6 th Dubai International Food Safety Conference Dubai

6 th Dubai International Food Safety Conference. Dubai International Convention and Exhibition Centre (28 th Feb to 1 st March 2011) Workshop 2: International Workshop on Responsible Consumer Information on Nutrition and Health claims (Venue: Umm Al Quwain Room. 1 st March 2011) Scientific Substantiation of Health Claims made on Foods in the EU Andreu Palou University of Balearic Islands (UIB) and CIBERobn. Palma de Mallorca (SPAIN) andreu. palou@uib. es

Regulation (EC) nº 1924/2006 of the European Parliament and of the Council of 20 December 2006 on Nutrition and Health Claims made on Foods CORRIGENDA Official Journal of the European Union L 12, 3 -18, 18 January 2007 “Nutrition and Health Claims on Food must be substantiated by scientific evidence” (EFSA. European Food Safety Authority)

Regulation (EC) 178/2002 The European Food Safety Authority (EFSA): Risk (and benefit) assessment 1. Independent scientific advice, information and scientific and technical support for the Community’s legislation and policies in all fields which have a direct or indirect impact on food and feed safety including nutrition 2. High level of scientific excellence, independence and transparency 3. Communication ----------- EC and member states: Management

RISK ANALYSIS Process initiation Risk Assessment Risk Management EFSA EC-MSs Science based Policy based d n a t n e s n m o s i s s i e c s e s d a ( Thresholds, authorizations, restrictions, t o s n n legislation, inspections, sanctions, etc. o d i n n i a p ) o n : o i A A system to protect human health t S a c i EF n and which allows initiatives and u m m progress: “transparency” co Risk Communication DECISIONS

The context

“ F O O D Q U A L I T Y ” SAFETY FOOD QUALITY ASPECTS NUTRITION - HEALTH VARIACIÓN CONTROL NUTRITION - HEALTH CULTURAL ASPECTS ECOLOGY SOUSTAINABILITY ETHICS ANIMAL WELLBEING. . .

CONCEPTUAL CHANGES IN NUTRITION/FOOD: Adequate Nutrition SCIENCE Driving Consumer demand forces Economics - calories, nutrients - metabolic needs - satisfy hunger - enjoyment Wellbeing “Optimal Nutrition” - Promoting health - Improving well-being -Reducing risk of illness ‘FUNCTIONAL FOODS’

NUTRITION Milk + calcium Milk + w 3 Margarine + plant sterols. . . DR UG FUNCTIONAL FOODS MEDICINES FO O D There is a frontier between drugs and food THERAPEUTIC FIELD

NUTRITION Milk + calcium Milk + w 3 Margarine + plant sterols. . . DR UG FUNCTIONAL FOODS NUTRACEUTICALS OIL CAPSULES PROTEIN PREPARATIONS THERAPEUTIC FIELD FO O D

NUTRITION DR UG Milk + calcium Milk + w 3 Margarine + plant sterols. . . MEDICINES FUNCTIONAL FOODS NUTRACEUTICALS OIL CAPSULES PROTEIN PREPARATIONS THERAPEUTIC FIELD FO O D

NUTRITION DR UG Milk + calcium Milk + w 3 Margarine + plant sterols. . . The FUNCTIONAL FOODS MEDICINES n a r lea NUTRACEUTICALS r e i t fron m l l i dw c t o is n OIL CAPSULES PROTEIN PREPARATIONS THERAPEUTIC FIELD . F. O. . e ov O D

1. The labelling. . . must not attribute to any foodstuff the property of preventing, treating or curing a human disease, or refer to such properties. . but: The “new” challenges in Nutrition and Food are the CHRONIC DISEASES and all wellbeing aspects that are known to be related with FOOD CVD, diabetes, obesity, cancer, d n a h t l a e h osteoporosis, . . . n o t c a p m i s g c n i i s m a o e 46% of total illness and 59% of total deaths in the world n r o c Inc e(FAO/WHO) Directly related with diet

We knew that malnutrition kills…

…now we know that obesity also kills Obesity is associated to: - hypertension - dislipidemia - Insulin resistance - respiratory problems - Type 2 diabetes - CVD - certain cancers. . .

