authorisation of nutrition & health claims Scientific substantiation of health claims Role of the European Food Safety Authority

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1 Second Congress on Food Supplements The Scientific Substantiation of Health Claims Professor David P. Richardson DPR Nutrition Ltd, UK 11 th December 2009 Belgrade

2 OUTLINE The scope, classification and routes for authorisation of nutrition & health claims Scientific substantiation of health claims Role of the European Food Safety Authority (EFSA) Global and commercial impacts

3 The clear aims of the European legislation are to: Achieve a high degree of consumer protection. Ensure confidence in claims on foods by requiring i that t all health claims are scientifically substantiated. Promote and protect innovation.

4 MAJOR IMPACTS ON: Existing and new product claims and formulations/recipes All commercial communications, e.g. labelling, advertising, websites, point-of-sale literature Marketing and R & D strategies Academic research Codex & international regulatory developments

5 European classification of claims on foods Nutrition claims nutrient content comparative other substance Annex Health claims Based on Based on Reduction of generally newly disease risk accepted developed and claims scientific scientific referring to evidence data/ipr children s protection development and health Article 13.1 Article 13.5 Article 14

6 Article 2 (5) Health claim means any claim that states, suggests or implies that a relationship exists between a food category, a food or one of its constituents and health. Article 2 (6) Reduction of disease risk claim means 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 for the development of a human disease.

7 HEALTH CLAIMS 3 ROUTES FOR AUTHORISATION Article 13.1 Generic generally accepted claims (Article 13 procedure) Article 13.5 Newly developed scientific data/ipr (Article 18 procedure) Article 14 Full authorisation procedure (Articles 15, 16, 17 and 19; EFSA Guidance, 23 rd July 2007)

8 Article 13: Health claims other than those referring to the reduction of disease risk and to children s development and health Role of nutrient or other substance in growth, development and the functions of the body Psychological and behavioural functions Slimming, i weight control, reduction in sense of hunger, increase in satiety or reduction of available energy

9 Requirements for Article 13 claims To be included in the Community list the claims shall be: - Based on generally accepted scientific evidence Well understood by the average consumer Accompanied by: - The conditions applying to them, and not defined not defined References to the relevant scientific justification

10 Scientific guidance from EFSA/European Commission Article 14 claims EFSA Scientific & Technical Guidance for the preparation and presentation of the application for authorisation of a health claim EFSA Journal (2007) 530, 1 44; Regulation 353/2008 establishing implementing i rules for applications Article 13.5 claims Idem Atil Article No guidance; industry initiativeiti

11 Practical steps for Article 13.1 Community list CIAA/ERNA/EBF coordinate industry list 2007/2008 Member States submitted national lists to Commission, 31 Jan 2008 Member States & stakeholders consulted in June/July 2008 Consolidated list submitted to EFSA 31 July 2008 together with terms of reference (44000 health relationships) Commission, Member States and EFSA screening processes on duplicates, vague, missing & comparative claims and branded products EFSA Opinions Sept, Nov 2009, Feb and later in 2010 First batch of claims likely to be adopted by Regulatory Committee 31 Jan 2010

12 Community classification of claims Vitamins Minerals Macronutrients Fibre Probiotics Foods Diets Botanicals Other substances

13 EFSA NDA Panel assessments (STEP 1) Consider the extent to which: The food/constituent is defined and characterised The claimed effect is defined and has a beneficial nutritional or physiological effect ( beneficial to human health ) A cause and effect relationship is established between the consumption of the food/constituent and the claimed effect (for the target group under the proposed conditions of use) Reference: Technical Report of EFSA: EFSA Journal (2009) 7 (11): 1386

14 EFSA NDA Panel assessments (STEP 2) If a cause and effect relationship is considered to be established, whether: The quantity of food/pattern of consumption required to obtain the claimed effect can reasonably be consumed within a balanced diet The proposed wording reflects the scientific evidence The proposed wording complies with the criteria for the use of claims specified in the Regulation The proposed conditions/restrictions of use are appropriate

