Scientific Substantiation of Health Claims made on Foods in the EU.ppt

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
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

DECISIONS
Thresholds, authorizations, restrictions,
legislation, inspections, sanctions, etc.
A system to protect human health
and which allows initiatives and
progress: “transparency”
RISK ANALYSIS
Risk Assessment
EFSA
Science based
Risk Management
EC-MSs
Policy based
Risk Communication
Process initiation

“ F O O D Q U A L I T Y ”
SAFETY
FOOD QUALITY ASPECTS
NUTRITION - HEALTH
VARIACIÓN
CONTROL
CULTURAL ASPECTS
ECOLOGY
SOUSTAINABILITY
ETHICS
ANIMAL 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:
Driving
forces
‘FUNCTIONAL FOODS’
SCIENCE
Consumer demand
Economics
Wellbeing

THERAPEUTIC FIELD
NUTRITION
MEDICINES
FUNCTIONAL
FOODS
Milk + calcium
Milk + w3
Margarine + plant sterols
...
There is a frontier between drugs and food

THERAPEUTIC FIELD
NUTRITION
NUTRACEUTICALS
FUNCTIONAL
FOODS
OIL CAPSULES
PROTEIN PREPARATIONS
Milk + calcium
Milk + w3
...

THERAPEUTIC FIELD
NUTRITION
MEDICINES
NUTRACEUTICALS
FUNCTIONAL
FOODS
OIL CAPSULES
PROTEIN PREPARATIONS
Milk + calcium
Milk + w3
...

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,...
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 LOS
ALIMENTOS:
SE ESPERA QUE LOS
SE ESPERA QUE LOS
ALIMENTOS:
ALIMENTOS:
SEGUROS
NUTRITIVOS
APETECIBLES
ACCIÓN TERAPÉUTICA
ACCIÓN PREVENTIVA
The new perspective: efficacy and health
FOOD IS EXPECTED TO BE:
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
A need for a more strict use of
health claims made on foods and
what foods can bear health claims
NEW SNACK
WITHOUT
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
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 :
1.Nutrition claims: content
(High in fibre, low in salt, low in energy, source of...)
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 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 (approximately 1 teaspoon of sucrose), applies.
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.
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 kJ)/100 ml. For table-top sweeteners the limit of 0,4 kcal (1,7
kJ)/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….
…
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....

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):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.

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 (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 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?
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.

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 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.
1. CONTROLLED INTERVENTION
STUDIES IN HUMANS
2. BENEFICIAL EFFECT
3. BIOLOGICAL PLAUSIBILITY

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 ?

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
dietary intake of NIACIN and normal energy-yielding metabolism, normal function of the
nervous system, and maintenance of normal skin and mucous membranes.
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.
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.
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.
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 1,5mg
Blood Ca concentrations Vit D 0,75ug
Blood Cholesterol concentrations ALA 0,3g; LA 3g, Beta-glucanos 3g;
Glucomanan 4g
Blood clotting Ca 120mg; Vit K 11,25ug
Blood formation Folato 30ug
Blood pressure EPA/DHA 0,45g
Blood vessels Vit C, 12mg
Bone Vit D 0,75ug; P 105mg; Zn 1,5mg
Mg 56,25mg; Ca 120mg, Mn 0,3mg
Vit K 11,25ug
Bone function Vit C 12mg
Cartilage Vit C 12mg
Cell differentiation Vit A 120mg
Cell division Vit B12 0,375ug; Vit D 0,75ug; Fe 2,1mg
Zn 1,5mg; Mg 56,25mg; Folato 30ug

Health relation (II)
Cell membranes P 105mg
Cognitive function Fe 2,1mg; Zn 1,5mg
Connective tissues Cu 0,15mg
Digestive enzynes Ca 120mg
Electrolyte 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 1,5mg
Fertility and reproduction Zn 1,5mg
Gum Vit C 12mg
Hair Biotina 7,5mg; Cu 0,15mg
Heart Tiamina 0,165mg
Homocysteine metabolism Folato 30ug
Hormonal activity Vit B6 0,21mg

Health relation (III):
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 30ug
Se 8,25ug
Iron absorption Vit C 12mg
Iron metabolism Vit A 120ug
Iron transport Cu 0,15mg
Lactose (break down) Lactasa
Macronutrient metabolism Biotina 7,5ug
Mental performance Ácido pantoténico 0,9mg
Fatty acids metabolism Zn 1,5mg
Vit A metabolism Zn 1,5mg
Mucous membranes Vit A 120ug; Niacina 2,4mg;
Biotina 7,5ug
Muscle function Mg 56,25mg
Muscle function and neurotransmission Ca 120 mg
Nerve function Mg 56,25mg
Nervous system Tiamina 0,165mg; Vit B6 0,21mg;
Vit C 12mg; Biotina 7,5ug; Cu 0,15mg;
Niacina 2,4mg

Health relation (IV):
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 2,1mg
Tissue growth (pregnancy) Folato 30ug
Protein and glycogen metabolism Vit B6 0,21mg
Protein synthsis Mg 56,35mg
Red blood cell formation Vit B6 0,21mg; Vit B12 0,375ug;
Fe 2,1mg
Skin Biotina 7,5ug; Vit A 120ug; Cu 0,15mg;
Niacina 2,4mg; I 22,5ug; Vit C 12mg
Spermatogenesis Se 8,25 ug
Synthesis and metabolism steroid
hormones, vit D and others… Ácido pantoténico 0,9mg
Teeth 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 8,25ug
Triglyceride 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……

Ca
Vit D
Prot
n3
EPA
DHA
B3
B6
B12
Vit K
Se
P
PUFA
...
Function: CV, bones, metabolism, nervous system,
spermatogenesis, blood cells, immunity, oxidative damage,
muscle, cell division, skin...
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
NATURALLY/NATURAL
Where a food naturally meets the condition(s) the term
‘naturally / natural’ may be used as a prefix to the claim.

37 withdrawn
87 adopted
19 favourables
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)

Art. 14.1a. RISK REDUCTION
CORONARY CARDIOPATIES
Phystosterols (esthers and free froms)(2g/d) Cholesterol reduction Regulation 983/2009
Phytostanols esthers (2g/d) Cholestero reduction Regulation 983/2009
CARIES (CHILDREN)
Xylitol chewing goum (2-3 x3)/d Dental plaque red. Regulation 1024/2009
Other 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/development
Vitamin D (source) Normal bone growth/development
Proteins D (source) Normal bone growth/development
Phosphor (source) Normal bone growth/development (*)
DHA and ARA Visual development
Art. 13.5 NEW SCIENCIE/PROPRIETARY DATA
WS-Tomato-Ext. I and II Maintains normal platelet agregation
(3g I/d or 300mg II/d in orange juice, that favors good bloof flow
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...
...

‘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”.
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):
Antioxidant
Anti-inflammatory
Metabolic stress
Homeostatic robustness
Wellness
...

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: €6M
Coordinating person: Prof. Dr. Andreu PALOU
claims
BIO

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

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 27
Evaluation
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 this
Regulation on dietary choices and the potential impact on
obesity and non-communicable diseases.
Thanks for your attention

Scientific Substantiation of Health Claims made on Foods in the EU.ppt

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