Source: EURLEX
Language: en
Format: md

**EN**

# **EN EN**

COMMISSION OF THE EUROPEAN COMMUNITIES

Brussels, 5.11.2008
SEC(2008) 2411

**COMMISSION STAFF WORKING PAPER**

_**accompanying the**_

**Proposal for a**

**DIRECTIVE OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL**

**on the protection of animals used for scientific purposes**

## **_SUMMARY OF THE IMPACT ASSESSMENT_**

{COM(2008) 543}
{SEC(2008) 2410}

# EN 1 EN

## **SUMMARY**

**1. What are the problems?**

Directive 86/609/EEC is the central legislative act of the European Community aiming at
harmonising Member States' rules protecting animals used for experimental and other
scientific purposes. It was adopted in 1986 and has never been significantly changed. Since
the adoption of the Directive, significant progress in experimental techniques has been
achieved and new scientific knowledge about the capacity of animals to feel pain and
suffering has become available. Furthermore, the ethical dimension of the use of animals for
experiments is not sufficiently reflected in the current provisions of the Directive. The
Directive does not explicitly refer to, nor ensure the full application of the Three Rs
principle [1], even though it is now recognised as the leading principle in this field by all
stakeholders.

To compensate for these weaknesses, a number of Member States have gone further when
adopting national measures. This has resulted in a highly diversified, unequal competitive
environment for industry and the research community, defeating the objective of the Directive
to avoid fragmentation of the internal market. Furthermore, the wording of the Directive,
closely following that of an international Convention, results in unclear provisions,
inconsistencies and ambiguities, causing transposition problems.

The problem analysis confirmed that four problems appear across 12 policy areas:

a) Economic problems affecting the internal market include competitive disadvantages for
countries with high animal welfare standards resulting primarily from price differences,
diverging regulatory and authorisation procedures and criteria in the Member States leading to
variable cost of projects and delays, unsatisfactory (working) conditions of researchers,
obstacles to horizontal mobility and increasing activist criminality. Similar problems can be
identified for the breeders and suppliers of animals, especially in terms of the cost of housing
and care.

b) Animal welfare problems relate to different levels of animal welfare resulting from
different standards that are in force and from a relatively high number of animals not
protected by national legislation.

c) Scientific problems concern low innovation and poor quality science resulting from project
delays, potentially unnecessary duplication of experiments, low incentive to develop and use
alternative methods, risk of variable research results due to non-consistent scrutiny of study
design and implementation of refinement, and obstacles to free movement of researchers.

d) Public/societal problems occur due to the increasing dissociation between weak legislation
and strong public concern, evolving from changed ethical and societal values and increased
public interest in the acceptability of animal testing.

1 The Three Rs Principle (Replace, Reduce and Refine the use of animals in experiments) is widely
accepted as the guiding principles when using animals in experiments both at national and international
(e.g. OECD, OIE) level. It dates back to the book "The Principles of Humane Experimental Technique"
by W.M.S. Russell and R.L. Burch in 1959.

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**2. What are the policy objectives?**

The main objective of the European Commission in this field is to create a level playing field
for researchers and industry. At the same time, in line with the Animal Welfare Protocol
annexed to the EC Treaty, the proposal will aim at increasing the level of welfare and
protection of animals used in experiments.

Increased uptake of alternative methods will boost EU industry. The revision of the Directive
also strives to simplify the regulatory environment and ensure the competitiveness of EU
research and industry.

**3. What are the policy options?**

Four basic policy options for achieving the objectives have been screened: deregulation, nopolicy-change, self-regulation and reinforcement of the existing Directive. Only an upgrade of
Directive 86/609/EEC proved viable.

25 specific options were analysed:

I. Scope

The options include extending the scope of animals and procedures covered under the current
Directive 86/609/EEC to cover:

Option 1: animals used in basic research

Option 2: animals bred for their tissue and organs to be used in experiments or for other
scientific purposes

Option 3: selected invertebrates species

Option 4: embryonic and foetal forms from the last third of gestation until birth

Option 5: animals used in education and training

**II. Authorisation of projects**

A level playing-field should be established to guarantee minimum requirements for the
authorisation of projects, while safeguarding competitiveness in the field of research:

Option 1: Authorisation of individual projects within 30 days
Option 2: Authorisation of a group of projects for regulatory testing

**III. Ethical Evaluation of projects**

The revised Directive could make an ethical evaluation of all projects using animals
mandatory and set out minimum requirements.

