6th Dubai International Food Safety Conference. Dubai International Convention and Exhibition Centre (28th Feb to 1st March 2011)

Workshop 2: International Workshop on Responsible Consumer Information on Nutrition and Health claims (Venue: Umm Al Quwain Room. 1st 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

CORRIGENDAOfficial 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 andtechnical 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

DECISIONS

Thresholds, authorizations, restrictions, legislation, inspections, sanctions, etc.

A system to protect human health and which allows initiatives and

progress: “transparency”

RISK ANALYSIS

Risk AssessmentEFSA

Science based

Risk ManagementEC-MSs

Policy based

Risk Communication

Process initiation

EFSA: opinions (assessment and

communication) and not decisions

The context

“ F O O D Q U A L I T Y ”

SAFETY

FOOD QUALITY ASPECTSNUTRITION - HEALTH

VARIACIÓNCONTROL

CULTURAL ASPECTS

ECOLOGYSOUSTAINABILITY

ETHICSANIMAL WELLBEING

.....

NUTRITION - HEALTH

Adequate Nutrition

“Optimal Nutrition”

- calories, nutrients- metabolic needs- satisfy hunger- enjoyment

- Promoting health- Improving well-being

-Reducing risk of illness

CONCEPTUAL CHANGES IN NUTRITION/FOOD:

Drivingforces

‘FUNCTIONAL FOODS’

SCIENCEConsumer demand

EconomicsWellbeing

THERAPEUTIC FIELD

NUTRITIOND

RU

G FOODMEDICINES

FUNCTIONALFOODS

Milk + calciumMilk + 3Margarine + plant sterols...

There is a frontier between drugs and food

THERAPEUTIC FIELD

NUTRITIOND

RU

G FOODNUTRACEUTICALS

FUNCTIONALFOODS

OIL CAPSULES PROTEIN PREPARATIONS

Milk + calciumMilk + 3Margarine + plant sterols...

THERAPEUTIC FIELD

NUTRITIOND

RU

G FOODMEDICINES

NUTRACEUTICALS

FUNCTIONALFOODS

OIL CAPSULES PROTEIN PREPARATIONS

Milk + calciumMilk + 3Margarine + plant sterols...

THERAPEUTIC FIELD

NUTRITIOND

RU

G FOODMEDICINES

NUTRACEUTICALS

FUNCTIONALFOODS

OIL CAPSULES PROTEIN PREPARATIONS

Milk + calciumMilk + 3Margarine + plant sterols...

The frontier is not clear and will move....

The “new” challenges in Nutrition and Food are the CHRONIC DISEASES and all wellbeing aspects that are

known to be related with FOOD

46% of total illness and 59% of total deaths in the world (FAO/WHO)

Directly related with diet

CVD, diabetes, obesity, cancer, osteoporosis,...

Increasing impact on health and

economics

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:

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

...

SE ESPERA QUE LOSALIMENTOS:

SE ESPERA QUE LOSSE ESPERA QUE LOSALIMENTOS:ALIMENTOS:

SEGUROS NUTRITIVOS APETECIBLES ACCIÓN TERAPÉUTICA ACCIÓN PREVENTIVA

The new perspective: efficacy and health

“The three most beautiful words that can be

said are not “I love you” but “it is benign”

Woody Allen

FOOD IS EXPECTED TO BE:

SAFENUTRITIVE

PALATABLETHERAPEUTICPREVENTIVE

Increased consumption of functional foods in Increased consumption of functional foods in EuropeEurope

Alimarket last newshttp://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

A need for a more strict use A need for a more strict use of health claims made on of health claims made on foods and what foods can foods and what foods can

bear health claimsbear health claims

NEW SNACKWITHOUT

CHOLESTEROL

Regulation (EC) nº 1924/2006 of the European Parliament and of the Council of 20 December 2006 on Nutrition and Health Claims made on

FoodsCORRIGENDA

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 :

1.Nutrition claims: content(High in fibre, low in salt, low in energy, source of...)

