From the design to validation of health claims. What about claims and food benefits? Dr. Francesc Puiggròs discusses (1) the analysis of communication related to health claims on foods and benefits, (2) how science communication is a matter for all stakeholders, and (3) ways to gain consumer reliability through science. He analyzes global recommendations for healthier diets and initiatives in the EU to promote better habits. However, there is controversy around communicating food properties due to uncertainty about health effects and potential overconsumption. Regulation aims to increase trust but challenges remain in consumer understanding of claims.

1. From the design to validation of health
claims. What about claims and food benefits?
Dr. Francesc Puiggròs,
Scientific Coordinator of Technological Center of Nutrition and
Health (CTNS‐TECNIO)

2.  Analysis of communication related facts
 Claims made on foods – Communicating health benefits
 Science communication – a matter of all stakeholders
 How to get consumer’s reliability thorugh science
 Conclusions

3. Analysis of communication related facts

4. FACT 1 – Global recommendations for healthier diet habits
Global
recommendations
Population
Health Public Policy Strategies
RECOMMENDED DIET COMPOSITION
55-60% carbohydrates
10-15 % proteins
30% fat
5 a day (vitamins and minerals)
Less salt, saturated fat and simple sugars
More physical activity

5. FACT 2 – are they really effective?
Mediterranean food is being consumed less and less in the
Mediterranean region and more and more in other parts of the world.
This alarming fact, which has been observed by many researchers and
professionals (Rastoin, 2009; Abos, 2009), illustrates the challenges of
restoring the Mediterranean Diet to its region of origin.
Mediterra 2012. The Mediterranean Diet for Sustainable Regional Development. International Centre for
Advanced Mediterranean Agronomic Studies (CIHEAM)- Paris: Presses de Sciences po, 2012

6. FACT 3 – Obesity data
Evolution of energy uptake (kcal/person/d)
1961 2001
No disponibles 2.200 – 2.400 3.200 – 3.400
< 1.600 2.400 – 2.600 3.400 – 3.600
1.600 – 1.800 2.600 – 2.800 > 3.600
1.800 – 2.000 2.800 – 3.000
2.000 – 2.200 3.000 – 3.200

7. FACT 4 – The Risk Transition

8. FACT 5 – Many EU initiatives to promote healthier habits

9. FACT 6 – Increase the scientific knowledge on nutrition
Role of dietary compounds in human nutrition  increasing area of concern and investigation
Findings Findings
Findings
Wide‐ranging implications for all stakeholders
producers
processors
distributors
health‐care providers
regulators
educators
consumers

10. FACT 7 – Controversial on communicating food properties
Ways for living more…. And better?
Lifestyle
Diet
Physical activity
Technology
Medicine
Science
Increase of the incidence of non
communicable chronic diseases
Success of the reduction measures will depend
strikingly on the balance between these factors.

11. FACT 8 – Food Industry‐Media‐Consumers
Channel Year Channel Year Channel Year
TV3 2005 TV2 2005 TV2 1997
Nº % Nº % Nº %
Foods counter to
improved nutrition 260 76,6 342 66,0 235 87,5
Foods favoring to
improved nutrition 12 3,6 32 6,2 22 8,2
Foods/meals with
balanced concern /not 68 20 144 27,9 12 4,5
concern health profiles
Total 340 100 518 100 269 100
Wilson N et al., Marketing fat and sugar to children on New Zealand television.
Preventive Medicine, 2006.

13. CONSEQUENCES (1)
food influence the health
new dimension of appreciation on how
and wellfare of people, beyond providing the nutrients needed

14. CONSEQUENCES (2)
Huge increase in World’s Functional Food Market

15. Claims made on foods – Communicating health benefits

16. Definition of a Functional Food
“A Functional Food is similar in appearance to conventional foods, is consumed as a part of a
normal diet and has demonstrated physiological benefits and/or reduces risk of chronic disease
beyond basic nutritional function”
(Health Canada, 1999)
A food that beneficially affects one or more target functions in the body beyond adequate
nutritional effects in a way that is relevant to either an improved state of health and well‐being
and/or reduction of risk of disease. It is consumed as part of a normal food pattern. It is not a
pill, a capsule or any form of dietary supplement.
EC Concerted Action on Functional Food Science in Europe (FUFOSE, 2001)
a natural food, modified or not by plant breeding or other
technologies (e.g. lycopene‐enhanced tomatoes, vitamin E‐enriched
vegetable oils, vitamin A‐enriched rice) or with an added component;
or removed component
food in which one or several components, have been modified,
replaced or enhanced to improve its health properties (e.g. a juice
drink with enhanced antioxidant content, a yogurt with added prebiotic
or probiotic).

