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EN
EN
EUROPEAN COMMISSION
Brussels, 8.12.2010
SEC(2010) 1107 final/2
CORRIGENDUM:
Annule et remplace le document SEC(2010) 1107 du 30.9.2010 final
Concerne : toutes les versions
EN
EN
TABLE OF CONTENTS
I.
INTRODUCTION ....................................................................................................... 4
II.
II.1.
II.2.
II.3.
III.2.
III.3.
III.4.
III.5.
III.6.
III.7.
III.8.
Results of EU Table 7: Animals used in toxicity tests for toxicological and other
safety evaluations....................................................................................................... 37
III.9.
Results of EU Table 8: Type of toxicity tests carried out for toxicological and other
safety evaluations of products.................................................................................... 41
EN
EN
EN
EN
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 of 24 November 1986 on the
approximation of laws, regulations and administrative provisions of the Member States
regarding the protection of animals used for experimental and other scientific purposes1, the
statistical data on the number of animals used for experimental and other scientific purposes
in the Member States of the EU.
The first two statistical reports drafted in accordance with the provisions of the above
mentioned directive which were published in 19942 and 19993, covering data on experimental
animals collected in 1991 and 1996 respectively in the Member States, allowed only a limited
amount of statistical analysis due to the absence of a consistent system of reporting the data.
In 1997 an agreement was reached between the Commission and the competent authorities of
the Member States to submit data for future reports using a format of eight harmonized tables.
The third and fourth statistical reports published in 20034 and 20055 covering data collected in
1999 and 2002 were based on these agreed harmonized tables. This allowed a much wider
interpretation of the results on the use of experimental animals in the EU. In spite of the
progress made in the content of these two statistical reports, it ought to be stressed that there
were some inconsistencies in the data submitted by the Member States and also that in all
cases except the report of 2003, one Member State collected data from another year. The Fifth
Statistical Report, published in 20076, contained for the first time data collected in the 10
Member States which joined the EU in 2004. In the Sixth Statistical Report the complete set
of standardized tables provided by all 27 Member States were successfully evaluated,
although comparison of the results with previous reports was essentially qualitative owing to
the addition of data from the new Member States.
This Report includes data submitted by Romania and Bulgaria, which joined the EU in 2007.
It gives an overview of the number of animals used in the Member States for experimental
purposes for the year 2008 with the exception of one Member State which provided data from
2007.
The Commission Staff Working Document accompanies the Report from the Commission to
the Council and the European Parliament Sixth Report on the Statistics on the Number of
Animals used for Experimental and other Scientific Purposes in the Member States of the
European Union. The report summarizes the data and conclusions presented in this Staff
Working Document.
1
2
3
4
5
6
EN
EN
II.
II.1.
General assessment
EN
OJ C 331, 23.12.86, p. 2.
EN
Therefore, a number of Member States have also included animals covered by the Resolution
in the report.
The first part of this report aims at providing a comprehensive overview on the numbers of
animals used for various experimental purposes in the Community in 2008. The purposes of
the use of animals have been analysed, and some of these purposes have been broken down
further into more precise parameters. It also considers different legislative requirements
regarding the use of experimental animals and the type of testing carried out on different
species.
As the two newest Member States, Bulgaria and Romania, have submitted data for the first
time, it is in principle not possible to draw accurate quantitative conclusions on the evolution
of the use of animals for experimental purposes in the EU by comparing data with those of the
previous reports. However, as their total use amounts to less than 1% of the total number of
animals used in 2008, some comparisons in trends have been attempted, and significant
changes in use have been highlighted in the report.
The second part of this report provides the individual data from the Member States together
with their respective comments and interpretations.
In the EU, the total number of animals used for experimental and other scientific purposes in
2008 in the Member States amounts to just over 12 million (with data from France from
2007).
As in previous reports rodents together with rabbits represent more than 80% of the total
number of animals used in the EU. Mice are by far the most commonly used species
accounting for 59% of the total use, followed by rats with 17%.
The second most used group of animals was, as in previous years, cold-blooded animals
which represent almost 10%. The third largest group of animals used was birds with a little
over 6% of the total use.
As stated in the previous two statistical reports no Great Apes were used in experiments in the
EU in 2008.
EN
EN
II.3.
EN
EN
Two types of information can be drawn from the data submitted by the Member States in EU
Table 1. The first relates to the total number of animals subdivided into 25 species used by the
Member States. The second type of information relates to the place of origin of the animals
used for experimental or other scientific purposes.
III.1.1. The data on the total number of animals used in the MS
Table 1.1 of this report presents the consolidated data on the number of animals used for
experimental purposes, by species, submitted by 27 Member States. Whereas in previous
years Malta had not used animals for scientific purposes, in 2008 this country reported animal
use for the first time.
The total number of animals used in 2008 in the 27 Member States amounts to 12.0 million
animals. It is important to note that the number of animals used in the new Member States
who joined the EU in 2008 (Bulgaria and Romania) represents not even 1,0% of the total
number of animals used in the EU 27.
III.1.2. Treatment and interpretation of the data of Table 1.1
In order to present an overall evaluation and subsequently a graphical analysis, animal species
were grouped. The result of this exercise is presented in Table 1.2 at the end of this chapter.
This grouping in Table 1.2 allows an overview of the species used and is illustrated in Figure
1.1.
It should also be pointed out that re-used animals are not included in the figures so that
animals are not counted twice.
EN
EN
Figure 1.1
Percentages of animals used by classes in the Member
States
Artio+Perissodactyla
1,39%
Carnivores
0,26%
Prosimians+monkeys+a
pes 0,08%
Other Mammals
0,05%
Birds 6,38%
Cold-blooded animals
9,62%
Rabbits 2,78%
Other rodents 0,60%
Mice 59,30%
Guinea-Pigs 1,84%
Rats 17,70%
Rodents together with rabbits represent more than 80% of the total number of animals used.
Mice (59,3%) and rats (17,6%) are by far the most commonly used species.
The second most used group is represented by cold-blooded animals namely reptiles,
amphibians and fish at 9,6%.
Birds is the next highest animal group used for experimental purposes at 6,3%.
The Artiodactyla and Perissodactyla group including horses, donkeys and crossbreeds
(Perrissodactyla), pigs, goats, sheep and cattle (Artiodactyla) represents 1,4% of the total
number of animals used in the Member States.
Carnivores represent 0,3% of the total number of animals used and non-human primates
represent 0,08% of the animals used in 2008.
III.1.3. Comparison with the data of the previous reports
In this chapter, and the following chapters where comparisons are addressed, the reader is
invited to take note of the fact that in 1996, in 2002, in 2005 and for this report France has
reported data respectively for 1997, 2001, 2004 and 2007 which does not allow a rigorous
comparison between data reported for each year. Nevertheless, assuming that fluctuations in
the annual numbers of animals used per species in a country are limited, it is possible to make
semi-quantitative estimates of the observed trends by comparing changes in proportions of
use, expressed as a percentage.
EN
10
EN
Comparison between proportions of classes of animals used in 1996, 1999, 2002, 2005
and 2008
Class of species
% Rodents-rabbits
% Cold-blooded animals
% Birds
% Artio and Perissodactyla
1996(*)
81,3
12,9
1999
86,9
6,6
4,7
1,2
2002(**)
78,0
15,4
5
1,2
2005(***)
77,5
15,
5,4
1,1
2008(****)
82,2
9,6
6,4
1,4
Overall, the percentage of rodents and rabbits shows some fluctuation, but remains close to
80%. For cold-blooded animals the proportion used in 1996, in 2002 and 2005 is between 12
to 15%. In 2008 the use of cold-blooded animals has dropped considerably to below 10%.
However, in 1999 a much lower percentage of 6,6% was observed.
Birds representing the third largest percentage of animals used, seems to be in constant
increase over the years from 4 to 6,4%. The group of horses, donkeys and cross-bred animals
(artiodactyla) and pigs, goats, sheep and cattle (perissodactyla) fluctuates at around 1%.
Contrary to what would have been expected, the effect of the inclusion of the data of new
Member States since 2005 i.e. Bulgaria and Romania, did not lead to an increase in the total
number of animals, on the contrary, there is a decrease of more than 116,500 animals.
Table 1.0 contains a comparison of the change that has taken place since 2008 for each
species, expressed in number of animals per species, between EU 27 (data from 2008) and EU
25 (data from 2005) (first three columns) and in percentage per species (fourth column). The
second half is a comparison between EU 25 (data of 2008 without Romania and Bulgaria)
EN
11
EN
Table 1.0 : Changes in species number and proportion between 2005 and 2008
Species
Number of
animals
in EU 25
Number
of
animals
in EU 27
Change
since
2005
%
change
by
species
Change
since
2005
1.a
6430346
2008
7122188
691842
10,76
630992
Number of
animals
EU 25
2008
excl.
RO,BG
7061338
1.b
2336032
2121727
-214305
-9,17
-223989
2112043
-9,59
257307
220985
-36322
-14,12
-46774
210533
-18,18
31535
32739
1204
3,82
759
32294
2,41
64474
39506
-24968
-38,73
-24968
39506
-38,73
312681
333213
20532
6,57
17514
330195
5,60
3898
4088
190
4,87
179
4077
4,59
24119
21315
-2804
-11,63
-2819
21300
-11,69
2005
1.c
Guinea-Pigs (Cavia
porcellus)
1.d
Hamsters (Mesocricetus )
1.e
Other Rodents (other
Rodentia)
1.f
Rabbits (Oryctolagus
cuniculus)
1.g
Cats (Felis catus)
%
change
by
species
9,81
1.h
1.i
furo)
1.j
2690
3208
518
19,26
518
3208
19,26
Other Carnivores
8711
2853
-5858
-67,25
-5858
2853
-67,25
5312
5976
664
12,50
633
5945
11,92
66305
92813
26508
39,98
26369
92674
39,77
2146
3840
1694
78,94
1614
3760
75,21
-0,71
1.k
Horses, donkeys and cross
breds (Equidae)
1.l
Pigs (Sus)
1.m
Goats (Capra)
1.n
Sheep (Ovis)
30021
30190
169
0,56
-212
29809
1.o
Cattle (Bos)
36271
33952
-2319
-6,39
-2448
33823
-6,75
1.p
Prosimians (Prosimia)
677
1261
584
86,26
584
1261
86,26
1.q
New World Monkeys
(Ceboidea)
-1.r
Old World Monkeys
(Cercopithecoidea)
1.s
Apes (Hominoidea)
1564
904
-660
-42,20
-660
904
-42,20
8208
7404
-804
-9,80
-804
7404
-9,80
1.t
Other Mammals (other
Mammalia)
1.u
Quail (Coturnix coturnix)
9950
1.v
1.w
Reptiles (Reptilia)
1.x
Amphibians (Amphibia)
1.y
Fish (Pisces)
1.z
TOTAL
0,00
5704
-4246
-42,67
-4246
5704
0,00
-42,67
9246
9626
380
4,11
371
9617
4,01
649813
754485
104672
16,11
101999
751812
15,70
2477
4101
1624
65,56
1624
4101
65,56
74620
61789
-12831
-17,20
-17631
56989
-23,63
1749178
1087155
-662023
-37,85
-662073
1087105
-37,85
12117581
12001022
-116559
-0,96
-209326
11908255
-1,73
There is an increase in the number of mice used since 2005 of 691,842 which is 10,7% of the
total number of mice used in 2005 and a decrease for rats (9,2%) and fish (37,8%). The
largest change in 2008, increase in the use of mice, is almost entirely compensated for by the
decrease in the use of fish.
The total number of pigs, goats, prosimians, and reptiles has increased by between 40%
86,3%.
EN
12
EN
The total number of rats, guinea-pigs, other rodents, dogs, cattle and other mammals as well
as amphibians and fish used has decreased substantially since the last report. When expressed
in percentages these decreases range from more than 40 to around 9%.
The largest percentile change has, however, been noted in the decrease of the use of other
carnivores. However, these species are not used in great numbers (from 8,711 to 2,853).
There is also a large decrease of 42,7% in the total number of 'other mammals'.
It is also worth noting the large decrease in the use of new world monkeys of 42,2% as well as
a decrease of 9,8% of old world monkeys. Prosimian use overall, however, has increased by
86,3%.
For species used in greater numbers, significant increases occurred in 2008 for mice, rabbits,
pigs and 'other birds' where percentage changes ranged from 6,6 to 40%.
The following animals which are normally used in fewer numbers show an increase in use:
ferrets (19,3%), horses, donkeys and cross-breeds (12,5%), goats (78,9%) and reptiles
(65,5%).
As in 2002 and 2005, no great apes were used for experimental or other scientific purposes in
2008.
Member States provided examples of the type of species covered by category 'other' as
follows:
Other rodents: gerbils, old world jerboas (Jaculus jaculus); chinchillas, beavers, ground
squirrels, hamsters, grey dwarf hamsters (Cricetulus migratorius) and different species of
mice.
Other carnivores: wild-life species used for zoological and ecological studies e.g. foxes,
badgers, seals, otters and fitchew.
Other mammals: boars, bats and shrews, llamas, moles, European bison and red deer.
Other birds: mainly Japanese Quail (coturnix japonica) and bob-white quail, poultry species,
and zebra finches, canaries, parakeets, parrots and farmed avian species for example,
chickens.
In the three columns in the second half of the table, the addition of data from Bulgaria,
Romania has virtually no effect on the proportional changes between the species.
Romania has little effect on the proportional changes between the species ranging from no
change to very marginal variations per species. However, there is a net decrease of guinea
pigs 4%, and 10% for amphibians, when data from Bulgaria and Romania are excluded.
EN
13
EN
Table 1.1: Total number of animals used for experimental purposes in the EU Member States
Data of 2008 (*)
Species
a. Mice
b. Rats
c. Guinea-Pigs
d. Hamsters
e.Other Rodents
f. Rabbits
g. Cats
h. Dogs
i. Ferrets
j.Other
Carnivores
k. horses,
donkeys &
cross-breeds
l. Pigs
m. Goats
n. Sheep
o. Cattle
p. Prosimians
q.N W Monkeys
r.O W Monkeys
s. Apes
.t.Other
Mammals
u. Quail
v. Other birds
w. Reptiles
x. Amphibians
y. Fish
z.TOTAL
BG
CY
CZ
177544
9928
AT
480681
108580
BE
16265
4513
2114
0
54776
21531
168164
75850
ET
FI
LV
LT
LU
PT
RO
28754
5268
78446
26058
1561809
392773
1314493
390853
19786
4367
158799
89375
71224
11741
553000
230347
6912
2407
3827
1194
3280
430
50
44
237681
105780
123897
45824
39811
6571
44585
5171
543680
175325
6942
9692
10313
1675
203112
53141
1212243
343289
7122188
2121727
3284
36554
3845
1902
693
47
2124
1055
182
251
1233
5343
22
215
46030
35870
45
9743
91
13875
32
93
100
6062
6495
152
6607
12620
982
1766
29250
220985
4
1760
120
0
302
3142
12063
3594
7061
8392
215
356
68
717
1235
0
0
3358
2439
312
11966
29
263
1262
251
0
45
0
0
864
2033
2851
1958
32739
39506
18761
42025
813
2
41
78
788
11
15
0
0
6304
2931
630
814
96427
97938
1498
8134
204
9706
48
199
20
7418
3086
99
2205
19626
679
307
1332
12009
333213
45
552
154
271
0
0
54
1848
4131
798
4450
4
44
40
686
295
557
26
943
0
0
0
0
0
0
0
0
253
1244
83
230
0
0
100
1046
18
4
0
0
149
1982
184
4277
4088
21315
14
0
324
0
122
45
117
101
0
0
800
0
55
410
0
0
0
0
0
0
472
10
0
520
287
5
761
0
0
39
53
978
948
3208
2853
47
62
17
378
54
37
652
584
40
144
46
2562
529
14
90
423
290
5976
5086
39
2969
195
137
80
2013
174
6863
107
819
8768
1159
12361
531
624
24
1193
92
224
3607
41
0
0
11729
229
11742
300
222
15121
372
22
5
3
0
1973
5
7255
487
92813
3840
142
356
250
1148
88
574
0
657
0
126
0
799
0
939
0
0
0
0
0
0
41
0
0
0
0
0
80
0
0
0
0
151
1774
243
FR
DE
EL
HU
IE
IT
456
469
3486
2217
28
131
2386
152
9818
30190
93
0
4019
462
0
2236
0
7540
0
10
0
0
3
0
1091
0
0
0
1379
0
4194
0
33952
1261
233
1797
305
1415
0
0
5
1
18
344
0
0
0
0
0
0
0
0
73
82
0
0
0
0
8
517
0
0
0
0
0
35
262
3092
904
7404
202
1246
84
541
1548
1803
13
156814
53986
88
32554
0
16
32
151
582
32241
5568
1012
221
317
758
192
108
454
3016
54836
293
31245
34
21078
9451
20228
10815
67496
200
1200
1182
2077
23198
2432
13955
300713
297568
138600
2328380
2021782
28021
304922
112835
864318
34794
Totals
200
2820
2114
UK
68
32581
SE
72
0
148722
725370
SL
4638
220456
SK
6252
543
1477
4800
50
SP
3573
431
374
PL
3206
718
17151
2388
28386
NL
571
14
17
80
MT
300
1367
277
2579
DK
249
0
0
9399
40
5100
90890
27391
121
248
149
0
0
600
870
23859
1221
25941
3800
5582
3830
694
501056
275888
50888
160
28
21
263
952
5704
138
120
201
9626
1196
52104
696
129
3432
125077
754485
170
109
4101
704
71098
25
0
0
641
211459
23316
484045
61789
1087155
897859
19260
12438
484604
2266884
12001022
60186
EN
14
EN
Table 1.2: Classes of animals used for experimental purposes in the EU Member States
Data of 2008 (*)
Species
BE
BG
CY
CZ
DK
ET
FI
LV
LT
PT
RO
177544
480681
16265
2114
54776
168164
28754
78446
1561809
1314493
19786
158799
71224
553000
6912
3827
3280
50
237681
123897
39811
44585
543680
6942
10313
203112
1212243
7122188
9928
3284
740
108580
36554
3179
4513
3845
182
0
0
0
21531
1902
1484
75850
5343
1764
5268
22
120
26058
215
3444
392773
46030
15657
390853
35870
15453
4367
45
0
89375
9743
571
11741
91
68
230347
13875
1952
2407
32
0
1194
93
0
430
100
0
44
0
0
105780
6062
5797
45824
6495
12278
6571
152
29
5171
6607
263
175325
12620
1513
9692
982
45
1675
7
0
53141
1766
2897
343289
29250
4809
2121727
220985
72245
18761
42025
813
6304
2931
630
814
96427
97938
1498
8134
204
9706
48
199
20
7418
3086
99
2205
19626
679
307
1332
12009
333213
2873
31148
4850
58864
31759
21429
30437
78503
1400
3367
23198
16841
149
600
24850
27410
3800
71802
25
212270
507470
1153045
1381
5888
17582
4239
1477
610
0
0
148722
4512
2820
8051
0
0
5568
1727
158362
17358
55789
24366
88
789
32567
1618
582
4843
32490
4625
0
0
40
80
0
0
0
0
90890
20242
32491
22328
160
266
1205
150
52242
19060
816
36
129
7
3633
3932
125077
22044
764111
166771
57
0
1190
41
26
0
0
0
764
80
643
0
0
0
815
0
6779
2748
5713
2263
48
0
726
6
852
0
969
362
0
0
0
0
0
0
0
0
1979
155
833
0
0
0
0
0
1438
525
22
0
0
0
2223
35
6387
3354
31464
9569
151
1774
243
84
541
16
32
151
202
1246
28
21
263
952
5704
TOTAL
220456
725370
300713
297568
138600
2328380
2021782
28021
304922
112835
864318
501056
275888
897859
19260
12438
484604
2266884
12001022
Species %
AT
BE
FR
DE
UK
Mice
Rats
Guinea-Pigs
Hamsters +
other rodents
Rabbits
Cold-blooded
animals (1)
Birds (2)
Artio+perisso
dactyla (3)
Carnivores
Prosimians+
monkeys
+apes
Other
mammals
Mice
Rats
Guinea-Pigs
Hamsters +
other rodents
Rabbits
Cold-blooded
animals (1)
Birds (2)
Artio+perisso
dactyla (3)
Carnivores
Prosimians+
monkeys+
apes
Other
mammals
Mice
TOTAL
AT
32581
BG
2114
CY
CZ
DK
34794
FR
DE
EL
HU
IE
IT
LU
MT
NL
9399
5582
3830
LU
694
MT
PL
SP
50888
60186
RO
SK
SP
SL
SK
SE
UK
Totals
ET
FI
EL
HU
IE
IT
LV
LT
NL
PL
PT
SL
SE
80,53
66,27
49,92
100,00
18,22
56,51
82,64
56,60
67,08
65,02
70,61
52,08
63,12
63,98
73,54
68,56
85,64
7,20
47,44
44,91
78,23
74,08
60,55
36,04
82,92
41,91
53,48
Totals
59,35
4,50
14,97
13,85
0,00
7,16
25,49
15,14
18,80
16,87
19,33
15,58
29,31
10,41
26,65
25,61
21,39
11,23
6,34
21,11
16,61
12,91
8,59
19,53
50,32
13,47
10,97
15,14
17,68
1,49
0,34
5,04
0,44
11,80
0,56
0,00
0,00
0,63
0,49
1,80
0,59
0,06
0,34
0,16
2,48
1,98
0,67
1,77
0,76
0,16
0,00
3,20
0,19
0,08
0,06
1,61
0,23
0,34
0,00
1,67
0,00
2,61
0,00
0,00
0,00
1,21
1,16
2,35
4,45
0,30
0,06
10,98
0,44
1,41
0,17
5,10
0,23
0,06
0,00
0,36
0,60
1,29
0,21
1,84
0,60
8,51
1,30
5,79
4,29
2,50
14,89
0,00
0,00
2,10
19,57
0,98
10,67
1,81
0,00
0,59
15,46
4,14
1,31
4,84
3,88
5,35
5,00
2,67
1,10
0,18
20,56
1,12
1,95
0,51
0,00
3,57
2,67
0,52
0,00
0,00
86,46
1,48
4,96
1,12
9,94
0,19
7,47
3,66
0,00
2,19
8,00
3,53
0,13
2,47
0,00
0,27
43,80
0,53
22,39
2,78
9,61
0,63
2,42
4,53
0,00
49,46
0,95
0,00
4,02
6,80
2,76
0,31
10,68
0,52
3,76
0,00
0,72
0,00
0,00
18,14
11,78
0,31
2,00
5,82
4,24
1,04
0,75
5,52
6,37
2,67
0,58
1,87
0,00
1,50
2,71
0,00
1,25
0,75
1,21
2,82
0,53
4,29
0,54
0,00
1,43
0,00
0,00
4,04
8,09
0,52
0,25
2,12
0,19
0,06
0,81
0,97
1,39
0,03
0,16
0,08
0,00
0,25
0,22
0,00
0,59
0,29
0,28
0,17
0,24
0,76
0,11
0,00
0,00
0,00
0,00
0,39
0,30
0,00
0,00
0,16
0,11
0,00
0,46
0,28
0,26
0,00
0,01
0,00
0,00
0,03
0,00
0,00
0,00
0,12
0,11
0,00
0,00
0,00
0,04
0,00
0,00
0,00
0,00
0,03
0,00
0,00
0,00
0,06
0,00
0,00
0,01
0,15
0,08
0,00
0,02
0,00
0,00
0,59
0,08
0,00
0,06
0,00
0,03
0,00
0,01
0,03
0,02
0,00
0,00
0,00
0,00
0,04
0,45
0,00
0,00
0,00
0,11
0,00
0,05
0,04
0,05
100
100
100
100
100
100
100
100
100
100
100
100
100
100
100
100
100
100
100
100
100
100
100
100
100
100
100
100
EN
15
EN
III.2.
Other countries
20%
Quail
Apes
Prosimians
Dogs
Ferrets
Cats
Rabbits
Guinea-Pigs
Mice
Rats
Hamsters
EU countries
0%
The chart shows clearly that the majority of the species originated from EU countries. However,
certain species such as cats, dogs and ferrets and old world monkeys are also of non-European
origin.
EN
16
EN
EN
17
EN
1.4. Animals
coming from
elsewhere in the
EC
7122188
2121727
220985
32739
333213
4088
21315
3208
1261
904
7404
0
9626
6042205
1761785
161973
24999
315006
2306
12467
1847
718
816
3213
0
7824
900230
329385
56167
5476
14753
726
2885
442
543
83
850
0
1500
21382
9844
2051
1074
364
14
309
0
0
5
5
0
0
158371
20713
792
1190
3087
1042
5654
919
0
0
3336
0
302
1.z. TOTAL
9878658
8335159
1313040
35048
195406
1.2. Total
1.7. Re-used
animals
3768
3035
962
54
15958
1181
4178
64
33
346
1509
0
0
EN
18
EN
III.3.
Figure 2.1
Purposes of experiments
Other 12,2%
Education and training
1,7%
Diagnosis of disease
1,6%
Fundamental biology
studies 38,1%
Toxicological and other
safety evaluation 8,7%
More than 60% of animals were used in research and development for human medicine,
veterinary medicine, dentistry and in fundamental biological studies.
Production and quality control of products and devices in human medicine, veterinary
medicine and dentistry required the use of 14,9% of the total number of animals.
Toxicological and other safety evaluation represents 8,7% of the total number of animals used
for experimental purposes.
Other purposes of procedures represents 12% of the total number of animals and covers a
wide range of experiments such as virology, immunology for production of monoclonal and
polyclonal antibodies, physiology of foetal-maternal interaction in mouse gene transgensis,
EN
19
EN
oncological treatment, pharmaceutical research and development, combined drug testing and
genetics.
III.3.3. Comparison with the data of the previous report
The comparison aims to detect changes in trends rather than draw formal conclusions. The
most significant change that has taken place since 2005 is that the number of animals used for
research and development for human medicine, dentistry and veterinary medicine has dropped
sharply from 31% to 22,8% (in terms of animal numbers the decrease is from 3,746,028 to
2,733,706). To be noted in particular is the significant reduction of more than 800,000 coldblooded animals since the last report of 2005. On the other hand, the percentage of animals
used for fundamental biological research has increased from 33% to 38% (that is, from
4,035,470 to 4,575,054) as well as for 'other purposes', from 8% to 12%. It should be
underlined that both fundamental biology and research and development in human and
veterinary medicine are the areas using by far the highest number of animals for experimental
purposes in the EU.
The number of animals used for toxicological and other safety evaluation has remained
virtually unchanged since the last report and amounts to 8,7% of the total number of animals
used for experimental purposes in the EU. This represents 1,042,153 animals.
In general the number of animals used for production and quality control of devices for
medicine, veterinary medicine and dentistry has also remained unchanged since 2005.
However, regarding the use by species, the use of mice and rabbits has increased substantially
for production and quality control of products and devices for human medicine and dentistry.
One Member State indicated that funding had been made available for pre-clinical trials for
human medicine, which lead to an increase in use of experimental animals.
Another Member State using a large number of rabbits for production and quality control of
veterinary medicine indicated that the laboratory responsible for that increase had reported the
data in the wrong column, that is, they should have been reported under production and
quality control of human medicine and dentistry rather than for products and devices for
veterinary medicine. The increase was due to the production of polyclonal antibodies to
improve transplant in human medicine. However, it was no longer possible to correct the error
in the consolidated report.
Regarding increases in other purposes of use, there is a substantial increase in the use of mice,
pigs and birds for 'fundamental biological research' and in 'other experiments'.
Several Member States confirmed that the increase in the use of mice for fundamental
biological research is attributed to the new research possibilities offered by the transgenic
species. These animal models are being used both for human and animal health studies. An
increase was also reported for the purpose of experiments in anatomy and developmental
biology, physiology, genetics and cancer research, and for immunology and microbiology.
There are several reasons for the increase in the use of pigs in fundamental biological and
also in other studies. One Member State using a large number of pigs for fundamental
biological studies and for other procedures indicated that in recent years funding for projects
relating to cardiovascular research has increased significantly. The same applies in the case of
experimental surgery which is taking place in many hospitals in the same Member State.
Another area using an increased number of pigs relates to pig disease studies, including for
EN
20
EN
example the observation of vaccine effectiveness. It was reported that the increase was also
due to fundamental research on pigs enzymes and digestive functions, and because the
tissues and organs of transgenic pigs are used for transplants in humans.
The large number of birds used for fundamental biological research in one Member State was
due to a campaign of bird ringing. The increase of the number of birds used for 'other
experiments' was reported to be due to parasitology/immunology studies and to the
development of genetically modified birds.
Table 2.2: Number of animals used for selected purposes versus species
Species
Mice
Rats
Other rodents
Rabbits
Carnivores
Artio+perissodactyla
Prosimians+monkeys+apes
Other mammals
Birds
Cold-blooded animals
TOTAL
Biological
studies of
a
fundament
al nature
3080775
595542
44240
17813
4804
55080
1213
5279
292895
477413
4575054
Research,
developm
ent and
quality
control of
products
and
devices
for human
medicine
and
dentistry
and for
veterinary
medicine
2624856
1060290
195427
212618
11378
56359
1260
177
247618
113766
4523749
Toxicologic
al and other
safety
evaluations
(including
safety
evaluation
of products)
398199
294683
33858
39987
11964
8996
6507
0
53477
194482
1042153
Diagnosi
s of
disease
Education
and
training
137578
22997
3145
3376
1360
4620
153
12
8415
3651
185307
82606
59412
7826
3326
515
13134
10
25
11444
29159
207457
Other
798174
88803
8734
56093
1443
28582
426
211
150262
334574
1467302
Total
7122188
2121727
293230
333213
31464
166771
9569
5704
764111
1153045
12001022
Figure 2.2 presents the number of animals used for selected purposes by classes of species.
The highest number of mice and rats is attributed to fundamental biological studies and
research, development and quality control of products and devices for medicine, dentistry and
veterinary medicine. It is noteworthy that a high number of cold-blooded animals have been
used for 'other purposes' as well as for 'biological studies of a fundamental nature'.
One can observe a significant reduction in the use of cold-blooded animals for research and
development of devices for human and veterinary medicine and for dentistry since the last
report of 2005.
EN
21
EN
Figure 2.2
Species and experimental purposes
3500000
3000000
2500000
2000000
Other
1500000
1000000
500000
EN
Cold-blooded animals
Birds
Other Mammals
Prosimians+monkeys+apes
Artio+perissodactyla
Carnivors
Other rodents
22
2.2.Biological
studies of a
fundamental
nature
2.4. Production
and quality control
of products and
devices for human
medicine and
dentistry
3080775
595542
10632
6994
26614
17813
560
1814
551
1879
1402
1597381
840909
44344
8041
9006
29764
1738
4405
1287
75
728
856048
181140
103852
376
30
131031
57
157
564
0
224
171427
38241
17265
12513
0
51823
679
2070
8
338
2559
398199
294683
31883
1580
395
39987
322
11077
269
296
22
137578
22997
1940
278
927
3376
124
1111
45
80
239
82606
59412
5804
520
1502
3326
97
362
56
0
489
798174
88803
5265
2437
1032
56093
514
316
428
185
313
7122188
2121727
220985
32739
39506
333213
4091
21312
3208
2853
5976
23531
1098
9727
19322
568
235
410
22799
721
4098
3990
0
235
761
423
93
6020
214
0
33
231
9001
26
2149
3314
0
0
0
8065
43
409
457
543
270
5694
1452
90
1616
1223
150
0
3
8134
422
1243
2846
0
0
10
19408
1347
4928
2586
0
131
295
92813
3840
30190
33952
1261
904
7404
0
5279
5520
287375
3781
32780
440852
4575054
0
86
57
77748
94
1914
83525
2733706
0
28
0
10593
0
0
20418
1311532
0
63
0
159220
0
0
7815
478511
0
0
2170
51307
0
291
194191
1042153
0
12
9
8406
0
202
3449
185307
0
25
1575
9869
147
12213
16799
207457
0
211
295
149967
79
14389
320106
1467302
0
5704
9626
754485
4101
61789
1087155
12001022
2.5. Production
and quality
control of
products and
devices for
veterinary
medicine
2.7.
Diagnosis of
disease
2.8.
Education
and training
2.9. Other
2.10. Total
EN
23
EN
III.4.
3.7 Products/
substances used or
intended to be used mainly
as additives in food for
human consumption
0,60%
3.2 Products/
substances or devices for
human medicine and
dentistry and for veterinary
medicine
50,81%
3.6 Products/
substances used or
intended to be used mainly
as cosmetics or toiletries
0,19%
3.5 Products/
substances used or
intended to be used mainly
in the household
0,41%
3.4 Products/
substances used or
intended to be used mainly
in industry
7,91
3.3
Products/
substances used or
intended to be used mainly
in agriculture
7,11%
The number of animals used for toxicological and other safety evaluation for different
products or environmental test schemes amounts to 1,042,153, which represents 8,7% of the
total number of animals used for experimental purposes in 2008 (see Table 2.1, column 2.6).
Toxicological or other safety evaluations are split up according to the type of sector for which
they are intended. The percentage of animals used for toxicological evaluation of three groups
of products/substances, i.e. additives in food for human consumption, cosmetics and
household products, is very small (1,18%) when compared to the other product groups.
EN
24
EN
Products or devices used for human medicine, veterinary medicine and dentistry represents
50,8% of the animals used for toxicological or other safety evaluations.
The group of products/substances falling under the scrutiny of Member States authorities
concerned with safety of health and of the environment by chemical products, such as
industrial chemicals and pesticides, used 15% of the animals for toxicological and other safety
evaluations.
There is a clear decrease in the number of animals used for toxicological tests for products
intended for industry, for agriculture and for potential contaminants of the environment. The
decrease ranges respectively from above 96,000 to about 82,000; from below 98,000 to about
74,000 and from above 84,000 to about 65,000 in comparison to the data submitted in the
2005 statistical report.
There is also a significant decrease in the number of animals used for testing of products for
cosmetics and toiletries ranging from 5,500 to just below 2,000 (a 65% drop). This change has
to be seen in light of the legal requirement to phase out animal testing for cosmetics in the EU
where a ban on testing has been applicable since 2009 for all human health effects with the
exception of three toxicological end-points: repeated-dose toxicity, reproductive toxicity and
toxicokinetics. The year 2013 is the deadline for a marketing ban for cosmetics tested for
these remaining specific health effects.
There is however also a significant increase since 2005 in the number of animals used for
tests for additives in food for animal consumption (from 34,225 to 54,164). This may reflect
the animal feed sanitary concerns expressed in the EU after the discovery of harmful
contaminants in such products over the last 10 years.
It should also be noted that in comparison to the 2005 report, there is a significant increase in
the number of animals used for other toxicological or safety evaluation (ranging from
around 180,000 to about 220,000). Member States reported that this particular use of animals
concerned new methods and tests, such as tests on transmission of microcystins on embryonic
membrane, bioassays, toxicity evaluation for humans via the environment, and control of
safety of toys.
EN
25
EN
Table 3.1: Number of animals used in toxicological and other safety evaluation
Products versus species
Data of 2008*
3.1.Species
1.a.
1.b.
1.c.
1.d.
1.e.
1.f.
