Eur J Nutr 42 [Suppl 1] (2003) : I/96–I/111DOI 10.1007/s00394-003-1105-z

David P. RichardsonDPR Nutrition Ltd34 Grimwade AvenueCroydon CRO 5DG Surrey, UKTage AffertsholtJ. M. Moerks Gade 1Postbox 51048100 Aarhus C, DenmarkNils-Georg AspLund University and SNFSwedish Nutrition FoundationResearch Park Ideon22370 Lund, SwedenÅke BruceNational Food AdministrationP. O. Box 62275126 Uppsala, SwedenRolf GrossklausBgVV, Bundesinstitut für gesundheitlichen,Verbraucherschutz und VeterinärmedizinThielallee 88–9214195 Berlin, GermanyJohn Howlett74, West HillWembley ParkMiddlesex HA9 9RS, UKDaphne Pannemans (�)ILSI EuropeAvenue E. Mounier 83box 61200 Brussels, BelgiumE-Mail: publications@ilsieurope.beRichard RossGlaxoSmithKlineNutritional Health Care R&DRoyal Forest FactoryColefordGloucestershire GL16 8JB, UKHans VerhagenUnilever Health InstituteP. O. Box 1143130 AC Vlaardingen, The NetherlandsVolker ViechtbauerRed BullAm Brunnen 15330 Fuschl am See, Austria

■ Summary Several approaches tothe use of health claims on foodshave been made around the world,and the common theme is that anyhealth claim will require scientificvalidation and substantiation.There is also broad consensus thatany regulatory framework shouldprotect the consumer, promote fairtrade and encourage innovation inthe food industry.

This paper is based on a criticalevaluation of existing internationalapproaches to the scientific sub-stantiation of health claims, with aview to identifying common newideas, definitions, best practice anda methodology to underpin cur-rent and future developments.

There is a clear need to haveuniform understanding, terminol-ogy and description of types of nu-trition and health claims. Twobroad categories were defined: Nu-trition Claims, i. e. what the prod-uct contains, and Health Claims,i. e. relating to health, well-beingand/or performance, includingwell-established nutrient functionclaims, enhanced function claimsand disease risk reduction claims.Such health claims relate to whatthe food or food components doesor do. The categories of healthclaims are closely and progres-sively related and are, in practice,part of a continuum. Provision isalso made for “generic” or well-es-tablished, generally acceptedclaims and for “innovative” or

“product-specific” claims. Specialattention was paid to reflect thehealth-promoting properties of afood or food component in such away as to facilitate the making ofrisk reduction claims outside themedical scope of the term preven-tion.

The paper sets out basic princi-ples and guidelines for communi-cation of health claims and princi-ples of nutritional safety. The mainbody of the work examines theprocess for the assessment of sci-entific support for health claims onfood and emphasises an evidence-based approach consisting of:� Identification of all relevant

studies exploring the collectionof evidence, data searches, thenature of the scientific evidence,sources of scientific data (in-cluding human interventionstudies, human observationalstudies, animal studies and invitro studies, and the use of bio-markers in human studies

� Evaluation of the quality of indi-vidual studies to ensure goodexperimental design and inter-pretation

� Interpretation of the totality ofevidence to apply scientificjudgement to interpret theweight of evidence as a whole

� Assessment of significant scien-tific agreement on a case-by-

David P. RichardsonTage AffertsholtNils-Georg AspÅke BruceRolf GrossklausJohn HowlettDaphne PannemansRichard RossHans VerhagenVolker Viechtbauer

PASSCLAIM1 – Synthesis and review of existing processes

1 Process for the Assessment of ScientificSupport for Claims on Foods

D. P. Richardson et al. I/97PASSCLAIM – Synthesis and review of existing processes

Introduction

The primary roles of diet are to provide sufficient nutri-ents to meet the metabolic requirements of an individ-ual and to give the consumer a feeling of satisfaction andwell-being through the pleasure of eating. In addition,particular diets, foods and food components can pro-vide additional physiological, cognitive and psychologi-cal benefits and biological activities beyond their widelyaccepted nutritional effects. In fact,diet not only helps toachieve optimal health and development but can alsoplay an important role in reducing the risk of specificdiseases.

Much attention is now being paid to health claims forfoods, especially those related to the newly discoveredfunctions of diet. Several approaches to the use of healthclaims on foods have been made around the world, andthe common theme is that any health claim will requirescientific validation and substantiation. There is alsobroad consensus that any regulatory framework shouldprotect the consumer, promote fair trade and encourageinnovation in the food industry [1].

A main impetus in the European Union (EU) was theConsensus Document on Scientific Concepts of Func-tional Foods in Europe (FUFOSE) produced from the EUDG XII Concerted Action Project, whose objective wasto suggest a scheme to link “enhanced function” claimsand “reduced risk of disease” claims to solid scientificevidence [2, 3]. The FUFOSE conclusions are now beingdeveloped in the current project to establish a Processfor the Assessment of Scientific Support for Claims onFoods (PASSCLAIM).

The objectives of PASSCLAIM are the following:� Produce a generic tool with principles for assessing

the scientific support for health-related claims forfoods and food components

� Evaluate critically the existing schemes that assessthe scientific substantiation of claims

� Select common criteria for how markers should beidentified, validated and used in well-designed stud-ies to explore links between diet and health.

The following commentary is based on a critical evalua-tion of existing international approaches to the scien-tific substantiation of health claims, with a view to iden-tifying common new ideas and definitions, best practiceand a methodology to underpin current and future de-velopments.

Several European countries are already developingguidelines on what to do with health claims [4]. Many ofthese codes are still evolving, and although there is anunderlying consistency of approach, there are diffe-rences – sometimes in minor, and sometimes in major,aspects. Similarly, international comparisons of regula-tory approaches indicate the need for promoting har-monisation (see Table 1). Difficulties arise in the analy-sis of the different codes to determine how importantthey are, what kind of supporting information and sub-stantiating evidence is required, who is going to evaluatethe application, what are the associated costs andtimescales involved.This lack of a harmonised approachto health claims, the lack of a unified system for autho-risation and the increasing number of local regulations,guidelines or codes of practice can create major ineffi-ciencies. For example, in some countries lists have beencompiled with defined wording for health claims, e. g.the USA, whereas in others, such as the UK, the wordingof the scientific linkage between a health benefit and afood or food component is carefully formulated by anexpert panel of scientists to reflect the evidence onwhich the claim is approved. However, the wording ofthe claim for labelling and advertising itself may be al-tered after consultation with the code administrators,provided that the claim does not imply health benefitsbeyond the scope of the evidence, change the meaningor confuse consumers [5].

