Status of nutrition and health claims in Europe

Archives of Biochemistry and Biophysics 501 (2010) 6–15

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Review

Status of nutrition and health claims in Europe q Hans Verhagen a,b,c,*, Ellen Vos b, Sheila Francl d, Marina Heinonen e, Henk van Loveren a,b a

National Institute for Public Health and the Environment (RIVM), The Netherlands Maastricht University, Maastricht, The Netherlands c Northern Ireland Centre for Food and Health, University of Ulster, Coleraine, Northern Ireland, UK d Open University, Heerlen, The Netherlands e Helsinki University, Helsinki, Finland b

a r t i c l e

i n f o

Article history: Received 3 February 2010 and in revised form 7 April 2010 Available online 22 April 2010 Keywords: Nutrition claims Health claims Europe Regulation 1924/2006 Nutrient profiles Antioxidants Consumer understanding

a b s t r a c t Functional foods are closely associated with claims on foods. There are two categories of claims on foods: nutrition claims and health claims. Health claims on (functional) foods must be scientifically substantiated. In December 2006, the European Union published its Regulation 1924/2006 on nutrition and health claims made on foods. As concerns scientific evaluation, the EU-project PASSCLAIM resulted in a set of criteria for the scientific substantiation of health claims on foods. The European Food Safety Authority provides the scientific advise to the European Commission for health claims submitted under Regulation 1924/2006 and has hitherto published several hundreds of opinions on health claims, part of which are positive, part which are negative and a few with insufficient evidence. Antioxidant claims have been approved for the general function of vitamins but not for direct health effects in humans. Another issue with claims is consumer understanding. Consumers can hardly distinguish between graded levels of evidence, and they do make only little or no distinction between nutrition and health claims. Consumers understand nutrition and health claims different from scientists and regulators. Therefore, innovation in industry can readily proceed via approved nutrition claims and approved health claims. The market and the shelves in the stores will not be empty; rather they will look different in the years to come. Ó 2010 Elsevier Inc. All rights reserved.

Introduction In the second half of the 20th century the political and socioeconomic developments in developed countries has resulted in a more secure and abundant food supply then ever before. In part due to this, life expectancy has increased steadily. Paradoxically, at the same time a huge increase in several chronic diseases was observed, and it was more and more recognized that these chronic diseases could be linked to dietary and lifestyle factors. In 2002, the World Health Organization (WHO)1 concluded that ‘‘non-communicable diseases” or ‘‘chronic diseases”, such as cardio-vascular diseases, cancer, obesity and type 2 diabetes, currently kill more people than any other cause of death. Four factors in the epidemiology of these diseases (poor diet, physical inactivity, tobacco and alcohol use) are of overwhelming importance to public health [1].

q This paper is an update of and extension to earlier published papers: Verhagen (2008) and Verhagen and van den Berg (2008). * Corresponding author at: National Institute for Public Health and the Environment (RIVM), P.O. Box 1, 3720 BA, Bilthoven, The Netherlands. E-mail address: [email protected] (H. Verhagen). 1 Abbreviations used: WHO, World Health Organization; EU, European Union; PASSCLAIM, Process for the Assessment of Scientific Support for Claims on Foods; FUFOSE, Functional Food Science in Europe; EFSA, European Food Safety Authority; FOSHU, foods for specific health use; SSA, Significant Scientific Agreement.

0003-9861/$ - see front matter Ó 2010 Elsevier Inc. All rights reserved. doi:10.1016/j.abb.2010.04.012

In 2003 a Joint WHO/FAO Expert Consultation provided an overview of the strength of evidence for dietary factors related to undesirable health outcomes indicating a convincing positive or negative association for several non-communicable diseases: obesity (positive association: energy-dense foods; negative association: dietary fiber, fruits and vegetables), cardio-vascular disease (positive association: saturated fatty acids, trans fatty acids, sodium; negative association: linoleic acid, n 3 long-chain polyunsaturated fatty acids, potassium, fruits and vegetables), osteoporosis (negative association: vitamin D, calcium) and dental caries (positive association: sugar) [2]. In 2004 the WHO has issued its Global Strategy on Diet, Physical Activity and Health [3]. WHO-Europe has finished its First Nutrition Action Plan 2000–2005 [4], with priority areas obesity and chronic disease and micronutrient deficiencies. A sequel ‘‘WHO European action plan for food and nutrition policy 2007–2012” is now in place [5]. The European Union is now active in combating obesity in e.g. the European Platform on ‘‘Diet, Physical Activity and Health” [6]. Thus, on the one hand, nutrition can significantly improve health status under conditions where under-nutrition and malnutrition are still eminent. On the other hand, nutrition, diet and foods can be a major determinant underlying chronic diseases such as obesity, diabetes, cardio-vascular disease, and cancer. In addition to under-nutrition, over-nutrition and malnutrition, food safety is an inherent aspect associated with food and nutrition. In

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modern societies, the safety of foods is now essentially under control. In the European Union (EU), the general policy on food safety has been laid down in the EU White Paper on Food Safety [7]. For a proper risk assessment, the risks and benefits of foods and diets must be weighed in an integrated assessment. To this end, in the Netherlands the risks of major and minor determinants of nutrition and health have recently been compared [8]. This assessment showed that health risks of inappropriate nutritional behavior outweigh health risks of food contamination (of microbiological, chemical and physical origin) by approximately two orders of magnitude. This implies that for improvement of public health the largest gain can only come from changes in dietary behavior and from changes in nutritional composition of commonly eaten foods [9,10]. Functional foods are foods with claims Interest in healthy food and diet encompasses the generation of foods with improvements on negative aspects (e.g. lower in calories, sugar, sodium) as well as the incorporation of beneficial nutrients and ingredients (e.g. phytosterols/-stanols, pro- and prebiotics). This double focus on healthy eating is a trigger for new developments in the food industry: functional foods. In the 20th century, foods with health claims were first introduced in Japan. Thereafter, they have also been introduced in the USA, Europe and the rest of the world. There is no official definition of functional foods, but the EU-project ‘‘Functional Food Science in Europe” (FUFOSE) [11] seems to give an appropriate working definition, stating that: ‘‘A food 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,. . .”. Functional foods therefore comprise foods in which the composition of ingredients has been changed by addition, deletion or modification of ingredients. Functional foods are therefore the prime candidates to bear health claims. According to the Codex Alimentarius, a claim is ‘‘any representation which states, suggests or implies that a food has particular characteristics relating to its origin, nutritional properties, nature, production, processing, composition or any other quality” [12]. There is general consensus among scientists, consumers, authorities as well as industry that health claims on (functional) foods must be scientifically substantiated. This is at the interest of all stakeholders and contributes to fair trade. In the European Union there are several important developments; these cover scientific as well as regulatory aspects. As regards the scientific aspects, we may observe that a set of criteria for the scientific substantiation of health claims on foods was developed in 2005 by an EU-sponsored and International Life Sciences Institute Europe—coordinated project: ‘‘Process for the Assessment of Scientific Support for Claims on Foods” (PASSCLAIM) [13–15]. The PASSCLAIM criteria cover: (1) the characterization of the food or food ingredients for the health claim, (2) the necessity of human data for the substantiation of a health claim (by preference data coming from human intervention studies but also accepting human observational data), (3) the use of valid endpoints or biomarkers as well as statistically significant and biological relevant changes therein, and (4) the requirement for the totality of the data and weighing of the evidence before making a judgment whether a health claims is or is not substantiated. EU Regulation 1924/2006 on nutrition and health claims made on foods As regards the regulatory aspects, in December 2006 the EU adopted Regulation 1924/2006 on nutrition and health claims