1.g.
1.h.
1.i.
1.j.
1.k.
3.2. Products/
substances or
devices for
human
medicine and
dentistry and
for veterinary
medicine
3.3.
Products/
substance
s 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
188227
187283
23152
1559
0
30516
312
9888
269
296
22
10129
31421
2830
0
164
2696
0
340
0
0
0
20249
41562
3679
21
0
4453
0
16
0
0
0
1922
1709
0
0
0
50
0
0
0
0
0
880
174
38
0
0
153
0
0
0
0
0
3169
21
408
409
543
200
5121
0
0
64
8838
0
179
69021
529497
90
14
0
4
0
0
0
0
210
2110
2116
0
108
21915
74147
0
0
0
0
0
0
0
0
0
0
30
0
0
12416
82426
0
0
0
0
0
0
0
0
0
0
0
0
0
601
4282
0
0
0
0
0
0
0
0
0
0
0
0
0
722
1967
3.8.Products
/ substances
used or
intended to
be used
mainly as
additives in
food for
animal
consumption
3.9.Potential
or actual
contaminants
in the general
environment
which do not
appear in
other
columns
2818
2764
24
0
0
11
0
0
0
0
0
1680
303
7
0
0
7
0
0
0
0
0
9433
2932
0
0
204
12
0
0
0
0
0
162919
26496
2192
0
27
2127
10
833
0
0
0
398257
294644
31922
1580
395
40025
322
11077
269
296
22
100
0
0
0
0
0
0
0
0
0
0
0
0
523
6240
4584
0
0
0
0
0
0
0
0
0
39553
0
0
8030
54164
64
8
0
0
0
0
0
0
0
0
97
0
0
53062
65812
66
0
1
44
0
70
573
0
0
0
320
0
4
27936
223618
8073
43
409
457
543
270
5694
0
210
2174
50954
0
291
194226
1042153
3.6.Products 3.7.Products/
/ substances substances
used or
used or
intended to intended to be
be used
used mainly
mainly as as additives in
food for
cosmetics or
human
toiletries
consumption
3.10.Other
toxicological
or safety
evaluations
3.11.Total
EN
26
EN
III.5.
Specific to animal
diseases
9,7%
Human cardiovascular
diseases
6,4%
Human cancer
(excluding evaluations
of carcino hazards )
13,5%
Overall in 2008 there is a 50% decrease in the number of animals used for studies on specific
animal diseases - from 1,329,000 to 614,000. In particular, a significant change occurred in the
use of cold-blooded species where figures decreased from around 954,000 animals in 2005 to
43,914 in 2008.
Interesting to note is that despite the overall decrease, the use of mice increased substantially
in 2008. Around 30% of the increase (about 681,000) can be attributed to different studies of
diseases (see also observations under chapter III.3.3).
EN
27
EN
Some Member States confirmed that the increase of the use of animals in general, or mice in
particular in table 4, is also reported under several headings of table 2, such as fundamental
biological research and research and development of products for human and veterinary
medicine and even production and control process for human and veterinary medicine. For the
2008 data one Member States indicated, however, that the increase of use of mice was
primarily attributed to fundamental biological research.
It should be remembered that the studies on specific animal diseases are important in light of
epidemic diseases affecting animals such as in the case of foot and mouth disease, swine fever
and more recently avian flew. However, animals have also been used in studies on genetic
diseases. According to 2008 data there has been more than a 50% reduction in animals used
for studies on animal diseases. This could be because there have been no new significant
animal disease epidemics in 2008 or in the preceding years.
The above observation is not necessarily reflected in the use of all species in particular for the
use of mice and other birds by some Member States.
Regarding the specific animal diseases studies linked to the increase in the number of birds,
Member States reported studies on bird flu, Gumboro disease and bronchitis including studies
on quality and safety of vaccines.
EN
28
EN
Table 4.1: Number of animals used in experiments for studies on human and animal diseases
Main category of diseases versus species
Data of 2008 *
4.1 Species
TOTAL
4.2 Human
cardiovascular
diseases
4.3 Human
nervous and
mental disorders
4.7 Total
249486
125904
2856
1940
673
5373
14
1233
20
72
3
858612
489630
5004
2986
6737
1386
169
207
184
0
0
803038
43336
262
791
239
1781
0
144
0
0
0
1883499
600979
47326
6751
5093
28138
126
4544
2153
468
154
292772
16909
3252
3104
4617
6983
1930
3810
105
411
1614
4087407
1276758
58700
15572
17359
43661
2239
9938
2462
951
1771
4638
170
597
243
0
7
111
0
29
0
4769
0
362
5841
404341
417
39
601
36
40
101
261
0
55
400
4563
90
603
57964
1430085
100
87
24
0
0
0
6
0
5
0
47
0
2886
2458
855204
9589
478
8065
2860
311
419
3173
0
887
177
21365
0
10852
381109
3018516
17299
1014
6833
13756
370
21
8
0
449
413
194727
934
2022
40958
614311
32043
1788
16120
16895
721
548
3559
0
1425
990
225471
1024
16725
488330
6322457
EN
29
EN
Mice
Rats
Guinea-Pigs
Other rodents
Rabbits
Carnivores
Artio + Perrisodactyla
Prosimians+Monkeys+Apes
Other Mammals
Birds
Cold-blooded animals
TOTAL
Classes of animals%
Mice
Rats
Guinea-Pigs
Other rodents
Rabbits
Carnivores
Artio + Perrisodactyla
Prosimians+Monkeys+Apes
Other Mammals
Birds
Cold-blooded animals
EN
Human
Cardiovascular
diseases
249486
125904
2856
2613
5373
1339
5651
118
29
4769
6203
404341
Human
Cardiovascular
diseases
6,10
9,86
4,87
7,93
12,31
8,59
8,24
2,44
2,04
2,11
1,23
Human
nervous and
mental disorder
Human cancer
(excl. evaluation of
carcino. hazards)
858612
489630
5004
9723
1386
560
1093
402
55
4963
58657
1430085
803038
43336
262
1030
1781
144
211
6
5
47
5344
855204
Human
nervous and
mental disorder
Human cancer
(excl. evaluation of
carcino. hazards)
21,01
38,35
8,52
29,53
3,17
3,59
1,59
8,33
3,86
2,19
11,59
19,65
3,39
0,45
3,13
4,08
0,92
0,31
0,12
0,35
0,02
1,06
30
Other human
diseases
1883499
600979
47326
11844
28138
7291
21146
3903
887
21542
391961
3018516
Other human
diseases
46,08
47,07
80,62
35,97
64,45
46,77
30,82
80,84
62,25
9,51
77,45
Specific animal
diseases
292772
16909
3252
7721
6983
6256
40516
399
449
195140
43914
614311
Specific animal
diseases
7,16
1,32
5,54
23,45
15,99
40,13
59,05
8,26
31,51
86,17
8,68
Total
4087407
1276758
58700
32931
43661
15590
68617
4828
1425
226461
506079
6322457
Total
100,00
100,00
100,00
100,00
100,00
100,00
100,00
100,00
100,00
100,00
100,00
EN
Species of Table 4.1 were grouped into classes of animals and presented in Table 4.2. The
relative percentage of animals per class of species used in studies by type of disease has been
calculated and is also presented in the lower part of Table 4.2.
Figure 4.2 presents the proportion of animals used by classes per type of studies of diseases.
Figure 4.2
Proportion of animals used by classes per type of studies of diseases
100%
80%
60%
40%
Birds
Other Mammals
Prosimians+Monkeys+Apes
Artio + Perrisodactyla
Rabbits
Carnivors
Other rodents
Rats
Guinea-Pigs
Mice
0%
The top of each bar shows the relative percentage of animals used for studies on specific
animal diseases. Significant numbers of both artiodactyla and perissodactyla and birds are
used for this purpose. Member States reported that it is still current practice to test vaccines
on these species. However, in some Member States only birds are used if the infection
concerns bird species.
The data on the use of most species for all types of studies on both human and animal diseases
show a great similarity to the data of 2005. However, there is a substantial decrease in the use
of other mammals for studies of human diseases in particular 'other human diseases',
whereas the opposite is observed for cold-blooded animals which have been more widely
used in studies on human diseases rather than animal diseases.
EN
31
EN
III.6.
III.6.1. The data on animals used in production and quality control of products for human
medicine and dentistry and for veterinary medicine
The consolidated table for the 27 Member States reporting the origin of the regulatory
requirements in relation to animals used for the production and quality control of products for
human medicine and dentistry and for veterinary medicine (EU Table 5) is presented in Table
5.1 at the end of this chapter.
III.6.2. Treatment and interpretation of the data
The number of animals used in tests for the production and quality control of products for
human medicine and dentistry and for veterinary medicine represents 14,9% of the total
number of animals used for experimental purposes. Figure 5 gives the percentages of the
animals used to satisfy the different regional regulatory requirements in this area.
Figure 5
Percentages of animals used for regulatory requirements for the production and
quality control of products and devices for human medicine, dentistry and for
veterinary medicine
0,00
5.2 National legislation
specific to a single EC Member
State
10,00
20,00
30,00
5.5
5.6
Other legislation
41,1
0,049
2,6
5.7
No regulatory
requirements
50,00
2,6
40,00
47,0
6,4
The largest proportion of animals in this area (47%) was used to satisfy requirements from
several pieces of legislation (from national, the EU, the Council of Europe member country
legislation, and from legislation outside of the EU (Fig 5)). The testing carried out to satisfy
EU legislation including the European Pharmacopoeia covered 41,1% of the animals used in
this area.
In comparison to the report of 2005 there is a net decrease in the number of animals used to
satisfy simultaneously several pieces of legislation. On the other hand there is a net increase
of tests carried out for the European legislation (including the European Pharmacopoeia).
EN
32
EN
Consequently, there is a net decrease in the number of animals used to satisfy national
legislation, which is an encouraging trend showing an attempt to move towards EU
harmonisation of regulatory requirements.
EN
33
EN
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
Regulatory requirements versus species
Data of 2008 *
5.1. Species
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.
5.2. National
legislation
specific to a
single EC
Member State1
33233
5107
2519
0
0
851
43
208
0
27
307
518
68
805
139
0
0
0
0
13
0
1887
0
0
2260
47985
5.3. EC legislation
including
European
Pharmacopoeia
(requirements)
359722
86403
43916
8916
0
107271
614
985
2
311
225
5436
27
1523
2500
0
0
0
0
50
0
117540
0
0
1430
736871
5.4. Member
Country of Council
of Europe (but not
EC) legislation2)
371
405
0
0
0
0
0
0
0
0
0
0
0
54
0
0
0
0
0
0
0
60
0
0
0
890
5.5. Other
legislation
21567
16406
6494
358
0
1077
8
0
0
0
0
91
3
5
6
0
0
0
0
0
0
1676
0
0
0
47691
5.6. Any
combination of
5.2/ 5.3/ 5.4/
5.5
5.7. No
regulatory
requirements
569279
105741
62550
3613
30
53039
58
982
522
0
164
2385
10
703
414
0
33
231
0
0
0
41194
0
0
406
841354
5.8. Total
43303
5319
5615
2
0
20539
10
55
48
0
2087
994
11
5079
469
0
0
0
0
28
0
7556
0
0
24137
115252
1027475
219381
121094
12889
30
182777
733
2230
572
338
2783
9424
119
8169
3528
0
33
231
0
91
0
169913
0
0
28233
1790043
Footnotes:
Example:
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
1)
2)
EN
Note:
EC Member States: Austria, Belgium, Bulgaria, Cyprus, Czech Rep., Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta,
Netherlands, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, United Kingdom
Member Countries of Council of Europe (non-EC): Albania, Andorra, Croatia, Iceland, Liechtenstein, Moldova, Norway, Russia, San Marino, Switzerland, 'the former Yugoslav Rep. of
Macedonia' Turkey, Ukraine
34
EN
III.7.
III.7.1. The data on the origin of regulatory requirements for animals used in toxicological
and other safety evaluations
The consolidated table for the 27 Member States reporting data on animals used in
toxicological and other safety evaluations in relation to the origin of regulatory requirements
(EU Table 6) is presented in Table 6.1 at the end of this chapter.
III.7.2. Treatment and interpretation of the data
The use of animals for the regulatory requirements of different regions in the area of
toxicological or other safety evaluation presented in Figure 6 follows a similar pattern to that
of the use of animals used for regulatory purposes in human medicine, dentistry and in
veterinary medicine in different regions, presented in the Figure 5 in the previous chapter.
As pointed out earlier, the number of animals used in toxicological or other safety evaluation
represents 8,7% of the total number of animals used for experimental purposes in the EU.
Figure 6
Percentages of animals used for regulatory requirements for toxicological and other
safety evaluation
0,00
10,00
20,00
6.5
6.6
Other legislation
No regulatory
requirements
50,00
60,00
23,96
0,10
2,58
6.7
40,00
8,55
30,00
49,66
15,15
EN
35
EN
In comparison to the last report there is a net slight decrease in the proportion of animals used
to simultaneously satisfy several pieces of regional legislation from 54% to nearly 50%.
However, there is a substantial increase in the proportion of animals used for no regulatory
requirements. In order to explain what is meant by the term 'no regulatory requirements', some
Member States gave as an example projects using in-house methods to verify the safety and
efficacy of veterinary biologicals and medicinal products using animals, and carried out
according to a companys standards. The results may be accepted by that Member State
national authority, although not required by legislation.
The testing carried out in 2008 to satisfy national legislation specific to a single Member State
showed a decrease of about 7,500 animals which represents roughly a 1% decrease compared
to the last report.
EN
36
EN
Table 6.1:
6.1. Species
6.2. National
legislation specific
to a single EC
Member State1)
6.3. EC legislation
including European
Pharmacopoeia
(requirements)
35721
17191
660
101
204
1179
97
626
211
296
0
129353
51343
14723
238
0
12694
126
1421
32
0
0
752
89
84
0
0
2
4
58
0
0
0
5034
11496
390
0
0
1744
0
769
26
0
0
198942
194371
15166
1106
191
23426
85
8023
0
0
1
28397
20093
960
135
0
942
10
180
0
0
21
398199
294583
31983
1580
395
39987
322
11077
269
296
22
172
29
2
10
0
0
0
0
0
24
10
0
0
32582
89115
1177
0
75
226
543
0
265
0
0
680
7406
0
0
29413
249715
8
0
0
0
0
0
0
0
0
0
0
0
0
0
997
181
0
0
44
0
0
732
0
0
0
5000
0
0
1517
26933
6102
14
322
173
0
246
4599
0
0
1466
36017
0
179
27071
517500
425
0
10
0
0
24
98
0
0
0
2798
0
112
103688
157893
8065
43
409
453
543
270
5694
0
0
2170
51231
0
291
194271
1042153
6.4. Member
Country of Council
of Europe (but not
EC) legislation2)
6.5. Other
legislation
6.6. Any
combination of
5.2/ 5.3/ 5.4/ 5.5
6.7. No
regulatory
requirements
6.8.Total
Note:
Footnotes:
1)
2)
EN
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
EC Member States: Austria, Belgium, Bulgaria, Cyprus, Czech Rep., Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta,
Netherlands, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, United Kingdom
Member Countries of Council of Europe (non-EC): Albania, Andorra, Croatia, Iceland, Liechtenstein, Moldova, Norway, Russia, San Marino, Switzerland, 'the former Yugoslav Rep. of
Macedonia' Turkey, Ukraine
37
EN
III.8.
Results of EU Table 7: Animals used in toxicity tests for toxicological and other
safety evaluations
III.8.1. The data on animals used in toxicity test for toxicological and other safety evaluations
The consolidated table for the 27 Member States reporting on animals used in toxicity tests for
the purpose of toxicological and other safety evaluations of products (EU Table 7) is presented
in Table 7.1 at the end of this chapter.
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 according to systemic and local toxicity and CMR (carcinogenicity, mutagenicity
and toxicity to reproduction) effects in Table 7.2. A graph showing the percentage of animals
used per toxicity test groups in 2008 is presented in Figure 7.
Figure 7
Percentages of animals used in toxicity tests for toxicological
and other safety evaluation
0,00
10,00
20,00
30,00
50,00
44,99
4,61
9,88
4,58
40,00
9,13
2,41
other
24,40
As pointed out in the previous chapter, the number of animals used in toxicological and other
safety evaluations represents 8,7% of the total number of animals used for experimental
purposes.
In Figure 7 the largest percentage (almost 45%) of use of animals in toxicological and other
safety evaluations is due to acute and sub-acute toxicity tests. Also taking into account subchronic and chronic toxicity, the percentage of animals used in short and long term systemic
toxicity testing accounts for 55% in this area.
13,7% of animals were used for testing carcinogenicity, mutagenicity and toxicity to
reproduction. Another important category of use of animals in 2008 is for 'other tests' with 24%.
Breaking down further the category 'other', Member States reported testing in areas such as
biological screening for pharmaceutical, healthcare and veterinary products. This includes
neurotoxicity, toxicokinetics, testing of biological evaluation of medical devices: Intracutaneous
testing of reactivity in rabbits, studies into the penetration of nanoparticles through tissue and
EN
38
EN
their biocompatibility, studies into the evaluation of sensitization potential of dyestuffs used in
the textile industry and pharmacological studies included in safety tests.
By looking both in numbers and relative percentages of use of animals in comparison to the
previous reports there are two noticeable changes:
There is a continuous increase over the last three reports of the proportion of animals used for
acute and sub-acute tests, ranging from 36% - 42% to almost 45% respectively. This represents
in animal numbers an increase of more than 37,000 animals since the last report. Member States
attributed the increase in part to several phases in new product development and new legislation,
for example requiring that all generic substances should be tested.
On the other hand one can observe a steady decrease over the last three reports of the animals
used for reproductive toxicity testing from: 12% to 10% and to 9% respectively. This
demonstrates a saving since the 2005 report of 8,650 animals.
A general decrease in the number of animals used for regulatory toxicological evaluation could
be attributed to the use of alternative methods according to some Member States. However,
others have suggested that replacement methods have a much greater impact on research and
development than on regulatory requirements.
EN
39
EN
Table 7.1: Number of animals used in toxicological and other safety evaluations
Type of tests versus species
Data of 2008*
7.1. Species
7.2.1.
LD50,
LC50
7.2.2.
Other
lethal
methods
7.3.
Skin
irritation
7.4.
Skin
sensitis
ation
7.5. Eye
irritation
926
768
140
22
0
4200
0
0
0
0
16742
1465
20198
0
0
32
0
0
0
0
30
78
6
0
0
2105
0
0
0
0
27173
54915
618
310
204
1240
62
4582
0
0
7.6. Subchronic
and
chronic
toxicity
7.7.
Carcinogenicity
7.8.
Develop
- mental
toxicity
7.9.
Mutagenicity
10375
10219
0
0
0
0
0
0
0
0
3744
20263
120
0
0
6047
0
0
0
0
12858
14043
0
21
0
0
0
0
0
0
2759
51314
101
0
0
5349
0
20
0
0
7.10.
Reproductive
toxicity
7.11.
Toxicity
to
aquatic
vertebra
-tes not
included
in other
columns
7.12.
Other
7.13.
Total
200
26
7
0
0
7
0
0
0
0
101843
46957
6027
868
164
14984
236
1484
58
296
398199
294683
31883
1580
395
39987
322
11077
269
296
87440
7060
1000
16
27
110
0
15
0
0
87455
12651
303
0
0
38
0
339
0
0
7.2.3. Non
lethal
clinical
signs
methods
46654
74924
3363
343
0
5875
24
4637
211
0
22
22
0
0
0
0
0
0
18
11
0
0
0
0
0
0
535
0
36
60
261
65
1735
115
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
937
0
34
12
143
71
2861
0
0
0
0
0
0
0
0
0
0
0
0
64
176
0
0
0
0
0
0
0
112
0
0
22
0
0
58
0
0
0
0
0
0
0
6355
43
339
359
139
70
846
8065
43
409
453
543
270
5694
0
0
819
456
0
0
50983
147944
0
0
241
135
0
0
70000
171173
0
0
0
5937
0
0
5110
149770
0
0
0
1020
0
0
119
7310
0
0
0
0
0
0
0
38437
0
0
0
65
0
0
0
2284
0
0
0
0
0
108
9735
103005
0
0
0
0
0
0
213
20807
0
0
0
0
0
4
868
31286
0
0
0
0
0
0
0
26922
0
0
176
108
0
0
3796
63815
0
0
0
0
0
0
24857
25097
0
0
934
43510
0
179
28590
254303
0
0
2170
51231
0
291
194271
1042153
EN
40
EN
1.a.
1.b.
1.c.
1.d.
Hamsters (Mesocricetus )
1.e.
1.f.
1.g.
1.h.
1.i.
1.j.
Mutagenicity
and
carcinogenicity
Reproductive
and
developmental
toxicity
Toxicity to
aquatic
vertebrates not
included in
other columns
other
Total
17698
2311
20344
22
0
6337
0
0
0
0
0
27173
54915
618
310
204
1240
62
4582
0
0
0
23233
24262
0
21
0
0
0
0
0
0
0
6503
71577
221
0
0
11396
0
20
0
0
0
200
26
7
0
0
7
0
0
0
0
0
101843
46957
6027
868
164
14984
236
1484
58
296
22
398199
294683
31883
1580
395
39987
322
11077
269
296
22
115
0
0
0
0
0
0
0
0
0
1085
0
0
119
937
0
34
12
143
71
2861
0
0
0
0
0
108
9735
0
0
0
0
0
0
0
0
0
0
0
0
0
213
112
0
0
22
0
64
234
0
0
176
108
0
4
4664
0
0
0
0
0
0
0
0
0
0
0
0
0
24857
6355
43
339
359
139
70
846
0
0
934
43510
0
179
28590
8065
43
409
453
543
270
5694
0
0
2170
51231
0
291
194271
48031
103005
47729
95101
25097
254303
1042153
1.n.
Sheep (Ovis)
1.o.
Cattle (Bos)
1.p.
Prosimians (Prosimia)
1.q.
1.r.
1.s.
Apes (Hominoidea)
1.t.
1.u.
1.v.
1.w.
Reptiles (Reptilia)
1.x.
Amphibians (Amphibia)
1.y.
Fish (Pisces)
1.z.
TOTAL
468887
EN
Sub- chronic
and chronic
toxicity
221549
94635
4666
359
27
6023
24
4991
211
0
0
546
0
36
60
261
65
1753
0
0
1060
6528
0
0
126093
Irritation
/sensitization
tests
41
EN
III.9.
Results of EU Table 8: Type of toxicity tests carried out for toxicological and
other safety evaluations of products
III.9.1. The data on type of toxicity tests carried out for toxicological and other safety
evaluations of products
The consolidated table for the type of toxicity tests carried out for toxicological or other
safety evaluations of products for the 27 Member States reporting (EU table 8) is presented in
table 8.1 of this report. The data in table 8 have been subjected to a further quality criteria
check developed by the Commission. The data provided by all Member States for this report
were coherent.
III.9.2. Treatment and interpretation of the data
As pointed out earlier, animals used in toxicological and other safety evaluation represent
8,7% of the total number of animals used for experimental purposes.
In order to facilitate the interpretation of the results some types of toxicity testing have been
grouped and the results can be found in consolidated table 8.2 at the end of this chapter.
Figure 8 gives the proportion of animals used for toxicity and other safety evaluation by types
of products.
The treatment and interpretation of the data on animals used for toxicity tests with regard to
the type of products was done for the first time in the Fifth Statistical Report. However,
because the graph in that report represented more the relative importance of tests within a
type of product rather than the proportion of animals used per type of test for the different
products, the graph was modified accordingly for this report.
Figure 8
Proportion of animals used for toxicity tests for toxicological and other safety evaluation by
types of products
C) used in industry
Irritation/sensitization tests
Other
0%
20%
40%
60%
80%
100%
EN
42
EN
Figure 8 shows that the majority of animals tested in acute/sub-acute toxicity are intended for
the purpose of human medicine, dentistry and veterinary medicine. This is followed by tests
carried out for other toxicological or safety evaluation and then for agriculture and industrial
products.
Products intended for medicine, dentistry and veterinary medicine require the highest
proportion of animals for the different types of tests i.e. approximately 50%. The next highest
proportion is for other toxicological evaluations, above 20%, followed by animals used in
tests for products for agriculture and industry each above 7%.
EN
43
EN
Table 8.1: Number of animals used in toxicological and other safety evaluations
Type of tests versus products
Data of 2008*
8.1. Products
8.2.1.
LD50,
LC50
8.2.2.
Other
lethal
methods
8.3. Skin
irritation
8.4. Skin
sensitisa
tion
8.5. Eye
irritation
8.6. Subchronic
and
chronic
toxicity
8.7.
Carcinogenicity
8.8.
Develop
- mental
toxicity
8.9.
Mutagenicity
8.10.
Reproductive
toxicity
8.11.
Toxicity to
aquatic
vertebrates not
included
in other
columns
8.12.
Other
8.13.
Total
8.2.3. Non
lethal
clinical
signs
methods
43643
85795
116481
3732
17719
506
62442
15063
12314
14286
37079
3917
116640
529617
9066
4192
4987
724
4252
581
10089
3590
3120
2224
11578
11884
7860
74147
5263
4832
12483
2368
11129
1001
8324
306
11475
6490
8863
2870
7022
82426
617
1636
50
143
27
159
114
1016
520
4282
822
207
98
87
699
54
1967
64
112
213
1421
649
3157
320
167
128
6240
9142
177
100
80
44665
54164
37714
6243
2206
119
6294
213
85
1502
4111
4713
3410
66610
10080
60404
7909
173
1797
94
8004
2625
319
2937
3176
1234
123948
222700
107269
172563
144604
7349
35596
2269
96833
22446
30470
27873
65990
24698
304193
1042153
EN
44
EN
Table 8.2: Number of animals used in toxicological and other safety evaluation per types of products
8.1. Products
Irritation/sensitization
tests
Subchronic
and
chronic
toxicity
carcinogenicity,
Mutagenicity
and Reprotox.
Toxicity to
aquatic
vertebrates
not
included in
other
columns
Other
Total
245919
21957
62442
78742
3917
116640
529617
18245
5557
10089
20512
11884
7860
74147
22578
14498
8324
27134
2870
7022
82426
2303
170
159
1130
520
4282
1127
840
1967
389
1421
4293
128
6240
9319
100
80
44665
54164
46163
119
6294
5911
4713
3410
66610
78393
2064
8004
9057
1234
123948
222700
424436
45214
96833
146779
24698
304193
1042153
EN
Acute and
sub-acute
toxicity
testing
methods
(including
limit test)
45
EN
BELGIUM
Statistical data submitted
The statistical data have been submitted by the SPF Sant Publique, Scurit de la Chaine
Alimentaire et Environnement (Federal Public Service of Public Health, Food Chain Safety and
Environment).
LABORATORIES
Every year, all laboratories in Belgium that use animals for experimental purposes must provide
statistical information on the number of animals used the previous year.
In 2008, 389 laboratories were approved as regards the use of animals for experimental purposes
and they all provided their statistical data. A quarter of these laboratories had not used any animals
for experimental purposes in 2008.
2.
In all 725370 animals were used. Rodents and rabbits accounted for 93%, fish, reptiles and
amphibians for 4% and birds for 2% of the total number of animals used.
Dogs, cats and primates accounted respectively for 0,10%, 0,01% and 0,005% of the animals used in 2008
(Figure 1: Breakdown of species used in experiments)
EN
46
Primates - Apen
0,005%
Oiseaux - Vogels
2%
Animaux sang froid Koudbloed dieren
4%
Rongeurs Knaagdieren
87%
A comparison of the absolute figures for 2008 with those for 2007 (Table 1: Trend in the number of
animals used in experiments) shows an overall decrease of 54,490 animals (-7%).
This decrease concerns mainly rodents (-53,454; -8%) and fish (-12,489; -31%). However, for some
species there has been a marked increase. These are rabbits (+7,301; +21%), mainly used in certain
therapeutic polyclonal antibody development programmes, and birds (+4,622; +36%) which were
used in 2008 for food tests on poultry. The number of monkeys remained stable and limited in 2008
(41 animals) and in 2007 (38 animals). These primates are used for vaccine quality control tests and
for studies of human diseases (neurophysiology).
EN
47
TOTAL ANIMALS
480.681
108.580
36.554
2.124
1.055
42.025
671.019
78
788
324
0
1.190
62
2.969
195
356
657
4.239
0
0
41
0
41
151
676.640
431
17.151
17.582
374
2.388
28.386
31.148
725.370
2007
2006
518.208
116.991
43.499
1.882
1.908
34.724
717.212
46
747
336
0
1.129
103
2.657
122
291
616
3.789
0
0
38
0
38
124
722.292
18
12.942
12.960
256
3477
40.875
44.608
779.860
2005
516.148
104.272
38.542
1.614
1.627
30.518
692.721
107
1.207
234
0
1.548
108
2.022
116
295
758
3.299
0
0
196
0
196
88
697.852
35
16.127
16.162
121
3.516
39.064
42.701
756.715
2004
488.125
106.483
39.530
1.874
2.260
21.159
659.431
81
1.295
154
0
1.530
108
1.876
157
445
944
3.530
0
0
449
0
449
59
664.999
425
13.266
13.691
1.44
6.177
33.965
40.286
718.976
482.810
119.193
38.781
1.688
3.921
18.577
664.970
184
1.014
102
0
1.300
65
2.272
125
495
982
3.939
0
7
579
0
586
44
670.839
350
10.492
10.842
129
6.362
20.574
27.065
708.746
The headings in the statistical tables have remained unchanged since 1999. Taking 1999 as a
reference year, figure 2 (figure 2: Trend in the number of animals used since 1999) shows that the
number of animals used in Belgian laboratories has been relatively stable since then. In 2008 the
figure was 8% lower than in 1999.
However, the number of animals has been increasing slightly each year since 2000. This trend must
be seen in the context of the high level of research in Belgium, as the increase is essentially due to
the rise in the number of animals used in basic research (+34,8% between 2000 and 2008).
EN
48
900000
800000
790.089
700000
695.091
651.504
655.217
708.746
676.564
756.715
718.976
779.860
725.370
600000
500000
400000
300000
200000
100000
0
19 9 9
2000
2001
2002
2003
2004
2005
2006
2007
2008
In descending order, animals were used mainly to research and develop products and devices used
in human and veterinary medicine (32% of the animals used), in basic research studies (30%) and in
tests on the production and quality control of such products and devices (30%) (Figure 3:
Breakdown of the experimental fields).
As regards production and quality control tests, 99% of the animals were used to comply with
statutory requirements.
EN
49
Diagnostic Diagnose
1%
Toxicologie
3%
QC
30%
Formation Opleiding
3%
Autres - Overige
1%
Biol.fond. - Fund.
Biol.
30%
R&D
32%
The following diagram (Figure 4: Breakdown of experimental fields by the animals most used)
shows that of all the species, rodents are the most used. Rodents account for 82% of animals used
for basic research, 94% of animals used for research and development tests on products and devices
used in human and veterinary medicine and 84% of animals used for tests on the production and
quality control of medical products and devices. Fish account for 11% of the animals used in basic
research.
Toxicology and safety tests account for 3% of the animals used in experiments in 2008; 85% of the
animals used in toxicology tests were used in safety trials required by law (Figure 5: Proportion of
quality control and toxicology tests imposed by law).
Rodents account for 91% of all the animals used in toxicology tests. The other species used are
mainly rabbits (5%) and dogs (2,8%).
EN
50
250000
200000
150000
100000
50000
0
Autres
Formation
Diagnostic
Toxicologie
QC
R&D
Biologie fondamentale
Ro
O is ngeu r
Ani eaux s
ma
ux
Lap
s
i ns
ang
fr
oid
98,96%
85,41%
100,00%
75,00%
50,00%
Non /
Niet
Reglem.
Qualit Contrle /
Kw aliteit Controle
Reglem.
Non /
Niet
Reglem.
Reglem.
0,00%
14,59%
1,04%
25,00%
Toxicologie
EN
51
EN
52
TABLE 1:
1.1
Species
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.
1.2
Total
480681
108580
36554
2124
1055
42025
78
788
324
0
62
2969
195
356
657
0
0
41
0
151
431
17151
374
2388
28386
725370
1.3
Animals coming from registered
breeding or supplying
establishments within the reporting
country
1.4
Animals coming from
elsewhere in the EC
141865
19139
4648
724
1.6
Animals coming from
other origins
317570
88029
29865
289
1.5
Animals coming from
Member Countries of the
Council of Europe which are
parties to the Convention ETS
123 (excluding EC Member
States)
2367
116
2041
1074
38836
31
47
0
3189
47
289
185
0
0
0
0
0
0
452
139
589
48
483
0
0
0
0
0
0
0
12
0
0
0
0
0
0
0
29
0
0
5
28
0
431
1.7
Re-used animals
18879
1296
0
37
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:
Note 3:
The number of re-used animals in column 1.7 should be excluded from the total in the column 1.2
EN
53
EN
TABLE 2:
2.1
Species
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.
EN
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
2.2
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
2.6
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
155149
20692
388
377
391
1441
27
49
12
0
25
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)
155327
59947
3531
0
660
5293
33
38
312
0
2
138227
11668
29243
2
0
3389
0
0
0
0
0
2445
697
647
1653
0
30388
18
18
0
0
0
8950
12705
153
30
0
1213
0
682
0
0
0
8282
246
0
0
0
4
0
1
0
0
0
10086
2266
2583
62
4
251
0
0
0
0
35
2215
359
9
0
0
46
0
0
0
0
0
480681
108580
36554
2124
1055
42025
78
788
324
0
62
1309
53
183
130
0
0
11
0
95
431
10729
374
553
23406
215825
486
142
161
85
0
0
0
0
32
0
5855
0
1500
265
233669
0
0
0
0
0
0
29
0
24
0
0
0
0
0
182582
1097
0
4
374
0
0
0
0
0
0
87
0
0
0
37428
0
0
0
44
0
0
0
0
0
0
0
0
108
66
23951
2
0
0
0
0
0
1
0
0
0
0
0
0
0
8536
11
0
8
19
0
0
0
0
0
0
0
0
227
3116
18668
64
0
0
5
0
0
0
0
0
0
480
0
0
1533
4711
2969
195
356
657
0
0
41
0
151
431
17151
374
2388
28386
725370
54
2.8
Education and
training
2.9
Other
2.10
Total
EN
TABLE 3:
3.1
Species
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.
EN
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
3.2
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
6754
11310
153
30
0
1213
0
682
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
20142
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
108
0
108
0
45
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
66
111
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
55
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
3.9
Potential or
actual contaminents in the
general environment which
do not appear in
other columns
3.10
Other toxicological or
safety
evaluations
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
2196
1350
0
0
0
0
0
0
0
0
0
0
0
0
44
0
0
0
0
0
0
0
0
0
0
3590
3.11
Total
8950
12705
153
30
0
1213
0
682
0
0
0
0
0
0
44
0
0
0
0
0
0
0
0
108
66
23951
EN
TABLE 4:
NUMBER OF ANIMALS USED IN EXPERIMENTS FOR STUDIES ON HUMAN AND ANIMAL DISEASES
Main categories versus species
4.1
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.
