The global regulatory environment for health claims with particular emphasis on Asia

Transcription

1 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

2 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.

3 The main players 28 Member States 10 Member States

4 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: China: Different rules for food and dietary supplements Health Foods cover both food and supplements ASEAN: Only harmonisation of health supplements Dietetic foods are mostly regulated separately

5 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

6 Codex Alimentarius Guidelines for nutrition and health claims (CAC/GL ) 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.

7 Codex Alimentarius Guidelines for nutrition and health claims (CAC/GL ) 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.

8 Historic Perspective Regulations on Nutrition and Health Claims Fairly recent development in most countries US: 1990 Japan: 1991 (FOSHU) Codex Alimentarius: (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

9 Agreed Health Supplement claims framework Type of claims Scope Examples General or Nutritional Functional Disease risk reduction For Nutritional Support & General Health Maintenance Benefits derived from supplementation beyond a person s daily dietary intake Relate to a positive contribution to health or to the improvement of a function or to modifying or preserving health in the context of the total diet on normal functions or biological activities of the body 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) Significantly altering or reducing a risk factor of a disease or health related condition Supplements nutrition Supports healthy growth and development Nourishes the body Helps to maintain good health Aids in digestion to relieve indigestion Supports health in ageing Supports health in menopause helps to reduce risk of osteoporosis by strengthening bone

10 System Pre-marketing Authorisation Exhaustive list of permitted claims General requirements + Notification No premarketing requirements Scientific principles Conclusive Significant Scientific Agreement Authoritative Statements Qualified Claims

11 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 2003 : Qualified Health Claims General agreement Grade convincing Authorisation Qualified wording Totality of the evidence Ranking Grade probable possible

12 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 2005: Qualified FOSHU claims Qualified wording: insufficient scientific evidence, but still certain efficacy FOSHU 2015: Foods with functional claims Notification

13 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

14 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

15 Health Supplement claims substantiation Totality of evidence to support HS benefit claim General or Nutritional Functional Disease Risk Reduction Human intervention study on ingredient / product Human observational studies on ingredient/product Animal Studies Published scientific review Authoritative reference texts Reputable/ international organizations or recognized regulatory authorities Documented history of use (e.g. classical texts, scholar or expert s reports) Calcium contributes to strong bone and reducing risk of osteoporosis Calcium contributes to strong bones To supply your calcium need

16 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

17 How do companies deal with the claims requirements? Looking for the easy way Use the strongest claims that are allowed and available Sometimes this may be a nutrition claim In most cases this is a claims for vitamins/minerals, included in a list In the US for dietary supplements, this is virtually any structure/function claim This means that doing research for a specific claim needs incentives Use claims that are not considered as health claims General non-specific health benefits Claims relating to ingredients (e.g. contains milk, organic, natural, ) Claims for products that are not covered (e.g. foods for particular nutritional use Use exemptions in the law e.g. brand names and trade marks e.g. medical foods Go to other less strict jurisdictions

18 How do companies deal with the claims requirements? For most fields of health there are approved function claims Calcium Magnesium contributes to Vitamin C contributes to to Zinc contributes to normal blood clotting normal cell division normal a normal normal function of of the the immune system system normal energy-yielding metabolism maintain normal maintenance the normal normal muscle muscle of normal function function and bone of the immune system during and after intense physical exercise including neurotransmission the heart muscle normal maintenance normal function of nerve function of normal digestive vision to normal collagen formation enzymes and the normal function of bones, teeth, is normal needed normal acid-base cartilage, protein for gums, the synthesis maintenance metabolism skin and blood of vessels normal bones and teeth normal cognitive function the normal maintenance energy-yielding of normal metabolism bone normal DNA synthesis and cell division electrolyte the normal balance function of the nervous system normal fertility and reproduction the maintenance protection of of cell normal constituents teeth from oxidative damage normal metabolism of fatty acids increases non-haem iron absorption normal metabolism of vitamin A the protection of cell constituents from oxidative damage

19 How do companies deal with these strict requirements? What is the added value of a claim? Contains calcium Is a source of calcium Is rich in calcium Calcium is necessary for bones Calcium contributes to strengthening of bones Calcium makes bones stronger Calcium increases bone density Calcium reduces the risk of osteoporosis Calcium Improves osteoporosis lesions Calcium for the dietary management of osteoporosis Calcium treats osteoporosis Calcium prevents osteoporosis Requirement s for scientific justifcation increase

20 How do companies deal with the claims requirements? What is the added value of a claim? e.g. US qualified claims: Selenium may reduce the risk of certain cancers. Some scientific evidence suggests that consumption of selenium may reduce the risk of certain forms of cancer. However, FDA has determined that this evidence is limited and not conclusive. Green tea may reduce the risk of breast or prostate cancer although the FDA has concluded that there is very little scientific evidence for this claim. One study suggests that consuming tomatoes does not reduce the risk of pancreatic cancer, but one weaker, more limited study suggests that consuming tomatoes may reduce this risk. Based on these studies, FDA concludes that it is highly unlikely that tomatoes reduce the risk of pancreatic cancer.

