COMMISSION STAFF WORKING DOCUMENT Accompanying the document REPORT FROM THE COMMISSION TO THE EUROPEAN PARLIAMENT AND THE COUNCIL on the implementation of Directive 2010/63/EU on the protection of animals used for scientific purposes in the Member States of the European Union

EN EN
EUROPEAN
COMMISSION
Brussels, 5.2.2020
SWD(2020) 15 final
COMMISSION STAFF WORKING DOCUMENT
Accompanying the document
REPORT FROM THE COMMISSION TO THE EUROPEAN PARLIAMENT AND
THE COUNCIL
on the implementation of Directive 2010/63/EU on the protection of animals used for
scientific purposes in the Member States of the European Union
{COM(2020) 15 final}
Europaudvalget 2020
KOM (2020) 0015
Offentligt
1
CONTENTS
Introduction............................................................................................................................................ 3
i. Information from the Member States.................................................................................................... 3
ii. Structure of the Report.......................................................................................................................... 4
A. GENERAL INFORMATION.................................................................................................................... 4
B. STRUCTURES AND FRAMEWORK........................................................................................................ 5
B.1. Competent authorities (Article 59 of Directive 2010/63/EU)............................................................ 5
B.2. National committee (Article 49 of Directive 2010/63/EU) .............................................................. 11
B.3. Education and training of personnel (Article 23 of Directive 2010/63/EU)..................................... 14
B.4. Project evaluation and authorisation (Articles 38 and 40 of Directive 2010/63/EU) ...................... 20
C. OPERATION....................................................................................................................................... 28
C.1. Projects............................................................................................................................................. 28
C.1.i. Granting of project authorisation (Articles 40 and 41 of Directive 2010/63/EU) ...................... 28
C.1.ii. Retrospective assessment, non-technical project summaries (Articles 38, 39 and 43 of
Directive 2010/63/EU)......................................................................................................................... 32
C.2. Animals bred for use in procedures (Articles 10, 28 and 30)........................................................... 37
C.2.i. Animal bred, killed and not used in procedures ........................................................................ 37
C.2.ii. Sourcing of non-human primates.............................................................................................. 42
C.3. Exemptions....................................................................................................................................... 43
C.4. Animal Welfare Body (Articles 26 and 27 of Directive 2010/63/EU)............................................... 46
D. PRINCIPLES OF REPLACEMENT, REDUCTION AND REFINEMENT..................................................... 50
D.1. Principle of replacement, reduction and refinement (Articles 4 and 13 of Directive 2010/63/EU) 50
D.2. Avoidance of duplication (Article 46 of Directive 2010/63/EU) ...................................................... 53
D.3. Tissue sampling of genetically altered animals (Articles 4, 30 and 38 of Directive 2010/63/EU .... 54
E. ENFORCEMENT................................................................................................................................. 57
E.1. Authorisation of breeders, suppliers and users (Articles 20 and 21 of Directive 2010/63/EU)....... 57
E.2. Inspections (Article 34 of Directive 2010/63/EU)............................................................................. 62
E.3. Withdrawals of project authorisation (Article 44 of Directive 2010/63/EU) ................................... 66
E.4. Penalties (Article 60 of Directive 2010/63/EU) ................................................................................ 67
F. OTHER – ADDITIONAL VOLUNTARY QUESTIONS.............................................................................. 69
F.1. Problematic areas for implementation of the Directive .................................................................. 69
F.2. Views on well-functioning elements of the Directive in your Member State.................................. 70
F.3. Views on issues that would benefit from collaborative efforts to improve implementation of the
Directive .................................................................................................................................................. 70
F.4. Any other additional comments concerning the implementation of the Directive ........................ 71
2
G. Commission activities to facilitate the imlementation of the Directive.......................................... 71
G.1. Transposition conformity checks..................................................................................................... 71
G.2. Other activities to facilitate correct and uniform implementation of the Directive. ...................... 71
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INTRODUCTION
This Staff Working Document is an annex to the main report1
to the European Parliament and the
Council on Member States’ implementation of Directive 2010/63/EU on the protection of animals
used for scientific purposes2
(“the Directive”).
Under Article 54(1), Member States are required to send the information on the implementation
of the Directive and in particular Articles 10(1), 26, 28, 34, 38, 39, 43 and 46 to the Commission.
The detailed content of Member State reporting requirements is laid out in Annex I of
Commission Implementing Decision 2012/707/EU3
(“the Annex”).
In June 2019, the Directive was amended by Regulation (EU) 2019/10104
(“the Regulation”). In
particular, Article 54(1) was amended to require the next Member State implementation reports to
be submitted to the Commission through electronic transfer by 10 November 2023, and every
five years thereafter. Furthermore, the obligation for the Commission to submit a report on its
implementation to the European Parliament and the Council by 10 November 2019 (Article
57(1)) was deleted.
As the Regulation was adopted after Member States had already submitted the information
covering the first five years of the functioning of the Directive, i.e. the period 2013-2017, the
European Commission considers it appropriate, especially given that improved transparency is
one of the key objectives of the Directive, to provide a consolidated EU report on its
implementation.
This Commission Staff Working Document presents the results of the examination of the reports
by the Member States in greater detail than in the report to the European institutions, which
focuses on the main elements. It describes how Member States have implemented the Directive,
in line with the requirements of the Annex, and highlights any identified issues. It does not
provide an exhaustive account of all national implementation measures.
i. Information from the Member States
Member States were requested to submit their national implementation reports using a tailored
questionnaire. The deadline for the submission was 10 November 2018 in accordance with
Article 54(1), as applicable at the relevant time. The questionnaire covered all the elements
described in the Annex to Commission Implementing Decision 2012/707/EU. Furthermore, it
contained some additional, voluntary, questions (marked with an asterisk) to provide wider
context to the answers. In some cases, an element described in the Annex was broken down to
sub-questions to aid comprehension of the reporting obligation.
22 Member States submitted their reports by the deadline. Of the six Member States that were
late, the last submitted the report at the end of February 2019. When reviewing the content and
the quality of the provided information, on the one hand several shortfalls were identified
including unanswered compulsory questions, incorrect data due to misunderstanding of the
reporting obligation, or the report containing conflicting information. On the other, some Member
State reports gave very detailed information and often provided additional, voluntary information,
1
COM(2020)15 final
2
OJ L 276, 20.10.2010, p. 33–79
3
OJ L 320, 17.11.2012, p. 33–50
4
OJ L 170, 25.6.2019, p. 115–127
4
to aid understanding. Concerning the shortfalls, in some cases further clarity was obtained
through bilateral communication, but in a number of cases it was not possible due to the tight
deadline set for the publication of the EU report. The conclusions and tables included in this
report are based on the original submissions and incorporate directly any later updates/corrections
to these. The last Member State correction to the original submission was received as late as
September 2019. Member State submissions can be found at
https://ec.europa.eu/environment/chemicals/lab_animals/index_en.htm.
The inconsistent quality of reporting has made drawing of conclusions at EU level challenging.
Some such areas will be highlighted in the report.
ii. Structure of the Report
The structure of the report will follow the format and order as set out in the Annex. In addition, to
the legal reporting obligations, the questions from the questionnaire precede the analysis. In some
cases, survey questions are grouped together when these are closely linked and would have
otherwise resulted in repeated answers. Some comparative tables are presented but only drawing
from elements that make part of compulsory Annex I reporting obligations, and for which the
basis of the reporting is assumed to be similar.
A. GENERAL INFORMATION
Reporting obligation
“Changes made to national measures regarding the implementation of Directive 2010/63/EU
since the previous report”
Analysis
Question in the questionnaire
A - 1 Describe main changes made to national legislative measures regarding the
implementation of Directive 2010/63/EU. For the purposes of the first implementation
report, the changes should reflect those made to the previous legislation (under Directive
86/609/EEC) as a result of the transposition of the Directive, and any subsequent
amendments. "Description of main changes" should provide an understanding of the key
elements that underwent legislative changes.
Ten Member States indicated that the national legislation had been changed to meet the
provisions of the new Directive, but did not provide any information on what changes were
required to the previous legislation.
Of the remaining responses, some Member States reported major changes to their legislative
structure, for example with the introduction for the first time of project evaluation and
authorisation processes, the publication of non-technical project summaries and the
requirement to have Animal Welfare Bodies in each establishment.
Others reported fewer changes, for example, Member States where project authorisation
systems had already been in place under Directive 86/609/EEC. However, the new
requirements for severity classification and reporting, non-technical project summaries,
retrospective assessment and timeliness of authorisation decisions necessitated changes to
5
legislation in all Member States. In addition, the following elements were reported by a
majority of Member States as having resulted in significant changes:
 the extended scope to include foetal forms of mammals and also Cephalopods;
 the new requirements for accommodation and care and methods of killing;
 the risk-based approach to, and frequency of, inspections.
The focus on alternatives has also required many Member States to consider how best to meet
the provisions in the Directive. A number of Member States have developed voluntary Three
Rs centres to promote improved availability of information and development of alternatives.
National Committees were new to many Member States.
In summary, from the responses received, there were significant differences among Member
States on the extent of changes required to existing legislation to meet the requirements of the
new Directive.
B. STRUCTURES AND FRAMEWORK
B.1. Competent authorities (Article 59 of Directive 2010/63/EU)
Reporting obligation
“information on the framework for competent authorities, including the numbers and types of
authorities”
Background
The Directive requires that the following tasks are performed by a competent authority
1) Authorisation of breeders, suppliers and users (Article 20(1))
2) Inspections (Article34(1))
3) Project evaluation (Article 36(2))
4) Project authorisation (Article 36(1))
5) Retrospective assessment of projects (Article 39(1))
A competent authority is usually a public authority. However, the Directive allows also
bodies other than public authorities to be designated as competent authorities provided the
conditions in Article 59(1) are met, namely, that the body
“(a) has the expertise and infrastructure required to carry out the tasks; and
(b) is free of any conflict of interests as regards the performance of the tasks.”
Finally, in reference to the task of project evaluation, the Directive further requires in its
Article 38(3) and (4):
“3. The competent authority carrying out the project evaluation shall consider
expertise in particular in the following areas:
(a) the areas of scientific use for which animals will be used including
replacement, reduction and refinement in the respective areas;
(b) experimental design, including statistics where appropriate;
6
(c) veterinary practice in laboratory animal science or wildlife veterinary
practice where appropriate;
(d) animal husbandry and care, in relation to the species that are intended to
be used.
4. The project evaluation process shall be transparent.
Subject to safeguarding intellectual property and confidential information, the project
evaluation shall be performed in an impartial manner and may integrate the opinion
of independent parties. “
Analysis
Questions in the questionnaire
2 - Is the implementation of Directive 2010/63/EU a responsibility of one or more
ministry/ministries
2.bis - Please provide the name of the ministry
2.tris - Please provide the name of the ministries involved and briefly describe the
distribution of responsibilities
B - 1.1 Provide information on the framework for competent authorities. Where there is
more than one competent authority, explain 1) how the tasks are divided between
different authorities 2) how the authorities interact to ensure that the Directive is
implemented effectively. If possible, please explain what measures are in place to
ensure coherent approach and consistency of outcomes. Make sure to consider all five
tasks requiring a competent authority i.e. authorisation of establishments, inspections,
project evaluation, project authorisation and retrospective assessment.
* B - 1.1.bis An organogram or another explanatory document can be uploaded here.
B – 1.2 There is only one public competent authority for the Member State, or for each
region (where regional structure) who is tasked with all five tasks requiring competent
authority (I.e., the same competent authority (national/regional) performs all tasks:
authorisation of establishments, inspections, project evaluation, project authorisation
and retrospective assessment of projects). Yes/No
B - 1.2.bis If your MS has a regional structure, how many regional authorities are there?
B - 1.3 Other than single national or regional authority: Please provide information on the
numbers and types of authorities per task
B - 1.3.bis Please explain if "other" than national/regional authority and/or "non-public
authority" was selected
Implementation of the Directive
In addition to requiring information on competent authorities assigned for the tasks in the
Directive, the questionnaire also invited Member States to specify the ministry(/ies)
responsible for the implementation of the Directive. Where the responsibility was shared,
further clarification was requested on the distribution of responsibilities.
7
Is the implementation of Directive 2010/63/EU a responsibility of one or more
ministry/ministries?
Responsibility of a single ministry 21
Shared responsibility between two or more ministries 7
Total 28
Most ministries responsible for the implementation of the Directive are those responsible for
agriculture and the environment, although some are responsible for health, education, science
and innovation.
Competent authorities
It is challenging to draw EU level conclusions on the way in which tasks are assigned to
competent authorities. Member States have highly different structures varying from central to
regional and local structures. In addition, in some cases the designation of tasks between
competent authorities may vary even between different regions within a single Member State.
Member States have implemented the responsibilities for competent authorities in a number of
different ways, to some extent reflecting the different national legislative frameworks and to
some extent reflecting the numbers of animals used.
The analysis is further complicated by the fact that some Member States may seem to have
misunderstood some of the questions, for example, reporting only one single public authority,
however, having a regional structure with regional authorities.
Finally, it is not certain that the term ‘competent authority’ is understood in the same manner
by all Member States. On one hand, some Member States have stated that only one competent
authority is responsible for five tasks in the Directive. On the other, in written comments,
reference is made for example to project evaluation which is delegated to ‘ethics committees’.
Is there only one public competent authority for the Member State?
Yes 15
No; there are two or more different types of competent authorities depending on the
task
13
Total 28
Of the 15 Member States who reported having one public competent authority, nine
(Bulgaria, Ireland, Croatia, Cyprus, Latvia, Lithuania, Luxembourg, Portugal and Slovakia)
indicated a single competent authority being responsible for all five tasks, namely
If your Member State has a regional structure, how many regional authorities are
there?
Latvia 1
Luxembourg 0
Austria 10
United Kingdom 2
Total 13
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authorisation of establishments, inspections, project evaluation, project authorisation and
retrospective assessment.
Two Member States (Austria and United Kingdom) stated that there were regional competent
authorities (ten and two regional authorities respectively) but that one competent authority in
each region is responsible for all five tasks.
Four Member States (Denmark, Italy, Romania and Slovenia) gave conflicting information:
 Denmark – indicated one competent authority – but in another instance reported split
responsibility between Danish Experimentation Council and Animal Experiments
Inspectorate;
 Italy – indicated one competent authority – but in another instance reported split
responsibility for tasks and separate competent authorities for authorisation and
inspection of breeders, suppliers and users;
 Romania - indicated one competent authority - but in another instance stated that the
evaluation of the projects is carried out by ethics committees established within the
establishments of users;
 Slovenia – indicated one competent authority – but in another instance reported ten
regional offices;
13 Member States (Belgium, Czechia, Germany, Estonia, Greece, Spain, France, Hungary,
Malta, Netherlands, Poland, Finland and Sweden) indicated more than one competent
authority.
9
Other than single national or regional authority: Please provide information on the numbers and types of authorities per task.
N = National; R = Regional; O = Other ; P = Public authority; NP = Non-public authority
Member State Number of CA for
authorisation of
establishments
Number of CA for
inspections
Number of CA for
project evaluation
Number of CA for
project authorisation
Number of CA for
retrospective
assessment of projects
Belgium 3 R P 3 R P 33 O NP 33 O NP 33 O NP
Czechia 1 N P 14 R P 8 O P 8 O P 8 O P
Germany 26 R P 285 R P 26 R P 26 R P 26 R P
Estonia 11 R 11 R 1 N 1 N 1 N
Greece 13 R P 71 R P 57 R P 13 R P 57 R P
Spain 17 R P 17 R P 89 N P/NP 17 R P 89 N P/NP
France 1 N P 1 N P 125 O NP 1 N P 125 O NP
Hungary 19 R 1 N P 19 R 1 N
Malta 1 N P 1 N P 2 N P 2 N P 1 N P
Netherlands 1 N P 1 N P 17 R NP 1 N P 1 N P
Poland 305 O P 305 O P 11 O P 11 O P 11 O P
Finland 2 R P 2 R P 1 N P 1 N P 1 N P
Sweden 1 N P 21 R P 6 R P 6 R P 1 N P
10
A number of Member States have formal regional structures, for example Germany, Spain and
Austria, where all five tasks are allocated to the regional governments who determine the
allocation of tasks within their respective region.