EN
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
4.2
Human cardiovascular
diseases
6291
1652
428
15
0
152
0
202
0
0
0
271
42
145
0
0
0
0
0
3
0
0
0
20
0
9221
4.3
Human nervous and
mental disorders
65749
37145
95
0
640
9
0
0
0
0
0
8
0
0
0
0
0
0
0
6
400
0
0
0
0
104052
4.4
Human cancer (excluding
evaluations of carcinogenic
hazards or risks)
42230
1426
0
18
0
3
0
0
0
0
0
0
0
0
0
0
0
0
0
5
0
0
0
0
0
43682
56
4.5
Other human diseases
136336
33261
1805
322
320
322
31
56
312
0
0
245
101
0
0
0
0
12
0
4
0
0
0
0
0
173127
4.6
Studies specific to animal
diseases
3178
106
67
0
76
181
3
0
12
0
36
440
28
3
66
0
0
0
0
61
0
7881
43
0
2111
14292
4.7
Total
253784
73590
2395
355
1036
667
34
258
324
0
36
964
171
148
66
0
0
12
0
79
400
7881
43
20
2111
344374
EN
TABLE 5:
NUMBER OF ANIMALS USED IN PRODUCTION AND QUALITY CONTROL OF PRODUCTS AND DEVICES FOR
HUMAN MEDICINE AND DENTISTRY AND FOR VETERINARY MEDICINE
Regulatory requirements versus species
5.1
Species
5.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.
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
Examples:
Footnotes:
EN
5.2
National legislation
specific to a single EC
Member State
1)
0
0
0
0
0
0
0
0
0
0
0
0
0
0
13
0
0
0
0
0
0
0
0
0
0
13
5.3
EC legislation
including European
Pharmacopoeia
(requirements)
13396
752
1609
579
0
1960
18
18
0
0
0
1097
0
4
361
0
0
0
0
0
0
87
0
0
0
19881
5.4
Member Country of Council
of Europe (but not EC)
legislation
2)
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
5.5
Other legislation
17081
2135
4708
0
0
1049
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
24973
5.6
Any combination of
5.2/ 5.3/ 5.4/ 5.5
109778
7635
23573
1074
0
30766
0
0
0
0
0
0
0
0
0
0
0
29
0
0
0
0
0
0
0
172855
5.7
No regulatory
requirements
417
1843
0
2
0
2
0
0
0
0
0
0
0
0
0
0
0
0
0
24
0
0
0
0
0
2288
5.8
Total
140672
12365
29890
1655
0
33777
18
18
0
0
0
1097
0
4
374
0
0
29
0
24
0
87
0
0
0
220010
57
EN
TABLE 6:
6.1
Species
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.
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
Examples:
Footnotes:
EN
6.2
National legislation
specific to a single EC
Member State
1)
626
61
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
687
6.3
EC legislation
including European
Pharmacopoeia
(requirements)
1113
76
104
0
0
183
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
1476
6.4
Member Country of Council
of Europe (but not EC)
legislation
2)
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
6.5
Other legislation
0
1350
0
0
0
0
0
0
0
0
0
0
0
0
44
0
0
0
0
0
0
0
0
0
66
1460
6.6
Any combination of
6.2/ 6.3/ 6.4/ 6.5
5268
9775
49
30
0
1030
0
682
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
16834
6.7
No regulatory
requirements
1943
1443
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
108
0
3494
6.8
Total
8950
12705
153
30
0
1213
0
682
0
0
0
0
0
0
44
0
0
0
0
0
0
0
0
108
66
23951
58
EN
TABLE 7:
7.1
Species
7.2
Acute and sub-acute toxicity testing methods
(including limit test)
7.2.1.
LD50,
LC50
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.
EN
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
7.2.2
Other lethal
methods
471
0
0
0
0
0
0
0
0
0
0
9
301
0
0
0
0
0
0
0
0
0
7.2.3
Non lethal
clinical signs
methods
2068
4533
27
0
0
306
0
409
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
66
537
0
0
0
0
0
0
0
0
0
0
0
0
0
0
310
0
0
0
0
0
0
0
0
0
0
0
0
0
0
7343
7.3
Skin
irritation
7.4
Skin
sensitisatio
n
7.5
Eye
irritation
7.6
Subchronic and
chronic
toxicity
7.7
Carcinogenicity
7.8
Developmental
toxicity
7.9
Mutagenicit
y
0
0
0
0
0
156
0
0
0
0
0
0
0
104
0
0
9
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
553
1611
0
0
0
0
0
82
0
0
0
821
1428
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
202
1236
0
0
0
0
0
0
0
0
0
1611
2151
0
0
0
610
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
3215
1445
22
30
0
132
0
191
0
0
0
8950
12705
153
30
0
1213
0
682
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
113
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
12
0
0
0
0
0
0
0
0
108
0
2366
0
0
0
0
0
0
0
0
0
0
0
0
0
0
2249
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
1438
0
0
0
22
0
0
0
0
0
0
0
0
0
0
4394
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
10
0
0
0
0
0
0
0
0
0
0
5045
0
0
0
44
0
0
0
0
0
0
0
0
108
66
23951
59
7.10
Reproductive
toxicity
7.11
Toxicity
to aquatic
vertebrates not
included
in other
columns
7.12
Other
7.13
Total
EN
TABLE 8:
8.1
Products
8.2
Acute and sub-acute toxicity testing
methods (including limit test)
8.2.1.
LD50,
LC50
8.a.
8.b.
8.c.
8.d.
8.e.
8.f.
8.g.
8.h.
8.i.
8.j.
EN
8.3
Skin
irritation
8.4
Skin
sensitisatio
n
8.5
Eye
irritation
8.6
Subchronic
and
chronic
toxicity
8.7
Carcino
genicity
8.8
Developmental
toxicity
8.9
Mutagenicit
y
8.10
Reproductive
toxicity
8.11
Toxicity
to aquatic
vertebrates not
included
in other
columns
8.12
Other
8.13
Total
8.2.2
Other lethal
methods
8.2.3
Non lethal
clinical signs
methods
471
283
7020
156
113
1786
2228
853
4372
2860
20142
108
108
66
27
18
111
305
472
21
585
22
2185
3590
537
310
7343
156
113
2366
2249
1438
4394
5045
23951
60
EN
BULGARIA
Statistical data submitted
The statistical data have been submitted by the National Veterinary Service.
EN
61
EN
R&D - 35%
E&T - 24%
S&D od disease - 8%
Mice -49,9%
Rabbits- 2,5%
Pigs - 0,42%
Other birds - 4,54%
Rats -13,85%
Cats - 0,03%
Goats - 0,25%
Amphibians - 14,74%
Guinea-Pigs - 11,8%
Dogs - 0,05%
Sheep - 0,77%
Fish - 0,15%
Hamsters- 0,56%
Horses - 0,05%
Cattle - 0,39%
The total number of animals used for experimental purposes was 32,581 in 2008 (mostly mice and
hamsters). There have not been any non-human primates used for experimental purposes.
Experiments not permitted in Bulgaria:
1. for educational purposes, which cause death of animals; in educational establishments animal
experiments shall be replaced by other methods for visualizing the subject taught in all cases where
the use of animals might be replaced by other methods and if the aim is not to provide the students
with specific practical skills.
2. if the result can be achieved with any method not involving the use of live animal(s);
3. if they use stray and/or domestic dogs or cats as experimental animals.
EN
62
EN
TABLE 1:
1.1
Species
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.
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
16265
4513
3845
182
15820
3124
3807
112
445
1389
38
70
813
11
15
0
807
11
13
1.7
Re-used animals
17
137
80
250
126
0
0
0
0
0
1477
4800
50
32581
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:
Note 3:
The number of re-used animals in column 1.7 should be excluded from the total in the column 1.2
EN
63
EN
TABLE 2:
2.1
Species
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.
EN
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
2.2
Biological
studies of a
fundamenta
l nature
6197
237
4
178
37
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)
108
684
634
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)
7050
529
2057
264
30
54
1964
1080
1000
24
393
5
60
3
62
4
2.7
Diagnosis of
disease
2.8
Education and
training
2.9
Other
2.10
Total
682
1953
96
4
13
216
2
10
17
24
60
46
10
20
16
239
16
30
10
93
920
15
16
173
110
224
48
268
4600
50
8054
200
7130
1596
10074
1341
64
4110
16265
4513
3845
182
0
813
14
12
0
0
17
137
80
250
126
0
0
0
0
0
0
1477
0
4800
50
32581
EN
TABLE 3:
3.1
Species
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.
EN
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
3.2
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
1900
1080
1000
3.7
Products/
substances
used or
intended to be
used mainly
as additives in
food for
human
consumption
64
3.8
Products/
substances
used or
intended to be
used mainly
as additives in
food for
animal
consumption
64
3.9
Potential or
actual contaminents in the
general environment which
do not appear in
other columns
3.10
Other toxicological or
safety
evaluations
62
4
4046
65
3.11
Total
1964
1080
1000
0
0
62
4
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
4110
EN
TABLE 4:
NUMBER OF ANIMALS USED IN EXPERIMENTS FOR STUDIES ON HUMAN AND ANIMAL DISEASES
Main categories versus species
4.1
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.
EN
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
4.2
Human cardiovascular
diseases
4.3
Human nervous and
mental disorders
40
4
4.4
Human cancer (excluding
evaluations of carcinogenic
hazards or risks)
480
50
100
4.5
Other human diseases
4.6
Studies specific to animal
diseases
1800
85
8
2
13
15
16
48
630
66
254
1904
298
4.7
Total
2280
175
4
108
0
19
0
0
0
0
0
0
0
15
16
0
0
0
0
0
0
263
0
0
0
2880
EN
TABLE 5:
NUMBER OF ANIMALS USED IN PRODUCTION AND QUALITY CONTROL OF PRODUCTS AND DEVICES FOR
HUMAN MEDICINE AND DENTISTRY AND FOR VETERINARY MEDICINE
Regulatory requirements versus species
5.1
Species
5.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.
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
Examples:
Footnotes:
EN
5.2
National legislation
specific to a single EC
Member State
1)
5.3
EC legislation
including European
Pharmacopoeia
(requirements)
7314
30
2054
10
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
529
57
443
5
10
30
920
43
10776
10
596
7314
559
2111
0
0
453
5
3
0
0
0
20
0
0
0
0
0
0
0
0
0
950
0
0
0
11415
67
EN
TABLE 6:
6.1
Species
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.
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
Examples:
Footnotes:
EN
6.2
National legislation
specific to a single EC
Member State
1)
150
100
250
6.3
EC legislation
including European
Pharmacopoeia
(requirements)
1700
200
1000
6.4
Member Country of Council
of Europe (but not EC)
legislation
2)
64
60
2
4
2960
70
6.5
Other legislation
6.6
Any combination of
6.2/ 6.3/ 6.4/ 6.5
6.7
No regulatory
requirements
50
780
830
6.8
Total
1964
980
1100
0
0
62
4
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
4110
68
EN
TABLE 7:
7.1
Species
7.2
Acute and sub-acute toxicity testing methods
(including limit test)
7.2.1.
LD50,
LC50
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.
EN
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
1864
900
1000
7.2.2
Other lethal
methods
130
7.3
Skin
irritation
7.4
Skin
sensitisatio
n
7.5
Eye
irritation
7.6
Subchronic and
chronic
toxicity
7.7
Carcinogenicity
7.8
Developmental
toxicity
7.9
Mutagenicit
y
7.10
Reproductive
toxicity
7.11
Toxicity
to aquatic
vertebrates not
included
in other
columns
7.12
Other
7.2.3
Non lethal
clinical signs
methods
100
50
60
2
4
3824
130
150
69
7.13
Total
1964
1080
1000
0
0
62
4
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
4110
EN
TABLE 8:
8.1
Products
8.2
Acute and sub-acute toxicity testing
methods (including limit test)
8.2.1.
LD50,
LC50
8.a.
8.b.
8.c.
8.d.
8.e.
8.f.
8.g.
8.h.
8.i.
8.j.
EN
3760
8.2.2
Other lethal
methods
130
8.2.3
Non lethal
clinical signs
methods
150
8.3
Skin
irritation
8.4
Skin
sensitisatio
n
8.5
Eye
irritation
8.6
Subchronic
and
chronic
toxicity
8.7
Carcino
genicity
8.8
Developmental
toxicity
8.9
Mutagenicit
y
8.10
Reproductive
toxicity
8.11
Toxicity
to aquatic
vertebrates not
included
in other
columns
8.12
Other
8.13
Total
4046
0
0
0
0
64
64
0
3824
130
150
70
4110
EN
CZECH REPUBLIC
Statistical data submitted
The statistical data have been submitted by the Central Commission for Animal Welfare (stedn
komise pro ochranu zvat).
EN
71
EN
TABLE 1:
1.1
Species
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.
1.2
Total
54776
21531
1902
251
1233
6304
45
552
122
45
378
2013
174
1148
799
0
0
80
0
1774
0
148722
1012
3016
54836
300713
1.3
Animals coming from registered
breeding or supplying
establishments within the reporting
country
1.4
Animals coming from
elsewhere in the EC
51832
20600
1902
251
2888
931
56
6263
15
478
122
14
30
30
27
47
44
18
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
80
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:
Note 3:
The number of re-used animals in column 1.7 should be excluded from the total in the column 1.2
EN
72
EN
TABLE 2:
2.1
Species
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.
EN
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
2.2
Biological
studies of a
fundamenta
l nature
14326
9878
169
14
1125
918
44
9
19
1146
32
108
54
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)
9138
4523
545
180
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
2019
133
39
15795
1260
905
703
3270
132
6172
3
35
467
30
335
118
36
30
122
3533
15
18
202
217
151
2
4
306
208
23
550
2359
77
57
83
780
100
100
332
250
162
506
746
54
90
23328
37402
42710
300
7207
2.9
Other
2.10
Total
6073
105
25
65
13
468
29
2.8
Education and
training
83
119
65
184
10
625
34
80
1774
146422
958
2915
16894
196805
594
16336
2313
73
371
54
101
150
5048
29
6966
54776
21531
1902
251
1233
6304
45
552
122
45
378
2013
174
1148
799
0
0
80
0
1774
0
148722
1012
3016
54836
300713
EN
TABLE 3:
3.1
Species
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.
EN
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
3.2
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
553
947
71
8
405
155
1825
100
142
24
60
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
45
54
12
151
100
210
349
48
305
2518
677
1384
1945
4085
549
549
422
422
74
523
625
32066
32177
950
950
3.11
Total
761
3231
171
0
0
240
0
151
0
0
0
108
0
0
4
0
0
0
0
210
0
397
0
0
37437
42710
EN
TABLE 4:
NUMBER OF ANIMALS USED IN EXPERIMENTS FOR STUDIES ON HUMAN AND ANIMAL DISEASES
Main categories versus species
4.1
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.
EN
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
4.2
Human cardiovascular
diseases
185
2629
4.3
Human nervous and
mental disorders
181
1865
4.4
Human cancer (excluding
evaluations of carcinogenic
hazards or risks)
6411
1996
12
134
39
60
2
4.5
Other human diseases
4.6
Studies specific to animal
diseases
10073
1901
135
52
118
2
122
102
18
250
31
49
2945
2803
35
281
42
7
537
147
37
114
10
3138
2048
8479
75
212
1641
12927
1925
10514
4.7
Total
19795
11194
147
52
35
593
0
85
122
0
7
642
147
305
114
0
0
80
0
10
0
1853
0
0
1925
37106
EN
TABLE 5:
NUMBER OF ANIMALS USED IN PRODUCTION AND QUALITY CONTROL OF PRODUCTS AND DEVICES FOR
HUMAN MEDICINE AND DENTISTRY AND FOR VETERINARY MEDICINE
Regulatory requirements versus species
5.1
Species
5.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.
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
Examples:
Footnotes:
EN
5.2
National legislation
specific to a single EC
Member State
1)
5884
67
180
5.3
EC legislation
including European
Pharmacopoeia
(requirements)
11930
1260
741
88
3490
15
18
292
46
14
422
97
332
48
458
90
6698
18777
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
66
100
66
100
5.8
Total
17814
1393
921
0
0
3578
15
18
0
0
306
468
0
100
332
0
0
0
0
0
0
606
0
0
90
25641
76
EN
TABLE 6:
6.1
Species
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.
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
Examples:
Footnotes:
EN
6.2
National legislation
specific to a single EC
Member State
1)
511
2755
100
171
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
192
474
41
32
12
19
151
100
670
24468
28156
9179
9264
3835
5290
703
3270
132
0
0
202
0
151
0
0
0
100
0
0
0
0
0
0
0
0
0
670
0
0
37482
42710
77
EN
TABLE 7:
7.1
Species
7.2
Acute and sub-acute toxicity testing methods
(including limit test)
7.2.1.
LD50,
LC50
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.
EN
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
7.2.2
Other lethal
methods
7.3
Skin
irritation
7.5
Eye
irritation
7.6
Subchronic and
chronic
toxicity
7.7
Carcinogenicity
7.8
Developmental
toxicity
7.9
Mutagenicit
y
387
115
7.10
Reproductive
toxicity
7.11
Toxicity
to aquatic
vertebrates not
included
in other
columns
7.12
Other
10
155
12
116
97
19
26
718
679
15
42
490
532
60
80
56
100
670
33782
34134
506
7.13
Total
7.2.3
Non lethal
clinical signs
methods
506
337
7.4
Skin
sensitisatio
n
718
107
302
78
32
759
387
115
532
3700
3700
1418
703
3270
132
0
0
202
0
151
0
0
0
100
0
0
0
0
0
0
0
0
0
670
0
0
37482
42710
EN
TABLE 8:
8.1
Products
8.2
Acute and sub-acute toxicity testing
methods (including limit test)
8.2.1.
LD50,
LC50
8.a.
8.b.
8.c.
8.d.
8.e.
8.f.
8.g.
8.h.
8.i.
8.j.
EN
255
8.2.2
Other lethal
methods
8.3
Skin
irritation
8.4
Skin
sensitisatio
n
8.5
Eye
irritation
68
35
11
8.6
Subchronic
and
chronic
toxicity
8.7
Carcino
genicity
8.8
Developmental
toxicity
8.9
Mutagenicit
y
8.10
Reproductive
toxicity
8.11
Toxicity
to aquatic
vertebrates not
included
in other
columns
8.12
Other
8.13
Total
8.2.3
Non lethal
clinical signs
methods
506
750
400
1067
318
12
39
255
477
138
12
21
270
387
95
532
975
1028
2518
210
1384
126
4085
549
549
422
422
625
625
30421
20
45
1637
54
950
33464
506
718
107
79
302
32
759
625
387
115
577
3700
32177
950
1418
42710
EN
DENMARK
Statistical data submitted
The statistical data have been submitted by the Dyreforsgstilsynet (Animal Experiments
Inspectorate).
EN
80
EN
TABLE 1:
1.1
Species
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.
1.2
Total
168164
75850
5343
4
1760
2931
154
271
117
101
54
6863
107
88
939
0
0
0
0
243
0
2820
221
293
31245
1.3
Animals coming from registered
breeding or supplying
establishments within the reporting
country
1.4
Animals coming from
elsewhere in the EC
119674
42343
703
4
1.6
Animals coming from
other origins
44406
30618
4640
0
1.5
Animals coming from
Member Countries of the
Council of Europe which are
parties to the Convention ETS
123 (excluding EC Member
States)
337
687
0
0
758
0
0
97
1044
17
250
20
0
4
0
0
1129
133
21
0
140
0
39
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
1.7
Re-used animals
3747
2202
0
0
297568
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:
Note 3:
The number of re-used animals in column 1.7 should be excluded from the total in the column 1.2
EN
81
EN
TABLE 2:
2.1
Species
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.
EN
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
2.2
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
2.6
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
53293
15346
207
4
62
357
123
1
97
62
15
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)
82439
45628
2017
0
1698
1808
0
119
20
39
13
11900
3244
1695
0
0
447
0
0
0
0
7
155
0
25
0
0
4
0
0
0
0
0
4923
7269
1311
0
0
218
0
130
0
0
0
2932
833
76
0
0
2
10
21
0
0
0
1096
2628
12
0
0
42
0
0
0
0
19
11426
902
0
0
0
53
21
0
0
0
0
168164
75850
5343
4
1760
2931
154
271
117
101
54
2245
0
5
616
0
0
0
0
233
0
2604
198
92
5939
81499
1862
93
38
124
0
0
0
0
0
0
111
23
65
16602
152699
0
0
26
0
0
0
0
0
0
0
2
0
0
0
17321
43
0
6
18
0
0
0
0
0
0
84
0
0
0
335
648
0
0
0
0
0
0
0
0
0
6
0
0
8443
22948
102
0
0
131
0
0
0
0
0
0
13
0
136
0
4256
1029
0
13
50
0
0
0
0
10
0
0
0
0
261
5160
934
14
0
0
0
0
0
0
0
0
0
0
0
0
13350
6863
107
88
939
0
0
0
0
243
0
2820
221
293
31245
297568
82
2.8
Education and
training
2.9
Other
2.10
Total
EN
TABLE 3:
3.1
Species
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.
EN
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
3.2
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
2845
4515
1260
0
0
215
0
130
0
0
0
648
0
0
0
0
0
0
0
0
0
0
0
0
0
9613
0
74
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
74
537
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
493
1030
0
1346
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
1346
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
83
3.7
Products/
substances
used or
intended to be
used mainly
as additives in
food for
human
consumption
62
120
24
0
0
3
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
209
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
7950
7950
3.9
Potential or
actual contaminents in the
general environment which
do not appear in
other columns
3.10
Other toxicological or
safety
evaluations
439
127
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
566
1040
1087
27
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
6
0
0
0
2160
3.11
Total
4923
7269
1311
0
0
218
0
130
0
0
0
648
0
0
0
0
0
0
0
0
0
6
0
0
8443
22948
EN
TABLE 4:
NUMBER OF ANIMALS USED IN EXPERIMENTS FOR STUDIES ON HUMAN AND ANIMAL DISEASES
Main categories versus species
4.1
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.
EN
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
4.2
Human cardiovascular
diseases
2802
2075
269
0
0
199
0
21
0
0
0
471
0
0
0
0
0
0
0
0
0
64
0
0
0
5901
4.3
Human nervous and
mental disorders
59758
34100
1700
0
1416
0
0
39
20
0
0
179
0
0
0
0
0
0
0
0
0
0
0
151
8165
105528
4.4
Human cancer (excluding
evaluations of carcinogenic
hazards or risks)
13426
823
0
0
0
1129
0
0
0
0
0
0
87
0
0
0
0
0
0
0
0
0
0
0
0
15465
84
4.5
Other human diseases
35581
19699
194
0
282
757
0
80
97
0
0
1869
6
0
79
0
0
0
0
0
0
0
0
0
0
58644
4.6
Studies specific to animal
diseases
1150
40
0
0
24
21
85
0
0
0
15
111
0
0
36
0
0
0
0
130
0
240
0
0
1180
3032
4.7
Total
112717
56737
2163
0
1722
2106
85
140
117
0
15
2630
93
0
115
0
0
0
0
130
0
304
0
151
9345
188570
EN
TABLE 5:
NUMBER OF ANIMALS USED IN PRODUCTION AND QUALITY CONTROL OF PRODUCTS AND DEVICES FOR HUMAN
MEDICINE AND DENTISTRY AND FOR VETERINARY MEDICINE
Regulatory requirements versus species
5.1
Species
5.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.
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
Examples:
Footnotes:
EN
5.2
National legislation
specific to a single EC
Member State
1)
155
0
25
0
0
4
0
0
0
0
0
43
0
6
18
0
0
0
0
0
0
84
0
0
0
335
5.3
EC legislation
including European
Pharmacopoeia
(requirements)
14
2408
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
2422
5.4
Member Country of Council
of Europe (but not EC)
legislation
2)
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
5.5
Other legislation
0
0
0
0
0
28
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
28
5.6
Any combination of
5.2/ 5.3/ 5.4/ 5.5
11870
836
1310
0
0
22
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
14038
5.7
No regulatory
requirements
16
0
385
0
0
397
0
0
0
0
7
0
0
26
0
0
0
0
0
0
0
2
0
0
0
833
5.8
Total
12055
3244
1720
0
0
451
0
0
0
0
7
43
0
32
18
0
0
0
0
0
0
86
0
0
0
17656
85
EN
TABLE 6:
6.1
Species
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.
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
Examples:
Footnotes:
EN
6.2
National legislation
specific to a single EC
Member State
1)
667
98
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
6
0
0
493
1264
6.3
EC legislation
including European
Pharmacopoeia
(requirements)
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
6.4
Member Country of Council
of Europe (but not EC)
legislation
2)
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
6.5
Other legislation
0
50
72
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
122
6.6
Any combination of
6.2/ 6.3/ 6.4/ 6.5
2366
4502
1188
0
0
216
0
130
0
0
0
648
0
0
0
0
0
0
0
0
0
0
0
0
0
9050
6.7
No regulatory
requirements
1890
2619
51
0
0
2
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
7950
12512
6.8
Total
4923
7269
1311
0
0
218
0
130
0
0
0
648
0
0
0
0
0
0
0
0
0
6
0
0
8443
22948
86
EN
TABLE 7:
7.1
Species
7.2
Acute and sub-acute toxicity testing methods
(including limit test)
7.2.1.
LD50,
LC50
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.
EN
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
7.2.2
Other lethal
methods
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
7.2.3
Non lethal
clinical signs
methods
1955
1146
1223
0
0
46
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
199
199
0
0
0
0
0
0
0
0
0
0
0
0
0
7950
7950
8
0
0
0
0
0
0
0
0
0
6
0
0
0
4384
7.3
Skin
irritation
7.4
Skin
sensitisatio
n
7.5
Eye
irritation
7.6
Subchronic and
chronic
toxicity
7.7
Carcinogenicity
7.8
Developmental
toxicity
7.9
Mutagenicit
y
0
0
0
0
0
19
0
0
0
0
0
931
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
3
0
0
0
0
0
382
3146
0
0
0
39
0
126
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
658
174
0
0
0
0
0
0
0
0
0
45
2372
0
0
0
109
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
952
431
88
0
0
2
0
4
0
0
0
4923
7269
1311
0
0
218
0
130
0
0
0
12
0
0
0
0
0
0
0
0
0
0
0
0
0
31
0
0
0
0
0
0
0
0
0
0
0
0
0
0
931
0
0
0
0
0
0
0
0
0
0
0
0
0
0
3
600
0
0
0
0
0
0
0
0
0
0
0
0
0
4293
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
832
28
0
0
0
0
0
0
0
0
0
0
0
0
0
2554
0
0
0
0
0
0
0
0
0
0
0
0
0
294
294
0
0
0
0
0
0
0
0
0
0
0
0
0
0
1477
648
0
0
0
0
0
0
0
0
0
6
0
0
8443
22948
87
7.10
Reproductive
toxicity
7.11
Toxicity
to aquatic
vertebrates not
included
in other
columns
7.12
Other
7.13
Total
EN
TABLE 8:
8.1
Products
8.2
Acute and sub-acute toxicity testing
methods (including limit test)
8.2.1.
LD50,
LC50
8.a.
8.b.
8.c.
8.d.
8.e.
8.f.
8.g.
8.h.
8.i.
8.j.
EN
8.2.2
Other lethal
methods
8.3
Skin
irritation
8.4
Skin
sensitisatio
n
8.5
Eye
irritation
31
407
4366
8.6
Subchronic
and
chronic
toxicity
8.7
Carcino
genicity
8.8
Developmental
toxicity
8.9
Mutagenicit
y
8.10
Reproductive
toxicity
8.11
Toxicity
to aquatic
vertebrates not
included
in other
columns
148
401
108
9613
8.12
Other
8.13
Total
125
8.2.3
Non lethal
clinical signs
methods
4027
18
56
74
199
188
294
45
304
1030
1016
330
1346
120
86
209
7950
7950
566
566
21
336
118
1041
644
2160
324
7950
4048
31
931
4798
832
2559
1472
22948
88
EN
GERMANY
Statistical data submitted
The statistical data have been submitted by the "Bundesministerium fr Verbraucherschutz,
Ernhrung und Landwirtschaft" (Federal Ministry for Consumer protection, Food and Agriculture).
EN
89
EN
For products or substances used primarily in cosmetics or toiletries, no toxicological tests were
carried out on animals in 2008 in Germany.
The proportion of animals used for research into human or animal diseases fell in 2008 compared
with the previous year from 58,5% to 56,1%.
24,6% of the animals were used for legally required experiments in the manufacture or quality control
of products for human, dental or veterinary medicine and/or for toxicological safety tests. Their
proportion therefore increased by 5,0%.
EN
90
EN
TABLE 1:
1.1
Species
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.
1.2
Total
1.314.493
390.853
35.870
7.061
8.392
97.938
798
4.450
55
410
584
12.361
531
4.638
6.252
543
305
1.415
0
541
1.803
53.986
192
10.815
67.496
2.021.782
1.3
Animals coming from registered
breeding or supplying
establishments within the reporting
country
1.4
Animals coming from
elsewhere in the EC
1.167.335
305.309
35.624
6.782
1.6
Animals coming from
other origins
129.636
79.003
246
149
1.5
Animals coming from
Member Countries of the
Council of Europe which are
parties to the Convention ETS
123 (excluding EC Member
States)
10.760
5.395
0
0
97.313
246
1.911
11
621
294
1.536
44
4
0
0
0
0
258
1.003
0
9.076
303
1.081
0
0
252
102
0
543
48
205
0
0
5
0
0
0
0
1.108
0
0
63
396
0
1.803
1.7
Re-used animals
6.762
1.146
0
130
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:
Note 3:
The number of re-used animals in column 1.7 should be excluded from the total in the column 1.2
EN
91
EN
TABLE 2:
2.1
Species
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.
EN
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
2.2
Biological
studies of a
fundamenta
l nature
2.3
Research and
development of
products and devices
for human medicine
and dentistry and for
veterinary medicine
(excluding
toxicological and other
safety evaluations
counted in column 2.6)
2.4
Production and
quality control of
products and
devices for human
medicine and
dentistry
723.037
74.880
936
2.036
3.497
2.453
79
193
42
15
346
273.935
180.418
6.002
2.822
3.934
5.387
547
1.003
0
0
121
148.754
51.412
16.870
16
0
50.713
39
0
0
0
0
41.668
10.468
3.700
1.331
0
1.809
10
939
2
311
2
2.6
Toxicological and
other safety
evaluations
(including safety
evaluation of
products and
devices for human
medicine and
dentistry and for
veterinary
medicine)
75.985
53.312
6.623
40
0
4.483
98
1.935
0
0
0
2.633
225
692
4.295
0
49
43
0
495
0
7.095
151
9.477
34.405
867.074
5.918
271
1.150
528
0
91
91
0
6
0
29.863
21
234
2.730
515.072
29
11
2.151
22
0
0
0
0
4
0
307
0
0
0
270.328
447
2
116
436
0
0
0
0
0
0
11.714
0
0
40
72.995
352
4
3
33
543
147
1.168
0
0
1.786
885
0
4
23.853
171.254
2.5
Production and
quality control
of products and
devices for
veterinary
medicine
92
2.7
Diagnosis of
disease
2.8
Education
and training
2.9
Other
2.10
Total
7.855
1.609
18
52
17
791
0
189
0
80
75
26.200
16.248
616
295
391
196
13
161
1
0
39
17.059
2.506
1.105
469
553
32.106
12
30
10
4
1
1.314.493
390.853
35.870
7.061
8.392
97.938
798
4.450
55
410
584
693
10
167
622
0
0
2
0
0
0
2.245
0
0
2.421
16.846
2.079
2
216
282
0
0
10
0
7
17
462
20
1.064
3.571
51.890
210
6
143
34
0
18
101
0
29
0
1.415
0
36
476
56.323
12.361
531
4.638
6.252
543
305
1.415
0
541
1.803
53.986
192
10.815
67.496
2.021.782
EN
TABLE 3:
3.1
Species
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.
EN
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
3.2
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
61.040
33.080
3.613
40
0
2.861
88
1.902
0
0
0
352
0
3
33
543
147
1.168
0
0
0
182
0
0
3.855
108.907
4.146
8.284
1.449
0
0
952
0
20
0
0
0
0
4
0
0
0
0
0
0
0
1.786
577
0
0
14.681
31.899
10.375
11.425
1.482
0
0
633
0
8
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
2.367
26.290
0
16
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
0
0
0
0
0
0
0
0
93
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
44
0
0
80
124
3.9
Potential or
actual contaminents in the
general environment which
do not appear in
other columns
3.10
Other toxicological or
safety
evaluations
217
239
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
2.870
3.326
207
268
79
0
0
37
10
5
0
0
0
0
0
0
0
0
0
0
0
0
0
82
0
4
0
692
3.11
Total
75.985
53.312
6.623
40
0
4.483
98
1.935
0
0
0
352
4
3
33
543
147
1.168
0
0
1.786
885
0
4
23.853
171.254
EN
TABLE 4:
NUMBER OF ANIMALS USED IN EXPERIMENTS FOR STUDIES ON HUMAN AND ANIMAL DISEASES
Main categories versus species
4.1
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.
EN
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
4.2
Human cardiovascular
diseases
60.950
16.279
130
387
0
758
0
3
0
0
0
447
0
59
9
0
0
4
0
0
0
118
0
224
1.768
81.136
4.3
Human nervous and
mental disorders
105.707
26.241
47
825
814
106
40
0
0
0
0
7
29
48
21
0
21
16
0
44
0
48
10
56
958
135.038
4.4
Human cancer (excluding
evaluations of carcinogenic
hazards or risks)
107.646
4.369
0
98
0
304
0
75
0
0
0
10
0
0
0
0
0
0
0
0
0
0
0
0
131
112.633
94
4.5
Other human diseases
388.614
87.061
4.271
2.531
2.623
2.413
0
84
35
2
43
2.170
203
528
79
0
26
80
0
42
0
2.239
0
468
3.913
497.425
4.6
Studies specific to animal
diseases
5.404
1.014
239
45
1.439
194
527
765
0
80
294
2.359
10
919
4.603
0
0
0
0
0
0
7.706
47
0
5.368
31.013
4.7
Total
668.321
134.964
4.687
3.886
4.876
3.775
567
927
35
82
337
4.993
242
1.554
4.712
0
47
100
0
86
0
10.111
57
748
12.138
857.245
EN
TABLE 5:
NUMBER OF ANIMALS USED IN PRODUCTION AND QUALITY CONTROL OF PRODUCTS AND DEVICES FOR
HUMAN MEDICINE AND DENTISTRY AND FOR VETERINARY MEDICINE
Regulatory requirements versus species
5.1
Species
5.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.
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
Examples:
Footnotes:
EN
5.2
National legislation
specific to a single EC
Member State
1)
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
5.3
EC legislation
including European
Pharmacopoeia
(requirements)
174.107
61.747
19.743
1.347
0
42.765
39
217
2
311
2
436
0
0
412
0
0
0
0
0
0
1.005
0
0
40
302.173
5.4
Member Country of Council
of Europe (but not EC)
legislation
2)
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
5.5
Other legislation
850
0
512
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
1.362
5.6
Any combination of
5.2/ 5.3/ 5.4/ 5.5
11.320
0
0
0
0
8.697
0
680
0
0
0
0
2
58
0
0
0
0
0
0
0
10.158
0
0
0
30.915
5.7
No regulatory
requirements
4.145
133
315
0
0
1.060
10
42
0
0
0
40
11
2.209
46
0
0
0
0
4
0
858
0
0
0
8.873
5.8
Total
190.422
61.880
20.570
1.347
0
52.522
49
939
2
311
2
476
13
2.267
458
0
0
0
0
4
0
12.021
0
0
40
343.323
95
EN
TABLE 6:
6.1
Species
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.
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
Examples:
Footnotes:
EN
6.2
National legislation
specific to a single EC
Member State
1)
153
110
0
0
0
0
14
36
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
1.270
1.583
6.3
EC legislation
including European
Pharmacopoeia
(requirements)
55.706
27.852
4.117
40
0
3.515
74
777
0
0
0
205
0
0
33
543
0
0
0
0
320
320
0
0
8.128
101.630
6.4
Member Country of Council
of Europe (but not EC)
legislation
2)
0
10
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
10
6.5
Other legislation
537
16
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
553
6.6
Any combination of
6.2/ 6.3/ 6.4/ 6.5
16.213
21.608
2.503
0
0
891
0
1.093
0
0
0
135
4
0
0
0
147
1.168
0
0
1.466
483
0
0
12.847
58.558
6.7
No regulatory
requirements
3.376
3.716
3
0
0
77
10
29
0
0
0
12
0
3
0
0
0
0
0
0
0
82
0
4
1.608
8.920
6.8
Total
75.985
53.312
6.623
40
0
4.483
98
1.935
0
0
0
352
4
3
33
543
147
1.168
0
0
1.786
885
0
4
23.853
171.254
96
EN
TABLE 7:
7.1
Species
7.2
Acute and sub-acute toxicity testing methods
(including limit test)
7.2.1.
LD50,
LC50
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.
EN
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
7.2.2
Other lethal
methods
28.611
2.510
0
0
0
28
0
0
0
0
0
8.594
5.884
0
0
0
18
0
339
0
0
0
7.2.3
Non lethal
clinical signs
methods
12.390
18.972
843
0
0
171
24
747
0
0
0
0
0
0
0
0
0
0
0
0
459
204
0
0
2.446
34.258
11
0
0
0
0
0
0
0
0
217
0
0
0
326
15.389
88
0
0
16
261
36
184
0
0
0
205
0
0
0
33.937
7.3
Skin
irritation
7.4
Skin
sensitisatio
n
7.5
Eye
irritation
7.6
Subchronic and
chronic
toxicity
7.7
Carcinogenicity
7.8
Developmental
toxicity
7.9
Mutagenicit
y
70
25
0
0
0
925
0
0
0
0
0
9.944
0
5.653
0
0
0
0
0
0
0
0
0
0
0
0
0
479
0
0
0
0
0
1.804
5.704
0
0
0
0
62
639
0
0
0
1.068
0
0
0
0
0
0
0
0
0
0
0
3.393
0
0
0
925
0
0
0
0
0
6.227
3.974
0
0
0
0
0
0
0
0
0
0
5.647
15
0
0
1.426
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
1.020
0
0
0
0
0
0
0
0
0
0
0
0
0
0
15.597
0
0
0
0
0
0
0
0
0
0
0
0
0
0
479
34
0
0
0
143
47
750
0
0
0
0
0
0
294
9.477
0
0
0
0
0
0
0
0
0
0
0
0
0
0
1.068
0
0
0
0
0
64
176
0
0
0
0
0
4
0
4.562
0
0
0
0
0
0
0
0
0
0
0
0
0
0
10.201
0
0
0
0
0
0
58
0
0
176
0
0
0
129
7.451
97
7.10
Reproductive
toxicity
7.11
Toxicity
to aquatic
vertebrates not
included
in other
columns
7.12
Other
7.13
Total
0
0
0
0
0
0
0
0
0
0
0
7.277
7.203
112
40
0
511
12
210
0
0
0
75.985
53.312
6.623
40
0
4.483
98
1.935
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
19.443
19.443
219
4
3
17
139
0
0
0
0
934
476
0
0
1.215
18.372
352
4
3
33
543
147
1.168
0
0
1.786
885
0
4
23.853
171.254
EN
TABLE 8:
8.1
Products
8.2
Acute and sub-acute toxicity testing
methods (including limit test)
8.2.1.
LD50,
LC50
8.a.
8.b.
8.c.
8.d.
8.e.
8.f.
8.g.
8.h.
8.i.
8.j.
EN
8.2.2
Other lethal
methods
8.3
Skin
irritation
8.4
Skin
sensitisatio
n
8.5
Eye
irritation
497
5.551
7.274
8.6
Subchronic
and
chronic
toxicity
8.7
Carcino
genicity
8.8
Developmental
toxicity
8.9
Mutagenicit
y
8.10
Reproductive
toxicity
8.11
Toxicity
to aquatic
vertebrates not
included
in other
columns
1.008
1.551
4.218
4.786
8.12
Other
8.13
Total
3.412
13.739
108.907
28.654
12.043
8.2.3
Non lethal
clinical signs
methods
26.171
3.244
2.572
2.680
367
2.793
372
974
1.072
1.271
725
11.884
3.945
31.899
2.046
566
4.671
156
7.177
91
1.209
60
1.935
4.322
1.928
1.895
234
26.290
16
16
80
44
124
289
208
239
20
12
2.172
386
3.326
176
76
13
390
24
692
34.258
15.389
33.937
1.020
15.597
479
9.477
1.068
4.562
10.201
7.451
19.443
18.372
171.254
98
EN
ESTONIA
Statistical data submitted
The statistical data have been submitted by the Animal Welfare and Zootechnics bureau of the
Ministry of Agriculture
EN
99
EN
TABLE 1:
1.1
Species
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.
1.2
Total
28754
5268
22
120
0
630
0
0
0
0
0
1.3
Animals coming from registered
breeding or supplying
establishments within the reporting
country
1.4
Animals coming from
elsewhere in the EC
11779
2058
13137
3210
22
120
630
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
3838
0
1.7
Re-used animals
0
0
0
0
0
0
0
34794
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:
Note 3:
The number of re-used animals in column 1.7 should be excluded from the total in the column 1.2
EN
100
EN
TABLE 2:
2.1
Species
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.
EN
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
2.2
Biological
studies of a
fundamenta
l nature
24323
2870
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)
4291
2398
15
105
510
120
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)
2.7
Diagnosis of
disease
2.8
Education and
training
2.9
Other
2.10
Total
40
28754
5268
22
120
0
630
0
0
0
0
0
22
27718
6914
100
101
40
22
0
0
0
0
0
0
0
0
0
0
0
0
0
0
34794
EN
TABLE 3:
3.1
Species
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.
EN
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
3.2
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
102
3.7
Products/
substances
used or
intended to be
used mainly
as additives in
food for
human
consumption
40
3.8
Products/
substances
used or
intended to be
used mainly
as additives in
food for
animal
consumption
40
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
40
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
40
EN
TABLE 4:
NUMBER OF ANIMALS USED IN EXPERIMENTS FOR STUDIES ON HUMAN AND ANIMAL DISEASES
Main categories versus species
4.1
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.
EN
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
4.2
Human cardiovascular
diseases
621
510
4.3
Human nervous and
mental disorders
11357
3412
4.4
Human cancer (excluding
evaluations of carcinogenic
hazards or risks)
10124
4.5
Other human diseases
4.6
Studies specific to animal
diseases
6512
1346
22
120
630
1131
14769
10124
103
8608
22
4.7
Total
28614
5268
22
120
0
630
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
34654
EN
TABLE 5:
NUMBER OF ANIMALS USED IN PRODUCTION AND QUALITY CONTROL OF PRODUCTS AND DEVICES FOR
HUMAN MEDICINE AND DENTISTRY AND FOR VETERINARY MEDICINE
Regulatory requirements versus species
5.1
Species
5.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.
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
Examples:
Footnotes:
EN
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
100
100
100
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
104
EN
TABLE 6:
6.1
Species
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.
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
Examples:
Footnotes:
EN
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
40
40
40
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
40
105
EN
TABLE 7:
7.1
Species
7.2
Acute and sub-acute toxicity testing methods
(including limit test)
7.2.1.
LD50,
LC50
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.
EN
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
7.2.2
Other lethal
methods
7.3
Skin
irritation
7.4
Skin
sensitisatio
n
7.5
Eye
irritation
7.6
Subchronic and
chronic
toxicity
7.7
Carcinogenicity
7.8
Developmental
toxicity
7.9
Mutagenicit
y
7.10
Reproductive
toxicity
7.11
Toxicity
to aquatic
vertebrates not
included
in other
columns
7.12
Other
7.2.3
Non lethal
clinical signs
methods
40
40
7.13
Total
40
0
0
0
0
0
0
0
0
0
0
106
0
0
0
0
0
0
0
0
0
0
0
0
0
0
40
EN
TABLE 8:
8.1
Products
8.2
Acute and sub-acute toxicity testing
methods (including limit test)
8.2.1.
LD50,
LC50
8.a.
8.b.
8.c.
8.d.
8.e.
8.f.
8.g.
8.h.
8.i.
8.j.
EN
8.2.2
Other lethal
methods
8.3
Skin
irritation
8.4
Skin
sensitisatio
n
8.5
Eye
irritation
8.6
Subchronic
and
chronic
toxicity
8.7
Carcino
genicity
8.8
Developmental
toxicity
8.9
Mutagenicit
y
8.10
Reproductive
toxicity
8.11
Toxicity
to aquatic
vertebrates not
included
in other
columns
8.12
Other
8.13
Total
8.2.3
Non lethal
clinical signs
methods
0
0
0
0
0
40
40
0
0
40
107
EN
40
IRELAND
Statistical data submitted
The statistical data for Ireland have been provided by the Department of Health and Children.
EN
108
EN
TABLE 1:
1.1
Species
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.
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
71.224
11.741
91
68
12.271
4.396
59
4
204
295
557
6
295
547
1.6
Animals coming from
other origins
57.264
4.423
32
64
1.5
Animals coming from
Member Countries of the
Council of Europe which are
parties to the Convention ETS
123 (excluding EC Member
States)
1.009
2.880
0
0
198
0
10
0
0
0
0
0
0
1.7
Re-used animals
680
42
0
0
0
16
198
144
224
456
4.019
32
582
23.198
112.835
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:
Note 3:
The number of re-used animals in column 1.7 should be excluded from the total in the column 1.2
EN
109
EN
TABLE 2:
2.1
Species
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.
EN
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
2.2
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
2.6
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
15.813
6.750
32
4
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)
2.487
4.506
0
64
0
0
0
0
0
0
0
0
51.456
243
59
0
426
57
0
0
14
12
0
0
1.028
173
0
0
6
0
0
114
197
442
0
0
0
0
0
0
84
98
105
0
0
0
0
0
0
0
0
10
21
99
13
175
21
12
16
282
3.563
2
29
0
0
10
139
0
0
120
90
42
12
0
186
32
201
287
90
3.019
29.866
1.400
9.581
0
0
0
260
0
52.065
0
786
0
93
18.779
20.184
110
2.8
Education and
training
2.9
Other
2.10
Total
71.224
11.741
91
68
0
204
295
557
0
0
144
224
0
456
4.019
0
0
0
0
32
0
582
0
0
23.198
112.835
EN
TABLE 3:
3.1
Species
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.
EN
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
3.2
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
12
3.7
Products/
substances
used or
intended to be
used mainly
as additives in
food for
human
consumption
0
98
105
0
0
0
0
16
235
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
3.8
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
0
0
51.444
243
59
0
0
0
0
84
0
0
51.830
111
3.11
Total
51.456
243
59
0
0
84
98
105
0
0
0
16
0
0
0
0
0
0
0
0
4
0
0
0
0
52.065
EN
TABLE 4:
NUMBER OF ANIMALS USED IN EXPERIMENTS FOR STUDIES ON HUMAN AND ANIMAL DISEASES
Main categories versus species
4.1
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.
EN
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
4.2
Human cardiovascular
diseases
4.3
Human nervous and
mental disorders
770
1.525
0
0
5.534
7.778
0
0
4.4
Human cancer (excluding
evaluations of carcinogenic
hazards or risks)
2.374
42
0
0
49
0
0
0
0
0
94
2
0
0
0
4.5
Other human diseases
4.6
Studies specific to animal
diseases
9.030
1.840
32
64
1.018
128
0
4
0
0
0
69
0
4
2
197
438
43
24
59
0
0
0
0
402
3.682
32
12
60
2.512
0
13.312
112
563
0
2.461
0
11.040
4.359
10.908
4.7
Total
18.726
11.313
32
68
0
120
197
442
0
0
24
196
0
404
3.682
0
0
0
0
32
0
578
0
0
4.419
40.233
EN
TABLE 5:
NUMBER OF ANIMALS USED IN PRODUCTION AND QUALITY CONTROL OF PRODUCTS AND DEVICES FOR
HUMAN MEDICINE AND DENTISTRY AND FOR VETERINARY MEDICINE
Regulatory requirements versus species
5.1
Species
5.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.
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
Examples:
Footnotes:
EN
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
0
12
99
0
0
0
0
0
0
0
0
0
0
0
10
91
0
0
0
0
0
0
0
48
12
200
48
0
0
0
0
0
0
0
0
0
0
99
12
0
10
139
0
0
0
0
0
0
0
0
0
0
260
113
EN
TABLE 6:
6.1
Species
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.
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
Examples:
Footnotes:
EN
6.2
National legislation
specific to a single EC
Member State
1)
0
15
0
6.3
EC legislation
including European
Pharmacopoeia
(requirements)
5.106
0
0
6.4
Member Country of Council
of Europe (but not EC)
legislation
2)
0
0
0
0
83
57
0
15
48
16
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
0
0
0
46.328
228
59
22
0
0
0
0
0
0
0
0
84
0
0
0
0
0
175
5.169
46.699
22
51.456
243
59
0
0
84
98
105
0
0
0
16
0
0
0
0
0
0
0
0
0
4
0
0
0
52.065
114
EN
TABLE 7:
7.1
Species
7.2
Acute and sub-acute toxicity testing methods
(including limit test)
7.2.1.
LD50,
LC50
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.
EN
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
7.2.2
Other lethal
methods
7.3
Skin
irritation
7.4
Skin
sensitisatio
n
7.5
Eye
irritation
7.6
Subchronic and
chronic
toxicity
7.7
Carcinogenicity
7.8
Developmental
toxicity
7.9
Mutagenicit
y
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
15
0
0
0
0
42.721
0
0
1.866
0
0
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
0
0
0
0
42.721
1.866
115
7.10
Reproductive
toxicity
7.11
Toxicity
to aquatic
vertebrates not
included
in other
columns
7.12
Other
0
0
0
0
0
0
6.869
228
59
0
0
0
0
0
0
84
98
105
16
15
7.463
7.13
Total
51.456
243
59
0
0
84
98
105
0
0
0
16
0
0
0
0
0
0
0
0
0
4
0
0
0
52.065
EN
TABLE 8:
8.1
Products
8.2
Acute and sub-acute toxicity testing
methods (including limit test)
8.2.1.
LD50,
LC50
8.a.
8.b.
8.c.
8.d.
8.e.
8.f.
8.g.
8.h.
8.i.
8.j.
EN
8.2.2
Other lethal
methods
8.3
Skin
irritation
8.4
Skin
sensitisatio
n
8.5
Eye
irritation
8.6
Subchronic
and
chronic
toxicity
8.7
Carcino
genicity
8.8
Developmental
toxicity
8.9
Mutagenicit
y
8.10
Reproductive
toxicity
8.11
Toxicity
to aquatic
vertebrates not
included
in other
columns
223
235
8.12
Other
8.13
Total
12
8.2.3
Non lethal
clinical signs
methods
0
1.866
15
49.949
51.830
1.878
15
50.172
52.065
116
EN
GREECE
Statistical data submitted
The statistical data have been submitted by the /
(Ministry of Rural Development and Food, Directorate for Veterinary Care,
Drugs & Practice).
EN
117
EN
Pigs accounted for 2,26% of the animals used (624 animals) of which 14,58% were used to study
fundamental biological characteristics, 47,27% for research and development of medical, dental and
veterinary products and appliances, 2,24% to control the production and quality of medical and
dental products and appliances, and 35,89% for education and training purposes.
Amphibians accounted for 0,71% of the animals used (200 animals) of which 100% were used for
education and training purposes.
Other birds accounted for 0,31% of the animals used (88 animals), of which 57,95% were used to
study fundamental biological characteristics, 34% for diagnosing illnesses, 6,81% for education and
training purposes, and 1,13% for other purposes.
Bovines accounted for 0,25% of the animals used (72 animals), and were used for education and
training purposes.
Sheep accounted for 0,4% of the animals used (68 animals) of which 51,47% were used for
diagnosing illnesses, 47,05% for education and training purposes, and 1,47% for other purposes.
Dogs accounted for 0,18% of the animals used (44 animals) of which 88,63% were used for research
and development of medical, dental and veterinary products and appliances and 11,36% for
education and training purposes.
Goats accounted for 0,09% of the animals used (24 animals), of which 75% were used for
diagnosing illnesses and 25% for education and training purposes
Cats accounted for 0,01% of the animals used (4 animals), and were used for research and
development of medical, dental and veterinary products and appliances.
Finally, only one (1) equid was used, for education and training purposes.
It is apparent from the above data that the two main categories of experiments conducted in Greece
are on the one hand, research and development of medical, dental and veterinary products and
appliances and on the other, the study of fundamental biological characteristics.
It is apparent from the above data and from the tables that in 2008 the four categories of tests which
used most animals were biological studies, followed by toxicological and other safety studies,
research and development of medical, dental and veterinary products, and the diagnosis of illnesses.
The main species used were rodents, fish, and rabbits.
EN
118
EN
TABLE 1:
1.1
Species
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.
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
19786
4367
45
0
19493
4332
21
206
20
1498
4
44
0
1467
4
34
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
87
15
24
31
10
1
624
24
68
72
0
0
0
0
0
88
200
1200
28021
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:
Note 3:
The number of re-used animals in column 1.7 should be excluded from the total in the column 1.2
EN
119
EN
TABLE 2:
2.1
Species
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.
EN
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
2.2
Biological
studies of a
fundamenta
l nature
6274
1670
542
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)
2271
1408
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
60
732
4
39
55
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
7197
468
3574
264
40
172
427
5
298
70
40
40
88
2.8
Education and
training
2.9
Other
2.10
Total
1
91
295
14
51
18
35
224
6
32
72
30
200
1200
9828
4749
74
55
120
7705
4001
1238
371
19786
4367
45
0
0
1498
4
44
0
0
1
624
24
68
72
0
0
0
0
0
0
88
0
200
1200
28021
EN
TABLE 3:
3.1
Species
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.
EN
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
3.2
Products/
substances or
devices for
human
medicine and
dentistry and
for veterinary
medicine
120
430
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
7077
12
26
40
590
12
121
26
7077
3.11
Total
7197
468
0
0
0
40
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
7705
EN
TABLE 4:
NUMBER OF ANIMALS USED IN EXPERIMENTS FOR STUDIES ON HUMAN AND ANIMAL DISEASES
Main categories versus species
4.1
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.
EN
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
4.2
Human cardiovascular
diseases
4.3
Human nervous and
mental disorders
1838
570
1756
447
489
18
4.4
Human cancer (excluding
evaluations of carcinogenic
hazards or risks)
1196
40
237
4.5
Other human diseases
4.6
Studies specific to animal
diseases
2512
1138
207
11
40
625
31
122
18
35
30
1000
4134
200
2421
1236
122
4397
372
4.7
Total
7509
2206
40
0
0
1163
0
0
0
0
0
359
18
35
0
0
0
0
0
0
0
30
0
0
1200
12560
EN
TABLE 5:
NUMBER OF ANIMALS USED IN PRODUCTION AND QUALITY CONTROL OF PRODUCTS AND DEVICES FOR
HUMAN MEDICINE AND DENTISTRY AND FOR VETERINARY MEDICINE
Regulatory requirements versus species
5.1
Species
5.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.
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
Examples:
Footnotes:
EN
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
60
55
14
129
0
60
0
0
0
55
0
0
0
0
0
14
0
0
0
0
0
0
0
0
0
0
0
0
0
129
123
EN
TABLE 6:
6.1
Species
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.
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
Examples:
Footnotes:
EN
6.2
National legislation
specific to a single EC
Member State
1)
38
6.3
EC legislation
including European
Pharmacopoeia
(requirements)
120
430
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
7077
40
38
590
7077
7197
468
0
0
0
40
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
7705
124
EN
TABLE 7:
7.1
Species
7.2
Acute and sub-acute toxicity testing methods
(including limit test)
7.2.1.
LD50,
LC50
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.
EN
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
7.2.2
Other lethal
methods
7.3
Skin
irritation
7.4
Skin
sensitisatio
n
7.5
Eye
irritation
7.6
Subchronic and
chronic
toxicity
7.7
Carcinogenicity
7.8
Developmental
toxicity
7.9
Mutagenicit
y
7.10
Reproductive
toxicity
7.11
Toxicity
to aquatic
vertebrates not
included
in other
columns
7.12
Other
7.2.3
Non lethal
clinical signs
methods
7077
12
120
430
26
40
7077
7.13
Total
12
125
26
590
7197
468
0
0
0
40
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
7705
EN
TABLE 8:
8.1
Products
8.2
Acute and sub-acute toxicity testing
methods (including limit test)
8.2.1.
LD50,
LC50
8.a.
8.b.
8.c.
8.d.
8.e.
8.f.
8.g.
8.h.
8.i.
8.j.
EN
8.2.2
Other lethal
methods
8.3
Skin
irritation
8.4
Skin
sensitisatio
n
8.5
Eye
irritation
8.6
Subchronic
and
chronic
toxicity
8.7
Carcino
genicity
8.8
Developmental
toxicity
8.9
Mutagenicit
y
8.10
Reproductive
toxicity
8.11
Toxicity
to aquatic
vertebrates not
included
in other
columns
8.12
Other
8.13
Total
8.2.3
Non lethal
clinical signs
methods
590
590
12
12
0
0
0
26
26
7077
0
7077
7077
12
126
26
590
7705
EN
SPAIN
Statistical data submitted
The Statistical data have been provided by the: "Ministerio de Agricultura, Pesca y
Alimentacin, Subdireccin General de Ordenacion de explotaciones" (Ministry of
Agriculture, Fisheries and Food, Sub-directorate of Management of Developments).
EN
127
EN
TABLE 1:
1.1
Species
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.
EN
1.2
Total
543680
175325
12620
1262
251
19626
100
1046
287
5
90
15121
372
2386
1091
0
8
517
0
28
138
52104
1.3
Animals coming from registered
breeding or supplying
establishments within the reporting
country
1.4
Animals coming from
elsewhere in the EC
467820
147505
9601
1138
18651
73
990
14
1.6
Animals coming from
other origins
67595
27397
3019
113
1.5
Animals coming from
Member Countries of the
Council of Europe which are
parties to the Convention ETS
123 (excluding EC Member
States)
41
0
0
0
873
0
43
0
0
0
0
0
102
27
13
273
8224
423
0
11
1.7
Re-used animals
275
396
0
1
0
902
20
3
0
0
362
0
0
8
152
0
0
0
3
0
0
0
0
0
81
57
704
71098
897859
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:
Note 3:
The number of re-used animals in column 1.7 should be excluded from the total in the column 1.2
128
EN
TABLE 2:
2.1
Species
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.
EN
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
2.2
Biological
studies of a
fundamental
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
2.6
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
268703
63513
149
564
206
1247
48
65
14
5
0
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)
136072
65305
4537
409
10
3658
17
389
241
0
0
16012
2311
868
0
0
879
0
0
0
0
0
19904
9750
3370
0
0
5318
4
176
0
0
90
63052
8810
3566
156
0
6765
0
349
32
0
0
20338
11256
102
119
0
488
0
6
0
0
0
6665
8305
28
14
0
232
0
44
0
0
0
12934
6075
0
0
35
1039
31
17
0
0
0
543680
175325
12620
1262
251
19626
100
1046
287
5
90
841
52
186
154
0
8
16
0
0
57
664
0
661
52521
389674
2428
37
1070
472
0
0
74
0
0
57
4113
0
0
5780
224669
0
27
50
0
0
0
0
0
0
0
344
0
0
0
20491
903
0
812
304
0
0
0
0
16
0
4991
0
0
0
45638
4925
0
78
58
0
0
427
0
0
24
35297
0
0
940
124479
329
0
44
0
0
0
0
0
12
0
30
0
0
400
33124
2013
125
124
103
0
0
0
0
0
0
42
0
13
152
17860
3682
131
22
0
0
0
0
0
0
0
6623
0
30
11305
41924
15121
372
2386
1091
0
8
517
0
28
138
52104
0
704
71098
897859
129
EN
2.8
Education and
training
2.9
Other
2.10
Total
TABLE 3:
3.1
Species
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.
EN
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
3.2
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
19644
6570
3530
156
0
6298
0
254
32
0
0
791
0
78
58
0
0
427
0
0
0
1268
0
0
0
39106
0
170
0
0
0
43
0
52
0
0
0
0
0
0
0
0
0
0
0
0
24
0
0
0
0
289
0
296
32
0
0
272
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
504
1104
0
120
0
0
0
42
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
162
126
124
0
0
0
110
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
360
130
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
1023
0
0
0
0
0
0
0
0
0
0
4134
0
0
0
0
0
0
0
0
0
34029
0
0
0
39186
EN
3.9
Potential or
actual contaminents in the
general environment which
do not appear in
other columns
3.10
Other toxicological or
safety
evaluations
557
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
286
843
41702
1530
4
0
0
0
0
43
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
150
43429
3.11
Total
63052
8810
3566
156
0
6765
0
349
32
0
0
4925
0
78
58
0
0
427
0
0
24
35297
0
0
940
124479
TABLE 4:
NUMBER OF ANIMALS USED IN EXPERIMENTS FOR STUDIES ON HUMAN AND ANIMAL DISEASES
Main categories versus species
4.1
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.
EN
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
4.2
Human cardiovascular
diseases
15692
11159
0
51
0
6
4
47
0
27
0
352
20
26
0
0
0
0
0
0
0
0
0
0
200
27584
131
4.3
Human nervous and
mental disorders
36425
33110
234
103
231
6
9
0
0
0
0
5
0
36
0
0
3
59
0
0
0
0
0
5
500
70726
4.4
Human cancer (excluding
evaluations of carcinogenic
hazards or risks)
85628
2520
60
349
0
0
0
45
0
0
0
3
0
24
0
0
0
0
0
0
0
0
0
130
485
89244
4.5
Other human diseases
48186
58447
4687
68
10
1989
3
88
241
4
0
906
8
170
0
3
0
15
0
0
57
20
0
382
23378
138662
EN
4.6
Studies specific to animal
diseases
7331
586
298
175
0
2541
0
94
0
5
86
2592
0
873
606
0
0
8
0
12
0
7325
0
0
4866
27398
4.7
Total
193262
105822
5279
746
241
4542
16
274
241
36
86
3858
28
1129
606
3
3
82
0
12
57
7345
0
517
29429
353614
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.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.
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
Examples:
Footnotes:
EN
5.2
National legislation
specific to a single EC
Member State
1)
0
0
0
0
0
0
4
176
0
0
0
0
0
0
26
0
0
0
0
0
0
0
0
0
0
206
5.3
EC legislation
including European
Pharmacopoeia
(requirements)
33234
11278
3344
0
0
5337
0
0
0
0
90
507
27
749
278
0
0
0
0
16
0
3496
0
0
0
58356
5.4
Member Country of Council
of Europe (but not EC)
legislation
2)
0
0
0
0
0
0
0
0
0
0
0
0
0
54
0
0
0
0
0
0
0
0
0
0
0
54
5.5
Other legislation
403
655
731
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
1321
0
0
0
3110
5.6
Any combination of
5.2/ 5.3/ 5.4/ 5.5
5.7
No regulatory
requirements
0
128
0
0
0
16
0
0
0
0
0
130
0
0
0
0
0
0
0
0
0
0
0
0
0
274
2279
0
163
0
0
844
0
0
0
0
0
266
0
59
0
0
0
0
0
0
0
518
0
0
0
4129
5.8
Total
35916
12061
4238
0
0
6197
4
176
0
0
90
903
27
862
304
0
0
0
0
16
0
5335
0
0
0
66129
132
EN
TABLE 6:
6.1
Species
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.
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
Examples:
Footnotes:
EN
6.3
EC legislation
including European
Pharmacopoeia
(requirements)
18053
2934
434
76
0
764
0
30
32
0
0
329
0
28
0
0
0
75
0
0
0
1
0
0
150
22906
6.4
Member Country of Council
of Europe (but not EC)
legislation
2)
30
0
84
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
114
6.5
Other legislation
0
244
288
0
0
218
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
750
6.6
Any combination of
6.2/ 6.3/ 6.4/ 6.5
40120
4286
2752
0
0
5547
0
284
0
0
0
4585
0
44
58
0
0
352
0
0
0
34029
0
0
286
92343
6.7
No regulatory
requirements
3702
1056
8
0
0
136
0
35
0
0
0
11
0
6
0
0
0
0
0
0
0
1267
0
0
0
6221
6.8
Total
63052
8810
3566
156
0
6765
0
349
32
0
0
4925
0
78
58
0
0
427
0
0
24
35297
0
0
940
124479
133
EN
TABLE 7:
7.1
Species
7.2
Acute and sub-acute toxicity testing methods
(including limit test)
7.2.1.
LD50,
LC50
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.
EN
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
7.2.2
Other lethal
methods
6991
246
0
16
0
22
0
0
0
0
0
39161
398
303
0
0
0
0
0
0
0
0
7.2.3
Non lethal
clinical signs
methods
908
949
24
0
0
143
0
0
0
0
0
0
0
0
0
0
0
18
0
0
0
0
0
0
0
7293
0
0
0
0
0
0
0
0
0
24
0
0
0
0
39886
0
0
0
0
0
0
0
0
0
0
0
0
0
0
2024
134
7.3
Skin
irritation
7.4
Skin
sensitisatio
n
7.5
Eye
irritation
7.6
Subchronic and
chronic
toxicity
7.7
Carcinogenicity
7.8
Developmental
toxicity
7.9
Mutagenicit
y
56
290
0
0
0
397
0
0
0
0
0
298
76
326
0
0
0
0
0
0
0
0
0
0
0
0
0
248
0
0
0
0
0
840
2593
0
80
0
0
0
276
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
94
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
437
0
0
0
69
0
0
0
0
0
40
0
0
0
0
0
0
0
0
0
0
0
0
0
783
0
0
0
0
0
0
0
0
0
0
0
0
0
0
700
0
0
0
0
0
0
0
0
0
0
0
0
0
0
248
119
0
0
0
0
0
405
0
0
0
0
0
0
0
4313
0
0
0
0
0
0
0
0
0
0
0
0
0
213
213
0
0
0
0
0
0
0
0
0
0
0
0
0
504
598
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
506
EN
7.10
Reproductive
toxicity
7.11
Toxicity
to aquatic
vertebrates not
included
in other
columns
7.12
Other
7.13
Total
0
0
0
0
0
0
0
0
0
0
0
14798
3821
2913
60
0
5792
0
73
32
0
0
63052
8810
3566
156
0
6765
0
349
32
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
4766
0
78
58
0
0
4
0
0
0
35297
0
0
223
67915
4925
0
78
58
0
0
427
0
0
24
35297
0
0
940
124479
TABLE 8:
8.1
Products
8.2
Acute and sub-acute toxicity testing
methods (including limit test)
8.2.1.
LD50,
LC50
8.a.
8.b.
8.c.
8.d.
8.e.
8.f.
8.g.
8.h.
8.i.
8.j.
EN
8.2.2
Other lethal
methods
8.2.3
Non lethal
clinical signs
methods
2797
1788
2082
39
28
60
8.3
Skin
irritation
8.4
Skin
sensitisatio
n
8.5
Eye
irritation
416
602
62
105
236
202
75
8.6
Subchronic
and
chronic
toxicity
8.7
Carcino
genicity
3942
8.8
Developmental
toxicity
8.9
Mutagenicit
y
94
8.10
Reproductive
toxicity
8.11
Toxicity
to
aquatic
vertebrates not
included
in other
columns
506
141
98
113
50
8.12
Other
8.13
Total
26817
39106
289
504
1104
139
23
162
48
50
360
1023
557
213
4594
35797
7293
39886
135
180
2024
783
700
248
4313
EN
213
598
506
38163
39186
73
843
2858
43429
67915
124479
FRANCE
Statistical data submitted
The statistical data have been submitted by the Ministre de la Recherche et des Nouvelles
Technologies (Ministry for Research and New Technologies).
EN
136
EN
TABLE 1:
1.1
Species
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.
1.2
Total
1.561.809
392.773
46.030
12.063
3.594
96.427
1.848
4.131
800
0
652
8.768
1.159
3.573
3.206
718
233
1.797
0
0
1.548
156.814
758
9.451
20.228
2.328.380
1.3
Animals coming from registered
breeding or supplying
establishments within the reporting
country
1.4
Animals coming from
elsewhere in the EC
1.423.488
367.102
41.952
10.271
1.6
Animals coming from
other origins
47.564
16.411
3.895
959
1.5
Animals coming from
Member Countries of the
Council of Europe which are
parties to the Convention ETS
123 (excluding EC Member
States)
2.534
10
0
0
96.169
1.391
2.928
591
5
245
262
0
0
3
0
0
253
209
941
209
430
644
805
0
718
213
610
0
0
20
262
0
0
0
0
0
0
0
925
0
33
135
244
0
48
1.500
1.7
Re-used animals
88.223
9.250
183
833
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:
Note 3:
The number of re-used animals in column 1.7 should be excluded from the total in the column 1.2
EN
137
EN
TABLE 2:
2.1
Species
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.
EN
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
2.2
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
2.6
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
585.129
80.421
739
1.590
941
3.348
138
354
0
0
196
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)
429.558
182.333
3.705
2.618
1.690
6.202
790
1.072
162
0
139
279.987
5.161
30.748
0
0
50.152
0
0
8
0
83
45.522
13.121
2.230
6.414
0
7.147
544
732
0
0
20
50.866
47.447
7.317
21
0
7.737
24
1.834
237
0
0
12.308
697
2
10
0
125
0
0
0
0
0
18.947
14.196
274
4
918
799
3
8
13
0
75
139.492
49.397
1.015
1.406
45
20.917
349
131
380
0
139
1.561.809
392.773
46.030
12.063
3.594
96.427
1.848
4.131
800
0
652
470
330
1.331
310
568
63
184
0
0
0
2.821
758
5.013
5.836
690.540
2.860
41
638
541
0
77
198
0
0
0
7.491
0
52
200
640.367
0
3
27
0
0
0
139
0
0
0
9.280
0
0
0
375.588
2.545
19
655
298
0
0
0
0
0
0
86.122
0
0
0
165.369
434
29
205
84
0
0
1.128
0
0
0
5.251
0
179
2.954
125.747
23
0
0
140
150
0
0
0
0
0
1.400
0
0
0
14.855
241
18
56
30
0
0
0
0
0
1.548
6.593
0
4.207
7.643
55.573
2.195
719
661
1.803
0
93
148
0
0
0
37.856
0
0
3.595
260.341
8.768
1.159
3.573
3.206
718
233
1.797
0
0
1.548
156.814
758
9.451
20.228
2.328.380
138
2.8
Education and
training
2.9
Other
2.10
Total
EN
TABLE 3:
3.1
Species
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.
EN
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
3.2
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
23.187
26.440
4.468
0
0
5.247
24
1.160
237
0
0
404
21
205
84
0
0
930
0
0
0
25
0
179
0
62.611
3.441
6.006
608
0
0
563
0
104
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
1.457
12.179
2.074
3.375
1.755
21
0
481
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
7.706
0
159
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
159
704
0
38
0
0
43
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
300
1.085
139
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
5.000
0
0
0
5.000
3.9
Potential or
actual contaminents in the
general environment which
do not appear in
other columns
3.10
Other toxicological or
safety
evaluations
3.776
1.499
0
0
0
0
0
0
0
0
0
30
8
0
0
0
0
0
0
0
0
0
0
0
1.047
6.360
17.684
9.968
448
0
0
1.403
0
570
0
0
0
0
0
0
0
0
0
198
0
0
0
226
0
0
150
30.647
3.11
Total
50.866
47.447
7.317
21
0
7.737
24
1.834
237
0
0
434
29
205
84
0
0
1.128
0
0
0
5.251
0
179
2.954
125.747
EN
TABLE 4:
NUMBER OF ANIMALS USED IN EXPERIMENTS FOR STUDIES ON HUMAN AND ANIMAL DISEASES
Main categories versus species
4.1
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.
EN
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
4.2
Human cardiovascular
diseases
60.574
45.947
479
434
300
1.197
0
114
0
0
0
736
0
140
0
0
0
0
0
0
0
0
0
0
900
110.821
4.3
Human nervous and
mental disorders
232.877
84.717
312
708
1.774
2
31
133
0
0
0
0
10
62
0
40
4
20
0
0
0
120
0
52
250
321.112
4.4
Human cancer (excluding
evaluations of carcinogenic
hazards or risks)
180.979
15.812
190
0
60
123
0
13
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
2.399
0
199.576
140
4.5
Other human diseases
333.623
106.175
2.639
1.042
191
6.710
60
499
162
0
0
547
6
97
0
308
115
362
0
0
0
0
0
658
930
454.124
4.6
Studies specific to animal
diseases
218.942
10.800
826
2.034
306
1.643
837
667
0
0
335
2.070
355
1.670
991
370
21
0
0
0
0
11.592
758
1.956
3.956
260.129
4.7
Total
1.026.995
263.451
4.446
4.218
2.631
9.675
928
1.426
162
0
335
3.353
371
1.969
991
718
140
382
0
0
0
11.712
758
5.065
6.036
1.345.762
EN
TABLE 5:
NUMBER OF ANIMALS USED IN PRODUCTION AND QUALITY CONTROL OF PRODUCTS AND DEVICES FOR HUMAN
MEDICINE AND DENTISTRY AND FOR VETERINARY MEDICINE
Regulatory requirements versus species
5.1
Species
5.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.
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
Examples:
Footnotes:
EN
5.2
National legislation
specific to a single EC
Member State
1)
2.709
4.053
0
0
0
10
0
0
0
0
0
0
19
189
0
0
0
0
0
0
0
0
0
0
0
6.980
5.3
EC legislation
including European
Pharmacopoeia
(requirements)
71.121
194
5.042
6.414
0
37.019
536
732
0
0
20
2.454
0
466
298
0
0
0
0
0
0
86.034
0
0
0
210.330
5.4
Member Country of Council
of Europe (but not EC)
legislation
2)
371
405
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
776
5.5
Other legislation
407
12.732
32
0
0
0
8
0
0
0
0
91
0
0
0
0
0
0
0
0
0
80
0
0
0
13.350
5.6
Any combination of
5.2/ 5.3/ 5.4/ 5.5
244.482
383
27.904
0
0
3.859
0
0
8
0
83
0
3
27
0
0
0
139
0
0
0
9.280
0
0
0
286.168
5.7
No regulatory
requirements
6.419
515
0
0
0
16.411
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
8
0
0
0
23.353
5.8
Total
325.509
18.282
32.978
6.414
0
57.299
544
732
8
0
103
2.545
22
682
298
0
0
139
0
0
0
95.402
0
0
0
540.957
141
EN
TABLE 6:
6.1
Species
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.
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
Examples:
Footnotes:
EN
6.2
National legislation
specific to a single EC
Member State
1)
6.960
8.250
286
21
0
260
0
53
211
0
0
55
29
0
0
0
0
0
0
0
0
0
0
0
82
16.207
6.3
EC legislation
including European
Pharmacopoeia
(requirements)
13.193
5.748
2.516
0
0
1.314
24
191
0
0
0
18
0
0
84
0
0
190
0
0
0
25
0
0
0
23.303
6.4
Member Country of Council
of Europe (but not EC)
legislation
2)
658
79
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
737
6.5
Other legislation
2.783
9.219
0
0
0
1.405
0
723
26
0
0
149
0
0
0
0
0
732
0
0
0
5.000
0
0
0
20.037
6.6
Any combination of
6.2/ 6.3/ 6.4/ 6.5
20.930
20.712
4.515
0
0
4.734
0
867
0
0
0
212
0
205
0
0
0
198
0
0
0
0
0
179
1.457
54.009
6.7
No regulatory
requirements
6.342
3.439
0
0
0
24
0
0
0
0
0
0
0
0
0
0
0
8
0
0
0
226
0
0
1.415
11.454
6.8
Total
50.866
47.447
7.317
21
0
7.737
24
1.834
237
0
0
434
29
205
84
0
0
1.128
0
0
0
5.251
0
179
2.954
125.747
142
EN
TABLE 7:
7.1
Species
7.2
Acute and sub-acute toxicity testing methods
(including limit test)
7.2.1.
LD50,
LC50
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.
EN
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
7.2.2
Other lethal
methods
1.455
36
0
0
0
0
0
0
0
0
0
7.107
1.169
0
0
0
0
0
0
0
0
0
7.2.3
Non lethal
clinical signs
methods
9.877
5.128
36
0
0
349
0
461
211
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
1.907
3.398
0
0
0
0
0
0
0
0
0
0
0
0
0
0
8.276
0
0
0
0
0
0
80
0
0
0
0
0
0
0
16.142
7.3
Skin
irritation
7.4
Skin
sensitisatio
n
7.5
Eye
irritation
7.6
Subchronic and
chronic
toxicity
7.7
Carcinogenicity
7.8
Developmental
toxicity
7.9
Mutagenicit
y
648
12
0
0
0
1.059
0
0
0
0
0
1.733
1.290
6.584
0
0
0
0
0
0
0
0
0
78
0
0
0
377
0
0
0
0
0
12.298
16.839
0
0
0
568
0
1.106
0
0
0
2.524
5.287
0
0
0
0
0
0
0
0
0
730
2.075
0
0
0
669
0
0
0
0
0
139
1.547
0
21
0
0
0
0
0
0
0
0
4.489
86
0
0
965
0
18
0
0
0
0
0
0
0
0
0
0
0
0
0
0
14.355
9.497
611
0
0
3.750
24
249
26
0
0
50.866
47.447
7.317
21
0
7.737
24
1.834
237
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
1.719
0
0
0
0
0
0
0
0
0
0
0
0
0
0
9.607
0
0
0
0
0
0
0
0
0
0
0
0
0
0
455
56
0
0
0
0
0
864
0
0
0
0
0
0
890
32.621
0
0
0
0
0
0
0
0
0
0
0
0
0
0
7.811
0
0
0
0
0
0
0
0
0
0
0
0
0
0
3.474
0
0
0
0
0
0
0
0
0
0
0
0
0
0
1.707
84
0
0
0
0
0
0
0
0
0
0
0
0
0
5.642
0
0
0
0
0
0
0
0
0
0
0
0
0
82
82
294
29
205
84
0
0
184
0
0
0
5.251
0
179
75
34.813
434
29
205
84
0
0
1.128
0
0
0
5.251
0
179
2.954
125.747
143
7.10
Reproductive
toxicity
7.11
Toxicity
to aquatic
vertebrates not
included
in other
columns
7.12
Other
7.13
Total
EN
TABLE 8:
8.1
Products
8.2
Acute and sub-acute toxicity testing
methods (including limit test)
8.2.1.
LD50,
LC50
8.a.
8.b.
8.c.
8.d.
8.e.
8.f.
8.g.
8.h.
8.i.
8.j.
EN
8.2.2
Other lethal
methods
8.3
Skin
irritation
8.4
Skin
sensitisatio
n
8.5
Eye
irritation
638
4.460
170
14.646
8.6
Subchronic
and
chronic
toxicity
8.7
Carcino
genicity
8.8
Developmental
toxicity
8.9
Mutagenicit
y
8.10
Reproductive
toxicity
8.11
Toxicity
to aquatic
vertebrates not
included
in other
columns
3.293
1.141
1.480
5.211
14.720
62.611
8.12
Other
8.13
Total
1.965
5.233
8.2.3
Non lethal
clinical signs
methods
9.654
1.430
310
100
608
88
5.944
2.682
867
150
12.179
1.378
665
942
1.673
182
230
246
626
101
60
1.603
7.706
159
159
300
43
39
699
1.085
5.000
5.000
2.600
2.014
890
327
82
447
6.360
221
3.397
589
3.792
2.604
300
1.902
17.836
30.647
3.916
12.918
10.951
1.719
7.440
450
26.785
8.825
2.934
2.471
7.650
82
39.606
125.747
144
EN
ITALY
Statistical data submitted
The statistical data have been submitted by the Ministry of Health Department for public veterinary
health food and animal safety, Directorate-General for animal health and veterinary medicines, Office X
EN
145
EN
TABLE 1:
1.1
Species
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.
1.2
Total
553000
230347
13875
717
1235
9706
26
943
0
0
46
3607
41
469
462
0
18
344
0
151
249
32241
454
2432
13955
864318
1.3
Animals coming from registered
breeding or supplying
establishments within the reporting
country
1.4
Animals coming from
elsewhere in the EC
528861
224605
9924
604
1.6
Animals coming from
other origins
12593
5077
3951
36
1.5
Animals coming from
Member Countries of the
Council of Europe which are
parties to the Convention ETS
123 (excluding EC Member
States)
223
0
0
0
9061
0
720
0
645
0
70
0
0
0
0
0
0
26
153
0
603
0
52
0
0
11
182
0
0
7
107
0
0
0
2
0
0
0
53
0
0
53
72
0
245
1.7
Re-used animals
11323
665
0
77
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:
Note 3:
The number of re-used animals in column 1.7 should be excluded from the total in the column 1.2
EN
146
EN
TABLE 2:
2.1
Species
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.
EN
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
2.2
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
2.6
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
311807
86363
2710
227
160
1628
26
20
0
0
31
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)
143156
55681
2170
258
215
1140
0
46
0
0
0
26423
67788
3521
0
0
4538
0
0
0
0
15
2300
205
397
0
0
305
0
0
0
0
0
34150
17730
4751
145
0
2009
0
877
0
0
0
21911
1340
30
87
860
6
0
0
0
0
0
10
159
0
0
0
0
0
0
0
0
0
13243
1081
296
0
0
80
0
0
0
0
0
553000
230347
13875
717
1235
9706
26
943
0
0
46
1350
37
171
270
0
0
12
0
104
4
7393
454
2346
6049
421162
1174
3
190
134
0
18
41
0
0
0
3565
0
20
400
208211
15
0
62
0
0
0
51
0
0
0
12
0
0
0
102425
84
1
12
6
0
0
0
0
47
0
12736
0
0
2518
18611
435
0
23
9
0
0
238
0
0
0
6621
0
0
2018
69006
0
0
0
2
0
0
0
0
0
0
1081
0
66
0
25383
344
0
0
0
0
0
0
0
0
0
0
0
0
0
513
205
0
11
41
0
0
2
0
0
245
833
0
0
2970
19007
3607
41
469
462
0
18
344
0
151
249
32241
454
2432
13955
864318
147
2.8
Education and
training
2.9
Other
2.10
Total
EN
TABLE 3:
3.1
Species
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.
EN
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
3.2
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
8016
14149
4408
145
0
1896
0
877
0
0
0
147
0
23
9
0
0
238
0
0
0
5691
0
0
210
35809
80
254
87
0
0
9
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
450
0
0
0
880
208
1142
215
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
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
3.7
Products/
substances
used or
intended to be
used mainly
as additives in
food for
human
consumption
54
205
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
158
1764
0
0
0
0
0
0
0
0
0
0
0
259
148
3.8
Products/
substances
used or
intended to be
used mainly
as additives in
food for
animal
consumption
169
0
0
0
0
0
0
0
0
0
0
288
0
0
0
0
0
0
0
0
0
480
0
0
0
937
3.9
Potential or
actual
contaminants in
the general
environment
which do not
appear in other
columns
3.10
Other toxicological or
safety
evaluations
4082
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
1650
5732
21541
1980
41
0
0
63
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
23625
3.11
Total
34150
17730
4751
145
0
2009
0
877
0
0
0
435
0
23
9
0
0
238
0
0
0
6621
0
0
2018
69006
EN
TABLE 4:
NUMBER OF ANIMALS USED IN EXPERIMENTS FOR STUDIES ON HUMAN AND ANIMAL DISEASES
Main categories versus species
4.1
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.
EN
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
4.2
Human cardiovascular
diseases
17719
6348
380
20
0
82
0
12
0
0
0
163
0
31
7
0
0
0
0
0
0
0
0
0
0
24762
4.3
Human nervous and
mental disorders
72970
42732
326
21
244
262
0
0
0
0
0
0
0
0
0
0
18
2
0
0
0
0
0
101
0
116676
4.4
Human cancer (excluding
evaluations of carcinogenic
hazards or risks)
123899
4325
0
50
0
54
0
0
0
0
0
8
0
0
0
0
0
0
0
0
0
0
0
0
1629
129965
149
4.5
Other human diseases
130189
33482
2366
357
297
1410
0
17
0
0
0
170
0
42
2
0
0
41
0
0
0
0
0
241
66
168680
4.6
Studies specific to animal
diseases
7073
545
182
0
654
13
0
0
0
0
31
110
3
16
2
0
0
0
0
6
249
1358
86
66
3268
13662
4.7
Total
351850
87432
3254
448
1195
1821
0
29
0
0
31
451
3
89
11
0
18
43
0
6
249
1358
86
408
4963
453745
EN
TABLE 5:
NUMBER OF ANIMALS USED IN PRODUCTION AND QUALITY CONTROL OF PRODUCTS AND DEVICES FOR
HUMAN MEDICINE AND DENTISTRY AND FOR VETERINARY MEDICINE
Regulatory requirements versus species
5.1
Species
5.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.
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
Examples:
Footnotes:
EN
5.2
National legislation
specific to a single EC
Member State
1)
6375
241
657
0
0
344
0
0
0
0
15
99
1
65
6
0
0
0
0
13
0
853
0
0
2170
10839
5.3
EC legislation
including European
Pharmacopoeia
(requirements)
7376
1730
627
0
0
3773
0
0
0
0
0
0
0
0
0
0
0
0
0
34
0
11895
0
0
0
25435
5.4
Member Country of Council
of Europe (but not EC)
legislation
2)
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
5.5
Other legislation
100
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
5.6
Any combination of
5.2/ 5.3/ 5.4/ 5.5
13027
64208
2634
0
0
714
0
0
0
0
0
0
0
0
0
0
0
51
0
0
0
0
0
0
348
80982
5.7
No regulatory
requirements
1845
1814
0
0
0
12
0
0
0
0
0
0
0
9
0
0
0
0
0
0
0
0
0
0
0
3680
5.8
Total
28723
67993
3918
0
0
4843
0
0
0
0
15
99
1
74
6
0
0
51
0
47
0
12748
0
0
2518
121036
150
EN
TABLE 6:
6.1
Species
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.
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
Examples:
Footnotes:
EN
6.2
National legislation
specific to a single EC
Member State
1)
19994
2093
104
0
0
6
0
176
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
1650
24023
6.3
EC legislation
including European
Pharmacopoeia
(requirements)
4665
5724
3731
122
0
1389
0
305
0
0
0
435
0
23
9
0
0
0
0
0
0
6171
0
0
158
22732
6.4
Member Country of Council
of Europe (but not EC)
legislation
2)
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
6.5
Other legislation
6.6
Any combination of
6.2/ 6.3/ 6.4/ 6.5
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
9102
9557
916
23
0
566
0
396
0
0
0
0
0
0
0
0
0
238
0
0
0
0
0
0
0
20798
6.7
No regulatory
requirements
389
356
0
0
0
48
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
450
0
0
210
1453
6.8
Total
34150
17730
4751
145
0
2009
0
877
0
0
0
435
0
23
9
0
0
238
0
0
0
6621
0
0
2018
69006
151
EN
TABLE 7:
7.1
Species
7.2
Acute and sub-acute toxicity testing methods
(including limit test)
7.2.1.
LD50,
LC50
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.
EN
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
7.2.2
Other lethal
methods
590
104
0
0
0
0
0
0
0
0
0
5698
453
0
0
0
0
0
0
0
0
0
7.2.3
Non lethal
clinical signs
methods
7128
3884
23
0
0
371
0
179
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
930
1624
0
0
0
0
0
0
0
0
0
0
0
0
0
0
6151
56
0
0
0
0
0
57
0
0
0
4595
0
0
368
16661
7.3
Skin
irritation
7.4
Skin
sensitisatio
n
7.5
Eye
irritation
7.6
Subchronic and
chronic
toxicity
7.7
Carcinogenicity
7.8
Developmental
toxicity
7.9
Mutagenicit
y
110
38
80
0
0
250
0
0
0
0
0
0
2
4630
0
0
0
0
0
0
0
0
0
0
0
0
0
90
0
0
0
0
0
5666
10261
0
0
0
130
0
681
0
0
0
77
2
0
0
0
0
0
0
0
0
0
177
507
0
0
0
235
0
0
0
0
0
344
363
0
0
0
0
0
0
0
0
0
743
717
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
1020
0
0
0
1498
0
0
0
0
0
0
0
0
0
0
0
0
0
0
4632
0
0
0
0
0
0
0
0
0
0
0
0
0
0
90
40
0
0
0
0
0
122
0
0
0
0
0
0
720
17620
0
0
0
0
0
0
0
0
0
0
0
0
0
0
79
0
0
0
0
0
0
0
0
0
0
0
0
0
0
919
0
0
0
0
0
0
0
0
0
0
0
0
0
0
707
0
0
0
0
0
0
0
0
0
0
0
0
0
0
1460
152
7.10
Reproductive
toxicity
7.11
Toxicity
to aquatic
vertebrates not
included
in other
columns
7.12
Other
7.13
Total
0
0
0
0
0
0
0
0
0
0
0
13617
1399
18
145
0
933
0
17
0
0
0
34150
17730
4751
145
0
2009
0
877
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
339
0
23
9
0
0
59
0
0
0
1006
0
0
0
17565
435
0
23
9
0
0
238
0
0
0
6621
0
0
2018
69006
EN
TABLE 8:
8.1
Products
8.2
Acute and sub-acute toxicity testing
methods (including limit test)
8.2.1.
LD50,
LC50
8.a.
8.b.
8.c.
8.d.
8.e.
8.f.
8.g.
8.h.
8.i.
8.j.
EN
8.2.2
Other lethal
methods
8.3
Skin
irritation
8.4
Skin
sensitisatio
n
8.5
Eye
irritation
1469
4330
69
11879
8.6
Subchronic
and
chronic
toxicity
8.7
Carcino
genicity
8.8
Developmental
toxicity
8.9
Mutagenicit
y
8.10
Reproductive
toxicity
8.11
Toxicity
to aquatic
vertebrates not
included
in other
columns
79
625
513
701
2838
35809
8.12
Other
8.13
Total
184
350
8.2.3
Non lethal
clinical signs
methods
12772
120
65
87
100
499
880
224
361
26
215
15
200
244
194
189
96
1764
35
174
50
259
169
768
937
930
3099
470
1233
5732
510
5288
3428
2268
12131
23625
1624
6151
16661
1498
4632
90
17620
79
919
707
1460
17565
69006
153
EN
CYPRUS
Statistical data submitted
The statistical data have been submitted by Veterinary Services of the Republic of Cyprus.
Remark: Cyprus reported data only in tables 1, 2, 4 and 5. The remaining tables are not applicable.
EN
154
EN
TABLE 1:
1.1
Species
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.
1.2
Total
1.3
Animals coming from registered
breeding or supplying
establishments within the reporting
country
2114
0
0
0
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
2114
0
0
0
0
0
0
0
0
0
2114
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:
Note 3:
The number of re-used animals in column 1.7 should be excluded from the total in the column 1.2
EN
155
EN
TABLE 2:
2.1
Species
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.
EN
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
2.2
Biological
studies of a
fundamenta
l nature
2.3
Research and development
of products and devices
for human medicine and
dentistry and for
veterinary medicine
(excluding toxicological
and other safety
evaluations counted in
column 2.6)
1701
1701
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
320
2.8
Education and
training
2.9
Other
2.10
Total
93
320
156
93
2114
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
2114
EN
TABLE 4:
NUMBER OF ANIMALS USED IN EXPERIMENTS FOR STUDIES ON HUMAN AND ANIMAL DISEASES
Main categories versus species
4.1
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.
EN
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
4.2
Human cardiovascular
diseases
4.3
Human nervous and
mental disorders
205
4.4
Human cancer (excluding
evaluations of carcinogenic
hazards or risks)
70
205
70
157
4.5
Other human diseases
4.6
Studies specific to animal
diseases
4.7
Total
165
165
440
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
440
EN
TABLE 5:
NUMBER OF ANIMALS USED IN PRODUCTION AND QUALITY CONTROL OF PRODUCTS AND DEVICES FOR
HUMAN MEDICINE AND DENTISTRY AND FOR VETERINARY MEDICINE
Regulatory requirements versus species
5.1
Species
5.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.
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
Examples:
Footnotes:
EN
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
320
320
5.8
Total
320
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
320
158
EN
LATVIA
Statistical data submitted
The statistical data have been submitted by the Ministry of Agriculture State Food
and veterinary service
EN
159
EN
TABLE 1:
1.1
Species
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.
1.2
Total
1.3
Animals coming from registered
breeding or supplying
establishments within the reporting
country
6912
2407
32
0
6912
2407
32
48
0
0
0
48
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
0
0
0
0
0
9399
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:
Note 3:
The number of re-used animals in column 1.7 should be excluded from the total in the column 1.2
EN
160
EN
TABLE 2:
2.1
Species
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.
EN
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
2.2
Biological
studies of a
fundamenta
l nature
1032
325
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)
1952
460
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)
2710
1037
2.7
Diagnosis of
disease
668
280
2.8
Education and
training
2.9
Other
2.10
Total
550
305
6912
2407
32
0
0
48
0
0
0
0
0
32
48
1357
2412
3795
161
32
948
855
0
0
0
0
0
0
0
0
0
0
0
0
0
0
9399
EN
TABLE 3:
3.1
Species
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.
EN
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
3.2
Products/
substances or
devices for
human
medicine and
dentistry and
for veterinary
medicine
3.3
Products/
substances
used or
intended to
be used
mainly in
agriculture
3.4
Products/
substances
used or
intended to
be used
mainly in
industry
3.5
Products/
substances
used or
intended to
be used
mainly in
the
household
3.6
Products/
substances
used or
intended to
be used
mainly as
cosmetics
or toiletries
3.7
Products/
substances
used or
intended to be
used mainly
as additives in
food for
human
consumption
3.8
Products/
substances
used or
intended to be
used mainly
as additives in
food for
animal
consumption
3.9
Potential or
actual contaminants in the
general environment which
do not appear in
other columns
3.10
Other toxicological or
safety
evaluations
32
32
162
3.11
Total
0
0
32
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
32
EN
TABLE 4:
NUMBER OF ANIMALS USED IN EXPERIMENTS FOR STUDIES ON HUMAN AND ANIMAL DISEASES
Main categories versus species
4.1
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.
EN
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
4.2
Human cardiovascular
diseases
4.3
Human nervous and
mental disorders
995
394
634
195
4.4
Human cancer (excluding
evaluations of carcinogenic
hazards or risks)
1353
360
1389
829
1713
163
4.5
Other human diseases
4.6
Studies specific to animal
diseases
548
116
122
664
122
4.7
Total
3652
1065
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
4717
EN
TABLE 5:
NUMBER OF ANIMALS USED IN PRODUCTION AND QUALITY CONTROL OF PRODUCTS AND DEVICES FOR
HUMAN MEDICINE AND DENTISTRY AND FOR VETERINARY MEDICINE
Regulatory requirements versus species
5.1
Species
5.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.
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
Examples:
Footnotes:
EN
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
2710
1037
48
3795
2710
1037
0
0
0
48
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
3795
164
EN
TABLE 6:
6.1
Species
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.
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
Examples:
Footnotes:
EN
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
0
32
32
32
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
32
165
EN
TABLE 7:
7.1
Species
7.2
Acute and sub-acute toxicity testing methods
(including limit test)
7.2.1.
LD50,
LC50
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.
EN
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
7.2.2
Other lethal
methods
7.3
Skin
irritation
7.4
Skin
sensitisatio
n
7.5
Eye
irritation
7.6
Subchronic and
chronic
toxicity
7.7
Carcinogenicity
7.8
Developmental
toxicity
7.9
Mutagenicit
y
7.10
Reproductive
toxicity
7.11
Toxicity
to aquatic
vertebrates not
included
in other
columns
7.12
Other
7.13
Total
7.2.3
Non lethal
clinical signs
methods
0
32
32
32
0
0
0
0
0
0
0
0
166
0
0
0
0
0
0
0
0
0
0
0
0
0
0
32
EN
TABLE 8:
8.1
Products
8.2
Acute and sub-acute toxicity testing
methods (including limit test)
8.2.1.
LD50,
LC50
8.a.
8.b.
8.c.
8.d.
8.e.
8.f.
8.g.
8.h.
8.i.
8.j.
EN
8.2.2
Other lethal
methods
8.3
Skin
irritation
8.4
Skin
sensitisatio
n
8.5
Eye
irritation
8.6
Subchronic
and
chronic
toxicity
8.7
Carcino
genicity
8.8
Developmental
toxicity
8.9
Mutagenicit
y
8.10
Reproductive
toxicity
8.11
Toxicity
to aquatic
vertebrates not
included
in other
columns
8.12
Other
8.13
Total
8.2.3
Non lethal
clinical signs
methods
32
32
0
0
0
0
0
0
32
167
EN
32
LITHUANIA
Statistical data submitted
The statistical data have been submitted by the Animal Health and Welfare
Department of the State Food and Veterinary Service of the Republic of Lithuania.
EN
168
EN
TABLE 1:
1.1
Species
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.
1.2
Total
1.3
Animals coming from registered
breeding or supplying
establishments within the reporting
country
3827
1194
93
0
3827
1194
93
199
0
0
0
199
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
80
0
0
0
0
0
40
149
5582
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:
Note 3:
The number of re-used animals in column 1.7 should be excluded from the total in the column 1.2
EN
169
EN
TABLE 2:
2.1
Species
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.
EN
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
2.2
Biological
studies of a
fundamenta
l nature
718
44
41
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)
1367
1070
40
148
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
525
33
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
4
21
1213
26
7
31
30
2.9
Other
2.10
Total
3827
1194
93
0
0
199
0
0
0
0
0
50
40
43
811
2738
106
558
10
170
1253
212
80
0
0
0
0
0
0
0
0
0
40
0
149
0
5582
EN
TABLE 3:
3.1
Species
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.
EN
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
3.2
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
239
3.8
Products/
substances
used or
intended to be
used mainly
as additives in
food for
animal
consumption
200
26
7
3.9
Potential or
actual contaminants in the
general environment which
do not appear in
other columns
3.10
Other toxicological or
safety
evaluations
774
239
171
240
774
3.11
Total
1213
26
7
0
0
7
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
1253
EN
TABLE 4:
NUMBER OF ANIMALS USED IN EXPERIMENTS FOR STUDIES ON HUMAN AND ANIMAL DISEASES
Main categories versus species
4.1
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.
EN
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
4.2
Human cardiovascular
diseases
4.3
Human nervous and
mental disorders
189
22
39
30
4.4
Human cancer (excluding
evaluations of carcinogenic
hazards or risks)
300
33
24
4.5
Other human diseases
4.6
Studies specific to animal
diseases
1496
959
22
100
100
20
82
20
20
20
2579
260
30
43
310
67
333
172
4.7
Total
2085
1114
81
0
0
156
0
0
0
0
0
30
0
0
0
0
0
0
0
0
0
40
0
43
0
3549
EN
TABLE 5:
NUMBER OF ANIMALS USED IN PRODUCTION AND QUALITY CONTROL OF PRODUCTS AND DEVICES FOR
HUMAN MEDICINE AND DENTISTRY AND FOR VETERINARY MEDICINE
Regulatory requirements versus species
5.1
Species
5.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.
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
Examples:
Footnotes:
EN
5.2
National legislation
specific to a single EC
Member State
1)
525
33
5
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
568
525
33
5
0
0
5
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
568
173
EN
TABLE 6:
6.1
Species
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:
Footnotes:
EN
6.2
National legislation
specific to a single EC
Member State
1)
1013
6.3
EC legislation
including European
Pharmacopoeia
(requirements)
200
26
7
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
1013
240
1213
26
7
0
0
7
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
1253
174
EN
TABLE 7:
7.1
Species
7.2
Acute and sub-acute toxicity testing methods
(including limit test)
7.2.1.
LD50,
LC50
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.
EN
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
7.2.2
Other lethal
methods
7.3
Skin
irritation
7.4
Skin
sensitisatio
n
7.5
Eye
irritation
7.6
Subchronic and
chronic
toxicity
7.7
Carcinogenicity
7.8
Developmental
toxicity
7.9
Mutagenicit
y
7.10
Reproductive
toxicity
7.11
Toxicity
to aquatic
vertebrates not
included
in other
columns
7.12
Other
7.2.3
Non lethal
clinical signs
methods
172
246
200
26
7
595
172
7.13
Total
175
246
240
595
1213
26
7
0
0
7
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
1253
EN
TABLE 8:
8.1
Products
8.2
Acute and sub-acute toxicity testing
methods (including limit test)
8.2.1.
LD50,
LC50
8.a.
8.b.
8.c.
8.d.
8.e.
8.f.
8.g.
8.h.
8.i.
8.j.
EN
8.2.2
Other lethal
methods
8.3
Skin
irritation
8.4
Skin
sensitisatio
n
8.5
Eye
irritation
8.6
Subchronic
and
chronic
toxicity
8.7
Carcino
genicity
8.8
Developmental
toxicity
8.9
Mutagenicit
y
8.10
Reproductive
toxicity
8.11
Toxicity
to aquatic
vertebrates not
included
in other
columns
8.12
Other
8.13
Total
8.2.3
Non lethal
clinical signs
methods
172
67
239
0
0
0
0
240
240
246
172
176
246
528
774
835
1253
EN
LUXEMBOURG
Statistical data submitted
The statistical data have been submitted by the Ministre de lAgriculture, de la
viticulture et du developpement rural. Administration des Services Vtrinaires
(Ministry of Agriculture, viticulture and rural development. Administration of
Veterinary Services)
Remark: Luxembourg reported data only in tables 1, 2 and 4 with the remaining tables
not applicable.
EN
177
EN
TABLE 1:
1.1
Species
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.
1.2
Total
1.3
Animals coming from registered
breeding or supplying
establishments within the reporting
country
3280
430
100
0
0
20
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
3830
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
3280
430
100
20
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:
Note 3:
The number of re-used animals in column 1.7 should be excluded from the total in the column 1.2
EN
178
EN
TABLE 2:
2.1
Species
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.
EN
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
2.2
Biological
studies of a
fundamenta
l nature
2.3
Research and
development of
products and
devices for human
medicine and
dentistry and for
veterinary
medicine
(excluding
toxicological and
other safety
evaluations
counted in column
2.6)
3280
430
100
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
3280
430
100
0
0
20
0
0
0
0
0
20
3830
179
0
0
0
0
0
0
0
0
0
0
0
0
0
0
3830
EN
TABLE 4:
NUMBER OF ANIMALS USED IN EXPERIMENTS FOR STUDIES ON HUMAN AND ANIMAL DISEASES
Main categories versus species
4.1
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.
EN
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
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
3280
430
100
20
180
3830
4.7
Total
3280
430
100
0
0
20
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
3830
EN
HUNGARY
Statistical data submitted
The statistical data have been submitted by the Ministry of Agriculture and Rural Development.
EN
181
EN
TABLE 1:
1.1
Species
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.
1.2
Total
158799
89375
9743
215
356
8134
40
686
0
0
40
1193
92
200
93
0
5
1
0
16
13
32554
108
1182
2077
304922
1.3
Animals coming from registered
breeding or supplying
establishments within the reporting
country
1.4
Animals coming from
elsewhere in the EC
129817
73336
6064
215
7560
40
412
1.6
Animals coming from
other origins
26099
15248
3669
0
1.5
Animals coming from
Member Countries of the
Council of Europe which are
parties to the Convention ETS
123 (excluding EC Member
States)
1131
340
10
0
14
0
12
360
0
262
200
0
0
1.7
Re-used animals
1752
451
0
0
598
65
5
1
13
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:
Note 3:
The number of re-used animals in column 1.7 should be excluded from the total in the column 1.2
EN
182
EN
TABLE 2:
2.1
Species
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.
EN
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
2.2
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
2.6
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
50186
24239
2304
214
356
1360
6
352
0
0
0
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)
57384
60144
629
0
0
2183
34
59
0
0
0
23136
0
3699
0
0
0
0
7
0
0
0
0
0
774
0
0
618
0
0
0
0
0
13495
2809
2006
0
0
3620
0
240
0
0
0
3935
15
0
0
0
66
0
0
0
0
0
5706
2143
235
1
0
287
0
23
0
0
40
4957
25
96
0
0
0
0
5
0
0
0
158799
89375
9743
215
356
8134
40
686
0
0
40
399
2
10
6
0
5
1
0
0
13
7558
0
120
345
87476
292
0
26
4
0
0
0
0
16
0
8158
50
0
0
128979
0
0
0
0
0
0
0
0
0
0
0
0
0
0
26842
159
0
82
2
0
0
0
0
0
0
13390
0
0
0
15025
156
0
0
30
0
0
0
0
0
0
462
0
0
1126
23944
130
50
0
51
0
0
0
0
0
0
10
0
0
100
4357
57
40
82
0
0
0
0
0
0
0
576
58
1062
506
10816
0
0
0
0
0
0
0
0
0
0
2400
0
0
0
7483
1193
92
200
93
0
5
1
0
16
13
32554
108
1182
2077
304922
183
2.8
Education and
training
2.9
Other
2.10
Total
EN
TABLE 3:
3.1
Species
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.
