The EU food safety system is underpinned by risk assessment to ensure science-based policy making on risks associated with the food chain. As the EU’s risk assessment body, EFSA provides scientific advice produced in keeping with the key values based on its Founding Regulation: independence, excellence in science, openness and transparency and responsiveness. EFSA must provide the best scientific advice possible at the right time in order to support policy makers in their decision making.
At the EU level the task of providing scientific advice is assigned to EFSA which means that the Authority’s work and its outputs need to live up to these key values.
EFSA works closely with all of its partners, in particular the national food safety agencies as well as with stakeholders in the food chain including consumer, environmental and other interest groups as well as industry. While dialogue is important, independence is critical, and EFSA ensures that the experts on its Scientific Committee and Panels are able to discuss and adopt scientific opinions free from any inappropriate influence.
On 15 December 2011, EFSA’s Management Board adopted the Authority’s new Policy on independence and scientific decision-making processes, which brings together and strengthens all the measures EFSA has put in place to ensure the objectivity of its scientific advice.
EFSA is managed by the Executive Director, who in turn reports to an independent Management Board governing EFSA. The members of the Management Board are appointed by the Council of the European Union in consultation with the European Parliament following an open call for expression of interest organised by the European Commission. They are appointed to act in the public interest and do not represent any government, organisation or sector. All members sign a declaration of interests. The Management Board has no power to review EFSA’s scientific outputs or to influence their adoption procedure.
How EFSA ensures the independence of its scientific work
The Authority applies a robust set of internal mechanisms and working processes to safeguard the independence of its scientific work and that of its Scientific Committee and Panels.
Rules on the selection of experts
Members of the Scientific Committee, Scientific Panels and their Working Groups, as well as other external experts contributing to the work of EFSA, are selected based on their scientific competence and expertise, and according to objective and transparent criteria. During the selection process, interests declared by the applicants are also reviewed. In addition, independent external evaluators review the assessment of applications for scientific panel membership to ensure that the selection process is coherent.
- Decision of the Executive Director concerning the selection of members of the Scientific Committee, Scientific Panels and external experts
Good risk assessment practices and adoption of scientific opinions
EFSA has developed a comprehensive body of good risk assessment practices to guide the work of its Scientific Committee and Panels to help ensure its opinions respect the highest scientific standards. EFSA’s Scientific Committee has also adopted a set of recommendations on transparency in risk assessment to ensure maximum transparency of its independent scientific work.
All the final scientific opinions adopted by the Scientific Committee and Scientific Panels are based on most up-to-date scientific information and knowledge. They are the outcome of collective deliberations and decisions, each member having an equal say. No one expert can unduly influence the decisions of the Panel, and minority views are recorded. If EFSA has identified a conflict of interest for a panel member to participate in the scientific activities related to a certain a topic, it is recorded in the final opinion. In addition, as part of the review process to ensure the quality of its scientific opinions, EFSA verifies appropriate implementation of its policy with respect to Declaration of Interests.
Declaration of interests (DOIs)
All experts of the Scientific Committee, Scientific Panels and Working Groups are required to sign a declaration of commitment, including a commitment to act independently, and to provide an annual declaration of interests (ADoI) for each EFSA group of which they are a member. EFSA closely monitors and reviews the ADoIs of all its scientists. In accordance with the principle of transparency, all of the ADoIs as well as the mandates for each Panel and working group are published on the EFSA website.
Experts are also required to declare in advance their specific interests for each agenda point of a meeting in writing, through a specific declaration of interests (SDoI), and any additional interests orally at the beginning of the meeting. Minutes of meetings are published which show how the policy on declarations has been followed. For example, they will show when an expert declared a particular interest and if that led to his/her withdrawing from the meeting for a particular item.
Potential conflicts of interest
EFSA recognises that high quality scientific expertise – which is the main prerequisite for an expert to be invited to contribute to EFSA’s work – is by nature based on prior experience. Moreover, having an interest does not necessarily imply that there is a conflict of interest. EFSA screens the information provided by an expert in the DOI and assesses whether a declared interest constitutes a conflict on a case-by-case basis. The evaluation takes into account the interests declared by the expert in relation to the mandate of the group in question and the role of the expert in this group. For instance, involvement in industry-funded research does not necessarily constitute a conflict of interest provided that the research does not relate directly to the topic being considered by the Panel or Working Group.
In 2012, EFSA adopted detailed rules for the implementation of the Authority’s Policy on Independence and Scientific Decision-Making Processes with respect to Declarations of Interest (DoIs). The Implementing Rules strengthen the procedures in place for screening and managing interests declared by those involved in EFSA’s activities, in particular those submitted by EFSA’s scientific experts and other individuals and organisations involved in EFSA’s scientific work. They provide a definition of what EFSA considers to be a conflict of interest (in line with OECD guidelines) and also a clear and transparent set of definitions and general principles for the declaration of interests applicable to all DoIs.
