Enhancing Scientific Cooperation between EFSA and Member States 1

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1 EFSA supporting publication 2014:EN-567 TECHNICAL REPORT Enhancing Scientific Cooperation between EFSA and Member States 1 European Food Safety Authority 2, 3 European Food Safety Authority (EFSA), Parma, Italy SUMMARY In 2013, an Advisory Forum Discussion Group on Scientific Cooperation (AFDGSC) was established in response to the recommendation from the EFSA Management Board for EFSA to enhance the coordination of work programmes with national authorities, including through the Advisory Forum, to enable better sharing of data and scientific studies and better planning of joint projects. The AFDGSC was tasked with providing proposals on strengthening scientific cooperation in particular to share work programmes, plan joint projects and further enhancing EU risk assessment capacity. The discussion group proposes the following recommendations for consideration by EFSA to enhance scientific cooperation between EFSA and Member States: 1. As previously agreed through the Declaration of Intent agreement (2006), work plans should continue to be shared through the Advisory Forum, Focal Point Network and the IEP. Regular updates on unplanned risk assessment activities should be shared through the Advisory Forum. 2. Member States and EFSA should continue to work towards the harmonisation of methodologies and guidance. The Advisory Forum should be provided with regular updates on activities and the Scientific Network on the Harmonisation of Risk Assessment Methodologies should be invited in 2014 to update the AF as part of the recommendations from the Self Review of EFSA s Scientific Networks (2014). 3. As previously recommended by the Advisory Forum, EFSA s scientific networks should clearly set out their work activities and their role in sharing information should be explored further to include the sharing of work plans. 4. The role of Focal Points should be expanded to include a coordinating role in support of members of the EFSA s scientific networks and other activities. These activities should be formally included within the Focal Point Agreements in As per the previous recommendation of the AF discussion group on data collection, existing networks and working groups should continue to work towards harmonisation of data collection, focusing on data collection on areas of public health concern, and reducing 1 On request from EFSA, Question No EFSA-Q Approved on 7 th April Correspondence: AFSCO@efsa.europa.eu 3 Acknowledgement: EFSA wishes to thank the members of the Advisory Forum Discussion Group on Scientific Cooperation for the preparatory work on this output and the Advisory Forum and Scientific Cooperation Unit for the support provided to this output. Suggested citation: European Food Safety Authority, 2014; Enhancing Scientific Cooperation between EFSA and Member States. EFSA supporting publication 2014:EN pp. Available online: European Food Safety Authority, 2014

2 duplication. Priority should be given to developing data access rules to allow the publication, analysis and distribution of data collected by EFSA to interested parties. 6. A framework should be developed to allow the possibility to launch thematic grants in Additional means of outsourcing scientific work should be investigated, including the use of framework partnership agreements that can support networks of excellence under the current Article 36 framework. 8. The BTSF training programmes should continue with the possibility of making the training materials more widely available and support similar training opportunities at national and regional level. 9. Consider the feasibility to open EFSA s advanced risk assessment training courses to participants from the Member States in A pilot scheme for facilitating short term guest scientist exchanges between EFSA and Member States should be established for implementation in A multi-annual programme on international cooperation should be developed and shared with the Advisory Forum. KEY WORDS Advisory Forum Discussion Group on Scientific Cooperation, Member States, Scientific Cooperation. EFSA supporting publication 2014:EN-567 2

3 TABLE OF CONTENTS Summary... 1 Table of contents... 3 Background as provided by EFSA... 4 Terms of reference as provided by EFSA... 4 Consideration... 5 Opportunities to enhance scientific cooperation Sharing of information and data Sharing of work programmes and work planning Scientific Networks Data Sharing Harmonisation of methodologies and guidance Strengthening risk assessment capacity Outsourcing of scientific work Thematic Grants Networks of Excellence Risk assessment training opportunities Opportunities for staff exchange between EFSA and Member States Focal point network International Scientific Cooperation Recommendations Appendices Appendix A. Legal Basis for Scientific Cooperation Appendix B. Overview of Strategies and Agreement on Scientific Cooperation Appendix C. Summary of Strategic Documents on Scientific Cooperation Glossary and abbreviations EFSA supporting publication 2014:EN-567 3

