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Functional Foods Task Force

Assessment of Benefits and Risks

Background

The concept of functional foods derives from the realisation that specific components of the diet can provide benefits beyond those of basic nutrition. The last decades have seen the development of this concept to the point where it has elicited significant interest of the food industry, consumers and the regulatory authorities.

Objectives

The Functional Foods Task Force develops tools to support the substantiation and establishment of health benefits on foods, promotes development and validation of markers for health outcomes, and addresses related societal developments.

Recent key task force activities are:

Review of Existing Criteria for Validation of Markers
Provide guidelines for a standardised approach to prove the efficacy of foods and food components and to weigh the scientific evidence
Provide guidelines on how to conduct human intervention studies according to Good Nutritional Practice
Provide ‘best common practice’ guidelines on how to design human intervention studies
Provide criteria for validation of markers in the area of cardiovascular health
Provide detailed information on the variety of types of functional foods and drinks, with perspective on oral aspects

Impact

In 1999, the Functional Foods Task Force successfully completed the EC Concerted Action on Functional Food Science in Europe (FUFOSE). The project linked claims for functional foods to solid scientific evidence and reached consensus on scientific concepts related to functional foods. It also provided scientific evidence that specific nutrients positively affect physiological functions and reduce the risk of certain diseases. Building on the results from FUFOSE, the task force initiated the EC Fifth Framework Programme Concerted Action entitled ‘The Process for the Assessment of Scientific Support for Claims on Foods – PASSCLAIM’ (2001-2005). The PASSCLAIM consensus document assists those making claims - as well as those regulating claims - by offering a practical scientific framework for the assessment of scientific dossiers supporting claims.

The task force continues to provide national and international institutions with timely scientific input in anticipation of regulatory developments.

The work of the task force and its expert groups is widely disseminated through publications for different audiences: from articles in peer-reviewed journals to concise monographs for the general public but also through talks in Europe and overseas.

Upcoming Activities

Providing a Specific Update on Markers of Cardiovascular Health

Backed by a strong public health need, cardiovascular health continues to be among the main functional food benefit areas and is of high interest to both academic nutrition research and food industry. Recent authorisations of health claims for cholesterol lowering food (ingredients), but even more so the denial of health claims in critical areas identified as targets for primary prevention such as blood pressure or triglyceride control, justify further investment into establishing appropriate biomarkers in the wider field of nutrition research aiming at cardiovascular endpoints.

In 2001, the PASSCLAIM initiative identified a number of biomarkers in the cardiovascular research field. In 2009, a workshop in Nice identified the need for a standardised approach to biomarker evaluation in the field of Nutrition Research, which recently led to the current ILSI Europe Marker Initiative in Nutrition Research (see pages 175-180 for further info). Within this activity one approach consists in broadly reviewing the biomarkers used in nutrition research and an expert group was created specifically to focus on markers in cardiovascular health.

While publications planned by the Marker Initiative will primarily focus on criteria and evaluation of biomarkers, this new activity aims specifically at publishing an update on biomarkers broadly used in cardiovascular health. This project would achieve a publication in a peer-reviewed journal, providing an update on markers used in the broad context of cardiovascular research.

Antioxidants and anti-inflammatory agents - Concise Monograph

ILSI Europe published a Concise Monograph on ‘Oxidants, Antioxidants and Disease Prevention’ in 1995. Considering the significant development in science on this topic since then, it was suggested to update it, developing a monograph that could be useful to a variety of stakeholders. However, antioxidants are still controversial in the public debate. Therefore, there is a need to clearly line out the actual and potential benefits of antioxidants as well as the limitations and the potential negative aspects for the non-specialist scientific community and policy makers.

The concise monograph should clearly lay out the state-of-the-art in different areas, providing basic mechanisms and theories on how inflammation and oxidation may contribute to genesis of disease, what the role of anti-inflammatory and antioxidant agents are or may be. It should address data from in-vivo experiments including human trials as well epidemiological evidence, a list of biomarkers including the state of validation for each of the biomarker, and a list of foods and food ingredients that have or may have related bioactivity.