In many Member States, the tasks are allocated to two, three or four different types of
competent authorities, responsible for different tasks in the Directive.
Where there are two or more different types of competent authority depending on the task,
numbers of these in five Member States suggest that there may be grouping of tasks such that
authorisation of establishments and inspections may be done by the same authority, and
project authorisation and retrospective assessment by a separate authority. In two additional
Member States the same authority may perform project evaluation and retrospective
assessment.
The more common division is a separation of inspection and authorisation of breeders,
suppliers and users, from project evaluation and authorisation, and retrospective assessment.
In some Member States, for example Hungary and Netherlands, a single competent authority
is responsible for authorisation of breeders, suppliers and users and inspections, but separate
competent authority/(ies) have responsibility for project evaluation and authorisation, and
retrospective assessment.
In contrast, for example, in Poland, although the division of functions is similar, they reported
305 competent authorities with responsibility for inspection and authorisation of breeders,
suppliers and users. Inspection is often undertaken by Veterinary Authorities, and the
competent authority role for this function is often undertaken at a local or regional level – for
example Greece reported 71, Germany 285.
The structures for project evaluation and authorisation also differ significantly – from single
committees (competent authorities) charged with evaluation and authorisation for all projects
in the Member State, to regional structures (for example Germany (26), Austria (10) and
Sweden (6)) to local ethics committees which evaluate only projects local to that area, or
within a single establishment (for example Belgium (33), France (125)). Authorisation may be
performed by another competent authority.
It has been acknowledged that the greater the number of competent authorities involved in the
implementation of the Directive within a Member State, the greater the challenges are to
ensure a common and consistent approach and outcomes.
Methods adopted to promote a consistent approach include training for project evaluators and
inspectors, regular meetings of competent authorities, standardised project application and
evaluation forms, standard checklists for authorisation and inspection of establishments.
The 2017 review of the Directive5
identified difficulties for the scientific community due to
variations in implementation within and between Member States. Given the significant
variations in competent authority structures across Member States it is perhaps not surprising
that concerns over inconsistencies were raised.
5
https://eur-lex.europa.eu/legal-content/EN/TXT/?qid=1510219889073&uri=COM:2017:631:FIN
11
Five Member States submitted an organogram or another explanatory document (Belgium,
Germany, Latvia, Netherlands and Slovakia). Three of these gave a pictorial representation,
which appear to correlate with elements of written text. These are included in the detailed
Member State summaries.
B.2. National committee (Article 49 of Directive 2010/63/EU)
Reporting obligation:
“information on the structure and operation of the national committee”
Background
Article 49
National committees for the protection of animals used for scientific purposes
1. Each Member State shall establish a national committee for the protection of animals used
for scientific purposes. It shall advise the competent authorities and animal-welfare bodies on
matters dealing with the acquisition, breeding, accommodation, care and use of animals in
procedures and ensure sharing of best practice.
2. The national committees referred to in paragraph 1 shall exchange information on the
operation of animal-welfare bodies and project evaluation and share best practice within the
Union.
Analysis
A number of Member States already had in place similar committees advising on matters
relating to the use of animals in research, whereas for others this was a new requirement.
Although many Member States had a committee in place soon after transposition, in others it
took some years to develop the necessary framework, and therefore experience of the various
National Committee functions are varied.
The general view given is that as the role evolves, links between Animal Welfare Bodies and
National Committees continue to strengthen, but their effectiveness is almost wholly
dependent on suitable resourcing by the Member State.
2.1.Structure
Question in the questionnaire
B - 2.1 Provide information on the structure of your National Committee
National Committees vary in composition, but generally include members of differing
scientific and welfare backgrounds and disciplines, with logistical support provided by the
ministry(/ies)/authorities – depending on Member State structure. Some members are also
members of Animal Welfare Bodies.
Membership is generally for a limited period, and appointments are endorsed by
ministry(/ies)/authorities.
The frequency of meetings varies significantly, largely dependent on the size and complexity
of scientific work conducted, and whether or not additional responsibilities, such as project
evaluation, have been added to their remit. Meetings reported vary from annual to monthly.
12
Financial support varies, and this is reflected in the level of activities achieved.
A number of National Committees have bespoke web-sites6
, and publish their activities.
2.2.Advice to competent authorities, in particular with regard to project evaluation
Question in the questionnaire
B - 2.2 Provide information on the operation of your National Committee in relation to its
task to advise competent authorities, including on how it aims to address coherent
approach to project evaluation and review strategies at national level as provided in
Recital 48
In a few Member States, the National Committee has also assumed the task of project
evaluation for all projects in the Member State. In others, the competent authorities refer
specified types of projects (for example those using non-human primates, or those presenting
difficult or novel ethical challenges) to the National Committee or invite their view on
requests for exemption, for example, to conduct of procedures outside establishments.
A number of National Committees have developed templates and guidance for project
applications and evaluations to facilitate consistency. These have been found to be helpful
where there are multiple competent authorities responsible for project evaluation. In a few
Member States, the National Committee is involved in training of project evaluators.
Standardised formats for submission of non-technical project summaries and retrospective
assessment have also been developed by some. Several National Committees are involved in
oversight and approval of education and training courses for personnel involved in animal use
and care.
Competent authorities in many Member States have utilised the National Committee to
address specific questions, but the level of consultation varies significantly, with one response
indicating that the National Committee had received no requests from competent authorities.
Other National Committees have been consulted by competent authorities, for example on
appropriate accommodation and care practices for species without detailed requirements in
Annex III. National Committees have also been invited to develop guidance on specific areas
of scientific use and care, for example on staff responsibilities for animal use and care, on
rehoming and, on advice to avoid duplication of procedures.
2.3.Advice to Animal Welfare Bodies
Question in the questionnaire
B - 2.3 Provide information on the operation of your National Committee in relation to its
task to advise animal welfare bodies
In the majority of Member States, National Committees have developed effective
communication channels with Animal Welfare Bodies to disseminate relevant information and
have provided mechanisms for Q&A and sharing of best practice. In some Member States the
ministry(/ies)/authorities remain a valuable source of information.
6
https://ec.europa.eu/environment/chemicals/lab_animals/nc_en.htm
13
A few National Committees have invited contributions from Animal Welfare Bodies by means
of questionnaires to inform and focus their future work programme.
Provision of up-to-date information on replacement (alternatives) has been requested of a few
National Committees. One National Committee reported that no advice had been sought by
Animal Welfare Bodies.
2.4.Sharing of best practice
Question in the questionnaire
B - 2.4 Provide information on the operation of your National Committee in relation to its
task to share best practice
Some National Committees have organised meetings of Animal Welfare Bodies and arranged
training sessions for Animal Welfare Body members, for example, a symposium on
experimental design.
One Member State hosts an annual symposium to showcase best practice initiatives, and
provides financial support to encourage further improvements.
Symposia are organised by some National Committees on relevant topics, for example
neurological and psychiatric models, promoting consistency in statistical reporting, and
procedural training for animals.
Good practice guidance has been developed on a number of topics, either at the request of the
competent authority, feedback from Animal Welfare Bodies, or on their own initiative.
Examples include guidelines on tumour models, blood sampling, recognising and alleviating
pain, water and food restriction for scientific reasons.
Questions in the questionnaire [voluntary question]
* B - 2.5 Has the EU Guidance on Animal Welfare Bodies and National Committees
been made available to the members of National Committee and establishment Animal
Welfare Bodies?
EU Guidance made available
Yes 25
No 1
No response 2
Total 28
Question in the questionnaire [voluntary question]
* B - 2.6 Has additional official guidance for Animal Welfare Bodies and National
Committee been developed to facilitate implementation?
Additional guidance developed
Yes 7
No 18
14
No response 3
Total 28
Question in the questionnaire [voluntary question]
* B - 2.6.bis If you consider this guidance helpful for other Member States to facilitate the
implementation of the Directive, please provide web-address for the guidance, where
available
Some Member States have developed additional guidance and websites are provided in the
detailed Member State summaries.
B.3. Education and training of personnel (Article 23 of Directive 2010/63/EU)
Reporting obligation
“information on the minimum requirements referred to in Article 23(3) of Directive 2010/63/EU
including any additional educational and training requirements for staff coming from another
Member State.”
Background:
Directive provides, in its Article 23 that
“1. Member States shall ensure that each breeder, supplier and user has sufficient staff
on site.
2. The staff shall be adequately educated and trained before they perform any of the
following functions:
(a) carrying out procedures on animals;
(b) designing procedures and projects;
(c) taking care of animals; or
(d) killing animals.
Persons carrying out the functions referred to in point (b) shall have received instruction
in a scientific discipline relevant to the work being undertaken and shall have species-
specific knowledge.
Staff carrying out functions referred to in points (a), (c) or (d) shall be supervised in the
performance of their tasks until they have demonstrated the requisite competence.
Member States shall ensure, through authorisation or by other means, that the
requirements laid down in this paragraph are fulfilled.
3. Member States shall publish, on the basis of the elements set out in Annex V, minimum
requirements with regard to education and training and the requirements for obtaining,
maintaining and demonstrating requisite competence for the functions set out in
paragraph 2.
15
4. Non-binding guidelines at the level of the Union on the requirements laid down in
paragraph 2 may be adopted in accordance with the advisory procedure referred to in
Article 56(2).”
Analysis
Question in the questionnaire
B - 3.1 Provide information on the minimum requirements for education and training for
functions in Article 23(2)
The level of detail and clarity in responses vary significantly, making it challenging to
determine with certainty what the exact training requirements are across the EU. It is
important to note in this context that education and training matters remain the competence of
the Member States, although minimum requirements are listed in the Directive (see Annex V
of the Directive).
The national legislation requires appropriate education and training for the personnel listed in
Article 23(2). General requirements are included in national legislation, the majority of
Member States have published the EU Guidance document on Education and Training
Framework7
and a minority have produced additional Member State guidance. Several
Member States reported that recent improvements in training provision are underway.
Some Member States state that there are minimum educational requirements, including higher
education degrees required for the role as project designer in several Member States.
From the information provided
Training courses are provided Number of MS
Accredited and/or MS approved
courses
6
Training course provided but not
formally accredited/approved
4
Local/establishment level training 5
Unclear 10
None 3
Accredited/Member State approved courses seem to be available only in a minority of
Member States. Training courses without reported quality assurance are provided by a few
others. Local training and supervision occurs in some Member States, and what training, if
any, is delivered in other Member States is unclear on the basis of the responses.
Some Member States define a syllabus for training courses and some determine a minimum
duration of training, which can differ between Member States. Many training courses still
relate to teaching hours, or numbers of lessons, but not attainment of specific Learning
Outcomes – contrary to what is promoted in the EU Guidance document on Education and
Training Framework endorsed by the Member States.
7
https://ec.europa.eu/environment/chemicals/lab_animals/pdf/guidance/education_training/en.pdf
16
A small number, perhaps as many as nine, seem to have implemented the EU guidance
document on Education and Training Framework. For others it is unclear how quality of
training ensures that all necessary learning is acquired to an adequate standard.
In three cases, while training courses are required, they may be completed within the first 6-12
months of starting work. It was not clear from the responses, whether it is systematically
required that these persons, when working with animals, work under supervision as obliged by
the Directive, until such time training is completed and competence demonstrated.
From the responses provided (November 2018), there seem to be three Member States where
no formal requirement for training have been adopted.
 Italy: “With regard to the information on the minimum requirements for education and
training of staff referred to in Article 23(2) of D.lgs. 26/2014, we should point out that no
ministerial decree governing this matter has yet been issued”
 Cyprus: “So far there are general requirements for education and training for functions in
Article 23(2) and these are fulfilled via authorization of the persons who carry out
procedures on animals (personal license) and via evaluation of the competence of the
persons designing procedures and projects during project evaluation. Moreover, in 2019
the National Committee schedules to start organizing training programs for all functions
so that the education and training is more consistent and invariable”
 Romania: “There are no specific requirements other than those established by law. A
specific legal order on training for functions in Art. 23(2) is currently being drafted;”
Greece indicated that a ministerial decision regulating the procedures required in order to
authorise training of scientific associations or other training bodies and training programs for
all four functions is about to be issued.
There remain differing requirements among Member States for training of personnel under
Article 23, in terms of course content, duration and minimum educational requirements,
although there are now mechanisms in place in the majority of Member States to consider the
suitability of training elsewhere when applications are submitted, to avoid unnecessary
duplication of training, costs and delays to the personnel concerned.
Question in the questionnaire
B – 3.2 Provide information on the requirements for obtaining, maintaining and
demonstrating requisite competence for functions in Article 23 (2) – that is carrying out
procedures on animals, taking care of animals or killing animals
Information, often repetition from earlier question in the questionnaire, was provided on
training courses, but little on attainment and maintenance of competence, which was a new
obligation introduced by the Directive. It is not clear in many responses what systems are
required to ensure attainment and maintenance of competence.
In some Member States, it is the responsibility of the establishment to train and ensure
competence of the personnel, seemingly in the absence of formal training courses. Within the
establishment, this is often effected by the person identified in Article 24(1)(c) – person
17
responsible for ensuring staff are adequately educated, supervised until competent, that
competence is maintained and that they are continuously trained.
This is a new requirement for Member States and acknowledgement was made that in many
Member States there are no formal systems for supervision and competence assessment. A few
Member States noted that further guidance was in preparation, and some training providers are
working on measures for consistent assessment of competence (for example DOPS – Direct
Observation of Procedural/practical Skills).
Some Member States indicated that if staff had not been working with animals for a specified
period of time, the individual would have to undergo re-training and/or a period of
supervision.
One Member State noted that annual refresher training would be provided by the
establishment, and that if there are extended breaks between carrying out any of the tasks, re-
training would be required. A few (for example Spain, Luxembourg and Slovakia) noted
formal requirements for maintaining standards (CPD – Continued Professional Development),
and some professional organisations, for example for veterinarians and animal technologists,
have published guidance.
Despite the diversity of training, there were no comments suggesting that lack of competence
was an issue. It was often noted that implementation of education and training requirements,
including attainment and maintenance of competence, is checked during inspections,
suggesting that there is oversight of outcomes (at least in some Member States) and that if
training were less than ideal, it could be identified and remedied.
A few responses giving examples of some different approaches to supervision and competence
assessment are included below
 Spain: “Maintenance of training:
1. The initial training shall be maintained through ongoing training activities.
2. The ongoing training activities shall aim to ensure the improvement and updating of
the skills and knowledge initially acquired and shall meet the following conditions
a) They shall include the delivery of or attendance at courses, seminars, lectures,
workshops or scientific conferences; authorised stays in research centres or
other similar activities which are specified by the competent bodies and are
aimed at learning about new or updated techniques, methods or rules
applicable to animal experiments.
b) They shall be related to the learning outcomes of the modules corresponding to
the function in question.
c) As a whole, they shall have the minimum duration set out in Annex III for each
function.
d) They shall be accredited through diplomas or certificates of attendance in
which reference is made to their content and duration.
e) Their content shall enable the training for one or more functions to be
maintained.
f) They shall respect the conditions laid down for the use of live animals in
training courses.”
18
 Luxembourg: “The framework for obtaining the competence for carrying procedures,
taking care of animals and performing euthanasia begins with the trainee initially
observing the procedures/euthanasia/taking care of animals being carried out, he then
carries out the procedures/euthanasia/taking care of animals under close supervision
until competency is acquired. The supervision period and the time until competency is
attained vary for each individual, the task being performed, technical complexity and the
ability of the individual. Only after full competency has been attained the trainee is
allowed to conduct the procedure/ euthanasia/ taking care of animals unsupervised. The
demonstration and the assessment of requisite competence is performed by the designated
veterinarian (Article 25) or/and the person responsible for education, competence and
CPD (Article 24). The progress of obtaining requisite competence for functions listed in
Article 23§2 must be documented in a record at the breeder/supplier/user establishment
for each individual and for each procedure, function and task.”