4 BACKGROUND AS PROVIDED BY EFSA In 2012, an external review of EFSA identified the need to further strengthen cooperation with Member States by improving the system of the exchange of information, increasing the communication of EFSA s risk assessments in Member States, sharing agendas, working plans and developing joint activities. In drawing on the conclusions from the external evaluation, the Management Board recommended that EFSA should enhance EU risk assessment capacity by cooperating with Member States in relation to planning EU work in areas within its remit, to enable better priority setting and more efficient and effective use of resources. In particular, the Board recommended that EFSA should enhance the coordination of work programmes with national authorities, including through the Advisory Forum, to enable better sharing of data and scientific studies and better planning of joint projects 4. In March 2013, the Management Board requested further details on how EFSA planned to enhance scientific cooperation between Member States within its Multi-Annual Plan (MAP) in line with its recommendations. The Board highlighted the need to explore scientific cooperation beyond the current Article 36 grants and procurement schemes. The Advisory Forum Discussion Group was established in May 2013 at the request of EFSA to provide advice on how scientific cooperation could be improved with European Member States. This paper, in addition to other reviews currently being conducted on the tools and mechanisms will assist EFSA in making improvements to enhance scientific cooperation with Member States. TERMS OF REFERENCE AS PROVIDED BY EFSA The terms of reference of the Advisory Forum Discussion Group were: Identify any gaps in scientific cooperation that need to be addressed in order to help meet EFSA s priorities; Advise on good practice that is being used in other organisations on mechanisms for enhancing scientific cooperation; Provide input for EFSA s consideration on how EFSA and Member States can work together to strengthen scientific cooperation in particular to share work programmes, plan joint projects and further enhance EU risk assessment capacity. Process In May 2013, an internal mandate was accepted by EFSA to establish an Advisory Forum Discussion Group on Scientific Cooperation. The Secretariat of the group was provided by EFSA (Advisory Forum and Scientific Cooperation Unit) and members were composed of representatives of the Advisory Forum from France, Ireland, Cyprus, Sweden, Germany, Belgium, Slovakia and Spain. Three meetings occurred on 24 th May, 5 th September and 12 th November, This paper has been prepared from those discussions. 4 Available at EFSA website: EFSA s external evaluation and recommendations from EFSA s Management Board (2012). EFSA supporting publication 2014:EN-567 4

5 CONSIDERATION Opportunities to enhance scientific cooperation Having established quite a number of scientific cooperation tools after some years of scientific cooperation in many areas, it is proper to review and identify opportunities to further enhance scientific cooperation. This chapter presents an overview of the challenges with regards to scientific cooperation and proposes suggestions on how to enhance scientific cooperation further. The aim of this review is to move beyond the operation of specific scientific cooperation tools, to identify ways and actions on how to enhance scientific cooperation further so that it will help to build a common multi-annual EU risk assessment agenda that will meet the long-term needs of EFSA and Member States. The content is based on discussions of the Advisory Forum Discussion Group on Scientific Cooperation and breakout groups conducted with Advisory Forum members. 1. Sharing of information and data 1.1. Sharing of work programmes and work planning Being aware of work programmes or key priorities of EFSA and Member States may help to avoid duplication of work, create opportunities for scientific cooperation and help to avoid diverging opinions. Where such work plans exist, sharing through the Information Exchange Platform (IEP) is recommended. However, it is recognised that not all Member States have established work plans or programmes specifically for food safety risk assessment. For many Member States, particularly smaller Member States, risk assessment activities are frequently reactive in nature, originating from ad hoc national requests. Furthermore, these risk assessments may be done by different organisations within one country with minimum inter-agency communication. As detailed work programmes are not available in every Member State and countries are organised differently, it is important to emphasize that information on risk assessment activities of common interest can be shared through other avenues such as the Focal Point Network and Advisory Forum, especially for short term activities which are not usually captured in work plans. The advantage of using these fora is that it allows for direct interaction where EFSA and Member States can provide better feedback on the use made of the information shared by the Scientific Panels. To counter the difficulty of having to cover the large remit of food and feed safety, while Member States are organised differently, it may be necessary to break down the sharing of work planning into more specialised areas. Therefore, an additional means to foster the sharing of work planning information could be to coordinate exchange of such information on specific areas through the different scientific networks. Another opportunity to help improve the sharing of information could be to make better use of the network of Article 36 organisations. Currently, EFSA fosters networking through electronic tools and by providing financial support for tasks entrusted to the organisations on the Article 36 list. EFSA could explore how to stimulate the sharing of work programmes among the Article 36 organisations. This networking could be further strengthened by creating partnerships between organisations in certain areas of expertise; sharing training opportunities and announcements of scientific events organised by Article 36 organisations via the Article 36 Extranet Workspace (Art36-NET); and organise risk assessment conferences or EFSA information days. Sharing of work planning can also help to identify as early as possible any controversial scientific issues that may arise between different bodies performing risk assessment. Early detection of these issues would allow the opportunity to exchange views (through expert meetings and/or consultation with scientific bodies involved) to prevent diverging scientific opinions. EFSA supporting publication 2014:EN-567 5