It is clear that the various initiatives on health claimsaround Europe and beyond could lead to divergent andinconsistent interpretations and enforcement of the ex-isting European legal provisions, and, potentially, a dif-ferent regulatory status for a given product with thesame composition between Member States. Nutritionand medical sciences now recognise the contributionsthat diet and individual foods may make to the promo-tion and maintenance of health. Currently, however, EUlaw prevents the communication of these benefits toconsumers, whilst law on medicinal products is estab-lished on a very broad basis that also encompasses foodsmaking preventive, therapeutic or curative claims. Theconcept “disease risk reduction”as proposed by FUFOSEand other international bodies has been developed to re-flect the “health-promoting”properties of a food or foodcomponents in such a way as to facilitate such healthclaims for “risk reduction” to be made outside the med-ical scope of the term “prevention” [6, 7]. The new con-cepts of health claims, including disease risk reduction

case basis to agree within therelevant scientific communitythat an association between afood or a food component and ahealth benefit is valid.Annexes include an interna-

tional comparison of regulatoryapproaches to health claims, sug-gestions for the documentationand presentation of evidence, and aprocedure for reviewing the evi-dence.

■ Key words health claims –definitions – scientificsubstantiation

I/98 European Journal of Nutrition, Vol. 42, Supplement 1 (2003)© Steinkopff Verlag 2003

claims, reflect the fact that foods with health claims areaimed either at the healthy population or healthy indi-viduals, i. e. recognising that the disease is not present;the cause of the disease is multifactorial, including di-etary, behavioural, environmental and genetic factors,and that the modification of certain dietary componentsalone cannot ensure that a disease will not develop,sinceit does not affect the other confounding factors. Never-theless, the food or food component may help signifi-cantly to reduce the likelihood of developing the disease.

The purpose of this review is, therefore, to developthe process for the assessment of scientific support forhealth claims on foods. Once the scientific validity of alink between a food or a food component and a healthbenefit has been established, health claims, including re-duction of disease risk claims, should be permitted infood labelling and advertising to express clearly, andmore directly, the beneficial relationship between eithera diet, a food or a food component and human health.

Table 1 International comparison of regulatory approaches to health claims (✓ = yes sometimes still under development, X = no, – = not applicable)

e. g. (UK) JHCI (5) Sweden (10, 21, 32) Canada (33) CIAA (34) Japan (34, 35)

Website www.jhci.co.uk www.snf.ideon.se www.hc-sc.gc.ca/food- www.ciaa.be Available in Japanesealiment/english/subjects/health_claims/

Voluntary/mandatory Voluntary Voluntary Mandatory Voluntary Mandatory

Origin Industry, consumers, Industry (from Government Food manufacturing Governmentenforcement primary production to industry guidelinespartnerships retail organisations).

Supported by mainconsumer organisations

Definitions ✓ ✓ ✓ ✓ ✓

Health claims ✓ ✓ ✓ ✓ ✓

Enhanced function ✓ ✓ ✓ ✓

Disease risk reduction X ✓, for generic claims ✓ ✓ Xin two steps

Generic claims ✓ ✓ ✓ X ✓

Product specific ✓ ✓ ✓ X ✓

Communication guidelines ✓ ✓ ✓ ✓

Nutrition principles ✓ ✓ ✓ ✓

Amount and frequency ✓ ✓ ✓ ✓specified

Safety Refers to existing law Refers to existing law ✓ Refers to existing law ✓ data required

Quality assurance Refers to existing law In general terms ✓ Refers to existing law ✓

Guidelines for dossier ✓ X ✓ ✓ ✓

Process for substantiation ✓ ✓ ✓ X ✓

Approval procedure Level of data required ✓ outlined X ✓

Administrative procedures ✓ ✓ X ✓

Use of independent ✓ (7 experts) At least 3 experts X ✓ (Ministry)expert panel appointed case by case

Defined wording of X X X ✓ (6 months)health claims

Start date of code 2000 12 years generic still evolving – Since 1991< 1 year product (revised 2001)specific

Health claims approved 6 8 generic since 1990. – 302 product specific(to Sept. 2002) 1 product specific claims

Financial support Mainly industry Principals of code – Fees to be paid forfunding/project grants basic funding. evaluationfrom FSA, moving to Fees for evaluation ofmembership scheme product-specific claimsin 2002

Timescale for approval X ✓ (4 months) – ✓ (6 monthsminimum)

D. P. Richardson et al. I/99PASSCLAIM – Synthesis and review of existing processes

Definitions

■ Background

There is a clear need to have uniform understanding,terminology and descriptions of the types of nutritionand health claims in order to provide clarity in commu-

nication and presentation of the concepts, particularlywith regard to the nature and extent of the scientific sub-stantiation that will ultimately be required. Descriptionsthat are likely to be most appropriate are those based onthe experience developed internationally throughCodex. The concepts set out by the European Commis-sion Concerted Action on Functional Food Science inEurope (FUFOSE) project can also provide guidance as

Table 1 Continued

USA (18, 36) Codex (9) Council of Europe (16) The Netherlands (22) Belgium (37)

Website www.cfsan.fda.gov/ http://www.codex www.coe.fr/soc-sp www.voedingscentrum.nl~dms/hclaims.html alimentarius.

net/reports.asp

Voluntary/mandatory Voluntary Voluntary Voluntary Voluntary Voluntary

Origin Manufacturers, federal Codex members Council of Europe Industry, consumers, Industryscientific bodies, e. g. scientistsNAS, NIH etc.

Definitions ✓ ✓ ✓ ✓ ✓

Health claims ✓ ✓ ✓ ✓ ✓

Enhanced function ✓ ✓ ✓ ✓ ✓

Disease risk reduction ✓ ✓ ✓ ✓ ✓

Generic claims ✓ ✓ (X) X ✓

Product specific ✓ ✓ ✓ X ✓

Communication guidelines ✓ ✓ ✓ ✓

Nutrition principles ✓ ✓ ✓ ✓ ✓

Amount and frequency ✓ ✓ X Xguidelines

Safety Refers to existing law ✓ Refers to existing law Refers to existing law X

Quality assurance ✓ ✓ X X

Guidelines for dossier ✓ ✓ X X X

Process for substantiation ✓ ✓ ✓ ✓ ✓

Approval procedure ✓ (except medical – – ✓ Xfoods)

Administrative procedures ✓ X ✓ X

Use of independent FDA, federal scientific – – ✓ Xexpert panel bodies

Defined wording of health ✓ X X X Xclaims

Start date of code 1990 (NLEA authorised At step 5 of the – 1998 Draft 1998health claims) Codex procedure1997 (FDAMA, basedon authoritativestatement)2000 (Qualified healthclaims)

Health claims approved 12 generic since 1993 – 2 X(to May 2002) 2 generic health claims

based on authoritativestatements since 1997

Financial support – Fees for evaluation X

Timescale for approval Yes (more than 1 year – 3 months Xunder NLEA)FDAMA gives FDA120 days to respond thehealth claim notification

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well as the guidelines concerning scientific substantia-tion of health-related claims for functional foods re-cently issued by The Council of Europe.

