bijeenkomst 12 november leergang functional food
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Bijeenkomst 12 novemberTRANSCRIPT
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Workshop Workshop 2 2 12 november 12 november 20092009
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“Productclaims en Gezondheidclaims: Wat mag ikop de verpakking zeggen tegen de consument?”29 september
Hans Verhagen: Rijksinstituut voor
Volksgezondheid en Milieu (RIVM)
“Gezondheidsclaims en wetgeving: de positie van Nederland binnen Europa: wat mag en wat kan niet?”
Quirien Veldman: Syntens
“Alternatieven voor claims. Is een gezondheidsclaim altijd nodig?
Welke alternatieven zijn er om je product te positioneren.”
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Nutrition and health claimsin Europe
Prof. Hans VerhagenWageningen, 12-11-2009
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Menu1. Scientific substantiation – role of EFSA
2. EU Regulation 1924/2006- background to claims Regulation- nutrient profiles- nutrition claims- article 14 health claims- article 13 health claims
3. Consumer understanding
4. Conclusions
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Claims
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What is a Claim?(1979):
“ a claim is any representation which
states, suggests or implies that
a food has particular characteristics
National Institutefor Public Healthand the Environment
a food has particular characteristics
relating to its origin, nutritional properties,
nature, production, processing, composition
or any other quality ”
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Health claims should be substantiated
Health claims should be substantiated
Health claims should be substantiated
Health claims should be
substantiated
National Institutefor Public Healthand the Environment
authorities
scientists
industry
consumers
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National Institutefor Public Healthand the Environment
ILSI Europe 2001 - 2005 EFSA 2007
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� Nutrient Profiles (Art.4) – scientific advice √√√√ and technical support
� Scientific and Technical Guidance for Health Claim Applications subject to authorisation procedure (Art.14 & Art.13.5/18) √√√√
Role of EFSA on Claims
(Art.14 & Art.13.5/18) √√√√
� Evaluation (scientific substantiation) of health claims– Art.14: Disease risk reduction – Art.14: Children’s development & health– Art.13.5 (=Art 18): Function claims based on newly developed
science/proprietary data)– Art.13.1: Evaluation of list of function claims based on generally
accepted scientific evidence
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- All pertinent scientific data inin favourfavour + not in favour
(totality of the scientific data ; weighing the evidence.)
- characteristics of the food required.
- Human data required.
- Study group(s) representative for the target population.
- Claimed effect must be relevant for human health.
- Causal relationship food consumption - health outcome in humans.
- effect can reasonably be achieved as part of a balanced diet.
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However
� The applicants to comply with the relevant
EFSA DisclaimerRegulation (EC) No 1924/2006
� No requirements for safety data
� Safety not directly assessed by EFSA
� The applicants to comply with the relevant legislation applicable
� EFSA Opinion: Where applicable, conditions or restriction of use, additional statement or warning
� Authorisation decision: Commission/Member States
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Menu1. Scientific substantiation – role of EFSA
2. EU Regulation 1924/2006- background to claims Regulation- nutrient profiles- nutrition claims- article 14 health claims- article 13 health claims
3. Consumer understanding
4. Conclusions
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National Institutefor Public Healthand the Environment
EU Regulation 1924/2006
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EU Regulation 1924/2006
National Institutefor Public Healthand the Environment
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Why do we need a claim regulation?
National Institutefor Public Healthand the Environment
“antioxidants”
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Why do we need a claim regulation?
National Institutefor Public Healthand the Environment
"The World's Strongest Fat Burner"
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Why do we need a claim regulation?
National Institutefor Public Healthand the Environment
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Why do we need a claim regulation?
“performance”
National Institutefor Public Healthand the Environment
…… our newest thermogenic energizing formulathat can help you burn stored body fat thanks to a process called Lipid Mobilization .
“performance”
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Now 25% More, Same Price,
Why do we need a claim regulation?
National Institutefor Public Healthand the Environment
Now 25% More, Same Price, 240 capsules
Acetyl-L-Carnitine, Alpha Lipoic Acid, and Bioperine
LIFESPAN EXTENSION COMPLEX
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Health claims
Function claims Reduction of disease
What it does
EU Regulation 1924/2006
Nutritionclaims
What it contains
National Institutefor Public Healthand the Environment
Function claimsBased on generally accepted scientific data
Based on newlydeveloped scientific data
of disease risk claims+ claims growthand developmentof children
claims
• content claims• Comparative claims
Article 14Article 13.5Article 13.1
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Objectives EU Regulation 1924/2006
- achieve high level of consumer confidence
- improve free movement of goods in EU
National Institutefor Public Healthand the Environment
- improve free movement of goods in EU
- increase legal security for food industry
- ensure fair competition
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Scope EU Regulation 1924/2006
- Labelling- Presentation
National Institutefor Public Healthand the Environment
- Presentation- Advertising - Brand names- Trademarks
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General principles EU Regulation 1924/2006
- Claims ≠ false, misleading
- Claims ≠ prevent, treat or cure disease
National Institutefor Public Healthand the Environment
- Claims ≠ prevent, treat or cure disease
- Scientifically justified
- Benefit from normal consumption of food
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Menu1. Scientific substantiation – role of EFSA
2. EU Regulation 1924/2006- background to claims Regulation- nutrient profiles- nutrition claims
National Institutefor Public Healthand the Environment
- article 14 health claims- article 13 health claims
3. Consumer understanding
4. Reactions
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Claim = “healthy for children”
But 25.6 g/100 g = sugarIngredients:
Why the 1924/2006 claims regulation?
National Institutefor Public Healthand the Environment
But 25.6 g/100 g = sugar
Only 7.5% of milk
Ingredients:
--------
--------
--------
--------
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Why the 1924/2006 claims regulation?