 Netherlands: “The person (responsible for training) checks that staff are trained in
accordance with the requirements, both in theoretical subjects in order to maintain
competence (additional and continuing development) and in practical subjects in order to
maintain or obtain proficiency (skill). Although the Dutch authorities leave open the
possibility of laying down more detailed requirements, there are at present no additional
rules regarding the continuing development of staff who carry out procedures on animals
or who design animal experiments”
 Slovenia: “The basic training for animal keepers and persons responsible for killing
animals comprises at least 30 lessons, whereas the basic training for persons who
perform procedures on animals comprises at least 40 lessons. After a person has
successfully completed his or her basic training, he or she works under the supervision of
a mentor for at least six months. The mentor is appointed by the animal welfare expert in
the organisation where the above-mentioned persons work. When a person demonstrates
the requisite professional competence, the animal welfare expert enters him or her in the
register of qualified persons on the basis of the mentor’s written opinion. The persons
referred to in Article 23(2) (a), (c) and (d) of the Directive must maintain their
professional competence through regular work, by keeping up to date and by refreshing
their knowledge in their scientific or professional field, as demonstrated by scientific or
expert publications or by participating in scientific or expert meetings within five years of
the completion of basic training. The further training of animal keepers and persons
responsible for killing animals must comprise at least four lessons, whereas the further
training of persons who perform procedures must comprise at least eight lessons.
 Finland: “After the theoretical education & training, persons may get more practical
training when necessary. They work under supervision until they have needed knowledge
and skills. The demonstration and assessment for the official competency is not yet
working. This is, however, under a joint development – the assessment, assessment forms
and training of evaluators are planned in the working group of FinLAS. The goal is that
this process will be working 2019.”
Questions in the questionnaire
19
B - 3.3 Are there any additional education and training requirements for staff coming from
another Member State?
B - 3.3.bis Provide information on additional education and training requirements for staff
coming from another Member State
The 2017 review of the Directive8
suggested that there were still difficulties for staff and
researchers in moving between Member States as education and training requirements differed
and additional training was required, causing delays in being able to start work.
There was acknowledgement in some Member States of acceptability of training courses,
which had been provided by other Member States or other external course accreditors, for
example FELASA9
, such that persons coming from another Member State need not
necessarily complete all within-Member State training. Details are generally checked by the
competent authority during assessment of an application for authority to work with animals in
scientific procedures.
Only eight Member States (Belgium, Denmark, Ireland, France, Netherlands, Poland, Portugal
and United Kingdom) indicated that there were additional training requirements for personnel
coming from another Member State.
Of these responses, six indicated that training in local legislation and practices would be
required. In Denmark there is an e-learning module available.
The UK requires further additional training for project designers and applicants.
The competent authorities will assess the previous training of the applicant to determine
whether any further additional training will be necessary. If training in another Member state
has been completed and is determined to be equivalent, then the other Member State training
is accepted.
There is evidence that training from other Member States is recognised by some others
allowing exemption from repeated training in the new Member State.
Question in the questionnaire [voluntary questions]
* B - 3.4 Has the EU Guidance on Education and Training Framework been made
available to those responsible for education, training and competence in establishments?
See table below (3.5).
* B - 3.5 Have specific training requirements been introduced by authorities for persons
in Articles 24, 25 and 38 as recommended by the EU Guidance?
* B - 3.6 Has additional official guidance on education, training and competence been
developed to facilitate implementation?
8
https://eur-lex.europa.eu/legal-content/EN/TXT/?qid=1510219889073&uri=COM:2017:631:FIN
9
Federation for Laboratory Animal Science Associations
20
* B - 3.6.bis If you consider this guidance helpful for other Member States to facilitate the
implementation of the Directive, please provide web-address for the guidance, where
available?
EU
Guidance
made
available
MS
Guidance
produced
Training
of named
welfare
and care
persons
Training of
named
person
responsible
for
information
Training of
named
person
responsible
for training
Training
of DV
Training
of project
evaluators
Yes 24 4 8 5 5 8 4
No 4 19 12 15 15 11 16
Unclear 1
Blank 5 8 8 8 8 8
Total
No+Blank
4 24 20 23 23 19 24
Grand total 28 28 28 28 28 28 28
Specific training relevant to animal care is required for any person responsible for animal care
and welfare in a number of Member States, with some but not all requiring degree level
training. Few Member States have requirements for training of person responsible for
information. In some cases, joint posts are held with the person responsible for care and
welfare.
Designated Veterinarian (DV) training: Responding countries mentioned the requirement to be
a trained / practising veterinarian. One Member State mentioned an option to appoint another
relevant expert, with species specific knowledge and expertise as a requirement. Only one
country (the UK) reported a specific training course for DV. Some countries have additional
training requirements for DVs including attending modules for other functions. Some
mentioned the importance of CPD.
These figures and statements show that many Member State have yet to develop training for
the persons named in Article 24 of the Directive.
Five Member States reported that they had developed additional guidance and four of these
have provided weblinks available in the detailed Member State summaries.
B.4. Project evaluation and authorisation (Articles 38 and 40 of Directive 2010/63/EU)
Reporting obligation:
“description of the processes of project evaluation and authorisation and how the requirements
of Articles 38 and 40 of Directive 2010/63/EU are met”
Background:
The Directive provides the following in its Article 38 on project evaluation:
1. The project evaluation shall be performed with a degree of detail appropriate for the
type of project and shall verify that the project meets the following criteria:
21
(a) the project is justified from a scientific or educational point of view or required
by law;
(b) the purposes of the project justify the use of animals; and
(c) the project is designed so as to enable procedures to be carried out in the most
humane and environmentally sensitive manner possible.
2. The project evaluation shall consist in particular of the following:
(a) an evaluation of the objectives of the project, the predicted scientific benefits or
educational value;
(b) an assessment of the compliance of the project with the requirement of
replacement, reduction and refinement;
(c) an assessment and assignment of the classification of the severity of procedures;
(d) a harm-benefit analysis of the project, to assess whether the harm to the animals
in terms of suffering, pain and distress is justified by the expected outcome taking
into account ethical considerations, and may ultimately benefit human beings,
animals or the environment;
(e) an assessment of any justification referred to in Articles 6 to 12, 14, 16 and 33;
and
(f) a determination as to whether and when the project should be assessed
retrospectively.
3. The competent authority carrying out the project evaluation shall consider expertise in
particular in the following areas:
(a) the areas of scientific use for which animals will be used including replacement,
reduction and refinement in the respective areas;
(b) experimental design, including statistics where appropriate;
(c) veterinary practice in laboratory animal science or wildlife veterinary practice
where appropriate;
(d) animal husbandry and care, in relation to the species that are intended to be
used.
4. The project evaluation process shall be transparent.
Subject to safeguarding intellectual property and confidential information, the project
evaluation shall be performed in an impartial manner and may integrate the opinion of
independent parties”
And on project authorisation in its Article 40 that:
“1. The project authorisation shall be limited to procedures which have been subject to:
(a) a project evaluation; and
(b) the severity classifications assigned to those procedures.
22
2. The project authorisation shall specify the following:
(a) the user who undertakes the project;
(b) the persons responsible for the overall implementation of the project and its
compliance with the project authorisation;
(c) the establishments in which the project will be undertaken, where applicable; and
(d) any specific conditions following the project evaluation, including whether and
when the project shall be assessed retrospectively.
3. Project authorisations shall be granted for a period not exceeding 5 years.
4. Member States may allow the authorisation of multiple generic projects carried out by
the same user if such projects are to satisfy regulatory requirements or if such projects
use animals for production or diagnostic purposes with established methods.”
Analysis
Questions in the questionnaire
B - 4.1 Have the processes of project evaluation and authorisation been published as a
means to implement the requirement of Article 38(4)?
B - 4.1.bis Please provide the web-address where these processes can be found [voluntary
question]
B - 4.1.tris Please explain how the obligation for the project evaluation process to be
transparent has been achieved?
22 Member States provided web-links to the published processes for project evaluation and
authorisation. Of the remaining Member States two referred to templates provided for project
application available for applicants on their web-site. Three (Malta, Slovakia and Slovenia)
describe briefly their respective processes but not how the transparency of the process is
ensured. Lithuania reported non-technical summary publication as the means for transparency.
Question in the questionnaire
B - 4.2 Explain the key steps of the project evaluation and authorisation processes
including those for multiple generic projects and simplified administrative procedures in
a Member State where these are allowed
A variable amount of information was provided by Member States, which has made it
challenging to confirm that all the elements of project evaluation and authorisation processes
have been adequately addressed.
Many Member States have a common structure for application to facilitate consistency and
invite the correct information. Guidance on completion of application forms is available in
many Member States. Other tools include training for project applicants which is provided in a
few Member States, and the introduction of electronic application processes, which are
reported to be speeding up the processing times.
23
Different evaluation processes have been developed, ranging from national to regional and
local processes. Equally, there are variable sizes to committee structures – from very large to
small groups or evaluations by individuals (with other support where necessary).
Some utilise local establishment processes through Animal Welfare Bodies or local ethical
review groups to provide further information, a local perspective and/or opinion on the
application to better inform the evaluation process.
Methods of decision making vary from simple majority, 2/3 majority to consensus.
Refusals tend to be relatively low as applications are generally revised and improved during
the application and evaluation process, and also because the applicant may withdraw an
application before it is formally refused.
Little feedback was provided on training of evaluators or what competencies are involved,
equally only a few comments were received on the process of harm benefit assessment
Some Member States do not describe the steps in the process, rather providing only the legal
framework with little information on how the process works in practice.
An appeals procedure was mentioned by a few - in other Member States no appeal against the
project authorisation decision can be made.
It is clear that most Member States are making strenuous efforts to comply with the
requirements of the Directive with respect to project evaluation and authorisation. There are
multiple requirements in Article 38 and 40, and in most Member States, it cannot be concluded
just from responses to question 4.2 that all requirements of these articles are complied with.
However, much information on the process is provided by most Member States and links to
websites provided (see 4.1), which may provide more evidence of full compliance.
Question in the questionnaire
B - 4.2.bis Where allowed, please explain what type of projects are accepted under
simplified administrative procedure?
Not all Member States use the option of the simplified administrative procedure; 10 Member
States report using it and a small number of others have it available, but have not yet used it.
Not all Member States utilise the option of multiple generic projects.
Types of projects reported to be accepted under simplified administrative procedure, were
largely as permitted in Article 42, that is projects
 necessary to satisfy regulatory requirements,
 which use animals for production or diagnostic purposes with established methods, and
 animal experiments carried out to produce, obtain, preserve or propagate substances,
products or organisms using established methods.
And which
 contain only procedures classified as ‘non-recovery’, ‘mild’ or ‘moderate’, and
 are not using non-human primates.
24
Some Member States require reports of substances tested and harms to animals
retrospectively, and one that if severe harms occur the project leader needs to submit a non-
technical project summary, which is not required at the point of authorisation. Several do not
require non-technical project summaries for this type of project.
Question in the questionnaire
B - 4.3 What is the maximum length (in years) for a project authorisation implementing
the requirement under Article 40(3)?
All Member States reported maximum durations of five years except one, Greece, where only
three years is permitted.
Question in the questionnaire
B - 4.4 Explain how the requirement for expertise for project evaluation in Article 38 (3)
is considered.
There appeared to be some variation in how this article has been interpreted, leading to
differences in responses. Contrary to the intention of the Directive, a significant number of
Member States appear to have interpreted the requirement to be that project evaluation should
determine whether these areas of expertise are available for the project, not the evaluation
process.
Many Member State responses replicated the competencies set out in Article 38. Eight
Member States specifically stated that the project evaluation process involves expertise in all
four areas. Others responded how the required expertise set out in Article 38(3) would be
considered as part of the evaluation process. However, very little information was provided on
what competences were involved and whether training was provided for those tasked with
project evaluation.
The importance of, as well as the difficulty of, getting expertise in experimental design and
statistics was emphasised, as well as expertise in particular scientific areas, especially if
dealing with projects in narrow fields with few experts.
A number of project evaluation systems retained the option of co-opting external expertise in
specific subjects, where the main committee may not have sufficient knowledge to offer an
opinion.
In a small number of Member States, the systems were still evolving.
Questions in the questionnaire
B - 4.5 Explain if and how the opinions of independent parties are integrated as provided
in Article 38(4)
B - 4.7 When project evaluation is tasked to a non-public authority and/or within an
establishment, please describe how the impartiality of the process is achieved, in line with
Article 38(4)
25
The Directive allows the option to integrate independent parties in the process, but few
Member States reported utilising them. Responses indicated that independent parties may be
integrated within ethics committees or national committees providing advice on project
evaluation, or may be called upon if required. In some cases, these independent members are
from animal welfare organisations, medical doctors, patient group representatives, or members
of staff within the establishment not involved in research.
15 Member States reported having a single competent authority performing project evaluation
(based on responses provided to question B.1 on competent authorities). Whilst not
specifically reported, it is assumed that these are public bodies and are therefore independent.
Of the remaining 13 Member States, seven are public bodies for project evaluation, and 11 for
project authorisation. When conducted by public authorities there should be no issues of
impartiality.
Most Member States reported that conflict of interest is addressed by requiring that committee
members do not take part if their own work, or that of a family member, or department’s work
is being assessed. This is an issue in particular for project evaluation performed by local
committees. Declarations are used to state impartiality/lack of conflict of interest.
In the case of local committees, in some cases there is reported oversight by an independent
member of the government department which implements the Directive, or a second tier of
review at national level.
A few Member States actively encourage independent involvement in the process. For
example, in Poland 3/12 members of the local evaluation committees are representatives of
organisations promoting animal welfare, and 1/12 must also represent an organisation whose
statutory aims include the protection of patients’ rights. Sweden requires half of the members
in the ethics committees are laypersons who are included to represent society’s point of view
regarding benefit and necessity of research versus ethical justification of harm inflicted to the
animals. Two of these laypersons represent animal welfare organisations. Another Member
State encourages involvement of persons within the establishment who are not involved in the
scientific programmes to provide a “lay” perspective.
Question in the questionnaire
B - 4.6 The decision within the project evaluation process is reached by
Decision reached by
Consensus 9
Vote or simple
majority
11
Other 8
Total 28
Where vote or simple majority or other were reported, these are mostly by simple majority
with a chairman’s casting vote following discussion. One Member State reported that
members are given the opportunity to register dissent from the decision, which is included in
the report on the evaluation. One Member State reported that there is variability between the
26
different competent authorities responsible for project evaluation on how decisions are
reached.
Question in the questionnaire [voluntary question]
* B - 4.8 Two key elements which impact on the project evaluation and authorisation
processes are the definition of "a project" and the interpretation of "a complete and
correct application please provide a short description of the types of "projects"
authorised in your MS - e.g., are projects limited to single procedures of short duration or
are more complex multi-species, multi-procedure projects of up to 5 years also
authorised; how is a "complete and correct application" determined, and communicated
to applicant; how are the interactions between applicant and competent authority
accounted for in the authorisation deadlines as required in Article 41
Background:
During the review of the Directive10
, a number of comments were raised over the apparent
interpretation of the term “project”, suggestive that there were Member States who had taken a
very narrow interpretation, effectively only authorising single procedures as projects.
In the review responses, it was also reported that delays were being encountered and the
timescales for project authorisation were not being met as the “time allowed” did not begin
until an entirely correct application was received for evaluation.
Analysis
Eighteen Member States have included a response to these non-mandatory questions.
“project”
The majority of responses confirmed that projects vary in size and complexity, and can
involve multiple procedures and species, and are issued for different periods up to a maximum
of five years.