The new perspective: efficacy and health FOOD IS EXPECTED TO BE: e b n a c t a h t s d r o w l u f i t ” u a n e g i b n t e s b o s i m t e i “ e r t h u t b e ” n e u l l o “Th A y y e d v o oo l I W “ t o n said are SAFE NUTRITIVE PALATABLE THERAPEUTIC PREVENTIVE

Increased consumption of functional foods in Europe Alimarket last news http: //www. alimarket. es/noticias/not_frames. php? salto=RJ “…In Spain the functional foods marked is increasing at an anual rate around 15% (>3. 000 M€…)”

Confusion: false messages Marketing and labelling may mislead the consumer NEW SNACK WITHOUT CHOLESTEROL A need for a more strict use of health claims made on foods and what foods can bear health claims

Regulation (EC) nº 1924/2006 of the European Parliament and of the Council of 20 December 2006 on Nutrition and Health Claims made on Foods CORRIGENDA Official Journal of the European Union L 12, 3 -18, 18 January 2007 “Nutrition and health claims on food must be substantiated by scientific evidence” (EFSA)

The EU Regulation covers two general types of claims used in the labelling, presentation and advertising of foods : h t i w h t o b F h f t l o O a S n N e o h M i O I I t c T a A i f n L i A i c C N b I e H m p B 1. Nutrition claims: content T s o M L c n O u A e ( (High in fibre, low in salt, low in energy, source of. . . ) C E h 3 T. H E … 0 H ) + 1 T s Nlaim e l O c I i art TRIT c NU 2. Health claims: effects A) Function claims B) Reduction of disease risk C) Claims on children growth and development

ANNEX (Regulation (EC) nº 1924/2006) Nutrition claims (composition) and conditions applying to them LOW ENERGY A claim that a food is low in energy, and any claim likely to have the same meaning for the consumer, may only be made where the product does not contain more than 40 kcal (170 k. J)/100 g for solids or more than 20 kcal (80 k. J)/100 ml for liquids. For table-top sweeteners the limit of 4 kcal (17 k. J)/portion, with equivalent sweetening properties to 6 g of sucrose (approximately 1 teaspoon of sucrose), applies. 29 nutrition claims authorized ENERGY-REDUCED A claim that a food is energy-reduced, and any claim likely to have the same meaning for the consumer, may only be made where 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. 8 under discusion ENERGY-FREE A claim that a food is energy-free, and any claim likely to have the same meaning for the consumer, may only be made where the product does not contain more than 4 kcal (17 k. J)/100 ml. For table-top sweeteners the limit of 0, 4 kcal (1, 7 k. J)/portion, with equivalent sweetening properties to 6 g of sucrose (approximately 1 teaspoon of sucrose), applies. LOW FAT A claim that a food is low in fat, and any claim likely to have the same meaning for the consumer, may only be made where the product contains no more than 3 g of fat per 100 g for solids or 1, 5 g of fat per 100 ml for liquids (1, 8 g of fat per 100 ml for semi-skimmed milk). LOW SATURATED FAT A claim that a food is low in saturated fat, and any claim likely to have the same meaning for the consumer, may only be made if the sum of saturated fatty acids and trans-fatty acids in the product does not exceed 1, 5 g per 100 … SOURCE OF [NAME OF VITAMIN/S] AND/OR [NAME OF MINERAL/S] A claim that a food is a source of vitamins and/or minerals……. where the product contains at least a significant amount as defined in the Annex to Directive 90/496/EEC…. …

The EU Regulation covers two general types of claims used in the labelling, presentation and advertising of foods : 1. Nutrition claims: content (High in fibre, low in salt, low in energy, source of. . . ) 2. Health claims: effects A) Function claims (Art 13) Existing claims list (Art 13. 3) New claims added to the list based on new science (Art 13. 5) B) Reduction of disease risk (Art 14) C) children's development and health (Art 14)

Three key aspects in Regulation (EC) nº 1924/2006: this is going ahead but. . . 1. Nutrition and health claims on food must be substantiated by scientific evidence h t l a e h this is delayed. . e n v o i o t r 2. Only those foods with an ‘appropriate’ a v o Imp t n e n i k r nutrient profile will be allowed to bear e a c m n l a a n r Enh claims e t n i e v i t c e f f E R+D estimulation but uncertainty. . 3. intellectual property drawn from research efforts will be protected (5 years)