6 1.2. Scientific Networks The overall findings of the Self Review of EFSA s Scientific Networks found that the networks contribute to the risk assessment activities of both EFSA and the Member States. It was noted that coordination at national level could be improved to better prepare representatives attending network meetings and to provide timely feedback at national level. In some cases there was no clear indication of the work activity of the networks. The report suggested that when the terms of references are updated, which usually occurred every three years, a clear indication of the work activity of each scientific network should be included. To improve the support provided to representatives at national level and facilitate feedback, there is a potential role for Focal Points as co-ordinators of these activities. This role could be detailed and included in the list of specific tasks allocated to Focal Points in the agreements made between EFSA and the Member State. The scientific networks have greater potential for coordinating the exchange of information in each of the specific domains covered. While some currently carry out this activity, it is not the case for all networks. It is recommended that the networks play a greater role in the exchange of data and information in areas such as work planning, new research, exchange of models and literature searches. Currently, there is a potential area of duplication of effort with regard to identifying new, relevant scientific literature and other reports. Sharing of information on work planning, new research, exchange of models and literature searches through the scientific networks will help to reduce duplication and enhance cooperation Data Sharing EFSA s Management Board recently recommended that EFSA should improve the quality and availability of data and other information it collects, and further enhance the coordination of data collection activities with Member States and other EU and international bodies. There are many data collection initiatives and activities being carried out with Member States and several specific working groups and networks have been established on specific aspects of data collection. There is room to further improve the way in which data is collected, transferred and handled between Member States and EFSA. In relation to data collection, the challenging recommendation is to align all Member States to report data to EFSA using a harmonised format. It is also important to recognise that in general, data is mainly collected for compliance with legal limits whereas the data is used by EFSA for exposure assessments. While a lot of progress has been achieved, it is also recognised that important elements on the data collection process, as identified in Commission Regulation (EC) No 1829/2003 are still missing. They concern aspects of data storage and access to these databases, as well as the establishment of multi-annual programmes on data collection. These are essential to provide the data collectors with access to data, feedback and recognition that they need to remain motivated. In 2011, an Advisory Forum Discussion Group on Data Collection 5 recommended areas for improvement in the way data is collection and managed between Member States and EFSA. The recommendations included developing a medium term data collection plan, developing guidance on analysing data and working towards the harmonisation of data collections with Member States. In 2012, EFSA initiated a project to develop a Data Warehouse (DWH) that will allow the publication, analysis and distribution, in different formats and at different level of granularity of data collected by EFSA. These data include among others information on zoonoses, antimicrobial resistance, foodborne outbreaks, pesticide residues, chemical contaminants, food consumption and chemical hazards. In the EFSA s DWH, data will be accessible through specific web reporting tools by means of tables, reports, graphs, maps and dashboards. According to the proposed DWH access rules, EFSA s staff 5 Technical Report of EFSA: Advisory Forum Discussion Group on Data Collection, September EFSA supporting publication 2014:EN-567 6

7 members and nominated European Commission s staff members have access to all data that are relevant to their duties at the lowest level of aggregation. Members of EFSA s scientific panels and working groups have a similar access to data, which are relevant to the specific mandate they are working with, but only until the mandate is completed. The data providers always have full access to their data. All stakeholders, including the general public, will have access to the data through predefined queries at the level of aggregation decided by EFSA in consultation with the European Commission, the Member States and the data providers. However, some data collections, such as the chemical hazard database and ad-hoc data collection may apply more specific data access rules Harmonisation of methodologies and guidance The harmonisation of risk assessment approaches and methodologies in specific scientific areas is addressed by EFSA s scientific networks. The general risk assessment methodology with regards to food and feed will benefit from further harmonisation to accomplish an integrated approach across the specific scientific fields and different organisations carrying out risk assessment within the EU. Recently the Scientific Committee reviewed its own cross cutting risk assessment guidance documents to identify gaps requiring either the development of new guidance or the revision of existing guidance 6. The following four topics were identified as gaps requiring the development of new guidance: the interpretation of epidemiological studies; the use of weight of evidence approach in risk assessment; the identification of biological relevance in toxicology; and import risk assessment. Work for the development of guidance documents is already ongoing on environmental risk assessment and uncertainty in risk assessment. The scientific network on the harmonisation of risk assessment methodologies 7 aims at building mutual understanding of risk assessment principles and methodologies with particular emphasis on general risk assessment methodologies of crosscutting nature, as developed by the Scientific Committee, and to provide increased transparency in the cooperation between competent risk assessment authorities in Member States and EFSA. The network constitutes an environment in which to share information and methodologies, thus facilitating harmonisation of the general risk assessment practices in order to build consensus on how to approach key elements of risk assessment throughout the EU. It is acknowledged that harmonisation of risk assessment is a long-term objective and that further progress is needed. Importantly there is a need to consider how EFSA s guidance is being implemented and used by the Member States. It may be worthwhile to consider the involvement of Member States in the planning of guidance development at an earlier stage, for instance by notifying the appropriate platforms (e.g. AF, FP, scientific networks) when the Scientific Panels and Scientific Committee are considering which questions need to be addressed and which scope should be formulated for a new guidance development. Holding workshops or dedicated meetings with Member States during a public consultation and organising similar trainings as those currently given to EFSA s scientific experts and staff may also help to ensure an adequate understanding and implementation of EFSA s guidance across the Member States. Engagement, involvement and participation are important factors to make a risk assessment harmonisation process successful. 2. Strengthening risk assessment capacity 2.1. Outsourcing of scientific work EFSA outsources scientific work through its grant and procurement schemes. The evaluation of the schemes in 2010 confirmed the importance of these activities to EFSA`s scientific work, as well as the positive impact on the organisations who were awarded contracts or grants. The evaluation highlighted 6 EFSA SC (EFSA Scientific Committee), Scientific Opinion on Priority topics for the development of risk assessment guidance by EFSA s Scientific Committee. EFSA Journal 2013;11(8):3345, 20 pp. doi: /j.efsa ; 7 Scientifc Network on the Harmonisation of Risk Assessment Methodologies, EFSA supporting publication 2014:EN-567 7

