The global regulatory environment for health claims with particular emphasis on Asia How food regulations are changing the way we market our products Patrick Coppens Regional Director EAS Europe & MEA patrickcoppens@eas-strategies.com
About EAS EAS was established more than 20 years ago as a centre of expertise in European and international food, nutrition and health policy. Today, with offices in Singapore, Brussels, London, Moscow and Buenos Aires and networks in over 70 countries, we are leading experts in navigating the global challenges and opportunities in business. Our core specialisation is the food and nutritional product area.
The main players 28 Member States 10 Member States
The category of ‘functional food’ does not exist anywhere Regulations are build around product and claims definitions Different rules apply for different categories Either the regulations cover all foods or specific categories e.g. EU: Both foods and food supplements US: Different rules for food and dietary supplements China: Health Foods cover both food and supplements ASEAN: Only harmonisation of health supplements Dietetic foods are mostly regulated separately
Codex Alimentarius Codex Alimentarius means ‘Food Law’ or ‘Food Code’ Codex Alimentarius is a United Nation ‘institution’, ‘parented’ jointly by the Food and Agriculture Organisation (FAO) and World Health Organisation (WHO) It was founded in 1963 It today has over 185 Member governments as members Over 240 finalised Standards Over 40 adopted Codes of Practise Evaluation of over 100 additives, 25 contaminants and 3300 Pesticide Residues Recognised as authorititive body in trade disputes by WTO
Codex Alimentarius Guidelines for nutrition and health claims (CAC/GL 23-1997) Health claim means any representation that states, suggests, or implies that a relationship exists between a food or a constituent of that food and health. Health claims include the following: • Nutrient function claim is a nutrition claim that describes the physiological role of the nutrient in growth, development and normal functions of the body. Example: “Nutrient A (naming a physiological role of nutrient A in the body in the maintenance of health and promotion of normal growth and development). Food X is a source of/ high in nutrient A.” • Other function claim is a claim that concerns specific beneficial effects of the consumption of foods or their constituents, in the context of the total diet on normal functions or biological activities of the body. Such claims relate to a positive contribution to health or to the improvement of a function or to modifying or preserving health. Examples: “Substance A (naming the effect of substance A on improving or modifying a physiological function or biological activity associated with health). Food Y contains x grams of substance A.”
Codex Alimentarius Guidelines for nutrition and health claims (CAC/GL 23-1997) • Reduction of disease risk claim is a claim relating the consumption of a food or food constituent, in the context of the total diet, to the reduced risk of developing a disease or health-related condition. Risk reduction means significantly altering a major risk factor(s) for a disease or health-related condition. Diseases have multiple risk factors and altering one of these risk factors may or may not have a beneficial effect. The presentation of risk reduction claims must ensure, for example, by use of appropriate language and reference to other risk factors, that consumers do not interpret them as prevention claims. Example: “A healthful diet low in nutrient or substance A may reduce the risk of disease D. Food X is low in nutrient or substance A.” Example: “A healthful diet rich in nutrient or substance A may reduce the risk of disease D. Food X is high in nutrient or substance A.”
