Commission Memo (MEMO/12/869), 16 November 2012
This week EFSA celebrated its 10th anniversary. To mark this occasion which also coincides with 10 years of EU General Food law, EFSA in collaboration with the European Commission organised a high level conference in Parma, Italy on 13 November 2012 titled "Ready for the challenges of tomorrow". Gathering international experts in the field, the conference aimed to mark this anniversary by looking back over past achievements and reflected on the best ways to handle the challenges that lie ahead.
Why did the EU decide to create a food safety Agency?
During the 1990s, the EU was faced with a number of food-related crises, such as BSE, Salmonella and dioxins that had undermined consumer confidence in the food production and distribution system and demonstrated shortfalls in the system that was then in place.
What was the Commission's response to these food crises?
In January 2000 the Commission published a policy paper (White Paper) which identified a wide range of measures that were necessary to overhaul food safety policy in Europe. The paper highlighted two central pillars that were targeted at regaining public confidence: the creation of an EU framework on General Food law and an independent European Food Safety Authority (EFSA). The EU food legislation was adopted in January 2002 and EFSA started work in May 2002.
Does EFSA's work duplicate the activities of national food agencies?
EU food legislation recognises that EFSA should build on the capacities of Member States through networking of organisations operating in the fields with similar missions as the Authority. EFSA currently has a network in excess of 1,500 external experts and more than 300 scientific institutions. EFSA's own staff is by comparison relatively small at around 450.
What is the role of EFSA?
EFSA is charged with providing independent scientific advice and technical support for EU policy in all areas that have a direct or indirect impact on food and feed safety. It is also responsible for communicating on all matters within these fields and to communicate on any risks associated with the food chain
EFSA is also mandated to provide scientific advice on human nutrition when requested by the Commission. It also provides scientific opinions on animal health and welfare, plant health and genetically modified organisms even when these are not related to food safety. In all its activities it should work in close cooperation with competent bodies in Member States carrying out similar tasks to those of the Authority.
Is EFSA really independent?
EFSA's founding Regulation imposes strict requirements in respect of independence and conflicts of interest which apply across all its activities. In order to comply with these requirements, EFSA has established internal rules on these matters which it has progressively strengthened, most recently in December 2011 with the adoption of its policy on independence and scientific decision-making processes. The related implementing rules which came into effect in July 2012 have improved the procedures in place for screening and managing interests declared by all involved in EFSA's activities. They include scientific experts, staff, Management Board members and third parties including contractors. Before adoption of the new rules, EFSA consulted interested parties extensively on the draft rules.
EFSA devotes considerable resources to implementing its new policy and rules. It has developed its own dedicated IT tools to manage more than 8000 declarations of interest and examines 40,000 meeting agenda items every year and reports annually on the results achieved.
In addition, EFSA's independence is also assured by the collective decision making of its scientific panels and its transparent manner of working. This involves publication of scientific opinions including where applicable minority opinions, the publication of agendas and minutes of meetings, publication of declarations of interest of members of the Management Board and of members of the Scientific Committee and Panels.
It is also necessary to distinguish between having an interest and it being a conflict of interest. The new rules aim at balancing the need to secure Europe's best scientific experts for scientific advice while ensuring that experts have no financial or other interests that could jeopardise their impartiality.
Allegations of conflict of interest can also arise due to genuine misunderstanding by third parties of the rules in place. This can negatively reflect on EFSA and undermine what is a sound system. However, it is important to recognise that no system will be 100% error proof and instances of potential conflict of interest will periodically arise. In these cases it is necessary to assess them on a case-by-case basis and take appropriate action as outlined in EFSA’s rules. On the rare occasion that a conflict of interest has occurred, EFSA has in place a breach of trust procedure to take appropriate action should an expert have failed to report any interest.
Following a request of the European Parliament in 2011, the Court of Auditors carried out an audit on the management of conflict of interests by EU Agencies. Even though EFSA was recognised as having developed one of the most advanced policies and procedures for detecting conflict of interests, some shortcomings were identified by the report. The Commission together with EFSA will address them in the near future since confidence in the Agency's work if of the utmost importance.
What have been EFSA's main achievements over the last decade?
EFSA has made a significant contribution to the progress in dealing with crucial food safety areas such as the reduction in Salmonella, limitation of exposure to pesticides and setting of safe levels of their residues and the evaluation of food and feed additives. Its work also ensures that European consumers can have confidence that the nutrition or health claims on their food labels have a sound scientific basis. The EU has continued to experience the highest level of food safety and effective containment of food related incidents over the past decade, both in terms of public health and economic impact.