“Rich in calcium, magnesium and vitamins”
But 34,5 g/100 g = fat
National Institutefor Public Healthand the Environment
Ingredients:
--------
--------
--------
True claim -wrong message
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Nutrient Profiling:
“Categorization of foods
for specific purposes
National Institutefor Public Healthand the Environment
on basis of their nutrient composition
according to scientific principles”
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Conclusion
“There is no mere scientific
rationale on which to base
National Institutefor Public Healthand the Environment
rationale on which to base
nutrient profiles”
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Health claims
Function claims Reduction of disease
What it does
EU Regulation 1924/2006
Nutritionclaims
What it contains
National Institutefor Public Healthand the Environment
Function claimsBased on generally accepted scientific data
Based on newlydeveloped scientific data
of disease risk claims+ claims growthand developmentof children
claims
• content claims• Comparative claims
Article 14Article 13.5Article 13.1
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EU Regulation 1924/2006
Nutritionclaims
What it contains
Exemptions:
• nutrition claim referrring to the reduction of a nutrient
National Institutefor Public Healthand the Environment
claims
• content claims• Comparative claims
• where a single nutrientexceeds the profile(add statement)
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Health Claims
Function claims
what it does
EU Regulation 1924/2006
National Institutefor Public Healthand the Environment
Function claimsBased ongenerallyacceptedscientificdata
Based onnewlydevelopedscientificdata
Reductionof diseaserisk claims
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EU Regulation 1924/2006
Article 4: … Jan 2009, the Commission shall … establish specific nutrient profiles … which food or certain categories of food must comply with ….
National Institutefor Public Healthand the Environment
must comply with ….
… in order to bear nutrition or health claims
and the conditions for the use of nutrition or health claims for foods or categories of foods with respect to the nutrient profiles.
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A simple visual model to compare existing nutrient
profiling schemes
Hans Verhagen & Henk van den Berg
Food and Nutrition Research 2008
Last updated 10 December 2008
Citation: H. Verhagen & H. van den Berg - Food & Nutrition Research, vol 52, 2008. http://journals.sfu.ca/coaction/index.php/fnr/article/view/1649/1541 ; DOI: 10.3402/fnr.v52i0.1649
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Acrossthe board
Disqual.ingredients
100 g/100 ml
100 kcal/kJ
Threshold
Testing /
Total fat
SAFA
TFA
Cholesterol
Sodium
Sugar
Non-milk sugar
Energy
Food category
Qualifyingingredients
100 kcal/kJ
Referenceamount
Scoring
validationVit A
Vit C
iron
protein
calcium
fiber
W-3 LC PUFA
Fruits & veg’s
folateFig 1a
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Acrossthe board
Disqual.ingredients
100 g/100 ml
100 kcal/kJ
Threshold
Testing /
Total fat
SAFA
TFA
Cholesterol
Sodium
Sugar
Non-milk sugar
Energy
Food category
Qualifyingingredients
100 kcal/kJ
Referenceamount
Scoring
validationVit A
Vit C
iron
protein
calcium
fiber
W-3 LC PUFA
Fruits & veg’s
folateFig 1b
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Total fat
SAFA
TFA
Cholesterol
Sodium
Sugar
Non-milk sugar
Energy
100 g/100 ml
100 kcal/kJ
Threshold
Testing /
Acrossthe board
Disqual.ingredients
Vit A
Vit C
iron
protein
calcium
fiber
W-3 LC PUFA
100 kcal/kJ
Referenceamount
Scoring
validation
Fruits & veg’s, nuts
folate
Food category
Qualifyingingredients
http://www.food.gov.uk/Fig 2a
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Total fat
SAFA
TFA
Cholesterol
Sodium
Sugar
Non-milk sugar
Energy
100 g/100 ml
100 kcal/kJ
Threshold
Testing /
Acrossthe board
Disqual.ingredients
Vit A
Vit C
iron
protein
calcium
fiber
W-3 LC PUFA
100 kcal/kJ
Referenceamount
Scoring
validation
Fruits & veg’s
folate
Food category
Qualifyingingredients
http://www.cfsan.fda.gov/~dms/hclaims.htmlhttp://www.cfsan.fda.gov/~dms/flg-6c.html
Fig 2b
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Total fat
SAFA
TFA
Cholesterol
Sodium
Sugar
Non-milk sugar
Energy
100 g/100 ml
100 kcal/kJ
Threshold
Testing /
Acrossthe board
Disqual.ingredients
Vit A
Vit C
iron
protein
calcium
fiber
W-3 LC PUFA
100 kcal/kJ
Referenceamount
Scoring
validation