Claim means any representation that states, suggestsor implies that a food has particular characteristics re-lating to its origin, nutritional properties, function, na-ture, production, processing, composition or any otherquality.

There are two broad categories of claims relevant tofood:� Nutrition claim, i. e. what the product contains (see

Nutrition claim section)� Health claim, i. e. a claim related to health, well-being

and/or performance, including nutrient functionclaims, enhanced function claims and disease risk re-duction claims. Such claims relate to what the food orfood components of the products does or do (seeHealth claim section).

■ Nutrition claim

Nutrition claim means any representation that states,suggests or implies that a food has particular nutritionalproperties including, but not limited to, the energy valueand the content of protein, fat and carbohydrates, as wellas the content of vitamins and minerals.

■ Nutrient content claim is a nutrition claim that de-scribes the level of a nutrient contained in a food. Nutri-ent means any substance normally consumed as a con-stituent of food: a) which provides energy; or b) whichis needed for growth, development and maintenance oflife; or c) a deficit of which will cause characteristic bio-chemical or physiological changes to occur [8].

■ Comparative claim is a claim that compares the nutri-ent levels and/or energy value of two or more foods (ex-amples: “reduced”, “less than”, “fewer”, “increased”,“more than”).

These are factual statements that draw consumers’at-tention to an aspect of the product’s nutrient contentthat may be of interest and benefit to them, e. g. low fat,high fibre, source of calcium. These claims may signal achange from the manufacturers’ standard product orfrom the standard product of a competitor; or it may bethat the product is particularly high or low in a specificnutrient, which would make that product of interest togroups of consumers seeking to increase or reduce theirintake of that nutrient.

■ Health claim

Health claim means any representation that states, sug-gests or implies that a relationship exists between a food

or a constituent of that food and health [9]. Healthclaims include the following:

■ A nutrient function claim promotes the role of a nutri-ent in its broadest understanding in growth, develop-ment and normal physiological functions of the body,e. g. calcium aids in the development of strong bonesand teeth. These claims are generally based on well-es-tablished and generally accepted scientific knowledge.

■ An enhanced function claim refers to specific beneficialeffects of foods and food components on physiologicaland psychological, cognitive functions or biological ac-tivities, but does not include nutrient function claims.Beneficial health effects of nutrients (where an addi-tional function is identified or claimed, i. e. beyond itsgenerally accepted nutritional effect), ingredients andnon-nutritive substances are included under the defini-tion of food component. Diseases or disorders are notnamed. Such claims have recently been referred to as“(other) function claims”[9] and relate to FUFOSE TypeA claims (Fig. 1).

For example, enhanced function could apply to thefollowing:� An additional function of a listed nutrient (usually at

a higher level of intake)� A function of a food component (e. g. an ingredient

that has cholesterol-lowering, calcium-absorption-stimulating, prebiotic effects etc.)

� A specific physical or chemical property of the foodor food components (e. g. low glycaemic index due tospecific structural or starch properties).

■ A reduction of disease risk claim refers to the fact thatthe consumption of a food may help to reduce the risk ofa disease. The disease or disorder is named and the riskreduction is explicitly stated. These claims relate to FU-FOSE Type B claims.“Reduction of disease risk claims”may currently often be regarded as illegal under the in-terpretation of food labelling legislation. However, risk

Fig. 1 Functional foods; a proposal for a scientific basis for claims

D. P. Richardson et al. I/101PASSCLAIM – Synthesis and review of existing processes

reduction means significantly altering a major risk fac-tor for a disease or health-related condition. Diseaseshave multiple risk factors and altering one of these riskfactors may or may not have a beneficial effect. The pre-sentation of risk reduction claims must ensure, for ex-ample by use of appropriate language and reference toother risk factors, that consumers do not interpret themas prevention claims [7, 9].

Continuum

The categories of health claims set out above are closelyand progressively related and are, in practice, part of acontinuum. The use of health claims relating a food or afood component, in the context of the total diet, to thereduced risk of developing a disease, has made it neces-sary to clarify in the EU regulatory framework that suchclaims do not fall under the prohibition of preventiveclaims. In addition, the prohibition deriving from theability “to modify a particular physiological function”needs to be re-considered in the light of the recognitionthat physiological effects of foods and food componentsare normal and commonplace. Developments in the nu-trition and medical sciences now recognise many im-portant contributions that diet, individual foods andfood components can make to the promotion and main-tenance of health. In particular, the concept that foodscan reduce the risk of disease over and above the provi-sion of nutrients that they contain is now generally ac-cepted.

Generic versus product-specific claims

Two approaches, which have been developed in theSwedish, UK, Canadian and Australia New Zealandcodes, include Generic Health Claims and Product-spe-cific Health Claims.

Claims may relate to diets, broad food categories,food components including nutrients (“generic”), or re-late to particular food products (“product specific”).The degree of substantiation required may relate to thisdistinction. The scientific standard for the substantia-tion of generic and product-specific health claimsshould be the same, although the sources and nature ofthe supporting evidence for health claims may be diffe-rent. Product-specific health claims are likely to bebased primarily on human intervention studies showingthe claimed effect when the product is consumed as partof a normal diet.

■ A generic claim is based on well-established, generallyaccepted evidence in the scientific literature and/or torecommendations from national or international publichealth bodies, e. g. EU SCF and US FDA and national sci-entific advisory committees.

Based on this definition, the scientific linkages for

generic health claims, including nutrient functionclaims,should be pronounced once the totality of the ev-idence that supports the claim has been assessed (see theSources of scientific data section). A generic healthclaim may be relevant for complying diets, foods or foodcomponents including nutrients. A “complying” foodcomprises or contains the components in sufficientquantity to produce the effect claimed,or falls within thecategory of foods to which the generic claim applies.

“Two-step” health claims are based on the establish-ment of a diet and health relationship and linkage of thehealth claim to a nutrition claim about what the productcontains. The principle for these claims is similar to thatused in the USA. In Sweden, the so-called “two-stepprinciple” has been used since 1997 to ensure compati-bility with the general prohibition on medicinal claimsin the EU. The National Food Administration in Swedenconsiders the “two-step claims” to be compatible withexisting EU law. A good example is the link of a generichealth claim “saturated fatty acids increase the level ofcholesterol in the blood” and a nutrient content claimthat the product contains low levels of saturated fat.Within CODEX, the two-step principle is now suggestedfor both nutrient function claims and reduction of dis-ease risk claims.

