EN    EN  COMMISSION OF THE E UROPEAN 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 Nu mber of Animals used for Experimental and 
other Scientific Purposes in the Member States of the European Union 
 
 
{COM (2007) 675 final}
 
EN 2   EN Important notice 
This Report is a document of the Commission serv ices and cannot be considered binding to 
this institution in any way.
 
EN 3   EN PART B I: DATA AND SUMMARY OF THE COMMENTS SUBMITTED BY THE 
MEMBER STATES
 
EN 4   EN 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 
 
EN 5   EN 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 Forestr y, the Environment and 
Water Mangement – Economic Affairs and La bour - Education, Science and Culture). 
Comments from the Austrian authorities 
In accordance with Directive 86/609/EEC regarding th e protection of animals used for experimental 
and other scientific purposes, animal e xperiments in Austria are regulated by the Tierversuchsgesetz  
(Animal Experiments Act) (Feder al Law of 27 September 1989 on expe riments using live animals, 
Federal Law Gesetz, (BGBL. No 501/1989, as mo st recently amended by Federal Law No.162/2005. 
Responsibility for enforcing the Animal Experiments Ac t in Austria rests with the Federal Minister for 
Health and Women, the Federal Minister for Econom ic affairs and Labour, the Federal Minister for 
Agriculture, Forestry, the Environment and Wa ter 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) for research and development b) for vocational training c) for medical diagnosis and therapy d) for testing natural or synthetic ma terials, preparations or products 
e) for detecting environmental risks f) 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 di seases in human beings or animals,  
b) for detecting or influencing physiological conditi ons 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 
 
EN 6   EN 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 te aching aids, in 
particular films or ot her audiovisual media. 
Experiments on animal s are never permitted,  
a) if the results of a similar experiment are de  facto and de jure accessi ble and no justified doubts 
exist as to the accuracy  and meaningfulness of the said results,  
b) if no further or new knowledge is lik ely to come from the experiment,  
c) if the experiment is not necessa ry, even for control purposes, or  
d) if the results of an animal e xperiment carried out in Austria or abroad are de facto or de jure 
accessible, no justified doubts exist regarding the accu racy and meaningfulness of those results and 
they are officially recognised in Austria on th e 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 experime nts since they are outdated in the light of 
scientific progress achieved. By wa y 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 pr inciples for all scientis ts and other personnel 
involved in animal experiments and these are bindi ng, also on the competent au thorities. Particular 
features of these are that: 
Animal experiments must be consistent with the pr inciples 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 obtaini ng as much new knowledge 
as possible. 
The meaningfulness and practicability of model an imal 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 expe riments as well as developments in measurement 
and laboratory techniques are to  be taken into accoun t in order to minimize the stress that 
experimental animals undergo. 
All persons involved in carrying out an imal experiments ar e 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 experi ment that he has planned, headed and completed, 
weighing them against the stress to which the animals are subjected. 
 
EN 7   EN Accordingly, Austria's Animal Experiments Act ha s express provision, as a legal requirement, for 
applying the principles of the '3 Rs ' (reduction, refinement, replacement). 
As regards the keeping of experimental animal s (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 husba ndry, 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 (s ee above) are required 
by law (the Animal Experiments Act) to promot e the development of alternative methods and 
procedures that do not involve an imal experiments (see above) in line with the relevant Federal 
financial legislation and progress in science and to promote altern ative methods and procedures. The 
aim is to develop alternative methods that are scie ntifically meaningful and which make it possible to 
reduce the number of experimental animals and the st ress to which they are e xposed or even to make 
animal experiments wholly redundant. 
Promoting the objective of the 3Rs is thus an e xpress component of Austria's Animal Experiments 
Act, the aim being to improve the protection of an imals. 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 Educa tion, 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 connec tion that conferences on animal experiments and 
alternative methods have in the past been organise d under Austrian Presidency. By way of example, in 
November 1998 a conference was organised in c onjunction 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 implementati on 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 count ries that have meanwhile become  EU Member States. One of the 
resolutions adopted at this sympos ium was forwarded to the Council of Ministers of the EU and to the 
European Commission for furthe r 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 positi on of the European Community w ith regard to the proposal to 
amend Annex A of the European Convention on pr otecting animals used for experiments and other 
scientific purposes (s ee Council of the European Union 7643/06 Legislative Acts and other legal 
instruments, adopted by the Counc il 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 re vised Appendix A of the 
Convention that contained guidelines for the housing and care of such animals. 
Statistics on animal experiments 
 
EN 8   EN Statistics on animal experiments in Austria are produced in accordance with  Article 13 of Directive 
86/609/EEC pursuant to § 16 of the Animal Experime nts Act and the Regulati on on Statistics relating 
to Animal Experiments (Tierversuchsstatistik -Verordnung), which is based on it (BGBl. II 
No 199/2000), and sets out the standard ised statistics for animal experi ments 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 prev ious year. The following 
information is to be provided: 
a) the number and type of experimental animals used overall plus the or igin and number, with 
breakdown, of the animals used, 
b) the number and types of animals used (type s of experimental animals, with breakdown), 
c) the number and types of experimental animals used for toxicological and other safety tests, 
d) the number and types of experimental animal s 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 veteri nary 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 st atutory 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 ar e 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 th ere 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 experi ment 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 "f luctuating" numbers of the past few years (ranging from 160,000 to 
200,000). The number of experimental animals is theref ore again significantly lo wer 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%. 
 
EN 9   EN 050.000100.000150.000200.000250.000300.000350.000400.000450.000500.000
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 th e Federal Ministries 
responsible for enforcing the Animal Experiments Ac t, namely the Federal Ministry for Health and 
Women, the Federal Ministry for Economic affairs a nd 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 th e 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 ri se in the number of biom edical and bioscientific 
as well as pharmaceutical firms conducting researc h, in particular research and development of 
products for human and veterinary  medicine, along with the manufac ture 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 a nd AIDS. Cancer research concentrates primarily on 
the development of improved and more effective th erapies 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 in crease 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 ex ample the development and production of human 
vaccines and therapeutic products. The greater emphasis placed on th e development of medical and 
pharmaceutical medicaments means that despite ever y effort to find altern ative methods, animal 
experiments are, with a view to protecti ng the health and safety of human beings and animals, 
indispensable as a preliminary stage prior to  any decision on clinic al 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 clinic al 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 
 
EN 10   EN 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 gui nea 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 we re 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 experime nts for cosmetics that has been in place since 
1999 has meant that in accordance with  §(5) of the Animal Experime nts Act it goes without saying 
that no animal experiments were conducted in Aust ria for cosmetics. Austria is in this respect 
particularly committed to protecting Europe's animals. 
No primates for experimental purposes 
Statutory ban on experiment s on or involving primates . 
It can happily be reported that in 2005 Austria c ontinued to forgo the use of primates for animal 
experiments. This is consistent with the pan-Europ ean 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 exam ination – a Parliamentary Bill to the National 
Council for a statutory ban on animal experiments i nvolving primates, which it adopted in December 
2005. The provision entered into force on 1 January 2006. 
Austria's figures for animal experiments a re comparatively low in international terms 
With a total of 167.312 experimental animals (pri marily mice and rats) used in 2005, Austria had 
significantly fewer animal experiments in internationa l 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 us ed in animal experiments – accounting for a 65% 
drop since 1991 – can be explained by at least two in ter-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, researcher s and practical scientists th emselves as well as ensuri ng, as far as possible, the 
availability of alterna tive methods to replace animal experime nts as this is expressly required by 
Austria's Animal Experiments Act. 
 
EN 11   EN 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 compet ent 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 sc ience/research involving animal 
experiments.  
Greater effort to promote the development of alternatives to animal experiments 
In September of last year the Federal Ministry fo r Education, Science and Cu lture in agreement with 
all the other Federal Ministries responsible for enforcing the Animal Experiments Act (Federal 
Ministries for Health and Women, for Economic Af fairs and Labour and for Agriculture and Forestry, 
the Environment and Water) renewed its public call fo r the submission of resear ch projects targeting 
alternatives to animal experiments, the aim of whic h is to provide greater s upport 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 projec ts by the Federal Ministry for Education Science and 
Culture was again used to award a national prize for alternativ es to animal experiments , in other 
words particular recognition by the State of scientific results already achieved. 
 
 
EN 12   EN TABLE 1: NUMBER OF ANIMALS USED IN RELATION TO THEIR PLACE OF ORIGIN 
Origin versus species 
1.1 
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 1.5 
Animals coming from 
Member Countries of the 
Council of Europe which are 
parties to the Convention ETS 
123 (excluding EC Member 
States) 1.6 
Animals coming from 
other origins 1.7 
Re-used animals 
1.a. Mice ( Mus musculus ) 128 634 28 469 99 702 184 279 59 
1.b. Rats ( Rattus norvegicus ) 11 920 5 278 6 642 0 0 47 
1.c. Guinea-Pigs ( Cavia porcellus ) 3 149 340 2 809 0 0 0 
1.d. Hamsters ( Mesocricetus ) 117 0 117 0 0 0 
1.e. Other Rodents (other Rodentia ) 107 60 25 0 22 0 
1.f. Rabbits ( Oryctolagus cuniculus ) 18 439 11 165 7 253 0 21 41 
1.g. Cats ( Felis catus ) 12 0 2 0 10 10 
1.h. Dogs ( Canis familiaris ) 85 67 0 0 18 7 
1.i. Ferrets ( Mustela putorius furo ) 0 0 0 0 0 0 
1.j. Other Carnivores (other Carnivora ) 0 0 0 0 0 0 
1.k. Horses, donkeys and cross breds ( Equidae ) 71 21 0 0 50 12 
1.l. Pigs ( Sus) 818 594 61 0 163 41 
1.m. Goats ( Capra ) 44 20 0 0 24 3 
1.n. Sheep ( Ovis)  195 127 20 0 48 34 
1.o. Cattle ( Bos) 536 352 16 0 168 9 
1.p. Prosimians ( Prosimia ) 0 0 0 0 0 0 
1.q. New World Monkeys ( Ceboidea ) 0 0 0 0 0 0 
1.r. Old World Monkeys ( Cercopithecoidea ) 56 56 0 0 0 41 
1.s. Apes ( Hominoidea ) 0 0 0 0 0 0 
1.t. Other Mammals (other Mammalia ) 0 0 0 0 0 0 
1.u. Quail ( Coturnix coturnix)  14 14 0 0 0 0 
1.v. Other birds (other Aves ) 1 011 352 300 0 359 22 
1.w. Reptiles ( Reptilia ) 40 0 0 0 40 0 
1.x. Amphibians ( Amphibia ) 865 62 40 0 763 0 
1.y. Fish ( Pisces ) 1 199 192 4 0 1 003 0 
1.z. TOTAL 167 312 47 169 116 991 184 2 968 326 
Note 1: Column 1.5 concerns only those Member countries of the Council of Europe which, at the beginning of the reporting perio d, 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 b oxes 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 13   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 2.3 
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 25 313 74 677 20 884 177 2 956 1 296 106 3 225 128 634 
2.b. Rats 5 019 2 949 131 232 3 167 0 422 0 11 920 
2.c. Guinea-Pigs 24 548 1 411 197 967 0 2 0 3 149 
2.d. Hamsters 0 117 0 0 0 0 0 0 117 
2.e. Other Rodents 47 0 0 0 0 0 0 60 107 
2.f. Rabbits 344 75 17 019 23 928 0 8 42 18 439 
2.g. Cats 0 2 0 0 0 10 0 0 12 
2.h. Dogs 6 56 0 0 0 0 12 11 85 
2.i. Ferrets 0 0 0 0 0 0 0 0 0 
2.j. Other Carnivores 0 0 0 0 0 0 0 0 0 
2.k. Horses, donkeys and cross 
breds 33 10 0 0 0 22 2 4 71 
2.l. Pigs 265 255 73 0 0 0 189 36 818 
2.m. Goats 0 4 0 0 0 0 40 0 44 
2.n. Sheep 20 50 1 42 12 0 70 0 195 
2.o. Cattle 333 0 0 12 3 0 140 48 536 
2.p. Prosimians 0 0 0 0 0 0 0 0 0 
2.q. New World Monkeys 0 0 0 0 0 0 0 0 0 
2.r. Old World Monkeys 0 56 0 0 0 0 0 0 56 
2.s. Apes 0 0 0 0 0 0 0 0 0 
2.t. Other Mammals 0 0 0 0 0 0 0 0 0 
2.u. Quail 14 0 0 0 0 0 0 0 14 
2.v. Other birds 725 151 4 0 0 60 71 0 1 011 
2.w. Reptiles 40 0 0 0 0 0 0 0 40 
2.x. Amphibians 860 0 0 0 0 0 5 0 865 
2.y. Fish 876 180 0 0 143 0 0 0 1 199 
2.z. TOTAL 33 919 79 130 39 523 683 8 176 1 388 1 067 3 426 167 312 
 
EN 14   EN TABLE 3: NUMBER OF ANIMALS USED IN TOXI COLOGICAL 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 3.7 
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 
contaminants in 
the general 
environment 
which do not 
appear in other 
columns 3.10 
Other 
toxicological 
or safety 
evaluations 3.11 
Total 
3.a. Mice 2 026 0 0 0 0 0 0 0 930 2 956 
3.b. Rats 1 415 0 0 0 0 0 0 0 1 752 3 167 
3.c. Guinea-Pigs 279 0 0 0 0 0 0 0 688 967 
3.d. Hamsters 0 0 0 0 0 0 0 0 0 0 
3.e. Other Rodents 0 0 0 0 0 0 0 0 0 0 
3.f. Rabbits 715 0 0 0 0 0 0 0 213 928 
3.g. Cats 0 0 0 0 0 0 0 0 0 0 
3.h. Dogs 0 0 0 0 0 0 0 0 0 0 
3.i. Ferrets 0 0 0 0 0 0 0 0 0 0 
3.j. Other Carnivores 0 0 0 0 0 0 0 0 0 0 
3.k. Horses, donkeys and cross breds 0 0 0 0 0 0 0 0 0 0 
3.l. Pigs 0 0 0 0 0 0 0 0 0 0 
3.m. Goats 0 0 0 0 0 0 0 0 0 0 
3.n. Sheep 0 0 0 0 0 0 0 0 12 12 
3.o. Cattle 3 0 0 0 0 0 0 0 0 3 
3.p. Prosimians 0 0 0 0 0 0 0 0 0 0 
3.q. New World Monkeys 0 0 0 0 0 0 0 0 0 0 
3.r. Old World Monkeys 0 0 0 0 0 0 0 0 0 0 
3.s. Apes 0 0 0 0 0 0 0 0 0 0 
3.t. Other Mammals 0 0 0 0 0 0 0 0 0 0 
3.u. Quail 0 0 0 0 0 0 0 0 0 0 
3.v. Other birds 0 0 0 0 0 0 0 0 0 0 
3.w. Reptiles 0 0 0 0 0 0 0 0 0 0 
3.x. Amphibians 0 0 0 0 0 0 0 0 0 0 
3.y. Fish 0 0 0 0 0 0 0 0 143 143 
3.z. TOTAL 4 438 0 0 0 0 0 0 0 3 738 8 176 
 
EN 15   EN TABLE 4: NUMBER OF ANIMALS USED IN EXPERIME NTS FOR STUDIES ON HUM AN 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) 4.5 
Other human diseases 4.6 
Studies specific to animal 
diseases 4.7 
Total 
4.a. Mice 1 275 3 407 15 919 45 266 95 65 962 
4.b. Rats 506 1 777 609 4 919 0 7 811 
4.c. Guinea-Pigs 0 0 0 905 0 905 
4.d. Hamsters 0 0 0 117 0 117 
4.e. Other Rodents 0 0 0 0 0 0 
4.f. Rabbits 53 31 89 294 0 467 
4.g. Cats 0 0 0 0 0 0 
4.h. Dogs 0 0 0 0 0 0 
4.i. Ferrets 0 0 0 0 0 0 
4.j. Other Carnivores 0 0 0 0 0 0 
4.k. Horses, donkeys and cross breds 0 0 0 0 0 0 
4.l. Pigs 106 0 0 292 0 398 
4.m. Goats 0 0 0 4 0 4 
4.n. Sheep 2 0 12 26 0 40 
4.o. Cattle 0 0 0 0 0 0 
4.p. Prosimians 0 0 0 0 0 0 
4.q. New World Monkeys 0 0 0 0 0 0 
4.r. Old World Monkeys 0 0 0 56 0 56 
4.s. Apes 0 0 0 0 0 0 
4.t. Other Mammals 0 0 0 0 0 0 
4.u. Quail 0 0 0 0 0 0 
4.v. Other birds 54 0 0 6 0 60 
4.w. Reptiles 0 0 0 0 0 0 
4.x. Amphibians 25 25 0 12 0 62 
4.y. Fish 0 0 0 0 0 0 
4.z. TOTAL 2 021 5 240 16 629 51 897 95 75 882 
 
EN 16   EN TABLE 5: NUMBER OF ANIMALS USED IN PRODUCTION AN D QUALITY CONTROL OF PRO DUCTS 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 177 887 0 0 19 909 88 21 061 
5.b. Rats 131 0 0 232 0 0 363 
5.c. Guinea-Pigs 0 636 0 197 775 0 1 608 
5.d. Hamsters 0 0 0 0 0 0 0 
5.e. Other Rodents 0 0 0 0 0 0 0 
5.f. Rabbits 0 12 884 0 32 3 981 145 17 042 
5.g. Cats 0 0 0 0 0 0 0 
5.h. Dogs 0 0 0 0 0 0 0 
5.i. Ferrets 0 0 0 0 0 0 0 
5.j. Other Carnivores 0 0 0 0 0 0 0 
5.k. Horses, donkeys and cross breds 0 0 0 0 0 0 0 
5.l. Pigs 0 0 0 0 0 73 73 
5.m. Goats 0 0 0 0 0 0 0 
5.n. Sheep 21 22 0 0 0 0 43 
5.o. Cattle 12 0 0 0 0 0 12 
5.p. Prosimians 0 0 0 0 0 0 0 
5.q. New World Monkeys 0 0 0 0 0 0 0 
5.r. Old World Monkeys 0 0 0 0 0 0 0 
5.s. Apes 0 0 0 0 0 0 0 
5.t. Other Mammals 0 0 0 0 0 0 0 
5.u. Quail 0 0 0 0 0 0 0 
5.v. Other birds 4 0 0 0 0 0 4 
5.w. Reptiles 0 0 0 0 0 0 0 
5.x. Amphibians 0 0 0 0 0 0 0 
5.y. Fish 0 0 0 0 0 0 0 
5.z. TOTAL 345 14 429 0 461 24 665 306 40 206 
Examples: 5.2 – France is testing due to a UK (or FR) specific  requirement Note: columns 5.2 - 5. 5 refer to the legislation imp osing that the test be carried out and 
 5.3 - UK is testing according to EC legislation  not to the bo dy which has issued the actual te st method, guidel ine or protoco l. 
 5.4 – Spain is testing due to a Hungarian requirement Example: a test required by French legislation and carried out in Belgiu m according to an 
 5.5 – Sweden is testing due to a US specific requirement  ISO protocol must be coded as a national (FR) legislative requiremen t and be 
 5.6 – Germany is testing due to  a Czech requirement (also an EC 
requirement)  entered into column 5.2 in the tables submitted by Belgium. 
Footnotes: 1) EC Member States: Austria, Belgium, Denmark, Finl and, France, Germany, Greece, Ir eland, Italy, Luxembourg, Nether lands, Portugal, Spain, Sw eden, United Kingdom 
 2) Member Countries of Council of Europe (non-EC): Albania, A ndorra, Bulgaria, Croatia, Cyprus, Czech Rep., Estonia, Hungary, Iceland, Latvia, Liechtenstein, Lithuania, 
Malta, Moldova, Norway, Poland, Romania, Ru ssia, San Marino, Slovakia, Slovenia, Switz erland, ‘the former Yugoslav Rep. of Mace donia’, Turkey, Ukraine 
 
EN 17   EN TABLE 6: NUMBER OF ANIMALS USED IN TOXI COLOGICAL 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 0 1 595 0 1 060 60 241 2 956 
6.b. Rats 0 210 0 2 094 576 287 3 167 
6.c. Guinea-Pigs 0 204 0 763 0 0 967 
6.d. Hamsters 0 0 0 0 0 0 0 
6.e. Other Rodents 0 0 0 0 0 0 0 
6.f. Rabbits 0 595 0 213 77 43 928 
6.g. Cats 0 0 0 0 0 0 0 
6.h. Dogs 0 0 0 0 0 0 0 
6.i. Ferrets 0 0 0 0 0 0 0 
6.j. Other Carnivores 0 0 0 0 0 0 0 
6.k. Horses, donkeys and cross breds 0 0 0 0 0 0 0 
6.l. Pigs 0 0 0 0 0 0 0 
6.m. Goats 0 0 0 0 0 0 0 
6.n. Sheep 0 0 0 0 0 12 12 
6.o. Cattle 0 3 0 0 0 0 3 
6.p. Prosimians 0 0 0 0 0 0 0 
6.q. New World Monkeys 0 0 0 0 0 0 0 
6.r. Old World Monkeys 0 0 0 0 0 0 0 
6.s. Apes 0 0 0 0 0 0 0 
6.t. Other Mammals 0 0 0 0 0 0 0 
6.u. Quail 0 0 0 0 0 0 0 
6.v. Other birds 0 0 0 0 0 0 0 
6.w. Reptiles 0 0 0 0 0 0 0 
6.x. Amphibians 0 0 0 0 0 0 0 
6.y. Fish 0 0 0 143 0 0 143 
6.z. TOTAL 0 2 607 0 4 273 713 583 8 176 
Examples: 6.2 – France is testing due to a UK (or FR) specific  requirement Note: columns 6.2 - 6. 5 refer to the legislation imp osing that the test be carried out and 
 6.3 - UK is testing according to EC legislation  not to the bo dy which has issued the actual te st method, guidel ine or protoco l. 
 6.4 – Spain is testing due to a Hungarian requirement Example: a test required by French legislation and carried out in Belgiu m according to an 
 6.5 – Sweden is testing due to a US specific requirement  ISO protocol must be coded as a national (FR) legislative requiremen t and be 
 6.6 – Germany is testing due to  a Czech requirement (also an EC 
requirement)  entered into column 6.2 in the tables submitted by Belgium. 
Footnotes: 1) EC Member States: Austria, Belgium, Denmark, Finl and, France, Germany, Greece, Ir eland, Italy, Luxembourg, Nether lands, Portugal, Spain, Sw eden, United Kingdom 
 2) Member Countries of Council of Europe (non-EC): Albania, A ndorra, Bulgaria, Croatia, Cyprus, Czech Rep., Estonia, Hungary, Iceland, Latvia, Liechtenst ein, Lithuania, Malta, 
Moldova, Norway, Poland, Romania, Russia, San Marino, Slovakia, Slovenia, Switzerland,  ‘the former Yugoslav Rep. of Macedonia’,  Turkey, Ukraine 
 
EN 18   EN TABLE 7: NUMBER OF ANIMALS USED IN TOXI COLOGICAL AND OTHER SAFETY EVALUATIONS 
Types of tests versus species 
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 7.11 
Toxicity 
to aquatic 
vertebra-
tes not 
included 
in other 
columns 7.12 
Other 7.13 
Total 
  7.2.1. 
LD50, 
LC50 7.2.2 
Other lethal 
methods 7.2.3 
Non lethal 
clinical signs 
methods            
7.a. Mice 0 293 1 580 0 784 0 0 0 0 154 0 0 145 2 956 
7.b. Rats 0 726 229 104 0 0 1 596 0 0 12 0 0 500 3 167 
7.c. Guinea-Pigs 0 0 119 0 688 0 0 0 0 0 0 0 160 967 
7.d. Hamsters 0 0 0 0 0 0 0 0 0 0 0 0 0 0 
7.e. Other Rodents 0 0 0 0 0 0 0 0 0 0 0 0 0 0 
7.f. Rabbits 0 0 70 123 0 88 0 0 0 0 0 0 647 928 
7.g. Cats 0 0 0 0 0 0 0 0 0 0 0 0 0 0 
7.h. Dogs 0 0 0 0 0 0 0 0 0 0 0 0 0 0 
7.i. Ferrets 0 0 0 0 0 0 0 0 0 0 0 0 0 0 
7.j. Other Carnivores 0 0 0 0 0 0 0 0 0 0 0 0 0 0 
7.k. Horses, donkeys and cross 
breds 0 0 0 0 0 0 0 0 0 0 0 0 0 0 
7.l. Pigs 0 0 0 0 0 0 0 0 0 0 0 0 0 0 
7.m. Goats 0 0 0 0 0 0 0 0 0 0 0 0 0 0 
7.n. Sheep 0 0 0 0 0 0 0 0 0 0 0 0 12 12 
7.o. Cattle 0 0 3 0 0 0 0 0 0 0 0 0 0 3 
7.p. Prosimians 0 0 0 0 0 0 0 0 0 0 0 0 0 0 
7.q. New World Monkeys 0 0 0 0 0 0 0 0 0 0 0 0 0 0 
7.r. Old World Monkeys 0 0 0 0 0 0 0 0 0 0 0 0 0 0 
7.s. Apes 0 0 0 0 0 0 0 0 0 0 0 0 0 0 
7.t. Other Mammals 0 0 0 0 0 0 0 0 0 0 0 0 0 0 
7.u. Quail 0 0 0 0 0 0 0 0 0 0 0 0 0 0 
7.v. Other birds 0 0 0 0 0 0 0 0 0 0 0 0 0 0 
7.w. Reptiles 0 0 0 0 0 0 0 0 0 0 0 0 0 0 
7.x. Amphibians 0 0 0 0 0 0 0 0 0 0 0 0 0 0 
7.y. Fish 0 143 0 0 0 0 0 0 0 0 0 0 0 143 
7.z. TOTAL 0 1 162 2 001 227 1 472 88 1 596 0 0 166 0 0 1 464 8 176 
 
