www.syntens.nl
Workshop 2 12 november 2009 Powered by: www.agrofood-community.nl
29 september
“Productclaims en Gezondheidclaims: Wat mag ik op de verpakking zeggen tegen de consument?”
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.”
Nutrition and health claims in Europe Prof. Hans Verhagen Wageningen, 12-11-2009
Menu 1. 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
Claims
What is a Claim? (1979): “a claim is any representation which states, suggests or implies that a food has particular characteristics relating to its origin, nutritional properties, nature, production, processing, composition or any other quality�
National Institute for Public Health and the Environment
Health claims Health claims should be should be substantiated substantiated
scientists
consumers
authorities industry National Institute for Public Health and the Environment
ILSI Europe 2001 - 2005
National Institute for Public Health and the Environment
EFSA 2007
Role of EFSA on Claims 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) √ 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
- All pertinent scientific data in favour + 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.
EFSA Disclaimer Regulation (EC) No 1924/2006
No requirements for safety data Safety not directly assessed by EFSA
However 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
Menu 1. 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
EU Regulation 1924/2006 National Institute for Public Health and the Environment
EU Regulation 1924/2006
National Institute for Public Health and the Environment
Why do we need a claim regulation?
“antioxidants”
National Institute for Public Health and the Environment
Why do we need a claim regulation?
"The World's Strongest Fat Burner"
National Institute for Public Health and the Environment
Why do we need a claim regulation?
National Institute for Public Health and the Environment
Why do we need a claim regulation?
“performance”
…… our newest thermogenic energizing formula that can help you burn stored body fat thanks to a process called Lipid Mobilization. National Institute for Public Health and the Environment
Why do we need a claim regulation?
Now 25% More, Same Price, 240 capsules LIFESPAN EXTENSION COMPLEX
National Institute for Public Health and the Environment
Acetyl-L-Carnitine, Alpha Lipoic Acid, and Bioperine
EU Regulation 1924/2006 What it does
What it contains
Nutrition claims • content claims • Comparative claims
Health claims Function claims Based on generally accepted scientific data
Based on newly developed scientific data
Reduction of disease risk claims + claims growth and development of children
National Institute for Public Health and the Environment
Article 13.1 Article 13.5 Article 14
Objectives EU Regulation 1924/2006 - achieve high level of consumer confidence - improve free movement of goods in EU - increase legal security for food industry - ensure fair competition National Institute for Public Health and the Environment
Scope EU Regulation 1924/2006
National Institute for Public Health and the Environment
Labelling Presentation Advertising Brand names Trademarks
General principles EU Regulation 1924/2006 - Claims ≠false, misleading - Claims ≠prevent, treat or cure disease - Scientifically justified - Benefit from normal consumption of food National Institute for Public Health and the Environment
Menu 1. 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. Reactions National Institute for Public Health and the Environment
Why the 1924/2006 claims regulation?
Claim = “healthy for children� Ingredients:
But 25.6 g/100 g = sugar
-----------------------------
National Institute for Public Health and the Environment
Only 7.5% of milk
Why the 1924/2006 claims regulation? “Rich in calcium, magnesium and vitamins� But 34,5 g/100 g = fat
Ingredients: ----------------------
National Institute for Public Health and the Environment
True claim wrong message
Nutrient Profiling: “Categorization of foods for specific purposes on basis of their nutrient composition according to scientific principles�
National Institute for Public Health and the Environment
Conclusion “There is no mere scientific rationale on which to base nutrient profiles�
National Institute for Public Health and the Environment
EU Regulation 1924/2006 What it does
What it contains
Nutrition claims • content claims • Comparative claims
Health claims Function claims Based on generally accepted scientific data
Based on newly developed scientific data
Reduction of disease risk claims + claims growth and development of children
National Institute for Public Health and the Environment
Article 13.1 Article 13.5 Article 14
EU Regulation 1924/2006 What it contains
Exemptions:
Nutrition claims • content claims • Comparative claims
National Institute for Public Health and the Environment
• nutrition claim referrring to the reduction of a nutrient • where a single nutrient exceeds the profile (add statement)
EU Regulation 1924/2006 what it does
Health Claims Function claims Based on generally accepted scientific data
National Institute for Public Health and the Environment
Based on newly developed scientific data
Reduction of disease risk claims
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 …. … 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.