The main challenges: 1. HEALTH CLAIMS SCIENTIFIC SUBSTANTIATION

COMUNICATION OF BENEFITS: claims should reflect the scientific evidence and should be beneficial 1. Scientific trueness ( “The entire truth and nothing but the truth”) Too simple message is wrong while too complex cannot be understood EFSA Journal 2010; 8(10): 1738 SCIENTIFIC OPINION Scientific Opinion on the substantiation of health claims related to various food(s)/food constituent(s) and “energy and vitality” (ID 18, 26, 62, 105, 122, 145, 165, 3962, 4054, 4440), “invigoration of the body” (ID 2383, 2386, 2391, 2393, 2409, 2441, 2463, 2488, 3834, 3883), “general health” (ID 1313, 3348, 4182, 4613), “rejuvenation” (ID 3981, 4023), “tonic” (ID 1703, 3462, 3581, 4418), “stimulant” (ID 3190, 3506) and “metabolic benefits” (ID 4438) pursuant to Article 13(1) of Regulation (EC) No 1924/20061 SUMMARY …. The Panel considers that the claimed effects are not sufficiently defined… The Panel considers that these claimed effects are general and non-specific (do not refer to any specific health claim as required by Regulation (EC) No 1924/2006

Article 6 Scientific substantiation for claims 1. Nutrition and health claims shall be based on and substantiated by generally accepted scientific evidence. E? T A H W T I S DOE N I S N MEA C I T C PRA

PANEL MEMBERS Jean-Louis Bresson, Albert Flynn (Chair) Marina Heinonen, Karin Hulshof, Hannu Korhonen, Pagona Lagiou, Martinus Løvik, Rosangela Marchelli, Ambroise Martin, Bevan Moseley, Andreu Palou (Vice. Chair), Hildegard Przyrembel (Vice. Chair), Seppo Salminen, J (Sean) J Strain, Stephan Strobel, Inge Tetens, Henk van den Berg, Hendrik van Loveren, and Hans Verhagen.

COMMISSION REGULATION (EC) No 353/2008 of 18 April 2008 establishing implementing rules for applications for authorisation of health claims as provided for in Article 15 of Regulation (EC) No 1924/2006 of the European Parliament and of the Council. (OJ L 109, 19. 4. 2008, p. 11) COMMISSION REGULATION (EC) No 1169/2009 of 30 November 2009 amending Regulation (EC) No 353/2008 establishing implementing rules for applications for authorisation of health claims as provided for in Article 15 of Regulation (EC) No 1924/2006 of the European Parliament and of the Council Official Journal of the European Union (1. 12. 2009) L 314/34

The guidance presents a common format to assist the applicant in the preparation of a well-structured application. The application must contain: (a)Characteristics of the food/constituent. (b) Proposal for the wording of the health claim, including, as appropriate, the specific conditions of use and a rationale (target; quantity, pattern of consumption as part of a balanced diet…) c) All pertinent scientific data (published and unpublished, data in favour and not in favour). Data from studies in humans. Studies in animals or models may be included only as supporting evidence. d) A comprehensive literature search and review of the data from human studies balance of all the evidence available.

The outcome of each assessment is one of 3 possible conclusions: 1. A cause and effect relationship has been established between the consumption of the food/constituent and the claimed effect. 2. The evidence provided is insufficient (not conclusive) to establish a cause and effect relationship between the consumption of the food/constituent and the claimed effect. 3. A cause and effect relationship is not established (at most, limited scientific evidence) between the consumption of the food/constituent and the claimed effect.

The following main topics are addressed by the EFSA Panel: 1. The target group: healthy population 2. How does the NDA Panel decide whether a health claim is substantiated? 3. What is the totality of the available scientific data? 4. What are pertinent studies for substantiation of a claim? 5. On what basis does the NDA Panel propose wordings of health claims? 1. 6. To what extent should a food be characterised? 2. 7. How should the claimed effect be shown to be beneficial? 3. 8. What is a suitable biomarker for a function and what is a risk factor for the development of a disease?