Fruits & veg’s
folate
Food category
Qualifyingingredients
http://www.voedingscentrum.nl/NR/rdonlyres/0AF85A19-79B1-4DB5-A0E8-C8BFFD44B089/0/Criteriaengelssite.pdfFig 2c
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Total fat
SAFA
TFA
Cholesterol
Sodium
Sugar
Non-milk sugar
Energy
100 g/100 ml
100 kcal/kJ
Threshold
Testing /
Acrossthe board
Disqual.ingredients
Vit A
Vit C
iron
protein
calcium
fiber
W-3 LC PUFA
100 kcal/kJ
Referenceamount
Scoring
validation
Fruits & veg’s
folate
Food category
Qualifyingingredients
http://www.slv.se/templates/SLV_Page.aspx?id=12220&epslanguage=EN-GBFig 2d
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Total fat
SAFA
TFA
Cholesterol
Sodium
Added sugar
Non-milk sugar
Energy
100 g/100 ml
100 kcal/kJ
Threshold
Testing /
Acrossthe board
Disqual.ingredients
Vit A
Vit C
iron
protein
calcium
fiber
W-3 LC PUFA
100 kcal/kJ
Referenceamount
Scoring
validation
Fruits & veg’s
folate
Food category
Qualifyingingredients
http://www.ikkiesbewust.nlFig 2e
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Total fat
SAFA
TFA
Cholesterol
Sodium
Sugar
Non-milk sugar
Energy
100 g/100 ml
100 kcal/kJ
Threshold
Testing /
Acrossthe board
Disqual.ingredients
Vit A
Vit C
iron
protein
calcium
fiber
W-3 LC PUFA
100 kcal/kJ
Referenceamount
Scoring
validation
Fruits & veg’s
folate
Food category
Qualifyingingredients
http://www.ah.nl/gezondekeuze/Fig 2f
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Total fat
SAFA
TFA
Cholesterol
Sodium
Sugar
Non-milk sugar
Energy
100 g/100 ml
100 kcal/kJ
Threshold
Testing /
Acrossthe board
Disqual.ingredients
February 2008
Vit A
Vit C
iron
protein
calcium
fiber
W-3 LC PUFA
100 kcal/kJ
Referenceamount
Scoring
validation
Fruits & veg’s
folate
Food category
Qualifyingingredients
http://www.efsa.europa.eu/EFSA/efsa_locale-1178620753812_1178689506673.htm
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Total fat
SAFA
TFA
Cholesterol
Sodium
Sugar
Non-milk sugar
Energy
100 g/100 ml
100 kcal/kJ
Threshold
Testing /
Acrossthe board
Disqual.ingredients
November 2008
Vit A
Vit C
iron
protein
calcium
fiber
W-3 LC PUFA
100 kcal/kJ
Referenceamount
Scoring
validation
Fruits & veg’s
folate
Food category
Qualifyingingredients
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Feb
2009
National Institutefor Public Healthand the Environment
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Feb
2009
National Institutefor Public Healthand the Environment
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EU
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Menu1. Scientific substantiation – role of EFSA
2. EU Regulation 1924/2006- background to claims Regulation- nutrient profiles- nutrition claims- article 14 health claims- article 13 health claims
3. Consumer understanding
4. Conclusions
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Nutritionclaims
What it contains
EU Regulation 1924/2006
Light
National Institutefor Public Healthand the Environment
claims
• content claims• Comparative claims
+ Vit C
In future?
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Nutrition claims and conditions applying to them
• LOW ENERGY- Max 40 kcal (170 kJ)/100 g for solids- Max 20 kcal (80 kJ)/100 ml for liquids- table-top sweeteners max 4 kcal (17 kJ)/portion
• ENERGY-REDUCED
National Institutefor Public Healthand the Environment
• ENERGY-REDUCED- energy value is reduced by at least 30 %
• ENERGY-FREE- Max 4 kcal (17 kJ)/100 ml
EU Regulation 1924/2006
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Nutrition claims and conditions applying to them
• LOW FAT- Max 3 g of fat per 100 g for solids- Max 1,5 g of fat per 100 ml for liquids- Max 1,8 g of fat per 100 ml for semi-skimmed milk).
• FAT-FREE- Max 0,5 g of fat per 100 g or 100 ml- ‘X % fat-free’ prohibited
National Institutefor Public Healthand the Environment
- ‘X % fat-free’ prohibited
• LOW SATURATED FAT- 1,5 g per 100 g for solids- 0,75 g/100 ml for liquids - SAFA + TFA max 10 % of energy
• SATURATED FAT-FREE- Max 0,1 g per 100 g or 100 ml
EU Regulation 1924/2006
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Nutrition claims and conditions applying to them
• LOW SUGARS- Max 5 g of sugars per 100 g for solids
- Max 2,5 g of sugars per 100 ml for liquids
• SUGARS-FREE
National Institutefor Public Healthand the Environment
• SUGARS-FREE- Max 0,5 g of sugars per 100 g or 100 ml
• WITH NO ADDED SUGARS- No added mono- or disaccharides or any other food used for
its sweetening properties
- ‘CONTAINS NATURALLY OCCURRING SUGARS’.
