'The Role of EFSA: Legislative Processes in the EU', Seminar on Food Law and Regulations on Hygiene and Control, Oslo

Catherine Geslain-Lanéelle

Ministers, ladies and gentlemen,

It gives me great pleasure to be here with you today in Oslo and I am very grateful to the organisers (the Norwegian Ministries of Health and Care Services, Agriculture and Food, and Fisheries and Coastal Affairs) for the opportunity to address this seminar.

EFSA was established in 2002. If we cast our memories back, the 90s will be remembered as a difficult time for the European consumer, characterised by a series of food scares and, consequently, loss of confidence in the policies and systems designed to protect the consumer.

Out of this came the European Commission’s “White Paper on Food Safety” in January 2000.

This far-reaching document set the stage for reform, with the ultimate goals of strengthening the European food system and assuring the safety of the food chain, from “field to plate”.

Eight years later, we can claim that the main pillars of that White Paper have been put in place, thanks to a series of regulations and directives, beginning with the most significant – the groundbreaking 178/2002 – which laid down the general principles and requirements of food law and established the European Food Safety Authority.

The new European food safety system has, above all else, delivered one crucial reform: the separation of risk assessment and risk management. EFSA was established in 2002 to be an integral part of the overall European food and feed safety system, but especially and primarily as an independent source of scientific advice and communication on risks associated with the food chain.

As the risk assessor, EFSA produces scientific opinions and advice that provide a scientific, evidence-based foundation for European policies and legislation and support the European Commission, the European Parliament, Member States and neighbouring countries in taking effective, appropriate and timely risk management decisions.

Operating with the principles of openness, independence and transparency, EFSA protects the European consumer by developing scientific opinions and advice in cooperation and dialogue with all players in the food and feed chains.

While EFSA has adopted more than 500 opinions since its inception in 2002, quantity is not the only consideration. It is critical that the Authority’s outputs meet the usability criteria of its “customers” – the Commission and national risk managers among others.

To ensure that its scientific work is of the highest quality, last year EFSA designed and began to implement a system to objectively assess, both internally and externally, the quality of its scientific outputs.

EFSA leaves no stone unturned in ensuring that its founding principles are adhered to; by way of example, in 2007 we reviewed the processes associated with the Declarations of Interest of EFSA staff, scientific experts, Advisory Forum members, and Management Board. To ensure transparency in all our operations, EFSA makes extensive use of its website to provide open access to all its outputs: publications, mandates, opinions, and stakeholder activities.

In addition, the meetings of its Management Board are webcast live – and archived for subsequent reference – and the Authority regularly consults the public on issues such as cloning, botanicals and health claims.

Scientifically independent but accountable for the role it plays in supporting risk management decisions, EFSA’s outputs represent the first step in the food safety system and its scientific outputs inform the decisions of risk managers.

Food safety is not, of course, a static paradigm and the landscape in which EFSA operates is constantly evolving. Risks change: new ones emerge and old ones re-emerge or change in nature. As the guardian of European food safety, EFSA has to scan the horizon for new threats to our food supply as well as remaining vigilant to our “older friends”.

Technology advances relentlessly, leading to new food products and production methods. Detection methods become increasingly more sensitive and smaller amounts of contaminants and other substances can be measured. The implications for food safety of the relatively new field of nanotechnology must be assessed; EFSA expects to adopt an opinion on nanoparticles in mid-2008.

Advances in animal cloning, in particular the use of somatic cell nucleus transfer, have taken up much of our attention in 2007 and a draft opinion is currently available for public consultation on the EFSA website.

Scientific research continues to build the food safety knowledge base, meaning that risk assessments have to be regularly re-visited in light of new evidence, as is the case with EFSA’s re-evaluation of food and feed additives permitted in Europe in the past 30 years – a huge task. In 2007, new research was published linking certain food colours with hyperactivity and the AFC Panel has been mandated to assess that work.

Increasing globalization has meant the increased movement of both animal and plant food commodities, raising the likelihood of foodborne disease. Socio-demographic changes in Europe have changed the traditional diets of many families with, for example, increasing consumption of convenience foods. Obesity and its related disorders continue to challenge European public health resources.

EFSA is increasing its nutrition-related activities to support health authorities across Europe in managing this chronic disease burden by, among other things, providing a scientific basis for assessing health claims, facilitating the establishment of nutrient profiles, setting recommended dietary intakes for Europeans, and compiling food consumption databases that identify trends in diet.