National Institute for Public Health and the Environment
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
Total fat SAFA TFA Cholesterol Sodium Sugar Non-milk sugar Across the board
Disqual. ingredients
Qualifying ingredients
Vit C iron protein calcium fiber W-3 LC PUFA Fruits & veg’s
Fig 1a
Threshold
Energy Vit A
Food category
100 g/100 ml
folate
Testing / validation
100 kcal/kJ Scoring Reference amount
Total fat SAFA TFA Cholesterol Sodium Sugar Non-milk sugar Across the board
Disqual. ingredients
Qualifying ingredients
Vit C iron protein calcium fiber W-3 LC PUFA Fruits & veg’s
Fig 1b
Threshold
Energy Vit A
Food category
100 g/100 ml
folate
Testing / validation
100 kcal/kJ Scoring Reference amount
Total fat SAFA TFA Cholesterol Sodium Sugar Non-milk sugar Across the board
Disqual. ingredients
Qualifying ingredients
Threshold
Energy Vit A
Food category
100 g/100 ml
Vit C iron
Testing / validation
100 kcal/kJ Scoring Reference amount
protein calcium fiber W-3 LC PUFA Fruits & veg’s, nuts
Fig 2a
folate
http://www.food.gov.uk/
Total fat SAFA TFA Cholesterol Sodium Sugar Non-milk sugar Across the board
Disqual. ingredients
Qualifying ingredients
Threshold
Energy Vit A
Food category
100 g/100 ml
Vit C iron
Testing / validation
100 kcal/kJ Scoring Reference amount
protein calcium fiber W-3 LC PUFA Fruits & veg’s
Fig 2b
folate
http://www.cfsan.fda.gov/~dms/hclaims.html http://www.cfsan.fda.gov/~dms/flg-6c.html
Total fat SAFA TFA Cholesterol Sodium Sugar Non-milk sugar Across the board
Disqual. ingredients
Qualifying ingredients
Threshold
Energy Vit A
Food category
100 g/100 ml
Vit C iron
Testing / validation
100 kcal/kJ Scoring Reference amount
protein calcium fiber W-3 LC PUFA Fruits & veg’s
Fig 2c
folate
http://www.voedingscentrum.nl/NR/rdonlyres/0AF8 5A19-79B1-4DB5-A0E8C8BFFD44B089/0/Criteriaengelssite.pdf
Total fat SAFA TFA Cholesterol Sodium Sugar Non-milk sugar Across the board
Disqual. ingredients
Qualifying ingredients
Threshold
Energy Vit A
Food category
100 g/100 ml
Vit C iron
Testing / validation
100 kcal/kJ Scoring Reference amount
protein calcium fiber W-3 LC PUFA Fruits & veg’s
Fig 2d
folate
http://www.slv.se/templates/SLV_Page.aspx?id=1 2220&epslanguage=EN-GB
Total fat SAFA TFA Cholesterol Sodium Added sugar Non-milk sugar Across the board
Disqual. ingredients
Qualifying ingredients
Threshold
Energy Vit A
Food category
100 g/100 ml
Vit C iron
Testing / validation
100 kcal/kJ Scoring Reference amount
protein calcium fiber W-3 LC PUFA Fruits & veg’s
Fig 2e
folate
http://www.ikkiesbewust.nl
Total fat SAFA TFA Cholesterol Sodium Sugar Non-milk sugar Across the board
Disqual. ingredients
Qualifying ingredients
Threshold
Energy Vit A
Food category
100 g/100 ml
Vit C iron
Testing / validation
100 kcal/kJ Scoring Reference amount
protein calcium fiber W-3 LC PUFA Fruits & veg’s
Fig 2f
folate
http://www.ah.nl/gezondekeuze/
Total fat SAFA TFA
February 2008
Cholesterol Sodium Sugar Non-milk sugar
Across the board
Disqual. ingredients
Qualifying ingredients
Threshold
Energy
Testing / validation
100 kcal/kJ
Vit A Food category
100 g/100 ml
Scoring
Vit C
Reference amount
iron protein calcium fiber W-3 LC PUFA Fruits & veg’s folate
http://www.efsa.europa.eu/EFSA/efsa_locale-1178620753812_1178689506673.htm
Total fat SAFA TFA
November 2008
Cholesterol Sodium Sugar Non-milk sugar
Across the board
Disqual. ingredients
Qualifying ingredients
Threshold
Energy Vit A
Food category
100 g/100 ml
Vit C iron protein calcium fiber W-3 LC PUFA Fruits & veg’s folate
Testing / validation
100 kcal/kJ Scoring Reference amount