EU Regulation 1924/2006
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Nutrition claims and conditions applying to them
• LOW SODIUM/SALT- Max 0,12 g of sodium (0,3 g salt) per 100 g or per 100 ml
- Waters: Max 2 mg of sodium per 100 ml*
• VERY LOW SODIUM/SALT
National Institutefor Public Healthand the Environment
• VERY LOW SODIUM/SALT- Max 0,04 g of sodium (0,1 g salt) per 100 g or per 100 ml
- Waters: do not use
• SODIUM-FREE or SALT-FREE- Max 0,005 g of sodium (0,0125 g salt) per 100 g or per 100 ml
EU Regulation 1924/2006
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Nutrition claims and conditions applying to them
• SOURCE OF FIBRE- Min 3 g of fibre per 100 g
- Min 1,5 g of fibre per 100 kcal
• HIGH FIBRE
National Institutefor Public Healthand the Environment
• HIGH FIBRE- Min 6 g of fibre per 100 g
- Min 3 g of fibre per 100 kcal
EU Regulation 1924/2006
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Nutrition claims and conditions applying to them
• SOURCE OF PROTEIN- Min 12 % of the energy value of the food
• HIGH PROTEIN- Min 20 % of the energy value of the food
National Institutefor Public Healthand the Environment
- Min 20 % of the energy value of the food
EU Regulation 1924/2006
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Nutrition claims and conditions applying to them
• SOURCE OF [VITAMIN/S] AND/OR [MINERAL/S]- Min ‘significant amount’ as per Regulation 1925/2006
• HIGH [VITAMIN/S] AND/OR [MINERAL/S]- Min 2* value for source
National Institutefor Public Healthand the Environment
- Min 2* value for source
• CONTAINS [NUTRIENT OR OTHER SUBSTANCE]- See vitamins, minerals, etc. ; Article 5 of 1924/2006
EU Regulation 1924/2006
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Nutrition claims and conditions applying to them
• INCREASED [NUTRIENT]- Conditions for ‘source of’- Min. increase is 30%
• REDUCED [NUTRIENT]- Min. reduction is 30%- Sodium / salt min. reduction is 25%
National Institutefor Public Healthand the Environment
- Sodium / salt min. reduction is 25%- Micronutrients Min. 10% (90/496/EEC)
• LIGHT/LITE- See reduced + indication of the characteristic(s)
• NATURALLY/NATURAL- When food naturally meets the condition(s) laid down in Annex to
1924/2006 for the use of a nutritional claim
EU Regulation 1924/2006
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Nutrition claims and conditions applying to themamending Regulation (EC) No 1924/2006
• SOURCE OF OMEGA-3 FATTY ACIDS- Min 0,3g ALA per 100g and per 100kcal, or min. 40mg of the sum
EPA and DHA per 100g and per 100kcal
• HIGH OMEGA-3 FATTY ACIDS- Min 0,6g ALA per 100g and per 100kcal, or min. 80mg of the sum
EPA and DHA per 100g and per 100kcal
National Institutefor Public Healthand the Environment
• HIGH MONO UNSATURATED FAT- Min 45% of the fatty acids is MUFA ; MUFA min. 20% of energy
• HIGH POLY UNSATURATED FAT- Min 45% of the fatty acids is PUFA ; PUFA min. 20% of energy
• HIGH UNSATURATED FAT
- Min 70 % of the fatty acids is UFA ; UFA min. 20% of energy
EU Regulation 1924/2006
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Nutrition claims and conditions applying to them
•Additional nutrition claims per 2009
• "SOURCE OF OMEGA-3 FATTY ACIDS”
• “HIGH OMEGA -3 FATTY ACIDS”
National Institutefor Public Healthand the Environment
• “HIGH OMEGA -3 FATTY ACIDS”
• “HIGH MONO UNSATURATED FAT”
• “HIGH POLY UNSATURATED FAT”
• “HIGH UNSATURATED FAT”
EU Regulation 1924/2006
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Menu1. Scientific substantiation – role of EFSA
2. EU Regulation 1924/2006- background to claims Regulation- nutrient profiles- nutrition claims
National Institutefor Public Healthand the Environment
- article 14 health claims- article 13 health claims
3. Consumer understanding
4. Conclusions
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Health claims
Function claims Reduction of disease
What it does
EU Regulation 1924/2006
Nutritionclaims
What it contains
National Institutefor Public Healthand the Environment
Function claimsBased on generally accepted scientific data
Based on newlydeveloped scientific data
of disease risk claims+ claims growthand developmentof children
claims
• content claims• Comparative claims
Article 14Article 13.5Article 13.1
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EU Regulation 1924/2006
Health claims
Function claims Reduction of disease
What it does
National Institutefor Public Healthand the Environment Article 14
CalciumCalcium
Function claimsBased on generally accepted scientific data
Based on newlydeveloped scientific data
of disease risk claims+ claims growthand developmentof children
Article 13.5
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• Industry send application to Member State
- total 281
EU Regulation 1924/2006:
List of Article 14 claims dossiers
National Institutefor Public Healthand the Environment
• EFSA assessment and opinion
• EC/MS: decide on authorisation of claims
• Community list of article 14 claims
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EFSA health claims evaluation status (30 October 2009)
Claim type Received Withdrawn Adopted In progress
Children (Art. 14) 213 23
45 opinions covering 52 applications
6*
Disease risk
63
Disease risk reduction (Art. 14)
47 3 14 4**
New science/ proprietary (Art. 13.5)
23 6 14 2***
Total 283 32 73 covering 80 applications
12
* 2 in clock stop** 2 in clock stop*** 0 in clock stop
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21 August 2008: EFSA adopts first opinions on healt h claims made on foods relating to disease risk reduc tion and children’s health
National Institutefor Public Healthand the Environment
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Claim OK * Plant sterols & cholesterol lowering & heart disease
* wording
Cause & effect OK * Linoleic acid, alpha-linolenic acid & growth-dev. kids
Amount can be consumed by diet
Cause & effect not OK Food suppl. & growth-dev. Kids
Cause & effect not OK Food suppl.-soy-flax & bone
Cause & effect not OK Dairy foods & body weight in
EFSA Opinions article 14 – August 2008
National Institutefor Public Healthand the Environment
Cause & effect not OK Dairy foods & body weight in kids and adolescents
Cause & effect not OK Dairy (milk – cheese) & dental health kids
Cause & effect not OK Food suppl. (prickle pear cactus) & blood lipid parameters
Cause & effect not OK Food suppl (CLA, polyols, extracts) & body weight
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EFSA verdicts on food claims send shockwaves through the industry
National Institutefor Public Healthand the Environment
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EFSA health claim rejections 'shock' industry
National Institutefor Public Healthand the Environment
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National Institutefor Public Healthand the Environment
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Industry: “EFSA verdicts on food claims send shockwaves through the industry”
Consumer organizations: “ welcomesEFSA approach”
National Institutefor Public Healthand the Environment
EFSA approach”
Scientists: “generally supportfor EFSA opinions”
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Example: Plant Sterols
� Constituent well defined - sufficiently characterised
� Target: People who want to lower blood cholesterol
� Claimed effect: lower/reduce blood cholesterol and reduce the risk of (coronary) heart disease.�Studies with the constituent in several food matrices (fat-based foods and low-
fat foods such as milk and yoghurt), in the target population, concerning the LDL-cholesterolloweringeffect: consistent results, dose-response. LDL-cholesterolloweringeffect: consistent results, dose-response.
