GAINS & LOSSES in the HEALTH CLAIM ARENA

1. GAINS & LOSSES in theHEALTH CLAIM ARENA Dr Janice Harland Associates, UK

2. Outline • Health Claims • Energy – just what can be claimed now? • Digestive health – a marketing success story, but who are the winners for claims? • What’s on the horizon for weight loss claims? • Movement – muscle, bone and joint health EFSA update • Other gains & losses • Other considerations 2

3. Introduction • Health Claims – health warning! • Await wording from EC on approved claims • Await confirmation that EC will adopt all of EFSA opinions • Await final assessments from EFSA • Await nutrient profiles • The views expressed are personal, every attempt is made to be accurate, but please take advice, as interpretationof the Regulation is not finalised 3

4. Energy: just what can be claimed now? EFSA - cause & effect relationship has been established between: • thiamine/niacin/riboflavin/pantothenic acid/ vitamin B6, vitamin B12, vitamin C, biotin, Ca, P, Mg, Cu, I, Mn and normal energy-yielding metabolism • the consumption of glycaemic carbohydrates and maintenance of normal brain function • the consumption of creatine and an increase in physical performance during short-term, high intensity, repeated exercise bouts 4

5. Energy: just what can be claimed now? EFSA - cause & effect relationship has been established between: carbohydrate electrolyte solutions that contribute to the maintenance of endurance performance during prolonged endurance exercise enhance the absorption of water during physical exercise Conditions of use: 80-350 kcal/L from carbohydrates, and at least 75 % of the energy should be derived from carbohydrates which induce a high glycaemic response, such as glucose, glucose polymers and sucrose. In addition, these beverages should contain between 20 mmol/L (460 mg/L) and 50 mmol/L (1,150 mg/L) of sodium, and have an osmolality between 200-330 mOsm/kg water.. 5

6. Energy: just what can be claimed now? EFSA - cause & effect relationship has been established between the consumption of: • caffeine and increase in endurance performance /endurance capacity reduction in the rated perceived exertion during exercise • caffeine and increased alertness • caffeine and increased attention In order to bear the claim, a product should contain at least 75 mg caffeine per serving • For children, consumption of a dose of 5 mg/kg body weight could result in transient behavioural changes, such as increased arousal, irritability, nervousness or anxiety. In relation to pregnancy and lactation, moderation of caffeine intake, from whatever source, is advisable. 6

7. Energy: New Opportunities • the consumption of fructose in place of sucrose or glucose in foods or beverages • xylitol, sorbitol, mannitol, maltitol, lactitol, isomalt, erythritol, D-tagatose, isomaltulose, sucralose or polydextrose instead of sugar • pectins, beta-glucans from oats and barley, arabinoxylan produced from wheat endosperm, resistant starch, slowly digestible starch, Hydroxypropyl Methylcellulose (HPMC) ....and reduction of post-prandial glycaemic responses lower blood glucose rise after a meal • BUT NOT • and the long-term maintenance or achievement of normal blood glucose concentrations • glycaemic carbohydrates and energy metabolism 7

8. Energy: not established • the consumption of caffeine • and an increased fat oxidation leading to a reduction in body fat mass • and increased energy expenditure leading to the reduction of body weight • ... the consumption of carnitine, Coenzyme Q10, folate, taurine and normal energy metabolism BUT • a cause and effect relationship has been established between the dietary intake of folate and the reduction of tiredness and fatigue. 8

9. Energy: take CARE 9

10. Energy: take CARE • Wording from EC critical • Await confirmation that EC will adopt all of EFSA opinions 10

11. Digestive health – a marketing success story • UK sales of pre and probiotic yogurts are expected to show strong growth from £12.63 to £15.78 per head by 2016 • Claims related to digestive health are key to consumers • Everyone knows about friendly bacteria 11

12. Digestive health – scientific uncertainty • Probiotics - no positive opinions from EFSA (276 rejections) • Prebiotics – no positive opinion for galacto oligosaccharides, resistant starch, polydextrose, gums • Insufficient characterisation of bacteria • Studies conducted on inappropriate subjects (not healthy) • ...EFSA Panel considers that the evidence provided does not establish that increasing numbers of intestinal microorganisms is a beneficial physiological effect. The Panel considers that decreasing potentially pathogenic gastro-intestinal microorganisms might be a beneficial physiological effect.... • Studies and claim not perfect match • Inconsistent results 12

13. Digestive health – Future • Yakult says its rejected EU health claim for upper respiratory tract infection (URTI) benefits won’t alter its core sell in Europe • Feb 2012 Danone formed the Global Alliance for Probiotics (GAP) with other sector businesses: Yakult, DuPont-Danisco and Chr Hansen as industry seeks to win first EU health claim • Mar 2012 GAP state a complete rethink of probiotic health claim rules is required in EU, and Industry should be part of the process • In the meantime... 13

