Short Introduction to Health Claims for SMVs

1. Health claims for dietary supplements Helle Buchardt Boyd Senior Toxicologist, M.Sc. (food science), Environment and Toxicology hbb@dhigroup.com, 4516 9097 June 15, 2011

3. The legal basis

4. Procedure for approval

5. Criteria for approval of healthclaims

6. Experience from the assessment of submittedhealthclaims

8. Definition of healthclaims ‘health claim’ means any claim that states, suggests or implies that a relationship exists between a food category, a food or one of its constituents and health ‘claim’ means any message or representation, which is not mandatory …., including pictorial, graphic or symbolic representation, in any form, which states, suggests or implies that a food has particular characteristics

9. Examples of health claims submitted for approval Increased insulin sensitivity Improved blood glucose control Change in body shape Reduction of waist circumference Good for maintenance of joints Reduced risk of osteoarthritis Protection of skin from UV-induced damage Maintenance of skin function Antioxidant Antioxidant defence Protection of cells from premature aging Contributes to a normal homocysteine metabolism Maintenance of normal blood pressure

11. psychological and behavioural functions; or

14. Procedure for approval (2) Article 13.5 claims submitted to the Commission via a Member State at any time EFSA issues opinion on the newly developed and/or proprietary evidence within 5 months Applicant is protected from subsequentapplicantsusing his data for 5 years The commission decides the Permission within two months and after consultation of Member States

15. Procedure for approval (3) Article 14 claims submitted to the Commission via a Member State at any time EFSA issues opinion on Scientific evidence and wording within 5 months The commission decides the Permission within two months and after consultation of Member States

16. Main criteria for approval of claims The health claim must be substantiated by generally accepted scientific evidence The claimed effect must be beneficial The average consumer can be expected to understand the beneficial effects as expressed in the claim The substance must be available in sufficient quantity and form to exert the claimed effect

17. Experience so far Generally acceptedevidence = human intervention studies of goodquality; meta analyses; maybesupported by animal data and other data. Characterisation of substance is veryimportant Antioxidant claims: theseeffectsremains to beproved as beneficial for humans, and theyneed to be more specific Avoidpitfalls in measurements of oxidativedamage to lipids, DNA or proteins in the body Youare not excluded from usingstudy populations whichare not entirelyhealthy, such as hypercholesteremic persons …….and much more

18. What can we learn from this?