2. Health claims: effectsA) Function claims

B) Reduction of disease riskC) Claims on children growth and development

THE COMBINATION OF

NUTRITION + HEALTH CLAIMS

The combination of both with

article 10.3 (unspecific health

claims)…

ANNEX (Regulation (EC) nº 1924/2006)

Nutrition claims (composition) and conditions applying to them

LOW ENERGYA claim that a food is low in energy, and any claim likely to have the same meaning for the consumer, may only be madewhere the product does not contain more than 40 kcal (170 kJ)/100 g for solids or more than 20 kcal (80 kJ)/100 ml forliquids. For table-top sweeteners the limit of 4 kcal (17 kJ)/portion, with equivalent sweetening properties to 6 g ofsucrose (approximately 1 teaspoon of sucrose), applies.

ENERGY-REDUCEDA claim that a food is energy-reduced, and any claim likely to have the same meaning for the consumer, may only bemade where the energy value is reduced by at least 30 %, with an indication of the characteristic(s) which make(s) thefood reduced in its total energy value.

ENERGY-FREEA claim that a food is energy-free, and any claim likely to have the same meaning for the consumer, may only be madewhere 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 (approximately 1 teaspoon of sucrose), applies.

LOW FATA claim that a food is low in fat, and any claim likely to have the same meaning for the consumer, may only be madewhere 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 offat per 100 ml for semi-skimmed milk).

LOW SATURATED FATA claim that a food is low in saturated fat, and any claim likely to have the same meaning for the consumer, may only bemade 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….…

29 nutrition claims authorized

8 under discusion

Three key aspects in Regulation (EC) nº 1924/2006:

1.Nutrition and health claims on food must be substantiated by scientific evidence

2. Only those foods with an ‘appropriate’ nutrient profile will be allowed to bear

claims

3. intellectual property drawn from research efforts will be protected (5 years)

this is going ahead but...

this is delayed....

R+D estimulation but uncertainty....

Improve health

Enhance innovation

Effective internal market

The main challenges:

1. HEALTH CLAIMS SCIENTIFIC SUBSTANTIATION

1. Scientific trueness ( “The entire truth and nothing but the truth”)

Too simple message is wrong while too complex cannot be understood

COMUNICATION OF BENEFITS: claims should reflect the scientific evidence and should be beneficial

EFSA Journal 2010;8(10):1738SCIENTIFIC OPINIONScientific 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 6Scientific substantiation for claims

1. Nutrition and health claims shall be based on and substantiated by generally accepted scientific evidence.

WHAT DOES IT MEANS IN PRACTICE?

PANEL MEMBERSJean-Louis Bresson, Albert Flynn (Chair) Marina Heinonen, Karin Hulshof, Hannu Korhonen, Pagona Lagiou, Martinus Løvik, Rosangela Marchelli, Ambroise Martin,

Bevan Moseley, Andreu Palou (ViceChair), Hildegard Przyrembel (ViceChair), 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 2008establishing 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 2009amending 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 CouncilOfficial 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?

6. To what extent should a food be characterised?

7. How should the claimed effect be shown to be beneficial?

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 wording reflects the scientific evidence and complies with the criteria laid down in the Regulation (e.g. it should not refer only to general, non-specific health benefits of the food/constituent); if not, EFSA may propose an appropriate wording.

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.

Strict agreement with scientific evidence

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.

— HELMUT SIES

(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

Consequently, it is clear that less STORKS imply less BABIES...Many studies in this category?

CAUSALITY?

A new parameter for sex educationSir – There is concern in West Germany over the falling birth rate. The graph might suggest a solution that every child knows makes sense.

1. CONTROLLED INTERVENTION STUDIES IN HUMANS

2. BENEFICIAL EFFECT

3. BIOLOGICAL PLAUSIBILITY

HEALTH CLAIMS SUBSTANTIATION:

the European situation at presentEU REGULATION 1924/2006. Article 13Health 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 ?

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”)…

Summary (February 2011) of the 1.745 claims on functions already assessed by EFSA out of 4.637 submissions

(ART.13.1)

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 dietary intake of VITAMIN B6 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.

The Panel concludes that a cause and effect relationship has been established between the dietary intake of VITAMIN B12 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 energy-yielding metabolism and maintenance of normal bone and teeth.…..

FUTURE:

NORMAL vs OPTIMAL ?