Source: EU Food Law 20 Feb 2009 National Institute for Public Health and the Environment
Source: EU Food Law 20 Feb 2009 National Institute for Public Health and the Environment
Menu 1. 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
EU Regulation 1924/2006 What it contains
Light
Nutrition claims In future? • content claims • Comparative claims
+ Vit C National Institute for Public Health and the Environment
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 - energy value is reduced by at least 30 %
• ENERGY-FREE - Max 4 kcal (17 kJ)/100 ml
National Institute for Public Health and the Environment
EU Regulation 1924/2006
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 • 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 National Institute for Public Health and the Environment
EU Regulation 1924/2006
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 - 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’. National Institute for Public Health and the Environment
EU Regulation 1924/2006
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 - 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
National Institute for Public Health and the Environment
EU Regulation 1924/2006
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 - Min 6 g of fibre per 100 g - Min 3 g of fibre per 100 kcal
National Institute for Public Health and the Environment
EU Regulation 1924/2006
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 Institute for Public Health and the Environment
EU Regulation 1924/2006
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
• CONTAINS [NUTRIENT OR OTHER SUBSTANCE] - See vitamins, minerals, etc. ; Article 5 of 1924/2006
National Institute for Public Health and the Environment
EU Regulation 1924/2006
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% - 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 National Institute for Public Health and the Environment
EU Regulation 1924/2006
Nutrition claims and conditions applying to them amending 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 • 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 National Institute for Public Health and the Environment
EU Regulation 1924/2006
Nutrition claims and conditions applying to them
• Additional nutrition claims per 2009 • "SOURCE OF OMEGA-3 FATTY ACIDS” • “HIGH OMEGA-3 FATTY ACIDS” • “HIGH MONO UNSATURATED FAT” • “HIGH POLY UNSATURATED FAT” • “HIGH UNSATURATED FAT”
National Institute for Public Health and the Environment
EU Regulation 1924/2006
Menu 1. 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 National Institute for Public Health and the Environment
EU Regulation 1924/2006 What it does
What it contains
Nutrition claims • content claims • Comparative claims
Health claims Function claims Based on generally accepted scientific data
Based on newly developed scientific data
Reduction of disease risk claims + claims growth and development of children
National Institute for Public Health and the Environment
Article 13.1 Article 13.5 Article 14
EU Regulation 1924/2006 What it does
Health claims Function claims Calcium
National Institute for Public Health and the Environment
Based on generally accepted scientific data
Based on newly developed scientific data
Reduction of disease risk claims + claims growth and development of children
Article 13.5 Article 14
EU Regulation 1924/2006: List of Article 14 claims
dossiers
• Industry send application to Member State
- total 281 • EFSA assessment and opinion • EC/MS: decide on authorisation of claims • