Report from the Commission to the Council and the European Parliament - Third Report from the Commission to the Council and the European Parliament on the Statistics on the number of animals used for experimental and other scientific purposes in the member states of the European Union
Date: 2003-01-22
Institutions: European Commission
Subjects: EU statistics, animal experimentation, research method

COMMISSION OF THE EUROPEAN COMMUNITIES

Brussels, 22.01.2003
COM(2003) 19 final

REPORT FROM THE COMMISSION TO THE COUNCIL AND THE EUROPEAN
PARLIAMENT

THIRD REPORT FROM THE COMMISSION TO THE COUNCIL AND THE
EUROPEAN PARLIAMENT ON THE STATISTICS ON THE NUMBER OF
ANIMALS USED FOR EXPERIMENTAL AND OTHER SCIENTIFIC PURPOSES IN
THE MEMBER STATES OF THE EUROPEAN UNION

   
Table of contents

I. INTRODUCTION .................................................................................................................. 4

II.

STATISTICS ............................................................................................................... 5

II.1. General................................................................................................................................ 5

II.2. Data submitted by the Member States ................................................................................ 6

II. 3. Structure of the Report ...................................................................................................... 7

PART A: COMPILATION AND OVERVIEW OF THE DATA OF 1999 .............................. 8

III.1.

Results of EU Table 1: Species and number of animals used...................................... 8

III.2.

Results of EU Table 1: Origin of animals used ......................................................... 12

III.3.

Results of EU Table 2: Purposes of the procedures .................................................. 14

III.4.

Results of EU Table 3: Toxicological or safety evaluation for type of
products/endpoints ..................................................................................................... 20

III.5.

Results of EU Table 4: Animals used for studies of diseases .................................... 26

III.6.

III.7.

III.8.

III.9.

Results of EU Table 5: Animals used in production and quality control of products
for human medicine and dentistry and for veterinary medicine ................................ 30

Results of EU harmonized Table 6: Origin of regulatory requirements for animals
used in toxicological and other safety evaluations .................................................... 32

Results of EU Table 7: Animals used in toxicity test for toxicological or other safety
evaluations ................................................................................................................. 34

Results of EU Table 8: Type of toxicity tests carried out for toxicological or other
safety evaluations of products.................................................................................... 37

PART B: DATA AND SUMMARY OF THE COMMENTS SUBMITTED BY THE

MEMBER STATES................................................................................................... 39

BELGIUM................................................................................................................................ 39

DENMARK.............................................................................................................................. 49

GERMANY.............................................................................................................................. 59

GREECE ................................................................................................................................. 65

SPAIN...................................................................................................................................... 74

FRANCE ................................................................................................................................. 83

IRELAND................................................................................................................................. 94

ITALY ...................................................................................................................... 104

LUXEMBOURG ................................................................................................................... 114

THE NETHERLANDS ......................................................................................................... 117

2

AUSTRIA............................................................................................................................... 128

PORTUGAL.......................................................................................................................... 139

FINLAND............................................................................................................................... 148

SWEDEN .............................................................................................................................. 157

UNITED KINGDOM............................................................................................................. 167

3

I. INTRODUCTION

The  objective  of  this  report  is  to  present  to  the  Council  and  the  European  Parliament,  in
accordance  with Article  26 of  Directive  86/609/EEC  1, the statistical data on the number of
animals used for experimental and other scientific purposes in the Member States of the EU.

The first Report, COM (94) 195  final,  published in 1994,  covered data  on  animals  used  for
experimental purposes in 1991 in the Member States of the Community.

The  second  Report,  COM  (1999)  191  final,  was  published  1999  and  covered  data  from  the
Member States from 19962.

At the end of 1997, the Commission services reached an agreement with the authorities of the
Member  States  to  submit  data  on  animals  used  for  experimental  purposes  in  a  standardized
format constituted by a set of eight harmonized statistical tables. Because the data had already
been collected for 1996, only a few Member States were able to submit data in the new agreed
format for the second Report.

For the third Report, Member States agreed to submit the data from 1999, as far as possible,
in the format of the above mentioned eight harmonized statistical tables. In this report these
tables will be referred to as EU Tables.  Apart from Germany, due  to an  amendment, which
was needed in the existing federal law, fourteen Member States submitted data in accordance
with the EU Tables.

1

2

OJ L 358, 18.12.1986, p.1.
including 1997 data from France

4

                                                
II. STATISTICS

II.1. General

Each Member State is requested, pursuant to Articles 13 and 26 of Directive 86/609/EEC, to
submit to the Commission the statistical data on the animals used for experimental and other
scientific purposes. This report contains data from the year 1999.

Council Resolution 86/C331/023 allows the use of animals in experiments for education and
training, but where the purposes of such experiments are not covered by the Directive i.e. they
are not experimental or scientific in the sense of the Directive, Member States will according
to  the  Resolution  apply  national  provisions  which  are  no  less  severe  than  those  of  the
Directive. Therefore a number of Member States have also included animals covered by this
Resolution in the report.

The  aim  of  this  report  is  to  provide  a  comprehensive  overview  on  the  numbers  of  animals
used in various experimental purposes in the Community in 1999. Because  previous reports
have been compiled on the basis on non-harmonized data it was only possible to make very
limited comparison with the results of the previous reports.

The purpose of the report is not to draw conclusions or to interpret individual data submitted
by the Member States but rather to give a general picture of the situation regarding animals
used for experimental purposes at the Community level. Comments and interpretations from
the Member States can be found in the second part of the report.

The main difference with the previous reports is that the data submitted by the Member States
now covers a much wider range of procedures and purposes. This is due to the introduction of
the  harmonised  tables.  The  purposes  of  experiments  are  described  in  more  detail  including
aspects such as regulatory requirements and types of tests versus products. This allows for a
much more precise and comprehensive picture to be drawn at the EU level for the first time.

The use of the harmonised EU Tables is intended to simplify and increase the coherence and
the  subsequent  statistical  analysis.  However,  it  must  also  be  recognised  that  because  the
system is put into practice for the first time, many reporting laboratories had some difficulties
in adapting  to  the new  situation. Nevertheless,  it is expected  that  in  the  coming  years  some
shortcomings will be overcome and the system will operate on a more routinely basis.

The estimated total number of animals used for experimental and other scientific purposes in
1999 is 9,8 millions. The total number of animals reported in 19964 was 11,6 millions. Even
though it is not possible make statistically correct estimate of the reduction of the number of
animals  used  since  the  report  of  1996,  it  can  nevertheless  be  seen  that  in  1999  the  total
number has passed below the 10 millions mark, which indicates a significant reduction trend.

As  with  the  previous  results,  by  far  the  biggest  group  of  animals  was  rodents  and  rabbits.
6,6% of animals used are cold-blooded animals. The readers are invited to further examine the
distribution between the different groups of species in Chapter III.1.2.

3

4

OJ C 331, 23.12.86, p. 2
including 1997 data from France

5

                                                
II.2. Data submitted by the Member States

Before  examining  further  the  statistical  data,  it  is  necessary  to  draw  the  attention  of  the
readers to the difficulties which have arisen from the  collection of data in the format of the
eight EU Tables.

After  the  preliminary  compilation  of  the  data,  some  discrepancies  were  noted.  The
relationship between some of the tables and their totals provided a tool for a quality control.
These relationships have clearly not been understood in some cases.

The first of these relationships is the total number of animals used by species, column 1.2 of
the EU Table 1, which is broken down into purposes of experiments in EU Table 2. Thus, the
totals of the Tables 1 and 2 must be identical.

The second relationship concerns column 2.6 of EU Table 2 “animals used for toxicological
and other safety evaluation” which is broken down into type of products/endpoints, EU Table
3, into Regulatory requirements, EU Table 6, and into type of toxicological tests, EU Table 7.

A third  relationship  is  between the sum  of  column  2.4  and  2.5  of  EU  Table  2  and  with  the
total of EU Table 5.

For  the  total  number  of  animals  used  in  the  EU,  Tables  1  and  2,  it  was  decided  to  apply  a
conservative rule, namely to make the calculations on the highest number of animals reported
by species. This method allowed drawing a relative error on the total number of animals used
in the 15 Member States of no more than 0.085%. This reassuring result shows a very high
consistency of the data submitted by the Member States on the total numbers of animals used
for experimental purposes in the EU in 1999.

For the reason that “animals used for toxicological and other safety evaluation”, column 2.6
of EU Table 2, is broken down in several EU Tables addressing non comparable parameters,
it was not possible to apply the above conservative rule between EU Table 2 and Tables 3, 6
and 7. The differences in totals have been used to calculate a relative error, which amounts to
an acceptable 0.39 %. It must be born in mind, however, that the number of animals used for
toxicological  and  other  safety  evaluation  represents  only  10%  of  all  animals  used  for
experimental purposes.

The  different  values  reported  by  some  Member  States  in  the  case  of  the  third  relationship
resulted in a much higher relative error of 3.3%. Consequently it was decided not to interpret
further the data of EU Table 5.

In  conclusion,  considering  that  a  new  protocol  of  data  submission  was  applied  for  the  first
time, there is a good consistency of the data submitted by the Member States.

6

II. 3. Structure of the Report

The report is divided into two parts:

A

B

A  global  compilation  and  overview  for  the  European  Union  of  the  statistical  data
submitted by the Member States for 1999.

A consolidated Table has been  computed on the basis of the data  submitted  by  the
Member  States  for  each  EU  Table  and  is  appearing  in  the  beginning  of  each  sub-
chapter.

The data submitted by the Member States with a summary of the comments provided
by the Member States.

The reader is invited to take note that the numbering of tables and figures of Part A
of the report is linked to the numbers of the EU Tables and not to the numbering of
the chapters of the report.

7

PART A: COMPILATION AND OVERVIEW OF THE
DATA OF 1999

III.1. Results of EU Table 1: Species and number of animals used

III.1.1. The data

Fourteen  Member  States  reported  the  total  number  of  animals  used  by  species  for
experimental purposes in the format of the EU Table 1. One Member State reported data in
accordance with the format of the statistical table from the Council of Europe.

The  different  species  of  animals  used  for  experimental  purposes  or  other  safety  evaluation
reported  in  Table  1  of  the  Council  of  Europe  are  similar  to  those  of  EU  Table  1.  The
difference lies in the fact that the table of the Council of Europe presents the following four
grouped species:

–  Golden hamsters + other rodents

–  New world +old world monkeys

–  Goats and sheep

–  Quails + other birds

Table  1.1  of  this  report  presents  the  consolidated  data  on  the  number  of  animals  used  for
experimental purposes, by species, submitted by the 15 Member States of the Community.

The estimated total number of animals used in 1999 is 9,814,171.

III.1.2. Treatment and interpretation of the data

In order to include the data in the format of the Council of Europe, submitted by one Member
State, into the overall evaluation and subsequent graphical analysis of the number of animals
used  by  the  14  other  Member  States,  it  was  first  necessary  to  create  the  same  grouping  as
listed above in the data of these Member States.

In  a  second  step,  for  a  better  graphical  presentation  of  the  results  of  the  data,  species  were
grouped further into classes of animals.

Table 1.2 represents classes of animals used for experimental purposes.

Figure 1.1 shows the percentages of animals per class of animals.

8

Figure 1.1
Class of animals

Rats 26,6%

Mice 54%

Guinea-Pigs 3,00%

Other rodents 1,0 %

Rabbits 2,3%

Cold-blooded animals 
6,6%

Birds 4,7%

Artio+perissodactyla 
1,26%

Carnivores 0,36%

Prosimians+Monkeys+
Apes 0,09%

Other mamals 0,05%

Mice  and  rats  are  by  far  the  most  used  species.  Rodents  together  with  rabbits  represent  the
majority of animals with some 86,9%.

There is a significant reduction in the use of cold-blooded animals compared to the previous
report (12,9%); however, it still amounts to 6,6% of all the species used.

Artio and Perissodactyla group horses, donkeys and cross-breds (Perrisodactyla), pigs, goats,
sheep  and  cattle  (Artiodactyla).  This  group  represents  only  1,25%  of  the  total  number  of
animals used.

Carnivores represent 0,36 % of the total number of animals used and primates represent less
than 0,1% of the animals used in 1999.

Table 1.3: Comparison between results of 1996 and 1999

Number  of  animals
used
% Rodents-rabbits
% 
animals

Cold-blooded

Report 1996
11,646,130 (*)

Data of 1999
9,814,171

81,3 %
12,9 %

86,9 %
6,6 %

Comments

Clear 
trend

decreasing

50% reduction

(*) 14 countries reporting for 1996, one country reporting for 1997

9

Table 1.1: Total number of animals used for experimental purposes in the EU Member States

Data of 1999

1.a.
1.b.
1.c.
1.d.
1.e.
1.f.
1.g.
1.h.
1.i.
1.j.
1.k.

1.l.
1.m.
1.n.
1.o.
1.p.
1.q.
1.r.
1.s.
1.t.
1.u.
1.v.
1.w.
1.x.
1.y.

Species

Mice (Mus musculus)
Rats (Rattus norvegicus)
Guinea-Pigs (Cavia porcellus)
Hamsters (Mesocricetus )
Other Rodents (other Rodentia)
Rabbits (Oryctolagus cuniculus)
Cats (Felis catus)
Dogs (Canis familiaris)
Ferrets (Mustela putorius furo)
Other Carnivores (other Carnivora)
Horses,  donkeys  and  cross  breds
(Equidae)
Pigs (Sus)
Goats (Capra)
Sheep (Ovis)
Cattle (Bos)
Prosimians (Prosimia)
New World Monkeys (Ceboidea)
Old World Monkeys (Cercopithecoidea)
Apes (Hominoidea)
Other Mammals (other Mammalia)
Quail (Coturnix coturnix)
Other birds (other Aves)
Reptiles (Reptilia)
Amphibians (Amphibia)
Fish (Pisces)

B
446677
169662
37397
4074
15567
20968
104
1453
0
0

104
6511
104
1014
1141
0
21
469
0
0
915
18811
147
2143
62807

DK
163680
96864
10431
773 
537 
6543
44
143
20 
1151

85
7192
111 
140 
1476
0
0 
0 
0
11
0 
5225 
10
267
28741

D
775932
403227
42891

EL
3566
1900
240

50623
1124 
6031

632

2

376 

657
10494

6
65

1146
209

60
20

1840

4018
271 

0 
660 

21 
5915
173933 

E

F

261301 1552330
460407
134070
77021
13892
16200
674
9405
553
49836
19496
1855
1080
5203
725
190
26
169
0

6
3292
100
677
106
0
96
0
0
0
318
18709
0
255
20350

440
8897
1839
4455
3104
455
53
1814
0
272
442
86168
50
6187
22805

IRL
31251
14484
1041
133
0
915
129
312
0
0

192
844
0
1472
1862
0
0
0
0
13
0
1229
0
0
20052

I(*)
410788
500625
18474
3595
2428
19030
86
745
16
0
20

2049
64
620
542
0
62
450
0
25
226
19931
1410
2940
3645

L
3000
20
20
0
0
20
0
0
0
0

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

NL
277774
159758
10246
4661
606
9222
222
803
64
64

219
12299
334
3121
1457
0
42
272
6
45
4738
88085
34
3186
44208

A
91194
12699
7367
208
188
15056
24 
68
0 
0 

21
366
23
142
118
0 
0 
7 
0 
0
50 
1317
0
709
738

P(*)
23669
9836
1452
1182
29
730

94

3
546
138
700
365

301

267
110
79
350

FIN
89959
32519
1737
100
1663
1686
0
104
90
1650

93
1163
38
439
614
0
0
9
0
2148
62
5166
182
246
88666

S
184230
84374
9355
315
235
5031
155
412
132
75

71
3278
6
104
706
0
6
60
0
353
0
6920
10
1585
26654

UK
990162
526904
61308
10186
8662
27578
683
5938
1115
2896

519
9135
419
14462
4841
0
1073
2118
0
937
0
105931
56
9254
121285

Total
5305513
2607349
292872
42101
39873
227366
5506
22033
1653
6381

2436
66131
3176
28492
20559
726
1353
5199
6
4765
6811
357779
2030
34606
614234

sub-total

790089

323444 

9686

475726 2309597

73929

987771

3060

621466

130295

39851

228334

324067 1905462

9698950

Golden hamsters + other rodents
New world + old world monkeys
goats + sheeps
quails + other birds

1.z.

TOTAL

18020 
1813 
2596 
92792 

790089

1591394 
323444 1591394

* The highest number of animals between column 1.2 and 2.10

9686

475726 2309597

73929

987771

3060

621466

130295

39851

228334

324067 1905462

18020
1813
2596
92792

9814171
9814171

10

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Table 1.2: Classes of animals used for experimental purposes in the EU Member States

Data of 1999

Species

B

DK

D

EL

E

F

IRL

I(*)

L

NL

A

P(*)

FIN

S

UK

Total

Mice
Rats
Guinea-Pigs
Golden hamsters + other rodents
Rabbits
Cold-blooded animals (1)
birds (2)
Artio + Perissodactyla (3)
Carnivores (4)
Prosimians + monkeys + apes
Other Mammals

446677
169662
37397
19641
20968
65097
19726
8874
1557
490
0

163680
96864
10431
1310
6543
29018
5225
9004
1358
0
11

775932
403227
42891
18020
50623
179869
92792
17765
7531
2084
660 

3566
1900
240
0
632
1840
80
1426
2
0

261301
134070
13892
1227
19496
20605
19027
4181
1831
96
0

1552330
460407
77021
25605
49836
29042
86610
18735
7417
2322
272

31251
14484
1041
133
915
20052
1229
4370
441
0
13

410788
500625
18474
6023
19030
7995
20157
3295
847
512
25

3000
20
20
0
20
0
0
0
0
0
0

277774
159758
10246
5267
9222
47428
92823
17430
1153
320
45

91194
12699
7367
396
15056
1447
1367
670
92
7
0

23669
9836
1452
1211
730
539
267
1752
94
0
301

89959
32519
1737
1763
1686
89094
5228
2347
1844
9
2148

184230
84374
9355
550
5031
28249
6920
4165
774
66
353

990162
526904
61308
18848
27578
130595
105931
29376
10632
3191
937

Total

790089

323444

1591394

9686

475726

2309597

73929

987771

3060

621466

130295

39851

228334

324067

1905462

5305513
2607349
292872
99994
227366
650870
457382
123390
35573
9097
4765
9814171
9814171

Species % total

B

DK

D

EL

E

F

IRL

I

L

NL

A

P

FIN

S

UK

Mean

Mice
Rats
Guinea-Pigs
Golden hamsters + other rodents
Rabbits
Cold-blooded animals (1)
birds (2)
Artio + Perissodactyla (3)
Carnivores (4)
Prosimians + monkeys + apes
Other Mammals

56,54
21,47
4,73
2,49
2,65
8,24
2,50
1,12
0,20
0,06
0,00

50,61
29,95
3,22
0,41
2,02
8,97
1,62
2,78
0,42
0,00
0,00

2,70
1,13
3,18

48,76 36,82
25,34 19,62
2,48
0,00
6,52
11,30 19,00
0,83
5,83
1,12 14,72
0,02
0,47
0,00
0,13
0,00
0,04

54,93
28,18
2,92
0,26
4,10
4,33
4,00
0,88
0,38
0,02
0,00

67,21
19,93
3,33
1,11
2,16
1,26
3,75
0,81
0,32
0,10
0,01

42,27
19,59
1,41
0,18
1,24
27,12
1,66
5,91
0,60
0,00
0,02

41,59 98,04
0,65
50,68
0,65
1,87
0,00
0,61
0,65
1,93
0,00
0,81
0,00
2,04
0,00
0,33
0,00
0,09
0,00
0,05
0,00
0,00

44,70
25,71
1,65
0,85
1,48
7,63
14,94
2,80
0,19
0,05
0,01

69,99
9,75
5,65
0,30
11,56
1,11
1,05
0,51
0,07
0,01
0,00

59,39
24,68
3,64
3,04
1,83
1,35
0,67
4,40
0,24
0,00
0,76

39,40
14,24
0,76
0,77
0,74
39,02
2,29
1,03
0,81
0,00
0,94

56,85
26,04
2,89
0,17
1,55
8,72
2,14
1,29
0,24
0,02
0,11

51,96
27,65
3,22
0,99
1,45
6,85
5,56
1,54
0,56
0,17
0,05

54,06
26,57
2,98
1,02
2,32
6,63
4,66
1,26
0,36
0,09
0,05

Total
*
(1) 
(2) 
(3) 
(4) 

100,00

100,00

100,00 100,00

100,00

100,00

100,00

100,00 100,00

100,00

100,00

100,00

100,00

100,00

100,00

100,00

The highest number of animals between column 1.2 and 2.10 (see also table 1.1)

= Reptiles +amphibians + fish
= Quails and other birds
= Horses, donkeys and cross bred + pigs +goats and sheep + cattle
= cats + dogs + ferrets + other carnivores

11

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
III.2. Results of EU Table 1: Origin of animals used

III.2.1. The data

EU  Table  1  is  not  only  providing  the  total  number  of  animals  used  in  the  Member
States, it also requires reporting the origin of some experimental animals. EU Table 1
requires  also  that  Member  States  report  the  number  of  animals  re-used  in
experimental purposes.

The  consolidated  results  of  EU  Table  1  on  the  origin  of  some  species  used  for
experimental purposes in the 14 Member States are reported in table 1.4 of the present
report.

III.2.2. Treatment and interpretation of the data

The  data  of  column  1.3  and  1.4  of  table  1.4  of  this  report  have  been  grouped  to
represent animals coming from the Community.

Figure 1.2 represents the relative percentage of origin of animals versus the species.
(The origin must be reported only for certain species).

Figure 1.2
Origin of species
Data of 1999 

100%

80%

60%

40%

20%

0%

e
c
M

i

s
t
a
R

Other Countries
ETS123 Count
EC countries

s
e
p
A

l
i

a
u
Q

s
y
e
k
n
o
M
W
N

.

.

s
y
e
k
n
o
M
W
O

.

.

s
r
e
t
s
m
a
H

s
t
i
b
b
a
R

s
t
a
C

s
g
o
D

s
t
e
r
r
e
F

i

s
n
a
m
s
o
r
P

i

s
g
P

i

-
a
e
n
u
G

i

It  appears  that  the  majority  of  common  species  originated  from  the  Community.
However, for certain species shown on the right side of the graph there is clear shift
towards  non-European  origin.  It  is  important  to  underline  that  the  bar  for  apes
represents only 6 animals. All the other bars range between 102 to 106 animals.

12

 
 
 
 
 
 
 
 
 
 
 
Table 1.4: Number of animals used in relation to their place of origin

Data of 1999

1.1 Spieces

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.
1.b.
1.c.
1.d.
1.f.
1.g.
1.h.
1.i.
1.p.
1.q.
1.r.

1.s.
1.u.

1.z.

Mice (Mus musculus)
Rats (Rattus norvegicus)
Guinea-Pigs (Cavia porcellus)
Hamsters (Mesocricetus )
Rabbits (Oryctolagus cuniculus)
Cats (Felis catus)
Dogs (Canis familiaris)
Ferrets (Mustela putorius furo)
Prosimians (Prosimia)
New World Monkeys (Ceboidea)
Old 
World 
(Cercopithecoidea)
Apes (Hominoidea)
Quail (Coturnix coturnix)

Monkeys

TOTAL

4529581
2204122
249937
40488
176743
4382
15998
1653
455
1353
5199

6
6811

7236728

4049813
2032257
192984
33511
151164
3479
12179
1363
323
1169
2274

6
1633

300463
133002
44213
3335
21266
651
1797
0
0
46
181

0
0

6482155

504954

12353
234
7785
510
0
0
54
0
0
0
0

0
0

20936

166952
38629
4955
3132
4307
252
1968
274
132
56
2736

0
5128

228521

6610
583
2318
20
0
364
595

1

Note 1

(Note 2:
Note 3:

Column  1.5  concerns  only  those  Member  Countries  of  the  Council  of  Europe  which,  at  the
beginning of the reporting period, are Parties to the Convention ETS 123. Thus an updated list of
those countries has to be used when filling this column
Only species for which origin has to be reported are included in this table)
The number of re-used animals in column 1.7 should be excluded from the total in the column 1.2.

13

III.3. Results of EU Table 2: Purposes of the procedures

III.3.1. The data

Fourteen  Member  States  reported  the  purposes  of  the  procedures  in  the  format  of  the  EU
Table 2. One Member State reported data in accordance with the format of the statistical table
from the Council of Europe.

The consolidated results for 14 Member States are presented in table 2.1 of this report.

III.3.2. Treatment and interpretation of the data

Table  2.2  presents  the  results  of  the  consolidated  data  of  the  purposes  of  the  procedures
carried out in the 14 Member States in 1999. For the sake of a better presentation of results
some species were grouped.

Table 2.2: Number of animals used for selected purposes versus species

Species

Biological
studies of a
fundamenta
l nature

Research,
development and
quality control of
products and
devices for
human medicine
and dentistry and
for veterinary
medicine

Toxicological
and other
safety
evaluations
(including
safety
evaluation of
products)

Diagnosis of
disease

Education
and training

Other

Total

Mice

Rats
Other rodents

Rabbits
Carnivores

Artio+perissodactyla
Prosimians+monkeys+apes

Other mammals
Birds

Cold-blooded animals

1452583

567904
40631

22701
6930

45687
1279

3430
101487

215412

2347842

1265125
215796

84159
8963

34135
1796

312
165879

56186

285132

284940
51397

30104
9190

3584
3687

274
18571

82113

1.z.

TOTAL

2458044

4180193

768992

93218

4837
3618

9108
221

3573
22

0
4107

21317

140021

27719

36157
1571

3316
594

4824
4

0
1707

11300

87192

219937

4426431

24959
11897

9850
1995

13129
206

89
71472

82470

2183922
324910

159238
27893

104932
6994

4105
363223

468798

436004

8070446

The  percentage  of  the  number  of  animals  used  for  selected  purposes  is  presented  in
Figure 2.1.

14

Table 2.1: Number of animals used in experiments for selected purposes
Purposes versus species

2.1

Species

2.2 Biological
studies of a
fundamental
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

1.a.
1.b.
1.c.
1.d.
1.e.
1.f.
1.g.
1.h.
1.i.
1.j.
1.k.

1.l.
1.m.
1.n.
1.o.
1.p.
1.q.
1.r.

1.s.
1.t.
1.u.
1.v.
1.w.
1.x.
1.y.

1.z.

Mice (Mus musculus)
Rats (Rattus norvegicus)
Guinea-Pigs (Cavia porcellus)
Hamsters (Mesocricetus )
Other Rodents (other Rodentia)
Rabbits (Oryctolagus cuniculus)
Cats (Felis catus)
Dogs (Canis familiaris)
Ferrets (Mustela putorius furo)
Other Carnivores (other Carnivora)
Horses,  donkeys  and  cross  breds
(Equidae)
Pigs (Sus)
Goats (Capra)
Sheep (Ovis)
Cattle (Bos)
Prosimians (Prosimia)
New World Monkeys (Ceboidea)
Old 
World 
(Cercopithecoidea)
Apes (Hominoidea)
Other Mammals (other Mammalia)
Quail (Coturnix coturnix)
Other birds (other Aves)
Reptiles (Reptilia)
Amphibians (Amphibia)
Fish (Pisces)

Monkeys

TOTAL

1452583
567904
16639
14346
9646
22701
721
898
720
4591

534
21078
1351
15614
7110
455
355

469
0
3430
1738
99749
1925
17285
196202
2458044

1358524
866719
56837
9422
28514
42303
1545
4791
752
54

453
13462
53
4328
2850
0
410

483
6
312
0
76894
0
67
44299
2513078

685184
391208
81243
1380
15
35132
64
95
40
0

95
399
21
557
0
0
0

895
0
0
30
10809
0
0
0
1207167

15

304134
7198
31485
6900
0
6724
422
602
6
592

142
8585
0
1335
1855
0
0

2
0
0
160
77986
0
0
11820
459948

285132
284940
47427
3786
184
30104
282
8898
10
0

129
2284
3
780
388
0
568

3119
0
274
4738
13833
0
845
81268
768992

93218
4837
1604
1649
365
9108
51
42
11
117

96
1500
214
1503
260
0
0

22
0
0
0
4107
0
0
21317
140021

27719
36157
1147
154
270
3316
41
529
24
0

243
2480
220
783
1098
0
0

4
0
0
83
1624
84
8778
2438
87192

219937
24959
6950
4256
691
9850
1175
79
90
651

66
5483
1268
3450
2862
0
8

4426431
2183922
243332
41893
39685
159238
4301
15934
1653
6005

1758
55271
3130
28350
16423
455
1341

198
0
89
12
71460
0
251
82219
436004

5192
6
4105
6761
356462
2009
27226
439563
8070446

Figure 2.1
purposes of experiments 

Education and 
training 1%

Diagnosis of 
disease 2%

 Other 5%

Toxicological 
and other safety 
evaluation10%

Production and 
quality control 
veterinary 
medicine 6%

Production and 
quality control 
human medicine 
and dentistry 15%

Fundamental 
biology studies 
30%

Reaserch and 
develop human 
medicine+veteri+
dentistry 31%

More than 60 % of  animals have been used in research and development for human
medicine, veterinary medicine, dentistry and in fundamental biology studies.

Production and quality control of products and devices in human medicine, veterinary
medicine  and  dentistry  required  the  use  of  21  %  of  the  total  number  of  animals
reported in 1999.

Toxicological  and  other  safety  evaluation  represents  the  third  important  group  of
experimental purposes with 10% of animals used.

Table 2.3: Comparison between results of 1996 and 1999

in 

Purpose
Research  development  and  quality
human  medicine,
control 
veterinary medicine and dentistry
Fundamental biology studies
Toxicological and safety evaluation
* 13 Member States reported purposes of experiments

1996 Report* Data 1999 Comment

44%

52%

25%
9%

30%
10%

Status quo

16

Since the introduction  of EU  Tables has  improved  the  resolution  of  the  data  for  the
different  purposes  of  experiments  in  the  Member  States,  it  is  worth  noting  that
purpose “other” has decreased from 17% to 5%.

The  3D  figure  2.2  presents  the  number  of  animals  used  for  selected  purposes  by
species.  In  comparison  to  the  data  of  1996  a  more  detailed  graph  could  be  drawn
regarding species used. The general pattern of uses has not changed significantly for
rodents  and  rabbits  (except  for  details  by  species).  For  the  group  of  cold-blooded
animals including fish however, it is observed that this group has been more used in
fundamental biological studies than in 1996.

17

2500000

2000000

1500000

1000000

500000

0

e
c
M

i

s
t

a
R

s
t

n
e
d
o
r

r
e
h
O

t

s
t
i

b
b
a
R

s
e
r
o
v
n
r
a
C

i

l

a
y
t
c
a
d
o
s
s
i
r
e
p
+
o

i
t
r

A

Figure 2.2
Species and purposes 

s
d
r
i

B

l

s
a
m
m
a
m

r
e
h
O

t

l

s
a
m
n
a

i

l

d
e
d
o
o
b
-
d
o
C

l

Other

Education and training

Diagnosis of disease

Toxicological and other safety evaluations (including safety evaluation
of product s)

Research, development and quality control of products and devices
for  human medicine and dentistry and for veterinary medicine

Biological studies of a fundamental nature

18

s
e
p
a
+
s
y
e
k
n
o
m
+
s
n
a
m
s
o
r

i

i

P

 
 
 
III.3.3. Diagnosis of disease

Column  2.7  of  EU  Table  2  presents  a  parameter,  which  could  be  important  in  the
future in the light of new emerging epidemic in the Community. Table 2.4 shows the
number of animals used in the 14 Member States by groups of species.

Table 2.4: Classes of animals used in the diagnosis of disease

Rodents +rabbits
Carnivores
Horses,  donkeys  and  cross  bred
(Equidae)
Pigs (Sus)
Goats (Capra)
Sheep (Ovis)
Cattle (Bos)
Prosimians +primates
Birds (Aves)
Cold blooded animals

110781
221
96

1500
214
1503
260
22
4107
21317

Cold-blooded  animals  represent  15,2  %  of  the  total  number  of  animals  used  for
diagnosis of disease.

Figure 2.3
Diagnosis of disease 

7
1
3
1
2

l

d
e
d
o
o
b
-
d
o
C

l

7
0
1
4
s
d
r
i

B

2
2
s
e
t
a
m

i
r
p
+
s
n
a
m
s
o
r
P

i

i

8

9

10

120000

100000

80000

60000

40000

20000

0

1
8
7
0
1
1
s
t
i
b
b
a
R
+
s
t
n
e
d
o
R

1

1
2
2

s
e
r
o
v
n
r
a
C

i

2

5
0
1

i

s
d
u
q
E

3

0
0
5
1

s
g
P

i

4

4
1
2
s
t
a
o
G

5

3
0
5
1

p
e
e
h
S

6

0
6
2

e
l
t
t
a
C

7

19

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
III.4. Results  of  EU  Table  3:  Toxicological  or  safety  evaluation  for  type  of

products/endpoints

III.4.1. The data

Fourteen Member States reported data on animals used in toxicological or other safety
evaluation for products or other endpoints.

The  consolidated  table  of  results  on  animals  used  in  toxicological  and  other  safety
evaluation (EU Table 3) in 14 Member States is presented in table 3.1 of this report.

III.4.2. Treatment and interpretation of the data

Figure 3.1
Animals used in toxicological or other safety evaluations
products
1999 Data

f

3.7    Products/
substances used or
intended to be used
mainly as additives in
food for human
consumption
3%

3.6    Products/
substances used or
intended to be used
mainly as cosmetics
or  toiletries
0,4%

3.5   Products/
substances used or
intended to be used
mainly in the
household
0,25%

3.8    Products/
substances used or
intended to be used
mainly as additives in
food for animal
consumption
0,4%

3.9   Potential  or
actual contaminents in
the general
environment which do
not appear in other
columns
7%

3.10    Other
toxicological or safety
evaluations
16%

3.2    Products/
substances or devices
for humanmedicine
and dentistry and for
veterinary medicine
54%

3.4   Products/
substances used or
intended to be used
mainly in industry
11%

3.3     Products/
substances used or
intended to be used
mainly in agriculture
8%

For the first time the statistical report can give a representative outlook of the number
of  animals  used  in  toxicological  or  other  safety  evaluation  experiments  in  the  14
Member  States  when  broken  down  into  type  of  products  for  which  the  tests  were
required.

20

It  must  first  be  remembered  that  animals  used  for  toxicological  and  other  safety
evaluation represent only 10% of the total number of  animals used for  experimental
purposes.

The  number  of  animals  used  for  toxicological  evaluation  of  products/substances  for
animal  feed,  for  additives  for  human  food  consumption,  for  cosmetics  and  for
household are very small (4%) when compared to the other products or endpoints.

Products  or  devices  used  for  human  medicine,  veterinary  medicine  and  dentistry
occupy 54% of the chart surface.

The group of products/substances falling under the scrutiny of  authorities concerned
with safety of health and of the environment by chemical products, such as industrial
chemicals and pesticides, is responsible for the use of 19 % of animals.

Another important group is the “other” toxicological evaluations (16%).

21

Table 3.1: Number of animals used in toxicological and other safety evaluation
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
contaminents
in the general
environment
which do not
appear in other
columns

3.10 Other
toxicological or
safety
evaluations

3.11 Total

1.a.
1.b.
1.c.
1.d.
1.e.
1.f.
1.g.
1.h.
1.i.
1.j.
1.k.

1.l.
1.m.
1.n.
1.o.
1.p.
1.q.
1.r.

1.s.
1.t.
1.u.
1.v.
1.w.
1.x.
1.y.

1.z.

Mice (Mus musculus)
Rats (Rattus norvegicus)
Guinea-Pigs (Cavia porcellus)
Hamsters (Mesocricetus )
Other Rodents (other Rodentia)
Rabbits (Oryctolagus cuniculus)
Cats (Felis catus)
Dogs (Canis familiaris)
Ferrets (Mustela putorius furo)
Other Carnivores (other Carnivora)
Horses,  donkeys  and  cross  breds
(Equidae)
Pigs (Sus)
Goats (Capra)
Sheep (Ovis)
Cattle (Bos)
Prosimians (Prosimia)
New World Monkeys (Ceboidea)
Old 
World 
(Cercopithecoidea)
Apes (Hominoidea)
Other Mammals (other Mammalia)
Quail (Coturnix coturnix)
Other birds (other Aves)
Reptiles (Reptilia)
Amphibians (Amphibia)
Fish (Pisces)

Monkeys

TOTAL

178484
181155
22953
2588
0
21175
274
8373
10
10

129
2165
4
613
319
0
496

3078
0
0
0
8150
0
0
3702
433678

4360
29470
5120
871
0
1504
0
357
0
0

0
48
23
97
57
0
0

0
0
270
4738
5788
0
0
8274
60977

931
563
39
0
0
438
0
0
0
0

0
0
0
0
0
0
0

0
0
0
0
0
0
0
70
2041

10677
45040
15351
0
0
5520
0
3
0
0

0
0
0
0
0
0
0

10
0
0
0
0
0
0
9991
86592

22

1621
237
27
0
0
1447
0
0
0
0

0
0
0
0
0
0
0

0
0
0
0
0
0
0
15
3347

14758
5779
120
115
0
57
0
0
0
0

0
0
0
0
6
0
0

0
0
0
0
0
0
0
30
20865

486
942
30
0
26
0
0
0
0
0

0
0
0
0
5
0
0

0
0
0
0
0
0
0
1820
3309

1782
2161
74
0
158
203
0
0
0
0

0
14
0
24
0
0
0

0
0
4
0
0
0
845
52047
57312

91728
25773
4270
212
0
1037
16
165
0
0

0
120
0
46
4
0
72

30
0
0
0
112
0
0
5862
129447

305587
292597
48422
3786
184
31573
290
8898
10
10

129
2347
27
780
391
0
568

3119
0
274
4738
14050
0
845
82163
800788

III.4.3

Species versus type of products

For convenience of presentation, some products of EU Table 3 have been grouped as
well as some species in table 3.2 of this report.

The 3D Figure 3.2 shows the number of animals used per class of animals versus the
type of products/endpoints.

An  interesting  feature  of  the  “potential  or  actual  contaminants  in  the  general
environment”  is  a  characteristic  tendency  towards  the  use  of  environmental
representative species such as the fish and amphibians.

23

Table 3.2: Number of animals used in toxicological and other safety evaluation of products

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

3.5-3.8
Products/substances
used for additives in
animal feed and
food for human
consumption, in
cosmetics and
toiletries and in the
household

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

Mice
Rats
Other rodents
Rabbits
Carnivores
Artio + perisodactyla
Prosimians+monkeys+apes
Other mammals
Birds
cold-blooded animals

1.z.