“a complete and correct application”
The responses confirmed that often the initial application for a project contains insufficient
information to allow a full project evaluation to be undertaken.
Member States have different structures for conducting project evaluation, but in all
circumstances reported, there is the possibility for interaction (and indeed this is regularly
utilised) with the applicant to secure the necessary additional information to allow project
evaluation to be undertaken.
Correction/improvement to the application seems the preferred solution, rather than outright
rejection of an initial incomplete application.
Many Member States have issued a standard project application form together with guidance
for completion, and a few provide training for applicants in the application requirements.
10
https://eur-lex.europa.eu/legal-content/EN/TXT/?qid=1510219889073&uri=COM:2017:631:FIN
27
Question in the questionnaire [voluntary question]
* B - 4.9 - Are the processes for amendments to projects the same as for the initial project
evaluation and authorisation (including the deadlines in Article 41)? If not, please
describe the main differences. What changes to a project will require a request for an
amendment?
19 Member States responded to this non-mandatory question.
All indicated that any changes to a project which may negatively impact on animal welfare
would require a further, proportionate, evaluation.
Many responses indicated that amendments would be required for changes to projects, not
involving additional welfare costs, but that such amendments would be dealt with in a
different, but proportionate manner, for example through Animal Welfare Bodies, and
generally these would be dealt with more quickly, and in a few cases by a simple notification.
One Member State (Malta) indicated that a new application would be required on each
occasion an amendment was required.
Question in the questionnaire [voluntary question]
* B - 4.10 Has the EU Guidance on Project Evaluation and Retrospective Assessment
been made available to all project evaluators?
EU Guidance made available
Yes 24
No 1
No response 3
Total 28
Question in the questionnaire [voluntary question]
* B - 4.11 Has additional official guidance on project evaluation and retrospective
assessment been developed to facilitate implementation?
Additional guidance developed
Yes 7
No 16
No response 5
Total 28
Question in the questionnaire [voluntary question]
* B - 4.11.bis If you consider this guidance helpful for other Member States to facilitate
the implementation of the Directive, please provide web-address for the guidance, where
available.
Five Member States provided links to websites which may be helpful to others, available in
the detailed Member State summaries.
28
C. OPERATION
C.1. Projects
C.1.i. Granting of project authorisation (Articles 40 and 41 of Directive 2010/63/EU)
Reporting obligation
“information on the annual number of projects authorised, and on the number and type
authorised as ‘multiple generic projects’;
information on the circumstances and proportion of total authorisations where the deadline of
40 days has been extended as permitted by Article 41(2) of Directive 2010/63/EU.”
Background:
The Directive provides the following in its Articles 40 and 41 on project authorisation:
“Article 40
Granting of project authorisation
1. The project authorisation shall be limited to procedures which have been subject to:
(a) a project evaluation; and
(b) the severity classifications assigned to those procedures.
2. The project authorisation shall specify the following:
(a) the user who undertakes the project;
(b) the persons responsible for the overall implementation of the project and its
compliance with the project authorisation;
(c) the establishments in which the project will be undertaken, where applicable; and
(d) any specific conditions following the project evaluation, including whether and when
the project shall be assessed retrospectively.
3. Project authorisations shall be granted for a period not exceeding 5 years.
4. Member States may allow the authorisation of multiple generic projects carried out by the
same user if such projects are to satisfy regulatory requirements or if such projects use
animals for production or diagnostic purposes with established methods.
Article 41
Authorisation decisions
1. Member States shall ensure that the decision regarding authorisation is taken and
communicated to the applicant 40 working days at the latest from the receipt of the complete
and correct application. This period shall include the project evaluation.
2. When justified by the complexity or the multi-disciplinary nature of the project, the
competent authority may extend the period referred to in paragraph 1 once, by an additional
29
period not exceeding 15 working days. The extension and its duration shall be duly motivated
and shall be notified to the applicant before the expiry of the period referred to in paragraph
1.
3. Competent authorities shall acknowledge to the applicant all applications for
authorisations as quickly as possible, and shall indicate the period referred to in paragraph 1
within which the decision is to be taken.
4. In the case of an incomplete or incorrect application, the competent authority shall, as
quickly as possible, inform the applicant of the need to supply any additional documentation
and of any possible effects on the running of the applicable time period.“
Analysis
Question in the questionnaire
C - 1.i.1 Granting of project authorisations (Articles 40 and 41)
Total EU projects
Year Number of
projects
authorised
Total number
of decisions
(authorised and
rejected)
total number
rejected
(calculated)
Number of
decisions
>40days
Proportions >40
days of all
decisions
2013 6,063 6,119 56 945 15%
2014 11,210 11,226 16 4,140 37%
2015 15,044 15,401 357 5,289 34%
2016 15,246 15,849 603 6,144 39%
2017 16,708 17,230 522 6,951 40%
It is important to note in this context that the lower numbers during the first years reflects the
fact that the Directive obligations had yet to be transposed in the national legislation in some
Member States. The last Member State adopted national legislation only in the spring of 2015.
A comparison of numbers of authorised projects between Member States is less informative
due to differences in interpretation of what constitutes a project (see question B.4.8).
However, to facilitate competitive EU research, the Directive introduced a 40-day deadline
within which the decision has to be taken and communicated by the authorities. Only in cases
justified by the complexity or the multi-disciplinary nature of the project, this deadline could
be extended by 15 days. There are significant differences between Member States of the
proportion of decisions taken beyond 40 days, varying from 0% to 100%. This is illustrated
below with the data provided for 2017. Three Member states did not provide data on this.
30
Member
State
Number of
projects
authorised in
2017
Total number
of decisions
(authorised
and rejected)
Number
rejected
(calculated)
Number of
decisions >40
days
Proportions
>40 days of all
decisions
AT 717 721 4 10 1%
BE 1,605 1,621 16 146 9%
BG 23 23 0 9 39%
CY 6 6 0
CZ 528*)
528 0*)
3 1%
DE 3,800 3,800 0 3,000 79%
DK 269 269 0 31 12%
EE 17 17 0 0 0%
EL 175 183 8 15 8%
ES 1,569 1,569*)
0*)
84 5%
FI 124 124 0 0 0%
FR 3,708 3,708 0 2,433 66%
HR 47 50 3 9 18%
HU 206 271 65 135 50%
IE 120 120 0 3 3%
IT 1,005 1,264 259 929 73%
LT 24 24 0 24 100%
LU 22 22 0 22 100%
LV 13 15 2
MT 1 1 0 0 0%
NL 431 440 9 31 7%
PL 774 914 140
PT 56 56 0 34 61%
RO 114 114 0 0 0%
SE 657 662 5 20 3%
SI 18 28 10 12 43%
SK 92 93*)
1*)
0 0%
UK 587 587 0 1 >0%
*) Numbers calculated from the data provided in the other columns
Question in the questionnaire
C - 1.i.1.bis Provide information of circumstances where the deadline of 40 days has been
extended as provided in Article 41(2)
Circumstances for the deadline being extended included: projects of complex or of a multi-
disciplinary nature, where large numbers of animals are to be used, where large amounts of
information had been requested of applicants, or when there were controversial procedures
being used. In some cases, it was reported that the deadline was exceeded because there were
insufficient staff to process the applications.
31
Question in the questionnaire
C - 1.i.2 Number and type authorised as "multiple generic projects”
Total EU multiple generic projects
Year Number of multiple
generic projects
authorised for
regulatory purposes
Number of multiple
generic projects
authorised for routine
production
Number of multiple
generic projects
authorised for
diagnostic purposes
Total number of
multiple generic
projects authorised
Total number of
projects authorised
(from C1.i.1)
Proportion of multiple
generic projects of all
authorised projects
2013 43 20 14 77 6,063 1%
2014 148 30 58 236 11,210 2%
2015 213 37 54 304 15,044 2%
2016 223 55 82 360 15,246 2%
2017 267 79 103 449 16,708 2%
32
C.1.ii. Retrospective assessment, non-technical project summaries (Articles 38, 39 and 43 of
Directive 2010/63/EU)
Reporting obligation
“information on the operation of non-technical project summaries; how it is assured that the
requirements under Article 43(1) of Directive 2010/63/EU are met and whether the non-
technical project summaries will indicate projects chosen for retrospective review (Article 43
(2) of Directive 2010/63/EU);
information on the proportion and types of projects submitted for retrospective assessment
under Article 38(2)(f) of Directive 2010/63/EU beyond those compulsory under Article 39(2)
of that Directive.”
Non-technical project summaries
Background
Directive provides in its Article 44 the following:
“1. Subject to safeguarding intellectual property and confidential information, the non-
technical project summary shall provide the following:
(a) information on the objectives of the project, including the predicted harm and
benefits and the number and types of animals to be used;
(b) a demonstration of compliance with the requirement of replacement, reduction and
refinement.
The non-technical project summary shall be anonymous and shall not contain the names
and addresses of the user and its personnel.
2. Member States may require the non-technical project summary to specify whether a
project is to undergo a retrospective assessment and by what deadline. In such a case,
Member States shall ensure that the non-technical project summary is updated with the
results of any retrospective assessment.
3. Member States shall publish the non-technical project summaries of authorised projects
and any updates thereto.”
Analysis
Question in the questionnaire
C – 1.ii.1 Provide information on the operation of non-technical project summaries; and
on how it is assured that the requirements under Article 43(1) are met. Requirements of
Article 43(1): (a) information on the objectives of the project, including the predicted
harm and benefits and the number and types of animals; (b) demonstration of compliance
with the requirement of Replacement, Reduction and Refinement; (c) anonymity
The essential requirements for non-technical project summaries have been transposed in
the national legislation of the Member States.
33
During the project evaluation process, the non-technical summaries should be checked for
appropriateness of content, and that the summaries do not contain information of a
confidential nature, or information which may compromise intellectual property rights.
All Member States have a template for non-technical project summaries included in the
project application, with many using the EU template developed as guidance.
It was acknowledged in a few responses that although initially the quality of the content
and the time to publication were a concern (for example Italy), the content has improved
as experience developed, and time to publication has been reduced as systems have been
put in place to host these non-technical project summaries.
One Member State (Denmark) reported that, subject to personal data and IP issues, the
full contents of project applications are published, including the non-technical project
summaries.
Question in the questionnaire
C - 1.ii.1.bis Based on the information on the operation the non-technical summaries
during the first five years, what is the average time (in months) from authorisation to
publication?
Average time (in months) from authorisation to publication?
Belgium 18
Bulgaria 1
Czechia 1
Denmark 0
Germany 3
Estonia 2
Ireland 6
Greece 2
Spain 6
France 12
Croatia 12
Italy 24
Cyprus 2
Latvia 3
Lithuania 2
Luxembourg 2
Hungary 5
Malta 0
Netherlands 1
Austria 6
Poland 1
Portugal 12
Romania 3
Slovenia 1
Slovakia 6
34
Finland 6
Sweden 36
United Kingdom 12
In some cases Member States provided additional information on efforts made to improve the
situation. As an example, Sweden stated that “To date, only few non-technical summaries
have been published. However, the Swedish Board of Agriculture has recently finalised a new
improved publishing format. The delay in publishing is unfortunate, and has resulted in a long
average time from authorisation to publication, but the Board now envisions a steady
publication rate in a user-friendly format.”
Question in the questionnaire
C - 1.ii.2 Do the non-technical project summaries indicate projects chosen for
retrospective assessment (Article 43(2))
NTS indicates projects selected for retrospective
assessment
Yes 13
No 15
Total 28
13 Member States have determined that they update the non-technical project summaries with
the results of any retrospective assessment.
Question in the questionnaire
C - 1.ii.3 Please provide the web-address where non-technical project summaries are
published
Links to Member State publications are now available on the Commission web-site at
https://ec.europa.eu/environment/chemicals/lab_animals/nts_en.htm
Retrospective assessment of projects
Background
Directive provides in its Article 38(2)(f) the following:
“2. The project evaluation shall consist in particular of the following:
…
(f) a determination as to whether and when the project should be assessed
retrospectively.”
And in its Article 39 that:
35
1. Member States shall ensure that when determined in accordance with Article 38(2)(f),
the retrospective assessment shall be carried out by the competent authority which shall,
on the basis of the necessary documentation submitted by the user, evaluate the following:
(a) whether the objectives of the project were achieved;
(b) the harm inflicted on animals, including the numbers and species of animals used, and
the severity of the procedures; and
(c) any elements that may contribute to the further implementation of the requirement of
replacement, reduction and refinement.
2. All projects using non-human primates and projects involving procedures classified as
‘severe’, including those referred to in Article 15(2), shall undergo a retrospective
assessment.
3. Without prejudice to paragraph 2 and by way of derogation from Article 38(2)(f),
Member States may exempt projects involving only procedures classified as ‘mild’ or
‘non- recovery’ from the requirement for a retrospective assessment.”
Analysis
Question in the questionnaire
C - 1.ii.4 Provide information on the proportion and types of projects submitted for
retrospective assessment (RA) beyond those compulsory under Article 39(2)
Projects required to have Retrospective Assessment - all Member States
Year Number of
projects
involving
non-human
primates
(NHP)
Number of
projects
involving
severe
procedures
Number of
projects
involving
NHP and
severe
procedures
Number of
"other"
projects
(than those
involving
NHP/severe
procedures)
submitted for
RA
Total
number of
projects
submitted for
RA (sum of
previous four
columns)
Proportion of
"other"
projects
versus all
authorised
2013 6 559 4 886 1,464 61%
2014 15 776 0 1,120 1,968 60%
2015 21 1,477 0 1,595 3,274 49%
2016 34 1,475 7 1,475 3,403 43%
2017 51 1,528 7 1,573 3,721 42%
It is important to note in this context that the lower numbers in the Member State submissions
during the first years reflect the fact that the Directive obligations had yet to be transposed in
the national legislation in some Member States. The last Member State adopted national
legislation only in the spring of 2015.
Furthermore, it should be noted that some Member States (for example United Kingdom) had
misunderstood this question to refer to completed retrospective assessments, instead of those
36
selected, during project evaluation (Article 38(2)(f) between 2013 and 2017, for future
retrospective assessment after the completion of the project. In addition, Germany stated that
roughly 10% (during years 2013-2017) is requested for retrospective assessment beyond those
compulsory, without providing any numbers. France and Spain provided numbers for only
those beyond compulsory but not of those required by law.
Due to the lack of exact numbers from Member States presenting some of the highest volumes
of animal use in EU (Germany, Spain, France and United Kingdom) the accuracy of the total
value of the above table is likely to be poor. Of the remaining Member States, the proportion
called for retrospective assessment beyond those compulsory is relatively high, above 40%.
Question in the questionnaire
C - 1.ii.5 Provide reasons for other projects (beyond those compulsory) being submitted
for retrospective assessment broken down by each reporting year
Many Member States applied a requirement for retrospective assessment for projects (beyond
those compulsory) for a number of reasons. These reasons fell into a number of categories:
Refinement - examples included:
 to ensure suitability of severity scoring sheets;
 to review monitoring during procedures - potential cumulative suffering;
 to review impact of an extended duration of the procedure on the animals;
 to review the effectiveness of proposed humane endpoints;
 projects from which further insights might be gained on the actual functioning
of refinement strategies;
 project where mortality rate of 20-30 % was expected;
 to review impact on animals being reused in oncological tests;
 to review fate of animals when being released or rehomed.
Reduction - examples included:
 uncertainty over the number of animals born and used during the experiment;
 projects involving large numbers of animals;
 uncertainties over proposed design or group sizes.
Uncertainty - examples included:
 complex pathway of experiments with multiple options making severity
assessment challenging;
 project involving the use of complex technology and lengthy anaesthetic
episodes;
 project involved a novel disease model with the potential to cause higher
suffering than predicted;
 unknown effects of device implantation and possible rejection;
 multiple generic projects - useful to review the individual studies performed
under generic authorisation;
37
 use of models not well established within that particular research group, within
the establishment, or not well established in any location;
 newly authorised establishment and their first ever project.
