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3 SNF Swedish Nutrition Foundation, Ideon Science Park, SE-22370 Lund, Sweden and 4 Lund University, Lund, Sweden
* To whom correspondence should be addressed. E-mail: asp{at}snf.ideon.se.
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| Introduction |
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The main obstacle to the use of health claims for foods has traditionally been the incompatibility with medicinal product legislation defining products intended for the alleviation, prevention, and treatment of diseases as drugs. The European Commission made a key statement in April 2003 that foods could indeed contribute to health and even risk reduction of specific diseases, a view that had in fact been expressed indirectly by authorities ever since the first official nutrition recommendations had been issued. The first version of the Regulation was released in mid-2003.
The Process for the Assessment of Scientific Support for Claims on Foods (PASSCLAIM) project was sponsored by the European Commission within framework program 5 and coordinated by the International Life Sciences Institute, ISLI Europe. It was carried out during 2001–2005 with the overall aim to define a set of generally applicable criteria for the scientific substantiation of claims on foods.
The objective of this article is to give an overview of the European Regulation and the PASSCLAIM project together with some relevant experience from voluntary Codes of Practice employed in some EU countries, awaiting the Regulation.
The European Regulation and its implementation
The EU Regulation. The main objectives of Regulation (EC) No. 1924/2006 of the European Parliament and of the Council of December 2006 on nutrition and health claims made on foods (1) have been to ensure a high level of consumer protection, effective functioning of the internal market within the EU, fair competition within the food industry, and both stimulation and protection of innovations.
The Regulation defines a health claim in general as "any claim that states, suggests or implies that a relationship exists between a food category, a food or one of its constituents and health." A reduction of disease risk claim is defined as "any health claim that states, suggests or implies that the consumption of a food category, a food or one of its constituents significantly reduces a risk factor in the development of a human disease." Reduction of disease risk claims and claims referring to children's development and health are addressed specifically in Article 14, whereas other health claims belong to Article 13. Table 1 lists the different types of health claims contained in the European Regulation.
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Article 13.5 regulates addition of claims to the list "based on newly developed scientific evidence and/or which include a request for the protection of proprietary data." Whereas the Article 13.1 claims are based on "generally accepted scientific evidence" and only "references to the relevant scientific justification" are requested when suggesting such claims, applications for Article 13.5 claims will require submission of an extensive dossier. Submissions were first accepted on 1 February 2008. The Authority, EFSA, is required to give its opinion within 5 mo after request from the Commission, with additional time if required for completion of the application. The Commission must then make a decision within another 2 mo, after having consulted the member states.
Reduction of disease risk claims and claims referring to children's development and health, according to Article 14. All such claims according to Article 14 are required to go through a rigorous authorization procedure based on an extensive dossier that must be submitted for review. Guidelines for submission have been published by EFSA (2). These guidelines include requirements of an extensive literature review in addition to the specific studies supporting the claim. Submissions must be made to the competent authorities of the member states for further handling by the Commission and EFSA. The Authority, EFSA, must give its opinion within 5 mo, but time is added if required for completion of the application, and the Commission must then make a draft decision within another 2 mo for final decision according to a specific Committee procedure.
Regulatory framework regarding vague claims. Article 10.3 states that "reference to general, nonspecific benefits of the nutrient or food for overall good health or health-related well-being may only be made if accompanied by a specific health claim included in the lists provided for in Article 13 or 14." This means that such vague claims as "good for the heart," "strengthens the immune response/helps the body to protect itself," and the like would be allowed only if they relate to 1 or several authorized additional specific health claims.
Nutrient profiles. One of the conditions for use of both nutrition claims and health claims is that the product fulfills certain nutrient profiles to be set by the Commission by 31 January 2009 as stated in Article 4 (1). The rationale of nutrient profiles is worded as follows in the "whereas clause" 11 (1): "The application of nutrient profiles as a criterion would aim to avoid a situation where nutrition or health claims mask the overall nutritional status of a food product, which could mislead consumers when trying to make healthy choices in the context of a balanced diet." Fat, saturated fat, trans-fatty acids, salt or sodium, and sugars are mentioned as nutrients relevant for setting the nutrient profiles. The nutrient profiles issue became particularly controversial, and a compromise was obtained in that nutrition claims "shall be allowed where a single nutrient exceeds the nutrient profile provided that a statement about the specific nutrient appears in close proximity to, on the same side and with the same prominence as the claim. This statement shall read High [...(*)] content," where (*) refers to the name of the nutrient exceeding the nutrient profile.
The setting of nutrient profiles continues to be controversial, with a key issue being the "category based" or "across the board" setting of the profiles. Another difficult point is to fulfill the requirement that "the nutrient profiles shall be based on scientific knowledge about diet and nutrition, and their relation to health." This issue is highlighted in the recently published conference proceedings "Nutritional characterization of foods: Science-based approach to nutrient profiling" (3).
Although general scientific knowledge is the basis for establishing a health claim, a considerable amount of pragmatism must be applied in setting the profiles in practice. However, evaluation of the effects of nutrient profiles for both product development and consumer choice should always be monitored by scientifically sound methodology.
The Community Register. The Commission shall establish and maintain a Community Register of claims (1, Article 20) including nutrition claims and conditions for their use, restrictions related to nutrient profiles, and authorized health claims and the conditions for their use. Notably, a list of rejected claims will also be established, including the reasons for their rejection. The Register shall be available to the public.
Unresolved issues concerning EU health claims regulation. The EU Regulation provides the framework for future claims within the EU countries, but several issues remain to be sorted out in its interpretation and implementation. One example of such considerations is whether "reduction of LDL-cholesterol" or "reduction of blood pressure" will be regarded as "implicit reduction of disease risk" claims and thus classified as Article 14 claims requiring a full application and dossier. Other examples include whether wordings such as "antioxidant" or "probiotic" will be regarded as health claims in themselves and thus require authorization. Guidelines on such issues are expected from the Commission.
Comparison with Codex Guidelines. In 2004 the Codex Alimentarius Commission adopted Guidelines for Use of Nutrition and Health Claims (4). Three types of health claims are defined in these guidelines: 1) nutrient function claims, 2) other function claims, and 3) disease risk reduction claims. As shown in Table 2, the first 2 types of claims correspond to the Article 13 claims of the EU Regulation. "Other function claims" were previously referred to as "enhanced function claims" according to the nomenclature used in the Functional Foods Science in Europe project (5).
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In some European countries, it has been possible to use Codes of Practices regarding health claims while awaiting the EU Regulation. An important difference between the 2 is that these codes have dealt specifically with food products, whereas the EU Regulation is applicable also to food supplements.
Sweden health claim regulatory framework. The Swedish Food Sector's Code of Practice regarding health claims in the labeling and marketing of food products is a voluntary program that was launched in 1990, and in fact, the first set of rules regarding health claims for foods worldwide. The development and use of the Swedish Code has been reviewed recently (6,7). It was established with close collaboration of appropriate agencies, especially the National Food Administration and the Medical Products Agency. The first version allowed 8 generic disease risk reduction claims that were all based on the official nutrition recommendations. An additional generic claim on whole grain and reduced risk of coronary heart disease was introduced in 2003. The approved generic disease risk reduction claims in the Swedish Code are listed in Table 3.
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The Swedish Code clearly distinguishes between generic claims and product-specific claims. Generic claims are based on generally recognized knowledge of diet-health relations and can be used on a range of products. The requirement is that certain compositional criteria are met regarding the nutrient behind the diet-health relation as well as regarding nutritional composition in general and importance for a healthy diet; i.e., certain nutrient profiles had to be met.
Product-specific claims, on the other hand, would require that the product in itself has an already substantiated effect on physiological functions with benefits regarding health, well-being, and/or performance. The Swedish Code was extended to product-specific claims in 2001. Eleven products have been evaluated by at least 3 internationally renowned experts appointed by the Swedish Nutrition Foundation (SNF) research committee. The expert reports of these evaluations are publicly available at the homepage of the SNF, web addresses listed (7). "Low glycemic index" (GI) has also been regarded as a product-specific physiological claim, and conditions for use of this claim were set in the Swedish Code (9). Two independent GI determinations are required, both showing GI < 55 compared with a glucose standard. A simplified expert evaluation was introduced for GI, and 15 products have been listed as fulfilling the criteria for "low GI."
