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2. Health Claims: Latest Developments Functional Food and Product Health Claims Seminar Melton Mowbray, 20th April 2004 Melanie Ruffell, Executive Director UK Joint Health Claims Initiative Food Industry Enforcement Consumers

3. Overview • What is the JHCI • EC proposed Nutrition and Health Claims Regulation • Key issues • Well-established health statements: project overview • Well-established nutrient function statements • Examples • Applications • JHCI approved generic health claims

4. What is the JHCI? • A unique joint venture between consumer organisations, enforcement authorities and industry trade associations • To establish a voluntary Code of Practice for the use of health claims on food, beverages and supplements • To provide case by case advice and an independent scientific opinion about the validity of health claims • To help ensure claims do not mislead consumers or contravene food law

5. Who is JHCI Council - 3 Enforcement authority reps - 3 Food industry reps - 3 Consumer interest reps - Independent Chairman Secretariat - Executive Director - Administration Assistant Expert Committee- 7 independent scientists Observers - FSA, ITC, CAP/ASA, BACC

6. Stated claims • Wording • Implied claims • Brand name • Pictures • Images • Endorsement NB: Has not been considered by JHCI

7. JHCI Objectives • to protect and promote public health • to help companies to provide accurate & responsible information relating to food to enable consumers to make informed choices • to promote fair trade & innovation in the food industry • to promote consistency in the use of health claims in the UK, Europe and internationally.

8. Scope of the Code Applies to any claim in promotional material for food, beverages or dietary supplements: • direct (whole product) • indirect (ingredients) • implied (logos, endorsements, pictures) • in product labelling • in advertising, marketing (TV, radio, Internet) • in scientific literature associated with products

9. How JHCI can help • Compliance with the Code assists companies to establish a defence of all due diligence in the event of prosecution over the truthfulness of claims • Lack of high profile cases helps restore consumer faith in products carrying health claims The Code is not part of food legislation and does not replace or compete with the current UK systems of regulation and self-regulation

10. Claims approval in UK based on systematic review of evidence What is a systematic review of the evidence? • Evidence directly linked to the claim • Searched, reviewed and presented in an objective and unbiased manner • Using a pre-defined and reproducible methodology. Why? Reassures the JHCI Expert Committee that all relevant papers have been included, so it can make an informed decision based on the totality of evidence.

11. Proposed Health Claims Regulation • Health claims may be used on complying food products if: • They appear on the Register of claims based on generally-accepted science • OR • They have been authorised for use by the Commission Some practical considerations … • Approval timeframe could be 9 - 12 months • Submission of claims in all Community languages • Centralised assessment of consumer understanding • Centralised assessment of nutrition profiles

12. Prohibitions • Blanket prohibitions - • in addition to prior approval scheme • Weight management, satiety • Too non-specific (general well-being) • Too specific (e.g. folic acid and homocysteine) • Health charity endorsements • Alcohol • Psychological / behavioural • Medicinal

13. Types of Health Claims Ca+ helps reduce the risk of developing osteoporosis (disease risk reduction) Ca+ is necessary for the normal structure of bones (nutrient function) Ca+ helps maintain healthy bones (health maintenance) Ca+ helps prevent osteoporosis (medicinal) Ca+ helps strengthen bones (enhanced function) MEDICINE FOOD Borderline Area

14. Timeframe for approval • Approval timeframe 180 days bare minimum • Dossier must be prepared to the standard, and the format, required by the Authority, so not to create further delays • Dossier preparation is time consuming and expensive; submitter cannot afford costly errors during preparation

15. Wording of Claims • Requirement to submit claims in all Community languages • Overly burdensome with the variability in local culture, traditions, tastes and diet? • Will appropriate translations of the claim exist for language-specific terms? • Will full re-submission be required if a small change of wording in one Member State is requested?

16. Consumer Understanding • Centralised assessment of local consumer understanding • How will the Authority verify that the proposed claim is understandable and meaningful to all consumers across the EU Member States? • ‘Average consumer’ vs ‘intended consumer’

17. Nutrition Profiles • Centralised assessment of nutrition profile of local foods • Subject of massive debate • Strict criteria for all foods too restrictive - possibility of exemptions, e.g. oily fish • Overly burdensome with the variability in local culture, traditions, tastes and diet? • Development of European nutrition framework proposed

18. Community Register • Member States to contribute to the Register of well-established claims (Article 12): • ‘…health claims describing the role of a nutrient or of any other substance in growth, development and normal physiological functions of the body, which are based on generally accepted scientific data and well understood by the average consumer…’

19. Types of Health Claims Ca+ helps reduce the risk of developing osteoporosis (disease risk reduction) Ca+ is necessary for the normal structure of bones (nutrient function) Ca+ helps maintain healthy bones (health maintenance) Ca+ helps prevent osteoporosis (medicinal) Ca+ helps strengthen bones (enhanced function) MEDICINE FOOD Borderline Area

20. JHCI ‘Well-established Health Statements’ project • UK government funded project to: • develop a process to identify and define ‘well-established’ health statements • produce a list of ‘well-established’ nutrient function statements • help provide a mechanism for continuation of well-established claims currently in use • Published on UK Food Standards Agency website: http://www.food.gov.uk/news/newsarchive/jhcinews170304

21. JHCI ‘Well-established Health Statements’ project KEY AIMS: • To help inform the UK position during negotiations with the E C on its proposed health claims legislation. • To help develop a mechanism for handling existing health claims during the implementation of the legislation. • To provide a framework for identifying claims that are based on generally accepted scientific data, which can be added to the EC Register • To help form the UK’s contribution to a European-wide positive list of well-established health statements.