1. Target group The NDA Panel considers that the population group for which health claims are intended is the general (healthy) population or specific subgroups thereof, e. g. elderly people, sports people, pregnant women… In its evaluation, the NDA Panel considers that where a health claim relates to a function/effect that may be associated with a disease, subjects with the disease are not the target population for the claim, e. g. joint health and osteoarthritis patients. Applications for claims that specify target groups other than the general (healthy) population are the subject of ongoing discussions with the Commission and Member States with regard to their admissibility.

2. How does the NDA Panel decide whether a claim is substantiated? All the evidence from the pertinent studies (i. e, studies from which scientific conclusions can be drawn for substantiation of the claim) is weighed with respect to its overall strength, consistency and biological plausibility, taking into account the quality of individual studies and with particular regard to the population group for which the claim is intended and the conditions of use proposed for the claimed effect. Assesing if the specific study group(s) is representative of the target population. While studies in animals or in vitro may provide supportive evidence, human data are central for the substantiation of the claim. There is no pre-established formula as to what type or how many studies are needed to substantiate a claim.

3. What is the totality of the available scientific data? The totality of data refers to all studies available to EFSA that are considered pertinent (i. e. the studies from which scientific conclusions can be drawn for substantiation of the claim), including those that support the relationship as well as studies showing no effect and/or opposing effects. EFSA uses the references received from the Applicants, Member States, and Stakeholders. In the assessment the Panel may use data which are not included in the references provided if they are considered pertinent to the claim. However, EFSA is not required to search for additional references.

4. What are pertinent studies for substantiation of a claim? (studies from which scientific conclusions can be drawn for the claim substantiation) Have the studies been carried out with the food/constituent for which the claim is made? Have the human studies used an appropriate outcome (biomarker/risk factor) measure(s)? How do the conditions of human studies relate to the conditions of use? Have the human studies been carried out in a study group representative of the population group for which the claim is intended? To what extent can evidence derived from studies in animals/in vitro support the claimed effect in humans? As human data are central for the substantiation of a claim, particular attention is given to whether the human studies provided are pertinent to the claim.

5. On what basis does EFSA propose wordings of claims? Only for claims for which a cause and effect relationship has been established, EFSA considers whether the proposed e cthe wording reflects the scientific evidence and compliesidwith n e v refer only e c i f criteria laid down in the Regulation (e. g. it should not i t n e i c s h t to general, non-specific health benefits of the food/constituent); i w t n e m e if not, EFSA may propose an appropriate wording. e gr a t c i r t S It should be noted that the wording adopted by the Commission during authorisation may need to take into account aspects other than agreement with the scientific evidence, e. g. understanding by consumers.

6. To what extent should a food/constituent be characterised? There should be sufficient definition of the food/constituent used in the studies provided for substantiation of the claim. Characterisation should be sufficient to allow appropriate conditions of use to be defined and to allow control authorities to verify that the food/constituent which bears a claim is the one that was authorised If the claim is for a specific formulation or fixed combination of constituents, then studies are needed on this specific formulation or combination. EFSA considers whether sufficient information is provided to identify the role of each relevant constituent proposed to contribute to the claimed effect.

7. How should the claimed effect be shown to be beneficial? The NDA Panel makes a scientific judgement on whether the claimed effect is considered to be a beneficial nutritional or physiological effect. For function claims, a beneficial effect may relate to maintenance or improvement of a function. For reduction of disease risk claims, „beneficial‟ refers to whether the claimed effect relates to the reduction of a risk factor for development of a disease. The claimed effect must be sufficiently defined and needs to be specific enough to be testable and measurable by generally accepted methods. Where a health claim relates to a function that may be associated with a disease, subjects with the disease are not the target for the claim.