17. Functional food is a food that beneficially affects […]. It is consumed as part of a normal food pattern. It is not a pill, a
capsule or any form of dietary supplement.
EC Concerted Action on Functional Food Science in Europe (FUFOSE, 2001)
Nutraceutical
“ A food or food ingredients that have defined physiological effects
A Nutraceutical is a product isolated from foods but sold in powders, pills and other
medicinal forms not generally associated with food and is demonstrated to have
physiological benefits or provode protection agains chronic diseases.
Health Canada, 1999

18. FAVOURABLE
 Expansion opportunity on market of functional food seems to be
quite favorable,
 Consumer interest is quite high.
UNFAVOURABLE
 Insufficient clarity of information
provided by producers
Disinformation of consumers may involve a number of risks, due
not only to the UNCERTATINTY about health promoted effects,
but also by enhancing an overconsumption

19. XANTHOHUMOL

20. So…could this claim exist in future?

21. Need of regulation. Goal: Consumer trust
2004
Allowed HC of function and risk reduction
HC depending on nutrients
Regulatory framwork to allow specific products bearing specific HC
Developing a regulatory framwork
Specific HC
Codex as a legal framework

22. Need of regulation. Goal: Consumer trust
2009
Allowed HC of function and risk reduction
HC depending on nutrients
Regulatory framwork to allow specific products bearing specific HC
Developing a regulatory framwork
Specific HC
Codex as a legal framework

23. FOSHU (MHLW)

24. EU Nutrition & Health Claims Regulation 1924/2006 (NHCR)
Main goals
 lays down harmonised EU-wide rules for the use of health or nutritional
claims on foodstuffs.
 help European consumers to make more informed choices about their
diet
 scientific soundness
 easy to read – easy to understand (to average consumer)

25. Claims What are they?
any message or representation, which is not mandatory under
Community or national legislation, including pictorial, graphic or
symbolic representation, in any form, which states, suggest or
implies that a food has particular characteristics (art.2.2)
HEALTH CLAIM … health benefits can result from consuming a
given food.

26. But…
Do we need health claims?
Do we really need to communicate them?
 Claims on food labels/packaging/associated
advertising/promotional literature provide the most direct way of
comunicating the benefits of functional food to consumers
 The simplest and most direct way in which consumers can learn ?
 …. about functional foods is through product labelling ??
 but labelling information must be easily understood and
trusted !!! .

27. This is good for you Calcium improves
bone strength Improves your health GOOD
NIGHT
`t~xá çÉâ {tÑÑç Slim fast Vitamin C boosts
your immunity Contains Probiotics
Eat 5 a day Gives you power
Phytosterols decrease cholesterol absorption
thus disminishing cardiovascular risk injury

28. There are different types of claims
1 2 3 4 5
Other Puffery
Nutrition Health Ingredient
regulated claims
claims Claims claims
claims (slogans)
“Source of “Calcium helps to “100% fruit” “Organic” “Red Bull gives
calcium” maintain strong you wings”
teeth and bones” “With fresh “Suitable for “Haribo makes
milk” vegetarians” your children
happy”
“High fiber” “Food X helps “Free from “Hallal” “Get on with
decrease preservatives” it!”
cholesterol,
which “With barn “Gluten free” “Bring out the
contributes to eggs” tiger in you!”
reducing the risk
of heart
disease”
COVERED by REG‐1924/2006 Source: EAS