Suggestions of claims about generally recognized functions of nutrients and other substances according to Article 13.1 based on principles in the Swedish Code. As the coordinating body of the Swedish Code, the SNF was invited by the National Food Administration to make proposals for the Article 13.1 list of health claims. In relation to key principles of the Code, important factors considered in compiling these proposals were relevance and meaningfulness to the consumer. One consideration used was that, to be useful to the consumer choosing a healthy diet, claims should primarily aim to stimulate an intake of nutrients in agreement with official nutrition recommendations. Nutrients for which a considerable part of the population, at least 25%, has intakes below recommendations were therefore given priority, although, by definition, scientifically true Article 13.1-type claims can be made for all nutrients. Furthermore, suggestions of claims for vitamins and minerals commonly involved in many functions of the body were limited to those effects that were considered most important to communicate. Those general functions true for all essential nutrients, e.g., "necessary for normal growth," "essential for the metabolism," and the like, were also considered as less relevant to claim for single vitamins and minerals. This resulted in a rather short list of 24 generic claims for vitamins, minerals, and macronutrients (9). Other claimants have proposed considerably longer lists of claims. For instance, the Confederation of the Food and Drink Industries in the EU compiled a list of 759 claims, also including claims for "other substances" (e.g., probiotics), foods, diets, and botanicals such as herbs and spices that are included in the EU Regulation as well (10).
Consumer relevance is not explicitly highlighted in the EU Regulation, but it is clearly stated that claims must be "truthful, clear, reliable and useful for the consumer in choosing a healthy diet" (clause 29). It remains to be seen how and to what extent EFSA and finally the Commission will consider "relevance" in compiling the final list of permitted claims.
As described above, a number of reduction of disease risk claims, based on generally recognized diet-health relations, were allowed according to the Swedish Code, provided that the wording followed the 2-step principle (Table 3). These would fall under Article 14 in the EU Regulation and require a full application with review of all the evidence. Obviously, a full evaluation of such claims would have to repeat recent systematic reviews behind the general dietary recommendation as well as the ongoing process within EFSA to establish population reference intakes for the EU. Although such generic reduction of disease risk claims is built on "generally recognized scientific knowledge," there is no option in the EU Regulation to include such claims according to the Article 13 procedure. SNF therefore reworded these claims in terms of maintenance of health and suggested their inclusion on the Article 13.1 list. For instance, "reduction of the risk of osteoporosis" in relation to the calcium content of foods would correspond to "maintenance/promotion of healthy/strong bones." In fact, the U.K. Joint Health Claims Initiative (JHCI) (11) already used wording in terms of "healthy heart" and "helps to maintain heart health" to avoid explicit reference to disease (Table 3).
The Netherlands health claim regulatory framework. The Dutch "Code of Practice assessing the scientific evidence for health benefits stated in health claims on food and drink products" was introduced in 1998 on the initiative of the Netherlands Nutrition Centre (12). This Code regards voluntary evaluation of the scientific evidence behind planned product-specific health claims on foods and drinks. As of August 2007, 8 products have passed this evaluation with a positive result.
U.K. health claim regulatory framework. In the United Kingdom, the JHCI (11) was established in 2000. Consumer organizations, enforcement authorities, and industry trade associations were the principals of this voluntary code of practice. JHCI defines both generic and product-specific (innovative) claims. At the time of close down by March 31, 2007, only the generic claims listed in Table 3 had been approved.
Scientific substantiation of claims as addressed in PASSCLAIM
The PASSCLAIM project engaged >160 scientists from academia, industry, research institutes, public interest groups, and the regulatory environment. Its primary objective was to produce a generic tool for assessing the scientific support for health claims in foods (13).
PASSCLAIM defined a number of generally applicable criteria for the scientific support of claims. These criteria emphasized the need for direct evidence of benefits to humans, recognized the usefulness of markers of intermediate effects, and emphasized that effects should be both statistically and biologically meaningful.
The PASSCLAIM project built on a previous European concerted action, Functional Foods Science in Europe (5), which highlighted the use of intermediate or surrogate markers as "outcomes," especially regarding disease risk reduction and validation and quality control of the markers with respect to repeatability, reproducibility, specificity, and selectivity. Markers were assessed as becoming more specific and quantitative the nearer they were to the true endpoint in question. The use of markers was further developed as a main issue in the PASSCLAIM project.
In the first phases of the project, 7 comprehensive reviews were prepared on 1) diet-related cardiovascular disease, 2) bone health and osteoporosis, 3) physical performance and fitness, 4) body weight regulation, insulin sensitivity, and diabetes, 5) diet-related cancer, 6) mental state and performance, and 7) gut and immunity. These reviews formed the basis for development of the criteria. One working group conducted a review and synthesis of existing processes. Two publications (14,15) contain the reviews produced by the theme groups in these key areas. The consensus report (13) presents the criteria and gives an outline of the context within which they are to be assessed.