EN
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
3.2
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
11093
1129
1236
0
0
3428
0
240
0
0
0
122
0
0
30
0
0
0
0
0
0
462
0
0
0
17740
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
126
126
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
184
3.7
Products/
substances
used or
intended to be
used mainly
as additives in
food for
human
consumption
0
78
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
78
3.8
Products/
substances
used or
intended to be
used mainly
as additives in
food for
animal
consumption
288
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
288
3.9
Potential or
actual contaminents in the
general environment which
do not appear in
other columns
3.10
Other toxicological or
safety
evaluations
0
0
0
0
0
0
0
0
0
0
0
34
0
0
0
0
0
0
0
0
0
0
0
0
1000
1034
2114
1602
770
0
0
192
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
4678
3.11
Total
13495
2809
2006
0
0
3620
0
240
0
0
0
156
0
0
30
0
0
0
0
0
0
462
0
0
1126
23944
EN
TABLE 4:
NUMBER OF ANIMALS USED IN EXPERIMENTS FOR STUDIES ON HUMAN AND ANIMAL DISEASES
Main categories versus species
4.1
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.
EN
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
4.2
Human cardiovascular
diseases
886
2564
72
0
0
447
0
390
0
0
0
194
2
0
0
0
5
1
0
16
0
0
0
0
0
4577
4.3
Human nervous and
mental disorders
69114
72436
314
109
290
613
30
21
0
0
0
0
0
0
0
0
0
0
0
0
0
0
50
120
0
143097
4.4
Human cancer (excluding
evaluations of carcinogenic
hazards or risks)
8615
1777
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
10392
185
4.5
Other human diseases
27448
7621
2482
83
66
1782
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
39482
4.6
Studies specific to animal
diseases
5442
0
65
22
0
767
10
0
0
0
0
627
50
36
61
0
0
0
0
0
13
15726
0
0
445
23264
4.7
Total
111505
84398
2933
214
356
3609
40
411
0
0
0
821
52
36
61
0
5
1
0
16
13
15726
50
120
445
220812
EN
TABLE 5:
NUMBER OF ANIMALS USED IN PRODUCTION AND QUALITY CONTROL OF PRODUCTS AND DEVICES FOR
HUMAN MEDICINE AND DENTISTRY AND FOR VETERINARY MEDICINE
Regulatory requirements versus species
5.1
Species
5.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.
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
Examples:
Footnotes:
EN
5.2
National legislation
specific to a single EC
Member State
1)
9363
0
586
0
0
40
0
7
0
0
0
0
0
6
0
0
0
0
0
0
0
11
0
0
0
10013
5.3
EC legislation
including European
Pharmacopoeia
(requirements)
13523
0
3887
0
0
578
0
0
0
0
0
159
0
76
2
0
0
0
0
0
0
13379
0
0
0
31604
5.4
Member Country of Council
of Europe (but not EC)
legislation
2)
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
5.5
Other legislation
5.6
Any combination of
5.2/ 5.3/ 5.4/ 5.5
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
5.7
No regulatory
requirements
250
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
250
5.8
Total
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
23136
0
4473
0
0
618
0
7
0
0
0
159
0
82
2
0
0
0
0
0
0
13390
0
0
0
41867
186
EN
TABLE 6:
6.1
Species
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.
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
Examples:
Footnotes:
EN
6.2
National legislation
specific to a single EC
Member State
1)
60
152
0
0
0
550
0
110
0
0
0
81
0
0
0
0
0
0
0
0
0
0
0
0
1000
1953
6.3
EC legislation
including European
Pharmacopoeia
(requirements)
12533
1657
1236
0
0
2878
0
66
0
0
0
67
0
0
30
0
0
0
0
0
0
462
0
0
126
19055
6.4
Member Country of Council
of Europe (but not EC)
legislation
2)
0
0
0
0
0
0
0
58
0
0
0
8
0
0
0
0
0
0
0
0
0
0
0
0
0
66
6.5
Other legislation
6.6
Any combination of
6.2/ 6.3/ 6.4/ 6.5
0
0
0
0
0
0
0
6
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
6
460
910
770
0
0
192
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
2332
6.7
No regulatory
requirements
442
90
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
532
6.8
Total
13495
2809
2006
0
0
3620
0
240
0
0
0
156
0
0
30
0
0
0
0
0
0
462
0
0
1126
23944
187
EN
TABLE 7:
7.1
Species
7.2
Acute and sub-acute toxicity testing methods
(including limit test)
7.2.1.
LD50,
LC50
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.
EN
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
7.2.2
Other lethal
methods
3307
30
0
0
0
0
0
0
0
0
0
4492
26
0
0
0
0
0
0
0
0
0
7.2.3
Non lethal
clinical signs
methods
3194
1200
976
0
0
3420
0
108
0
0
0
0
0
0
0
0
0
0
0
0
0
72
0
0
626
4035
0
0
0
0
0
0
0
0
0
0
0
0
0
0
4518
77
0
0
0
0
0
0
0
0
0
390
0
0
0
9365
7.3
Skin
irritation
7.4
Skin
sensitisatio
n
7.5
Eye
irritation
7.6
Subchronic and
chronic
toxicity
7.7
Carcinogenicity
7.8
Developmental
toxicity
7.9
Mutagenicit
y
0
0
0
0
0
41
0
0
0
0
0
0
85
420
0
0
4
0
0
0
0
0
0
0
0
0
0
28
0
0
0
0
0
160
400
490
0
0
0
0
132
0
0
0
0
24
0
0
0
0
0
0
0
0
0
0
190
120
0
0
127
0
0
0
0
323
30
0
0
0
0
0
0
0
0
0
0
218
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
2019
606
0
0
0
0
0
0
0
0
0
13495
2809
2006
0
0
3620
0
240
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
509
0
0
0
0
0
0
0
0
0
0
0
0
0
0
28
20
0
0
0
0
0
0
0
0
0
0
0
0
0
1202
0
0
0
0
0
0
0
0
0
0
0
0
0
0
24
0
0
0
0
0
0
0
0
0
0
0
0
0
0
437
0
0
0
0
0
0
0
0
0
0
0
0
0
0
353
0
0
0
0
0
0
0
0
0
0
0
0
0
0
218
0
0
0
0
0
0
0
0
0
0
0
0
0
500
500
59
0
0
30
0
0
0
0
0
0
0
0
0
0
2714
156
0
0
30
0
0
0
0
0
0
462
0
0
1126
23944
41
188
7.10
Reproductive
toxicity
7.11
Toxicity
to aquatic
vertebrates not
included
in other
columns
7.12
Other
7.13
Total
EN
TABLE 8:
8.1
Products
8.2
Acute and sub-acute toxicity testing
methods (including limit test)
8.2.1.
LD50,
LC50
8.a.
8.b.
8.c.
8.d.
8.e.
8.f.
8.g.
8.h.
8.i.
8.j.
EN
8.2.2
Other lethal
methods
8.3
Skin
irritation
8.4
Skin
sensitisatio
n
8.5
Eye
irritation
41
509
28
1202
8.6
Subchronic
and
chronic
toxicity
8.7
Carcino
genicity
8.8
Developmental
toxicity
8.9
Mutagenicit
y
8.10
Reproductive
toxicity
8.11
Toxicity
to aquatic
vertebrates not
included
in other
columns
437
353
218
89
17740
8.12
Other
8.13
Total
3374
4492
8.2.3
Non lethal
clinical signs
methods
6997
126
126
26
28
24
78
288
288
500
34
500
1034
35
2306
2337
4678
4035
4518
9365
41
509
28
1202
24
437
353
218
500
2714
23944
189
EN
MALTA
Statistical data submitted
The data were submitted by the Ministry of Resources and Rural Affairs
EN
190
EN
TABLE 1:
1.1
Species
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.
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
50
44
0
0
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
50
44
0
0
0
0
0
0
0
0
0
600
694
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:
Note 3:
The number of re-used animals in column 1.7 should be excluded from the total in the column 1.2
EN
191
EN
TABLE 2:
2.1
Species
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.
EN
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
2.2
Biological
studies of a
fundamenta
l nature
2.3
Research and
development of
products and
devices for human
medicine and
dentistry and for
veterinary
medicine
(excluding
toxicological and
other safety
evaluations
counted in column
2.6)
50
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
50
44
0
0
0
0
0
0
0
0
0
44
50
44
192
600
600
0
0
0
0
0
0
0
0
0
0
0
0
0
600
694
EN
TABLE 3:
3.1
Species
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.
EN
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
3.2
Products/
substances or
devices for
human
medicine and
dentistry and
for veterinary
medicine
600
600
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
193
3.7
Products/
substances
used or
intended to be
used mainly
as additives in
food for
human
consumption
3.8
Products/
substances
used or
intended to be
used mainly
as additives in
food for
animal
consumption
3.9
Potential or
actual contaminants in the
general environment which
do not appear in
other columns
3.10
Other toxicological or
safety
evaluations
3.11
Total
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
600
600
EN
TABLE 4:
NUMBER OF ANIMALS USED IN EXPERIMENTS FOR STUDIES ON HUMAN AND ANIMAL DISEASES
Main categories versus species
4.1
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.
EN
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
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
50
44
50
44
194
50
44
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
94
EN
TABLE 5:
NUMBER OF ANIMALS USED IN PRODUCTION AND QUALITY CONTROL OF PRODUCTS AND DEVICES FOR
HUMAN MEDICINE AND DENTISTRY AND FOR VETERINARY MEDICINE
Regulatory requirements versus species
5.1
Species
5.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.
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
Examples:
Footnotes:
EN
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
0
44
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
44
195
EN
TABLE 6:
6.1
Species
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.
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
Examples:
Footnotes:
EN
6.2
National legislation
specific to a single EC
Member State
1)
600
600
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
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
600
600
196
EN
TABLE 7:
7.1
Species
7.2
Acute and sub-acute toxicity testing methods
(including limit test)
7.2.1.
LD50,
LC50
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.
EN
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
7.2.2
Other lethal
methods
7.3
Skin
irritation
7.4
Skin
sensitisatio
n
7.5
Eye
irritation
7.6
Subchronic and
chronic
toxicity
7.7
Carcinogenicity
7.8
Developmental
toxicity
7.9
Mutagenicit
y
7.10
Reproductive
toxicity
7.11
Toxicity
to aquatic
vertebrates not
included
in other
columns
7.12
Other
7.13
Total
7.2.3
Non lethal
clinical signs
methods
0
0
0
0
0
0
0
0
0
0
0
600
600
197
0
0
0
0
0
0
0
0
0
0
0
0
0
600
600
EN
TABLE 8:
8.1
Products
8.2
Acute and sub-acute toxicity testing
methods (including limit test)
8.2.1.
LD50,
LC50
8.a.
8.b.
8.c.
8.d.
8.e.
8.f.
8.g.
8.h.
8.i.
8.j.
EN
8.2.2
Other lethal
methods
8.3
Skin
irritation
8.4
Skin
sensitisatio
n
8.5
Eye
irritation
8.6
Subchronic
and
chronic
toxicity
8.7
Carcino
genicity
8.8
Developmental
toxicity
8.9
Mutagenicit
y
8.10
Reproductive
toxicity
8.11
Toxicity
to aquatic
vertebrates not
included
in other
columns
8.12
Other
8.13
Total
8.2.3
Non lethal
clinical signs
methods
600
600
0
0
0
0
0
600
198
600
EN
THE NETHERLANDS
Statistical data submitted
The statistical data have been submitted by the Keuringsdienst van Waren, Ministerie voor
Volksgezondheid, Welzijn en Sport (Inspectorate for Goods, Ministry for Public Health,
Welfare and Sports
The statistical data were prepared, quality assured and submitted by the Voedsel en Waren
Autoriteit, (Dutch Food and Consumer Product Safety Authority
EN
199
EN
The enforcement of the Act has been commissioned to the Food and Consumer Product
Safety Authority.
15
1
8
8
4
40
8
3
The killing of an animal without any previous intervention & re-use of animals
In the Netherlands, the killing of an animal without any previous intervention in the
framework of research or testing, e.g. for organ/blood collection, 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.
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.
In 2008, 60,391 animals were killed without previous intervention.
Re-use of the animals (in 2008 17,220 animals) is included as well in the Dutch statistics.
EN
200
EN
EN
201
EN
TABLE 1:
1.1
Species
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.
EN
1.2
Total
237681
105780
6062
3358
2439
7418
253
1244
472
10
2562
11729
229
3486
2236
0
73
82
0
202
0
90890
121
870
23859
501056
1.3
Animals coming from registered
breeding or supplying
establishments within the reporting
country
1.4
Animals coming from
elsewhere in the EC
228113
105300
2939
3077
1642
6755
100
464
0
0
3
4192
52
67
232
0
73
62
0
0
0
12995
100
785
8518
0
8160
231
3123
281
73
646
0
208
193
0
0
216
0
0
35
0
0
16
0
0
0
472
0
0
126
0
1.5
Animals coming from
Member Countries of the
Council of Europe which are
parties to the Convention ETS
123 (excluding EC Member
States)
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
1.6
Animals coming from
other origins
1408
249
0
0
724
17
153
572
279
10
2559
7321
177
3419
1969
0
0
4
0
202
0
77423
21
85
15215
0
1.7
Re-used animals
2164
2716
130
54
0
109
23
268
20
0
164
125
80
470
187
0
8
202
0
7
0
4119
28
482
270
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:
Note 3:
The number of re-used animals in column 1.7 should be excluded from the total in the column 1.2
202
EN
TABLE 2:
2.1
Species
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.
EN
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
2.2
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
2.6
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
152304
31930
488
444
2222
727
0
157
28
10
65
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)
40617
15348
373
330
217
393
45
285
414
0
377
5624
28320
767
0
0
16
0
11
0
0
110
15653
2700
4181
2539
0
1653
85
187
0
0
2007
7522
23284
183
30
0
4543
44
519
0
0
0
8859
0
0
0
0
5
0
0
0
0
0
7102
4198
70
15
0
81
79
85
30
0
3
0
0
0
0
0
0
0
0
0
0
0
237681
105780
6062
3358
2439
7418
253
1244
472
10
2562
5138
135
133
248
0
28
21
0
202
0
51806
108
788
19503
266485
3693
50
639
1012
0
45
61
0
0
0
17171
0
0
0
81070
3
0
2576
129
0
0
0
0
0
0
4
0
0
0
37560
2283
0
85
598
0
0
0
0
0
0
20684
0
0
0
52655
188
0
0
0
0
0
0
0
0
0
0
0
0
3383
39696
0
0
0
0
0
0
0
0
0
0
395
0
0
0
9259
424
44
53
249
0
0
0
0
0
0
830
13
82
973
14331
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
11729
229
3486
2236
0
73
82
0
202
0
90890
121
870
23859
501056
203
EN
2.8
Education and
training
2.9
Other
2.10
Total
TABLE 3:
3.1
Species
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.
EN
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
3.2
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
3224
5838
134
30
0
2222
44
471
0
0
0
26
0
0
0
0
0
0
0
0
0
0
0
0
353
12342
201
4193
0
0
0
634
0
48
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
5076
1499
11700
49
0
0
1681
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
365
15294
0
48
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
48
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
204
3.7
Products/
substances
used or
intended to be
used mainly
as additives in
food for
human
consumption
2598
1286
0
0
0
6
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
3890
3.8
Products/
substances
used or
intended to be
used mainly
as additives in
food for
animal
consumption
0
177
0
0
0
0
0
0
0
0
0
162
0
0
0
0
0
0
0
0
0
0
0
0
0
339
EN
3.9
Potential or
actual contaminants in the
general environment which
do not appear in
other columns
3.10
Other toxicological or
safety
evaluations
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
2665
2665
0
42
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
42
3.11
Total
7522
23284
183
30
0
4543
44
519
0
0
0
188
0
0
0
0
0
0
0
0
0
0
0
0
3383
39696
TABLE 4:
NUMBER OF ANIMALS USED IN EXPERIMENTS FOR STUDIES ON HUMAN AND ANIMAL DISEASES
Main categories versus species
4.1
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.
EN
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
4.2
Human cardiovascular
diseases
16595
4070
0
0
0
369
0
61
0
0
0
293
106
32
0
0
0
0
0
0
0
0
0
0
0
21526
205
4.3
Human nervous and
mental disorders
13267
11472
98
9
27
5
0
0
0
0
0
0
0
0
0
0
9
0
0
0
0
0
0
0
148
25035
4.4
Human cancer (excluding
evaluations of carcinogenic
hazards or risks)
47276
1554
0
0
0
56
0
0
0
0
0
36
0
0
0
0
0
0
0
0
0
0
0
0
210
49132
4.5
Other human diseases
84369
20855
463
263
619
476
6
28
355
0
37
263
75
271
129
0
64
72
0
0
0
1160
0
0
1003
110508
EN
4.6
Studies specific to animal
diseases
11454
46
40
240
0
38
39
269
87
0
350
3784
4
467
997
0
0
0
0
0
0
39694
0
0
95
57604
4.7
Total
172961
37997
601
512
646
944
45
358
442
0
387
4376
185
770
1126
0
73
72
0
0
0
40854
0
0
1456
263805
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.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.
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
Examples:
Footnotes:
EN
5.2
National legislation
specific to a single EC
Member State
1)
0
0
0
0
0
0
27
22
0
0
0
0
0
2
16
0
0
0
0
0
0
75
0
0
0
142
5.3
EC legislation
including European
Pharmacopoeia
(requirements)
2725
4000
543
0
0
1
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
7269
5.4
Member Country of Council
of Europe (but not EC)
legislation
2)
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
60
0
0
0
60
5.5
Other legislation
1978
758
160
0
0
0
0
0
0
0
0
0
0
0
6
0
0
0
0
0
0
0
0
0
0
2902
5.6
Any combination of
5.2/ 5.3/ 5.4/ 5.5
15087
26194
2400
2539
0
1582
58
165
0
0
60
1610
0
10
359
0
0
0
0
0
0
15474
0
0
0
65538
5.7
No regulatory
requirements
1487
68
1845
0
0
86
0
11
0
0
2057
676
0
2649
346
0
0
0
0
0
0
5079
0
0
0
14304
5.8
Total
21277
31020
4948
2539
0
1669
85
198
0
0
2117
2286
0
2661
727
0
0
0
0
0
0
20688
0
0
0
90215
206
EN
TABLE 6:
6.1
Species
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.
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
Examples:
Footnotes:
EN
6.2
National legislation
specific to a single EC
Member State
1)
4
77
4
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
77
162
6.3
EC legislation
including European
Pharmacopoeia
(requirements)
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
6.4
Member Country of Council
of Europe (but not EC)
legislation
2)
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
6.5
Other legislation
6.6
Any combination of
6.2/ 6.3/ 6.4/ 6.5
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
6870
22654
57
30
0
4540
44
519
0
0
0
13
0
0
0
0
0
0
0
0
0
0
0
0
2898
37625
6.7
No regulatory
requirements
648
553
122
0
0
3
0
0
0
0
0
175
0
0
0
0
0
0
0
0
0
0
0
0
408
1909
6.8
Total
7522
23284
183
30
0
4543
44
519
0
0
0
188
0
0
0
0
0
0
0
0
0
0
0
0
3383
39696
207
EN
TABLE 7:
7.1
Species
7.2
Acute and sub-acute toxicity testing methods
(including limit test)
7.2.1.
LD50,
LC50
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.
EN
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
7.2.2
Other lethal
methods
0
0
0
0
0
0
0
0
0
0
0
251
960
0
0
0
0
0
0
0
0
0
7.2.3
Non lethal
clinical signs
methods
396
4486
114
0
0
508
0
227
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
1198
1198
0
0
0
0
0
0
0
0
0
0
0
0
0
421
1632
13
0
0
0
0
0
0
0
0
0
0
0
0
1344
7088
208
7.3
Skin
irritation
7.4
Skin
sensitisatio
n
7.5
Eye
irritation
7.6
Subchronic and
chronic
toxicity
7.7
Carcinogenicity
7.8
Developmental
toxicity
7.9
Mutagenicit
y
0
391
18
22
0
249
0
0
0
0
0
2020
0
49
0
0
0
0
0
0
0
0
0
0
0
0
0
186
0
0
0
0
0
40
3231
0
0
0
428
0
250
0
0
0
106
0
0
0
0
0
0
0
0
0
0
2293
7844
0
0
0
0
0
0
0
0
0
1026
553
0
0
0
0
0
0
0
0
0
360
4512
0
0
0
2084
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
1030
1307
2
8
0
1088
44
42
0
0
0
7522
23284
183
30
0
4543
44
519
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
119
799
0
0
0
0
0
0
0
0
0
0
0
0
0
0
2069
0
0
0
0
0
0
0
0
0
0
0
0
0
0
186
0
0
0
0
0
0
0
0
0
0
0
0
0
301
4250
0
0
0
0
0
0
0
0
0
0
0
0
0
0
106
0
0
0
0
0
0
0
0
0
0
0
0
0
0
10137
0
0
0
0
0
0
0
0
0
0
0
0
0
0
1579
0
0
0
0
0
0
0
0
0
0
0
0
0
0
6956
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
175
0
0
0
0
0
0
0
0
0
0
0
0
0
3696
188
0
0
0
0
0
0
0
0
0
0
0
0
3383
39696
EN
7.10
Reproductive
toxicity
7.11
Toxicity
to aquatic
vertebrates not
included
in other
columns
7.12
Other
7.13
Total
TABLE 8:
8.1
Products
8.2
Acute and sub-acute toxicity testing
methods (including limit test)
8.2.1.
LD50,
LC50
8.a.
8.b.
8.c.
8.d.
8.e.
8.f.
8.g.
8.h.
8.i.
8.j.
EN
8.2.2
Other lethal
methods
8.3
Skin
irritation
8.4
Skin
sensitisatio
n
8.5
Eye
irritation
0182
0832
028
02.490
8.6
Subchronic
and
chronic
toxicity
8.7
Carcino
genicity
8.8
Developmental
toxicity
8.9
Mutagenicit
y
8.10
Reproductive
toxicity
8.11
Toxicity
to aquatic
vertebrates not
included
in other
columns
0106
0673
0994
8.12
Other
8.13
Total
02.986
12342
0406
8.2.3
Non lethal
clinical signs
methods
03.645
034
0390
030
044
03
0120
0703
0184
03.568
5076
0365
0749
01.833
0465
01.193
0152
0288
07.141
0375
02.227
0506
15294
016
032
48
06
0120
03
03
0951
02.293
0305
0167
042
3890
077
0100
0162
339
0833
0421
0991
0119
0301
2665
042
42
1198
1632
7088
799
2069
186
4250
106
10137
1579
6956
3696
39696
209
EN
AUSTRIA
Statistical data submitted
The statistical data have been submitted by the Bundesministerien fr Gesundheit und FrauenLand und Forstwirtshaft, Umwelt und Wasserwirtschaft Wirtschaft und Arbeit - Bildung,
Wissenschaft und Kultur (Federal Ministries for Health and Women -Agriculture Forestry, the
Environment and Water Mangement Economic Affairs and Labour - Education, Science and
Culture).
Comments from the Austrian authorities
The number of animals used in procedures in Austria during 2008 has risen by 11,4% as compared
to 2007. However, relative to international figures the Austrian number still remains low. The
animal use statistics for 2008 show that in total 220,456 animals were used in procedures in Austria.
Compared to previous years, this total number lies within the range of variation of the last years, yet
is still well below the number of the earliest years. Relative to 1990 (the year statistics were
recorded for the first time, in which year 482,166 animals were used in procedures) the number of
animals is reduced by about 55%. No great apes were used in 2008. No animals have been used for
cosmetics testing. The statistics have been presented in the EU-wide standardized format.
EN
210
EN
94
19
95
19
96
19
97
19
98
19
99
20
00
20
01
20
02
20
03
20
04
20
05
20
06
20
07
20
08
93
19
92
19
91
19
19
19
90
EN
211
EN
BMLFUW
1,8%
BMWFJ
1,1%
BMWFJ
1,1%
BMLFUW
1,8%
BMWF
26,7%
BMG
70,4%
BMWF
26,8%
BMG
70,3%
EN
187.472
85,0%
18.761
8,5%
rabbits
3.284
1,5%
guinea pigs
5.888
2,7%
agricultural animals
1.381
0,6%
birds
2.579
1,2%
fish
754
0,3%
294
0,1%
41
dogs
cats
212
EN
Guinea pigs
1%
Fish
1%
Small
animals
0%
Birds
1%
Agric.
Animals
3%
Amphibia /
Reptiles
0%
Rabbits
9%
Dogs and
Cats
0%
Mice and
Rats
85%
EN
Rabbits
Agric. Animals
Guinea pigs
Fish
Birds
Small animals
Amphibia / Reptiles
213
EN
EN
214
EN
restrict such experiments as far as possible and to avoid them altogether according to the best
available science.
Statistics in EU-wide standardized format
In accordance with the amended Animal Experiments Law (BGBl. I, Nr. 169/1999) and the
Ordinance on Animal Use Statistics (BGBl. II Nr. 199/2000) the Animal Use Statistics 2008
requires the use of eight statistical tables which should contain data in a standardized format and
give details on, inter alia, the origin of the animals, the purposes for which they were used (basic
research, R&D for medicines and medicinal products, for quality control, etc.).
Internationally Compared Low Animal Numbers in Austria
The number of animals used in procedures in Austria contributed less than 1,5% to the total number
of 12.1 million vertebrate animals used in Europe, as can be seen from the EU-wide animal use
statistics for 2005 (the last year for which the European Commission compiled such a statistical
report). When comparing at an international level, the figures of animal numbers in Austrian still
remain low. These comparatively low numbers of animals are due to at least three interconnected
developments in relation to animals experiments:
1. Application of 3R
Firstly, scientists, researchers and users themselves apply the principles of the 3R(Replacement,
Reduction, Refinement) - which also guide the Austrian Animal Experiments Law - to the widest
possible extent, as well as using alternatives.
2. Restrictive authorization practice for projects
Second, all authorities issue permits for projects very restrictively in accordance with the strict
provisions of the Animal Experiments Law and the Ordinance on Animal Experiments, which allow
animal experiments only under very restrictive conditions and stipulate that projects may only be
permitted, if no other satisfactory methods are available to achieve the aim without using live
animals.
3. Support for research on Alternative Methods to Animal Testing
Finally, public financial support for developing and promoting alternative methods contributes to
motivation of users and researches:
3.1. Financial support for research projects aimed at developing alternative methods, totalling more
than 2,562m EUR for 29 projects, as well as promoting the use of alternative methods nationally
and internationally,
3.2. National Award for Alternative Methods, i.e. a specific award publicly recognizing scientific
achievements in the area of alternative methods.
EN
215
EN
TABLE 1:
1.1
Species
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.
1.2
Total
177544
9928
3284
693
47
18761
2
41
14
0
47
5086
39
142
574
0
0
0
0
0
14
1367
17
277
2579
220456
1.3
Animals coming from registered
breeding or supplying
establishments within the reporting
country
1.4
Animals coming from
elsewhere in the EC
41.468
4.140
737
0
0
14.886
0
6
0
0
16
4889
35
98
539
0
0
0
0
0
14
548
0
19
1880
133.479
5.652
2.547
693
20
3.857
2
13
0
0
20
6
0
0
14
0
0
0
0
0
0
119
0
0
65
1.5
Animals coming from
Member Countries of the
Council of Europe which are
parties to the Convention ETS
123 (excluding EC Member
States)
116
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
1.6
Animals coming from
other origins
1.7
Re-used animals
2.481
136
0
0
27
18
0
22
14
0
11
191
4
44
21
0
0
0
0
0
0
700
17
258
634
61
20
0
0
0
0
0
22
0
0
20
0
0
23
4
0
0
0
0
0
0
77
0
20
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:
Note 3:
The number of re-used animals in column 1.7 should be excluded from the total in the column 1.2
EN
216
EN
TABLE 2:
2.1
Species
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.
EN
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
2.2
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
2.6
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
44.234
4.106
211
0
47
143
2
0
0
0
35
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)
76.102
3.036
522
185
0
520
0
14
14
0
0
51.086
68
1.618
358
0
17.276
0
0
0
0
0
0
0
0
0
0
14
0
0
0
0
0
3.420
2.352
925
150
0
726
0
0
0
0
0
1.083
0
0
0
0
0
0
0
0
0
12
713
366
8
0
0
82
0
12
0
0
0
906
0
0
0
0
0
0
15
0
0
0
177544
9928
3284
693
47
18761
2
41
14
0
47
1.730
0
46
334
0
0
0
0
0
14
1.174
17
277
2.053
54423
2.665
1
17
14
0
0
0
0
0
0
84
0
0
0
83174
0
3
5
0
0
0
0
0
0
0
14
0
0
0
70428
0
0
0
0
0
0
0
0
0
0
0
0
0
0
14
63
0
0
0
0
0
0
0
0
0
0
0
0
416
8052
125
0
0
5
0
0
0
0
0
0
12
0
0
60
1297
382
35
74
176
0
0
0
0
0
0
83
0
0
0
1931
121
0
0
45
0
0
0
0
0
0
0
0
0
50
1137
5086
39
142
574
0
0
0
0
0
14
1367
17
277
2579
220456
217
2.8
Education and
training
2.9
Other
2.10
Total
EN
TABLE 3:
3.1
Species
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.
EN
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
3.2
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
2.720
824
250
150
0
580
0
0
0
0
0
63
0
0
0
0
0
0
0
0
0
0
0
0
0
4587
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
218
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
3.9
Potential or
actual
contaminants in
the general
environment
which do not
appear in other
columns
3.10
Other
toxicological
or safety
evaluations
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
132
132
700
1.528
675
0
0
146
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
284
3333
3.11
Total
3420
2352
925
150
0
726
0
0
0
0
0
63
0
0
0
0
0
0
0
0
0
0
0
0
416
8052
EN
TABLE 4:
NUMBER OF ANIMALS USED IN EXPERIMENTS FOR STUDIES ON HUMAN AND ANIMAL DISEASES
Main categories versus species
4.1
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.
EN
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
4.2
Human cardiovascular
diseases
3.871
893
108
0
0
94
0
0
0
0
0
275
0
9
0
0
0
0
0
0
0
0
0
7
1.794
7051
4.3
Human nervous and
mental disorders
4.726
598
92
358
0
14
0
0
0
0
0
10
0
0
0
0
0
0
0
0
0
0
0
6
0
5804
4.4
Human cancer (excluding
evaluations of carcinogenic
hazards or risks)
21.735
1.683
0
0
0
2
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
6
0
23426
219
4.5
Other human diseases
48.038
3.482
546
185
0
841
0
0
14
0
0
200
1
38
0
0
0
0
0
0
0
149
0
0
0
53494
4.6
Studies specific to animal
diseases
103
27
0
0
0
0
2
35
0
0
24
154
0
4
344
0
0
0
0
0
0
541
0
0
60
1294
4.7
Total
78473
6683
746
543
0
951
2
35
14
0
24
639
1
51
344
0
0
0
0
0
0
690
0
19
1854
91069
EN
TABLE 5:
NUMBER OF ANIMALS USED IN PRODUCTION AND QUALITY CONTROL OF PRODUCTS AND DEVICES FOR HUMAN
MEDICINE AND DENTISTRY AND FOR VETERINARY MEDICINE
Regulatory requirements versus species
5.1
Species
5.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.
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
Examples:
Footnotes:
EN
5.2
National legislation
specific to a single EC
Member State
1)
0
60
0
0
0
26
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
4
0
0
0
90
5.3
EC legislation
including European
Pharmacopoeia
(requirements)
7.019
8
236
0
0
11.078
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
18.341
5.4
Member Country of Council
of Europe (but not EC)
legislation
2)
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
5.5
Other legislation
0
0
0
358
0
0
0
0
0
0
0
0
3
5
0
0
0
0
0
0
0
10
0
0
0
376
5.6
Any combination of
5.2/ 5.3/ 5.4/ 5.5
44.067
0
1.382
0
0
6.172
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
51.621
5.7
No regulatory
requirements
5.8
Total
0
0
0
0
0
14
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
14
51086
68
1618
358
0
17290
0
0
0
0
0
0
3
5
0
0
0
0
0
0
0
14
0
0
0
70442
220
EN
TABLE 6:
6.1
Species
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.
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
Examples:
Footnotes:
EN
6.2
National legislation
specific to a single EC
Member State
1)
0
0
0
0
0
20
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
132
152
6.3
EC legislation
including European
Pharmacopoeia
(requirements)
2596
212
104
0
0
271
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
3183
6.4
Member Country of Council
of Europe (but not EC)
legislation
2)
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
6.5
Other legislation
6.6
Any combination of
6.2/ 6.3/ 6.4/ 6.5
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
824
2045
821
150
0
435
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
284
4559
6.7
No regulatory
requirements
0
95
0
0
0
0
0
0
0
0
0
63
0
0
0
0
0
0
0
0
0
0
0
0
0
158
6.8
Total
3420
2352
925
150
0
726
0
0
0
0
0
63
0
0
0
0
0
0
0
0
0
0
0
0
416
8052
221
EN
TABLE 7:
7.1
Species
7.2
Acute and sub-acute toxicity testing methods
(including limit test)
7.2.1.
LD50,
LC50
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.
EN
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
7.2.2
Other lethal
methods
0
0
0
0
0
0
0
0
0
0
0
36
1124
0
0
0
20
0
0
0
0
0
7.2.3
Non lethal
clinical signs
methods
1670
136
80
0
0
18
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
1180
0
0
0
0
0
0
0
0
0
0
0
0
0
0
1904
7.3
Skin
irritation
7.4
Skin
sensitisatio
n
7.5
Eye
irritation
7.6
Subchronic and
chronic
toxicity
7.7
Carcinogenicity
7.8
Developmental
toxicity
7.9
Mutagenicit
y
0
12
0
0
0
74
0
0
0
0
0
522
0
695
0
0
0
0
0
0
0
0
0
0
0
0
0
89
0
0
0
0
0
0
629
126
150
0
75
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
266
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
926
451
24
0
0
450
0
0
0
0
0
3420
2352
925
150
0
726
0
0
0
0
0
63
0
0
0
0
0
0
0
0
0
0
0
0
0
149
0
0
0
0
0
0
0
0
0
0
0
0
0
0
1217
0
0
0
0
0
0
0
0
0
0
0
0
0
0
89
0
0
0
0
0
0
0
0
0
0
0
0
0
0
980
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
266
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
416
416
0
0
0
0
0
0
0
0
0
0
0
0
0
0
1851
63
0
0
0
0
0
0
0
0
0
0
0
0
416
8052
222
7.10
Reproductive
toxicity
7.11
Toxicity
to aquatic
vertebrates not
included
in other
columns
7.12
Other
7.13
Total
EN
TABLE 8:
8.1
Products
8.2
Acute and sub-acute toxicity testing
methods (including limit test)
8.2.1.
LD50,
LC50
8.a.
8.b.
8.c.
8.d.
8.e.
8.f.
8.g.
8.h.
8.i.
8.j.
EN
8.2.2
Other lethal
methods
8.3
Skin
irritation
8.4
Skin
sensitisatio
n
8.5
Eye
irritation
20
17
420
8.6
Subchronic
and
chronic
toxicity
8.7
Carcino
genicity
8.8
Developmental
toxicity
8.9
Mutagenicit
y
8.10
Reproductive
toxicity
8.11
Toxicity
to aquatic
vertebrates not
included
in other
columns
88
1.851
4587
224
8.12
Other
8.13
Total
224
1.904
8.2.3
Non lethal
clinical signs
methods
63
956
86
1.197
72
560
178
284
3333
1180
1904
149
1217
89
980
266
416
1851
8052
223
EN
POLAND
Statistical data submitted
The statistical data have been submitted by the Ministry of Science and Higher
Education Warsaw.
EN
224
EN
TABLE 1:
1.1
Species
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.
1.2
Total
123897
45824
6495
312
11966
3086
83
230
0
520
529
11742
300
2217
7540
0
0
0
0
1246
5100
27391
248
1221
25941
275888
1.3
Animals coming from registered
breeding or supplying
establishments within the reporting
country
1.4
Animals coming from
elsewhere in the EC
122068
44646
6495
280
1.6
Animals coming from
other origins
705
61
0
0
1.5
Animals coming from
Member Countries of the
Council of Europe which are
parties to the Convention ETS
123 (excluding EC Member
States)
227
150
0
0
2804
21
9
0
0
0
0
0
0
0
0
0
282
62
221
0
137
0
18
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
5100
1.7
Re-used animals
897
967
0
32
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:
Note 3:
The number of re-used animals in column 1.7 should be excluded from the total in the column 1.2
EN
225
EN
TABLE 2:
2.1
Species
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.
EN
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
2.2
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
2.6
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
61614
33700
26
186
11526
718
0
25
0
510
309
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)
2649
1277
0
100
0
167
0
0
0
0
0
12230
1703
5309
0
0
853
13
0
0
0
0
4911
0
323
0
0
587
0
0
0
0
0
7243
4845
815
0
204
358
1
0
0
0
0
2855
2519
0
10
50
65
9
180
0
0
130
1620
891
9
6
106
171
0
0
0
0
65
30775
889
13
10
80
167
60
25
0
10
25
123897
45824
6495
312
11966
3086
83
230
0
520
529
3118
147
1374
6380
0
0
0
0
1238
4730
21006
246
697
11022
158572
16
0
0
0
0
0
0
0
0
0
88
0
0
0
4297
10
48
0
60
0
0
0
0
0
0
524
0
0
0
20750
0
0
0
0
0
0
0
0
0
0
0
0
0
0
5821
20
0
0
0
0
0
0
0
0
360
97
0
0
3748
17691
40
0
0
0
0
0
0
0
0
0
222
0
0
168
6248
107
33
244
1070
0
0
0
0
8
10
650
2
524
33
5549
8431
72
599
30
0
0
0
0
0
0
4804
0
0
10970
56960
11742
300
2217
7540
0
0
0
0
1246
5100
27391
248
1221
25941
275888
226
2.8
Education and
training
2.9
Other
2.10
Total
EN
TABLE 3:
3.1
Species
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.
EN
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
3.2
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
2571
1397
489
0
0
177
1
0
0
0
0
0
0
0
0
0
0
0
0
0
60
0
0
0
1127
5822
347
472
280
0
0
129
0
0
0
0
0
20
0
0
0
0
0
0
0
0
300
0
0
0
2260
3808
0
230
46
0
0
44
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
169
489
0
0
0
0
0
8
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
52
60
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
227
3.7
Products/
substances
used or
intended to be
used mainly
as additives in
food for
human
consumption
0
920
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
920
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
3.9
Potential or
actual contaminants in the
general environment which
do not appear in
other columns
3.10
Other toxicological or
safety
evaluations
0
897
0
0
204
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
97
0
0
140
1338
4325
929
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
5254
3.11
Total
7243
4845
815
0
204
358
1
0
0
0
0
20
0
0
0
0
0
0
0
0
360
97
0
0
3748
17691
EN
TABLE 4:
NUMBER OF ANIMALS USED IN EXPERIMENTS FOR STUDIES ON HUMAN AND ANIMAL DISEASES
Main categories versus species
4.1
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.
EN
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
4.2
Human cardiovascular
diseases
1041
1985
0
0
154
0
0
0
0
0
0
40
0
0
0
0
0
0
0
0
0
0
0
0
0
3220
4.3
Human nervous and
mental disorders
44644
7400
0
0
440
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
1800
0
0
0
54284
4.4
Human cancer (excluding
evaluations of carcinogenic
hazards or risks)
7545
493
0
176
0
0
0
9
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
8223
228
4.5
Other human diseases
7020
7393
0
40
50
455
0
0
0
0
0
87
0
24
0
0
0
0
0
0
0
12
0
0
0
15081
4.6
Studies specific to animal
diseases
1703
30
0
0
70
0
0
180
0
0
130
0
0
0
0
0
0
0
0
0
0
292
0
0
260
2665
4.7
Total
61953
17301
0
216
714
455
0
189
0
0
130
127
0
24
0
0
0
0
0
0
0
2104
0
0
260
83473
EN
TABLE 5:
NUMBER OF ANIMALS USED IN PRODUCTION AND QUALITY CONTROL OF PRODUCTS AND DEVICES FOR
HUMAN MEDICINE AND DENTISTRY AND FOR VETERINARY MEDICINE
Regulatory requirements versus species
5.1
Species
5.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.
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
Examples:
Footnotes:
EN
5.2
National legislation
specific to a single EC
Member State
1)
7974
549
745
0
0
305
12
0
0
0
0
0
48
0
60
0
0
0
0
0
0
524
0
0
0
10217
5.3
EC legislation
including European
Pharmacopoeia
(requirements)
5575
1062
4658
0
0
348
1
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
11644
5.4
Member Country of Council
of Europe (but not EC)
legislation
2)
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
5.5
Other legislation
590
60
195
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
845
5.6
Any combination of
5.2/ 5.3/ 5.4/ 5.5
5.7
No regulatory
requirements
257
32
0
0
0
647
0
0
0
0
0
10
0
0
0
0
0
0
0
0
0
0
0
0
0
946
2745
0
34
0
0
140
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
2919
5.8
Total
17141
1703
5632
0
0
1440
13
0
0
0
0
10
48
0
60
0
0
0
0
0
0
524
0
0
0
26571
229
EN
TABLE 6:
6.1
Species
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.
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
Examples:
Footnotes:
EN
6.2
National legislation
specific to a single EC
Member State
1)
2445
2135
66
0
204
30
0
0
0
0
0
20
0
0
0
0
0
0
0
0
0
0
0
0
100
5000
6.3
EC legislation
including European
Pharmacopoeia
(requirements)
3920
2462
749
0
0
298
1
0
0
0
0
0
0
0
0
0
0
0
0
0
360
0
0
0
2598
10388
6.4
Member Country of Council
of Europe (but not EC)
legislation
2)
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
6.5
Other legislation
6.6
Any combination of
6.2/ 6.3/ 6.4/ 6.5
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
6.7
No regulatory
requirements
0
70
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
70
878
178
0
0
0
30
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
97
0
0
1050
2233
6.8
Total
7243
4845
815
0
204
358
1
0
0
0
0
20
0
0
0
0
0
0
0
0
360
97
0
0
3748
17691
230
EN
TABLE 7:
7.1
Species
7.2
Acute and sub-acute toxicity testing methods
(including limit test)
7.2.1.
LD50,
LC50
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.
EN
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
7.2.2
Other lethal
methods
280
584
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
7.2.3
Non lethal
clinical signs
methods
664
881
0
0
0
15
0
0
0
0
0
0
0
0
0
0
0
0
0
0
360
0
0
0
3326
4550
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
1560
7.3
Skin
irritation
7.4
Skin
sensitisatio
n
7.5
Eye
irritation
7.6
Subchronic and
chronic
toxicity
7.7
Carcinog
enicity
7.8
Developmental
toxicity
7.9
Mutagenicit
y
0
0
0
0
0
182
0
0
0
0
0
0
0
546
0
0
0
0
0
0
0
0
0
0
0
0
0
86
0
0
0
0
0
384
859
0
0
204
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
1692
0
0
0
25
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
545
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
5915
284
269
0
0
50
1
0
0
0
0
7243
4845
815
0
204
358
1
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
182
0
0
0
0
0
0
0
0
0
0
0
0
0
0
546
0
0
0
0
0
0
0
0
0
0
0
0
0
0
86
0
0
0
0
0
0
0
0
0
0
0
0
0
0
1447
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
1717
0
0
0
0
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
645
0
0
0
0
0
0
0
0
0
0
0
0
0
232
232
20
0
0
0
0
0
0
0
0
0
97
0
0
90
6726
20
0
0
0
0
0
0
0
0
360
97
0
0
3748
17691
231
7.10
Reproductive
toxicity
7.11
Toxicity
to aquatic
vertebrates not
included
in other
columns
7.12
Other
7.13
Total
EN
TABLE 8:
8.1
Products
8.2
Acute and sub-acute toxicity testing
methods (including limit test)
8.2.1.
LD50,
LC50
8.a.
8.b.
8.c.
8.d.
8.e.
8.f.
8.g.
8.h.
8.i.
8.j.
EN
8.2.2
Other lethal
methods
8.3
Skin
irritation
8.4
Skin
sensitisatio
n
8.5
Eye
irritation
53
274
8.6
Subchronic
and
chronic
toxicity
8.7
Carcinog
enicity
8.8
Developmental
toxicity
8.9
Mutagenicit
y
8.10
Reproductive
toxicity
8.11
Toxicity
to aquatic
vertebrates not
included
in other
columns
381
447
391
367
1518
5822
8.12
Other
8.13
Total
1307
8.2.3
Non lethal
clinical signs
methods
1078
2670
62
251
56
241
146
283
99
3808
139
47
18
16
10
101
34
88
36
489
52
60
106
814
920
381
860
97
1338
577
743
84
556
187
3107
5254
4745
381
1868
221
541
76
2245
1441
187
762
367
4857
17691
232
EN
PORTUGAL
Statistical data submitted
The statistical data have been submitted by the Ministrio da Agricultura,
Desenvolvimento Rural e das Pescas Direco Geral de Veterinria Direco de
Servios de Sade e Proteco Animal (Ministry of Agriculture, Rural Development
and Fisheries General Direction of Veterinary Directorate for Animal Health and
Protection)
EN
2005
2008
Mice
68,04
78,23
Rats
16,32
12,91
Guinea-pigs
0,91
0,30
Hamsters and
other rodents
0,31
0,06
233
EN
Rabbits
1,43
0,19
Cold-blooded
animals
11,53
7,47
0,27
0,31
Artio
Perissodactyla
1,11
0,52
Carnivors
0,09
0,00
In 2008, looking at the data by groups of animals, the percentage of all of them
decreased. However the largest increase occurred, again, in mice and a slight increase
in the Birds group (quail and other birds). The biggest decrease occurred in the use of
cold-blooded animals (4,06%) followed in descending order, by the use of rats
(3.41%) and in rabbits (1,24%).
Within the group of cold-blooded animals, fish were the only animals used.
Within the Artiodactyla, Pigs were the most used animals (61,67%).
2. Number of animals used by purposes of experiments
In 2008, the percentage of animals (total 50,888) used by purposes of experiments
was the following:
83,82% of animals were used in Fundamental biology;
9,74% in Research and development for human medicine, veterinary medicine,
dentistry;
0% in Production and quality control of products and devices in human medicine
and dentistry and veterinary medicine;
0,61% in Toxicological and other safety evaluation;
1,44% in Diagnosis of disease;
1,83% in Education and training;
2,55% in Other purposes;
Referring to the use of species versus experimental purposes, the highest amount of
use of mice and of rats is in fundamental biology and in research and development
for human medicine, veterinary medicine, dentistry.
Comparison with the data of the previous report (data of 2005)
EN
234
EN
The most significant increase in 2008 is the number of animals that were used for
Fundamental biology, which increased from 78,78%, in 2005, to 83,82%, in 2008.
The other increases that occurred were in the percentage of animals used in Research
and development for human medicine, veterinary medicine, dentistry which
increased from 6,78%, in 2005, to 9,74%, in 2008, and in Other purposes which
increased from 1,39% in 2005, to 2,55% in 2008.
The use of animals in the rest of the other categories decreased, for example:
The percentage of animals used for Production and quality control of products and
devices in human medicine and dentistry and veterinary medicine was the biggest
decrease in 2008 as no animal was used for this purpose, compared to 2005 in which
5,09% of all animals were used to this same purpose.
The percentage of animals used for Toxicological and other safety evaluation
decreased from 2,26% to 0,61%.
The percentage of animals used for Education and training decreased from 3,02% to
0,61%.
3. Number of animals used for Toxicological and safety evaluation by type of
products
In 2008, the use of animals in Toxicological and other safety evaluation represents
only 0,61%, which only refers to 310 animals (mice), of a total of 50,888 animals that
were used for experimental purposes in Portugal.
Potential or actual contaminants in the general environment which do not appear in
other columns represents 61,30% of the animals used for Toxicological and other
safety evaluation and Other toxicological or safety evaluations represent 38,70%.
Comparison with the data of the previous report (data of 2005)
Compared to the data of 2005, in 2008 there was a decrease in the use of animals in
Toxicological and other safety evaluation.
The percentage of animals used for Toxicological and other safety evaluation
decreased from 2,26% to 0,61% (from 939 to 310 animals).
The data of 2008 refers to the same category of products that had been tested in 2005,
except for the category of Products/substances or devices for human medicine and
dentistry and for veterinary medicine where no animals were used in 2008.
Potential or actual contaminants in the general environment which do not appear in
other columns represented, in 2005, 21,29% of the animals used for Toxicological
and other safety evaluation and, in 2008, 61,30%; Other toxicological or safety
evaluations represented 26,62% in 2005 while, in 2008, 38,70%, which means that
there was an increase in 2008.
EN
235
EN
As in 2005, in 2008 the other groups of products/substances were not tested which
means that, for example, there were no animals used for the purpose of evaluating the
safety of cosmetics or additives in food for animal consumption.
4. Number of animals used for the study of diseases
In 2008, the number of animals used for the Studies on human and animal diseases
was 14,753, which represents 29% of the total number of animals (50,888 animals)
that were used.
The percentages of animals per type of diseases were:
2,70% in Human cardiovascular diseases;
15,66% in Human nervous and mental disorders;
2,22% in Human cancer (excl. evaluation of carcino hazards);
75,57% in Other human diseases;
3,85% in Specific animal diseases.
The percentage of the number of animals used for studies of human diseases
represents 96,15% (14,185 animals) of the total number of animals used for all studies
of diseases (14,753 animals).
In 2008, the number of animals used to study animal diseases was only 568 (3.85%)
while in 2005, that number had been 271 (1.40%), which means that in 2008, there
was an increase on the use of animals for the study of animal diseases.
5. Number of animals used for Toxicological and other safety evaluations by
the types of tests
As referred previously, in 2008, the use of animals in Toxicological and other safety
evaluation represents only 0,61%, which only refers to 310 animals, of a total of
50,888 animals that were used for experimental purposes in Portugal.
Comparison with the data of the previous report (data of 2005)
The percentages of animals used in toxicity tests for Toxicological and other safety
evaluation in 2005 (939 animals) and in 2008 (310 animals) are represented in the
following table:
Type of tests
2005
2008
(%)
Acute and sub-acute
toxicity testing methods
(including limit test)
EN
236
37,6
EN
Irritation/sensitization
tests
27,8
Mutagenicity
Carcinogenicity
and
32
38,71
Reproductive
and
developmental toxicity
Toxicity
of
aquatic
vertebrates not included
in other columns
2,7
61,29
Other tests
In 2008, the uses of animals in toxicity tests only fell into the categories of
Carcinogenicity and Other tests which means that there was a decrease in the
other uses of tests compared to data of 2005, i.e., Acute and sub-acute toxicity
testing methods (including the 'limit test') and Irritation/sensitization tests the
percentage of which decreased to 0%.
6. Type of toxicity tests carried out for Toxicological and other safety
evaluations of products
As pointed out previously, in 2008, the use of animals in Toxicological and other
safety evaluation represents only 0,61%, which only refers to 310 animals, of a total
of 50,888 animals that were used for experimental purposes in Portugal.
Comparison with the data of the previous report (data of 2005)
The numbers of animals used for Toxicological and other safety evaluation per
types of products in 2005 (939 animals) and in 2008 (310 animals) are represented in
the following tables:
EN
237
EN
Types of products
2005
2008
(%)
Products/substances or
devices
for
human
medicine and dentistry
and
for
veterinary
medicine
689
120
Potential
or
actual
contaminants
in
the
general
environment
which do not appear in
othe columns
190
250
Other toxicological
safety evaluations
or
EN
238
EN
TABLE 1:
1.1
Species
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.
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
39811
6571
152
29
29109
1463
137
27
9094
4819
15
2
99
94
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
1608
289
60
24
8
10
6
222
28
10
160
3800
50888
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:
Note 3:
The number of re-used animals in column 1.7 should be excluded from the total in the column 1.2
EN
239
EN
TABLE 2:
2.1
Species
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.
EN
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
2.2
Biological
studies of a
fundamenta
l nature
33487
5255
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)
4272
665
15
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
310
646
89
2.8
Education and
training
2.10
Total
196
492
8
900
70
129
9
15
12
20
69
2.9
Other
6
4
198
20
8
10
3800
42655
4955
240
310
735
933
39811
6571
152
29
0
99
6
20
222
28
10
160
160
1300
3800
50888
EN
TABLE 3:
3.1
Species
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.
EN
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
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
241
3.7
Products/
substances
used or
intended to be
used mainly
as additives in
food for
human
consumption
3.8
Products/
substances
used or
intended to be
used mainly
as additives in
food for
animal
consumption
3.9
Potential or
actual contaminants in the
general environment which
do not appear in
other columns
3.10
Other toxicological or
safety
evaluations
190
120
310
190
120
310
3.11
Total
EN
TABLE 4:
NUMBER OF ANIMALS USED IN EXPERIMENTS FOR STUDIES ON HUMAN AND ANIMAL DISEASES
Main categories versus species
4.1
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.
EN
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
4.2
Human cardiovascular
diseases
31
327
4.3
Human nervous and
mental disorders
1443
868
4.4
Human cancer (excluding
evaluations of carcinogenic
hazards or risks)
262
65
40
398
2311
327
242
4.5
Other human diseases
4.6
Studies specific to animal
diseases
10022
928
129
27
41
12326
2188
129
27
0
81
11149
568
4.7
Total
568
14753
EN
TABLE 5:
NUMBER OF ANIMALS USED IN PRODUCTION AND QUALITY CONTROL OF PRODUCTS AND DEVICES FOR
HUMAN MEDICINE AND DENTISTRY AND FOR VETERINARY MEDICINE
Regulatory requirements versus species
5.1
Species
5.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.
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
Examples:
Footnotes:
EN
5.2
National legislation
specific to a single EC
Member State
1)
243
EN
TABLE 6:
6.1
Species
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.
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
Examples:
Footnotes:
EN
6.2
National legislation
specific to a single EC
Member State
1)
6.3
EC legislation
including European
Pharmacopoeia
(requirements)
190
6.4
Member Country of Council
of Europe (but not EC)
legislation
2)
190
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
120
310
120
310
244
EN
TABLE 7:
7.1
Species
7.2
Acute and sub-acute toxicity testing methods
(including limit test)
7.2.1.
LD50,
LC50
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.
EN
7.2.2
Other lethal
methods
7.3
Skin
irritation
7.4
Skin
sensitisatio
n
7.5
Eye
irritation
7.6
Subchronic and
chronic
toxicity
7.7
Carcinogenicity
7.8
Developmental
toxicity
7.9
Mutagenicit
y
7.10
Reproductive
toxicity
7.11
Toxicity
to aquatic
vertebrates not
included
in other
columns
7.12
Other
7.13
Total
7.2.3
Non lethal
clinical signs
methods
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
245
120
190
310
120
190
310
EN
TABLE 8:
8.1
Products
8.2
Acute and sub-acute toxicity testing
methods (including limit test)
8.2.1.
LD50,
LC50
8.a.
8.b.
8.c.
8.d.
8.e.
8.f.
8.g.
8.h.
8.i.
8.j.
EN
8.2.2
Other lethal
methods
8.3
Skin
irritation
8.4
Skin
sensitisatio
n
8.5
Eye
irritation
8.6
Subchronic
and
chronic
toxicity
8.7
Carcino
genicity
8.8
Developmental
toxicity
8.9
Mutagenicit
y
8.10
Reproductive
toxicity
8.11
Toxicity
to aquatic
vertebrates not
included
in other
columns
8.12
Other
8.13
Total
8.2.3
Non lethal
clinical signs
methods
120
120
246
120
190
190
190
310
EN
ROMANIA
Statistical data submitted
International Relations and Community Programme Directorate, National Sanitary Veterinary
and Food Safety Authority
EN
247
EN
TABLE 1:
1.1
Species
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.
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
44585
5171
6607
263
44349
4834
6060
263
236
337
547
1483
2205
0
0
0
1755
450
444
14
2
14
2
131
3
0
0
0
0
131
3
9
1196
9
943
824
11
253
12
60186
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:
Note 3:
The number of re-used animals in column 1.7 should be excluded from the total in the column 1.2
EN
248
EN
TABLE 2:
2.1
Species
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.
EN
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
2.2
Biological
studies of a
fundamenta
l nature
1448
952
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)
2620
263
56
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
8243
8008
148
17559
3266
1447
140
150
1663
1189
2622
5378
540
671
65
1409
80
79
526
41
2.8
Education and
training
2.9
Other
2.10
Total
263
2
112
3
66
2663
3072
17
9
286
747
12398
8990
249
6668
23093
97
1958
1344
44585
5171
6607
263
0
2205
0
0
0
0
14
2
0
131
3
0
0
0
0
0
9
1196
0
0
0
60186
EN
TABLE 3:
3.1
Species
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.
EN
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
3.2
Products/
substances or
devices for
human
medicine and
dentistry and
for veterinary
medicine
4808
50
671
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
370
50
50
170
20
50
50
370
100
190
100
3.7
Products/
substances
used or
intended to be
used mainly
as additives in
food for
human
consumption
3.8
Products/
substances
used or
intended to be
used mainly
as additives in
food for
animal
consumption
3.9
Potential or
actual contaminants in the
general environment which
do not appear in
other columns
3.10
Other toxicological or
safety
evaluations
300
79
5608
250
300
3.11
Total
5378
540
671
0
0
79
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
6668
EN
TABLE 4:
NUMBER OF ANIMALS USED IN EXPERIMENTS FOR STUDIES ON HUMAN AND ANIMAL DISEASES
Main categories versus species
4.1
Species
4.a.
Mice
4.b.
Rats
4.c.
Guinea-Pigs
4.d.
Hamsters
4.e.
Other Rodents
4.f.
Rabbits
4.g.
Cats
4.h.
Dogs
4.i.
Ferrets
4.j.
Other Carnivores
4.k.
4.l.
Pigs
4.m.
Goats
4.n.
Sheep
4.o.
Cattle
4.p.
Prosimians
4.q.
4.r.
4.s.
Apes
4.t.
Other Mammals
4.u.
Quail
4.v.
Other birds
4.w.
Reptiles
4.x.
Amphibians
4.y.
Fish
4.z.
TOTAL
EN
4.2
Human cardiovascular
diseases
4.3
Human nervous and
mental disorders
4.4
Human cancer (excluding
evaluations of carcinogenic
hazards or risks)
259
56
236
430
300
250
103
40
4.5
Other human diseases
443
221
25
120
421
4.6
Studies specific to animal
diseases
4.7
Total
1620
4
706
550
251
809
1625
2858
957
29
263
0
4
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
4111
EN
TABLE 5:
NUMBER OF ANIMALS USED IN PRODUCTION AND QUALITY CONTROL OF PRODUCTS AND DEVICES FOR
HUMAN MEDICINE AND DENTISTRY AND FOR VETERINARY MEDICINE
Regulatory requirements versus species
5.1
Species
5.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.
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
Examples:
Footnotes:
EN
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
16251
2770
1489
12
2
114
3
747
21388
16251
0
2770
0
0
1489
0
0
0
0
12
2
0
114
3
0
0
0
0
0
0
747
0
0
0
21388
252
EN
TABLE 6:
6.1
Species
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.
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
Examples:
Footnotes:
EN
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
5378
540
671
79
6668
5378
540
671
0
0
79
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
6668
253
EN
TABLE 7:
7.1
Species
7.2
Acute and sub-acute toxicity testing methods
(including limit test)
7.2.1.
LD50,
LC50
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.
EN
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
40
370
7.2.2
Other lethal
methods
1842
20
7.2.3
Non lethal
clinical signs
methods
82
7.3
Skin
irritation
7.4
Skin
sensitisatio
n
7.5
Eye
irritation
7.6
Subchronic and
chronic
toxicity
30
30
30
1682
5
2
669
7.7
Carcinogenicity
7.8
Developmental
toxicity
7.9
Mutagenicit
y
7.10
Reproductive
toxicity
7.11
Toxicity
to aquatic
vertebrates not
included
in other
columns
7.12
Other
1642
145
79
410
1862
82
30
699
254
30
1689
1866
7.13
Total
5378
540
671
0
0
79
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
6668
EN
TABLE 8:
8.1
Products
8.2
Acute and sub-acute toxicity testing
methods (including limit test)
8.2.1.
LD50,
LC50
8.a.
8.b.
8.c.
8.d.
8.e.
8.f.
8.g.
8.h.
8.i.
8.j.
EN
320
8.2.2
Other lethal
methods
50
50
8.2.3
Non lethal
clinical signs
methods
70
8.3
Skin
irritation
8.4
Skin
sensitisatio
n
8.5
Eye
irritation
30
30
30
8.6
Subchronic
and
chronic
toxicity
8.7
Carcino
genicity
8.8
Developmental
toxicity
8.9
Mutagenicit
y
8.10
Reproductive
toxicity
8.11
Toxicity
to aquatic
vertebrates not
included
in other
columns
50
8.12
Other
5028
5608
370
370
50
100
190
40
8.13
Total
55
190
100
410
55
175
30
255
30
30
50
300
300
5888
6668
EN
SLOVENIA
Statistical data submitted
The statistical data have been submitted by the "Veterinary Administration of the
Republic of Slovenia" (VARS)
EN
256
EN
EN
257
EN
All laboratory rodents and rabbits used originate from the approved rearing
establishments, where one half of approved rearing establishments are situated
nationally and the other half in the other EU Member States. Most rodents were used
in pharmaceutical industry within the applied research projects for the manufacture
and quality control of products and devices intended for human medicine, dentistry
and veterinary medicine and, to a lesser extent, within their research and development
for the assessment of toxicity. Less rodents were used in biological studies of a
fundamental nature. Only a minor number of laboratory rodents and rabbits were used
for other purposes, such as educational purposes, other non-defined purposes of use,
and for diagnosing diseases. Rabbits were the more frequently used animals in
sequences of experiments within the scope of experiments required for the assessment
of quality of products intended for human medicine, dentistry and veterinary
medicine. As regards farmed animals, three pigs originating from an agricultural
holding were used in experiments, based on a preliminary consensus obtained from
the animal keeper/breeder, for the educational purposes and training of surgeons in
human medicine.
In the Republic of Slovenia, the mean of animals used in experiments in the recent 5
years amounts to around 12,700 animals. Most used are laboratory rodents with
around 95%. In the past 2 years, no cats or dogs were used in experiments. Nonhuman primates are not used in experiments in the Republic of Slovenia. On adoption
of relevant legislation and taking into account the 3R principles, and conducting
official controls, the use of animals in experiments has decreased. Following the
specific training of staff involved in experiments on animals, the responsibility of
researchers has increased, and their attitude towards animals used in experiments
improved, which is reflected in the accurate experiment protocols, careful selection of
methods and subsequent consistent implementation of experiments. The use of
validated alternative methods and/or cell cultures and tissues has played an important
part in decreasing the number of animals used in experiments particularly in
pharmaceutical industry.
EN
258
EN
TABLE 1:
1.1
Species
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.
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
4974
1142
7
5339
533
29
278
10313
1675
7
0
0
307
0
0
0
0
0
3
0
4
0
0
0
0
0
0
0
129
0
0
0
12438
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
278
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:
Note 3:
The number of re-used animals in column 1.7 should be excluded from the total in the column 1.2
EN
259
EN
TABLE 2:
2.1
Species
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.
EN
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
2.2
Biological
studies of a
fundamenta
l nature
763
542
7
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)
3009
173
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
5742
434
285
446
512
292
2.8
Education and
training
36
14
2.9
Other
2.10
Total
30
12
3
4
1319
126
3182
6468
411
260
961
65
30
10313
1675
7
0
0
307
0
0
0
0
0
3
0
4
0
0
0
0
0
0
0
129
0
0
0
12438
EN
TABLE 3:
3.1
Species
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.
EN
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
3.2
Products/
substances or
devices for
human
medicine and
dentistry and
for veterinary
medicine
3.3
Products/
substances
used or
intended to
be used
mainly in
agriculture
3.4
Products/
substances
used or
intended to
be used
mainly in
industry
3.5
Products/
substances
used or
intended to
be used
mainly in
the
household
3.6
Products/
substances
used or
intended to
be used
mainly as
cosmetics
or toiletries
3.7
Products/
substances
used or
intended to be
used mainly
as additives in
food for
human
consumption
3.8
Products/
substances
used or
intended to be
used mainly
as additives in
food for
animal
consumption
3.9
Potential or
actual contaminants in the
general environment which
do not appear in
other columns
50
512
3.10
Other toxicological or
safety
evaluations
396
565
261
396
3.11
Total
446
512
0
0
0
3
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
961
EN
TABLE 4:
NUMBER OF ANIMALS USED IN EXPERIMENTS FOR STUDIES ON HUMAN AND ANIMAL DISEASES
Main categories versus species
4.1
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.
EN
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
4.2
Human cardiovascular
diseases
4.3
Human nervous and
mental disorders
20
199
4.4
Human cancer (excluding
evaluations of carcinogenic
hazards or risks)
2764
3
219
2767
262
4.5
Other human diseases
4.6
Studies specific to animal
diseases
268
197
7
366
102
472
468
4.7
Total
3418
501
7
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
3926
EN
TABLE 5:
NUMBER OF ANIMALS USED IN PRODUCTION AND QUALITY CONTROL OF PRODUCTS AND DEVICES FOR
HUMAN MEDICINE AND DENTISTRY AND FOR VETERINARY MEDICINE
Regulatory requirements versus species
5.1
Species
5.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.
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
Examples:
Footnotes:
EN
5.2
National legislation
specific to a single EC
Member State
1)
5.3
EC legislation
including European
Pharmacopoeia
(requirements)
6027
434
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
292
126
6753
126
5.8
Total
6027
434
0
0
0
292
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
126
0
0
0
6879
263
EN
TABLE 6:
6.1
Species
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.
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
Examples:
Footnotes:
EN
6.2
National legislation
specific to a single EC
Member State
1)
314
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
50
6.8
Total
82
512
314
512
50
85
446
512
0
0
0
3
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
961
264
EN
TABLE 7:
7.1
Species
7.2
Acute and sub-acute toxicity testing methods
(including limit test)
7.2.1.
LD50,
LC50
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.
EN
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
7.2.2
Other lethal
methods
7.3
Skin
irritation
7.4
Skin
sensitisatio
n
7.5
Eye
irritation
7.6
Subchronic and
chronic
toxicity
7.7
Carcinogenicity
7.8
Developmental
toxicity
7.9
Mutagenicit
y
7.10
Reproductive
toxicity
7.11
Toxicity
to aquatic
vertebrates not
included
in other
columns
7.12
Other
7.2.3
Non lethal
clinical signs
methods
364
82
250
260
250
364
7.13
Total
265
260
82
446
512
0
0
0
3
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
961
EN
TABLE 8:
8.1
Products
8.2
Acute and sub-acute toxicity testing
methods (including limit test)
8.2.1.
LD50,
LC50
8.a.
8.b.
8.c.
8.d.
8.e.
8.f.
8.g.
8.h.
8.i.
8.j.
EN
250
8.2.2
Other lethal
methods
8.3
Skin
irritation
8.4
Skin
sensitisatio
n
8.5
Eye
irritation
8.6
Subchronic
and
chronic
toxicity
8.7
Carcino
genicity
8.8
Developmental
toxicity
8.9
Mutagenicit
y
8.10
Reproductive
toxicity
8.11
Toxicity
to aquatic
vertebrates not
included
in other
columns
8.12
Other
8.13
Total
8.2.3
Non lethal
clinical signs
methods
50
260
565
0
0
0
0
314
250
364
266
260
82
396
82
961
EN
SLOVAKIA
Statistical data submitted
The statistical data have been submitted by the State Veterinary and Food
Administration of the Slovak Republic.
EN
267
EN
Number
Experimental establishment
46
20
Breeding establishment
Supplying establishment
Total:
75
The SVFA SR approves the experiments performed upon animals based on the
application for approval of the experiment submitted by an applicant - approved
experimental establishment. Each application for approval of an experiment shall be
submitted by an applicant in compliance with Article 20 of the Ordinance of the
Government of the Slovak Republic No. 289/2003 Coll. in order to be judged by the
Ethic Commission. Each approved experimental establishment shall have founded its
own ethic commission comprised of minimum 5 members, out of which 1/3 must not
be dependent from the experimental establishment. Ethic commission, on the
submitted project of an experiment, shall assess observance of 3R, existence of
alternative method contrary to presented project, justification of each experiment, use
of the animals in the experiment and specification of species and number of animals
in the experiment. An applicant may submit his/her project of an experiment for
approval by the SVFA SR only after recommendation for submission, issued by the
ethic commission. The SVFA SR has in compliance with the Act No. 71/1967 Coll.
on Administrative Proceedings (Administrative Codex) minimum 30 days for
assessment of an application for approval of the experiment. The SVFA SR as a
competent authority shall issue a decision by which the performance of the
experiment and administrative proceeding may be approved, refused, suspended or
stopped. The SVFA SR in case of the need of professional consultation concerning
the aim of the experiment, the need of use of the animals in the experiment and the
number of used animals shall ask the members of the advisory body for their opinion
to the submitted application for approval of the experiment with observance of
rules of personal data protection and protection of trade secret data or intellectual
property.
Table No. 1: Most of experimental animals originate in domestic breeding
establishments or in experimental establishments with breeding of animals for use
within that establishment. As far as foreign suppliers are concerned, the animals
originate mainly from the EU Member States (Czech Republic, Hungary, Germany,
Poland and France) as well as from countries are signatories to ETS 123. The number
of 25 fish marked in column 1.6 as "animals coming from other origins" was entered
incorrectly these fish originate from the Slovak republic. We do apologise incorrect
information being provided.
EN
268
EN
Table No. 2: The SVFA SR approved 273 experiments with use of experimental
animals; stopped the proceeding in 4 applications; refused 5 applications for approval
of the experiment and suspended the proceeding in 36 applications in the year 2008.
The total number of 19,260 animals used does not reflect the number of approved
experiments in the year 2008, because within the total of the number of animals used
are included also the animals which were used in the year 2008 from the experiments
approved in the year 2005, 2006, 2007 and 2008. Number of animals used in
preparatory studies for performed projects is listed in the column 2.8. Animals were
used for introduction of new surgical methods practised during projects. Some
preparatory studies were approved as individual projects. Numbers of animals used
for training of persons involved in projects were approved as pre-experiment within
the project in some cases.
