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European Functional Foods: Challenges Beyond the Regulatory Milestone

 Used abbreviations
 Filling-in the Law
 Scientific substantiation of claims
 Benefit/risk analysis and long-term effects
 Reaching the consumer
 Consumer Marketing & Communication
 The consumer is central to the new legislation
 New Science and Technology
 Future … Functional foods are part of the solution
This is an independent review of the International Symposium “Functional Foods in Europe – International Developments in Science and Health Claims”, organised by ILSI Europe in Malta, 9-11 May 2007

Used abbreviations

BfR: Federal Institute for Risk Assessment (Germany)
CNRS: National Center for Scientific Research (France)
DG Sanco: Directorate General for Health and Consumer Affairs (EU)
EC: European Commission (EU)
EFSA: European Food Safety Authority (EU)
FDA: Food & Drug Administration (USA)
ILSI: International Life Sciences Institute
INRA: National Institute of Agricultural Research (France)
KBBE: Knowledge-Based Bio-Economy
MS: member state(s)
N&H: Nutrition & Health
NDA: Panel on Dietetic Products, Nutrition and Allergies
P&G: Procter & Gamble
RIVM: Dutch National Institute for Public Health and the Environment
SNF: Swedish Nutrition Foundation (Sweden)
UCC: University College Cork (Ireland)
WHO : World Health Organization

AIDA model: Attention, Interest, Desire, Action


As the EU regulation on nutrition and health claims1 came into force on July 1, 2007, numerous and complex challenges – scientific, regulatory, consumer aspects – remain to be solved in the very near future. This legislation is ‘modular’. The basic framework was laid down in December 2006, but different elements still have to be filled-in in the coming years. Developments and issues were discussed by government officials, industrial and academic scientists at the international ILSI Europe symposium “Functional Foods in Europe – International Developments in Science and Health Claims” in Malta last May, with an audience of 325 participants from all 5 continents.

The crucial timing of this symposium motivated an excellent crew of speakers from the EU’s directorate generals for health and research (DG Sanco, DG Research), EFSA, CODEX alimentarius, WHO, public and private national research organisations from various EU countries, European and American universities, companies and ILSI itself (see Figure 1). The world’s perspective on health claim substantiation was completed by speakers from North America and Asia. I have the challenging task to write the press review.
Figure 1
As a lecturer, industrial trainer and advisor on functional foods for many years, I do it with the greatest pleasure. To extract the most important highlights, I took extra time and care to thoroughly review the contents of this symposium. Space only allows me to review the presentations. The many posters presented during the symposium and other information can be accessed via http://europe.ilsi.org/events/past/functionalfoods.htm.

Filling-in the Law

The new health claims regulation has received a general welcome because it promises to bring needed solidity and clarity to the European functional foods market. But it is not starting with a blank page: Many products in the market already have health-related claims and companies have been using health-related claims for years. So the present regulatory situation is chaotic. On the one hand the EU central bodies and MS are trying to define difficult details of the new law, on the other companies are trying to comply and prepare to comply with yet non-existing elements, and still on another MS regulators are deciding on how to enforce the regulation. Hopefully enforcement will also be harmonised!

Member states are preparing their lists of health claims based on generally accepted science (commonly referred to as ‘generic claims’ or ‘Art. 13 claims’) to submit to EFSA by January 2008, and companies are urged to participate actively in this process. All lists will be used to prepare one positive list or ‘Community list of authorised claims’ which form part of the legislation by 2010. Mr. Griffin of the Food Standards Agency (UK) explained the process being followed by a member state; Figure 2 gives the submission format being used.
Figure 2: Template adopted by the UK (among other MS) for submission of Article 13 health claims for its national list.
Source: N. Griffin, Food Standards Agency, United Kingdom.

Nutrient profiles, which will also form part of the law, will be established by the EC by January 2009, following advice from EFSA. “They will be prepared by the NDA panel”, informed Pilar Rodriguez of EFSA. This is a complex and highly debated issue. They were included in the law for consumer protection and their purpose is to prevent that N&H claims are used on foods of ‘unhealthy composition’. Thus EFSA has a very important and ‘huge job’ in this sensitive area, as independent advisor to the EC. The complexities and difficulties involved in this task were summarised by Albert Flynn of the University College Cork (Ireland), who elaborated on various key questions of great consequence, such as ‘whether nutrient profiles should be applied to foods or to categories of foods’, and ‘which specific nutrition concepts should be used’.