Option 1: Compulsory ethical evaluation of projects with minimum requirements

Option 2: Introduction of retrospective assessment of all projects

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**IV. Permanent Ethical Review Body and National Animal Welfare and Ethics**
**Committee**

A combination of a national animal welfare and ethics committee for ethical review co
ordination and an ethical review body at establishment level could ensure consistent ethical
review.

Option 1: National animal welfare and ethics committee

Option 2: Permanent ethical review body in each establishment

**V. Housing and care standards**

The Directive could incorporate elements of the Council of Europe’s revised Appendix A to
Convention ETS 123 as compulsory minimum standards.

Option 1: Compliance with the revised Appendix A to the Council of Europe Convention ETS
123

**VI. Transparency / Access to information**

The Directive could incorporate minimum requirements on transparency and public
accountability by requiring non-confidential information on ethical evaluations and project
authorisation to be made publicly available.

Option 1: Non-confidential information from the ethical evaluation reports and project
authorisation decisions to be made publicly available

**VII. Non-human Primates (NHP)**

The revised Directive could reinforce the ban on wild-caught NHPs and further restrict the
research areas in which NHP can be used. A gradual switch to permitting use of secondgeneration (F2) and higher generations of purpose-bred NHPs could be desirable. The use of
Great Apes could be highly restricted.

Option 1: Shift to only use of F2 and subsequent generations of purpose bred NHP
Option 2: Ban of the use of Great Apes with very limited exceptions

**VIII. Inspections**

The Directive could harmonise the minimum requirements for annual inspections to two (one
unannounced). A system of European Community inspections could also be envisaged.

Option 1: Minimum twice-yearly inspections by national authorities (one unannounced)

Option 2: EC inspections

**IX. Education and training**

The revised Directive could incorporate minimum training requirements for personnel and set
requirements for demonstrating and maintaining competence over time, to reduce different
cost environments.

# EN 4 EN

Option 1: Requirement for competence and minimum elements for education and training

**X. Avoiding duplication of animal experiments**

A centralised Community-wide database for information on project authorisation and
scientific results could be established. This could allow knowledge sharing, and provide
transparency on results.

Option 1: Establishing a centralised database

**XI. Use of CO** **2** **for euthanasia**

The Directive could detail humane methods of euthanasia to remove cost advantages for
establishments due to method choice. The use of CO 2 could be prohibited unless the animal is
unconscious prior to its exposure.

Option 1: Prohibit use of CO 2 unless animals are first rendered unconscious by exposure to
anaesthetic gases

**XII. Statistical Reporting**

The revised Directive could increase the quality of annual statistical reporting of Member
States by introducing the following elements:

Option 1: Number of genetically modified animals, certain invertebrate species and
embryonic and foetal forms (excluding larvae) in the last third of their development

Option 2: Numbers of animals killed for use of their organs and tissues in scientific
procedures

Option 3: Numbers of projects and types of establishments

Option 4: Severity classification [2] of the experiments

**XIII. Promotion of alternative test methods**

Every Member State could designate a national reference laboratory to speed up the validation
of animal testing alternatives.

Option 1: National reference laboratories

2 The severity of an experiment is classified based on the duration, intensity and frequency of potential
pain, suffering or distress caused to an animal.

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**4. What are the impacts of the specific options?**

The 25 specific options were analysed and evaluated, where possible in a quantified and
monetised form. Benefits were assessed based on the four problem dimensions, costs were
evaluated separately for user establishments and public authorities. In some cases, the original
options were revised in the light of the results of an external study performed by contractor,
Prognos AG.