Table No. 3: Most animals indicated in the column 3.2 were used for evaluation of
products and substances for human medicine (testing of new drugs, medical supplies,
surgical supplies collagen surgical implants). In the column 3.3 the animals were
used for control of products/substances used in agriculture mainly pesticide,
herbicide, rodenticide products, growth stimulators for plants and biocide substances.
In the column 3.4 the animals used for control of various chemical products/
substances being a part of oils, lubricants and rubber industry materials are indicated.
The orders for re-test of the same substance produced in various batches were done in
several establishments. In some cases, whole series of standard toxicological safety
tests were carried out with the same substance, depending on EU legislation
(REACH).
Table No. 4: Explanation on column 4.5: Animals were used for the purpose of
investigation of immune systems, infectious diseases and metabolism disorders in
humans and in the column 4.6 in animals.
Table No. 5: In the Slovak Republic the experiments on animals are performed in
compliance with the valid Slovak legislation, in which the legal acts of the European
Communities and the European Union are incorporated. The experiments are
performed in compliance with the valid legislation of the European Pharmacopoeia in
the column 5.3 while in the column 5.7 the methods in control of human
products/substances were used that were created by the experimental establishment as
a modified method based on the approved pharmacopoeia methods or as a new
individual method.
Table No. 6: The Slovak Republic has elaborated the valid legislation for the control
of drugs Act No. 140/1998 Coll. Act On Medicinal Products and Medical Devices
as amended; for the control of chemical substances and preparations the Act No.
163/2001 Coll. on Chemical Substances and Preparations; Decree of the Ministry of
Economy No. 2/2005 Annex 5 Part B Methods B, that are conformable to OECD
methods. In the column 6.3 the number of animals used in compliance with the
European Pharmacopoeia are indicated, in the column 6.7 a total of 4 rabbits and 70
mice were used in product quality testing: testing of efficiency on and harm to
animals. These projects are usually carried out mainly according to European
Pharmacopoeia 4 and Slovak Pharmacopoeia but this single project was performed in
accordance with obligatory safety control test described in producers documentation.
EN
269
EN
Table No. 7: In the column 7.2.1. the animals were used only in the 'limit test'. Tests
were performed mainly by OECD methods TG 402 and 403 while in the column
7.2.2. the OECD tests TG 423, B.1 tris were performed. In the column 7.2.3 mainly
tests in compliance with OECD TG 407, 420 and tolerance studies were performed; in
the column 7.12 were animals used in studies for determination of minimal lethal and
maximal non-lethal dose of certain substance (food additive); determination of MDT
minimal comparative dose of certain substances; harvesting of hepatic S9 fraction for
testing of metabolic activation in vitro genotoxicity.
In compliance with Article 17 paragraph 4 of the Ordinance of the Government of the
Slovak Republic No. 289/2003 Coll. each approved establishment shall be obliged, in
order to maintain its authorisation, to submit yearly by the end of January for the
previous year to the SVFA SR a notification on the number of animals used according
to the specimen laid down in the Ordinance of the Government of the Slovak
Republic No. 289/2003 Coll. Approved establishments shall be obliged to keep
records about the number of GMO animals used in procedures. Based on collected
data the SVFA SR shall work out on an annual basis a notification concerning the
activity of the SVFA SR in which the numbers of approved establishments and
approved or refused experiments, as well as numbers and species of used animals in
the experiment for the respective year are published.
The purpose of inspections in approved establishments is to control the observance of
requirements indicated in the Act No. 39/2007 Coll., in the Ordinance of the
Government of the Slovak Republic No. 289/2003 Coll. and the compliance of the
performed project in approved establishment with the project authorisation issued by
SVFA SR. Finding of infringements laid down in the Act No. 39/2007 Coll. and in
the Ordinance of the Government of the Slovak Republic No. 289/2003 Coll. is
classified as an administrative delict for which a penalty may be imposed on a legal or
natural person in compliance with the Act No. 39/2007 Coll.
The SVFA SR performs theoretical and practical trainings of all employees of
veterinary administration in performance of control with regard to housing, care and
protection of experimental animals.
The competent authority performs consulting services for the public in the field of
animal welfare, organizes trainings for employees of approved establishments the
purpose of which is interpretation of the valid legislation of the Slovak Republic in
the field of animal welfare. The SVFA SR organizes also seminars and lectures aimed
at protection of experimental animals used for experimental purposes. The owner,
keeper and dealer of an animal in compliance with the Article 37 of the Act. No.
39/2007 Coll. shall be obliged to educate demonstrably the persons handling the
animals so that such persons must avoid any acts that might cause injury or any other
damage to the health of animals or unnecessary suffering thereof.
EN
270
EN
TABLE 1:
1.1
Species
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.
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
6942
9692
982
0
45
679
18
4
0
5229
6767
536
1713
2789
446
22
5
9
22
5
9
0
0
0
0
21
120
696
21
120
438
45
646
25
19260
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
136
33
18
4
258
25
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:
Note 3:
The number of re-used animals in column 1.7 should be excluded from the total in the column 1.2
EN
271
EN
TABLE 2:
2.1
Species
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.
EN
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
2.2
Biological
studies of a
fundamenta
l nature
1199
4284
176
45
478
18
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)
2007
2734
344
2.4
Production and
quality control of
products and
devices for
human medicine
and dentistry
60
66
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
280
610
1371
421
2716
16
24
60
2.8
Education and
training
80
25
2.9
Other
2.10
Total
50
1218
41
35
12
10
5
21
120
208
6570
5155
126
272
333
155
629
25
2610
2716
105
1349
6942
9692
982
0
45
679
18
4
0
0
0
22
5
9
0
0
0
0
0
21
120
696
0
0
25
19260
EN
TABLE 3:
3.1
Species
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.
EN
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
3.2
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
507
40
15
103
50
406
941
12
12
3.5
Products/
substances
used or
intended to
be used
mainly in
the
household
3.6
Products/
substances
used or
intended to
be used
mainly as
cosmetics
or toiletries
3.7
Products/
substances
used or
intended to be
used mainly
as additives in
food for
human
consumption
3.8
Products/
substances
used or
intended to be
used mainly
as additives in
food for
animal
consumption
3.9
Potential or
actual contaminants in the
general environment which
do not appear in
other columns
155
100
85
155
100
85
3.10
Other toxicological or
safety
evaluations
155
733
571
941
273
25
25
3.11
Total
610
1371
421
0
0
24
0
4
0
0
0
0
0
0
0
0
0
0
0
0
0
155
0
0
25
2610
EN
TABLE 4:
NUMBER OF ANIMALS USED IN EXPERIMENTS FOR STUDIES ON HUMAN AND ANIMAL DISEASES
Main categories versus species
4.1
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.
EN
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
4.2
Human cardiovascular
diseases
2426
4.3
Human nervous and
mental disorders
115
1822
4.4
Human cancer (excluding
evaluations of carcinogenic
hazards or risks)
1439
584
25
12
4.5
Other human diseases
4.6
Studies specific to animal
diseases
2411
2149
520
511
18
1957
37
20
15
22
9
2426
1974
2023
274
21
120
88
120
5847
2171
4.7
Total
5922
7018
520
0
45
538
18
0
0
0
0
22
0
9
0
0
0
0
0
21
120
208
0
0
0
14441
EN
TABLE 5:
NUMBER OF ANIMALS USED IN PRODUCTION AND QUALITY CONTROL OF PRODUCTS AND DEVICES FOR HUMAN
MEDICINE AND DENTISTRY AND FOR VETERINARY MEDICINE
Regulatory requirements versus species
5.1
Species
5.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.
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
Examples:
Footnotes:
EN
5.2
National legislation
specific to a single EC
Member State
1)
5.3
EC legislation
including European
Pharmacopoeia
(requirements)
200
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
80
60
10
72
258
60
328
260
15
167
280
60
0
0
0
82
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
333
0
0
0
755
275
EN
TABLE 6:
6.1
Species
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.
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
Examples:
Footnotes:
EN
6.2
National legislation
specific to a single EC
Member State
1)
412
12
6.3
EC legislation
including European
Pharmacopoeia
(requirements)
540
959
421
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
70
155
25
449
2087
74
610
1371
421
0
0
24
0
4
0
0
0
0
0
0
0
0
0
0
0
0
0
155
0
0
25
2610
276
EN
TABLE 7:
7.1
Species
7.2
Acute and sub-acute toxicity testing methods
(including limit test)
7.2.1.
LD50,
LC50
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.
EN
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
7.2.2
Other lethal
methods
21
144
7.3
Skin
irritation
7.2.3
Non lethal
clinical signs
methods
220
287
15
7.4
Skin
sensitisatio
n
7.5
Eye
irritation
7.6
Subchronic and
chronic
toxicity
7.7
Carcinogenicity
7.8
Developmental
toxicity
7.9
Mutagenicit
y
85
334
15
35
560
7.10
Reproductive
toxicity
7.11
Toxicity
to aquatic
vertebrates not
included
in other
columns
7.12
Other
280
406
14
4
90
21
25
169
616
65
441
277
79
560
85
349
284
7.13
Total
610
1371
421
0
0
24
0
4
0
0
0
0
0
0
0
0
0
0
0
0
0
155
0
0
25
2610
EN
TABLE 8:
8.1
Products
8.2
Acute and sub-acute toxicity testing
methods (including limit test)
8.2.1.
LD50,
LC50
8.a.
8.b.
8.c.
8.d.
8.e.
8.f.
8.g.
8.h.
8.i.
8.j.
EN
8.2.2
Other lethal
methods
21
8.3
Skin
irritation
8.4
Skin
sensitisatio
n
8.2.3
Non lethal
clinical signs
methods
329
8.5
Eye
irritation
73
50
8.6
Subchronic
and
chronic
toxicity
8.7
Carcino
genicity
8.8
Developmental
toxicity
40
441
54
157
40
30
8.9
Mutagenicit
y
8.10
Reproductive
toxicity
8.11
Toxicity
to aquatic
vertebrates not
included
in other
columns
8.13
Total
266
733
68
12
571
268
941
450
70
8.12
Other
15
155
100
100
85
85
25
21
169
25
616
278
441
79
560
85
349
284
2610
EN
FINLAND
Statistical data submitted
The data were submitted by the Ministry of Agriculture and Forestry
EN
279
EN
TABLE 1:
1.1
Species
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.
1.2
Total
78446
26058
215
302
3142
814
1.3
Animals coming from registered
breeding or supplying
establishments within the reporting
country
1.4
Animals coming from
elsewhere in the EC
56285
7989
4
18160
16756
211
302
250
564
54
1.5
Animals coming from
Member Countries of the
Council of Europe which are
parties to the Convention ETS
123 (excluding EC Member
States)
2464
25
1.6
Animals coming from
other origins
1.7
Re-used animals
1537
1288
32
54
761
37
819
37
571
300
84
5568
317
34
21078
138600
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:
Note 3:
The number of re-used animals in column 1.7 should be excluded from the total in the column 1.2
EN
280
EN
TABLE 2:
2.1
Species
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.
EN
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
2.2
Biological
studies of a
fundamenta
l nature
66628
12548
16
24
3072
518
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)
11186
12317
195
278
70
248
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
30
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
20
608
89
34
426
382
67
169
4
12
10
10
16
2.8
Education and
training
43
761
33
149
318
18
19
29
10
520
2.10
Total
267
2.9
Other
1
39
46
203
4
68
54
470
27
185
1327
536
1383
84
4779
317
7
17344
106435
265
24490
868
2215
2483
281
798
1481
133
78446
26058
215
302
3142
814
0
54
0
761
37
819
0
571
300
0
0
0
0
84
0
5568
317
34
21078
138600
EN
TABLE 3:
3.1
Species
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.
EN
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
3.2
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
20
608
12
43
683
282
798
798
3.11
Total
20
608
0
0
0
12
0
43
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
798
1481
EN
TABLE 4:
NUMBER OF ANIMALS USED IN EXPERIMENTS FOR STUDIES ON HUMAN AND ANIMAL DISEASES
Main categories versus species
4.1
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.
EN
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
4.2
Human cardiovascular
diseases
2935
3842
184
227
4.3
Human nervous and
mental disorders
12967
6958
9
51
70
4.4
Human cancer (excluding
evaluations of carcinogenic
hazards or risks)
5328
1009
24
41
463
4.5
Other human diseases
4.6
Studies specific to animal
diseases
8799
4938
4.7
Total
201
8
305
52
18
11
647
7974
20055
6402
283
14001
2715
3371
30029
16748
193
278
94
705
0
8
0
0
0
357
0
29
0
0
0
0
0
0
0
647
0
0
2715
51803
EN
TABLE 5:
NUMBER OF ANIMALS USED IN PRODUCTION AND QUALITY CONTROL OF PRODUCTS AND DEVICES FOR
HUMAN MEDICINE AND DENTISTRY AND FOR VETERINARY MEDICINE
Regulatory requirements versus species
5.1
Species
5.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.
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
Examples:
Footnotes:
EN
5.2
National legislation
specific to a single EC
Member State
1)
30
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
3
318
520
265
868
265
2215
2218
30
0
0
0
0
0
0
0
0
0
3
318
0
520
0
0
0
0
0
0
0
265
0
0
2215
3351
284
EN
TABLE 6:
6.1
Species
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.
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
Examples:
Footnotes:
EN
6.2
National legislation
specific to a single EC
Member State
1)
20
608
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
12
43
683
798
798
6.8
Total
20
608
0
0
0
12
0
43
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
798
1481
285
EN
TABLE 7:
7.1
Species
7.2
Acute and sub-acute toxicity testing methods
(including limit test)
7.2.1.
LD50,
LC50
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.
EN
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
7.2.2
Other lethal
methods
7.3
Skin
irritation
7.4
Skin
sensitisatio
n
7.5
Eye
irritation
7.6
Subchronic and
chronic
toxicity
7.7
Carcinogenicity
7.8
Developmental
toxicity
7.9
Mutagenicit
y
7.10
Reproductive
toxicity
7.11
Toxicity
to aquatic
vertebrates not
included
in other
columns
7.12
Other
7.2.3
Non lethal
clinical signs
methods
20
304
19
285
12
43
19
7.13
Total
286
367
798
798
297
20
608
0
0
0
12
0
43
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
798
1481
EN
TABLE 8:
8.1
Products
8.2
Acute and sub-acute toxicity testing
methods (including limit test)
8.2.1.
LD50,
LC50
8.a.
8.b.
8.c.
8.d.
8.e.
8.f.
8.g.
8.h.
8.i.
8.j.
EN
8.2.2
Other lethal
methods
8.3
Skin
irritation
8.4
Skin
sensitisatio
n
8.5
Eye
irritation
8.6
Subchronic
and
chronic
toxicity
8.7
Carcino
genicity
8.8
Developmental
toxicity
8.9
Mutagenicit
y
8.10
Reproductive
toxicity
8.11
Toxicity
to
aquatic
vertebrates not
included
in other
columns
8.12
Other
8.13
Total
8.2.3
Non lethal
clinical signs
methods
19
367
297
683
0
0
0
0
798
798
0
19
287
367
798
297
1481
EN
SWEDEN
Statistical data submitted
The statistical data have been submitted by the National Board for Laboratory
Animals.
number of aimals
5 0 0 .0 0 0
4 0 0 .0 0 0
3 0 0 .0 0 0
2 0 0 .0 0 0
1 0 0 .0 0 0
0
1992
EN
1993
1994
1995
1996
1997
1998
1999
2000
2001
288
2002
2003
2004
2005
2006
2007
2008
2009
EN
EN
289
EN
TABLE 1:
1.1
Species
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.
1.2
Total
203112
53141
1766
864
2033
1332
149
1982
39
53
423
1973
5
152
1379
0
0
35
0
263
201
3432
170
641
211459
484604
1.3
Animals coming from registered
breeding or supplying
establishments within the reporting
country
1.4
Animals coming from
elsewhere in the EC
197709
25727
1766
2763
27348
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
2640
66
864
1332
450
39
13
21
36
7
47
121
1449
222
0
35
11
201
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:
Note 3:
The number of re-used animals in column 1.7 should be excluded from the total in the column 1.2
EN
290
EN
TABLE 2:
2.1
Species
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.
EN
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
2.2
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
2.6
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
127301
22531
276
6
2033
309
32
548
39
0
253
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)
64066
24299
1455
661
0
401
0
175
0
0
0
140
0
12
0
0
11
0
0
0
0
0
516
10
14
0
0
1
0
0
0
0
8
2305
5225
0
135
0
371
0
546
0
0
0
1685
70
0
0
0
0
105
701
0
0
0
689
486
5
62
0
16
0
12
0
0
162
6410
520
4
0
0
223
12
0
0
53
0
203112
53141
1766
864
2033
1332
149
1982
39
53
423
951
0
19
135
265
0
40
856
0
0
0
0
0
0
12
3
0
0
0
0
0
0
0
0
757
0
53
276
0
5
28
109
35
208
151
401
170
641
6852
162856
0
0
45
0
0
1671
93969
0
0
60
0
0
0
223
0
0
43
0
0
0
607
0
0
0
0
0
1370
9952
0
0
146
0
0
0
2707
0
0
0
0
0
42
2560
55
50
2737
0
0
201524
211730
1973
5
152
1379
0
0
35
0
263
201
3432
170
641
211459
484604
291
2.8
Education and
training
2.9
Other
2.10
Total
EN
TABLE 3:
3.1
Species
3.a.
Mice
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.
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
EN
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
636
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
1620
3.9
Potential or
actual contaminants in the
general environment which
do not appear in
other columns
3.10
Other toxicological or
safety
evaluations
49
2305
1060
1109
5225
0
135
0
371
0
546
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
1370
9952
5225
135
371
546
6913
250
250
1620
292
3.11
Total
60
60
EN
TABLE 4:
NUMBER OF ANIMALS USED IN EXPERIMENTS FOR STUDIES ON HUMAN AND ANIMAL DISEASES
Main categories versus species
4.1
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.
EN
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
4.2
Human cardiovascular
diseases
4.3
Human nervous and
mental disorders
30075
4439
88
636
57
201
0
90
0
33514
20559
1070
0
0
99
16
12
39
4.4
Human cancer (excluding
evaluations of carcinogenic
hazards or risks)
29932
1365
0
0
0
9
0
0
0
0
467
0
65
40
1
4.5
Other human diseases
4.6
Studies specific to animal
diseases
4.7
Total
89604
17804
583
31
10
412
0
73
0
1627
28
16
0
1966
1
107
1221
0
0
0
0
430
69
145
0
0
0
0
17
0
14
859
23
0
0
2
0
0
0
0
0
45
0
0
218
208
151
203
15
0
36111
36
0
55416
0
0
31357
590
0
109795
0
1676
8291
293
184752
44195
1757
667
2033
722
123
1396
39
0
69
1107
0
71
860
0
0
35
0
208
151
468
0
641
1676
240970
EN
TABLE 5:
NUMBER OF ANIMALS USED IN PRODUCTION AND QUALITY CONTROL OF PRODUCTS AND DEVICES FOR
HUMAN MEDICINE AND DENTISTRY AND FOR VETERINARY MEDICINE
Regulatory requirements versus species
5.1
Species
5.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.
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
Examples:
Footnotes:
EN
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
140
5.8
Total
516
10
26
12
12
3
103
140
690
656
10
26
0
0
12
0
0
0
0
8
0
0
12
3
0
0
0
0
0
0
103
0
0
0
830
294
EN
TABLE 6:
6.1
Species
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.
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
Examples:
Footnotes:
EN
6.2
National legislation
specific to a single EC
Member State
1)
1620
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
636
5225
6.8
Total
49
135
371
546
870
2490
6407
500
1055
2305
5225
0
135
0
371
0
546
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
1370
9952
295
EN
TABLE 7:
7.1
Species
7.2
Acute and sub-acute toxicity testing methods
(including limit test)
7.2.1.
LD50,
LC50
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.
EN
7.2.2
Other lethal
methods
7.3
Skin
irritation
7.4
Skin
sensitisatio
n
7.5
Eye
irritation
7.6
Subchronic and
chronic
toxicity
7.7
Carcinogenicity
7.8
Developmental
toxicity
7.9
Mutagenicit
y
132
170
655
7.11
Toxicity
to aquatic
vertebrates not
included
in other
columns
7.12
Other
2399
515
1833
206
135
34
337
486
1620
7.13
Total
7.2.3
Non lethal
clinical signs
methods
1620
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
7.10
Reproductive
toxicity
3054
60
296
469
825
1180
1386
190
190
2408
2305
5225
0
135
0
371
0
546
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
1370
9952
EN
TABLE 8:
8.1
Products
8.2
Acute and sub-acute toxicity testing
methods (including limit test)
8.2.1.
LD50,
LC50
8.a.
8.b.
8.c.
8.d.
8.e.
8.f.
8.g.
8.h.
8.i.
8.j.
EN
8.2.2
Other lethal
methods
8.3
Skin
irritation
8.4
Skin
sensitisatio
n
8.5
Eye
irritation
8.6
Subchronic
and
chronic
toxicity
8.7
Carcino
genicity
8.2.3
Non lethal
clinical signs
methods
3054
8.8
Developmental
toxicity
8.9
Mutagenicit
y
8.10
Reproductive
toxicity
469
825
206
8.11
Toxicity
to aquatic
vertebrates not
included
in other
columns
8.12
Other
2359
250
8.13
Total
6913
250
0
1620
1620
0
870
190
49
1109
60
0
1620
3054
297
469
825
1386
60
190
2408
9952
EN
UNITED KINGDOM
Statistical data submitted
The United Kingdom statistical data for 2008 were prepared, quality assured and
submitted by the "Home Office".
Within the United Kingdom (UK), Great Britain (GB) and Northern Ireland (NI)
publish separate, annual statistical reports based largely on the number of procedures
started rather than numbers of animals used.
In accord with our established practice the UK figures presented here have been
recompiled from the original data in terms of animal numbers for the classes of
animal use recorded in the EU statistical tables. It should be noted that the UK also
regulates, and the UK domestic statistical reports enumerate, animals bred for the
maintenance of colonies of genetically modified or harmful mutant animals, and that
category of animal use largely accounts for the differences in the figures in the
original GB & NI publications and those in this EU report.
EN
298
EN
up 65,117 compared with 2005 (29,068) in 2005, largely due to an increases in such
use of fish (+80,098).
176,362 animals (8%) were used for the production and quality control of products
and devices for human medicine, dentistry or veterinary medicine almost 66,000
more than in 2005. This increase was accounted for almost entirely by an increase in
the number of mice (+48,000) and fish (+17,000).
Approximately 40% of animals used received some form of anaesthesia, hardly
changed from 2005. For the other animals the use of anaesthesia would have been
deemed to increase the severity of the procedure.
As in 2005 no animals were used in 2008 to evaluate the safety of either cosmetic
products or cosmetic ingredients.
No animals were used in 2008 for monoclonal antibody production using the ascites
method.
EN
299
EN
TABLE 1:
1.1
Species
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.
1.2
Total
1212243
343289
29250
2851
1.958
12009
184
4277
978
948
290
7.255
487
9.818
4.194
0
262
3092
0
952
0
125.077
109
23.316
484.045
2266884
1.3
Animals coming from
registered breeding or supplying
establishments within the
reporting country
1.4
Animals coming from
elsewhere in the EC
1.206.713
341.897
28.762
1.247
1.6
Animals coming from
other origins
1.809
785
488
1.604
1.5
Animals coming from
Member Countries of the
Council of Europe which are
parties to the Convention ETS
123 (excluding EC Member
States)
173
105
0
0
9.297
79
3.458
973
2.140
52
58
0
0
0
0
0
572
53
761
5
3.066
147
896
44
0
262
1.814
0
0
0
96
0
0
0
0
0
0
0
1.182
0
0
82
497
0
1.7
Re-used animals
3.548
502
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:
Note 3:
The number of re-used animals in column 1.7 should be excluded from the total in the column 1.2
EN
300
EN
TABLE 2:
2.1
Species
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.
EN
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
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
2.6
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
374.109
92.466
1.753
828
931
996
61
4
319
507
54
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)
88.038
115.862
17.474
31
512
611
41
381
6
0
44
115.790
7.135
4.784
0
30
427
0
139
556
0
0
13.721
0
492
576
0
230
0
0
6
27
21
56.951
100.777
1.911
873
191
7.431
53
3.662
0
296
22
13.683
419
168
0
0
1.018
0
11
41
0
19
829
1.386
115
0
0
12
0
0
12
0
0
549.122
25.244
2.553
543
294
1.284
29
80
38
118
130
1212243
343289
29250
2851
1958
12009
184
4277
978
948
290
1.652
65
5.120
2.808
0
82
122
0
825
0
22.221
30
8.993
230.664
403
0
52
152
0
4
181
0
0
0
201
0
0
54.477
24
1
491
0
0
33
12
0
0
0
16
0
0
20.418
948
4
253
804
0
0
0
0
0
0
6.472
0
0
2.952
728
10
100
195
0
123
2.733
0
0
0
1.783
0
0
107.049
0
12
985
4
0
0
0
0
0
0
2.168
0
0
0
0
0
0
0
0
0
0
0
0
0
154
0
0
117
3.500
395
2.817
231
0
20
44
0
127
0
92.062
79
14.323
68.368
7255
487
9818
4194
0
262
3092
0
952
0
125077
109
23316
484045
301
2.8
Education and
training
2.9
Other
2.10
Total
EN
2.z.
EN
TOTAL
744610
278470
149856
26506
302
284888
18528
2625
761401
2266884
EN
TABLE 3:
3.1
Species
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.
EN
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
3.2
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
38.288
73.139
1.822
873
0
5.658
53
3.323
0
296
22
600
0
99
195
0
53
2.358
0
0
0
706
0
0
62.571
190056
1.803
11.131
0
0
164
330
0
116
0
0
0
62
10
0
0
0
0
0
0
0
0
1.041
0
0
2.464
17121
5.351
10.533
0
0
0
1.241
0
8
0
0
0
0
0
0
0
0
0
0
0
0
0
30
0
0
6.349
23512
132
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
132
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
303
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
3.9
Potential or
actual contaminants in the
general environment which
do not appear in
other columns
3.10
Other toxicological or
safety
evaluations
78
5
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
10.146
10229
11.299
5.969
89
0
27
202
0
215
0
0
0
66
0
1
0
0
70
375
0
0
0
6
0
0
25.519
43838
3.11
Total
56951
100777
1911
873
191
7431
53
3662
0
296
22
728
10
100
195
0
123
2733
0
0
0
1783
0
0
107049
284888
EN
TABLE 4:
NUMBER OF ANIMALS USED IN EXPERIMENTS FOR STUDIES ON HUMAN AND ANIMAL DISEASES
Main categories versus species
4.1
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.
EN
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
4.2
Human cardiovascular
diseases
25.167
16.152
675
67
162
656
10
254
20
45
3
161
0
77
226
0
2
75
0
10
0
4.573
0
96
119
48550
4.3
Human nervous and
mental disorders
85.363
95.146
707
762
766
216
43
0
125
0
0
143
0
455
15
0
46
158
0
5
0
2.595
30
33
47.743
234351
4.4
Human cancer (excluding
evaluations of carcinogenic
hazards or risks)
101.726
2.713
0
0
155
0
0
2
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
351
3
104950
304
4.5
Other human diseases
500.412
189.881
26.420
1.438
625
8.292
8
3.613
815
462
74
2.523
78
6.608
2.571
0
214
2.519
0
810
0
17.237
0
8.513
351.819
1124932
4.6
Studies specific to animal
diseases
17.182
75
1.333
584
27
1.201
123
91
6
326
213
4.289
399
2.342
1.379
0
0
0
0
0
0
98.894
0
0
8.674
137138
4.7
Total
729850
303967
29135
2851
1735
10365
184
3960
966
833
290
7116
477
9482
4191
0
262
2752
0
825
0
123299
30
8993
408358
1649921
EN
TABLE 5:
NUMBER OF ANIMALS USED IN PRODUCTION AND QUALITY CONTROL OF PRODUCTS AND DEVICES FOR
HUMAN MEDICINE AND DENTISTRY AND FOR VETERINARY MEDICINE
Regulatory requirements versus species
5.1
Species
5.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.
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
Examples:
EN
5.2
National legislation
specific to a single EC
Member State
1)
218
0
321
0
0
9
0
0
0
27
0
0
0
14
0
0
0
0
0
0
0
0
0
0
0
589
5.3
EC legislation
including European
Pharmacopoeia
(requirements)
6161
1440
1432
576
0
132
0
0
0
0
0
337
0
121
726
0
0
0
0
0
0
206
0
0
1390
12521
5.4
Member Country of Council
of Europe (but not EC)
legislation
2)
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
Note:
Example:
305
5.5
Other legislation
158
0
156
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
314
5.6
Any combination of
5.2/ 5.3/ 5.4/ 5.5
116191
5288
3347
0
30
516
0
137
514
0
21
635
5
608
55
0
33
12
0
0
0
6282
0
0
58
133732
5.7
No regulatory
requirements
6783
407
20
0
0
0
0
2
48
0
0
0
0
1
23
0
0
0
0
0
0
0
0
0
21922
29206
5.8
Total
129511
7135
5276
576
30
657
0
139
562
27
21
972
5
744
804
0
33
12
0
0
0
6488
0
0
23370
176362
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.
EN
Footnotes:
1)
2)
EN
EC Member States: Austria, Belgium, Bulgaria, Cyprus, Czech Rep, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Ireland, Italy, Latvia, Lithuania,
Luxembourg, Malta, Netherlands, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, United Kingdom
Member Countries of Council of Europe (non-EC): Albania, Andorra, Armenia, Azerbaijan, Bosnia and Herzegovina, Croatia, Georgia, Iceland, Liechtenstein, Moldova,
Monaco, Norway, Russia, San Marino, Serbia and Montenegro, Switzerland, the former Yugoslav Rep. of Macedonia, Turkey, Ukraine
306
EN
TABLE 6:
6.1
Species
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.
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
Examples:
Footnotes:
EN
6.2
National legislation
specific to a single EC
Member State
1)
37
97
0
0
0
18
0
0
0
296
0
0
0
2
10
0
0
0
0
0
0
0
0
0
1311
1771
6.3
EC legislation
including European
Pharmacopoeia
(requirements)
9718
2510
272
0
0
1955
12
0
0
0
0
123
0
24
70
0
0
0
0
0
0
272
0
0
9074
24030
6.4
Member Country of Council
of Europe (but not EC)
legislation
2)
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
6.5
Other legislation
1714
617
30
0
0
121
0
40
0
0
0
32
0
0
0
0
0
0
0
0
0
0
0
0
1451
4005
6.6
Any combination of
6.2/ 6.3/ 6.4/ 6.5
42538
92799
1504
873
191
5191
41
3506
0
0
1
509
10
73
115
0
99
2643
0
0
0
1505
0
0
9299
160897
6.7
No regulatory
requirements
2944
4754
105
0
0
146
0
116
0
0
21
64
0
1
0
0
24
90
0
0
0
6
0
0
85914
94185
6.8
Total
56951
100777
1911
873
191
7431
53
3662
0
296
22
728
10
100
195
0
123
2733
0
0
0
1783
0
0
107049
284888
307
EN
2)
EN
Member Countries of Council of Europe (non-EC): Albania, Andorra, Armenia, Azerbaijan, Bosnia and Herzegovina, Croatia, Georgia, Iceland, Liechtenstein, Moldova, Monaco,
Norway, Russia, San Marino, Serbia and Montenegro, Switzerland, the former Yugoslav Rep. of Macedonia, Turkey, Ukraine
308
EN
TABLE 7:
7.1
Species
7.2
Acute and sub-acute toxicity testing methods
(including limit test)
7.2.1.
LD50,
LC50
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.
EN
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
7.2.2
Other lethal
methods
917
1.674
0
0
27
0
0
0
0
0
0
8.832
2.042
0
0
0
0
0
0
0
0
0
7.2.3
Non lethal
clinical signs
methods
5.962
30.143
2
208
0
490
0
2.020
0
0
0
0
0
0
0
0
0
0
0
0
0
180
0
0
5.903
8701
0
0
0
0
0
0
0
0
0
0
135
0
0
61.278
72287
293
0
36
44
0
29
1.414
0
0
0
651
0
0
3.398
44690
7.3
Skin
irritation
7.4
Skin
sensitisatio
n
7.5
Eye
irritation
7.6
Subchronic and
chronic
toxicity
7.7
Carcinogenicity
7.8
Developmental
toxicity
7.9
Mutagenicit
y
12
0
0
0
0
740
0
0
0
0
0
1.074
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
479
0
0
0
0
0
3.344
7.834
0
80
0
0
0
1.167
0
0
0
5.659
3.478
0
0
0
0
0
0
0
0
0
544
3.943
0
0
0
3.635
0
0
0
0
0
2.923
5.353
0
0
0
0
0
0
0
0
0
0
29.488
0
0
0
86
0
2
0
0
0
0
0
0
0
0
0
0
0
0
0
0
27.684
16.822
1.909
585
164
2.001
53
473
0
296
22
56951
100777
1911
873
191
7431
53
3662
0
296
22
0
0
0
0
0
0
0
0
0
0
0
0
0
0
752
0
0
0
0
0
0
0
0
0
0
0
0
0
0
1074
0
0
0
0
0
0
0
0
0
0
0
0
0
0
479
68
0
34
0
0
24
720
0
0
0
0
0
0
7.530
20801
0
0
0
0
0
0
0
0
0
0
0
0
0
0
9137
0
0
0
0
0
0
0
0
0
0
0
0
0
364
8486
0
0
0
0
0
0
0
0
0
0
0
0
0
0
8276
0
0
0
0
0
0
0
0
0
0
108
0
0
1.589
31273
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
367
10
30
151
0
70
599
0
0
0
709
0
0
26.987
78932
728
10
100
195
0
123
2733
0
0
0
1783
0
0
107049
284888
309
7.10
Reproductive
toxicity
7.11
Toxicity
to aquatic
vertebrates not
included
in other
columns
7.12
Other
7.13
Total
EN
TABLE 8:
8.1
Products
8.2
Acute and sub-acute toxicity testing
methods (including limit test)
8.2.1.
LD50,
LC50
8.a.
8.b.
8.c.
8.d.
8.e.
8.f.
8.g.
8.h.
8.i.
8.j.
EN
8.2.2
Other lethal
methods
8.3
Skin
irritation
8.4
Skin
sensitisatio
n
8.5
Eye
irritation
51
556
12862
8.6
Subchronic
and
chronic
toxicity
8.7
Carcino
genicity
8.8
Developmental
toxicity
8.9
Mutagenicit
y
8.10
Reproductive
toxicity
8.11
Toxicity
to aquatic
vertebrates not
included
in other
columns
8229
7550
4867
19293
8.12
Other
8.13
Total
39514
190056
72
59231
8.2.3
Non lethal
clinical signs
methods
37822
846
1067
1440
57
16
56
2531
908
332
701
6446
2721
17121
1331
1806
4127
641
314
411
5232
604
1403
3794
3849
23512
18
114
132
4184
2633
942
1589
881
10229
2268
7550
341
188
176
1191
151
31967
43838
8701
72287
44690
752
1074
479
20801
9137
8486
8276
31273
78932
284888
310
EN
EN
311
EN