Other issues: Wording of the claim in the various EU languages [there are 23 official ones!] and consumer understanding of it were other crucial questions asked. Hereto Basil Mathioudakis, Head of the Unit Food Law, Nutrition and Labeling at DG Sanco, expressed that “there will be quite many interpretations issues” and “national authorities will have a key role in interpreting and enforcing the law”. It should also be noted that amendments to this recent law are already ongoing (e.g., in the area of children development and health).

Scientific substantiation of claims

This regulation makes scientific underpinning compulsory for health claims on the products it covers (all foods -including fresh, prepacked and unpacked- and food supplements). To establish criteria and serve as a guidance tool for assessing scientific substantiation of claims, the PASSCLAIM concerted action (EC/ILSI Europe) was carried out in 2001-2005. Peter Aggett of the School of Health of Lancashire University (UK) summarized the project and explained unresolved issues. “PASSCLAIM has become a standard for the world. It helps to harmonize, not only in Europe but also in other parts of the world like South East Asia”. The hope is for a common approach worldwide, based on one sound and practical system.
One confounding issue in establishing a beneficial effect is that “it may not be a clear-cut picture” said Aggett. “One food component may contribute to more than one function, one component may have several outcomes and several outcomes may be influenced by several components”. Another important issue is getting to good, appropriate markers of disease.

But beyond PASSCLAIM, the question still remains over which types of studies really prove a health benefit. It is clear that the claim should “not be based only on observational studies” said Rolf Grossklaus speaking for the CODEX alimentarius. Solid proof requires the use of well-designed interventional human studies(REF). “Studies must be carried out on healthy individuals; if done on sick ones they are drug studies” said Joanne Lupton (Texas A&M University) speaking from her previous experience working with the FDA. Whether the principle of Grading of Evidence will be applied in Europe is not clear, and the question is whether this is the right approach for a real sound claim. “PASSCLAIM must now be translated into a workable concept” said Detlef Müller of P&G. Scientific substantiation remains a challenge: it is difficult, long and expensive undertaking.

As the scientific community focuses on the long-term benefits of functional foods, several speakers expressed that health claims should be re-evaluated as new science emerges - as discussed further below.

Benefit/risk analysis and long-term effects

The real (long-term) benefits and risks of functional foods were one of the major issues recurring throughout the symposium. Klaus Grossklaus (chair of a CODEX alimentarius committee) remarked on the importance of establishing “the real efficacy of disease risk reduction claims, especially since a disease may have multiple risk factors and altering one may or not have a beneficial effect”. Also, with some functional foods in the market for some years already, the long-term assessment of the benefits is now emerging as an important consideration. Several speakers indicated the need to reassess claims with new science; Grossklaus expressed that claims should be reassessed “after a period of time, when significant new evidence appeared and if new evidence questioned the validity of a health claim”. Whether this would be good for consumer understanding who needs ‘information homeostasis’ (see below under ‘Consumer’) is questionable. The risk is that, as has occurred with previous topics in nutrition communication, changing messages from ‘this is good for you’ to ‘this is not good for you anymore’ confuses the consumer and undermines the trust in nutritional science.

And there are several safety risks associated with functional foods. Niels Asp (SNF) addressed the ‘generally needed’ risk, and remarked on the “need to communicate within the context and on the need of proper surveillance”. Examples are the risk of toxicity when an added ingredient is already consumed in abundance in the normal food chain (e.g., vitamin A) or when the “requirement is not known and no deficiency has been identified (e.g., panthotenic acid)”.
Over-usage due to cumulative intake from all sources is a serious toxicity risk. It may occur, for example, when a generic claim becomes popular. Exposure assessment, said Grossklaus (CODEX) “should be based on evaluation of the distribution of the total intake for the general population, or where relevant for vulnerable population groups”.

Unresolved issues mentioned by Lupton (Texas A&M) included safety issues due to the isolation of active components, their interaction with other substances, their side effects and toxicity (over-dosage). She also pinpointed at the “distorted picture” in dietary patterns in USA now: 50% of the dietary fiber recommendation? are from non-fiber-rich sources, e.g., fiber-rich hamburgers. Will this have an impact on healthy meal patterns? she made us reflect. Gérard Pascal of INRA indicated that besides biological risks, there are also “societal, economic, environmental and ethical risks –or ‘social acceptability’- that will have to be taken into consideration in future scientific risks assessments of functional foods”.