made on foods [16,17]. The general objective of the Regulation 1924/2006 [16] is to harmonize the national rules on nutrition and health claims. In doing so, it wants to ensure the free movements of foods whilst also providing a high level of consumer protection. In addition it aims to allow consumers to choose products in full knowledge of the facts and to ensure fair competition [para. 8 of the preamble of Regulation 1924/2006]. The scope of Regulation 1924/2006 encompasses all aspects of food products made in commercial communications to the final consumer: labeling, presentation, advertising and in some cases brand names, and trademarks. The general principles of Regulation 1924/2006 are that claims shall: (1) not be false, ambiguous nor misleading; (2) not give rise to doubts as to the safety of nutritional adequacy of other foods; (3) not encourage or condone excess consumption of a food; (4) not state or suggest that a balanced and varied diet cannot provide for appropriate quantities of nutrients in general; (5) not refer to changes in bodily functions which could create or exploit fear in consumers [Article 3 Regulation 1924/2006]. In addition the Regulation determines that these claims need to be based on and be substantiated by generally accepted scientific data [Article 6 Regulation 1924/2006]. Importantly, health claims on food are prohibited if these refer to the prevention, the treatment or the cure of a human disease (e.g. ‘‘this food can prevent stomach cancer”) (Article 2, Directive 2000/13/EC). Regulation 1924/2006 identifies two categories of claims on foods: nutrition claims and health claims (Fig. 1) [16,17]. In the context of EU Regulation 1924/2006, health claims are claims that state, suggest or imply a relationship between a food or food category and health. Examples hereof are function claims, reduction of risk of disease claims, or claims referring to the growth and development of children. Function claims are based on generally accepted scientific knowledge and are called ‘‘Article 13.1 claims”, e.g. ‘‘this product contains calcium; calcium is relevant for the development of strong bone and teeth”. Nutrition claims are claims that state, suggest or imply that a food has particular beneficial nutritional properties due to the energy it provides or the nutrients it contains. Examples hereof are content claims or comparative claims, e.g. ‘‘this product contains calcium” or ‘‘this product is low in sugar”. Explicit conditions are described in EU Regulation 1924/2006 for claims such as ‘‘source of”, ‘‘rich in”, ‘‘reduced fat”, ‘‘reduced energy”, ‘‘fat-free” (see Table 1 for a short overview of the currently allowed nutrition claims on foods).

EU Regulation 1924/2006 What it contains

Nutrition claims • Content claims • Comparative claims

What it does

Health claims Function claims Based on generally accepted scientific data

Article 13.1

Based on newly developed scientific data

Reduction of disease risk claims + claims growth and development of children

Article 13.5 Article 14

Fig. 1. Overview of nutrition and health claims in EU Regulation 1924/2006 [16]; figure modified from Verhagen (2008) [17].

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Table 1 Nutrition claims and conditions applying to them.a Nutrition claim

Conditions of use

Low energy

Max 40 kcal (170 kJ)/100 g for solids Max 20 kcal (80 kJ)/100 ml for liquids Table-top sweeteners max 4 kcal (17 kJ)/portion Energy-reduced Energy value is reduced by at least 30% Energy-free Max 4 kcal (17 kJ)/100 ml Low fat Max 3 g of fat per 100 g for solids Max 1.5 g of fat per 100 ml for liquids Max 1.8 g of fat per 100 ml for semi-skimmed milk Fat-free Max 0.5 g of fat per 100 g or 100 ml Claim ‘X% fat-free’ prohibited Low saturated fat 1.5 g per 100 g for solids 0.75 g/100 ml for liquids SAFA + TFA max 10% of energy Saturated fat-free Max 0.1 g per 100 g or 100 ml Low sugars Max 5 g of sugars per 100 g for solids Max 2.5 g of sugars per 100 ml for liquids Sugars-free Max 0.5 g of sugars per 100 g or 100 ml With no added sugars No added mono- or disaccharides or any other food used for its sweetening properties Add ‘contains naturally occurring sugars’ if sugars are naturally present in the food Low sodium/salt Max 0.12 g of sodium (0.3 g salt) per 100 g or per 100 ml Waters: max 2 mg of sodium per 100 ml Very low sodium/salt Max 0.04 g of sodium (0.1 g salt) per 100 g or per 100 ml Waters: do not use this claim Sodium-free or salt-free Max 0.005 g of sodium (0.0125 g salt) per 100 g or per 100 ml Source of fiber Min 3 g of fiber per 100 g Min 1.5 g of fiber per 100 kcal High fiber Min 6 g of fiber per 100 g Min 3 g of fiber per 100 kcal Source of protein Min 12% of the energy value of the food High protein Min 20% of the energy value of the food Source of [vitamin/s] Min ‘significant amount’ as per Regulation 1925/ and/or [mineral/s] 2006 High [vitamin/s] and/or Min 2a value for source [mineral/s] Contains [nutrient or See Regulation 1924/2006, in particular Article 5; other substance] vitamins, minerals = min ‘‘source of” Increased [nutrient] Conditions for ‘source of’ Min increase is 30% Reduced [nutrient] Min reduction is 30% Sodium/salt min reduction is 25% Micronutrients min reduction is 10% (90/496/EEC) Light/lite See reduced + indication of the characteristic(s) Naturally/natural When food naturally meets the condition(s) laid down in Annex to 1924/2006 for the use of a nutritional claim Source of omegaMin 0.3 g ALA per 100 g and per 100 kcal, or min 3 fatty acidsb 40 mg of the sum EPA and DHA per 100 g and per 100 kcal High omegaMin 0.6 g ALA per 100 g and per 100 kcal, or min 3 fatty acidsb 80 mg of the sum EPA and DHA per 100 g and per 100 kcal High mono Min 45% of the fatty acids is MUFA; MUFA min 20% unsaturated fatb of energy High poly Min 45% of the fatty acids is PUFA; PUFA min 20% of b unsaturated fat energy b High unsaturated fat Min 70% of the fatty acids is UFA; UFA min 20% of energy a

This is a simplified text version from EU Regulation 1924/2006 [16], which applies in all instances). b These five nutrition claims are not part of the original list in EU Regulation 1924/2006, but these will soon be taken up as additional nutrition claims.