■ A product-specific claim is one other than a genericclaim. It means that in the marketing of a product, thereis a claim concerning the health-promoting effect of theproduct itself. The food product must have been de-signed to provide a specific and documented effect [10].

It is very important that the distinction is made be-tween generic claims made in two steps, and product-specific claims. For the former, there is no requirementto document the effect(s) of a particular product in hu-man studies where the composition of the product ful-fils the nutrient content claim condition, e. g. a productlow in saturated fatty acids may have a claim relating toa cholesterol-lowering effect.

■ Medicinal claims and human disease

A medicinal claim is a claim that states or implies that afood or a food component (including any nutrient) hasthe property of treating, preventing or curing humandisease or makes any reference to such a property.“Hu-man disease” means any injury, ailment or adverse con-dition, whether of body or mind. These claims are pro-hibited absolutely in the labelling or advertising of foodin current EU legislation [7, 11].

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■ Claims relating to foods for particular nutritional uses (PARNUTS)

There is a basic difference between foodstuffs qualifyingfor health claims and PARNUTS/Foods for special di-etary uses. The former products are intended for basic-ally healthy individuals, who want to stay healthy, whilethe latter are intended for individuals with a particularphysical or physiological condition and/or a specific dis-ease or disorder.

The present Codex definition of Foods for special di-etary uses is as follows:

Foods which are specially processed or formulated tosatisfy particular dietary requirements which exist be-cause of a particular physical or physiological conditionand/or specific diseases or disorders and which are pre-sented as such. The composition of these foodstuffsmust differ significantly from the composition of ordi-nary foods of comparable nature, if such ordinary foodsexist [12].

Foodstuffs intended for particular nutritional uses[13, 13 with later amendments] are products that, owingto their special composition or manufacturing process,are:� Clearly distinguishable from foodstuffs of normal

composition;� Suitable for their claimed nutritional purposes and� Marketed in such a way as to indicate such suitability.

The particular nutritional nature of these productsmeans that they must fulfil the particular nutritional re-quirement of:� Certain categories of persons whose digestive

processes of metabolism are disturbed or� Certain categories of persons who are in a special

physiological condition and who are therefore able toobtain special benefit from controlled consumptionof certain substances in foodstuffs.Within the category of PARNUT products there are

also infant and baby foods and foods intended for use inenergy-restricted diets for weight reduction.

A new category is:� Dietetic foods for special medical purposes [14].

Moreover, special provisions regarding ‘foods intendedto meet the expenditure of intense muscular effort, es-pecially for sportsmen’ will be laid down by specific di-rectives.

The different categories of health claims should beconsidered as parts of a health continuum, however, andin practice it may not be clear where an enhanced func-tion, disease risk reduction or dietetic (medicinal) claimbegins and ends. It is important to clarify these aspectsin the near future.

Communication aspects

Communication of the health benefits to the consumeris an important challenge in the development and mar-keting of health-promoting foods. Communicationshould not only aim at informing about the quality of aparticular food but it should also play, where appropri-ate, an education role in addition to existing nutritioneducation programmes. The importance of adequatenutrition and the relationships between diet and healthand between diet and disease risk should be empha-sised.

The claim must be communicated in such a way as toassist consumer understanding of the basis of the claim.

■ Basic principles

Health claims must be truthful and must not mislead,exaggerate or deceive either directly or by implication.The claim must not suggest or imply health benefits be-yond the scope of the evidence.

■ Guidelines for communication of health claims

The claims may suggest that consuming a food or a foodcomponent with a health claim may contribute to theimprovement of the diet or well-being but it should notsuggest or imply that intake of that food alone can cor-rect otherwise unhealthy lifestyles and/or dietary habitsor is the only way to enhance a particular physiologicaleffect or to reduce the risk of a given disease,unless true.

Communication of health-related claims to the con-sumer may include all means of communication, e. g.package label, advertisements, product informationsheets, recipe brochure, marketing brochure, spokenand textual content of video, film and TV commercialsand Website.

Communication of health-related claims should trig-ger nutrition labelling in accordance with relevant EUlaws; this should be in the form of Group 2, i. e. energy,protein, carbohydrate, sugars, fat, saturates, fibre andsodium, in accordance with Council directive90/496/EEC. In addition any further information rele-vant to the claim must be given.

It must be truthful, unambiguous and understand-able for the intended consumer; make clear that thehealth-related claim applies only to the food consumedin the context of a total dietary pattern; not encourageover consumption of a given food to the detriment ofothers unless justifiable; include information on the in-tended consumer or potentially vulnerable segment ofthe population; include information on how to consumeor use the functional food to obtain the claimed effect,and finally, the likely consumer perception of the health-

D. P. Richardson et al. I/103PASSCLAIM – Synthesis and review of existing processes

related claims should be taken into consideration. Spe-cial care should be taken in the case of advertising di-rected at children.

The labelling and the labelling methods used, thepresentation and the advertising of foods must not sug-gest or imply the prevention, treatment or cure of hu-man disease. With regard to PARNUTS, this fact shouldnot prevent the dissemination of any useful informationor recommendations exclusively intended for personshaving qualifications in medicine, nutrition or phar-macy.

Principles of nutritional safety

Food safety is already covered by general rules of exist-ing legislation. However, the development of foods andfood components with health claims must take into ac-count basic nutritional principles and nutritional safetyconsiderations. As such, nutritional safety is an impor-tant issue related to a claim but is NOT part of a claim.

Across the codes there is great variation in the use ofthe word “safety” or “safe”. Some codes do mention“safety” or “safe” but state that their code does not con-cern safety. The absence of “safety” or “safe” from thecodes does not mean that this is not a concern of theoriginator. Rather food safety is subject to extensive reg-ulations throughout the world.Several codes have there-fore not made mention thereof or have just indicatedthat this is taken care of elsewhere.

■ Basic principles

All foods, including those for which health claims aremade, should as a matter of routine comply with thegeneral requirements as laid down in applicable foodlaws and take into account basic principles of nutritionand safety. In all circumstances food should be safe.Where appropriate, foods should conform to the re-quirements of the European Novel Food Regulation[15]. The Council of Europe paper on the guidelines ofhealth claims for food and food components has con-sidered these safety aspects in detail [16].

