

6768 
887 

50 

38 

56 

38 

23 
7335 

1155 

4790 
12627 

158 

106 

27 
1432 

44 

110 

1595 
3472 

10683 
7652 
4 
0 
0 
365 
10 
38 
0 
0 
0 
263 
0 
66 
1432 
0 
0 
0 
0 
48 
0 
117 
0 
0 
6408 
27086 

EN 

121 

EN 

 
  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
TABLE 5:  NUMBER OF ANIMALS USED IN PRODUCTION AND QUALITY CONTROL OF PRODUCTS AND DEVICES FOR HUMAN 
MEDICINE AND DENTISTRY AND FOR VETERINARY MEDICINE 

Regulatory requirements versus species 

5.1 
Species 

5.2  
National legislation 
specific to a single EC 
Member State 
1) 

5.3 
EC legislation 
including European 
Pharmacopoeia 
(requirements) 

5.4 
Member Country of Council 
of Europe (but not EC) 
legislation 
2) 

5.5 
Other legislation 

5.6 
Any combination of  
5.2/ 5.3/ 5.4/ 5.5 

5.7 
No regulatory 
requirements 

5.8 
Total 

5.a.  Mice 
Rats 
5.b. 
Guinea-Pigs 
5.c. 
Hamsters 
5.d. 
Other Rodents 
5.e. 
Rabbits 
5.f. 
Cats 
5.g. 
Dogs 
5.h. 
Ferrets 
5.i. 
Other Carnivores 
5.j. 
Horses, donkeys and cross breds 
5.k. 
Pigs 
5.l. 
5.m.  Goats 
Sheep 
5.n. 
Cattle 
5.o. 
Prosimians 
5.p. 
New World Monkeys 
5.q. 
Old World Monkeys 
5.r. 
Apes 
5.s. 
Other Mammals 
5.t. 
Quail 
5.u. 
Other birds 
5.v. 
Reptiles 
5.w. 
Amphibians 
5.x. 
Fish 
5.y. 
5.z. 
TOTAL 
Examples: 

Footnotes: 

EN 

172 

72 
286 

0 

530 

5.2 – France is testing due to a UK (or FR) specific requirement 
5.3 - UK is testing according to EC legislation 
5.4 – Spain is testing due to a Hungarian requirement 
5.5 – Sweden is testing due to a US specific requirement 
5.6  –  Germany  is  testing  due  to  a  Czech  requirement  (also  an  EC 
requirement) 
1)  EC Member States: Austria, Belgium, Denmark, Finland, France, Germany, Greece, Ireland, Italy, Luxembourg, Netherlands, Portugal, Spain, Sweden, United Kingdom 

ISO protocol must be coded as a national (FR) legislative requirement and be 
entered into column 5.2 in the tables submitted by Belgium. 

Example:  a test required by French legislation and carried out in Belgium according to an 

43 
columns 5.2 - 5.5 refer to the legislation imposing that the test be carried out and 
not to the body which has issued the actual test method, guideline or protocol. 

Note: 

87 

0 

0 

122 

EN 

45 
42 

43 

0 
0 
0 
0 
0 
0 
45 
42 
0 
0 
172 
0 
0 
72 
329 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
660 

 
  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
2)  Member  Countries  of  Council  of  Europe  (non-EC):  Albania,  Andorra,  Bulgaria,  Croatia,  Cyprus,  Czech  Rep.,  Estonia,  Hungary,  Iceland,  Latvia,  Liechtenstein,  Lithuania, 

Malta, Moldova, Norway, Poland, Romania, Russia, San Marino, Slovakia, Slovenia, Switzerland, ‘the former Yugoslav Rep. of Macedonia’, Turkey, Ukraine 

EN 

123 

EN 

 
  
 
TABLE 6:  NUMBER OF ANIMALS USED IN TOXICOLOGICAL AND OTHER SAFETY EVALUATIONS 

Regulatory requirements versus species 

6.1 
Species 

6.2  
National legislation 
specific to a single EC 
Member State 
1) 

6.3 
EC legislation 
including European 
Pharmacopoeia 
(requirements) 

6.4 
Member Country of Council 
of Europe (but not EC) 
legislation 
2) 

6.5 
Other legislation 

6.6 
Any combination of  
6.2/ 6.3/ 6.4/ 6.5 

6.7 
No regulatory 
requirements 

6.8 
Total 

5238 

1465 

6.a.  Mice 
Rats 
6.b. 
Guinea-Pigs 
6.c. 
Hamsters 
6.d. 
Other Rodents 
6.e. 
Rabbits 
6.f. 
Cats 
6.g. 
Dogs 
6.h. 
Ferrets 
6.i. 
Other Carnivores 
6.j. 
Horses, donkeys and cross breds 
6.k. 
6.l. 
Pigs 
6.m.  Goats 
Sheep 
6.n. 
Cattle 
6.o. 
Prosimians 
6.p. 
New World Monkeys 
6.q. 
Old World Monkeys 
6.r. 
Apes 
6.s. 
Other Mammals 
6.t. 
Quail 
6.u. 
Other birds 
6.v. 
Reptiles 
6.w. 
Amphibians 
6.x. 
Fish 
6.y. 
6.z. 
TOTAL 
Examples: 

64 
87 

151 

5238 

6703 
0 
0 
0 
0 
0 
64 
87 
0 
0 
0 
0 
0 
0 
15 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
6869 

15 

6.2 – France is testing due to a UK (or FR) specific requirement 
6.3 - UK is testing according to EC legislation 
6.4 – Spain is testing due to a Hungarian requirement 
6.5 – Sweden is testing due to a US specific requirement 
6.6  –  Germany  is  testing  due  to  a  Czech  requirement  (also  an  EC 
requirement) 
1)  EC Member States: Austria, Belgium, Denmark, Finland, France, Germany, Greece, Ireland, Italy, Luxembourg, Netherlands, Portugal, Spain, Sweden, United Kingdom 
2)  Member Countries of Council of Europe (non-EC): Albania, Andorra, Bulgaria, Croatia, Cyprus, Czech Rep., Estonia, Hungary, Iceland, Latvia, Liechtenstein, Lithuania, Malta, 

ISO protocol must be coded as a national (FR) legislative requirement and be 
entered into column 6.2 in the tables submitted by Belgium. 

