For debate in the Standing Committee — see Rule 15 of the Rules of Procedure

Doc. 9604

16 October 2002

Functional food: serving the interests of the consumer or the food industry?

Report

Committee on the Environment, Agriculture and Local and Regional Affairs

Rapporteur: Mr Bill Etherington, United Kingdom, Socialist Group

Summary

Dietary habits and consumption patterns have changed considerably in our society. Many new kinds of processed food are penetrating the market, including those which are purported to have the potential to improve mental and physical well-being and reduce the risk of diseases. Such foods are known as functional foods.

The Assembly is convinced that a healthy lifestyle and a balanced diet are key factors for good health. Functional foods must in no way be seen as a magic solution to health and disease prevention. Yet, if supported by scientific evidence and in a proper legal framework, these foods may prove to contribute to the reduction of the risk of disease.

No proper legal framework governing functional foods and health claims exists today in most European countries. The Assembly supports the recent Council of Europe initiative to introduce “Guidelines Concerning Scientific Substantiation of Health-related Claims for Functional Food” and calls on the member states as well as the European Commission and the UN WHO/FAO to work in collaboration with the Council of Europe on the harmonisation of legislation in this specific field at the pan-European level.

I.       Draft resolution

1.        Dietary habits have evolved along with the socio-cultural development of our societies. Food production is no longer purely about satisfying basic dietary needs and processed food products account for a growing share of the market thanks to the advances made by the agro-food industry. New food products, which are purported to have the potential to improve mental and physical well being and may also reduce the risk of diseases, are being developed. Such products, known as functional foods, are similar in appearance to conventional foods and are consumed as part of the usual diet. However, in addition to their nutritional function, they are designed to offer a particular health benefit over and above the traditional nutrients they contain.

2.       Functional foods are associated with the prevention and/or treatment of at least four of the leading causes of death in Europe – cancer, diabetes, cardiovascular disease, and hypertension – and with the prevention and/or treatment of other medical ailments. Statistics indicate that one in three cancer deaths are diet related and that 8 out of 10 cancers have a nutrition/diet component.

3.       The term “functional food” has met with much controversy. Confusion persists about how to describe this newly evolving area of food and food technology. No agreed definition of functional foods exists today. However, without a clear and distinct definition encompassing all different facets of the concept, it would be unthinkable to establish elaborate procedures for legitimate claims contributing to the improvement, maintenance and reinforcement of the health of consumers via a better diet.

4.       Consumer acceptance and understanding of functional foods varies between different European countries, which is due to the wide range of functional foods and ingredients available, and the diverse cultures and eating habits in different regions. Despite the limited knowledge of European consumers on the concept, functional foods represent one of the fastest growing markets in the developed world, representing 32 Bn USD and 15-20% annual growth worldwide. The market offers numerous opportunities for food and ingredient manufacturers and endless possibilities for future development.

5.       Good health is closely linked to a healthy life-style. Eating a balanced diet should be considered as the main message to the consumer. If supported by sound scientific evidence, functional food, as part of such a diet, could be of additional benefit to the consumers’ health and well-being and contribute to reducing the risk of disease. However, functional foods must in no way be seen as a magic solution to health and disease prevention.

6.       The future success and growth of functional foods will largely depend on the regulatory framework within which they may be marketed. The key to the marketing of such products is the information with which they may be labelled, including the claims that they may carry in respect of their beneficial properties. The consumers need a viable guarantee that these new food products are not only an opportunity for more profits but also a real progress allowing them to better control their health.

7.        European countries have no separate legal category for functional foods. From a legislative point, they are categorised as foods and as such, are subject to regulations concerning foods. They cannot make medicinal claims that they can prevent, treat or cure a specified disease. Some countries have adopted legislation and voluntary codes, which has resulted in different approaches and in numerous discrepancies both regarding the definition of the terms used and the conditions warranting the use of claims. Furthermore, these voluntary codes are unenforceable.

8.       The Parliamentary Assembly notes with satisfaction the recent Council of Europe initiative to introduce the “Guidelines Concerning Scientific Substantiation of Health-related Claims for Functional Food” and hopes that the adoption of this document would lead to further elaboration at the inter-governmental level of the legal framework governing nutrition, food safety and consumer health related to the emerging market of functional foods.

9.       The Assembly also notes the ongoing discussions in the UN FAO/WHO Codex Alimentarius and around the European Union discussion paper on “Nutrition Claims and Functional Claims” (SANCO/134/2001) and hopes that these would lead to a more harmonised legislation at European Union level.