29. Health claims context in EU
NUTRITIONAL
HEALTH CLAIMS
CLAIMS
Referring to the Referring to the functional properties of the product
nutritional properties
of the product ARTICLE 13
ARTICLE 14
Energy, nutrients or ARTICLE 13.1 ARTICLE 13.5
substances
Examples
 Low in sugar
 Energy intake free
 Source of fiber
 Growth, development and body Specific health topics
functions  Disease risk
 Psychological and behavioural functions reduction
 Weight loss, weight control, reducing  Child health and
Listing of these claims
hunger feeling,, increasing sense of development
in annex of
1924/2006/CE satiety, reducing the energy value of diet
regulation

30. Health claims context in EU
Publication of the positive list of
Reg. 1924/2006 generic claims (13.3)
2.758 functional generic claims (6 Batches)
End of the transition
period
1 2 3 4 5 6
Oct 2009 July 2011
July 2007 June 2012 December 2012
Approved claims
Unapproved claims
Unevaluated claims
On‐hold claims ‐ 1.548
?
Claims not submitted for
evaluation must be pulled off
from the market
Approved 13.5 or 14 claims

31. Health claims context in EU  Claims under Art. 13.1
44.000 HC submitted  4.637 claims IDs
14 December 2012
222 authorised HC
+ 14 further potential positive claims
(prunes, alpha‐cyclodextrines, etc.)
+ c. 2000 Ids botanica claims “on hold”

32. Health claims context in EU  Claims under Art. 13.1
Authorised Article 13.1 Claims

33. Health claims context in EU  Claims under Art. 13.5 & 14
Authorised Article 13.5 and 14 Claims

34. Health claims context in EU
On‐hold claims ‐ 1.548 Breathing Space for Product Developers
1 yr?‐2 yr? …
Compared with vitamins and minerals, there is much more
uncertaninty abou communication of plants
Dietary supplements allowed claims not allowed before
To innovate  realm of possibilities very high for new plants or new extracts
Easy to find for a contract manufacturer
Regulation (EC) 258/97 of Novel Food (under revision) – Safety based on…
…but in terms of Scientific evidence and significant consumption before 1997
communication No danger , nor misleading neither unfavorable nutritive effect or…
Demonstration of substancial equivalence (composition; metabolism; expected use;…)
In contrast with vitamins and minerals there is no Europen harmonization on plants
Each European country applies its own legislation
Each European country free to establish its own list of
authorized and/or banned plants

35. As a citizen… do we need health claims regulation?
 Are we too much overprotected?
As a food company… do we really need to communicate
them?
 Responsability  It is not about the claim, it is how to
use it since HC is one part of an overall consumer
pattern.
 To make consumer’s choice easier and confirm (renew)
their trust on food company
As a regulator… do we really know how to regulate claims?
 Definition and scientific rules to define scientific evidence?
As a consumer …. do we need health claims?
… are we really able to understand the claims?
 HC into a consumer a concept and know the health benefit
 Right to be informed and provide a reference to rely on.
 Consumer average concept?

36. Science communication – a matter of all stakeholders

37. Consumer’s research at a very early stage of product development process
Understand consumer’s needs and expectations
What are the influencing factors for a purchasing decision?
Image of the manufacturer
Health care
Accepted food
Official bodies professionals Ingredient
matrix
knowledge
(Social) Media Product
positioning
Socio-demographic
Claims
factors State of health
Brand trust &
Information Food choices Distribution awareness
patterns channel

38. Communication gap between producers of functional food and
the market place
Regulation NHC in 2006
Nutrition
Food Industry Functional Food
PRODUCERS
Research
Standards Regulations
Health
Communication Gap Communication Gap
Claims
MARKET PLACE
Retail Regulators
Consumers
Media Consumers
Organisations
Adapted of M. Ginman, E. Väliverronen (eds.): Communicating Health and New Genetics: Workshop Proceedings, 17‐18th
September 2001). Finnish Information Studies 20, Åbo; Tampere; Oulu, 2002, pp. 57‐84.