14. Digestive health – Future • Italian Ministry of Health revised probiotic characterisation, labelling & claim guidelines – opportunity to open claim-making around the idea of microflora balance. ....EFSA has said increasing healthy gut flora is not of itself a health benefit, the Italian ministry indicates “supports balance of the internal microflora” is a condition of use ... • ...therefore this indication is not considered as a health claim in the sense of the Regulation (Barbara Klaus, legal firm Meyer Meistererns, Italy) • Nutrition labelling options? 14

15. Digestive health – Future Potential loopholes that could fall under nutritional labelling or “nutrition claim” rules; where the probiotic bacterial strain was used as a “generic descriptor” Probiotic strain forms part of the name of a product, (i.e. part of trade mark or brand name of product) which had been traditionally used prior to 1/1/2005 may be marketed until 19/1/2022 . 15

16. Digestive health – Future Probiotic claims still awaiting evaluation EFSA committed £4500 to produce characterisation document for probiotic Opinions on re-assessed dossiers expected by June 2012 Once EU has a list of approved health claims, products not complying will have to be removed from supermarket shelves 6 mo after the law comes into effect By 2013 many products currently labelled as probiotics will have to be removed from the market, but .... 16 EFSA on Dietetic Products, Nutrition and Allergies (NDA); Guidance on the scientific requirements for health claims related to gut and immune function. EFSA Journal 2011;9(4):1984. [12 pp.]

17. Digestive health – Future • Permitted claims – digestive health • “Wheat bran fibre contributes to a reduction in intestinal transit time” • “the consumption of lactulose and a reduction in intestinal transit time” • “Wheat bran fibre contributes to an increase in faecal bulk” • “Barley grain fibre contributes to an increase in faecal bulk” • “Oat grain fibre contributes to an increase in faecal bulk” • “Rye fibre and changes in bowel function” • Watch this space • ...evidence provided is insufficient to establish a cause and effect relationship between the consumption of dried plums of ‘prune’ cultivars (Prunus domestica L.) and maintenance of normal bowel function 17

18. What’s on the horizon for weight loss claims? 18

19. What’s on the horizon for weight loss claims? • EFSA - established health relationships1: • Reduction in body weight • Body weight maintenance after weight loss • Reduction in waist circumference, if accompanied by improvement in adverse health effects of an excess abdominal fat, is a beneficial physiological effect • Sustained reduction in body fat, and particularly abdominal fat, is a beneficial physiological effect for overweight and obese subjects in the general population • Changes in “body shape” 19 1. EFSA Panel on Dietetic Products, Nutrition and Allergies (NDA); Draft guidance on the scientific requirements for health claims related to appetite ratings, weight management, and blood glucose concentrations released for public consultation. EFSA Journal 20xx;x(x):xxxx.

20. Weight loss claims? • Health relationships: • Increased satiety and/or reduced sense of hunger/appetite • The health benefit of changing appetite ratings is to decrease subsequent energy intake, subsequent energy intake should be measured using appropriate methods, and the effect should be sustained over time, taking into account possible compensatory effects • The reduction of energy intake during or after consumption of a food/constituent will be considered on a case-by-case basis after chronic consumption of the food (1 month). If the health benefit of changing energy intake is to decrease body weight, body weight changes should be measured (3 month). 20 EFSA Panel on Dietetic Products, Nutrition and Allergies (NDA); Draft guidance on the scientific requirements for health claims related to appetite ratings, weight management, and blood glucose concentrations released for public consultation. EFSA Journal 20xx;x(x):xxxx.

21. What’s on the horizon for weight loss claims? Increased satiety and/or reduced sense of hunger/appetite - not a claim in its own right 21

22. What’s on the horizon for weight loss claims? • Permitted claims: • ...a cause and effect relationship has been established between the consumption of a very low calorie diet and reduction in body weight. • VLCDs are diets which contain: • Energy levels between 450 and 800 kcal per day, • 100 % of the recommended daily intakes for vitamins & minerals. • Not less than 50 g high-quality protein (PDCAAS of 1) • Not less than 3 g linoleic acid and not less than 0.5 g alpha-linolenic acid with a linoleic acid/alpha-linolenic acid ratio between 5 and 15 • Should provide not less than 50 g available carbohydrates 22

23. What’s on the horizon for weight loss claims? • Permitted claims: • ...a cause and effect relationship has been established between the consumption of meal replacements in substitution of regular meals in the context of energy restricted diets ... and reduction in body weight • and the maintenance of body weight after weight loss • Meal replacements contain: • A maximum of 250 kcal/serving and comply with specifications laid down in Directive 96/8/EC • In order to achieve the claimed effect, one or two meals should be substituted with meal replacements daily. • The target population is overweight subjects in the general population who wish to maintain their body weight after significant weight loss. 23

24. What’s on the horizon for weight loss claims? • Permitted claims: • ...a cause and effect relationship has been established between Glucomannan in the context of an energy restricted diet contributes to weight loss • Conditions of use: • 1 g of glucomannan per quantified portion • daily intake of 3 g of glucomannan in three doses of 1 g each, together with 1-2 glasses of water, before meals and in the context of an energy-restricted diet 24