�Cause-effect relationship established
�No studies demonstrating that plant sterols reduce the risk of coronary heartdisease.
� EFSA: «Plant sterols have been shown to lower/reduce bloodcholesterol. Blood cholesterol may reduce the risk of coronarydisease ». Should be consumed only by people who want to lower theirblood cholesterol. Patients on cholesterol lowering medication shouldonly consume the product under medical supervision.
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Example: Regulat.pro.kid BRAIN
� Fermented vegetables/fruits with probiotics, lecithinand Rhodiola rosea exact
� Claimed effect: Contribute to mental and cognitive development
� Target: children3-6 years� Target: children3-6 years
� Bacteria strains not characterised
� The claimed effect not defined by the applicant
� No study with the final product, in the target population, concerning the claimed effect
�Cause-effect relationship not established
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National Institutefor Public Healthand the Environment
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October 2009:
Regulations on articel 14/13.5 claims
National Institutefor Public Healthand the Environment
•EU Regulation 983/2009: 7 permitted claims; 14 rejectedclaims•EU Regulation 984/2009: 2 rejectedclaims
•EU Regulation 1024/2009: 2 permitted claims; 14 rejected claims•EU Regulation 1025/2009: 2 rejected claims
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Menu1. Scientific substantiation – role of EFSA
2. EU Regulation 1924/2006- background to claims Regulation- nutrient profiles- nutrition claims
National Institutefor Public Healthand the Environment
- article 14 health claims- article 13 health claims
3. Consumer understanding
4. Conclusions
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Health claims
Function claims
What it does
EU Regulation 1924/2006
a) growth, development and
the functions of the body
b) psychological and
behavioral functions
c) claims related to
National Institutefor Public Healthand the Environment
Function claimsBased on generally accepted scientific data
Based on newlydeveloped scientific data
slimming, bodyweight
control
Calcium: good for bonesWeight
reduction
Article 13
Article 13.1
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•Member States send to EC lists by 31 Jan 2008
total ~ 44.000 • EC: Compilation > 4.000
EU Regulation 1924/2006:
List of Article 13 claims“Dossiers”papers etc
National Institutefor Public Healthand the Environment
• EC: Compilation > 4.000
• EFSA Opinion
• EC to adopt list by 31 Jan 2010
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Claims Claims receivedreceived byby categorycategory
Foods8%
Macronutrients9%
Minerals5%
Vitamins5%
Probiotics8%
Diets1%
Fibre3%
8%Botanicals45%
Other substances16%
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Specifics of Article 13.1 claims
�Generic function claims
�List of MS claims provided via the Commission
�No applicant, no dossier
�EFSA to evaluate claims based on the
78
�EFSA to evaluate claims based on the literature provided
�Some claims in the list are expressed only very vague (no clear health relationship, wordings referring to several endpoints)
�Not the responsibility of EFSA to define a claim
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Art. 13 claims: Terms of Reference
EFSA to evaluate whether: • Adequate characteristics of the food pertinent to the
beneficial effect is provided• Effect is beneficial to human health• Beneficial effect of food on the function is substantiated
(EFSA to comment on the nature and quality of the evidence provided)(EFSA to comment on the nature and quality of the evidence provided)
• Specific importance of the food for the claimed effect• Effect on the function is significant in relation to the
quantity to be consumed• Study group is representative of the target population• Wording • Conditions and restrictions of use
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Art. 13 Claims–Pre-screening Criteria
� Claims where clarification on scope is needed�e.g. risk reduction, children, or medicinal claims
� General well-being claims�e.g. “X supplementation sustains vitality while aging”,
“supports well-being”
� Too vague claims(claimed effect not specified/measurable)
�e.g. “Good for mental activity”, “effectively purifies the body”
� Foods not sufficiently characterised or conditions of use not sufficiently specified�e.g. “Beef and beef products”
� Combination of constituents that are not sufficiently defined� Claims in other languages than English
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General function claims (Art. 13.1)
• Ongoing evaluation of Art. 13.1 list
• 44,000 claims submitted by MS to EC (Jan 2008)
• EC consolidated list (4,185 claims) published by EFSA Jan ‘09EFSA Jan ‘09
– approx. 2,000 under evaluation by EFSA
– approx. 2,000 require further clarification by EC/M S (ongoing)
– Updated EC consolidated list - EFSA to by end of 09 (taking into account missing/misplaced claims)
– List of references – EFSA published in Sep 0981
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Timelines for Art. 13.1 claims
• October 2009: Publication of 521 claims evaluations (covered in 94 opinions) adopted by NDA Panel on 2 July 2009
• EFSA is continuing evaluation – progressive adoption/publication of opinions thoughoutadoption/publication of opinions thoughout2010 and 2011
• EFSA timeframe for evaluation of outstanding claims awaits:– confirmation by Commission of status of approx.
2000 claims sent to MS for clarification – addendum to list (300-500 claims)
82
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Art. 13 Claims Sub-Working Groups
Sub-working groups on various health relationship to
prepare first draft, to be reviewed by Standing WG on
claims and to be adopted by NDA Panel
� Gut and Immune System� Gut and Immune System
� Cardiovascular Health
� Bone, dental health, connective tissue
� Weight management, satiety, physical performance
� Mental health, CNS, vision
� Miscellaneous
� Characterisation of Botanicals
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National Institutefor Public Healthand the Environment
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3 levels of evidence:
• a cause and effect has been established
National Institutefor Public Healthand the Environment
• a cause and effect has not been established
• Insufficient evidence for cause and effect ….
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• Calcium & bones• Calcium, vitD & bones• Fluoride & teeth• Magnesium & energy, cell division, electrolyte• Biotin, niacin & energy• Selenium & antioxidant, immune, ….