Other – examples included:
 projects using animals for education purposes within the universities,
especially to review the availability of alternatives;
 project using wild and / or endangered species.
C.2. Animals bred for use in procedures (Articles 10, 28 and 30)
C.2.i. Animal bred, killed and not used in procedures
Reporting obligation
“animals bred, killed and not used in procedures including genetically altered animals not
covered in the annual statistics, covering the calendar year prior to that in which the 5-year
report is submitted; the global figure shall differentiate those animals involved in GA creation
and maintenance of established GA-lines (including wild-type offspring)”
Background
Directive provides in its Article 10(1) the following:
“1. Member States shall ensure that animals belonging to the species listed in Annex I
may only be used in procedures where those animals have been bred for use in
procedures. ..”
And in its Article 30 on animal records that:
“1. Member States shall ensure that all breeders, suppliers and users keep records of at
least the following:
(a) the number and the species of animals bred, acquired, supplied, used in
procedures, set-free or rehomed;
…
(f) the number and species of animals which died or were killed in each
establishment…”
Analysis
Question in the questionnaire
C - 2.i Animals bred, killed and not used in procedures including genetically altered (GA)
animals not otherwise reported in the annual statistics. This section covers animals only
from the last calendar year preceding submission of information for the 5-year
implementation report, that is 2017.
Columns 3 and 4 exclude animals that were genotyped using invasive method as these
have already been included in the annual statistics. Equally, any animal from a harmful
38
phenotype line that experienced adverse effects before being killed will already have been
reported.
This element of the implementation report will provide complementary information to the
annual statistical data reported by the Member States under Article 54(2) of the Directive. As
part of the implementation report, Member States are required to provide information of all
other animals not reported otherwise. Together, once every five years, the annual statistical
report, and the information provided by the implementation report will give a comprehensive
picture of all animals needed to support research, testing and education/training needs using
animals in the EU in a given year:
 annual statistical report:
o animals used in scientific procedures
o animals used for the creation and maintenance of genetically altered animal lines
(that have experienced harm during the process)
 implementation report once every five years:
o animals bred, but not used in scientific procedures before being killed, including
 conventional and
 those not reported otherwise under creation and maintenance of genetically
altered animal lines.
Animals that are bred, but not used in procedures cover all animals that for one reason or
another were not used or were unsuitable for scientific purposes. It is important to note that
these numbers include also those bred and humanely killed for the purpose of providing
organs and tissues, including to advance or be used in alternative (animal based) methods.
These numbers will also include many breeding animals at the end of their breeding life.
To ensure that sufficient suitable animals are available to meet scientific demand, more
animals are bred than used. Often, for example the age or sex of the animals will render them
unsuitable for an intended scientific purpose. Other elements that impact on the size of a
breeding stock include fecundity and gestation length. However, the most important factor is
fluctuation in scientific demand. This can apply to both conventional (row 1 in table below)
and genetically altered animals (row 3 in the table below).
Some of these animals may have been used in scientific studies (for example, observation of
behaviour) which did not cause harm beyond the minimum threshold as provided in Article
3(1) of the directive, as these are not classified as procedures.
A number of ways exist aiming to reduce breeding surplus. These will be briefly discussed at
the end of this section.
In reference to genetically altered animals, unless there is breeding of a homozygous
genetically altered line, where all offspring will be genetically altered, crossing of
heterozygotes will necessarily lead to some wild-type (conventional) animals being born (row
2 and row 3).
Row 3 also includes animals which are genetically altered, but which have suffered no harms
as a consequence, and therefore were not reported in the annual statistical report.
39
Finally, these animals also include those that were intended to be used, but for example have
fallen ill and killed humanely before being used. This would also include health status
breakdowns, where a number of animals would need to be killed to protect the health and
scientific integrity of the colony.
The total numbers of animals in 2017 for the three reported categories in the EU were as
follows:
Types of animals Numbers
Number of conventional animals bred, killed and not used in procedures
(excluding those involved in the creation or maintenance of a genetically
altered animal (GA) line)
6,484,535
Number of genetically normal animals (wild type offspring) produced,
bred and killed as a result of creation of a new genetically altered (GA)
line*
525,085
Number of animals bred and killed for the maintenance of an established
genetically altered (GA) line
5,588,196
Total number of animals bred, killed and not used in procedures and not
covered in annual statistical reporting
12,597,816
* This category includes all animals (all GA and wild type offspring) bred and killed from both harmful and non-
harmful phenotype lines, that were not otherwise reported in the annual statistics
The table below shows by species the total number of animals bred, killed and not used in
procedures including genetically altered (GA) animals not otherwise reported in the annual
statistics reported by Member States, combining all the categories discussed above.
Species Numbers
Mice 10,496,190
Zebra fish 961,802
Rats 557,880
Other fish 320,230
Guinea-pigs 75,590
Rabbits 64,633
Domestic fowl 35,593
Pigs 21,588
Other rodents 18,842
Mongolian gerbil 15,046
Xenopus 10,470
Rana 5,248
Other birds 3,631
Other carnivores 3,021
Amphibians 2,181
Ferrets 1,937
Syrian Hamster 1,355
40
Cattle 1,303
Sheep 461
Other mammals 346
Dogs 230
Marmosets and tamarins 107
Rhesus monkey 48
Cynomolgus monkey 32
Goats 17
Horses, donkeys & cross-breeds (Equidae) 12
Prosimians 10
Reptiles 7
Cats 4
Cephalopods 2
Total 12,597,816
Other fish includes Oryzias latipes -Japanese rice fish, Onchorynchus mykiss- Rainbow trout,
brown trout, Salmo salar salmon, Anguilla anguilla - European eel, Killifish, Oreochromis
niloticus -tilapia, Whitefish
Other rodents includes hamsters including specified species Cricetus cricetus - European
hamster, Phodopus sungorus - Winter white dwarf hamster, Myodes glareolus - bank vole.
Other carnivores includes: Vulpes lagopus – Bluefox, Neovison vison – mink, badger
Other mammals includes: Reindeer, Monodelphis domestica - short tailed opossum,
Laboratory opossum
Two Member States reported no animals that were bred and killed without being used in
procedures (Bulgaria and Malta). All other Member States reported such animals, which are
shown below with Member State data reported in the different reporting categories.
Member
State
Conventional
animals
Creation of a
new
genetically
altered
animal line
GA
maintenance
Total GA
(creation and
maintenance)
Total per
Member
State
AT 146,925 13,004 138,277 151,281 298,206
BE 183,147 9,088 283,534 292,622 475,769
BG 0 0 0
CY 242 997 997 1,239
CZ 115,058 7,463 49,779 57,242 172,300
DE 1,410,300 288,000 2,246,000 2,534,000 3,944,300
DK 270,081 11,946 266,917 278,863 548,944
EE 11,006 16 11,625 11,641 22,647
EL 10,400 2,800 25,000 27,800 38,200
ES 148,367 14,971 126,052 141,023 289,390
FI 90,554 1,532 59,246 60,778 151,332
41
FR 1,452,168 61,205 609,996 671,201 2,123,369
HR 7,193 328 2,608 2,936 10,129
HU 50,272 6,389 36,876 43,265 93,537
IE 438,224 311 91 402 438,626
IT 92,981 4,792 53,902 58,694 151,675
LT 721 14 14 735
LU 2,679 146 7,052 7,198 9,877
LV 539 0 539
MT 0 0 0
NL 396,648 32,542 72,081 104,623 501,271
PL 17,708 1,589 22,075 23,664 41,372
PT 13,842 1,000 7,172 8,172 22,014
RO 1,936 0 40 40 1,976
SE 68,956 13,463 112,586 126,049 195,005
SI 4,855 68 1,838 1,906 6,761
SK 4,467 547 547 5,014
UK 1,545,266 54,432 1,453,891 1,508,323 3,053,589
Total 6,484,535 525,085 5,588,196 6,113,281 12,597,816
It is important that there is good oversight of breeding programmes to minimize as far as is
practicable surplus animals, but it is acknowledged given the fluctuations in supply and
demand, and the specificity of requirements for certain studies there will always be some
animals which cannot be used for scientific studies.
Other avenues for their use should be considered, for example rodents as food for raptors or
reptiles, and farm animals being returned for agricultural use.
Matching supply and demand of laboratory animals
The list below has been developed as part of an EU Expert Working Group focusing on the
use of genetically altered animals. A number of the recommendations included in a draft report
(still under preparation) are equally suitable in a conventional breeding environment.
 Ensure that exacting specific requirements made by scientists are necessary and justified –
use of single sex; age/weight range.
 Efficiencies are generally found in large breeding colonies servicing multiple users
(commercial breeders) or internal collaborations.
 Effective communication over availability of, and sharing of tissues.
 Ensure appropriate notification by scientists to colony managers of numbers required and
when to allow lead in times to studies to facilitate optimum management of breeding
colonies.
 Effective preventive and reactive disease control.
 Consider using ex-breeding animals.
42
With respect to breeding of genetically altered animals
 There are likely to be animals of the incorrect genetic make-up which make them
unsuitable for the proposed scientific use.
 Method of generation of GA animals will influence number of animals unsuitable for
scientific use. Efficient methodologies should be selected when available and where
increased harms are outweighed by a significant reduction in numbers.
C.2.ii. Sourcing of non-human primates
Reporting obligation
“the sourcing of non-human primates and how the requirements of Articles 10 and 28 of
Directive 2010/63/EU are met”
Background
The Directive provides in its Article 10 concerning animals bred for use in procedures the
following:
“1.Member States shall ensure that animals belonging to the species listed in Annex I may
only be used in procedures where those animals have been bred for use in procedures.
However, from the dates set out in Annex II, Member States shall ensure that non-human
primates listed therein may be used in procedures only where they are the offspring of
non-human primates which have been bred in captivity or where they are sourced from
self-sustaining colonies.
For the purposes of this Article a ‘self-sustaining colony’ means a colony in which
animals are bred only within the colony or sourced from other colonies but not taken from
the wild, and where the animals are kept in a way that ensures that they are accustomed
to humans. …..
2. ……
3.Competent authorities may grant exemptions from paragraph 1 on the basis of scientific
justification.”
In Article 28 on breeding strategy for non-human primates:
“Member States shall ensure that breeders of non-human primates have a strategy in
place for increasing the proportion of animals that are the offspring of non-human
primates that have been bred in captivity.”
Analysis
Questions in the questionnaire
C - 2.ii Do you have any authorised users, breeders or suppliers of non-human primates
(NHP) in your Member State? Yes/No
C - 2.ii.bis Provide information on the sourcing of NHP and how the requirements of
Article 10 are being met. For example, what measures have been taken to
promote/require the use of F2 NHP or those sourced from self-sustaining colonies,
including when sourcing from outside the EU?
43
C - 2.ii.tris Provide information on strategies in place to increase the proportion of
animals of F2 (or higher) in line with Article 28
12 Member States reported that they had authorised establishments for the use, breeding
and/or supplying no-human primates.
The objective of the provision in Article 28 is to facilitate the move towards second or higher
generation purpose-bred (F2/F2+) breeding of non-human primates in the EU. However, on
the basis of the implementation reports received from the Member States it can be concluded
that this objective has already been achieved in the EU. All authorised breeding establishments
in the EU are already today supplying only F2/F2+ animals, confirming the findings of the
feasibility study11
conducted under Article 10 and published in November 2017.
To further the aims of the Directive globally, in Member States where animals are sourced
from overseas, Member States are making efforts to obtain only F2/F2+ animals, and although
not within EU jurisdiction, are encouraging overseas breeders to increase the supply of F2/F2+
animals available.
C.3. Exemptions
Reporting obligation
“information on circumstances under which exemptions were granted in accordance with
Articles 10(3), 12(1), 33(3) of Directive 2010/63/EU and in particular on the exceptional
circumstances referred to in Article 16(2) of that Directive where a reuse of an animal after a
procedure in which the actual suffering was assessed as severe was authorised during the
reporting period”
It is important to note that no detailed, numerical data are required on exemptions.
Instead, Member States are required to provide information on the type of circumstances under
which such exemptions have been granted. However, in some instances Member States did
provide voluntarily numerical, more detailed data.
Analysis
Article 10 - Animals bred for use in procedures
Directive provides:
“1. Member States shall ensure that animals belonging to the species listed in Annex I
may only be used in procedures where those animals have been bred for use in
procedures.
2. ….
3. Competent authorities may grant exemptions from paragraph 1 on the basis of
scientific justification.”
Question in the questionnaire
11
https://ec.europa.eu/environment/chemicals/lab_animals/related_topics_en.htm
44
C - 3.1 Provide cumulative information covering years 2013-2017 on circumstances
under which exemptions were granted to the requirement to use animals (listed in Annex
I) purpose bred for scientific use; and/or to the use of marmosets that not of F2/F2+
generation (Article 10(3). Please remember to indicate the type of species involved in
these exemptions. Where possible, provide an estimate of the relative frequency of such
exemptions.
During the reporting period 2013-2017, 15 Member States reported authorising exemptions.
Where numerical data were voluntarily provided, the numbers of exemptions varied
significantly from one exemption in five years to more than one hundred per annum.
The main exemptions were for work in the wild (for example using mice or rats naturally bred
in the wild) investigating for example wild populations or disease/zoonotic status, or work
using pet dogs and cats in veterinary research to investigate clinical disease and novel
treatments. Other examples included scientific need for breeds of dogs that develop naturally
the disease of interest and which are not available from authorised breeders. Wild-caught frogs
were also reported as having been used.
There were no reported exemptions given for the use of marmosets that were not of F2/F2+
generation.
Article 12 - Procedures
Directive provides:
“1.Member States shall ensure that procedures are carried out in a user’s establishment.
The competent authority may grant an exemption from the first subparagraph on the basis
of scientific justification.”
Question in the questionnaire
C - 3.2 Provide cumulative information covering years 2013-2017 on circumstances (such
as work on animals in the wild, work on animals in a commercial farm) under which
exemptions were granted to the requirement to carry out a project in user’s establishment
(Article 12(1)). Where possible, provide an estimate of the relative frequency of such
exemptions.
22 Member States authorised exemptions under Article 12 to enable work to be performed
outside a user establishment.
Work in the wild is the most common exemption, used for investigating animals in their
natural habitat, for example behavioural, population or health studies, although many
exemptions are also authorised for research work under commercial conditions on farm
animals. Work in veterinary practices has also been authorised. Authorisations have been
given to enable work in hospitals with specialist equipment (for example CT scan) not
available within the scientist’s own establishment.
On the basis of additional voluntary data, the frequencies of such exemptions were estimated
by a few Member States to be around 5% of projects.
Article 16 - Reuse
45
Directive provides:
“1. Member States shall ensure that an animal already used in one or more procedures,
when a different animal on which no procedure has previously been carried out could
also be used, may only be reused in a new procedure provided that the following
conditions are met:
a) the actual severity of the previous procedures was ‘mild’ or ‘moderate’;
b) it is demonstrated that the animal’s general state of health and well-being has
been fully restored;
c) the further procedure is classified as ‘mild’, ‘moderate’ or ‘non-recovery’; and
d) it is in accordance with veterinary advice, taking into account the lifetime
experience of the animal.
2. In exceptional circumstances, by way of derogation from point (a) of paragraph 1 and
after a veterinary examination of the animal, the competent authority may allow reuse of
an animal, provided the animal has not been used more than once in a procedure
entailing severe pain, distress or equivalent suffering.
Question in the questionnaire
C - 3.3 Provide cumulative information covering years 2013-2017 on the exceptional
circumstances under which exemptions were granted for the reuse of an animal after a
procedure in which the actual suffering was assessed as severe (Article 16(2)). Please
remember to indicate the type of species involved in these exemptions. Where possible,
provide an estimate of the relative frequency of such exemptions.
Two Member States stated that they have disallowed this option under their national
legislation.