8 the challenges faced by organisations and EFSA, particularly in relation to the processes of the schemes. A difficulty with outsourcing preparatory work concerns the administrative burden resulting from relatively small ad hoc calls requiring an intensive effort to prepare the proposal for a project of short duration with limited financial compensation. Under the grant system this needs to be partially selffunded and requires substantial documentation to justify the expenses eligible for compensation by EFSA. Another difficulty concerning particularly smaller organisations who whilst having the expertise may not have the full level of resource that is required in the application. This has resulted in the scheme being less attractive to certain Member State organisations. EFSA has taken steps to simplify the procedures, as much as possible, under the Financial Regulation. Checklists, templates and guidance documents have been developed to support potential applicants in the application process. Further analysis showed that organisations who gain experience in applying to calls, also in the context of a consortium, find it easier to apply to subsequent calls. Training on administrative processes during project implementation is provided to organisations at project kick-off meetings. Training initiatives offered by EFSA could be expanded to target organisations interested in applying to calls, thereby enhancing their knowledge of procedures, generating interest and willingness in applying to calls and participating in EFSA projects. In addition this would also provide a opportunity and platform for organisations to network, establishing and strengthening ties. Members States have varying levels of resources and capacities to conduct risk assessment in the area of food and feed. Collaboration between organisations can be beneficial for optimising resources, for developing more expertise and increasing capacity in risk assessment in the area of food and feed, particularly as the necessary expertise do not always reside in one particular organisation. Organisations with past experience of working together are more likely to work together in the future. The training initiatives amongst others, could support European networking of organisations within EFSA s remit. Involvement of organisations in EFSA s scientific projects can further be promoted by allowing them to foresee and plan work more efficiently. Planned projects are published on EFSA s website to inform organisations of activities at an early stage. Increasing emphasis is placed on establishing and sharing multi-annual plans. In addition to this support for preparing for future projects, EFSA can foster more interest in projects and more continuous collaboration with organisations through the implementation of more long-term projects. These projects also improve the cost-benefit ratio for organisations. Therefore, more emphasis could be placed on such projects, e.g. through framework contracts or framework partnership agreements. To allow for different mechanisms of outsourcing work, EFSA could explore the use of a wider variety of financial tools available under the EU Financial Framework Thematic Grants As stipulated in Article 36 of EFSA s Founding Regulation and in Commission Regulation (EC) No 2230/2004, EFSA may implement joint projects to promote the European networking of organisations operating in the fields within the Authority's mission. In addition to the current scheme which is based on a specific call for a specific project, EFSA could propose broad thematic areas, inviting Article 36 organisations to submit project proposals. The objective of such an additional grant scheme would be to foster networking with the organisations on the list and to promote active scientific cooperation in the fields within its mission. Grants could take the form of a single call for proposals launched by EFSA. Applications could be open for a number of months to allow eligible applicants to form consortia and submit project proposals for co-financing. Such a grant scheme would stimulate networking projects with a public health and/or capacity building nature. The co-financing from EFSA could allow certain innovative projects to be started EFSA supporting publication 2014:EN-567 8