EN 19   EN TABLE 8: NUMBER OF ANIMALS USED IN TOXI COLOGICAL AND OTHER SAFETY EVALUATIONS 
Types of tests versus products 
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 8.6 
Sub- 
chronic 
and 
chronic 
toxicity 8.7 
Carcino 
genicity 8.8 
Develop- 
mental 
toxicity 8.9 
Muta- 
genicit
y 8.10 
Repro-
ductive 
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            
8.a. Products/substances or devices for 
human medicine and dentistry and for 
veterinary medicine 0 381 2 001 62 8 0 662 0 0 6 0 0 1 318 4 438 
8.b. Products/substances used or intended to 
be used mainly in agriculture 0 0 0 0 0 0 0 0 0 0 0 0 0 0 
8.c. Products/substances used or intended to 
be used mainly in industry 0 0 0 0 0 0 0 0 0 0 0 0 0 0 
8.d. Products/substances used or intended to 
be used mainly in the household 0 0 0 0 0 0 0 0 0 0 0 0 0 0 
8.e. Products/substances used or intended to 
be used mainly as cosmetics or 
toiletries 0 0 0 0 0 0 0 0 0 0 0 0 0 0 
8.f. 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 
8.g. 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 
8.h. 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 
8.i. Other toxicological or safety 
evaluations 0 781 0 165 1 464 88 934 0 0 160 0 0 146 3 738 
8.j. TOTAL 0 1 162 2 001 227 1 472 88 1 596 0 0 166 0 0 1 464 8 176 
 
EN 20   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 laboratori es in operation which, pursuant to Article 15 of the 
Royal Decree of 14 November 1993 on the protection of an imals used for experimental purposes, provided data 
on their use of animals for experiments. As in prev ious years, 25% of laboratories used no animals. 
In 2005, four laboratory a pprovals were withdrawn at the request of  the head of the laboratory because it had 
ceased operations; five new approvals were issued fo r 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 speci es 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 à sang froid - 
Koudbloed dieren
6%
Lapins - Konijnen
3%Autres animaux à sang 
chaud - Andere w armbloed 
dieren
0,03%
Chiens/Chats - 
Honden/Katten
0,19%Oiseaux - Vogels
2%Animaux agricoles - 
Landbouw  dieren
0,49%Primates - Apen
0,06%
Rongeurs - Knaagdieren
89%
 
 
EN 21   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; Anima ux à sang froid – cold-bl ooded 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 tota l number of animals of 1.44% over 2004. 
That increase was due mainly to greater use of fi sh (+ 13 391, 65%), birds (+ 2 849, 26%), mice (+ 5 
315, 1.1%) and, to a lesser extent, d ogs (+ 201, 27%) and ferrets (+ 52,  51%). There was a substantial 
drop in the number of monkeys (- 137, 23%), ra ts (- 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 488125 482810 430251 460487 436266
Rats 106483 119193 128284 116340 112040
Guinea pigs 39530 38781 40510 34305 40204
Hamsters 1874 1688 2590 2645 3163
Other rodents 2260 3921 11332 16670 12693
Rabbits 21159 18577 18714 10805 14631
Total rodents and rabbits 659431 664970 631681 641252 61899 7
Cats 81 184 90 100 75
Dogs 1295 1014 1000 1071 1036
Ferrets 154 102 36 20 20
Other carnivores 0 0 0 0 0
Total carnivores 1530 1300 112 6 1191 1131
Horses, donkeys and cross-breds 108 65 93 138 102
Pigs 1876 2272 2637 3587 4079
Goats 157 125 114 102 217
Sheep 445 495 339 524 492
Cattle 944 982 1055 1135 714
Total ungulates 3530 3939 4238 548 6 5604
Prosimians 0 0 0 0 0
New world monkeys 0 7 7 20 21
Old world monkeys 449 579 281 547 689
A p e s 000  00
Total primates 449 58 6 288 56 7 710
Other mammals 59 44 22 8 0
Total mammals 664999 670839 637355 648504 626442
Quails 425 350 514 326 134
Other birds 13266 10492 12499 20026 8711
Total birds 13691 10842 13013 20352 884 5
Reptiles 144 129 30 15 95
Amphibians 6177 6362 1803 1601 2460
Fish 33965 20574 24363 24619 17375
Total cold-blooded animals 4028 6 2706 5 2619 6 2623 5 19930
TOTAL ANIMALS 718976 708746 676564 695.091 655.217
 
EN 22   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 labora tories fell between 1997 and 2005 (by 16%), even 
though there were some unreprese ntative annual fluctuations. 
859.620837.560
790.089
651.504 655.217695.091676.564708.746 718.976
2005 2004 2003 2002 2001 2000 1 999 1 998 1 99701000002000003000004000005000006000007000008000009000001000000
 
Figure 2:  Trend in the number of animals used since 1997  
3. Experiments carried out 
In descending order, animals were used mainly fo r research and to develop products and devices used 
in human and veterinary medicine (33% of the anim als 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 numbe r of animals used for basic research and 
the figure in 2005 was the highest ever for this category. As regards produc tion and quality control 
tests and toxicology tests, 98% and 90% respectiv ely of the animals were used to meet legal 
requirements.  
 
EN 23   EN QC
24%Diagnostic - Diagnose
2%
Toxicologie
9%Formation - Opleiding
2%
Biol.fond. - Fund. Biol.
29%
R&D
33%Autres - Overige
1%
 
Figure 3: Breakdown of the experimental fields  
Diagnostic – diagnostics; Formation –tra ining; 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, ra ts and mice are used mainly for basic research and the development 
of products and material for medicine  (65%) and for safety tests (22%). 
Biologie fondamentaleR&DQCToxicologieDiagnosticFormationAutresRongeursOiseaux Animaux à sang froidLapins050000100000150000200000250000
 
 
EN 24   EN Figure 4: Breakdown of experimental fiel ds by the animals most used   
Biologie fondamentale – basic biology; R&D – res earch and development; QC – quality control; 
Toxicologie – toxicology; Diagnostic – diagnostics; Formation – training; Autres – other; Lapins – 
rabbits; Animaux à sang froid – cold-blooded an imals; Oiseaux – birds;  Rongeurs – rodents. 
As regards the other species, 92% of primates a nd 78% of dogs were used in toxicology tests for 
safety. 
The use of primates is still linked to the Wo rld 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 sa fety trials required by  laws and regulations ( Figure 5: 
Proportion of quality control and toxi cology tests imposed by law ). 
0,00%25,00%50,00%75,00%100,00%Obligation
Légale /
Legale
verplichtNon
obligatoire
/ Niet
verplichtObligation
Légale /
Legale
verplichtNon
obligatoire
/ Niet
verplicht
Qualité Contrôle /
Kw aliteit ControleToxicologie
 
Figure 5: Proportion of quality control and toxi cology tests imposed by law   
Obligation légale – legal requirement; Non obligatoi re – not compulsory; Qualité Contrôle – quality 
control; Toxicologie –toxicology. 
4. Origin of animals used in experiments 
The Royal Decree of 14 November 1993 on the protecti on 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 25   EN Animals belonging to agricultural sp ecies and other animals, includi ng 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 legislati on in force for such establishments. 
0100000200000300000400000500000600000700000
Elevage
spécifique -
Specifiek
fokkerijAnimaux
agricoles -
Landbouw
dierenAutres -
AndereRéutilisés -
HergebruiktB+UE+CdE -
B+EG+RvEAutre -
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 26   EN TABLE 1: NUMBER OF ANIMALS USED IN RELATION TO THEIR PLACE OF ORIGIN 
Origin versus species 
1.1 
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 1.5 
Animals coming from 
Member Countries of the 
Council of Europe which are 
parties to the Convention ETS 
123 (excluding EC Member 
States) 1.6 
Animals coming from 
other origins 1.7 
Re-used animals 
1.a. Mice ( Mus musculus ) 488125 166973 298054 1079 22019  
1.b. Rats ( Rattus norvegicus ) 106483 19125 80233 6535 590  
1.c. Guinea-Pigs ( Cavia porcellus ) 39530 5352 34178 0 0  
1.d. Hamsters ( Mesocricetus ) 1874 69 1773 0 32  
1.e. Other Rodents (other Rodentia ) 2260      
1.f. Rabbits ( Oryctolagus cuniculus ) 21159 18347 2806 0 6 536 
1.g. Cats ( Felis catus ) 81 49 32 0 0 78 
1.h. Dogs ( Canis familiaris ) 1295 82 898 23 292 475 
1.i. Ferrets ( Mustela putorius furo ) 154 0 154 0 0 0 
1.j. Other Carnivores (other Carnivora ) 0      
1.k. Horses, donkeys and cross breds ( Equidae ) 108      
1.l. Pigs ( Sus) 1876      
1.m. Goats ( Capra ) 157      
1.n. Sheep ( Ovis)  445      
1.o. Cattle ( Bos) 944      
1.p. Prosimians ( Prosimia ) 0 0 0 0 0 0 
1.q. New World Monkeys ( Ceboidea ) 0 0 0 0 0 7 
1.r. Old World Monkeys ( Cercopithecoidea ) 449 0 37 0 412 22 
1.s. Apes ( Hominoidea ) 0 0 0 0 0 0 
1.t. Other Mammals (other Mammalia ) 59      
1.u. Quail ( Coturnix coturnix)  425 421 0 0 4  
1.v. Other birds (other Aves ) 13266      
1.w. Reptiles ( Reptilia ) 144      
1.x. Amphibians ( Amphibia ) 6177      
1.y. Fish ( Pisces ) 33965      
1.z. TOTAL 718976      
Note 1: Column 1.5 concerns only those Member Countries of the Council of Europe which, at the beginning of the reporting perio d, 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 b oxes 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 27   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 2.3 
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 142620 168987 114435 6487 31740 15303 5518 3035 488125 
2.b. Rats 20078 56836 13598 131 12960 487 1843 550 106483 
2.c. Guinea-Pigs 247 5497 18039 1006 14190 26 525 0 39530 
2.d. Hamsters 131 1 0 1660 0 0 34 48 1874 
2.e. Other Rodents 411 1697 0 0 142 0 0 10 2260 
2.f. Rabbits 1326 3888 14276 329 1095 0 84 161 21159 
2.g. Cats 49 0 0 32 0 0 0 0 81 
2.h. Dogs 115 104 0 38 1018 7 13 0 1295 
2.i. Ferrets 0 154 0 0 0 0 0 0 154 
2.j. Other Carnivores 0 0 0 0 0 0 0 0 0 
2.k. Horses, donkeys and cross 
breds 28 27 15 2 0 1 31 4 108 
2.l. Pigs 1197 144 21 187 95 16 113 103 1876 
2.m. Goats 26 54 0 40 0 0 32 5 157 
2.n. Sheep 177 123 0 34 24 0 2 85 445 
2.o. Cattle 97 136 0 484 15 83 17 112 944 
2.p. Prosimians 0 0 0 0 0 0 0 0 0 
2.q. New World Monkeys 0 0 0 0 0 0 0 0 0 
2.r. Old World Monkeys 37 0 0 0 412 0 0 0 449 
2.s. Apes 0 0 0 0 0 0 0 0 0 
2.t. Other Mammals 28 31 0 0 0 0 0 0 59 
2.u. Quail 421 0 0 0 0 0 4 0 425 
2.v. Other birds 11546 1269 165 36 238 0 2 10 13266 
2.w. Reptiles 144 0 0 0 0 0 0 0 144 
2.x. Amphibians 5071 0 0 0 0 30 1076 0 6177 
2.y. Fish 25466 0 0 0 1769 0 3130 3600 33965 
2.z. TOTAL 209215 238948 160549 10466 63698 15953 12424 7723 718976 
 
EN 28   EN TABLE 3: NUMBER OF ANIMALS USED IN TOXI COLOGICAL 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 3.7 
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 3.10 
Other toxico- 
logical or 
safety 
evaluations 3.11 
Total 
3.a. Mice 30371 50 50 0 0 0 0 1254 15 31740 
3.b. Rats 12260 0 0 0 0 0 0 0 700 12960 
3.c. Guinea-Pigs 14190 0 0 0 0 0 0 0 0 14190 
3.d. Hamsters 0 0 0 0 0 0 0 0 0 0 
3.e. Other Rodents 0 0 0 0 0 0 0 142 0 142 
3.f. Rabbits 1095 0 0 0 0 0 0 0 0 1095 
3.g. Cats 0 0 0 0 0 0 0 0 0 0 
3.h. Dogs 1018 0 0 0 0 0 0 0 0 1018 
3.i. Ferrets 0 0 0 0 0 0 0 0 0 0 
3.j. Other Carnivores 0 0 0 0 0 0 0 0 0 0 
3.k. Horses, donkeys and cross breds 0 0 0 0 0 0 0 0 0 0 
3.l. Pigs 80 0 0 0 0 0 0 0 15 95 
3.m. Goats 0 0 0 0 0 0 0 0 0 0 
3.n. Sheep 24 0 0 0 0 0 0 0 0 24 
3.o. Cattle 0 0 0 0 0 0 0 0 15 15 
3.p. Prosimians 0 0 0 0 0 0 0 0 0 0 
3.q. New World Monkeys 0 0 0 0 0 0 0 0 0 0 
3.r. Old World Monkeys 412 0 0 0 0 0 0 0 0 412 
3.s. Apes 0 0 0 0 0 0 0 0 0 0 
3.t. Other Mammals 0 0 0 0 0 0 0 0 0 0 
3.u. Quail 0 0 0 0 0 0 0 0 0 0 
3.v. Other birds 118 0 0 0 0 0 0 120 0 238 
3.w. Reptiles 0 0 0 0 0 0 0 0 0 0 
3.x. Amphibians 0 0 0 0 0 0 0 0 0 0 
3.y. Fish 275 510 0 0 0 0 0 444 540 1769 
3.z. TOTAL 59843 560 50 0 0 0 0 1960 1285 63698 
 
EN 29   EN TABLE 4: NUMBER OF ANIMALS USED IN EXPERIME NTS FOR STUDIES ON HUM AN 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) 4.5 
Other human diseases 4.6 
Studies specific to animal 
diseases 4.7 
Total 
4.a. Mice 5754 62251 46356 193220 9749 317330 
4.b. Rats 1845 29488 2602 41694 119 75748 
4.c. Guinea-Pigs 233 2134 0 15491 5 17863 
4.d. Hamsters 0 0 0 70 0 70 
4.e. Other Rodents 36 585 0 846 198 1665 
4.f. Rabbits 260 5 18 219 321 823 
4.g. Cats 0 0 0 0 0 0 
4.h. Dogs 56 16 0 121 2 195 
4.i. Ferrets 0 0 0 154 0 154 
4.j. Other Carnivores 0 0 0 0 0 0 
4.k. Horses, donkeys and cross breds 0 0 0 0 28 28 
4.l. Pigs 71 0 0 116 286 473 
4.m. Goats 0 0 0 60 0 60 
4.n. Sheep 39 0 0 75 0 114 
4.o. Cattle 4 0 0 0 136 140 
4.p. Prosimians 0 0 0 0 0 0 
4.q. New World Monkeys 0 0 0 0 0 0 
4.r. Old World Monkeys 0 0 0 25 0 25 
4.s. Apes 0 0 0 0 0 0 
4.t. Other Mammals 6 0 3 25 0 34 
4.u. Quail 0 0 0 0 0 0 
4.v. Other birds 0 0 0 211 1724 1935 
4.w. Reptiles 0 0 0 0 0 0 
4.x. Amphibians 9 0 0 3 0 12 
4.y. Fish 0 0 0 0 1000 1000 
4.z. TOTAL 8313 94479 48979 252330 13568 417669 
 
EN 30   EN TABLE 5: NUMBER OF ANIMALS USED IN PRODUCTION AN D QUALITY CONTROL OF PRO DUCTS 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 0 26663 0 9365 83891 1003 120922 
5.b. Rats 0 294 0 1385 9621 2429 13729 
5.c. Guinea-Pigs 0 2534 0 4092 12410 9 19045 
5.d. Hamsters 0 840 0 0 820 0 1660 
5.e. Other Rodents 0 0 0 0 0 0 0 
5.f. Rabbits 0 81 0 219 14281 24 14605 
5.g. Cats 0 26 0 0 6 0 32 
5.h. Dogs 0 22 0 0 16 0 38 
5.i. Ferrets 0 0 0 0 0 0 0 
5.j. Other Carnivores 0 0 0 0 0 0 0 
5.k. Horses, donkeys and cross breds 0 0 0 2 0 15 17 
5.l. Pigs 0 82 0 0 105 21 208 
5.m. Goats 0 0 0 0 40 0 40 
5.n. Sheep 0 2 0 0 32 0 34 
5.o. Cattle 0 484 0 0 0 0 484 
5.p. Prosimians 0 0 0 0 0 0 0 
5.q. New World Monkeys 0 0 0 0 0 0 0 
5.r. Old World Monkeys 0 0 0 0 0 0 0 
5.s. Apes 0 0 0 0 0 0 0 
5.t. Other Mammals 0 0 0 0 0 0 0 
5.u. Quail 0 0 0 0 0 0 0 
5.v. Other birds 0 201 0 0 0 0 201 
5.w. Reptiles 0 0 0 0 0 0 0 
5.x. Amphibians 0 0 0 0 0 0 0 
5.y. Fish 0 0 0 0 0 0 0 
5.z. TOTAL 0 31229 0 15063 121222 3501 171015 
Examples: 5.2 – France is testing due to a UK (or FR) specific  requirement Note: columns 5.2 - 5. 5 refer to the legislation imp osing that the test be carried out and 
 5.3 - UK is testing according to EC legislation  not to the bo dy which has issued the actual te st method, guidel ine or protoco l. 
 5.4 – Spain is testing due to a Hungarian requirement Example: a test required by French legislation and carried out in Belgiu m according to an 
 5.5 – Sweden is testing due to a US specific requirement  ISO protocol must be coded as a national (FR) legislative requiremen t and be 
 5.6 – Germany is testing due to  a Czech requirement (also an EC 
requirement)  entered into column 5.2 in the tables submitted by Belgium. 
Footnotes: 1) EC Member States: Austria, Belgium, Denmark, Finl and, France, Germany, Greece, Ir eland, Italy, Luxembourg, Nether lands, Portugal, Spain, Sw eden, United Kingdom 
 2) Member Countries of Council of Europe (non-EC): Albania, A ndorra, Bulgaria, Croatia, Cyprus, Czech Rep., Estonia, Hungary, Iceland, Latvia, Liechtenstein, Lithuania, 
Malta, Moldova, Norway, Poland, Romania, Ru ssia, San Marino, Slovakia, Slovenia, Switz erland, ‘the former Yugoslav Rep. of Mace donia’, Turkey, Ukraine 
 
EN 31   EN TABLE 6: NUMBER OF ANIMALS USED IN TOXI COLOGICAL 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 0 3234 0 3180 21142 4184 31740 
6.b. Rats 0 0 0 640 11501 819 12960 
6.c. Guinea-Pigs 0 40 0 403 13747 0 14190 
6.d. Hamsters 0 0 0 0 0 0 0 
6.e. Other Rodents 0 0 0 0 0 142 142 
6.f. Rabbits 0 12 0 0 1069 14 1095 
6.g. Cats 0 0 0 0 0 0 0 
6.h. Dogs 0 0 0 0 1018 0 1018 
6.i. Ferrets 0 0 0 0 0 0 0 
6.j. Other Carnivores 0 0 0 0 0 0 0 
6.k. Horses, donkeys and cross breds 0 0 0 0 0 0 0 
6.l. Pigs 0 80 0 0 0 15 95 
6.m. Goats 0 0 0 0 0 0 0 
6.n. Sheep 0 24 0 0 0 0 24 
6.o. Cattle 0 0 0 15 0 0 15 
6.p. Prosimians 0 0 0 0 0 0 0 
6.q. New World Monkeys 0 0 0 0 0 0 0 
6.r. Old World Monkeys 0 0 0 0 412 0 412 
6.s. Apes 0 0 0 0 0 0 0 
6.t. Other Mammals 0 0 0 0 0 0 0 
6.u. Quail 0 0 0 0 0 0 0 
6.v. Other birds 0 82 0 0 0 156 238 
6.w. Reptiles 0 0 0 0 0 0 0 
6.x. Amphibians 0 0 0 0 0 0 0 
6.y. Fish 230 0 0 590 275 674 1769 
6.z. TOTAL 230 3472 0 4828 49164 6004 63698 
Examples: 6.2 – France is testing due to a UK (or FR) specific  requirement Note: columns 6.2 - 6. 5 refer to the legislation imp osing that the test be carried out and 
 6.3 - UK is testing according to EC legislation  not to the bo dy which has issued the actual te st method, guidel ine or protoco l. 
 6.4 – Spain is testing due to a Hungarian requirement Example: a test required by French legislation and carried out in Belgiu m according to an 
 6.5 – Sweden is testing due to a US specific requirement  ISO protocol must be coded as a national (FR) legislative requiremen t and be 
 6.6 – Germany is testing due to  a Czech requirement (also an EC 
requirement)  entered into column 6.2 in the tables submitted by Belgium. 
Footnotes: 1) EC Member States: Austria, Belgium, Denmark, Finl and, France, Germany, Greece, Ir eland, Italy, Luxembourg, Nether lands, Portugal, Spain, Sw eden, United Kingdom 
 2) Member Countries of Council of Europe (non-EC): Albania, A ndorra, Bulgaria, Croatia, Cyprus, Czech Rep., Estonia, Hungary, Iceland, Latvia, Liechtenst ein, Lithuania, Malta, 
Moldova, Norway, Poland, Romania, Russia, San Marino, Slovakia, Slovenia, Switzerland,  ‘the former Yugoslav Rep. of Macedonia’,  Turkey, Ukraine 
 
EN 32   EN TABLE 7: NUMBER OF ANIMALS USED IN TOXI COLOGICAL AND OTHER SAFETY EVALUATIONS 
Types of tests versus species 
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 7.11 
Toxicity 
to aquatic 
vertebra-
tes not 
included 
in other 
columns 7.12 
Other 7.13 
Total 
  7.2.1. 
LD50, 
LC50 7.2.2 
Other lethal 
methods 7.2.3 
Non lethal 
clinical signs 
methods            
7.a. Mice 1534 15 24673 0 0 0 1720 854 457 1611 100 0 776 31740 
7.b. Rats 0 60 5297 0 0 0 1718 1604 1657 531 326 0 1767 12960 
7.c. Guinea-Pigs 0 0 14030 0 160 0 0 0 0 0 0 0 0 14190 
7.d. Hamsters 0 0 0 0 0 0 0 0 0 0 0 0 0 0 
7.e. Other Rodents 0 142 0 0 0 0 0 0 0 0 0 0 0 142 
7.f. Rabbits 0 0 169 18 9 12 0 0 814 0 0 0 73 1095 
7.g. Cats 0 0 0 0 0 0 0 0 0 0 0 0 0 0 
7.h. Dogs 0 0 474 0 0 0 215 0 0 0 0 0 329 1018 
7.i. Ferrets 0 0 0 0 0 0 0 0 0 0 0 0 0 0 
7.j. Other Carnivores 0 0 0 0 0 0 0 0 0 0 0 0 0 0 
7.k. Horses, donkeys and cross 
breds 0 0 0 0 0 0 0 0 0 0 0 0 0 0 
7.l. Pigs 0 0 0 0 0 0 0 0 0 0 0 0 95 95 
7.m. Goats 0 0 0 0 0 0 0 0 0 0 0 0 0 0 
7.n. Sheep 0 0 0 0 0 0 0 0 0 0 0 0 24 24 
7.o. Cattle 0 0 0 0 0 0 0 0 0 0 0 0 15 15 
7.p. Prosimians 0 0 0 0 0 0 0 0 0 0 0 0 0 0 
7.q. New World Monkeys 0 0 0 0 0 0 0 0 0 0 0 0 0 0 
7.r. Old World Monkeys 0 0 412 0 0 0 0 0 0 0 0 0 0 412 
7.s. Apes 0 0 0 0 0 0 0 0 0 0 0 0 0 0 
7.t. Other Mammals 0 0 0 0 0 0 0 0 0 0 0 0 0 0 
7.u. Quail 0 0 0 0 0 0 0 0 0 0 0 0 0 0 
7.v. Other birds 0 100 0 0 0 0 0 0 0 0 0 0 138 238 
7.w. Reptiles 0 0 0 0 0 0 0 0 0 0 0 0 0 0 
7.x. Amphibians 0 0 0 0 0 0 0 0 0 0 0 0 0 0 
7.y. Fish 1298 0 0 0 0 0 76 0 0 0 0 0 395 1769 
7.z. TOTAL 2832 317 45055 18 169 12 3729 2458 2928 2142 426 0 3612 63698 
 
EN 33   EN TABLE 8: NUMBER OF ANIMALS USED IN TOXI COLOGICAL AND OTHER SAFETY EVALUATIONS 
Types of tests versus products 
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 8.6 
Sub- 
chronic 
and 
chronic 
toxicity 8.7 
Carcino 
genicity 8.8 
Develop- 
mental 
toxicity 8.9 
Muta- 
genicit
y 8.10 
Repro-
ductive 
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            
8.a. Products/substances or devices for 
human medicine and dentistry and for 
veterinary medicine 1534 0 43801 18 169 12 3013 2458 2622 2142 426 1669 1788 59652 
8.b. Products/substances used or intended to 
be used mainly in agriculture 390 0 0 0 0 0 0 0 0 0 0 0 0 390 
8.c. Products/substances used or intended to 
be used mainly in industry 0 0 0 0 0 0 0 0 0 0 0 0 0 0 
8.d. Products/substances used or intended to 
be used mainly in the household 0 0 0 0 0 0 0 0 0 0 0 0 0 0 
8.e. Products/substances used or intended to 
be used mainly as cosmetics or 
toiletries 0 0 0 0 0 0 0 0 0 0 0 0 0 0 
8.f. 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 
8.g. 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 
8.h. Potential or actual contaminants in the 
general environment which do not 
appear in other columns 368 317 0 0 0 0 76 0 0 0 0 0 155 916 
8.i. Other toxicological or safety 
evaluations 540 0 1254 0 0 0 640 0 306 0 0 0 0 2740 
8.j. TOTAL 2832 317 45055 18 169 12 3729 2458 2928 2142 426 1669 1943 63698 
 