21 Functional Food Claims In ASEAN National rules apply. No harmonization in ASEAN. Brunei Darussalam: Very restrictive. Only nutrient content claims allowed, and not even for vitamins and minerals. No health claims allowed. Indonesia: Nutrient content/comparative claims, nutrient function claims and disease risk reduction claims are allowed. Products need to be registered Malaysia: Nutrient content/comparative claims, nutrient function claims and other function claims are allowed, when included in a list. Disease risk reduction claims are not allowed. Singapore: Nutrient content/comparative claims, nutrient function claims that are on the permitted list are allowed, as well as 5 specific diet related health claims (similar to disease risk reduction claims US style). Also the phytosterol claims has been allowed. Thailand: Nutrient content/comparative and nutrient function claim, included in a positive list, are permitted. ALlst with accepted probiotic claims exist. No approvals yet for reduction of disease risk claims. Viet Nam: nutrient content/comparative claims, nutrient function claims and disease risk reduction claims are permitted. No specific rules in Cambodia, Lao PDR, Myanmar, Philippines

22 Key Legislations Pertaining to Health Foods Food Safety Law 2015 Upcoming Changes To be effective 1 Oct 2015 New regulatory framework for health foods 2016 Regulation on Health Food Registration and Notification Regulation on Health Food Functional Claims and Raw Materials Catalogues Regulation on Health Food Labelling To be effective mid 2016

23 Definition of Health Food Legal Definition: Foods with specific health functions or to supplement vitamins and minerals For specific populations Not intended for diseases treatment Does not cause actual or chronic harms Subcategories: Nutrient Supplements products aimed to supply vitamins and minerals and not energy, thus to replenish dietary insufficiency and reduce the risk of chronic degenerative diseases. Most vitamins and minerals supplements fall under this category. Health Food with Functional Claims foods that have specific health benefits, which are given by the active ingredients in the products. The use of functional ingredients in health foods should be in compliance with several regulatory documents including permitted / banned substances.

24 Health Food with Claims 27 permitted health food claims Antioxidant Clears throat Helps in reducing blood pressure Improves growth Protects against harmful radiation Improves skin oil content Reduces blood lipid level Improves anaemic condition Lower blood sugar level Improves memory Improves sleep Improves hypoxia tolerance Increasing bone density Promote lactation Promotes lead elimination Protects the liver against chemical damage Relieves eye fatigue Relieves fatigue Slimming Strengthens immunity Improves skin moisture Eradicates acne Eradicates freckles Promotes digestion Relieves constipation Regulates intestinal flora Helps in the protection of gastrointestinal mucosal membrane Max 2 claims on each product Proposal to reduce the list to 18 claims

25 Health Food Registration Process Preregistration Studies (by designated laboratories) safety stability efficacy toxicology Submit Application to CFDA Technical Evaluation by CFDA Health Food Evaluation Committee CFDA Approval & Issue Certificate Lengthy process, ~2 years

26 Upcoming Change of Regulations More focus on food safety Stricter rules, heavier punishments More science-based More focus on ingredient safety Simplified pre-market requirements Registration for Products that use new ingredients outside the Health Food Ingredients Catalogue Products that are imported for the first time into China Notification for Products that use ingredients from the Health Food Ingredients Catalogue Products that are imported for the first time into China but belong to nutritional supplements such as vitamins and minerals Products that are already notified and require update of information More focus on post-market surveillence More inspection programmes

27 Conclusions Regulatory approaches for claims approval vary widely Product classification is important Determines the regulatory framework Determines what is possible and what not The type of claim is equally important Determines what (authorisation) procedure to follow Claims systems have a tendency to evolve over time Becoming less bureaucratic Evolving towards notification systems for certain claims Including qualified language to express the extent of scientific agreement Claims is mainly a marketing tool Companies look for the easiest way to market foods with claims Companies look for ways to differentiate between products Claims development strategy must consider all elements from the start Product classification / Type of claim / Authorisation procedure / Safety aspects Requires in depth knowledge of the local market

28 Thank You EAS Strategies Globally eas-strategies.com