10.       In the light of the above elements, the Assembly:

i.       urges the governments of member states and observers, in co-operation with the European Food Safety Authority, to adopt a common definition for foods or food components that may reduce the risk of a specific disease or health concern with a view to facilitating communication with consumers and establishing a proper legal framework;

ii.       encourages all members states:

a. to promote sound and comprehensive scientific research to back claims for functional foods. The alleged benefits of functional foods must be scientifically demonstrated, including a proper assessment of their safety. The health claims made for food products must be clearly expressed in ways that are understandable to the consumer;

b. to prioritise what foods need to be produced for the benefit of public health rather than leaving it to manufacturers to decide purely on commercial considerations;

c. to establish or draw up national legislation on health claims in line with the Council of Europe “Guidelines Concerning Scientific Substantiation of Health-related Claims for Functional Foods”, assuring consistency with wider public health objectives and national and international dietary and nutritional recommendations;

d. to make additional efforts in public health education to promote a balanced diet and healthy a lifestyle.

iii.       encourages the European Union to give a clear statement on its position with regard to functional foods and make a concrete commitment to the development of a common framework and rules on claims at European Union level, to ensure harmonisation and consistency of approach; and in particular to call on the newly established European Food Safety Authority to implement requirements for health claims and validate such claims.

iv.       calls on the European Commission, the World Health Organisation (WHO) and the Food and Agriculture Organisation (FAO) to work in collaboration with the Council of Europe on the harmonisation of legislation in this specific field at the pan-European level, establishing that health claims be:

a. legal, justified and understandable, and presented in the context of an overall balanced diet and other healthy life-style factors;

b. communicated clearly, understandably and truthfully to the consumer, disclosing comprehensive information on product labels (quantities of functional ingredients, target population, length and quantity of optimum consumption, interaction with other components or drugs, side-effects, impact of cooking methods, etc.);

d. void of medical claims, save for exceptions that can reasonably be expected to make a significant overall contribution to a healthy diet, based on the totality of scientific evidence;

e. prohibited for food products that contain unhealthy ingredients or for foods with minimal nutritional value.

II.       Explanatory memorandum by Mr Etherington

CONTENTS

1.       Preamble ………………………………………………………………………………………..

2.       Introduction ……………………………………………………………………………………..

3.       Misleading terminology ………………………………………………………………………..

4.       Towards a common definition? ……………………………………………………………….

5.       Health association of functional food …………………………………………………………

6.       Types of functional food ………………………………………………………………………..

7.       Who benefits from functional food …………………………………………………………….

8.       Health claims of functional foods ………………………………………………………………

9.       Harmonisation of legislation ……………………………………………………………………

10.       Conclusions ……………………………………………………………………………………..

1.       The Council of Europe has been dealing with food products for years and plays an important role in harmonising food standards and monitoring the quality of ingredients. At a time when the agro-food sector and the food industry are becoming increasingly complex and making ever greater use of new technologies, in an enlarged Europe, the Council of Europe has a duty to pursue this task for the benefit of our populations.

2.       The Council of Europe was one of the first international organisations to tackle the issue of functional foods by organising the First Forum on Functional Food on 1 and 2 December 1998. It is still keeping the forerunner’s role among European institutions as demonstrated by the adoption in July 2001 of a technical document on “Guidelines Concerning Scientific Substantiation of Health-related Claims for Functional Food”, laying down a policy statement aimed at supporting the development of a framework for the scientific substantiation of claims for functional foods.

3.       The Parliamentary Assembly has already dealt in the past with issues related to nutrition and food consumption, as shown by Recommendations 1244 (1994) on food and health and 1389 (1998) on consumer safety and food quality. The Sub-Committee on Food (former Committee on Agriculture and Rural Development) also participated in the First Forum on functional Food in 1998. In the context of preparing this report, a hearing was held on 21 May 2002 in Paris with the representatives of the scientific community, food industry, consumer organisations and medical profession in order to discuss the latest developments in the field (see document AS/Ena (2002) 35 for full report of the hearing).

4.       The Parliamentary Assembly follows with interest the work done in the inter-governmental sector concerning food safety and consumer protection. To this end, it welcomes the initiative to introduce the above guidelines and hopes that the adoption of this document would lead to further elaboration at the inter-governmental level of the legal framework governing nutrition, food safety and consumer health related to the emerging market of functional foods. Given that no European legislation regulates this particular field today, it would open a unique opportunity for the Council of Europe to contribute to the harmonisation of European legislation in this specific field and to work towards a pan-European convention.

