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# 52003DC0019

**Report from the Commission to the Council and the European Parliament - Third Report from the Commission to the Council and the European Parliament on the Statistics on the number of animals used for experimental and other scientific purposes in the member states of the European Union /\* COM/2003/0019 final \*/**

  

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

Table of contents

I. INTRODUCTION

II. STATISTICS

II.1. General

II.2. Data submitted by the Member States

II. 3. Structure of the Report

PART A: COMPILATION AND OVERVIEW OF THE DATA OF 1999

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

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

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

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

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

III.6. Results of EU Table 5: Animals used in production and quality control of products for human medicine and dentistry and for veterinary medicine

III.7. Results of EU harmonized Table 6: Origin of regulatory requirements for animals used in toxicological and other safety evaluations

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

III.9. Results of EU Table 8: Type of toxicity tests carried out for toxicological or other safety evaluations of products

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

BELGIUM

DENMARK

GERMANY

GREECE

SPAIN

FRANCE

IRELAND

ITALY

LUXEMBOURG

THE NETHERLANDS

AUSTRIA

PORTUGAL

FINLAND

SWEDEN

UNITED KINGDOM

I. INTRODUCTION

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

[1] OJ L 358, 18.12.1986, p.1.

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

The second Report, COM (1999) 191 final, was published 1999 and covered data from the Member States from 1996 [2].

[2] including 1997 data from France

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

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

II. STATISTICS

II.1. General

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

Council Resolution 86/C331/02 [3] allows the use of animals in experiments for education and training, but where the purposes of such experiments are not covered by the Directive i.e. they are not experimental or scientific in the sense of the Directive, Member States will according to the Resolution apply national provisions which are no less severe than those of the Directive. Therefore a number of Member States have also included animals covered by this Resolution in the report.

[3] OJ C 331, 23.12.86, p. 2

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

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

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

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

The estimated total number of animals used for experimental and other scientific purposes in 1999 is 9,8 millions. The total number of animals reported in 1996 [4] was 11,6 millions. Even though it is not possible make statistically correct estimate of the reduction of the number of animals used since the report of 1996, it can nevertheless be seen that in 1999 the total number has passed below the 10 millions mark, which indicates a significant reduction trend.

[4] including 1997 data from France

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

II.2. Data submitted by the Member States

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

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

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

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

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

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

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

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

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

II. 3. Structure of the Report

The report is divided into two parts:

A A global compilation and overview for the European Union of the statistical data submitted by the Member States for 1999. A consolidated Table has been computed on the basis of the data submitted by the Member States for each EU Table and is appearing in the beginning of each sub-chapter.

B The data submitted by the Member States with a summary of the comments provided by the Member States. The reader is invited to take note that the numbering of tables and figures of Part A of the report is linked to the numbers of the EU Tables and not to the numbering of the chapters of the report.

PART A: COMPILATION AND OVERVIEW OF THE DATA OF 1999

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

III.1.1. The data

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

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

- Golden hamsters + other rodents

- New world +old world monkeys

- Goats and sheep

- Quails + other birds

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

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

III.1.2. Treatment and interpretation of the data

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

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

Table 1.2 represents classes of animals used for experimental purposes.

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

&gt;REFERENCE TO A GRAPHIC&gt;

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

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

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

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

Table 1.3: Comparison between results of 1996 and 1999

&gt;TABLE POSITION&gt;

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

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

Data of 1999

&gt;TABLE POSITION&gt;

\* The highest number of animals between column 1.2 and 2.10

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

Data of 1999

&gt;TABLE POSITION&gt;

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

(1) = Reptiles +amphibians + fish

(2) = Quails and other birds

(3) = Horses, donkeys and cross bred + pigs +goats and sheep + cattle

(4) = cats + dogs + ferrets + other carnivores

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

III.2.1. The data

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

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

III.2.2. Treatment and interpretation of the data

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

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

&gt;REFERENCE TO A GRAPHIC&gt;

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

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

Data of 1999

&gt;TABLE POSITION&gt;

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 this column

(Note 2: // Only species for which origin has to be reported are included in this table)

Note 3: // The number of re-used animals in column 1.7 should be excluded from the total in the column 1.2.

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

III.3.1. The data

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

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

III.3.2. Treatment and interpretation of the data

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

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

&gt;TABLE POSITION&gt;

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

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

&gt;TABLE POSITION&gt;

&gt;REFERENCE TO A GRAPHIC&gt;

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

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

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

Table 2.3: Comparison between results of 1996 and 1999

&gt;TABLE POSITION&gt;

\* 13 Member States reported purposes of experiments

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

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

&gt;REFERENCE TO A GRAPHIC&gt;

III.3.3. Diagnosis of disease

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

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

Rodents +rabbits // 110781

Carnivores // 221

Horses, donkeys and cross bred (Equidae) // 96

Pigs (Sus) // 1500

Goats (Capra) // 214

Sheep (Ovis) // 1503

Cattle (Bos) // 260

Prosimians +primates // 22

Birds (Aves) // 4107

Cold blooded animals // 21317

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

&gt;REFERENCE TO A GRAPHIC&gt;

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

III.4.1. The data

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

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

III.4.2. Treatment and interpretation of the data

&gt;REFERENCE TO A GRAPHIC&gt;

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

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

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

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

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

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

Table 3.1: Number of animals used in toxicological and other safety evaluation Products versus species