“Risk assessment should be systematic and quantitative” said Pascal (INRA). Several tools have been developed for assessing benefit/risk, and one often used is the estimation of Disability adjusted life years (DALY). The RIVM used it to show the effects of diet-related diseases (obesity) and the potential gain of dietary interventions (see below ‘Obesity’). To reach a common scale of quantitative measurement of health risks and benefits of foods and food compounds, ILSI Europe is starting the EC Specific Support Action ‘BRAFO’ addressing these issues, which will last till 2010.


”The most important risk factors for disease burden in Europe are related to the diet” said Pirjo Pietinen of the National Public Health Institute (Finland) and advisor to WHO, and “non-communicable diseases are the leading cause of disease”. Obesity/overweight are an indicator.

“Obesity is a socio-economic problem” said Pietinen. It is related to “social class, education and income level”. Using DALY’s as quantifying tool, Nynke de Jong (RIVM) explained that only “a proportion of the health loss can be reversed by dietary interventions”, and that healthy diet has a health gain potential 70 times greater than overcoming food hazards (microorganisms, allergens, chemicals and unsafe food) in The Netherlands.

With the EU projection of 26% of the population in all countries becoming obese/overweight by year 2010, governments are pressured to find effective solutions to reverse this trend. Multiple programmes have been started at various levels in all MS. The food supply keeps being called to “decrease marketing pressure, improve the supply of healthier foods, reformulate and take economic measures that facilitate healthier food choices” as stated by the WHO at this symposium. “Governments have legislation and partnerships as tools to implement policy” is warned. Yet, the key to obesity is in effectively reaching the consumer to effect a change in diet and physical activity level, since the final decision on food choice and amount is up to him/her. This remains the greatest challenge yet.

The view of the social-psychologist Claude Fischler (CNRS) is that “obesity is the result from a ‘toxic environment’. Changing the environment is the best way to change behaviour. The food supply is part of the environment” he indicated.

Reaching the consumer

“The EU dietary goals set in the ‘EURODIET’ are not being met”, said Pietinen (WHO). Actually “some negative trends -increase in energy and reduction of fruit and vegetable intake- were found in The Netherlands”, remarked de-Jong (RIVM). “Skipping breakfast, grazing and snacking are also on the increase”, she added. 80% of the consumers do not care about dietary recommendations. “Nutrition education has failed” said Ulrich Oltendorf of the BfE, “because it was based on the premise that knowledge leads to the right behaviour and this is not the case. It is almost impossible to alter behaviour by knowledge transfer and formal education” he added.

In his presentation on ‘human nutrition behaviour theory’, Oltendorf (BfE) explained that nutrition behaviour has a combined biological, biopsychological, sociological and economic basis. “Humans have a need for information homeostasis, i.e., controlled and stable information; stable but it can be adapted. Adaptation is easier during ‘events’ in life, he continued. “People have like an ‘internal library’ of previously acquired knowledge and convictions, and every new input is checked against it”, he explained. In the learning process one must keep in mind that it is very difficult to change existing convictions and that new behaviour has to be trained to become automatic.

Consumer Marketing & Communication

From the practical standpoint of qualitative market researchers, Jens Lönneker of Rheingold illustrated how variable the ‘wants’ and opinions of consumers are. Soon after they say that they want something (e.g., clean label products), they start questioning it (e.g., “the product is not so good anymore”; “it was the additives that made it so good”). It is very difficult indeed to get to the core of what they want. Lönneker explained the consumer needs for “clarity, orientation, predictability and security. The consumer keeps trying to reduce mental costs in decision making”. To facilitate his decision, complexity should be reduced. “Thus not too many logos and not too much information on the package. The power of brands is being diluted by the great number of products that are put under one brandname” he explained.

Buying is “an emotional decision based on rational considerations” said Edward Fern of Nestlé. From a psychological point of view, “health (rational) is not a value on its own but it is strongly linked to pleasure and enjoyment (emotional)” said Lönneker (Rheingold). “When adding a function (e.g., health) to traditional foods, the first interest is taste (the food itself) and the second is the health function” said Fern.

From the socio-psychological angle, Claude Fischler of the CNRS expanded on the “natural superiority of natural” for humans. “Adding anything –even in minute amounts - destroys naturalness, and has a much greater effect than substraction. The process (organic, chemical) is more important than the content” he continued.