In parallel with this, changes in food legislation can have important implications for EFSA, its operations and its resourcing. Enactment of the new legislation on food improving agents, and in particular the safety assessment of enzymes used in food production, will add to the growing challenge represented by food and feed additives; in total, approximately 700 food additives, 2800 food flavourings and 2600 substances used as feed additives need evaluation.

In the pesticides area, EFSA also has an increasing workload. To date, we have completed more than 55 peer reviews and many more are in the pipeline. In addition, EFSA is examining proposed temporary Maximum Residue Levels.

The majority of the GMO Panel’s work is related to authorisation applications, since all GM food and feed products must be evaluated before they can be authorised in Europe. To date, the GMO Panel has published more than 45 evaluations, between opinions, statements on specific or more general topics, and guidance documents.

When EFSA identifies, during the course of its regular work, particular issues that require further analysis and guidance, self-tasking activities are undertaken. The GMO Panel has launched self-mandates to investigate the long-term effects of GMOs on the environment and allergenicity and the statistical methodologies required to perform the assessments.

All the factors I have mentioned emphasise the fact that the context of EFSA’s work has changed radically since 2002. Its workload has quadrupled since its inception and is expected to double in 2008 alone. Last year, we adopted a record number of opinions, more than 200 in total, in addition to a growing number of other outputs: guidance documents, reports, statements and other forms of scientific advice.

More than 1000 applications or renewals were submitted to EFSA in 2007 and approximately 1000 claims must be assessed in 2008-2009.

How are we planning to cope with this increasing workload while continuing to deliver the best scientific advice in a timely manner?

To begin with, EFSA reviews its priorities on a regular basis and in close relation with Commission services, to ensure that it can respond to changes in the food safety environment and to align its resources with its priorities. EFSA is still a growing organisation. At the end of 2006 it employed 228 staff, by the end of last year that had risen to 310 and by the end of 2008 we expect to reach 412. In addition, the Authority continues to look for efficiencies in its governance and in 2008 we have reorganised its organigramme to reflect its priority objectives, creating two scientific directorates, one responsible for risk assessment, the other responsible for scientific co-operation.

Thankfully, EFSA is not alone in its efforts and looks to the assistance and cooperation of its partners and stakeholders to exercise its mandate. Cooperation with the national agencies is, without any doubt, a key tool and a top priority in EFSA’s work programme. To be able to deliver the best risk assessments for Europe, EFSA has to be plugged in to scientific information and data at the national and international level. To facilitate information sharing, collaboration between national authorities and coordination of risk communication, national Focal Points will be established in all 27 Member States by mid-2008; 20 agreements have already been signed.

We have put cooperation with Member States and neighbouring countries and the building of strong networks with national authorities on top of EFSA’s agenda. The directorate for Scientific Cooperation and Assistance was established to build scientific cooperation and support our risk assessment activities. The directorate assists our Scientific Panels by providing specific expertise in data collection, exposure, emerging risk, and assessment methodologies. It facilitates the provision of scientific advice and enables us to respond promptly to requests for advice.

EFSA works closely with Member States and neighbouring countries in a number of areas involving information and data collection, such as zoonotic diseases, dietary intakes and food additives. In line with the Authority’s priority objective of enhanced cooperation and networking in Europe, Article 36 of EFSA’s founding regulation authorises competent Member State organisations to undertake work on behalf of
EFSA. In 2007, a total of 12 Article 36 calls were issued and, in many cases, successful proposals were financially supported by EFSA. Many more calls are expected in 2008.

By sharing information and being well informed about each other’s activities, we can move towards a more common understanding of both existing and emerging risks at national and European level, assist risk managers in developing more coherent risk management strategies, avoid duplication of effort in risk assessment, and improve the coherence of risk communications across Europe.

In this context, EFSA’s Advisory Forum is at the heart of our collaborative approach to risk assessment. The Forum, where the national agencies of the 27 Member States and the EU-neighbouring Countries are represented, advises on our work programme and emerging risks and enables the effective sharing of information on food safety and risk assessment. It also forges close links between EFSA and national authorities in Member States and neighbouring countries. I would like to avail of this opportunity to thank our Norwegian member of the Advisory Forum, Kirstin Færden, as well as Knut Albert Solem of the Forum Working Group on Communications, for their valued contribution to our activities.