&gt;TABLE POSITION&gt;

III.4.3 Species versus type of products

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

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

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

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

&gt;TABLE POSITION&gt;

&gt;REFERENCE TO A GRAPHIC&gt;

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

III.5.1. The data

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

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

III.5.2. Treatment and interpretation of the data

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

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

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

&gt;REFERENCE TO A GRAPHIC&gt;

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

Main category versus species

&gt;TABLE POSITION&gt;

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

&gt;TABLE POSITION&gt;

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

&gt;REFERENCE TO A GRAPHIC&gt;

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

III.6. Results of EU Table 5: Animals used in production and quality control of products for human medicine and dentistry and for veterinary medicine

III.6.1. The data

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

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

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

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

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

&gt;TABLE POSITION&gt;

III.7. Results of EU harmonized Table 6: Origin of regulatory requirements for animals used in toxicological and other safety evaluations

III.7.1. The data

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

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

III.7.2. Treatment and interpretation of the data

Figure 6.1

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

&gt;REFERENCE TO A GRAPHIC&gt;

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

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

Regulatory requirements versus species

&gt;TABLE POSITION&gt;

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

III.8.1. The data

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

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

III.8.2. Treatment and interpretation of the data

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

&gt;REFERENCE TO A GRAPHIC&gt;

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

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

Environmental toxicity represents a low percentage.

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

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

Type of tests versus species

&gt;TABLE POSITION&gt;

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

&gt;TABLE POSITION&gt;

III.9. Results of EU Table 8: Type of toxicity tests carried out for toxicological or other safety evaluations of products

III.9.1. The data

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

III.9.2. Treatment and interpretation of the data

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

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

Type of tests versus products

&gt;TABLE POSITION&gt;

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

BELGIUM

Comments of Belgian authorities

Statistical data submitted

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

General comments

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

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

Specific comments

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

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

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

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

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

2.4. The number of rodents and rabbits increased by 2.11 %.

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

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

2.7. The number of primates is reduced by 41.7 %.

2.8. The number of birds decreased by 64.2 %.

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

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

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

Origin versus species

&gt;TABLE POSITION&gt;

Note 1: Column 1.5 concerns only those Member Countries of the Council of Europe which, at the beginning of the reporting period, are Parties to the Convention ETS 123. Thus an updated list of those countries has to be used when filling in this column.

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

Note 3: The number of re-used animals in column 1.7 should be excluded from the total in the column 1.2

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

Purpose versus species

&gt;TABLE POSITION&gt;

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

Products versus species

&gt;TABLE POSITION&gt;

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

Main categories versus species

&gt;TABLE POSITION&gt;

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

&gt;TABLE POSITION&gt;

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

Regulatory requirements versus species

&gt;TABLE POSITION&gt;

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

Types of tests versus species

&gt;TABLE POSITION&gt;

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

Types of tests versus products

&gt;TABLE POSITION&gt;

DENMARK

Statistical data submitted

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

Comments of Danish authorities

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

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

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

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

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

Apart from the total numbers involved, there are not many differences in the patterns of use of experimental animals compared with previous years. Changes in pattern that are worthy of special mention are the following. There has been a marked decline in basic biological tests involving experimental animals, from just under 100 000 to 66 797. At the same time, the use of experimental animals for research and development involving medical, odontological and veterinary products and articles has increased significantly from 102 823 in 1998 to 153 671 in 1999, although this latter figure reflects levels of use in previous years. Similarly, the use of experimental animals for toxicological and other safety assessments has risen from 14 573 in 1998 to 17 696 in 1999, which again is in line with patterns of use in previous years.

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

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

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

Origin versus species

&gt;TABLE POSITION&gt;

Note 1: Column 1.5 concerns only those Member Countries of the Council of Europe which, at the beginning of the reporting period, are Parties to the Convention ETS 123. Thus an updated list of those countries has to be used when filling in this column.

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

Note 3: The number of re-used animals in column 1.7 should be excluded from the total in the column 1.2

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

Purpose versus species

&gt;TABLE POSITION&gt;

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

Products versus species

&gt;TABLE POSITION&gt;

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

Main categories versus species

&gt;TABLE POSITION&gt;

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

&gt;TABLE POSITION&gt;

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

Regulatory requirements versus species

&gt;TABLE POSITION&gt;

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

Types of tests versus species

&gt;TABLE POSITION&gt;

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

Types of tests versus products

&gt;TABLE POSITION&gt;

GERMANY

Statistical data submitted

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

Comments of German authorities

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

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

The numbers, kinds and sources of animals used in

procedures during 1999 in Germany

&gt;TABLE POSITION&gt;

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

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

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

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

The number of animals used in procedures for selected purposes

during 1999 in Germany

&gt;TABLE POSITION&gt;

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

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

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

The number of animals used in procedures for selected purposes for the protection of man, animals and the environment by toxicological or safety evaluationduring 1999 in Germany (including safety evaluation of products or appliances for human and veterinary medicine )1

&gt;TABLE POSITION&gt;

1 Information on this aspect is not collected separately.

The number of animals used in procedures

concerned with diseases and disorders1

during (year) in the Bundesrepublik Deutschland

&gt;TABLE POSITION&gt;

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

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

The number of animals used in procedures required by law

during 1999 in Germany

&gt;TABLE POSITION&gt;

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

GREECE

Statistical data submitted

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

Comments of Greek authorities

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

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

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

In accordance with the above provisions:

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

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

1. ESTABLISHMENTS

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

These can be broken down as follows:

&gt;TABLE POSITION&gt;

2. EXPERIMENTS

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

68.1% on human and animal diseases

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

1.72% on toxicological and other safety testing.