9 which otherwise may not receive funding. These projects could be larger in size and duration benefiting both EFSA and Member States Networks of Excellence Another grant opportunity to be explored further could be framework partnership agreements. One of the main difficulties in the outsourcing of work has been to achieve cooperation through short term projects with limited budgets. A way forward to optimise resources would be to consider increasing the outsourcing of certain preparatory tasks for scientific risk assessments such as literature reviews, data collection and experimental work to Member States. These tasks could be assigned to Member States through an improved grant mechanism based on a long term framework partnership agreement. This would allow for long term relationships to be built with networks of excellence. Such long term partnerships should also provide a mechanism to support partnership between different Member States. In addition to enabling networking between MS institutions, provisions can be made for shortterm exchange of staff between MS institutions as a means of capacity building. A legal framework for such centres or networks of excellence, where individuals or networks of organisations carry out specific areas of preparatory work to contribute to EFSA s scientific outputs, can be found in Article 36 (2) of EFSA s Founding Regulation, where it states that Competent organisations designated by the Member States which may assist the Authority, either individually or in networks, with its mission. The Authority may entrust to these organisations certain tasks, in particular preparatory work for scientific opinions, scientific and technical assistance, collection of data and identification of emerging risks. The tasks which may be entrusted to the organisations on the list are detailed further in Article 4 (3) of Commission Regulation (EC) No 2230/ Risk assessment training opportunities Training programmes help to build expertise and risk assessment capacity in Member States and may contribute to further harmonisation in risk assessment approaches. There are few courses available on risk assessment and there is a need for training programmes to be targeted to scientists in different stages of their career. Training programmes can consist of on the job training, graduate training, programmes aimed at young scientists and continued professional training for more experienced experts. One possibility could involve linking graduate study programmes to selected centres of excellence that are involved in risk assessments, or a mentoring scheme whereby an expert or organisation could provide mentorship guidance in risk assessment. Good experience is being obtained from the risk assessment courses being run through the Better Training for Safer Food (BTSF) scheme. The training material developed for these courses has been adapted to different audiences for training courses prepared for the EU Pre-Accession countries. Feedback from the BTSF training has been discussed at recent Focal Point meetings where it has been agreed to consider the setting up of risk assessment training courses at national or regional level by adapting the BTSF risk assessment training material. EFSA has recently started offering training courses in advanced aspects of risk assessment to members of the scientific panels and EFSA staff. It should be considered whether these training courses could be adapted and opened to scientists from Member States Opportunities for staff exchange between EFSA and Member States There are currently a number of mechanisms in place to support staff exchange between different Member State organisations and EFSA. These include the Seconded National Expert Scheme, where 8 Commission Regulation (EC) No 2230/2004 of 23 December 2004 laying down detailed rules for the implementation of European Parliament and Council Regulation (EC) No 178/2002 with regard to the network of organisations operating in the fields within the European Food Safety Authority s mission. OJ L 379, , p EFSA supporting publication 2014:EN-567 9

10 experts can be seconded for one or more years and the National Experts in Professional Training (NEPT), an in-service professional traineeship for short term assignments. The detailed rules 9 of the schemes are available on EFSA s website. In addition to these schemes, further and more flexible opportunities for staff exchange between Member States and EFSA are needed, to allow staff exchanges on specific projects. This could take the form of guest scientists being seconded to EFSA for a certain period of time, combined with the detachment of an EFSA staff member to the sending organisation for a similar period of time. Another possibility to explore could be to foresee staff detachment in the framework of grants or procurements scheme. Such staff exchanges would benefit both parties and would help to build risk assessment capacity throughout Europe Focal point network At the 49 th AF meeting, members discussed the outcome of a recent SWOT analysis that reviewed objectives and analysed the strengths, weaknesses, opportunities and threats of the Focal Point network over the past 5 years. Among the strengths of the network, it was highlighted that the active networking environment established has strengthened scientific cooperation and facilitated the exchange of scientific information. Focal Points have been particular effective in supporting AF members in the development and management of EFSA cooperation tools (e.g. IEP, EDB and Article 36); establishing and maintaining national networks; and increasing the visibility of EFSA s scientific work in Member States. The AF members acknowledged the Focal Point Network as a strong, operational network meeting its overall objective to strengthen scientific cooperation and networking. The most important opportunities identified were to define more explicitly the tasks and roles of the Focal Points, to help further improve sharing of information to a wider audience at the national level and in particular on work planning. The main weaknesses and threats discussed were the heterogenicity amongst networking structures, resources and roles of the Focal Points in the different countries. Another important issue is the lack of a clear financial and formal framework, which can undermine the authority of the Focal Points and lead to a lack of clarity on the roles and responsibilities of the Focal Points by their national counterparts. Other important issues are the technical limitations of the cooperation tools (e.g. table on planned activities, IEP) and the concern that their use will reduce overtime (e.g. Art. 36, EDB) if not continuously promoted. National networks are not always comprehensive, meaning that not all scientific information of relevance is exchanged. Finally, it was acknowledged that Focal Points have difficulties to cope with the current tasks and activities because while resources have remained stable, the workload of Focal Points has increased overtime. EFSA and the Focal Points should build on strengths and work to address the weaknesses, opportunities and threats identified. For the coming years, it will be important to explore options to strengthen the formal and financial framework, particularly in light of the fact that the workload for Focal Points is expected to increase. To fulfil this role as EFSA liaison, the Focal Points should have a clear mandate to coordinate the work of national representatives in EFSA s scientific networks and coordinate the Article 36 organisations within their country. This will contribute to strengthening networking at national or international level. They also have an important role to play at national level in the promotion of training in risk assessment (under the BTSF programme or using the training material generated by such a programme); in coordination of international and stakeholder relations; and in coordinating networks of excellence. The implementation of these activities at national level will require increased coordination capacity at Member State level. This means an increased workload for Focal Points, which may imply that a Focal Point is not merely one person but rather an organisation or a team of people detaining the tasks of Focal Points. 9 Rules on the secondment to the European Food Safety Authority of national experts and national experts in professional training EFSA supporting publication 2014:EN