The responsibility for ensuring that DoIs are complete and truthful lies exclusively with the person submitting the declaration, for example the scientific expert. After the DoI is submitted, it is assessed by EFSA to determine if there is a potential conflict of interest. Depending on the outcome of this assessment, and in line with the guidelines set out in the Implementing Rules, EFSA makes a decision on whether or not the person is allowed to participate in EFSA’s scientific work and in what role (for example as Chair, Vice-Chair or Member of a Scientific Panel or working group). In addition to this screening, EFSA will review on a regular basis a representative sample of the Annual Declarations of Interest (ADoIs) to monitor for completeness and coherence with EFSA’s rules.
Review of the EFSA Implementing Rules
EFSA is committed to reviewing its policies and procedures to ensure they remain fit for purpose. A technical review of its implementing rules on Declarations of Interest in July 2014 was part of EFSA’s ongoing efforts to refine its processes. The review was carried out to build on EFSA’s experience from applying the rules over the past two years. The Authority also considered feedback from the European Parliament, European Ombudsman, European Court of Auditors and civil society stakeholders.
To ensure openness and transparency on the review process EFSA held a dedicated meeting between senior EFSA staff and members of EFSA’s Stakeholder Consultative Platform in June 2014.
- 25th meeting of the EFSA Stakeholder Consultative Platform: dedicated meeting on the review of the 2012 implementing rules of EFSA’s Declarations of Interest Policy
The next important step in this direction will be the review of EFSA’s Policy on Independence and Scientific Decision-Making Processes, which will begin in 2015. Key learning from the meeting with stakeholders will feed into those more strategic reflections.
Role of EFSA staff
EFSA staff act in the public interest and are subject to several obligations under EU staff regulations, including that of acting with independence and integrity and of avoiding conflicts of interests. EFSA staff may provide scientific and administrative support to the Scientific Panels but the Panel experts independently deliberate, decide conclusions and adopt final scientific opinions. In order to ensure a coherent implementation of staff obligations with respect to independence, EFSA requires all its professional staff to fill out an annual declaration of interests. These ADoIs are screened and those of EFSA’s Management Team are published on the EFSA website. EFSA ensures that staff members are not assigned to projects where potential conflicts of interests may arise.
Staff who leave EFSA are required to inform the Authority with respect to future employment, within two years of leaving, so that EFSA can consider whether that may lead to a conflict of interest.
1. What is EFSA’s Policy on Independence and Scientific Decision-Making Processes?
This Policy integrates in one document the wide range of initiatives EFSA has put in place to uphold its core values of scientific excellence, openness, independence, transparency and responsiveness. It not only covers issues related to interests and independence but also sets out the various internal mechanisms and processes that EFSA follows to ensure good governance within the organisation and throughout the scientific decision-making process. The policy was subject to a public consultation and was also discussed with stakeholders and other interested parties at a conference in Brussels in October 2011 before being adopted by EFSA’s Management Board in December of the same year.
A review of the Policy will begin in 2015.
2. Why does EFSA have Implementing Rules for its Independence Policy?
EFSA’s rules related to Declarations of Interests are a key element in the implementation of its Policy on Independence and Scientific Decision-Making Processes. The policy outlines all of the measures that the Authority has put in place, including those related to Declarations of Interests, to ensure high-quality scientific outputs based on transparent, open and unbiased scientific decision-making processes.
EFSA developed rules regarding Declarations of Interests as part of its ongoing efforts to safeguard independence and integrity in its work and taking into account feedback received during the extensive public consultation on its overarching policy. These rules, further refined in 2014, strengthen and clarify the processes in place regarding the screening and management of declarations of interests while also achieving a higher level of transparency and readability. The correct application of the rules ensures EFSA retains access to the best scientific expertise while ensuring impartiality. The rules reflect the growing complexity of our work and the need to maintain the highest level of probity in how EFSA deals with potential conflicts of interest.
3. What are the Implementing Rules?
The Implementing Rules concern the screening and management of Declarations of Interest submitted by scientific experts and other individuals and organisations involved in EFSA’s work. The rules ensure a high level of scrutiny and safeguards in this process. They provide definitions of interests to be declared, what EFSA considers to be a conflict of interest (in line with OECD guidelines) and also a clear and transparent set of general principles applicable to all those engaging in EFSA’s work – scientific experts, staff, members of the Management Board and third party organisations, including external contractors.
4. Who are the Implementing Rules intended for?
The Implementing Rules apply to a wide range of individuals and organisations that are engaged by EFSA or that have a role to play in the delivery of its work. These include (but are not limited to) scientific experts such as members of its Scientific Committee, Scientific Panels and their working groups. The rules also apply to members of the Management Board, the Advisory Forum, EFSA Networks, the Executive Director and EFSA staff, as well as, in certain circumstances, to contractors, grant beneficiaries and to their respective employees. Importantly, these rules provide an important layer of protection for EFSA’s scientific experts in recognition of their commitment to support the organisation in fulfilling its public health mission.