The EFSA-NDA Panel considers the extent to which: 1. The food/constituent is defined and characterised ; 2. The claimed effect is defined and is a beneficial nutritional or physiological effect (“beneficial to human health”) ; 3. A cause and effect relationship is established between the consumption of the food/constituent and the claimed effect (for the target group under the proposed conditions of use) ; and, if a cause and effect relationship is considered to be established, whether: 1. The quantity of food/pattern of consumption required to obtain the claimed effect can reasonably be consumed within a balanced diet ; 2. The proposed wording reflects the scientific evidence ; 3. The proposed wording complies with the criteria for the use of claims specified in the Regulation ; 4. The proposed restrictions/conditions of use are appropriate.

Pertinent studies in humans (DBPC) are essential If a cause and effect relationship is considered to be established, to check that: 1. The quantity of food/pattern of consumption compatible within a balanced diet ; 2. The proposed wording reflects the scientific evidence ; 3. The proposed wording complies with the criteria specified in the Regulation ; 4. The proposed restrictions/conditions of use are appropriate.

A new parameter for sex education Sir – There is concern in West Germany over the falling birth rate. The graph might suggest a solution that every child knows makes sense. — HELMUT SIES CAUSALITY? 1. CONTROLLED INTERVENTION STUDIES IN HUMANS Consequently, it is clear that less STORKS imply 2. BENEFICIAL EFFECT less BABIES. . . Many studies in this category? 3. BIOLOGICAL PLAUSIBILITY (1) Fachserie Gebiet und Bevölkerung (Statistisches Bundesamt, Kohlhammer, Stuttgart, 1984). (2) Bauer. S. & Thielcke, G. Die Vogelwarte 31, 183 -191 (1982). http: //www. timebubble. org/writings/biology. html

HEALTH CLAIMS SUBSTANTIATION: the European situation at present EU REGULATION 1924/2006. Article 13 Health claims other than those referring to the reduction of disease risk and to children's development and health … 3. After consulting the Authority, the Commission shall adopt, in accordance with the procedure referred to in Article 25(2), a Community list of permitted claims as referred to in paragraph 1, and all necessary conditions for the use of these claims by 31 January 2010 at the latest. … The Commission has already announced a delay (2012) … 2013…. 2014 ?

Summary (February 2011) of the 1. 745 claims on functions already assessed by EFSA out of 4. 637 submissions (ART. 13. 1) Favourable: around 20% These favourable opinions refer to claims for which there is well established consensus among scientific experts as to their substantiation, e. g. many of the functions of the essential nutrients (vitamins, minerals and essential FAs…), some chewing gums, specific fibres, some foods for special uses. . . Negative: around 80% 50% due to insufficient characterization (probiotics, botanicals, fibres). Other: ambiguous, non-specific, no benefit (e. g. probiotics “per se”)…

Examples of favorable conclusions of EFSA (Art 13. 1) (FUNCTION CLAIMs) The Panel concludes that a cause and effect relationship has been established between the dietary intake of VITAMIN K and the maintenance of normal bone and normal blood coagulation The Panel concludes that a cause and effect relationship has been established between the dietary intake of NIACIN and normal energy-yielding metabolism, normal function of the nervous system, and maintenance of normal skin and mucous membranes. The Panel concludes that a cause and effect relationship has been established between the FUTURE: dietary intake of VITAMIN B 6 and normal protein and glycogen metabolism, normal function of the nervous system, normal red blood cell formation, normal function of the immune system and regulation of hormonal activity. NORMAL vs OPTIMAL ? The Panel concludes that a cause and effect relationship has been established between the dietary intake of VITAMIN B 12 and normal red blood cell formation, normal cell division, normal energy-yielding metabolism and normal function of the immune system. The Panel concludes that a cause and effect relationship has been established between the dietary intake of SELENIUM and protection of DNA, proteins and lipids from oxidative damage, normal function of the immune system, normal thyroid function and normal spermatogenesis. The Panel concludes that a cause and effect relationship has been established between the dietary intake of PHOSPHORUS and normal function of cell membranes, normal energyyielding metabolism and maintenance of normal bone and teeth. …