Regulatory environment related to nutrition and health claims In the EU, nutrition and health claims made on foods are not only subject to the rules laid down in Regulation 1924/2006 [16], but also to the wider set of Regulations and Directives in the area of food, nutrition and food safety (http://ec.europa.eu/food/food/

foodlaw/index_en.htm). This means that Regulation 1924/2006 cannot be studied in isolation. First, this Regulation itself underlines that it applies in addition to the EU provisions on the addition of vitamins and minerals and of certain other substances to foods (Directive 1925/2006), the exploitation and marketing of natural mineral waters (Directive 2009/54/EC), foodstuffs for particular nutritional uses (Directive 2009/39/EC) and food supplements (Directive 2002/46/EC). Moreover, it expressly refers to the rules in relation to the labeling of food (Directive 2000/13/EC) and misleading and comparative advertising (Directive 2006/114/EC). In addition, it takes over various definitions that are detailed in other EU directives. Thus nutrition and health claims need to observe also these rules (see for an overview of the relevant rules Table 2). Importantly, also the provisions of the General Food Law apply and in particular the ones that govern the functioning of the European Food Safety Authority (EFSA). In the USA [18,19], Japan [20,21] and Codex Alimentarius [22,23] different rules apply. In the USA, claims on food and dietary supplement labels fall into three categories: nutrient content claims, structure/function claims and health claims (http:// www.fda.gov/Food/LabelingNutrition/LabelClaims/ucm111447.htm; http://www.fda.gov/Food/LabelingNutrition/default.htm). These are quite similar in nature to their European equivalent, albeit that their Regulatory status and procedures for use and approval are very different. In Japan, the ‘‘foods for specific health use” (FOSHU) law only requires some evidence (http://www.mhlw.go.jp/english/ topics/foodsafety/fhc/02.html). In the USA, initially only health claims were allowed that have ‘‘Significant Scientific Agreement”, but since the Pearson versus Shalala court case, also ‘‘qualified health claims” (see also further in text) are legally allowed under the provision that they carry a disclaimer to indicate the lower level of scientific evidence [18]. Whereas the Japanese and US have quite liberal regulatory provisions for health claims, Europe displays requirements for a high level of scientific substantiation. This is reflected in the Regulation 1924/2006 and is widely supported by scientists in Europe who do not favor qualified health claims (quote from PASSCLAIM 2nd plenary meeting report [24]: ‘‘There was support for the idea that a structured approach to characterizing the quality of data would assist assessors in weighing the evidence but caution was expressed that this should not lead to a weighted characterization of the claim itself. In this context participants expressed opposition to the idea of ‘‘qualified claims” on the grounds that a claim should either be judged substantiated or not.”). These scientists in PASSCLAIM also acknowledge that grading of evidence is a political/policy rather than scientific issue [14]. Even though the scientific requirements in Europe are high, as reflected by the Regulation and widely supported by scientists, some appeals are made towards a more liberal system in Europe and more in line with the USA and Japan [25–27].

The practice of evaluation of health claims in Europe Regulation 1924/2006 [16] demands that both nutrition and health claims that are placed on foods fulfill the requirements laid down. As for nutrition claims the Regulation stipulates that such claims are only permitted if they are listed in its annex, and to be sure, fulfil the conditions laid down in the Regulation. Producers and/or Member States who would like to use a specific nutrition claim not on the list should therefore consult with the Commission who has to power to amend the annex of Regulation 1924/2006. The Commission will adopt such a decision amending the annex (possibly after consulting EFSA where necessary) on the basis of a committee procedure whereby representatives of Member States will be allowed to have a say about the Commission’s view. In addition, this procedure (the regulatory committee procedure with

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H. Verhagen et al. / Archives of Biochemistry and Biophysics 501 (2010) 6–15 Table 2 Overview of EU legislation that is relevant for nutrition and health claims. EU legislation

Topic

Relevance

Legal reference

European Parliament and Council Regulation 178/2002 European Parliament and Council Regulation 1924/2006 (as consolidated) plus amendments [16] European Parliament and Council Directive 98/83/EC (as amended by Regulation (EC) 1882/2003) European Parliament and Council Directive 90/496/EEC (as consolidated)

General Food Law

General principles to be taken into account, and the procedures governing the operation of EFSA Sets the basic law; main requirements; authorization procedure

OJ L 31, 1.2.2002, p. 1

Commission Directive 96/8/EC (as amended by Commission Directive 2007/29/EC)

Labeling, advertising or presenting foods intended for use in energy-restricted diets for weight reduction

Council Decision 1999/468/EC (as amended by 2006/512/EC)

Comitology procedures

European Parliament and Council Directive 2000/13/EC (lastly amended by Commission Directive 2006/142/EC) European Parliament and Council Directive 2002/46/EC (as lastly amended by Regulation (EC) 1170/ 2009) European Parliament and Council Directive 2005/29 (amending European Parliament and Council Directive 84/450/EEC) European Parliament and Council Directive 2006/114/EC (replacing 84/450/EEC) European Parliament and Council Regulation (EC) 1925/2006

Labeling, presentation and advertising of foodstuffs

Nutrition and health claims on foods

Quality of water intended for human consumption Nutrition labeling of foodstuffs

Food supplements

Unfair Commercial Practices

Misleading and comparative advertising Addition of vitamins and minerals and of certain other substances to foods

European Parliament and Council Directive 2009/39/EC (recast) and implementing directives European Parliament and Council Directive 2009/54/EC (recast)

Foodstuffs intended for particular nutritional uses (PARNUTS) Exploitation and marketing of natural mineral waters

