Informed choices: the role of science, Brussels
Distinguished guests, ladies and gentlemen,
It gives me great pleasure to be with you here in Brussels this morning and I would like to thank the organisers for the opportunity to address the conference. I would also like to thank the organisers for providing this platform which brings together some of the key actors in the formulation of European nutrition policy, many of whom also provide a valued international perspective. By ensuring that Europe’s policies and legislation are based on robust science, the European Food Safety Authority has an important contribution to make to the debate on healthy choices. We are reminded on a daily basis of the burden of chronic disease posed by poor dietary choices. Non-communicable diseases remain the greatest contributors to mortality and morbidity across Europe and we have a collective responsibility to tackle the problem.
Obesity, and in particular childhood obesity, continues to be a major concern to public health authorities. While very recent evidence suggests that the rising tide of obesity may be stabilising in some countries, the statistics remain challenging: according to the WHO, 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. The “obesogenic” lifestyle that is all too common in Europe – high energy intakes and low levels of physical activity – means that we may be storing up a major public health problem for future generations unless we take action. The need for coordinated, science-based nutrition policies is clear. Diet is a personal choice and while people cannot be told what to eat, we can help them to make informed choices and ensure access to a safe and healthy food supply.
The title of my address highlights EFSA’s scientific role in facilitating healthy consumer choices. It is important to remember EFSA’s raison d’être. EFSA was established in 2002 as the EU’s independent risk assessment body in direct response to the food crises of the previous decade. The tenth anniversary of the European Commission’s White Paper on Food Safety occurred last month, January 2010.
It is therefore timely to reflect on that ground-breaking document as it introduced a new food safety system for Europe and paved the way for the establishment of EFSA. It emphasised science-based policy and for the first time recognised the importance of the separation of risk assessment from risk management.
The scientific underpinning of European food and feed legislation has been greatly reinforced by the increasing level of resources devoted to scientific risk assessment. To mention just a few figures: EFSA has a staff of over 400, approximately 60% of whom are engaged in scientific activities. We form a close network with the national food safety agencies and more than 350 scientific organisations in the Member States work with us as part of that network. Annually over 1500 experts from countries inside and outside the EU contribute to our core mandate of providing scientific advice. We maintain highly active communication with all those involved in the food chain and we work closely with risk communicators in the Commission and the national agencies. We have put in place stringent operating procedures and policies to safeguard the independence and credibility of our scientific advice and ultimately to build consumer confidence.
Legislation on health claims
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 including the assessment of health claims for foods. As we know, foods have long been subject to claims of all sorts and it is crucial that these claims have a robust scientific basis. To enhance consumer confidence and provide market operators with a level playing field, Regulation (EC) 1924/2006 (the so-called Claims Regulation) was adopted in 2006. It lays down harmonised EU-wide rules for the use of health or nutrition claims on foods. The key objective of the Regulation is to ensure that any claim made on a food label in the EU is clear and substantiated by scientific evidence. EFSA was given responsibility for verifying the scientific substantiation of the submitted claims thereby providing consumers with an independent guarantee of their validity. Our scientific evaluations serve as a basis for risk managers, the European Commission and Member States, who ultimately decide whether to authorise a claim or not.
EFSA embarked upon a process of dialogue with stakeholders soon after the enactment of the Claims Regulation, beginning with a conference involving a wide range of stakeholders, experts and interested parties in Bologna in late 2006. The task of assessing claims was given to EFSA’s Scientific Panel on Dietetic Products, Nutrition and Allergies Panel (NDA Panel), and it has maintained regular dialogue with stakeholders through, for example, technical meetings, briefings, and regular updates to EFSA’s Stakeholder Platform. In addition, EFSA has 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 290 applications in relation to child health, disease risk reduction and functional claims based on new scientific evidence and has already issued over 75 opinions. 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 received 4000 main entries – corresponding to over 10,000 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. It is also possible that we may yet receive an addendum of further claims.
The first series of 94 opinions in relation to general function health claims under Article 13.1 was published in October 2009 covering over 500 claims for 200 foods and food components. Favourable outcomes were achieved in about one-third of cases. Claims received a negative evaluation mainly because of the poor scientific evidence provided, insufficient data for the characterisation of the substance that formed the basis of the claim, or inappropriate target groups. EFSA met with Member States and the Commission to discuss the outcome of the first batch of opinions and discussions were also held with stakeholders. These exchanges were instrumental in clarifying procedural and technical issues and in reiterating the role of EFSA in scientific risk assessment and not in decision making vis-à-vis authorisation. The second batch of opinions covering over 400 listed general function health claims will be published tomorrow and, in many cases, the outcome will again reflect the fact that insufficient scientific evidence has been provided to support claims.