EN 34   EN CYPRUS 
Statistical data submitted 
The statistical data have been submitted by “Vet erinary 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 Se rvices of the Republic of Cyprus is empowered by Law to regulate all 
activities that rela te to the use of experimental animals. At present, within th e areas under the control of the 
Republic, only rodents (mice) are used in animal e xperimentation. These primarily include genetic models 
for various diseases or processes with main em phasis on Central Nervous Sy stem complications and 
development. 
These activities began to take plac e in Cyprus in March 2003 and are all carried out in  one research 
establishment, the Cyprus Institu te of Neurology and Genetics ( www.cing.ac.cy) . 
The Veterinary Services are satisfied that the animal s 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 prin ciples of the three Rs are duly adhered to. 
Dr. Giorgos Neophytou Director of Veterinary Services 
 
EN 35   EN TABLE 1: NUMBER OF ANIMALS USED IN RELATION TO THEIR PLACE OF ORIGIN 
Origin versus species 
1.1 
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 1.5 
Animals coming from 
Member Countries of the 
Council of Europe which are 
parties to the Convention ETS 
123 (excluding EC Member 
States) 1.6 
Animals coming from 
other origins 1.7 
Re-used animals 
1.a. Mice ( Mus musculus ) 967 930 12  25  
1.b. Rats ( Rattus norvegicus ) 0      
1.c. Guinea-Pigs ( Cavia porcellus ) 0      
1.d. Hamsters ( Mesocricetus ) 0      
1.e. Other Rodents (other Rodentia )       
1.f. Rabbits ( Oryctolagus cuniculus ) 0      
1.g. Cats ( Felis catus ) 0      
1.h. Dogs ( Canis familiaris ) 0      
1.i. Ferrets ( Mustela putorius furo ) 0      
1.j. Other Carnivores (other Carnivora )       
1.k. Horses, donkeys and cross breds ( Equidae )       
1.l. Pigs ( Sus)       
1.m. Goats ( Capra )       
1.n. Sheep ( Ovis)        
1.o. Cattle ( Bos)       
1.p. Prosimians ( Prosimia ) 0      
1.q. New World Monkeys ( Ceboidea ) 0      
1.r. Old World Monkeys ( Cercopithecoidea ) 0      
1.s. Apes ( Hominoidea ) 0      
1.t. Other Mammals (other Mammalia )       
1.u. Quail ( Coturnix coturnix)  0      
1.v. Other birds (other Aves )       
1.w. Reptiles ( Reptilia )       
1.x. Amphibians ( Amphibia )       
1.y. Fish ( Pisces )       
1.z. TOTAL 967      
Note 1: Column 1.5 concerns only those Member Countries of the Co uncil of Europe which, at the beginning of the reporting perio d, 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 b oxes 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 36   EN 
 
EN 37   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 2.3 
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 822      145  967 
2.b. Rats         0 
2.c. Guinea-Pigs         0 
2.d. Hamsters         0 
2.e. Other Rodents         0 
2.f. Rabbits         0 
2.g. Cats         0 
2.h. Dogs         0 
2.i. Ferrets         0 
2.j. Other Carnivores         0 
2.k. Horses, donkeys and cross 
breds         0 
2.l. Pigs         0 
2.m. Goats         0 
2.n. Sheep         0 
2.o. Cattle         0 
2.p. Prosimians         0 
2.q. New World Monkeys         0 
2.r. Old World Monkeys         0 
2.s. Apes         0 
2.t. Other Mammals         0 
2.u. Quail         0 
2.v. Other birds         0 
2.w. Reptiles         0 
2.x. Amphibians         0 
2.y. Fish         0 
 
EN 38   EN 2.z. TOTAL 822 0 0 0 0 0 145 0 967 
 
EN 39   EN  TABLE 4: NUMBER OF ANIMALS USED IN EXPERIME NTS FOR STUDIES ON HUM AN 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) 4.5 
Other human diseases 4.6 
Studies specific to animal 
diseases 4.7 
Total 
4.a. Mice  792  175  967 
4.b. Rats      0 
4.c. Guinea-Pigs      0 
4.d. Hamsters      0 
4.e. Other Rodents      0 
4.f. Rabbits      0 
4.g. Cats      0 
4.h. Dogs      0 
4.i. Ferrets      0 
4.j. Other Carnivores      0 
4.k. Horses, donkeys and cross breds      0 
4.l. Pigs      0 
4.m. Goats      0 
4.n. Sheep      0 
4.o. Cattle      0 
4.p. Prosimians      0 
4.q. New World Monkeys      0 
4.r. Old World Monkeys      0 
4.s. Apes      0 
4.t. Other Mammals      0 
4.u. Quail      0 
4.v. Other birds      0 
4.w. Reptiles      0 
4.x. Amphibians      0 
4.y. Fish      0 
4.z. TOTAL 0 792 0 175 0 967 
 
EN 40   EN CZECH REPUBLIC 
Statistical data submitted 
The statistical data have been submitted by the “Central Commissi on for Animal Welfare (Ústřední 
komise pro ochranu zví řat)”. 
Comments of the Czech authorities 
National comments for the preparation of the 5th Statistical report on th e use of experimental 
animals - Czech Republic  
Protection of animals and animal welfare in the C zech Republic is the responsibility of the Ministry 
of Agriculture, which provides the organisation b ackground necessary for the activities performed by 
the Central Commission for Animal Welfare (Ústřední komise pro ochranu zví řat). 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 th ese matters has been th e 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 conducte d 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 experi mental and other scientif ic purposes in the CR. 
It shall be pointed out that 36.99 % of it is represented by ringed bi rds (122 422 birds) since pursuant 
to the relevant Czech legislation ev en bird ringing is an experiment. 
Of the remaining 208 511 animals used for experimental and scie ntific 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 num ber 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 becau se these experiments are usually conducted on a 
large group of animals (a flock in hous es or stock in water reservoirs). 
The use of alternative me thods to experiments on animals has b een pushed through in the CR. Persons 
who manage, control and conduct experiments on anim als are obliged to seek  in the registers of 
validated alternative methods su ch methods which are applicable  to their experiment. In the 
experimental project the applicant shall declare in writing that no va lidated alternative method can be 
applied for the given purpose. 
The training courses for persons who manage, c ontrol 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 41   EN TABLE 1: NUMBER OF ANIMALS USED IN RELATION TO THEIR PLACE OF ORIGIN 
Origin versus species 
1.1 
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 1.5 
Animals coming from 
Member Countries of the 
Council of Europe which are 
parties to the Convention ETS 
123 (excluding EC Member 
States) 1.6 
Animals coming from 
other origins 1.7 
Re-used animals 
1.a. Mice ( Mus musculus ) 82252 75473 4708 2071   
1.b. Rats ( Rattus norvegicus ) 31703 29924 1087 240 452  
1.c. Guinea-Pigs ( Cavia porcellus ) 4075 4075     
1.d. Hamsters ( Mesocricetus ) 220 220     
1.e. Other Rodents (other Rodentia ) 5798      
1.f. Rabbits ( Oryctolagus cuniculus ) 5567 5567    119 
1.g. Cats ( Felis catus ) 29 3   26  
1.h. Dogs ( Canis familiaris ) 264 264    24 
1.i. Ferrets ( Mustela putorius furo ) 159 159     
1.j. Other Carnivores (other Carnivora ) 7      
1.k. Horses, donkeys and cross breds ( Equidae ) 314      
1.l. Pigs ( Sus) 1392      
1.m. Goats ( Capra ) 56      
1.n. Sheep ( Ovis)  720      
1.o. Cattle ( Bos) 711      
1.p. Prosimians ( Prosimia ) 0      
1.q. New World Monkeys ( Ceboidea ) 0      
1.r. Old World Monkeys ( Cercopithecoidea ) 51 51    30 
1.s. Apes ( Hominoidea ) 0      
1.t. Other Mammals (other Mammalia ) 188      
1.u. Quail ( Coturnix coturnix)  30 30     
1.v. Other birds (other Aves ) 126211      
1.w. Reptiles ( Reptilia ) 1475      
1.x. Amphibians ( Amphibia ) 293      
1.y. Fish ( Pisces ) 69418      
1.z. TOTAL 330933      
Note 1: Column 1.5 concerns only those Member Countries of the Co uncil of Europe which, at the beginning of the reporting perio d, 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 b oxes 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 42   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 2.3 
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 33319 4698 8962 14401 2673 9320 3338 5541 82252 
2.b. Rats 25532 2462 146 920 911 77 1655  31703 
2.c. Guinea-Pigs 433 4 1575 1048 527 457 31  4075 
2.d. Hamsters 115  55 40  10   220 
2.e. Other Rodents 5449   187   162  5798 
2.f. Rabbits 352 16 1351 2962 448 344 83 11 5567 
2.g. Cats 3   26     29 
2.h. Dogs 4  10 100 145 5   264 
2.i. Ferrets  126 7   6 20  159 
2.j. Other Carnivores 7        7 
2.k. Horses, donkeys and cross 
breds    208   100 6 314 
2.l. Pigs 502   569  85 236  1392 
2.m. Goats 56        56 
2.n. Sheep 83   51   19 567 720 
2.o. Cattle 152 241  40  12 84 182 711 
2.p. Prosimians         0 
2.q. New World Monkeys         0 
2.r. Old World Monkeys     51    51 
2.s. Apes         0 
2.t. Other Mammals 188        188 
2.u. Quail     30    30 
2.v. Other birds 122422  42 2556  6 585 600 126211 
2.w. Reptiles 755      720  1475 
2.x. Amphibians 208      85  293 
2.y. Fish 26935   1422 26693 870 11866 1632 69418 
 
EN 43   EN 2.z. TOTAL 216515 7547 12148 24530 31478 11192 18984 8539 330933 
 
EN 44   EN TABLE 3: NUMBER OF ANIMALS USED IN TOXI COLOGICAL 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 3.7 
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 3.10 
Other toxico- 
logical or 
safety 
evaluations 3.11 
Total 
3.a. Mice 2300  68    600 405  3373 
3.b. Rats 663  248    150 200  1261 
3.c. Guinea-Pigs 30 26 471       527 
3.d. Hamsters          0  
3.e. Other Rodents          0  
3.f. Rabbits 245 4 174     25  448 
3.g. Cats          0  
3.h. Dogs 145         145 
3.i. Ferrets          0  
3.j. Other Carnivores          0  
3.k. Horses, donkeys and cross breds          0  
3.l. Pigs          0  
3.m. Goats          0  
3.n. Sheep          0  
3.o. Cattle          0  
3.p. Prosimians          0  
3.q. New World Monkeys          0  
3.r. Old World Monkeys 51         51 
3.s. Apes          0  
3.t. Other Mammals          0  
3.u. Quail        25  25 
3.v. Other birds          0  
3.w. Reptiles          0  
3.x. Amphibians          0  
3.y. Fish 1468 90 2676     19523 1891 25648 
3.z. TOTAL 4902 120 3637 0 0 0 750 20178 1891 31478 
 
EN 45   EN TABLE 4: NUMBER OF ANIMALS USED IN EXPERIME NTS FOR STUDIES ON HUM AN 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) 4.5 
Other human diseases 4.6 
Studies specific to animal 
diseases 4.7 
Total 
4.a. Mice 1473 1230 9036 15146 4672 31557 
4.b. Rats 5697 2896 694 6104 136 15527 
4.c. Guinea-Pigs 10   13 6 29 
4.d. Hamsters    10 20 30 
4.e. Other Rodents     361 361 
4.f. Rabbits 167  3 161 72 403 
4.g. Cats 3     3 
4.h. Dogs 2     2 
4.i. Ferrets 126   6  132 
4.j. Other Carnivores      0 
4.k. Horses, donkeys and cross breds      0 
4.l. Pigs 31  30 188 40 289 
4.m. Goats     56 56 
4.n. Sheep 29    28 57 
4.o. Cattle     17 17 
4.p. Prosimians      0 
4.q. New World Monkeys      0 
4.r. Old World Monkeys      0 
4.s. Apes      0 
4.t. Other Mammals      0 
4.u. Quail    5  5 
4.v. Other birds    111 1093 1204 
4.w. Reptiles      0 
4.x. Amphibians      0 
4.y. Fish     1430 1430 
4.z. TOTAL 7538 4126 9763 21744 7931 51102 
 
EN 46   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 4422 17623    1368 23413 
5.b. Rats 211 880  8  117 1216 
5.c. Guinea-Pigs 3 2620     2623 
5.d. Hamsters  95     95 
5.e. Other Rodents     187  187 
5.f. Rabbits 483 3433  11  386 4313 
5.g. Cats  26     26 
5.h. Dogs  110     110 
5.i. Ferrets  7     7 
5.j. Other Carnivores       0  
5.k. Horses, donkeys and cross breds 205 3     208 
5.l. Pigs  556    13 569 
5.m. Goats       0  
5.n. Sheep  51     51 
5.o. Cattle  40     40 
5.p. Prosimians       0  
5.q. New World Monkeys       0  
5.r. Old World Monkeys       0  
5.s. Apes       0  
5.t. Other Mammals       0  
5.u. Quail       0  
5.v. Other birds  2543    55 2598 
5.w. Reptiles       0  
5.x. Amphibians       0  
5.y. Fish 1222      1222 
5.z. TOTAL 6546 27987 0 19 187 1939 36678 
Examples: 5.2 – France is testing due to a UK (or FR) specific  requirement Note: columns 5.2 - 5. 5 refer to the legislation imp osing that the test be carried out and 
 5.3 - UK is testing according to EC legislation  not to the bo dy which has issued the actual te st method, guidel ine or protoco l. 
 5.4 – Spain is testing due to a Hungarian requirement Example: a test required by French legislation and carried out in Belgiu m according to an 
 5.5 – Sweden is testing due to a US specific requirement  ISO protocol must be coded as a national (FR) legislative requiremen t and be 
 5.6 – Germany is testing due to  a Czech requirement (also an EC 
requirement)  entered into column 5.2 in the tables submitted by Belgium. 
Footnotes: 1) EC Member States: Austria, Belgium, Denmark, Finl and, France, Germany, Greece, Ir eland, Italy, Luxembourg, Nether lands, Portugal, Spain, Sw eden, United Kingdom 
 
EN 47   EN  2) Member Countries of Council of Europe (non-EC): Albania, A ndorra, Bulgaria, Croatia, Cyprus, Czech Rep., Estonia, Hungary, Iceland, Latvia, Liechtenstein, Lithuania, 
Malta, Moldova, Norway, Poland, Romania, Ru ssia, San Marino, Slovakia, Slovenia, Switz erland, ‘the former Yugoslav Rep. of Mace donia’, Turkey, Ukraine 
 
EN 48   EN TABLE 6: NUMBER OF ANIMALS USED IN TOXI COLOGICAL 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 278 2170    225 2673 
6.b. Rats 224 663 24    911 
6.c. Guinea-Pigs 351 106 70    527 
6.d. Hamsters       0  
6.e. Other Rodents       0  
6.f. Rabbits 182 257 9    448 
6.g. Cats       0  
6.h. Dogs  145     145 
6.i. Ferrets       0  
6.j. Other Carnivores       0  
6.k. Horses, donkeys and cross breds       0  
6.l. Pigs       0  
6.m. Goats       0  
6.n. Sheep       0  
6.o. Cattle       0  
6.p. Prosimians       0  
6.q. New World Monkeys       0  
6.r. Old World Monkeys  51     51 
6.s. Apes       0  
6.t. Other Mammals       0  
6.u. Quail      25 25 
6.v. Other birds       0  
6.w. Reptiles       0  
6.x. Amphibians       0  
6.y. Fish 6476 15055 312   4855 26698 
6.z. TOTAL 7511 18447 415 0 0 5105 31478 
Examples: 6.2 – France is testing due to a UK (or FR) specific  requirement Note: columns 6.2 - 6. 5 refer to the legislation imp osing that the test be carried out and 
 6.3 - UK is testing according to EC legislation  not to the bo dy which has issued the actual te st method, guidel ine or protoco l. 
 6.4 – Spain is testing due to a Hungarian requirement Example: a test required by French legislation and carried out in Belgiu m according to an 
 6.5 – Sweden is testing due to a US specific requirement  ISO protocol must be coded as a national (FR) legislative requiremen t and be 
 6.6 – Germany is testing due to  a Czech requirement (also an EC 
requirement)  entered into column 6.2 in the tables submitted by Belgium. 
Footnotes: 1) EC Member States: Austria, Belgium, Denmark, Finl and, France, Germany, Greece, Ir eland, Italy, Luxembourg, Nether lands, Portugal, Spain, Sw eden, United Kingdom 
 2) Member Countries of Council of Europe (non-EC): Albania, A ndorra, Bulgaria, Croatia, Cyprus, Czech Rep., Estonia, Hungary, Iceland, Latvia, Liechtenst ein, Lithuania, Malta, 
Moldova, Norway, Poland, Romania, Russia, San Marino, Slovakia, Slovenia, Switzerland,  ‘the former Yugoslav Rep. of Macedonia’,  Turkey, Ukraine 
 
EN 49   EN TABLE 7: NUMBER OF ANIMALS USED IN TOXI COLOGICAL AND OTHER SAFETY EVALUATIONS 
Types of tests versus species 
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 7.11 
Toxicity 
to aquatic 
vertebra-
tes not 
included 
in other 
columns 7.12 
Other 7.13 
Total 
  7.2.1. 
LD50, 
LC50 7.2.2 
Other lethal 
methods 7.2.3 
Non lethal 
clinical signs 
methods            
7.a. Mice 1055    68  1115  120  90  225 2673 
7.b. Rats 298      613       911 
7.c. Guinea-Pigs    40 487         527 
7.d. Hamsters              0  
7.e. Other Rodents              0  
7.f. Rabbits    259  164    25    448 
7.g. Cats              0  
7.h. Dogs       145       145 
7.i. Ferrets              0  
7.j. Other Carnivores              0  
7.k. Horses, donkeys and cross 
breds              0  
7.l. Pigs              0  
7.m. Goats              0  
7.n. Sheep              0  
7.o. Cattle              0  
7.p. Prosimians              0  
7.q. New World Monkeys              0  
7.r. Old World Monkeys       51       51 
7.s. Apes              0  
7.t. Other Mammals              0  
7.u. Quail   25           25 
7.v. Other birds              0  
7.w. Reptiles              0  
7.x. Amphibians              0  
7.y. Fish 22501      155    1600 2442  26698 
7.z. TOTAL 23854 0 25 299 555 164 2079 0 120 25 1690 2442 225 31478 
 
EN 50   EN TABLE 8: NUMBER OF ANIMALS USED IN TOXI COLOGICAL AND OTHER SAFETY EVALUATIONS 
Types of tests versus products 
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 8.6 
Sub- 
chronic 
and 
chronic 
toxicity 8.7 
Carcino 
genicity 8.8 
Develop- 
mental 
toxicity 8.9 
Muta- 
genicit
y 8.10 
Repro-
ductive 
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            
8.a. Products/substances or devices for 
human medicine and dentistry and for 
veterinary medicine 1213   145 30 100 1924       3412 
8.b. Products/substances used or intended to 
be used mainly in agriculture 90   12 18         120 
8.c. Products/substances used or intended to 
be used mainly in industry 1450   142 507 64 100     1374  3637 
8.d. Products/substances used or intended to 
be used mainly in the household              0  
8.e. Products/substances used or intended to 
be used mainly as cosmetics or 
toiletries              0  
8.f. Products/substances used or intended to 
be used mainly as additives in food for 
human consumption              0  
8.g. Products/substances used or intended to 
be used mainly as additives in food for 
animal consumption              0  
8.h. Potential or actual contaminants in the 
general environment which do not 
appear in other columns 19510  25      120 25 90 1068  20838 
8.i. Other toxicological or safety 
evaluations 591           2655 225 3471 
8.j. TOTAL 22854 0 25 299 555 164 2024 0 120 25 90 5097 225 31478 
 
EN 51   ENDENMARK  
Statistical data submitted 
The statistical data have been submitted by the “ Dyreforsøgstilsynet ” (Animal 
Experiments Inspectorate). 
Comments of Danish authorities  
None 
 
EN 52   EN TABLE 1: NUMBER OF ANIMALS USED IN RELATION TO THEIR PLACE OF ORIGIN 
Origin versus species 
1.1 
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 1.5 
Animals coming from 
Member Countries of the 
Council of Europe which are 
parties to the Convention ETS 
123 (excluding EC Member 
States) 1.6 
Animals coming from 
other origins 1.7 
Re-used animals 
1.a. Mice ( Mus musculus ) 208375 109300 96573 0 2502 145 
1.b. Rats ( Rattus norvegicus ) 85664 45960 37649 725 1330 71 
1.c. Guinea-Pigs ( Cavia porcellus ) 5046 1204 3838 0 4 2 
1.d. Hamsters ( Mesocricetus ) 402 402 0 0 0 0 
1.e. Other Rodents (other Rodentia ) 6381 0 0 0 0 0 
1.f. Rabbits ( Oryctolagus cuniculus ) 5805 4288 1359 18 140 739 
1.g. Cats ( Felis catus ) 16 4 0 4 8 0 
1.h. Dogs ( Canis familiaris ) 566 10 514 0 42 84 
1.i. Ferrets ( Mustela putorius furo ) 19 0 0 0 19 0 
1.j. Other Carnivores (other Carnivora ) 242 0 0 0 0 0 
1.k. Horses, donkeys and cross breds ( Equidae ) 62 0 0 0 0 0 
1.l. Pigs ( Sus) 7697 0 0 0 0 0 
1.m. Goats ( Capra ) 199 0 0 0 0 0 
1.n. Sheep ( Ovis)  156 0 0 0 0 0 
1.o. Cattle ( Bos) 489 0 0 0 0 0 
1.p. Prosimians ( Prosimia ) 0 0 0 0 0 0 
1.q. New World Monkeys ( Ceboidea ) 0 0 0 0 0 0 
1.r. Old World Monkeys ( Cercopithecoidea ) 0 0 0 0 0 0 
1.s. Apes ( Hominoidea ) 0 0 0 0 0 0 
1.t. Other Mammals (other Mammalia ) 185 0 0 0 0 0 
1.u. Quail ( Coturnix coturnix)  0 0 0 0 0 0 
1.v. Other birds (other Aves ) 7784 0 0 0 0 0 
1.w. Reptiles ( Reptilia ) 54 0 0 0 0 0 
1.x. Amphibians ( Amphibia ) 840 0 0 0 0 0 
1.y. Fish ( Pisces ) 35958 0 0 0 0 0 
1.z. TOTAL 365940 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 perio d, 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 b oxes 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 53   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 2.3 
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 50339 128153 13842 165 3742 2524 1441 8169 208375 
2.b. Rats 18795 54087 860 0 8786 703 1984 449 85664 
2.c. Guinea-Pigs 393 850 1434 0 2303 66 0 0 5046 
2.d. Hamsters 338 0 0 0 64 0 0 0 402 
2.e. Other Rodents 0 6343 0 0 0 38 0 0 6381 
2.f. Rabbits 247 700 882 82 556 3232 104 2 5805 
2.g. Cats 12 0 0 0 0 0 4 0 16 
2.h. Dogs 46 109 0 0 407 0 4 0 566 
2.i. Ferrets 19 0 0 0 0 0 0 0 19 
2.j. Other Carnivores 242 0 0 0 0 0 0 0 242 
2.k. Horses, donkeys and cross 
breds 39 0 12 0 0 0 11 0 62 
2.l. Pigs 3992 1807 20 29 581 483 350 435 7697 
2.m. Goats 26 3 0 0 0 163 1 6 199 
2.n. Sheep 125 27 4 0 0 0 0 0 156 
2.o. Cattle 444 30 0 2 0 0 13 0 489 
2.p. Prosimians 0 0 0 0 0 0 0 0 0 
2.q. New World Monkeys 0 0 0 0 0 0 0 0 0 
2.r. Old World Monkeys 0 0 0 0 0 0 0 0 0 
2.s. Apes 0 0 0 0 0 0 0 0 0 
2.t. Other Mammals 137 48 0 0 0 0 0 0 185 
2.u. Quail 0 0 0 0 0 0 0 0 0 
2.v. Other birds 2695 0 2 0 0 5087 0 0 7784 
2.w. Reptiles 54 0 0 0 0 0 0 0 54 
2.x. Amphibians 597 93 0 0 0 0 150 0 840 
2.y. Fish 10284 23710 0 0 1480 0 84 400 35958 
2.z. TOTAL 88824 215960 17056 278 17919 12296 4146 9461 365940 
 
EN 54   EN TABLE 3: NUMBER OF ANIMALS USED IN TOXI COLOGICAL 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 3.7 
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 3.10 
Other toxico- 
logical or 
safety 
evaluations 3.11 
Total 
3.a. Mice 2733 0 556 51 0 0 0 25 377 3742 
3.b. Rats 5453 2138 355 134 0 33 0 561 112 8786 
3.c. Guinea-Pigs 2102 0 45 0 0 0 0 156 0 2303 
3.d. Hamsters 64 0 0 0 0 0 0 0 0 64 
3.e. Other Rodents 0 0 0 0 0 0 0 0 0 0 
3.f. Rabbits 407 0 9 0 0 135 0 0 5 556 
3.g. Cats 0 0 0 0 0 0 0 0 0 0 
3.h. Dogs 407 0 0 0 0 0 0 0 0 407 
3.i. Ferrets 0 0 0 0 0 0 0 0 0 0 
3.j. Other Carnivores 0 0 0 0 0 0 0 0 0 0 
3.k. Horses, donkeys and cross breds 0 0 0 0 0 0 0 0 0 0 
3.l. Pigs 581 0 0 0 0 0 0 0 0 581 
3.m. Goats 0 0 0 0 0 0 0 0 0 0 
3.n. Sheep 0 0 0 0 0 0 0 0 0 0 
3.o. Cattle 0 0 0 0 0 0 0 0 0 0 
3.p. Prosimians 0 0 0 0 0 0 0 0 0 0 
3.q. New World Monkeys 0 0 0 0 0 0 0 0 0 0 
3.r. Old World Monkeys 0 0 0 0 0 0 0 0 0 0 
3.s. Apes 0 0 0 0 0 0 0 0 0 0 
3.t. Other Mammals 0 0 0 0 0 0 0 0 0 0 
3.u. Quail 0 0 0 0 0 0 0 0 0 0 
3.v. Other birds 0 0 0 0 0 0 0 0 0 0 
3.w. Reptiles 0 0 0 0 0 0 0 0 0 0 
3.x. Amphibians 0 0 0 0 0 0 0 0 0 0 
3.y. Fish 0 0 1080 0 0 0 0 400 0 1480 
3.z. TOTAL 11747 2138 2045 185 0 168 0 1142 494 17919 
 