TOTAL

178484
181155
25541
21175
8667
3230
3574
0
8150
3702

433678

4360
29470
5991
1504
357
225
0
270
10526
8274

60977

10677
45040
15351
5520
3
0
10
0
0
9991

86592

17796
7521
357
1942
0
11
0
0
0
1935

29562

1782
2161
232
203
0
38
0
4
0
52892

57312

91728
25773
4482
1037
181
170
102
0
112
5862

129447

305587
292597
52392
31573
9208
3674
3687
274
18788
83008

800788

24

e
c
M

i

s
t
a
R

s
i
t
i

b
b
a
R

i

s
r
o
v
n
r
a
C

s
t
n
e
d
o
r

r
e
h
O

t

l

a
y
t
c
a
d
o
s
i
r
e
p
+
o
i
t
r

A

F ig u r e  3 .2
S p e c ie s  v e rs u s  ty p e  o f p ro d u c ts /e n d p o in ts  

2 0 0 0 0 0

1 5 0 0 0 0

1 0 0 0 0 0

5 0 0 0 0

0

3 .3      P ro d u c t s /
s u b s t a n c e s  u s e d
o r in t e n d e d  t o  b e
u s e d  m a in ly in
a g ric u lt u re

3 .4    P ro d u c t s /
s u b s t a n c e s  u s e d
o r in t e n d e d  t o  b e
u s e d  m a in ly in
in d u s t ry

3 .5 -3 .8   
P ro d u c t s / s u b s t a n
c e s  u s e d  f o r
a d d it iv e s  in  a n im a l
f e e d  a n d  f o o d  f o r
h u m a n
c o n s u m p t io n , in  
c o m e t ic s  a n d
t o ile t re ie s  a n d  in
t h e  h o u s e h o ld

3 .10     O t h e r 
t o xic o lo g ic a l o r
s a f e t y e v a lu a t io n s

3 .9    P o t e n t ia l  o r
a c t u a l
c o n t a m in e n t s  in
t h e  g e n e ra l
e n v iro n m e n t  wh ic h
d o  n o t  a p p e a r in
o t h e r c o lu m n s

s
d
r
i

B

l

s
a
m
m
a
m

r
e
h
t
O

s
e
p
a
+
s
y
e
k
n
o
m
+
s
n
a
m
s
o
r

i

i

i

l

s 3 .2     P ro d u c t s /
s u b s t a n c e s  o r
a
m
d e v ic e s  f o r h u m a n
m e d ic in e  a n d
n
a
d e n t is t ry a n d  f o r
d
v e t e rin a ry m e d ic in e
e
d
o
o
b
-
d
o
c

l

l

P

25

 
 
 
 
 
 
 
III.5. Results of EU Table 4: Animals used for studies of diseases

III.5.1. The data

Fourteen  Member  States  reported  data  on  animals  used  in  procedures  for  studies  of  human
and animal diseases compared to nine in 1996-1997.

The consolidated table of results (EU Table 4) for 14 Member States is presented in table 4.1
of this report.

III.5.2. Treatment and interpretation of the data

Figure 4.1 presents the relative percentage of animals used in studies per type of diseases.

The number of animals used for studies of diseases represents 50,4% of the total number of
animals used for experimental purposes.

In 1999 the pattern of uses is similar to that observed in 1996 except for a decrease of animals
used for studying human cancer.

Figure 4.1
Number of animals used in studies of diseases
Data of 1999

Specific animal 
diseases
10%

Human 
Cardiovascular 
diseases
6%

Other human 
diseases
50%

Human nervous 
and mental 
disorder
23%

Human cancer 
(excl. evaluation 
of carcino 
hazards)
11%

26

Table 4.1: Number of animals used in experiments for studies on human and animal diseases

Main category versus species

4.1

Species

Mice (Mus musculus)
Rats (Rattus norvegicus)
Guinea-Pigs (Cavia porcellus)
Hamsters (Mesocricetus )
Other Rodents (other Rodentia)
Rabbits (Oryctolagus cuniculus)
Cats (Felis catus)
Dogs (Canis familiaris)
Ferrets (Mustela putorius furo)
Other Carnivores (other Carnivora)
Horses,  donkeys  and  cross  breds
(Equidae)
Pigs (Sus)
Goats (Capra)
Sheep (Ovis)
Cattle (Bos)
Prosimians (Prosimia)
New World Monkeys (Ceboidea)
Old 
World 
(Cercopithecoidea)
Apes (Hominoidea)
Other Mammals (other Mammalia)
Quail (Coturnix coturnix)
Other birds (other Aves)
Reptiles (Reptilia)
Amphibians (Amphibia)
Fish (Pisces)

Monkeys

TOTAL

1.a.
1.b.
1.c.
1.d.
1.e.
1.f.
1.g.
1.h.
1.i.
1.j.
1.k.

1.l.
1.m.
1.n.
1.o.
1.p.
1.q.
1.r.

1.s.
1.t.
1.u.
1.v.
1.w.
1.x.
1.y.

1.z.

4.2 Human
cardiovascular
diseases

4.3Human nervous
and mental
disorders

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

4.5Other human
diseases

4.6Studies specific to
animal diseases

4.7Total

125795
140217
7507
3226
744
14037
83
2085
159
0

16
4485
133
614
147
0
37

84
0
68
0
2053
0
550
153
302193

483527
50931
1324
424
0
1583
3
158
12
0

0
125
3
48
0
0
5

176
0
0
0
211
0
500
0
539030

557955
528076
10683
2281
26761
1610
401
192
611
28

0
283
0
525
0
0
274

469
0
22
160
8322
24
436
935
1140048

27

1619102
591762
75658
14268
7779
34847
433
6039
705
2999

588
9518
970
15405
3665
455
922

2528
6
764
270
33738
242
9018
57996
2489677

176115
12545
5818
6445
1005
5803
1640
1352
23
322

434
13393
90
6666
5639
0
0

0
0
144
0
148908
114
250
89612
476318

2962494
1323531
100990
26644
36289
57880
2560
9826
1510
3349

1038
27804
1196
23258
9451
455
1238

3257
6
998
430
193232
380
10754
148696
4947266

Table 4.2: Animals used in studies of diseases by classes of animals

Species

Human
Cardiovascular
diseases

Mice
Rats
Guinea-Pigs
Other rodents
Rabbits
Carnivores
Artio+Perissodactyla
Primates
Other Mammals
Birds
Cold-blooded animals

TOTAL

125795
140217
7507
3970
14037
2327
5395
121
68
2053
703
302193

Species %

Human
Cardiovascular
diseases

Mice
Rats
Guinea-Pigs
Other rodents
Rabbits
Carnivores
Artio+perissodactyla
Primates
Other Mammals
Birds
Cold-blooded animals

4,25
10,59
7,43
6,31
24,25
13,49
8,60
2,44
6,81
1,06
0,44

Human nervous
and mental disorder
557955
528076
10683
29042
1610
1232
808
743
22
8482
1395
1140048

Human nervous
and mental disorder
18,83
39,90
10,58
46,15
2,78
7,14
1,29
14,99
2,20
4,38
0,87

28

Human cancer
(excl. evaluation
of carcino
hazards)

Other human
diseases

Specific animal
diseases

483527
50931
1324
424
1583
173
176
181
0
211
500
539030

1619102
591762
75658
22047
34847
10176
30146
3911
764
34008
67256
2489677

176115
12545
5818
7450
5803
3337
26222
0
144
148908
89976
476318

Total
2962494
1323531
100990
62933
57880
17245
62747
4956
998
193662
159830
4947266

Human cancer
(excl. evaluation
of carcino
hazards)

Other human
diseases

Specific animal
diseases

Total

16,32
3,85
1,31
0,67
2,73
1,00
0,28
3,65
0,00
0,11
0,31

54,65
44,71
74,92
35,03
60,21
59,01
48,04
78,91
76,55
17,56
42,08

5,94
0,95
5,76
11,84
10,03
19,35
41,79
0,00
14,43
76,89
56,29

100,00
100,00
100,00
100,00
100,00
100,00
100,00
100,00
100,00
100,00
100,00

Species of Table 4.1 were grouped by classes of animals to give table 4.2. The relative
percentage  of  species/animal  groups  used  in  studies  per  type  of  diseases  has  been
calculated and is also presented in the lower part of table 4.2.

Figure 4.2
Species of animals used for studies of diseases
Data of 1999 

100%

80%

60%

40%

20%

0%

e
c
M

i

s
t
a
R

i

s
g
P
-
a
e
n
u
G

i

s
t
i
b
b
a
R

s
e
r
o
v
n
r
a
C

i

s
t
n
e
d
o
r

r
e
h
t
O

l

a
y
t
c
a
d
o
s
s
i
r
e
p
+
o
i
t
r

A

Specific animal
diseases  

Other human
diseases 

Human cancer
(excl. evaluation of
carcino hazards) 
Human nervous
and mental disorder 

Human
Cardiovascular
diseases

l

d
e
d
o
o
b
-
d
o
C

l

s
d
r
i

B

l

s
a
m
m
a
M

r
e
h
t
O

s
e
t
a
m

i
r

P

The  top  of  the  stack  shows  the  relative  percentage  of  animals  used  for  studies  on
animal  diseases.  Two  groups  of  animals  i.e.  birds  and  cold-blooded  animals  are
significant. It was reported at the National experts meeting that a lot of vaccines  are
tested on these groups of animals.

29

 
 
 
 
 
 
 
 
 
III.6. Results of EU Table 5: Animals used in production and quality control of

products for human medicine and dentistry and for veterinary medicine

III.6.1. The data

Fourteen  Member  States  reported  data  on  animals  used  in  production  and  quality
control of products for human medicine and dentistry and veterinary medicine.

The number of animals used in production and quality control of products for human
medicine  and  dentistry  and  for  veterinary  medicine  represents  14%  of  the  total
number of animals used for experimental purposes.

The consolidated table for the 14 Member States reporting these data (EU Table 5) is
presented in table 5.1 of this report.

Owing to variations in the data submitted by some Member States, the data of table
5.1 will not be interpreted further.

30

Table 5.1: Number of animals used in the production and quality control of products and devices for human
medicine and dentistry and for veterinary medicine

1.a.
1.b.
1.c.
1.d.
1.e.
1.f.
1.g.
1.h.
1.i.
1.j.
1.k.

1.l.
1.m.
1.n.
1.o.
1.p.
1.q.
1.r.

1.s.
1.t.
1.u.
1.v.
1.w.
1.x.
1.y.
1.z.
Examples:

5.1

Species

Mice (Mus musculus)
Rats (Rattus norvegicus)
Guinea-Pigs (Cavia porcellus)
Hamsters (Mesocricetus )
Other Rodents (other Rodentia)
Rabbits (Oryctolagus cuniculus)
Cats (Felis catus)
Dogs (Canis familiaris)
Ferrets (Mustela putorius furo)
Other Carnivores (other Carnivora)
Horses,  donkeys  and  cross  breds
(Equidae)
Pigs (Sus)
Goats (Capra)
Sheep (Ovis)
Cattle (Bos)
Prosimians (Prosimia)
New World Monkeys (Ceboidea)
Old 
World 
(Cercopithecoidea)
Apes (Hominoidea)
Other Mammals (other Mammalia)
Quail (Coturnix coturnix)
Other birds (other Aves)
Reptiles (Reptilia)
Amphibians (Amphibia)
Fish (Pisces)
TOTAL

Monkeys

Regulatory requirements versus species

5.2 National
legislation specific
to a single EC
Member State1)

5.3 EC legislation
including European
Pharmacopoeia
(requirements)

5.4 Member
Country of Council
of Europe (but not
EC) legislation2)

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

34884
5243
10460
1249
15
1193
68
0
0
0

70
605
2
292
283
0
0

0
0
0
160
1140
0
70
0
55734

478819
14758
50807
6330
0
28251
427
508
0
582

122
3072
0
832
1077
0
0

519
0
0
30
70492
0
0
2850
659476

27
150
39
376
0
224
0
0
0
0

0
5
0
0
55
0
0

0
0
0
0
48
0
0
4690
5614

24506
4874
4512
21
0
487
16
0
0
0

0
0
0
0
0
0
0

12
0
0
0
1248
0
0
0
35676

380716
81349
43998
198
0
15884
25
76
30
0

7
1885
16
517
281
0
0

276
0
0
0
8747
0
0
4280
538285

69798
18277
2649
189
0
5438
11
180
104
10

102
3217
1
464
184
0
35

37
0
0
0
4198
0
0
0
104894

988750
124651
112465
8363
15
51477
547
764
134
592

301
8784
19
2105
1880
0
35

844
0
0
190
85873
0
70
11820
1399679

5.2 - France is testing due to a UK (or FR) specific requirement
5.3 - UK is testing according to EC legislation

Note:

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

5.4 - Spain is testing due to a Hungarian requirement

Example:

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

5.5 - Sweden is testing due to a US specific requirement

ISO protocol must be coded as a national (FR) legislative requirement 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.

31

III.7. Results of EU harmonized Table 6: Origin of regulatory requirements for animals used

in toxicological and other safety evaluations

III.7.1. The data

Fourteen Member States reported data on the origin of regulatory requirements for animals used in
toxicological and other safety evaluations.

The consolidated table for the 14 Member States reporting these data (EU Table 6) is presented in
table 6.1 of this report.

III.7.2. Treatment and interpretation of the data

Figure 6.1

Percentage of animals used versus regulatory requirements for toxicological or
other safety evaluations

0,0

10,0 20,0 30,0 40,0 50,0 60,0

6.2     National legislation specific to a single EC
Member State1

6,4

6.3     EC legislation (including European
Pharmacopoeia requirements)

16,4

6.4     Member Country of Council of Europe (but not
EC) legislation2

2,4

6.5    Other legislation

6,1

6.6      Any combination of 6.2/ 6.3/ 6.4 /6.5

53,7

 6.7       No regulatory requirements

15,0

It  is  observed  that  sum  of  percentages  of  individual  requirements  such  as  in  columns  6.2  to  6.5
represent a much lower number of animals used (31,3%) than for combined requirements (53,7%).

32

Table 6.1: Number of animals used in toxicological and other safety evaluations

Regulatory requirements versus species

6.1

Species

Mice (Mus musculus)
Rats (Rattus norvegicus)
Guinea-Pigs (Cavia porcellus)
Hamsters (Mesocricetus )
Other Rodents (other Rodentia)
Rabbits (Oryctolagus cuniculus)
Cats (Felis catus)
Dogs (Canis familiaris)
Ferrets (Mustela putorius furo)
Other Carnivores (other Carnivora)
Horses, donkeys and cross breds (Equidae)
Pigs (Sus)
Goats (Capra)
Sheep (Ovis)
Cattle (Bos)
Prosimians (Prosimia)
New World Monkeys (Ceboidea)
Old World Monkeys (Cercopithecoidea)
Apes (Hominoidea)
Other Mammals (other Mammalia)
Quail (Coturnix coturnix)
Other birds (other Aves)
Reptiles (Reptilia)
Amphibians (Amphibia)
Fish (Pisces)
TOTAL

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

6.2 National
legislation specific to
a single EC Member
State1)

6.3 EC legislation
including
European
Pharmacopoeia
(requirements)

6.4 Member Country of
Council of Europe (but not
EC) legislation2)

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

13840
9629
5098
247
0
1799
17
119
0
0
0
190
0
45
57
0
0
0
0
0
0
717
0
0
16892
48650

64353
30571
8410
26
0
6098
40
437
0
0
126
508
0
279
256
0
5
299
0
0
0
4348
0
0
9442
125198

2049
8550
662
500
0
894
0
1284
0
0
0
18
0
0
4
0
192
605
0
0
0
162
0
0
3120
18040

13467
18462
4196
0
0
4626
0
92
0
0
0
14
0
0
0
0
0
41
0
0
0
150
0
0
5814
46862

137089
190880
26421
2767
32
16438
229
6678
10
0
3
1198
3
348
67
0
358
2083
0
0
4738
5077
0
0
15234
409653

51000
25287
3618
246
158
576
1
256
0
0
0
356
0
100
7
0
13
91
0
274
0
369
0
845
31661
114858

281798
283379
48405
3786
190
30431
287
8866
10
0
129
2284
3
772
391
0
568
3119
0
274
4738
10823
0
845
82163
763261

Examples:

6.2 - France is testing due to a UK (or FR) specific requirement
6.3 - UK is testing according to EC legislation

6.4 - Spain is testing due to a Hungarian requirement

6.5 - Sweden is testing due to a US specific requirement

6.6 - Germany is testing due to a Czech requirement (also an EC requirement)

Note:

Example:

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

a  test  required  by  French  legislation  and  carried  out  in  Belgium  according  to
anISO protocol must be coded as a national (FR) legislative requirement and be
entered into column 6.2 in the tables submitted by Belgium.

33

III.8. Results  of  EU  Table  7:  Animals  used  in  toxicity  test  for  toxicological  or  other  safety

evaluations

III.8.1. The data

Fourteen  Member  States  reported  data  on  animals  used  in  toxicity  tests  for  the  purpose  of
toxicological or other safety evaluations of products.

The consolidated table for the 14 Member States reporting animals used in different toxicity tests
(EU Table 7) is presented in table 7.1 of this report.

III.8.2. Treatment and interpretation of the data

For the convenience of the presentation of results some of the toxicity tests of table 7.1 have been
grouped in table 7.2 of this report. A 3D chart showing the percentage of animals used per toxicity
test groups is presented in figure 7.1.

Acute and sub-acute toxicity tests on experimental animals are the most  widely used  tests (38%).
With  the  addition  of  sub-chronic  and  chronic  toxicity,  the  short  and  long  term  classical  toxicity
testing accounts for the use of more than half of the experimental animals in 1999 for toxicological
and other safety evaluations (52 %).

Systemic  effects,  special  effects  (carcinogenicity,  mutagenicity)  and  toxicity  to  reproduction
represent approximately half of the above percentages of classical toxicity.

Environmental toxicity represents a low percentage.

Finally, the 19,5 % for “other tests” where no further indication is given.

34

Table 7.1: Number of animals used in toxicological and other safety evaluations

Type of tests versus species

7.1. Spieces

1.a.
1.b.
1.c.
1.d.
1.e.
1.f.
1.g.
1.h.
1.i.
1.j.
1.k.

1.l.
1.m.
1.n.
1.o.
1.p.
1.q.
1.r.

1.s.
1.t.
1.u.
1.v.
1.w.
1.x.
1.y.
1.z.

Mice (Mus musculus)
Rats (Rattus norvegicus)
Guinea-Pigs (Cavia porcellus)
Hamsters (Mesocricetus )
Other Rodents (other Rodentia)
Rabbits (Oryctolagus cuniculus)
Cats (Felis catus)
Dogs (Canis familiaris)
Ferrets (Mustela putorius furo)
Other Carnivores (other Carnivora)
Horses,  donkeys  and  cross  breds
(Equidae)
Pigs (Sus)
Goats (Capra)
Sheep (Ovis)
Cattle (Bos)
Prosimians (Prosimia)
New World Monkeys (Ceboidea)
Old 
World 
(Cercopithecoidea)
Apes (Hominoidea)
Other Mammals (other Mammalia)
Quail (Coturnix coturnix)
Other birds (other Aves)
Reptiles (Reptilia)
Amphibians (Amphibia)
Fish (Pisces)
TOTAL

Monkeys

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

7.2.2 Other
lethal
methods

7.2.3 Non
lethal clinical
signs
methods

7.2.1. LD50,
LC50

16992
11910
60
0
0
6
0
0
0
0

0
0
0
0
0
0
0

0
0
270
1566
521
0
0
20636
51961

63444
18533
812
0
26
127
0
19
0
0

0
185
0
0
0
0
0

8
0
0
104
4
0
0
12744
96137

55215
64353
7278
588
0
4209
40
3500
0
6

83
442
0
133
162
0
233

1157
0
0
114
4395
0
50
8962
151173

7.3 Skin
irritation

7.4 Skin
sensitisati
on

7.5 Eye
irritation

7.6 Sub-
chronic and
chronic
toxicity

7.7 Carcino-
genicity

7.8
Develop-
mental
toxicity

7.9 Muta-
genicity

7.10
Repro-
ductive
toxicity

7.11 Toxicity
to aquatic
vertebrates
not included in
other columns

7.12
Other

7.13 Total

0
0
0
31
0
4331
0
0
0
0

0
0
0
0
0
0
0

0
0
0
0
0
0
0
0
4371

39255
46180
2572
515
0
1650
184
4085
0
0

22
533
0
72
61
0
195

1567
0
0
120
2545
0
0
7273
107505

11931
10267
0
1029
0
0
0
0
0
0

0
0
0
0
0
0
0

0
0
0
50
0
0
0
0
23277

2128
14459
0
0
0
5251
0
0
0
0

0
39
0
0
0
0
0

0
0
0
4358
2790
0
0
8410
37435

14917
9449
0
20
0
0
0
0
0
0

0
0
0
0
0
0
0

0
0
0
0
0
0
0
0
24386

3180
64331
0
0
0
4237
0
0
0
0

0
0
0
41
0
0
0

0
0
0
360
0
0
0
10471
83140

42
0
0
0
0
0
0
0
0
0

0
0
0
0
0
0
0

77884
45231
5958
1583
158
4525
63
1212
10
0

18
1073
23
492
162
0
140

427
0
0
0
522
0
0
0
1657
0
0
0
795
0
4085
10201
4222 152764

288994
286628
48401
3786
184
31512
287
8970
10
6

123
2284
23
758
385
0
568

3159
0
792
6672
11912
0
845
83247
781866

3006
80
31225
0
0
385
0
0
0
0

0
0
0
20
0
0
0

0
0
0
0
0
0
0
0
34716

20
1064
496
20
0
6723
0
118
0
0

0
12
0
0
0
0
0

0
0
0
0
0
0
0
0
8459

35

 
 
 
 
 
 
 
 
 
 
 
 
Table 7.2: Grouping of certain type of tests on animals of table 7.1

7.1. Spieces

Acute and sub-
acute toxicity
(including limit
tests)

irritation/sensitization

Sub-
chronic and
chronic
toxicity

Muta and
carcinogenicity

 Repro-
ductive and
develop.
toxicity

Toxicity to
aquatic
vertebrates
not included
in other
columns

 Other

 Total

1.a.
1.b.
1.c.
1.d.
1.e.
1.f.
1.g.
1.h.
1.i.
1.j.
1.k.

1.l.
1.m.
1.n.
1.o.
1.p.
1.q.
1.r.

1.s.
1.t.
1.u.
1.v.
1.w.
1.x.
1.y.

1.z.

Mice (Mus musculus)
Rats (Rattus norvegicus)
Guinea-Pigs (Cavia porcellus)
Hamsters (Mesocricetus )
Other Rodents (other Rodentia)
Rabbits (Oryctolagus cuniculus)
Cats (Felis catus)
Dogs (Canis familiaris)
Ferrets (Mustela putorius furo)
Other Carnivores (other Carnivora)
Horses,  donkeys  and  cross  breds
(Equidae)
Pigs (Sus)
Goats (Capra)
Sheep (Ovis)
Cattle (Bos)
Prosimians (Prosimia)
New World Monkeys (Ceboidea)
Old 
World 
(Cercopithecoidea)
Apes (Hominoidea)
Other Mammals (other Mammalia)
Quail (Coturnix coturnix)
Other birds (other Aves)
Reptiles (Reptilia)
Amphibians (Amphibia)
Fish (Pisces)

Monkeys

TOTAL

135651
94796
8150
588
26
4342
40
3519
0
6

83
627
0
133
162
0
233

1165
0
270
1784
4920
0
50
42342
299271

3026
1144
31721
51
0
11439
0
118
0
0

0
12
0
20
0
0
0

39255
46180
2572
515
0
1650
184
4085
0
0

22
533
0
72
61
0
195

26848
19716
0
1049
0
0
0
0
0
0

0
0
0
0
0
0
0

5308
78790
0
0
0
9488
0
0
0
0

0
39
0
41
0
0
0

42
0
0
0
0
0
0
0
0
0

0
0
0
0
0
0
0

77884
45231
5958
1583
158
4525
63
1212
10
0

18
1073
23
492
162
0
140

0
0
0
0
0
0
0
0
47546

1567
0
0
120
2545
0
0
7273
107505

0
0
0
50
0
0
0
0
47663

0
0
0
4718
2790
0
0
18881
120575

0
0
0
0
0
0
0
4085
4222

427
0
522
0
1657
0
795
10201
152764

288994
286628
48401
3786
184
31512
287
8970
10
6

123
2284
23
758
385
0
568

3159
0
792
6672
11912
0
845
83247
781866

36

III.9. Results  of  EU  Table  8:  Type  of  toxicity  tests  carried  out  for

toxicological or other safety evaluations of products

III.9.1. The data

The  consolidated  table  for  the  type  of  toxicity  tests  carried  out  for  toxicological  or
other safety evaluations of products, for the 14 Member States reporting (EU Table 8)
is presented in table 8.1 of this report.

III.9.2. Treatment and interpretation of the data

Owing to variations in data reported it was decided not to interpret results further.

37

Table 8.1: Number of animals used in toxicological and other safety evaluations

Type of tests versus products

8.1. Products

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

8.2.2 Other
lethal
methods

8.2.3 Non
lethal clinical
signs
methods

8.2.1. LD50,
LC50

8.3 Skin
irritation

8.4 Skin
sensitisation

8.5 Eye
irritation

8.6 Sub-
chronic and
chronic
toxicity

8.7
Carcino-
genicity

8.8 Develop-
mental toxicity

8.9 Muta-
genicity

8.10 Repro-
ductive
toxicity

8.11 Toxicity
to aquatic
vertebrates
not included in
other columns

8.12
Other

8.13 Total

for 

8.a.  Products/  substances  or
devices  for  human  medicine  and
dentistry  and 
veterinary
medicine
8.b.  Products/  substances  used
or  intended  to  be  used  mainly  in
agriculture
8.c. Products/ substances used or
intended  to  be  used  mainly  in
industry
8.d.  Products/  substances  used
or  intended  to  be  used  mainly  in
the household
8.e.  Products/  substances  used
or  intended  to  be  used mainly  as
cosmetics or toiletries
8.f. Products/ substances used or
intended  to  be  used  mainly  as
additives 
for  human
food 
in 
consumption
8.g.  Products/  substances  used
or  intended  to  be  used mainly  as
for  animal
food 
in 
additives 
consumption
or 
actual
Potential 
8.h. 
contaminants 
the  general
in 
environment which do not appear
in other columns

8.i.  Other  toxicological  or  safety
evaluations
8.j. TOTAL

11115

22418

111669

1857

9682

1556

87409

20158

15424

15564

40599

0 104855

442306

7431

5156

10641

605

5472

570

2968

2173

7590

1001

14401

326

7666

66000

8432

9764

16216

4295

16498

1359

3545

52

2940

4535

14113

15

4951

86715

0

0

360

417

0

9

1667

267

66

897

313

534

0

0

0

0

367

4341

1222

103

352

81

1527

839

0

0

51

0

0

0

0

408

0

570

0

0

0

55

0

410

85

341

1212

15

108

4902

237

197

0

1291

10557

0

0

0

600

1059

16342

19924

19709

477

1412

329

10447

4000

7352

2008

10971

3449

8458

104878

8510
47214

41455
82143

5010
136474

218
7963

2399
33304

117
3897

4791
100945

897
20887

3557
33585

2582
22664

2323
79476

0

14836
3890 135894

86695
708336

38

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

BELGIUM

Comments of Belgian authorities

Statistical data submitted

The statistical data have been submitted by the “Ministère des Classes Moyennes et de l’Agriculture”
(Ministry of Small Enterprises and Agriculture).

General comments

1.

2.

The  legal  basis  for  the  collection  of  statistical  data  in  Belgium  is  the  royal  decree  of  14
November  1993  which  states  that  all  laboratories  must  send  each  year  to  the  Veterinary
services their statistical data on the use of animals.

Statistical data of 1999 were, for the first time, collected on the standardised set of statistical
tables of the European Union. Prior to collection guidelines were dispatched to all laboratory
directors. The purpose was to precise the way of recording  re-used  animals  in  the  tables  as
well  as  to  explain  the  links  between  the  different  tables.  All  the  laboratories  in  activity  in
1999 have sent their statistical data.

Specific comments

1.

2.

2.1.

2.2.

2.3.

2.4.

2.5.

It is noteworthy that the total number of animals used in research or other scientific purposes,
when it is compared with the figure of 1996, has been reduced in 1999 in Belgium by 47,87
%.

More  precisely  comparison  of  data  of  1999  with  the  figures  of  1998  shows  the  following
trends:

Rodents  and  rabbits  still  represent  the  most  used  group  of  animals  used  and  mainly  for
“research  -development  and  quality  control  of  products  and  devices  for  human  medicine,
veterinary medicine and dentistry “.

The  second  group  is  represented  by  the  cold-blooded  animals  in  fundamental  research,
environmental toxicity evaluation and in food research.

The total number of animals used in 1999 (790,089 animals) decreased by 5.6 % when it is
compared with the figure of 1998 (837,560 animals).

The number of rodents and rabbits increased by 2.11 %.

The use of  sensitive  carnivores shows  a  regular  reduction:  the number used  in  experiments
has been reduced by 20.8 % for dogs and by 40.9 % for cats.

39

2.6.

2.7.

2.8.

2.9.

The  number  of  pigs  is  increased  by  7.1  %  but  other  farm  animals  were  less  used  (sheep:  -
15.7 %, goats: - 7.1 %, cattle: - 4.9 %, horses and donkeys: - 11.1 %).

The number of primates is reduced by 41.7 %.

The number of birds decreased by 64.2 %.

As far as cold-blooded animals are concerned 28.2 % less have been used in 1999.

As a conclusion we can notice that two strong trends in the use of animals in experiments in Belgium
are shown. The first one is a confirmed decrease of use of dogs and cats and the second trend is the
reduction of use of primates. The latter reduction is due to less primates being used  for some safety
evaluation of pharmacological products.

40

TABLE 1:

NUMBER OF ANIMALS USED IN RELATION TO THEIR PLACE OF ORIGIN

1.1
Species

Origin versus species

1.2
Total

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

1.4
Animals coming from
elsewhere in the EC

1.6
Animals coming from
other origins

1.7
Re-used animals

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

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

Mice (Mus musculus)
Rats (Rattus norvegicus)
Guinea-Pigs (Cavia porcellus)
Hamsters (Mesocricetus )
Other Rodents (other Rodentia)
Rabbits (Oryctolagus cuniculus)
Cats (Felis catus)
Dogs (Canis familiaris)
Ferrets (Mustela putorius furo)
Other Carnivores (other Carnivora)
Horses, donkeys and cross breds (Equidae)
Pigs (Sus)
Goats (Capra)
Sheep (Ovis)
Cattle (Bos)
Prosimians (Prosimia)
New World Monkeys (Ceboidea)
Old World Monkeys (Cercopithecoidea)
Apes (Hominoidea)
Other Mammals (other Mammalia)
Quail (Coturnix coturnix)
Other birds (other Aves)
Reptiles (Reptilia)
Amphibians (Amphibia)
Fish (Pisces)
TOTAL

446677
169662
37397
4074
15567
20968
104
1453
0
0
104
6511
104
1014
1141
0
21
469
0
0
915
18811
147
2143
62807
790089

346842
106913
11994
1448

15787
51
618
0

0
21
0
0

915

69164
57209
25145
2616

5063
53
789
0

0
0
2
0

0

8587
0
178
0

0
0
28
0

0
0
0
0

0

22084
5540
80
10

118
0
18
0

0
0
467
0

0

631
66
554
0

0
21
62
0

Note 1:

Column 1.5 concerns only those Member Countries of the Council of Europe which, at the beginning of the reporting period, are Parties to the Convention ETS 123. Thus an updated list of
those countries has to be used when filling in this column.

Note 2:

Only the white boxes need to be completed.

Note 3:

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

41

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
TABLE 2:

NUMBER OF ANIMALS USED IN EXPERIMENTS FOR SELECTED PURPOSES

Purpose versus species

2.1
Species

2.2
Biological
studies of a
fundamenta
l nature

2.a.
2.b.
2.c.
2.d.
2.e.
2.f.
2.g.
2.h.
2.i.
2.j.
2.k.

2.l.
2.m.
2.n.
2.o.
2.p.
2.q.
2.r.
2.s.
2.t.
2.u.
2.v.
2.w.
2.x.
2.y.
2.z.

Mice
Rats
Guinea-Pigs
Hamsters
Other Rodents
Rabbits
Cats
Dogs
Ferrets
Other Carnivores
Horses,  donkeys  and  cross
breds
Pigs
Goats
Sheep
Cattle
Prosimians
New World Monkeys
Old World Monkeys
Apes
Other Mammals
Quail
Other birds
Reptiles
Amphibians
Fish
TOTAL

119965
28738
594
1123
617
2749
35
271
0
0

24
1536
2
292
184
0
20
3
0
0
915
6340
147
673
9750
173978

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)

157688
114431
9590
369
14856
10803
13
246
0
0

1
228
2
84
180
0
1
32
0
0
0
667
0
0
23
309214

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

26811
9686
5016
1200
0
718
0
531
0
0

0
134
0
0
31
0
0
160
0
0
0
63
0
0
4666
49016

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

110706
13577
21383
1255
0
5860
3
0
0
0

2
0
16
0
0
0
0
272
0
0
0
0
0
0
0
153074

974
313
100
104
0
74
28
70
0
0

3
2875
0
3
246
0
0
2
0
0
0
69
0
0
0
4861

42

2.7
Diagnosis of
disease

2.8
Education and
training

2.9
Other

2.10
Total

25549
181
161
9
0
5
0
1
0
0

0
22
0
14
0
0
0
0
0
0
0
0
0
0
0
25942

2001
1579
369
14
94
108
25
334
0
0

67
132
84
23
45
0
0
0
0
0
0
411
0
1470
368
7124

2983
1157
184
0
0
651
0
0
0
0

7
1584
0
598
455
0
0
0
0
0
0
11261
0
0
48000
66880

446677
169662
37397
4074
15567
20968
104
1453
0
0

104
6511
104
1014
1141
0
21
469
0
0
915
18811
147
2143
62807
790089

TABLE 3:

NUMBER OF ANIMALS USED IN TOXICOLOGICAL AND OTHER SAFETY EVALUATIONS

Products versus species

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

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

3.11
Total

3.10
Other toxico-
logical or
safety
evaluations

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

60
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
740
800

376
1108
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
1484

26623
9874
5016
1200
0
718
0
531
0
0
0
134
0
0
31
0
0
160
0
0
0
63
0
0
4666
49016

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
inteded to
be used
mainly in
industry

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

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

3.a.
3.b.
3.c.
3.d.
3.e.
3.f.
3.g.
3.h.
3.i.
3.j.
3.k.
3.l.
3.m.
3.n.
3.o.
3.p.
3.q.
3.r.
3.s.
3.t.
3.u.
3.v.
3.w.
3.x.
3.y.
3.z.

Mice
Rats
Guinea-Pigs
Hamsters
Other Rodents
Rabbits
Cats
Dogs
Ferrets
Other Carnivores
Horses, donkeys and cross breds
Pigs
Goats
Sheep
Cattle
Prosimians
New World Monkeys
Old World Monkeys
Apes
Other Mammals
Quail
Other birds
Reptiles
Amphibians
Fish
TOTAL

26187
8606
5016
1200
0
700
0
531
0
0
0
86
0
0
31
0
0
160
0
0
0
63
0
0
1400
43980

0
0
0
0
0
0
0
0
0
0
0
48
0
0
0
0
0
0
0
0
0
0
0
0
1526
1574

0
138
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
1000
1138

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

0
22
0
0
0
18
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
40

43

TABLE 4:

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

4.1
Species

4.2
Human cardiovascular
diseases

4.3
Human nervous and
mental disorders

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

4.5
Other human diseases

4.6
Studies specific to animal
diseases

4.7
Total

Main categories versus species

4.a.
4.b.
4.c.
4.d.
4.e.
4.f.
4.g.
4.h.
4.i.
4.j.
4.k.
4.l.
4.m.
4.n.
4.o.
4.p.
4.q.
4.r.
4.s.
4.t.
4.u.
4.v.
4.w.
4.x.
4.y.
4.z.

Mice
Rats
Guinea-Pigs
Hamsters
Other Rodents
Rabbits
Cats
Dogs
Ferrets
Other Carnivores
Horses, donkeys and cross breds
Pigs
Goats
Sheep
Cattle
Prosimians
New World Monkeys
Old World Monkeys
Apes
Other Mammals
Quail
Other birds
Reptiles
Amphibians
Fish
TOTAL

25812
3335
894
627
155
1670
0
215
0
0
0
319
4
154
0
0
0
0
0
0
0
0
0
0
0
33185

44837
47550
923
100
13015
70
0
32
0
0
0
0
0
0
0
0
0
2
0
0
0
0
0
0
0
106529

45676
3089
0
67
0
190
0
0
0
0
0
9
0
0
0
0
0
0
0
0
0
0
0
0
0
49031

204995
72611
19567
502
2104
1382
0
204
0
0
0
39
0
140
0
0
1
304
0
0
0
7
0
0
120
301976

3064
838
20
104
97
354
0
42
3
0
6
673
0
15
347
0
0
0
0
0
0
1321
114
0
305
7303

324384
127423
21404
1400
15371
3666
0
493
3
0
6
1040
4
309
347
0
1
306
0
0
0
1328
114
0
425
498024

44

TABLE 5:

NUMBER OF ANIMALS USED IN PRODUCTION AND QUALITY CONTROL OF PRODUCTS AND DEVICES FOR HUMAN

MEDICINE AND DENTISTRY AND FOR VETERINARY MEDICINE

5.1
Species

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

5.3
EC legislation
including European
Pharmacopoeia
(requirements)

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

5.5
Other legislation

5.6
Any combination of
5.2/ 5.3/ 5.4/ 5.5

5.7
No regulatory
requirements

5.8
Total

Regulatory requirements versus species

Mice
Rats
Guinea-Pigs
Hamsters
Other Rodents
Rabbits
Cats
Dogs
Ferrets
Other Carnivores
Horses, donkeys and cross breds
Pigs
Goats
Sheep
Cattle
Prosimians
New World Monkeys
Old World Monkeys
Apes
Other Mammals
Quail
Other birds
Reptiles
Amphibians
Fish
TOTAL

5.a.
5.b.
5.c.
5.d.
5.e.
5.f.
5.g.
5.h.
5.i.
5.j.
5.k.
5.l.
5.m.
5.n.
5.o.
5.p.
5.q.
5.r.
5.s.
5.t.
5.u.
5.v.
5.w.
5.x.
5.y.
5.z.
Examples:

8563
2938
504
1249
0
66
3
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
13323

15713
534
2212
104
0
271
28
42
0
0
0
180
0
3
147
0
0
0
0
0
0
10
0
0
0
19244

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

20755
0
3834
0
0
217
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
24806

1003
1204
0
6
0
996
0
0
0
0
0
2110
0
0
22
0
0
0
0
0
0
0
0
0
0
5341
columns 5.2 - 5.5 refer to the legislation imposing that the test be carried out and
not to the body which has issued the actual test method, guideline or protocol.
a test required by French legislation and carried out in Belgium according to an
ISO protocol must be coded as a national (FR) legislative requirement and be
entered into column 5.2 in the tables submitted by Belgium.