Historic Perspective Regulations on Nutrition and Health Claims Fairly recent development in most countries • US: 1990 • Japan: 1991 (FOSHU) • Codex Alimentarius: 1997 – 2009 (guidelines) • EU: 2006 • ASEAN: under development Learning process • EU: multiple adjustments needed • US: new standards developed over time • Japan: extended over time (e.g. qualified and standardised FOSHU) over time + new law in 2015 • China: new law in 2016 Divergent systems worldwide • Most jurisdictions with recent laws on claims do follow these definitions • However, the most influential ones with established legislation do not – e.g. US, EU, Japan
Agreed Health Supplement claims framework Type of claims Scope Examples General or Nutritional For Nutritional Support & General Health • Supplements nutrition Maintenance • Supports healthy growth and development Benefits derived from supplementation • Nourishes the body beyond a person’s daily dietary intake • Helps to maintain good health Functional Relate to a positive contribution to health or • Aids in digestion to relieve to the improvement of a function or to indigestion modifying or preserving health in the • Supports health in ageing context of the total diet on normal functions • Supports health in or biological activities of the body menopause Maintains or enhances structure or function of the body, excluding disease related claims Supports health and to relieve/ reduce/ lessen/ ease* minor body discomforts in some physiological processes (e.g. ageing, menopause, pregnancy) Disease risk reduction Significantly altering or reducing a risk • helps to reduce risk of factor of a disease or health related osteoporosis by strengthening condition bone
System No pre- Exhaustive list General Pre-marketing marketing of permitted requirements + Authorisation requirements claims Notification Scientific principles Significant Authoritative Qualified Conclusive Scientific Statements Claims Agreement
1990 : Health Claims (= Reduction of disease risk) Authorisation – Significant Scientific Agreement Totality of the Evidence + Grade ‘convincing’ 1994 : Structure/Function claims (Only Dietary Supplements) Notification + disclaimer - No authorisation 1997 : Authoritative Health Claims Authorisation – Authoritative Statements General agreement – Grade ‘convincing’ 2003 : Qualified Health Claims Authorisation – Qualified wording Totality of the evidence Ranking– Grade ‘probable – possible’
1991: Foods for Special Health Use (FOSHU) Beneficial effects on the physiological functions of the human body, maintain or promote health and improve health-related conditions FOSHU Authorisation 2001: Foods with Nutrient Function Claims Standardised list – No product autorisation 2005: Standardised FOSHU No detailed review of safety and efficacy 2005: FOSHU for disease risk reduction FOSHU 2005: Qualified’ FOSHU claims Qualified wording: insufficient scientific evidence, but still certain efficacy 2015: Foods with functional claims • Notification
2003: Health Functional Foods A product intended to be used to enhance and/or preserve the human health that contains one or more of the functional food/constituents, manufactured or processed in a form of tablet, capsule, powder, granule, liquid or pill, etc. with ingredients or components, that possess the functionality useful for human body General Health Functional Foods Standardized list - No product authorization Product-Specific Health Functional Foods Reduction of disease risk claims Ingredient based Authorization Other function claims Ingredient based Authorisation + Qualified wording Three levels of grading: ‘convincing’, ‘probable’ and ‘insufficient’ 2008: Extended to regular foods
2006: Function claims Authorisation - List General agreement – Grade ‘convincing’ 2006: Reduction of disease risk claims Authorisation – Conclusive standard General agreement – Grade ‘convincing’ No consideration of totality of the evidence No acceptance of the grades ‘probable – possible’ 2010: 50% of claims put on hold 2012: Challenges before the Court of Justice So far all cases have supported the legislation 2013: Discussions on how to cover botanicals
Health Supplement claims substantiation Totality of evidence to support HS benefit claim Disease Risk Reduction Human “Calcium contributes to strong intervention bone and reducing risk of study on osteoporosis ” ingredient / product • Human observational Functional studies on “ Calcium contributes to strong ingredient/product bones ” Animal Studies • • Published scientific review Authoritative reference texts • Nutritional General or • Reputable/ international organizations or “ To supply your calcium need ” recognized regulatory authorities Documented history of use (e.g. classical texts, • scholar or expert’s reports)
How do companies deal with the claims requirements? There are three types of companies using health claims 1. Companies that look for opportunities for highlighting beneficial effects of existing products For natural products (e.g. milk, cheese, kiwi, nut, …) For products because of their nutritional properties (e.g low in fat) For products with added vitamins/minerals 2. Companies that need communication of health benefits for consumer communication E.g. for dietary supplements to inform consumers about the product’s indication E.g. children products to inform consumers about the specific intended use 3. Companies that explore the use of a new food ingredient
Recommend
More recommend