The context within which a claim is made should be considered in relation to existing legislation as well as dietary guidelines. Foods for which health claims are made should fit into a healthy diet. Other important contextual points are that the regulations should, in principle, reflect the evolving science base and take into account new scientific developments as appropriate rather than, exclude certain areas a priori. The important points that a claim should reflect its scientific basis and at the same time be understandable and not be misleading for the intended consumer were mentioned as issues of context but otherwise considered to fall outside the scope of the PASSCLAIM project (13).
The individual theme groups independently developed criteria for valid scientific study designs and for identification, validation, and use of markers to explore the effects of diet on health, each focusing on a specific theme. The criteria themselves describe the standards by which the quality and relevance of the scientific evidence should be judged and thus the extent to which a claim based on them can be said to be scientifically valid. Therefore, the criteria have the potential to increase public confidence in the role of diet in maintaining and improving health and well-being.
The consensus criteria are listed in Table 4. A key issue is that substantiation of a claim should be based on human data, primarily from intervention studies. There are many forms of human studies, which may be broadly classified into intervention and observational studies. Intervention studies include the randomized controlled trial (RCT) investigating physiological or psychological effects. RCT are often the final piece of evidence for a claim, after data have been gathered from observational and other types of studies such as animal and in vitro cell studies. It is desirable to have >1 RCT showing the effect to be claimed. Mechanisms for the effects are desirable but not essential to know.
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PASSCLAIM criteria for generic claims. With the requirement of RCT as the final and most rigorous piece of evidence, the PASSCLAIM criteria were primarily developed to apply to product- or ingredient-specific claims. Generic claims that are applicable to a range of food products are commented on briefly in the consensus document (13). The same high standard of scientific evidence was decided would apply to all categories of health claims, although the nature of the scientific evidence presented might be somewhat different. Whereas RCT can provide key data for substantiation of innovative and/or product-specific claims for food products, observational studies may provide important methodology in the substantiation of generic claims. Such claims, e.g., those authorized by the FDA of the United States, would require "significant scientific agreement," which is equivalent to "convincing" in the abovementioned grading of evidence (16). Evidence accepted by scientific bodies, e.g., official national or international nutrition recommendations, would then be regarded as "convincing" to establish a basis for the corresponding generic health claims (17).
Conclusion
The recent EU Regulation provides the basis for allowance of health claims on foods and harmonization of these claims within the European community. Codes of practice, applied in some EU countries currently awaiting the Regulation, have provided experience with health claims and their scientific substantiation that will be useful in the implementation of the EU Regulation.
PASSCLAIM provides a scientifically robust tool for evaluating the quality of the data submitted in support of health claims on foods. It could assist both those preparing scientific dossiers supporting claims as well as regulatory bodies assessing those dossiers. PASSCLAIM could also improve the credibility of claims for consumers.
Other articles in this supplement include references (18–27).
| FOOTNOTES |
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2 Author disclosures: N.-G. Asp, and S. Bryngelsson, no conflicts of interest. The supplement sponsor, Danone Institute International, is one of
40 member companies in the Swedish Nutrition Foundation. ![]()
5 Abbreviations used: EFSA, European Food Safety Authority; EU, European Union; GI, glycemic index; JHCI, Joint Health Claims Initiative; PASSCLAIM, Process for the Assessment of Scientific Support for Claims on Foods; RCT, randomized controlled trial; SNF, Swedish Nutrition Foundation. ![]()
| LITERATURE CITED |
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23. L'Abbé MR, Dumais L, Chao E, Junkins B. Health claims on foods in Canada. J Nutr. 2008;138:1221S–7S.
24. Jew S, Vanstone CA, Antoine J-M, Jones PJH. Generic and product-specific health claim processes for functional foods across global jurisdictions. J Nutr. 2008;138:1228S–36S.
25. Ames NP, Rhymer CR. Issues surrounding health claims for barley. J Nutr. 2008;138:1237S–43S.
26. Xiao CW. Health effects of soy protein and isoflavones in humans. J Nutr. 2008;138:1244S–9S.
27. Farnworth ER. The evidence to support health claims for probiotics. J Nutr. 2008;138:1250S–4S.
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