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}



Contents Introduction i. Information from the Member States ii. Structure of the Report A. GENERAL INFORMATION B. STRUCTURES AND FRAMEWORK B.1. Competent authorities (Article 59 of Directive 2010/63/EU) B.2. National committee (Article 49 of Directive 2010/63/EU) B.3. Education and training of personnel (Article 23 of Directive 2010/63/EU) B.4. Project evaluation and authorisation (Articles 38 and 40 of Directive 2010/63/EU) C. OPERATION C.1. Projects C.1.i. Granting of project authorisation (Articles 40 and 41 of Directive 2010/63/EU) C.1.ii. Retrospective assessment, non-technical project summaries (Articles 38, 39 and 43 of Directive 2010/63/EU) C.2. Animals bred for use in procedures (Articles 10, 28 and 30) C.2.i. Animal bred, killed and not used in procedures C.2.ii. Sourcing of non-human primates C.3. Exemptions

C.4. Animal Welfare Body (Articles 26 and 27 of Directive 2010/63/EU) D. PRINCIPLES OF REPLACEMENT, REDUCTION AND REFINEMENT D.1. Principle of replacement, reduction and refinement (Articles 4 and 13 of Directive 2010/63/EU) D.2. Avoidance of duplication (Article 46 of Directive 2010/63/EU) D.3. Tissue sampling of genetically altered animals (Articles 4, 30 and 38 of Directive 2010/63/EU E. ENFORCEMENT E.1. Authorisation of breeders, suppliers and users (Articles 20 and 21 of Directive 2010/63/EU) E.2. Inspections (Article 34 of Directive 2010/63/EU) E.3. Withdrawals of project authorisation (Article 44 of Directive 2010/63/EU) E.4. Penalties (Article 60 of Directive 2010/63/EU) F. OTHER – ADDITIONAL VOLUNTARY QUESTIONS F.1. Problematic areas for implementation of the Directive F.2. Views on well-functioning elements of the Directive in your Member State F.3. Views on issues that would benefit from collaborative efforts to improve implementation of the Directive F.4. Any other additional comments concerning the implementation of the Directive G. Commission activities to facilitate the imlementation of the Directive G.1. Transposition conformity checks G.2. Other activities to facilitate correct and uniform implementation of the Directive.





Introduction This Staff Working Document is an annex to the main report to the European Parliament and the Council on Member States’ implementation of Directive 2010/63/EU on the protection of animals used for scientific purposes (“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/EU (“the Annex”). In June 2019, the Directive was amended by Regulation (EU) 2019/1010 (“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, 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 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; (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. 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 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



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 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. 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 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 Directive 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. 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. Financial support varies, and this is reflected in the level of activities achieved. A number of National Committees have bespoke web-sites, 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. 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 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. 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 Framework 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. 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 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.”

·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 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 Directive 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 FELASA , 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? * 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: (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. 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. 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. 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) 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 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 Directive, 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. 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. 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 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. 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.

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%

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.

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 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: 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 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; ·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 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: oanimals used in scientific procedures oanimals used for the creation and maintenance of genetically altered animal lines (that have experienced harm during the process) ·implementation report once every five years: oanimals 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. 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 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 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. 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? 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 study 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

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 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. 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 coverin