On-going Activities

Review of Existing Criteria for Validation of Markers

There is a need for clearer criteria for the validation of markers in nutrition research, as marker validity is an important element in the scientific substantiation of health benefits. Therefore, the Functional Foods Task Force commissioned an activity involving several task forces to identify consensus criteria for validation of markers and to identify consensus markers in nutrition research.

The general objective of this transversal activity is to identify criteria that determine a marker’s validity in terms of informing meaningfully about an aspect of health or functioning.

In particular, one expert group of this initiative focused on:

An inventory of the published criteria for evaluation of markers related to nutrition, health and disease.
A proposal for the generic criteria that should be applied in a validation process of markers related to nutrition, health and disease, to be used in nutrition research.
The specific outcomes of the activity will be presented and discussed at the Marker Initiative in Nutrition Research workshop on 27-29 June 2012, in Lisbon, Portugal.

Further information is provided at the section on the transversal activity - Marker Validation Initiative ‘Step 1’.

Identification of Criteria for Validation of Markers in the Area of Cardiovascular Health

As a complementary activity to the previous one, this expert group made an inventory of markers in the field of cardiovascular health and will try to identify the criteria of validation of some of them.

The pathophysiological basis of the genesis and manifestation of cardiovascular disease is based around the concept of vascular dysfunction commencing with endothelial dysfunction and the formation, progression, destabilisation and rupture/erosion of the atheromatous plaque.

For a large number of biomarkers, there are methodological problems with lack of calibration, standardisation and traceability and any form of quality assurance. An example of an easily measurable marker without any of the above would be antioxidant status. The only biochemical biomarkers currently in use that would meet laboratory accreditation standards are the lipid biomarkers. However, even with measurement of both high density lipoprotein (HDL) and low density lipoprotein (LDL) there are methodological and standardisation problems.

Some of these considerations together with criteria of marker validation from other areas in nutrition research will be discussed at a workshop on 27-29 June in Lisbon, Portugal. The identification of criteria of validation for broadly used markers might also help compare results from different studies. Eventually, by presenting a consensus list of markers that should be used, future results will be easier to compare and evidence-based decisions could be made.

Further information is provided at the section on the transversal activity - Marker Validation Initiative ‘Step 1’.

Good Nutritional Practice (GNP)

To test efficacy and safety of new foods or food ingredients and to substantiate (health – benefit) claims, experiments need to be performed involving humans. Safety and well-being of volunteers participating in such experiments need to be safeguarded. Different policies and systems have been developed for ethical considerations and quality standards of experiments with humans, e.g. the “Declaration of Helsinki”, and “Good Clinical Practices” has been developed specifically for testing of medicines (drugs) in humans. The procedures described are very thorough and extensive, aimed at maximizing the possibility to retrieve data for a certain study participant, allowing evaluation of any effect of the treatment, including side-effects and negative effects.

In experiments involving humans to test efficacy or safety of foods or food ingredients, such a rigorous system is often overly extensive. Many of the tested foods or food-derivatives are commonly consumed by humans for long periods and are, consequently, considered safe. Many food ingredients are to be used in healthy people and their physiological or health effect usually is of moderate magnitude compared to medicines. Food or food-components are not aimed at curing a disease.

There is a need of the food and food ingredient industry for a system that safeguards ethics, safety, quality, and scientific standard of human experiments, but which is more focused on the needs for nutrition studies compared to Good Clinical Practices (GCP) systems used in the pharmaceutical industry. This system, “Good Nutritional Practice” (GNP), should be the basic quality system applied throughout the food industry.

The objectives of the activity are to write a position paper in which those aspects of GCP that are relevant for nutrition research will be discussed. Connected to this, an investigation about the working methods of medical ethics committees regarding nutrition research is being organised. Results will be reported as part of the paper.

Standardised Approach Towards PROving the Efficacy of Foods and Food Constituents (PROCLAIM): providing guidelines

Diet is well known to have beneficial health properties that extend beyond traditionally accepted nutritional effects. The approach involved in elucidating these beneficial physiological effects is becoming more important as reflected by increasing research being undertaken. With growing consumer awareness of foods and food constituents and their relationship to health, the key questions for regulators, scientists and the food industry continue to relate to: (1) how consumers could be protected and have confidence that the health claims on foods are well supported by the evidence; (2) how research on physiological effects of food (constituents) and their health benefits could be stimulated and supported; and (3) how research findings could be used in the development of innovative new food products.