National Institutefor Public Healthand the Environment
• Selenium & antioxidant, immune, ….• VitC & antioxidant• Sugar-free chewing gum & teeth• Betaglucans & cholesterol • …… etc
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• Probiotics ≠ strengthen immune system
• >100 probiotics insufficiently characterised
• Botanicals ≠ characterised, poor data
National Institutefor Public Healthand the Environment
• Taurine ≠ energy, performance
• Glucosamine, shark cartilage ≠ joint health
• …… etc
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National Institutefor Public Healthand the Environment
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National Institutefor Public Healthand the Environment
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Menu1. Scientific substantiation – role of EFSA
2. EU Regulation 1924/2006- background to claims Regulation- nutrient profiles- nutrition claims
National Institutefor Public Healthand the Environment
- article 14 health claims- article 13 health claims
3. Consumer understanding
4. Conclusions
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Consumer understanding
�consumer understanding not assessed by EFSA
However
93
�EFSA is providing a wording, which is reflecting the scientific evidence. Other factors, like consumer understanding, will be taken into account by risk manager
�Discussion on flexible vs fixed wording ongoing
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Nutrition claims
Significant scientific agreement
Moderate LowExtremely
low
Consumer understanding
Function claims
Reduction risk of disease
claims
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Nutrition claims Little effect of claim strength level
Significant scientific agreement
Moderate LowExtremely
low
Function claims
Reduction risk of disease
claims
strength level
(more for personalrelevance)
Netherlands: Van Kleef, van Trijp et al, 2005
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Consumers do notclearly distinguish
Significant scientific agreement
Moderate LowExtremely
low
Nutrition claims
clearly distinguish between:
Nutrient content claims
Structure function claims
Health claims
Australia: P. Williams, 2005
Structure function claims
Health claims
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�Little distinction between level A through D claims
Significant scientific agreement
Moderate LowExtremely
low
Nutrition claims
level A through D claims
USA: FDA 2005
Function claims
Reduction risk of disease
claims
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• Is mentioned in Regulation 1924/2006
• No requirements by EFSA in dossier
EU Regulation 1924/2006:
Consumer understanding
National Institutefor Public Healthand the Environment
(except examples of wording)
• EC/MS: enforcement on consumer understanding
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Menu1. Scientific substantiation – role of EFSA
2. EU Regulation 1924/2006- background to claims Regulation- nutrient profiles- nutrition claims
National Institutefor Public Healthand the Environment
- article 14 health claims- article 13 health claims
3. Consumer understanding
4. Conclusions
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Health claims should be substantiated
Health claims should be substantiated
Health claims should be substantiated
Health claims should be
substantiated
National Institutefor Public Healthand the Environment
authorities
scientists
industry
consumers
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Health claims
Function claims Reduction of disease
What it does
EU Regulation 1924/2006
Nutritionclaims
What it contains
National Institutefor Public Healthand the Environment
Function claimsBased on generally accepted scientific data
Based on newlydeveloped scientific data
of disease risk claims+ claims growthand developmentof children
claims
• content claims• Comparative claims
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Questions ?
National Institutefor Public Healthand the Environment
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©=============================================Dr. Hans VerhagenHead, Centre for Nutrition and HealthNational Institute for Public Health and the Environment (RIVM)PO Box 1 3720 BA BilthovenThe Netherlands
National Institutefor Public Healthand the Environment
The Netherlands Tel +31 30 274 3391 Secretariat +31 30 274 3318 Fax +31 30 274 4466 [email protected]://www.rivm.nl/en/aboutrivm/organization/vgc/cvg/index.jsp============================================
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Alternatieven voor claims
10 manieren om je product te 10 manieren om je product te positioneren zonder te claimen
Quirien Veldman – Syntens12 november 2009
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Claim:
Een bewering over je product die je gebruikt om de beoogde klant te overtuigenbeoogde klant te overtuigen
Overtuigen:
1) met wetenschappelijk onderbouwde claims
2) door aan te spreken op emotie
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Opwarmer: welke claim beweert dat dit product het beste is?
● Coca Cola: it’s the real thing
● Miele, er is geen betere
Fresh Tapas van de Greenery – jaarprijs gezonde voeding● Fresh Tapas van de Greenery – jaarprijs gezonde voeding
● Verrijkt met Aloë Vera voor een zachtere huid
● Oral B. Poets als een tandarts
● Gilette’s beste scheerresultaat
● De enige rol die niet kan rollen, van de smaak
● Eén theelepel Dreft volstaat voor de hele vaat
● Campina. Het zit in onze natuur.
● Hou van je hart. Becel.
● Milner, boordevol bouwstoffen.
● Milner: minder zout, meer genieten.
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Wie niet sterk is moet slim zijn
● Veel bedrijven streven naar superioriteit bij de ontwikkeling van een nieuw product. Daarbij gaan ze ervan uit dat klanten altijd rationeel kiezen voor kwaliteit.kwaliteit.
● Dat is prima als jouw producten ook werkelijk superieur zijn. Maar wat als dat niet zo is? Of als je het niet kan bewijzen? Of als je het niet mag zeggen?
● Klanten worden niet alleen beinvloed dooe rationele specificaties en bewijzen, maar laten zich ook leiden door aantrekkelijke beloften.
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Product - Ingrediënt - Functie
BiologischScharrel-Omega 3
NatuurlijkDiervriendelijk
Verbetert geheugen
GroentenEieren
Boter / vis Omega 3Calcium
Rechtsdraaiend melkzuurBifidus ActiRegularis cultuur
Onverzadigde vettenVezels
Van het land….
Verbetert geheugenSterke botten
Licht verteerbaarStoelgang
Hart en bloedvatenDarmwerking
Lekkerder….