Proposal for a Regulation of the European Parliament and of the Council

The provision of food information to consumers

Sets rules on the quality of water for human consumption; to be taken into account for nutrition and health claims for those products Sets general requirements to be taken into account Article 7 Reg. 1924/2006: where a nutrition claim is made for sugars, saturates, fiber or sodium, the information to be given should be that of Group 2 as defined in Article 4(1) of Directive 90/496/EEC. The same applies mutated mutandis for health claims Prohibits in the labeling, presentation and advertising of foods intended for use in energy-restricted diets for weight reduction, any reference to the rate or amount of weight loss which may result from their use; Preamble Reg. 1924/2006: wants to extend this to all foods Sets out the regulatory committee procedure and the regulatory committee procedure with scrutiny (see e.g. Article 8(2) for nutrition claims and Article 13(3) for health claims), generally referred to in Article 25(3) Regulation 1924/2006 Sets general labeling requirements on foods to be taken into account Prohibits the use of information that would mislead the purchaser or attribute medicinal properties to food Sets rules for the labeling of food supplements and introduces specific rules on vitamins and minerals in food supplements

OJ L 12, 18.1.2007, p. 3 (consolidated version: 2006R1924— EN—04.03.2008— 001.001—1) OJ L 330, 5.12.1998, p. 32

OJ L 276, 6.10.1990, p. 40 (consolidated version: 1990L0496—EN—11.12.2008— 004.001—1)

OJ L 55, 6.3.1996, p. 22 (OJ L 139, 31.5.2007, p. 22)

OJ L 184, 17.7.1999, p. 23 (OJ L 200, 22.7.2006, p. 11)

OJ L 109, 6.5.2000, p. 29 (OJ L 368, 23.12.2006, p. 110)

OJ L 183, 12.7.2002, p. 51 (OJ L 314, 1.12.2009 p. 6)

Annex I, commercial practices which are in all circumstances considered Unfair, N 17. Falsely claiming that a product is able to cure illnesses, dysfunction or malformations To be taken into account in general, when advertising a food with a nutrition or health claim

OJ L 149, 11.6.2005, p. 22

Set requirements on the labeling of products to which vitamins and minerals have been added may bear a statement indicating such addition under the conditions laid down in Regulation 1924/2006 Sets rules for particular nutritional uses

OJ L 404, 30.12.2006, p. 26

Sets rules on natural mineral waters; to be taken into account for nutrition and health claims for those products

OJ L 164, 26.6.2009, p. 45

scrutiny) gives both the Council and the European Parliament specific powers of scrutiny. Importantly, in cases where Member States representatives, who are member of Standing Committee on the Food Chain and Animal Health, do not agree (or fail to agree) with the Commission’s view, the Council and/or the European Parliament may oppose to the Commission adopting a decision. As regards health claims, there are different procedures to be followed. For Article 14 claims, the reduction of disease risk claims and claims referring to children’s development and health, the European Commission (together with the Member States in the context of a comitology procedure) will formally need to authorize all individual applications for health claims which need to be scientifically substantiated. An application needs to be submitted through an appropriate national food authority, who will then forward the application to EFSA. EFSA, through its Panel on Nutrition, Dietetic Products and Allergies (http://www.efsa.europa.eu/en/

OJ L 376, 27/12/2006

OJ L 124, 20.5.2009, p. 21

COM 2008 40 final

panels/nda.htm), will give a scientific advice on the substantiation of the health claim and send this to the European Commission. Already in July 2007 EFSA published its ‘‘scientific and technical guidance for the preparation and presentation of the application for authorization of a health claim” pursuant to Article 14 of Regulation 1924/2006 [28] in order to assist the applicant. The content of that guidance document is essentially in line with the criteria laid down in the PASSCLAIM consensus paper [14]. EFSA has also indicated how a dossier for the substantiation of a health claim should be presented, that literature searches should be conducted and it is indicated that all available data need to be provided. The EFSA requirements for the scientific substantiation of health claims are in line with the general principle of Regulation 1924/2006 [16] that all health claims should be scientifically substantiated. This means that in fact a claim according to Article 14 of Regulation 1924/2006 [16] will require an extensive dossier containing all

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relevant scientific data. The Commission will decide whether or not to authorize the application for a health claim on the basis of the regulatory committee procedure with scrutiny. This means that as soon as the Commission receives EFSA’s opinion it will submit a draft decision to the Standing Committee on the Food Chain and Animal Health. Representatives of Member States have quite an important say in the decision-making procedure as in cases where they do not agree (or fail to agree) with the Commission’s view, the Council and/or the European Parliament may oppose to the Commission adopting a decision. Moreover, as indicated above, both the Council and European Parliament have important powers of scrutiny under this procedure also in cases where Member State representatives agree with the Commission. For health claims according to Article 13.1 (function claims), a different procedure applies. For these claims, a positive list will be established by the European Commission. Until 31 January 2008, all Member States of the European Union were able to send their national proposals for inclusion to the list to the European Commission. The European Commission has requested the EFSA to assess all these proposals from a scientific perspective. Based on the EFSA opinions, the European Commission will establish a list of positive health claims in accordance with the regulatory committee procedure with scrutiny as explained above. Health claims thus approved can subsequently be used by producers without recurrence to the European Commission, provided that they are in conformity with the various legal requirements set. The proposals for Article 13.1 claims do not require a full substantiation dossier, but only the submission of relevant references. Whereas proposals for Article 13.1 (function) claims need to be discussed with the Commission (either by Member States or by individual companies) as it is the Commission who is empowered to adopt a Community list, in consultation with EFSA, proposals for Article 14 claims need to be initiated by individual companies. Moreover, whilst for Article 13.1 claims it suffices to refer to generally accepted scientific evidence and mere references to relevant literature, the proposals for Article 14 claims need to be accompanied

with a complete scientific dossier. New additions to the list of Article 13 claims (so called ‘‘Article 13.5 claims”) can be requested via a procedure similar to the one for Article 14 claims (Article 18). All relevant EFSA documents, databases and additional information can be found on the EFSA website [http://www.efsa.europa.eu/ en/nda/ndaclaims.htm]. Nutrient profiles Foods with health claims may have an impact on the dietary behavior. Therefore, a special requirement in Regulation 1924/ 2006 [16] deals with nutrient profiles (Article 4), which manages that foods with claims do not have an undesirable composition of nutrients. In EU Regulation 1924/2006 [16], it is allowed for the derogation for one nutrient in the case of a nutrition claim, provided that the exemption is indicated on the product label. In contrast, for health claims no exemptions to the nutrient profile will be allowed. Nutrient profiling has been defined as ‘‘the science of categorizing foods according to their nutritional composition” [29,30] and ‘‘categorization of foods for specific purposes on basis of their nutrient composition according to scientific principles” [31]. Many national and international governmental bodies as well as industry have developed a variety of systems for nutrient profiling (see [32,33] for recent review). It is generally agreed that the ‘overall’ mean nutritional quality of the foods eaten, and a balanced dietary pattern, are the main determinants of a ‘healthy’ diet. A healthy food choice by the consumer requires that consumers are adequately informed. Adoption of nutrient profiles might also stimulate the development by the food industry of products with an improved nutritional composition and as such food reformulation can contribute to public health [10]. In the discussion about setting nutrient profiles it appeared very complicated to compare existing nutrient profiling scheme with one another. To this end, Verhagen and van den Berg [33] published a simple visual model to compare existing nutrient profiling schemes, a model that has helped many in presentations elsewhere (Fig. 2).