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

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

Origin versus species

&gt;TABLE POSITION&gt;

Note 1: Column 1.5 concerns only those Member Countries of the Council of Europe which, at the beginning of the reporting period, are Parties to the Convention ETS 123. Thus an updated list of those countries has to be used when filling in this column.

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

Note 3: The number of re-used animals in column 1.7 should be excluded from the total in the column 1.2

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

Purpose versus species

&gt;TABLE POSITION&gt;

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

Products versus species

&gt;TABLE POSITION&gt;

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

Main categories versus species

&gt;TABLE POSITION&gt;

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

&gt;TABLE POSITION&gt;

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

Regulatory requirements versus species

&gt;TABLE POSITION&gt;

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

Types of tests versus species

&gt;TABLE POSITION&gt;

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

Types of tests versus products

&gt;TABLE POSITION&gt;

SPAIN

Statistical data submitted

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

Comments of Spanish authorities

No comments

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

Origin versus species

&gt;TABLE POSITION&gt;

Note 1: Column 1.5 concerns only those Member Countries of the Council of Europe which, at the beginning of the reporting period, are Parties to the Convention ETS 123. Thus an updated list of those countries has to be used when filling in this column.

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

Note 3: The number of re-used animals in column 1.7 should be excluded from the total in the column 1.2

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

Purpose versus species

&gt;TABLE POSITION&gt;

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

Products versus species

&gt;TABLE POSITION&gt;

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

Main categories versus species

&gt;TABLE POSITION&gt;

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

&gt;TABLE POSITION&gt;

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

Regulatory requirements versus species

&gt;TABLE POSITION&gt;

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

Types of tests versus species

&gt;TABLE POSITION&gt;

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

Types of tests versus products

&gt;TABLE POSITION&gt;

FRANCE

Statistical data submitted

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

Comments of the French authorities

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

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

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

The analysis of these results leads to some comments.

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

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

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

\* As regards rabbits, their number decreased by 56% between 1990 and 1999 but there was a significant increase in their use by public laboratories between 1997 and 1999.

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

\* The use of cats, with a decrease of 34% between 1990 and 1999, was similar as regards public sector laboratories.

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

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

\* The number of goats and sheep rose by 46% from 1997 to 1999. The annual average increase from 1990 to 1999 is 4%.

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

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

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

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

There are two main reasons for these divergences:

1. In each table the respondent institutions had to indicate individual data (broken down by type of use and by species) and the corresponding totals. It was noted on a number of occasions that the sum of the individual data was different - usually lower - than the totals indicated. The basic reason seems to be the fact that the person ordering the animals is not always the same as the person carrying out the experiments.

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

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

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

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

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

Origin versus species

&gt;TABLE POSITION&gt;

Note 1: Column 1.5 concerns only those Member Countries of the Council of Europe which, at the beginning of the reporting period, are Parties to the Convention ETS 123. Thus an updated list of those countries has to be used when filling in this column.

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

Note 3: The number of re-used animals in column 1.7 should be excluded from the total in the column 1.2

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

Purpose versus species

&gt;TABLE POSITION&gt;

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

Products versus species

&gt;TABLE POSITION&gt;

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

Main categories versus species

&gt;TABLE POSITION&gt;

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

&gt;TABLE POSITION&gt;

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

Regulatory requirements versus species

&gt;TABLE POSITION&gt;

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

Types of tests versus species

&gt;TABLE POSITION&gt;

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

Types of tests versus products

&gt;TABLE POSITION&gt;

IRELAND

Statistical data submitted

The 1999 statistical data for Ireland have been provided by the Department of Health and Children.

Comments of Irish authorities

General

\* A total of 73,929 animals were used, this represents an increase of 7% from 1998.

\* There were 456 valid licences during this period.

\* 182 new licences were issued in 1999, this was a reduction of 27% in the number of licences issued the previous year.

\* Rodents accounted for 63% of all animals used.

\* No primates were used. This was in accordance with Ireland's policy not to licence for the use of primates.

\* Of the animals used, 66% (48,913) were bred in registered breeding establishments in Ireland.

\* Commercial concerns accounted for 26% (19,165) of the animals used. This represents a reduction of 5% from 1998 in the commercial use of animals.

\* Universities and Colleges accounted for 37% (27,507) of all animals used in scientific procedures.

\* 58% of all procedures (49,922) used no anaesthesia, usually because the procedure was so minor that anaesthesia was inappropriate.

\* 6% of animals (4,524) were used in procedures involving anaesthesia with permitted recovery (Certificate B).

\* 691 genetically modified animals were used in experimental activity. This represents 1% of the total numbers used.

Animals Used for Selected Purposes

\* 32% of animals (23,463) were involved in studies specific to animal diseases.

\* 20,000 fish (over 99% of all fish used) were used in the regulatory monitoring of infection in farmed stocks.

\* Of the 844 pigs used in 1999, 78% were involved in studies on animal diseases.

\* 129 cats were used in total, 87% (112) of which were used in studies on feline disease.