25. What’s on the horizon for weight loss claims? • Permitted appetite/weight management health claims: • Few left • New strategies required: • Opportunity to make greater use of nutrition claims? • If you believe you have strong proposition conduct research for your product, with the view of making Article 13.5 Application • Position product demonstrating it meets healthy eating objectives 25

26. Permitted Nutrition Claims • LOW ENERGY • A claim that a food is low in energy - the product does not contain more than 40 kcal (170 kJ)/100 g for solids or more than 20 kcal (80 kJ)/100 ml for liquids. • For table-top sweeteners the limit of 4 kcal (17 kJ)/portion, with equivalent sweetening properties to 6 g of sucrose applies. • ENERGY-REDUCED • A claim that a food is energy-reduced - the energy value is reduced by at least 30% with an indication of the characteristic(s) which make(s) the food reduced in its total energy value. • ENERGY-FREE • A claim that a food is energy-free - the product does not contain more than 4 kcal (17 kJ)/100 ml. • For table-top sweeteners the limit of 0.4 kcal (1.7kJ)/portion, with equivalent sweetening properties to 6 g of sucrose applies. • LIGHT/LITE • A claim stating that a product is ‘light’ or ‘lite - same conditions as those set for the term ‘reduced’; the claim shall also be accompanied by an indication of the characteristic(s) which make(s) the food ‘light’ or ‘lite’. 26

27. What’s on the horizon for weight loss claims? • WHO cited the following about European people: • 30–80% adults are overweight in the countries of the WHO European Region • About 20% children & adolescents are overweight, and 1/3 are obese • Prevalence of obesity is rising rapidly by 2010 likely to be 150 million adults & 15 million children • The trend in obesity is especially alarming in children & adolescents. Annual rate of increase in childhood obesity is growing steadily – the current rate is 10 X that in the 1970s 27 WHO, The challenge of obesity in the WHO European Region and the strategies for response ed. F. Branca, H. Nikogosian, and T. Lobstein. 2007, Copenhagen, Denmark: WHO Europe.

28. What’s on the horizon for weight loss claims? • WHO recommendations: • Promote the inclusion of low energy density in the dietFor example: • Eating more fruit, vegetables, legumes, whole grains, nuts and seeds and reducing the amount of energy-rich foods, is a simple and easy way to help manage weight • Promote foods on basis of nutrition content not using health claims 28 WHO, 5.2 Recommendations for preventing excess weight gain and obesity, p61-71. 2003, www.who.org.

29. Other gains & Losses 1. EFSA Panel on Dietetic Products, Nutrition and Allergies (NDA); Draft guidance on the scientific requirements for health claims related to bone, joints, and oral health released for public consultation. EFSA Journal 20xx;x(x):xxxx. [11 pp.]. doi:10.2903/j.efsa.20NN.NNNN • Movement – muscle, bone and joint health EFSA update1 • Article 14 claims: Ca, Vit D, Ca +Vit D, bone health Ca(+Vit D) and reducing the loss of BMD, which may contribute to a reduction in the risk of bone fracture • Article 13 claims: Ca, Vit D, Ca +Vit D & bone health protein & growth or maintenance of muscle massor bone 29

30. Other gains & Losses • Claims not established in respect of muscle, bone and joint health • chondroitin or chondroitin sulphate • methylsulfonylmethane, either alone or in combination with glucosamine hydrochloride • glucosamine hydrochloride or as glucosamine sulphate, either alone or in combination with chondroitin sulphate • Gamma-linolenic • Boron • EPA, DHA and bone/joint maintenance 30

31. Other gains & Losses Claims not established in respect of whole grains, soy protein, soy isoflavones, prunes, fruits & tea and antioxidant, cranberries etc 31

32. Gains and Losses Health Claims • Target audience • B2B • Health Professionals/influencers communication programme backed by good science (not overstated or “too medical”) • Claims that meet public nutrition health policy • Simple consumer messaging with few claims • Claim and brand image should be comfortable partners 32

33. Other Gains – labelling requirements • Health/Nutrition claims prompt full 8 Nutrition Label + nutrient subject of claim • All claims subject to profiles • Trigger the following additional information: • Statement indicating the importance of a varied and balanced diet and a healthy lifestyle • Quantity and pattern of food to be consumed to achieve benefit • If appropriate, statement addressed to those who should avoid food • Appropriate warning for foods likely to be consumed to excess 33

34. Health Claims - Gains & Losses Conclusions • More losses than gains! • Consider using health claims already assessed (largely nutrients) • Can nutrition claims be used to good effect? • Wording of EFSA assessed claims to be finalised by EC • Take care to ensure wording you use gives same impression as authorised claim • Ensure all labelling requirements are met • All claims subject to profiles (when finalised) 34

35. Associates jan.harland@harlandhall.co.uk tel: + 44 1285 850661 • Every attempt is made to be accurate, but please take advice, as interpretation of the Regulation is not finalised. Thank you for your attention 35