Total fat SAFA TFA Cholesterol Sodium Added sugar Non-milk sugar Across the board

Disqual. ingredients

Qualifying ingredients

Threshold

Energy Vit A

Food category

100 g/100 ml

Vit C iron

Testing / validation

100 kcal/kJ Scoring Reference amount

protein calcium fiber W-3 LC PUFA Fruits & veg’s folate

Fig. 2. Basic figure to illustrate existing nutrient profiling schemes (from Verhagen and van den Berg [33].

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H. Verhagen et al. / Archives of Biochemistry and Biophysics 501 (2010) 6–15 Table 3 Overview of implementation and application of Regulation 1924/2006 [16]. Regulation/directive

Topic

Legal reference

Commission Regulation (EC) No. 353/2008 Commission Regulation (EC) 983/2009 Commission Regulation (EC) 984/2009 Commission Regulation (EC) 1024/2009 Commission Regulation (EC) 1025/2009 Commission Regulation (EC) 1167/2009 Commission Regulation (EC) 1168/2009 Commission Decision 2009/ 980/EU

Implementing rules for applications for authorization of health claims

OJ L 109, 19.4.2008, p. 11 OJ L 277, 22.10.2009, p. 3 OJ L 277, 22.10.2009, p.13 OJ L 283, 30.10.2009, p. 22 OJ, L 283, 30.10.2009, p. 30 OJ L 314, 1.12.2009, p. 29 OJ L 314, 1.12.2009, p. 32 OJ L 336, 18.12.2009, p. 55

Authorization and refusal of authorization of certain health claims made on food and referring to the reduction of disease risk and to children’s development and health Refusing to authorize certain health claims made on food, other than those referring to the reduction of disease risk and to children’s development and health Authorization and refusal of authorization of certain health claims made on food and referring to the reduction of disease risk and to children’s development and health Refusing to authorize certain health claims made on food, other than those referring to the reduction of disease risk and to children’s development and health Refusing to authorize certain health claims made on foods and referring to the reduction of disease risk and to children’s development and health Refusing to authorize a health claim made on foods, other than those referring to the reduction of disease risk and to children’s development and health Authorizing a health claim on the effect of water-soluble tomato concentrate on platelet aggregation and granting the protection of proprietary data under Regulation (EC) No. 1924/2006 of the European Parliament and of the Council

Upon request by the European Commission [34], in February 2008, the EFSA published its scientific opinion on nutrient profiling [35]. The EFSA gave specific advise on:  whether profiles for food in general and/or categories of food (one system ‘‘across the board” apply to all foods or a system with several distinct categories of foods such as oils and fats, dairy, cereals, beverages, etc.;  what should be the choice and balance of nutrients (only disqualifying ingredients and which ones such as salt, saturated fat, trans fat, sugar, cholesterol, energy, etc. and/or also qualifying ingredients and which ones such as fiber, calcium, protein, vitamins and minerals, etc.);  what should be the choice of reference quantity/basis (per weight/volume, per energy basis, and/or per serving/portion);  what should be the approach to the calculation of profiles (a threshold system for all qualifying and/or disqualifying ingredients or a scoring system balancing qualifying and disqualifying ingredients into a total score);  the feasibility and testing of a proposed system. There is no mere scientific rationale on which to base nutrient profiles. The establishment of nutrient profiles requires policy decisions within the scientific constraints. In a sequel to the EFSA Opinion on nutrient profiles, the European Commission will publish its decision on nutrient profiles in the nearby future. Their current position is to have a simple system comprising [36]:  an across the board system, plus a limited number of specific categories of food (vegetable oils and spreadable fats; fruits, vegetables, seeds and their products except oils; meat and meat-based products; fish, fishery products, crustaceans and molluscs; dairy based products (without cheeses and cheeses separately); cereals and cereal products (with subcategories); ready meals, soups and sandwiches; non-alcoholic beverages);  only three disqualifying ingredients (salt, saturated fat, sugar);  the reference quantity per 100 g or 100 ml (unless specified otherwise);  a threshold system for all disqualifying ingredients. Recent evaluations by EFSA Since the submission of dossiers for Article 14 and 13.5 claims by companies and the submission of proposals for the Article 13.1 list by the Member States, the European Commission and subsequent EFSA has received many thousands of health claim appli-

cations: over 280 for Article 13.5/14 and over 4000 for Article 13.1 (amalgamated from over 44,000 received from all Member States); a short overview is presented in Table 4. There is a very extensive database published on the EFSA website (http://www.efsa.europa.eu/en/ndaclaims/ndaclaims13.htm) that comprises all information such as the total list of Article 13.1 health claims submitted, the literature references submitted to substantiate Article 13.1 claims as well as all the opinions published so far by EFSA. In addition, the EFSA website contains additional documents such as frequently asked questions, guidance documents, terms of reference etc., thereby making the entire process as transparent as possible. By early 2010, EFSA has evaluated and published about 80 opinions related to Article 13.5/14 and almost 1000 health claims (in ca. 100 opinions) related to Article 13.1 claims. EFSA displayed the following formats for its final conclusion:  a cause and effect has been established;  there is insufficient evidence to establish a cause and effect relationship;  a cause and effect has not been established. Until December 2009, 25 nutrition claims have been annexed to Regulation 1924/2006. In addition the Commission has approved three health claims that refer to the reduction of a risk factor in the development of a disease (Article 14(1) (a) claims), six health claims that refer to children’s development and health (Article 14(1) (b) claims) and one health claim based on newly developed scientific evidence and/or including a request for the protection of proprietary data (Article 13(5) claim). At the same time quite a number of applications for health claims has been rejected, the majority of them relating to the health claims that refer to chil-