11 2.7. International Scientific Cooperation Scientific cooperation involves many partners, there is a need to involve relevant international stakeholders in the further development of scientific cooperation. The Management Board recommended that the international role and reputation of EFSA, should be further enhanced for the benefit of the EU food safety system, in concert with EFSA s partner organisations within the Member States, European institutions and agencies; relevant agencies in third countries and international organisations. Frameworks for cooperation with key international partners such as WHO, OIE, FAO, IPPC/EPPO and Codex Alimentarius are being developed, and EFSA is defining a multi-annual programme on International Scientific Cooperation for 2014 to It will be beneficial to exchange experiences through the Advisory Forum and share information on relevant international activities. EFSA supporting publication 2014:EN

12 RECOMMENDATIONS To address the challenges and suggestions on how to enhance scientific cooperation, the Advisory Forum Discussion Group recommends the following: 1. As previously agreed through the Declaration of Intent agreement (2006) 10, work plans should continue to be shared through the Advisory Forum, Focal Point Network and the IEP. Regular updates on unplanned risk assessment activities should be shared through the Advisory Forum. 2. Member States and EFSA should continue to work towards the harmonisation of methodologies and guidance. The Advisory Forum should be provided with regular updates on activities and the Scientific Network on the Harmonisation of Risk Assessment Methodologies should be invited in 2014 to update the AF as part of the recommendations from the Self Review of EFSA s Scientific Networks (2014). 3. As previously recommended by the Advisory Forum, EFSA s scientific networks should clearly set out their work activities and their role in sharing information should be explored further to include the sharing of work plans. 4. The role of Focal Points should be expanded to include a coordinating role in support of members of the EFSA s scientific networks and other activities. These activities should be formally included within the Focal Point Agreements in As per the previous recommendation of the AF discussion group on data collection, existing networks and working groups should continue to work towards harmonisation of data collection, focusing on data collection on areas of public health concern, and reducing duplication. Priority should be given to developing data access rules to allow the publication, analysis and distribution of data collected by EFSA to interested parties. 6. A framework should be developed to allow the possibility to launch thematic grants in Additional means of outsourcing scientific work should be investigated, including the use of framework partnership agreements that can support networks of excellence under the current Article 36 framework. 8. The BTSF training programmes should continue with the possibility of making the training materials more widely available and support similar training opportunities at national and regional level. 9. Consider the feasibility to open EFSA s advanced risk assessment training courses to participants from the Member States in A pilot scheme for facilitating short term guest scientist exchanges between EFSA and Member States should be established for implementation in A multi-annual programme on international cooperation should be developed and shared with the Advisory Forum. 10 Available at EFSA website: Declaration of Intent of Members of the EFSA Advisory Forum (2006). EFSA supporting publication 2014:EN

13 APPENDICES Appendix A. LEGAL BASIS FOR SCIENTIFIC COOPERATION This section provides a brief description of the legal framework in relation to scientific cooperation in areas within EFSA s remit. Founding Regulation (EC) No 178/2002 Regulation (EC) No 178/ lays down the establishment of EFSA and procedures in matters of food safety. Scientific cooperation and networking between Member States and EFSA is an integral part of this Regulation. The basis and scope of scientific cooperation is described in a number of its recitals (40, 44, 51, 53, 55) and Articles (22, 23, 24, 27, 30, 36). The Regulation places a number of obligations on EFSA and Member States to cooperate closely to enable EFSA to carry out its mission. The regulation defines the nature and scope of the cooperation as follows: EFSA should act in close cooperation with the competent bodies in the Member States carrying out similar tasks of EFSA and that Member States shall cooperate with the Authority to ensure the accomplishment of its mission 12. Article 27 provides for the creation of the Advisory Forum consisting of designated representatives from competent bodies in the Member States. The role of the Advisory Forum is to ensure close cooperation between the Authority and the competent bodies in the Member States. In particular to avoid the duplication of work completed by the Authority and work completed by Member States, cooperate where a substantive divergence over scientific issues has been identified, in promoting the networking of organisations, and where an emerging risk is identified. The Regulation also describes the role of Member States in EFSA s specific tasks. Article 33(2) and (3) places a reciprocal duty on EFSA and Member States organisations working in the field of data collection to cooperate and also an obligation for Member States to transmit data to EFSA. In the area of the identification of emerging risks, Article 34 requires Member States to respond as a matter of urgency to requests for information from EFSA on emerging risks. Article 36 sets out the basis for networking with and among Member States organisations in the fields within the Authority s mission. It foresees the establishment by the Management Board of EFSA of a list of competent organisations, designated by the Member States, which may assist the Authority by carrying out preparatory work for scientific opinions, for scientific and technical assistance; collection of data and identification of emerging risks. Furthermore, Article 23 requires EFSA to provide scientific and technical assistance, when requested to do so by the EC, with a view to improving cooperation between the Community, applicant countries, international organisations and third countries in the fields within its mission. Other regulations The following regulations cover the scientific areas within EFSA remit where Member States and EFSA are formally obligated to cooperate or collaborate. The procedures for the evaluation and authorisation of GM foods are laid down in Regulation (EC) No 1829/2003 on GM food and feed and Directive 2001/18/EC on the release of GMOs in the environment. Under this regulation, EFSA works in collaboration with Member States and national 11 Regulation (EC) No 178/2002 of the European Parliament and of the Council of 28 January 2008 laying down the general principles and requirements of food law establishing the EFSA and laying down procedures in matters of food safety; 12 Article 22 of Regulation No178/2002. EFSA supporting publication 2014:EN