The objectives of this expert group were to provide a set of recommendations on the scientific substantiation of health claims for foods, to develop further guidance on the choice of validated markers (or marker patterns) and what effects are considered to be beneficial to the health of the general public (or specific target groups). Finally, the case for developing a standardised approach for assessing the totality of the available scientific data and weighing the evidence was proposed.

The outcomes of this activity along with the outcomes of the activity on ‘Guidelines for Human Intervention Studies to Evaluate Functional Foods’ will be published as a supplement in the British Journal of Nutrition.

Guidelines for Human Intervention Studies to Evaluate Functional Foods

There is substantial evidence to link what we eat to the reduction of the risk of major chronic diseases and/or the improvement of functions. Thus, it is important for public health agencies and the food industry to facilitate the consumption of foods with particular health benefits by providing consumer products and messages based on scientific evidence. Although fragmentary advice is available from a range of sources, there is a lack of comprehensive scientific guidelines for the design, conduct and reporting of human intervention studies to evaluate the health benefits of foods. Such guidelines are needed both to support nutrition science in general, and to facilitate the substantiation of health claims.

The objectives of this expert group were to analyse and explore:

Published studies as included in scientific dossiers supporting claims and registered in databases;
Control products – address the lack of perfect controls, and how the type required depends on the nature of tested ingredients or foods;
Responder selection and status, including how to deal with ‘low’, ‘normal’ and ‘high’ responders;
Criteria for validation of biomarkers – rationale for supporting substantiated and valid markers;
Design of studies and ultimately propose a guideline for best practice of conducting intervention studies.

The outcomes of this activity along with the outcomes of the activity on ‘Standardised Approach Towards PROving the Efficacy of Foods and Food Constituents (PROCLAIM): providing guidelines’ will be published as a supplement in the British Journal of Nutrition.

Application of PASSCLAIM Criteria on Polyphenols Antioxidative Activity

Evidence of beneficial health effects of polyphenols in the prevention of cancers and cardiovascular and neurodegenerative diseases is growing. Polyphenols are thought to modulate not only oxidative stress but also several other specific biological pathways, such as the ability to modulate the activity of many enzymes and cell receptors. However, this is an area that needs further research.

The objective of this expert group was to apply the PASSCLAIM criteria to provide the scientific substantiation of a polyphenol claim. While PASSCLAIM was a theoretical exercise, this activity tested the criteria to reassess the tool and applicability of the criteria to substantiate a claim using polyphenols as an example. Because of the broad range of potential functions of polyphenols in the body it was decided to focus this activity on antioxidant actions of polyphenols related to cardiovascular health.

The results of this project were recently published in the Journal of Nutrition. The full publication can be downloaded at the following link.

Food Ingredients Promoting Oral and Dental Health

It is recognised that various dietary components may impair oral health. For example, food acids (phosphoric, citric acid etc.) are risk factors for dental erosion and a high frequency of consumption of fermentable carbohydrates such as sugars and starches are considered a risk factor for dental caries when a frequent intake is associated with low oral hygiene. The tooth-friendliness of non-fermentable bulk sweeteners such as polyols, (e.g. erythritol, isomalt, lactitol, mannitol, sorbitol and xylitol) has been well established and has led to sugar-free confectionary and chewing gums in which they replace fermentable ingredients.

The purpose of this expert group was to provide information on the oral aspects of functional foods and drinks, and dietary supplements with perspective on oral aspects. The effects on various oral health conditions and diseases were summarised respectively; their characteristic targets and the practical release methodology were assessed; the possible functional mechanisms were also discussed.

The paper of the expert group was accepted in the European Journal of Nutrition and it will be published in 2012.

International Symposium on Health Benefits of Foods – From Emerging Science to Innovative Products

This event was the 3rd ILSI Europe International Symposium in the continuum of functional foods symposia. It took place in Prague (CZ), on 5-7 October 2011. The latest was organised in 2007, in Portomaso, Malta, and brought together more than 350 experts from industry, academia and government.