EN 55   EN TABLE 4: NUMBER OF ANIMALS USED IN EXPERIME NTS FOR STUDIES ON HUM AN 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) 4.5 
Other human diseases 4.6 
Studies specific to animal 
diseases 4.7 
Total 
4.a. Mice 1902 92293 20255 30999 716 146165 
4.b. Rats 3072 35360 332 27760 96 66620 
4.c. Guinea-Pigs 65 629 0 281 24 999 
4.d. Hamsters 171 0 0 0 0 171 
4.e. Other Rodents 0 5923 0 420 0 6343 
4.f. Rabbits 142 8 0 740 2 892 
4.g. Cats 0 12 0 0 0 12 
4.h. Dogs 0 17 0 92 42 151 
4.i. Ferrets 0 19 0 0 0 19 
4.j. Other Carnivores 0 0 0 0 102 102 
4.k. Horses, donkeys and cross breds 0 0 0 0 26 26 
4.l. Pigs 254 172 0 1616 665 2707 
4.m. Goats 0 0 0 29 0 29 
4.n. Sheep 0 0 0 50 0 50 
4.o. Cattle 0 0 0 0 10 10 
4.p. Prosimians 0 0 0 0 0 0 
4.q. New World Monkeys 0 0 0 0 0 0 
4.r. Old World Monkeys 0 0 0 0 0 0 
4.s. Apes 0 0 0 0 0 0 
4.t. Other Mammals 0 0 0 0 0 0 
4.u. Quail 0 0 0 0 0 0 
4.v. Other birds 0 0 0 0 3714 3714 
4.w. Reptiles 0 0 0 0 0 0 
4.x. Amphibians 0 127 0 0 0 127 
4.y. Fish 0 0 0 0 2800 2800 
4.z. TOTAL 5606 134560 20587 61987 8197 230937 
 
EN 56   EN TABLE 5: NUMBER OF ANIMALS USED IN PRODUCTION AN D QUALITY CONTROL OF PRO DUCTS 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 86 517 0 0 12882 522 14007 
5.b. Rats 96 0 0 0 764 0 860 
5.c. Guinea-Pigs 0 0 0 0 1332 102 1434 
5.d. Hamsters 0 0 0 0 0 0 0 
5.e. Other Rodents 0 0 0 0 0 0 0 
5.f. Rabbits 7 0 0 30 397 530 964 
5.g. Cats 0 0 0 0 0 0 0 
5.h. Dogs 0 0 0 0 0 0 0 
5.i. Ferrets 0 0 0 0 0 0 0 
5.j. Other Carnivores 0 0 0 0 0 0 0 
5.k. Horses, donkeys and cross breds 0 0 0 0 0 12 12 
5.l. Pigs 25 0 0 0 24 0 49 
5.m. Goats 0 0 0 0 0 0 0 
5.n. Sheep 0 0 0 0 0 4 4 
5.o. Cattle 0 0 0 0 2 0 2 
5.p. Prosimians 0 0 0 0 0 0 0 
5.q. New World Monkeys 0 0 0 0 0 0 0 
5.r. Old World Monkeys 0 0 0 0 0 0 0 
5.s. Apes 0 0 0 0 0 0 0 
5.t. Other Mammals 0 0 0 0 0 0 0 
5.u. Quail 0 0 0 0 0 0 0 
5.v. Other birds 0 0 0 2 0 0 2 
5.w. Reptiles 0 0 0 0 0 0 0 
5.x. Amphibians 0 0 0 0 0 0 0 
5.y. Fish 0 0 0 0 0 0 0 
5.z. TOTAL 214 517 0 32 15401 1170 17334 
Examples: 5.2 – France is testing due to a UK (or FR) specific  requirement Note: columns 5.2 - 5. 5 refer to the legislation imp osing that the test be carried out and 
 5.3 - UK is testing according to EC legislation  not to the bo dy which has issued the actual te st method, guidel ine or protoco l. 
 5.4 – Spain is testing due to a Hungarian requirement Example: a test required by French legislation and carried out in Belgiu m according to an 
 5.5 – Sweden is testing due to a US specific requirement  ISO protocol must be coded as a national (FR) legislative requiremen t and be 
 5.6 – Germany is testing due to  a Czech requirement (also an EC 
requirement)  entered into column 5.2 in the tables submitted by Belgium. 
Footnotes: 1) EC Member States: Austria, Belgium, Denmark, Finl and, France, Germany, Greece, Ir eland, Italy, Luxembourg, Nether lands, Portugal, Spain, Sw eden, United Kingdom 
 2) Member Countries of Council of Europe (non-EC): Albania, A ndorra, Bulgaria, Croatia, Cyprus, Czech Rep., Estonia, Hungary, Iceland, Latvia, Liechtenstein, Lithuania, 
Malta, Moldova, Norway, Poland, Romania, Ru ssia, San Marino, Slovakia, Slovenia, Switz erland, ‘the former Yugoslav Rep. of Mace donia’, Turkey, Ukraine 
 
EN 57   EN TABLE 6: NUMBER OF ANIMALS USED IN TOXI COLOGICAL 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 223 0 0 0 2190 1329 3742 
6.b. Rats 0 0 0 0 5850 2936 8786 
6.c. Guinea-Pigs 0 0 0 0 2112 191 2303 
6.d. Hamsters 0 0 0 0 64 0 64 
6.e. Other Rodents 0 0 0 0 0 0 0 
6.f. Rabbits 0 0 0 0 416 140 556 
6.g. Cats 0 0 0 0 0 0 0 
6.h. Dogs 0 0 0 0 407 0 407 
6.i. Ferrets 0 0 0 0 0 0 0 
6.j. Other Carnivores 0 0 0 0 0 0 0 
6.k. Horses, donkeys and cross breds 0 0 0 0 0 0 0 
6.l. Pigs 0 0 0 0 581 0 581 
6.m. Goats 0 0 0 0 0 0 0 
6.n. Sheep 0 0 0 0 0 0 0 
6.o. Cattle 0 0 0 0 0 0 0 
6.p. Prosimians 0 0 0 0 0 0 0 
6.q. New World Monkeys 0 0 0 0 0 0 0 
6.r. Old World Monkeys 0 0 0 0 0 0 0 
6.s. Apes 0 0 0 0 0 0 0 
6.t. Other Mammals 0 0 0 0 0 0 0 
6.u. Quail 0 0 0 0 0 0 0 
6.v. Other birds 0 0 0 0 0 0 0 
6.w. Reptiles 0 0 0 0 0 0 0 
6.x. Amphibians 0 0 0 0 0 0 0 
6.y. Fish 0 0 0 1080 0 400 1480 
6.z. TOTAL 223 0 0 1080 11620 4996 17919 
Examples: 6.2 – France is testing due to a UK (or FR) specific  requirement Note: columns 6.2 - 6. 5 refer to the legislation imp osing that the test be carried out and 
 6.3 - UK is testing according to EC legislation  not to the bo dy which has issued the actual te st method, guidel ine or protoco l. 
 6.4 – Spain is testing due to a Hungarian requirement Example: a test required by French legislation and carried out in Belgiu m according to an 
 6.5 – Sweden is testing due to a US specific requirement  ISO protocol must be coded as a national (FR) legislative requiremen t and be 
 6.6 – Germany is testing due to  a Czech requirement (also an EC 
requirement)  entered into column 6.2 in the tables submitted by Belgium. 
Footnotes: 1) EC Member States: Austria, Belgium, Denmark, Finl and, France, Germany, Greece, Ir eland, Italy, Luxembourg, Nether lands, Portugal, Spain, Sw eden, United Kingdom 
 2) Member Countries of Council of Europe (non-EC): Albania, A ndorra, Bulgaria, Croatia, Cyprus, Czech Rep., Estonia, Hungary, Iceland, Latvia, Liechtenst ein, Lithuania, Malta, 
Moldova, Norway, Poland, Romania, Russia, San Marino, Slovakia, Slovenia, Switzerland,  ‘the former Yugoslav Rep. of Macedonia’,  Turkey, Ukraine 
 
EN 58   EN TABLE 7: NUMBER OF ANIMALS USED IN TOXI COLOGICAL AND OTHER SAFETY EVALUATIONS 
Types of tests versus species 
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 7.11 
Toxicity 
to aquatic 
vertebra-
tes not 
included 
in other 
columns 7.12 
Other 7.13 
Total 
  7.2.1. 
LD50, 
LC50 7.2.2 
Other lethal 
methods 7.2.3 
Non lethal 
clinical signs 
methods            
7.a. Mice 0 0 2363 0 30 0 216 0 0 325 14 0 794 3742 
7.b. Rats 0 0 1244 0 0 0 4585 3 116 0 2612 0 226 8786 
7.c. Guinea-Pigs 0 0 1177 0 801 0 169 0 0 0 0 0 156 2303 
7.d. Hamsters 0 0 28 0 0 0 36 0 0 0 0 0 0 64 
7.e. Other Rodents 0 0 0 0 0 0 0 0 0 0 0 0 0 0 
7.f. Rabbits 0 0 0 53 0 5 294 0 0 0 0 0 204 556 
7.g. Cats 0 0 0 0 0 0 0 0 0 0 0 0 0 0 
7.h. Dogs 0 0 20 0 0 0 381 0 0 0 0 0 6 407 
7.i. Ferrets 0 0 0 0 0 0 0 0 0 0 0 0 0 0 
7.j. Other Carnivores 0 0 0 0 0 0 0 0 0 0 0 0 0 0 
7.k. Horses, donkeys and cross 
breds 0 0 0 0 0 0 0 0 0 0 0 0 0 0 
7.l. Pigs 0 0 0 8 0 0 473 0 0 0 100 0 0 581 
7.m. Goats 0 0 0 0 0 0 0 0 0 0 0 0 0 0 
7.n. Sheep 0 0 0 0 0 0 0 0 0 0 0 0 0 0 
7.o. Cattle 0 0 0 0 0 0 0 0 0 0 0 0 0 0 
7.p. Prosimians 0 0 0 0 0 0 0 0 0 0 0 0 0 0 
7.q. New World Monkeys 0 0 0 0 0 0 0 0 0 0 0 0 0 0 
7.r. Old World Monkeys 0 0 0 0 0 0 0 0 0 0 0 0 0 0 
7.s. Apes 0 0 0 0 0 0 0 0 0 0 0 0 0 0 
7.t. Other Mammals 0 0 0 0 0 0 0 0 0 0 0 0 0 0 
7.u. Quail 0 0 0 0 0 0 0 0 0 0 0 0 0 0 
7.v. Other birds 0 0 0 0 0 0 0 0 0 0 0 0 0 0 
7.w. Reptiles 0 0 0 0 0 0 0 0 0 0 0 0 0 0 
7.x. Amphibians 0 0 0 0 0 0 0 0 0 0 0 0 0 0 
7.y. Fish 1080 0 0 0 0 0 0 0 0 0 0 400 0 1480 
7.z. TOTAL 1080 0 4832 61 831 5 6154 3 116 325 2726 400 1386 17919 
 
EN 59   EN TABLE 8: NUMBER OF ANIMALS USED IN TOXI COLOGICAL AND OTHER SAFETY EVALUATIONS 
Types of tests versus products 
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 8.6 
Sub- 
chronic 
and 
chronic 
toxicity 8.7 
Carcino 
genicity 8.8 
Develop- 
mental 
toxicity 8.9 
Muta- 
genicit
y 8.10 
Repro-
ductive 
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            
8.a. Products/substances or devices for 
human medicine and dentistry and for 
veterinary medicine 0 0 4654 43 786 5 5739 0 116 48 100 0 320 11811 
8.b. Products/substances used or intended to 
be used mainly in agriculture 0 0 0 8 0 0 0 0 0 0 2051 0 14 2073 
8.c. Products/substances used or intended to 
be used mainly in industry 1080 0 105 9 45 0 350 0 0 0 0 400 456 2445 
8.d. Products/substances used or intended to 
be used mainly in the household 0 0 0 0 0 0 8 3 0 51 0 0 123 185 
8.e. Products/substances used or intended to 
be used mainly as cosmetics or 
toiletries 0 0 0 0 0 0 0 0 0 0 0 0 0 0 
8.f. Products/substances used or intended to 
be used mainly as additives in food for 
human consumption 0 0 34 0 0 0 0 0 0 0 0 0 135 169 
8.g. 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 
8.h. Potential or actual contaminants in the 
general environment which do not 
appear in other columns 0 0 0 0 0 0 0 0 0 0 561 0 181 742 
8.i. Other toxicological or safety 
evaluations 0 0 8 0 0 0 88 0 0 226 14 0 158 494 
8.j. TOTAL 1080 0 4801 60 831 5 6185 3 116 325 2726 400 1387 17919 
 
EN 60   ENGERMANY  
Statistical data submitted 
The statistical data have been submitted by the " Bundesministerium für 
Verbraucherschutz, Ernährung und Landwirtschaft " (Federal Ministry for Consumer 
protection, Food and Agriculture).  
Comments of German authorities  
Further to the German Government's co mmunications of 27 July 2006 regarding 
statistical information on the use of anim als 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 volum e 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, Agricult ure and Consumer Protection has been 
awarding a "research prize to support work  on methods aimed at restricting and 
replacing animal experiments"; the pri ze carries an award of €15 000. In 2006 the 
25th animal protection research prize will be awarded. 
Based at the Federal Institute for Risk A ssessment, the Central Office for recording 
and assessing methods to replace animal experiments was establ ished 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 au thorisation 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 res earch projects as part of 
major joint projects and takes part in validation studies and collaborative tests within the EU. Furthermore, for many years a da tabase on methods to replace animal 
experiments has been maintained at the Federal Institute for Risk Assessment; the 
database is available free of charge to sc ientists from the research world and industry 
at http://www.dimdi.de/stati c/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, rode nts are the largest group at 1 573 074 animals or 86%. It is 
striking that up to 2005 their share con tinually increased from 75% in 2001. The 
number of dogs and cats has increased by 581 and 395 respectively compared with the 
 
EN 61   ENprevious 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 sinc e 2000. Apes were last reported in 
Germany in 1991. 
The decline by 92 270 or 59% in the number of fish used is encour aging. In particular, 
there has been a reduction by 64 083 fish with in 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 investig ations and tests by 1 562 (1.0%). 
No uniform trend is discernible in the cas e of animals used in the diagnosis of 
diseases; while their number rose by 158% to 39 013 in 2004 co mpared 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 me dicine, dentistry or veterinary medicine, 
their research and development saw a ma rked increase by 13 869 animals and their 
manufacture or quality control by 101 535 animals. 
Of those animals, 58% were used to rese arch diseases in humans or animals. 
For legally stipulated  experiments for the manufacture or quality control of products 
for medicine, dentistry or vete rinary medicine, or for toxi cological safety tests, 24.9% 
of the animals were used. 
On behalf of the ministry, Dr Polten 
 
EN 62   EN TABLE 1: NUMBER OF ANIMALS USED IN RELATION TO THEIR PLACE OF ORIGIN 
Origin versus species 
1.1 
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 1.5 
Animals coming from 
Member Countries of the 
Council of Europe which are 
parties to the Convention ETS 
123 (excluding EC Member 
States) 1.6 
Animals coming from 
other origins 1.7 
Re-used animals 
1.a. Mice ( Mus musculus ) 1 084 358 921 971 141 721 18 197 2 469  
1.b. Rats ( Rattus norvegicus ) 435 417 339 626 90 339 3 516 1 936  
1.c. Guinea-Pigs ( Cavia porcellus ) 37 761 37 372 389 0 0  
1.d. Hamsters ( Mesocricetus ) 7 916 6 965 861 13 77  
1.e. Other Rodents (other Rodentia ) 7 622      
1.f. Rabbits ( Oryctolagus cuniculus ) 103 329 101 939 1 354 4 32 6 532 
1.g. Cats ( Felis catus ) 1 023 569 316 0 138 262 
1.h. Dogs ( Canis familiaris ) 4 868 2 923 671 0 1 274 1 056 
1.i. Ferrets ( Mustela putorius furo ) 560 131 4 0 425 4 
1.j. Other Carnivores (other Carnivora ) 235      
1.k. Horses, donkeys and cross breds ( Equidae ) 755      
1.l. Pigs ( Sus) 13 166      
1.m. Goats ( Capra ) 275      
1.n. Sheep ( Ovis)  3 517      
1.o. Cattle ( Bos) 2 909      
1.p. Prosimians ( Prosimia ) 99 0 99 0 0 81 
1.q. New World Monkeys ( Ceboidea ) 408 347 61 0 0 67 
1.r. Old World Monkeys ( Cercopithecoidea ) 1 579 120 247 0 1 212 327 
1.s. Apes ( Hominoidea ) 0 0 0 0 0 0 
1.t. Other Mammals (other Mammalia ) 115      
1.u. Quail ( Coturnix coturnix)  2 457 2 457 0 0 0  
1.v. Other birds (other Aves ) 39 150      
1.w. Reptiles ( Reptilia ) 136      
1.x. Amphibians ( Amphibia ) 10 432      
1.y. Fish ( Pisces ) 64 337      
1.z. TOTAL 1 822 424      
Note 1: Column 1.5 concerns only those Member Countries of the Council of Europe which, at the beginning of the reporting perio d, 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 b oxes 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 63   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 2.3 
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 548 649 277 287 106 512 42 650 50 280 4 411 16 146 38 423 1 084 358 
2.b. Rats 101 199 195 642 47 486 11 683 62 982 885 13 472 2 068 435 417 
2.c. Guinea-Pigs 1 907 4 999 14 251 5 921 9 755 11 402 515 37 761 
2.d. Hamsters 3 583 2 227 3 1 195 56 6 307 539 7 916 
2.e. Other Rodents 3 161 3 901 0 0 0 6 186 368 7 622 
2.f. Rabbits 2 600 7 083 81 097 5 204 4 568 1 188 194 1 395 103 329 
2.g. Cats 293 490 35 38 128 3 13 23 1 023 
2.h. Dogs 410 1 568 34 245 2 422 63 89 37 4 868 
2.i. Ferrets 4 542 0 0 0 0 0 14 560 
2.j. Other Carnivores 27 0 0 202 0 0 0 6 235 
2.k. Horses, donkeys and cross 
breds 385 202 0 2 10 54 102 0 755 
2.l. Pigs 3 140 4 845 32 985 327 925 1 978 934 13 166 
2.m. Goats 151 43 7 1 2 3 55 13 275 
2.n. Sheep 882 583 54 101 2 359 104 1 432 3 517 
2.o. Cattle 435 1 159 0 147 91 734 161 182 2 909 
2.p. Prosimians 2 0 0 0 97 0 0 0 99 
2.q. New World Monkeys 196 89 0 0 122 0 0 1 408 
2.r. Old World Monkeys 51 158 0 0 1 299 0 8 63 1 579 
2.s. Apes 0 0 0 0 0 0 0 0 0 
2.t. Other Mammals 107 7 0 0 0 0 1 0 115 
2.u. Quail 0 0 0 0 2 447 0 0 10 2 457 
2.v. Other birds 9 089 10 329 690 13 117 1 644 857 1 271 2 153 39 150 
2.w. Reptiles 114 13 0 0 0 0 9 0 136 
2.x. Amphibians 8 836 0 0 0 0 0 1 596 0 10 432 
2.y. Fish 30 135 0 0 825 23 180 4 156 2 177 3 864 64 337 
2.z. TOTAL 715 356 511 167 250 201 82 316 159 412 13 661 38 271 52 040 1 822 424 
 
EN 64   EN TABLE 3: NUMBER OF ANIMALS USED IN TOXI COLOGICAL 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 3.7 
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 3.10 
Other toxico- 
logical or 
safety 
evaluations 3.11 
Total 
3.a. Mice 32 474 6 930 10 388 0 0 0 0 10 478 50 280 
3.b. Rats 36 143 10 131 15 018 113 0 0 0 451 1 126 62 982 
3.c. Guinea-Pigs 5 364 2 290 2 061 0 0 0 0 0 40 9 755 
3.d. Hamsters 36 20 0 0 0 0 0 0 0 56 
3.e. Other Rodents 0 0 0 0 0 0 0 0 0 0 
3.f. Rabbits 3 182 851 501 4 0 0 0 0 30 4 568 
3.g. Cats 128 0 0 0 0 0 0 0 0 128 
3.h. Dogs 2 135 184 103 0 0 0 0 0 0 2 422 
3.i. Ferrets 0 0 0 0 0 0 0 0 0 0 
3.j. Other Carnivores 0 0 0 0 0 0 0 0 0 0 
3.k. Horses, donkeys and cross breds 10 0 0 0 0 0 0 0 0 10 
3.l. Pigs 303 0 8 0 0 0 0 0 16 327 
3.m. Goats 0 2 0 0 0 0 0 0 0 2 
3.n. Sheep 2 0 0 0 0 0 0 0 0 2 
3.o. Cattle 91 0 0 0 0 0 0 0 0 91 
3.p. Prosimians 97 0 0 0 0 0 0 0 0 97 
3.q. New World Monkeys 122 0 0 0 0 0 0 0 0 122 
3.r. Old World Monkeys 1 299 0 0 0 0 0 0 0 0 1 299 
3.s. Apes 0 0 0 0 0 0 0 0 0 0 
3.t. Other Mammals 0 0 0 0 0 0 0 0 0 0 
3.u. Quail 0 2 447 0 0 0 0 0 0 0 2 447 
3.v. Other birds 60 1 084 0 0 0 0 480 20 0 1 644 
3.w. Reptiles 0 0 0 0 0 0 0 0 0 0 
3.x. Amphibians 0 0 0 0 0 0 0 0 0 0 
3.y. Fish 313 8 521 2 664 0 0 0 0 9 744 1 938 23 180 
3.z. TOTAL 81 759 32 460 30 743 117 0 0 480 10 225 3 628 159 412 
 
EN 65   EN TABLE 4: NUMBER OF ANIMALS USED IN EXPERIME NTS FOR STUDIES ON HUM AN 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) 4.5 
Other human diseases 4.6 
Studies specific to animal 
diseases 4.7 
Total 
4.a. Mice 53 032 131 336 161 390 361 742 3 918 711 418 
4.b. Rats 45 836 110 443 9 632 110 670 289 276 870 
4.c. Guinea-Pigs 614 289 37 4 777 144 5 861 
4.d. Hamsters 661 1 783 182 2 426 0 5 052 
4.e. Other Rodents 10 1 006 362 3 615 634 5 627 
4.f. Rabbits 4 559 221 124 2 725 480 8 109 
4.g. Cats 0 60 0 28 360 448 
4.h. Dogs 543 3 28 195 955 1 724 
4.i. Ferrets 0 0 0 533 0 533 
4.j. Other Carnivores 0 0 0 0 0 0 
4.k. Horses, donkeys and cross breds 0 0 8 16 451 475 
4.l. Pigs 2 156 172 118 1 677 2 368 6 491 
4.m. Goats 15 1 3 6 12 37 
4.n. Sheep 375 9 0 253 933 1 570 
4.o. Cattle 0 43 0 142 1 884 2 069 
4.p. Prosimians 0 0 0 0 0 0 
4.q. New World Monkeys 16 105 2 129 0 252 
4.r. Old World Monkeys 3 18 2 96 0 119 
4.s. Apes 0 0 0 0 0 0 
4.t. Other Mammals 0 7 0 42 0 49 
4.u. Quail 0 0 0 0 0 0 
4.v. Other birds 0 8 0 915 10 965 11 888 
4.w. Reptiles 13 0 0 12 78 103 
4.x. Amphibians 561 131 16 239 0 947 
4.y. Fish 300 593 0 2 000 6 756 9 649 
4.z. TOTAL 108 694 246 228 171 904 492 238 30 227 1 049 291 
 
EN 66   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 391 110 626 0 872 33 610 3 663 149 162 
5.b. Rats 0 52 998 0 0 5 874 297 59 169 
5.c. Guinea-Pigs 0 16 475 0 436 3 125 136 20 172 
5.d. Hamsters 0 859 0 0 275 64 1 198 
5.e. Other Rodents 0 0 0 0 0 0 0 
5.f. Rabbits 0 52 271 0 0 8 292 25 738 86 301 
5.g. Cats 0 73 0 0 0 0 73 
5.h. Dogs 0 245 0 0 34 0 279 
5.i. Ferrets 0 0 0 0 0 0 0 
5.j. Other Carnivores 0 202 0 0 0 0 202 
5.k. Horses, donkeys and cross breds 0 2 0 0 0 0 2 
5.l. Pigs 15 948 0 0 0 54 1 017 
5.m. Goats 0 4 0 0 1 3 8 
5.n. Sheep 0 15 0 0 79 61 155 
5.o. Cattle 0 128 0 0 17 2 147 
5.p. Prosimians 0 0 0 0 0 0 0 
5.q. New World Monkeys 0 0 0 0 0 0 0 
5.r. Old World Monkeys 0 0 0 0 0 0 0 
5.s. Apes 0 0 0 0 0 0 0 
5.t. Other Mammals 0 0 0 0 0 0 0 
5.u. Quail 0 0 0 0 0 0 0 
5.v. Other birds 863 1 931 0 0 10 963 50 13 807 
5.w. Reptiles 0 0 0 0 0 0 0 
5.x. Amphibians 0 0 0 0 0 0 0 
5.y. Fish 0 825 0 0 0 0 825 
5.z. TOTAL 1 269 237 602 0 1 308 62 270 30 068 332 517 
Examples: 5.2 – France is testing due to a UK (or FR) specific  requirement Note: columns 5.2 - 5. 5 refer to the legislation imp osing that the test be carried out and 
 5.3 - UK is testing according to EC legislation  not to the bo dy which has issued the actual te st method, guidel ine or protoco l. 
 5.4 – Spain is testing due to a Hungarian requirement Example: a test required by French legislation and carried out in Belgiu m according to an 
 5.5 – Sweden is testing due to a US specific requirement  ISO protocol must be coded as a national (FR) legislative requiremen t and be 
 5.6 – Germany is testing due to  a Czech requirement (also an EC 
requirement)  entered into column 5.2 in the tables submitted by Belgium. 
Footnotes: 1) EC Member States: Austria, Belgium, Denmark, Finl and, France, Germany, Greece, Ir eland, Italy, Luxembourg, Nether lands, Portugal, Spain, Sw eden, United Kingdom 
 
