Connecting with Self-Care: the Future of Self-Medication in the New Europe, Dubrovnik
11 juin 2010
Mr. Chairman, Vice-President of the European Parliament, dear Mrs. Roth-Behrendt, dear Dagmar, ladies and gentlemen,
It gives me great pleasure to address this meeting of the Association and I would like to thank the organisers for the invitation and for this valuable opportunity to present the work of the European Food Safety Authority (EFSA) in the field of health claims. I am delighted that the Chair of EFSA’s Scientific Committee, Prof. Vittorio Silano, has been able to join us today and he will address the meeting later. The so-called “Health Claims Regulation” which was enacted back in 2006 is a very important legislative measure that has implications for a wide range of stakeholders in the food chain in Europe and indeed beyond.
The Regulation impacts on all of us – consumers, the food industry, manufacturers of self-care products, your association’s members, risk assessment bodies at European and national levels, and decision makers alike – and it has significant social and economic implications.
For those of you who may not be very familiar with EFSA, I would like to briefly describe our background and mission. The Authority was established by European legislators in 2002 as the EU’s independent risk assessment body for food and feed safety as a direct consequence of the food crises of the late 1990s, in particular BSE and dioxins. Those crises provoked much public concern and, as a result, confidence in European food for both consumers and trading partners was severely compromised. The economic consequences for Europe were significant.
In response, the European Commission issued a White Paper on Food Safety in 2000 which proposed a new food safety model for Europe and paved the way for reform. The new model proposed the functional separation of risk assessment and risk management and promoted science-based regulation and cooperation between all actors in the food chain.
Subsequently, a series of legislative measures were put in place beginning with our Founding Regulation (178/2002), which laid down the general principles and requirements of food law and established EFSA as an independent source of scientific advice and communication on risks associated with the food chain. EFSA is mandated to provide the evidence base that enables appropriate measures to be taken to protect public health and the environment. Our founding legislation emphasises the core values that underpin our work and that derived from the lessons learned from the food crises of the ‘90s: independence in the provision of scientific advice, transparency, and excellence in our science.
EFSA has a very broad remit – the entire food chain, farm to fork, or field to plate – and to fulfil our mandate, dialogue with all actors and stakeholders in the food chain is prerequisite. As our risk assessments increase in complexity, we are frequently asked to consider aspects of the food chain which would not be traditionally regarded as belonging to the realm of food safety – for instance, the environmental risk assessment of GMOs or pesticides. Furthermore, there is an increasing demand for assessment of the efficacy of products such as food additives or pesticides, or benefits for health, such as our ongoing work on health claims.
Based in Parma, Italy and with a workforce of over 400, EFSA forms a close network with the national food safety agencies, many of which were established at the same time. Although independent, we are certainly not isolated. Annually, over 1500 experts from countries inside and outside the EU contribute to the work of our ten Scientific Panels and Scientific Committee and over 350 national scientific organisations from around Europe support our work.
We are reminded on a daily basis that the most important public health challenges Europe faces are related to non-communicable diseases. With the growing burden of chronic, lifestyle-related diseases linked in particular with obesity and overweight, it is important that our citizens understand the relationship between diet and health. We have all grown accustomed to hearing statistics on the prevalence of obesity and overweight but we cannot become complacent to the fact that at least 30% of the European adult population is either overweight or obese and there are 23 million overweight or obese children across the EU. These numbers are of great concern. They threaten the gains in public health that Europe has achieved and challenge our health care systems.
Through increased access to information, particularly via the internet, consumers are faced with an often bewildering array of information. That makes it all the more important to ensure that we – risk assessors, risk managers, manufacturers and scientists alike – provide consumers with meaningful, science-based information on the relationship between diet and health.
Although the word “nutrition” does not appear in EFSA’s name, both our founding regulation and other sectoral legislation confer particular responsibilities to the Authority in relation to nutrition. 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. Our advice on nutrient intakes provides an important evidence base to underpin nutritional policies, set dietary targets and develop consumer information programmes on healthy diets. For example, DRVs can be used as a basis for reference values in food labelling and for establishing food-based dietary guidelines that translate national nutritional recommendations into messages to guide consumers on healthy dietary choices.
T o 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 of which were adopted after consultation with Member States, the scientific community, and other stakeholders. Our work in this area will continue with the establishment of DRVs for vitamins and minerals and, again, we will consult broadly before finalising our opinions.
Secondly, and more relevant to our discussion today, in the framework of the Health Claims Regulation, EFSA has been mandated to evaluate whether nutrition and health claims for foods are supported by sound science. Adopted in 2006, the Regulation was introduced to ensure that consumers are not misled and to provide market operators with a level playing field. It lays down harmonised EU-wide rules for the use of health or nutrition claims on foods with the key objective of ensuring that any claim made on a food label in the EU is clear and substantiated by scientific evidence. It is the first piece of European legislation specifically dealing with nutrition and health claims and the first that allows business operators to refer to diseases when advertising foods. As such it is a groundbreaking piece of legislation and a challenging one for all parties involved.
The task of assessing claims was given to EFSA’s Scientific Panel on Dietetic Products, Nutrition and Allergies Panel (NDA Panel), which has maintained regular dialogue with stakeholders and provided extensive guidance for applicants. For health claims subject to a full application (Articles 13.5 and 14 of the Claims Regulation), EFSA has received over 300 applications in relation to child health, disease risk reduction and functional claims based on new scientific evidence. In contrast, the anticipated number of general function claims included in the Article 13.1 list vastly exceeded expectation. Based on industry estimates, we had anticipated somewhere in the region of 1000 claims, however we have received over 4600 main entries – corresponding to over 10,000 health claims – even after initial screening by the Commission and Member States. Further screening by EFSA resulted in over 2000 claims being returned to the Commission and Member States for further information or clarification.
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) claims, 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 supporting scientific evidence; and sometimes inappropriate target groups.
There is little precedent, not just in Europe but worldwide, of implementing legislation of this nature and that has meant that all actors are to some extent working in uncharted territory. Just last week in Parma, we organised the latest in our programme of technical meetings to consult with stakeholders, Member States and the Commission.
The meeting acknowledged the tremendous effort expended to date, not just by EFSA, but also by industry, national agencies, the Commission and not least the NDA Panel members whom we must remember are independent scientists with a “day job” to look after. The outcomes also point towards the challenges of working with this complex regulation and, more than anything else, confirmed the need for enhanced dialogue and interaction with applicants. And that is something we are very committed to at EFSA. Like all parties involved, we want to make the evaluation process as smooth as possible and ensure that there is a clear and common understanding of the way forward. That is why we have planned further technical meetings with stakeholders, beginning later this year with a meeting specifically on claims related to immunity and gut health. We will continue to identify appropriate and effective mechanisms by which we can ensure that all actors are fully informed and engaged in the implementation of the Regulation.
One of the issues that has been raised in relation to health claims is the balance between innovation and consumer protection. EFSA does not work in a vacuum and, while our raison d’être is the protection of the European consumer, we are aware of the wider implications of our work.
The current global economic difficulties have emphasised the need for European industry to become more competitive and EFSA is aware of its responsibilities in supporting innovation. To me, the goals of consumer protection and innovation are not contradictory. Innovation will not be successful unless the consumer is confident that the products and technologies generated by industry are not just safe, but also deliver real benefits. EFSA is confident that its evaluations of claims can and will support industry in establishing the future directions for innovation and research.
In conclusion, EFSA is a science-based organisation that is fully committed to playing its role in ensuring that the policies that are put in place to protect the European consumer are grounded in robust science. The vision laid down by the Commission’s strategy Europe 2020 emphasises smart, sustainable and inclusive growth and it provides a useful context for our work on health claims.
Europe is committed to a knowledge-based economy and we must ensure that the principles of sound science, meaningful benefits for all our citizens, and sustainable innovation guide us in the implementation of the Regulation. EFSA will continue to work with all actors to ensure that this vision is realised.
Thank you for your very kind attention
Published: 14 June 2010