The Food And Drink Innovation Network Omega-3 Seminar, Northamptonshire, 19 th Oct 2005

1. Healthy Claims The Food And Drink Innovation Network Omega-3 Seminar, Northamptonshire, 19th Oct 2005 Melanie Ruffell, Executive Director UK Joint Health Claims Initiative Food Industry Enforcement Consumers

2. Overview • JHCI background • General principles for making healthy claims • Substantiation requirements overview • JHCI approved claim for LC omega-3 PUFA

3. 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

4. Who is the 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

5. 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 across different media • to promote consistency in the regulation of health claims in the UK, Europe and internationally.

6. How JHCI can help The Code is not part of food legislation and does not replace or compete with the current UK systems of regulation and self-regulation IN THE SHORT TERM: • Compliance with the Code assists companies to establish a defence of all due diligence in the event of prosecution over the truthfulness of claims IN THE LONG TERM: • Lack of high profile cases helps restore consumer faith in products carrying health claims • Help prepare for the new legal environment and help ensure suitable claims stay on the market under new legislation

7. Types of claims LC n-3 PUFA helps reduce the risk of CVD (disease risk reduction) LC n-3 PUFA improves vascular endothelial function (enhanced function) LC n-3 PUFA contributes to normal vascular endothelial function (nutrient function) Lc n-3 PUFA helps maintain a healthy heart (health maintenance) LC n-3 PUFA helps prevent heart attacks (medicinal) Borderline Area FOOD MEDICINE

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

9. 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?

10. 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 • include quantification of the active ingredient • be supported by instructions for recommended consumption patterns and amounts

11. 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

12. Working with the Evidence:Substantiation of Health Claims

13. Approval process requirements Dossier must include: • Proposed health claim • Systematic Review of Evidence • Supplementary information: • Relevance to UK public health context • Potential implications • Typical products likely to carry the claim • Sample labels • Statement of intended use; level and frequency of consumption • Other documentation (see JHCI Code)

14. Approved claims 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.

15. Filtering the Evidence

16. Statistical summary of data (forest plot) Demonstrates overall consistency of results

17. Dossier requirements put simply… • Unbiased, transparent systematic approach • Evidence reflects application • Set in (UK) public health context • Anticipated use of claims • Complies with legal and nutrition principles in Code

18. LC n-3 PUFA JHCI Claim Eating 3g weekly, or 0.45g daily, long chain omega-3 polyunsaturated fatty acids, as part of a healthy lifestyle, helps maintain heart health. (11/02/05) POINTS TO NOTE: A. The claim relatesonly to very long chain polyunsaturated fatty acids (of chain length 20 carbons or above) including EPA, DPA and DHA (i.e. 20:3n-3, 20:4n-3, 20:5n-3, 22:5n-3 and 22:6n-3), and not all long chain polyunsaturated fatty acids, such as alpha-linolenic acid (i.e. 18:3n-3 and 18:4n-3). The ratio of EPA and DHA should reflect that which occurs naturally in oily fish.

19. LC n-3 PUFA JHCI Claim B. Products carrying the claim should: • Include the statement: ‘The Government advises that at least 2 servings of fish, one of which should be oily, containing approximately 3g LC n-3 PUFA, is consumed each week’. • For fortified foods and supplements, inform consumers that oil-rich fish is an alternative source of LC n-3 PUFA. • When a product is presented as a stand alone serving, then each serving must contain no less than 0.2g LC n-3 PUFA. • Not personalise the claim to the individual, e.g. “provides half your daily needs”.

20. LC n-3 PUFA JHCI Claim B. Products carrying the claim should (cont’d): • When a product carries a recommendation for a number of portions per day or week then: • the total LC n-3 PUFA content of the daily recommendation (daily serving) must be greater than 0.2g. • the total LC n-3 PUFA content of the weekly recommendation (weekly serving) must be greater than 0.5g. 6. State the proportion (i.e. a ‘quarter’, ‘third’, ‘half’ etc) of the 0.45g daily intake, or 3g weekly intake, in each serving or portion.

21. LC n-3 PUFA JHCI Claim B. Products carrying the claim should (cont’d): 7. Clarify the distinction between servings of a product and portions of oily fish. 8. Clarify to consumers when products have been fortified with LC n-3 PUFA and make clear to consumers the origin of the oil. 9. Products containing significant amounts of contaminants (identified by the SACN/COT Inter-Committee Subgroup to be marlin, swordfish, shark and, to a lesser extent, tuna) carrying the claim should also carry a warning for pregnant women and children.

22. LC n-3 PUFA JHCI Claim POINTS TO NOTE (cont’d): C. The JHCI Code states that health claims that could encourage high levels of consumption must not be made for any substances where there is evidence that high intakes of the food or substance could be harmful or unlikely to contribute to a healthy diet (refer section 6.2.16). JHCI advises that products carrying the claim should make a positive contribution to healthy eating. Products high in saturated fatty acids, salt, sugar etc should therefore not be promoted on this basis.

23. LC n-3 PUFA JHCI Claim POINTS TO NOTE (cont’d): D. The JHCI strongly recommends that companies seek advice from the Secretariat before using this claim to help ensure that the food product is consistent with good nutrition principles and complies with the JHCI Code of Practice for Health Claims on Food. E. The wording of the claim has been carefully formulated to reflect the evidence on which the claim has been approved. Wording may be altered, in consultation with the JHCI, as long as the claim does not imply health benefits beyond the scope of the evidence change the meaning of the claim; or, confuse consumers.

24. LC n-3 PUFA JHCI Claim NUTRIENT CONTENT CLAIMS Approval of the use of nutrient content claims on food labels is beyond the remit of JHCI, therefore appropriate legal advice must be sought by those wishing to use such claims. However, the JHCI Expert Committee considered, from a scientific basis, that nutrient content claims could be substantiated as follows and recommended that it be made clear to consumers when these claims were in relation to the daily amount or weekly amount.

25. LC n-3 PUFA JHCI Claim NUTRIENT CONTENT CLAIMS (cont’d) • Based on a WEEKLY intake amount: • ‘A good source of the weekly intake’ • = at least 1/6th of 3g LC n-3 PUFA per week • ‘A rich source of the weekly intake’ • = at least ½ of 3g LC n-3 PUFA per week • Based on a DAILY intake amount: • ‘A rich source of the daily intake’ • = at least ½ of 0.45g LC n-3 PUFA per day Quantification of nutrient content claims should be reported to the nearest 0.1g/100g, so not to imply a higher level of precision than exists.

26. LC n-3 PUFA JHCI Claim General advice: • Don’t dilute the claim – ensure all salient points are included in any revised wordings. • The claim is about long chain n-3 PUFA – this should not abbreviated to ‘omega-3’. • Ensure nutrition composition panel also is expressed in ‘g’ not ‘mg’ (to be consistent with claim).

27. 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