|Col1|BENEFITS<br>(quantified where possible)|Col3|Col4|COSTS<br>(monetised where possible)|Col6|Col7|
|---|---|---|---|---|---|---|
|I <br>Scope<br>– <br>Option<br>1 <br>– <br>Basic research|Animal welfare|++|500.000<br>animals|Costs for public<br>authorities|-|80,000 €|
|I <br>Scope<br>– <br>Option<br>1 <br>– <br>Basic research|Control|+++||Costs<br>due<br>to<br>authorisation|--|4 Mio €|
|I <br>Scope<br>– <br>Option<br>1 <br>– <br>Basic research||||Costs due to ethical<br>evaluation|--|2.6 Mio €|
|I <br>Scope<br>– <br>Option<br>1 <br>– <br>Basic research||||Delays<br>due<br>to<br>authorisation<br>and<br>ethical evaluation|-||
|I <br>Scope<br>– <br>Option<br>2 <br>- <br>Tissues|Animal welfare|+++|1.8<br>Mio<br>animals|Cost<br>of<br>experiments using<br>tissue and organs|-||
|I <br>Scope<br>– <br>Option<br>2 <br>- <br>Tissues|Public<br>accountability and<br>transparency|+++||Cost<br>to<br>public<br>authorities|-|320,000 €|
|I <br>Scope<br>- <br>Option<br>3 <br>- <br>invertebrates|Animal welfare|++|Animals<br>used in 1000<br>experiments|Costs for public<br>authorities|-||
|I <br>Scope<br>- <br>Option<br>3 <br>- <br>invertebrates|Control|++||Costs<br>for<br>user<br>establishments|---||
|I <br>Scope<br>- <br>Option<br>4 <br>- <br>foetal forms|Animal welfare|(++)|175.000<br>mammalian<br>animals<br>alone|Costs for public<br>authorities|-|12.6 Mio €|
|I <br>Scope<br>- <br>Option<br>4 <br>- <br>foetal forms|Control|+++||Cost<br>for<br>user<br>establishments|-|845.000 €|
|I <br>Scope<br>- <br>Option<br>5 <br>- <br>Education<br>& <br>Training|Animal welfare|++|199.000<br>animals|Costs for public<br>authorities|-|35.000 €|
|I <br>Scope<br>- <br>Option<br>5 <br>- <br>Education<br>& <br>Training|Control|+++||Cost<br>for<br>user<br>establishments|-|1.4 Mio €|

# EN 6 EN

|II<br>Authorisation -<br>Option 1 -<br>individual|Animal welfare<br>Animal welfare<br>(additional)|++<br>+++|950.000<br>animals|Costs for MS<br>without project<br>authorisation|- -|57,000 €|
|---|---|---|---|---|---|---|
|II<br>Authorisation -<br>Option<br>1 <br>- <br>individual|Control<br>and<br>transparency|++||Costs for MS with<br>project-<br>authorisation|+|11,500 €|
|II<br>Authorisation -<br>Option<br>1 <br>- <br>individual|Control<br>and<br>transparency<br>(additional)|+||Cost<br>for<br>user<br>establishments<br>in<br>MS without project<br>author.|-|11 Mio €|
|II<br>Authorisation -<br>Option<br>1 <br>- <br>individual|Competitiveness|+++||Cost<br>for<br>user<br>establishments<br>in<br>MS without project<br>author|-|12.6 Mio €|
|II<br>Authorisation -<br>Option<br>2 <br>- <br>group|Costs for users /<br>Competitiveness<br>SMEs/research|+++|reduction of<br>21.2 Mio €|Public image|-||
|II<br>Authorisation -<br>Option<br>2 <br>- <br>group|Costs for public<br>authorities|++|1.9 Mio €<br>(reduction of<br>700,000 €)|Animal welfare|0||

|III Ethical<br>Review (A) -<br>Option 1|Animal welfare|+++|11.7 Mio<br>animals /<br>371,000<br>animals|Administrative<br>costs to enterprises|- -|9 Mio € (7 Mio<br>€)|
|---|---|---|---|---|---|---|
|III<br>Ethical<br>Review (A) -<br>Option 1|Awareness<br>and<br>work satisfaction<br>researchers|++||Competitiveness|- -||
|III<br>Ethical<br>Review (A) -<br>Option 1|Quality of science|++|up to 70 Mio<br>€|Costs for public<br>authorities|- -||
|III<br>Ethical<br>Review (A) -<br>Option 1|Level<br>playing<br>field|++||Delay of projects|-||
|III<br>Ethical<br>Review (A) -<br>Option 2|Transparency|++|12.1<br>Mio<br>animals|Cost<br>to<br>establishments|- -|revised option<br>4 Mio €|
|III<br>Ethical<br>Review (A) -<br>Option 2|Quality of science|++||Costs to national<br>authorities|- -||

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|IV Ethical<br>Review (B) -<br>Option 1|Transparency|++|12.1 Mio<br>animals|Costs infrastructure|-|Col7|
|---|---|---|---|---|---|---|
|IV<br>Ethical<br>Review (B) -<br>Option 1|Public<br>accountability|+||Costs infrastructure<br>for Member States|-||
|IV<br>Ethical<br>Review (B) -<br>Option 2|Animal welfare|+++|12.1<br>Mio<br>animals|Costs<br>for<br>establishments|- -||
|IV<br>Ethical<br>Review (B) -<br>Option 2|Ethical discussion<br>and awareness|++|||||

|V Housing &<br>Care - Option<br>1 - ETS 123|Animal welfare|+++|12.1 Mio<br>animals|Upgrading costs for<br>smaller animals|-|Col7|
|---|---|---|---|---|---|---|
|V Housing &<br>Care - Option<br>1 - ETS 123|Science|++||Upgrading costs for<br>larger animals|- - -||
|V Housing &<br>Care - Option<br>1 - ETS 123|Level<br>playing<br>field|++||Yearly Costs for<br>user establishments||37 Mio €|