Examples of favorable conclusions of EFSA (Art 13.1) (FUNCTION CLAIMs)

Health relation (I)CONTRIBUTES TO (MAINTENANCE OF) NORMAL FUNCTION

Acid-base balance Zn 1,5mgBlood Ca concentrations Vit D 0,75ugBlood Cholesterol concentrations ALA 0,3g; LA 3g, Beta-glucanos 3g;

Glucomanan 4gBlood clotting Ca 120mg; Vit K 11,25ugBlood formation Folato 30ugBlood pressure EPA/DHA 0,45gBlood vessels Vit C, 12mgBone Vit D 0,75ug; P 105mg; Zn 1,5mg

Mg 56,25mg; Ca 120mg, Mn 0,3mgVit K 11,25ug

Bone function Vit C 12mgCartilage Vit C 12mgCell differentiation Vit A 120mgCell division Vit B12 0,375ug; Vit D 0,75ug; Fe 2,1mg

Zn 1,5mg; Mg 56,25mg; Folato 30ug

Health relation (II)CONTRIBUTES TO (MAINTENANCE OF) NORMAL FUNCTION

Cell membranes P 105mgCognitive function Fe 2,1mg; Zn 1,5mgConnective tissues Cu 0,15mgDigestive enzynes Ca 120mgElectrolyte balance Mg 56,25mg

Metabolism (energy) Cu 0,15mg; Biotina 7,5ug,VitB12 0,375ug; Tiamina 0,165mg;Ácido pantoténico 0,9mg; P 105mg;Fe 2,1mg; Niacina 2,4mg; I 22,5ug;Mg 56,25mg; Vit C12mg; Mn 0,3mg;Ca 120mg

Eyes Vit A 120 ug; Zn 1,5mgFertility and reproduction Zn 1,5mgGum Vit C 12mgHair Biotina 7,5mg; Cu 0,15mgHeart Tiamina 0,165mgHomocysteine metabolism Folato 30ugHormonal activity Vit B6 0,21mg

Health relation (III):CONTRIBUTES TO (MAINTENANCE OF) NORMAL FUNCTION

Immune system Vit B12 0,375ug; Vit B6 0,21mg; Vit A 120 ug; Fe 2,1 mg; Zn 1,5mg;Vit C 12mg; Cu 0,15mg; Folato 30ugSe 8,25ug

Iron absorption Vit C 12mgIron metabolism Vit A 120ugIron transport Cu 0,15mgLactose (break down) LactasaMacronutrient metabolism Biotina 7,5ugMental performance Ácido pantoténico 0,9mgFatty acids metabolism Zn 1,5mgVit A metabolism Zn 1,5mgMucous membranes Vit A 120ug; Niacina 2,4mg;

Biotina 7,5ugMuscle function Mg 56,25mgMuscle function and neurotransmission Ca 120 mgNerve function Mg 56,25mgNervous system Tiamina 0,165mg; Vit B6 0,21mg;

Vit C 12mg; Biotina 7,5ug; Cu 0,15mg;Niacina 2,4mg

Health relation (IV):CONTRIBUTES TO (MAINTENANCE OF) NORMAL FUNCTION

Oxidative damage (protection cell) Zn 1,5mg; Vit C 12mg; Cu 0,15mg;Mn 0,3mg; Se 8,25ug

Oral dryness (reduction of) Sugar free chewing gum Oxygen transport Fe 2,1mgTissue growth (pregnancy) Folato 30ugProtein and glycogen metabolism Vit B6 0,21mgProtein synthsis Mg 56,35mgRed blood cell formation Vit B6 0,21mg; Vit B12 0,375ug;

Fe 2,1mgSkin Biotina 7,5ug; Vit A 120ug; Cu 0,15mg;

Niacina 2,4mg; I 22,5ug; Vit C 12mgSpermatogenesis Se 8,25 ugSynthesis and metabolism steroidhormones, vit D and others… Ácido pantoténico 0,9mgTeeth Vit D 0,75ug; P 105mg; Mg 56,25mg;

Vit C 12mg; Chicle sin azúcar;Ca 120mg; F 0,525mg

Thyroid I 22,5ug; Se 8,25ugTriglyceride concentrations EPA/DHA 0,45g

Etc, Etc………

IMMUNE SYSTEM:

12mg Vit C; 0,375mg Vit B12; 0,21mg Vit B6; 120mg Vit A; 2,1mg Fe, 1,5mg Zn; 30ug Folato o 8,25ug Se.