65646
9214
14933
0
0
4384
0
28
0
0
5
585
16
0
77
0
0
274
0
0
0
59
0
0
0
95221

111680
13890
21483
1359
0
5934
31
70
0
0
5
2875
16
3
246
0
0
274
0
0
0
69
0
0
0
157935

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

EC Member States: Austria, Belgium, Denmark, Finland, France, Germany, Greece, Ireland, Italy, Luxembourg, Netherlands, Portugal, Spain, Sweden, United Kingdom

Example:

Note:

Footnotes:

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

45

TABLE 6:

NUMBER OF ANIMALS USED IN TOXICOLOGICAL AND OTHER SAFETY EVALUATIONS

6.1
Species

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

6.3
EC legislation
including European
Pharmacopoeia
(requirements)

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

6.5
Other legislation

6.6
Any combination of
6.2/ 6.3/ 6.4/ 6.5

6.7
No regulatory
requirements

6.8
Total

Regulatory requirements versus species

Mice
Rats
Guinea-Pigs
Hamsters
Other Rodents
Rabbits
Cats
Dogs
Ferrets
Other Carnivores
Horses, donkeys and cross breds
Pigs
Goats
Sheep
Cattle
Prosimians
New World Monkeys
Old World Monkeys
Apes
Other Mammals
Quail
Other birds
Reptiles
Amphibians
Fish
TOTAL

6.a.
6.b.
6.c.
6.d.
6.e.
6.f.
6.g.
6.h.
6.i.
6.j.
6.k.
6.l.
6.m.
6.n.
6.o.
6.p.
6.q.
6.r.
6.s.
6.t.
6.u.
6.v.
6.w.
6.x.
6.y.
6.z.
Examples:

902
330
0
0
0
0
0
0
0
0
0
108
0
0
31
0
0
0
0
0
0
63
0
0
2000
3434

1540
0
256
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
526
2322

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

262
590
272
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
1124

607
652
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
740
1999
columns 6.2 - 6.5 refer to the legislation imposing that the test be carried out and
not to the body which has issued the actual test method, guideline or protocol.
a test required by French legislation and carried out in Belgium according to an
ISO protocol must be coded as a national (FR) legislative requirement and be
entered into column 6.2 in the tables submitted by Belgium.

23500
8114
4488
1200
0
718
0
531
0
0
0
26
0
0
0
0
0
160
0
0
0
0
0
0
1400
40137

26811
9686
5016
1200
0
718
0
531
0
0
0
134
0
0
31
0
0
160
0
0
0
63
0
0
4666
49016

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

EC Member States: Austria, Belgium, Denmark, Finland, France, Germany, Greece, Ireland, Italy, Luxembourg, Netherlands, Portugal, Spain, Sweden, United Kingdom

Example:

Note:

Footnotes:

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

46

TABLE 7:

NUMBER OF ANIMALS USED IN TOXICOLOGICAL AND OTHER SAFETY EVALUATIONS

7.1
Species

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

7.3
Skin
irritation

7.4
Skin
sensitisatio
n

7.5
Eye
irritation

7.6
Sub-
chronic and
chronic
toxicity

7.7
Carcino-
genicity

7.8
Develop-
mental
toxicity

7.9
Muta-
genicit
y

7.10
Repro-
ductive
toxicity

Types of tests versus species

7.12
Other

7.13
Total

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

7.2.1.
LD50,
LC50

7.2.2
Other lethal
methods

7.2.3
Non lethal
clinical signs
methods

7.a.
7.b.
7.c.
7.d.
7.e.
7.f.
7.g.
7.h.
7.i.
7.j.
7.k.

7.l..
7.m.
7.n.
7.o.
7.p.
7.q.
7.r.
7.s.
7.t.
7.u.
7.v.
7.w.
7.x.
7.y.
7.z.

Mice
Rats
Guinea-Pigs
Hamsters
Other Rodents
Rabbits
Cats
Dogs
Ferrets
Other Carnivores
Horses,  donkeys  and  cross
breds
Pigs
Goats
Sheep
Cattle
Prosimians
New World Monkeys
Old World Monkeys
Apes
Other Mammals
Quail
Other birds
Reptiles
Amphibians
Fish
TOTAL

888
0
0
0
0
0
0
0
0
0

0
0
0
0
0
0
0
0
0
0
0
0
0
0
1015
1903

174
138
0
0
0
0
0
0
0
0

0
0
0
0
0
0
0
0
0
0
0
0
0
0
500
812

20625
3859
4579
0
0
305
0
210
0
0

0
26
0
0
0
0
0
160
0
0
0
0
0
0
0
29764

0
0
0
0
0
49
0
0
0
0

0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
49

0
0
186
0
0
0
0
0
0
0

0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
186

47

0
0
0
0
0
9
0
0
0
0

0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
9

920
3320
0
0
0
112
0
321
0
0

0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
4673

0
0
0
0
0
0
0
0
0
0

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

0
986
0
0
0
243
0
0
0
0

0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
1229

800
32
0
0
0
0
0
0
0
0

0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
832

86
468
0
0
0
0
0
0
0
0

0
0
0
0
0
0
0
0
0
0
0
0
0
0
900
1454

0
0
0
0
0
0
0
0
0
0

0
0
0
0
0
0
0
0
0
0
0
0
0
0
851
851

3318
883
251
1200
0
0
0
0
0
0

0
108
0
0
31
0
0
0
0
0
0
63
0
0
1400
7254

26811
9686
5016
1200
0
718
0
531
0
0

0
134
0
0
31
0
0
160
0
0
0
63
0
0
4666
49016

TABLE 8:

NUMBER OF ANIMALS USED IN TOXICOLOGICAL AND OTHER SAFETY EVALUATIONS

8.1
Products

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

8.3
Skin
irritation

8.4
Skin
sensitisatio
n

8.5
Eye
irritation

Types of tests versus products

8.6
Sub-
chronic
and
chronic
toxicity

4072

0

0

0

0

0

0

0

8.7
Carcino
genicity

8.8
Develop-
mental
toxicity

8.9
Muta-
genicit
y

8.10
Repro-
ductive
toxicity

8.12
Other

8.13
Total

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

0

0

0

0

0

0

0

0

0
0

1229

832

494

0

6675

43984

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0
1229

0
832

0

326

48

1474

900

0

0

0

0

60

0
1454

0

0

0

0

0

525

0
851

0

0

0

0

0

0

1238

36

0

0

0

800

532
7255

1484
49016

186

0

0

0

0

0

0

0

9

0

0

3

0

0

0

0

0
186

0
12

590
4662

8.a.

8.b.

8.c.

8.d.

8.e.

8.f.

8.g.

8.h.

8.i.

8.j.

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

safety

or 

8.2.1.
LD50,
LC50

8.2.2
Other lethal
methods

8.2.3
Non lethal
clinical signs
methods

700

750

50

0

0

0

0

215

188
1903

0

29744

200

138

0

0

0

0

0

150

150

18

0

0

0

0

174
512

0
30062

43

0

0

15

0

0

0

0

0
58

48

DENMARK

Statistical data submitted

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

Comments of Danish authorities

An animal is included in the statistics when it is first used for experimental purposes.
However, animals that have been used for experimental purposes over a period dating
back to before 1 January 1999 are not included in the statistics for the reporting year.

As  the  following  pages  indicate,  the  total  number  of  experimental  animals  used  in
1999  was  323 444  (of  which  29 018  were  “other  vertebrate  animals”,  mainly  fish).
For many years the number of animals used for experimental purposes has remained
constant  at  around  350  000  with  only  a  few  fluctuations,  as,  for  example,  in  1998,
when  the  number  fell  to  290 590.  This  sudden  reduction  could  be  regarded  as  a
random fluctuation, and this is borne out by the figures for 1997 and 1999 (380 322
and 323 444 animals, respectively).

In contrast to the situation in Denmark, the number of animals used in several other
European countries has fallen significantly over the last two decades. According to the
Animal Experiments Inspectorate (Dyreforsøgstilsynet), this difference is attributable
to  the  fact  that  the  Danish  pharmaceuticals  industry  has  stepped  up  its  activities
significantly in recent years, due in part to the launching of new companies. However,
this increase in activity has not been accompanied by a corresponding increase in the
number  of  animals  used  for  experimental  purposes.  For  instance,  one  large  Danish
pharmaceuticals  company  has  informed  the  Animal  Experiments  Inspectorate  that,
over  recent  years,  it  has  been  able  to  conduct  a  substantial  part  of  its  development
research  through  the  use  of  newly  developed,  refined  (alternative)  methods,  which
significantly reduce the need for experimental animals. In the year 2000 the company
expects  to  use  about  70 000  experimental  animals  for  development  research.  If  the
company had been forced to rely solely on the methods available in 1990, the number
of  experimental  animals  required  in  2000  by  this  one  company  alone  would  have
come to about 1 million.

In  terms  of  numbers,  the  most  significant  fluctuation  is  in  the  use  of  mice  and  rats,
which in 1999 stands at 260 544 animals, i.e. 81 %. Guinea-pigs and rabbits account
for 16 974 animals in total (5%). The number of fish, totalling 28 741 (9%), is higher
than in the two preceding years.

The  numbers  for  animal  species  such  as  cats,  dogs  and  monkeys  have  never  been
lower than in 1999 (44, 143 and 0 respectively, i.e. 0.6 per thousand collectively).

Apart from the total numbers involved, there are not many differences in the patterns
of use of experimental animals compared with previous years. Changes in pattern that
are worthy of special mention are the following. There has been a marked decline in
basic  biological  tests  involving  experimental  animals,  from  just  under  100 000  to

49

66 797.  At  the  same  time,  the  use  of  experimental  animals  for  research  and
development  involving  medical,  odontological  and  veterinary  products  and  articles
has  increased  significantly  from  102 823  in  1998  to  153 671  in  1999,  although  this
latter figure reflects levels of use in previous years. Similarly, the use of experimental
animals for toxicological and other safety assessments has risen from 14 573 in 1998
to 17 696 in 1999, which again is in line with patterns of use in previous years.

The  number  of  animals  used  in  experiments  relating  to  diseases  in  humans  and
animals  has  risen  significantly  compared  with  previous  years,  involving  a  total  of
195 666  animals,  i.e.  60%.  While  levels  of  use  in  cases  involving  human
cardiovascular diseases have more than halved, the use of experimental animals in the
context of human nervous and mental disorders has risen sharply, and this is reflected
in the case of other human diseases.

In the area of toxicology, it is worth pointing out that the number of animals used in
connection with “other lethal methods” is continuing to decline. Similarly, the number
of animals  used  in  skin irritation and skin  sensitisation  tests  is  constantly  falling.  In
1999, 21 rodents were used in acute or subacute toxicity tests involving cosmetics or
toiletries.

50

TABLE 1:

NUMBER OF ANIMALS USED IN RELATION TO THEIR PLACE OF ORIGIN

1.1
Species

Origin versus species

1.2
Total

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

1.4
Animals coming from
elsewhere in the EC

1.6
Animals coming from
other origins

1.7
Re-used animals

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

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

Mice (Mus musculus)
Rats (Rattus norvegicus)
Guinea-Pigs (Cavia porcellus)
Hamsters (Mesocricetus )
Other Rodents (other Rodentia)
Rabbits (Oryctolagus cuniculus)
Cats (Felis catus)
Dogs (Canis familiaris)
Ferrets (Mustela putorius furo)
Other Carnivores (other Carnivora)
Horses, donkeys and cross breds (Equidae)
Pigs (Sus)
Goats (Capra)
Sheep (Ovis)
Cattle (Bos)
Prosimians (Prosimia)
New World Monkeys (Ceboidea)
Old World Monkeys (Cercopithecoidea)
Apes (Hominoidea)
Other Mammals (other Mammalia)
Quail (Coturnix coturnix)
Other birds (other Aves)
Reptiles (Reptilia)
Amphibians (Amphibia)
Fish (Pisces)
TOTAL

163680
96864
10431
773
537
6543
44
143
20
1151
85
7192
111
140
1476
0
0
0
0
11
0
5225
10
267
28741
323444

161674
91881
9148
701

6049
16
7
20

0
0
0
0

0

1527
4340
1044
62

494
28
108
0

0
0
0
0

0

118
0
239
10

0
0
10
0

0
0
0
0

0

361
643
0
0

0
0
18
0

0
0
0
0

0

435
3
16
0

0
0
0
0

Note 1:

Column 1.5 concerns only those Member Countries of the Council of Europe which, at the beginning of the reporting period, are Parties to the Convention ETS 123. Thus an updated list of
those countries has to be used when filling in this column.

Note 2:

Only the white boxes need to be completed.

Note 3:

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

51

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
TABLE 2:

NUMBER OF ANIMALS USED IN EXPERIMENTS FOR SELECTED PURPOSES

Purpose versus species

2.1
Species

2.2
Biological
studies of a
fundamenta
l nature

2.a.
2.b.
2.c.
2.d.
2.e.
2.f.
2.g.
2.h.
2.i.
2.j.
2.k.

2.l.
2.m.
2.n.
2.o.
2.p.
2.q.
2.r.
2.s.
2.t.
2.u.
2.v.
2.w.
2.x.
2.y.
2.z.

Mice
Rats
Guinea-Pigs
Hamsters
Other Rodents
Rabbits
Cats
Dogs
Ferrets
Other Carnivores
Horses,  donkeys  and  cross
breds
Pigs
Goats
Sheep
Cattle
Prosimians
New World Monkeys
Old World Monkeys
Apes
Other Mammals
Quail
Other birds
Reptiles
Amphibians
Fish
TOTAL

36250
17889
45
100
0
928
7
14
20
521

39
3847
1
139
1164
0
0
0
0
11
0
5019
10
75
718
66797

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)

84530
55990
2317
653
511
1153
12
47
0
29

0
1742
11
0
52
0
0
0
0
0
0
44
0
0
6580
153671

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

7098
6510
2365
10
26
512
0
69
0
0

0
557
0
0
0
0
0
0
0
0
0
0
0
0
549
17696

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

25432
8138
3931
0
0
1442
17
3
0
0

0
16
0
0
0
0
0
0
0
0
0
23
0
0
0
39002

315
0
1003
0
0
0
0
0
0
582

2
368
0
1
40
0
0
0
0
0
0
10
0
0
0
2321

52

2.7
Diagnosis of
disease

2.8
Education and
training

2.9
Other

2.10
Total

1507
6
12
0
0
2093
0
0
0
19

5
9
99
0
12
0
0
0
0
0
0
91
0
0
0
3853

868
1550
92
10
0
163
8
0
0
0

39
541
0
0
63
0
0
0
0
0
0
0
0
192
172
3698

7680
6781
666
0
0
252
0
10
0
0

0
112
0
0
145
0
0
0
0
0
0
38
0
0
20722
36406

163680
96864
10431
773
537
6543
44
143
20
1151

85
7192
111
140
1476
0
0
0
0
11
0
5225
10
267
28741
323444

TABLE 3:

NUMBER OF ANIMALS USED IN TOXICOLOGICAL AND OTHER SAFETY EVALUATIONS

Products versus species

3.7
Products/
substances
used or
intended to be
used mainly
as additives in
food for
human
consumption
207
892
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
1099

3.8
Products/
substances
used or
intended to be
used mainly
as additives in
food for
animal
consumption
58
755
0
0
26
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
839

3.11
Total

3.10
Other toxico-
logical or
safety
evaluations

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

0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
549
549

270
774
151
0
0
56
0
0
0
0
0
4
0
0
0
0
0
0
0
0
0
0
0
0
0
1255

7098
6510
2365
10
26
512
0
69
0
0
0
557
0
0
0
0
0
0
0
0
0
0
0
0
549
17696

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
inteded to
be used
mainly in
industry

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

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

3.a.
3.b.
3.c.
3.d.
3.e.
3.f.
3.g.
3.h.
3.i.
3.j.
3.k.
3.l.
3.m.
3.n.
3.o.
3.p.
3.q.
3.r.
3.s.
3.t.
3.u.
3.v.
3.w.
3.x.
3.y.
3.z.

Mice
Rats
Guinea-Pigs
Hamsters
Other Rodents
Rabbits
Cats
Dogs
Ferrets
Other Carnivores
Horses, donkeys and cross breds
Pigs
Goats
Sheep
Cattle
Prosimians
New World Monkeys
Old World Monkeys
Apes
Other Mammals
Quail
Other birds
Reptiles
Amphibians
Fish
TOTAL

4643
2955
1991
10
0
420
0
69
0
0
0
553
0
0
0
0
0
0
0
0
0
0
0
0
0
10641

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

1920
1120
200
0
0
33
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
3273

0
14
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
14

0
0
23
0
0
3
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
26

53

TABLE 4:

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

4.1
Species

4.2
Human cardiovascular
diseases

4.3
Human nervous and
mental disorders

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

4.5
Other human diseases

4.6
Studies specific to animal
diseases

4.7
Total

Main categories versus species

4.a.
4.b.
4.c.
4.d.
4.e.
4.f.
4.g.
4.h.
4.i.
4.j.
4.k.
4.l.
4.m.
4.n.
4.o.
4.p.
4.q.
4.r.
4.s.
4.t.
4.u.
4.v.
4.w.
4.x.
4.y.
4.z.

Mice
Rats
Guinea-Pigs
Hamsters
Other Rodents
Rabbits
Cats
Dogs
Ferrets
Other Carnivores
Horses, donkeys and cross breds
Pigs
Goats
Sheep
Cattle
Prosimians
New World Monkeys
Old World Monkeys
Apes
Other Mammals
Quail
Other birds
Reptiles
Amphibians
Fish
TOTAL

537
680
0
0
0
262
0
0
0
0
0
285
2
0
0
0
0
0
0
0
0
0
0
0
0
1766

50006
38568
961
0
511
245
19
18
0
0
0
170
0
0
0
0
0
0
0
0
0
0
0
0
0
90498

18038
1325
0
0
0
0
0
1
0
0
0
4
0
0
0
0
0
0
0
0
0
0
0
0
0
19368

43260
20115
1128
704
0
864
0
34
0
0
5
683
9
0
0
0
0
0
0
0
0
44
0
46
500
67392

5262
303
16
0
0
171
0
0
20
297
0
2049
0
134
99
0
0
0
0
0
0
1711
0
0
6580
16642

117103
60991
2105
704
511
1542
19
53
20
297
5
3191
11
134
99
0
0
0
0
0
0
1755
0
46
7080
195666

54

TABLE 5:

NUMBER OF ANIMALS USED IN PRODUCTION AND QUALITY CONTROL OF PRODUCTS AND DEVICES FOR HUMAN

MEDICINE AND DENTISTRY AND FOR VETERINARY MEDICINE

5.1
Species

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

5.3
EC legislation
including European
Pharmacopoeia
(requirements)

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

5.5
Other legislation

5.6
Any combination of
5.2/ 5.3/ 5.4/ 5.5

5.7
No regulatory
requirements

5.8
Total

Regulatory requirements versus species

Mice
Rats
Guinea-Pigs
Hamsters
Other Rodents
Rabbits
Cats
Dogs
Ferrets
Other Carnivores
Horses, donkeys and cross breds
Pigs
Goats
Sheep
Cattle
Prosimians
New World Monkeys
Old World Monkeys
Apes
Other Mammals
Quail
Other birds
Reptiles
Amphibians
Fish
TOTAL

5.a.
5.b.
5.c.
5.d.
5.e.
5.f.
5.g.
5.h.
5.i.
5.j.
5.k.
5.l.
5.m.
5.n.
5.o.
5.p.
5.q.
5.r.
5.s.
5.t.
5.u.
5.v.
5.w.
5.x.
5.y.
5.z.
Examples:

162
0
1003
0
0
13
0
0
0
0
0
337
0
0
36
0
0
0
0
0
0
0
0
0
0
1551

75
501
0
0
0
0
3
0
0
582
0
0
0
0
0
0
0
0
0
0
0
21
0
0
0
1182

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

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

1206
1073
0
0
0
314
7
3
0
0
0
32
0
0
0
0
0
0
0
0
0
0
0
0
0
2635
columns 5.2 - 5.5 refer to the legislation imposing that the test be carried out and
not to the body which has issued the actual test method, guideline or protocol.
a test required by French legislation and carried out in Belgium according to an
ISO protocol must be coded as a national (FR) legislative requirement and be
entered into column 5.2 in the tables submitted by Belgium.

24304
6564
3931
0
0
1115
7
0
0
0
2
15
0
1
4
0
0
0
0
0
0
12
0
0
0
35955

25747
8138
4934
0
0
1442
17
3
0
582
2
384
0
1
40
0
0
0
0
0
0
33
0
0
0
41323

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

EC Member States: Austria, Belgium, Denmark, Finland, France, Germany, Greece, Ireland, Italy, Luxembourg, Netherlands, Portugal, Spain, Sweden, United Kingdom

Example:

Note:

Footnotes:

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

55

TABLE 6:

NUMBER OF ANIMALS USED IN TOXICOLOGICAL AND OTHER SAFETY EVALUATIONS

6.1
Species

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

6.3
EC legislation
including European
Pharmacopoeia
(requirements)

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

6.5
Other legislation

6.6
Any combination of
6.2/ 6.3/ 6.4/ 6.5

6.7
No regulatory
requirements

6.8
Total

Regulatory requirements versus species

Mice
Rats
Guinea-Pigs
Hamsters
Other Rodents
Rabbits
Cats
Dogs
Ferrets
Other Carnivores
Horses, donkeys and cross breds
Pigs
Goats
Sheep
Cattle
Prosimians
New World Monkeys
Old World Monkeys
Apes
Other Mammals
Quail
Other birds
Reptiles
Amphibians
Fish
TOTAL

6.a.
6.b.
6.c.
6.d.
6.e.
6.f.
6.g.
6.h.
6.i.
6.j.
6.k.
6.l.
6.m.
6.n.
6.o.
6.p.
6.q.
6.r.
6.s.
6.t.
6.u.
6.v.
6.w.
6.x.
6.y.
6.z.
Examples:

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

194
140
0
0
0
40
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
374

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

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

4318
1895
112
0
0
62
0
0
0
0
0
26
0
0
0
0
0
0
0
0
0
0
0
0
549
6962
columns 6.2 - 6.5 refer to the legislation imposing that the test be carried out and
not to the body which has issued the actual test method, guideline or protocol.
a test required by French legislation and carried out in Belgium according to an
ISO protocol must be coded as a national (FR) legislative requirement and be
entered into column 6.2 in the tables submitted by Belgium.

2586
4387
2253
10
26
410
0
69
0
0
0
531
0
0
0
0
0
0
0
0
0
0
0
0
0
10272

7098
6510
2365
10
26
512
0
69
0
0
0
557
0
0
0
0
0
0
0
0
0
0
0
0
549
17696

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

EC Member States: Austria, Belgium, Denmark, Finland, France, Germany, Greece, Ireland, Italy, Luxembourg, Netherlands, Portugal, Spain, Sweden, United Kingdom

Example:

Note:

Footnotes:

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

56

TABLE 7:

NUMBER OF ANIMALS USED IN TOXICOLOGICAL AND OTHER SAFETY EVALUATIONS

7.1
Species

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

7.3
Skin
irritation

7.4
Skin
sensitisatio
n

7.5
Eye
irritation

7.6
Sub-
chronic and
chronic
toxicity

7.7
Carcino-
genicity

7.8
Develop-
mental
toxicity

7.9
Muta-
genicit
y

7.10
Repro-
ductive
toxicity

Types of tests versus species

7.12
Other

7.13
Total

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

7.a.
7.b.
7.c.
7.d.
7.e.
7.f.
7.g.
7.h.
7.i.
7.j.
7.k.

7.l..
7.m.
7.n.
7.o.
7.p.
7.q.
7.r.
7.s.
7.t.
7.u.
7.v.
7.w.
7.x.
7.y.
7.z.

Mice
Rats
Guinea-Pigs
Hamsters
Other Rodents
Rabbits
Cats
Dogs
Ferrets
Other Carnivores
Horses,  donkeys  and  cross
breds
Pigs
Goats
Sheep
Cattle
Prosimians
New World Monkeys
Old World Monkeys
Apes
Other Mammals
Quail
Other birds
Reptiles
Amphibians
Fish
TOTAL

7.2.1.
LD50,
LC50

7.2.2
Other lethal
methods

7.2.3
Non lethal
clinical signs
methods

0
0
0
0
0
0
0
0
0
0

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

714
704
0
0
26
0
0
0
0
0

0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
1444

2992
962
623
10
0
49
0
6
0
0

0
194
0
0
0
0
0
0
0
0
0
0
0
0
0
4836

0
0
56
0
0
57
0
0
0
0

0
6
0
0
0
0
0
0
0
0
0
0
0
0
0
119

0
0
1600
0
0
0
0
0
0
0

0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
1600

57

0
0
0
0
0
18
0
0
0
0

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

410
1653
0
0
0
126
0
54
0
0

0
335
0
0
0
0
0
0
0
0
0
0
0
0
0
2578

143
972
0
0
0
0
0
0
0
0

0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
1115

0
446
0
0
0
0
0
0
0
0

0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
446

145
0
0
0
0
0
0
0
0
0

0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
145

452
1507
0
0
0
134
0
0
0
0

0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
2093

0
0
0
0
0
0
0
0
0
0

0
0
0
0
0
0
0
0
0
0
0
0
0
0
549
549

2242
266
86
0
0
128
0
9
0
0

0
22
0
0
0
0
0
0
0
0
0
0
0
0
0
2753

7098
6510
2365
10
26
512
0
69
0
0

0
557
0
0
0
0
0
0
0
0
0
0
0
0
549
17696

TABLE 8:

NUMBER OF ANIMALS USED IN TOXICOLOGICAL AND OTHER SAFETY EVALUATIONS

8.1
Products

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

8.3
Skin
irritation

8.4
Skin
sensitisatio
n

8.5
Eye
irritation

Types of tests versus products

8.7
Carcino
genicity

8.8
Develop-
mental
toxicity

8.9
Muta-
genicit
y

8.10
Repro-
ductive
toxicity

8.6
Sub-
chronic
and
chronic
toxicity

8.12
Other

8.13
Total

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

8.2.1.
LD50,
LC50

8.2.2
Other lethal
methods

8.2.3
Non lethal
clinical signs
methods

8.a.

8.b.

8.c.

8.d.

8.e.

8.f.

8.g.

8.h.

8.i.

8.j.

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

safety

or 

0

0

0

0

0

0

0

0

0
0

656

3585

0

0

0

0

0

0

0

0

866

23

21

270

51

0

91

0

28

0

0

0

0

0

1345

0

190

0

0

0

0

0

15

190

0

0

3

0

0

0

0

1928

554

0

0

0

0

52

0

0

320

509

0

0

0

0

30

0

328

104

1230

0

41

0

142

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

788
1444

20
4836

0
119

65
1600

0
18

140
2578

0
1115

88
446

0
145

721
2093

58

0

0

0

0

0

0

0

549

0
549

1122

10645

0

0

1414

3266

0

0

0

0

0

26

21

1099

51

549

217
2753

2039
17696

GERMANY

Statistical data submitted

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

the  “Bundesministerium 

Comments of German authorities

The official  figures at the time  of  drafting  this  report  refer  to  the  year  1999.  In  this
reporting period the number of the experimental animals increased by 58,822 animals
to  1.591  million  compared  with  the  previous  year.  This  means  an  increase  of  3.8%
vis-a-vis  1998.  The  rise  is  due  in  particular  to  the  basic  research  as  well  as  the
development of diagnostics etc. Although it is difficult to draw  detailed conclusions
on the basis of the  statistics, it  is  expected  that  the  development  of  new  diagnostics
and gene-technological procedures could be a cause of the rise. The rise in the animal
numbers  could also be  attributed  to  the  increasing  importance  of  the  basic  research.
On  the  other  hand,  it  has  to  be  pointed  out,  that  in  the  field  of  product-testing,  for
example for development of medicine products, the number of animals used continue
to decrease since years.

The trends in animal use are different in individual categories; the largest decreases in
1999 with regard to the previous year concern guinea pigs (-7,8 %) and rabbits (21.7
%). In contrast to  this,  the experimental animal numbers  have  risen in particular for
fish  (29.6  %),  birds  (23  %)  and  mouse  (1.8  %).  The  number  of  monkeys  and
pro-simians rose compared with the previous year by 21.8%. Also the number of dogs
and cats rose in the reporting period. With regard to these numbers, it is to be born in
mind, however, that in view of the small absolute numbers, a single large project can
cause a significant increase. Great apes have no longer  been  used in Germany  since
1991.

59

The numbers, kinds and sources of animals used in

procedures during 1999 in Germany

Total

From 1)

From 1)

breeding or user other Parties
establ. registered
within the Party Convention

to the

From 1)
other
sources

Re-
used

Mice
Rats
Guinea pigs
Golden hamsters 2)
Other rodents
Rabbits
Prosimians
New World Monkeys 3)
Old World Monkeys 3)
Apes
Dogs
Cats
Other carnivores
Horses, donkeys and cross breds
Pigs
Goats and sheep
Cattle
Other mammals
Quails 4)
Other birds
Reptiles
Amphibians
Fish
Total

775.932 
403.227 
42.891 

18.020 
50.623 
271 

1.813 
0 
6.031 
1.124 
376 
657 
10.494 
2.596 
4.018 
660 

92.792 
21 
5.915 
173.933 
1.591.394 

428
0

123

213
31

1)

2)

3)

4)

The Order of 1 August 1988 on the notification of vertebrates used in experiments does not
provide the legal basis for collecting information on the sources of animals.

Animals of this species are counted under "other rodents".

New World and Old World Monkeys are counted together as "other simians".

These Animals are not counted separately, but under "birds".

60

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
The number of animals used in procedures for selected purposes

during 1999 in Germany

Selected species

All species

Rodents and
rabbits

Dogs and
cats

Primates

1Biological (including medical) studies

438.017

346.596

471

251

of a fundamental nature

2Research into, development and
quality control (including safety
evaluation) of products or appliances  
for human and veterinary medicine

3Diagnosis of disease1
4Protection of man, animals and the

environment  by 
safety
evaluation2

toxicological  or

5Education and training3
6Others

643.423

620.878

4.611

1.484

312.057
170.439

249.700
63.967

1.306
389

398
53

1  These  data  refer  only  to  vertebrates  used  in  procedures  for  research  into  or  testing  of  methods  of
diagnosis, preventive or curative treatment.

2  These  data  include  -  in  a  relatively  low  proportion  -  also  animals,  which  have  not  been  used  for
safety evaluations in the proper sense, but f. ex. for efficacy testing.

3 The Animal Welfare Act of 1986 does not provide the legal basis to collect statistical information in
this field

61

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
The number of animals used in procedures for selected purposes for the protection

of man, animals and the environment by toxicological or safety evaluationduring 1999 in
Germany

(including safety evaluation of products or appliances

for human and veterinary medicine )1

Selected species

All species
46.673

Rodents and Dogs and

rabbits

cats

31.755

233

Primates
38

49.553

28.196

156

0

74.213

4.016

0

15

1Substances used or intended to be

used mainly in agriculture

2Substances used or intended to be
used mainly in households1
3Substances used or intended to be

used mainly as cosmetics or
toiletries1
4Substances used or intended to be
used mainly as additives in food for
human consumption1
5Substances used or intended to be
used mainly in industry which do
not appear in rows 1, 2, 3 and 4 1
6Potential or actual hazards of
contaminants in the general
environment which do not appear in
the other rows

7Safety evaluation of products or

appliances for human or veterinary
medicine1

1 Information on this aspect is not collected separately.

62

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
The number of animals used in procedures

concerned with diseases and disorders1

during (year) in the Bundesrepublik Deutschland

Selected species

All species

Rodents and
rabbits

Dogs and
cats

Primates

1Human cancer (excluding evaluations  

of carcinogenic hazards)

2Cardiovascular human diseases
3Nervous and mental human disorders  
4Other human diseases
5Animal diseases

Note: When a procedure covers cancer  under any  item from 2 to 4, the cancer classification should
take precedence

1 If the type of human disease or disorder is not precisely known, the data should be entered in row 4

63

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
The number of animals used in procedures required by law

during 1999 in Germany

Selected species

Rodents and Dogs and

All species

rabbits

cats

Primates

1Party only

Other Parties

2and

other States
Both (1 + 2):

3Party and

Other Parties
or member States  
Other States

other Parties/States  

4Total

450.690

406.213

3.536

450.690

406.213

3.536

607

607

Note: These data refer to statutory testing for notification or authorization of substances or products.

64

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
GREECE

Statistical data submitted

The  statistical  data  have  been  submitted  by  the  “Ypoyrgeio  Gevrgiaw,  Gen.  Diey/Nsh
Kthniatrikhw””“ (Ministry of Agriculture, Veterinary Services).

Comments of Greek authorities

Experiments on vertebrate animals in Greece are governed by the following provisions:

(a)

(b)

Law No 2015/92 (Government Gazette I 30) approving the European Convention on
the Protection of Vertebrates used for Experimental and Other Scientific Purposes;

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

In accordance with the above provisions:

- licences are issued to scientists who carry out experiments with animals (Articles 7 and 14
of Directive 86/609/EEC)

- establishments breeding and supplying animals for experiments are registered (Articles 15,
16, 19 and 21 of Directive 86/609/EEC).

1. ESTABLISHMENTS

Experiments are carried out at registered establishments, of which there are 21 in all.

These can be broken down as follows:

a)
b)
c)
d)
e)
f)

Universities and university hospitals
Hospitals
Research institutes
Pharmaceuticals companies
Agricultural and veterinary laboratories
Other research institutes

7
3
5
2
3
1

2. EXPERIMENTS

The total number of experiments conducted can be broken down as follows:

68.1% on human and animal diseases

2.1% on  checking  the  quality  of  medicines,  and  of  dental  and  veterinary  products  and
equipment

1.72% on toxicological and other safety testing.

Animals are not used for the testing of cosmetics and detergents.

65

TABLE 1:

NUMBER OF ANIMALS USED IN RELATION TO THEIR PLACE OF ORIGIN

1.1
Species

Origin versus species

1.2
Total

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

1.4
Animals coming from
elsewhere in the EC

1.6
Animals coming from
other origins

1.7
Re-used animals

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

3566
1900
240

595

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

Mice (Mus musculus)
Rats (Rattus norvegicus)
Guinea-Pigs (Cavia porcellus)
Hamsters (Mesocricetus )
Other Rodents (other Rodentia)
Rabbits (Oryctolagus cuniculus)
Cats (Felis catus)
Dogs (Canis familiaris)
Ferrets (Mustela putorius furo)
Other Carnivores (other Carnivora)
Horses, donkeys and cross breds (Equidae)
Pigs (Sus)
Goats (Capra)
Sheep (Ovis)
Cattle (Bos)
Prosimians (Prosimia)
New World Monkeys (Ceboidea)
Old World Monkeys (Cercopithecoidea)
Apes (Hominoidea)
Other Mammals (other Mammalia)
Quail (Coturnix coturnix)
Other birds (other Aves)
Reptiles (Reptilia)
Amphibians (Amphibia)
Fish (Pisces)
TOTAL

3566
1900
240

632

2

6
65

1146
209

60
20

1840

9686

50

37

2

60

Note 1:

Column 1.5 concerns only those Member Countries of the Council of Europe which, at the beginning of the reporting period, are Parties to the Convention ETS 123. Thus an updated list of
those countries has to be used when filling in this column.

Note 2:

Only the white boxes need to be completed.

Note 3:

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

66

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
TABLE 2:

NUMBER OF ANIMALS USED IN EXPERIMENTS FOR SELECTED PURPOSES

2.1
Species

2.2
Biological
studies of a
fundamenta
l nature

2.7
Diagnosis of
disease

2.8
Education and
training

2.9
Other

2.10
Total

Purpose versus species

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)

650
253

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

100

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

148

1831
450

305

8

18

17

1088
139

19

20

8

200

4013

930

118

25

168

1613

67

735
493
200

119

31

15

20

250
556
40

165

2

6
34

4
62

60

1640

2819

3566
1900
240

632

2

6
65

1146
209

60
20

1840

9602

2.a.
2.b.
2.c.
2.d.
2.e.
2.f.
2.g.
2.h.
2.i.
2.j.
2.k.

2.l.
2.m.
2.n.
2.o.
2.p.
2.q.
2.r.
2.s.
2.t.
2.u.
2.v.
2.w.
2.x.
2.y.
2.z.

Mice
Rats
Guinea-Pigs
Hamsters
Other Rodents
Rabbits
Cats
Dogs
Ferrets
Other Carnivores
Horses,  donkeys  and  cross
breds
Pigs
Goats
Sheep
Cattle
Prosimians
New World Monkeys
Old World Monkeys
Apes
Other Mammals
Quail
Other birds
Reptiles
Amphibians
Fish
TOTAL

TABLE 3:

NUMBER OF ANIMALS USED IN TOXICOLOGICAL AND OTHER SAFETY EVALUATIONS

Products versus species

3.1
Species

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

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

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

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

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

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

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

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

3.11
Total

3.10
Other toxico-
logical or
safety
evaluations

3.a.
3.b.
3.c.
3.d.
3.e.
3.f.
3.g.
3.h.
3.i.
3.j.
3.k.
3.l.
3.m.
3.n.
3.o.
3.p.
3.q.
3.r.
3.s.
3.t.
3.u.
3.v.
3.w.
3.x.
3.y.
3.z.

Mice
Rats
Guinea-Pigs
Hamsters
Other Rodents
Rabbits
Cats
Dogs
Ferrets
Other Carnivores
Horses, donkeys and cross breds
Pigs
Goats
Sheep
Cattle
Prosimians
New World Monkeys
Old World Monkeys
Apes
Other Mammals
Quail
Other birds
Reptiles
Amphibians
Fish
TOTAL

72

20

92

68

10

66

148

20

10

66

168

TABLE 4:

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

4.1
Species

4.2
Human cardiovascular
diseases

4.3
Human nervous and
mental disorders

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

4.5
Other human diseases

4.6
Studies specific to animal
diseases

4.7
Total

Main categories versus species

4.a.
4.b.
4.c.
4.d.
4.e.
4.f.
4.g.
4.h.
4.i.
4.j.
4.k.
4.l.
4.m.
4.n.
4.o.
4.p.
4.q.
4.r.
4.s.
4.t.
4.u.
4.v.
4.w.
4.x.
4.y.
4.z.

Mice
Rats
Guinea-Pigs
Hamsters
Other Rodents
Rabbits
Cats
Dogs
Ferrets
Other Carnivores
Horses, donkeys and cross breds
Pigs
Goats
Sheep
Cattle
Prosimians
New World Monkeys
Old World Monkeys
Apes
Other Mammals
Quail
Other birds
Reptiles
Amphibians
Fish
TOTAL

71
110

105

15

19

621
91

689
222

4

1785
623

253

16

320

712

915

2677

50
150
240

70

1103
139

20

200

1972

3216
1196
240

432

31

1122
139

20

200

6596

69

TABLE 5:

NUMBER OF ANIMALS USED IN PRODUCTION AND QUALITY CONTROL OF PRODUCTS AND DEVICES FOR HUMAN

MEDICINE AND DENTISTRY AND FOR VETERINARY MEDICINE

5.1
Species

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

5.3
EC legislation
including European
Pharmacopoeia
(requirements)

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

5.5
Other legislation

5.6
Any combination of
5.2/ 5.3/ 5.4/ 5.5

5.7
No regulatory
requirements

5.8
Total

Regulatory requirements versus species

Mice
Rats
Guinea-Pigs
Hamsters
Other Rodents
Rabbits
Cats
Dogs
Ferrets
Other Carnivores
Horses, donkeys and cross breds
Pigs
Goats
Sheep
Cattle
Prosimians
New World Monkeys
Old World Monkeys
Apes
Other Mammals
Quail
Other birds
Reptiles
Amphibians
Fish
TOTAL

5.a.
5.b.
5.c.
5.d.
5.e.
5.f.
5.g.
5.h.
5.i.
5.j.
5.k.
5.l.
5.m.
5.n.
5.o.
5.p.
5.q.
5.r.
5.s.
5.t.
5.u.
5.v.
5.w.
5.x.
5.y.
5.z.
Examples:

10

160

25

8

10

193

160

35

8

203

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

columns 5.2 - 5.5 refer to the legislation imposing that the test be carried out and
not to the body which has issued the actual test method, guideline or protocol.
a test required by French legislation and carried out in Belgium according to an
ISO protocol must be coded as a national (FR) legislative requirement and be
entered into column 5.2 in the tables submitted by Belgium.

EC Member States: Austria, Belgium, Denmark, Finland, France, Germany, Greece, Ireland, Italy, Luxembourg, Netherlands, Portugal, Spain, Sweden, United Kingdom

Example:

Note:

Footnotes:

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

70

TABLE 6:

NUMBER OF ANIMALS USED IN TOXICOLOGICAL AND OTHER SAFETY EVALUATIONS

6.1
Species

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

6.3
EC legislation
including European
Pharmacopoeia
(requirements)

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

6.5
Other legislation

6.6
Any combination of
6.2/ 6.3/ 6.4/ 6.5

6.7
No regulatory
requirements

6.8
Total

Regulatory requirements versus species

Mice
Rats
Guinea-Pigs
Hamsters
Other Rodents
Rabbits
Cats
Dogs
Ferrets
Other Carnivores
Horses, donkeys and cross breds
Pigs
Goats
Sheep
Cattle
Prosimians
New World Monkeys
Old World Monkeys
Apes
Other Mammals
Quail
Other birds
Reptiles
Amphibians
Fish
TOTAL

6.a.
6.b.
6.c.
6.d.
6.e.
6.f.
6.g.
6.h.
6.i.
6.j.
6.k.
6.l.
6.m.
6.n.
6.o.
6.p.
6.q.
6.r.
6.s.
6.t.
6.u.
6.v.
6.w.
6.x.
6.y.
6.z.
Examples:

148

20

148

20

148

20

168

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

columns 6.2 - 6.5 refer to the legislation imposing that the test be carried out and
not to the body which has issued the actual test method, guideline or protocol.
a test required by French legislation and carried out in Belgium according to an
ISO protocol must be coded as a national (FR) legislative requirement and be
entered into column 6.2 in the tables submitted by Belgium.

EC Member States: Austria, Belgium, Denmark, Finland, France, Germany, Greece, Ireland, Italy, Luxembourg, Netherlands, Portugal, Spain, Sweden, United Kingdom

Example:

Note:

Footnotes:

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

71

TABLE 7:

NUMBER OF ANIMALS USED IN TOXICOLOGICAL AND OTHER SAFETY EVALUATIONS

7.1
Species

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

7.3
Skin
irritation

7.4
Skin
sensitisatio
n

7.5
Eye
irritation

7.6
Sub-
chronic and
chronic
toxicity

7.7
Carcino-
genicity

7.8
Develop-
mental
toxicity

7.9
Muta-
genicit
y

7.10
Repro-
ductive
toxicity

Types of tests versus species

7.12
Other

7.13
Total

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

7.a.
7.b.
7.c.
7.d.
7.e.
7.f.
7.g.
7.h.
7.i.
7.j.
7.k.

7.l..
7.m.
7.n.
7.o.
7.p.
7.q.
7.r.
7.s.
7.t.
7.u.
7.v.
7.w.
7.x.
7.y.
7.z.

Mice
Rats
Guinea-Pigs
Hamsters
Other Rodents
Rabbits
Cats
Dogs
Ferrets
Other Carnivores
Horses,  donkeys  and  cross
breds
Pigs
Goats
Sheep
Cattle
Prosimians
New World Monkeys
Old World Monkeys
Apes
Other Mammals
Quail
Other birds
Reptiles
Amphibians
Fish
TOTAL

7.2.1.
LD50,
LC50

7.2.2
Other lethal
methods

7.2.3
Non lethal
clinical signs
methods

84

64

20

84

64

20

72

148

20

168

TABLE 8:

NUMBER OF ANIMALS USED IN TOXICOLOGICAL AND OTHER SAFETY EVALUATIONS

8.1
Products

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

8.3
Skin
irritation

8.4
Skin
sensitisatio
n

8.5
Eye
irritation

Types of tests versus products

8.7
Carcino
genicity

8.8
Develop-
mental
toxicity

8.9
Muta-
genicit
y

8.10
Repro-
ductive
toxicity

8.6
Sub-
chronic
and
chronic
toxicity

8.12
Other

8.13
Total

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

8.a.

8.b.

8.c.

8.d.

8.e.

8.f.

8.g.

8.h.

8.i.

8.j.

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

safety

or 

8.2.1.
LD50,
LC50

8.2.2
Other lethal
methods

8.2.3
Non lethal
clinical signs
methods

20

52

20

54

10

84

12
64

20

73

92

54

10

12
168

SPAIN

Statistical data submitted

The  Statistical  data  have  been  provided  by  the  :”Ministerio  de  Agricultura,  Pesca  y
Alimentación,  Subdirección  General  de  Sanidad  Animal”  (Ministry  of  Agriculture,
Fisheries  and  Food,  Directorate  General  of  Livestock,  Subdirectorate  General  of
Animal Health).

Comments of Spanish authorities

No comments

74

TABLE 1:

NUMBER OF ANIMALS USED IN RELATION TO THEIR PLACE OF ORIGIN

1.1
Species

Origin versus species

1.2
Total

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

1.4
Animals coming from
elsewhere in the EC

1.6
Animals coming from
other origins

1.7
Re-used animals

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

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

Mice (Mus musculus)
Rats (Rattus norvegicus)
Guinea-Pigs (Cavia porcellus)
Hamsters (Mesocricetus )
Other Rodents (other Rodentia)
Rabbits (Oryctolagus cuniculus)
Cats (Felis catus)
Dogs (Canis familiaris)
Ferrets (Mustela putorius furo)
Other Carnivores (other Carnivora)
Horses, donkeys and cross breds (Equidae)
Pigs (Sus)
Goats (Capra)
Sheep (Ovis)
Cattle (Bos)
Prosimians (Prosimia)
New World Monkeys (Ceboidea)
Old World Monkeys (Cercopithecoidea)
Apes (Hominoidea)
Other Mammals (other Mammalia)
Quail (Coturnix coturnix)
Other birds (other Aves)
Reptiles (Reptilia)
Amphibians (Amphibia)
Fish (Pisces)
TOTAL

261.301
134.070
13.892
674
553
19.496
1.080
725
26
0
6
3.292
100
677
106
0
96
0
0
0
318
18.709
0
255
20.350
475.726

187.840
123.669
11.448
559
0
19.193
1.080
522
26
0
0
0
0
0
0
0
82
0
0
0
0
0
0
0
0

70.008
9.514
2.059
40
0
230
0
197
0
0
0
0
0
0
0
0
6
0
0
0
0
0
0
0
0

985
0
370
0
0
6
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0

2.468
887
15
75
0
67
0
6
0
0
0
0
0
0
0
0
8
0
0
0
318
0
0
0
0

0
0
0
0
0
1.350
7
83
0
0
0
0
0
0
0
0
40
0
0
0
0
0
0
0
0

Note 1:

Column 1.5 concerns only those Member Countries of the Council of Europe which, at the beginning of the reporting period, are Parties to the Convention ETS 123. Thus an updated list of
those countries has to be used when filling in this column.

Note 2:

Only the white boxes need to be completed.

Note 3:

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

75

 
 
 
 
 
TABLE 2:

NUMBER OF ANIMALS USED IN EXPERIMENTS FOR SELECTED PURPOSES

Purpose versus species

2.1
Species

2.2
Biological
studies of a
fundamenta
l nature

2.a.
2.b.
2.c.
2.d.
2.e.
2.f.
2.g.
2.h.
2.i.
2.j.
2.k.

2.l.
2.m.
2.n.
2.o.
2.p.
2.q.
2.r.
2.s.
2.t.
2.u.
2.v.
2.w.
2.x.
2.y.
2.z.

Mice
Rats
Guinea-Pigs
Hamsters
Other Rodents
Rabbits
Cats
Dogs
Ferrets
Other Carnivores
Horses,  donkeys  and  cross
breds
Pigs
Goats
Sheep
Cattle
Prosimians
New World Monkeys
Old World Monkeys
Apes
Other Mammals
Quail
Other birds
Reptiles
Amphibians
Fish
TOTAL

54.241
33.455
274
206
130
730
8
30
0
0

0
319
0
42
0
0
31
0
0
0
288
9.776
0
85
625
100.240

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)

84.143
74.640
7.284
195
106
4.713
43
378
26
0

0
1.468
0
178
36
0
54
0
0
0
0
1.498
0
10
17.400
192.172

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

65.037
12.299
3.281
0
0
5.066
0
227
0
0

0
339
0
170
49
0
11
0
0
0
0
2.461
0
0
2.275
91.215

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

5.074
3.015
445
79
0
454
16
0
0
0

0
0
0
0
0
0
0
0
0
0
30
0
0
0
0
9.113

18.432
0
2.409
120
0
3.744
7
21
0
0

0
584
0
178
0
0
0
0
0
0
0
1.498
0
0
0
26.993

76

2.7
Diagnosis of
disease

2.8
Education and
training

2.9
Other

2.10
Total

27.745
1.005
90
21
0
3.375
0
0
0
0

0
62
100
32
0
0
0
0
0
0
0
507
0
0
50
32.987

3.922
7.886
38
24
136
961
0
66
0
0

6
349
0
17
21
0
0
0
0
0
0
0
0
160
0
13.586

2.707
1.770
71
29
181
453
1.006
3
0
0

0
171
0
60
0
0
0
0
0
0
0
2.969
0
0
0
9.420

261.301
134.070
13.892
674
553
19.496
1.080
725
26
0

6
3.292
100
677
106
0
96
0
0
0
318
18.709
0
255
20.350
475.726

TABLE 3:

NUMBER OF ANIMALS USED IN TOXICOLOGICAL AND OTHER SAFETY EVALUATIONS

Products versus species

3.7
Products/
substances
used or
intended to be
used mainly
as additives in
food for
human
consumption
30
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
30
60

3.8
Products/
substances
used or
intended to be
used mainly
as additives in
food for
animal
consumption
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
1.820
1.820

3.11
Total

3.10
Other toxico-
logical or
safety
evaluations

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

0
256
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
100
356

29.616
45
153
0
0
72
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
97
0
0
0
29.983

65.037
12.299
3.281
0
0
5.066
0
227
0
0
0
339
0
170
49
0
11
0
0
0
0
2.461
0
0
2.275
91.215

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
inteded to
be used
mainly in
industry

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

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

3.a.
3.b.
3.c.
3.d.
3.e.
3.f.
3.g.
3.h.
3.i.
3.j.
3.k.
3.l.
3.m.
3.n.
3.o.
3.p.
3.q.
3.r.
3.s.
3.t.
3.u.
3.v.
3.w.
3.x.
3.y.
3.z.

Mice
Rats
Guinea-Pigs
Hamsters
Other Rodents
Rabbits
Cats
Dogs
Ferrets
Other Carnivores
Horses, donkeys and cross breds
Pigs
Goats
Sheep
Cattle
Prosimians
New World Monkeys
Old World Monkeys
Apes
Other Mammals
Quail
Other birds
Reptiles
Amphibians
Fish
TOTAL

33.589
11.332
3.061
0
0
2.843
0
227
0
0
0
339
0
170
49
0
11
0
0
0
0
2.364
0
0
50
54.035

210
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
210

31
586
40
0
0
528
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
275
1.460

1.561
80
27
0
0
1.266
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
2.934

0
0
0
0
0
357
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
357

77

TABLE 4:

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

4.1
Species

4.2
Human cardiovascular
diseases

4.3
Human nervous and
mental disorders

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

4.5
Other human diseases

4.6
Studies specific to animal
diseases

4.7
Total

Main categories versus species

4.a.
4.b.
4.c.
4.d.
4.e.
4.f.
4.g.
4.h.
4.i.
4.j.
4.k.
4.l.
4.m.
4.n.
4.o.
4.p.
4.q.
4.r.
4.s.
4.t.
4.u.
4.v.
4.w.
4.x.
4.y.
4.z.

Mice
Rats
Guinea-Pigs
Hamsters
Other Rodents
Rabbits
Cats
Dogs
Ferrets
Other Carnivores
Horses, donkeys and cross breds
Pigs
Goats
Sheep
Cattle
Prosimians
New World Monkeys
Old World Monkeys
Apes
Other Mammals
Quail
Other birds
Reptiles
Amphibians
Fish
TOTAL

759
3.911
37
0
0
260
0
53
0
0
0
153
0
0
0
0
0
0
0
0
0
0
0
0
0
5.173

5.479
7.928
40
30
89
2
8
0
0
0
0
1
0
0
0
0
12
0
0
0
0
0
0
0
0
13.589

11.592
3.385
0
0
0
2
0
0
0
0
0
0
0
0
0
0
5
0
0
0
0
0
0
10
0
14.994

38.755
10.648
433
46
53
365
0
22
0
0
110
290
0
46
0
0
31
0
0
0
0
0
0
0
0
50.799

3.156
295
29
20
100
118
0
0
0
0
0
428
0
22
0
0
0
0
0
0
0
0
0
0
8.975
13.143

59.741
26.167
539
96
242
747
8
75
0
0
110
872
0
68
0
0
48
0
0
0
0
0
0
10
8.975
97.698

78

TABLE 5:

NUMBER OF ANIMALS USED IN PRODUCTION AND QUALITY CONTROL OF PRODUCTS AND DEVICES FOR HUMAN

MEDICINE AND DENTISTRY AND FOR VETERINARY MEDICINE

5.1
Species

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

5.3
EC legislation
including European
Pharmacopoeia
(requirements)

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

5.5
Other legislation

5.6
Any combination of
5.2/ 5.3/ 5.4/ 5.5

5.7
No regulatory
requirements

5.8
Total

Regulatory requirements versus species

Mice
Rats
Guinea-Pigs
Hamsters
Other Rodents
Rabbits
Cats
Dogs
Ferrets
Other Carnivores
Horses, donkeys and cross breds
Pigs
Goats
Sheep
Cattle
Prosimians
New World Monkeys
Old World Monkeys
Apes
Other Mammals
Quail
Other birds
Reptiles
Amphibians
Fish
TOTAL

5.a.
5.b.
5.c.
5.d.
5.e.
5.f.
5.g.
5.h.
5.i.
5.j.
5.k.
5.l.
5.m.
5.n.
5.o.
5.p.
5.q.
5.r.
5.s.
5.t.
5.u.
5.v.
5.w.
5.x.
5.y.
5.z.
Examples:

1.079
0
34
0
0
343
0
0
0
0
0
122
0
0
0
0
0
0
0
0
0
0
0
0
0
1.578

22.337
2.916
2.740
124
0
1.736
7
21
0
0
0
408
0
166
0
0
0
0
0
0
30
1.498
0
0
0
31.983

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

0
0
0
0
0
0
16
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
16

0
74
70
75
0
2.091
0
0
0
0
0
54
0
0
0
0
0
0
0
0
0
0
0
0
0
2.364
columns 5.2 - 5.5 refer to the legislation imposing that the test be carried out and
not to the body which has issued the actual test method, guideline or protocol.
a test required by French legislation and carried out in Belgium according to an
ISO protocol must be coded as a national (FR) legislative requirement and be
entered into column 5.2 in the tables submitted by Belgium.

90
25
10
0
0
28
0
0
0
0
0
0
0
12
0
0
0
0
0
0
0
0
0
0
0
165

23.506
3.015
2.854
199
0
4.198
23
21
0
0
0
584
0
178
0
0
0
0
0
0
30
1.498
0
0
0
36.106

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

EC Member States: Austria, Belgium, Denmark, Finland, France, Germany, Greece, Ireland, Italy, Luxembourg, Netherlands, Portugal, Spain, Sweden, United Kingdom

Example:

Note:

Footnotes:

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

79

TABLE 6:

NUMBER OF ANIMALS USED IN TOXICOLOGICAL AND OTHER SAFETY EVALUATIONS

6.1
Species

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

6.3
EC legislation
including European
Pharmacopoeia
(requirements)

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

6.5
Other legislation

6.6
Any combination of
6.2/ 6.3/ 6.4/ 6.5

6.7
No regulatory
requirements

6.8
Total

Regulatory requirements versus species

Mice
Rats
Guinea-Pigs
Hamsters
Other Rodents
Rabbits
Cats
Dogs
Ferrets
Other Carnivores
Horses, donkeys and cross breds
Pigs
Goats
Sheep
Cattle
Prosimians
New World Monkeys
Old World Monkeys
Apes
Other Mammals
Quail
Other birds
Reptiles
Amphibians
Fish
TOTAL

6.a.
6.b.
6.c.
6.d.
6.e.
6.f.
6.g.
6.h.
6.i.
6.j.
6.k.
6.l.
6.m.
6.n.
6.o.
6.p.
6.q.
6.r.
6.s.
6.t.
6.u.
6.v.
6.w.
6.x.
6.y.
6.z.
Examples:

563
200
179
0
0
451
0
32
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
100
1.525

29.799
10.073
2.756
0
0
3.428
0
50
0
0
0
339
0
49
0
0
5
0
0
0
0
2.461
0
0
150
49.110

920
34
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
954

100
0
0
0
0
79
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
179

2.078
87
0
0
0
222
0
26
0
0
0
0
0
49
0
0
6
0
0
0
0
0
0
0
1.750
4.218
columns 6.2 - 6.5 refer to the legislation imposing that the test be carried out and
not to the body which has issued the actual test method, guideline or protocol.
a test required by French legislation and carried out in Belgium according to an
ISO protocol must be coded as a national (FR) legislative requirement and be
entered into column 6.2 in the tables submitted by Belgium.

31.577
1.905
346
0
0
886
0
119
0
0
0
0
0
72
49
0
0
0
0
0
0
0
0
0
275
35.229

65.037
12.299
3.281
0
0
5.066
0
227
0
0
0
339
0
170
49
0
11
0
0
0
0
2.461
0
0
2.275
91.215

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

EC Member States: Austria, Belgium, Denmark, Finland, France, Germany, Greece, Ireland, Italy, Luxembourg, Netherlands, Portugal, Spain, Sweden, United Kingdom

Example:

Note:

Footnotes:

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

80

TABLE 7:

NUMBER OF ANIMALS USED IN TOXICOLOGICAL AND OTHER SAFETY EVALUATIONS

7.1
Species

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

7.3
Skin
irritation

7.4
Skin
sensitisatio
n

7.5
Eye
irritation

7.6
Sub-
chronic and
chronic
toxicity

7.7
Carcino-
genicity

7.8
Develop-
mental
toxicity

7.9
Muta-
genicit
y

7.10
Repro-
ductive
toxicity

Types of tests versus species

7.12
Other

7.13
Total

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

7.2.1.
LD50,
LC50

7.2.2
Other lethal
methods

7.2.3
Non lethal
clinical signs
methods

7.a.
7.b.
7.c.
7.d.
7.e.
7.f.
7.g.
7.h.
7.i.
7.j.
7.k.

7.l..
7.m.
7.n.
7.o.
7.p.
7.q.
7.r.
7.s.
7.t.
7.u.
7.v.
7.w.
7.x.
7.y.
7.z.

Mice
Rats
Guinea-Pigs
Hamsters
Other Rodents
Rabbits
Cats
Dogs
Ferrets
Other Carnivores
Horses,  donkeys  and  cross
breds
Pigs
Goats
Sheep
Cattle
Prosimians
New World Monkeys
Old World Monkeys
Apes
Other Mammals
Quail
Other birds
Reptiles
Amphibians
Fish
TOTAL

2.848
1.302
0
0
0
0
0
0
0
0

0
0
0
0
0
0
0
0
0
0
0
0
0
0
425
4.575

31.737
288
224
0
0
0
0
0
0
0

0
155
0
0
0
0
0
0
0
0
0
0
0
0
0
32.404

3.050
582
185
0
0
2.201
0
0
0
0

0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
6.018

20
54
0
0
0
1.312
0
23
0
0

0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
1.409

0
80
566
0
0
357
0
0
0
0

0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
1.003

81

0
0
0
0
0
615
0
0
0
0

0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
615

23.800
2.496
2.306
0
0
76
0
180
0
0

0
178
0
72
49
0
11
0
0
0
0
2.461
0
0
0
31.629

0
0
0
0
0
0
0
0
0
0

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

279
211
0
0
0
129
0
0
0
0

0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
619

570
0
0
0
0
0
0
0
0
0

0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
570

300
100
0
0
0
70
0
0
0
0

0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
470

0
0
0
0
0
0
0
0
0
0

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

2.433
7.186
0
0
0
306
0
24
0
0

0
6
0
98
0
0
0
0
0
0
0
0
0
0
1.850
11.903

65.037
12.299
3.281
0
0
5.066
0
227
0
0

0
339
0
170
49
0
11
0
0
0
0
2.461
0
0
2.275
91.215

TABLE 8:

NUMBER OF ANIMALS USED IN TOXICOLOGICAL AND OTHER SAFETY EVALUATIONS

8.1
Products

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

8.3
Skin
irritation

8.4
Skin
sensitisatio
n

8.5
Eye
irritation

Types of tests versus products

8.7
Carcino
genicity

8.8
Develop-
mental
toxicity

8.9
Muta-
genicit
y

8.10
Repro-
ductive
toxicity

8.6
Sub-
chronic
and
chronic
toxicity

8.12
Other

8.13
Total

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

8.a.

8.b.

8.c.

8.d.

8.e.

8.f.

8.g.

8.h.

8.i.

8.j.

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

safety

or 

8.2.1.
LD50,
LC50

8.2.2
Other lethal
methods

8.2.3
Non lethal
clinical signs
methods

2.089

3.186

5.919

0

695

0

1.561

0

0

0

128

0

0

0

0

180

954

0

69

0

0

0

0

0

50
4.575

28.136
32.404

30
6.018

791

107

447

346

160

31.532

0

397

0

0

8

0

0

0

0

0

0

0

153
1.003

0
615

97
31.629

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0
0

508

360

470

0

0

0

0

0

0

0

210

0

0

0

0

0

0

0

0

0

0

0

0

0

111
619

0
570

0
470

0

0

0

0

0

0

0

0

0
0

9.853

54.497

0

0

0

210

1.460

357

28

2.934

30

30

600

600

0

1.158

1.392
11.903

29.969
91.215

74

0

163

357

0

0

24

0
1.409

82

FRANCE

Statistical data submitted

The statistical data have been submitted by the “Ministère de la Recherche” (Ministry
of Research).

Comments of the French authorities

In accordance with Articles 13 and 26 of Directive 86/609/EEC of 24 November 1986
on  the  protection  of  animals  used  for  experimental  and  other  scientific  purposes,  a
statistical  survey  on  the  use  of  animals  for  experimental  purposes  during  1999  was
made.  The  French  statistical  data,  presented  in  standard  form,  has  been  sent  to  the
European  Commission  by  the  Ministry  for  Research  which  is  responsible  for  these
studies.

The series of  eight tables indicating the categories of information  required,  finalised
by the Commission and the Member States' competent authorities, have been used for
this purpose. It is worth recalling that these tables were used before in conducting the
survey  on  1997,  as  the  French  authorities  were  involved  in  testing  the  new
harmonised structure on that occasion.

In methodological terms, an innovation compared with the preceding study  was that
establishments were asked to reply to the questionnaire, if they so wished,  either  on
diskette  in  PC  or  Mac  format,  including  tables  with  results  formatted  in  an  Excel
software package, or by e-mail, the inbox being  protected by a password. The latter
system was greatly appreciated, since almost 20% of mailings (and replies) used this
channel.

The analysis of these results leads to some comments.

(cid:1)  Between  1990  and  1999,  i.e.  in  almost  10  years,  the  total  number  of  animal
vertebrates  used  for  experiments  fell  by  37%,  corresponding  to  an  average
decrease of 5% per annum.

(cid:1)  This decrease is more significant in private-sector establishments than in the public
sector  as  regards  the  total  number  of  animals  used,  which  was  75.6%  in  1997,
falling to 61% in 1999.

(cid:1)  Rodents still provide the largest experimentation contingent. Although there was a
reduction of 36% in the number used between 1990 and 1999, their weight in the
total has notably increased. It was 90.8% in 1990 and reached 91.6% in 1999, with
a  notable  net  increase  in  the  number  of  rodents  used  between  1997  and  1999  in
public-sector laboratories.

(cid:1)  As  regards  rabbits,  their  number  decreased  by  56%  between  1990  and  1999  but
there  was  a  significant  increase  in  their  use  by  public  laboratories  between  1997
and 1999.

83

(cid:1)  In  1999,  the  number  of  dogs  used,  which  had  fallen  by  33%  since  1990,  rose
between  1997  and  1999.  Private  establishments  use  them  the  most,  even  though
public sector laboratories have significantly increased their requirements.

(cid:1)  The use  of  cats,  with  a  decrease  of  34%  between  1990  and  1999,  was  similar  as

regards public sector laboratories.

(cid:1)  The number of primates used decreased by 26% between 1990 and 1999. After a
decrease  in  their  use  of  only  2%  between  1993  and  1997,  a  further  reduction  in
their use  of  11%  between  1997  and  1999  was  recorded.  As  in  1997,  no  apes  are
used.

(cid:1)  The use of pigs has been decreasing steadily since 1993, with an average reduction
of 11% per annum. In 1999, pigs represented 0.4% of vertebrates used, compared
to 0.6% in 1993.

(cid:1)  The  number  of  goats  and  sheep  rose  by  46%  from  1997  to  1999.  The  annual

average increase from 1990 to 1999 is 4%.

(cid:1)  The variations  in  the use  of  cows  is similar  to that recorded  for  goats and  sheep.
However, the increase between 1997 and 1999 is higher, reaching 90%. It rose on
average by 3% between 1990  and 1999,  with public sector laboratories  being the
largest users.

Finally,  and  as  in  the  previous  surveys,  the  Ministry  for  Research  has  deemed  it
necessary, to ensure transparency, to draw up a non-Community table, in order to take
account of a particular category of animals, the use of which does not comply with the
experiment definition in Article 2 of Directive 86/609/EEC. According to this Article,
sacrificing  an  animal  by  a  "humane"  method  (least  painful  method  accepted  by
modern-day  practices)  with  regard  to  removing  cells,  tissue  or  organs,  does  not
constitute an experiment. This table  shows that the number  of  animals  put  down  by
"humane" methods to implement in vitro studies remains significant: 255 089. There
are clear differences between the two  related types of use. Between  1997 and 1999,
the  use  of  vertebrates  in  "alternative  methods  to  animal  experiments"  increased  by
66%, whilst their use in "basic research" fell by 51%.

In a note dated 20 April 2001 our attention was drawn to the fact that some statistical
survey  tables  on  the  use  of  laboratory  animals  in  France  in  1999  showed
inconsistencies.  Specifically,  the  totals  of  Tables  3,  6,  7  and  8  should  have  been
identical to the total in column 2.6 of Table 2.

This  was  a  known  problem  but,  nevertheless  it  was  decided  to  abide  by  the  data
supplied, in order to ensure transparency and because these data could be informative
to the Commission and the competent authorities of the Member States.

There are two main reasons for these divergences:

1.

In  each  table  the  respondent  institutions  had  to  indicate  individual  data
(broken down by type of use and by species) and the corresponding totals. It
was noted on a number of occasions that the sum of the individual data was
different - usually lower - than the totals indicated. The basic reason seems to

84

be the fact that the person ordering the animals is not always the same as the
person carrying out the experiments.

2.

The  system  of  checking  coherence  within  this  survey  was  based  on
exceptions. In other words, when results were recorded all tables that did not
meet  the  coherence  criteria  were  rejected  for  verification  at  the  institutions
concerned.

2.1
If  upon  verification  at  these  institutions  it  appeared  that  they  were  unable  to
correct the data within an acceptable time span, the approach adopted was to respect
the totals indicated. Accordingly, it is likely that the actual number of animals used is
substantially lower (about 0.25%). This largely explains why the figures are slightly
higher than those that should have appeared in the totals of Tables 3, 6, 7 and 8.

2.2 Moreover,  if  the  replies  came  from  a  central  animal  house,  the  verification
procedure  was  more  complex  because  of  the  need  to  first  identify  the  laboratory  or
laboratories using the joint service where the divergence originated and in some cases
because of the difficulty of distinguishing animals ordered from animals used.

Finally,  it  should  be  noted  that  the  strongest  margin  of  error  noted  between  the
dependent tables is 0.4%. Of course it would have been preferable for this margin to
be  nil,  but  the  data-collating  procedure  and  the  heterogeneity  of  the  institutions  in
practice make such divergences unavoidable, however minor they may be.

85

TABLE 1:

NUMBER OF ANIMALS USED IN RELATION TO THEIR PLACE OF ORIGIN

1.1
Species

Origin versus species

1.2
Total

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

1.4
Animals coming from
elsewhere in the EC

1.6
Animals coming from
other origins

1.7
Re-used animals

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

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

Mice (Mus musculus)
Rats (Rattus norvegicus)
Guinea-Pigs (Cavia porcellus)
Hamsters (Mesocricetus )
Other Rodents (other Rodentia)
Rabbits (Oryctolagus cuniculus)
Cats (Felis catus)
Dogs (Canis familiaris)
Ferrets (Mustela putorius furo)
Other Carnivores (other Carnivora)
Horses, donkeys and cross breds (Equidae)
Pigs (Sus)
Goats (Capra)
Sheep (Ovis)
Cattle (Bos)
Prosimians (Prosimia)
New World Monkeys (Ceboidea)
Old World Monkeys (Cercopithecoidea)
Apes (Hominoidea)
Other Mammals (other Mammalia)
Quail (Coturnix coturnix)
Other birds (other Aves)
Reptiles (Reptilia)
Amphibians (Amphibia)
Fish (Pisces)
TOTAL

1.552.330
460.407
77.021
16.200
9.405
49.836
1.855
5.203
190
169
440
8.897
1.839
4.455
3.104
455
53
1.814
0
272
442
86.168
50
6.187
22.805
2.309.597

1.469.187
452.908
76.860
14.854

48.202
1.176
3.130
76

323
15
290
0

430

5.153
729
0
56

1.597
492
541
0

0
38
16
0

0

953
0
0
0

0
0
0
0

0
0
0
0

0

77.037
6.770
161
1.290

37
187
1.532
114

132
0
1.508
0

12

1.717
86
266
0

0
0
24
0

Note 1:

Column 1.5 concerns only those Member Countries of the Council of Europe which, at the beginning of the reporting period, are Parties to the Convention ETS 123. Thus an updated list of
those countries has to be used when filling in this column.

Note 2:

Only the white boxes need to be completed.

Note 3:

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

86

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
TABLE 2:

NUMBER OF ANIMALS USED IN EXPERIMENTS FOR SELECTED PURPOSES

Purpose versus species

2.1
Species

2.2
Biological
studies of a
fundamenta
l nature

2.a.
2.b.
2.c.
2.d.
2.e.
2.f.
2.g.
2.h.
2.i.
2.j.
2.k.

2.l.
2.m.
2.n.
2.o.
2.p.
2.q.
2.r.
2.s.
2.t.
2.u.
2.v.
2.w.
2.x.
2.y.
2.z.

Mice
Rats
Guinea-Pigs
Hamsters
Other Rodents
Rabbits
Cats
Dogs
Ferrets
Other Carnivores
Horses,  donkeys  and  cross
breds
Pigs
Goats
Sheep
Cattle
Prosimians
New World Monkeys
Old World Monkeys
Apes
Other Mammals
Quail
Other birds
Reptiles
Amphibians
Fish
TOTAL

366.493
106.582
1.769
3.800
2.416
4.428
151
20
20
134

200
1.106
616
3.121
1.213
455
15
239
0
2
430
8.804
0
2.580
10.295
514.889

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)

541.115
266.242
13.660
2.137
6.914
10.775
1.191
2.220
164
25

85
3.842
11
502
1.222
0
38
72
0
0
0
11.964
0
16
9.648
871.843

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

38.646
55.933
6.349
221
0
6.711
184
2.486
0
0

46
152
0
244
23
0
0
957
0
270
0
486
0
0
2.022
114.730

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

318.644
17.028
30.857
0
15
18.853
14
0
0
0

55
35
0
0
0
0
0
519
0
0
0
10.034
0
0
0
396.054

250.072
0
23.919
6.102
0
1.219
210
410
6
10

42
1.811
0
217
255
0
0
0
0
0
0
54.754
0
0
0
339.027

87

2.7
Diagnosis of
disease

2.8
Education and
training

2.9
Other

2.10
Total

3.191
320
53
0
50
16
0
0
0
0

0
0
0
0
44
0
0
0
0
0
0
0
0
0
10
3.684

14.509
13.174
275
72
0
1.520
0
67
0
0

12
693
32
4
2
0
0
4
0
0
0
0
50
3.591
830
34.835

19.660
1.128
139
3.868
10
6.314
105
0
0
0

0
1.258
1.180
367
345
0
0
23
0
0
12
126
0
0
0
34.535

1.552.330
460.407
77.021
16.200
9.405
49.836
1.855
5.203
190
169

440
8.897
1.839
4.455
3.104
455
53
1.814
0
272
442
86.168
50
6.187
22.805
2.309.597

TABLE 3:

NUMBER OF ANIMALS USED IN TOXICOLOGICAL AND OTHER SAFETY EVALUATIONS

Products versus species

3.7
Products/
substances
used or
intended to be
used mainly
as additives in
food for
human
consumption
1.131
946
120
115
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
2.312

3.8
Products/
substances
used or
intended to be
used mainly
as additives in
food for
animal
consumption
0
0
0
0
0
0
0
0
0
0
0
0
0
0
5
0
0
0
0
0
0
0
0
0
0
5

3.11
Total

3.10
Other toxico-
logical or
safety
evaluations

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

222
84
74
0
0
0
0
0
0
0
0
14
0
5
0
0
0
0
0
0
0
0
0
0
0
399

3.389
4.660
746
26
0
352
0
52
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
20
9.245

38.646
55.973
6.393
221
0
6.778
184
2.486
0
10
46
148
4
264
23
0
0
957
0
270
0
486
0
0
2.022
114.911

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
inteded to
be used
mainly in
industry

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

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

3.a.
3.b.
3.c.
3.d.
3.e.
3.f.
3.g.
3.h.
3.i.
3.j.
3.k.
3.l.
3.m.
3.n.
3.o.
3.p.
3.q.
3.r.
3.s.
3.t.
3.u.
3.v.
3.w.
3.x.
3.y.
3.z.

Mice
Rats
Guinea-Pigs
Hamsters
Other Rodents
Rabbits
Cats
Dogs
Ferrets
Other Carnivores
Horses, donkeys and cross breds
Pigs
Goats
Sheep
Cattle
Prosimians
New World Monkeys
Old World Monkeys
Apes
Other Mammals
Quail
Other birds
Reptiles
Amphibians
Fish
TOTAL

32.373
47.498
4.561
80
0
6.016
184
2.434
0
10
46
134
4
239
18
0
0
947
0
0
0
147
0
0
1.502
96.193

100
710
500
0
0
145
0
0
0
0
0
0
0
20
0
0
0
0
0
270
0
339
0
0
500
2.584

1.371
2.030
392
0
0
42
0
0
0
0
0
0
0
0
0
0
0
10
0
0
0
0
0
0
0
3.845

60
45
0
0
0
181
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
286

0
0
0
0
0
42
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
42

88

TABLE 4:

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

4.1
Species

4.2
Human cardiovascular
diseases

4.3
Human nervous and
mental disorders

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

4.5
Other human diseases

4.6
Studies specific to animal
diseases

4.7
Total

Main categories versus species

4.a.
4.b.
4.c.
4.d.
4.e.
4.f.
4.g.
4.h.
4.i.
4.j.
4.k.
4.l.
4.m.
4.n.
4.o.
4.p.
4.q.
4.r.
4.s.
4.t.
4.u.
4.v.
4.w.
4.x.
4.y.
4.z.

Mice
Rats
Guinea-Pigs
Hamsters
Other Rodents
Rabbits
Cats
Dogs
Ferrets
Other Carnivores
Horses, donkeys and cross breds
Pigs
Goats
Sheep
Cattle
Prosimians
New World Monkeys
Old World Monkeys
Apes
Other Mammals
Quail
Other birds
Reptiles
Amphibians
Fish
TOTAL

36.985
65.011
3.271
1.087
520
5.898
0
577
0
0
0
1.338
0
81
0
0
0
17
0
0
0
0
0
0
135
114.920

229.938
158.054
830
0
6.767
6
19
24
0
0
0
4
0
0
0
0
50
67
0
0
160
399
0
16
0
396.334

97.889
9.871
338
0
0
95
0
0
0
0
0
11
0
16
0
0
0
0
0
0
0
136
0
0
0
108.356

453.530
139.795
10.470
4.500
1.593
7.502
186
892
184
134
215
881
537
2.336
1.512
455
3
185
0
2
270
3.795
18
2.530
8.876
640.401

92.184
698
573
350
500
1.714
1.137
747
0
25
70
2.190
90
1.190
967
0
0
0
0
0
0
15.904
0
50
10.942
129.331

910.526
373.429
15.482
5.937
9.380
15.215
1.342
2.240
184
159
285
4.424
627
3.623
2.479
455
53
269
0
2
430
20.234
18
2.596
19.953
1.389.342

89

TABLE 5:

NUMBER OF ANIMALS USED IN PRODUCTION AND QUALITY CONTROL OF PRODUCTS AND DEVICES FOR HUMAN

MEDICINE AND DENTISTRY AND FOR VETERINARY MEDICINE

5.1
Species

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

5.3
EC legislation
including European
Pharmacopoeia
(requirements)

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

5.5
Other legislation

5.6
Any combination of
5.2/ 5.3/ 5.4/ 5.5

5.7
No regulatory
requirements

5.8
Total

Regulatory requirements versus species

Mice
Rats
Guinea-Pigs
Hamsters
Other Rodents
Rabbits
Cats
Dogs
Ferrets
Other Carnivores
Horses, donkeys and cross breds
Pigs
Goats
Sheep
Cattle
Prosimians
New World Monkeys
Old World Monkeys
Apes
Other Mammals
Quail
Other birds
Reptiles
Amphibians
Fish
TOTAL

5.a.
5.b.
5.c.
5.d.
5.e.
5.f.
5.g.
5.h.
5.i.
5.j.
5.k.
5.l.
5.m.
5.n.
5.o.
5.p.
5.q.
5.r.
5.s.
5.t.
5.u.
5.v.
5.w.
5.x.
5.y.
5.z.
Examples:

1.510
0
96
0
15
14
0
0
0
0
55
0
0
0
0
0
0
0
0
0
0
0
0
0
0
1.690

327.441
3.219
35.757
6.102
0
11.668
224
410
0
0
42
1.846
0
217
255
0
0
519
0
0
0
64.210
0
0
0
451.910

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

1.751
4.490
0
0
0
8
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
578
0
0
0
6.827

29.456
1.455
0
0
0
450
0
0
0
10
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
31.371
columns 5.2 - 5.5 refer to the legislation imposing that the test be carried out and
not to the body which has issued the actual test method, guideline or protocol.
a test required by French legislation and carried out in Belgium according to an
ISO protocol must be coded as a national (FR) legislative requirement and be
entered into column 5.2 in the tables submitted by Belgium.

208.558
7.864
18.923
0
0
7932
0
0
6
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
243.283

568.716
17.028
54.776
6.102
15
20.072
224
410
6
10
97
1.846
0
217
255
0
0
519
0
0
0
64.788
0
0
0
735.081

5.2 – France is testing due to a UK (or FR) specific requirement
5.3 - UK is testing according to EC legislation
5.4 – Spain is testing due to a Hungarian requirement
5.5 – Sweden is testing due to a US specific requirement
5.6  –  Germany  is  testing  due  to  a  Czech  requirement  (also  an  EC
requirement)
1)
2) Member Countries of Council of Europe (non-EC): Albania, Andorra, Bulgaria, Croatia, Cyprus, Czech Rep., Estonia, Hungary, Iceland, Latvia, Liechtenstein, Lithuania, Malta,

EC Member States: Austria, Belgium, Denmark, Finland, France, Germany, Greece, Ireland, Italy, Luxembourg, Netherlands, Portugal, Spain, Sweden, United Kingdom

Example:

Note:

Footnotes:

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

90

TABLE 6:

NUMBER OF ANIMALS USED IN TOXICOLOGICAL AND OTHER SAFETY EVALUATIONS

6.1
Species

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

6.3
EC legislation
including European
Pharmacopoeia
(requirements)

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

6.5
Other legislation

6.6
Any combination of
6.2/ 6.3/ 6.4/ 6.5

6.7
No regulatory
requirements

6.8
Total

Regulatory requirements versus species

Mice
Rats
Guinea-Pigs
Hamsters
Other Rodents
Rabbits
Cats
Dogs
Ferrets
Other Carnivores
Horses, donkeys and cross breds
Pigs
Goats
Sheep
Cattle
Prosimians
New World Monkeys
Old World Monkeys
Apes
Other Mammals
Quail
Other birds
Reptiles
Amphibians
Fish
TOTAL

6.a.
6.b.
6.c.
6.d.
6.e.
6.f.
6.g.
6.h.
6.i.
6.j.
6.k.
6.l.
6.m.
6.n.
6.o.
6.p.
6.q.
6.r.
6.s.
6.t.
6.u.
6.v.
6.w.
6.x.
6.y.
6.z.
Examples:

950
1.392
0
0
0
124
0
12
0
0
0
4
0
0
0
0
0
0
0
0
0
70
0
0
0
2.552

3.455
4.319
941
26
0
1.138
24
20
0
0
46
79
0
57
23
0
0
0
0
0
0
134
0
0
20
10.282

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

8.582
1.581
424
0
0
2.040
0
3
0
0
0
14
0
0
0
0
0
40
0
0
0
0
0
0
500
13.184

4.512
6.515
1.084
175
0
92
0
103
0
0
0
0
0
0
0
0
0
40
0
270
0
282
0
0
1.502
14.575
columns 6.2 - 6.5 refer to the legislation imposing that the test be carried out and
not to the body which has issued the actual test method, guideline or protocol.
a test required by French legislation and carried out in Belgium according to an
ISO protocol must be coded as a national (FR) legislative requirement and be
entered into column 6.2 in the tables submitted by Belgium.

21.107
42.136
3.974
20
0
3.317
160
2.348
0
0
0
55
0
187
0
0
0
877
0
0
0
0
0
0
0
74.181

38.606
55.943
6.423
221
0
6.711
184
2.486
0
0
46
152
0
244
23
0
0
957
0
270
0
486
0
0
2.022
114.774

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

EC Member States: Austria, Belgium, Denmark, Finland, France, Germany, Greece, Ireland, Italy, Luxembourg, Netherlands, Portugal, Spain, Sweden, United Kingdom

Example:

Note:

Footnotes:

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

91

TABLE 7:

NUMBER OF ANIMALS USED IN TOXICOLOGICAL AND OTHER SAFETY EVALUATIONS

7.1
Species

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

7.3
Skin
irritation

7.4
Skin
sensitisatio
n

7.5
Eye
irritation

7.6
Sub-
chronic and
chronic
toxicity

7.7
Carcino-
genicity

7.8
Develop-
mental
toxicity

7.9
Muta-
genicit
y

7.10
Repro-
ductive
toxicity

Types of tests versus species

7.12
Other

7.13
Total

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

7.2.1.
LD50,
LC50

7.2.2
Other lethal
methods

7.2.3
Non lethal
clinical signs
methods

7.a.
7.b.
7.c.
7.d.
7.e.
7.f.
7.g.
7.h.
7.i.
7.j.
7.k.

7.l..
7.m.
7.n.
7.o.
7.p.
7.q.
7.r.
7.s.
7.t.
7.u.
7.v.
7.w.
7.x.
7.y.
7.z.

Mice
Rats
Guinea-Pigs
Hamsters
Other Rodents
Rabbits
Cats
Dogs
Ferrets
Other Carnivores
Horses,  donkeys  and  cross
breds
Pigs
Goats
Sheep
Cattle
Prosimians
New World Monkeys
Old World Monkeys
Apes
Other Mammals
Quail
Other birds
Reptiles
Amphibians
Fish
TOTAL

3.035
2.671
0
0
0
0
0
0
0
0

0
0
0
0
0
0
0
0
0
270
0
269
0
0
0
6.245

3.282
1.789
79
0
0
15
0
0
0
0

0
0
0
0
0
0
0
7
0
0
0
0
0
0
1.502
6.674

7.096
8.414
62
40
0
397
0
341
0
6

0
8
0
6
0
0
0
49
0
0
0
133
0
0
112
16.664

0
259
281
20
0
870
0
95
0
0

0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
1.525

0
0
4.335
0
0
0
0
0
0
0

0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
4.335

92

0
0
0
0
0
771
0
0
0
0

0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
771

7.111
18.604
0
0
0
641
184
1.699
0
0

22
20
0
0
12
0
0
901
0
0
0
84
0
0
100
29.378

1.280
2.834
0
0
0
0
0
0
0
0

0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
4.114

0
4.394
0
0
0
1.375
0
0
0
0

0
39
0
0
0
0
0
0
0
0
0
0
0
0
100
5.908

1.073
3.678
0
20
0
0
0
0
0
0

0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
4.771

550
3.205
0
0
0
459
0
0
0
0

0
0
0
0
0
0
0
0
0
0
0
0
0
0
100
4.314

0
0
0
0
0
0
0
0
0
0

0
0
0
0
0
0
0
0
0
0
0
0
0
0
100
100

15.219
10.095
1.666
141
0
2.491
0
351
0
0

18
85
20
224
5
0
0
40
0
0
0
0
0
0
40
30.395

38.646
55.943
6.423
221
0
7.019
184
2.486
0
6

40
152
20
230
17
0
0
997
0
270
0
486
0
0
2.054
115.194

TABLE 8:

NUMBER OF ANIMALS USED IN TOXICOLOGICAL AND OTHER SAFETY EVALUATIONS

8.1
Products

Types of tests versus products

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

8.3
Skin
irritation

8.4
Skin
sensitisatio
n

8.5
Eye
irritation

8.7
Carcino
genicity

8.8
Develop-
mental
toxicity

8.9
Muta-
genicit
y

8.10
Repro-
ductive
toxicity

8.6
Sub-
chronic
and
chronic
toxicity

8.12
Other

8.13
Total

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

8.a.

8.b.

8.c.

8.d.

8.e.

8.f.

8.g.

8.h.

8.i.

8.j.

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

safety

or 

8.2.1.
LD50,
LC50

8.2.2
Other lethal
methods

8.2.3
Non lethal
clinical signs
methods

3.542

5.158

14.733

904

2.827

567

26.338

5.754

4.026

4.225

3.359

1.349

172

0

0

0

0

0

170

0

0

48

252

42

60

45

100

288

736

179

0

0

0

0

0

0

0

0

0

0

5.351

500

142

0

120

0

0

0

30

100

1.249

0

0

260

0

0

0

81

0

0

0

0

0

0

0

0

0

100

550

0

0

0

0

0

0

0

56

0

0

0

0

137

0

100

0

0

0

0

0

0

0

38

180

1.219

0

29.204

5.934

4.676

4.418

3.459

720

6.674

1.500

179

16.627

1.525

746

4.335

93

771

93

0

0

0

0

0

0

0

0

0

0

25.482

96.915

100

2.497

1.424

3.845

0

42

20

426

729

2.192

0

0

274

629

4.119

8.576

32.148 115.122

IRELAND

Statistical data submitted

The  1999  statistical  data  for  Ireland  have  been  provided  by  the  Department  of  Health  and
Children.

Comments of Irish authorities

General

(cid:1)  A total of 73,929 animals were used, this represents an increase of 7% from 1998.

(cid:1)  There were 456 valid licences during this period.

(cid:1)  182  new  licences  were  issued  in  1999,  this  was  a  reduction  of  27%  in  the  number  of

licences issued the previous year.

(cid:1)  Rodents accounted for 63% of all animals used.

(cid:1)  No primates were used. This was in accordance with Ireland’s policy not to licence for the

use of primates.

(cid:1)  Of  the  animals  used,  66%  (48,913)  were  bred  in  registered  breeding  establishments  in

Ireland.

(cid:1)  Commercial concerns accounted for 26% (19,165) of the animals used. This represents a

reduction of 5% from 1998 in the commercial use of animals.

(cid:1)  Universities  and  Colleges  accounted  for  37%  (27,507)  of  all  animals  used  in  scientific

procedures.

(cid:1)  58% of all procedures (49,922) used no anaesthesia, usually because the procedure was so

minor that anaesthesia was inappropriate.

(cid:1)  6%  of  animals  (4,524)  were  used  in  procedures  involving  anaesthesia  with  permitted

recovery (Certificate B).

(cid:1)  691 genetically modified animals were used in experimental activity. This represents 1%

of the total numbers used.

Animals Used for Selected Purposes

(cid:1)  32% of animals (23,463) were involved in studies specific to animal diseases.

(cid:1)  20,000 fish (over 99% of all fish used) were used in the regulatory monitoring of infection

in farmed stocks.

(cid:1)  Of the 844 pigs used in 1999, 78% were involved in studies on animal diseases.

94

(cid:1)  129 cats were used in total, 87% (112) of which were used in studies on feline disease.

(cid:1)  312 dogs were used in 1999, of which 132 were used in studies on human disease.

(cid:1)  Approximately 10% of the animals were used for studies on human nervous and  mental

disorders.

(cid:1)  Education and training accounted for 2.5% of the animals used.

Toxicological and other Safety Evaluations

(cid:1)  No animals were used in the testing of cosmetic products.

(cid:1)  Toxicological and other safety evaluations accounted for 17%  (12,347) of  animals used.

97% of these tests were conducted to comply with legislation.

(cid:1)  90% of the animals used in toxicological and other safety evaluations were mice.

(cid:1)  No animals were used to conduct LD50 or LC50 tests.

95

TABLE 1:

NUMBER OF ANIMALS USED IN RELATION TO THEIR PLACE OF ORIGIN

1.1
Species

Origin versus species

1.2
Total

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

1.4
Animals coming from
elsewhere in the EC

1.6
Animals coming from
other origins

1.7
Re-used animals

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

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

Mice (Mus musculus)
Rats (Rattus norvegicus)
Guinea-Pigs (Cavia porcellus)
Hamsters (Mesocricetus )
Other Rodents (other Rodentia)
Rabbits (Oryctolagus cuniculus)
Cats (Felis catus)
Dogs (Canis familiaris)
Ferrets (Mustela putorius furo)
Other Carnivores (other Carnivora)
Horses, donkeys and cross breds (Equidae)
Pigs (Sus)
Goats (Capra)
Sheep (Ovis)
Cattle (Bos)
Prosimians (Prosimia)
New World Monkeys (Ceboidea)
Old World Monkeys (Cercopithecoidea)
Apes (Hominoidea)
Other Mammals (other Mammalia)
Quail (Coturnix coturnix)
Other birds (other Aves)
Reptiles (Reptilia)
Amphibians (Amphibia)
Fish (Pisces)
TOTAL

31251
14484
1041
133
0
915
129
312
0
0
192
844
0
1472
1862
0
0
0
0
13
0
1229
0
0
20052
73929

29244
11940
1041
6

814
129
304
0

0
0
0
0

0

1851
2544
0
108

101
0
0
0

0
0
0
0

0

0
0
0
0

0
0
8
0

0
0
0
0

0

156
0
0
19

0
0
0
0

0
0
0
0

0

0
12
93
0

0
0
0
0

Note 1:

Column 1.5 concerns only those Member Countries of the Council of Europe which, at the beginning of the reporting period, are Parties to the Convention ETS 123. Thus an updated list of
those countries has to be used when filling in this column.

Note 2:

Only the white boxes need to be completed.

Note 3:

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

96

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
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

2.4
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

2.3
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.a.
2.b.
2.c.
2.d.
2.e.
2.f.
2.g.
2.h.
2.i.
2.j.
2.k.

2.l.
2.m.
2.n.
2.o.
2.p.
2.q.
2.r.
2.s.
2.t.
2.u.
2.v.
2.w.
2.x.
2.y.
2.z.

Mice
Rats
Guinea-Pigs
Hamsters
Other Rodents
Rabbits
Cats
Dogs
Ferrets
Other Carnivores
Horses,  donkeys  and  cross
breds
Pigs
Goats
Sheep
Cattle
Prosimians
New World Monkeys
Old World Monkeys
Apes
Other Mammals
Quail
Other birds
Reptiles
Amphibians
Fish
TOTAL

5700
6260
0
108
0
301
20
31
0
0
0

129
0
741
649
0
0
0
0
13
0
100
0
0
52
14104

2562
3158
0
25
0
15
92
114
0
0
0

16
0
8
23
0
0
0
0
0
0
320
0
0
0
6333

11142
4324
388
0
0
348
0
5
0
0
0

0
0
0
0
0
0
0
0
0
0
0
0
0
0
16207

380
0
124
0
0
120
0
0
0
0
83

6
0
0
184
0
0
0
0
0
0
12
0
0
0
909

97

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

11040
232
484
0
0
116
17
162
0
0
80

6
0
74
136
0
0
0
0
0
0
0
0
0
0
12347

2.7
Diagnosis of
disease

2.8
Education and
training

2.9
Other

2.10
Total

63
0
9
0
0
2
0
0
0
0
0

539
0
21
65
0
0
0
0
0
0
12
0
0
20000
20711

328
269
36
0
0
4
0
0
0
0
29

18
0
510
250
0
0
0
0
0
0
0
0
0
0
1444

36
241
0
0
0
9
0
0
0
0
0

130
0
118
555
0
0
0
0
0
0
785
0
0
0
1874

31251
14484
1041
133
0
915
129
312
0
0
192

844
0
1472
1862
0
0
0
0
13
0
1229
0
0
20052
73929

TABLE 3:

NUMBER OF ANIMALS USED IN TOXICOLOGICAL AND OTHER SAFETY EVALUATIONS

Products versus species

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

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

3.11
Total

3.10
Other toxico-
logical or
safety
evaluations

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

0
0
0
0
0
0
0
0
0
0
0
0
0
19
0
0
0
0
0
0
0
0
0
0
0
19

10092
0
34
0
0
0
0
0
0
0
0
0
0
22
0
0
0
0
0
0
0
0
0
0
0
10148

11040
232
484
0
0
116
17
162
0
0
80
6
0
74
136
0
0
0
0
0
0
0
0
0
0
12347

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
inteded to
be used
mainly in
industry

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

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

3.a.
3.b.
3.c.
3.d.
3.e.
3.f.
3.g.
3.h.
3.i.
3.j.
3.k.
3.l.
3.m.
3.n.
3.o.
3.p.
3.q.
3.r.
3.s.
3.t.
3.u.
3.v.
3.w.
3.x.
3.y.
3.z.

Mice
Rats
Guinea-Pigs
Hamsters
Other Rodents
Rabbits
Cats
Dogs
Ferrets
Other Carnivores
Horses, donkeys and cross breds
Pigs
Goats
Sheep
Cattle
Prosimians
New World Monkeys
Old World Monkeys
Apes
Other Mammals
Quail
Other birds
Reptiles
Amphibians
Fish
TOTAL

948
232
450
0
0
116
17
162
0
0
80
6
0
33
136
0
0
0
0
0
0
0
0
0
0
2180

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

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

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

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

98

TABLE 4:

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

4.1
Species

4.2
Human cardiovascular
diseases

4.3
Human nervous and
mental disorders

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

4.5
Other human diseases

4.6
Studies specific to animal
diseases

4.7
Total

Main categories versus species

4.a.
4.b.
4.c.
4.d.
4.e.
4.f.
4.g.
4.h.
4.i.
4.j.
4.k.
4.l.
4.m.
4.n.
4.o.
4.p.
4.q.
4.r.
4.s.
4.t.
4.u.
4.v.
4.w.
4.x.
4.y.
4.z.

Mice
Rats
Guinea-Pigs
Hamsters
Other Rodents
Rabbits
Cats
Dogs
Ferrets
Other Carnivores
Horses, donkeys and cross breds
Pigs
Goats
Sheep
Cattle
Prosimians
New World Monkeys
Old World Monkeys
Apes
Other Mammals
Quail
Other birds
Reptiles
Amphibians
Fish
TOTAL

179
1024
0
0
0
40
0
26
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
1269

3352
3777
0
108
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
52
7289

1075
451
0
0
0
4
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
1530

3082
4097
0
4
0
272
0
106
0
0
0
22
0
14
0
0
0
0
0
0
0
0
0
0
0
7597

637
69
9
21
0
2
112
13
0
0
0
662
0
756
737
0
0
0
0
13
0
432
0
0
20000
23463

8325
9418
9
133
0
318
112
145
0
0
0
684
0
770
737
0
0
0
0
13
0
432
0
0
20052
41148

99

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

Mice
Rats
Guinea-Pigs
Hamsters
Other Rodents
Rabbits
Cats
Dogs
Ferrets
Other Carnivores
Horses, donkeys and cross breds
Pigs
Goats
Sheep
Cattle
Prosimians
New World Monkeys
Old World Monkeys
Apes
Other Mammals
Quail
Other birds
Reptiles
Amphibians
Fish
TOTAL

5.a.
5.b.
5.c.
5.d.
5.e.
5.f.
5.g.
5.h.
5.i.
5.j.
5.k.
5.l.
5.m.
5.n.
5.o.
5.p.
5.q.
5.r.
5.s.
5.t.
5.u.
5.v.
5.w.
5.x.
5.y.
5.z.
Examples:

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

11522
4324
512
0
0
468
0
0
0
0
80
6
0
0
112
0
0
0
0
0
0
12
0
0
0
17036

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

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

0
0
0
0
0
0
0
5
0
0
3
0
0
0
72
0
0
0
0
0
0
0
0
0
0
80
columns 5.2 - 5.5 refer to the legislation imposing that the test be carried out and
not to the body which has issued the actual test method, guideline or protocol.
a test required by French legislation and carried out in Belgium according to an
ISO protocol must be coded as a national (FR) legislative requirement and be
entered into column 5.2 in the tables submitted by Belgium.

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

11522
4324
512
0
0
468
0
5
0
0
83
6
0
0
184

0
0
0
0
0
12
0
0
0
17116

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

EC Member States: Austria, Belgium, Denmark, Finland, France, Germany, Greece, Ireland, Italy, Luxembourg, Netherlands, Portugal, Spain, Sweden, United Kingdom

Example:

Note:

Footnotes:

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

100

TABLE 6:

NUMBER OF ANIMALS USED IN TOXICOLOGICAL AND OTHER SAFETY EVALUATIONS

6.1
Species

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

6.3
EC legislation
including European
Pharmacopoeia
(requirements)

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

6.5
Other legislation

6.6
Any combination of
6.2/ 6.3/ 6.4/ 6.5

6.7
No regulatory
requirements

6.8
Total

Regulatory requirements versus species

Mice
Rats
Guinea-Pigs
Hamsters
Other Rodents
Rabbits
Cats
Dogs
Ferrets
Other Carnivores
Horses, donkeys and cross breds
Pigs
Goats
Sheep
Cattle
Prosimians
New World Monkeys
Old World Monkeys
Apes
Other Mammals
Quail
Other birds
Reptiles
Amphibians
Fish
TOTAL

6.a.
6.b.
6.c.
6.d.
6.e.
6.f.
6.g.
6.h.
6.i.
6.j.
6.k.
6.l.
6.m.
6.n.
6.o.
6.p.
6.q.
6.r.
6.s.
6.t.
6.u.
6.v.
6.w.
6.x.
6.y.
6.z.
Examples:

0
0
0
0
0
0
17
39
0
0
0
0
0
28
0
0
0
0
0
0
0
0
0
0
0
84

5522
0
450
0
0
116
0
123
0
0
80
6
0
24
136
0
0
0
0
0
0
0
0
0
0
6457

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

8
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
8

0
232
34
0
0
0
0
0
0
0
0
0
0
22
0
0
0
0
0
0
0
0
0
0
0
288
columns 6.2 - 6.5 refer to the legislation imposing that the test be carried out and
not to the body which has issued the actual test method, guideline or protocol.
a test required by French legislation and carried out in Belgium according to an
ISO protocol must be coded as a national (FR) legislative requirement and be
entered into column 6.2 in the tables submitted by Belgium.

5510
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
5510

11040
232
484
0
0
116
17
162
0
0
80
6
0
74
136
0
0
0
0
0
0
0
0
0
0
12347

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

EC Member States: Austria, Belgium, Denmark, Finland, France, Germany, Greece, Ireland, Italy, Luxembourg, Netherlands, Portugal, Spain, Sweden, United Kingdom

Example:

Note:

Footnotes:

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

101

TABLE 7:

NUMBER OF ANIMALS USED IN TOXICOLOGICAL AND OTHER SAFETY EVALUATIONS

7.1
Species

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

7.3
Skin
irritation

7.4
Skin
sensitisatio
n

7.5
Eye
irritation

7.6
Sub-
chronic and
chronic
toxicity

7.7
Carcino-
genicity

7.8
Develop-
mental
toxicity

7.9
Muta-
genicit
y

7.10
Repro-
ductive
toxicity

Types of tests versus species

7.12
Other

7.13
Total

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

7.2.1.
LD50,
LC50

7.2.2
Other lethal
methods

7.2.3
Non lethal
clinical signs
methods

7.a.
7.b.
7.c.
7.d.
7.e.
7.f.
7.g.
7.h.
7.i.
7.j.
7.k.

7.l..
7.m.
7.n.
7.o.
7.p.
7.q.
7.r.
7.s.
7.t.
7.u.
7.v.
7.w.
7.x.
7.y.
7.z.

Mice
Rats
Guinea-Pigs
Hamsters
Other Rodents
Rabbits
Cats
Dogs
Ferrets
Other Carnivores
Horses,  donkeys  and  cross
breds
Pigs
Goats
Sheep
Cattle
Prosimians
New World Monkeys
Old World Monkeys
Apes
Other Mammals
Quail
Other birds
Reptiles
Amphibians
Fish
TOTAL

10092
0
0
0
0
0
0
0
0
0
0

0
0
0
0
0
0
0
0
0
0
0
0
0
0
10092

0
232
0
0
0
0
0
0
0
0
80

6
0
9
112
0
0
0
0
0
0
0
0
0
0
439

0
0
0
0
0
0
0
0
0
0
0

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

0
0
450
0
0
0
0
0
0
0
0

0
0
0
0
0
0
0
0
0
0
0
0
0
0
450

0
0
0
0
0
0
0
0
0
0
0

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

0
0
0
0
0
0
0
0
0
0
0

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

0
0
0
0
0
0
0
0
0
0
0

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

0
0
0
0
0
0
0
0
0
0
0

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

0
0
0
0
0
0
0
0
0
0
0

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

0
0
0
0
0
0
0
0
0
0
0

0
0
41
0
0
0
0
0
0
0
0
0
0
0
41

0
0
0
0
0
0
0
0
0
0
0

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

948
0
34
0
0
116
17
162
0
0
0

0
0
24
24
0
0
0
0
0
0
0
0
0
0
1325

11040
232
484
0
0
116
17
162
0
0
80

6
0
74
136
0
0
0
0
0
0
0
0
0
0
12347

102

TABLE 8:

NUMBER OF ANIMALS USED IN TOXICOLOGICAL AND OTHER SAFETY EVALUATIONS

8.1
Products

Types of tests versus products

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

8.3
Skin
irritation

8.4
Skin
sensitisatio
n

8.5
Eye
irritation

8.7
Carcino
genicity

8.8
Develop-
mental
toxicity

8.9
Muta-
genicit
y

8.10
Repro-
ductive
toxicity

8.6
Sub-
chronic
and
chronic
toxicity

8.12
Other

8.13
Total

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

8.a.

8.b.

8.c.

8.d.

8.e.

8.f.

8.g.

8.h.

8.i.

8.j.

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

safety

or 

8.2.1.
LD50,
LC50

8.2.2
Other lethal
methods

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

10092

10092

8.2.3
Non lethal
clinical signs
methods

430

0

0

0

0

0

0

0

0

430

0

0

0

0

0

0

0

0

0

0

103

450

0

0

0

0

0

0

0

0

450

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

41

0

41

0

0

0

0

0

0

0

0

0

0

1334

2214

0

0

0

0

0

0

0

0

0

0

0

0

0

41

0

10092

1334

12347

ITALY

Statistical data submitted

The  statistical  data  have  been  submitted  by  the  “Ministero  della  Sanita’  Dipartiemento
Alimenti,  Nutrizione  e  della  Sanità  Pubblica  Veterinaria”  (Ministry  of  Health,  Directorate-
General for Veterinary Public Health, Food and Nutrition).

Comments of Italian authorities

The  collected  data  have  been  entered  into  the  “standard  statistical  tables”  agreed  by  the
competent national authorities in the EU in 1997.

Generally speaking, they confirm the downward trend in the total number of animals used in
experiments, which in 1999 fell below one million.

Species
ALL

1997
1 130 536

1998
1 099 491

1999
959 105

Diff. % 1997-1999
- 15.16 %

Details of the various species of animal:

Species

1997

1998

1999

RATS
GUINEA PIGS
OTHER RODENTS
RABBITS
CATS
DOGS
GOATS
PROSIMIANS
OTHER MAMMALS
OTHER BIRDS
REPTILES

688 145
31 564
2 782
31 004
263
897
45
--
24
6 673
910

579 479
29 471
5 372
22 920
89
876
206
103 (?)
70
24 992
1 739

491 966
18 455
2 428
16 430
29
745
41
--
25
19 931
1 410

Diff. %
1997-1999

- 28.5%
- 41.5%

The tables also include data on animals used for in vitro studies (sacrificed for the removal of
organs,  tissue  and  cells),  for  teaching  purposes  and  for  diagnosis  of  human  and  animal
diseases.

Mice and rats account for 92.4% of the animal species used.

Dogs, cats and simians represent 0.13% of all animals used, i.e. a fall of 26.9% since 1997.
For details of the various species, see Annex 1.

88.58% of the animals are used in basic biological studies, the research and development of
products  and  devices  for  human  medicine,  dentistry  and  veterinary  medicine  and  the
production and quality control of products and devices for human medicine and dentistry.

104

Annex I

2.1 Species

2.a. Mice (Mus musculus)

2.b. Rats (Rattus norvegicus)

2.c. Guinea pigs (Cavia porcellus)

2.d. Hamsters (Mesocricetus)

2.e. Other rodents (other Rodentia)

2.f. Rabbits (Oryctolagus cuniculus)

2.g. Cats (Felis catus)

2.h. Dogs (Canis familiaris)

2.i. Ferrets (Mustela putorius furo)

2.j. Other carnivores (other Carnivora)

2.k. Horses, donkeys and cross-breds (Equidae)

2.l. Pigs (Sus)

2.m. Goats (Capra)

2.n. Sheep (Ovis)

2.m. Cattle (Bos)

2.p. Prosimians (Prosimia)

2.q. New World monkeys (Ceboidea)

2.r. Old World monkeys (Cercopithecoidea)

2.s. Apes (Hominoidea)

2.t. Other mammals (other Mammalia)

2.u. Quail (Coturnix coturnix)

2.v. Other birds (other Aves)

2.w. Reptiles (Reptilia)

2.x. Amphibians (Amphibia)

2.y. Fish (Pisces)

2.z. TOTAL

2.10 1997 Total

2.10 1999 Total

2. Percentage difference

394.310

491.966

18.455

3.565

2.428

16.430

29

745

16

0

20

2.045

41

612

542

0

50

450

0

25

226

19.931

1.410

2.164

3.645

959.105

356.887

688.145

31.564

2.957

2.782

31.004

263

897

8

0

31

1.708

45

415

182

0

27

556

0

24

88

6.673

910

1.725

3.645

1.130.536

105

10,49

-28,51

-41,53

20,56

-12,72

-47,01

-88,97

-16,95

100,00

0,00

-35,48

19,73

-8,89

47,47

197,80

0,00

85,19

-19,06

0,00

4,17

156,82

198,68

54,95

25,45

0,00

-15,16

TABLE 1:

NUMBER OF ANIMALS USED IN RELATION TO THEIR PLACE OF ORIGIN

1.1
Species

Origin versus species

1.2
Total

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

1.4
Animals coming from
elsewhere in the EC

1.6
Animals coming from
other origins

1.7
Re-used animals

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

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

Mice (Mus musculus)
Rats (Rattus norvegicus)
Guinea-Pigs (Cavia porcellus)
Hamsters (Mesocricetus )
Other Rodents (other Rodentia)
Rabbits (Oryctolagus cuniculus)
Cats (Felis catus)
Dogs (Canis familiaris)
Ferrets (Mustela putorius furo)
Other Carnivores (other Carnivora)
Horses, donkeys and cross breds (Equidae)
Pigs (Sus)
Goats (Capra)
Sheep (Ovis)
Cattle (Bos)
Prosimians (Prosimia)
New World Monkeys (Ceboidea)
Old World Monkeys (Cercopithecoidea)
Apes (Hominoidea)
Other Mammals (other Mammalia)
Quail (Coturnix coturnix)
Other birds (other Aves)
Reptiles (Reptilia)
Amphibians (Amphibia)
Fish (Pisces)
TOTAL

410788
500625
18430
2773
629
19030
86
741
16
0
20
1924
64
477
518
0
62
450
0
25
226
15680
1410
2940
3528
980442

390176
491881
11388
1639
459
18711
26
738
4
0
20
1691
58
469
421
0
59
25
0
0
226
14759
1160
2497
3154
939561

11768
7356
70
0
160
10
60
0
12
0
0
233
6
3
94
0
2
163
0
25
0
380
50
0
0
20392

773
204
6972
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
7949

8071
1184
0
1134
10
309
0
3
0
0
0
0
0
5
3
0
1
262
0
0
0
541
200
443
374
12540

2437
1527
17
0
32
739
0
94
0
0
15
6
12
142
3
0
73
100
0
0
0
0
0
20
0
5217

Note 1:

Column 1.5 concerns only those Member Countries of the Council of Europe which, at the beginning of the reporting period, are Parties to the Convention ETS 123. Thus an updated list of
those countries has to be used when filling in this column.

Note 2:

Only the white boxes need to be completed.

Note 3:

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

106

TABLE 2:

NUMBER OF ANIMALS USED IN EXPERIMENTS FOR SELECTED PURPOSES

Purpose versus species

2.1
Species

2.2
Biological
studies of a
fundamenta
l nature

2.a.
2.b.
2.c.
2.d.
2.e.
2.f.
2.g.
2.h.
2.i.
2.j.
2.k.

2.l.
2.m.
2.n.
2.o.
2.p.
2.q.
2.r.
2.s.
2.t.
2.u.
2.v.
2.w.
2.x.
2.y.
2.z.

Mice
Rats
Guinea-Pigs
Hamsters
Other Rodents
Rabbits
Cats
Dogs
Ferrets
Other Carnivores
Horses,  donkeys  and  cross
breds
Pigs
Goats
Sheep
Cattle
Prosimians
New World Monkeys
Old World Monkeys
Apes
Other Mammals
Quail
Other birds
Reptiles
Amphibians
Fish
TOTAL

147044
79135
3903
2245
468
3104
14
32
4
0
5

415
26
156
78
0
28
6
0
25
66
3463
1410
2184
2460
246271

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)

136132
110252
1324
1259
1680
6505
0
291
12
0
0

466
0
93
26
0
22
70
0
0
0
7048
0
0
0
265180

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

41229
16901
2675
31
0
1805
11
416
0
0
0

52
0
27
0
0
0
317
0
0
0
3785
0
0
374
67623

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

47910
281652
8908
0
0
3826
4
0
0
0
0

0
0
0
0
0
0
56
0
0
0
0
0
0
0
342356

978
1962
10
0
0
174
0
0
0
0
0

171
0
35
84
0
0
0
0
0
160
3997
0
0
0
7571

107

2.7
Diagnosis of
disease

2.8
Education and
training

2.9
Other

2.10
Total

15027
439
615
60
280
108
0
0
0
0
0

4
0
56
7
0
0
0
0
0
0
40
0
0
0
16636

363
2173
8
0
0
22
0
0
0
0
0

92
0
30
16
0
0
0
0
0
0
0
0
0
11
2715

7798
1598
1031
0
0
961
0
6
0
0
15

849
15
223
331
0
0
1
0
0
0
1598
0
0
800
15226

396481
494112
18474
3595
2428
16505
29
745
16
0
20

2049
41
620
542
0
50
450
0
25
226
19931
1410
2184
3645
963578

TABLE 3:

NUMBER OF ANIMALS USED IN TOXICOLOGICAL AND OTHER SAFETY EVALUATIONS

Products versus species

3.7
Products/
substances
used or
intended to be
used mainly
as additives in
food for
human
consumption
9472
66
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
9538

3.8
Products/
substances
used or
intended to be
used mainly
as additives in
food for
animal
consumption
0
187
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
187

3.11
Total

3.10
Other toxico-
logical or
safety
evaluations

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

308
44
0
0
0
11
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
363

14412
4167
1272
0
0
317
0
36
0
0
0
18
0
0
0
0
0
24
0
0
0
15
0
0
22
20283

57732
22911
2650
31
0
2449
3
416
0
0
0
119
0
27
0
0
0
317
0
0
0
4002
0
0
614
91271

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
inteded to
be used
mainly in
industry

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

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

3.a.
3.b.
3.c.
3.d.
3.e.
3.f.
3.g.
3.h.
3.i.
3.j.
3.k.
3.l.
3.m.
3.n.
3.o.
3.p.
3.q.
3.r.
3.s.
3.t.
3.u.
3.v.
3.w.
3.x.
3.y.
3.z.

Mice
Rats
Guinea-Pigs
Hamsters
Other Rodents
Rabbits
Cats
Dogs
Ferrets
Other Carnivores
Horses, donkeys and cross breds
Pigs
Goats
Sheep
Cattle
Prosimians
New World Monkeys
Old World Monkeys
Apes
Other Mammals
Quail
Other birds
Reptiles
Amphibians
Fish
TOTAL

32102
16672
940
31
0
1917
3
380
0
0
0
101
0
27
0
0
0
292
0
0
0
3987
0
0
240
56692

0
98
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
98

678
200
0
0
0
12
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
890

108

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
TABLE 4:

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

4.1
Species

4.2
Human cardiovascular
diseases

4.3
Human nervous and
mental disorders

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

4.5
Other human diseases

4.6
Studies specific to animal
diseases

4.7
Total

Main categories versus species

4.a.
4.b.
4.c.
4.d.
4.e.
4.f.
4.g.
4.h.
4.i.
4.j.
4.k.
4.l.
4.m.
4.n.
4.o.
4.p.
4.q.
4.r.
4.s.
4.t.
4.u.
4.v.
4.w.
4.x.
4.y.
4.z.

Mice
Rats
Guinea-Pigs
Hamsters
Other Rodents
Rabbits
Cats
Dogs
Ferrets
Other Carnivores
Horses, donkeys and cross breds
Pigs
Goats
Sheep
Cattle
Prosimians
New World Monkeys
Old World Monkeys
Apes
Other Mammals
Quail
Other birds
Reptiles
Amphibians
Fish
TOTAL

8728
10047
644
1144
0
1234
6
65
0
0
0
49
2
29
2
0
0
0
0
0
0
8
0
20
0
21978

31020
44607
67
420
1712
104
0
30
0
0
0
8
0
0
0
0
22
0
0
0
0
534
0
41
0
78565

58763
8904
70
12
0
491
3
122
12
0
0
8
0
0
0
0
0
162
0
0
0
0
0
0
0
68547

112714
43042
1194
53
0
2906
60
312
4
0
0
241
0
38
0
0
0
128
0
0
0
50
0
830
0
161572

5179
336
596
60
290
183
0
0
0
0
0
45
0
0
7
0
0
0
0
0
0
246
0
0
0
6942

216404
106936
2571
1689
2002
4918
69
529
16
0
0
351
2
67
9
0
22
290
0
0
0
838
0
891
0
337604

109

TABLE 5:

NUMBER OF ANIMALS USED IN PRODUCTION AND QUALITY CONTROL OF PRODUCTS AND DEVICES FOR HUMAN

MEDICINE AND DENTISTRY AND FOR VETERINARY MEDICINE

5.1
Species

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

5.3
EC legislation
including European
Pharmacopoeia
(requirements)

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

5.5
Other legislation

5.6
Any combination of
5.2/ 5.3/ 5.4/ 5.5

5.7
No regulatory
requirements

5.8
Total

Regulatory requirements versus species

Mice
Rats
Guinea-Pigs
Hamsters
Other Rodents
Rabbits
Cats
Dogs
Ferrets
Other Carnivores
Horses, donkeys and cross breds
Pigs
Goats
Sheep
Cattle
Prosimians
New World Monkeys
Old World Monkeys
Apes
Other Mammals
Quail
Other birds
Reptiles
Amphibians
Fish
TOTAL

5.a.
5.b.
5.c.
5.d.
5.e.
5.f.
5.g.
5.h.
5.i.
5.j.
5.k.
5.l.
5.m.
5.n.
5.o.
5.p.
5.q.
5.r.
5.s.
5.t.
5.u.
5.v.
5.w.
5.x.
5.y.
5.z.
Examples:

11422
478
2726
0
0
444
65
0
0
0
15
96
0
111
87
0
0
0
0
0
160
1070
0
70
0
16744

0

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

0
columns 5.2 - 5.5 refer to the legislation imposing that the test be carried out and
not to the body which has issued the actual test method, guideline or protocol.
a test required by French legislation and carried out in Belgium according to an
ISO protocol must be coded as a national (FR) legislative requirement and be
entered into column 5.2 in the tables submitted by Belgium.

EC Member States: Austria, Belgium, Denmark, Finland, France, Germany, Greece, Ireland, Italy, Luxembourg, Netherlands, Portugal, Spain, Sweden, United Kingdom

Example:

Note:

16744

0

0

0

Footnotes:

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

110

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
TABLE 6:

NUMBER OF ANIMALS USED IN TOXICOLOGICAL AND OTHER SAFETY EVALUATIONS

6.1
Species

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

6.3
EC legislation
including European
Pharmacopoeia
(requirements)

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

6.5
Other legislation

6.6
Any combination of
6.2/ 6.3/ 6.4/ 6.5

6.7
No regulatory
requirements

6.8
Total

Regulatory requirements versus species

Mice
Rats
Guinea-Pigs
Hamsters
Other Rodents
Rabbits
Cats
Dogs
Ferrets
Other Carnivores
Horses, donkeys and cross breds
Pigs
Goats
Sheep
Cattle
Prosimians
New World Monkeys
Old World Monkeys
Apes
Other Mammals
Quail
Other birds
Reptiles
Amphibians
Fish
TOTAL

6.a.
6.b.
6.c.
6.d.
6.e.
6.f.
6.g.
6.h.
6.i.
6.j.
6.k.
6.l.
6.m.
6.n.
6.o.
6.p.
6.q.
6.r.
6.s.
6.t.
6.u.
6.v.
6.w.
6.x.
6.y.
6.z.
Examples:

6000
357
1472
0
0
99
0
0
0
0
0
18
0
0
0
0
0
0
0
0
0
0
0
0
0
7946

8539
1218
72
0
0
265
0
0
0
0
0
34
0
19
0
0
0
0
0
0
0
775
0
0
0
10922

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

0
21
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
21

8228
57
110
0
0
3
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
240
8638
columns 6.2 - 6.5 refer to the legislation imposing that the test be carried out and
not to the body which has issued the actual test method, guideline or protocol.
a test required by French legislation and carried out in Belgium according to an
ISO protocol must be coded as a national (FR) legislative requirement and be
entered into column 6.2 in the tables submitted by Belgium.

11690
12423
949
31
6
1007
0
384
0
0
0
0
0
0
0
0
0
317
0
0
0
0
0
0
374
27181

34457
14076
2603
31
6
1374
0
384
0
0
0
52
0
19
0
0
0
317
0
0
0
775
0
0
614
54708

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

EC Member States: Austria, Belgium, Denmark, Finland, France, Germany, Greece, Ireland, Italy, Luxembourg, Netherlands, Portugal, Spain, Sweden, United Kingdom

Example:

Note:

Footnotes:

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

111

TABLE 7:

NUMBER OF ANIMALS USED IN TOXICOLOGICAL AND OTHER SAFETY EVALUATIONS

7.1
Species

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

7.3
Skin
irritation

7.4
Skin
sensitisatio
n

7.5
Eye
irritation

7.6
Sub-
chronic and
chronic
toxicity

7.7
Carcino-
genicity

7.8
Develop-
mental
toxicity

7.9
Muta-
genicit
y

7.10
Repro-
ductive
toxicity

Types of tests versus species

7.12
Other

7.13
Total

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

7.2.1.
LD50,
LC50

7.2.2
Other lethal
methods

7.2.3
Non lethal
clinical signs
methods

7.a.
7.b.
7.c.
7.d.
7.e.
7.f.
7.g.
7.h.
7.i.
7.j.
7.k.

7.l..
7.m.
7.n.
7.o.
7.p.
7.q.
7.r.
7.s.
7.t.
7.u.
7.v.
7.w.
7.x.
7.y.
7.z.

Mice
Rats
Guinea-Pigs
Hamsters
Other Rodents
Rabbits
Cats
Dogs
Ferrets
Other Carnivores
Horses,  donkeys  and  cross
breds
Pigs
Goats
Sheep
Cattle
Prosimians
New World Monkeys
Old World Monkeys
Apes
Other Mammals
Quail
Other birds
Reptiles
Amphibians
Fish
TOTAL

1807
1672
60
0
0
6
0
0
0
0
0

0
0
0
0
0
0
0
0
0
0
0
0
0
350
3895

11340
2553
19
0
0
0
0
19
0
0
0

0
0
0
0
0
0
1
0
0
0
0
0
0
0
13932

4945
3833
1016
0
0
639
0
106
0
0
0

18
0
0
0
0
0
118
0
0
0
3770
0
0
0
14445

0
161
70
0
0
262
0
0
0
0
0

0
0
0
0
0
0
0
0
0
0
0
0
0
0
493

0
0
1412
0
0
0
0
0
0
0
0

0
0
0
0
0
0
0
0
0
0
0
0
0
0
1412

0
0
0
31
0
428
0
0
0
0
0

0
0
0
0
0
0
0
0
0
0
0
0
0
0
459

1678
2840
0
0
0
65
0
264
0
0
0

0
0
0
0
0
0
176
0
0
0
0
0
0
0
5023

2685
1525
0
0
0
0
0
0
0
0
0

0
0
0
0
0
0
0
0
0
0
0
0
0
0
4210

1725
549
0
0
0
344
0
0
0
0
0

0
0
0
0
0
0
0
0
0
0
0
0
0
0
2618

861
508
0
0
0
0
0
0
0
0
0

0
0
0
0
0
0
0
0
0
0
0
0
0
0
1369

274
1369
0
0
0
126
0
0
0
0
0

0
0
0
0
0
0
0
0
0
0
0
0
0
0
1769

0
0
0
0
0
0
0
0
0
0
0

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

14362
1249
37
0
0
141
0
27
0
0
0

34
0
19
0
0
0
22
0
518
0
28
0
0
386
16823

39677
16259
2614
31
0
2011
0
416
0
0
0

52
0
19
0
0
0
317
0
518
0
3798
0
0
736
66448

112

TABLE 8:

NUMBER OF ANIMALS USED IN TOXICOLOGICAL AND OTHER SAFETY EVALUATIONS

8.1
Products

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

8.3
Skin
irritation

8.4
Skin
sensitisatio
n

8.5
Eye
irritation

Types of tests versus products

8.7
Carcino
genicity

8.8
Develop-
mental
toxicity

8.9
Muta-
genicit
y

8.10
Repro-
ductive
toxicity

8.6
Sub-
chronic
and
chronic
toxicity

8.12
Other

8.13
Total

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

8.a.

8.b.

8.c.

8.d.

8.e.

8.f.

8.g.

8.h.

8.i.

8.j.

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

safety

or 

8.2.1.
LD50,
LC50

8.2.2
Other lethal
methods

8.2.3
Non lethal
clinical signs
methods

3074

9929

10269

347

934

245

4871

3820

1354

1496

1357

120

0

3960

106

207

25

0

455

0

0

6

0

0

6

40

86

100

352

0

0

0

6

78

0

0

0

0

0

0

0

0

0

0

0

0

570

55

410

0

0

108

0

2

0

0

0

0

0

0

2113

39809

1081

5201

60

1506

352

1478

0

0

3325

10591

14235

453

1412

329

4871

3820

1924

1659

1769

0

3606

47994

113

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
LUXEMBOURG

Statistical data submitted

The  statistical  data  have  been  submitted  by  the  “Ministère  de  l’Agriculture,
Administration des Services Vétérinaires” (Ministry of Agriculture, Administration of
Veterinary Services)

Comments of Luxembourg authorities

No comments

Remark:
Please note that only relevant EU tables containing data are included in this report. No
animals were reported in Tables 3-8.

114

TABLE 1:

NUMBER OF ANIMALS USED IN RELATION TO THEIR PLACE OF ORIGIN

1.1
Species

Origin versus species

1.2
Total

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

1.4
Animals coming
from elsewhere in
the EC

1.5
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

3000
20
20

20

1.a.
1.b.
1.c.
1.d.
1.e.
1.f.
1.g.

1.h.

1.i.

1.j.

1.k.

1.l.

Mice (Mus musculus)
Rats (Rattus norvegicus)
Guinea-Pigs (Cavia porcellus)
Hamsters (Mesocricetus )
Other Rodents (other Rodentia)
Rabbits (Oryctolagus cuniculus)
Cats (Felis catus)

Dogs (Canis familiaris)

Ferrets (Mustela putorius furo)

Other Carnivores (other Carnivora)

Horses, donkeys and cross breds (Equidae)

Pigs (Sus)

1.m.

Goats (Capra)

1.n.

1.o.

1.p.

1.q.

1.r.

1.s.

1.t.

1.u.

1.v.

Sheep (Ovis)

Cattle (Bos)

Prosimians (Prosimia)

New World Monkeys (Ceboidea)

Old World Monkeys (Cercopithecoidea)

Apes (Hominoidea)

Other Mammals (other Mammalia)

Quail (Coturnix coturnix)

Other birds (other Aves)

1.w.

Reptiles (Reptilia)

1.x.

1.y.

1.z.

Amphibians (Amphibia)

Fish (Pisces)

TOTAL

3000
20
20
0

20

0

0

0

0

0

0

0

0

3060

Note 1:

Note 2:
Note 3:

Column 1.5 concerns only those Member Countries of the Council of Europe which, at the beginning of the reporting period, are Parties to the Convention ETS 123. Thus an updated list of
those countries has to be used when filling in this column.
Only the white boxes need to be completed.
The number of re-used animals in column 1.7 should be excluded from the total in the column 1.2

115

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
TABLE 2:

NUMBER OF ANIMALS USED IN EXPERIMENTS FOR SELECTED PURPOSES

2.1
Species

2.2
Biological
studies of a
fundamenta
l nature

2.7
Diagnosis of
disease

2.8
Education and
training

2.9
Other

2.10
Total

Purpose versus species

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

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

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

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

3000
20
20

20

2.a.
2.b.
2.c.
2.d.
2.e.
2.f.
2.g.
2.h.
2.i.
2.j.
2.k.

2.l.
2.m.
2.n.
2.o.
2.p.
2.q.
2.r.
2.s.
2.t.
2.u.
2.v.
2.w.
2.x.
2.y.
2.z.

Mice
Rats
Guinea-Pigs
Hamsters
Other Rodents
Rabbits
Cats
Dogs
Ferrets
Other Carnivores
Horses,  donkeys  and  cross
breds
Pigs
Goats
Sheep
Cattle
Prosimians
New World Monkeys
Old World Monkeys
Apes
Other Mammals
Quail
Other birds
Reptiles
Amphibians
Fish
TOTAL

0

3060

0

0

0

0

0

0

116

3000
20
20
0
0
20
0
0
0
0

0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
3060

THE NETHERLANDS

Statistical data submitted

The statistical data have been submitted by the “Keuringsdienst van  Waren, Ministerie voor
Volksgezondheid, Welzijn en Sport” (Inspectorate for Health Protection Welfare and Sport and
Veterinary Public Health).

Comments of Netherlands authorities

On 5 February 1997, the revised version of the Experiments on Animals Act (1977) entered
into force. This act presents a comprehensive system for regulation of animal experimentation
and  only  covers  vertebrate  animals.  However,  also  invertebrate  species  to  be  designated  by
Order in Council can be brought under the scope of this act.

The  provisions  of  the  European  Directive  on  the  approximation  of  laws,  regulations  and
administrative provisions of the Member States regarding the protection of animals used for
experimental and other scientific purposes (86/609/EEC) have been implemented.

In addition, among others the following provisions have been issued:

- animal experiments using LD50/LC50 methods are prohibited. However, for acute dermal and
acute  respiratory  toxicity  tests  a  general  exemption  is  granted,  due  to  the  lack  of  validated
alternative methods.

- animal experiments for new or existing cosmetics are prohibited.

- every  animal  experiment  to  be  performed  has  to  be  recommended  by  a  recognised  ethical
review committee. Such a committee comprises at least seven members, one of whom is the
chairperson. In addition, such a committee comprises in equal numbers experts in the fields of
animal experiments, experts in the field of alternative methods, experts in the field of animal
welfare  and  protection  and  experts  in  the  field  of  ethical  assessment.  At  least  two  of  these
experts  are  not  involved  in  the  conduct  of  experiments  on  animals.  The  chairperson  and  at
least two members are not in the employ of any licence holder applying to the committee. The
animal welfare officer is involved already at an early stage in the review of experiments and
acts  as  a  permanent  advisor  for  the  ethical  review  committee.  In  2001,  after  a  three  years
period, the functioning of these committees will be evaluated.

Licenses to perform animal experiments are issued by the Minister of Public Health, Welfare
and Sport to a natural or legal person who is a mandated  representative of  an establishment
for  animal  use.  So  licensed,  those  people  are  responsible  for  assuring  that  the  legal
requirements are complied with. The welfare of the experimental animals is supervised by a
qualified veterinarian or another competent person in charge of the licensee.

A  Standing  Committee  advises  the  Minister  on  the  administration  of  the  Act  and  other
related  issues.  The  Committee  consists  of  experts  in  the  field  of  animal  experimentation,
laboratory animal science and animal welfare.

The enforcement of the Act has been commissioned to the Inspectorate for Health Protection
and Veterinary Public Health.

117

The creation of transgenic animals

Within the framework of the Animal Health and Welfare Act (1992) a system of licensing has
entered into force with respect to experiments aiming at a genetic modification of animals. A
national  committee  on  ethical  evaluation  of  genetic  modification  of  animals,  called  the
Committee  on  Animal  Biotechnology  will  advise  the  Minister  of  Agriculture,  Nature
Management  and  Fisheries  on  the  ethical  aspects  of  the  creation  and  the  use  of  transgenic
animals in general and on the admissibility of proposed projects.

In  addition, such projects  have  to  be  evaluated  within  the  framework  of  the  Experiments  of
Animals  Act  and  the  Environmental  Conservation  Act.  Tuning  of  these  three  types  of
evaluation needs due consideration.

In 1999, for the creation of transgenic animals, 39,275 animals were used.

Collection of data

83 establishments (with 330 sub-units) completed the 1999 registration form.

These establishments can be categorized as follows:

a) Universities and university hospitals

b) Other hospitals, regional public health laboratories

c) Public health research institutes

d) Agricultural and veterinary research institutes

e) Other research institutes

f) Industries

g) Schools for vocational training

h) Miscellaneous

16

5

9

10

4

27

10

2

Up to 1999 data of animal experiment had to be registered in advance. Therefore, the degree
of  discomfort  had  to  be  estimated.  However,  as  from  1999  a  new  system  is  in  use  which
obliges licence holders to fill in the forms after the experiment has been performed.

This data collection system is based on

- the old system.

-  additional  national  requirements,  such  as  a  breakdown  of  the  nature  of  the  animals  used:
genetically modified, from the wild, other animals.

-  the  so  called  EU  Tables  to  be  used  by  the  EU  Members  States  to  provide  for  data  to  be
included  in  the  European  Commission’s  report  on  animal  experimentation  to  be  sent  to  the
European Parliament.

118

The killing of an animal without any previous intervention

In the Netherlands, if an animal is killed without any previous intervention in the framework
of  research  or  testing,  e.g.  for  organ/blood  collection,  the  killing  is  considered  to  be  an
experiment. The rationale of this is that the Inspectorate must have the power to supervise the
killing  of  laboratory  animals.  In  1999,  63,920  animals  were  killed  without  previous
intervention.

This is in contrast to the Council of Europe Convention ETS 123 and Directive 86/609/EEC,
where the use of an animal for an experimental or other scientific purpose is not considered an
experiment  if  the  least  painful  method  of  killing  accepted  in  modern  practice  (‘humane’
methods’) is used.

Total number of animals used

In 1999, according to the EU Tables, the total number of animals used was 621,466.

Discomfort and pain prevention

General

As mentioned before, data has to be registered after an experiment has been performed. This
includes data on the degree of discomfort; i.e. experienced discomfort.

Discomfort is defined as a state including impairment of the animal's health, or as appreciable
pain,  injury  or  other  grave  distress  caused  to  the  animal.  For  assessment  of  the  degree  of
discomfort no objective criteria are available. However, respondents are advised to attend to
the effect of interferences on the behaviour and/or on the bodily functioning of the animal.

At  meetings  of  animal  welfare  officers  information  will  be  exchanged  and  discussed  to
promote consensus of opinion.

119

TABLE 1:

NUMBER OF ANIMALS USED IN RELATION TO THEIR PLACE OF ORIGIN

1.1
Species

Origin versus species

1.2
Total

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

1.4
Animals coming from
elsewhere in the EC

1.6
Animals coming from
other origins

1.7
Re-used animals

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

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

Mice (Mus musculus)
Rats (Rattus norvegicus)
Guinea-Pigs (Cavia porcellus)
Hamsters (Mesocricetus )
Other Rodents (other Rodentia)
Rabbits (Oryctolagus cuniculus)
Cats (Felis catus)
Dogs (Canis familiaris)
Ferrets (Mustela putorius furo)
Other Carnivores (other Carnivora)
Horses, donkeys and cross breds (Equidae)
Pigs (Sus)
Goats (Capra)
Sheep (Ovis)
Cattle (Bos)
Prosimians (Prosimia)
New World Monkeys (Ceboidea)
Old World Monkeys (Cercopithecoidea)
Apes (Hominoidea)
Other Mammals (other Mammalia)
Quail (Coturnix coturnix)
Other birds (other Aves)
Reptiles (Reptilia)
Amphibians (Amphibia)
Fish (Pisces)
TOTAL

277774
159758
10246
4661
606
9222
222
803
64
64
219
12299
334
3121
1457
0
42
272
6
45
4738
88085
34
3186
44208
621466

242358
139179
5557
4344

6512
188
503
64

32
166
6

35416
20579
4689
317

2710
34
300

10
106

4738

196
25
173
5

35
175
1

Note 1:

Column 1.5 concerns only those Member Countries of the Council of Europe which, at the beginning of the reporting period, are Parties to the Convention ETS 123. Thus an updated list of
those countries has to be used when filling in this column.

Note 2:

Only the white boxes need to be completed.

Note 3:

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

120

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
TABLE 2:

NUMBER OF ANIMALS USED IN EXPERIMENTS FOR SELECTED PURPOSES

Purpose versus species

2.1
Species

2.2
Biological
studies of a
fundamenta
l nature

2.a.
2.b.
2.c.
2.d.
2.e.
2.f.
2.g.
2.h.
2.i.
2.j.
2.k.

2.l.
2.m.
2.n.
2.o.
2.p.
2.q.
2.r.
2.s.
2.t.
2.u.
2.v.
2.w.
2.x.
2.y.
2.z.

Mice
Rats
Guinea-Pigs
Hamsters
Other Rodents
Rabbits
Cats
Dogs
Ferrets
Other Carnivores
Horses,  donkeys  and  cross
breds
Pigs
Goats
Sheep
Cattle
Prosimians
New World Monkeys
Old World Monkeys
Apes
Other Mammals
Quail
Other birds
Reptiles
Amphibians
Fish
TOTAL

172635
58524
1256
557
476
1227
94
208
53
64

38
5935
239
319
570
0
16
109
0
34
0
25448
0
3053
23937
294792

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

10762
23443
4821
0

4271
41
332

0
336

24
37

7
1

4738
3252

50
20067
72182

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)

56208
21971
1938
4013
120
3392
80
195

126
4316
11
2402
594

19
155
6
11

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

6848
4579
928
83

73
6
38

10
1471

190
148

27418
47844
1201
0

126
0

38
83

73
0

7

51670

231

6387

147227

77021

20761

121

2.7
Diagnosis of
disease

2.8
Education and
training

2.9
Other

2.10
Total

2972
49
20
0
6
13
0

0
41

2

118

3221

886
3348
82
8
4
120
1
30
11

7
117
84
111
108

979
34
83
204
6217

45

45

277774
159758
10246
4661
606
9222
222
803
64
64

219
12299
334
3121
1457
0
42
272
6
45
4738
88085
34
3186
44208
621466

TABLE 3:

NUMBER OF ANIMALS USED IN TOXICOLOGICAL AND OTHER SAFETY EVALUATIONS

Products versus species

3.1
Species

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

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

3.4
Products/
substances
used or
inteded 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

41
23

1375
6560
2880

504

16

3.a.
3.b.
3.c.
3.d.
3.e.
3.f.
3.g.
3.h.
3.i.
3.j.
3.k.
3.l.
3.m.
3.n.
3.o.
3.p.
3.q.
3.r.
3.s.
3.t.
3.u.
3.v.
3.w.
3.x.
3.y.
3.z.

Mice
Rats
Guinea-Pigs
Hamsters
Other Rodents
Rabbits
Cats
Dogs
Ferrets
Other Carnivores
Horses, donkeys and cross breds
Pigs
Goats
Sheep
Cattle
Prosimians
New World Monkeys
Old World Monkeys
Apes
Other Mammals
Quail
Other birds
Reptiles
Amphibians
Fish
TOTAL

3487
13212
1487

3759
41
332

300

36

1
1

322

22978

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

112

3.7
Products/
substances
used or
intended to be
used mainly
as additives in
food for
human
consumption
629
1758

6

3.11
Total

3.10
Other toxico-
logical or
safety
evaluations

5159
1872
415

2

36

24
1

6

10762
23443
4821
0
0
4271
41
332
0
0
0
336
0
24
37
0
7
1
0
0
4738
3252
0
50
20067
72182

4738
2930

342
8074

5173
16492

16

0

2393

0

50
10519
10681

4033
11548

122

TABLE 4:

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

4.1
Species

4.2
Human cardiovascular
diseases

4.3
Human nervous and
mental disorders

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

4.5
Other human diseases

4.6
Studies specific to animal
diseases

4.7
Total

Main categories versus species

4.a.
4.b.
4.c.
4.d.
4.e.
4.f.
4.g.
4.h.
4.i.
4.j.
4.k.
4.l.
4.m.
4.n.
4.o.
4.p.
4.q.
4.r.
4.s.
4.t.
4.u.
4.v.
4.w.
4.x.
4.y.
4.z.

Mice
Rats
Guinea-Pigs
Hamsters
Other Rodents
Rabbits
Cats
Dogs
Ferrets
Other Carnivores
Horses, donkeys and cross breds
Pigs
Goats
Sheep
Cattle
Prosimians
New World Monkeys
Old World Monkeys
Apes
Other Mammals
Quail
Other birds
Reptiles
Amphibians
Fish
TOTAL

19566
9604
20
99

437
4
96

488
71
53

1

3270
17341
150
55

33
43

12
2

30439

20906

80267
7443
100
69

82

26
3

14

132

88136

70240
32048
1214
195
120
2146
26
96
53
0
28
328
35
2447
36

23
214
6
0

28

3
0
109286

22159
678
1376
3818
0
1580
74
198

82
4932

176
704

0

11
0
59574

637
95999

195502
67114
2860
4236
120
4278
147
390
53
0
110
5774
109
2676
740
0
35
231
6
11
0
59602
0
135
637
344766

123

TABLE 5:

NUMBER OF ANIMALS USED IN PRODUCTION AND QUALITY CONTROL OF PRODUCTS AND DEVICES FOR HUMAN

MEDICINE AND DENTISTRY AND FOR VETERINARY MEDICINE

5.1
Species

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

5.3
EC legislation
including European
Pharmacopoeia
(requirements)

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

5.5
Other legislation

5.6
Any combination of
5.2/ 5.3/ 5.4/ 5.5

5.7
No regulatory
requirements

5.8
Total

Regulatory requirements versus species

Mice
Rats
Guinea-Pigs
Hamsters
Other Rodents
Rabbits
Cats
Dogs
Ferrets
Other Carnivores
Horses, donkeys and cross breds
Pigs
Goats
Sheep
Cattle
Prosimians
New World Monkeys
Old World Monkeys
Apes
Other Mammals
Quail
Other birds
Reptiles
Amphibians
Fish
TOTAL

5.a.
5.b.
5.c.
5.d.
5.e.
5.f.
5.g.
5.h.
5.i.
5.j.
5.k.
5.l.
5.m.
5.n.
5.o.
5.p.
5.q.
5.r.
5.s.
5.t.
5.u.
5.v.
5.w.
5.x.
5.y.
5.z.
Examples:

150

70

28034
397
237

12

462

180
115

934

220

30.371

150
25

24

93
132
380

64

1515
50133
737
83

12
6
26

0
397

0

2

4474
1611
680

87
0
12

48
695

83
33

5

2874

2810

34266
52423
2129
83
0
199
6
38
0
0
48
1554
0
263
148
0
0
7
0
0
0
6618
0
0
0
97782

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

10538
columns 5.2 - 5.5 refer to the legislation imposing that the test be carried out and
not to the body which has issued the actual test method, guideline or protocol.
a test required by French legislation and carried out in Belgium according to an
ISO protocol must be coded as a national (FR) legislative requirement and be
entered into column 5.2 in the tables submitted by Belgium.

EC Member States: Austria, Belgium, Denmark, Finland, France, Germany, Greece, Ireland, Italy, Luxembourg, Netherlands, Portugal, Spain, Sweden, United Kingdom

Example:

Note:

55785

199

669

Footnotes:

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

124

TABLE 6:

NUMBER OF ANIMALS USED IN TOXICOLOGICAL AND OTHER SAFETY EVALUATIONS

6.1
Species

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

6.3
EC legislation
including European
Pharmacopoeia
(requirements)

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

6.5
Other legislation

6.6
Any combination of
6.2/ 6.3/ 6.4/ 6.5

6.7
No regulatory
requirements

6.8
Total

Regulatory requirements versus species

Mice
Rats
Guinea-Pigs
Hamsters
Other Rodents
Rabbits
Cats
Dogs
Ferrets
Other Carnivores
Horses, donkeys and cross breds
Pigs
Goats
Sheep
Cattle
Prosimians
New World Monkeys
Old World Monkeys
Apes
Other Mammals
Quail
Other birds
Reptiles
Amphibians
Fish
TOTAL

6.a.
6.b.
6.c.
6.d.
6.e.
6.f.
6.g.
6.h.
6.i.
6.j.
6.k.
6.l.
6.m.
6.n.
6.o.
6.p.
6.q.
6.r.
6.s.
6.t.
6.u.
6.v.
6.w.
6.x.
6.y.
6.z.
Examples:

55
684

38

52

50

30

287

1309
2505

3123
3123

419

45

4096
19638
3453

4231
40
231

1

4738
2942

6611
2702
1368

2
1
4

286

24
7

6
1

23

10762
23443
4821
0
0
4271
41
332
0
0
0
336
0
24
37
0
7
1
0
0
4738
3252
0
50
20067
72182

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

EC Member States: Austria, Belgium, Denmark, Finland, France, Germany, Greece, Ireland, Italy, Luxembourg, Netherlands, Portugal, Spain, Sweden, United Kingdom

50
10896
21981
columns 6.2 - 6.5 refer to the legislation imposing that the test be carried out and
not to the body which has issued the actual test method, guideline or protocol.
a test required by French legislation and carried out in Belgium according to an
ISO protocol must be coded as a national (FR) legislative requirement and be
entered into column 6.2 in the tables submitted by Belgium.

3997
43367

Example:

260
260

482
946

Note:

Footnotes:

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

125

TABLE 7:

NUMBER OF ANIMALS USED IN TOXICOLOGICAL AND OTHER SAFETY EVALUATIONS

7.1
Species

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

7.3
Skin
irritation

7.4
Skin
sensitisatio
n

7.5
Eye
irritation

7.6
Sub-
chronic and
chronic
toxicity

7.7
Carcino-
genicity

7.8
Develop-
mental
toxicity

7.9
Muta-
genicit
y

7.10
Repro-
ductive
toxicity

Types of tests versus species

7.12
Other

7.13
Total

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

7.2.1.
LD50,
LC50

7.2.2
Other lethal
methods

7.2.3
Non lethal
clinical signs
methods

7.a.
7.b.
7.c.
7.d.
7.e.
7.f.
7.g.
7.h.
7.i.
7.j.
7.k.

7.l..
7.m.
7.n.
7.o.
7.p.
7.q.
7.r.
7.s.
7.t.
7.u.
7.v.
7.w.
7.x.
7.y.
7.z.

Mice
Rats
Guinea-Pigs
Hamsters
Other Rodents
Rabbits
Cats
Dogs
Ferrets
Other Carnivores
Horses,  donkeys  and  cross
breds
Pigs
Goats
Sheep
Cattle
Prosimians
New World Monkeys
Old World Monkeys
Apes
Other Mammals
Quail
Other birds
Reptiles
Amphibians
Fish
TOTAL

340
1753
128

2

356
152

4754
5262

24

627
2874

1188
6588
186

19
40
242

60

24
37

7
1

50
2880
11322

587

702

4215

475

28

322

1226
1891
46

78

1741

3820

3372
130

717
7781

3260

6

4358
2790

1068

4945

322

6205
9446

1741

2910
13878

3502

11758

0

1476
893
246

165
1
12

270

310

2691
6064

10762
23443
4821
0
0
4271
41
332
0
0

0
336
0
24
37
0
7
1
0
0
4738
3252
0
50
20067
72182

126

TABLE 8:

NUMBER OF ANIMALS USED IN TOXICOLOGICAL AND OTHER SAFETY EVALUATIONS

8.1
Products

Types of tests versus products

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

8.3
Skin
irritation

8.4
Skin
sensitisatio
n

8.5
Eye
irritation

8.7
Carcino
genicity

8.8
Develop-
mental
toxicity

8.9
Muta-
genicit
y

8.10
Repro-
ductive
toxicity

8.6
Sub-
chronic
and
chronic
toxicity

8.12
Other

8.13
Total

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

8.2.1.
LD50,
LC50

8.2.2
Other lethal
methods

8.2.3
Non lethal
clinical signs
methods

8.a.

8.b.

8.c.

8.d.

8.e.

8.f.

8.g.

8.h.

8.i.

8.j.

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

safety

or 

3598

100

1509

275

1502

724

2166

0

11353

1659

22978

12

496

80

36

29

23

7148

2876

1456

3517

959

2903

44

660

1458

1100

16

342

8074

1519

16492

16

0

735

3

3

947

330

195

180

2393

0

1878

5262

627

675
2874

2506

921
11322

6
1068

510
4945

322

4570

1767
9446

28

112

960

10681

687
1741

3078
13878

2290
3502

210
11758

1404
6064

11548
72182

0

127

AUSTRIA

Statistical data submitted

The  statistical  data  have  been  submitted  by  the  “Bundesministerien  (Land  und
Forstwirtshaft,  Umwelt  und  Wasserwirtschaft,  Soziale  Sicherheit  und  Generationen,
Bildung, Wissenschaft und Kultur)” Federal Ministries (Agriculture and Forestry, the
Environment  and  Water  Resources;  Social  Security  and  the  Generations;  Economic
Affairs and Labour; Education, Science and Culture).

Comments of Austrian authorities

There  is  a  clear  further  downward  trend  in  the  number  of  animal  experiments  and
animals  used  for  experimental  purposes  in  Austria.  The  statistics  on  animal
experiments  for  1999 (the statistics are published  each  year for  the previous  year  in
accordance  with  the Animal Experiments Act) show  that  a  total  of  130 295  animals
were used for experimental purposes in 1999, i.e. 26 953, or about 17%, fewer than in
1998  (157 248).  For  comparison:  1997  (168 696);  1993  (272 371)  and  1992
(308 308). Compared with 1991 (the first year in which statistics were recorded), the
number of animals used has been reduced by almost three-quarters: 482 166 animals
were still being used for experimental purposes in that year.

Following the 1999 amendment to the Animal Experiments Act, BGBl. (Federal Law
Gazette)  No  169/1999,  the  statistics  on  animal  experiments  have  for  the  first  time
been produced in standard EU format. The full animal experiment statistics, with the
tables  for  the  Federal  Ministries  (Agriculture  and  Forestry,  the  Environment  and
Water Resources; Social Security and the Generations; Economic Affairs and Labour;
Education,  Science  and  Culture)  responsible  for  the  implementation  of  the  Animal
Experiments  Act  are  given  on  the  homepage  of  the  Federal  Ministry  for  Education,
Science and Culture under hap://www.bt_nbwk.gy.at/4fte/tierversuch/sta.99.htm.

The right trend in animal experiments

"This  clear  reduction  in  the  numbers  of  animals  used  for  experiments,  a  73%
reduction since 1991, is, " according to Science Minister, Elisabeth Gehrer, "due to at
least two related courses of development in animal experiments":

The three Rs

Firstly  the  three  Rs:  reduction,  refinement  (improvement  of  scientific  methods)  and
replacement  (substitution  of  other  scientific  methods  for  experimental  animals)  by
scientists, researchers and scientific workers themselves and efforts to use alternative
methods as far as possible instead of experiments on animals, as specifically provided
for in the Austrian Animal Experiments Act.

Note:

In addition, in November 1998, during the Austrian EU Presidency (the second half of
the
1998), 

the  Ministry  of  Science  held  a  widely-reported  meeting  on 

128

"Implementation  of  the  3  Rs  -  Targets  in  the  EU,  in  science  and  industry",  in
cooperation  with  the Commission  and  with participants  from  all  EU  Member  States
and, for the first time, the East European candidate countries to support and promote
the aims of the three Rs in the EU framework as well. One of the resolutions adopted
at  this  meeting  was  forwarded  to  the  EU  Council  of  Ministers  and  the  European
Commission  for  further  consideration.  Special  attention  was  recently  drawn  to
Austria's initiatives for the recognition and implementation of methods at Community
level  to  replace  animal  experiments  at  a  follow-up  meeting  held  last  year  in  Berlin
(during  the  German  EU  Presidency)  and  these  initiatives  have  since  been  on  the
agenda at all EU discussions of animal experiments.

A restrictive approach and the promotion of alternative methods

Secondly,  a  restrictive  approach  is  taken  by  all  competent  authorities  as  regards
licences for animal experiments under Austria's strict Animal Experiments Act, which
was  refined  even  further  last  year  and  allows  animal  experiments  only  under  very
restrictive  conditions  and  only  if  the  experimental  objectives  cannot  be  achieved  by
other methods or processes (substitute methods).

Lastly,  the  government's  pro-active  approach,  which  includes  competitions  with
national  awards  for  research  projects  to  find  alternative  methods  and  efforts  to
increase  the  use,  both  within  Austria  and  abroad,  of  procedures  to  replace  animal
experiments,  has  also  made  scientists  and  researchers  more  aware  of  their
responsibility  in  this  area.  The  Ministry  of  Science  has  already  spent  over  SCH  20
million  in  the  last  two  years  on  research  contracts  to  find  substitutes  for  animal
experiments.

Experimental animals mainly rats and mice

The total number of animals used  for experimental purposes in 1999 in Austria  was
130 295: 103 893 rats and mice; 15 056 rabbits; 670 farm animals (sheep, goats, pigs,
cattle, etc.); 3 367 birds; 738 fish; 709 amphibians; 68 dogs and 24 cats.

Publication of

the Austrian Federal Ministry of Economic Affairs and Labour

(Line 30.581/5-III/A/9/2000);

the Austrian Federal Ministry for Social Security and the Generations

(Line 20.903/8-VIII/A/8/2000);

the Austrian Federal Ministry of Agriculture and Forestry, the Environment and

Water Resources

(Line 12 4650/1-I/2U/200) and

129

the Austrian Federal Ministry for Education, Science and Culture

(Line 5436/7-Pr/S/2000)

130

TABLE 1:

NUMBER OF ANIMALS USED IN RELATION TO THEIR PLACE OF ORIGIN

1.1
Species

Origin versus species

1.2
Total

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

1.4
Animals coming from
elsewhere in the EC

1.6
Animals coming from
other origins

1.7
Re-used animals

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

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

Mice (Mus musculus)
Rats (Rattus norvegicus)
Guinea-Pigs (Cavia porcellus)
Hamsters (Mesocricetus )
Other Rodents (other Rodentia)
Rabbits (Oryctolagus cuniculus)
Cats (Felis catus)
Dogs (Canis familiaris)
Ferrets (Mustela putorius furo)
Other Carnivores (other Carnivora)
Horses, donkeys and cross breds (Equidae)
Pigs (Sus)
Goats (Capra)
Sheep (Ovis)
Cattle (Bos)
Prosimians (Prosimia)
New World Monkeys (Ceboidea)
Old World Monkeys (Cercopithecoidea)
Apes (Hominoidea)
Other Mammals (other Mammalia)
Quail (Coturnix coturnix)
Other birds (other Aves)
Reptiles (Reptilia)
Amphibians (Amphibia)
Fish (Pisces)
TOTAL

91194
12699
7367
208
188
15056
24
68
0
0
21
366
23
142
118
0
0
7
0
0
50
1317
0
709
738
130295

19280
7657
1013
0
38
1829
0
33
0
0
9
59
18
88
91
0
0
7
0
0
50
23
0
0
83
30278

64883
4301
6354
208
0
12482
8
21
0
0
0
69
0
26
10
0
0
0
0
0
0
0
0
0
0
88362

35
0
0
0
150
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
185

6996
741
0
0
0
745
16
14
0
0
12
238
5
28
17
0
0
0
0
0
0
1294
0
709
655
11470

80

614

73

127

60

954

Note 1:

Column 1.5 concerns only those Member Countries of the Council of Europe which, at the beginning of the reporting period, are Parties to the Convention ETS 123. Thus an updated list of
those countries has to be used when filling in this column.

Note 2:

Only the white boxes need to be completed.

Note 3:

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

131

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
TABLE 2:

NUMBER OF ANIMALS USED IN EXPERIMENTS FOR SELECTED PURPOSES

Purpose versus species

2.1
Species

2.2
Biological
studies of a
fundamenta
l nature

2.a.
2.b.
2.c.
2.d.
2.e.
2.f.
2.g.
2.h.
2.i.
2.j.
2.k.

2.l.
2.m.
2.n.
2.o.
2.p.
2.q.
2.r.
2.s.
2.t.
2.u.
2.v.
2.w.
2.x.
2.y.
2.z.

Mice
Rats
Guinea-Pigs
Hamsters
Other Rodents
Rabbits
Cats
Dogs
Ferrets
Other Carnivores
Horses,  donkeys  and  cross
breds
Pigs
Goats
Sheep
Cattle
Prosimians
New World Monkeys
Old World Monkeys
Apes
Other Mammals
Quail
Other birds
Reptiles
Amphibians
Fish
TOTAL

8561
5499
129
0
150
839
8
0
0
0

0
46
0
42
50
0
0
0
0
0
0
1192
0
709
83
17308

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)

42764
3292
482
208
0
403
0
54
0
0

0
197
5
58
17
0
0
4
0
0
0
0
0
0
0
47484

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

4140
1419
976
0
0
758
16
0
0
0

0
0
0
0
3
0
0
0
0
0
0
0
0
0
655
7967

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

31713
1446
5694
0
0
12974
0
0
0
0

0
0
2
12
0
0
0
3
0
0
0
5
0
0
0
51849

0
0
0
0
0
0
0
0
0
0

0
0
0
10
0
0
0
0
0
0
0
0
0
0
0
10

132

2.7
Diagnosis of
disease

2.8
Education and
training

2.9
Other

2.10
Total

3657
0
0
0
38
0
0
0
0
0

9
0
0
0
0
0
0
0
0
0
0
0
0
0
0
3704

118
223
86
0
0
82
0
14
0
0

12
123
16
14
48
0
0
0
0
0
0
104
0
0
0
840

241
820
0
0
0
0
0
0
0
0

0
0
0
6
0
0
0
0
0
0
50
16
0
0
0
1133

91194
12699
7367
208
188
15056
24
68
0
0

21
366
23
142
118
0
0
7
0
0
50
1317
0
709
738
130295

TABLE 3:

NUMBER OF ANIMALS USED IN TOXICOLOGICAL AND OTHER SAFETY EVALUATIONS

Products versus species

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

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

3.11
Total

3.10
Other toxico-
logical or
safety
evaluations

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

0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
255
255

795
0
0
0
0
0
16
0
0
0
0
0
0
0
3
0
0
0
0
0
0
0
0
0
0
814

4140
1419
976
0
0
758
16
0
0
0
0
0
0
0
3
0
0
0
0
0
0
0
0
0
655
7967

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
inteded to
be used
mainly in
industry

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

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

3.a.
3.b.
3.c.
3.d.
3.e.
3.f.
3.g.
3.h.
3.i.
3.j.
3.k.
3.l.
3.m.
3.n.
3.o.
3.p.
3.q.
3.r.
3.s.
3.t.
3.u.
3.v.
3.w.
3.x.
3.y.
3.z.

Mice
Rats
Guinea-Pigs
Hamsters
Other Rodents
Rabbits
Cats
Dogs
Ferrets
Other Carnivores
Horses, donkeys and cross breds
Pigs
Goats
Sheep
Cattle
Prosimians
New World Monkeys
Old World Monkeys
Apes
Other Mammals
Quail
Other birds
Reptiles
Amphibians
Fish
TOTAL

2995
500
35
0
0
433
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
3963

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

350
919
941
0
0
325
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
400
2935

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

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

133

TABLE 4:

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

4.1
Species

4.2
Human cardiovascular
diseases

4.3
Human nervous and
mental disorders

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

4.5
Other human diseases

4.6
Studies specific to animal
diseases

4.7
Total

Main categories versus species

4.a.
4.b.
4.c.
4.d.
4.e.
4.f.
4.g.
4.h.
4.i.
4.j.
4.k.
4.l.
4.m.
4.n.
4.o.
4.p.
4.q.
4.r.
4.s.
4.t.
4.u.
4.v.
4.w.
4.x.
4.y.
4.z.

Mice
Rats
Guinea-Pigs
Hamsters
Other Rodents
Rabbits
Cats
Dogs
Ferrets
Other Carnivores
Horses, donkeys and cross breds
Pigs
Goats
Sheep
Cattle
Prosimians
New World Monkeys
Old World Monkeys
Apes
Other Mammals
Quail
Other birds
Reptiles
Amphibians
Fish
TOTAL

272
546
0
0
0
153
0
0
0
0
0
152
4
3
2
0
0
0
0
0
0
7
0
0
0
1139

120
1211
101
0
0
0
0
0
0
0
0
0
0
1
0
0
0
0
0
0
0
0
0
0
0
1433

9326
283
0
0
0
10
0
0
0
0
0
4
0
0
0
0
0
0
0
0
0
0
0
0
0
9623

11818
3960
98
208
0
174
0
5
0
0
0
78
3
79
0
0
0
7
0
0
0
801
0
0
0
17231

30
0
0
0
0
0
16
0
0
0
9
0
0
0
10
0
0
0
0
0
0
0
0
0
0
65

21566
6000
199
208
0
337
16
5
0
0
9
234
7
83
12
0
0
7
0
0
0
808
0
0
0
29491

134

TABLE 5:

NUMBER OF ANIMALS USED IN PRODUCTION AND QUALITY CONTROL OF PRODUCTS AND DEVICES FOR HUMAN

MEDICINE AND DENTISTRY AND FOR VETERINARY MEDICINE

5.1
Species

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

5.3
EC legislation
including European
Pharmacopoeia
(requirements)

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

5.5
Other legislation

5.6
Any combination of
5.2/ 5.3/ 5.4/ 5.5

5.7
No regulatory
requirements

5.8
Total

Regulatory requirements versus species

Mice
Rats
Guinea-Pigs
Hamsters
Other Rodents
Rabbits
Cats
Dogs
Ferrets
Other Carnivores
Horses, donkeys and cross breds
Pigs
Goats
Sheep
Cattle
Prosimians
New World Monkeys
Old World Monkeys
Apes
Other Mammals
Quail
Other birds
Reptiles
Amphibians
Fish
TOTAL

5.a.
5.b.
5.c.
5.d.
5.e.
5.f.
5.g.
5.h.
5.i.
5.j.
5.k.
5.l.
5.m.
5.n.
5.o.
5.p.
5.q.
5.r.
5.s.
5.t.
5.u.
5.v.
5.w.
5.x.
5.y.
5.z.
Examples:

791
444
306
0
0
184
0
0
0
0
0
0
2
12
0
0
0
0
0
0
0
5
0
0
0
1744

12643
0
3377
0
0
12101
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
28121

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

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

0
0
0
0
0
30
0
0
0
0
0
0
0
10
0
0
0
3
0
0
0
0
0
0
0
43
columns 5.2 - 5.5 refer to the legislation imposing that the test be carried out and
not to the body which has issued the actual test method, guideline or protocol.
a test required by French legislation and carried out in Belgium according to an
ISO protocol must be coded as a national (FR) legislative requirement and be
entered into column 5.2 in the tables submitted by Belgium.

18279
1002
2011
0
0
659
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
21951

31713
1446
5694
0
0
12974
0
0
0
0
0
0
2
22
0
0
0
3
0
0
0
5
0
0
0
51859

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

EC Member States: Austria, Belgium, Denmark, Finland, France, Germany, Greece, Ireland, Italy, Luxembourg, Netherlands, Portugal, Spain, Sweden, United Kingdom

Example:

Note:

Footnotes:

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

135

TABLE 6:

NUMBER OF ANIMALS USED IN TOXICOLOGICAL AND OTHER SAFETY EVALUATIONS

6.1
Species

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

6.3
EC legislation
including European
Pharmacopoeia
(requirements)

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

6.5
Other legislation

6.6
Any combination of
6.2/ 6.3/ 6.4/ 6.5

6.7
No regulatory
requirements

6.8
Total

Regulatory requirements versus species

Mice
Rats
Guinea-Pigs
Hamsters
Other Rodents
Rabbits
Cats
Dogs
Ferrets
Other Carnivores
Horses, donkeys and cross breds
Pigs
Goats
Sheep
Cattle
Prosimians
New World Monkeys
Old World Monkeys
Apes
Other Mammals
Quail
Other birds
Reptiles
Amphibians
Fish
TOTAL

6.a.
6.b.
6.c.
6.d.
6.e.
6.f.
6.g.
6.h.
6.i.
6.j.
6.k.
6.l.
6.m.
6.n.
6.o.
6.p.
6.q.
6.r.
6.s.
6.t.
6.u.
6.v.
6.w.
6.x.
6.y.
6.z.
Examples:

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

2180
490
0
0
0
381
16
0
0
0
0
0
0
0
3
0
0
0
0
0
0
0
0
0
0
3070

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

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

0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
columns 6.2 - 6.5 refer to the legislation imposing that the test be carried out and
not to the body which has issued the actual test method, guideline or protocol.
a test required by French legislation and carried out in Belgium according to an
ISO protocol must be coded as a national (FR) legislative requirement and be
entered into column 6.2 in the tables submitted by Belgium.

1960
929
976
0
0
377
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
655
4897

4140
1419
976
0
0
758
16
0
0
0
0
0
0
0
3
0
0
0
0
0
0
0
0
0
655
7967

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

EC Member States: Austria, Belgium, Denmark, Finland, France, Germany, Greece, Ireland, Italy, Luxembourg, Netherlands, Portugal, Spain, Sweden, United Kingdom

Example:

Note:

Footnotes:

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

136

TABLE 7:

NUMBER OF ANIMALS USED IN TOXICOLOGICAL AND OTHER SAFETY EVALUATIONS

7.1
Species

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

7.3
Skin
irritation

7.4
Skin
sensitisatio
n

7.5
Eye
irritation

7.6
Sub-
chronic and
chronic
toxicity

7.7
Carcino-
genicity

7.8
Develop-
mental
toxicity

7.9
Muta-
genicit
y

7.10
Repro-
ductive
toxicity

Types of tests versus species

7.12
Other

7.13
Total

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

7.2.1.
LD50,
LC50

7.2.2
Other lethal
methods

7.2.3
Non lethal
clinical signs
methods

7.a.
7.b.
7.c.
7.d.
7.e.
7.f.
7.g.
7.h.
7.i.
7.j.
7.k.

7.l..
7.m.
7.n.
7.o.
7.p.
7.q.
7.r.
7.s.
7.t.
7.u.
7.v.
7.w.
7.x.
7.y.
7.z.

Mice
Rats
Guinea-Pigs
Hamsters
Other Rodents
Rabbits
Cats
Dogs
Ferrets
Other Carnivores
Horses,  donkeys  and  cross
breds
Pigs
Goats
Sheep
Cattle
Prosimians
New World Monkeys
Old World Monkeys
Apes
Other Mammals
Quail
Other birds
Reptiles
Amphibians
Fish
TOTAL

86
598
0
0
0
0
0
0
0
0

0
0
0
0
0
0
0
0
0
0
0
0
0
0
400
1084

240
373
0
0
0
0
0
0
0
0

0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
613

1695
230
0
0
0
36
0
0
0
0

0
0
0
0
3
0
0
0
0
0
0
0
0
0
0
1964

0
0
0
0
0
165
0
0
0
0

0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
165

0
0
976
0
0
0
0
0
0
0

0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
976

0
0
0
0
0
160
0
0
0
0

0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
160

0
156
0
0
0
0
0
0
0
0

0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
156

0
0
0
0
0
0
0
0
0
0

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

0
0
0
0
0
0
0
0
0
0

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

510
12
0
0
0
0
0
0
0
0

0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
522

0
0
0
0
0
0
0
0
0
0

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

0
0
0
0
0
0
0
0
0
0

0
0
0
0
0
0
0
0
0
0
0
0
0
0
255
255

1609
50
0
0
0
397
16
0
0
0

0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
2072

4140
1419
976
0
0
758
16
0
0
0

0
0
0
0
3
0
0
0
0
0
0
0
0
0
655
7967

137

TABLE 8:

NUMBER OF ANIMALS USED IN TOXICOLOGICAL AND OTHER SAFETY EVALUATIONS

8.1
Products

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

8.3
Skin
irritation

8.4
Skin
sensitisatio
n

8.5
Eye
irritation

Types of tests versus products

8.7
Carcino
genicity

8.8
Develop-
mental
toxicity

8.9
Muta-
genicit
y

8.10
Repro-
ductive
toxicity

8.6
Sub-
chronic
and
chronic
toxicity

8.12
Other

8.13
Total

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

8.2.1.
LD50,
LC50

8.2.2
Other lethal
methods

8.2.3
Non lethal
clinical signs
methods

8.a.

8.b.

8.c.

8.d.

8.e.

8.f.

8.g.

8.h.

8.i.

8.j.

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

safety

or 

66

0

876

0

0

0

0

112

30
1084

450

0

163

0

0

0

0

0

1196

0

0

0

0

0

0

0

3

0

35

0

6

0

0

0

162

941

154

156

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0
613

768
1964

0
165

0
976

0
160

0
156

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

522

0

0

0

0

0

0
522

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

255

0
255

2056

3812

0

0

0

0

0

0

0

16
2072

2974

367

814
7967

138

 
 
 
 
 
 
 
 
PORTUGAL

Statistical data submitted

The  statistical  data  have  been  submitted  by  the  “Ministério  da  Agricultura,
Desenvolviementos  Rural  e  das  Pescas-  Direcção  Geral  Veterinária”  (Ministry  of
Agriculture,  Rural  Development  and  Fisheries-Directorate-General  for  Veterinary
Matters, Directorate for Animal Health Protection, Welfare and Feed)

Comments of Portuguese authorities

1.

2.

To reduce difficulties associated with the completion of the statistical tables
and,  in  the  process,  to  improve  the  quality  of  the  future  statistics,  we  are
going to reword the guidelines as requested earlier by the bodies conducting
experiments on animals.

Preparations  are  being  made  for  further  revision  of  Portugal's  national
legislation  on  the  protection  of  animals  used  for  experimental  and  other
scientific purposes. In principle, the main changes to be made will be:

(cid:1)  to make it compulsory for all bodies using animals for the purposes in question to

have a code of ethics;

(cid:1)  to  change  the  membership  of  the  advisory  committee  set  up  at  national  level  to

include new Ministries and replace the members who have left;

(cid:1)  to add a classification of the level of suffering caused to any animal.

3.

We consider it necessary to lay down uniform criteria at Member State level
for  vocational  training  for  researchers  and  laboratory  technicians  handling
animals  in  order  to  bring  credibility  to  this  category  of  technicians  and
promote equivalence within the European Union.

139

TABLE 1:

NUMBER OF ANIMALS USED IN RELATION TO THEIR PLACE OF ORIGIN

1.1
Species

Origin versus species

1.2
Total

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

1.4
Animals coming from
elsewhere in the EC

17024
5534
1457
895

532

74

1784
3294

3

20

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

Mice (Mus musculus)
Rats (Rattus norvegicus)
Guinea-Pigs (Cavia porcellus)
Hamsters (Mesocricetus )
Other Rodents (other Rodentia)
Rabbits (Oryctolagus cuniculus)
Cats (Felis catus)
Dogs (Canis familiaris)
Ferrets (Mustela putorius furo)
Other Carnivores (other Carnivora)
Horses, donkeys and cross breds (Equidae)
Pigs (Sus)
Goats (Capra)
Sheep (Ovis)
Cattle (Bos)
Prosimians (Prosimia)
New World Monkeys (Ceboidea)
Old World Monkeys (Cercopithecoidea)
Apes (Hominoidea)
Other Mammals (other Mammalia)
Quail (Coturnix coturnix)
Other birds (other Aves)
Reptiles (Reptilia)
Amphibians (Amphibia)
Fish (Pisces)
TOTAL

26020
8848
2170
1182
29
806

94

3
546
138
700
365

301

267
110
79
350
42008

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

516

1.6
Animals coming from
other origins

1.7
Re-used animals

6696
20
713
287
29
271

70

59

Note 1:

Column 1.5 concerns only those Member Countries of the Council of Europe which, at the beginning of the reporting period, are Parties to the Convention ETS 123. Thus an updated list of
those countries has to be used when filling in this column.

Note 2:

Only the white boxes need to be completed.

Note 3:

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

140

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
TABLE 2:

NUMBER OF ANIMALS USED IN EXPERIMENTS FOR SELECTED PURPOSES

2.1
Species

2.2
Biological
studies of a
fundamenta
l nature

2.a.
2.b.
2.c.
2.d.
2.e.
2.f.
2.g.
2.h.
2.i.
2.j.
2.k.

2.l.
2.m.
2.n.
2.o.
2.p.
2.q.
2.r.
2.s.
2.t.
2.u.
2.v.
2.w.
2.x.
2.y.
2.z.

Mice
Rats
Guinea-Pigs
Hamsters
Other Rodents
Rabbits
Cats
Dogs
Ferrets
Other Carnivores
Horses,  donkeys  and  cross
breds
Pigs
Goats
Sheep
Cattle
Prosimians
New World Monkeys
Old World Monkeys
Apes
Other Mammals
Quail
Other birds
Reptiles
Amphibians
Fish
TOTAL

8661
4015
9
1172
29
163

23

292
114
650
354

110

350
15942

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)

800
3262

34

24

301

2.7
Diagnosis of
disease

2.8
Education and
training

2.9
Other

2.10
Total

Purpose versus species

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

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

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

195

20

94

65

134
4
10

3503

573

4498
791
45

7248
143
331

248

130

105

90

30

124

41

461
571
25
10

18

6

3

20
10
10

60

78

654
66
1167

14

6

1

42

1

26020
8848
2170
1182
29
806

94

3
546
138
700
365

301

267
110
79
350
42008

4421

522

4568

5464

7868

1272

1951

141

TABLE 3:

NUMBER OF ANIMALS USED IN TOXICOLOGICAL AND OTHER SAFETY EVALUATIONS

Products versus species

3.1
Species

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

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

3.4
Products/
substances
used or
inteded 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
3100

3.8
Products/
substances
used or
intended to be
used mainly
as additives in
food for
animal
consumption
20

30

3.10
Other toxico-
logical or
safety
evaluations

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

100

392
150

3.11
Total

4498
791
45

130

886
641
15

130

3.a.
3.b.
3.c.
3.d.
3.e.
3.f.
3.g.
3.h.
3.i.
3.j.
3.k.
3.l.
3.m.
3.n.
3.o.
3.p.
3.q.
3.r.
3.s.
3.t.
3.u.
3.v.
3.w.
3.x.
3.y.
3.z.

Mice
Rats
Guinea-Pigs
Hamsters
Other Rodents
Rabbits
Cats
Dogs
Ferrets
Other Carnivores
Horses, donkeys and cross breds
Pigs
Goats
Sheep
Cattle
Prosimians
New World Monkeys
Old World Monkeys
Apes
Other Mammals
Quail
Other birds
Reptiles
Amphibians
Fish
TOTAL

1672

3100

50

100

542

5464

142

TABLE 4:

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

4.1
Species

4.2
Human cardiovascular
diseases

4.3
Human nervous and
mental disorders

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

4.5
Other human diseases

4.6
Studies specific to animal
diseases

4.7
Total

Main categories versus species

4.a.
4.b.
4.c.
4.d.
4.e.
4.f.
4.g.
4.h.
4.i.
4.j.
4.k.
4.l.
4.m.
4.n.
4.o.
4.p.
4.q.
4.r.
4.s.
4.t.
4.u.
4.v.
4.w.
4.x.
4.y.
4.z.

Mice
Rats
Guinea-Pigs
Hamsters
Other Rodents
Rabbits
Cats
Dogs
Ferrets
Other Carnivores
Horses, donkeys and cross breds
Pigs
Goats
Sheep
Cattle
Prosimians
New World Monkeys
Old World Monkeys
Apes
Other Mammals
Quail
Other birds
Reptiles
Amphibians
Fish
TOTAL

150

570

16

70
96

24

166

570

190

5425
679
225
1172

227

47

134
4
10

43

7966

508

9
1467

37

23

6003
1495
234
2639

264
16
70

158
4
10

43

2044

10936

143

TABLE 5:

NUMBER OF ANIMALS USED IN PRODUCTION AND QUALITY CONTROL OF PRODUCTS AND DEVICES FOR HUMAN

MEDICINE AND DENTISTRY AND FOR VETERINARY MEDICINE

5.1
Species

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

5.3
EC legislation
including European
Pharmacopoeia
(requirements)

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

5.5
Other legislation

5.6
Any combination of
5.2/ 5.3/ 5.4/ 5.5

5.7
No regulatory
requirements

5.8
Total

Regulatory requirements versus species

Mice
Rats
Guinea-Pigs
Hamsters
Other Rodents
Rabbits
Cats
Dogs
Ferrets
Other Carnivores
Horses, donkeys and cross breds
Pigs
Goats
Sheep
Cattle
Prosimians
New World Monkeys
Old World Monkeys
Apes
Other Mammals
Quail
Other birds
Reptiles
Amphibians
Fish
TOTAL

5.a.
5.b.
5.c.
5.d.
5.e.
5.f.
5.g.
5.h.
5.i.
5.j.
5.k.
5.l.
5.m.
5.n.
5.o.
5.p.
5.q.
5.r.
5.s.
5.t.
5.u.
5.v.
5.w.
5.x.
5.y.
5.z.
Examples:

370

15

50

435

3503

573

342

90

30

124

4662

3873

588

392

90

30

124

5097

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

columns 5.2 - 5.5 refer to the legislation imposing that the test be carried out and
not to the body which has issued the actual test method, guideline or protocol.
a test required by French legislation and carried out in Belgium according to an
ISO protocol must be coded as a national (FR) legislative requirement and be
entered into column 5.2 in the tables submitted by Belgium.

EC Member States: Austria, Belgium, Denmark, Finland, France, Germany, Greece, Ireland, Italy, Luxembourg, Netherlands, Portugal, Spain, Sweden, United Kingdom

Example:

Note:

Footnotes:

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

144

TABLE 6:

NUMBER OF ANIMALS USED IN TOXICOLOGICAL AND OTHER SAFETY EVALUATIONS

6.1
Species

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

500

Regulatory requirements versus species

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

3300

15

130

350
150

162

30

Mice
Rats
Guinea-Pigs
Hamsters
Other Rodents
Rabbits
Cats
Dogs
Ferrets
Other Carnivores
Horses, donkeys and cross breds
Pigs
Goats
Sheep
Cattle
Prosimians
New World Monkeys
Old World Monkeys
Apes
Other Mammals
Quail
Other birds
Reptiles
Amphibians
Fish
TOTAL

6.a.
6.b.
6.c.
6.d.
6.e.
6.f.
6.g.
6.h.
6.i.
6.j.
6.k.
6.l.
6.m.
6.n.
6.o.
6.p.
6.q.
6.r.
6.s.
6.t.
6.u.
6.v.
6.w.
6.x.
6.y.
6.z.
Examples:

500

3445

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

192
columns 6.2 - 6.5 refer to the legislation imposing that the test be carried out and
not to the body which has issued the actual test method, guideline or protocol.
a test required by French legislation and carried out in Belgium according to an
ISO protocol must be coded as a national (FR) legislative requirement and be
entered into column 6.2 in the tables submitted by Belgium.

EC Member States: Austria, Belgium, Denmark, Finland, France, Germany, Greece, Ireland, Italy, Luxembourg, Netherlands, Portugal, Spain, Sweden, United Kingdom

Example:

Note:

500

Footnotes:

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

145

4312
150
45

130

4637

TABLE 7:

NUMBER OF ANIMALS USED IN TOXICOLOGICAL AND OTHER SAFETY EVALUATIONS

7.1
Species

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

7.3
Skin
irritation

7.4
Skin
sensitisatio
n

7.5
Eye
irritation

7.6
Sub-
chronic and
chronic
toxicity

7.7
Carcino-
genicity

7.8
Develop-
mental
toxicity

7.9
Muta-
genicit
y

7.10
Repro-
ductive
toxicity

Types of tests versus species

7.12
Other

7.13
Total

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

7.a.
7.b.
7.c.
7.d.
7.e.
7.f.
7.g.
7.h.
7.i.
7.j.
7.k.

7.l..
7.m.
7.n.
7.o.
7.p.
7.q.
7.r.
7.s.
7.t.
7.u.
7.v.
7.w.
7.x.
7.y.
7.z.

Mice
Rats
Guinea-Pigs
Hamsters
Other Rodents
Rabbits
Cats
Dogs
Ferrets
Other Carnivores
Horses,  donkeys  and  cross
breds
Pigs
Goats
Sheep
Cattle
Prosimians
New World Monkeys
Old World Monkeys
Apes
Other Mammals
Quail
Other birds
Reptiles
Amphibians
Fish
TOTAL

7.2.1.
LD50,
LC50

7.2.2
Other lethal
methods

3120

30

7.2.3
Non lethal
clinical signs
methods

200

80

100

42

350
150

3812
150
30

50

130

3150

200

80

100

42

550

4122

146

TABLE 8:

NUMBER OF ANIMALS USED IN TOXICOLOGICAL AND OTHER SAFETY EVALUATIONS

8.1
Products

Types of tests versus products

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

8.3
Skin
irritation

8.4
Skin
sensitisatio
n

8.5
Eye
irritation

8.7
Carcino
genicity

8.8
Develop-
mental
toxicity

8.9
Muta-
genicit
y

8.10
Repro-
ductive
toxicity

8.6
Sub-
chronic
and
chronic
toxicity

8.12
Other

8.13
Total

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

8.a.

8.b.

8.c.

8.d.

8.e.

8.f.

8.g.

8.h.

8.i.

8.j.

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

safety

or 

8.2.1.
LD50,
LC50

8.2.2
Other lethal
methods

8.2.3
Non lethal
clinical signs
methods

200

80

3150

42
42

500
3650

200

80

100

100

147

FINLAND

Statistical data submitted

The statistical data have been submitted by the “ Maa – ja metsätalousministeriö Elintarvike-
ja terveysosasto” (Ministry of Agriculture and Forestry, Veterinary and Food Department).

Comments of Finnish authorities

The  amount  of  used  animals  has  grown  a  little  from  the  last  year.  One  explanation  to  that
according  to  the  information  from  the  Provincial  State  Offices  is  the  development  and
increased use of gene technology. The amount of animals, mostly mice, can be quite large in a
single study that develops a new strain with altered genes. The growth in animal numbers is
indeed all due to the increase in the amount of mice.

(cid:1)  Table 1: The  largest  group is mice. Proportion  of mice  is about 39  %  of all  the  animals.
Fish  are  the  second  largest  group  (about  38  %  of  all  the  animals)  and  the  third  largest
group  is  rats  (about  14  %  of  all  the  animals).  There  was  nine  primates  (Old  World
Monkey) used in 1999. Animals that were not used at all are cats, Prosimians, New World
monkeys and apes.

(cid:1)  Table  2:  Biological  studies  of  a  fundamental  nature  (2.2)  are  the  major  purposes  of  the
experiments. The amount of animals used in biological studies of a fundamental nature is
about 86 % compared to all animals used .

(cid:1)  Table 3: The number of animals used in toxicological and other safety evaluations is only
<2 % of all animals used. There has been no testing for cosmetic or toiletries products (3.6)
or  for  products  used  or  intended  to  be  used  mainly  as  additives  in  food  for  human
consumption (3.7).

(cid:1)  Table 4: About 90 % of the used animals are used in studies concerning human diseases or

disorders. The most used animal in studies specific to animal diseases is fish.

(cid:1)  Table  5:  The  proportion  of  animals  used  because  of  EC  legislation  or  European
Pharmacopoeia  requirements  (5.3.)  is  83  %  of  all  the  animals  used  in  production  and
quality  control  of  products  and  devices  for  human  medicine  and  dentistry  and  for
veterinary medicine.

(cid:1)  Table 6: The proportion of animals used with no regulatory requirements (6.7) is 49 % of

all the animals used in toxicological and other safety evaluations.

(cid:1)  Table  7:  Proportion  of  animals  used  in  acute  and  sub-acute  toxicity  testing  using  lethal
methods (7.2.1 and 7.2.2) is about 6 % of all the animals used in testing in toxicological
and other safety evaluations.

(cid:1)  Table  8:  Potential  or  actual  contaminants  in  the  general  environment  (8.h,  38  %)  and
products/substances  or  devices  for  human  medicine  and  dentistry  and  for  veterinary
medicine (8.a, 46 %) are the largest groups that within most of the animals are being used
in the field of toxicological and other safety evaluations.

148

TABLE 1:

NUMBER OF ANIMALS USED IN RELATION TO THEIR PLACE OF ORIGIN

1.1
Species

Origin versus species

1.2
Total

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

1.4
Animals coming from
elsewhere in the EC

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

Mice (Mus musculus)
Rats (Rattus norvegicus)
Guinea-Pigs (Cavia porcellus)
Hamsters (Mesocricetus )
Other Rodents (other Rodentia)
Rabbits (Oryctolagus cuniculus)
Cats (Felis catus)
Dogs (Canis familiaris)
Ferrets (Mustela putorius furo)
Other Carnivores (other Carnivora)
Horses, donkeys and cross breds (Equidae)
Pigs (Sus)
Goats (Capra)
Sheep (Ovis)
Cattle (Bos)
Prosimians (Prosimia)
New World Monkeys (Ceboidea)
Old World Monkeys (Cercopithecoidea)
Apes (Hominoidea)
Other Mammals (other Mammalia)
Quail (Coturnix coturnix)
Other birds (other Aves)
Reptiles (Reptilia)
Amphibians (Amphibia)
Fish (Pisces)
TOTAL

89959
32519
1737
100
1663
1686
0
104
90
1650
93
1163
38
439
614
0
0
9
0
2148
62
5166
182
246
88666
228334

10703
10688
1628
100

643

49

78490
21371
109

1043

55
90

62

1.6
Animals coming from
other origins

1.7
Re-used animals

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

766
460

17

1

8

Note 1:

Column 1.5 concerns only those Member Countries of the Council of Europe which, at the beginning of the reporting period, are Parties to the Convention ETS 123. Thus an updated list of
those countries has to be used when filling in this column.

Note 2:

Only the white boxes need to be completed.

Note 3:

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

149

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
TABLE 2:

NUMBER OF ANIMALS USED IN EXPERIMENTS FOR SELECTED PURPOSES

Purpose versus species

2.7
Diagnosis of
disease

2.8
Education and
training

2.9
Other

2.10
Total

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

980
771

68

36

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

745

51

2818
94
346

122

90

382

2.1
Species

2.2
Biological
studies of a
fundamenta
l nature

2.a.
2.b.
2.c.
2.d.
2.e.
2.f.
2.g.
2.h.
2.i.
2.j.
2.k.

2.l.
2.m.
2.n.
2.o.
2.p.
2.q.
2.r.
2.s.
2.t.
2.u.
2.v.
2.w.
2.x.
2.y.
2.z.

Mice
Rats
Guinea-Pigs
Hamsters
Other Rodents
Rabbits
Cats
Dogs
Ferrets
Other Carnivores
Horses,  donkeys  and  cross
breds
Pigs
Goats
Sheep
Cattle
Prosimians
New World Monkeys
Old World Monkeys
Apes
Other Mammals
Quail
Other birds
Reptiles
Amphibians
Fish
TOTAL

76984
22758
1284

1644
867

45

1002

73
843
38
18
530

9

2140
39
4467
182
53
84977
197953

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)

7118
8103

100

586

13

182

37
78

646

516
17379

3852

796

465
2320

947
1009

150

30
20
1

1

10

861
720

19
28

20
39

23
53

193
761
2717

423
53
55

14

90
648

9

2
6

8

1000
2308

89959
32519
1737
100
1663
1686
0
104
90
1650

93
1163
38
439
614
0
0
9
0
2148
62
5166
182
246
88666
228334

TABLE 3:

NUMBER OF ANIMALS USED IN TOXICOLOGICAL AND OTHER SAFETY EVALUATIONS

3.1
Species

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

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

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

Products versus species

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

253

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

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

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

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

3.11
Total

3.10
Other toxico-
logical or
safety
evaluations

476

48

203
771

53

36

9

6

3.a.
3.b.
3.c.
3.d.
3.e.
3.f.
3.g.
3.h.
3.i.
3.j.
3.k.
3.l.
3.m.
3.n.
3.o.
3.p.
3.q.
3.r.
3.s.
3.t.
3.u.
3.v.
3.w.
3.x.
3.y.
3.z.

Mice
Rats
Guinea-Pigs
Hamsters
Other Rodents
Rabbits
Cats
Dogs
Ferrets
Other Carnivores
Horses, donkeys and cross breds
Pigs
Goats
Sheep
Cattle
Prosimians
New World Monkeys
Old World Monkeys
Apes
Other Mammals
Quail
Other birds
Reptiles
Amphibians
Fish
TOTAL

1063

0

9

259

0

0

0

400
876

65
113

151

980
771
0
0
0
68
0
36
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
465
2320

4.a.
4.b.
4.c.
4.d.
4.e.
4.f.
4.g.
4.h.
4.i.
4.j.
4.k.
4.l.
4.m.
4.n.
4.o.
4.p.
4.q.
4.r.
4.s.
4.t.
4.u.
4.v.
4.w.
4.x.
4.y.
4.z.

Mice
Rats
Guinea-Pigs
Hamsters
Other Rodents
Rabbits
Cats
Dogs
Ferrets
Other Carnivores
Horses, donkeys and cross breds
Pigs
Goats
Sheep
Cattle
Prosimians
New World Monkeys
Old World Monkeys
Apes
Other Mammals
Quail
Other birds
Reptiles
Amphibians
Fish
TOTAL

TABLE 4:

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

Main categories versus species

4.1
Species

4.2
Human cardiovascular
diseases

4.3
Human nervous and
mental disorders

4.5
Other human diseases

4.6
Studies specific to animal
diseases

4.7
Total

23183
7211
990

736

175
16
55
41

449
182
13
200
33251

12

1

10

111

23

6113
6270

32948
19035
1279
100
0
1091
0
23
0
0
0
358
16
55
152
0
0
0
0
0
0
792
182
13
6313
62357

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

2962
1763

7

5144
7874

100

1

13

1647
2187
288

354

176

320

4972

13132

4732

152

TABLE 5:

NUMBER OF ANIMALS USED IN PRODUCTION AND QUALITY CONTROL OF PRODUCTS AND DEVICES FOR HUMAN

MEDICINE AND DENTISTRY AND FOR VETERINARY MEDICINE

5.1
Species

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

54

Regulatory requirements versus species

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

3389
94
356

19

120

41

103

90

382

Mice
Rats
Guinea-Pigs
Hamsters
Other Rodents
Rabbits
Cats
Dogs
Ferrets
Other Carnivores
Horses, donkeys and cross breds
Pigs
Goats
Sheep
Cattle
Prosimians
New World Monkeys
Old World Monkeys
Apes
Other Mammals
Quail
Other birds
Reptiles
Amphibians
Fish
TOTAL

5.a.
5.b.
5.c.
5.d.
5.e.
5.f.
5.g.
5.h.
5.i.
5.j.
5.k.
5.l.
5.m.
5.n.
5.o.
5.p.
5.q.
5.r.
5.s.
5.t.
5.u.
5.v.
5.w.
5.x.
5.y.
5.z.
Examples:

54

3858

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

264
columns 5.2 - 5.5 refer to the legislation imposing that the test be carried out and
not to the body which has issued the actual test method, guideline or protocol.
a test required by French legislation and carried out in Belgium according to an
ISO protocol must be coded as a national (FR) legislative requirement and be
entered into column 5.2 in the tables submitted by Belgium.

EC Member States: Austria, Belgium, Denmark, Finland, France, Germany, Greece, Ireland, Italy, Luxembourg, Netherlands, Portugal, Spain, Sweden, United Kingdom

Example:

Note:

472

0

0

Footnotes:

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

153

3563
94
397
0
0
122
0
0
0
0
0
90
0
382
0
0
0
0
0
0
0
0
0
0
0
4648

TABLE 6:

NUMBER OF ANIMALS USED IN TOXICOLOGICAL AND OTHER SAFETY EVALUATIONS

6.1
Species

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

6.3
EC legislation
including European
Pharmacopoeia
(requirements)

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

6.5
Other legislation

6.6
Any combination of
6.2/ 6.3/ 6.4/ 6.5

6.7
No regulatory
requirements

6.8
Total

Regulatory requirements versus species

Mice
Rats
Guinea-Pigs
Hamsters
Other Rodents
Rabbits
Cats
Dogs
Ferrets
Other Carnivores
Horses, donkeys and cross breds
Pigs
Goats
Sheep
Cattle
Prosimians
New World Monkeys
Old World Monkeys
Apes
Other Mammals
Quail
Other birds
Reptiles
Amphibians
Fish
TOTAL

6.a.
6.b.
6.c.
6.d.
6.e.
6.f.
6.g.
6.h.
6.i.
6.j.
6.k.
6.l.
6.m.
6.n.
6.o.
6.p.
6.q.
6.r.
6.s.
6.t.
6.u.
6.v.
6.w.
6.x.
6.y.
6.z.
Examples:

101

48
150

36

101

234

253
476

203
520

68

504
1247
0
0
0
68
0
36
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
465
2320

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

400
1129
columns 6.2 - 6.5 refer to the legislation imposing that the test be carried out and
not to the body which has issued the actual test method, guideline or protocol.
a test required by French legislation and carried out in Belgium according to an
ISO protocol must be coded as a national (FR) legislative requirement and be
entered into column 6.2 in the tables submitted by Belgium.

EC Member States: Austria, Belgium, Denmark, Finland, France, Germany, Greece, Ireland, Italy, Luxembourg, Netherlands, Portugal, Spain, Sweden, United Kingdom

Example:

65
856

Note:

0

0

Footnotes:

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

154

TABLE 7:

NUMBER OF ANIMALS USED IN TOXICOLOGICAL AND OTHER SAFETY EVALUATIONS

7.1
Species

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

7.3
Skin
irritation

7.4
Skin
sensitisatio
n

7.5
Eye
irritation

7.6
Sub-
chronic and
chronic
toxicity

7.7
Carcino-
genicity

7.8
Develop-
mental
toxicity

7.9
Muta-
genicit
y

7.10
Repro-
ductive
toxicity

Types of tests versus species

7.12
Other

7.13
Total

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

7.a.
7.b.
7.c.
7.d.
7.e.
7.f.
7.g.
7.h.
7.i.
7.j.
7.k.

7.l..
7.m.
7.n.
7.o.
7.p.
7.q.
7.r.
7.s.
7.t.
7.u.
7.v.
7.w.
7.x.
7.y.
7.z.

Mice
Rats
Guinea-Pigs
Hamsters
Other Rodents
Rabbits
Cats
Dogs
Ferrets
Other Carnivores
Horses,  donkeys  and  cross
breds
Pigs
Goats
Sheep
Cattle
Prosimians
New World Monkeys
Old World Monkeys
Apes
Other Mammals
Quail
Other birds
Reptiles
Amphibians
Fish
TOTAL

7.2.1.
LD50,
LC50

7.2.2
Other lethal
methods

7.2.3
Non lethal
clinical signs
methods

262

506

12

18

240
1040

72

300

952
202

106

0

393

759

18

0

27

2028

0

0

0

740
1560

190
285

1890

155

2940
2313
0
0
0
204
0
108
0
0

0
0
0
0
0
0
0
0
0
0
0
0
0
0
1395
9280

TABLE 8:

NUMBER OF ANIMALS USED IN TOXICOLOGICAL AND OTHER SAFETY EVALUATIONS

8.1
Products

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

8.3
Skin
irritation

8.4
Skin
sensitisatio
n

8.5
Eye
irritation

Types of tests versus products

8.7
Carcino
genicity

8.8
Develop-
mental
toxicity

8.9
Muta-
genicit
y

8.10
Repro-
ductive
toxicity

8.6
Sub-
chronic
and
chronic
toxicity

8.12
Other

8.13
Total

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

8.2.1.
LD50,
LC50

8.2.2
Other lethal
methods

8.2.3
Non lethal
clinical signs
methods

8.a.

8.b.

8.c.

8.d.

8.e.

8.f.

8.g.

8.h.

8.i.

8.j.

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

safety

or 

83

676

150

154

1063

3

3

253

6

3

65

9

0

324

0

0

0

370

30

476

876

0

48
131

253

6

0

9

676

0

0

0

520

95

630

48
2320

156

SWEDEN

Statistical data submitted

The  statistical  data  have  been  submitted  by  the  National  Board  for  Laboratory
Animals.

Comments of Swedish authorities

The  deadline  for  submitting  the  statistical  records  covering  the  use  of  laboratory
animals  during  1999  to  the  EU  commission  was  in  June  2000,  a  much  earlier  date
than previous  years. This  resulted  in  some  problems  when  collecting  and  compiling
our  data.  Most  university  researchers  were  prompt  and  submitted  their  reports  in
March,  although  some  were  as  late  as  May  despite  several  reminders  from  the
National  Board  for  Laboratory  Animals  (CFN).  Unfortunately,  three  responsible
researchers had to be warned by legal action over their failure to supply the required
data on their animal experimentation. Hopefully, the collecting of statistical data from
the universities will work smoother next year.

EU-Directive

According  to  the  EU  definition  (Directive  86/609/EEC)  the  number  of  laboratory
animals  used  during  1999  in  Sweden  reached  approx.  324  000.  This  is  a  7.6  %
increase (about 23 000 animals) compared to 1998. The reasons behind this increase
are hard to interpret and could be due to a number of factors including  an increased
input  in  biomedical  research,  more  accurate  reporting  of  the  numbers  of  animals  or
simply just a natural fluctuation. The Swedish statistical record show that throughout
the 1990s, three kinds of animals were predominantly used in animal experimentation,
the  mice,  the  rats  and  fish.  Indeed,  these  three  groups  comprised  about  90%  of  all
laboratory animals used during 1999. The most noticeable change observed for 1999
was  an  increase  in  the  number  of  mice,  which  were  27  000  individuals  more  than
previous  year.  This  probably  reflects  the  increased  use  of  transgenic  mice  in
biomedical  research.  At  the  same  time  the  number  of  rats  used  in  animal
experimentation  decreased.  The  number  of  fish  used  also  increased  during  1999
compared to the previous year.

The Swedish statistical records also indicates that whereas  the number of laboratory
animals  used  by  the  biomedical  companies  remained  the  same  as  in  1998,  the
numbers used in university research increased over the same period.

Specific use of animals

As  in  previous  years  most  laboratory  animals  were  used  in  either  fundamental
biological research (51%) or in development of product/devices (41%) used in human
or  veterinary  medicine.  In  1999,  5%  of  the  animals  were  used  in  toxicological
research,  and  finally,  less  than  3  %  of  the  total  number  of  laboratory  animals  were
used for diagnosing animal diseases. The most common animals used in toxicological
research are mice, rats and fish and to lesser extent dogs and rabbits. Mammals were
mostly  used  in  experiments  concerning  products/substances  or  devices  relating  to

157

human medicine, dentistry  and  veterinary  medicine  whereas  fish  are  mainly  used  in
the evaluation of hazardous environmental substances.

Swedish definition

Apart  from  the  information  required  according  to  the  EU  directive,  Sweden  also
collects  its  own  statistical  data  on  other  use  of  laboratory  animals.  According  to
Swedish  legislation  all  use  of  animals  which  have  a  scientific  purpose  should  be
recorded.  Therefore,  this  statistical  data  includes  all  animals  used  in  behaviour
studies,  feeding  trials  or  animals  being  euthanized  for  the  use  of  their  tissues  and
organs. During 1999 about

228 000 animals were reported according to this definition. The dominating animals
were fish and birds, the latter being mainly roosters in which the comb was used for
extraction of hyaloronic acids.

Transgenic animals

The  Swedish  statistical  records  do  not  separate  the  use  of  transgenic  animals  from
other  laboratory  animals.  In  agreement  with  EU  directive,  Sweden  do  not  regard
breeding of transgenic stocks as an experiment in it self. However, it is regarded as an
experiment when transgenic animals are used in experiments or when new transgenic
strains are created.

158

TABLE 1:

NUMBER OF ANIMALS USED IN RELATION TO THEIR PLACE OF ORIGIN

1.1
Species

Origin versus species

1.2
Total

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

1.4
Animals coming from
elsewhere in the EC

1.6
Animals coming from
other origins

1.7
Re-used animals

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

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

Mice (Mus musculus)
Rats (Rattus norvegicus)
Guinea-Pigs (Cavia porcellus)
Hamsters (Mesocricetus )
Other Rodents (other Rodentia)
Rabbits (Oryctolagus cuniculus)
Cats (Felis catus)
Dogs (Canis familiaris)
Ferrets (Mustela putorius furo)
Other Carnivores (other Carnivora)
Horses, donkeys and cross breds (Equidae)
Pigs (Sus)
Goats (Capra)
Sheep (Ovis)
Cattle (Bos)
Prosimians (Prosimia)
New World Monkeys (Ceboidea)
Old World Monkeys (Cercopithecoidea)
Apes (Hominoidea)
Other Mammals (other Mammalia)
Quail (Coturnix coturnix)
Other birds (other Aves)
Reptiles (Reptilia)
Amphibians (Amphibia)
Fish (Pisces)
TOTAL

184.230
84.374
9.355
315
235
5.031
155
412
132
75
71
3.278
6
104
706
0
6
60
0
353
0
6.920
10
1.585
26.654
324.067

125.871
51.120
1.551
170

4.459
155
402
126

0
6
0
0

0

56.866
32.564
7.804
145

572
0
2
0

0
0
0
0

0

0
0
0
0

0
0
8
0

0
0
0
0

0

1.493
690
0
0

0
0
0
6

0
0
60
0

0

6
9
234
0

0
30
62
0

Note 1:

Column 1.5 concerns only those Member Countries of the Council of Europe which, at the beginning of the reporting period, are Parties to the Convention ETS 123. Thus an updated list of
those countries has to be used when filling in this column.

Note 2:

Only the white boxes need to be completed.

Note 3:

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

159

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
2.1
Species

2.2
Biological
studies of a
fundamenta
l nature

2.a.
2.b.
2.c.
2.d.
2.e.
2.f.
2.g.
2.h.
2.i.
2.j.
2.k.

2.l.
2.m.
2.n.
2.o.
2.p.
2.q.
2.r.
2.s.
2.t.
2.u.
2.v.
2.w.
2.x.
2.y.
2.z.

Mice
Rats
Guinea-Pigs
Hamsters
Other Rodents
Rabbits
Cats
Dogs
Ferrets
Other Carnivores
Horses,  donkeys  and  cross
breds
Pigs
Goats
Sheep
Cattle
Prosimians
New World Monkeys
Old World Monkeys
Apes
Other Mammals
Quail
Other birds
Reptiles
Amphibians
Fish
TOTAL

91617
45041
1013
238
185
1862
96
6
118
75

1637
6
14
144

6
3

353

6097
10
1585
15854
165960

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)

78538
31979
6651
65
50
1265
8
222
12

614

63
50

52

733

TABLE 2:

NUMBER OF ANIMALS USED IN EXPERIMENTS FOR SELECTED PURPOSES

2.7
Diagnosis of
disease

2.8
Education and
training

2.9
Other

2.10
Total

Purpose versus species

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

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

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

6484
15
1569

583

35

5

3213
3138

171
1517

412

160

31
51

2

1463
1847
14
12

75

24

48
465

414

2744
837
108

803

23
527

27
98

90

5257

184230
84374
9355
315
235
5031
155
412
132
75

71
3278
6
104
706
0
6
60
0
353
0
6920
10
1585
26654
324067

1500
121802

8691

0

9210
16133

1772

90
4452

160

TABLE 3:

NUMBER OF ANIMALS USED IN TOXICOLOGICAL AND OTHER SAFETY EVALUATIONS

Products versus species

3.1
Species

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

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

3.4
Products/
substances
used or
inteded 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

3.11
Total

3.10
Other toxico-
logical or
safety
evaluations

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

84
65

3129
3073

412

160

3.a.
3.b.
3.c.
3.d.
3.e.
3.f.
3.g.
3.h.
3.i.
3.j.
3.k.
3.l.
3.m.
3.n.
3.o.
3.p.
3.q.
3.r.
3.s.
3.t.
3.u.
3.v.
3.w.
3.x.
3.y.
3.z.

Mice
Rats
Guinea-Pigs
Hamsters
Other Rodents
Rabbits
Cats
Dogs
Ferrets
Other Carnivores
Horses, donkeys and cross breds
Pigs
Goats
Sheep
Cattle
Prosimians
New World Monkeys
Old World Monkeys
Apes
Other Mammals
Quail
Other birds
Reptiles
Amphibians
Fish
TOTAL

6774

0

15
15

70
70

15
15

0

0

8110
8259

1000
1000

161

3213
3138
0
0
0
412
0
160
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
9210
16133

4.a.
4.b.
4.c.
4.d.
4.e.
4.f.
4.g.
4.h.
4.i.
4.j.
4.k.
4.l.
4.m.
4.n.
4.o.
4.p.
4.q.
4.r.
4.s.
4.t.
4.u.
4.v.
4.w.
4.x.
4.y.
4.z.

Mice
Rats
Guinea-Pigs
Hamsters
Other Rodents
Rabbits
Cats
Dogs
Ferrets
Other Carnivores
Horses, donkeys and cross breds
Pigs
Goats
Sheep
Cattle
Prosimians
New World Monkeys
Old World Monkeys
Apes
Other Mammals
Quail
Other birds
Reptiles
Amphibians
Fish
TOTAL

TABLE 4:

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

Main categories versus species

4.1
Species

4.2
Human cardiovascular
diseases

4.3
Human nervous and
mental disorders

4.5
Other human diseases

4.6
Studies specific to animal
diseases

4.7
Total

1151

15

12
20

33

178

6
76

120

565

4000
6176

158465
75715
9233
258
235
3299
155
228
132
0
0
1961
0
77
76
0
6
60
0
120
0
4234
10
25
4000
258289

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

28802
5344

524

3

75

12276
11656
270
135

559
51
118
2

782

63

27852
23807
421

50
340
48
5
118

7

6
3

2

25

88384
34908
8527
123
173
1856
56
72
12

998

1

57

3592
10

25912

52684

34748

138769

162

TABLE 5:

NUMBER OF ANIMALS USED IN PRODUCTION AND QUALITY CONTROL OF PRODUCTS AND DEVICES FOR HUMAN

MEDICINE AND DENTISTRY AND FOR VETERINARY MEDICINE

5.1
Species

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

5.3
EC legislation
including European
Pharmacopoeia
(requirements)

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

5.5
Other legislation

5.6
Any combination of
5.2/ 5.3/ 5.4/ 5.5

5.7
No regulatory
requirements

5.8
Total

Regulatory requirements versus species

Mice
Rats
Guinea-Pigs
Hamsters
Other Rodents
Rabbits
Cats
Dogs
Ferrets
Other Carnivores
Horses, donkeys and cross breds
Pigs
Goats
Sheep
Cattle
Prosimians
New World Monkeys
Old World Monkeys
Apes
Other Mammals
Quail
Other birds
Reptiles
Amphibians
Fish
TOTAL

5.a.
5.b.
5.c.
5.d.
5.e.
5.f.
5.g.
5.h.
5.i.
5.j.
5.k.
5.l.
5.m.
5.n.
5.o.
5.p.
5.q.
5.r.
5.s.
5.t.
5.u.
5.v.
5.w.
5.x.
5.y.
5.z.
Examples:

274

825

110

4986

1255

581

289
15
314

2

35

5

6484
15
1569
0
0
583
0
0
0
0
0
35
0
0
0
0
0
5
0
0
0
0
0
0
0
8691

274

825

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

660
columns 5.2 - 5.5 refer to the legislation imposing that the test be carried out and
not to the body which has issued the actual test method, guideline or protocol.
a test required by French legislation and carried out in Belgium according to an
ISO protocol must be coded as a national (FR) legislative requirement and be
entered into column 5.2 in the tables submitted by Belgium.

EC Member States: Austria, Belgium, Denmark, Finland, France, Germany, Greece, Ireland, Italy, Luxembourg, Netherlands, Portugal, Spain, Sweden, United Kingdom

Example:

Note:

6822

110

0

Footnotes:

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

163

TABLE 6:

NUMBER OF ANIMALS USED IN TOXICOLOGICAL AND OTHER SAFETY EVALUATIONS

Regulatory requirements versus species

6.1
Species

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

20

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

1245

178

84
65

1864
3073

234

160

Mice
Rats
Guinea-Pigs
Hamsters
Other Rodents
Rabbits
Cats
Dogs
Ferrets
Other Carnivores
Horses, donkeys and cross breds
Pigs
Goats
Sheep
Cattle
Prosimians
New World Monkeys
Old World Monkeys
Apes
Other Mammals
Quail
Other birds
Reptiles
Amphibians
Fish
TOTAL

6.a.
6.b.
6.c.
6.d.
6.e.
6.f.
6.g.
6.h.
6.i.
6.j.
6.k.
6.l.
6.m.
6.n.
6.o.
6.p.
6.q.
6.r.
6.s.
6.t.
6.u.
6.v.
6.w.
6.x.
6.y.
6.z.
Examples:

7440
7460

0

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

1770
1919
columns 6.2 - 6.5 refer to the legislation imposing that the test be carried out and
not to the body which has issued the actual test method, guideline or protocol.
a test required by French legislation and carried out in Belgium according to an
ISO protocol must be coded as a national (FR) legislative requirement and be
entered into column 6.2 in the tables submitted by Belgium.

EC Member States: Austria, Belgium, Denmark, Finland, France, Germany, Greece, Ireland, Italy, Luxembourg, Netherlands, Portugal, Spain, Sweden, United Kingdom

Example:

Note:

1423

5331

0

Footnotes:

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

164

3213
3138
0
0
0
412
0
160
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
9210
16133

TABLE 7:

NUMBER OF ANIMALS USED IN TOXICOLOGICAL AND OTHER SAFETY EVALUATIONS

7.1
Species

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

7.3
Skin
irritation

7.4
Skin
sensitisatio
n

7.5
Eye
irritation

7.6
Sub-
chronic and
chronic
toxicity

7.7
Carcino-
genicity

7.8
Develop-
mental
toxicity

7.9
Muta-
genicit
y

7.10
Repro-
ductive
toxicity

Types of tests versus species

7.12
Other

7.13
Total

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

7.a.
7.b.
7.c.
7.d.
7.e.
7.f.
7.g.
7.h.
7.i.
7.j.
7.k.

7.l..
7.m.
7.n.
7.o.
7.p.
7.q.
7.r.
7.s.
7.t.
7.u.
7.v.
7.w.
7.x.
7.y.
7.z.

Rats
Guinea-Pigs
Hamsters
Other Rodents
Rabbits
Cats
Dogs
Ferrets
Other Carnivores
Horses,  donkeys  and  cross
breds
Pigs
Goats
Sheep
Cattle
Prosimians
New World Monkeys
Old World Monkeys
Apes
Other Mammals
Quail
Other birds
Reptiles
Amphibians
Fish
TOTAL

7.2.1.
LD50,
LC50

7.2.2
Other lethal
methods

647
237

7.2.3
Non lethal
clinical signs
methods

1832
1060

78

80

342
843

64

382

124

633

320

10
241

14

16

0

1000
1884

400
3372

78

0

0

1249

0

5400
6353

382

270
394

2140
2140

281

165

3213
3138
0
0
0
412
0
160
0
0

0
0
0
0
0
0
0
0
0
0
0
0
0
0
9210
16133

TABLE 8:

NUMBER OF ANIMALS USED IN TOXICOLOGICAL AND OTHER SAFETY EVALUATIONS

8.1
Products

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

8.3
Skin
irritation

8.4
Skin
sensitisatio
n

8.5
Eye
irritation

Types of tests versus products

8.7
Carcino
genicity

8.8
Develop-
mental
toxicity

8.9
Muta-
genicit
y

8.10
Repro-
ductive
toxicity

8.6
Sub-
chronic
and
chronic
toxicity

8.12
Other

8.13
Total

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

8.2.1.
LD50,
LC50

8.2.2
Other lethal
methods

8.2.3
Non lethal
clinical signs
methods

8.a.

8.b.

8.c.

8.d.

8.e.

8.f.

8.g.

8.h.

8.i.

8.j.

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

safety

or 

884

2972

78

1249

953

382

124

281

6923

50

15

20

15

1000

350

5400

270

2090

0

1884

3372

78

0

0

1249

0

6353

382

394

2140

281

0

15

70

15

0

0

9110

0
16133

166

UNITED KINGDOM

Statistical data submitted

The statistical data have been submitted by the “Home Office”.

Comments of United Kingdom authorities

Some 1.9 million animals were used for the first time in procedures started in 1999.
This figure cannot be directly compared to previous years – see note below.

The statistical data for the United Kingdom were published in the UK in two separate
reports – one for Great Britain and the other for Northern Ireland. Overall there was a
decrease  in the  number of animals used  for the  first  time in  procedures regulated in
the UK compared with use in 1998.

About one third of animals received some form of anaesthesia to alleviate the severity
of the interventions. For most of the remaining animals the use of anaesthesia would
have increased the severity of the procedure.

For  the  species  which  should  be  obtained  from  registered  breeding  or  supplying
establishments  within  the  UK,  99%  of  animals  listed  were  so  sourced  and  less  than
0.5% were sourced outside of EC or Council of Europe member countries.

4 in 5 procedures (80% of the total) were carried out on mice or rats.

Dogs, cats, horses and non-human primates are accorded special protection in the UK
and collectively accounted for 0.5% of the animals used.

Cold blooded animals (fish and amphibians) represented 7% of the total animal use.

Fundamental biological research, or  applied studies in human  medicine  or  dentistry,
or veterinary medicine accounted for the use of 1.3 million animals – 68% of the total
animal use.

Slightly  less  than  30%  of  the  animals  were  used  for  toxicological  or  other  safety
evaluation, or  for production  and quality  control  of  products  and  devices  for  human
medicine, dentistry or veterinary medicine. The majority of that use (over 80%) was
to fulfil European or other regulatory requirements.

No  animals  were  used  in  1999  for  the  purpose  of  evaluating  the  safety  of  either
cosmetic products or cosmetic ingredients.

The use of animals for the production of monoclonal antibodies fell due to widespread
use of the in vitro alternative to live animal use.

Note:  Due  to  revisions  in  the  method  of  collecting  data,  in  1999  the  animal  use
submitted  does  NOT  include  those  animals  used  for  the  breeding  of  genetically
engineered (transgenic/mutant) animals, although those animals used to generate such
strains are included.

167

TABLE 1:

NUMBER OF ANIMALS USED IN RELATION TO THEIR PLACE OF ORIGIN

1.1
Species

Origin versus species

1.2
Total

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

1.4
Animals coming from
elsewhere in the EC

1.6
Animals coming from
other origins

1.7
Re-used animals

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

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

Mice (Mus musculus)
Rats (Rattus norvegicus)
Guinea-Pigs (Cavia porcellus)
Hamsters (Mesocricetus )
Other Rodents (other Rodentia)
Rabbits (Oryctolagus cuniculus)
Cats (Felis catus)
Dogs (Canis familiaris)
Ferrets (Mustela putorius furo)
Other Carnivores (other Carnivora)
Horses, donkeys and cross breds (Equidae)
Pigs (Sus)
Goats (Capra)
Sheep (Ovis)
Cattle (Bos)
Prosimians (Prosimia)
New World Monkeys (Ceboidea)
Old World Monkeys (Cercopithecoidea)
Apes (Hominoidea)
Other Mammals (other Mammalia)
Quail (Coturnix coturnix)
Other birds (other Aves)
Reptiles (Reptilia)
Amphibians (Amphibia)
Fish (Pisces)
TOTAL

990162
526904
61308
10186
8662
27578
683
5938
1115
2896
519
9135
419
14462
4841
-
1073
2118
-
937
-
105931
56
9254
121285
1905462

980612
525316
61193
9686

27511
658
5793
961

-
1036
1786
-

-

3756
443
89
-

54
10
70
-

-
-
-
-

-

386
30
26
500

-
-
-
-

-
-
-
-

-

5408
1115
-
-

13
15
75
154

-
37
332
-

-

802
375
656
15

-
165
164
-

Note 1:

Column 1.5 concerns only those Member Countries of the Council of Europe which, at the beginning of the reporting period, are Parties to the Convention ETS 123. Thus an updated list of
those countries has to be used when filling in this column.

Note 2:

Only the white boxes need to be completed.

Note 3:

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

168

TABLE 2:

NUMBER OF ANIMALS USED IN EXPERIMENTS FOR SELECTED PURPOSES

Purpose versus species

2.1
Species

2.2
Biological
studies of a
fundamenta
l nature

2.a.
2.b.
2.c.
2.d.
2.e.
2.f.
2.g.
2.h.
2.i.
2.j.
2.k.

2.l.
2.m.
2.n.
2.o.
2.p.
2.q.
2.r.
2.s.
2.t.
2.u.
2.v.
2.w.
2.x.
2.y.
2.z.

Mice
Rats
Guinea-Pigs
Hamsters
Other Rodents
Rabbits
Cats
Dogs
Ferrets
Other Carnivores
Horses,  donkeys  and  cross
breds
Pigs
Goats
Sheep
Cattle
Prosimians
New World Monkeys
Old World Monkeys
Apes
Other Mammals
Quail
Other birds
Reptiles
Amphibians
Fish
TOTAL

371162
165057
6492
4797
3681
6037
296
218
505
2795

155
5019
309
9034
2085
-
239
100
-
852
-
30235
56
6797
47184
663105

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)

206040
176418
14053
606
4277
3034
106
1065
538
-

241
564
18
942
589
-
276
102
-
-
-
2304
-
41
8632
419846

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

75818
155088
22391
2324
158
10295
29
4479
10
-

3
708
3
221
112
-
550
1684
-
4
-
3786
-
795
41640
320098

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

129261
15521
12195
46
-
3406
10
22
40
-

-
6
1
92
-
-
-
36
-
-
-
521
-
-
-
161157

21887
344
2368
491
-
1055
171
63
-
-

2
1209
-
681
890
-
-
-
-
-
-
11135
-
-
11820
52116

169

2.7
Diagnosis of
disease

2.8
Education and
training

2.9
Other

2.10
Total

8980
664
112
1559
29
3240
-
31
9
98

91
792
15
1363
132
-
-
22
-
-
-
3278
-
-
310
20725

1807
2484
168
4
17
132
7
-
13
-

6
-
-
74
107
-
-
-
-
-
-
121
-
1371
2
6313

175207
11328
3529
359
500
379
64
60
-
3

21
837
73
2055
926
-
8
174
-
81
-
54551
-
250
11697
262102

990162
526904
61308
10186
8662
27578
683
5938
1115
2896

519
9135
419
14462
4841
-
1073
2118
-
937
-
105931
56
9254
121285
1905462

TABLE 3:

NUMBER OF ANIMALS USED IN TOXICOLOGICAL AND OTHER SAFETY EVALUATIONS

Products versus species

3.7
Products/
substances
used or
intended to be
used mainly
as additives in
food for
human
consumption
189
2117
-
-
-
51
-
-
-
-
-
-
-
-
6
-
-
-
-
-
-
-
-
-
-
2363

3.8
Products/
substances
used or
intended to be
used mainly
as additives in
food for
animal
consumption
408
-
-
-
-
-
-
-
-
-
-
-
-
-
-
-
-
-
-
-
-
-
-
-
-
408

3.11
Total

3.10
Other toxico-
logical or
safety
evaluations

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

420
1702
-
-
158
192
-
-
-
-
-
-
-
-
-
-
-
-
-
4
-
-
-
795
31374
34645

27179
12931
1499
186
-
238
-
77
-
-
-
62
-
-
-
-
66
6
-
-
-
-
-
-
722
42966

75818
155088
22391
2324
158
10295
29
4479
10
-
3
708
3
221
112
-
550
1684
-
4
-
3786
-
795
41640
320098

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
inteded to
be used
mainly in
industry

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

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

3.a.
3.b.
3.c.
3.d.
3.e.
3.f.
3.g.
3.h.
3.i.
3.j.
3.k.
3.l.
3.m.
3.n.
3.o.
3.p.
3.q.
3.r.
3.s.
3.t.
3.u.
3.v.
3.w.
3.x.
3.y.
3.z.

Mice
Rats
Guinea-Pigs
Hamsters
Other Rodents
Rabbits
Cats
Dogs
Ferrets
Other Carnivores
Horses, donkeys and cross breds
Pigs
Goats
Sheep
Cattle
Prosimians
New World Monkeys
Old World Monkeys
Apes
Other Mammals
Quail
Other birds
Reptiles
Amphibians
Fish
TOTAL

37942
75663
5397
1267
-
4376
29
4042
10
-
3
646
-
144
49
-
484
1678
-
-
-
1267
-
-
510
133507

4050
28647
4597
871
-
1359
-
357
-
-
-
-
3
77
57
-
-
-
-
-
-
2519
-
-
5906
48443

5630
33687
10898
-
-
4079
-
3
-
-
-
-
-
-
-
-
-
-
-
-
-
-
-
-
3128
57425

-
-
-
-
-
-
-
-
-
-
-
-
-
-
-
-
-
-
-
-
-
-
-
-
-
-

-
341
-
-
-
-
-
-
-
-
-
-
-
-
-
-
-
-
-
-
-
-
-
-
-
341

170

TABLE 4:

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

4.1
Species

4.2
Human cardiovascular
diseases

4.3
Human nervous and
mental disorders

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

4.5
Other human diseases

4.6
Studies specific to animal
diseases

4.7
Total

Main categories versus species

4.a.
4.b.
4.c.
4.d.
4.e.
4.f.
4.g.
4.h.
4.i.
4.j.
4.k.
4.l.
4.m.
4.n.
4.o.
4.p.
4.q.
4.r.
4.s.
4.t.
4.u.
4.v.
4.w.
4.x.
4.y.
4.z.

Mice
Rats
Guinea-Pigs
Hamsters
Other Rodents
Rabbits
Cats
Dogs
Ferrets
Other Carnivores
Horses, donkeys and cross breds
Pigs
Goats
Sheep
Cattle
Prosimians
New World Monkeys
Old World Monkeys
Apes
Other Mammals
Quail
Other birds
Reptiles
Amphibians
Fish
TOTAL

18963
31956
2083
134
69
3065
6
935
157
-
16
728
50
212
143
-
37
66
-
68
-
1718
-
530
18
60954

156316
176698
7190
1468
4617
809
264
70
493
28
-
100
-
517
-
-
172
395
-
22
-
7387
24
354
883
357807

128378
8755
816
276
-
181
-
35
-
-
-
29
-
32
-
-
-
-
-
-
-
-
-
358
-
138860

561931
222025
31812
6761
3736
16164
105
4249
452
2865
230
5633
366
10239
2076
-
864
1633
-
762
-
24929
32
5596
48300
950760

42723
9178
2934
605
6
1554
301
286
-
-
267
2236
-
3264
2442
-
-
-
-
-
-
69112
-
-
32060
166968

908311
448612
44835
9244
8428
21773
676
5575
1102
2893
513
8726
416
14264
4661
-
1073
2094
-
852
-
103146
56
6838
81261
1675349

171

TABLE 5:

NUMBER OF ANIMALS USED IN PRODUCTION AND QUALITY CONTROL OF PRODUCTS AND DEVICES FOR HUMAN

MEDICINE AND DENTISTRY AND FOR VETERINARY MEDICINE

5.1
Species

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

Regulatory requirements versus species
5.4
5.5
Member Country of Council
Other legislation
of Europe (but not EC)
legislation
2)

5.3
EC legislation
including European
Pharmacopoeia
(requirements)

5.6
Any combination of
5.2/ 5.3/ 5.4/ 5.5

5.7
No regulatory
requirements

5.8
Total

Mice
Rats
Guinea-Pigs
Hamsters
Other Rodents
Rabbits
Cats
Dogs
Ferrets
Other Carnivores
Horses, donkeys and cross breds
Pigs
Goats
Sheep
Cattle
Prosimians
New World Monkeys
Old World Monkeys
Apes
Other Mammals
Quail
Other birds
Reptiles
Amphibians
Fish
TOTAL

5.a.
5.b.
5.c.
5.d.
5.e.
5.f.
5.g.
5.h.
5.i.
5.j.
5.k.
5.l.
5.m.
5.n.
5.o.
5.p.
5.q.
5.r.
5.s.
5.t.
5.u.
5.v.
5.w.
5.x.
5.y.
5.z.
Examples:

10879
1383
5721
-
-
119
-
-
-
-
-
50
-
169
160
-
-
-
-
-
-
65
-
-
-
18546

56470
2613
5601
-
-
1901
165
35
-
-
-
170
-
266
440
-
-
-
-
-
-
3807
-
-
2850
74318

27
-
14
376
-
200
-
-
-
-
-
5
-
-
55
-
-
-
-
-
-
48
-
-
4690
5415

1797
252
298
21
-
198
-
-
-
-
-
-
-
-
-
-
-
12
-
-
-
670
-
-
-
3248

33250
12845
1544
108
-
1365
4
160
104
-
51
291
1
371
57
-
35
24
-
-
-
1388
-
-
-
51598
columns 5.2 - 5.5 refer to the legislation imposing that the test be carried out and
not to the body which has issued the actual test method, guideline or protocol.
a test required by French legislation and carried out in Belgium according to an
ISO protocol must be coded as a national (FR) legislative requirement and be
entered into column 5.2 in the tables submitted by Belgium.

53835
6547
1625
115
-
831
12
22
24
-
-
708
-
92
200
-
-
-
-
-
-
5678
-
-
4280
73969

156258
23640
14803
620
-
4614
181
217
128
-
51
1224
1
898
912
-
35
36
-
-
-
11656
-
-
11820
227094

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

EC Member States: Austria, Belgium, Denmark, Finland, France, Germany, Greece, Ireland, Italy, Luxembourg, Netherlands, Portugal, Spain, Sweden, United Kingdom

Example:

Note:

Footnotes:

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

172

TABLE 6:

NUMBER OF ANIMALS USED IN TOXICOLOGICAL AND OTHER SAFETY EVALUATIONS

6.1
Species

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

6.3
EC legislation
including European
Pharmacopoeia
(requirements)

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

6.5
Other legislation

6.6
Any combination of
6.2/ 6.3/ 6.4/ 6.5

6.7
No regulatory
requirements

6.8
Total

Regulatory requirements versus species

Mice
Rats
Guinea-Pigs
Hamsters
Other Rodents
Rabbits
Cats
Dogs
Ferrets
Other Carnivores
Horses, donkeys and cross breds
Pigs
Goats
Sheep
Cattle
Prosimians
New World Monkeys
Old World Monkeys
Apes
Other Mammals
Quail
Other birds
Reptiles
Amphibians
Fish
TOTAL

6.a.
6.b.
6.c.
6.d.
6.e.
6.f.
6.g.
6.h.
6.i.
6.j.
6.k.
6.l.
6.m.
6.n.
6.o.
6.p.
6.q.
6.r.
6.s.
6.t.
6.u.
6.v.
6.w.
6.x.
6.y.
6.z.
Examples:

4905
7013
3447
247
-
1125
-
36
-
-
-
60
-
17
26
-
-
-
-
-
-
584
-
-
4229
21689

9721
13497
3920
-
-
562
-
156
-
-
-
-
-
110
64
-
-
299
-
-
-
691
-
-
7437
36457

1129
8516
662
500
-
894
-
1284
-
-
-
18
-
-
4
-
192
605
-
-
-
162
-
-
2860
16826

3270
15851
3500
-
-
2329
-
44
-
-
-
-
-
-
-
-
-
1
-
-
-
150
-
-
4832
29977

24147
12606
880
71
158
195
-
123
-
-
-
44
-
5
-
-
1
50
-
4
-
64
-
795
13814
52957
columns 6.2 - 6.5 refer to the legislation imposing that the test be carried out and
not to the body which has issued the actual test method, guideline or protocol.
a test required by French legislation and carried out in Belgium according to an
ISO protocol must be coded as a national (FR) legislative requirement and be
entered into column 6.2 in the tables submitted by Belgium.

32646
97605
9982
1506
-
5190
29
2836
10
-
3
586
3
89
18
-
357
729
-
-
-
2135
-
-
8468
162192

75818
155088
22391
2324
158
10295
29
4479
10
-
3
708
3
221
112
-
550
1684
-
4
-
3786
-
795
41640
320098

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

EC Member States: Austria, Belgium, Denmark, Finland, France, Germany, Greece, Ireland, Italy, Luxembourg, Netherlands, Portugal, Spain, Sweden, United Kingdom

Example:

Note:

Footnotes:

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

173

TABLE 7:

NUMBER OF ANIMALS USED IN TOXICOLOGICAL AND OTHER SAFETY EVALUATIONS

7.1
Species

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

7.3
Skin
irritation

7.4
Skin
sensitisatio
n

7.5
Eye
irritation

7.6
Sub-
chronic and
chronic
toxicity

7.7
Carcino-
genicity

7.8
Develop-
mental
toxicity

7.9
Muta-
genicit
y

7.10
Repro-
ductive
toxicity

Types of tests versus species

7.12
Other

7.13
Total

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

7.2.1.
LD50,
LC50

7.2.2
Other lethal
methods

7.2.3
Non lethal
clinical signs
methods

7.a.
7.b.
7.c.
7.d.
7.e.
7.f.
7.g.
7.h.
7.i.
7.j.
7.k.

7.l..
7.m.
7.n.
7.o.
7.p.
7.q.
7.r.
7.s.
7.t.
7.u.
7.v.
7.w.
7.x.
7.y.
7.z.

Mice
Rats
Guinea-Pigs
Hamsters
Other Rodents
Rabbits
Cats
Dogs
Ferrets
Other Carnivores
Horses,  donkeys  and  cross
breds
Pigs
Goats
Sheep
Cattle
Prosimians
New World Monkeys
Old World Monkeys
Apes
Other Mammals
Quail
Other birds
Reptiles
Amphibians
Fish
TOTAL

8328
5583
-
-
-
-
-
-
-
-

-
-
-
-
-
-
-
-
-
-
1210
100
-
-
13692
28913

1496
10698
332
-
-
110
-
-
-
-

-
30
-
-
-
-
-
-
-
-
80
4
-
-
9115
21865

11086
38529
627
538
-
563
-
2515
-
-

3
130
-
94
10
-
226
829
-
-
114
492
-
-
5570
61326

-
3
89
-
-
3443
-
-
-
-

-
-
-
-
-
-
-
-
-
-
-
-
-
-
-
3535

2304
-
17485
-
-
-
-
-
-
-

-
-
-
-
-
-
-
-
-
-
-
-
-
-
-
19789

-
-
-
-
-
1910
-
-
-
-

-
-
-
-
-
-
-
-
-
-
-
-
-
-
-
1910

3528
13337
220
515
-
630
-
1353
-
-

-
-
-
-
-
-
184
490
-
-
120
-
-
-
968
21345

6082
4936
-
1029
-
-
-
-
-
-

-
-
-
-
-
-
-
-
-
-
50
-
-
-
-
12097

124
3420
-
-
-
2840
-
-
-
-

-
-
-
-
-
-
-
-
-
-
-
-
-
-
-
6384

7104
5089
-
-
-
-
-
-
-
-

-
-
-
-
-
-
-
-
-
-
-
-
-
-
-
12193

801
49477
-
-
-
188
-
-
-
-

-
-
-
-
-
-
-
-
-
-
360
-
-
-
8461
59287

-
-
-
-
-
-
-
-
-
-

-
-
-
-
-
-
-
-
-
-
-

-
-
-
-

34965
24016
3638
242
158
611
29
611
10
-

-
548
3
127
102
-
140
365
-
4
-
1256
-
795
3834
71454

75818
155088
22391
2324
158
10295
29
4479
10
-

3
708
3
221
112
-
550
1684
-
4
1934
1852
-
795
41640
320098

174

TABLE 8:

NUMBER OF ANIMALS USED IN TOXICOLOGICAL AND OTHER SAFETY EVALUATIONS

8.1
Products

Types of tests versus products

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

8.3
Skin
irritation

8.4
Skin
sensitisatio
n

8.5
Eye
irritation

8.7
Carcino
genicity

8.8
Develop-
mental
toxicity

8.9
Muta-
genicit
y

8.10
Repro-
ductive
toxicity

8.6
Sub-
chronic
and
chronic
toxicity

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

8.12
Other

8.13
Total

8.2.1.
LD50,
LC50

8.2.2
Other lethal
methods

8.2.3
Non lethal
clinical signs
methods

8.a.

8.b.

8.c.

8.d.

8.e.

8.f.

8.g.

8.h.

8.i.

8.j.

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

safety

or 

1632

4696

3763

1992

4920

7879

39023

6280

217

554

2050

214

15241

9306

5158

8165

22062

4889

534

2868

2173

342

791

14301

11614

2731

11925

1138

1290

-

-

-

-

-

-

-

-

-

-

32

-

10622

6752

2618

-

-

-

-

-

-

-

-

-

-

-

-

-

-

-

-

-

-

-

408

-

-

-

-

968

-

604

2816

13071

-

-

-

-

-

-

-

129

-

-

-

-

-

-

8461

8200
28913

322
21865

1759
61326

33
3535

925
19789

24
1910

978
21345

210
12097

280
6384

292
12193

1392
59287

175

-

-

-

-

-

-

-

-

-
-

54126

159186

6095

48443

594

341

57425

341

-

-

-

-

161

408

3142

32563

7156
71454

21571
320098