■ Dietary significance

Foods with health claims have the potential to influencedietary habits, and hence it is essential that their com-position should contribute positively to a nutritionallyadequate diet. Food should be consumed in realisticamounts in the normal daily diet and the claim must bemade in the context of the total diet. Health claims thatrelate to dietary guidelines must be consistent with thepattern of eating described in the dietary guidelines.

Health claims should not unfairly denigrate other foodsor imply that normal foods cannot provide a healthydiet. The benefit must be fulfilled by the amount of thefood or food component and the frequency of con-sumption as recommended on the label, and the mar-keting information should give the consumer good in-sight into the connection between good diet and health.The extent of use of a product is important and healthclaims that could encourage high levels of consumptionmust not be made for any substance where there is evi-dence that high intakes of the food or food componentcould be harmful, or be unlikely to contribute to ahealthy diet.

■ Interactions with other constituents of the diet

It is important to be aware of any potential interactionsof the foods or food components with other constituentsof the diet. Possible interactions include the bioavai-lability of a nutrient or other ingredient (both impairedor increased digestive absorption).

■ Impact on metabolic pathways and physiological function

The consumption of nutrients and other bioactive mol-ecules can have diverse actions that may entail sustainedmetabolic changes, perhaps with toxicological signifi-cance. It is necessary to establish the nature of the effectsand any response or reversibility of the claimed effect af-ter ceasing use of a specific food or food component.

■ The intended consumer and vulnerable groups

Particular sections of the population such as the young,the elderly or those suffering from specific diseases ortaking medications may be susceptible to new dietarybehaviours. Relevant information should be providedwhere appropriate.Also the claim and evidence must berelevant to the intended consumer.

■ Overall toxicological assessments

Toxicological safety comprises basic aspects of toxicol-ogy such as dose (and associated aspects: over con-sumption, combined intakes from all sources, maximumsafe intake levels, recommended amounts/usage levels),effect (interactions) and risk factors (vulnerable groups,target groups, possible allergens). It is important toknow, where possible, the metabolic fate and biologicaldistribution of a particular component of interest.

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■ Post Launch Monitoring (PLM)

Long-term observation of consumers is important, es-pecially if functional foods are targeted at special popu-lation groups. The objective of Post Launch Monitoring(PLM is the preferred terminology to discriminate fromPost Market Surveillance, the terminology for pharma-ceuticals) is 1) to establish dietary intakes and comparethese with anticipated intakes, and 2) to identify any ad-verse effects that could not be identified in toxicologicaltests.PLM is explicitly not indicated to assess health out-comes: that carries the high risk of trying to establish ef-ficacy in a largely uncontrolled “study” design. The exe-cution of PLM should be considered on a case by casebasis.

■ Quality assurance

Quality assurance (QA) is an essential element of toxi-cological safety testing. As concerns QA, a subdivisionwas made into the QA of studies (GLP – Good Labora-tory Practice, GCP – Good Clinical Practice, GEP – GoodEpidemiological Practice), Quality Control of the activeprinciple in a food product, and GMP – Good Manufac-turing Practice/Sanitary safety of the food product.There is as yet no requirement for GLP/GCP/GEP in thestudies supporting the claims, and hence these are notconsidered essential. However, it is necessary to have in-sight into the actual levels of the bioactive ingredientscontained in the foods. This involves quality control inthe studies and GMP of the foods.

■ Ethical considerations

Studies with human volunteers and animals shouldcomply with (inter)national regulations and be ap-proved by the appropriate ethical committees.

Process for the assessment of scientific support for health claims on foods

All health claims in advertising, labelling or promotionmust be capable of substantiation. Whether generic orproduct-specific, the claimed benefit must be supportedby scientifically valid evidence demonstrating the effi-cacy of the food(s) or food component(s) in humans andunder typical conditions of use and exposure. The sci-entific evaluation must show that the scientific evidencefor the health claim outweighs opposing evidence oropinion. The health benefits must take account of thebest scientific evidence that is likely to stand the test oftime.

When a health claim is used for a food or food com-

ponent, the following criteria must be demonstrated, ifappropriate:� That the food or food component in question will

cause or contribute to a significant benefit when con-sumed by the target population in the context of anormal diet.

� That the claimed effect can be achieved by consum-ing a reasonable amount of the food or food compo-nent on a regular basis or by the food or food com-ponent making a reasonable contribution to the diet.

� That the effect is maintained over a reasonable pe-riod of time with continued consumption and is nota short-term response to which the body adjusts un-less the resultant health claim is relevant only for ashort- or medium-term benefit.

� The minimum and maximum amounts and the fre-quency of consumption required to achieve the ef-fect, or that the food or food component provides areasonable dietary contribution to that amount re-quired to achieve the effect.

� Who can benefit from the effect, e. g. whether it is theentire population,“at risk” groups or population sub-groups.

� How the effect is brought about, although the exactbiological mechanism(s) may not be fully under-stood or explainable.

� Reasonable assurance that foods and food compo-nents with health claims do not have negative nutri-tional and health impacts at recommended levels ofintake during long-term exposure.

■ Source and nature of scientific evidence: an evidence-based approach

Evidence-based science is being used for three featuresof public health nutrition: the establishment of dietaryreference values, including recommended daily intakes,the development and revision of dietary guidelines andthe validation of health claims on foods and food com-ponents [17]. Guidelines advise people, for example, toeat less saturated fat. Health claims declare a benefit, forexample that saturated fat may increase the blood cho-lesterol level, a risk factor for cardiovascular disease,connected with a nutrition claim that a food containsless saturated fat than similar foods do.

The type and extent of the evidence required will bedetermined by whether the claim relates to a particulardiet, a food group, a specific food, a proprietary foodproduct, or a food component. The evidence must pro-vide information on the scientific substantiation of thetypes of health-related claims.

Depending on the type of health claim, the followingdata should be considered for scientific substantiation,where applicable:� Identification of all relevant studies

D. P. Richardson et al. I/105PASSCLAIM – Synthesis and review of existing processes

� Human intervention studies� Human observational studies� Animal studies and in vitro studies� All other pertinent studies, such as consensus reports

and evidence-based dietary guidelines.The evidence should be based primarily on the re-

sults of well-designed human studies that are consistentwith generally recognised scientific procedures andprinciples. The research should assess the effects offoods or food components on the health status of humansubjects. In other words, the outcome – measured inclinical/observational, epidemiological and, where pos-sible, nutrition intervention studies – should be the im-provement in some indicators of health or well-being orthe reduction of risk of diseases.

It is acceptable to provide evidence of the effects ofthe food(s) or food component(s) on appropriatelyidentified, characterised and validated biomarkers.

