Abstract
This editorial summarises a longer note (95th Meeting of the EFSA Management Board, item 7. Available online: https://www.efsa.europa.eu/sites/default/files/event/mb95/item-07-doc1-partnership-with-mss-230622-d2.pdf) submitted to Management Board of the European Food Safety Authority (EFSA) for consideration prior to a discussion held in its 95th meeting, in June 2023. It presents the context and the framework of EFSA's current scientific cooperation activities and the vision of transitioning towards long‐term partnerships as the necessary evolution for the sustainability of food safety risk assessment in the EU. This new approach needs strategic alignment and political will to ensure the involvement of risk assessment organisations in the Member States. For that purpose, Management Board members can act as key advocates towards national risk managers and policy makers.
Keywords: Scientific cooperation, partnership, risk assessment, food safety
1. Introduction
Since EFSA's establishment in 2002, scientific cooperation has been essential for EFSA's success in providing the highest standards of food safety to EU consumers. Two decades later, the many challenges, from the complexity of fast‐changing contexts (food systems, policies, evolving science, innovation) to the tightening budgets, call for increased efforts in cooperation to secure the sustainability of the EU risk assessment. This notion was at the heart of the changes to EFSA's Founding Regulation 1 introduced in 2019 by the Transparency Regulation. 2
EFSA integrated the objective of enhancing its cooperation activities in its Strategy 2027 and has undertaken a review of its model, from ad‐hoc cooperation to long‐term partnerships with (groups of) competent organisations in the Member States (MS) for the co‐production of risk assessment.
This transition towards a more systemic and strategic approach is for the benefit of the EU food safety system as a whole but, also, requires raising political will. For that purpose, EFSA aims to leverage the position of its Management Board (MB) members, who could act as advocates with national and European authorities.
2. Cooperation to date
Cooperation is provided for by EFSA's Founding Regulation and ingrained in EFSA's operating model. Scientific expertise from across the EU is mobilised in three main ways:
At individual level: experts employed by other organisations work for EFSA in the preparation and adoption of scientific opinions. These experts include primarily the members of EFSA's Scientific Committee, Scientific Panels and their Working Groups but also the MS representatives in EFSA's Scientific Networks. In some cases, EFSA also gets support from Individual Scientific Advisors. 3
- At organisation level: institutes and bodies in the MS (ca. 400) provide services (preparatory tasks such as collation of data, literature review, hazard assessment, etc.) in the framework of contracts with EFSA. Two types of instruments are used for this:
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○Procurement: calls for tenders open to all economic operators in the EU.
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○Grants: calls for proposals restricted to the competent organisations designated by the MS (320 as of July 2023), as foreseen by Art. 36 of EFSA's Founding Regulation, forming the so‐called Article 36 List of organisations. Cooperation under this instrument gives more margin for co‐ownership, co‐design and co‐investment and is a better fit to build partnerships.
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Specific to pesticide active substances assessment: one or more rapporteur MS(s) prepare(s) a draft assessment report which is then peer reviewed by scientific experts nominated by MS and coordinated by EFSA.
For its ambition for increased cooperation, the Transparency Regulation provided EFSA with additional resources, which are mainly to be invested through EFSA's grants and procurement mechanism. The expenditure via this mechanism has increased from an average of EUR 9 million in the years prior to the legislation, to EUR 34.9 million in 2022 and EUR 33.5 M in the 2023 forecast. These figures show significant progress, but cooperation has not yet reached its full potential.
It is also worth noting that the bulk of the budget increase has flowed into projects in the area of preparedness, research, new capabilities, data and methods (i.e. not immediately helping EFSA's core business). Until now, expenditure in preparatory tasks for risk assessment opinions has grown at a smaller rate. EFSA aims to invert this balance and concentrate cooperation resources in the latter category, acknowledging that as key for boosting the speed and overall efficiency of risk assessment at EU and national level.
The experience to date brings many lessons for the success of current cooperation and the evolution of its model, which EFSA has been addressing over the years. Some aspects of technical nature (e.g. financial conditions, administrative burden, predictability of calls or legal restrictions) have been tackled through operational improvements, such as a digitalisation and simplification of processes or increased co‐financing rates.
Other more structural blockers include the lack of available staff or organisational capability by potential partners or the difficulty in finding applicable expertise familiar with EFSA's methodologies. To overcome these, EFSA is working to further exploit the Article 36 mechanism, 4 expanding the involvement or enlarging the list of national organisations when relevant and possible. EFSA in this sense is conducting various initiatives in the areas of capacity building and systematic training and continues to invest in (digital) platforms for cooperation. This investment of resources should complement a more strategic effort to align priorities and coordinate work programmes between EFSA and national risk assessors. The latter is important, as experience shows that national bodies are more likely to participate and commit resources if they can implement their own programmes whilst supporting EFSA and the EU risk assessment needs.