Boter / visMelk
YoghurtActimelOlijfolie
VolkorenbroodStreekbrood
….
Bijvoorbeeld: Actimel bevat de BAR cultuur, de BAR cultuur is goed voor de stoelgang, dus Actimel is goed voor de stoelgang.
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Van functie naar ziektebeeld: niet toegestaan
Verbetert geheugen Tegen dementieVerbetert geheugenSterke botten
Licht verteerbaarHart en bloedvaten
Tegen dementieVoorkomt artrose
Geneest spastiche darmVoorkomt hart- en vaatziekten
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Voorbeelden
Zonder water kun je niet leven. Appelsientje bestaat voor 90% uit water.
Vezels helpen voor een goede stoelgang. Volkorenbrood zit boordevol vezels.
Gezond eten helpt kanker voorkomen. AH stoommaaltijden hebben de Jaarprijs goede voeding ontvangen.
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10 typen claims
1. Superioriteits-claim
2. Gelijk aan de top-claim2. Gelijk aan de top-claim
3. Zelfreferentie-claim
4. Superioriteitsclaim met beperking
5. Uniekheids-claim
6. Intentie-claim
7. Statistische claim
8. Claim met open einde
9. De Vraag
10. Ondersteunde claim
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Veldman’s Regenwormgehakt
Regenwormgehakt – Proteïne - Spieropbouw
Veldman’s regenwormgehakt
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1. Superioriteitsclaim
Het makkelijkst te onthouden en veruit het meest effectief. Als je superioriteit kunt claimen: doe
1.1.1.1. SuperioriteitsclaimSuperioriteitsclaimSuperioriteitsclaimSuperioriteitsclaim
2. Gelijkheid aan de top- effectief. Als je superioriteit kunt claimen: doe het!
Formuleer in overtreffende trap: beste, snelste, grootste, gladste, makkelijkste, duurzaamste, goedkoopste, schoonste, hoogste…
● Samsung, ‘s werelds kleinste printer
● Durex, the best there is
2. Gelijkheid aan de top-claim
3. Zelfrefererende claim
4. Superioriteitsclaim met beperking
5. Uniekheids-claim
6. Intentie-claim
7. Statistische claim
8. Claim met open einde
9. De Vraag
10. Ondersteunde claim
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Superioriteitsclaim
Georgina is zo dom nog niet!
BEVAT MEER PROTEÏNE
DAN ALLE ANDERE
LEVENSMIDDELEN
Veldman’s regenwormgehakt
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2. Gelijkheid aan de top-claim
Klinkt als superioriteit, maar is dat het echt? Zolang je aan kunt tonen dat geen ander superieur
1. Superioriteits-claim
2.2.2.2. Gelijkheid aan de Gelijkheid aan de Gelijkheid aan de Gelijkheid aan de Zolang je aan kunt tonen dat geen ander superieur is kun je dit gebruiken.
● Miele, er is geen betere
● Er gaat niets boven Groningen
● Geen dagcreme haalt meer rimpels weg
2.2.2.2. Gelijkheid aan de Gelijkheid aan de Gelijkheid aan de Gelijkheid aan de toptoptoptop----claimclaimclaimclaim
3. Zelfrefererende claim
4. Superioriteitsclaim met beperking
5. Uniekheids-claim
6. Intentie-claim
7. Statistische claim
8. Claim met open einde
9. De Vraag
10. Ondersteunde claim
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Gelijkheid aan de top-claimBodybuilders kennen de kracht van regenwormgehakt
NIETS BEVAT MEER
PROTEÏNE
Veldman’s regenwormgehakt
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3. Zelfrefererende claim
Je claimt superioriteit, maar ten opzichte van je eigen producten.
1. Superioriteits-claim
2. Gelijkheid aan de eigen producten.
● Het beste stoomstrijkijzer, van Philips
● Geen Ariel waspoeder verwijdert zoveel vlekken
● Verbeterd! Absorbeert 20% meer vocht dan voorheen.
● Gilette’s beste scheerresultaat
2. Gelijkheid aan de top-claim
3.3.3.3. Zelfrefererende Zelfrefererende Zelfrefererende Zelfrefererende claimclaimclaimclaim
4. Superioriteitsclaim met beperking
5. Uniekheids-claim
6. Intentie-claim
7. Statistische claim
8. Claim met open einde
9. De Vraag
10. Ondersteunde claim
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Zelfrefererende claimSonja Bakker eet het ook
VELDMAN’S
EFFICIENTSTE GEHAKT
OOIT
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4. Superioriteitsclaim met beperking
Je claimt superioriteit maar bouwt een beperking in. Je beperkt je vergelijking tot een subcategorie van het concurrerende veld.
1. Superioriteits-claim
2. Gelijkheid aan de top- in. Je beperkt je vergelijking tot een subcategorie van het concurrerende veld.
● De beste waskracht van een vloeibaar wasmiddel
● Reedyk: de grootste hijskracht die door een deur kan
● Het beste scheerresultaat met 4 mesjes
2. Gelijkheid aan de top-claim
3. Zelfrefererende claim
4.4.4.4. Superioriteitsclaim Superioriteitsclaim Superioriteitsclaim Superioriteitsclaim met beperkingmet beperkingmet beperkingmet beperking
5. Uniekheids-claim
6. Intentie-claim
7. Statistische claim
8. Claim met open einde
9. De Vraag
10. Ondersteunde claim
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Geen wonder dat ze lacht!
Superioriteitsclaim met beperking
HET MEESTE PROTEÏNE
VAN ALLE WEEKDIER-
VLEESWAREN
Veldman’s regenwormgehakt
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5. Uniekheids-claim
Als eerste of als enige creëer je een vergelijking waarin jij de referentie bent
1. Superioriteits-claim
2. Gelijkheid aan de waarin jij de referentie bent
● Vodafone UMTS: de eerste, de enige.