39. The information problem
 Health benefits are invisible – they have to be communicated in a way that is
credible and understandable
 Health claims are regulated
 Consumers are sick and tired of complex, confusing and contradictory
information about what is healthy and what is not
 Consumers are confused
 by technical terms
 by verbal qualifiers like ’research shows…’, ’may help…’
 by probabilities and risk statements
INYS, Lund, November 29,
Dias 39
2006

40. The limits of information processing
Nutritional
label
Ingredients Under- Decision-
Perception Evaluation Purchase
list standing making
Health
claims
Brand
Associations Affect Purchase
Appearance
Source INYS, Lund

41. Simplification of communications gaps to answer:How to find
an optimal product claim?
Consumer acceptance
What would I like to claim
Product claim
Legal frame Technological feasibility
What am I allowed to claim? What could I claim

42. How to get consumer’s reliability thorugh
science

43. Health claims true & comprehensible
SCIENCE & COMMUNICATION
What are the main challenges for
reliable and serious communication of
health benefits on foods?

44. SCIENCE & COMMUNICATION
Consumer acceptance
Universal
CONCEPT FORMAT
SCIENCE COMMUNICATION Arial 20
 Bookshelf Symbol 20
SCIENCE COMMUNICATION Script MT Bold 18
Not misleading
Complex to easy translation

45. SCIENCE & COMMUNICATION
Consumer acceptance
THERAPEUTIC FIELD PREVENTIVE FIELD

46. SCIENCE & COMMUNICATION
Legal frame ‐ Food Industry – Technological Feasibility
Check list for achieving a HC*
Primary in importance
- Characterization if the food/constituents
- Demonstration of the claims effect
- Relevance to human health
Secondary in importance
- Bioavailability
- Mechanistic data
- Dose-response relationship
* According to NDA Panel

47. SCIENCE & COMMUNICATION
Legal frame ‐ Food Industry – Technological Feasibility
Demonstration of the claims effect
Relevance to human health
 Human intervention studies are needed
 The benefit is needed
 For combination products: Study conduct with the combination
product (final product)
 Study population must be the same like target group, perhaps
extrapolation of the data from patients/invalids will be accepted
 Effects must be clinically relevant (1cm sign. Reducing the waist
circumference is not considered to be relevant)
 The tested parameter has to be validated and accepted
 The statistical analysis must be conducted scientifically correct
 Correct blinding and randomization

48. SCIENCE & COMMUNICATION
Legal frame ‐ Food Industry – Technological Feasibility
Consensus on biomarkers
Published and unpublished data Opinions
(preclinical, clinical) etc Guidances
General positions
Identification of the best
combination:
“claim wording x population x EFSA & EC POSITION
dose
RISK ANALYSIS Data protection?
Go No Go
Gaps identification
Health claim application
between sceicnee R&D
writing and submission
anmd regulation
Time investment?
Cost investment?
Scientific risk?

49. SCIENCE & COMMUNICATION
Legal frame ‐ Food Industry – Technological Feasibility
 General guidance
 Scientific and technical
guidance
 Guidance for health claims related to gut and immune function
 Guidance on health claims related to antioxidants, oxidative damage and cardiovascular health
 Guidance on the scientific requirements for health claims related to appetite ratings, weight
management, and blood glucose concentrations
 Guidance on the scientific requirements for health claims related to bone, joints, skin and oral health
 Guidance on the scientific requirements for health claims related to physical performance
 Guidance on the scientific requirements for health claims related to functions of the nervous system,
including psychological functions

50. SCIENCE & COMMUNICATION
Updating data...

51. SCIENCE & COMMUNICATION
...while emerging
technologies...

52. ...while food industry increases its R&D
investment...
Consequences of the Union list?
“…strength the position of those companies that seriously invest on R&D”
“ … we will achieve a long term protection of functional food”
“Overall strengthening of functional food category on consumer mindset”
New strategies?
“… apply through the Article 13.5 process by reinforcing scientific studies.”

53. SCIENTIFIC EVIDENCE ACHIVEMENT
& COMMUNICATION

54. Conclusions

55.  At present, there is still lack of rigorousity on health claims
made on foods
 Investment on R&D is the most important way to achieve a new
HC for keeping/increasing competitiveness in the helthy sector
 Legal frameworks must (should) maintain their rules for industry
stakeholders?
 We are complaining about the misleading claims but we are
living on a serious risk by taking non-healthy habits.