Example:  a test required by French legislation and carried out in Belgium according to an 

15 
columns 6.2 - 6.5 refer to the legislation imposing that the test be carried out and 
not to the body which has issued the actual test method, guideline or protocol. 

Note: 

1465 

0 

0 

Moldova, Norway, Poland, Romania, Russia, San Marino, Slovakia, Slovenia, Switzerland, ‘the former Yugoslav Rep. of Macedonia’, Turkey, Ukraine 

124 

EN 

Footnotes: 

EN 

 
  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
TABLE 7:  NUMBER OF ANIMALS USED IN TOXICOLOGICAL AND OTHER SAFETY EVALUATIONS 

7.1 
Species 

7.2 
Acute and sub-acute toxicity testing methods 
(including limit test) 

7.3 
Skin 
irritation 

7.4 
Skin 
sensitisatio
n 

7.5 
Eye 
irritation 

7.6 
Sub- 
chronic and 
chronic 
toxicity 

7.7 
Carcino- 
genicity 

7.8 
Develop- 
mental 
toxicity 

7.9 
Muta- 
genicit
y 

7.10 
Repro-
ductive 
toxicity 

Types of tests versus species 

7.12 
Other 

7.13 
Total 

7.11 
Toxicity 
to aquatic 
vertebra-
tes not 
included 
in other 
columns 

7.a.  Mice 
Rats 
7.b. 
Guinea-Pigs 
7.c. 
Hamsters 
7.d. 
Other Rodents 
7.e. 
Rabbits 
7.f. 
Cats 
7.g. 
Dogs 
7.h. 
Ferrets 
7.i. 
Other Carnivores 
7.j. 
Horses,  donkeys  and  cross 
7.k. 
breds 
Pigs 

7.l. 
7.m.  Goats 
Sheep 
7.n. 
Cattle 
7.o. 
Prosimians 
7.p. 
New World Monkeys 
7.q. 
Old World Monkeys 
7.r. 
Apes 
7.s. 
Other Mammals 
7.t. 
Quail 
7.u. 
Other birds 
7.v. 
Reptiles 
7.w. 
Amphibians 
7.x. 
Fish 
7.y. 
TOTAL 
7.z. 

7.2.1. 
LD50, 
LC50 

7.2.2 
Other lethal 
methods 

875 

4363 

7.2.3 
Non lethal 
clinical signs 
methods 

1465 

64 
87 

15 

875 

4363 

15 

0 

0 

0 

1465 

0 

0 

0 

0 

0 

151 

EN 

125 

6703 
0 
0 
0 
0 
0 
64 
87 
0 
0 
0 

0 
0 
0 
15 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
6869 

EN 

 
  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
TABLE 8:  NUMBER OF ANIMALS USED IN TOXICOLOGICAL AND OTHER SAFETY EVALUATIONS 

8.1 
Products 

Types of tests versus products 

8.2 
Acute and sub-acute toxicity testing 
methods (including limit test) 

8.3 
Skin 
irritation 

8.4 
Skin 
sensitisatio
n 

8.5 
Eye 
irritation 

8.2.1. 
LD50, 
LC50 

8.2.2 
Other lethal 
methods 

8.2.3 
Non lethal 
clinical signs 
methods 

875 

4363 

15 

8.a. 

8.b. 

8.c. 

8.d. 

8.e. 

8.f. 

8.g. 

8.h. 

for 
Products/substances  or  devices 
human  medicine  and  dentistry  and  for 
veterinary medicine 
Products/substances used or intended to 
be used mainly in agriculture 
Products/substances used or intended to 
be used mainly in industry 
Products/substances used or intended to 
be used mainly in the household 
Products/substances used or intended to 
be  used  mainly  as  cosmetics  or 
toiletries 
Products/substances used or intended to 
be used mainly as additives in food for 
human consumption 
Products/substances used or intended to 
be used mainly as additives in food for 
animal consumption 
Potential  or  actual  contaminants  in  the 
general  environment  which  do  not 
appear in other columns 
toxicological 

safety 

or 

8.i.  Other 

8.7 
Carcino 
genicity 

8.8 
Develop- 
mental 
toxicity 

8.9 
Muta- 
genicit
y 

8.10 
Repro-
ductive 
toxicity 

8.6 
Sub- 
chronic 
and 
chronic 
toxicity 

8.12 
Other 

8.13 
Total 

8.11 
Toxicity 
to aquatic 
vertebra-
tes not 
included 
in other 
columns 

1465 

151 

6869 

0 

0 

0 

0 

0 

0 

0 

0 

evaluations 
TOTAL 

8.j. 

EN 

875 

4363 

15 

0 

0 

0 

0 

0 

0 

0 

0 

1465 

151 

6869 

126 

EN