EYES, VISION:

120mg Vit A; 1,5mg ZN; 250mg DHA o 0,21mg VIT B2

SKIN:

7,5ug Biotina; 0,15mg Cu; 12mg Vit C; 120mg Vit A; 2,4mg Niacina

HAIR, NAILS:

1,5mg Zn; 8,25mg Se

MUSCLE/BONES/ JOINS….BLOOD/ CIRCULATIÓN…SLEEP/ CONCENTRATIONN / SEDATION……

CaVit DProt

n3EPADHA

B3B6B12

Vit KSeP

PUFA...

Function: CV, bones, metabolism, nervous system, spermatogenesis, blood cells, immunity, oxidative damage,

muscle, cell division, skin...

1.SELECTION OF HCs2.Comparative BIOAVAILABILY3.SPECIFIC HCs for brands, specific foods

or food categories4. NEW HCs resulting from combination of

nutrients5. NEW products, new targets

NATURALLY/NATURALWhere a food naturally meets the condition(s) the term

‘naturally / natural’ may be used as a prefix to the claim.

37 withdrawn87 adopted

19 favourables

ARTICLE 14 CLAIMSHealth 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)

Art. 14.1a. RISK REDUCTION

CORONARY CARDIOPATIESPhystosterols (esthers and free froms)(2g/d) Cholesterol reduction Regulation 983/2009Phytostanols esthers (2g/d) Cholestero reduction Regulation 983/2009

CARIES (CHILDREN)Xylitol chewing goum (2-3 x3)/d Dental plaque red. Regulation 1024/2009Other related

Art. 14.1b. CHILDREN HEALTH/GROWTH Regulation 983/2009. (*)Reg 1024/2009)LA and ALA (1%E LA and 0.2%E ALA) Normal growth/development Calcium and VitD (sources of) Normal bone growth/development Calcium (source) Normal bone growth/developmentVitamin D (source) Normal bone growth/developmentProteins D (source) Normal bone growth/developmentPhosphor (source) Normal bone growth/development (*)DHA and ARA Visual development

Art. 13.5 NEW SCIENCIE/PROPRIETARY DATAWS-Tomato-Ext. I and II Maintains normal platelet agregation(3g I/d or 300mg II/d in orange juice, that favors good bloof flowflavoured drinks or yogurt drink)

Art. 13.1 LISTEssential minerals and vitaminsEssential fatty acids...Some kind of fibreMelatonin (0.5-5 mg dose) (subjective feeling of jet-lag)Meal replacements......

‘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 criteriaE.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 strongThere 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”.

The specific risk factor(s) for tooth decay affected by xylitol chewing gum is unclear.

A cause and effect relationship has been established between the consumption of chewing gum sweetened with 100% xylitol and a reduction

of the risk of tooth decay 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 in the context of a reduction of disease risk claim for dental caries for that specific dietary intervention.

NEW USEFUL BIOMARKERS CAN BE IDENTIFIED FROM NUTRITIONAL

INTERVENTION STUDIES

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”.

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.

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):

AntioxidantAnti-inflammatoryMetabolic stress

Homeostatic robustnessWellness

...

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 projectProposal number: 244995Work programme topics addressed: “KBBE-2009-2-2-03 Development of biomarkers for healthpromoting functions”CE contribution: €6M

Coordinating person: Prof. Dr. Andreu PALOU

claims

BIO

BIOCLAIMS a balanced consortium that has mobilised a critical mass in several fields

UIBA. Palou

CTNSL. Arola

WUJ. Keijer

TNOB. van Omen

ASCSJ. Kopecky

DIFES. Klaus

JUMPA. Dembinska-Kiec

UNIGrazB. Winklhofer-Roob

UWAP.J. Thornalley

USotonP.C. Calder

MUGJ.M. Roob

claimsBIO

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

CVD, diabetes, obesity, cancer, osteoporosis, and other health conditions

Article 27Evaluation

By 19 January 2013 at the latest, the Commission shall submit to the 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 thisRegulation on dietary choices and the potential impact onobesity and non-communicable diseases.

Thanks for your attention