■ The identification of all relevant studies

Collecting the evidence

A health claim must be based on a systematic and ob-jective compilation of all the available scientific evi-dence relating to the health claim, including publishedscientific literature. Compiling the evidence must bedone in a balanced and unbiased way to ensure that allrelevant data, both positive and negative, has been in-cluded in the documentation. It is expected that somestudies may provide negative or contradictory results;however, the weight of the evidence must clearly sub-stantiate the claim.

Data searches

A successful review of the scientific data depends on acarefully considered and clearly defined health benefit.A systematic approach must be employed to search fordata and retrieve all relevant information (Table 2). Anexplicit and reproducible methodology should be usedand recorded clearly while the search is undertaken.Clear search terms and defined key words are required,and they must relate explicitly to the proposed healthclaim.

The use of relevant databases, including electronicdatabase searches, requires judgement at every step ofthe process, about the suitability and quality of the evi-dence. It is sensible to search the evidence chronologi-cally, on a yearly basis starting from the present, and or-ganise the results in reverse chronological order,recording the different types and quality of the individ-ual studies.A search of the latest issues of major journalsfor relevant articles may also provide additional and ap-propriate information.

It is essential that the selection of studies should bebased on adherence to explicit and predefined inclusionand exclusion criteria, which link directly to the healthclaim. The reasons used for rejection of articles asflawed must be clear, the methodological quality of in-cluded studies must be high and each study should becarefully considered for its validity.

The search results will identify individual papers andreviews, and well-written abstracts should provide suf-ficient information to decide whether the study is rele-vant to the scientific question based around the healthclaim. The next stage is to retrieve the full article and toextract all the relevant information from all eligiblestudies. It is also helpful to present a synopsis of indi-vidual studies in a standardised way, which will help todetermine whether the study is methodologicallysound. The individual studies should be evaluated forrigour of design, appropriateness of methods and pro-cedures, reliability of measures of intake and outcomes,sufficient statistical power, strength of conclusions andcomprehensiveness of reporting (Table 3).

The presentation of the data can be done according tostudy type and design. Ideally, the overall results of thereview, that is, a summary of all individual study resultsshould be presented to illustrate the weight of scientificopinion.

Table 2 An example of a procedure for reviewing the evidence (adapted from ref. 5)

Proposed wording of health claimDefines and determines the

Scientific questionWhich in turn defines and determines the

Keywords for searching the evidence in databasesResults in

Reference list #1Including relevant documentation, which should be short-listed by assessing against

Broad inclusion/exclusion criteria (pre-defined)To decide whether a particular study is linked directly to the health claim. If yes, include for further inspection under

Reference list #2From which

Abstracts will be retrieved and readAnd included or excluded based on

Further refined inclusion criteria (pre-defined)Followed by

Retrieval of the full articles of all relevant studiesTo undergo a brief assessment of the full article to

Ensure direct relevance of each article to the health claimFollowed by

Full review and synopsisAccording to the review protocol and

With key points presented consistently according to study typeAnd individual study results represented, ideally, by a Forest plot (or odds ratio diagram).

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The literature search is likely to provide:� A body of consistent, relevant evidence from well-de-

signed studies� Critical reviews of evidence by experts� Nationally and internationally accepted evidence

from expert bodies and health professional organisa-tions, which forms the basis of public health recom-mendations.

The strength and consistency of the scientific evidenceunderpins the use of the term “significant scientificagreement” and that the balance of probabilities for thescientific link between a food or food component and ahealth benefit is justified (see Fig. 2).

The nature of the scientific evidence

It is clear from all the international laws, codes of prac-tice and guidelines that the claimed effect must be sup-ported by scientifically valid evidence that demonstratesthe efficacy of the food or food component in humansand under conditions that reflect the actual conditionsof use and exposure.

Many proposed codes of practice suggest that the lev-els and kinds of evidence should be evaluated within a

Table 3 Example for a synopsis protocol (adapted from ref. 5)

Following a review protocol and extracting the relevant data provides the Expertbody with key information in a consistent and systematic manner. Individualstudies should be presented in accordance with their study type and design toensure greatest comparability.

Individual synopses should be kept brief and presented under the followingheadings:

1) Title of the study2) Authors3) Journal reference4) Objective of the study5) Study type/design

If the study type/design is a pooled analysis (systematic review or meta-analysis) of many studies, then include:(i) Inclusion/exclusion criteria for the studies, and

(ii) Data extraction from the studies6) Study population (inclusion/exclusion criteria)7) Baseline characteristics of study subjects and controls8) Duration of the study9) Location of the study

10) Methodology (including quality of the active component)11) Dietary assessment technique12) Outcome measurement and other relevant measurements13) Statistics14) Results15) Conclusion16) Points to note/further comments

Fig. 2 Graphical representation for Assessing Strength and Consistency of Scientific Evidence Leading to Significant Scientific Agreement. US Food and Drug Administra-tion Centre for Food Safety and Applied Nutrition, Office of Special Nutritionals (1999) Guidance for Industry: Significant Scientific Agreement in the review of Health Claimsfor Conventional Foods and Dietary Supplements. US Food and Drug Administration, Washington, D.C.

D. P. Richardson et al. I/107PASSCLAIM – Synthesis and review of existing processes

predefined hierarchical scheme. However, the relation-ship between dietary components and health benefitscan be demonstrated by a number of different types ofstudies and designs, and methodological soundnessoverrides any hierarchy in studies on humans,given thatvalidity depends not only on the appropriateness of thestudy type, but also on the quality of its design, execu-tion and analysis. (The reader is referred to the FDA(2001) [18], the Canadian [19] and the Australia/NewZealand Guidance Notes [20] for further details.)

In brief, studies on human subjects are accordedgreater weight than animal and in vitro (preclinical)studies, and intervention (clinical) studies have greaterweight than observational studies. However, the criticalreview of the whole body of data is considered under theTotality of evidence section.

The principles summarised in sections Collecting theevidence, Data searches, and The nature of the scientificevidence relate primarily to claims based on a conside-rable body of published,and possibly to some extent un-published, scientific evidence. This is the case forgeneric claims, and the process is similar to that under-pinning the dietary recommendations issued by govern-mental or non-governmental bodies. In fact, such claimscould rely directly on the evidence-based procedurescarried out by such bodies for establishing dietary rec-ommendations and guidelines (which is the case for thegeneric claims allowed in the Swedish Code [10, 21]).