5.       The present report attempts to look into the major aspects of the emerging market of functional foods, identify the benefits and threats to the European consumer population and make proposals to the Committee of Ministers and member states in order to ensure that consumers are offered healthy, nutritious food which meets their expectations rather than food which simply serves the economic interests of the agro-food industry.

2.       Introduction

6.       Dietary habits have evolved along with the socio-cultural development of our societies. Food production is no longer purely about satisfying basic dietary needs and processed food products account for a growing share of the market thanks to the advances made by the agro-food industry.

7.       Consumption patterns have also changed. Euromonitor estimates that long working hours and the ‘snack culture’ mean that almost 80% of Europeans associate some difficulty with trying to eat a balanced diet. On the other hand, the importance of dietary changes to optimise health continues to gain recognition. This trend is driven by:

q the socio-demographic changes towards fewer family meals and the growing number of employment of women;

q increasing awareness of relationship between health and diet through clinical and medical research studies being published in a growing number of peer-reviewed journals and medical literature, and increasing media coverage of such research;

q increasing interest in finding alternatives to corrective medicine; general moving away from the treatment to the prevention of disease and from pharmaceutical toward “natural” products

q increasing role of General Practitioners in consumer education and a therapeutic approach towards “whole-body” wellness rather than condition or ailment specific healing;

q the importance attached to the quality of life resulting from the ageing of the population and increasing need for better body maintenance, growing GNP and changes in nutrient demand.

8.       As nutrition science is thought to be moving from the concept of "adequate nutrition" to "optimal nutrition", new food products, which are purported to have the potential to improve mental and physical well being and may also reduce the risk of diseases, are being developed. Such products, known as functional foods, are similar in appearance to conventional foods and are consumed as part of the usual diet. However, in addition to their nutritional function, they are designed to offer a particular health benefit over and above the traditional nutrients they contain.

9.       Widely accepted in the American and Japanese societies for almost two decades, functional food is not a term with which the majority of European consumers are familiar and recognition of other food-related terms, notably organic, bio, genetically modified and biotech is far higher. Consumer acceptance and understanding of functional foods varies between different European countries, which is not surprising considering the wide range of functional foods and ingredients available, and the diverse cultures and eating habits in different regions. According to a study carried out by International Food Ingredients (IFI), the highest awareness to functional foods in Europe is found in Germany where 25% had heard of the term of functional food. However, the same study showed that up to 80 % of the people thought that it was a good idea to fortify everyday foods with beneficial ingredients.

10.       Another study on Danish consumers’ attitudes towards functional foods shows that the main beliefs which consumers associate with functional foods are the convenience of enrichment through daily diet, (un)naturalness, apprehension about changes in taste, higher price, uncertainty about belief in the effect of enrichment, dosage, own ignorance and uncertainty about manufacturers’ knowledge of the health effects of eating enriched products. The respondents have very little knowledge of functional foods and were fairly sceptical. However, attitudes to concrete examples of functional foods were much more positive than attitudes to the concept of functional foods.

11.       Despite the limited knowledge of European consumers on the concept, functional foods represent one of the fastest growing markets in the developed world, representing 32 Bn USD and 15-20% annual growth world-wide (Euromonitor data). The United States takes 61% of this market’s share, Japan 17% and Europe 18 %, leaving only 4 % for the rest of the world. In Europe the market was estimated in 2000 at 4-8 Bn €. According to the Leatherhead RA, in 2003, 5-10 % of the total European retail and drinks sales will be functional. The market offers numerous opportunities for food and ingredient manufacturers and the possibilities for future development would appear to be endless.

12.       This market trend of rapidly increasing number of foods claiming to possess health-promoting properties, driven by big business ambition and scientists staking out new frontiers in nutrition science, is attracting both controversy and praise. Is the introduction of such food really necessary? Do consumers expect or ask for it? Does it only serve the interests of the food industry to sell more expensive food items? Is it geared towards affluent sections of the population in developed countries? What about food safety or consumer information? These and many other questions are a growing concern for regulatory bodies, health professions and consumer organisations alike. Tighter controls on labelling requirements are being worked on, and increased research to substantiate manufacturers’ health claims is being requested. However, the attempts to harmonise the markets and to regulate health claims of food products have so far yielded little results. The diversity of nutritional cultures in Europe has no doubt a role to play, making it even more difficult to obtain a consensus on the messages to be conveyed.