Feedback on the first evaluations
I’m sure that all parties involved in the implementation of the Claims Regulation will agree that it has been challenging but, on the other hand, we have learned a lot from the process. EFSA has received a considerable volume of feedback on the first series of Article 13.1 opinions particularly in relation to the evaluation criteria the NDA Panel uses and the characterisation of the food or food constituent. The Claims Regulation and the terms of reference provided by the Commission are unequivocal in relation to the evaluation criteria. The Regulation stipulates that health claims can only be authorised based on “scientific assessment of the highest possible standard”. Assessments must consider the totality of the available scientific data, the evidence must be weighed and substantiation of a claim must be based on generally accepted scientific evidence. The NDA Panel has no pre-established formula in relation to the number or type of studies required for substantiation of a claim; it takes all pertinent scientific data into consideration.
In common with the standards used by Codex Alimentarius and other international organisations, in particular the FDA and Health Canada, human studies are central to substantiation and there is a hierarchy of evidence: randomised controlled trials are generally recognized by the scientific community as highly relevant, as are observational studies, while animal studies and in vitro research may also be taken into account.
Accurate characterisation is a critical component of the substantiation process; for example strain identification is essential in the assessment of probiotics. In addition, the quantity of the food or food component required to achieve the claimed effect must form part of a balanced diet and the target population for a claim must be adequately identified. The target groups can be either the general population or subsections thereof, for example the elderly or pregnant women. In general, patients are not the target group for health claims although evidence from patients may be included in assessments.
Impact on innovation
Industry needs innovation to be competitive and is supported in its efforts by the Lisbon strategy and other EU and national policies.
One of the issues that has been raised in relation to health claims is the balance between innovation and consumer protection. To me, these goals are complementary: while European industry is challenged to generate tomorrow’s products and technologies, the consumer must be confident that those products and technologies are not just safe, but also effective. Sustainable innovation and consumer confidence in innovation can only be maintained if health claims made on foods represent a real benefit for consumers and are backed by robust science. Furthermore, EFSA’s evaluations of claims can support industry in establishing the future directions for innovation – again based on sound science. For the first time, EU industry will have certainty regarding the scientific evidence needed for claiming health benefits for their food products.
EFSA will continue its evaluation of claims taking into consideration the dialogue with Member States and the Commission. For Article 13 claims, we will progressively adopt and publish opinions during 2010 and 2011. In May of this year, EFSA will organise a conference on health claims in Parma involving all stakeholders, Member States and the Commission.
This event will provide a platform for open discussion and debate between stakeholders, the Commission, Member States and experts from the NDA Panel, and I hope that many of you will have the opportunity to participate.
Other nutrition activities
Of course, our work in nutrition is not limited to health claims. For example, EFSA has been asked to review the existing population reference intakes in light of new scientific evidence, taking into account recent national recommendations. To this end, EFSA organised a dedicated meeting with nutrition experts from Member States in September 2009. In addition, public consultations were launched on EFSA’s draft opinions on dietary reference values for fats and carbohydrates in August 2009, in line with our policy on openness and transparency. Dietary reference values are a key component of both dietary assessment and management and are also used in establishing food-based dietary guidelines, thereby guiding the consumer on healthy dietary choices. Dietary reference values for energy and protein will be published and work on micronutrients will start in 2010 – all draft opinions will also be subject to public consultation.
EFSA has also provided advice to the Commission on the establishment of nutrient profiles and in particular on the specific profiles that food must have in order to carry health claims.
The ability to collect and analyse data is central to our work. Exposure assessment is of course a key step in the risk assessment process which requires information on food consumption. Food consumption data therefore are not only valuable from a nutrition point of view but they are also essential for risk assessments. The consumption data that EFSA has collected and used in exposure assessment thus far are the best currently available in the EU. However, they still include important methodological differences making these data unsuitable for EU-wide analyses or country-to-country comparisons. EFSA has identified the need for accurate and harmonised food consumption data at European level and has developed a proposal for the establishment of an EU-wide standardised food consumption data collection system, called EUMenu. The proposal has been widely welcomed: in December 2009 by EFSA’s Management Board and in Seville just two weeks ago when the members of EFSA’s Advisory Forum – representing the 27 national agencies – signed a declaration of support for the project.
The collection of data is planned to be carried out as a rolling programme from 2012 to 2017, with a preparatory phase in 2010-2011. At EFSA we are excited by this project and the potential benefits it will bring to risk assessors, public health policy makers, stakeholders and ultimately to the European consumer. We trust that others will share our vision in the importance of this endeavour.
In conclusion, I would like to emphasise the central role of science in Europe’s policy-making and the importance of cooperation and dialogue in ensuring that we achieve the twin goals of protecting public health while ensuring competitiveness. I would like to wish this conference every success and I am happy to answer any questions.
Thank you for your kind attention.
Published: 24 February 2010