Only France reported that some derogation was permitted in certain projects without providing
further information on the specific circumstances.
Article 33 - Care and accommodation
Directive provides:
“1. Member States shall, as far as the care and accommodation of animals is concerned,
ensure that:
a) all animals are provided with accommodation, an environment, food, water and
care which are appropriate to their health and well-being;
b) any restrictions on the extent to which an animal can satisfy its physiological and
ethological needs are kept to a minimum;
c) the environmental conditions in which animals are bred, kept or used are checked
daily;
d) arrangements are made to ensure that any defect or avoidable pain, suffering,
distress or lasting harm discovered is eliminated as quickly as possible; and
e) animals are transported under appropriate conditions.
2. For the purposes of paragraph 1, Member States shall ensure that the care and
accommodation standards set out in Annex III are applied from the dates provided for
therein.
46
3.Member States may allow exemptions from the requirements of paragraph 1(a) or
paragraph 2 for scientific, animal-welfare or animal-health reasons.”
Question in the questionnaire
C - 3.4 Provide cumulative information covering years 2013-2017 on circumstances
(reasons) under which exemptions (such as for single housing, restriction of food/water,
restriction on enclosure sizes) were granted to the care and accommodation requirements
(Article 33(3)). Please remember to indicate the type of species involved in these
exemptions. Where possible, provide an estimate of the relative frequency of such
exemptions.
18 Member States reported that exemptions were authorised from the care and accommodation
standards. A number of responses merely indicated that exemptions had been given, whereas
others provided detailed information on the reasons for such exemptions. A few Member
States voluntarily provided numerical data.
The circumstances for exemptions included:
 Use of metabolic cages, whose dimensions were below those set out in Annex III
was a common reason for exemption;
 Use of “commercial stocking densities” during certain research studies in
agricultural animals into for example behaviour, mechanisms of spread of
infectious disease;
 Single housing for scientific reasons, for example to measure behavioural
responses to stimuli, food intake;
 Food / water control as a motivational tool in training animals to perform novel or
learned tasks required for a research protocol;
 Disruption to “normal” environment and group housing as behavioural stressors;
 Feeding altered diets to investigate for example mineral deficiencies.
It is perhaps surprising, given the scale and breadth of exemptions for variations in the housing
and care requirements to enable scientific projects to proceed, that 10 Member States had not
reported any requests for exemptions from these requirements.
C.4. Animal Welfare Body (Articles 26 and 27 of Directive 2010/63/EU)
Reporting obligation
“information on the structure and functioning of animal welfare bodies”
Background:
The Directive states in its Articles 26 and 27 the following:
“Article 26 Animal-welfare body
1. Member States shall ensure that each breeder, supplier and user sets up an
animal-welfare body.
2. The animal-welfare body shall include at least the person or persons responsible
for the welfare and care of the animals and, in the case of a user, a scientific
47
member. The animal- welfare body shall also receive input from the designated
veterinarian or the expert referred to in Article 25.
3. Member States may allow small breeders, suppliers and users to fulfil the tasks
laid down in Article 27(1) by other means.
Article 27 Tasks of the animal-welfare body
1. The animal-welfare body shall, as a minimum, carry out the following tasks:
a. advise the staff dealing with animals on matters related to the welfare of
animals, in relation to their acquisition, accommodation, care and use;
b. advise the staff on the application of the requirement of replacement,
reduction and refinement, and keep it informed of technical and scientific
developments concerning the application of that requirement;
c. establish and review internal operational processes as regards monitoring,
reporting and follow-up in relation to the welfare of animals housed or
used in the establishment;
d. follow the development and outcome of projects, taking into account the
effect on the animals used, and identify and advise as regards elements
that further contribute to replacement, reduction and refinement; and
e. advise on rehoming schemes, including the appropriate socialisation of the
animals to be rehomed.
2. Member States shall ensure that the records of any advice given by the animal-
welfare body and decisions taken regarding that advice are kept for at least 3
years.
The records shall be made available to the competent authority upon request.”
Analysis
The inclusion of the requirement to have Animal Welfare Bodies in every establishment has
been recognised as a very positive step to improve welfare and science. Their inputs at
establishments have raised awareness of the importance of the application of the Three Rs for
all animals, whether being used, bred or held in stock. Animal Welfare Bodies have improved
communication between those conducting procedures and those caring for the animals.
Questions in the questionnaire
C - 4.1 Provide general information on the structure and functioning of animal welfare
bodies
C - 4.2 In describing the structure of animal welfare bodies, does your MS require other
persons to be permanent members beyond those listed in Article 26(2)?
C - 4.2.bis Please provide a description of the other persons required to be members of
animal welfare bodies
C - 4.3 Does your MS allow achieving the tasks in Article 27(1) by other means than
through establishment of an animal welfare body?
48
C - 4.3.bis Please describe what other means are used to achieve the tasks in Article
27(1). Where possible, please include the definition for a "small" breeder, users and/or
supplier
Structure and functioning of Animal Welfare Bodies
Many Member States reported that the composition of Animal Welfare Bodies is broader than
the minimum set out in the Directive. Almost one-third of the Member States have mandated
additional members in their national legislation, and others have encouraged a wider
membership in administrative/guidance documents. The common mandated addition is
inclusion of the Designated Veterinarian, although the addition of lay persons has been
included by a few, as well as in one Member State a requirement for an ethologist for
establishments using non-human primates.
There was general agreement that the composition is dictated by the size and complexity of the
establishment. In large establishments, the frequency of meetings was higher (up to once a
month), and in some, the functions were divided up into sub-groups, to ensure all tasks were
covered efficiently and effectively.
The Directive gives the option in small establishments for the tasks of Animal Welfare Bodies
to be fulfilled by other means. Just under half of Member States include this option in their
national legislation. In practice, however, this option is not used commonly, and where it does
occur often a number of small establishments pool resources into a single animal welfare
forum. A further alternative strategy has been to require the “small” establishment fulfil all the
functions of the Animal Welfare Body, and secure external input, as necessary, to ensure
compliance. No Member States provided information on the criteria used for defining a
"small" breeder, user and/or supplier.
Additional tasks
In a number of Member States, the Animal Welfare Body has been given additional tasks –
generally relating to the oversight of project applications, ranging from providing local advice
and input to applications, to full project evaluation, and reviewing reports of retrospective
assessment, as, or before submitting to, the competent authority. Where this is happening, the
composition of the Animal Welfare Body is amended to include as necessary other members
to ensure the necessary expertise for project evaluation.
Some Member States have explicitly mentioned advice to manage surplus animals as part of
their Three Rs remit. Other additional tasks include approval and co-ordination of training of
scientific and care staff.
Question in the questionnaire [voluntary question]
* C - 4.4 If possible, based on experience obtained through inspections and through the
work of the National Committee that shares best practice and interacts with animal
welfare bodies, what aspects of the work of animal welfare bodies function well - please
provide examples if possible?
49
General view is that the majority of Animal Welfare Bodies are working well. Animal Welfare
Bodies have improved openness and communication internally and externally on animal use;
they encourage all to raise concerns, for example through the use of an anonymous mailbox.
Other reported benefits include:
 improved discussions on animal use before procedures begin;
 advising on resources required to maintain high standards of welfare and care;
 improved understanding/oversight of procedures enabling prompt interventions as
necessary, open dialogue on problems occurring;
 development and championing a culture of care;
 conditions of accommodation and care have improved – better knowledge;
application of enrichment programmes;
 improved education and training, and continued professional development
opportunities;
 networking with other Animal Welfare Bodies to share experiences and promote
the Three Rs;
 symposia/lectures on welfare and the Three Rs – either at local, regional or
national level.
In some cases, Animal Welfare Bodies also consider scientific research on animals beyond the
scope of the Directive (such as observation studies, or studies using species not falling within
the scope of the Directive). Some also consider the appropriateness of scientific research using
animals conducted by scientists from the establishment while working overseas.
Question in the questionnaire [voluntary question]
* C - 4.5 If possible, based on experience obtained through inspection and through the
work of the National Committee that shares best practice and interacts with animal
welfare bodies, what aspects of the work of animal welfare bodies could be improved -
please provide examples if possible.
Animal Welfare Bodies vary in their functioning, with some taking a lead role in the
establishment, in promoting the Three Rs and a culture of care, with others more reactive to
animal welfare issues and deal with adverse events as they arise.
There are still areas regarding communication that could be improved such as between
 Animal Welfare Bodies and some scientists: including a need for some awareness
raising among scientific staff over the role and benefits of Animal Welfare Body;
 committees tasked with project evaluation and Animal Welfare Bodies - including
clearer lines of responsibilities; minimising duplication of effort.
From the establishment perspective sufficient veterinary expertise and input
(availability/costs), as well as other resources need to be assured. This also includes sufficient
time and reward/acknowledgement for those involved, and empowerment of Animal Welfare
Body within the establishment to ensure recommendations are accepted and implemented.
Local input to project applications could be improved to streamline and make more efficient
the project evaluation/authorisation process. Other elements indicated include the need to:
50
 improve access to and dissemination of information on Three Rs, especially on
replacement;
 further develop networks of communication among Animal Welfare Bodies and
 further development in openness and culture of care.
Other initiatives
In a few Member States direct communication channels among Animal Welfare Bodies have
been developed either at national or regional level.
It was also reported that an informal trans-national network of Animal Welfare Bodies has
been developed.
D. PRINCIPLES OF REPLACEMENT, REDUCTION AND REFINEMENT
D.1. Principle of replacement, reduction and refinement (Articles 4 and 13 of Directive
2010/63/EU)
Reporting obligation
“the general measures taken to ensure that the principle of replacement, reduction and
refinement is satisfactorily addressed within authorised projects as well as during housing and
care also in breeding and supplying establishments”
Background
Directive provides in its Articles 4 and 13 the following:
“Article 4
Principle of replacement, reduction and refinement
1. Member States shall ensure that, wherever possible, a scientifically satisfactory method
or testing strategy, not entailing the use of live animals, shall be used instead of a
procedure.
2. Member States shall ensure that the number of animals used in projects is reduced to a
minimum without compromising the objectives of the project.
3. Member States shall ensure refinement of breeding, accommodation and care, and of
methods used in procedures, eliminating or reducing to the minimum any possible pain,
suffering, distress or lasting harm to the animals.
4. This Article shall, in the choice of methods, be implemented in accordance with Article
13.”
“Article 13
Choice of methods
1.Without prejudice to national legislation prohibiting certain types of methods, Member
States shall ensure that a procedure is not carried out if another method or testing
strategy for obtaining the result sought, not entailing the use of a live animal, is
recognised under the legislation of the Union.
51
2. In choosing between procedures, those which to the greatest extent meet the following
requirements shall be selected:
(a) use the minimum number of animals;
(b) involve animals with the lowest capacity to experience pain, suffering, distress
or lasting harm;
(c) cause the least pain, suffering, distress or lasting harm;
and are most likely to provide satisfactory results.
3. Death as the end-point of a procedure shall be avoided as far as possible and replaced
by early and humane end-points. Where death as the end-point is unavoidable, the
procedure shall be designed so as to:
(a) result in the deaths of as few animals as possible; and
(b) reduce the duration and intensity of suffering to the animal to the minimum
possible and, as far as possible, ensure a painless death.”
Analysis
15 Member States have voluntarily uploaded information to the EC website12
on their
activities in relation to the development, validation and promotion of alternative approaches at
national level.
Key Points from Member State responses included
 Project application forms have specific sections on the Three Rs.
 In some Member States, Animal Welfare Bodies advise the project applicant on
relevant Three Rs issues.
 Some Member States obligate literature reviews and searches on the Three Rs to be
included with application.
 One Member State requires screenshots of searches to be included in application form.
 Experts challenge on the Three Rs during evaluation process, and confirm that
application is compliant with the Three Rs.
 Three Rs are subject to continuous review and update during the course of the project.
Animal Welfare Body provide input and update on the Three Rs.
 Compliance with the Three Rs is checked as part of the inspection process.
Questions in the questionnaire
D - 1.1 Provide information on general measures taken to ensure that the principle of
Replacement, Reduction and Refinement is satisfactorily addressed within authorised
projects.
D - 1.2 Provide information on general measures taken to ensure that the principle of
Replacement, Reduction and Refinement is satisfactorily addressed during housing and
care including in breeding and supplying establishments.
12
https://ec.europa.eu/environment/chemicals/lab_animals/3r/advance_en.htm
52
Please note that the voluntary Article 47 report covers development, validation and
promotion of alternative approaches, and dissemination of information thereon at
national level with no specific focus on operational application of the Three Rs
Key Points from Member State responses cover
 Major benefits with introduction of Animal Welfare Bodies, whose remit covers
accommodation and care, and implementation of the Three Rs for all animals in the
establishment.
 Animal Welfare Bodies implement standardised practices throughout the
establishment – for example improved, standardised handling practices.
 Importance of ensuring Animal Welfare Bodies are supported and effective.
 Increased input of care staff to refinement opportunities.
 Improved communication and dissemination of information by information person/
Animal Welfare Body.
 Input from Designated Veterinarian
 Inspections and advice on the Three Rs from Inspectors
 The compliance with application of the law as regards applying the Three Rs is
checked during inspections in some Member States and this appears to be another key
measure to ensure the Three Rs are applied
 In project applications, the applicant must describe the housing and care arrangements
for the animals to be enrolled on the project - this should include social housing plus
environmental enrichment, as well as monitoring of health and welfare.
 Environmental and social enrichment for the animals, as appropriate for the species.
 Training and ongoing continuous training of care staff.
 Some Member States have programmes of education and training of personnel
(meetings/workshops/training days) including dissemination of experiences.
 In some Member States the National Committee has been active at improving
communication between Animal Welfare Bodies and communicating information on
Three Rs.
 Oversight of breeding practices to minimise surplus, to match supply and demand.
 Strategies in place to use surplus animals for organs and tissues.
 Use of refined methodologies in re-derivation programmes.
Question in the questionnaire [voluntary question]
* D - 1.3 Has the EU Guidance on Severity Assessment Framework been made available
to establishments, project evaluators and inspectors? Yes/No
EU Guidance made available
Yes 26
No 1
(blank) 1
Total 28
Question in the questionnaire [voluntary question]
53
* D - 1.4 Has additional official guidance on Replacement, Refinement and Reduction
been developed to facilitate implementation? Yes/No
Additional guidance developed
Yes 7
No 17
(blank) 4
Total 28
Question in the questionnaire [voluntary question]
* D - 1.4.bis If you consider this guidance helpful for other Member States to facilitate the
implementation of the Directive, please provide web-address for the guidance, where
available
Provided links to websites are available in the detailed Member State summaries.
D.2. Avoidance of duplication (Article 46 of Directive 2010/63/EU)
Reporting obligation
“general description of measures taken to ensure that there is no duplication of procedures”
Background
Directive provides in its Articles 4 and 13 the following:
“Article 4
Principle of replacement, reduction and refinement
1. Member States shall ensure that, wherever possible, a scientifically satisfactory method
or testing strategy, not entailing the use of live animals, shall be used instead of a
procedure.
2. Member States shall ensure that the number of animals used in projects is reduced to a
minimum without compromising the objectives of the project.
3. Member States shall ensure refinement of breeding, accommodation and care, and of
methods used in procedures, eliminating or reducing to the minimum any possible pain,
suffering, distress or lasting harm to the animals.
4.This Article shall, in the choice of methods, be implemented in accordance with Article
13.”
Analysis
Question in the questionnaire
D – 2 Provide general description of measures taken to ensure that there is no duplication
of procedures
Many Member States ask for information on database searches / declaration in project
application to provide reassurances that no unnecessary duplication of procedures will occur.
54
Some competent authorities request a minimum number of references indicating the date on
which the query was made and the key word(s) used in the search
Project evaluation process includes checks on information provided. If similar/related
procedures found, additional enquiries made and justification required.
The responses also encouraged publication of studies with negative results to help avoid
duplication.