In the case of product-specific claims for new foodproducts, the substantiation will rely primarily on a lim-ited number of human intervention studies carried outwith the product in question. These studies should havethe scientific standard described above and demon-strate the effect to be claimed at normal consumption.The number of studies required is generally not speci-fied, although for example, the Dutch Code, states that“the evidence must be reproduced” [22]. In practice, thenumber of studies with the product in question, as wellas the amount and nature of the supporting evidence re-quired, will depend on the type of claim. For instance,one appropriate study might be regarded as sufficient todemonstrate that a component or ingredient retains itsexpected and well-established physiological effect afterprocessing of a certain food product. On the other hand,at least two studies with the final product and appropri-ate supporting evidence, e. g. mechanistic animal stud-ies, would be required to substantiate a truly “new”claim.

■ Sources of scientific data

Human intervention studies

Well-designed, randomised controlled trials (RCTs)provide the most persuasive evidence of efficacy in hu-

man subjects. In a RCT,subjects similar to each other arerandomly assigned either to receive the intervention ornot to receive the intervention. As a result, subjects whoare most likely to have a favourable outcome, indepen-dent of any intervention, are not preferentially selectedto receive the intervention being studied (selectionbias). Bias may be further reduced if the researcher whoassesses the outcome does not know which subjects re-ceived the intervention (double blinding).

RCTs can be poor – when the number of subjectstested is too small, when there is no independent confir-mation of the experimental dietary change, or when theoutcome data may be insecure. RCTs of dietary changethrough to disease outcome are uncommon and aremost likely to involve addition or subtraction of a singlecomponent or nutrient. For example, it may not be pos-sible to use a placebo control group for food studies, andsubjects in such studies may not be blinded to the inter-vention. As a result of the greater likelihood for con-founders and bias, intervention studies with foods maygenerate data that have less certainty than data fromdrug or food supplement intervention studies. For someof the most firmly accepted precepts of healthy eating,RCT findings are unlikely to be available. Similarly, mostof the health claims allowed by the USFDA have not beensupported by RCTs. Hence, the lack of well-designedRCTs should not disqualify a body of substantiating ev-idence from other sources [17]. There are, however, hun-dreds of controlled trials of dietary change with a sur-rogate outcome – a risk factor such as plasma lipids,plasma glucose or blood pressure. Meta-analysis of col-lections of such trials can be used to establish scientificlinkages between diet and disease. For example, satu-rated fat has been shown to increase plasma total cho-lesterol and many cohort studies have found that plasmatotal cholesterol is a biomarker for coronary heart dis-ease (CHD). Hence, saturated fat increases the risk ofCHD.

Human observational studies

Whereas in an intervention study, the investigator con-trols whether the subjects receive an exposure or an in-tervention, in an observational study, the investigatorhas no control over the exposure or the intervention.There is no universally valid method for weighting cate-gories of observational studies. In general,observationalstudies include – in descending order of persuasiveness– cohort (longitudinal) studies, case-control studies,cross-sectional studies, uncontrolled case series or co-hort studies, time-series studies, ecological or cross-population studies, descriptive epidemiology, and casereports (see [23] for further detail). Observational stud-ies may be prospective or retrospective. In prospectivestudies, investigators recruit subjects and observe themprior to the occurrence of the outcome. In retrospective

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studies, investigators review the records of subjects andinterview them after the outcome has occurred.

A common weakness of observational studies is thelimited ability to ascertain the actual food, food compo-nent or nutrient intake for the population studied. Ob-servational data are also generally restricted to the iden-tification of associations between food substances andhealth outcomes, and often do not provide a sufficientbasis for determining whether a substance/disease asso-ciation reflects a causal rather than a coincidental rela-tionship. Nevertheless, cohort (prospective) studiesstand out among types of observational epidemiologyfor their driving role in building present concepts of dietand disease [17].

Human intervention and observational studies canuncover significant health- promoting or health-com-promising nutritional effects in individuals, groups ofindividuals and in whole populations. The sequencingand annotation of the human genome and the develop-ment of genomics, proteomics and metabolomics willprovide new opportunities to characterise the cause ofthe differences in biological responses and help to iden-tify appropriate dietary measures that could make a pro-found contribution to health and well-being and the de-velopment of nutritional regimens for reducing the riskof disease [17, 24–27].

Animal studies and in vitro studies

Animal studies and in vitro studies would be consideredas evidence to support a health claim. They can provideinformation on the mechanism of action, dose-responserelationships and the processes that cause a disease orhealth-related condition. These studies also permitgreater control over confounding variables, such as dietand genetics, and allow for more aggressive interven-tions. The strongest animal evidence is likely to be basedon the use of appropriate animal models and data thathave been reproduced in different laboratories. Ulti-mately, all these studies suffer from the uncertainties ofextrapolating results to physiological effects in humans.

■ The use of biomarkers in human studies

The reliability of measurements of both the indicators ofhealth and well-being and dietary intakes of a food orfood component are key factors for the review of data forhealth claims. This was addressed in a recent EU projecton biomarkers in relation to health and disease [28–30].

Biomarkers are defined as indicators of actual or pos-sible changes of systemic, organ, tissue, cellular and sub-cellular structured and functional integrity, which canbe used singly or in batteries to monitor health and ex-posure to compounds in populations and individuals.The EU DG X11 Concerted Action on Functional Food

Science in Europe (FUFOSE) Consensus Document sug-gested an outline of a scheme to link health claims forfoods or food components with beneficial physiologicaleffects to solid scientific evidence. FUFOSE suggestedthat the primary source of evidence for “enhanced func-tion” and “reduced risk of disease” is only justifiablewhen based on appropriate, validated markers of expo-sure,enhanced function or reduction of disease risk (seeFig. 1).

The development of validated and predictive bio-markers is an essential research objective. Biomarkersmust be both biologically and methodologically validand should reflect a future health outcome at a stagewhen dietary intervention will be effective. There are anumber of factors that influence the nature of the linkbetween diet and health, and that impact upon the use ofbiomarkers. These include predisposition and suscepti-bility, predictivity and intervention/reversibility. Byconsideration of these factors, it may be possible to pri-oritise the specific diet/health issues and assess thosemarkers that are used to confirm the link between a foodor a food component and a physiological effect [30].

The use of biomarkers must be subject to criticalevaluations taking into account intra-individual varia-tion; the use of single measurements; timing of mea-surements and progression of disease; intake; absorp-tion; metabolism; homeostatic regulation; other dietary,environmental and genetic influences; quality control incollections, processing, storage and analysis. Within astudy, the biomarker should change in a biologically rel-evant way and the change should be statistically signifi-cant for the target group.

■ The evaluation of the quality of individual studies

The provision of an explicit and standardised appraisalof all relevant studies that have been identified is thestarting point for determining the overall strengths andweaknesses of the data and for assessing the overallweight and quality of the evidence.