Table 4 EFSA health claims evaluation status (9 December 2009)—number op EFSA opinions. Claim type Children (Article 14) Disease-risk reduction (Article 14) New science/proprietary (Article 13.5) Total applications Article 13 list of health claims

Received Withdrawn Adopted 215

25

45

In progress

4

47 (covering 54 applications) 15

4 3

25

6

15

2

285

35

4185

119

77 (covering 9 84 applications) 940 3126

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H. Verhagen et al. / Archives of Biochemistry and Biophysics 501 (2010) 6–15

Table 5 Some examples of Article 13.1 health claims considered (not) established by EFSA.a Health relationships considered established

Health relationships considered not established

Calcium (plus vitD) and bones

Some probiotics and strengthening immune system >100 probiotics insufficiently characterized Gamma-linolenic acid and reduction of inflammation Some botanicals = poorly characterized, poor data Taurine and energy, performance Glucosamine and joint health Shark cartilage and joint health Tripeptides and normal blood pressure

Fluoride and teeth vitC and protection of DNA, proteins and lipids from oxidative damage Magnesium and energy, cell division Biotin, niacin and energy Selenium or vitC and antioxidant Sugar-free chewing gum and teeth Betaglucans and cholesterol

a These are examples only without any legal value: only the respective EFSA opinions are valid. The EFSA opinions need to be decided upon by the European Commission before turned into legislation.

dren’s development (29); three Article 14(1) (a) claims were rejected and five Article 13(5) claims were refused (see Table 3 for an overview of the relevant decisions relating the approval and rejection of applications). To date, no Article 13.1 health claims have been approved but the first series of EFSA opinions appeared only in October 2009. It is widely beyond the scope of the present paper to discuss the more than 1000 EFSA health claims evaluations, but the general outcome is that the EFSA conclusions are fully in line with the approaches already identified above, i.e. that health claims should be scientifically substantiated (see the opinions on the EFSA website; http://www.efsa.europa.eu/en/nda/ndaclaims.htm). This result became first evident with the first publication of the opinions on Article 13.5/14 claims in August 2008 and has extended to the first publication of large numbers of Article 13.1 claims as of October 2009. Some examples of (non) approved Article 13.1 health claims are provided in Table 5. As may be expected, the reactions from various stakeholders to the publication of the EFSA opinions differ considerably nearly every week comments can be seen in the popular scientific press (EU Food Law (http://www.agra-net.com/portal2/home.jsp?template=productpage&pubid=ag008), NutraIngredients (http://www.nutraingredients.com/), etc.).

Antioxidants Claims on antioxidants have been classified as health claims. Nutrition claims on antioxidants (Annex to Regulation 1924/ 2006) cannot be made. Thus, for example, ‘‘source of antioxidants” is considered a health claim that must be scientifically substantiated. In its opinions on Article 13.1 health claims the EFSA-NDA Panel has taken the view that protection of DNA, proteins and lipids from oxidative damage is beneficial to human health [37]. Reactive oxygen species (ROS) including several kinds of radicals are generated in biochemical processes (e.g. respiratory chain) and as a consequence of exposure to exogenous factors (e.g. radiation,

pollutants). These reactive intermediates damage biologically relevant molecules such as DNA, proteins and lipids if they are not intercepted by the antioxidant network which includes free radical scavengers like antioxidant nutrients. The claimed effects regarding antioxidants in the consolidated list for Article 13.1 health claims reflect a wide variety of wordings including the following: ‘‘antioxidant properties”, ‘‘high potent antioxidant”, ‘‘antioxidant activity/antioxidant”, ‘‘cell protection from free radical damage”, ‘‘protection of body cells from oxidative damage”, and ‘‘supports a healthy oxidative balance”. For the well known nutrients, such as vitamin C, selenium and manganese the antioxidant health claim is based on generally accepted science and the cause and effect relationship has been established between the dietary intake of the nutrient and the protection of DNA, proteins and lipids from oxidative damage. So far, EFSA has evaluated quite a few antioxidant health claims on nutrients and other substances (Table 6). For example, for vitamin C, the following wordings reflect the scientific evidence: ‘‘Vitamin C contributes to the protection of cell constituents from oxidative damage” and ‘‘In order to bear the antioxidant claim a food should be at least a source of nutrient as per Annex to Regulation 1924/2006” [EFSA J 2009; 7(9):1226]. Regarding ‘‘other substances”, such as carotenoids and phenolic constituents and their sources, the data provided generally show antioxidant properties in vitro only. According to EFSA ‘‘claims made on the antioxidant capacity/content or properties of food/food constituents based on their capability of scavenging free radicals in vitro refer to a property of the food/food constituent measured in model systems, and that the information provided does not establish that this capability exerts a beneficial physiological effect in humans” [EFSA J 2010; 8(2):1489]. Moreover, the human studies available provide limited or no evidence in support of an in vivo antioxidant effect. In most cases there are only a very few studies, if any, that have been carried out using relevant markers of oxidative damage to lipids, DNA or proteins as the outcome. For example, reliable markers of lipid peroxidation include measurements of F2-isoprostanes and estimates of oxidized LDL in vivo while measurements of total antioxidant capacity are unreliable concerning substituting a health claim. Another limitation to substantiation of an antioxidant health claim may be that the substance responsible for the claimed health effect has not been well characterized and cannot be verified by authorities by well established methods. As an example, tea (Camellia sinensis) is not sufficiently characterized while catechins in green tea and tannins in black tea are sufficiently characterized. However, no studies with appropriate endpoints to assess oxidative damage of DNA within cells, oxidative damage to proteins, or studies investigating a sustained effect of green tea catechins on lipid peroxidation were presented to establish a cause and effect relationship between the consumption of catechins in green tea and the claimed effect of protection of DNA, proteins or lipids from oxidative damage. [EFSA J 2010; 8(2):1463]. Consumer understanding of claims Regulation 1924/2006 requires that the claim is scientifically proven and that the evidence should be obtained according to

Table 6 Examples of Article 13.1 health claims on antioxidants. Substance

Health claim (wording)

EFSA Journal publication

Vitamin C Selenium Manganese Astaxanthin Catechins in green tea Various foods containing antioxidants

Vitamin C contributes to the protection of cell constituents from oxidative damage Selenium contributes to the protection of body cell constituents from oxidative damage Manganese contributes to the protection of body cells from oxidative damage Not approved Not approved Not approved

EFSA EFSA EFSA EFSA EFSA EFSA

J, J, J, J, J, J,

2009; 2009; 2009; 2009; 2010; 2010;

7(9):1226 7(9):1220 7(9):1217 7(9):1253 8(2):1463 8(2):1489

H. Verhagen et al. / Archives of Biochemistry and Biophysics 501 (2010) 6–15

generally accepted scientific criteria. Regulation 1924/2006 states that ‘‘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” [16]. Whereas the Regulation requires that consumers should be able to understand a health claim, EFSA decided that it was outside their competence to scientifically judge on the ability of consumers in 27 Member States and 23 official languages in the European Union. In their guidance document for Article 14 claims, EFSA only gives proposals of wording, leaving the judgment of understanding by consumers as well as enforcement of Regulation 1924/2006 to the national Food Safety Authorities [28].