Publication of non-technical project summaries may assist in preventing duplication of
procedures.
D.3. Tissue sampling of genetically altered animals (Articles 4, 30 and 38 of Directive
2010/63/EU
Reporting obligation
“representative information on approximate numbers, species, types of methods and their related
severities of tissue sampling for the purposes of genetic characterisation carried out with and
without project authorisation covering the calendar year prior to that in which the 5-year report
is submitted, and on efforts made to refine those methods”
Background:
Directive provides in its Articles 4 and 13 the following:
“Article 4
Principle of replacement, reduction and refinement
1. Member States shall ensure that, wherever possible, a scientifically satisfactory method
or testing strategy, not entailing the use of live animals, shall be used instead of a
procedure.
2. Member States shall ensure that the number of animals used in projects is reduced to a
minimum without compromising the objectives of the project.
3. Member States shall ensure refinement of breeding, accommodation and care, and of
methods used in procedures, eliminating or reducing to the minimum any possible pain,
suffering, distress or lasting harm to the animals.
4. This Article shall, in the choice of methods, be implemented in accordance with Article
13.”
Analysis
Question in the questionnaire
D - 3.1 Are genetically altered animals/animal lines (non-harmful and/or harmful
phenotype) being created, bred and/or used in your MS? Yes/No
26 Member States reported that genetically altered animals/animal lines were being created,
bred and/or used in their Member States. Bulgaria and Malta stated that no genetically altered
animals are created/bred and/or used in their Member State.
55
Questions in the questionnaire
D - 3.2 Provide representative information on approximate numbers, species, types of
methods and their related severities of tissue sampling for the purposes of genetic
characterisation carried out with and without project authorisation.
D - 3.4 Please indicate the criteria for sampling to obtain representative information
above (for example as a proportion of all establishments breeding GA animals and the
period during which the sample was taken)
It is important to note in this context that the Member States were required to only provide
representative information on methods used for tissue sampling. Therefore, the provided
figures are not comparable between Member States, as the basis on which the sample has
been given varies from one Member State to another. Nine Member States sampled all
establishments over a whole year, two sampled all establishments over six months, others
indicated a variety of differing systems, and no sampling information were provided from a
few.
The purpose of the data was to understand the relative distribution of different types of
methods and the related severities of methods authorised within projects.
However, it is not possible to provide quantitative EU level summary on the basis of the
Member State data submissions. The information requirements were not understood correctly
by all Member States, possibly partly due to insufficient precision in the formulation of the
question. As a result, the data either lacked the related sub-categorisation, or provided an
indication of sub-categories but without detailing the numbers or species involved in each. For
example, tail biopsy and ear biopsy were included in the same entry, thus it was impossible to
separate the numbers for each method.
Information was provided on sampling methods for around 5.9 million animals, 97% of these
being mice, with fish accounting for 2%.
As the quality of the information varied so significantly, further analysis was carried out only
on the data provided on mouse tissue sampling methods.
Data from only around 2 million animals (34%) of the total data submitted on mouse tissue
sampling methods contained in the Member State reports could be used for further analysis
and conclusions.
Qualitative analysis of the data that could be interpreted shows that, for mice, tail biopsy, ear
biopsy and removal of part or all of a digit remain the most commonly used methods to
provide tissue for genotyping in the EU, despite some more refined alternatives being used by
some, such as hair bulb or observation under special lighting conditions. In some cases,
genotyping can be performed post mortem, which does not increase the welfare impact on the
animals.
Acquisition of surplus tissue from methods of identification accounted for just over half of all
the mice sampled – of these methods ear punch/biopsy accounted for 89%, distal phalanx
biopsy 10.9% - although it was reported in a few cases that surplus tissue from tail sampling is
used for identification, tail sampling rarely can be used to identify animals: it provides only a
binomial marking system – normal length tail or short tail.
56
If surplus tissue from an identification method can be used, then this is fully refined as no
other technique need be applied. On the basis of the data that could be used for analysis,
surplus tissue from 87% of ear marks form the biopsy tissue for genotyping. This falls to 59%
for (partial) digit removal.
Blood sampling, skin sampling and post-mortem sampling are also unlikely to permit animal
identification, and these submissions may be in error.
With regard to methods of tissue sampling under project authorisation, tail biopsy is the most
commonly used (65%), followed by ear biopsy (20%), distal phalanx biopsy (13%) and blood
sampling (2%).
Even for these common techniques, there is variability in the reporting of severity. This may
be because of other techniques applied (including analgesia/anaesthesia) or phenotype effects
of the genetic mutation. However, it may reflect inconsistencies in the reporting of the same
technique.
The use of sampling methodologies considered non-invasive, not requiring a project
authorisation accounted for less than 2% of all sampling, with use of post-mortem material
accounting for the majority in this category, with a few using observation, exposure to specific
lighting conditions or hair sampling.
Question in the questionnaire
D - 3.3 Provide information on efforts being made to refine tissue sampling techniques for
genotyping
The replacement of tail biopsy by taking surplus tissue from identification is occurring in
many Member States.
Other methods to reduce and refine the effects on the animal include avoidance of the need for
tissue sampling/genotyping by use of particular breeding strategies, for example homozygous
x homozygous, genotyping post mortem, tissue taken is as small as possible, reliable analysis
methods which remove the need for second testing / sampling, saving part of tissue in case
resample is required, tail / toe biopsy technique is performed before ossification and
innervation is advanced (young animals), use of local and/or general anaesthesia, use of
analgesia, use of fluorescent markers (non-invasive). Size of sample required is now much
reduced due to the accuracy of analytical method.
For zebrafish rapid analyses reduces the time that fish must be kept single housed to one to
two days, and genotyping of larvae means that surplus animals can be removed before
independent feeding.
It is important that the obligation to refine tissue sampling methods, where possible, is
systematically addressed to ensure uptake of more refined methods and compliance with the
Directive. There are non-invasive methods becoming available and these should be taken up
where technically possible. When invasive methods are used for identification, these should
provide surplus tissue for genotyping. In the light of the fact that tail biopsy, ear biopsy and
removal of part or all of a digit remain the most commonly used methods in EU, inspections
57
should systematically address whether the most refined methods of identification and tissue
sampling are being used. Since tail biopsy does not allow identification, it is unlikely that this
method will be the most refined.
Question in the questionnaire [voluntary question]
* D - 3.5 Has the Working Document on Genetically Altered animals been made available
to establishments housing or using genetically altered animals? Yes/No
EU Guidance made available
Yes 20
No
n/a 2
(blank) 6
Total 28
22 Member States answered this voluntary question. Of these, 20 Member States have made
this available, and the two answering n/a do not use genetically altered animals.
Question in the questionnaire [voluntary question]
* D - 3.6 Has additional official guidance on genetically altered animals been developed
to facilitate implementation?
* D - 3.6.bis If you consider this guidance helpful for other Member States to facilitate the
implementation of the Directive, please provide web-address for the guidance, where
available
Additional guidance developed
Yes 4
No 16
n/a 2
(blank) 6
Total 28
Four Member States have created additional guidance and websites have been provided in the
detailed Member State summaries.
E. ENFORCEMENT
E.1. Authorisation of breeders, suppliers and users (Articles 20 and 21 of Directive
2010/63/EU)
Reporting obligation
“number of active authorised breeders, suppliers and users; information on suspensions or
withdrawals of authorisations of breeders, suppliers and users and the reasons therefore”
Background
58
Directive provides in its Articles 20 and 21 the following:
“Article 20
Authorisation of breeders, suppliers and users
1. Member States shall ensure that all breeders, suppliers and users are authorised by,
and registered with, the competent authority. Such authorisation may be granted for a
limited period.
Authorisation shall be granted only if the breeder, supplier or user and its establishment
is in compliance with the requirements of this Directive.
2. The authorisation shall specify the person responsible for ensuring compliance with the
provisions of this Directive and the person or persons referred to in Article 24(1) and in
Article 25.
3. Renewal of the authorisation shall be required for any significant change to the
structure or the function of an establishment of a breeder, supplier or user that could
negatively affect animal welfare.
4. Member States shall ensure that the competent authority is notified of any changes of
the person or persons referred to in paragraph 2.
Article 21
Suspension and withdrawal of authorisation
1. Where a breeder, supplier or user no longer complies with the requirements set out in
this Directive, the competent authority shall take appropriate remedial action, or require
such action to be taken, or suspend or withdraw its authorisation.
2. Member States shall ensure that, where the authorisation is suspended or withdrawn,
the welfare of the animals housed in the establishment is not adversely affected."
Analysis
Questions in the questionnaire
E - 1.1 Provide number of active authorised breeders, suppliers and users. The numbers
in this table indicate the total number of active establishments authorised and having
bred, used and/or supplied animals in the reporting year (not only those newly authorised
in a given year)
* E - 1.2 Provide number of active establishments keeping non-human primates
[voluntary question – requested for the purposes of assessing compliance with
requirements for inspections under section E-2]
It is important to note in this context that the lower numbers during the first years reflect the
fact that the Directive obligations had yet to be transposed in the national legislation in some
Member States. The last Member State adopted national legislation only in the spring of 2015.
59
Not all Member States gave complete data for all columns, and some only the total numbers of
breeders, suppliers and users combined.
Only half of the Member States using non-human primates answered the voluntary question on
establishments housing non-human primates.
60
Total number of active breeders, suppliers and users authorised in the EU
Year 1. Number of
active breeding
establishments
(not using
animals)
2. Number of
active
establishments
authorised
only to supply
animals bred
by others (not
breeding
/using animals)
3. Number of
active
establishments
authorised to
breed both
and supply
their own and
those bred by
others (not
using animals)
4. Total
number of
breeders
and/or
suppliers (from
columns 1 to
3)
5. Number of
active
establishments
authorised to
only use
animals
6. Number of
active
establishments
authorised to
use and breed
animals
7. Number of
active
establishments
authorised to
use and supply
animal
8. Number of
active
establishments
authorised to
use, breed and
supply animals
9. Total
number of
active
establishments
authorised to
use animals
(the total of
columns 5 to
8)
2013 115 36 84 696 1,348 251 6 176 1,781
2014 180 40 97 945 1,354 1,035 7 205 2,602
2015 255 49 106 1,044 1,405 1,141 7 211 2,772
2016 257 51 104 1,011 1,354 1,156 10 220 2,748
2017 258 50 106 1,093 1,338 1,197 10 216 2,769
Total number of authorised breeders, suppliers and
users in the EU (from columns 4 and 9)
2013 2,477
2014 3,547
2015 3,816
2016 3,759
2017 3,862
61
Member State comparison of active authorised breeders, suppliers and users.
0
100
200
300
400
500
600
700
800
900
AT BE BG CY CZ DE DK EL ES EE FI FR HR HU IE IT LT LU LV MT NL PL PT RO SK SI SE UK
Total number of active authorised establishments
by year (2013-2017) for each MS
2013
2014
2015
2016
2017
62
Withdrawals of breeders, suppliers and users
Question in the questionnaire
E - 1.3 Provide cumulative information covering years 2013-2017 on the suspensions or
withdrawals of authorisation of breeders, suppliers and users and reasons thereof
21 Member States reported that no authorisations for breeders, suppliers or users had been
withdrawn during the reporting period as a consequence of enforcement action.
A few reported that establishments had closed during this period but for reasons unrelated to
compliance, such as lack of funding or loss of expertise. One Member States reported that a
number of establishments closed due to their inability to meet the new requirements in Annex
III on housing and care practices.
Two Member States reported that authorisations had been removed. In one Member State, one
user was closed in 2014, one in 2016 and one in 2017, but no reasons were provided. In the
other Member State, three authorisations were withdrawn, one due to water damage, one for
failing to meet building requirements, and one where no application was received to continue.
Five Member States did not provide any information in response to this question.
E.2. Inspections (Article 34 of Directive 2010/63/EU)
Reporting obligation
“quantitative and qualitative operational information including criteria applied under Article
34(2) of Directive 2010/63/EU and proportion of unannounced inspections broken down by
year”
Background
Directive provides in its Articles 4 and 13 the following:
“1. Member States shall ensure that the competent authorities carry out regular
inspections of all breeders, suppliers and users, including their establishments, to verify
compliance with the requirements of this Directive.
2. The competent authority shall adapt the frequency of inspections on the basis of a risk
analysis for each establishment, taking account of:
(a) the number and species of animals housed;
(b) the record of the breeder, supplier or user in complying with the requirements
of this Directive;
(c) the number and types of projects carried out by the user in question; and
(d) any information that might indicate non-compliance.
3. Inspections shall be carried out on at least one third of the users each year in
accordance with the risk analysis referred to in paragraph 2. However, breeders,
suppliers and users of non- human primates shall be inspected at least once a year.
4. An appropriate proportion of the inspections shall be carried out without prior
warning.
63
5. Records of all inspections shall be kept for at least 5 years.”
Analysis
Questions in the questionnaire
E - 2.1 Is the endorsed EU Inspection Risk Analysis Criteria used as the basis for risk
assessment? Yes/No
E - 2.1.bis Please provide the criteria used for risk analysis in your MS (including web-
address where the criteria can be found)
24 Member States confirmed using EU Inspection Risk Analysis Criteria as the basis for risk
assessment. Three Member States gave other local criteria similar to the EU document, or with
one stating that the system was in development.
Several Member States made comment in other sections about the risk drivers for inspection
including outcomes of previous inspections of the establishment; types of animals held
especially use of special species, the number of animals kept and used, relating to that the
severity, duration and frequency of the procedures carried out influence the inspection
programme. Identification of any deficiencies, particularly if there is apparent resistance to
change or any unwillingness to provide information requested are significant drivers for
increased inspections.
Questions in the questionnaire
E - 2.2 Are all new establishments inspected before an authorisation is granted? Yes/No
E - 2.2.bis Provide description on how the compliance with the provisions of the Directive
is ensured as required in the second paragraph of Article 20(1)
27 Member States confirmed inspection of an establishment being necessary before granting
an authorisation. Austria stated that in most cases this includes an on-site visit before
authorisation is granted but not all new establishments were inspected before granting an
authorisation.
Questions in the questionnaire
E - 2.3 Provide quantitative operational information on inspections including proportion
of unannounced inspections broken down by reporting year
E - 2.4 Provide qualitative operational information on inspections carried out under
Article 34. Qualitative operational information includes e.g. effectiveness in terms of
impacts (such as declining trend in non-compliance); changes in risk profile of
establishments; reduction in legal and administrative actions due to infringements.
Explain unusual or outlying figures – in particular, if not meeting minimum requirements,
make clear the actions being taken to meet these.
* E - 2.5 What information is made publicly available on inspection / enforcement?
Please provide a web-address where any published material on inspections / enforcement
may be found [voluntary information]
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Year Number of
announced
inspections
Number of
unannounced
inspections
Total inspections Proportion
unannounced
2013 1,717 978 2,695 36%
2014 2,046 1,646 3,692 45%
2015 2,080 1,388 3,468 40%
2016 2,143 1,353 3,496 39%
2017 2,045 1,367 3,412 40%
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It is important to note in this context that the lower numbers during the first years reflects the
fact that the Directive obligations had yet to be transposed in the national legislation in some
Member States. The last Member State adopted national legislation only in the spring of 2015.
The Directive requires that one-third of user establishments should be inspected per year.
18 Member States have performed more inspections than on one-third of total number of user
establishments for that Member State for all years since the transposition of the Directive.
Other Member States appear not to have achieved this in some years. One Member States
(Hungary) has performed fewer inspections than one-third of total number of user
establishments for that Member State for all five years of this report.
All establishments breeding, supplying and/or using non-human primates must be inspected at
least once per year. Member States which have non-human primates have performed more
inspections each year than the number of establishments housing non-human primates.
However, the reporting obligations do not allow for a conclusion to be made on whether there
is compliance with this requirement specifically, that is to say, annual inspections in
establishments housing non-human primates, even if total number of inspections was to
exceed this.