Beyond these, however, the ultimate levers lie at a higher level: determination and steering by risk managers and policy makers in the EU and MSs (especially with regard to committing the necessary resources) are essential to making cooperation a structural part of the EU risk assessment work.
3. Partnership for preparatory tasks in risk assessment
Despite the diversity of forms, the prevailing model of cooperation until present has been limited in timeframe and scope, mostly done on an ad‐hoc transactional basis and involving individual organisations or relatively small consortia. To increase volume, consistency and impact of cooperation, EFSA aims to pursue a new approach based on partnership.
EFSA's Advisory Forum defined partnership as a long‐term, trust‐based cooperation, built on common values and goals, with attractive win‐win elements, primarily between EFSA and competent organisations in MS, EU Agencies, EC Services, where risks and benefits are shared and that generates, among others, tangible outputs.
The areas, scope and outputs of EFSA's partnership can be highly diverse. Whilst in research projects or development programmes such arrangements are relatively consolidated, they have proven more difficult in the production of question‐driven risk assessment opinions. This is, therefore, the priority of EFSA's efforts.
Entrusting preparatory tasks to partnerships is particularly relevant when tackling recurring and/or new risk assessment needs. Their coverage can range from parts of the scientific opinion requested up to preparation of the entire draft for peer review by EFSA's Scientific Panels, as provided for by the Transparency Regulation. This can be organised in different ways: assigning a mandate end‐to‐end to a single partnership, for instance, or breaking it down into tasks (e.g. data collection, hazard characterisation) distributed across partners and then assembled as necessary.
The latter format is the case of a recent grant agreement in food additives, flavourings, enzymes and feed additives. This incipient partnership is made up of a comprehensive consortium with organisations from several MS and is set to speed up the authorisation process of these substances by putting together draft opinions to be then peer‐reviewed by the responsible EFSA Panel. EFSA regards this as a piloting experience, potentially replicable in other critical risk assessment areas. As examples, plant and animal health, novel foods or pesticides also offer clear and substantial opportunities for partnerships to deliver more efficiently towards a growing workload and, in turn, help increase responsiveness to the many challenges around food safety at a European scale.
More generally, such partnership initiatives can support the RA activities beyond the demands of EFSA or the priorities determined at EU level. They can equally be driven by and respond to the needs of national actors.
4. Making partnerships happen
Developing and expanding partnerships with MSs requires that policy makers, risk managers and risk assessors at EU and national level intensify and coordinate their efforts and commitment of resources, in addition to those of EFSA. To tackle this, EFSA's framework foresees three organs governing relations with MS:
The Advisory Forum, which is a community of EU risk assessors, hence placing it in a central role for coordinating scientific cooperation and partnership. Its members can help strategize, align risk assessment work planning and stimulate the participation in partnerships of competent organisations in their country.
The Focal Points, which are the interface between EFSA and competent organisations in MS and, as such, are supporting and facilitating the implementation of partnerships. Their mandate has recently expanded to enable them to disseminate information, promote initiatives, facilitate the joint planning of work, identify partnership opportunities and foster networking and outreach towards more organisations.
The new Management Board, which since 2022 includes national government representatives, presents an opportunity to connect and advocate at political level in the MS. They can encourage risk managers and policy makers to consider the opportunity for joining forces at EU level when defining priorities and providing instructions and funding to national risk assessors. The approaches by the MB members may differ based on their positions in national administrations and the diverse set‐up in each MS' food safety administration, which is often fragmented across different branches.
The interaction among the three players at national level will be essential to jointly steer, coordinate and facilitate partnerships on the long run. With their support, efforts can be pursued towards mapping and aligning needs, tailoring messages, identifying political/policy interlocutors and, eventually, engaging with them to make partnerships the future keystone of the EU's food safety risk assessment.
Suggested citation: Spagnolli, A ., Gizzi, G ., Garofalakis, G ., Lucas, D ., Vlachou, A ., & Barcelo Moyano, J . (2023). Editorial: Partnerships with Member States: enhancing cooperation for EU food safety risk assessment. EFSA Journal, 21(8), 1–4. 10.2903/j.efsa.2023.e210801
Requestor: European Commission
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Approved: 2 August 2023
Notes
Regulation (EC) 178/2002.
Regulation (EU) 2019/1381.
Under the Remunerated External Experts provisions of EU Financial Regulation (Art. 237).
Article 36 of Regulation (EC) 178/2002.
