Patrick Coppens Regional Director EAS Europe & MEA - - PowerPoint PPT Presentation
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
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
Our core specialisation is the food and nutritional product area.
28 Member States 10 Member States
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
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
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 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.”
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.”
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.”
definitions
– e.g. US, EU, Japan
Type of claims Scope Examples
General or Nutritional For Nutritional Support & General Health Maintenance Benefits derived from supplementation beyond a person’s daily dietary intake
development
Functional 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
Maintains or enhances structure or function
claims Supports health and to relieve/ reduce/ lessen/ ease* minor body discomforts in some physiological processes (e.g. ageing, menopause, pregnancy)
indigestion
menopause Disease risk reduction Significantly altering or reducing a risk factor of a disease or health related condition
bone
Notification + disclaimer - No authorisation
Authorisation – Significant Scientific Agreement Authorisation – Authoritative Statements
Totality of the Evidence + Grade ‘convincing’ General agreement – Grade ‘convincing’
Authorisation – Qualified wording
Totality of the evidence Ranking– Grade ‘probable – possible’
FOSHU Authorisation
Beneficial effects on the physiological functions of the human body, maintain or promote health and improve health-related conditions
Qualified wording: insufficient scientific evidence, but still certain efficacy
No detailed review of safety and efficacy
Standardised list – No product autorisation
FOSHU
Standardized list - No product authorization
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
Reduction of disease risk claims
Three levels of grading: ‘convincing’, ‘probable’ and ‘insufficient’
Ingredient based Authorisation + Qualified wording Ingredient based Authorization Other function claims
Authorisation - List
Authorisation – Conclusive standard
General agreement – Grade ‘convincing’ No acceptance of the grades ‘probable – possible’ General agreement – Grade ‘convincing’ No consideration of totality of the evidence
So far all cases have supported the legislation
international
recognized regulatory authorities
scholar or expert’s reports)
studies
ingredient/product
scientific review Human intervention study on ingredient / product
Totality of evidence to support HS benefit claim
Disease Risk Reduction Functional General or Nutritional
“To supply your calcium need” “Calcium contributes to strong bones” “Calcium contributes to strong bone and reducing risk of
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
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
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
– normal blood clotting – normal energy-yielding metabolism – normal muscle function and neurotransmission – normal function of digestive enzymes – is needed for the maintenance of normal bones and teeth
– normal cell division – normal energy-yielding metabolism – normal muscle function including the heart muscle – normal nerve function – normal protein synthesis – the maintenance of normal bone – electrolyte balance – the maintenance of normal teeth
– a normal function of the immune system – maintain the normal function of the immune system during and after intense physical exercise – to normal collagen formation and the normal function of bones, teeth, cartilage, gums, skin and blood vessels – normal energy-yielding metabolism – the normal function of the nervous system – the protection of cell constituents from oxidative damage – increases non-haem iron absorption
– a normal function of the immune system – maintenance of normal bone – maintenance of normal vision – normal acid-base metabolism – normal cognitive function – normal DNA synthesis and cell division – normal fertility and reproduction – normal metabolism of fatty acids – normal metabolism of vitamin A – the protection of cell constituents from oxidative damage
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
Selenium may reduce the risk of certain cancers. Some scientific evidence suggests that consumption of selenium may reduce the risk of certain forms of
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.
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
(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
To be effective 1 Oct 2015
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
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.
27 permitted health food claims
Antioxidant Promotes lead elimination Clears throat Protects the liver against chemical damage Helps in reducing blood pressure Relieves eye fatigue Improves growth Relieves fatigue Protects against harmful radiation Slimming Improves skin oil content Strengthens immunity Reduces blood lipid level Improves skin moisture Improves anaemic condition Eradicates acne Lower blood sugar level Eradicates freckles Improves memory Promotes digestion Improves sleep Relieves constipation Improves hypoxia tolerance Regulates intestinal flora Increasing bone density Helps in the protection of gastrointestinal mucosal membrane Promote lactation Max 2 claims on each product Proposal to reduce the list to 18 claims
Lengthy process, ~2 years
Pre- registration Studies (by designated laboratories)
Submit Application to CFDA Technical Evaluation
Health Food Evaluation Committee
CFDA Approval & Issue Certificate
Stricter rules, heavier punishments More science-based More focus on ingredient safety
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 inspection programmes
Determines the regulatory framework Determines what is possible and what not
Determines what (authorisation) procedure to follow
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