The Regulation of Food Supplements in Europe: How Much Harmonisation is Needed?, Berlin
9 décembre 2011
Berlin, Speaking Notes
Distinguished guests, ladies and gentlemen,
It gives me great pleasure to address this conference on the regulation of food supplements in Europe and to provide an EFSA perspective on how we can ensure that we have a well-functioning regulatory system that protects our consumers on the one hand and supports innovation on the other. I would like to thank the organisers for their kind invitation to address you and to congratulate them for having organised this very stimulating event which is relevant to both consumer protection and the economic wellbeing of Europe. Because of the relevance of the agenda to public health, I would like to use this opportunity to describe our wider nutrition activities and to put our work on health claims into its broader context.
Public health: non-communicable diseases
Our discussions today take place against the backdrop of global concern over the rising tide of non-communicable diseases – cardiovascular diseases, cancers, diabetes and chronic lung diseases – which together are responsible for three in five deaths worldwide. These diseases are linked by common lifestyle-related risk factors, including unhealthy dietary choices and physical inactivity, and, in that regard, the rising trend in the rates of overweight and obesity is worrying. The UN General Assembly High Level meeting on non-communicable diseases in September heard of the global challenge that we face in this area. Here in Europe we have a heavy burden: WHO Europe statistics show that, while rates vary significantly between countries, over 50% of adults in the WHO European Region are overweight, and roughly 23% of women and 20% of men are obese. More worryingly, it is estimated that 25% of European children are overweight and the rate has increased steadily over the past 20 years. Clearly, effective and coordinated action is needed; however we must take encouragement from the fact that much of the disease burden is preventable by interventions such as the provision of clear and consistent information for the public on nutrition. Here, EFSA has an important role to play in supporting policy makers at European and national levels in developing policies and setting diet-related public health targets.
While, as our name indicates, food safety was the primary impetus for the establishment of EFSA, our Founding Regulation gives us an important mandate in nutrition. Furthermore, the increasing burden of nutrition-related diseases has had a significant impact on the evolution of our work programme. Our objective is two-fold: we need to know what Europeans are eating and we have to provide policy makers with the scientific basis for recommendations that will help consumers to make healthy dietary choices. That is why our work in this area currently has three main pillars:
- the collection of food consumption data and the harmonisation of collection methodologies across Member States;
- the establishment of dietary reference values and advising risk managers on how to translate them into food-based dietary guidelines;
- and of course the scientific evaluation of health claims made on foods.
Food consumption data collection
Before effective nutrition policies can be established, it is important to understand what people are eating. As well as its critical importance to nutrition policy, the availability of accurate and reliable data is a prerequisite for exposure assessment – a key component of the risk assessment process. Access to harmonised data also supports risk managers in making informed decisions to protect and promote consumer health; for example in assessing how dietary intakes of salt compare with the targets set for healthy diets. Data exist in some Member States but they are fragmented and are not comparable, whilst other Member States have yet to establish reliable food consumption databases.
In recent years, we have seen significant improvements in the accuracy of the data available to EFSA on the food consumption of adults, children and the elderly. EFSA’s Concise European Food Consumption Database has been operational since the end of February 2008 and this year we finalised work on the Comprehensive European Food Consumption Database. The latter contains detailed information on the daily food habits of almost 70,000 individuals across Europe with contributions from 22 Member States and collected from 32 different national dietary surveys.
Our work has benefited significantly from the availability of both databases, however one of the issues we face is that Member States use different methods to collect the data. This makes it difficult to carry out EU-wide analyses or country-to-country comparisons. That is why we are currently piloting a project called “EU Menu” to harmonise food consumption data collection across Europe. Coordinated by EFSA and in cooperation with Member States, the long-term objective of the project is to provide standardised information on what people eat in all countries and regions across the EU. It will assist policy makers in assessing the nutritional status of population groups, setting targets for healthy diets and monitoring progress over time. In this manner, the EU Menu will contribute to safer food and healthier diets for European citizens. Two pilot projects to develop the methodologies are already underway involving 12 Member States. EFSA will begin to provide support for Member States from the beginning of 2012 to harmonise their national dietary surveys and the EU Menu Survey proper is scheduled to start in full in 2013.
We are also working on an approach known as “total diet studies” in collaboration with the WHO and FAO to enhance the representativeness of our data. These studies assess the level of nutrients or contaminants in foods as eaten, with the food being prepared before any analysis is performed. We have recently published a joint guidance with the WHO and FAO for a harmonised total diet study approach which concludes that it is an effective tool to estimate population dietary exposure to both harmful and beneficial chemicals across the overall diet.
Dietary reference values
In relation to dietary reference values (DRVs), the European Commission asked EFSA to review and update the values for nutrient and energy intakes that were established in 1993 by the Scientific Committee on Food. The task was allocated to the Scientific Panel on Nutrition, Dietetic Products and Allergies (NDA Panel) which, in its work, is taking into consideration the latest scientific evidence and recent recommendations issued at national and international level. DRVs are a complete set of reference values and nutrient recommendations, including population reference intakes, average requirements, adequate intakes and tolerable upper intake levels. They are used to define the amount of a nutrient that must be consumed on a regular basis to maintain health and therefore provide a scientific basis for establishing nutrient recommendations and dietary guidelines. DRVs are calculated based on a defined set of scientific criteria including, for example, the amount of a nutrient required to prevent or reverse clinical deficiencies and maintain the functional competence of the body. To ensure a consistent approach to the calculations, the NDA Panel laid down general principles for establishing DRVs in an opinion published in 2010. Since then, we have published opinions on DRVs for fats, carbohydrates, dietary fibre and water. Work on establishing a DRV for protein is currently underway after a public consultation earlier this year. Energy and micronutrients will be addressed in 2012 and all of our work in this area is subject to extensive consultation with Member States, the scientific community, and other stakeholders.