EN 67   EN  2) Member Countries of Council of Europe (non-EC): Albania, A ndorra, Bulgaria, Croatia, Cyprus, Czech Rep., Estonia, Hungary, Iceland, Latvia, Liechtenstein, Lithuania, 
Malta, Moldova, Norway, Poland, Romania, Ru ssia, San Marino, Slovakia, Slovenia, Switz erland, ‘the former Yugoslav Rep. of Mace donia’, Turkey, Ukraine 
 
EN 68   EN TABLE 6: NUMBER OF ANIMALS USED IN TOXI COLOGICAL 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 0 33 677 0 4 357 10 625 1 621 50 280 
6.b. Rats 374 35 528 0 584 24 122 2 374 62 982 
6.c. Guinea-Pigs 0 7 055 0 20 2 487 193 9 755 
6.d. Hamsters 0 56 0 0 0 0 56 
6.e. Other Rodents 0 0 0 0 0 0 0 
6.f. Rabbits 0 3 484 0 0 1 034 50 4 568 
6.g. Cats 102 22 0 0 4 0 128 
6.h. Dogs 64 999 0 0 1 347 12 2 422 
6.i. Ferrets 0 0 0 0 0 0 0 
6.j. Other Carnivores 0 0 0 0 0 0 0 
6.k. Horses, donkeys and cross breds 0 0 0 0 0 10 10 
6.l. Pigs 0 139 0 0 172 16 327 
6.m. Goats 0 2 0 0 0 0 2 
6.n. Sheep 0 2 0 0 0 0 2 
6.o. Cattle 0 91 0 0 0 0 91 
6.p. Prosimians 0 97 0 0 0 0 97 
6.q. New World Monkeys 0 0 0 0 122 0 122 
6.r. Old World Monkeys 0 0 0 0 1 299 0 1 299 
6.s. Apes 0 0 0 0 0 0 0 
6.t. Other Mammals 0 0 0 0 0 0 0 
6.u. Quail 0 1 562 0 0 885 0 2 447 
6.v. Other birds 0 1 213 0 0 351 80 1 644 
6.w. Reptiles 0 0 0 0 0 0 0 
6.x. Amphibians 0 0 0 0 0 0 0 
6.y. Fish 4 770 5 653 0 0 9 865 2 892 23 180 
6.z. TOTAL 5 310 89 580 0 4 961 52 313 7 248 159 412 
Examples: 6.2 – France is testing due to a UK (or FR) specific  requirement Note: columns 6.2 - 6. 5 refer to the legislation imp osing that the test be carried out and 
 6.3 - UK is testing according to EC legislation  not to the bo dy which has issued the actual te st method, guidel ine or protoco l. 
 6.4 – Spain is testing due to a Hungarian requirement Example: a test required by French legislation and carried out in Belgiu m according to an 
 6.5 – Sweden is testing due to a US specific requirement  ISO protocol must be coded as a national (FR) legislative requiremen t and be 
 6.6 – Germany is testing due to  a Czech requirement (also an EC 
requirement)  entered into column 6.2 in the tables submitted by Belgium. 
Footnotes: 1) EC Member States: Austria, Belgium, Denmark, Finl and, France, Germany, Greece, Ir eland, Italy, Luxembourg, Nether lands, Portugal, Spain, Sw eden, United Kingdom 
 2) Member Countries of Council of Europe (non-EC): Albania, A ndorra, Bulgaria, Croatia, Cyprus, Czech Rep., Estonia, Hungary, Iceland, Latvia, Liechtenst ein, Lithuania, Malta, 
Moldova, Norway, Poland, Romania, Russia, San Marino, Slovakia, Slovenia, Switzerland,  ‘the former Yugoslav Rep. of Macedonia’,  Turkey, Ukraine 
 
EN 69   EN TABLE 7: NUMBER OF ANIMALS USED IN TOXI COLOGICAL AND OTHER SAFETY EVALUATIONS 
Types of tests versus species 
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 7.11 
Toxicity 
to aquatic 
vertebra-
tes not 
included 
in other 
columns 7.12 
Other 7.13 
Total 
  7.2.1. 
LD50, 
LC50 7.2.2 
Other lethal 
methods 7.2.3 
Non lethal 
clinical signs 
methods            
7.a. Mice 0 33 677 0 4 357 10 625 1 621 50 280 0 33 677 0 4 357 10 625 1 621 50 280 
7.b. Rats 374 35 528 0 584 24 122 2 374 62 982 374 35 528 0 584 24 122 2 374 62 982 
7.c. Guinea-Pigs 0 7 055 0 20 2 487 193 9 755 0 7 055 0 20 2 487 193 9 755 
7.d. Hamsters 0 56 0 0 0 0 56 0 56 0 0 0 0 56 
7.e. Other Rodents 0 0 0 0 0 0 0 0 0 0 0 0 0 0 
7.f. Rabbits 0 3 484 0 0 1 034 50 4 568 0 3 484 0 0 1 034 50 4 568 
7.g. Cats 102 22 0 0 4 0 128 102 22 0 0 4 0 128 
7.h. Dogs 64 999 0 0 1 347 12 2 422 64 999 0 0 1 347 12 2 422 
7.i. Ferrets 0 0 0 0 0 0 0 0 0 0 0 0 0 0 
7.j. Other Carnivores 0 0 0 0 0 0 0 0 0 0 0 0 0 0 
7.k. Horses, donkeys and cross 
breds 0 0 0 0 0 10 10 0 0 0 0 0 10 10 
7.l. Pigs 0 139 0 0 172 16 327 0 139 0 0 172 16 327 
7.m. Goats 0 2 0 0 0 0 2 0 2 0 0 0 0 2 
7.n. Sheep 0 2 0 0 0 0 2 0 2 0 0 0 0 2 
7.o. Cattle 0 91 0 0 0 0 91 0 91 0 0 0 0 91 
7.p. Prosimians 0 97 0 0 0 0 97 0 97 0 0 0 0 97 
7.q. New World Monkeys 0 0 0 0 122 0 122 0 0 0 0 122 0 122 
7.r. Old World Monkeys 0 0 0 0 1 299 0 1 299 0 0 0 0 1 299 0 1 299 
7.s. Apes 0 0 0 0 0 0 0 0 0 0 0 0 0 0 
7.t. Other Mammals 0 0 0 0 0 0 0 0 0 0 0 0 0 0 
7.u. Quail 0 1 562 0 0 885 0 2 447 0 1 562 0 0 885 0 2 447 
7.v. Other birds 0 1 213 0 0 351 80 1 644 0 1 213 0 0 351 80 1 644 
7.w. Reptiles 0 0 0 0 0 0 0 0 0 0 0 0 0 0 
7.x. Amphibians 0 0 0 0 0 0 0 0 0 0 0 0 0 0 
7.y. Fish 4 770 5 653 0 0 9 865 2 892 23 180 4 770 5 653 0 0 9 865 2 892 23 180 
7.z. TOTAL 5 310 89 580 0 4 961 52 313 7 248 159 412 5 310 89 580 0 4 961 52 313 7 248 159 412 
 
EN 70   EN TABLE 8: NUMBER OF ANIMALS USED IN TOXI COLOGICAL AND OTHER SAFETY EVALUATIONS 
Types of tests versus products 
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 8.6 
Sub- 
chronic 
and 
chronic 
toxicity 8.7 
Carcino 
genicity 8.8 
Develop- 
mental 
toxicity 8.9 
Muta- 
genicit
y 8.10 
Repro-
ductive 
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            
8.a. Products/substances or devices for 
human medicine and dentistry and for 
veterinary medicine 0 33 677 0 4 357 10 625 1 621 50 280 0 33 677 0 4 357 10 625 1 621 50 280 
8.b. Products/substances used or intended to 
be used mainly in agriculture 374 35 528 0 584 24 122 2 374 62 982 374 35 528 0 584 24 122 2 374 62 982 
8.c. Products/substances used or intended to 
be used mainly in industry 0 7 055 0 20 2 487 193 9 755 0 7 055 0 20 2 487 193 9 755 
8.d. Products/substances used or intended to 
be used mainly in the household 0 56 0 0 0 0 56 0 56 0 0 0 0 56 
8.e. Products/substances used or intended to 
be used mainly as cosmetics or 
toiletries 0 0 0 0 0 0 0 0 0 0 0 0 0 0 
8.f. Products/substances used or intended to 
be used mainly as additives in food for 
human consumption 0 3 484 0 0 1 034 50 4 568 0 3 484 0 0 1 034 50 4 568 
8.g. Products/substances used or intended to 
be used mainly as additives in food for 
animal consumption 102 22 0 0 4 0 128 102 22 0 0 4 0 128 
8.h. Potential or actual contaminants in the 
general environment which do not 
appear in other columns 64 999 0 0 1 347 12 2 422 64 999 0 0 1 347 12 2 422 
8.i. Other toxicological or safety 
evaluations 0 0 0 0 0 0 0 0 0 0 0 0 0 0 
8.j. TOTAL 0 0 0 0 0 0 0 0 0 0 0 0 0 0 
 
EN 71   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 72   EN TABLE 1: NUMBER OF ANIMALS USED IN RELATION TO THEIR PLACE OF ORIGIN 
Origin versus species 
1.1 
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 1.5 
Animals coming from 
Member Countries of the 
Council of Europe which are 
parties to the Convention ETS 
123 (excluding EC Member 
States) 1.6 
Animals coming from 
other origins 1.7 
Re-used animals 
1.a. Mice ( Mus musculus ) 4350 510 3460 0 380  
1.b. Rats ( Rattus norvegicus ) 484 0 484 0 0  
1.c. Guinea-Pigs ( Cavia porcellus ) 0      
1.d. Hamsters ( Mesocricetus ) 0      
1.e. Other Rodents (other Rodentia ) 0      
1.f. Rabbits ( Oryctolagus cuniculus ) 66 0 66 0 0 0 
1.g. Cats ( Felis catus ) 0      
1.h. Dogs ( Canis familiaris ) 0      
1.i. Ferrets ( Mustela putorius furo ) 0      
1.j. Other Carnivores (other Carnivora ) 0      
1.k. Horses, donkeys and cross breds ( Equidae ) 0      
1.l. Pigs ( Sus)       
1.m. Goats ( Capra ) 0      
1.n. Sheep ( Ovis)        
1.o. Cattle ( Bos) 0      
1.p. Prosimians ( Prosimia ) 0      
1.q. New World Monkeys ( Ceboidea ) 0      
1.r. Old World Monkeys ( Cercopithecoidea ) 0      
1.s. Apes ( Hominoidea ) 0      
1.t. Other Mammals (other Mammalia )       
1.u. Quail ( Coturnix coturnix)  0      
1.v. Other birds (other Aves )       
1.w. Reptiles ( Reptilia )       
1.x. Amphibians ( Amphibia )       
1.y. Fish ( Pisces )       
1.z. TOTAL 4900      
Note 1: Column 1.5 concerns only those Member Countries of the Co uncil of Europe which, at the beginning of the reporting perio d, 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 b oxes 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 73   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 2.3 
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 200 4150       4350 
2.b. Rats  484       484 
2.c. Guinea-Pigs         0 
2.d. Hamsters         0 
2.e. Other Rodents         0 
2.f. Rabbits  66       66 
2.g. Cats         0 
2.h. Dogs         0 
2.i. Ferrets         0 
2.j. Other Carnivores         0 
2.k. Horses, donkeys and cross 
breds         0 
2.l. Pigs         0 
2.m. Goats         0 
2.n. Sheep         0 
2.o. Cattle         0 
2.p. Prosimians         0 
2.q. New World Monkeys         0 
2.r. Old World Monkeys         0 
2.s. Apes         0 
2.t. Other Mammals         0 
2.u. Quail         0 
2.v. Other birds         0 
2.w. Reptiles         0 
2.x. Amphibians         0 
2.y. Fish         0 
 
EN 74   EN 2.z. TOTAL 200 4700 0 0 0 0 0 0 4900 
 
EN 75   EN  TABLE 4: NUMBER OF ANIMALS USED IN EXPERIME NTS FOR STUDIES ON HUM AN 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) 4.5 
Other human diseases 4.6 
Studies specific to animal 
diseases 4.7 
Total 
4.a. Mice 340 2300 1070 640  4350 
4.b. Rats 14 320  150  484 
4.c. Guinea-Pigs      0 
4.d. Hamsters      0 
4.e. Other Rodents      0 
4.f. Rabbits 66     66 
4.g. Cats      0 
4.h. Dogs      0 
4.i. Ferrets      0 
4.j. Other Carnivores      0 
4.k. Horses, donkeys and cross breds      0 
4.l. Pigs      0 
4.m. Goats      0 
4.n. Sheep      0 
4.o. Cattle      0 
4.p. Prosimians      0 
4.q. New World Monkeys      0 
4.r. Old World Monkeys      0 
4.s. Apes      0 
4.t. Other Mammals      0 
4.u. Quail      0 
4.v. Other birds      0 
4.w. Reptiles      0 
4.x. Amphibians      0 
4.y. Fish      0 
4.z. TOTAL 420 2620 1070 790 0 4900 
 
EN 76   EN GREECE  
Statistical data submitted 
The statistical data have been submitted by the “ ΥΠΟΥΡΓΕΙΟ  ΓΕΩΡΓΙΑΣ  ΓΕΝΙΚΗ  Δ/ΝΣΗ  
ΚΤΗΝΙΑΤΡΙΚΗΣ ” (Ministry of Rural Development a nd 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 Gazet te I 64) on the protection of animals used 
for experimental and other scientific pur poses, 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 experi mental 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 documen t 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 & Prac tice 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. Th ese 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 applianc es (not including toxi cological 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 pi gs – accounting for 2.61% and 40 other 
rodents – accounting for 0.18%), 36.95% of whic h were used to study fundamental biological 
characteristics, 18.48% for research and deve lopment 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 platelet s for further laboratory 
trials) 48.44% were used to study fundamental bi ological characteristic s, 2.78% for research 
and development of medical, dental and veteri nary products and appliances, 1.59% to control 
the production and quality of medical and dent al products and appliances, 9.32% to control 
 
EN 77   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 veterina ry products and applia nces 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 ed ucation 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 purpos es and 1.01% for other purposes. 
Three Old World Apes were used to study funda mental biological characteristics, of which 
two can be reused according to the research institution’s statement. 
Hens  accounted for 0.002% (21 animals), of wh ich 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 devel opment 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 per centage of fish endemic to the waters of the Mediterranean 
Sea are used (the main source of the la rge 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 78   EN TABLE 1: NUMBER OF ANIMALS USED IN RELATION TO THEIR PLACE OF ORIGIN 
Origin versus species 
1.1 
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 1.5 
Animals coming from 
Member Countries of the 
Council of Europe which are 
parties to the Convention ETS 
123 (excluding EC Member 
States) 1.6 
Animals coming from 
other origins 1.7 
Re-used animals 
1.a. Mice ( Mus musculus ) 15340 14050 80  1210  
1.b. Rats ( Rattus norvegicus ) 6024 5892   132  
1.c. Guinea-Pigs ( Cavia porcellus ) 574 324   250  
1.d. Hamsters ( Mesocricetus ) 0      
1.e. Other Rodents (other Rodentia ) 40      
1.f. Rabbits ( Oryctolagus cuniculus ) 1255 1255    10 
1.g. Cats ( Felis catus ) 0      
1.h. Dogs ( Canis familiaris ) 14 6 8    
1.i. Ferrets ( Mustela putorius furo ) 0      
1.j. Other Carnivores (other Carnivora )       
1.k. Horses, donkeys and cross breds ( Equidae ) 1      
1.l. Pigs ( Sus) 448      
1.m. Goats ( Capra )       
1.n. Sheep ( Ovis)  99      
1.o. Cattle ( Bos)       
1.p. Prosimians ( Prosimia ) 0      
1.q. New World Monkeys ( Ceboidea ) 0      
1.r. Old World Monkeys ( Cercopithecoidea ) 1  1   2 
1.s. Apes ( Hominoidea ) 0      
1.t. Other Mammals (other Mammalia )       
1.u. Quail ( Coturnix coturnix)  0      
1.v. Other birds (other Aves ) 21      
1.w. Reptiles ( Reptilia )       
1.x. Amphibians ( Amphibia ) 975      
1.y. Fish ( Pisces ) 901300      
1.z. TOTAL 926092      
Note 1: Column 1.5 concerns only those Member Countries of the Council of Europe which, at the beginning of the reporting perio d, 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 b oxes 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 79   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 2.3 
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 3279 3382 50  5324 2956 138 211 15340 
2.b. Rats 4629 641 80  144 37 280 213 6024 
2.c. Guinea-Pigs 215    85 270 4  574 
2.d. Hamsters         0 
2.e. Other Rodents  40       40 
2.f. Rabbits 608 35 20 117 12 28 202 233 1255 
2.g. Cats         0 
2.h. Dogs  10     4  14 
2.i. Ferrets         0 
2.j. Other Carnivores         0 
2.k. Horses, donkeys and cross 
breds       1  1 
2.l. Pigs 115 50     266 17 448 
2.m. Goats         0 
2.n. Sheep 20     54 24 1 99 
2.o. Cattle         0 
2.p. Prosimians         0 
2.q. New World Monkeys         0 
2.r. Old World Monkeys 1        1 
2.s. Apes         0 
2.t. Other Mammals         0 
2.u. Quail         0 
2.v. Other birds      15 6  21 
2.w. Reptiles         0 
2.x. Amphibians       975  975 
2.y. Fish 1300 900000       901300 
2.z. TOTAL 10167 904158 150 117 5565 3360 1900 675 926092 
 
EN 80   EN TABLE 3: NUMBER OF ANIMALS USED IN TOXI COLOGICAL 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 3.7 
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 3.10 
Other toxico- 
logical or 
safety 
evaluations 3.11 
Total 
3.a. Mice 105        5219 5324 
3.b. Rats  84 60       144 
3.c. Guinea-Pigs 85         85 
3.d. Hamsters          0  
3.e. Other Rodents          0  
3.f. Rabbits         1 2  1 2  
3.g. Cats          0  
3.h. Dogs          0  
3.i. Ferrets          0  
3.j. Other Carnivores          0  
3.k. Horses, donkeys and cross breds          0  
3.l. Pigs          0  
3.m. Goats          0  
3.n. Sheep          0  
3.o. Cattle          0  
3.p. Prosimians          0  
3.q. New World Monkeys          0  
3.r. Old World Monkeys          0  
3.s. Apes          0  
3.t. Other Mammals          0  
3.u. Quail          0  
3.v. Other birds          0  
3.w. Reptiles          0  
3.x. Amphibians          0  
3.y. Fish          0  
3.z. TOTAL 190 84 60 0 0 0 0 0 5231 5565 
 
EN 81   EN TABLE 4: NUMBER OF ANIMALS USED IN EXPERIME NTS FOR STUDIES ON HUM AN 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) 4.5 
Other human diseases 4.6 
Studies specific to animal 
diseases 4.7 
Total 
4.a. Mice 95 1458 410 2950 300 5213 
4.b. Rats 65 102  814  981 
4.c. Guinea-Pigs     270 270 
4.d. Hamsters      0 
4.e. Other Rodents   40   40 
4.f. Rabbits 162   321 28 511 
4.g. Cats      0 
4.h. Dogs      0 
4.i. Ferrets      0 
4.j. Other Carnivores      0 
4.k. Horses, donkeys and cross breds      0 
4.l. Pigs 36   79  115 
4.m. Goats      0 
4.n. Sheep     54 54 
4.o. Cattle      0 
4.p. Prosimians      0 
4.q. New World Monkeys      0 
4.r. Old World Monkeys      0 
4.s. Apes      0 
4.t. Other Mammals      0 
4.u. Quail      0 
4.v. Other birds     15 15 
4.w. Reptiles      0 
4.x. Amphibians      0 
4.y. Fish     900000 900000 
4.z. TOTAL 358 1560 450 4164 900667 907199 
 
EN 82   EN TABLE 5: NUMBER OF ANIMALS USED IN PRODUCTION AN D QUALITY CONTROL OF PRO DUCTS 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      50 50 
5.b. Rats 80      80 
5.c. Guinea-Pigs       0  
5.d. Hamsters       0  
5.e. Other Rodents       0  
5.f. Rabbits  117    20 137 
5.g. Cats       0  
5.h. Dogs       0  
5.i. Ferrets       0  
5.j. Other Carnivores       0  
5.k. Horses, donkeys and cross breds       0  
5.l. Pigs       0  
5.m. Goats       0  
5.n. Sheep       0  
5.o. Cattle       0  
5.p. Prosimians       0  
5.q. New World Monkeys       0  
5.r. Old World Monkeys       0  
5.s. Apes       0  
5.t. Other Mammals       0  
5.u. Quail       0  
5.v. Other birds       0  
5.w. Reptiles       0  
5.x. Amphibians       0  
5.y. Fish       0  
5.z. TOTAL 80 117 0 0 0 70 267 
Examples: 5.2 – France is testing due to a UK (or FR) specific  requirement Note: columns 5.2 - 5. 5 refer to the legislation imp osing that the test be carried out and 
 5.3 - UK is testing according to EC legislation  not to the bo dy which has issued the actual te st method, guidel ine or protoco l. 
 5.4 – Spain is testing due to a Hungarian requirement Example: a test required by French legislation and carried out in Belgiu m according to an 
 5.5 – Sweden is testing due to a US specific requirement  ISO protocol must be coded as a national (FR) legislative requiremen t and be 
 5.6 – Germany is testing due to  a Czech requirement (also an EC 
requirement)  entered into column 5.2 in the tables submitted by Belgium. 
Footnotes: 1) EC Member States: Austria, Belgium, Denmark, Finl and, France, Germany, Greece, Ir eland, Italy, Luxembourg, Nether lands, Portugal, Spain, Sw eden, United Kingdom 
 2) Member Countries of Council of Europe (non-EC): Albania, A ndorra, Bulgaria, Croatia, Cyprus, Czech Rep., Estonia, Hungary, Iceland, Latvia, Liechtenstein, Lithuania, 
Malta, Moldova, Norway, Poland, Romania, Ru ssia, San Marino, Slovakia, Slovenia, Switz erland, ‘the former Yugoslav Rep. of Mace donia’, Turkey, Ukraine 
 
EN 83   EN TABLE 6: NUMBER OF ANIMALS USED IN TOXI COLOGICAL 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  105   5219  5324 
6.b. Rats 89 55     144 
6.c. Guinea-Pigs  85     85 
6.d. Hamsters       0  
6.e. Other Rodents       0  
6.f. Rabbits      12 12 
6.g. Cats       0  
6.h. Dogs       0  
6.i. Ferrets       0  
6.j. Other Carnivores       0  
6.k. Horses, donkeys and cross breds       0  
6.l. Pigs       0  
6.m. Goats       0  
6.n. Sheep       0  
6.o. Cattle       0  
6.p. Prosimians       0  
6.q. New World Monkeys       0  
6.r. Old World Monkeys       0  
6.s. Apes       0  
6.t. Other Mammals       0  
6.u. Quail       0  
6.v. Other birds       0  
6.w. Reptiles       0  
6.x. Amphibians       0  
6.y. Fish       0  
6.z. TOTAL 89 245 0 0 5219 12 5565 
Examples: 6.2 – France is testing due to a UK (or FR) specific  requirement Note: columns 6.2 - 6. 5 refer to the legislation imp osing that the test be carried out and 
 6.3 - UK is testing according to EC legislation  not to the bo dy which has issued the actual te st method, guidel ine or protoco l. 
 6.4 – Spain is testing due to a Hungarian requirement Example: a test required by French legislation and carried out in Belgiu m according to an 
 6.5 – Sweden is testing due to a US specific requirement  ISO protocol must be coded as a national (FR) legislative requiremen t and be 
 6.6 – Germany is testing due to  a Czech requirement (also an EC 
requirement)  entered into column 6.2 in the tables submitted by Belgium. 
Footnotes: 1) EC Member States: Austria, Belgium, Denmark, Finl and, France, Germany, Greece, Ir eland, Italy, Luxembourg, Nether lands, Portugal, Spain, Sw eden, United Kingdom 
 2) Member Countries of Council of Europe (non-EC): Albania, A ndorra, Bulgaria, Croatia, Cyprus, Czech Rep., Estonia, Hungary, Iceland, Latvia, Liechtenst ein, Lithuania, Malta, 
Moldova, Norway, Poland, Romania, Russia, San Marino, Slovakia, Slovenia, Switzerland,  ‘the former Yugoslav Rep. of Macedonia’,  Turkey, Ukraine 
 