|VI<br>Transparency -<br>Option 1|Public<br>accountability and<br>transparency|++|Col4|Cost to<br>establishments|---|revised option:<br>520,000 €|
|---|---|---|---|---|---|---|
|VI<br>Transparency -<br>Option 1|Image of research<br>and<br>animal<br>experimentation|+||Costs for Member<br>States|-||

|VII Non-<br>human<br>primates -<br>Options 1|Animal welfare|+/-|+++ for 1300<br>animals,<br>-- for 12.000<br>animals|Costs for<br>establishments|--|Col7|
|---|---|---|---|---|---|---|
|VII<br>Non-<br>human<br>primates<br>-<br>Options 1|Public concern|++||Scientific need|---||
|VII<br>Non-<br>human<br>primates<br>-<br>Options 1|Biodiversity|+/0||Outsourcing/<br>Competitiveness|--||
|VII<br>Non-<br>human<br>primates Opt 2|Animal welfare|++||Research|-||
|VII<br>Non-<br>human<br>primates Opt 2|Public concern|++||Central Facility for<br>~~future demand~~|---||

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|VIII<br>Inspections -<br>Option 1 -<br>national|Animal welfare|++|12.1 Mio.<br>animals|Impact for<br>establishments|-|0.9 Mio €|
|---|---|---|---|---|---|---|
|VIII<br>Inspections<br>- <br>Option<br>1 <br>- <br>national|Accountability<br>and transparency|+++||Costs for Member<br>States|--|3.1 Mio. € /<br>2.5 Mio. €|
|VIII<br>Inspections<br>- <br>Option 2 - EU<br>inspections|(Animal welfare)|(++)|12.1<br>Mio<br>animals|Costs<br>for<br>establishments|-||
|VIII<br>Inspections<br>- <br>Option 2 - EU<br>inspections|(Accountability<br>and transparency)|(+++)||Costs to EU|---|4.2<br>Mio<br>€ <br>(revised option<br>2.7 to 3.3 Mio)|

|IX Education<br>and Training -<br>Option 1|Animal welfare|+++|12.1 Mio<br>animals|Additional costs to<br>national authorities|-|Col7|
|---|---|---|---|---|---|---|
|IX Education<br>and Training -<br>Option 1|Quality of science|+++||Additional costs to<br>establishments<br>|--|38 Mio €|
|IX Education<br>and Training -<br>Option 1|Free movement of<br>people/workers|+++|||||
|IX Education<br>and Training -<br>Option 1|Job satisfaction of<br>personnel|+++|||||

|X Duplication<br>- Option 1|Animal welfare –<br>basic research|(+)|slight<br>positive<br>effect|Cost to<br>establishments|---|6.2 Mio €|
|---|---|---|---|---|---|---|
|X Duplication<br>- Option 1|Animal welfare –<br>regulatory testing|0||Administrative<br>costs for Member<br>States|--|173,000 €|
|X Duplication<br>- Option 1|Cost<br>reductions<br>for<br>Member<br>States|+||Resource<br>requirements at an<br>EU-level|---|30,000 € one-<br>time<br>costs,<br>105,000<br>€ <br>yearly costs|

|XII Statistical<br>Reporting -<br>Option 1|Monitoring and<br>accountability|+++|Col4|Administrative<br>burden|-|7.4 Mio €|
|---|---|---|---|---|---|---|
|XII Statistical<br>Reporting<br>- <br>Option 1<br>|Policy making|++|||||

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|XII Statistical<br>Reporting -<br>Option 2|Monitoring and<br>accountability|+++|Col4|Administrative<br>burden to users|-|4 Mio €|
|---|---|---|---|---|---|---|
|XII Statistical<br>Reporting<br>- <br>Option 2|Image of research<br>and industry|+||Administrative<br>burden to Member<br>States|--||
|XII Statistical<br>Reporting<br>- <br>Option 2|Policy making|+++|||||
|XII Statistical<br>Reporting<br>- <br>Option 3|Monitoring<br>and<br>policy making|++||Administrative<br>burden to users|-||
|XII Statistical<br>Reporting<br>- <br>Option 3|Transparency|++||Administrative<br>burden to Member<br>States|--||
|XII Statistical<br>Reporting<br>- <br>Option 4|Monitoring<br>and<br>policy making /<br>transparency|+++||Administrative<br>burden to users|--||
|XII Statistical<br>Reporting<br>- <br>Option 4|Public awareness|+++||Administrative<br>burden to Member<br>States|--||