Health relation (I) CONTRIBUTES TO (MAINTENANCE OF) NORMAL FUNCTION Acid-base balance Blood Ca concentrations Blood Cholesterol concentrations Blood clotting Blood formation Blood pressure Blood vessels Bone function Cartilage Cell differentiation Cell division Zn 1, 5 mg Vit D 0, 75 ug ALA 0, 3 g; LA 3 g, Beta-glucanos 3 g; Glucomanan 4 g Ca 120 mg; Vit K 11, 25 ug Folato 30 ug EPA/DHA 0, 45 g Vit C, 12 mg Vit D 0, 75 ug; P 105 mg; Zn 1, 5 mg Mg 56, 25 mg; Ca 120 mg, Mn 0, 3 mg Vit K 11, 25 ug Vit C 12 mg Vit A 120 mg Vit B 12 0, 375 ug; Vit D 0, 75 ug; Fe 2, 1 mg Zn 1, 5 mg; Mg 56, 25 mg; Folato 30 ug

Health relation (II) CONTRIBUTES TO (MAINTENANCE OF) NORMAL FUNCTION Cell membranes Cognitive function Connective tissues Digestive enzynes Electrolyte balance P 105 mg Fe 2, 1 mg; Zn 1, 5 mg Cu 0, 15 mg Ca 120 mg Mg 56, 25 mg Metabolism (energy) Cu 0, 15 mg; Biotina 7, 5 ug, Vit. B 12 0, 375 ug; Tiamina 0, 165 mg; Ácido pantoténico 0, 9 mg; P 105 mg; Fe 2, 1 mg; Niacina 2, 4 mg; I 22, 5 ug; Mg 56, 25 mg; Vit C 12 mg; Mn 0, 3 mg; Ca 120 mg Eyes Fertility and reproduction Gum Hair Heart Homocysteine metabolism Hormonal activity Vit A 120 ug; Zn 1, 5 mg Vit C 12 mg Biotina 7, 5 mg; Cu 0, 15 mg Tiamina 0, 165 mg Folato 30 ug Vit B 6 0, 21 mg

Health relation (III): CONTRIBUTES TO (MAINTENANCE OF) NORMAL FUNCTION Immune system Iron absorption Iron metabolism Iron transport Lactose (break down) Macronutrient metabolism Mental performance Fatty acids metabolism Vit A metabolism Mucous membranes Muscle function and neurotransmission Nerve function Nervous system Vit B 12 0, 375 ug; Vit B 6 0, 21 mg; Vit A 120 ug; Fe 2, 1 mg; Zn 1, 5 mg; Vit C 12 mg; Cu 0, 15 mg; Folato 30 ug Se 8, 25 ug Vit C 12 mg Vit A 120 ug Cu 0, 15 mg Lactasa Biotina 7, 5 ug Ácido pantoténico 0, 9 mg Zn 1, 5 mg Vit A 120 ug; Niacina 2, 4 mg; Biotina 7, 5 ug Mg 56, 25 mg Ca 120 mg Mg 56, 25 mg Tiamina 0, 165 mg; Vit B 6 0, 21 mg; Vit C 12 mg; Biotina 7, 5 ug; Cu 0, 15 mg; Niacina 2, 4 mg

Health relation (IV): CONTRIBUTES TO (MAINTENANCE OF) NORMAL FUNCTION Oxidative damage (protection cell) Oral dryness (reduction of) Oxygen transport Tissue growth (pregnancy) Protein and glycogen metabolism Protein synthsis Red blood cell formation Skin Spermatogenesis Synthesis and metabolism steroid hormones, vit D and others… Teeth Thyroid Triglyceride concentrations Etc, Etc……… Zn 1, 5 mg; Vit C 12 mg; Cu 0, 15 mg; Mn 0, 3 mg; Se 8, 25 ug Sugar free chewing gum Fe 2, 1 mg Folato 30 ug Vit B 6 0, 21 mg Mg 56, 35 mg Vit B 6 0, 21 mg; Vit B 12 0, 375 ug; Fe 2, 1 mg Biotina 7, 5 ug; Vit A 120 ug; Cu 0, 15 mg; Niacina 2, 4 mg; I 22, 5 ug; Vit C 12 mg Se 8, 25 ug Ácido pantoténico 0, 9 mg Vit D 0, 75 ug; P 105 mg; Mg 56, 25 mg; Vit C 12 mg; Chicle sin azúcar; Ca 120 mg; F 0, 525 mg I 22, 5 ug; Se 8, 25 ug EPA/DHA 0, 45 g