● De originele boterbabbelaars
● De enige rol die niet kan rollen, van de smaak
● Heinz tomatenketchup. Welke andere?
2. Gelijkheid aan de top-claim
3. Zelfrefererende claim
4. Superioriteitsclaim met beperking
5.5.5.5. UniekheidsUniekheidsUniekheidsUniekheids----claimclaimclaimclaim
6. Intentie-claim
7. Statistische claim
8. Claim met open einde
9. De Vraag
10. Ondersteunde claim
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Ook je oma denkt weer aan vroeger
Uniekheids-claim
GEHAKT ZOALS GEHAKT
BEDOELD IS
Veldman’s regenwormgehakt
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6. Intentie-claim
Ook al kun je van een eigenschap niet bewijzen dat je het hebt bereikt, je kunt wel zeggen dat het
1. Superioriteits-claim
2. Gelijkheid aan de dat je het hebt bereikt, je kunt wel zeggen dat het je intentie was.
● Braun. Designed to make a difference.
● Verrijkt met Aloë Vera voor een zachtere huid
2. Gelijkheid aan de top-claim
3. Zelfrefererende claim
4. Superioriteitsclaim met beperking
5. Uniekheids-claim
6.6.6.6. IntentieIntentieIntentieIntentie----claimclaimclaimclaim
7. Statistische claim
8. Claim met open einde
9. De Vraag
10. Ondersteunde claim
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Intentie-claimArnold zweert erbij
ONTWIKKELD OM
SPIEROPBOUW TE
VERSNELLEN
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7. Statistische claim
Je product hoeft niet technisch beter te zijn, je kunt toch dankzij marketing en distributie meer
1. Superioriteits-claim
2. Gelijkheid aan de kunt toch dankzij marketing en distributie meer weten te verkopen. Dit suggereert dat je de massa aanspreekt.
● British Airlines: the world’s favourite airline
● Eén miljoen vrouwen kunnen het niet verkeerd hebben
● 95% van de computers ter wereld gebruiken onze software
2. Gelijkheid aan de top-claim
3. Zelfrefererende claim
4. Superioriteitsclaim met beperking
5. Uniekheids-claim
6. Intentie-claim
7.7.7.7. Statistische claimStatistische claimStatistische claimStatistische claim
8. Claim met open einde
9. De Vraag
10. Ondersteunde claim
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Statistische claim
Paris is wel in voor een feestje
WORDT AL OP 78% VAN
ALLE FEESTJES
GESERVEERD
Veldman’s regenwormgehakt
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8. Claim met open einde
Door een ‘vergrotende trap’ formulering te gebruiken zonder daarbij aan te geven waarmee je vergelijkt, nodigt deze claim met open einde uit
1. Superioriteits-claim
2. Gelijkheid aan de gebruiken zonder daarbij aan te geven waarmee je vergelijkt, nodigt deze claim met open einde uit voor eigen interpretatie.
● Onze restaurants geven je meer
● Ons reisbureau geeft je een prettigere start
● Rizla 3x beter. Rolt beter, plakt beter, brandt beter.
2. Gelijkheid aan de top-claim
3. Zelfrefererende claim
4. Superioriteitsclaim met beperking
5. Uniekheids-claim
6. Intentie-claim
7. Statistische claim
8.8.8.8. Claim met open Claim met open Claim met open Claim met open eindeeindeeindeeinde
9. De Vraag
10. Ondersteunde claim
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Claim met open einde
Tiesto pompt het volume op
WERKTEN ALLE
PROTEINEPRODUCTEN
MAAR ZO….
Veldman’s regenwormgehakt
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9. De Vraag
Een vraag suggereert dat jouw product het antwoord is, maar stelt dat niet letterlijk.
1. Superioriteits-claim
2. Gelijkheid aan de antwoord is, maar stelt dat niet letterlijk.
● Calvé pindakaas. Wie is er niet groot mee geworden?
● Andrelon. Omdat ik het waard ben. U toch ook?
● ANWB. Hebben we u ooit de verkeerde kant op gestuurd?
2. Gelijkheid aan de top-claim
3. Zelfrefererende claim
4. Superioriteitsclaim met beperking
5. Uniekheids-claim
6. Intentie-claim
7. Statistische claim
8. Claim met open einde
9.9.9.9. De VraagDe VraagDe VraagDe Vraag
10. Ondersteunde claim
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Hoe Amy erbovenop komt in rehab
De Vraag
WIE WIL ER NOU NIET
AANSTERKEN?
Veldman’s regenwormgehakt
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10. De ondersteunde claim
Ondersteuning door een ‘kenner’ werkt goed om de geloofwaardigheid van je producten te
1. Superioriteits-claim
2. Gelijkheid aan de de geloofwaardigheid van je producten te versterken
● Oral B. Poets als een tandarts.
● Pedigree. Aanbevolen door topfokkers.
2. Gelijkheid aan de top-claim
3. Zelfrefererende claim
4. Superioriteitsclaim met beperking
5. Uniekheids-claim
6. Intentie-claim
7. Statistische claim
8. Claim met open einde
9. De Vraag
10.10.10.10. Ondersteunde Ondersteunde Ondersteunde Ondersteunde claimclaimclaimclaim
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De ondersteunde claim
Het gehakt van de toekomst!
GETEST DOOR
WETENSCHAPPERS
Veldman’s regenwormgehakt
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Samenvatting
• Kies je ingrediënt en functie• Bepaal wat je wilt claimen
Veldman’s regenwormgehakt
• Bepaal wat je wilt claimen• Zoek een formulering die past
Proost!