|XIII<br>Promotion of<br>alternative<br>methods –<br>Option 1|Animal welfare<br>increase through<br>Reduction in<br>animal use or<br>method<br>refinement|+++|Col4|Costs to Member<br>States|-|One-off<br>costs 4-5<br>Mio €, plus<br>annual costs<br>1,5 – 3 Mio<br>€|
|---|---|---|---|---|---|---|
|XIII<br>Promotion of<br>alternative<br>methods<br>– <br>Option 1|Promotion<br>of<br>innovation<br>|+++||Costs to industry|++||
|XIII<br>Promotion of<br>alternative<br>methods<br>– <br>Option 1|Public awareness|++||Efficiency gains for<br>public<br>research<br>budgets|+||

**5. How do the options compare?**

The following are the most useful options to create a level playing field within the European
Community and to increase the welfare for all 12.2 million animals used annually in the
Community:

    - Strengthening the authorisation and ethical evaluation of projects would have a significant
impact on levelling economical differences between Member States;

    - Minimum housing and care standards would remove the current uneven competitive
environment for users and breeding and supplying establishments, whilst improving animal
welfare;

    - Standardised inspections would expose non-compliant establishments, ensuring
enforcement and improving public confidence.

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**6. Which options were finally chosen and what are their impacts?**

In the light of the table above, it becomes clear that some of the options that provide for the
highest animal welfare benefits also create the highest costs (Housing and Care standards,
Education and Training standards). However, inspections costs are relatively low and the cost
for transparency in the form of non-technical summaries is almost negligible.

Only the option of banning CO2 seems to entail costs that are out of proportion vis-à-vis
benefits. The remaining policy options do not go further than what is necessary to achieve the
objectives of the revision (principle of proportionality).

Therefore the options that are justified are:

    - Extending the scope to cover animals used in basic research, animals bred for their tissue
and organs, selected invertebrates species, foetal and embryonic forms in the last third of
development before birth or hatching and animals used in education and training;

    - Authorisation of individual projects including a compliance check and ethical evaluation
with decisions to be taken within 30 (maximum 60) days, but allowing group
authorisations in the area of regulatory testing and lighter authorisation process for projects
consisting of only "up to mild" procedures and not involving the use of non-human
primates;

    - Introduction of a national animal welfare and ethics committee to issue guidance;

    - Introduction of a permanent ethical review body in each establishment;

    - Minimum housing and care standards along the lines of the ETS 123 standards;

    - Improving transparency and access to information by publishing non-technical project
summaries;

    - Improving welfare of non-human primates through limiting further the research areas in
which they can be used and via a shift to use only F2 and subsequent generations of
purpose bred animals after a transitional period specific for certain types of species;

    - Banning the use of Great Apes with very limited exceptions;

    - Improving enforcement by twice yearly inspections by national authorities (one
unannounced);

    - Appropriate education and training standards;

    - Specific conditions for CO 2 use;

    - Improving statistical information;

    - National reference laboratories.

Total cost increase of favoured options could be 143.7 Mio € per year but would be largely
attributed to those three options which in return also provide the highest animal welfare
benefits. It is important to note that 23 Mio € attributed to the authorisation of projects reflects

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the scenario in which no Member State opts for the lighter authorisation process for project
consisting of only "up to mild" procedures and not involving the use of non-human primates.
The cost increase has to be assessed against the total costs for animal experiments which were
calculated to be around 2.9 Bio € per year in the EU-25. However, it is understood that
universities and public research institutes may need transitional periods to adapt to new
requirements, whereas some industrial sectors may be able to cope with new standards much
faster.

The benefits from reduced administrative costs and avoiding unnecessary testing were
estimated at around 90 Mio € per year. To calculate the net cost increase of the revision, one
may subtract these 90 Mio € savings from the 143.7 Mio € gross costs increase. The net cost
increase would then be about 51 Mio € per year.

Further benefits/savings from improved science are not yet included. For some options with a
very high potential to improve animal welfare, the corresponding benefits for science can be
monetised. If only a few percentages (1-3%) of the studies that currently suffer from a weak
experimental design, inappropriate housing and care standards or not fully competent
personnel can be improved, the benefits may be in the same order of magnitude as the
financial costs of these options.

All of the actions have been scrutinised to check that they pass the necessity test. They are
necessary to fulfil the requirements of the Protocol annexed to the EC Treaty to pay full
regard to animal welfare requirements in formulating internal market and research policies. At
the same time, they cannot be better carried out by Member States individually.

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