Unqualified versus qualified health claims It is evident that the eventual wording on the label of the product is understood by the consumer. This is different from understanding by scientists. Research on consumer understanding of health claims is not well developed but emerging [38]. In the United States, a distinction is made between ‘unqualified’ claims that are based on convincing evidence ‘‘Significant Scientific Agreement” (SSA) and ‘qualified’ health claims for which the evidence is only moderate, low or even extremely low [18,39]. The unqualified health claims for which the evidence is convincing can be used on the label without any restriction. Claims that do not have SSA must identify this by using a ‘disclaimer’. The disclaimer is ‘qualifying’ language that has to indicate to the consumer what the amount of evidence is. This has the consequence that consumers will see very long sentences, such as: ‘Scientific evidence suggests, but does not prove that eating 1.5 ounces per day of most nuts as part of a diet low in saturated fat and cholesterol, may decrease your risk of heart disease’ (http://www.fda.gov/Food/LabelingNutrition/LabelClaims/QualifiedHealthClaims/ucm072926.htm). The US-Food and Drug Administration has designed a visual ‘report card’ to make it easier for consumers to understand the level of scientific evidence supporting the claim [40]. Whereas, in the USA both unqualified (SSA) and qualified health claims are legally possible, it is interesting to note what consumers understand of this. This issue was the subject of work by Kapsak et al. [41], Derby and Levy [42] and Hooker and Teratanavat [43]. Kapsak et al. [41] in a web survey among 5642 adults, tested several text representations which varied the order of claim/disclaimer or the wording of the claim and a visual ‘report card’ graphic with these three products. Consumers were shown cards, with one of the tested claim formats, and had to put the cards in order of the amount of strength of evidence that supported the claim on the card. The majority of participants (78%) were not able to do this correctly. When rating the product for perceived strength of scientific evidence for the claim, consumers could at best distinguish two levels. The authors concluded that when using text only, consumers had trouble distinguishing the four distinct levels of science behind the health claims, regardless of which of several language options were used to describe them. Derby and Levy [42] did a shopping mall interview among 1920 respondents, which answered questions about consumers’ perception of the scientific evidence for the claim and about the perceived likelihood that the product has the relevant health benefit. The result of their work was that disclaimers in the text messages did not have the expected effect on the perceived strength of scientific evidence. Noteworthy, when comparing a ‘qualified claim’ with a disclaimer on it, to an ‘unqualified claim’ the participants did not evaluate the claim to have less scientific certainty but more. The results suggest that text sentences using adjectives instead of the letter grades do not correctly convey the intended strength of science. From these two studies, it is concluded that consumers cannot distinguish between health

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claims that are scientific substantiated and qualified health claims when reading a ‘text-only’ claim, no matter in which way it was formulated. Kapsak et al. [41] investigated the question ‘‘does a visual aid help to make the distinction between the levels of scientific support for the claim?” and found that consumers can better distinguish among the four levels of scientific evidence when presented with the FDA-graphic than with the text only claim. Derby and Levy [42] also used a report card with the qualified claim in words with the letter grade (B, C or D) assigned to the claim and a report card-graphic where the claim’s grade is indicated by a checkmark next to the B, C or D box. The report card grade disclaimer schemes resulted in correct linear pattern (B > C > D) and thus correctly conveyed the intended ordering of scientific certainty. The authors also expected that a disclaimer (having a letter B, C or D) would moderate the positive effect of an unqualified health claim, but this was not the case. When respondents saw ‘B’ and ‘C’ report card grade disclaimers, they became more certain about the scientific evidence supporting the claim than when they saw an unqualified text claim. Hooker and Teratanavat [43] tested level ‘A’ to ‘D’ claims in 186 students and found that respondents may be able to differentiate level D (the weakest claim) from other levels. However, there is no evidence that respondents evaluated the unqualified claim A (the claim with SSA) and qualified claim levels B and C differently. In a subsequent experiment among 109 students they tried to investigate the difference between using a ‘report card’ or a ‘text-only’ claim. When a report card was included, responses were different from those for labels without a report card. Respondents tended to react more negatively to a level ‘D’ and more positively to a level ‘A’ in the presence of a report card in comparison to the ‘text-only’ claim. From the above studies (in the USA) it seems that consumers do not discriminate between unqualified and qualified health claims when using text only, and that they make some albeit not always a correct discrimination when a visual aid is used.

Nutrition claims versus health claims In addition to understanding levels of scientific evidence, it is interesting to investigate the consumer understanding of nutrition versus health claims. Derby and Levy [42] found that consumers rated questions about other relevant health benefits and perceived importance of food as part of a healthy diet. The authors found that ‘health benefits’ and ‘importance in diet’ were perceived higher in an unqualified (scientifically proven) health claim than in a nutrition claim. In Australia, in a study by Food Standards Australia New Zealand [44] slightly more consumers understood a nutrition claim than a health claim. The nutrition content claim was understood by 63% of the participants, while 56% of consumers thought the health claim was fairly clear. Peter Williams in Australia found that consumers can hardly make a distinction between content claims, function claims and health claims [45]. Food Standards Australia New Zealand [46] also investigated content claims, function claims and health claims, in an online survey among 1044 shoppers. Respondents were significantly more likely to indicate that a product with a claim would provide a health benefit, compared to the same product without a health claim. Respondents were significantly more likely to indicate that a product with a health claim would ‘reduce the risk of heart disease’ (56%) compared to the nutrition content claim (32%), suggesting that a health claim communicates greater health benefits compared to a nutrition content claim. In Belgium, Vandercammen [47] held interviews among 250 Belgians about consumer awareness of nutrition claims and health