\* 312 dogs were used in 1999, of which 132 were used in studies on human disease.

\* Approximately 10% of the animals were used for studies on human nervous and mental disorders.

\* Education and training accounted for 2.5% of the animals used.

Toxicological and other Safety Evaluations

\* No animals were used in the testing of cosmetic products.

\* Toxicological and other safety evaluations accounted for 17% (12,347) of animals used. 97% of these tests were conducted to comply with legislation.

\* 90% of the animals used in toxicological and other safety evaluations were mice.

\* No animals were used to conduct LD50 or LC50 tests.

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

Origin versus species

&gt;TABLE POSITION&gt;

Note 1: Column 1.5 concerns only those Member Countries of the Council of Europe which, at the beginning of the reporting period, are Parties to the Convention ETS 123. Thus an updated list of those countries has to be used when filling in this column.

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

Note 3: The number of re-used animals in column 1.7 should be excluded from the total in the column 1.2

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

Purpose versus species

&gt;TABLE POSITION&gt;

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

Products versus species

&gt;TABLE POSITION&gt;

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

Main categories versus species

&gt;TABLE POSITION&gt;

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

&gt;TABLE POSITION&gt;

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

Regulatory requirements versus species

&gt;TABLE POSITION&gt;

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

Types of tests versus species

&gt;TABLE POSITION&gt;

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

Types of tests versus products

&gt;TABLE POSITION&gt;

ITALY

Statistical data submitted

The statistical data have been submitted by the "Ministero della Sanita' Dipartiemento Alimenti, Nutrizione e della Sanità Pubblica Veterinaria" (Ministry of Health, Directorate-General for Veterinary Public Health, Food and Nutrition).

Comments of Italian authorities

The collected data have been entered into the "standard statistical tables" agreed by the competent national authorities in the EU in 1997.

Generally speaking, they confirm the downward trend in the total number of animals used in experiments, which in 1999 fell below one million.

&gt;TABLE POSITION&gt;

Details of the various species of animal:

&gt;TABLE POSITION&gt;

The tables also include data on animals used for in vitro studies (sacrificed for the removal of organs, tissue and cells), for teaching purposes and for diagnosis of human and animal diseases.

Mice and rats account for 92.4% of the animal species used.

Dogs, cats and simians represent 0.13% of all animals used, i.e. a fall of 26.9% since 1997. For details of the various species, see Annex 1.

88.58% of the animals are used in basic biological studies, the research and development of products and devices for human medicine, dentistry and veterinary medicine and the production and quality control of products and devices for human medicine and dentistry.

Annex I

&gt;TABLE POSITION&gt;

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

Origin versus species

&gt;TABLE POSITION&gt;

Note 1: Column 1.5 concerns only those Member Countries of the Council of Europe which, at the beginning of the reporting period, are Parties to the Convention ETS 123. Thus an updated list of those countries has to be used when filling in this column.

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

Note 3: The number of re-used animals in column 1.7 should be excluded from the total in the column 1.2

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

Purpose versus species

&gt;TABLE POSITION&gt;

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

Products versus species

&gt;TABLE POSITION&gt;

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

Main categories versus species

&gt;TABLE POSITION&gt;

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

&gt;TABLE POSITION&gt;

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

Regulatory requirements versus species

&gt;TABLE POSITION&gt;

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

Types of tests versus species

&gt;TABLE POSITION&gt;

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

Types of tests versus products

&gt;TABLE POSITION&gt;

LUXEMBOURG

Statistical data submitted

The statistical data have been submitted by the "Ministère de l'Agriculture, Administration des Services Vétérinaires" (Ministry of Agriculture, Administration of Veterinary Services)

Comments of Luxembourg authorities

No comments

Remark:

Please note that only relevant EU tables containing data are included in this report. No animals were reported in Tables 3-8.

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

Origin versus species

&gt;TABLE POSITION&gt;

Note 1: Column 1.5 concerns only those Member Countries of the Council of Europe which, at the beginning of the reporting period, are Parties to the Convention ETS 123. Thus an updated list of those countries has to be used when filling in this column.

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

Note 3: The number of re-used animals in column 1.7 should be excluded from the total in the column 1.2

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

Purpose versus species

&gt;TABLE POSITION&gt;

THE NETHERLANDS

Statistical data submitted

The statistical data have been submitted by the "Keuringsdienst van Waren, Ministerie voor Volksgezondheid, Welzijn en Sport" (Inspectorate for Health Protection Welfare and Sport and Veterinary Public Health).

Comments of Netherlands authorities

On 5 February 1997, the revised version of the Experiments on Animals Act (1977) entered into force. This act presents a comprehensive system for regulation of animal experimentation and only covers vertebrate animals. However, also invertebrate species to be designated by Order in Council can be brought under the scope of this act.

The provisions of the European Directive on the approximation of laws, regulations and administrative provisions of the Member States regarding the protection of animals used for experimental and other scientific purposes (86/609/EEC) have been implemented.

In addition, among others the following provisions have been issued:

- animal experiments using LD50/LC50 methods are prohibited. However, for acute dermal and acute respiratory toxicity tests a general exemption is granted, due to the lack of validated alternative methods.

- animal experiments for new or existing cosmetics are prohibited.