3.       Misleading terminology

13.       The term “functional food” has met with much controversy. Confusion persists about how to describe this newly evolving area of food and food technology because numerous interchangeable or related terms have been suggested or published in the United States, Europe, and Japan. Besides the most widely used term ‘functional foods’ which was first introduced in Japan in 1984, these include terms such as pharmafoods, health foods, nutraceuticals, phytochemicals, chemopreventive agents, designer foods and therapeutic foods. Common to all of these terms is the assumption that these foods or components found within them have a potential beneficial role in the prevention and treatment of disease.

14.       In recent years, ‘functional foods’ has nevertheless taken root as the most widely acknowledged term to describe the concept.

15.       The term ‘functional food’ in itself is misleading because almost all foods, regardless of whether they contain added ingredients, affect health by providing calories and nutrients, and can thus be considered “functional”. Furthermore, health authorities have recognised for decades that certain types of foods may be especially beneficial or detrimental to health. For example, authorities have recognised that diets rich in fruits and vegetables can help reduce the risk of heart disease while diets rich in meat, meat products, dairy products, cakes and cookies, which are high in saturated fat, can increase the risk of heart disease.

16.       It may also be claimed that functional foods as such have always existed. As early as 2000 BC Emperor Shen Nong, the father of Chinese medicine, identified the healing properties of edible plants. His ancient Western counterpart Hippocrates said: ‘Let food be your medicine and medicine be your food’.

17.       There is no question that certain substances that occur naturally, or that are added to foods, may offer particular health benefits. For example, the importance of adding vitamins and minerals to processed foods has long been recognised as vital to compensating for nutrient deficiencies and maintaining good health. Iodised salt and vitamin-fortified milk, which were introduced in the 1930s to combat rickets, were, in a sense, the first functional foods of modern times. Bread, flour and breakfast cereals fortified with vitamins came into existence in the 1940s. However, research in this area is still in its infancy, and scientifically valid health claims cannot yet be made with regard to many ingredients.

4.       Towards a common definition?

18.       Not only does the term “functional food” induce much confusion, but also no country has to this day agreed on a definition of functional foods.

19.       There exists an endless list of possible definitions to the term functional food.

20.       In recent subject related literature (predominantly American), functional foods are most commonly referred to as any food or food ingredient that may provide a health benefit beyond the traditional nutrients it contains.

21.       Pariza (2001) emphasises that the driving force behind the functional food concept is to market products that impart desired physiologic effects beyond those ordinarily associated with typical nutrients. This marketing dimension suggests the manufacturer’s wish to inform the consumer of that functionality (beneficial effect). Unless such information is provided, there is little incentive for the manufacturer to develop the functional food. Hence, Pariza’s definition of functional food is "a manufactured food for which scientifically valid health claims can be made."

22.       The Council of Europe’s recent Guidelines Concerning Scientific Substantiation of Health-Related Claims for Functional Food establishes that “a food, a food component or a food ingredient can be regarded as functional if it is satisfactorily demonstrated to affect beneficially one or more target functions in the body, beyond adequate nutritional effects, in a way which is relevant to either the state of well-being and health or the reduction of the risk of a disease” (based on the definition of Prof Roberfroid and of the FUFOSE (EU) project).

23.       Regardless of the multitude of definitions, it is commonly accepted that ‘functional’ food can be a natural food, a food to which a component has been added, a food from which a component has been removed, a food in which the bio-availability of one or more of the components has been increased or any combination of these.

24.       There is a common understanding that functional foods are foods; they are not pills or capsules but components of a diet or part of a food pattern recognised as being beneficial for well-being and health. Obviously, many foods are naturally healthful and deliver life-sustaining nutrients, as well as many beneficial micronutrients. However, even healthy foods may not naturally contain specific functional (bioactive) ingredients that may provide great benefit. For example, fermented dairy products, such as yoghurt, contain valuable nutrients and are generally viewed as healthful foods. They provide basic nutrition through the delivery of fat, carbohydrates, and protein. However, these products are not necessarily fermented with probiotic cultures, which improve the intestinal microbial balance, and may provide additional health benefit over and above its basic nutritional value and, which is the case with functional foods.

25.       Several attempts have been made over the years on both sides of the Atlantic to find a common definition, however, these attempts have so far failed for different reasons.