EN 84   EN TABLE 7: NUMBER OF ANIMALS USED IN TOXI COLOGICAL AND OTHER SAFETY EVALUATIONS 
Types of tests versus species 
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 7.11 
Toxicity 
to aquatic 
vertebra-
tes not 
included 
in other 
columns 7.12 
Other 7.13 
Total 
  7.2.1. 
LD50, 
LC50 7.2.2 
Other lethal 
methods 7.2.3 
Non lethal 
clinical signs 
methods            
7.a. Mice  5219           105 5324 
7.b. Rats   34    60   50    144 
7.c. Guinea-Pigs             85 85 
7.d. Hamsters              0  
7.e. Other Rodents              0  
7.f. Rabbits             12 12 
7.g. Cats              0  
7.h. Dogs              0  
7.i. Ferrets              0  
7.j. Other Carnivores              0  
7.k. Horses, donkeys and cross 
breds              0  
7.l. Pigs              0  
7.m. Goats              0  
7.n. Sheep              0  
7.o. Cattle              0  
7.p. Prosimians              0  
7.q. New World Monkeys              0  
7.r. Old World Monkeys              0  
7.s. Apes              0  
7.t. Other Mammals              0  
7.u. Quail              0  
7.v. Other birds              0  
7.w. Reptiles              0  
7.x. Amphibians              0  
7.y. Fish              0  
7.z. TOTAL 0 5219 34 0 0 0 60 0 0 50 0 0 202 5565 
 
EN 85   EN TABLE 8: NUMBER OF ANIMALS USED IN TOXI COLOGICAL AND OTHER SAFETY EVALUATIONS 
Types of tests versus products 
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 8.6 
Sub- 
chronic 
and 
chronic 
toxicity 8.7 
Carcino 
genicity 8.8 
Develop- 
mental 
toxicity 8.9 
Muta- 
genicit
y 8.10 
Repro-
ductive 
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            
8.a. Products/substances or devices for 
human medicine and dentistry and for 
veterinary medicine             202 202 
8.b. Products/substances used or intended to 
be used mainly in agriculture   84           84 
8.c. Products/substances used or intended to 
be used mainly in industry       60       60 
8.d. Products/substances used or intended to 
be used mainly in the household              0  
8.e. Products/substances used or intended to 
be used mainly as cosmetics or 
toiletries              0  
8.f. Products/substances used or intended to 
be used mainly as additives in food for 
human consumption              0  
8.g. Products/substances used or intended to 
be used mainly as additives in food for 
animal consumption              0  
8.h. Potential or actual contaminants in the 
general environment which do not 
appear in other columns              0  
8.i. Other toxicological or safety 
evaluations  5219            5219 
8.j. TOTAL 0 5219 84 0 0 0 60 0 0 0 0 0 202 5565 
 
EN 86   ENSPAIN  
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-direct orate of Management of Developments). 
Comments of Spanish authorities  
None 
 
EN 87   EN TABLE 1: NUMBER OF ANIMALS USED IN RELATION TO THEIR PLACE OF ORIGIN 
Origin versus species 
1.1 
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 1.5 
Animals coming from 
Member Countries of the 
Council of Europe which are 
parties to the Convention ETS 
123 (excluding EC Member 
States) 1.6 
Animals coming from 
other origins 1.7 
Re-used animals 
1.a. Mice ( Mus musculus ) 393217 357390 31627 22 4178  
1.b. Rats ( Rattus norvegicus ) 125754 113623 10478 0 1653  
1.c. Guinea-Pigs ( Cavia porcellus ) 16780 14321 2459 0 0  
1.d. Hamsters ( Mesocricetus ) 908 877 31 0 0  
1.e. Other Rodents (other Rodentia ) 294      
1.f. Rabbits ( Oryctolagus cuniculus ) 11878 11111 767 0 0 0 
1.g. Cats ( Felis catus ) 168 84  0 84 0 
1.h. Dogs ( Canis familiaris ) 685 525 151 0 9 0 
1.i. Ferrets ( Mustela putorius furo ) 237 155 82 0 0 0 
1.j. Other Carnivores (other Carnivora ) 0      
1.k. Horses, donkeys and cross breds ( Equidae ) 42      
1.l. Pigs ( Sus) 4818      
1.m. Goats ( Capra ) 119      
1.n. Sheep ( Ovis)  821      
1.o. Cattle ( Bos) 294      
1.p. Prosimians ( Prosimia ) 0 0 0 0 0 0 
1.q. New World Monkeys ( Ceboidea ) 1 0 1 0 0 0 
1.r. Old World Monkeys ( Cercopithecoidea ) 81 52 29 0 0 0 
1.s. Apes ( Hominoidea ) 2 2 0 0 0 0 
1.t. Other Mammals (other Mammalia ) 60      
1.u. Quail ( Coturnix coturnix)  1 1 0 0 0  
1.v. Other birds (other Aves ) 8424      
1.w. Reptiles ( Reptilia ) 10      
1.x. Amphibians ( Amphibia ) 419      
1.y. Fish ( Pisces ) 30584      
1.z. TOTAL 595597 498141 45625 22 5924 0 
Note 1: Column 1.5 concerns only those Member Countries of the Council of Europe which, at the beginning of the reporting perio d, 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 b oxes 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 88   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 2.3 
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 130339 115641 6680 17599 62528 51405 8325 11300 403817 
2.b. Rats 51885 39077 2204 810 8379 5252 5085 2843 115535 
2.c. Guinea-Pigs 342 8343 1142 3310 3510 92 28 13 16780 
2.d. Hamsters 493 52 0 264 0 87 12 0 908 
2.e. Other Rodents 100 166 0 0 0 0 28 0 294 
2.f. Rabbits 854 2674 30 2106 5026 51 1008 90 11839 
2.g. Cats 76 3 13 0 0 0 3 73 168 
2.h. Dogs 44 81 6 0 272 5 18 0 426 
2.i. Ferrets 17 220 0 0 0 0 0 0 237 
2.j. Other Carnivores 0 0 0  0 0 0 0 0 
2.k. Horses, donkeys and cross 
breds 0 0 0 42 0 0 0 0 42 
2.l. Pigs 288 1531 0 921 368 40 1200 387 4735 
2.m. Goats 16 7 0 0 24 0 0 72 119 
2.n. Sheep 17 94 0 571 62 0 75 2 821 
2.o. Cattle 0 104 0 190 0 0 0 0 294 
2.p. Prosimians 0 0 0 0 0 0 0 0 0 
2.q. New World Monkeys 1 0 0 0 0 0 0 0 1 
2.r. Old World Monkeys 23 21 0 0 37 0 0 0 81 
2.s. Apes 2 0 0 0 0 0 0 0 2 
2.t. Other Mammals 0 0 0 60 0 0 0 0 60 
2.u. Quail 1 0 0 0 0 0 0 0 1 
2.v. Other birds 94 2682 0 4343 40 15 50 1200 8424 
2.w. Reptiles 10 0 0 0 0 0 0 0 10 
2.x. Amphibians 351 0 0 0 0 0 0 68 419 
2.y. Fish 28349 700 0 0 1269 0 266 0 30584 
2.z. TOTAL 213302 171396 10075 30216 81515 56947 16098 16048 595597 
 
EN 89   EN TABLE 3: NUMBER OF ANIMALS USED IN TOXI COLOGICAL 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 3.7 
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 3.10 
Other toxico- 
logical or 
safety 
evaluations 3.11 
Total 
3.a. Mice 21400 24 0 0 0 0 725 1285 40597 64031 
3.b. Rats 3870 359 768 0 0 0 0 230 1375 6602 
3.c. Guinea-Pigs 3287 0 63 0 0 0 0 0 160 3510 
3.d. Hamsters 0 0 0 0 0 0 0 0 0 0 
3.e. Other Rodents 0 0 0 0 0 0 0 0 0 0 
3.f. Rabbits 5187 0 111 0 75 0 0 0 45 5418 
3.g. Cats 0 0 0 0 0 0 0 0 0 0 
3.h. Dogs 179 0 0 0 0 0 0 0 77 256 
3.i. Ferrets 0 0 0 0 0 0 0 0 0 0 
3.j. Other Carnivores 0 0 0 0 0 0 0 0 0 0 
3.k. Horses, donkeys and cross breds 0 0 0 0 0 0 0 0 0 0 
3.l. Pigs 251 0 0 0 0 0 0 0 15 266 
3.m. Goats 24 0 0 0 0 0 0 0 0 24 
3.n. Sheep 62 0 0 0 0 0 0 0 0 62 
3.o. Cattle 0 0 0 0 0 0 0 0 0 0 
3.p. Prosimians 0 0 0 0 0 0 0 0 0 0 
3.q. New World Monkeys 0 0 0 0 0 0 0 0 0 0 
3.r. Old World Monkeys 37 0 0 0 0 0 0 0 0 37 
3.s. Apes 0 0 0 0 0 0 0 0 0 0 
3.t. Other Mammals 0 0 0 0 0 0 0 0 0 0 
3.u. Quail 0 0 0 0 0 0 0 0 0 0 
3.v. Other birds 40 0 0 0 0 0 0 0 0 40 
3.w. Reptiles 0 0 0 0 0 0 0 0 0 0 
3.x. Amphibians 0 0 0 0 0 0 0 0 0 0 
3.y. Fish 100 237 0 560 0 0 0 372 0 1269 
3.z. TOTAL 34437 620 942 560 75 0 725 1887 42269 81515 
 
EN 90   EN TABLE 4: NUMBER OF ANIMALS USED IN EXPERIME NTS FOR STUDIES ON HUM AN 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) 4.5 
Other human diseases 4.6 
Studies specific to animal 
diseases 4.7 
Total 
4.a. Mice 5844 13808 87612 80515 3839 191618 
4.b. Rats 5938 15263 1538 36055 579 59373 
4.c. Guinea-Pigs 44 286 110 637 325 1402 
4.d. Hamsters 0 87 52 46 143 328 
4.e. Other Rodents 0 120 0 74 448 642 
4.f. Rabbits 180 3 66 803 474 1526 
4.g. Cats 0 18 0 3 0 21 
4.h. Dogs 27 2 3 135 12 179 
4.i. Ferrets 0 0 0 0 0 0 
4.j. Other Carnivores 0 0 0 0 0 0 
4.k. Horses, donkeys and cross breds 0 17 0 0 0 17 
4.l. Pigs 273 0 21 468 420 1182 
4.m. Goats 40 24 0 7 0 71 
4.n. Sheep 0 0 0 45 55 100 
4.o. Cattle 0 0 0 0 14 14 
4.p. Prosimians 0 1 0 0 0 1 
4.q. New World Monkeys 0 3 0 0 0 3 
4.r. Old World Monkeys 0 0 0 28 0 28 
4.s. Apes 0 0 0 2 0 2 
4.t. Other Mammals 0 0 0 0 0 0 
4.u. Quail 0 57 0 0 0 57 
4.v. Other birds 0 0 0 0 1300 1300 
4.w. Reptiles 0 45 0 0 0 45 
4.x. Amphibians 0 192 50 50 0 292 
4.y. Fish 0  200 300 3966 4466 
4.z. TOTAL 12346 29926 89652 119168 11575 262667 
 
EN 91   EN TABLE 5: NUMBER OF ANIMALS USED IN PRODUCTION AN D QUALITY CONTROL OF PRO DUCTS 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 66 21771 0 0 5 2437 24279 
5.b. Rats 0 1342 0 1672 0 0 3014 
5.c. Guinea-Pigs 0 3340 0 1058 0 54 4452 
5.d. Hamsters 0 0 0 0 0 264 264 
5.e. Other Rodents 0 0 0 0 0 0 0 
5.f. Rabbits 2 1563 0 0 0 571 2136 
5.g. Cats 0 0 0 13 0 0 13 
5.h. Dogs 0 0 0 0 0 6 6 
5.i. Ferrets 0 0 0 0 0 0 0 
5.j. Other Carnivores 0 0 0 0 0 0 0 
5.k. Horses, donkeys and cross breds 0 42 0 0 0 0 42 
5.l. Pigs 22 553 0 0 20 326 921 
5.m. Goats 0 0 0 0 0 0 0 
5.n. Sheep 0 571 0 0 0 0 571 
5.o. Cattle 0 190 0 0 0 0 190 
5.p. Prosimians 0 0 0 0 0 0 0 
5.q. New World Monkeys 0 0 0 0 0 0 0 
5.r. Old World Monkeys 0 0 0 0 0 0 0 
5.s. Apes 0 0 0 0 0 0 0 
5.t. Other Mammals 0 60 0 0 0 0 60 
5.u. Quail 0 0 0 0 0 0 0 
5.v. Other birds 0 3349 0 681 0 313 4343 
5.w. Reptiles 0 0 0 0 0 0 0 
5.x. Amphibians 0 0 0 0 0 0 0 
5.y. Fish 0 0 0 0 0 0 0 
5.z. TOTAL 90 32781 0 3424 25 3971 40291 
Examples: 5.2 – France is testing due to a UK (or FR) specific  requirement Note: columns 5.2 - 5. 5 refer to the legislation imp osing that the test be carried out and 
 5.3 - UK is testing according to EC legislation  not to the bo dy which has issued the actual te st method, guidel ine or protoco l. 
 5.4 – Spain is testing due to a Hungarian requirement Example: a test required by French legislation and carried out in Belgiu m according to an 
 5.5 – Sweden is testing due to a US specific requirement  ISO protocol must be coded as a national (FR) legislative requiremen t and be 
 5.6 – Germany is testing due to  a Czech requirement (also an EC 
requirement)  entered into column 5.2 in the tables submitted by Belgium. 
Footnotes: 1) EC Member States: Austria, Belgium, Denmark, Finl and, France, Germany, Greece, Ir eland, Italy, Luxembourg, Nether lands, Portugal, Spain, Sw eden, United Kingdom 
 2) Member Countries of Council of Europe (non-EC): Albania, A ndorra, Bulgaria, Croatia, Cyprus, Czech Rep., Estonia, Hungary, Iceland, Latvia, Liechtenstein, Lithuania, 
Malta, Moldova, Norway, Poland, Romania, Ru ssia, San Marino, Slovakia, Slovenia, Switz erland, ‘the former Yugoslav Rep. of Mace donia’, Turkey, Ukraine 
 
EN 92   EN TABLE 6: NUMBER OF ANIMALS USED IN TOXI COLOGICAL 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 308 13299 0 441 46381 3602 64031 
6.b. Rats 96 1195 0 1509 2391 1411 6602 
6.c. Guinea-Pigs 41 703 0 287 2479 0 3510 
6.d. Hamsters 0 0 0 0 0 0 0 
6.e. Other Rodents 0 0 0 0 0 0 0 
6.f. Rabbits 133 194 0 175 4760 156 5418 
6.g. Cats 0 0 0 0 0 23 23 
6.h. Dogs 0 67 0 10 156 0 233 
6.i. Ferrets 0 0 0 0 0 0 0 
6.j. Other Carnivores 0 0 0 0 0 0 0 
6.k. Horses, donkeys and cross breds 0 0 0 0 0 0 0 
6.l. Pigs 6 244 0 0 16 0 266 
6.m. Goats 0 24 0 0 0 0 24 
6.n. Sheep 2 42 0 0 0 18 62 
6.o. Cattle 0 0 0 0 0 0 0 
6.p. Prosimians 0 0 0 0 0 0 0 
6.q. New World Monkeys 0 0 0 0 0 0 0 
6.r. Old World Monkeys 0 0 0 0 32 5 37 
6.s. Apes 0 0 0 0 0 0 0 
6.t. Other Mammals 0 0 0 0 0 0 0 
6.u. Quail 0 0 0 0 0 0 0 
6.v. Other birds 0 0 0 0 0 40 40 
6.w. Reptiles 0 0 0 0 0 0 0 
6.x. Amphibians 0 0 0 0 0 0 0 
6.y. Fish 0 0 0 72 1197 0 1269 
6.z. TOTAL 586 15768 0 2494 57412 5255 81515 
Examples: 6.2 – France is testing due to a UK (or FR) specific  requirement Note: columns 6.2 - 6. 5 refer to the legislation imp osing that the test be carried out and 
 6.3 - UK is testing according to EC legislation  not to the bo dy which has issued the actual te st method, guidel ine or protoco l. 
 6.4 – Spain is testing due to a Hungarian requirement Example: a test required by French legislation and carried out in Belgiu m according to an 
 6.5 – Sweden is testing due to a US specific requirement  ISO protocol must be coded as a national (FR) legislative requiremen t and be 
 6.6 – Germany is testing due to  a Czech requirement (also an EC 
requirement)  entered into column 6.2 in the tables submitted by Belgium. 
Footnotes: 1) EC Member States: Austria, Belgium, Denmark, Finl and, France, Germany, Greece, Ir eland, Italy, Luxembourg, Nether lands, Portugal, Spain, Sw eden, United Kingdom 
 2) Member Countries of Council of Europe (non-EC): Albania, A ndorra, Bulgaria, Croatia, Cyprus, Czech Rep., Estonia, Hungary, Iceland, Latvia, Liechtenst ein, Lithuania, Malta, 
Moldova, Norway, Poland, Romania, Russia, San Marino, Slovakia, Slovenia, Switzerland,  ‘the former Yugoslav Rep. of Macedonia’,  Turkey, Ukraine 
 
EN 93   EN TABLE 7: NUMBER OF ANIMALS USED IN TOXI COLOGICAL AND OTHER SAFETY EVALUATIONS 
Types of tests versus species 
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 7.11 
Toxicity 
to aquatic 
vertebra-
tes not 
included 
in other 
columns 7.12 
Other 7.13 
Total 
  7.2.1. 
LD50, 
LC50 7.2.2 
Other lethal 
methods 7.2.3 
Non lethal 
clinical signs 
methods            
7.a. Mice 9430 35486 1016 0 40 0 0 674 0 24 0 0 17361 64031 
7.b. Rats 831 365 601 135 0 0 1057 96 0 0 567 0 2956 6608 
7.c. Guinea-Pigs 0 399 12 16 463 0 0 0 0 0 0 0 2614 3504 
7.d. Hamsters 0 0 0 0 0 0 0 0 0 0 0 0 0 0 
7.e. Other Rodents 0 0 0 0 0 0 0 0 0 0 0 0 0 0 
7.f. Rabbits 6 16 24 282 0 64 6 0 113 0 0 0 4907 5418 
7.g. Cats 0 0 0 0 0 0 0 0 0 0 0 0 0 0 
7.h. Dogs 0 0 0 0 0 0 156 0 0 0 0 0 100 256 
7.i. Ferrets 0 0 0 0 0 0 0 0 0 0 0 0 0 0 
7.j. Other Carnivores 0 0 0 0 0 0 0 0 0 0 0 0 0 0 
7.k. Horses, donkeys and cross 
breds 0 0 0 0 0 0 0 0 0 0 0 0 0 0 
7.l. Pigs 0 0 0 0 0 0 0 0 0 0 0 0 266 266 
7.m. Goats 0 0 0 0 0 0 0 0 0 0 0 0 24 24 
7.n. Sheep 0 0 0 0 0 0 0 0 0 0 0 0 62 62 
7.o. Cattle 0 0 0 0 0 0 0 0 0 0 0 0 0 0 
7.p. Prosimians 0 0 0 0 0 0 0 0 0 0 0 0 0 0 
7.q. New World Monkeys 0 0 0 0 0 0 0 0 0 0 0 0 0 0 
7.r. Old World Monkeys 0 0 0 0 0 0 37 0 0 0 0 0 0 37 
7.s. Apes 0 0 0 0 0 0 0 0 0 0 0 0 0 0 
7.t. Other Mammals 0 0 0 0 0 0 0 0 0 0 0 0 0 0 
7.u. Quail 0 0 0 0 0 0 0 0 0 0 0 0 0 0 
7.v. Other birds 0 0 0 0 0 0 0 0 0 0 0 0 40 40 
7.w. Reptiles 0 0 0 0 0 0 0 0 0 0 0 0 0 0 
7.x. Amphibians 0 0 0 0 0 0 0 0 0 0 0 0 0 0 
7.y. Fish 287 0 0 0 0 0 860 0 50 0 72 0 0 1269 
7.z. TOTAL 10554 36266 1653 433 503 64 2116 770 163 24 639 0 28330 81515 
 
EN 94   EN TABLE 8: NUMBER OF ANIMALS USED IN TOXI COLOGICAL AND OTHER SAFETY EVALUATIONS 
Types of tests versus products 
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 8.6 
Sub- 
chronic 
and 
chronic 
toxicity 8.7 
Carcino 
genicity 8.8 
Develop- 
mental 
toxicity 8.9 
Muta- 
genicit
y 8.10 
Repro-
ductive 
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            
8.a. Products/substances or devices for 
human medicine and dentistry and for 
veterinary medicine 2563 2749 1633 281 445 24 897 0 163 0 567 0 25115 34437 
8.b. Products/substances used or intended to 
be used mainly in agriculture 237 0 0 0 0 0 359 0 0 24 0 0 0 620 
8.c. Products/substances used or intended to 
be used mainly in industry 601 71 0 90 58 21 0 96 0 0 0 0 5 942 
8.d. Products/substances used or intended to 
be used mainly in the household 0 0 0 0 0 0 560 0 0 0 0 0 0 560 
8.e. Products/substances used or intended to 
be used mainly as cosmetics or 
toiletries 0 0 0 56 0 19 0 0 0 0 0 0 0 75 
8.f. 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 
8.g. Products/substances used or intended to 
be used mainly as additives in food for 
animal consumption 0 725 0 0 0 0 0 0 0 0 0 0 0 725 
8.h. Potential or actual contaminants in the 
general environment which do not 
appear in other columns 473 812 6 0 0 0 300 0 0 0 72 0 224 1887 
8.i. Other toxicological or safety 
evaluations 6680 33075 14 6 0 0 0 674 0 0 0 0 1820 42269 
8.j. TOTAL 10554 37432 1653 433 503 64 2116 770 163 24 639 0 27164 81515 
 
EN 95   ENFRANCE  
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 comparis on with the figures of  the first study in 
1990. In 2004, a slight increasi ng tendency could have be en 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 gr oups 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 signifi cant 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 e volutions. Each time these di fferences were explained by 
either new activity, for example the obtainment of therapeutic antibodies for rabbits increased by 74 %, or the closure of labor atories. They could be explained too by 
mistakes typed in the 2001 study report (conc erning reptiles for example). The other 
variations are not significant and support the figures provi ded by experimental centres 
and laboratories. 
This study allows estimating that public sector uses a th ird of the total amount of 
animals, of which 65 % is for basic resear ch 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 establis hed in 1990. This decrease of the amount of 
experimental centres shows that henceforth  laboratories are regrouped in order to 
dispose of centralized instal lations and competent staff. The « disappearance » of 900 
experimental animal houses shows the pre ssure brought by the as sociations and the 
concerned authorities for fifteen years.  It was engendered by very significant 
investments to come up to the current sani tary, ethic and scientific expectances. Of 
course, this diminution did not obviously driv e to a decrease of the amount of animals 
with the same proportion, but it set practices  that assure respec t and well-being to 
animals. 
 