- every animal experiment to be performed has to be recommended by a recognised ethical review committee. Such a committee comprises at least seven members, one of whom is the chairperson. In addition, such a committee comprises in equal numbers experts in the fields of animal experiments, experts in the field of alternative methods, experts in the field of animal welfare and protection and experts in the field of ethical assessment. At least two of these experts are not involved in the conduct of experiments on animals. The chairperson and at least two members are not in the employ of any licence holder applying to the committee. The animal welfare officer is involved already at an early stage in the review of experiments and acts as a permanent advisor for the ethical review committee. In 2001, after a three years period, the functioning of these committees will be evaluated.

Licenses to perform animal experiments are issued by the Minister of Public Health, Welfare and Sport to a natural or legal person who is a mandated representative of an establishment for animal use. So licensed, those people are responsible for assuring that the legal requirements are complied with. The welfare of the experimental animals is supervised by a qualified veterinarian or another competent person in charge of the licensee.

A Standing Committee advises the Minister on the administration of the Act and other related issues. The Committee consists of experts in the field of animal experimentation, laboratory animal science and animal welfare.

The enforcement of the Act has been commissioned to the Inspectorate for Health Protection and Veterinary Public Health.

The creation of transgenic animals

Within the framework of the Animal Health and Welfare Act (1992) a system of licensing has entered into force with respect to experiments aiming at a genetic modification of animals. A national committee on ethical evaluation of genetic modification of animals, called the Committee on Animal Biotechnology will advise the Minister of Agriculture, Nature Management and Fisheries on the ethical aspects of the creation and the use of transgenic animals in general and on the admissibility of proposed projects.

In addition, such projects have to be evaluated within the framework of the Experiments of Animals Act and the Environmental Conservation Act. Tuning of these three types of evaluation needs due consideration.

In 1999, for the creation of transgenic animals, 39,275 animals were used.

Collection of data

83 establishments (with 330 sub-units) completed the 1999 registration form.

These establishments can be categorized as follows:

a) Universities and university hospitals // 16

b) Other hospitals, regional public health laboratories // 5

c) Public health research institutes // 9

d) Agricultural and veterinary research institutes // 10

e) Other research institutes // 4

f) Industries // 27

g) Schools for vocational training // 10

h) Miscellaneous // 2

Up to 1999 data of animal experiment had to be registered in advance. Therefore, the degree of discomfort had to be estimated. However, as from 1999 a new system is in use which obliges licence holders to fill in the forms after the experiment has been performed.

This data collection system is based on

- the old system.

- additional national requirements, such as a breakdown of the nature of the animals used: genetically modified, from the wild, other animals.

- the so called EU Tables to be used by the EU Members States to provide for data to be included in the European Commission's report on animal experimentation to be sent to the European Parliament.

The killing of an animal without any previous intervention

In the Netherlands, if an animal is killed without any previous intervention in the framework of research or testing, e.g. for organ/blood collection, the killing is considered to be an experiment. The rationale of this is that the Inspectorate must have the power to supervise the killing of laboratory animals. In 1999, 63,920 animals were killed without previous intervention.

This is in contrast to the Council of Europe Convention ETS 123 and Directive 86/609/EEC, where the use of an animal for an experimental or other scientific purpose is not considered an experiment if the least painful method of killing accepted in modern practice ('humane' methods') is used.

Total number of animals used

In 1999, according to the EU Tables, the total number of animals used was 621,466.

Discomfort and pain prevention

General

As mentioned before, data has to be registered after an experiment has been performed. This includes data on the degree of discomfort; i.e. experienced discomfort.

Discomfort is defined as a state including impairment of the animal's health, or as appreciable pain, injury or other grave distress caused to the animal. For assessment of the degree of discomfort no objective criteria are available. However, respondents are advised to attend to the effect of interferences on the behaviour and/or on the bodily functioning of the animal.

At meetings of animal welfare officers information will be exchanged and discussed to promote consensus of opinion.

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

Origin versus species

&gt;TABLE POSITION&gt;

Note 1: Column 1.5 concerns only those Member Countries of the Council of Europe which, at the beginning of the reporting period, are Parties to the Convention ETS 123. Thus an updated list of those countries has to be used when filling in this column.

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

Note 3: The number of re-used animals in column 1.7 should be excluded from the total in the column 1.2

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

Purpose versus species

&gt;TABLE POSITION&gt;

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

Products versus species

&gt;TABLE POSITION&gt;

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

Main categories versus species

&gt;TABLE POSITION&gt;

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

&gt;TABLE POSITION&gt;

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

Regulatory requirements versus species

&gt;TABLE POSITION&gt;

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

Types of tests versus species

&gt;TABLE POSITION&gt;

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

Types of tests versus products

&gt;TABLE POSITION&gt;

AUSTRIA

Statistical data submitted

The statistical data have been submitted by the "Bundesministerien (Land und Forstwirtshaft, Umwelt und Wasserwirtschaft, Soziale Sicherheit und Generationen, Bildung, Wissenschaft und Kultur)" Federal Ministries (Agriculture and Forestry, the Environment and Water Resources; Social Security and the Generations; Economic Affairs and Labour; Education, Science and Culture).