The overall objective of this event was to review and debate recent advances in substantiation of health benefits of foods, covering the establishment but also the communication of innovative nutrition science. The following topics were featured in the programme: food characterisation, markers or endpoints of health, targeting and testing benefits, and benefit communications.

This multidisciplinary meeting was of interest to food scientists, food technologists, nutritionists, dieticians, consumer scientists, product developers and regulators from industry, academia and government involved in health, innovation, safety and quality of functional foods.

Task Force Collaborators

Members 2012

Dr. Michele Kellerhals - Chair -	Coca-Cola Europe	BE
Dr. Loek Pijls - Co-Chair -	Nestlé	CH

Dr. Jean-Michel Antoine	Danone	FR
Ms. Murielle Cazaubiel	Institut Mérieux	FR
Dr. Peter de Cock	Cargill	BE
Mrs. Christina Erhardt	BASF SE	DE
Dr. John Flanagan	Naturex	ES
Dr. Sue Gatenby	PepsiCo International	UK
Dr. Oliver Hasselwander	DuPont Nutrition Biosciences	UK
Dr. Thomas Hatzold	Kraft Foods Europe	DE
Mr. Carsten Huettermann	Dow Europe	CH
Mr. Andreas Kadi	Red Bull	AT
Dr. Iris Kunz	DSM	CH
Dr. Dominique Lacan	Bionov	FR
Dr. Amy Mackey	Abbott Nutrition	US
Dr. Camilla Melegari	Barilla G & R Fratelli	IT
Prof. Gerhard Rechkemmer*	Max Rubner-Institute (MRI)	DE
Dr. Sara Salvatore	Soremartec Italia - Ferrero Group	IT
Mr. Matthias Sass	Rudolf Wild	DE
Dr. Bert Schwitters	International Nutrition Company - INC	NL
Prof. Colette Shortt	McNeil Nutritionals Europe	UK
Mr. Luc Sterkman	Newtricious	NL
Dr. Berenike Stracke	Schwabegroup	DE
Dr. Stephan Theis	Südzucker/BENEO Group	DE
Dr. Barbara Winters	Campbell Soup Company	US
Dr. Sheila Wiseman	Unilever	NL
Dr. Jia Zhao	Yakult Europe	NL
Dr. Renate Zwijsen	Royal FrieslandCampina	NL

Dr. Alessandro Chiodini	ILSI Europe	BE
Ms. Ria Dewit	ILSI Europe	BE

* Scientific Advisor

Review of Existing Criteria for Validation of Markers

Dr. Jan de Vries - Chair -	Consultant	NL

Dr. Jean-Michel Antoine	Danone	FR
Prof. Tomasz Burzykowski	Hasselt University	BE
Prof. Michael Gibney	University College Dublin	IE
Dr. Gunter Kuhnle	University of Reading	UK
Dr. Loek Pijls	Nestlé	CH
Prof. Ian Rowland	University of Reading	UK

Dr. Alessandro Chiodini	ILSI Europe	BE
Ms. Agnès Méheust	ILSI Europe	BE

Identification of Criteria for Validation of Markers in the Area of Cardiovascular Health

Dr. Paul Collinson - Chair-	St George's Hospital and Medical School	UK

Dr. Peter de Cock	Cargill	BE
Dr. Oliver Hasselwander	DuPont Nutrition Biosciences	UK
Dr. Henk Hendriks	TNO Quality of Life	NL
Dr. Michele Kellerhals	Coca-Cola Europe	BE
Dr. Gregory Lip	University of Birmingham	UK
Prof. Ronald Mensink	Maastricht University	NL
Prof. Markku Savolainen	University of Oulu	FI
Prof. Colette Shortt	McNeil Nutritionals	UK
Dr. Sheila Wiseman	Unilever	NL
Dr. Jayne Woodside	Queen's University	UK

Dr. Alessandro Chiodini	ILSI Europe	BE
Ms. Jilde Garst	ILSI Europe	BE

Good Nutritional Practice (GNP)

Dr. Arie Kies - Chair -	DSM	NL

Prof. Furio Brighenti	University of Parma	IT
Dr. Hakim Bouzamondo	Unilever	FR
Prof. Ian Macdonald	University of Nottingham	UK
Dr. Andreas Pfeiffer	German Institute of Human Nutrition - Potsdam	DE
Prof. Jeroen Schmitt	Nestlé	CH