EN 96   EN TABLE 1: NUMBER OF ANIMALS USED IN RELATION TO THEIR PLACE OF ORIGIN 
Origin versus species 
1.1 
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 1.5 
Animals coming from 
Member Countries of the 
Council of Europe which are 
parties to the Convention ETS 
123 (excluding EC Member 
States) 1.6 
Animals coming from 
other origins 1.7 
Re-used animals 
1.a. Mice ( Mus musculus ) 1 510 334 1 409 076 21 809 2 383 77 066  
1.b. Rats ( Rattus norvegicus ) 424 387 411 068 2 128 25 11 166  
1.c. Guinea-Pigs ( Cavia porcellus ) 79 350 56 862 16 679 0 5 809  
1.d. Hamsters ( Mesocricetus ) 8 691 7 672 75 0 944  
1.e. Other Rodents (other Rodentia ) 12 683      
1.f. Rabbits ( Oryctolagus cuniculus ) 93 282 92 897 10 0 375 1 542 
1.g. Cats ( Felis catus ) 1 313 622 9 0 682 408 
1.h. Dogs ( Canis familiaris ) 5 539 3 662 20 0 1 857 690 
1.i. Ferrets ( Mustela putorius furo ) 155 85 0 0 70 0 
1.j. Other Carnivores (other Carnivora ) 0      
1.k. Horses, donkeys and cross breds ( Equidae ) 223      
1.l. Pigs ( Sus) 6 587      
1.m. Goats ( Capra ) 442      
1.n. Sheep ( Ovis)  4 992      
1.o. Cattle ( Bos) 1 296      
1.p. Prosimians ( Prosimia ) 578 578 0 0 0 30 
1.q. New World Monkeys ( Ceboidea ) 433 340 20 13 60 96 
1.r. Old World Monkeys ( Cercopithecoidea ) 2 778 809 38 0 1 931 427 
1.s. Apes ( Hominoidea ) 0 0 0 0 0 0 
1.t. Other Mammals (other Mammalia ) 0      
1.u. Quail ( Coturnix coturnix)  4 023 3 983 0 0 40 0 
1.v. Other birds (other Aves ) 102 240      
1.w. Reptiles ( Reptilia ) 0      
1.x. Amphibians ( Amphibia ) 15 675      
1.y. Fish ( Pisces ) 50 397      
1.z. TOTAL 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 perio d, are Parties to the Convention ETS 123. Thus an updated 
list of those countries has to be us ed when filling in this column. 
Note 2: Only the white b oxes 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 97   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 2.3 
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 351 428 404 603 475 247 59 199 71 036 66 658 41 988 40 175 1 510 334 
2.b. Rats 73 253 205 258 19 913 14 031 69 933 497 15 714 25 788 424 387 
2.c. Guinea-Pigs 1 404 6 127 50 991 6 373 13 122 7 417 909 79 350 
2.d. Hamsters 2 043 3 320 151 2 103 144 910 12 8 8 691 
2.e. Other Rodents 745 10 645 0 0 0 27 0 1 266 12 683 
2.f. Rabbits 1 246 9 686 61 349 3 334 10 328 1 123 1 689 4 527 93 282 
2.g. Cats 53 396 0 458 24 0 9 373 1 313 
2.h. Dogs 106 1 062 148 491 3 427 0 32 273 5 539 
2.i. Ferrets 30 55 29 0 41 0 0 0 155 
2.j. Other Carnivores 0 0 0 0 0 0 0 0 0 
2.k. Horses, donkeys and cross 
breds 0 21 87 8 0 0 91 16 223 
2.l. Pigs 159 2 421 4 1 407 1 002 1 350 1 243 6 587 
2.m. Goats 26 106 77 0 10 0 23 200 442 
2.n. Sheep 731 936 3 062 0 10 26 111 116 4 992 
2.o. Cattle 56 461 1 11 92 20 141 514 1 296 
2.p. Prosimians 382 0 0 0 0 0 0 196 578 
2.q. New World Monkeys 24 121 35 0 168 0 5 80 433 
2.r. Old World Monkeys 238 216 326 0 1 874 0 29 95 2 778 
2.s. Apes 0 0 0 0 0 0 0 0 0 
2.t. Other Mammals 0 0 0 0 0 0 0 0 0 
2.u. Quail 20 0 0 0 0 0 100 3 903 4 023 
2.v. Other birds 3 768 10 718 10 857 37 069 36 332 435 1 209 1 852 102 240 
2.w. Reptiles 0 0 0 0 0 0 0 0 0 
2.x. Amphibians 4 760 53 0 0 500 0 9 362 1 000 15 675 
2.y. Fish 41 140 0 0 0 4 948 0 1 439 2 870 50 397 
2.z. TOTAL 481 612 656 205 622 277 124 484 212 991 69 704 72 721 85 404 2 325 398 
 
EN 98   EN TABLE 3: NUMBER OF ANIMALS USED IN TOXI COLOGICAL 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 3.7 
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 3.10 
Other toxico- 
logical or 
safety 
evaluations 3.11 
Total 
3.a. Mice 39 549 7 321 5 868 0 1 797 516 123 2 438 13 424 71 036 
3.b. Rats 44 318 3 177 5 693 16 2 226 229 0 1 565 12 709 69 933 
3.c. Guinea-Pigs 4 353 445 3 832 177 940 27 0 0 3 348 13 122 
3.d. Hamsters 142 0 2 0 0 0 0 0 0 144 
3.e. Other Rodents 0 0 0 0 0 0 0 0 0 0 
3.f. Rabbits 4 796 696 1 319 106 533 0 0 0 2 878 10 328 
3.g. Cats 24 0 0 0 0 0 0 0 0 24 
3.h. Dogs 2 623 134 108 0 0 0 0 0 562 3 427 
3.i. Ferrets 41 0 0 0 0 0 0 0 0 41 
3.j. Other Carnivores 0 0 0 0 0 0 0 0 0 0 
3.k. Horses, donkeys and cross breds 0 0 0 0 0 0 0 0 0 0 
3.l. Pigs 303 0 39 0 0 0 444 83 133 1 002 
3.m. Goats 0 0 0 0 0 0 0 10 0 10 
3.n. Sheep 0 0 0 0 0 0 10 0 0 10 
3.o. Cattle 67 0 0 0 0 0 25 0 0 92 
3.p. Prosimians 0 0 0 0 0 0 0 0 0 0 
3.q. New World Monkeys 168 0 0 0 0 0 0 0 0 168 
3.r. Old World Monkeys 970 0 6 0 0 0 0 0 898 1 874 
3.s. Apes 0 0 0 0 0 0 0 0 0 0 
3.t. Other Mammals 0 0 0 0 0 0 0 0 0 0 
3.u. Quail 0 0 0 0 0 0 0 0 0 0 
3.v. Other birds 262 0 98 0 0 0 30 519 366 5 087 36 332 
3.w. Reptiles 0 0 0 0 0 0 0 0 0 0 
3.x. Amphibians 0 400 0 0 0 0 100 0 0 500 
3.y. Fish 0 2 848 2 000 0 0 0 0 100 0 4 948 
3.z. TOTAL 97 616 15 021 18 965 299 5 496 772 31 221 4 562 39 039 212 991 
 
EN 99   EN TABLE 4: NUMBER OF ANIMALS USED IN EXPERIME NTS FOR STUDIES ON HUM AN 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) 4.5 
Other human diseases 4.6 
Studies specific to animal 
diseases 4.7 
Total 
4.a. Mice 69 470 226 646 154 806 307 007 64 760 822 689 
4.b. Rats 47 369 112 450 17 732 99 236 2 221 279 008 
4.c. Guinea-Pigs 1 719 924 149 2 980 1 766 7 538 
4.d. Hamsters 1 078 1 117 0 2 031 2 047 6 273 
4.e. Other Rodents 0 10 633 0 114 670 11 417 
4.f. Rabbits 3 349 0 93 4 504 4 109 12 055 
4.g. Cats 0 14 0 127 308 449 
4.h. Dogs 130 36 11 654 337 1 168 
4.i. Ferrets 0 0 0 85 0 85 
4.j. Other Carnivores 0 0 0 0 0 0 
4.k. Horses, donkeys and cross breds 0 0 0 0 21 21 
4.l. Pigs 830 1 6 245 1 499 2 581 
4.m. Goats 9 0 0 1 122 132 
4.n. Sheep 152 40 0 116 1 385 1 693 
4.o. Cattle 1 0 0 0 536 537 
4.p. Prosimians 0 382 0 0 0 382 
4.q. New World Monkeys 9 29 0 107 0 145 
4.r. Old World Monkeys 9 69 52 315 9 454 
4.s. Apes 0 0 0 0 0 0 
4.t. Other Mammals 0 0 0 0 0 0 
4.u. Quail 0 0 0 20 0 20 
4.v. Other birds 5 0 0 0 14 916 14 921 
4.w. Reptiles 0 0 0 0 0 0 
4.x. Amphibians 0 649 2 018 1 869 277 4 813 
4.y. Fish 0 0 0 32 809 8 331 41 140 
4.z. TOTAL 124 130 352 990 174 867 452 220 103 314 1 207 521 
 
EN 100   EN TABLE 5: NUMBER OF ANIMALS USED IN PRODUCTION AN D QUALITY CONTROL OF PRO DUCTS 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 5 219 92 021 0 500 428 624 8 082 534 446 
5.b. Rats 4 608 13 371 0 14 938 1 027 0 33 944 
5.c. Guinea-Pigs 0 9 411 0 0 47 947 6 57 364 
5.d. Hamsters 0 2 254 0 0 0 0 2 254 
5.e. Other Rodents 0 0 0 0 0 0 0 
5.f. Rabbits 6 7 978 0 0 56 680 19 64 683 
5.g. Cats 0 458 0 0 0 0 458 
5.h. Dogs 0 639 0 0 0 0 639 
5.i. Ferrets 0 23 0 0 6 0 29 
5.j. Other Carnivores 0 0 0 0 0 0 0 
5.k. Horses, donkeys and cross breds 0 0 0 0 95 0 95 
5.l. Pigs 0 1 342 0 0 4 65 1 411 
5.m. Goats 0 0 0 0 77 0 77 
5.n. Sheep 0 0 0 0 3 062 0 3 062 
5.o. Cattle 0 11 0 0 1 0 12 
5.p. Prosimians 0 0 0 0 0 0 0 
5.q. New World Monkeys 0 35 0 0 0 0 35 
5.r. Old World Monkeys 0 6 0 0 320 0 326 
5.s. Apes 0 0 0 0 0 0 0 
5.t. Other Mammals 0 0 0 0 0 0 0 
5.u. Quail 0 0 0 0 0 0 0 
5.v. Other birds 0 37 117 152 0 10 657 0 47 926 
5.w. Reptiles 0 0 0 0 0 0 0 
5.x. Amphibians 0 0 0 0 0 0 0 
5.y. Fish 0 0 0 0 0 0 0 
5.z. TOTAL 9 833 164 666 152 15 438 548 500 8 172 746 761 
Examples: 5.2 – France is testing due to a UK (or FR) specific  requirement Note: columns 5.2 - 5. 5 refer to the legislation imp osing that the test be carried out and 
 5.3 - UK is testing according to EC legislation  not to the bo dy which has issued the actual te st method, guidel ine or protoco l. 
 5.4 – Spain is testing due to a Hungarian requirement Example: a test required by French legislation and carried out in Belgiu m according to an 
 5.5 – Sweden is testing due to a US specific requirement  ISO protocol must be coded as a national (FR) legislative requiremen t and be 
 5.6 – Germany is testing due to  a Czech requirement (also an EC 
requirement)  entered into column 5.2 in the tables submitted by Belgium. 
Footnotes: 1) EC Member States: Austria, Belgium, Denmark, Finl and, France, Germany, Greece, Ir eland, Italy, Luxembourg, Nether lands, Portugal, Spain, Sw eden, United Kingdom 
 2) Member Countries of Council of Europe (non-EC): Albania, A ndorra, Bulgaria, Croatia, Cyprus, Czech Rep., Estonia, Hungary, Iceland, Latvia, Liechtens tein, Lithuania, Malta, 
Moldova, Norway, Poland, Romania, Russia, San Marino, Slovakia, Slovenia, Switzerland,  ‘the former Yugoslav Rep. of Macedonia’,  Turkey, Ukraine 
 
EN 101   EN TABLE 6: NUMBER OF ANIMALS USED IN TOXI COLOGICAL 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 7 381 17 787 22 3 586 34 457 7 803 71 036 
6.b. Rats 568 8 729 0 5 966 48 339 6 331 69 933 
6.c. Guinea-Pigs 414 9 751 0 323 2 107 527 13 122 
6.d. Hamsters 0 78 0 0 64 2 144 
6.e. Other Rodents 0 0 0 0 0 0 0 
6.f. Rabbits 502 1 631 0 1 726 4 669 1 800 10 328 
6.g. Cats 0 24 0 0 0 0 24 
6.h. Dogs 0 231 0 510 2 547 139 3 427 
6.i. Ferrets 0 0 0 0 41 0 41 
6.j. Other Carnivores 0 0 0 0 0 0 0 
6.k. Horses, donkeys and cross breds 0 0 0 0 0 0 0 
6.l. Pigs 31 187 0 132 512 140 1 002 
6.m. Goats 0 0 0 0 0 10 10 
6.n. Sheep 0 0 0 0 10 0 10 
6.o. Cattle 0 67 0 0 25 0 92 
6.p. Prosimians 0 0 0 0 0 0 0 
6.q. New World Monkeys 0 0 0 0 168 0 168 
6.r. Old World Monkeys 0 253 0 488 1 035 98 1 874 
6.s. Apes 0 0 0 0 0 0 0 
6.t. Other Mammals 0 0 0 0 0 0 0 
6.u. Quail 0 0 0 0 0 0 0 
6.v. Other birds 629 98 0 0 35 605 0 36 332 
6.w. Reptiles 0 0 0 0 0 0 0 
6.x. Amphibians 500 0 0 0 0 0 500 
6.y. Fish 0 3 000 0 0 33 1 915 4 948 
6.z. TOTAL 10 025 41 836 22 12 731 129 612 18 765 212 991 
Examples: 6.2 – France is testing due to a UK (or FR) specific  requirement Note: columns 6.2 - 6. 5 refer to the legislation imp osing that the test be carried out and 
 6.3 - UK is testing according to EC legislation  not to the bo dy which has issued the actual te st method, guidel ine or protoco l. 
 6.4 – Spain is testing due to a Hungarian requirement Example: a test required by French legislation and carried out in Belgiu m according to an 
 6.5 – Sweden is testing due to a US specific requirement  ISO protocol must be coded as a national (FR) legislative requiremen t and be 
 6.6 – Germany is testing due to  a Czech requirement (also an EC 
requirement)  entered into column 6.2 in the tables submitted by Belgium. 
Footnotes: 1) EC Member States: Austria, Belgium, Denmark, Finl and, France, Germany, Greece, Ir eland, Italy, Luxembourg, Nether lands, Portugal, Spain, Sw eden, United Kingdom 
 2) Member Countries of Council of Europe (non-EC): Albania, A ndorra, Bulgaria, Croatia, Cyprus, Czech Rep., Estonia, Hungary, Iceland, Latvia, Liechtenst ein, Lithuania, Malta, 
Moldova, Norway, Poland, Romania, Russia, San Marino, Slovakia, Slovenia, Switzerland,  ‘the former Yugoslav Rep. of Macedonia’,  Turkey, Ukraine 
 
EN 102   EN TABLE 7: NUMBER OF ANIMALS USED IN TOXI COLOGICAL AND OTHER SAFETY EVALUATIONS 
Types of tests versus species 
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 7.11 
Toxicity 
to aquatic 
vertebra-
tes not 
included 
in other 
columns 7.12 
Other 7.13 
Total 
  7.2.1. 
LD50, 
LC50 7.2.2 
Other lethal 
methods 7.2.3 
Non lethal 
clinical signs 
methods            
7.a. Mice 2 005 17 724 9 119 2 493 8 033 0 12 909 5 105 912 1 001 315 0 11 420 71 036 
7.b. Rats 1 881 8 642 5 955 0 0 142 20 645 6 386 5 301 4 573 6 247 0 10 161 69 933 
7.c. Guinea-Pigs 0 92 282 1 919 8 239 0 352 0 0 0 0 0 2 238 13 122 
7.d. Hamsters 0 64 0 0 0 0 2 0 0 0 0 0 78 144 
7.e. Other Rodents 0 0 0 0 0 0 0 0 0 0 0 0 0 0 
7.f. Rabbits 0 15 1 289 1 494 0 1 647 1 026 0 2 544 0 1 254 0 1 059 10 328 
7.g. Cats 0 0 0 0 0 0 0 0 0 0 0 0 24 24 
7.h. Dogs 0 166 599 0 0 0 2 429 0 0 0 0 0 233 3 427 
7.i. Ferrets 0 0 41 0 0 0 0 0 0 0 0 0 0 41 
7.j. Other Carnivores 0 0 0 0 0 0 0 0 0 0 0 0 0 0 
7.k. Horses, donkeys and cross 
breds 0 0 0 0 0 0 0 0 0 0 0 0 0 0 
7.l. Pigs 0 49 0 0 0 0 262 0 89 0 0 0 602 1 002 
7.m. Goats 0 0 0 0 0 0 0 0 0 0 0 0 10 10 
7.n. Sheep 0 0 0 0 0 0 0 0 0 0 0 0 10 10 
7.o. Cattle 0 0 0 0 0 0 0 0 0 0 0 0 92 92 
7.p. Prosimians 0 0 0 0 0 0 0 0 0 0 0 0 0 0 
7.q. New World Monkeys 0 72 78 0 0 0 18 0 0 0 0 0 0 168 
7.r. Old World Monkeys 0 0 259 0 0 33 1 556 0 0 0 0 0 26 1 874 
7.s. Apes 0 0 0 0 0 0 0 0 0 0 0 0 0 0 
7.t. Other Mammals 0 0 0 0 0 0 0 0 0 0 0 0 0 0 
7.u. Quail 0 0 0 0 0 0 0 0 0 0 0 0 0 0 
7.v. Other birds 0 0 5 087 0 0 0 98 0 0 0 0 0 31 147 36 332 
7.w. Reptiles 0 0 0 0 0 0 0 0 0 0 0 0 0 0 
7.x. Amphibians 0 0 0 0 0 0 0 0 0 0 0 0 500 500 
7.y. Fish 1 178 0 1 000 0 0 0 2 170 0 0 0 0 500 100 4 948 
7.z. TOTAL 5 064 26 824 23 709 5 906 16 272 1 822 41 467 11 491 8 846 5 574 7 816 500 57 700 212 991 
 
EN 103   EN TABLE 8: NUMBER OF ANIMALS USED IN TOXI COLOGICAL AND OTHER SAFETY EVALUATIONS 
Types of tests versus products 
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 8.6 
Sub- 
chronic 
and 
chronic 
toxicity 8.7 
Carcino 
genicity 8.8 
Develop- 
mental 
toxicity 8.9 
Muta- 
genicit
y 8.10 
Repro-
ductive 
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            
8.a. Products/substances or devices for 
human medicine and dentistry and for 
veterinary medicine 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.b. Products/substances used or intended to 
be used mainly in agriculture 2 111 1 683 1 865 102 230 56 5 896 1 723 666 0 134 555 0 15 021 
8.c. Products/substances used or intended to 
be used mainly in industry 568 1 080 1 218 2 455 972 119 9 156 2 488 873 2 0 0 34 18 965 
8.d. Products/substances used or intended to 
be used mainly in the household 0 18 0 36 133 67 0 0 0 0 0 0 45 299 
8.e. Products/substances used or intended to 
be used mainly as cosmetics or 
toiletries 0 349 684 413 2 222 281 966 0 368 213 0 0 0 5 496 
8.f. Products/substances used or intended to 
be used mainly as additives in food for 
human consumption 0 0 123 0 19 0 467 0 0 8 0 0 155 772 
8.g. Products/substances used or intended to 
be used mainly as additives in food for 
animal consumption 0 0 185 0 0 0 0 24 0 0 0 0 31 012 31 221 
8.h. Potential or actual contaminants in the 
general environment which do not 
appear in other columns 0 1 289 287 0 0 0 1 350 0 0 0 592 0 1 044 4 562 
8.i. Other toxicological or safety 
evaluations 409 6 943 1 779 372 2 096 367 18 251 473 2 298 2 042 1 180 0 2 829 39 039 
8.j. TOTAL 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 104   EN HUNGARY 
Statistical data submitted 
The statistical data have been submitted by the Mi nistry of Agriculture and Rural Development. 
Comments of the Hungarian authorities 
2005 was the first year when Hungarian user establis hments furnished data on the number of animals 
used for experimental and other scientific purposes in the harmonized eight tabl e version of statistical 
reporting format. Furthermore, the data in this format  were supplied on a voluntar y 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 prev ious 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 requ irements 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 experime ntal and other scientif ic 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 cas e of rats, 28% for guinea-pi gs, 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 us e of fish more than doubled (+ 138%) while the num ber 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 proport ion (86.4%) within the total number of animals. Notable changes can 
be observed in the proportion of bird s (a drop from 8.9% to 5.9%) and that  of fish (an increase from 1.1% 
to 3%). 
Due to the limiting conditions descri bed above, however, it cannot be fa irly judged whether these changes 
represent the beginning of a longer-term tendency or just refl ect natural variation of the data. 
When analysed by the purposes of the use of animals a slight increase can be obs erved in the fundamental 
biological research segment (3.7%) while the number of animals substantially decreased in education 
(51%), in diagnosis of disease a nd toxicological evaluations (32% each) and in the human and veterinary 
medicine field (21%) including re search, development, production and quality control. However, in 
absolute numbers the latter decrease (48.671) accounts fo r more than two thirds of the total decrease 
(68.008).  
Compared to 2004 the proportion of fundamental resear ch in overall usage augmented from 21% to 27% 
while that of medicine related use decreased from 62% to 60%. Toxico logical and safety investigations 
form the third largest part  (10%) of animal usage. 
 
 
EN 105   EN TABLE 1: NUMBER OF ANIMALS USED IN RELATION TO THEIR PLACE OF ORIGIN 
Origin versus species 
1.1 
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 1.5 
Animals coming from 
Member Countries of the 
Council of Europe which are 
parties to the Convention ETS 
123 (excluding EC Member 
States) 1.6 
Animals coming from 
other origins 1.7 
Re-used animals 
1.a. Mice ( Mus musculus ) 138312 106993 29067 0 2252  
1.b. Rats ( Rattus norvegicus ) 109479 102798 6681 0 0  
1.c. Guinea-Pigs ( Cavia porcellus ) 8360 4688 3672 0 0  
1.d. Hamsters ( Mesocricetus ) 137 137 0 0 0  
1.e. Other Rodents (other Rodentia ) 381      
1.f. Rabbits ( Oryctolagus cuniculus ) 9152 8640 0 0 512 0 
1.g. Cats ( Felis catus ) 124 121 0 0 3 0 
1.h. Dogs ( Canis familiaris ) 1206 966 104 0 136 0 
1.i. Ferrets ( Mustela putorius furo ) 0 0 0 0 0 0 
1.j. Other Carnivores (other Carnivora ) 0      
1.k. Horses, donkeys and cross breds ( Equidae ) 6      
1.l. Pigs ( Sus) 882      
1.m. Goats ( Capra ) 2      
1.n. Sheep ( Ovis)  381      
1.o. Cattle ( Bos) 32      
1.p. Prosimians ( Prosimia ) 0 0 0 0 0 0 
1.q. New World Monkeys ( Ceboidea ) 0 0 0 0 0 0 
1.r. Old World Monkeys ( Cercopithecoidea ) 6 3 0 0 3 0 
1.s. Apes ( Hominoidea ) 0 0 0 0 0 0 
1.t. Other Mammals (other Mammalia ) 0      
1.u. Quail ( Coturnix coturnix)  283 93 0 0 190  
1.v. Other birds (other Aves ) 17151      
1.w. Reptiles ( Reptilia ) 25      
1.x. Amphibians ( Amphibia ) 1709      
1.y. Fish ( Pisces ) 9581      
1.z. TOTAL 297209      
Note 1: Column 1.5 concerns only those Member Countries of the Co uncil of Europe which, at the beginning of the reporting perio d, 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 b oxes 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 106   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 2.3 
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 31950 67452 22717 0 8125 7050 988 30 138312 
2.b. Rats 35834 64523 0 0 7625 0 1497 0 109479 
2.c. Guinea-Pigs 771 2417 2562 0 2554 16 22 18 8360 
2.d. Hamsters 137 0 0 0 0 0 0 0 137 
2.e. Other Rodents 0 81 0 0 300 0 0 0 381 
2.f. Rabbits 1146 3995 3011 24 702 105 167 2 9152 
2.g. Cats 109 0 0 0 0 0 15 0 124 
2.h. Dogs 273 92 0 0 633 0 208 0 1206 
2.i. Ferrets 0 0 0 0 0 0 0 0 0 
2.j. Other Carnivores 0 0 0 0 0 0 0 0 0 
2.k. Horses, donkeys and cross 
breds 0 0 0 0 0 0 6 0 6 
2.l. Pigs 173 261 0 0 26 55 82 285 882 
2.m. Goats 0 0 0 0 0 0 2 0 2 
2.n. Sheep 19 189 0 24 4 3 2 140 381 
2.o. Cattle 6 12 0 0 8 0 6 0 32 
2.p. Prosimians 0 0 0 0 0 0 0 0 0 
2.q. New World Monkeys 0 0 0 0 0 0 0 0 0 
2.r. Old World Monkeys 6 0 0 0 0 0 0 0 6 
2.s. Apes 0 0 0 0 0 0 0 0 0 
2.t. Other Mammals 0 0 0 0 0 0 0 0 0 
2.u. Quail 93 0 0 0 190 0 0 0 283 
2.v. Other birds 3068 8070 132 3165 2244 360 109 3 17151 
2.w. Reptiles 25 0 0 0 0 0 0 0 25 
2.x. Amphibians 458 0 0 0 0 0 1251 0 1709 
2.y. Fish 5365 0 0 0 3330 0 386 500 9581 
 
EN 107   EN 2.z. TOTAL 79433 147092 28422 3213 25741 7589 4741 978 297209 
 
EN 108   EN TABLE 3: NUMBER OF ANIMALS USED IN TOXI COLOGICAL 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 3.7 
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 3.10 
Other toxico- 
logical or 
safety 
evaluations 3.11 
Total 
3.a. Mice 2994 321 0 0 0 0 0 556 4254 8125 
3.b. Rats 1556 1317 13 0 0 52 0 394 4293 7625 
3.c. Guinea-Pigs 208 2 0 0 0 0 0 0 2344 2554 
3.d. Hamsters 0 0 0 0 0 0 0 0 0 0 
3.e. Other Rodents 300 0 0 0 0 0 0 0 0 300 
3.f. Rabbits 55 18 0 0 0 0 0 0 629 702 
3.g. Cats 0 0 0 0 0 0 0 0 0 0 
3.h. Dogs 296 0 0 0 0 0 0 0 337 633 
3.i. Ferrets 0 0 0 0 0 0 0 0 0 0 
3.j. Other Carnivores 0 0 0 0 0 0 0 0 0 0 
3.k. Horses, donkeys and cross breds 0 0 0 0 0 0 0 0 0 0 
3.l. Pigs 6 0 0 0 0 0 0 20 0 26 
3.m. Goats 0 0 0 0 0 0 0 0 0 0 
3.n. Sheep 4 0 0 0 0 0 0 0 0 4 
3.o. Cattle 8 0 0 0 0 0 0 0 0 8 
3.p. Prosimians 0 0 0 0 0 0 0 0 0 0 
3.q. New World Monkeys 0 0 0 0 0 0 0 0 0 0 
3.r. Old World Monkeys 0 0 0 0 0 0 0 0 0 0 
3.s. Apes 0 0 0 0 0 0 0 0 0 0 
3.t. Other Mammals 0 0 0 0 0 0 0 0 0 0 
3.u. Quail 0 190 0 0 0 0 0 0 0 190 
3.v. Other birds 1444 0 0 0 0 0 0 800 0 2244 
3.w. Reptiles 0 0 0 0 0 0 0 0 0 0 
3.x. Amphibians 0 0 0 0 0 0 0 0 0 0 
3.y. Fish 1000 430 0 0 0 0 0 1000 900 3330 
3.z. TOTAL 7871 2278 13 0 0 52 0 2770 12757 25741 
 