Comments of Austrian authorities

There is a clear further downward trend in the number of animal experiments and animals used for experimental purposes in Austria. The statistics on animal experiments for 1999 (the statistics are published each year for the previous year in accordance with the Animal Experiments Act) show that a total of 130 295 animals were used for experimental purposes in 1999, i.e. 26 953, or about 17%, fewer than in 1998 (157 248). For comparison: 1997 (168 696); 1993 (272 371) and 1992 (308 308). Compared with 1991 (the first year in which statistics were recorded), the number of animals used has been reduced by almost three-quarters: 482 166 animals were still being used for experimental purposes in that year.

Following the 1999 amendment to the Animal Experiments Act, BGBl. (Federal Law Gazette) No 169/1999, the statistics on animal experiments have for the first time been produced in standard EU format. The full animal experiment statistics, with the tables for the Federal Ministries (Agriculture and Forestry, the Environment and Water Resources; Social Security and the Generations; Economic Affairs and Labour; Education, Science and Culture) responsible for the implementation of the Animal Experiments Act are given on the homepage of the Federal Ministry for Education, Science and Culture under hap://www.bt\_nbwk.gy.at/4fte/tierversuch/sta.99.htm.

The right trend in animal experiments

"This clear reduction in the numbers of animals used for experiments, a 73% reduction since 1991, is, " according to Science Minister, Elisabeth Gehrer, "due to at least two related courses of development in animal experiments":

The three Rs

Firstly the three Rs: reduction, refinement (improvement of scientific methods) and replacement (substitution of other scientific methods for experimental animals) by scientists, researchers and scientific workers themselves and efforts to use alternative methods as far as possible instead of experiments on animals, as specifically provided for in the Austrian Animal Experiments Act.

Note:

In addition, in November 1998, during the Austrian EU Presidency (the second half of 1998), the Ministry of Science held a widely-reported meeting on the "Implementation of the 3 Rs - Targets in the EU, in science and industry", in cooperation with the Commission and with participants from all EU Member States and, for the first time, the East European candidate countries to support and promote the aims of the three Rs in the EU framework as well. One of the resolutions adopted at this meeting was forwarded to the EU Council of Ministers and the European Commission for further consideration. Special attention was recently drawn to Austria's initiatives for the recognition and implementation of methods at Community level to replace animal experiments at a follow-up meeting held last year in Berlin (during the German EU Presidency) and these initiatives have since been on the agenda at all EU discussions of animal experiments.

A restrictive approach and the promotion of alternative methods

Secondly, a restrictive approach is taken by all competent authorities as regards licences for animal experiments under Austria's strict Animal Experiments Act, which was refined even further last year and allows animal experiments only under very restrictive conditions and only if the experimental objectives cannot be achieved by other methods or processes (substitute methods).

Lastly, the government's pro-active approach, which includes competitions with national awards for research projects to find alternative methods and efforts to increase the use, both within Austria and abroad, of procedures to replace animal experiments, has also made scientists and researchers more aware of their responsibility in this area. The Ministry of Science has already spent over SCH 20 million in the last two years on research contracts to find substitutes for animal experiments.

Experimental animals mainly rats and mice

The total number of animals used for experimental purposes in 1999 in Austria was 130 295: 103 893 rats and mice; 15 056 rabbits; 670 farm animals (sheep, goats, pigs, cattle, etc.); 3 367 birds; 738 fish; 709 amphibians; 68 dogs and 24 cats.

Publication of

the Austrian Federal Ministry of Economic Affairs and Labour

(Line 30.581/5-III/A/9/2000);

the Austrian Federal Ministry for Social Security and the Generations

(Line 20.903/8-VIII/A/8/2000);

the Austrian Federal Ministry of Agriculture and Forestry, the Environment and Water Resources

(Line 12 4650/1-I/2U/200) and

the Austrian Federal Ministry for Education, Science and Culture

(Line 5436/7-Pr/S/2000)

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

Origin versus species

&gt;TABLE POSITION&gt;

Note 1: Column 1.5 concerns only those Member Countries of the Council of Europe which, at the beginning of the reporting period, are Parties to the Convention ETS 123. Thus an updated list of those countries has to be used when filling in this column.

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

Note 3: The number of re-used animals in column 1.7 should be excluded from the total in the column 1.2

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

Purpose versus species

&gt;TABLE POSITION&gt;

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

Products versus species

&gt;TABLE POSITION&gt;

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

Main categories versus species

&gt;TABLE POSITION&gt;

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

&gt;TABLE POSITION&gt;

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

Regulatory requirements versus species

&gt;TABLE POSITION&gt;

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

Types of tests versus species

&gt;TABLE POSITION&gt;

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

Types of tests versus products

&gt;TABLE POSITION&gt;

PORTUGAL

Statistical data submitted

The statistical data have been submitted by the "Ministério da Agricultura, Desenvolviementos Rural e das Pescas- Direcção Geral Veterinária" (Ministry of Agriculture, Rural Development and Fisheries-Directorate-General for Veterinary Matters, Directorate for Animal Health Protection, Welfare and Feed)

Comments of Portuguese authorities

1. To reduce difficulties associated with the completion of the statistical tables and, in the process, to improve the quality of the future statistics, we are going to reword the guidelines as requested earlier by the bodies conducting experiments on animals.

2. Preparations are being made for further revision of Portugal's national legislation on the protection of animals used for experimental and other scientific purposes. In principle, the main changes to be made will be:

\* to make it compulsory for all bodies using animals for the purposes in question to have a code of ethics;

\* to change the membership of the advisory committee set up at national level to include new Ministries and replace the members who have left;

\* to add a classification of the level of suffering caused to any animal.