Dr. Alessandro Chiodini	ILSI Europe	BE

PROCLAIM Writing

Dr. Gert Meijer - Chair -	Unilever	NL

Dr. Allison Gallagher	University of Ulster	UK
Prof. David Richardson	Consultant	UK
Dr. Virginie Rondeau	University of Bordeaux	FR
Dr. Marianne Stasse Wolthuis	Consultant	NL
Dr. Guy Tweedie	Danone	FR
Prof. Renger Witkamp	Wageningen University	NL

Dr. Alessandro Chiodini	ILSI Europe	BE

After completion of its activities and publication of the results, this expert group was disbanded on December 2010.

PROCLAIM Editing

Dr. Jean-Michel Antoine	Danone	FR
Prof. Michael Gibney	University College Dublin	IE
Prof. Ambroise Martin	University of Lyon 2	FR
Prof. Andreu Palou	University of the Balearic Islands	ES
Prof. Gerhard Rechkemmer	Max-Rubner Institute (MRI)	DE
Prof. Wim Saris	DSM	NL

Dr. Alessandro Chiodini	ILSI Europe	BE

After completion of its activities and publication of the results, this expert group was disbanded on December 2010.

Guidelines for Human Intervention Studies to Evaluate Functional Foods

Dr. Jean-Michel Antoine - Chair -	Danone	FR

Prof. Arne Astrup	University of Copenhagen	DK
Dr. Jean-Louis Berta	Consultant	FR
Dr. Achim Bub	Max Rubner-Institute (MRI)	DE
Dr. Francisco Guarner	Hospital General Vall d'Hebron	ES
Dr. Oliver Hasselwander	DuPont Nutrition Biosciences	UK
Dr. Henk Hendriks	TNO Quality of Life	NL
Dr. Martin Jäkel	Unilever	NL
Prof. Berthold Koletzko	University of Munich	DE
Dr. Myriam Richelle	Nestlé	CH
Dr. Stephan Theis	Südzucker/BENEO Group	DE
Prof. Robert Welch	University of Ulster	UK
Dr. Jayne Woodside	Queens University	UK

Dr. Stéphane Vidry	ILSI Europe	BE
Dr. Alessandro Chiodini	ILSI Europe	BE

After completion of its activities and publication of the results, this expert group was disbanded on December 2010.

Application of PASSCLAIM Criteria on Polyphenols Antioxidative Activity

Dr. Peter Hollman - Chair -	RIKILT- Institute of Food Safety	NL

Prof. Aedín Cassidy	University of East Anglia	UK
Dr. Blandine Comte	National Institute for Agricultural Research (INRA)	FR
Dr. Thomas Hatzold	Kraft Foods Europe	DE
Dr. Marina Heinonen	University of Helsinki	FI
Dr. Michele Kellerhals	Coca-Cola Europe	UK
Dr. Myriam Richelle	Nestlé	CH
Prof. Elke Richling	University of Kaiserslautern	DE
Mr. Matthias Sass	Rudolf Wild	DE
Dr. Augustin Scalbert	International Agency for Research on Cancer (IARC)	FR
Dr. Mauro Serafini	National Institute of Nutrition	IT
Prof. Helmut Sies	Heinrich-Heine University of Düsseldorf	DE

Dr. Stéphane Vidry	ILSI Europe	BE
Dr. Alessandro Chiodini	ILSI Europe	BE

Food Ingredients Promoting Oral and Dental Health

Dr. Gunhild Kozianowski - Chair-	Südzucker/BENEO Group	DE

Mr. Michael Bond	DuPont Nutrition Biosciences	UK
Prof. Zdenek Broukal	Charles University of Prague	CZ
Prof. Wim Crielaard	Academic Centre for Dentistry Amsterdam – ACTA	NL
Dr. Michael Dodds	Mars	US
Dr. Michele Kellerhals	Coca-Cola Europe	BE
Prof. Adrian Lussi	University of Bern	CH
Prof. Jukka Meurman	University of Helsinki	FI
Prof. Colette Shortt	McNeil Nutritionals	UK
Dr. Cor van Loveren	Academic Centre for Dentistry Amsterdam – ACTA	NL