Cooperation on food safety issues has increased, and networks are now in place across Europe to share scientific information and co-ordinate communication activities, rapidly if needed in response to any kind of emergency. In 2011, EFSA co-ordinated the scientific investigation on the outbreak of Shiga-toxin producing Escherichia coli (STEC) in Germany and France which identified the likely source of the contamination and allowed EU risk managers to take measures to protect consumers.
Does EFSA systematically approve GMO authorisations?
No, EFSA is not responsible for authorisations which are the responsibility of risk managers.
GMO applicants are required to provide EFSA with specified studies which have to comply with EU/OECD study protocols and be performed under a given quality assurance system (Good Laboratory Practice or ISO) and in accordance with EFSA’s guidance for the risk assessment of GMOs. It is for the industry to provide the necessary toxicological and other data needed to substantiate the safety of the GMO concerned. For all regulated products such as GMOs, it is accepted worldwide practice that the onus is on applicants, who will directly profit from the marketing of the product, to carry out the necessary studies which underpin their risk assessments.
EFSA's risk assessment procedure is thorough and nearly always requires applicants to provide additional data and clarifications before an opinion is issued. In a small number of cases, applicants have withdrawn applications when industry considers that it will not be able to generate the information that EFSA requires.
What are the challenges facing EFSA?
Whilst EFSA has achieved much in its first ten years, we need to look forward to future challenges. It is not possible to predict all the issues that EFSA will have to confront in the coming years but the drivers are becoming increasingly clear. These include issues such as climate change, the changing demographics of Europe and the rapid expansion of global trade. EFSA will also have to deal with the challenges and opportunities of innovation which will both contribute to addressing some of these future demands and also create new ones. To this end, EFSA has already in place its Science Strategy 2012-2016 which lays down its vision on how it will continue to support European food safety in the coming years.
Can EFSA take decisions?
EU food legislation separates the roles of risk assessment and risk management. EFSA as an independent EU Agency is responsible for risk assessment or in other words scientific advice whilst risk management or decision-making is the responsibility of the European Commission, the Council and the European Parliament. This means that EFSA does not take authorisation decisions for GMO, pesticides, food additives and other regulated products related to the food chain but assesses the potential risks for consumers, animals and the environment which enables risk managers, in this case the European Commission, European Parliament and Council to make decisions taking into account scientific advice.
How does EFSA function?
Management Board - EFSA has a 15 member Management Board which is appointed by the European Council in consultation with the European Parliament following a call for expression of interest. The members of the Management Board are independent and do not represent governments or sectorial interests and are appointed to act in the public interest. The Board sets EFSA’s budget, approves the annual work programme and is responsible for ensuring that EFSA works effectively and co-operates successfully with partner organisations across the EU and beyond.
Executive Director - EFSA’s Executive Director is appointed by its Management Board. The Executive Director is supported by approximately 450 staff and is the legal representative of the Authority who is responsible for all operational matters, staffing issues and drawing up the annual work programme in consultation with the European Commission, the European Parliament and EU Member States.
EFSA Scientific Panels and Scientific Committee - EFSA’s Scientific Committee and Panels are responsible for providing scientific opinions and are composed of highly qualified independent scientists who are selected following an open call for expression of interest. Currently there are ten Scientific Panels which deal with subject areas such as food additives, plant health, genetically modified organisms, nutrition, contaminants, animal health and welfare etc.
The Scientific Committee is composed of the Chairpersons of the Scientific Panels and six additional experienced scientists who do not belong to any Panel but are selected following a call for expression of interest. The Scientific Committee is responsible for coordination and consistency of cross-cutting issues across the Panels as well as scientific matters of a horizontal nature. The Scientific Committee has been responsible for opinions such as those dealing with innovative risk assessment methodologies and opinions aiming at ensuring transparency and improving quality of specific components of risk assessment.
Advisory Forum - EFSA’s Advisory Forum ensures the link with the national food safety authorities of all 27 EU Member States, Iceland and Norway with Switzerland and the Candidate Countries as observers. It is composed of representatives from national competent authorities carrying out tasks similar to those of the Authority. It plays a key role in ensuring effective coordination between EFSA's work and that of Member States thereby maximising the use of resources.