Catherine Geslain-Lanéelle

Ladies and gentlemen,

 Introduction It gives me great pleasure to open this important meeting and I would like to begin by welcoming you all to EFSA and to Parma. We have organised this meeting as part of our ongoing programme of consultation with you, our stakeholders, and I thank each and every one of you for attending. Our work today is very important and it has implications for a wide range of stakeholders in the food chain in Europe and indeed beyond. The so-called “Claims Regulation”, impacts on all of us – consumers, industry, risk assessment bodies at European and national levels and decision makers alike – and it has significant social and economic implications.

Therefore, I am very happy to see such a wide representation of stakeholders here today including industry, Member States competent authorities and the European Commission, DG SANCO. Your views are very important to us and we will continue to identify opportunities to engage with you.

Context One of the most important public health challenges Europe faces today relates to non-communicable diseases. With the growing burden of chronic, lifestyle-related diseases on our health care resources, it is important that our citizens understand the relationship between diet, physical activity and health. A central part of nutrition policy is ensuring that consumers are provided with meaningful, science-based information on the relationship between diet and health. That does not mean that foods are to be regarded as medicines.

EFSA currently contributes to European nutrition policy in two ways. Firstly, the Commission has asked EFSA to set dietary reference values (DRVs) for nutrient intakes and to help national and European authorities establish practical food-based dietary guidelines.

To date, we have published opinions on DRVs for fats, carbohydrates, dietary fibre and water as well as on the general approach used to establish the DRVs. All draft opinions have been subject to public consultation and in September last year we organised a dedicated meeting with nutrition experts from Member States. In addition, we have published advice for policy makers on how to translate nutritional recommendations into practical messages for consumers on foods and healthy dietary choices.

Secondly, and this is the reason why we are here today, in the framework of the Claims Regulation, EFSA has been mandated to evaluate whether nutrition and health claims for foods are supported by sound science and, by doing so, it defines the scientific requirements for the substantiation of claims. The Claims Regulation is the first piece of European legislation specifically dealing with nutrition and health claims. It is a groundbreaking piece of legislation and a challenging one for all parties involved. It has demanded a substantial allocation of resources not just from EFSA, but also from industry, the Commission and Member States.

It has been particularly demanding on the experts in the Panel on Dietetic products, nutrition and allergies (NDA) who have had to cope with an unprecedented and unforeseen workload, coupled with very tight deadlines.

I would like to pay tribute to the professionalism and dedication of the Panel members and other contributing experts who have managed to produce high-quality evaluations and to meet those deadlines. I thank the Panel Chair, Albert Flynn who will address the meeting later, and his colleagues for their commitment and hard work. Similarly, I would also like to thank Juliane Kleiner and her staff in the NDA Unit, who have put in a tremendous effort to get us where we are today. The independent scientific evaluations that EFSA has delivered so far – framed by the terms of reference provided by both the Regulation and the Commission – have, we believe, established the evidence requirements that are needed to substantiate claims.

Progress update To briefly summarise progress to date, EFSA has adopted 63 scientific opinions related to children and disease risk reduction health claim applications (Article 14) and 22 opinions related to health claim applications based on newly developed science and/or proprietary data (Article 13.5). Of the more than 4,600 general function (Article 13.1) health claims submitted via the Member States and the European Commission, EFSA has evaluated over 930 claims and adopted 125 opinions, published in two series.

In general, positive opinions were granted to those claims that the NDA Panel considered to be supported by well-established science and clear, unambiguous identification of the food or the constituent. Some of the main reasons why claims were not deemed to be substantiated by the Panel included in particular: insufficient characterisation of the food or constituent; lack of evidence that the claimed effect is indeed beneficial for health; poor quality scientific evidence; and sometimes inappropriate target groups.

Dialogue with stakeholders The lack of precedent, not just in Europe but worldwide, of implementing legislation of this nature has meant that all of us are to some extent working in uncharted territory. It has been a steep learning curve that has highlighted the need for dialogue between risk assessors, scientists, decision makers and stakeholders. That is why we have organised today’s meeting which, as many of you will be aware, is not a one-off but is part of an ongoing programme of dialogue that started in Bologna in late 2006 just before EFSA began its evaluations.

We have consulted with you on several occasions since then and with your input we have produced a series of guidance and other documents to facilitate the evaluation of claims and guide you.

As our work evolves, it is important that we continue to hear your views and those of all actors in this process to ensure that we have a common understanding of what is required for the successful implementation of this legislation.

The importance of this work demands that we closely follow developments at both the Commission and Member State levels and EFSA participates in the key meetings to ensure that we are fully and actively engaged in the implementation of the Regulation. Following a meeting with Member States and the Commission to update them on the Article 13.1 evaluations, we published a briefing document in December last year. To ensure continuity and coherence in our dialogue with you, our stakeholders, we have prepared an updated briefing document to serve as a basis for our discussions today. We have made that updated draft available to you in advance for comment and I thank you for the useful comments that we have received.

Evolving role of EFSA I would like to take the opportunity to put our health claims work in the wider context of the evolution of EFSA since its establishment in 2002. In its early years of operation, most of EFSA’s efforts were devoted to generic food safety opinions on, for example, biological or chemical contaminants.

In contrast, our work programme for 2010 indicates that up to 80% of our scientific outputs this year will be devoted to applications for new products or existing products already on the market. This will demand 40% of our resources and we expect that 2011 will follow a similar pattern.

EFSA is now assessing much more than risk; increasingly we are also assessing benefits for health (our work on health claims is a good example of this), impacts on the environment (for example GMOs), or the efficacy of substances such as feed additives or pesticides. Although it is challenging, this work is crucial. As the Commission’s strategy paper Europe 2020 outlines, sustainable innovation must be based on robust science that delivers real benefits for consumer health or the environment. The vision for a knowledge-based economy expressed in Europe 2020 is highly relevant to our work on health claims. EFSA’s mission is to ensure that European citizens are protected by decisions grounded in the best science and that they are confident that the products they consume will deliver meaningful benefits.

EFSA does not work in a vacuum; while our raison d’être is the protection of the European consumer, we are aware of the wider implications of our work and our responsibilities in supporting the innovation that is required to keep our industries competitive.

By ensuring that there is a shared understanding of the scientific evidence required, the work we have delivered thus far will, we trust, support the work of industry by helping to establish future directions for research and innovation.

Conclusion In conclusion, let me re-emphasise our commitment to dialogue with you, our stakeholders, and with all interested parties including Member States and the Commission. On our programme today we have put together some of the key actors in the implementation of this complex and challenging piece of legislation and I am confident that this process of exchanging information and views will be productive.

Thank you to our speakers for their availability and to each and every one of you for attending. I hope you find the day informative and beneficial.

Thank you for your kind attention

Published: 1 June 2010