Dr. Alessandro Chiodini	ILSI Europe	BE

International Symposium on Health Benefits of Foods – From Emerging Science to Innovative Products -Scientific Programme Committee

Prof. Gerhard Rechkemmer - Chair -	Max Rubner-Institute (MRI)	DE

Dr. Jean-Michel Antoine	Danone	FR
Prof. Arne Astrup	University of Copenhagen	DK
Dr. Sandra Einerhand	Tate & Lyle Ingredients	FR
Prof. Susan Fairweather-Tait	University of East Anglia	UK
Mr. Andreas Kadi	Red Bull	AT
Dr. Michele Kellerhals	Coca-Cola Europe	UK
Prof. Jürgen König	University of Vienna - Institute of Nutrition	AT
Dr. Dominique Lacan	Bionov	FR
Dr. Loek Pijls	Nestlé	CH
Prof. Hildegard Przyrembel		DE
Dr. Ben van Ommen	TNO Quality of Life	NL

Dr. Alessandro Chiodini	ILSI Europe	BE
Dr. Stéphane Vidry	ILSI Europe	BE

Publications

A.M Gallagher, G.W. Meijer, D.P. Richardson et al. A standardised Approach Towards PROving the Efficacy of Foods and Food Constituents for Health Claims (PROCLAIM): Providing Guidance. Bristish Journal of Nutrition 106(2):S16-S28.

R.W. Welch, J-M. Antoine, J-L. Berta et al. Guidelines for the Design, Conduct and reporting of Human Interventions Studies to Evaluate the Health Benefits of Foods. Bristish Journal of Nutrition 106(2):S4-S15.

P.C.H. Hollman, A. Cassidy et al. The Biological Relevance of Direct Antioxidant Effects of Polyphenols for Cardiovascular Health in humans is Not Established. Journal of Nutrition 141(5):989-1009.

P. Aggett et al. Beyond Passclaim- Guidance to Substantiate Health Claims on Foods. ILSI Europe Report Series 2010: 1-24.

N-G. Asp. Functional Foods in Europe - International Developments in Science and Health Claims. European Journal of Nutrition 48(1):S1-S51.

N. Binns. Perspectives on ILSI's International Activities on Functional Foods

N. Binns, J. Howlett. Functional Foods in Europe - International Developments in Science and Health Claims. ILSI Europe Report Series 2008:1-20.

J. Howlett. Functional Foods - From Science to Health Claims. ILSI Europe Concise Monograph Series 2008:1-36

N-G. Asp, A. Drewnowski, A. Flynn et al. Nutritional Characterisation of Foods - Science-based Approach to Nutrient Profiling. European Journal of Nutrition 2007 46(2):1-46.

C. Madsen. Functional Foods in Europe - InterInternational Developments in Science and Health Claims. Annals of Nutrition & Metabolism 2007 51:298-299.

P. Aggett, J-M. Antoine, N-G. Asp et al. Process for the Assessment of Scientific Support for Claims on Foods (PASSCLAIM) - Consensus on Criteria. European Journal of Nutrition 2005 44(1):1-30.

N-G. Asp et al. Process for the Assessment of Scientific Support for Claims on Foods (PASSCLAIM) - Phase Two: Moving Forward. European Journal of Nutrition 2004 43(2):3-183.

N-G. Asp et al. Process for the Assessment of Scientific Support for Claims on Foods (PASSCLAIM) - Phase One: Preparing the Way. European Journal of Nutrition 2003 42(1):3-119.

M. Ashwell. Concepts of Functional Foods. ILSI Europe Concise Monograph Series 2002:1-40.

W.H.M Saris, P.M. Verschueren, S. Harris. Functional Foods - Scientific and Global Perspectives. British Journal of Nutrition 2002 88(2):123-235.

P.M. Verschuren. Functional Foods - Scientific and Global Perspectives. ILSI Europe Report Series 2002:1-15.

A.T. Diplock et al. Scientific Concepts of Functional Foods in Europe - Consensus Document. British Journal of Nutrition 1999 81(1):1-27.

To download the poster of this task force, please click here.

For more information, please contact info@ilseurope.be