14 competent authorities to evaluate GM foods. Member States may carry out initial environmental risk assessment and safety assessments of foods to help inform the Authority s opinion. Directive 2003/99/EU assigns EFSA the task of examining data submitted annually by Member States on zoonoses, zoonotic agents, food-borne outbreaks and antimicrobial resistance. Based on this data, every year EFSA prepares Community Summary Reports in close collaboration with the European Centre for Disease Control and Prevention (ECDC). In the authorisation procedure for active substances of plant protection products, under Regulation (EC) No 396/2005, Member States carry out the risk assessment of the dossiers submitted by petitioners as rapporteurs. EFSA is responsible for the EU peer review of these substances and is required to collate and analyse results of national controls on pesticide residues in food and feed. A consumer exposure assessment has to be carried out by EFSA before concluding on the safety of a maximum residue level. In 2009, a Pesticide Steering Committee was established to strengthen its role in reviewing the safety of active substances used in pesticides. For other areas within EFSA s remit, where there is no specific Directive or Regulation in place, EFSA is bound to adhere to the legislative framework provided in EFSA s Founding Regulation (Regulation (EC) No 178/2002) which foresees that risk assessments be done through scientific opinions adopted by EFSA scientific panels. This obviously should not pre-empt the Panels to make best use of scientific work carried out in Member States. EFSA supporting publication 2014:EN

15 Appendix B. OVERVIEW OF STRATEGIES AND AGREEMENT ON SCIENTIFIC COOPERATION In the last ten years, EFSA has adopted a variety of key policy statements outlining the need for scientific cooperation with Member States (see Figure 1). These are briefly described below. Declaration of intent In 2006, Members of the Advisory Forum made a commitment to strengthen scientific cooperation by signing a Declaration of Intent 13 agreement on enhancing the exchange of scientific information, including the sharing of national work plans, amongst themselves and EFSA. As part of the implementation of this commitment, the Information Exchange Platform, an extranet electronic tool was created by EFSA to help facilitate the sharing of work plans and risk assessment activities among Member States. Strategy on scientific cooperation and networking The Strategy on Scientific Cooperation and Networking (2006) 14 sets out the framework for cooperation and networking between the EU Member States and EFSA in order to support the development of risk assessments in all fields within EFSA s remit: food and feed safety; nutrition; animal health and welfare, plant health and plant protection. The strategy recognises four priority areas for the establishment of a common approach of risk assessments and communication outputs throughout Europe: Exchanging and collecting scientific data and information Sharing risk assessment practices Contributing to the harmonisation of methodologies for risk assessment Promoting coherence in risk communication. A review of the strategy was carried out in to examine progress on its implementation since its agreement in The review found that significant progress had been made in cooperation between Member States and EFSA, however, there was a need to further strengthen some of the existing initiatives developed. In particular, to establish a more permanent status for the scientific networks, to prioritise efforts on the harmonisation of risk assessment methodologies, to improve data collection activities on food composition and develop training opportunities in risk assessment. In 2011, EFSA again took stock of the progress made on the scientific cooperation tools and activities and reflected on further developments in the years ahead 16. The report identified a number of challenges for EFSA and a number of improvements to the current activities. Pre-accession programme In line with Article 23 of the Founding Regulation EFSA concluded Agreements with the EC within the framework of EU enlargement to implement the Programme entitled: Preparatory Measures for the Participation of the Candidate countries and the Potential Candidate countries in EFSA. The programme enables the Pre-Accession institutions and their experts to be involved in mechanisms of scientific cooperation established between EFSA and Member States, contributing to capacity building in the Pre-Accession countries in the areas of risk assessment and risk communication. 13 Declaration of Intent (2006); 14 Strategy for Cooperation and Networking between the EU Member States and EFSA (2006). 15 Interim Review of the Strategy for Cooperation and Networking between EU Member States and EFSA (2008). 16 Technical Report of EFSA on Scientific Cooperation between EFSA and Member States: Taking Stock and Looking Ahead (2011); EFSA supporting publication 2014:EN