Several projects have been identified by the Forum and are now being developed: safety assessment of botanicals, risks and benefits of fortification of food with folic acid, harmonization of chemical occurrence data collection, creation of a database of scientific experts in Europe, food consumption data collection, and harmonisation of risk assessment approaches. These are practical examples of how the Forum is contributing to the protection of the European consumer.

At this point, I must emphasise that EFSA depends on more than 500 scientists, and the goodwill of their institutions, to carry out its mission. The members of our Scientific Panels and Committee are selected according to strict procedures and recognised internationally as experts in the very specific fields required. EFSA’s ability to deliver scientific opinions depends on the dedication of all those scientists who, employed in research centres, universities and national institutes across Europe, commit a significant proportion of their time to EFSA. The Authority recognises and acknowledges the crucial importance of this scientific contribution and takes its responsibility in fostering and supporting this network of scientific excellence very seriously.

I would like to pay tribute to the Norwegian experts who contribute to our Scientific Panels and to other activities such as data collection and have helped us adopt opinions on, for example, seals hunting methods. Thank you very much for your input.

And EFSA is looking outside Europe: for example, in July 2007 we reached a milestone in international cooperation between risk assessors by signing a confidentiality agreement with the FDA. With these new arrangements, the confidentiality of information is clarified, thereby facilitating information exchange. The inclusion of data from around the world and from the scientific communities on both sides of the Atlantic will enhance the quality of our risk assessments. We are working with the national food safety authorities of Australia, New Zealand and Japan to establish similar agreements, as well as cementing our relationship with the WHO.

Communication of scientific information is indeed EFSA’s other core activity. The Authority aims to provide consistent, accurate and timely information for risk managers, risk assessment bodies in Member States, stakeholders and ultimately the public at large. To accurately translate the conclusions of our risk assessments into meaningful communications, close cooperation between communications professionals and scientists is required – a key strength of ours in Parma.

Given the social and cultural diversity of Europe, it is difficult to reach nearly 500 million consumers with a single message, hence the emphasis that EFSA places on close cooperation with national food safety authorities in Member States and EU neighbouring countries to ensure that messages are culturally appropriate, effective and meaningful.

In bridging the gap between the world of science and the consumer, it is important to understand public perception of risk and for an organization like EFSA, to understand, in particular, consumer attitudes to food and food-related risks. To address this, first of all we must identify what people are concerned about – and whether these concerns are scientifically justified or not – in order to be able to communicate the results of our risk assessment findings in a meaningful way.

The results of a Eurobarometer survey on risk issues conducted by EFSA and the European Commission in 2005 showed the diversity in food-related concerns across Europe.

Pesticide residues were the number 1 concern in Germany (as for consumers in 8 other Member States) whilst Austrian consumers worried most about GMOs, and consumers in Scandinavia cited the welfare of farmed animals as being a top concern.

This research also confirmed consumers’ tendency to worry less about those risks over which they have some control in comparison with those that are imposed or involuntary. While consumers, for instance, identified food hygiene outside the home (such as in restaurants) as a key concern, they seem to worry much less about food hygiene inside the home.

Understanding consumers’ level of awareness and understanding of issues is also key to defining effective communications. This is an important challenge for those communicating on technical, scientific subjects, and on new technologies in particular.

Another Eurobarometer survey on biotechnology, also conducted in 2005, showed that important knowledge gaps still exist regarding genes and genetic modification. This research showed, for example, that more than 1 in 3 consumers in Europe believe that ordinary foods such as tomatoes do not have genes but that genetically modified ones do. Against this background, one can perhaps better understand the level of concern expressed about genetically modified foods.

Looking ahead, technological advances in areas such as nanotechnology, animal cloning and intelligent packaging will present particular communications challenges that EFSA is already beginning to address.

To conclude, I would like to leave you with a few important messages:

• EFSA is the cornerstone of the European food and feed safety systems and the key player in risk assessment and RA methodologies in Europe.
• It is scientifically independent and its role is clearly distinguished from that of risk managers. It operates in an open, transparent and accountable manner in cooperation with its partners and stakeholders.
• It is at the centre of cooperation on food and feed safety in Europe with growing international connections.
• EFSA can be regarded as being in its second stage of development, its remit and workload having changed radically since its inception. It is adapting its governance to enhance its efficiency and to align its resources with the emerging priorities.

I would like to thank the organisers once again for their invitation, to wish the Seminar every success and to thank everyone for their kind attention.