15 Briefing document for MS and EC on the evaluation of Article 13.1 health claims (EFSA Journal (2009) 7 (11): 1386, published 19/11/2009) The outcome of each assessment has one of 3 possible conclusions: A cause and effect relationship has been established between the consumption of the food/constituent and the claimed effect (i.e. claim is substantiated by generally accepted scientific evidence). The evidence provided is insufficient to establish a cause and effect relationship between the consumption of the food/constituent and the claimed effect (i.e. the evidence is not conclusive; the claim is not substantiated by generally accepted scientific evidence). A cause and effect relationship is not established between the consumption of the food/constituent and the claimed effect (i.e. at most, limited scientific evidence; emerging evidence, conflicting evidence)

16 EFSA opinions Approved Rejected Article 14 (Reduction of disease risk claims) Article 14 (Children s claims) Article 13.5 (Newly developed scientific 1 13 data/proprietary claims Article 13.1 (Role in the body, psychological, slimming)

17 Reasons for rejection by EFSA The foods/food d constituents t were not sufficiently i characterised. Effects of food matrix, processing & stability information, bioavailability & content variability not sufficiently characterised A cause and effect relationship was not established between the food/food constituent & the claimed effect. Lack of systematic literature review and no specific inclusion/exclusion criteria Criticism of study designs, absence of power calculations, insufficient information on background diet & lifestyle, failure to describe target group, intervention trials lacking, no lowered risk factor/no measurable effect Patient (clinical studies) not used as evidence for health effects in general population

18 Observations on EFSA No scientific framework for weighing of evidence & determination of extent to which a causal relationship is demonstrated Focus on human intervention ti studies not totality t of evidence Limitations of RCTs in evidence-based nutrition (EBN) Lack of appreciation of evidence based on epidemiological/observational studies; true outcomes versus surrogate biomarkers & lack of definition of risk factor Difficulty of extrapolating results from RCTs in patients to the normal healthy population

19 Nutrition context Foods and food constituents exert their effects in many tissues. The effects manifest themselves in small differences over long periods of time. Nutrients work together rather than in isolation. The effects of foods/food constituents may not develop when the intake of other components are suboptimal. There is rarely a nutrient-free t state t against which h the nutrient effects can be compared low intakes are contrasted with high intakes (i.e. a nutritionally inadequate state). Homeostatic mechanisms keep physiology within an individual s normal range. Robert Heaney (2008) Nutrients, endpoints and the problem of proof. J. Nutr. 138:

20 Sources of scientific data National/international expert consensus reports, including authoritative i statements Human intervention i studies, including use of biomarkers (Randomised Controlled Trials, RCTs) Human observational/epidemiological studies Animal and in vitro studies Traditional l knowledge and history of use

21 FRAMEWORK FOR STRENGTH OF EVIDENCE CONVINCING: A Significant scientific agreement PROBABLE: B Good to moderate level of scientific agreement POSSIBLE: C Low level l of scientific agreement INSUFFICIENT: N D Very low level of scientific c agreement WCRF (2007); USFDA (2003); WHO (2004); CODEX (2008)

22 Application of EBN in the scientific substantiation of health claims Conclusions The totality of the available ailable scientific data must be considered, not only randomised controlled trials (RCTs). RCTs are part of EBN, but complexities pertaining to nutrition and limitations of RCTs and physiological biomarkers must be acknowledged, especially for disease risk reduction claims. The strength and consistency of the evidence should be judged using a framework of gradations about the certainty of a health relationship with a food/food constituent. Policy makers and regulators must be able to make decisions and recommendations and these must be qualified to reflect the strength, consistency and plausibility of the evidence.

23 Final remarks Confidence in claims is critical from the consumer, regulatory and industrial perspective. There is a need to emphasise that the assessment should take into account the totality of the available scientific data and weighing of the evidence. Wording of claims needs to reflect the strength and consistency of the scientific evidence. Regulation could impact significantly on strategic directions of scientific enterprise and level of investment in research.

24 David P. Richardson DPR Nutrition Limited Website Tel/fax: +44 (0)