In addition, the Commission has asked EFSA to help public authorities in Member States to translate nutrient-based recommendations into food-based dietary guidelines, practical science-based policy recommendations that are easily understood and culturally appropriate. In this regard, our 2010 opinion on establishing food-based dietary guidelines recommends a step-wise, multidisciplinary approach that is integrated with other food-related public policies.
But consumers are not just exposed to nutrient- or food-based recommendations from public health authorities. The last fifteen years have been characterised by the impressive development of health claims on foods. The objectives of the European Health Claims Regulation (2006) are (1) to protect the consumer by ensuring that no false or misleading claims are made for foods; (2) to improve the free movement of goods within the internal market through the harmonisation of rules; and (3) to promote innovation in the agri-food sector. According to this Regulation, health claims can only be authorised for use in the EU after a scientific assessment of the highest possible standard. EFSA’s role is to carry out such assessments. In July of this year, we published the final series of evaluations of so-called “general function” health claims under Article 13.1 of the Regulation, the culmination of more than three years’ work by the NDA Panel which since 2008 has assessed almost 3,000 claims.
I know that many of you involved in the implementation of the Regulation have found it challenging – and as risk assessors we can identify with that. Right from the outset, we were challenged by the unexpected volume of claims received. Based on industry estimates, we had anticipated somewhere in the region of 1000 claims, however we received over 4600 main entries – corresponding to over 10,000 health claims – even after screening by the Commission and Member States. Nevertheless, we met our targets and deadlines and I would like to pay tribute for this achievement to the NDA Panel, to over 30 other scientific experts who contributed to this work, and to EFSA staff. Earlier this week, in a meeting of the Standing Committee on the Food Chain and Animal Health, Member States supported the European Commission’s draft Regulation to adopt a list of 222 permitted health claims for use on foods.
The Health Claims Regulation is a groundbreaking piece of legislation; its equivalent cannot be found elsewhere. One of the first tasks the Panel had to address was its scientific approach and in particular how to translate the concepts of “generally accepted scientific evidence” and evaluations of the “highest possible standards” into practical working definitions. For many claims there was no precedent to refer to, meaning that EFSA had to define the scientific requirements. This has inevitably meant that many requirements were developed progressively in the course of the evaluation programme and, in our preparation of guidance for applicants, we have consulted widely. To date we have prepared guidance documents on gut and immune function; appetite ratings, weight management and blood glucose concentrations; protection against oxidative damage and cardiovascular health; and bone, joints, connective tissue and oral health. Each has been accompanied by a public consultation and we have held a series of technical meetings with stakeholders to ensure that there is a shared understanding of the scientific evaluation process. This has included the technical meeting on gut and immune function which we webcast live last year. Our activities are continuing with a public consultation on guidance for neurological and psychological functions closing on December 16 and ongoing preparation work for claims related to physical performance.
We have learned many lessons from our work in this area and I would like to share the main ones with you.
First of all, while EFSA has successfully completed its tasks in implementing the Regulation thus far, we can conclude from the experience gained that the process worked well for Article 13.5 and Article 14 claims which have a structured application process and which incorporate interaction with applicants. It was not quite as effective for Article 13.1 claims and we strongly recommend that a single interlocutor – i.e. the applicant – is used for any future work in this area.
Secondly, our evaluations have emphasised the need for high-quality scientific evidence to support claims. Some of the supporting evidence we have received in dossiers, including references to the Old Testament and Wikipedia, was diverse to put it mildly! With the comprehensive guidance documents we have put in place, there can be little doubt remaining as to the quality of scientific evidence needed to uphold a claim.
Thirdly, it is clear that this kind of work requires an infrastructure that is closer to those of agencies conceived for that purpose, such as the European Medicines Agency or the European Chemicals Agency. Though public health remains our raison d’être, in our recent reorganisation we have significantly strengthened our capacity to manage applications with the creation of a dedicated science directorate and a new Applications Desk unit to enhance interaction with stakeholders. This will be carried out gradually, particularly since the issue of fees is still under consideration by the European Commission.
Looking to the future, we expect to continue to receive somewhere in the region of 20-30 applications per year while 81 claims will be returned for reassessment later this month, mainly probiotics that were deemed to be insufficiently characterised originally and other claims for which the evidence was insufficient. The question of botanicals also remains; their evaluation has been put on hold by the Commission, however the possibility that they might need to be evaluated under the Health Claims Regulation still remains. I am sure our next speaker, Basil (Mathioudakis) from DG SANCO, will provide some insight into that situation.
I would like to thank the organisers once again for their kind invitation to address the conference and Matthias (Horst) of the BLL, who as a member of EFSA’s Management Board, makes a valued contribution to the governance of our organisation. Finally, I would like to reiterate EFSA’s commitment to providing the scientific evidence base to protect consumers and ensuring that the products of innovation are both safe and beneficial – a goal we all share.
Thank you very much for your kind attention.
Published: 12 December 2011