26.       Relying on the assumption that consumers tend to base purchasing decisions on quality, price, purpose and claim and not whether a food is in a particular defined category of food, consumer organisations argue against the establishment of a unique definition, pointing out that a definition would create another category of foods that would serve to make the situation more complex. They advise to concentrate the efforts on the harmonisation of health claims of functional foods rather than on finding a unique definition.

27.       It is certainly true that consumers need objective and scientifically justified information rather than a specifically defined category of foods. However, without a clear and distinct definition encompassing all different facets of the concept, it would be unthinkable to establish elaborate procedures for legitimate claims contributing to the improvement, maintenance and reinforcement of the health of consumers via a better diet.

5.       Health association of functional food

28.       Functional foods are associated with the prevention and/or treatment of at least four of the leading causes of death – cancer, diabetes, cardiovascular disease, and hypertension – and with the prevention and/or treatment of other medical ailments including neural tube defects, osteoporosis, abnormal bowel function, and arthritis. Certain statistics have indicated that one in three cancer deaths are diet related and that 8 of 10 cancers have a nutrition/diet component.

29.       Two of the principal areas targeted by functional foods — heart health through cholesterol-lowering products, and bone maintenance through products containing extra calcium and minerals. The other two major areas targeted are a balanced digestive system, achieved by eating products containing beneficial bacteria or extra fibre, and a healthy immune system, achieved through the intake of vitamins, minerals or the right bacteria.

6.       Types of functional food

30.       Currently five principal types of functional foods are found on the market. These types include:

q products with a naturally or normally present ingredient is either increased or reduced, e.g., breakfast cereals with added bran or dairy products with reduced fat;

q products with newly introduced ingredients, e.g., fruit juice with added fibre or spreads with fish oils;

q fermented dairy products such as yoghurts with active bacteria cultures;

q sports or energy drinks having providing balance fluid replacement and/or energy replacement;

q products providing slow release of carbohydrates for energy management, e.g. drinks or cereal products.

31.       In addition, there is an increasing variety of other products on the market available in European countries. These include cereal bars, breads, milks, biscuits, cheese spreads, eggs, bottled waters and confectionery. Bioactive ingredients used in the production of these functional foods include but are not limited to, the following: vitamins, minerals, phospholipids, amino acids and derivates, nutritional oils, herbals and other extracts, as well as probiotic cultures. Producers tend to be the major food and drink manufacturers such as Nestlé, Unilever, General Mills, Kellogg, Quaker Oats, Danone and Pepsico.

7.       Who benefits from functional food?

32.       Will consumers benefit from the development of functional foods? That depends. Some products provide significant health benefits, and it makes sense to foster their development, marketing, and consumption. For example, research has shown a positive association between dietary intake of food components found in fruits, vegetables, grains, fish oil, and legumes and their effect on chronic disease. Other nutrient-related correlations link dietary fat and fibre to prevention of colon cancer, folate to the prevention of neural tube defects, calcium to the prevention of osteoporosis, psyllium to the lowering of blood lipid levels, and antioxidant nutrients to disease prevention, to list just a few.

33.       On the other hand, the number of specific substances or combination of substances that scientists have identified as reducing the risk of disease is relatively small. Scientific evidence indicates that there is a need for caution in the use of functional foods to prevent and treat disease. Although most clinical data support a positive role for functional foods in the prevention of disease, some research indicates that certain food components may be deleterious to human health.

34.       The food industry in search for higher profits is, however, eager to market products that offer special benefits. The industry is betting that consumers, after years of being bombarded with negative health messages to cut back on fat, cholesterol, and sodium, are ready to warm up to foods that emphasise the positive benefits of newly added ingredients. The absence of convincing scientific research, pent-up consumer demand, and inadequate regulatory controls are allowing these companies to introduce in the market novel products of dubious benefit and exaggerated claims.

35.       For example, the herbs and other ingredients in functional foods do not have to undergo tests to see if they cause cancer, birth defects, liver toxicity, or any other serious problem. It is commonly considered that herbs must be safe because they have been used for hundreds of years. But without proper testing, it is impossible to know if an herb has occasionally caused cancer, kidney damage, or other problems, no matter how long it has been used.

36.       Also, some functional ingredients are present in some foods high in fat, saturated fat, sugar or salt, and are promoted as beneficial to health, when, in fact, such foods should be restricted to only a small part of the diet. For example, sweetened drinks such as fruit-flavoured beverages are promoted as containing essential vitamins.

