Scientific assessment of health claims: A European perspective Sean - PowerPoint PPT Presentation

Scientific assessment of health claims: A European perspective Sean Strain Emeritus Professor of Human Nutrition Northern Ireland Centre for Food & Health (NICHE) ulster.ac.uk

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Scientific assessment of health claims: A European perspective • General considerations - the Regulation • Concept of Essentiality • Claims under Article 13.1 • Weighing the Evidence

Scientific assessment of health claims: A European perspective • General considerations – the Regulation • Concept of Essentiality • Claims under Article 13.1 • Weighing the Evidence

Regulation (EC) No 1924/2006 of the European Parliament and of the Council • Recital (30): In some cases, scientific risk assessment alone cannot provide all the information on which a risk management decision should be based. Other legitimate factors relevant to the matter under consideration should therefore be taken into account

EFSA: Scientific advice from farm to fork Plant Protection Plant Health Genetically modified organisms Animal health Animal feed Biological and welfare and food their diseases chain hazards Food additives Nutrition, Food chain Flavourings and dietetic products contaminants Procesing aids and allergies Food packaging

NDA Panel + Working Groups Safety and suitability Safety Safety Dietetic Products Novel Foods Upper Levels NDA Panel 20 Experts Dietary Reference Values Food Allergy Health Claims Scientific advice Safety Scientific substantiation Supported by the EFSA Secretariat (Nutrition Unit)

What EFSA cannot do Be responsible for food safety legislation Take charge of food safety/quality controls, labelling or other such issues Act as a substitute for national authorities

What EFSA can do • Recital 17: A claim should be scientifically substantiated by taking into account the totality of the available scientific evidence, and by weighing the evidence. • Recital 23: Health claims should only be authorised for use in the Community after a scientific assessment of the highest possible standard. In order to ensure harmonised scientific assessment of these claims, the European Food Safety Authority should carry out such assessments. • Article 6: Nutrition and health claims shall be based on and substantiated by generally accepted scientific evidence.

What EFSA was expected to do • Recital 26: Health claims other than those referring to the reduction of disease risk and to children’s development and health, based on generally accepted scientific evidence, should undergo a different type of assessment and authorisation. It is therefore necessary to adopt a Community list of such permitted claims after consulting the European Food Safety Authority.

Health claims Article 13 Article 14 Reduction of disease a) Growth & development & Based on newly risk (risk factor functions of body developed reduction) and claims scientific b) Psychological & behavioural referring to children’s evidence or functions development and requesting health c) Slimming or weight control or protection of reduction in sense of hunger or proprietary increase in sense of satiety or data reduction of available energy Based on generally accepted Article 13.5 scientific evidence Article 13.1

Scientific assessment of health claims: A European perspective • General considerations • Concept of Essentiality • Claims under Article 13.1 • Weighing the Evidence

Concept of Essentiality • Essentiality of a nutrient can be determined by the observance of clinical symptoms of deficiency on dietary depletion of the nutrient and the disappearance of such symptoms upon dietary repletion with the nutrient. • Knowledge of the essential role of a nutrient in metabolism can also indicate essentiality.

Consequences for health claims • Difficult to define a precise health relationship as symptoms of deficiency can have effects on multiple functions across multiple organ or physiological systems. • Difficult to predict the consequences of deficiency on organ or physiological systems from knowledge of the metabolic essentiality. • Most of the knowledge on essentiality of nutrients is long- standing (>100 years for some) generally accepted scientific evidence and has not always been garnered from human studies using the widely accepted hierarchy of evidence.

Table : Hierarchy of evidence Level Criteria 1++ High-quality meta-analyses, systematic reviews of RCTs, or RCTs with a very low risk of bias 1+ Well conducted meta-analyses, systematic reviews of RCTs, or RCTs with a low risk of bias 1- Meta-analyses, systematic reviews of RCTs, or RCTs with a high risk of bias 2++ High-quality systematic reviews of case-control studies or cohort studies, or high-quality case-control or cohort studies with a very low risk of confounding, bias, or chance 2+ Well conducted case-control or cohort studies with a low risk, of confounding, bias, or chance 2- Case-control or cohort studies with a high risk of confounding, bias, or chance 3 Non-analytical studies (eg. case report, case studies) 4 Expert opinion RCTs = Randomised controlled trials;Harbour & Miller (2001) BMJ

Hierarchy of Evidence

Dealing with health claims relating to the essentiality of a nutrient • Not necessary or appropriate to try to define a specific health relationship. • Not necessary or appropriate to weigh the totality of evidence for well-established essential functions of essential nutrients.

Scientific assessment of health claims: A European perspective • General considerations • Concept of Essentiality • Claims under Article 13.1 • Weighing the Evidence

Health claims Article 13 Article 14 Reduction of disease a) Growth & development & Based on newly risk (risk factor functions of body developed reduction) and claims scientific b) Psychological & behavioural referring to children’s evidence or functions development and requesting health c) Slimming or weight control or protection of reduction in sense of hunger or proprietary increase in sense of satiety or data reduction of available energy Based on generally accepted Article 13.5 scientific evidence Article 13.1

Where did it all go wrong ? EC COM (2003) 0424 Being based on long-established and non-controversial science, health claims that describe the role of a nutrient or other substance in growth, development and normal physiological functions of the body shall undergo a different type of assessment…. EC 1924/2006 Based on generally accepted scientific evidence….

Health claims Article 13 Article 14 Reduction of disease a) Growth & development & Based on newly risk (risk factor functions of body developed reduction) and claims scientific b) Psychological & behavioural referring to children’s evidence or functions development and requesting health c) Slimming or weight control or protection of reduction in sense of hunger or proprietary increase in sense of satiety or data reduction of available energy Based on generally accepted Article 13.5 scientific evidence Article 13.1

ID Health Food or Food constituent Proposed wording Relationship 561 Xylitol-sweetened chewing Ears Xylitol is good for the health of gum ears. Maintains good health of the ears. Conditions of use Chewing gums with 65% xylitol. 2 pieces 3-5 times per day. The product may not - contain sugars capable of fermentation and the requirements for other Finnish Dental Association recommendations must be fulfilled.

The Citation Newsletter Ezekiel 27.17 The Old Testament In: The Holy Bible. ID 3668: “Panax ginseng (common name: Asian, Korean ginseng)” and “cognitive performance” Full text: Judah and Israel gave you their finest wheat, fancy figs, honey, olive oil, and spices in exchange for your merchandise. Beck, L, The complete idiot’s guide to total nutrition for Canadians. Hellmann J, 2006. Data in preparation – confidential. Intervention (n = 46). Study finished in May 2006 Anonymous, 2007. Andenne Omega3 – Menu. Not published intervention trial, realized from January to June 2007, Andenne, Belgium Tea association, 2003. Classical drink as trend: tea consumption stable at a high level. German tea industry satisfied with financial year. Press release

The Clarification Newsletter Food: Before: “Vitamins, minerals, lysine and/or taurine” After: “Combination of different vitamins and minerals, lysine and/or argine and/or taurine” Before: “Carbohydrates from pasta” After: “Pasta from different kinds of cereal grains, e.g. durum wheat, wheat, barley, oat and rye. Except autoclaved products” Before: “Green tea extract (Camelia sinesis) After: “Green tea extract (Camelia senesis); People have always been plagued by high blood pressure, which is triggered by the loss of elasticity in the… Before: “Antioxidants” After: “Antioxidants (Source of antioxidants from the list of health claims given a positive opinion by EFSA)”