The consumer is central to the new legislation

The consumer is also central to the N&H claims regulation, and the law is strict about it: “The use of nutrition and health claims shall only be permitted if the average consumer can be expected to understand the beneficial effects as expressed in the claim” (Art. 5.2). The practical implications of the legislation and the processes people use to understand and interpret claims were the focus of an international Consumer Science Task Force coordinated by ILSI Europe. “Claims make products visible. They make the health message a ‘search’ criterion” reported Hans van Trijp of Wageningen University and member of the task force. “Consumer are not recipients of information, but processors of information. They fill-in and associate the information we provide. They are not nutritionists, so messages should be simple and relevant to them. They need to understand the benefits, not the science. Thus the simpler the better, but it should be uniform” he added. Consumer scientists agreed that to move consumers to action, the well-known AIDA model works.

With regards to the recommended method for assessing consumer understanding of N&H claims, van-Trijp (Wageningen University) recommended a combination of
Figure 3: The proposed step-by step approach for assessing consumer understanding of N&H claims combines qualitative and quantitative methods.
Source: H. van Trijp, Wageningen University, Netherlands.
qualitative and quantitative methods. The proposed step-by step approach is given in Figure 3.

New Science and Technology

Peter Brown of Kraft Foods illustrated the contribution of new technologies, such as nanotechnology, digital technology and biomolecular technology. He discussed several examples and concluded that new solutions and opportunities will come up, with respect to “increased safety, quality, nutritional value, convenience, food information, household management and new product development”.

The short- and medium-term scenarios of personalised nutrition (i.e., designing foods according to the genetic code of individuals) were discussed by Michael Gibney of UCC. “The short-term is already possible with the present food supply (e.g., low MUFA, low salt foods, etc)” he explained. Manufacturing specific foods that exactly fit specific genetic requirement of the population may prove too complex to become practical, he concluded for the medium-term scenario.

The present EC research programme and available financiation from the DG Research were presented by Isabelle de Froidmont-Görtz, Scientific Officer at DG Research. The EC wants to potentiate the development of functional foods, nutrition and optimal health. Focus is on “prevention (e.g., old age, obesity), since cure is too expensive” said de-Froidmont. She drew attention to the European Technology Platform ‘Food For Life’ coordinated by CIAA to find out the future research needs of stakeholders, for which financial support is still available. After summarising the achievements in FP6, de-Froidmont talked about the topics and subsidies available now for FP7. For the KBBE program, she discussed ‘theme 2: Food, Agriculture and Biotechnology’, with a research budget of ca. 1.9 bio euros. Within this theme, she focused on the activity ‘Fork to Farm’ which is the one dedicated to food, health and wellbeing.

Future … Functional foods are part of the solution

The increase in non-communicable diseases and the chance to improve old age health have made governments see industrial foods as a whole, and functional foods in particular, as an important factor to improve the situation. In his address, His Excellency Health Minister Louis Deguara (Malta) reiterated “the need for constant collaboration between the key players so that through open and transparent discussion we can further explore the potential for functional foods and their role in health promotion and disease prevention”.

* Dr. Martha Cecilia Kühn (c.kuhn@foodlinkforum.com) was invited as specialised technical writer to prepare this independent review. She is global director of functional food services at FOODLINK FORUM. Dr. Kühn lectures and trains at companies and universities. She has authored articles and books, and is responsible for “The Functional Foods Dossier: Building Solid Health Claims” (ISBN 90-5859-004-6) and of the “State of the European Functional Foods Market” series.

FOODLINK FORUM (www.foodlinkforum.com) is the European supplier of technological business development services for the food industry and is based in The Netherlands. Independent services since 1997.

Korver, O., Kühn, M.C. and Richardson, Prof. D. -“The Functional Foods Dossier: Building Solid Health Claims” ISBN 90-5859-004-6. This is a practical industrial guide. Information: www.fooddossier.com

This symposium was hosted by the Functional Food Task Force of ILSI Europe. It is the second such event, the previous one being held in 2001.
ILSI Europe (established in 1986)
The European branch of the International Life Sciences Institute addresses critical scientific issues in nutrition, public health and food safety in Europe. ILSI Europe pools resources from academia, national research institutes, governments and the food and ingredients industry to carry out projects and concerted actions on issues of mutual concern to all stakeholders. It provides a neutral forum where stakeholders can come together around the same table in an open and constructive environment. Request free newsflash via: newsflash@ilsieurope.be. Membership information: rmarquet@ilsieurope.be. More information: http://europe.ilsi.org

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