37.       Another example of potential safety concerns are the functional food that contain high levels of nutrients that can cause harm, yet are promoted without adequate qualifications. For example, vitamin A is added to some products and is promoted in a manner that could encourage consumption at levels that could increase the risk of birth defects.

38.       Obviously, safety is an overarching consideration for the consumer, for whom health benefits are the embodiment of functionality. A food that is not safe will be unacceptable, irrespective of its functional properties. To deliver health benefits, a functional food must deliver a functional ingredient at a level that is both effective and safe both in short and long term.

39.       The development of functional foods may become a unique opportunity to contribute to the improvement of the quality of the food offered to the consumers for the benefit of their health and well-being. But only a rigorous scientific approach producing strong and significant data will guarantee the success of this new discipline of nutrition. Furthermore, only proven scientific basis can make a product into an economic success.

40.       It must not be left to food manufacturers and commerce in general to call the tune of this rapid advance of scientific knowledge; nor should it be left purely to the consumer. The future success and growth of functional foods will also largely depend on the regulatory framework within which they may be marketed. Key to the marketing of such products is the information with which they may be labelled, including the claims that they may carry in respect of their beneficial properties. The consumers need a viable guarantee that these new food products are not only an opportunity for more profits but also a real progress allowing them to better control their health.

41.       To provide this guarantee, the functional food products should meet specific requirements:

42.       Communication on the benefit to health of these foods serves an essential role for the public and health-related claims are an essential element of that communication. This information can also play an educational role in addition to existing nutrition education programmes.

43.       In many cases, functional foods are more expensive, and it is possible to get the same beneficial ingredients more cheaply and more naturally from a healthy, balanced diet. For example, a calcium-fortified fruit drink is much more expensive than a glass of milk which contains the mineral naturally. Nevertheless, functional foods have a potential to appeal because they are convenient for today’s lifestyle. Some are genuinely researched and offer novel ingredients that can bring about health benefits quicker than would normally be the case through eating conventionally healthy foods alone.

44.       Good health is closely linked to a healthy life-style. Eating balanced diet should be considered as the main message to the consumer. If supported by sound scientific evidence, functional food, as part of such diet, could be of additional benefit to the consumers’ health and well-being and contribute to reduce the risk of disease. However, functional foods must in no way be seen as a magic solution to health and disease prevention.

8.       Health claims of functional foods

45.       It is essential that functional food must not present a danger to the consumer, and that the marketing must not mislead the consumer.

46.       European countries have no separate legal category for functional foods. A product intended for consumption is by law defined as either a food or medicine and cannot be both; different legislation applies for each. From a legislative point, functional foods are categorised as foods and as such, are subject to regulations concerning foods. They cannot make medicinal claims that they can prevent, treat or cure a specified disease. For instance, a statement such as ‘provides calcium which is important for strong bones’ is a health claim that is perfectly acceptable whereas, by comparison, ‘provides calcium which helps prevent osteoporosis’ is a medicinal claim and therefore illegal. It is thus the ‘health claim’ that tends to differentiate functional foods from all other foods.

47.       Health claims are defined to refer to a positive correlation between a food substance in a diet and a disease or other health-related condition. The Codex Alimentarius divides these claims into nutrition claims and health claims. Nutrition claims are defined as any representation that states, suggests, or implies that food has particular nutritional properties. Health claims, on the other hand, are any representation that states, suggests, or implies that a relationship exists between a food or a nutrient or other substances contained in a food and a disease or health-related condition.

48.       Consumers are not likely to make distinctions between types of claim. Instead, they categorise them by the degree to which they could be understood. Consumer perception of nutrition and health claims should be the most important factor in evaluating their acceptability. Consumers must be able to clearly understand the claim; otherwise there is a risk that the claim will mislead. To avoid misleading, the health claims of functional foods should be based on viable scientific substantiation that these products fit into a nutritionally adequate diet and help preserve or promote body function, well-being and health and/or reduce the risk of disease.

49.       In order for consumers to make meaningful choices when making food purchases they need:

50.       Evidently, health-related information of this character should not be entrusted to food producers, whose income depends on the intensity and “smartness” of the advertising. Another important aspect is that even if the claim is true, it may lead to an undesirable consumption because of insecurity or fear of disease. Further, claims tend to highlight the favourable aspects of a food or food ingredient at the expense of possible adverse properties by its consumption. Last but not least, it is the total diet – the composition of foods in the diet – over an extended period, which is essential to health, an effect which will not be achieved by the occasional consumption of a functional food.