EN 109   EN TABLE 4: NUMBER OF ANIMALS USED IN EXPERIME NTS FOR STUDIES ON HUM AN 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) 4.5 
Other human diseases 4.6 
Studies specific to animal 
diseases 4.7 
Total 
4.a. Mice 2146 55622 7607 13195 5982 84552 
4.b. Rats 3601 54589 1003 6056 15 65264 
4.c. Guinea-Pigs 59 93 0 2167 301 2620 
4.d. Hamsters 0 0 0 0 0 0 
4.e. Other Rodents 0 75 0 6 0 81 
4.f. Rabbits 350 2753 0 196 707 4006 
4.g. Cats 0 0 0 0 0 0 
4.h. Dogs 165 9 0 18 43 235 
4.i. Ferrets 0 0 0 0 0 0 
4.j. Other Carnivores 0 0 0 0 0 0 
4.k. Horses, donkeys and cross breds 0 0 0 0 0 0 
4.l. Pigs 61 0 0 14 189 264 
4.m. Goats 0 0 0 0 0 0 
4.n. Sheep 0 0 0 3 277 280 
4.o. Cattle 0 0 0 0 20 20 
4.p. Prosimians 0 0 0 0 0 0 
4.q. New World Monkeys 0 0 0 0 0 0 
4.r. Old World Monkeys 0 0 0 0 0 0 
4.s. Apes 0 0 0 0 0 0 
4.t. Other Mammals 0 0 0 0 0 0 
4.u. Quail 0 0 0 0 0 0 
4.v. Other birds 0 818 0 10 9906 10734 
4.w. Reptiles 0 0 0 0 0 0 
4.x. Amphibians 0 0 0 0 0 0 
4.y. Fish 0 0 0 0 300 300 
4.z. TOTAL 6382 113959 8610 21665 17740 168356 
 
EN 110   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 0 17952 0 0 4340 425 22717 
5.b. Rats 0 0 0 0 0 0 0 
5.c. Guinea-Pigs 0 1317 0 0 1157 88 2562 
5.d. Hamsters 0 0 0 0 0 0 0 
5.e. Other Rodents 0 0 0 0 0 0 0 
5.f. Rabbits 24 2981 0 0 30 0 3035 
5.g. Cats 0 0 0 0 0 0 0 
5.h. Dogs 0 0 0 0 0 0 0 
5.i. Ferrets 0 0 0 0 0 0 0 
5.j. Other Carnivores 0 0 0 0 0 0 0 
5.k. Horses, donkeys and cross breds 0 0 0 0 0 0 0 
5.l. Pigs 0 0 0 0 0 0 0 
5.m. Goats 0 0 0 0 0 0 0 
5.n. Sheep 24 0 0 0 0 0 24 
5.o. Cattle 0 0 0 0 0 0 0 
5.p. Prosimians 0 0 0 0 0 0 0 
5.q. New World Monkeys 0 0 0 0 0 0 0 
5.r. Old World Monkeys 0 0 0 0 0 0 0 
5.s. Apes 0 0 0 0 0 0 0 
5.t. Other Mammals 0 0 0 0 0 0 0 
5.u. Quail 0 0 0 0 0 0 0 
5.v. Other birds 100 3065 0 0 130 2 3297 
5.w. Reptiles 0 0 0 0 0 0 0 
5.x. Amphibians 0 0 0 0 0 0 0 
5.y. Fish 0 0 0 0 0 0 0 
5.z. TOTAL 148 25315 0 0 5657 515 31635 
Examples: 5.2 – France is testing due to a UK (or FR) specific  requirement Note: columns 5.2 - 5. 5 refer to the legislation imp osing that the test be carried out and 
 5.3 - UK is testing according to EC legislation  not to the bo dy which has issued the actual te st method, guidel ine or protoco l. 
 5.4 – Spain is testing due to a Hungarian requirement Example: a test required by French legislation and carried out in Belgiu m according to an 
 5.5 – Sweden is testing due to a US specific requirement  ISO protocol must be coded as a national (FR) legislative requiremen t and be 
 5.6 – Germany is testing due to  a Czech requirement (also an EC 
requirement)  entered into column 5.2 in the tables submitted by Belgium. 
Footnotes: 1) EC Member States: Austria, Belgium, Denmark, Finl and, France, Germany, Greece, Ir eland, Italy, Luxembourg, Nether lands, Portugal, Spain, Sw eden, United Kingdom 
 
EN 111   EN  2) Member Countries of Council of Europe (non-EC): Albania, A ndorra, Bulgaria, Croatia, Cyprus, Czech Rep., Estonia, Hungary, Iceland, Latvia, Liechtenstein, Lithuania, 
Malta, Moldova, Norway, Poland, Romania, Ru ssia, San Marino, Slovakia, Slovenia, Switz erland, ‘the former Yugoslav Rep. of Mace donia’, Turkey, Ukraine 
 
EN 112   EN TABLE 6: NUMBER OF ANIMALS USED IN TOXI COLOGICAL 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 2779 1839 148 0 3359 0 8125 
6.b. Rats 945 900 646 0 5121 13 7625 
6.c. Guinea-Pigs 0 946 0 0 1608 0 2554 
6.d. Hamsters 0 0 0 0 0 0 0 
6.e. Other Rodents 0 300 0 0 0 0 300 
6.f. Rabbits 6 76 0 0 620 0 702 
6.g. Cats 0 0 0 0 0 0 0 
6.h. Dogs 242 60 0 0 331 0 633 
6.i. Ferrets 0 0 0 0 0 0 0 
6.j. Other Carnivores 0 0 0 0 0 0 0 
6.k. Horses, donkeys and cross breds 0 0 0 0 0 0 0 
6.l. Pigs 0 6 0 0 0 20 26 
6.m. Goats 0 0 0 0 0 0 0 
6.n. Sheep 0 4 0 0 0 0 4 
6.o. Cattle 0 8 0 0 0 0 8 
6.p. Prosimians 0 0 0 0 0 0 0 
6.q. New World Monkeys 0 0 0 0 0 0 0 
6.r. Old World Monkeys 0 0 0 0 0 0 0 
6.s. Apes 0 0 0 0 0 0 0 
6.t. Other Mammals 0 0 0 0 0 0 0 
6.u. Quail 0 190 0 0 0 0 190 
6.v. Other birds 0 1182 0 0 0 1062 2244 
6.w. Reptiles 0 0 0 0 0 0 0 
6.x. Amphibians 0 0 0 0 0 0 0 
6.y. Fish 1000 1430 0 0 900 0 3330 
6.z. TOTAL 4972 6941 794 0 11939 1095 25741 
Examples: 6.2 – France is testing due to a UK (or FR) specific  requirement Note: columns 6.2 - 6. 5 refer to the legislation imp osing that the test be carried out and 
 6.3 - UK is testing according to EC legislation  not to the bo dy which has issued the actual te st method, guidel ine or protoco l. 
 6.4 – Spain is testing due to a Hungarian requirement Example: a test required by French legislation and carried out in Belgiu m according to an 
 6.5 – Sweden is testing due to a US specific requirement  ISO protocol must be coded as a national (FR) legislative requiremen t and be 
 6.6 – Germany is testing due to  a Czech requirement (also an EC 
requirement)  entered into column 6.2 in the tables submitted by Belgium. 
Footnotes: 1) EC Member States: Austria, Belgium, Denmark, Finl and, France, Germany, Greece, Ir eland, Italy, Luxembourg, Nether lands, Portugal, Spain, Sw eden, United Kingdom 
 2) Member Countries of Council of Europe (non-EC): Albania, A ndorra, Bulgaria, Croatia, Cyprus, Czech Rep., Estonia, Hungary, Iceland, Latvia, Liechtenst ein, Lithuania, Malta, 
Moldova, Norway, Poland, Romania, Russia, San Marino, Slovakia, Slovenia, Switzerland,  ‘the former Yugoslav Rep. of Macedonia’,  Turkey, Ukraine 
 
EN 113   EN TABLE 7: NUMBER OF ANIMALS USED IN TOXI COLOGICAL AND OTHER SAFETY EVALUATIONS 
Types of tests versus species 
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 7.11 
Toxicity 
to aquatic 
vertebra-
tes not 
included 
in other 
columns 7.12 
Other 7.13 
Total 
  7.2.1. 
LD50, 
LC50 7.2.2 
Other lethal 
methods 7.2.3 
Non lethal 
clinical signs 
methods            
7.a. Mice 1781 427 2282 0 0 0 40 0 6 1068 0 0 2521 8125 
7.b. Rats 160 529 2915 0 0 0 1129 47 6 13 773 0 2053 7625 
7.c. Guinea-Pigs 368 0 419 0 1091 0 0 0 0 0 0 0 676 2554 
7.d. Hamsters 0 0 0 0 0 0 0 0 0 0 0 0 0 0 
7.e. Other Rodents 0 0 300 0 0 0 0 0 0 0 0 0 0 300 
7.f. Rabbits 0 0 64 143 0 111 0 0 0 0 252 0 132 702 
7.g. Cats 0 0 0 0 0 0 0 0 0 0 0 0 0 0 
7.h. Dogs 0 0 311 0 0 0 200 0 0 0 0 0 122 633 
7.i. Ferrets 0 0 0 0 0 0 0 0 0 0 0 0 0 0 
7.j. Other Carnivores 0 0 0 0 0 0 0 0 0 0 0 0 0 0 
7.k. Horses, donkeys and cross 
breds 0 0 0 0 0 0 0 0 0 0 0 0 0 0 
7.l. Pigs 0 0 6 0 0 0 0 0 0 0 0 0 20 26 
7.m. Goats 0 0 0 0 0 0 0 0 0 0 0 0 0 0 
7.n. Sheep 0 0 4 0 0 0 0 0 0 0 0 0 0 4 
7.o. Cattle 0 0 8 0 0 0 0 0 0 0 0 0 0 8 
7.p. Prosimians 0 0 0 0 0 0 0 0 0 0 0 0 0 0 
7.q. New World Monkeys 0 0 0 0 0 0 0 0 0 0 0 0 0 0 
7.r. Old World Monkeys 0 0 0 0 0 0 0 0 0 0 0 0 0 0 
7.s. Apes 0 0 0 0 0 0 0 0 0 0 0 0 0 0 
7.t. Other Mammals 0 0 0 0 0 0 0 0 0 0 0 0 0 0 
7.u. Quail 0 110 80 0 0 0 0 0 0 0 0 0 0 190 
7.v. Other birds 0 0 1008 0 0 0 0 0 0 0 0 0 1236 2244 
7.w. Reptiles 0 0 0 0 0 0 0 0 0 0 0 0 0 0 
7.x. Amphibians 0 0 0 0 0 0 0 0 0 0 0 0 0 0 
7.y. Fish 2330 0 900 0 0 0 0 0 100 0 0 0 0 3330 
7.z. TOTAL 4639 1066 8297 143 1091 111 1369 47 112 1081 1025 0 6760 25741 
 
EN 114   EN TABLE 8: NUMBER OF ANIMALS USED IN TOXI COLOGICAL AND OTHER SAFETY EVALUATIONS 
Types of tests versus products 
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 8.6 
Sub- 
chronic 
and 
chronic 
toxicity 8.7 
Carcino 
genicity 8.8 
Develop- 
mental 
toxicity 8.9 
Muta- 
genicit
y 8.10 
Repro-
ductive 
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            
8.a. Products/substances or devices for 
human medicine and dentistry and for 
veterinary medicine 2778 24 2924 9 0 0 0 0 100 0 0 0 2036 7871 
8.b. Products/substances used or intended to 
be used mainly in agriculture 490 110 1425 12 0 111 80 0 0 0 0 0 158 2386 
8.c. Products/substances used or intended to 
be used mainly in industry 0 0 0 0 0 0 0 0 0 13 0 0 0 13 
8.d. Products/substances used or intended to 
be used mainly in the household 0 0 0 0 0 0 0 0 0 0 0 0 0 0 
8.e. Products/substances used or intended to 
be used mainly as cosmetics or 
toiletries 0 0 0 0 0 0 0 0 0 0 0 0 0 0 
8.f. Products/substances used or intended to 
be used mainly as additives in food for 
human consumption 0 0 52 0 0 0 0 0 0 0 0 0 0 52 
8.g. 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 
8.h. Potential or actual contaminants in the 
general environment which do not 
appear in other columns 1000 0 760 0 0 0 0 47 12 0 131 0 820 2770 
8.i. Other toxicological or safety 
evaluations 371 932 3136 122 1091 0 1289 0 0 1068 894 0 3746 12649 
8.j. TOTAL 4639 1066 8297 143 1091 111 1369 47 112 1081 1025 0 6760 25741 
 
EN 115   EN IRELAND  
Statistical data submitted 
The statistical data for Ireland have been pr ovided by the Department of Health and Children. 
Comments of Irish authorities  
General 
-A total of 37,940 animals were used. This represents a redu ction of 27% compared to 2002 
(the last published figures). 
- There were 539 valid licences during th e 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 accord ance 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 anaesthes ia (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 incompatib le with the object of the experiment. 
- 20% of animals (7,557) were used in proc edures 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 othe r safety evaluations. 
- 167 dogs were used, a re duction of 14% since 2002. 
- Education and training accounted fo r 2% (688) of the animals used. 
- Of the 2,024 other birds, 95% (1,914) were used in behavioural studies. 
 
EN 116   EN - 82% (313) of the rabbits used were for th e study of human cardiovascular diseases. 
- 189 horses were used, an increase of 170 si nce 2002. 91% of the horses used were for EC 
legislation including European Pharmacopoeia requirements. 117 of the horses were used 
with a Certificate A. Certificat e A is granted where the anaesthe sia 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 th e 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 LD
50 and LC 50 testing, a reduction of 33% since 2002.  
 
EN 117   EN TABLE 1: NUMBER OF ANIMALS USED IN RELATION TO THEIR PLACE OF ORIGIN 
Origin versus species 
1.1 
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 1.5 
Animals coming from 
Member Countries of the 
Council of Europe which are 
parties to the Convention ETS 
123 (excluding EC Member 
States) 1.6 
Animals coming from 
other origins 1.7 
Re-used animals 
1.a. Mice ( Mus musculus ) 17 776 8 767 8 532  477  
1.b. Rats ( Rattus norvegicus ) 7 722 5 733 1 864 60 65  
1.c. Guinea-Pigs ( Cavia porcellus ) 4 4     
1.d. Hamsters ( Mesocricetus ) 0      
1.e. Other Rodents (other Rodentia ) 0      
1.f. Rabbits ( Oryctolagus cuniculus ) 379 19 360    
1.g. Cats ( Felis catus ) 119 119    60 
1.h. Dogs ( Canis familiaris ) 167 137 30   92 
1.i. Ferrets ( Mustela putorius furo ) 0      
1.j. Other Carnivores (other Carnivora ) 0      
1.k. Horses, donkeys and cross breds ( Equidae ) 189      
1.l. Pigs ( Sus) 382      
1.m. Goats ( Capra ) 0      
1.n. Sheep ( Ovis)  601      
1.o. Cattle ( Bos) 2 109      
1.p. Prosimians ( Prosimia ) 0      
1.q. New World Monkeys ( Ceboidea ) 0      
1.r. Old World Monkeys ( Cercopithecoidea ) 0      
1.s. Apes ( Hominoidea ) 0      
1.t. Other Mammals (other Mammalia ) 48      
1.u. Quail ( Coturnix coturnix)  0      
1.v. Other birds (other Aves ) 2024      
1.w. Reptiles ( Reptilia ) 0      
1.x. Amphibians ( Amphibia ) 0      
1.y. Fish ( Pisces ) 6 420      
1.z. TOTAL 37940      
Note 1: Column 1.5 concerns only those Member Countries of the Co uncil of Europe which, at the beginning of the reporting perio d, are Parties to the Convention ETS 123. Thus an updated list 
of those countries has to be us ed when filling in  this column. 
Note 2: Only the white b oxes 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 118   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 2.3 
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 9 922 603   6703 158 15 375 17776 
2.b. Rats 6 367 1209    76 26 44 7722 
2.c. Guinea-Pigs  4       4 
2.d. Hamsters         0 
2.e. Other Rodents         0 
2.f. Rabbits 61 304      14 379 
2.g. Cats  10 45  64    119 
2.h. Dogs  38 42  87    167 
2.i. Ferrets         0 
2.j. Other Carnivores         0 
2.k. Horses, donkeys and cross 
breds    172   5 12 189 
2.l. Pigs 130 123    10 99 20 382 
2.m. Goats         0 
2.n. Sheep 62 1  72  3 463  601 
2.o. Cattle 1417 15  329 15  20 313 2109 
2.p. Prosimians         0 
2.q. New World Monkeys         0 
2.r. Old World Monkeys         0 
2.s. Apes         0 
2.t. Other Mammals 4 44       48 
2.u. Quail         0 
2.v. Other birds  7    110 60 1847 2024 
2.w. Reptiles         0 
2.x. Amphibians         0 
2.y. Fish 6408       12 6420 
 
EN 119   EN 2.z. TOTAL 24371 2358 87 573 6869 357 688 2637 37940 
 
EN 120   EN TABLE 3: NUMBER OF ANIMALS USED IN TOXI COLOGICAL 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 3.7 
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 3.10 
Other toxico- 
logical or 
safety 
evaluations 3.11 
Total 
3.a. Mice 150        6553 6703 
3.b. Rats          0  
3.c. Guinea-Pigs          0  
3.d. Hamsters          0  
3.e. Other Rodents          0  
3.f. Rabbits          0  
3.g. Cats 64         64 
3.h. Dogs 87         87 
3.i. Ferrets          0  
3.j. Other Carnivores          0  
3.k. Horses, donkeys and cross breds          0  
3.l. Pigs          0  
3.m. Goats          0  
3.n. Sheep          0  
3.o. Cattle 15         15 
3.p. Prosimians          0  
3.q. New World Monkeys          0  
3.r. Old World Monkeys          0  
3.s. Apes          0  
3.t. Other Mammals          0  
3.u. Quail          0  
3.v. Other birds          0  
3.w. Reptiles          0  
3.x. Amphibians          0  
3.y. Fish          0  
3.z. TOTAL 316 0 0 0 0 0 0 0 6553 6869 
 
EN 121   EN TABLE 4: NUMBER OF ANIMALS USED IN EXPERIME NTS FOR STUDIES ON HUM AN 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) 4.5 
Other human diseases 4.6 
Studies specific to animal 
diseases 4.7 
Total 
4.a. Mice 675 1927 1155 6768 158 10683 
4.b. Rats 1386 5379  887  7652 
4.c. Guinea-Pigs  4    4 
4.d. Hamsters      0 
4.e. Other Rodents      0 
4.f. Rabbits 313 2  50  365 
4.g. Cats 10     10 
4.h. Dogs    38  38 
4.i. Ferrets      0 
4.j. Other Carnivores      0 
4.k. Horses, donkeys and cross breds      0 
4.l. Pigs 101   56 106 263 
4.m. Goats      0 
4.n. Sheep 1   38 27 66 
4.o. Cattle     1432 1432 
4.p. Prosimians      0 
4.q. New World Monkeys      0 
4.r. Old World Monkeys      0 
4.s. Apes      0 
4.t. Other Mammals 4    44 48 
4.u. Quail      0 
4.v. Other birds 7    110 117 
4.w. Reptiles      0 
4.x. Amphibians      0 
4.y. Fish  23  4790 1595 6408 
4.z. TOTAL 2497 7335 1155 12627 3472 27086 
 
EN 122   EN TABLE 5: NUMBER OF ANIMALS USED IN PRODUCTION AN D QUALITY CONTROL OF PRO DUCTS 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       0  
5.b. Rats       0  
5.c. Guinea-Pigs       0  
5.d. Hamsters       0  
5.e. Other Rodents       0  
5.f. Rabbits       0  
5.g. Cats     45  45 
5.h. Dogs     42  42 
5.i. Ferrets       0  
5.j. Other Carnivores       0  
5.k. Horses, donkeys and cross breds  172     172 
5.l. Pigs       0  
5.m. Goats       0  
5.n. Sheep  72     72 
5.o. Cattle  286    43 329 
5.p. Prosimians       0  
5.q. New World Monkeys       0  
5.r. Old World Monkeys       0  
5.s. Apes       0  
5.t. Other Mammals       0  
5.u. Quail       0  
5.v. Other birds       0  
5.w. Reptiles       0  
5.x. Amphibians       0  
5.y. Fish       0  
5.z. TOTAL 0 530 0 0 87 43 660 
Examples: 5.2 – France is testing due to a UK (or FR) specific  requirement Note: columns 5.2 - 5. 5 refer to the legislation imp osing that the test be carried out and 
 5.3 - UK is testing according to EC legislation  not to the bo dy which has issued the actual te st method, guidel ine or protoco l. 
 5.4 – Spain is testing due to a Hungarian requirement Example: a test required by French legislation and carried out in Belgiu m according to an 
 5.5 – Sweden is testing due to a US specific requirement  ISO protocol must be coded as a national (FR) legislative requiremen t and be 
 5.6 – Germany is testing due to  a Czech requirement (also an EC 
requirement)  entered into column 5.2 in the tables submitted by Belgium. 
Footnotes: 1) EC Member States: Austria, Belgium, Denmark, Finl and, France, Germany, Greece, Ir eland, Italy, Luxembourg, Nether lands, Portugal, Spain, Sw eden, United Kingdom 
 
EN 123   EN  2) Member Countries of Council of Europe (non-EC): Albania, A ndorra, Bulgaria, Croatia, Cyprus, Czech Rep., Estonia, Hungary, Iceland, Latvia, Liechtenstein, Lithuania, 
Malta, Moldova, Norway, Poland, Romania, Ru ssia, San Marino, Slovakia, Slovenia, Switz erland, ‘the former Yugoslav Rep. of Mace donia’, Turkey, Ukraine 
 
EN 124   EN TABLE 6: NUMBER OF ANIMALS USED IN TOXI COLOGICAL 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  5238   1465  6703 
6.b. Rats       0  
6.c. Guinea-Pigs       0  
6.d. Hamsters       0  
6.e. Other Rodents       0  
6.f. Rabbits       0  
6.g. Cats 64      64 
6.h. Dogs 87      87 
6.i. Ferrets       0  
6.j. Other Carnivores       0  
6.k. Horses, donkeys and cross breds       0  
6.l. Pigs       0  
6.m. Goats       0  
6.n. Sheep       0  
6.o. Cattle      15 15 
6.p. Prosimians       0  
6.q. New World Monkeys       0  
6.r. Old World Monkeys       0  
6.s. Apes       0  
6.t. Other Mammals       0  
6.u. Quail       0  
6.v. Other birds       0  
6.w. Reptiles       0  
6.x. Amphibians       0  
6.y. Fish       0  
6.z. TOTAL 151 5238 0 0 1465 15 6869 
Examples: 6.2 – France is testing due to a UK (or FR) specific  requirement Note: columns 6.2 - 6. 5 refer to the legislation imp osing that the test be carried out and 
 6.3 - UK is testing according to EC legislation  not to the bo dy which has issued the actual te st method, guidel ine or protoco l. 
 6.4 – Spain is testing due to a Hungarian requirement Example: a test required by French legislation and carried out in Belgiu m according to an 
 6.5 – Sweden is testing due to a US specific requirement  ISO protocol must be coded as a national (FR) legislative requiremen t and be 
 6.6 – Germany is testing due to  a Czech requirement (also an EC 
requirement)  entered into column 6.2 in the tables submitted by Belgium. 
Footnotes: 1) EC Member States: Austria, Belgium, Denmark, Finl and, France, Germany, Greece, Ir eland, Italy, Luxembourg, Nether lands, Portugal, Spain, Sw eden, United Kingdom 
 2) Member Countries of Council of Europe (non-EC): Albania, A ndorra, Bulgaria, Croatia, Cyprus, Czech Rep., Estonia, Hungary, Iceland, Latvia, Liechtenst ein, Lithuania, Malta, 
Moldova, Norway, Poland, Romania, Russia, San Marino, Slovakia, Slovenia, Switzerland,  ‘the former Yugoslav Rep. of Macedonia’,  Turkey, Ukraine 
 
EN 125   EN TABLE 7: NUMBER OF ANIMALS USED IN TOXI COLOGICAL AND OTHER SAFETY EVALUATIONS 
Types of tests versus species 
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 7.11 
Toxicity 
to aquatic 
vertebra-
tes not 
included 
in other 
columns 7.12 
Other 7.13 
Total 
  7.2.1. 
LD50, 
LC50 7.2.2 
Other lethal 
methods 7.2.3 
Non lethal 
clinical signs 
methods            
7.a. Mice 875 4363     1465       6703 
7.b. Rats              0  
7.c. Guinea-Pigs              0  
7.d. Hamsters              0  
7.e. Other Rodents              0  
7.f. Rabbits              0  
7.g. Cats             64 64 
7.h. Dogs             87 87 
7.i. Ferrets              0  
7.j. Other Carnivores              0  
7.k. Horses, donkeys and cross 
breds              0  
7.l. Pigs              0  
7.m. Goats              0  
7.n. Sheep              0  
7.o. Cattle   15           15 
7.p. Prosimians              0  
7.q. New World Monkeys              0  
7.r. Old World Monkeys              0  
7.s. Apes              0  
7.t. Other Mammals              0  
7.u. Quail              0  
7.v. Other birds              0  
7.w. Reptiles              0  
7.x. Amphibians              0  
7.y. Fish              0  
7.z. TOTAL 875 4363 15 0 0 0 1465 0 0 0 0 0 151 6869 
 
EN 126   EN TABLE 8: NUMBER OF ANIMALS USED IN TOXI COLOGICAL AND OTHER SAFETY EVALUATIONS 
Types of tests versus products 
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 8.6 
Sub- 
chronic 
and 
chronic 
toxicity 8.7 
Carcino 
genicity 8.8 
Develop- 
mental 
toxicity 8.9 
Muta- 
genicit
y 8.10 
Repro-
ductive 
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            
8.a. Products/substances or devices for 
human medicine and dentistry and for 
veterinary medicine 875 4363 15         1465 151 6869 
8.b. Products/substances used or intended to 
be used mainly in agriculture              0  
8.c. Products/substances used or intended to 
be used mainly in industry              0  
8.d. Products/substances used or intended to 
be used mainly in the household              0  
8.e. Products/substances used or intended to 
be used mainly as cosmetics or 
toiletries              0  
8.f. Products/substances used or intended to 
be used mainly as additives in food for 
human consumption              0  
8.g. Products/substances used or intended to 
be used mainly as additives in food for 
animal consumption              0  
8.h. Potential or actual contaminants in the 
general environment which do not 
appear in other columns              0  
8.i. Other toxicological or safety 
evaluations              0  
8.j. TOTAL 875 4363 15 0 0 0 0 0 0 0 0 1465 151 6869