IMMUNE SYSTEM: 12 mg Vit C; 0, 375 mg Vit B 12; 0, 21 mg Vit B 6; 120 mg Vit A; 2, 1 mg Fe, 1, 5 mg Zn; 30 ug Folato o 8, 25 ug Se. EYES, VISION: 120 mg Vit A; 1, 5 mg ZN; 250 mg DHA o 0, 21 mg VIT B 2 SKIN: 7, 5 ug Biotina; 0, 15 mg Cu; 12 mg Vit C; 120 mg Vit A; 2, 4 mg Niacina HAIR, NAILS: 1, 5 mg Zn; 8, 25 mg Se MUSCLE/BONES/ JOINS…. BLOOD/ CIRCULATIÓN… SLEEP/ CONCENTRATIONN / SEDATION……

n 3 EPA DHA Ca Vit D Prot Vit K Se P B 3 B 6 B 12 PUFA. . . NATURALLY/NATURAL Where a food naturally meets the condition(s) the term ‘naturally / natural’ may be used as a prefix to the claim. 1. SELECTION OF HCs 2. Comparative BIOAVAILABILY 3. SPECIFIC HCs for brands, specific foods or food categories 4. NEW HCs resulting from combination of nutrients 5. NEW products, new targets Function: CV, bones, metabolism, nervous system, spermatogenesis, blood cells, immunity, oxidative damage, muscle, cell division, skin. . .

ARTICLE 14 CLAIMS Health claims on reduction of disease risk and to children's development and health Summary of the 292 applications based on new science (Art. 13. 5, N=32) and disease risk reduction or related to childrens health (Art. 14, N=260) 37 withdrawn 87 adopted 19 favourables

Art. 14. 1 a. RISK REDUCTION CORONARY CARDIOPATIES Phystosterols (esthers and free froms)(2 g/d) Phytostanols esthers (2 g/d) CARIES (CHILDREN) Xylitol chewing goum (2 -3 x 3)/d Other related Art. 14. 1 b. CHILDREN HEALTH/GROWTH LA and ALA (1%E LA and 0. 2%E ALA) Calcium and Vit. D (sources of) Calcium (source) Vitamin D (source) Proteins D (source) Phosphor (source) DHA and ARA Cholesterol reduction Regulation 983/2009 Cholestero reduction Regulation 983/2009 Dental plaque red. Regulation 1024/2009 Regulation 983/2009. (*)Reg 1024/2009) Normal growth/development Normal bone growth/development Normal bone growth/development (*) Visual development Art. 13. 5 NEW SCIENCIE/PROPRIETARY DATA WS-Tomato-Ext. I and II (3 g I/d or 300 mg II/d in orange juice, flavoured drinks or yogurt drink) Art. 13. 1 LIST Essential minerals and vitamins Essential fatty acids. . . Some kind of fibre Melatonin (0. 5 -5 mg dose) (subjective feeling of jet-lag) Meal replacements. . . Maintains normal platelet agregation that favors good bloof flow

‘Reduction of disease risk claim’ means any health claim that states, suggests or implies that the consumption of a food category, a food or one of its constituents significantly reduces a risk factor in the development of a human disease

8. What is a risk factor for the development of a human disease? (The WHO International Statistical Classification of Diseases and Related Health http: //www. who. int/classifications/icd/en/ should be used). A risk factor is a factor associated with the risk of a disease that may serve as a predictor of development of that disease For reduction of a risk factor to be considered beneficial: • The risk factor is an independent predictor of disease risk (this may be established from intervention and/or observational studies) • The relationship of the risk factor to the development of the disease is biologically plausible

For some risk factors, there is strong evidence that they meet both criteria E. g. : elevated serum LDL cholesterol for risk reduction of coronary heart disease; reduction in systolic blood pressure for reduction of risk claim for CHD or stroke For other proposed risk factors, the evidence is not as strong There is the possibility to consider the evidence on whether the lowering of a “proposed risk factor” by a specific dietary intervention is accompanied by reduced incidence of the disease dental plaque and caries