51.       Given that claims are a valuable marketing tool for food manufacturers, their use should be strictly regulated to ensure that customers are informed and adequately protected from misleading, false or inappropriate claims. Establishing such rules should serve the aim to guarantee:

9.       Harmonisation of legislation

52.       The European policy regarding food safety has until recently been mainly based on the concept of monitoring food quality in microbiological and chemical terms. Yet it has become clear that a more positive approach to nutrition is needed and that diet should be stressed as a primary health factor. Nutrition and health claims have proliferated across the whole of the single market but to date there is no harmonised regulatory control for claims in Europe.

53.       Detailed rules on labelling, presentation and advertising of foodstuffs (Directive 2000/13/EC) and on nutritional labelling (Council Directive 90/496/EEC) have been established at European level. There is, however, no equivalent European legislation that relates specifically to claims made for functional foods.

54.       The regulation of functional foods across Europe, compared to Japan or the United States, falls truly into a regulatory grey zone. Its roots are buried, inter alia, in the diverse attitudes of European nations towards food in general and the powerful industry lobby that may welcome guidelines but opposes to any law enforcement. Food enforcement authorities are inhibited in taking action by the high costs involved and lack of certainty over outcomes in court.

55.       In view of the proliferation of the number and type of claims appearing on the labels of foodstuffs and in the absence of specific provisions at European level, some countries have adopted legislation and other measures to regulate their use. For example, the UK has introduced a Joint Health Claims Initiative and the Code of Good Practice on Health Claims for Foods, which aim to protect the consumer form misleading or unsubstantiated health claims. The Netherlands has introduced a voluntary Code of Practice for assessing the scientific evidence for the benefits stated in health claims. In Sweden, an industry code of self-regulation on health claims in the labelling and marketing of food products has existed for several years, whereas Finland has national legislation banning the use of health and medicinal claims. This has resulted in different approaches and in numerous discrepancies both regarding the definition of the terms used and the conditions warranting the use of claims. Furthermore, these voluntary codes suffer from the same fundamental flaw – they are unenforceable.

56.       At pan-European level, some moves to regulate health claims are happening, as demonstrated by the recent publication of the Council of Europe’s policy statement on “Guidelines Concerning Scientific Substantiation of Health-related Claims for Functional Food”, the ongoing discussions in the UN FAO/WHO Codex Alimentarius or the EU discussion paper on “Nutrition Claims and Functional Claims” (SANCO/1341/2001). However, these steps are advancing very slowly and remain as scientific guidelines rather than European-level policy documents. A more legalistic approach would surely be necessary to define and regulate functional foods, the claims and communication to the consumers.

57.       It is evident that further steps are urgently needed to harmonise legislation at European level. The harmonised legislation should establish that:

q the use of claims is consistent with wider public health objectives and national and international dietary and nutritional recommendations.

q all claims must be legal, justified and understandable, and should always be presented in the context of an overall balanced diet and other healthy life-style factors, and not encourage over-consumption or other habits harmful to health.

q All claims must be communicated clearly, understandably and truthfully to the consumer. The communication using claims may suggest that consuming a functional food may contribute to the improvement of the diet but it should not suggest or imply that the intake of the functional food alone can correct otherwise unhealthy lifestyles and/or dietary habits or be the only way to enhance a particular function or to reduce the risk of a given disease.

q labelling rules should be such that the consumer is able to assess clearly the effects of eating functional foods; claims should not have such a dominant place on a product that consumers get used to just look for claims and forget that food normally contains and the scope of the product.

q product labels should fully disclose

q requirements should be established for pre-market approval of claims. Laws that simply prohibit therapeutic claims for foods and the sale of un-licensed medicines are inadequate to deal with the new generation of foods that blur the distinction between food and medicine. No health claim should be made unless the government determined, based on a review of the totality of the available scientific evidence, that there is at least significant scientific agreement by experts in the field that the claim is valid.

q medical claims should be outlawed, save for specific exceptions that can reasonably be expected to make a significant overall contribution to a healthy diet, based on the totality of the scientific evidence (e.g. the claim that folic acid is indicated in the prevention of spina bifida).

q health claims should not lead the consumers with an impression that it is impossible to obtain sufficient amounts of one or another functional ingredient (e.g. fibre, calcium) from other ‘natural’ products (e.g. fruits, milk).

q health claims should be prohibited on products that are high in fat, saturated fat, cholesterol, or sodium or otherwise contain ingredients that would prevent them from being considered healthy food. Health claims should also be prohibited on foods with minimal nutritional value such as functional candy and soft drinks.