The features that are most important to address in-clude:� Appropriateness and validity of the methodology

used (e. g. quality of the design, conduct, analysis andinterpretation of the study)

� Completeness and description of the analyticalmethodology and quality control procedures

� Adequacy of the sample size to provide sufficient sta-tistical power to detect a significant effect. Statisticalmethodology to ensure good experimental design,the appropriateness of tests applied and proper inter-pretation of “statistical significance”, i. e. assess bothstatistical and biological significance.

� Adequacy of the description of the study populationcharacteristics. For example, factors such as age, gen-

D. P. Richardson et al. I/109PASSCLAIM – Synthesis and review of existing processes

der, distribution, race, socio-economic status, geog-raphic location, family history, health status andmotivation and relevance of the population to whichthe health claim is to be targeted. It is also importantto state inclusion/exclusion criteria for subjects in thestudy, recruitment procedures to minimise selectionbias and for controlled intervention, the matchingand randomisation procedures employed to assignthe subjects to the control and test groups.

� Characteristics of the intervention to ensure an ap-propriate level of intake to achieve the desired physi-ological effect, the background diets to which the testsubstance was added, the nature of the placebo, if ap-propriate, “lead-in” and “wash-out” periods, dietarycompliance, the use of well-defined outcomes, in-cluding biomarkers

� The susceptibility of the data to measurement biasand confounding variables. These aspects are partic-ularly important because an added nutrient or com-ponent may displace other nutrients in the diet andan observed health outcome may be the result of anunintended change, e. g. a reduction in total dietaryenergy intake and subsequent weight loss of subjects.Other potential confounders include variability inthe quantity or quality of the food being adminis-tered, including the bioavailability of the active com-ponent.

� Biological plausibility of the known or postulatedmechanism by which exposure to a food or foodcomponent may reasonably alter a health outcome.

■ Totality of evidence

After relevant, good quality studies have been identifiedand their strengths and weaknesses assessed, the total-ity of the evidence needs to be evaluated. The initial re-view of the whole body of data is to determine whethermost of the evidence is derived from the more persua-sive types of study designs, and that the researchmethodologies are sound. The design features and thequality of the research methodology should be consid-ered together. Determining the weight of evidence as awhole requires assessment of the persuasiveness of eachrelevant study. Factors to be considered include the con-sistency of results across different studies and study de-signs, consistency among various populations andwithin them, the magnitude of effect, strength of associ-ation, dose-response relationships, temporal relation-ships, biological plausibility, specificity of effect and sta-tistical validity.

The overall assessment should involve the applica-tion of scientific judgement and critical interpretationof the data as a whole.A meta-analysis can be consideredas supporting evidence, rather than as primary evi-dence, that can confirm the validity of data concerning a

hypothesis. The assessment should not be a numericaladdition of studies for and against,rather,a critical over-all consideration of the evidence.Studies cannot be eval-uated in isolation. The surrounding context of the scien-tific evidence is just as important as the internal validityof individual studies. Wide variation in outcomes ofstudies and inconsistent or conflicting results will raiseserious questions about the adequacy of a manufac-turer’s substantiation. Where there are inconsistenciesin the evidence, it is important to examine whether thereis a plausible explanation for those inconsistencies [31].

The final assessment involves judging a relationshipto be valid if the evidence in support of the relationshipoutweighs the evidence against it. The assessment of thetotality of the evidence should also be sufficient to per-mit the conclusion that a change in the dietary intake ofthe food or food component will result in a health ben-efit and/or health outcome, including a change in a dis-ease endpoint.

■ Assessment of significant scientific agreement

The use of health claims should be subjected to rigoroussubstantiation on a case-by-case basis. In order for qual-ified experts to reach an informed opinion regarding aparticular claim, the data and information that pertainto the claim must be available to the relevant scientificassessors. This information could be available in peer-reviewed journals and/or in unpublished studies, someof which may include confidential and sensitive infor-mation of a proprietary nature. Whenever the healthclaim is used,the studies substantiating the claim shouldbe available in total, if required, to competent authori-ties, and in an appropriate form in the public domain[16].

Significant scientific agreement refers to the extent ofagreement among qualified experts in an appropriatefield and reflects the process of scientific discovery. Thepoint of agreement within the relevant scientific com-munity that an association between a food or a foodcomponent and a health benefit is valid depends on thestrength and consistency of the body of evidence.

Fig. 2 provides a graphical representation of the in-terplay of considerations that contribute to determiningwhether significant scientific agreement has beenachieved. The scheme illustrates how the various typesand amounts of data for a food or food component anda health benefit can be combined to assess the overallstrength and consistency of the scientific evidence. Thescheme also reflects judgement, flexibility and respon-siveness to the variety of combinations of data from dif-ferent types of good quality studies that give rise to abody of evidence sufficient to establish the validity of ahealth claim.

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Independent review of the substantiating evidence

Many existing codes recommend that the scientific re-view be conducted by using independent experts, quali-fied by training and experience. The evidence-based re-view should use scientific principles, be comprehensive,unbiased and authoritative.

The composition of an expert body must be flexibleto accommodate the breadth of subject matter. A coregroup could, for example, be augmented by ad hoc ex-perts in the specific subject matter under review. Fol-lowing the scientific assessments, regulators and policymakers could then use the information in the relevantregulatory, legal and social contexts.

It is desirable that the review process should haveclear time scales without compromising the rigour andindependence of the review.

The totality of scientific evidence in support of ageneric or product-specific health claim must be pre-sented clearly. The documentation must demonstratethe specific physiological effects and reflect the totalityof the evidence without misinterpretation or overem-phasis of relevant information. Table 4 makes some sug-gestions for the layout of relevant information.

Table 4 Documentation of evidence

It is suggested that the documentation should:� Include a clear and truthful summary of the appropriate scientific data� Describe how the scientific data supporting the health claim have been col-

lected and evaluated� Explain the plausibility in terms of scientific knowledge� Indicate where and how the dossier could be made available to relevant bod-

ies

In addition, information should be available on:� A description of the foods or food components. A trademark, brand name,

fancy name and a copy of the product label (in draft form if not printed)should be included if available

� Examples of health claims to be made in either public health campaigns oradvertising and other promotions are useful to evaluate the methods of com-munication of the benefit

� Identification of specific components or combination of components forwhich the health claim is made, if appropriate

� Details of any chemical analysis carried out and appropriate nutrition la-belling and ingredient list

� A statement of intended use (level and frequency of consumption, storage,preparation, instructions for use, shelf-life etc.)

� Appropriate contra-indications or warnings (e. g. potential allergy or intole-rance factors)

� Name and address and contact details of the organisation or company

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