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claims. There was no difference in the amount of people that agreed with nutrition claims or health claims. Van Trijp et al. [48,49] studied content, structure function and disease-risk reduction claims among an Internet Panel with participants from the United Kingdom, the USA, Germany and Italy. Respondents were asked questions about the ability to understand the claim and its credibility. They found that the various claim types do not affect the perception of healthiness, and has only a small effect on difficulty to understand the claim. Rather the type of benefit was found important (e.g. cardio-vascular disease or weight problems), in combination with the type of claim. Although all these studies did not investigate the same question, nor came to the same conclusion, it appears that the consumers do make some distinction between nutrient content claims and health claims. A further refinement within health claim understanding is the difference between (structure) function claims and disease-risk reduction claims. In the USA, Camire and Dougherty [50] tested the knowledge of 136 food professionals on health claims. The authors found that the participants could recognize which of the health claims were approved or unapproved, but they had difficulty to identify the structure function claims. Kapsak et al. [41] in the USA found that the consumers thought that the evidence for a structure function claim (which is not evaluated by the FDA on the amount of evidence) was equal to that of a claim with SSA. Consumers did not perceive a difference among unqualified text health claims and structure function claims with respect to the scientific evidence. The UK Food Standards Agency [51] investigated functional claims and reduction of disease risk claims. There was very little consistency in how the claims were grouped. For example, some of the claims were grouped together as offering the same benefit: ‘because they’re all about reducing’ or ‘because they are all to do with cholesterol levels’. Some claims were grouped together ‘because they’re positive statements’. They found that consumers do make a distinction between the function claims and reduction of disease risk claims, but not based on understanding the underlying scientific basis for the grouping such as used in the European Regulation. Bech-Larsen and Grunert [52] investigated two function claims and two reduction of disease risk claims in a study with participants from the USA, Denmark and Finland. Danish and Finish respondents perceived the healthiness of food with the reduction of disease risk claim slightly higher than with the function claim. It seems that consumers do make a distinction between function claims and reduction of disease risk claims, but not based on understanding the underlying scientific basis for the grouping such as used by the European Commission, but on their own perceptions. In summary, consumers do not always understand health and nutrition claims as they are intended or the evidence supporting them. As research on the ability of consumers to differentiate between function claims and reduction of disease risk claims is limited, more research is needed, especially in Europe. Currently, the research is not done systematically. In order to fill this gap, Leathwood et al. [38] proposed a step by step method for future research.

Concluding remarks An issue brought up by some industry states that the high level of scientific approach in Europe will hamper or jeopardize innovation. Actually the question to this is quite straightforward: no, innovation is not blocked. Consumers fail to distinguish proven claims and qualified health claims and make also do not really make distinctions between a simple nutrition claim and a health

claim. Therefore, industry can pick their product claims from the extensive list of nutrition claims as well as from the (to be) established list of Article 13.1 claims. This opens hundreds of possible claims on foods and food ingredients within the applicable legislation in the EU. Only claims without sufficient scientific proof may disappear from the market, which is the explicit intention of Regulation 1924/2006. It will be a challenge for industry to produce products with appropriate claims in this new era. The market and the shelves in the stores will not be empty; rather they will look different in the years to come. At the same time, this will also be a challenge particularly for EFSA as it will add a new task and implies a considerable increase of its workload. Undoubtedly, with the entering into force of Regulation 1924/ 2006, the reliability and credibility of health claims on foods and food ingredients will improve. Yet, it remains to be established if this will also lead to an improvement of public health. This is an issue of public health and as such extends beyond the scope of this paper. However, it was already identified in 2004 that ‘‘functional foods and dietary supplements do not offer a solution to the health problems caused by an unhealthy diet” [8]. Conflicts of interest There are no conflicts of interest. Three authors (H.V., M.H., H.V.L.) are member of the EFSA-NDA Panel and/or its working groups (http://www.efsa.europa.eu/en/nda/ndamembers.htm; https://doi. efsa.europa.eu/doi/doiweb/wg/1788). References [1] World Health Organization, The world health report 2002, Reducing risks, promoting healthy life, 2002. Available from: . [2] World Health Organization, Diet, nutrition and the prevention of chronic diseases, WHO technical report series 916, 2003. Available from: . [3] World Health Organization, Global strategy on diet, physical activity and health, 2004. Available from: . [4] World Health Organization—Europe, The first action plan for food and nutrition policy 2000–2005, 2001. Available from: . [5] World Health Organization—Europe, The second food and nutrition action plan 2007–2012, 2007. Available from: . [6] EU platform for action on diet, physical activity and health. Available from: . [7] Commission of the European Communities, White paper on food safety, 2000. Available from: . [8] C.F. Van Kreijl, A.G.A.C. Knaap, J.M.A. van Raaij, Our food, our health—healthy diet and safe food in the Netherlands, 2006. Available from: . [9] Netherlands Ministry of Health, Welfare and sport, Gezonde voeding, van begin tot eind, Nota voeding en gezondheid, 2008. Available from: . [10] J. van Raaij, M. Hendriksen, H. Verhagen, Public Health Nutr. 12 (3) (2008) 325–330, doi:10.1017/S1368980008003376. [11] A.T. Dip lock et al., Br. J. Nutr. 81 (Suppl. 1) (1999) S1–S27. [12] Codex alimentarius, Codex general guidelines on claims, 1979. Available from: . [13] Ilsi Europe, PASSCLAIM, A European Commission Concerted Action Programme. Available from: . [14] P.J. Aggett, J.M. Antoine, N.G. Asp, F. Bellisle, L. Contor, J.H. Cummings, J. Howlett, D.J. Muller, C. Persin, L.T. Pijls, G. Rechkemmer, S. Tuijtelaars, H. Verhagen, Eur. J. Nutr. 44 (Suppl. 1) (2005) i5–i30. [15] P.J. Aggett, Eur. J. Nutr. (2009), doi:10.1007/s00394-009-0072-4. [16] Regulation (EC) No. 1924/2006 of the European Parliament and of the Council of 20 December 2006 on nutrition and health claims made on foods, 2006. Available from: . [17] H. Verhagen, J. Clin. Biochem. Nutr. 43 (Suppl. 1) (2008) 1–5. [18] J.R. Lupton, Eur. J. Nutr. (2009), doi:10.1007/s00394-009-0073-3. [19] B. Schneeman, J. Nutr. 137 (2007) 493–494. [20] T. Shimizu, Asia Pac. J. Clin. Nutr. 11 (2002) S94–S96. [21] T. Shimizu, Nutr. Res. Rev. 16 (2003) 241–252.

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