10.       Conclusions

58.       Significant developments have occurred in the understanding of the concept of functional food but there remains much scope for creating a better and wider understanding of the concept and the underlying science.

59.       The term “functional food” should become properly defined and categorised. A single term should be adopted to refer to foods or food components that may reduce the risk of a specific disease or health concern with a view to facilitating communication with consumers and establishing a proper legal framework.

60.       There is a real need for sound and comprehensive scientific evidence to back claims for functional foods. The alleged benefits of functional foods must be scientifically demonstrated, including a proper assessment of their safety. The health claims made for food products must be clearly expressed in ways that are understandable to the consumer. They must seek to prevent a situation where the over-use of particular products eventually leads to new imbalances, which will then have to be corrected.

61.       In the light of these elements, the Council of Europe should endeavour to persuade governments to prioritise what foods need to be produced for the benefit of mankind rather than be left to manufacturers to decide purely on commercial considerations. With the expansion of the global market, confusion will be unavoidable if different countries have different rules for health claims on foods. Europe should be called upon to give a clear statement of its position with regard to functional foods and make a concrete commitment to the development of a common framework and rules on claims at European level, to ensure harmonisation and consistency of approach.

62.       Keeping in mind that accurate and reliable health claims have a positive effect on consumer eating behaviour and consumer knowledge of the diet-disease link, the need to regulate functional foods is critical and should be addressed by European law-makers in collaboration with scientists, researchers, educators, the food industry and food professionals to promote accurate and appropriate research, dissemination of information, product development, regulation and consumer education in this area.

63.       The newly established European Food Safety Authority should be empowered to implement requirements for health claims and validate such claims. Its long-term objective should be to standardise nutrition labelling for all foods rather than the health claims used for functional foods for marketing purposes, which may prove more beneficial to consumers who want to improve their diets. All food stuffs, whether or not they make health claims, should be encouraged to carry full nutrition labelling indicating their standardised serving sizes, beneficial nutrient content, maximum or minimum amounts of daily consumption, whether a serving of the food is high or low in particular nutrients, etc..

64.       Finally, while functional foods potentially offer health benefits, it is important to keep these in perspective and that they are enjoyed in the knowledge not that they offer a magic bullet against health problems, but that they are a positive, health enhancing addition to an overall balanced diet and active lifestyle.

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Reporting committee: Committee on the Environment, Agriculture and Local and Regional Affairs

Committee for opinion: Social, Health and Family Affairs Committee

Reference to committee: Doc. 8322, Reference No. 2361of 30 March 1999.

Draft resolution adopted by the committee on 25 June 2002

Members of the committee: Mr Martinez Casañ (Alternate: Fernandez Aguilar) (Chairman), MM. Behrendt, Hornung, Stankevic (Vice-Chairmen), Mr Agius, Mrs Agudo, MM. Akçali, Akselsen, Mrs Angelovicova, MM. Annemans, Apostoli, Bartos, Bockel, Boros, Briane, Browne, Sir Sydney Chapman, MM. Churkin (Alternate: Sudarenkov), Ciemniak, Cosarciuc, Duivesteijn, von der Esch, Etherington, Frunda, Giovanelli, Gonzalez de Txabarri, Graas, Grachev, Grignon (Alternate: Goulet), Grissemann, Gubert, Hajiyeva, Haraldsson, Hladiy, Ilascu, Janowski, Juric, Kalkan, Mrs Kanelli (Alternate: Mr Pavlidis), Mr Kharitonov, Lord Kilclooney, MM. Klympush, Lachat (Alternate: Ms Fehr), Lozancic, Libicki, van der Linden, Manukyan, Mariot, Mauro (Alternate: Nessa), Meale, Mesquita, Müller, Nazaré Pereira, Oliverio, Podobnik, Pollozhani, Popov, Salaridze, Mrs Schicker, MM. Schmied, Skopal, Skoularikis, Ms Stoejberg, Mr Stoica (Alternate: Coifan), Ms Stoyanova, MM. Tabajdi, Theodorou, Timmermans, Tiuri, Truu, Vakilov, Velikov, Volpinari, Yürür, Mrs Zetterberg, MM Zhevago, Zierer.

N.B. The names of those members present at the meeting are printed in italics.

Secretariat to the committee: Mrs Cagnolati, Mr Sixto and Ms Odrats.