3. We consider it necessary to lay down uniform criteria at Member State level for vocational training for researchers and laboratory technicians handling animals in order to bring credibility to this category of technicians and promote equivalence within the European Union.

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

Origin versus species

&gt;TABLE POSITION&gt;

Note 1: Column 1.5 concerns only those Member Countries of the Council of Europe which, at the beginning of the reporting period, are Parties to the Convention ETS 123. Thus an updated list of those countries has to be used when filling in this column.

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

Note 3: The number of re-used animals in column 1.7 should be excluded from the total in the column 1.2

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

Purpose versus species

&gt;TABLE POSITION&gt;

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

Products versus species

&gt;TABLE POSITION&gt;

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

Main categories versus species

&gt;TABLE POSITION&gt;

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

&gt;TABLE POSITION&gt;

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

Regulatory requirements versus species

&gt;TABLE POSITION&gt;

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

Types of tests versus species

&gt;TABLE POSITION&gt;

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

Types of tests versus products

&gt;TABLE POSITION&gt;

FINLAND

Statistical data submitted

The statistical data have been submitted by the " Maa - ja metsätalousministeriö Elintarvike- ja terveysosasto" (Ministry of Agriculture and Forestry, Veterinary and Food Department).

Comments of Finnish authorities

The amount of used animals has grown a little from the last year. One explanation to that according to the information from the Provincial State Offices is the development and increased use of gene technology. The amount of animals, mostly mice, can be quite large in a single study that develops a new strain with altered genes. The growth in animal numbers is indeed all due to the increase in the amount of mice.

\* Table 1: The largest group is mice. Proportion of mice is about 39 % of all the animals. Fish are the second largest group (about 38 % of all the animals) and the third largest group is rats (about 14 % of all the animals). There was nine primates (Old World Monkey) used in 1999. Animals that were not used at all are cats, Prosimians, New World monkeys and apes.

\* Table 2: Biological studies of a fundamental nature (2.2) are the major purposes of the experiments. The amount of animals used in biological studies of a fundamental nature is about 86 % compared to all animals used .

\* Table 3: The number of animals used in toxicological and other safety evaluations is only &lt;2 % of all animals used. There has been no testing for cosmetic or toiletries products (3.6) or for products used or intended to be used mainly as additives in food for human consumption (3.7).

\* Table 4: About 90 % of the used animals are used in studies concerning human diseases or disorders. The most used animal in studies specific to animal diseases is fish.

\* Table 5: The proportion of animals used because of EC legislation or European Pharmacopoeia requirements (5.3.) is 83 % of all the animals used in production and quality control of products and devices for human medicine and dentistry and for veterinary medicine.

\* Table 6: The proportion of animals used with no regulatory requirements (6.7) is 49 % of all the animals used in toxicological and other safety evaluations.

\* Table 7: Proportion of animals used in acute and sub-acute toxicity testing using lethal methods (7.2.1 and 7.2.2) is about 6 % of all the animals used in testing in toxicological and other safety evaluations.

\* Table 8: Potential or actual contaminants in the general environment (8.h, 38 %) and products/substances or devices for human medicine and dentistry and for veterinary medicine (8.a, 46 %) are the largest groups that within most of the animals are being used in the field of toxicological and other safety evaluations.

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

Origin versus species

&gt;TABLE POSITION&gt;

Note 1: Column 1.5 concerns only those Member Countries of the Council of Europe which, at the beginning of the reporting period, are Parties to the Convention ETS 123. Thus an updated list of those countries has to be used when filling in this column.

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

Note 3: The number of re-used animals in column 1.7 should be excluded from the total in the column 1.2

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

Purpose versus species

&gt;TABLE POSITION&gt;

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

Products versus species

&gt;TABLE POSITION&gt;

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

Main categories versus species

&gt;TABLE POSITION&gt;

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

&gt;TABLE POSITION&gt;

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

Regulatory requirements versus species

&gt;TABLE POSITION&gt;

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

Types of tests versus species

&gt;TABLE POSITION&gt;

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

Types of tests versus products

&gt;TABLE POSITION&gt;

SWEDEN

Statistical data submitted

The statistical data have been submitted by the National Board for Laboratory Animals.

Comments of Swedish authorities

The deadline for submitting the statistical records covering the use of laboratory animals during 1999 to the EU commission was in June 2000, a much earlier date than previous years. This resulted in some problems when collecting and compiling our data. Most university researchers were prompt and submitted their reports in March, although some were as late as May despite several reminders from the National Board for Laboratory Animals (CFN). Unfortunately, three responsible researchers had to be warned by legal action over their failure to supply the required data on their animal experimentation. Hopefully, the collecting of statistical data from the universities will work smoother next year.

EU-Directive

According to the EU definition (Directive 86/609/EEC) the number of laboratory animals used during 1999 in Sweden reached approx. 324 000. This is a 7.6 % increase (about 23 000 animals) compared to 1998. The reasons behind this increase are hard to interpret and could be due to a number of factors including an increased input in biomedical research, more accurate reporting of the numbers of animals or simply just a natural fluctuation. The Swedish statistical record show that throughout the 1990s, three kinds of animals were predominantly used in animal experimentation, the mice, the rats and fish. Indeed, these three groups comprised about 90% of all laboratory animals used during 1999. The most noticeable change observed for 1999 was an increase in the number of mice, which were 27 000 individuals more than previous year. This probably reflects the increased use of transgenic mice in biomedical research. At the same time the number of rats used in animal experimentation decreased. The number of fish used also increased during 1999 compared to the previous year.