56. Whereas… Decision making tree for HC’ identification and communication
NO
Is your product
Is your claim a brand name or a meant for
trade mark construed as a children only e.g.
health claim? with cartoon,
etc..
YES NO
NO
Was it on a market Is your health claim a YES
Is your claim
before January 2005? health recommendation? You have on Art.
referring to
14 claim. Use an
reduction of a
Art.14 authorised
disease risk
claim
factor?
YES NO
YES NO
No changes You should
Is it a reco from a Is your claim general
required until 19 accompany it by
national/local Authority? or specific? SPECIFIC
Jan 2022 a health claim
Is your claim
NO
realting to
It is likely that you
children’s
claim is a health claim
development and
YES NO health?
GENERAL
It is likely you can make the Is it a reco. From a
Is it a marketing
claim in line with the nutritional, dietetic, Is your claim close in meaning
puffery?
national/local Authority rules professional‐related charity? to any claim from the
authorised list of 222 health
claims?
YES NO YES NO NO YES
It is likely you can Reco from individual Your claim is If it is a general non Is your claim referring You can make your
make the claim in line doctors, dieticians out of the specific claim, it to a plant/botanical claim but should
with national rules etc. are not scope of should be claim that is still under provide the info from
e.g. Greece authorised. Your Claim’s Reg. It accompanied by a EFSA evaluation? Art. 10.
claim has to be taken can satay on specific health claim
off the label and the market from the authorised
other advertising
list of claims. It can
material, including YES
stay on the market NO
TV adverts. You can keep using the
Your claim is not
claim in line with
authorised
national rules

57. This is good for you Calcium improves bone
strength Improves your health
GOOD NIGHT
`t~xá çÉâ {tÑÑç Slim fast Vitamin C boosts
Contains Probiotics
your immunity
Eat 5 a day Gives you power

58. Decision making tree for HC’ identification and communication
NO
Is your product
Is your claim a brand name or meant for
a trade mark construed as a children only e.g.
health claim? with cartoon,
etc..
NO
YES
Is your health claim a NO
Was it on a market YES
health Is your claim
before January 2005? You have on Art.
recommendation? referring to
14 claim. Use an
reduction of a
Art.14 authorised
disease risk
claim
factor?
YES NO
YES NO
No changes You should
Is it a reco from a Is your claim general
required until 19 accompany it by
national/local Authority? or specific? SPECIFIC
Jan 2022 a health claim
Is your claim
NO
realting to
It is likely that you
children’s
claim is a health claim
development and
YES NO health?
GENERAL
It is likely you can make the Is it a reco. From a
Is it a marketing
claim in line with the nutritional, dietetic, Is your claim close in meaning
puffery?
national/local Authority rules professional‐related charity? to any claim from the
authorised list of 222 health
claims?
YES NO YES NO NO YES
It is likely you can Reco from individual Your claim is If it is a general non Is your claim referring You can make your
make the claim in line doctors, dieticians out of the specific claim, it to a plant/botanical claim but should
with national rules etc. are not scope of should be claim that is still under provide the info from
e.g. Greece authorised. Your Claim’s Reg. It accompanied by a EFSA evaluation? Art. 10.
claim has to be taken can satay on specific health claim
off the label and the market from the authorised
other advertising
list of claims. It can
material, including YES
stay on the market NO
TV adverts. You can keep using the
Your claim is not
claim in line with
authorised
national rules

59. Goal From global recommendations for healthier diet
habits to personalised nutrition
Global Healthy Diet Personalised
recommendations Nutrition
Subpopulation Genotype/Phenotype
Population
Health Public Policy Clinical Nutrition Personalised Diet
Strategies
Nutritional Genomics
GLOBAL
RECOMENDATIONS
COULD BO NOT
OPTIMUM FOR YOU

60. Thank you and ….
…questions?
Dr. Francesc Puiggròs,
Scientific coordinator of Technological Center of Nutrition and
Health (CTNS‐TECNIO)