Concerning unannounced inspections, five Member States have reported no unannounced
inspections (Czechia, Cyprus, Malta, Poland and Portugal). Despite this, the total proportion of
unannounced inspection in the EU since the Directive took effect seem to be relatively high,
up to around 40%.
Inspections are carried out by a variety of persons, such as veterinarians, official experts.
Several Member States made reference to the minimum numbers of inspections as stated in the
Directive, that is to say one-third of all user establishments every year and all establishments
housing non-human primates. One Member State also inspects all establishments using
domestic carnivores annually.
The inspector is often accompanied by a representative of the establishment. In one Member
State, all inspections are identified in order to give notice to this person, although most
Member States did not report that this was necessary.
Several Member States stated aspects inspected including animal housing standards inter alia
ventilation, temperature, lighting, noise, availability of feed and water, stocking densities,
bedding, hygiene, enrichment, animal health and care, record keeping in projects, and whether
procedures complied with authorisations of projects. The documents from the Animal Welfare
Bodies, and the functioning of them were also included by some.
Several stated that the inspectors use a common check-list to ensure inspection of relevant
issues.
Some communicated the result of the inspection back to the establishment and some included
suggestions for improvement. One Member State has performed themed inspections aimed
specifically at improving standards, and published summaries of common findings annually.
66
In cases where more serious issues were identified, Member States stated that administrative /
legal procedures would be taken sometimes requiring improvement within a specified
timeframe. Some Member States have identified a declining trend in non-compliance, as
evidenced in their inspection reports.
One Member State has stated that centralising the duties of inspections has led to greater
consistency and efficiency.
E.3. Withdrawals of project authorisation (Article 44 of Directive 2010/63/EU)
Reporting obligation
“information and reasons for the withdrawals of project authorisation during the reporting
period”
It is important to note that no detailed, numerical data are required on withdrawals.
Instead, Member States are required to provide information on reasons for withdrawals.
Background
Directive provides in its Article 44 the following:
“1. Member States shall ensure that amendment or renewal of the project authorisation is
required for any change of the project that may have a negative impact on animal
welfare.
2. Any amendment or renewal of a project authorisation shall be subject to a further
favourable outcome of the project evaluation.
3. The competent authority may withdraw the project authorisation where the project is
not carried out in accordance with the project authorisation.
4. Where a project authorisation is withdrawn, the welfare of the animals used or
intended to be used in the project must not be adversely affected.
5. Member States shall establish and publish conditions for amendment and renewal of
project authorisations.”
Analysis
Question in the questionnaire
E - 3 Provide cumulative information covering years 2013-2017 on the withdrawals of
project authorisation, and reasons thereof
A few Member States commented in this section on refusals to grant authorities rather than
removal of authorities after project authorisation. Other Member States commented on
voluntary withdrawals by user or person responsible for project, for example when no funding
is secured to conduct the work.
One Member State noted that projects were withdrawn as under the new legislation, projects
were no longer required for killing and harvesting of tissues after death.
67
19 Member States reported that no project authorisations were withdrawn during the reporting
period. In other Member States where numbers were provided (voluntarily), only a few (one to
three) projects were withdrawn.
A variety of reasons were given:
 animal welfare concerns;
 poor experimental methodology/scientific design;
 use of higher numbers of animals than authorised;
 failing to provide statistical information on animal use;
 unsuitable facilities for the proposed animal work
 failure to provide the competent authority with reports on progress.
E.4. Penalties (Article 60 of Directive 2010/63/EU)
Reporting obligation
“information on the nature of infringements as well as legal and administrative actions resulting
from those infringements during the reporting period”
It is important to note that no detailed, numerical data are required on penalties. Instead,
Member States are required to provide information on the nature of infringements,
including those leading to legal and/or administrative actions.
Question in the questionnaire [voluntary question]
* E - 4.1 Provide a general description of the main rules and steps governing penalties in
your MS that will put into context the cumulative information provided below in section
4.2-4.4. Please note that administrative procedures may vary significantly between
countries
Although a non-mandatory question, 21 Member States provided some information on the
structures under which breaches of the legislation are dealt with, and/or some indication of the
penalties applied.
From the information provided, there is generally within the Member States a range of
administrative and legal actions, which can be taken, and these are applied proportionately
dependent on the nature of the infringement.
Typically, minor breaches will be dealt with administratively with timely, corrective action
required by the transgressor.
Tariffs are escalated where there is reluctance or delays to the introduction of corrective
measures, and, in particular, where avoidable animal suffering has occurred. In very severe
cases, a number of Member States have the option of imprisonment as a sanction.
Analysis
Questions in the questionnaire
E – 4.2 Provide cumulative information covering years 2013-2017 on the nature of
infringements
68
E – 4.3 Provide cumulative information covering years 2013-2017 on the nature of
administrative action as a result of infringements
E – 4.4 Provide cumulative information covering years 2013-2017 on the nature of legal
actions as a result of infringements
There were significant differences in the quantity and quality of information provided by
Member States on infringements encountered, and administrative and/or legal actions imposed
as a consequence of such infringements.
Three Member States (Estonia, Malta and Portugal) indicated that no infringements were
recorded in the reporting period and two Member States (Italia and Latvia) indicated that there
had been no cases severe enough to warrant administrative or legal action.
The remaining Member States provided information on the types of infringements that had
been encountered, and action taken.
Commonly reported infringements included performance of procedures without appropriate
authorisation, inappropriate record keeping, inadequate training and failure to meet
requirements of Annex III (accommodation and care).
All reported a proportionate response was taken, dependent on the severity of the
infringement.
The majority of infringements were dealt with by administrative means, requiring corrective
measures be put in place to prevent recurrence. A number of Member States noted that follow
up inspections were often made to ensure any deficiencies had been resolved.
Few reports of legal action were reported, with such action generally kept for the more severe
cases, in particular those involving unnecessary animal suffering.
One Member State (United Kingdom) reported that (anonymised) information on
infringements and actions were published annually.
Question in the questionnaire [voluntary question]
* E - 5 Has the EU Guidance on Inspections and Enforcement been made available to all
inspectors? Yes/No
EU Guidance made available
Yes 25
No 1
n/a 2
(blank) 6
Total 28
Question in the questionnaire [voluntary question]
* E - 6 Has additional official guidance on Inspections and Enforcement been developed
to facilitate implementation? Yes/No
69
National guidance developed
Yes 8
No 16
(blank) 6
Total 28
Question in the questionnaire [voluntary question]
* E - 6.bis If you consider this guidance helpful for other Member States to facilitate the
implementation of the Directive, please provide web-address for the guidance, where
available
Provided links to websites are available in the detailed Member State summaries.
F. OTHER – ADDITIONAL VOLUNTARY QUESTIONS
Member States were invited to provide their views and comments on the implementation of
the Directive, highlighting areas of difficulty, on well-functioning elements, on areas where
further collaborative efforts could improve implementation.
Eighteen Member States provided comments for one or more of the questions.
F.1. Problematic areas for implementation of the Directive
Question in the questionnaire [voluntary question]
* F -1 Please provide here views on problematic areas for implementation of the
Directive in your Member State
Fifteen Member States responded to this question. Answers included:
 Ensuring sufficient expertise for Animal Welfare Bodies and other roles in small
establishments.
 Provision for farm animal accommodation could be improved.
 Ensuring sufficient training for and trained staff for competent authority tasks, including
for National Committee. This can lead to delays in meeting project authorisation
deadlines.
 Availability of sufficient education and training courses can delay scientific work.
 Maintaining anonymity of non-technical project summaries in small Member States.
 The killing of animals for tissues and organs is not subject to authorisation, with only
numbers reported in the five-year cycle.
 No common up-to-date database of available alternative methods.
 Where not in place under previous legislation, significant increase in costs and
administrative burden to implement new requirements such as project authorisation
70
 Difficult to decide which animal has the lowest capacity to experience pain, suffering,
distress or lasting harm (text replaced from Directive 86/609 “…involve animals with the
lowest degree of neurophysiological sensitivity..”).
F.2. Views on well-functioning elements of the Directive in your Member State
Question in the questionnaire [voluntary question]
* F - 2 Please provide here views on well-functioning elements of the Directive in your
Member State
Fifteen Member States responded to this question. Answers included:
 Inspection is easier due to defined standards and authorities.
 Project evaluation and authorisation – improved implementation of the Three Rs.
Development of standardised project application and evaluation forms.
 Requirement for harmonised training and competence framework.
 Animal Welfare Bodies promoting and overseeing improved standards within
establishment, including culture of care.
 Improved transparency – non-technical project summaries and annual statistical reporting.
F.3. Views on issues that would benefit from collaborative efforts to improve
implementation of the Directive
Question in the questionnaire [voluntary question]
* F - 3 Please provide here views on issues that would benefit from collaborative efforts
to improve implementation of the Directive
Thirteen Member States responded to this question. Answers included:
 Continue to promote consistency in education and training requirements for all those with
responsibilities under the Directive. Consider some sort of European certification of
common standards. Central repository of “certified” training courses would be helpful.
 Guidance on good re-homing practices would be helpful.
 Provision of an easily searchable database for non-technical project summaries.
 Continue meetings of National Contact Points (Article 59) and National Committees
(Article 49).
 Improved use of EC IT tools for sharing of Member States guidance material.
 Central, up-to-date database on alternative (Three Rs, in particular replacement) methods.
 Development of training courses for the competent authorities, evaluators, inspectors, etc.
on their respective aspects and task (similar to DG SANTE’s BTSF (Better Training for
Safer Food) programme).
 Promote consistency in requirements concerning genetically altered animals.
71
F.4. Any other additional comments concerning the implementation of the Directive
Question in the questionnaire [voluntary question]
* F - 4 Please provide here any other additional comments concerning the
implementation of the Directive
Eight Member States responded to this question. All of the responses are available in the
Member State summaries.
 Nuances in transposition among Member States due to differing interpretations and an
indication that interpretation of some of the terminology is not straightforward depending
on local implementation. For example, in some Member States an establishment may have
several 'user' authorisations, whereas in others one 'user' authorisation may include several
facitilites.
 It was expressed that some time is needed without changes to the legislation, nor to its
interpretation, to facilitate its correct application.
 A review of reporting of exemptions in the next five-year implementation report has been
requested due to repetitive nature of exemptions and the likelihood of the reasons
remaining the same from one reporting period to another.
G. COMMISSION ACTIVITIES TO FACILITATE THE
IMPLEMENTATION OF THE DIRECTIVE
G.1. Transposition conformity checks
According to Article 61 of the Directive, the Member states were required to adopt and
publish, by 10 November 2012, the laws, regulations and administrative provisions necessary
to comply with the Directive.
A majority of Member states did not comply with this requirement and the Commission had,
in 2013, to open infringements procedures (in accordance with Article 258 of the Treaty of the
Functioning of the European Union) for non-communication of the transposition measures
against 15 Member states13
. Further to the subsequent adoption of the transposition measures,
these procedures were closed and finally all Member States have transposed into their national
law the Directive.
The Commission services carried out subsequently systematic, in-depth assessments of the
conformity of the transposition measures in order to check whether these measures correctly
transpose the provisions of the Directive. Since several instances of possible incorrect
transpositions issues were identified, the Commission services entered into dialogue with all
Member States in order to gather further explanations and information from them. The
dialogue between the Commission services and the Member States gives a possibility to the
Member States concerned to address identified shortcomings. Depending on the replies given
by the Member States, the Commission has been able to successfully conclude the discussions
with eight14
Member States. Where the issues could not be addressed in the frame of this
13
BG, DE, EL, ES, FR, IT, CY, HU, MT, NL, PL, PT, RO, SI and FI
14
BE, IE, EL, HR, CY, LT, LU and MT
72
dialogue, the Commission decided to open several infringement procedures in accordance with
Article 258 of the Treaty of the Functioning of the European Union.
By mid of October 2019, the Commission has opened 1515
infringement procedures for non-
conforming transposition of the Directive. Two16
out of these 15 procedures could be
successfully closed since the concerned Member States took the necessary measures. Further
procedures may be launched against other Member States on the basis of the ongoing
assessment of their replies.
G.2. Other activities to facilitate correct and comprehensive implementation of the
Directive.
To achieve the aims of the Directive, a uniform understanding on the Directive’s obligations
and objectives across the EU is imperative. The European Commission has gone to great
length to facilitate correct implementation of the Directive.
The European Commission hosts meetings of National Contact Points set up under Article 59
of the Directive twice a year to identify and discuss issues on implementation. These issues
can be divided in three categories:
1. Questions related to correct interpretation of a legal term or requirement;
2. Questions related to concepts in the Directive.
3. Questions related to Member State administrative processes for implementing the
Directive, including tools to reduce administrative burden;
For questions in the first category the Commission developed a Q&A document, which is
published on the Commission web-site17
, and is being kept up to date.
Concerning questions related to concepts in the Directive, the Commission hosted several
expert working groups, with experts nominated by Member States, science/academia, industry,
animal welfare organisations and other specialist organisations (such as laboratory animal
veterinarians, laboratory animal breeders, animal technologists). The objectives of these
working groups were to develop EU guidance and common lines to topics of importance to
harmonise their implementation.
The guidance documents, endorsed by the National Contacts Points of the Member States, are
available in all community languages to make them accessible to widest possible audience.
The current series of EU guidance consist of
 Project evaluation and retrospective assessment;
 Education and training framework;
 Severity assessment framework;
 Animal Welfare Bodies and National Committees;
 Inspections and enforcement.
15
CZ, DK, DE, EE, ES, IT, LV, HU, AT, PL, PT, RO, SI, SK and FI
16
EE and ES
17
https://ec.europa.eu/environment/chemicals/lab_animals/interpretation_en.htm
73
Questions on administrative processes are discussed on a regular basis, encouraging sharing of
good practice among Member States. Through discussions with Member States and other
stakeholders, the Commission developed tools covering inter alia
 inspection risk analysis criteria and Aide Memoire;
 pre-formulated questions for building a project application template;
 recommended template for a non-technical project summary.
In addition, the European Commission together with Member States developed a common
template for collecting and submitting statistical data under the Directive. This is to share
resources and minimise the administrative burden.
The role of National Committees is important for the functioning of the Animal Welfare
Bodies, and for advising competent authorities in matters dealing with the acquisition,
breeding, care and use of animals. To aid their work, the Commission hosted two meetings of
National Committees to explore areas of common interest and share good practice.
The review of the Directive, adopted in November 201718
, identified problems in the quality
and timeliness of the publication of non-technical project summaries of authorised projects.
The Commission took the initiative to streamline and modernise reporting obligations
resulting in adoption of amendments to the Directive through Regulation (EU) 2019/101019
in
June 2019. These include setting up open access, searchable central EU databases for non-
technical project summaries and statistical data, significantly improving transparency of
animal use in the EU.
With additional funds provided by the European Parliament, the Commission was able to
initiate an EP Pilot Project focusing on education, training and information sharing activities
on the Three Rs. The project aims at expediting the development and validation of new
alternatives, and the uptake of existing alternatives through better implementation of the
Directive. This project will deliver six interactive eLearning training modules covering some
of the key aspects of the Directive, such as on the severity assessment framework, project
evaluation and how to search for non-animal alternatives.
Making these modules available to project applicants, project evaluators, inspectors and those
working with animals, can have a significant impact in improving consistency of
implementation of the Directive across the EU. The modules are expected to be finalised by
the end of 2020.
Under the same project, funding was granted for the European Education and Training
Platform for Laboratory Animal Science (ETPLAS), established on the basis of a
recommendation in the EU Guidance on Education and Training Framework, to develop
practical tools and criteria for the assessment of learning outcomes and competence of staff.
The harmonised approach to competence assessment across the EU is expected to have a great
impact on improving the competence of those working with the animals, in line with the aims
of Directive obligations under Article 23.
18
COM/2017/0631 final
19
OJ L 170, 25.6.2019, p. 115–127