The Panel considers that the following wording reflects the scientific evidence: “Xylitol chewing gum reduces the risk of caries in children”. There is evidence that lowering plaque by a specific dietary intervention is accompanied by reduced incidence of dental caries then such a reduction in dental plaque might be considered beneficial specific riskoffactor(s) decay in the The context of a reduction disease risk for claimtooth for dental caries for that specific dietary affected byintervention. xylitol chewing gum is unclear. NEW USEFUL BIOMARKERS CAN BE IDENTIFIED FROM NUTRITIONAL A cause and effect relationship has been established between the consumption of chewing gum sweetened with 100% xylitol and a reduction INTERVENTION of the risk of tooth decay. STUDIES in children.

Comparative health claims Provided that the presence, absence or reduced content of a nutrient or other substance in a food or category of food, in respect of which the claim is made, has an independent role in the claimed effect. SCIENTIFIC OPINION. EFSA Journal 2010; 8(12): 1884 Scientific Opinion on the substantiation of a health claim related to “toothkind” drinks and reduction of tooth demineralisation pursuant to Article 13(5) of Regulation (EC) No 1924/20061 The Panel considers that the following wording reflects the scientific evidence: “Frequent consumption of typical juice drinks and sugar-containing, acidic, non-alcoholic beverages may contribute to tooth demineralisation; consumption of ”toothkind” juice drinks in replacement of typical juice drinks and sugar-containing, acidic, non-alcoholic beverages may help to reduce tooth demineralisation”.

THE CURRENT PROLIFERATION BASED ON NEW KNOWLEDGE ON HEALTH-FOOD RELATIONSHIPS IS ONLY THE SMALL TOP OF THE ICEBERG. . .

OTHER CHALLENGES: 1. NEW METHODS AND NEW MODELS (eg. for long term effects) 2. NEW CONCEPTS: HOMEOSTATIC ROBUSTNESS 3. SUBPOPULATIONS AND PERSONALIZATION (responders and non responders) Genetics and Epigenetics

BIOMARKERS / RISK FACTORS The description of some nutritional/physiological beneficial effects requires more appropriate parameters (new biomarkers): Antioxidant Anti-inflammatory Metabolic stress Homeostatic robustness Wellness. . .

BIO claims Proposal full title: BIOmarkers of Robustness of Metabolic Homeostasis for Nutrigenomics-derived Health CLAIMS Made on Food Proposal acronym: BIOCLAIMS Type of funding scheme: Collaborative Project. Large-scale integrating project Proposal number: 244995 Work programme topics addressed: “KBBE-2009 -2 -2 -03 Development of biomarkers for healthpromoting functions” CE contribution: € 6 M Coordinating person: Prof. Dr. Andreu PALOU

BIOCLAIMS a balanced consortium that has mobilised a critical mass in several fields BIO claims UWA P. J. Thornalley USoton P. C. Calder TNO B. van Omen DIFE S. Klaus JUMP A. Dembinska-Kiec WU J. Keijer ASCS J. Kopecky MUG J. M. Roob CTNS L. Arola UIB A. Palou UNIGraz B. Winklhofer-Roob

Three main lacks can be perceived which are strongly limiting the successful extension of health claims on foods: a) The lack of biomarkers for a number of physiologically relevant functions (antioxidant, anti-inflamatory, metabolic stress…) b) The lack of early biomarkers c) The lack of biomarkers on long term effects d) Personalization (genetics and epigenetics)

NEW TECHNOLOGIES: Omics: Genomics, transcriptomics, metabolomics. . Other: Epigenome, Epiproteome/metabolome, Dinamic processes. . .

The “new” challenges are the CHRONIC DISEASES and all wellbeing aspects that are known to be related with FOOD Article 27 Evaluation CVD, diabetes, obesity, cancer, osteoporosis, By 19 January 2013 at the latest, the Commission shall submit to the and other health conditions European Parliament and to the Council a report on the application of this Regulation, in particular on the evolution of the market in foods in respect of which nutrition or health claims are made and on the consumers' understanding of claims, together with a proposal for amendments if necessary. The report shall also include an evaluation of the impact of this Regulation on dietary choices and the potential impact on obesity and non-communicable diseases. Thanks for your attention