16 Figure 1 - Overview of strategies and agreements Year Milestone 2006 Declaration of Intent 2006 Strategy on Cooperation and Networking 2009 Strategic plan for Science Strategy for Strategic plan for In 2009, the Management Board gave its backing to proposals to boost risk assessment capacity and expertise in Europe and advised on developing a longer term strategic view on future joint cooperation initiative to allow better leverage and strengthening of expertise in Member States. This advice was implemented in EFSA s strategic plan for 2009 to 2013 which sets out its medium to long-term strategic direction to meet its mission for providing scientific advice and support. The strategy focuses on six strategic priorities as follows: Focus on providing an integrated approach to delivering scientific advice associated with the food chain from field to plate. Provide timely, high quality evaluation of products, substances and claims subject to the regulatory authorisation process. Coordinate the collation, dissemination and analysis of data in the fields within EFSA s remit Position EFSA at the forefront of risk assessment methodologies and practices in Europe and internationally. Reinforce confidence and trust in EFSA and the EU food safety system through effective risk communication and dialogue with partners and stakeholders. Assure the responsiveness, efficiency and effectiveness of EFSA. The strategic plan for recognises the importance of a continuing and further strengthened cooperation and networking between EFSA and the Member States food safety agencies and national scientific activities. Science Strategy EFSA s Science Strategy describes its key scientific activities to achieve its strategic objectives 17. The strategy focuses on the following four main objectives: Further develop excellence of EFSA s scientific advice; Optimise the use of risk assessment capacity in the EU; Develop and harmonise methodologies and approaches to assess risks associated with the food chain; Strengthen the scientific basis for risk assessment and risk monitoring. 17 Available at Efsa website: EFSA Science Strategy EFSA supporting publication 2014:EN

17 MECHANISMS FOR COOPERATION EFSA cooperates closely with Member States and has in collaboration with Member States established a number of mechanisms and activities to enhance networking and cooperation. These are briefly described below. Advisory Forum The Advisory Forum is composed of representatives from competent bodies in Member States who are responsible for tasks similar to those of EFSA. Their role is to advise the Executive Director and constitutes a mechanism of exchange of information to ensure close cooperation in particular with regards to networking, emerging risks, and avoiding duplication of work and diverging scientific opinions. The Advisory Forum plays a crucial role for the successful implementation of the Strategy on Cooperation and Networking between EU Members States and EFSA. Focal Point Network In 2008, as part of the implementing activities of the Strategy on Scientific Cooperation and Networking, EFSA established the Focal Point Network consisting of focal points representing each Member State including observers from Switzerland and EU candidate countries. Their tasks are (1) to facilitate the exchange of scientific information; (2) to support activities under Article 36; (3) to support the growth of EFSA's database of external scientific experts and (4) to raise the visibility of EFSA' s scientific work and outreach at national level. The Focal Point Network is funded and supported by EFSA. The work of the Focal Point Network is summarised in annual reports, which have been produced since In addition, the technical report on Scientific Cooperation between EFSA and Member State: Taking Stock and Looking Ahead (2011) outlines the achievements of the network since its establishment and discusses the outlook for the coming years. EFSA is currently undertaking a 5-year review of the Focal Point Network. This review will be integrated into the overall review on Scientific Cooperation, expected to be concluded by the end of EFSA Scientific Networks There are currently 13 scientific networks established in the following areas, animal health and welfare, biological hazards, biological monitoring, emerging risk, GMO, plant health, pesticides, nanotechnology and harmonisation of risk assessment methodologies, funded by EFSA. The aim of the networks is to facilitate scientific cooperation through the coordination of activities; the exchange of information; the development and implementation of joint projects and the exchange of expertise and best practices in the fields within EFSA s mission. The operation of scientific networks is defined in the Decision concerning the establishment and operation of European Networks of scientific organisations operating in the fields within the Authority s mission (2010) 18. A review of the networks was carried out in to identify good areas of practice and areas where improvements could be made to the operation of networks. The recommendations of the review included evaluating the terms of reference of all networks to ensure they are still relevant. The recommendations are currently being implemented by EFSA. Article 36 of Regulation 178/ Decision concerning the establishment and operation of European Networks of scientific organisations operating in the fields within the Authority s mission (2010) 19 Self Review of EFSA s Scientific Networks (2013). EFSA supporting publication 2014:EN