22. JHCI ‘Well-established Health Statements’ project SCOPE OF WORK: • based on well-established scientific evidence - not emerging scientific evidence • based on a normal physiological function - not an enhanced function; function that reduces the risk of developing a disease; or, function that that can be attributed to the prevention, treatment or cure of a disease • restricted to the vitamins and minerals listed in Annex 1 to the Food Supplements Directive (2002)

23. JHCI ‘Well-established Health Statements’ project SCOPE OF WORK, continued: • are related to quantities of nutrients that can be obtained from a normal diet - not pharmacological quantities • have not been considered in terms of their legal acceptability or meaningfulness to consumers • have not been considered in terms of their application to food products and as such are not approved health claims for food.

24. JHCI Well-established Health Statements project Process Overview Step 1. Clearly define ‘well-established’ Step 2. Determine priority order Step 3. Establish working definitions as necessary Step 4. Agree credible source documents to draw up a list of possible functions Step 5. Develop phraseology as necessary Step 6. Draw up comprehensive list of health statements.

25. Results Table 1a: Well-established nutrient function statements (common to all vitamins and minerals) ‘X’ contributes to normal reproduction ‘X’ contributes to normal conception ‘X’ contributes to normal development ‘X’ contributes to normal growth ‘X’ contributes to normal body maintenance

26. Results Table 1b: Approved well-established nutrient function statements (specific to certain vitamins and minerals), e.g.: VA1b: ‘Vitamin A is necessary for normal vision.’ Ni1: ‘Niacin is necessary for the normal release of energy from food.’ VB64: ‘Vitamin B6 contributes to the maintenance of normal blood homocysteine levels.’ Fo2: ‘Folate is necessary for the normal structure of the neural tube in developing embryos.’ VC1: ‘Vitamin C is necessary for the normal structure and function of connective tissue (such as that required for normal gums, skin, healing processes, bone and cartilage).’ Na1: ‘Sodium is necessary for normal water and electrolyte balance throughout the body.’

27. Results VA3: Vitamin A contributes to normal embryonic development. (see Table 1a) Table 2: Rejected nutrient function statements, e.g.: VC4: Vitamin C is necessary for the normal structure of gums. (see VC1) Fe6: Iron contributes to normal taste function. (data insufficient) Cr1: Chromium is necessary for the normal regulation of insulin. (no plausible mechanism) P3: Phosphorus contributes to the normal regulation of pH levels in the body. (too imprecise) Ca7: Calcium contributes to maintaining normal blood pressure. (data inconsistent)

28. Project Summary • not approved for use as health claims on foods • provide a sound scientific basis for the development of such claims. • food manufacturers and businesses wishing to generate health claims from these statements they should ensure that, when used in food labelling or to promote food products, they are meaningful and not misleading to consumers. They will also need to satisfy themselves that the claims comply with all the relevant legislation.

29. Consumer perception • Consumer perception is paramount • Not just one interpretation, but all likely interpretations of a health claim must comply with the Code • A range of factors which can determine consumer perception, e.g. use of pictures and logos on the packaging • HOW WILL THE CONSUMER INTERPRET THE STATED OR IMPLIED CLAIM?

30. Implied health claim Source: ASA Adjudications www.asa.org.uk/adjudications/

31. Legal and Nutrition Principles Claims should, e.g.: • not exaggerate the effect or claim benefits beyond the scope of evidence • be communicated in a way to assist consumer understanding of the basis of the health claim • not encourage consumption of foods high in added salt, sugar, saturated fat • be supported by instructions for recommended consumption patterns and amounts

32. Generic Claims in the UK JHCI has considered evidence in relation to:  saturates and blood cholesterol • wholegrain and heart health • soya protein and heart health • fruit & lung cancer* • vegetables and bowel cancer* • fruit and vegetables and stomach cancer* * illegal under current food law, but will be permitted under proposed new rules

33. Using pre-approved generic claims • Claims freely available from JHCI website • Approval includes claim-specific conditions for use and points to note • Companies strongly advised to discuss use of claims with JHCI to ensure products and marketing complies with the JHCI Code

34. JHCI Contact Details P.O. Box 43 Leatherhead, Surrey KT22 7ZW United Kingdom Ph: 0044 (0)1372 822 378 Fax: 0044 (0)1372 822 288 melanieruffell@jhci.org.uk www.jhci.org.uk

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