The Swedish statistical records also indicates that whereas the number of laboratory animals used by the biomedical companies remained the same as in 1998, the numbers used in university research increased over the same period.

Specific use of animals

As in previous years most laboratory animals were used in either fundamental biological research (51%) or in development of product/devices (41%) used in human or veterinary medicine. In 1999, 5% of the animals were used in toxicological research, and finally, less than 3 % of the total number of laboratory animals were used for diagnosing animal diseases. The most common animals used in toxicological research are mice, rats and fish and to lesser extent dogs and rabbits. Mammals were mostly used in experiments concerning products/substances or devices relating to human medicine, dentistry and veterinary medicine whereas fish are mainly used in the evaluation of hazardous environmental substances.

Swedish definition

Apart from the information required according to the EU directive, Sweden also collects its own statistical data on other use of laboratory animals. According to Swedish legislation all use of animals which have a scientific purpose should be recorded. Therefore, this statistical data includes all animals used in behaviour studies, feeding trials or animals being euthanized for the use of their tissues and organs. During 1999 about

228 000 animals were reported according to this definition. The dominating animals were fish and birds, the latter being mainly roosters in which the comb was used for extraction of hyaloronic acids.

Transgenic animals

The Swedish statistical records do not separate the use of transgenic animals from other laboratory animals. In agreement with EU directive, Sweden do not regard breeding of transgenic stocks as an experiment in it self. However, it is regarded as an experiment when transgenic animals are used in experiments or when new transgenic strains are created.

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

Origin versus species

&gt;TABLE POSITION&gt;

Note 1: Column 1.5 concerns only those Member Countries of the Council of Europe which, at the beginning of the reporting period, are Parties to the Convention ETS 123. Thus an updated list of those countries has to be used when filling in this column.

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

Note 3: The number of re-used animals in column 1.7 should be excluded from the total in the column 1.2

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

Purpose versus species

&gt;TABLE POSITION&gt;

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

Products versus species

&gt;TABLE POSITION&gt;

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

Main categories versus species

&gt;TABLE POSITION&gt;

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

&gt;TABLE POSITION&gt;

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

Regulatory requirements versus species

&gt;TABLE POSITION&gt;

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

Types of tests versus species

&gt;TABLE POSITION&gt;

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

Types of tests versus products

&gt;TABLE POSITION&gt;

UNITED KINGDOM

Statistical data submitted

The statistical data have been submitted by the "Home Office".

Comments of United Kingdom authorities

Some 1.9 million animals were used for the first time in procedures started in 1999. This figure cannot be directly compared to previous years - see note below.

The statistical data for the United Kingdom were published in the UK in two separate reports - one for Great Britain and the other for Northern Ireland. Overall there was a decrease in the number of animals used for the first time in procedures regulated in the UK compared with use in 1998.

About one third of animals received some form of anaesthesia to alleviate the severity of the interventions. For most of the remaining animals the use of anaesthesia would have increased the severity of the procedure.

For the species which should be obtained from registered breeding or supplying establishments within the UK, 99% of animals listed were so sourced and less than 0.5% were sourced outside of EC or Council of Europe member countries.

4 in 5 procedures (80% of the total) were carried out on mice or rats.

Dogs, cats, horses and non-human primates are accorded special protection in the UK and collectively accounted for 0.5% of the animals used.

Cold blooded animals (fish and amphibians) represented 7% of the total animal use.

Fundamental biological research, or applied studies in human medicine or dentistry, or veterinary medicine accounted for the use of 1.3 million animals - 68% of the total animal use.

Slightly less than 30% of the animals were used for toxicological or other safety evaluation, or for production and quality control of products and devices for human medicine, dentistry or veterinary medicine. The majority of that use (over 80%) was to fulfil European or other regulatory requirements.

No animals were used in 1999 for the purpose of evaluating the safety of either cosmetic products or cosmetic ingredients.

The use of animals for the production of monoclonal antibodies fell due to widespread use of the in vitro alternative to live animal use.

Note: Due to revisions in the method of collecting data, in 1999 the animal use submitted does NOT include those animals used for the breeding of genetically engineered (transgenic/mutant) animals, although those animals used to generate such strains are included.

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

Origin versus species

&gt;TABLE POSITION&gt;

Note 1: Column 1.5 concerns only those Member Countries of the Council of Europe which, at the beginning of the reporting period, are Parties to the Convention ETS 123. Thus an updated list of those countries has to be used when filling in this column.

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

Note 3: The number of re-used animals in column 1.7 should be excluded from the total in the column 1.2

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

Purpose versus species

&gt;TABLE POSITION&gt;

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

Products versus species

&gt;TABLE POSITION&gt;

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

Main categories versus species

&gt;TABLE POSITION&gt;

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

&gt;TABLE POSITION&gt;

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

Regulatory requirements versus species

&gt;TABLE POSITION&gt;

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

Types of tests versus species

&gt;TABLE POSITION&gt;

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

Types of tests versus products

&gt;TABLE POSITION&gt;

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