5. Who is responsible for ensuring that Declarations of Interest are complete and truthful?
The responsibility for ensuring that Declarations of Interest (DoIs) are complete and truthful lies with the declarer, for example a scientific expert. After the DoI is submitted, it is assessed by EFSA to determine if there is a potential conflict of interest. Depending on the outcome of this assessment, and in line with the guidelines set out in the Implementing Rules, EFSA makes a decision on whether or not the expert is allowed to participate in EFSA’s scientific work and in what role (for example as Chair, Vice-Chair or Member of a Scientific Panel or working group). As part of the overall verification of its declaration of interest procedures, EFSA reviews twice a year a representative sample of all Annual Declarations of Interest (ADoIs) to monitor for completeness and coherence with EFSA’s rules. The outcome of this exercise is published in the agency’s Annual Activity Report.
6. Why did EFSA update the Implementing Rules for its Declarations of Interest policy in July 2014?
EFSA is committed to reviewing its policies and procedures to ensure they remain fit for purpose. The technical review of its implementing rules on Declarations of Interest in July 2014 is part of EFSA’s ongoing efforts to refine its processes. The review was carried out to address feedback from the European Parliament, European Ombudsman, European Court of Auditors and civil society stakeholders. The Authority’s experience from applying the rules from 2012 onwards was also taken into account. To ensure openness and transparency on the review process EFSA held a dedicated meeting between senior EFSA staff and members of EFSA’s Stakeholder Consultative Platform earlier in 2014.
- 25th meeting of the EFSA Stakeholder Consultative Platform: dedicated meeting on the review of the 2012 implementing rules of EFSA’s Declarations of Interest Policy
The next important step in this direction will be the review of EFSA’s Policy on Independence and Scientific Decision-Making Processes, which will begin in 2015.
7. What were the main changes of the July 2014 update to the implementing rules on declarations of interests?
The update of the Implementing Rules published in July 2014 builds on the robust set of rules put in place in 2012. The overall objectives of the technical review leading to the update were to enhance understanding of the rules and of their application in the screening of EFSA scientific experts and staff. The revised text was shortened, reformatted for ease of use and included a re-wording of certain passages for greater clarity. In the process, EFSA believes it managed to make both the document and the procedures leaner and fitter for purpose.
Specific changes following the 2014 technical review:
- New provisions
- Insertion of obligation for EFSA staff of pre-employment and post-personal leave declaration of interest (DoI) screening
- Obligation to submit an Annual DoI extended to ASTs and FG I, II and III, thereby covering all EFSA staff to implement changes to Staff Regulations.
- Change of the rules regarding DoIs in grants and procurement processes to implement a risk based approach based on decision of Authorising Officer.
- New annex outlining clear screening criteria for DoIs in context of procurement and grants to make the process more transparent, combined with examples
- New obligation to implement systematic training courses to the benefit of staff and experts to improve support to staff and experts and increase compliance
- Deletion of requirement for experts to always maintain an exemplary conduct while cooperating with EFSA
- Simplification of provision on retention of personal data to ten years from the date of submission of each DoI to make the process leaner
- Formation of a body to advise on independence matters (the timing and composition of which has yet to be decided by EFSA’s Management Board).
- Clarifications and simplification
- The detailed wording explaining screening criteria is deleted and replaced by simplified wording
- A simplified and shorter presentation of the list of allowable and non allowable interests
- New graphical presentation of the screening criteria
- Addition of examples combined with screening criteria to make them more understandable
- Addition of explicit requirement for more than 50% public funding for an entity to be considered a "Food Safety Organisation"
- New definition of family members, namely spouses, registered partners and dependent descendants
- Screening of close family members is now explicit to increase transparency
- Inclusion of reference to “level of intensity” of a relation as instrumental in classifying the interest
- Voting rights deleted from activity “Membership in Scientific Advisory Body” to simplify transparency and readability of the definition
- Clarification that EFSA does not screen hearing experts and Advisory Forum members DoIs
- Deletion of obligation to declare in the DoIs previous EFSA activities to reduce number of interests declared.
- Legal references
- Inclusion of legal basis for DoI screening by candidates to Scientific Committee and Scientific Panels membership and wise men
- In Management Board DoI screening, inclusion of reference to Council decisions appointing the members.
8. What impact do the Implementing Rules have on EFSA’s work?
The Implementing Rules simplify and clarify the requirements of individuals regarding DoIs and provide a transparent set of criteria for all parties to better understand the decisions EFSA takes with regards to allowing or preventing experts from taking part in its work. Ultimately, the rules contribute to the ongoing processes in place to guarantee independence of EFSA’s scientific advice, from the selection of its scientific experts, through the screening and management of annual, specific and oral declarations of interests, to the collegial decision making of its Scientific Committee and Panels.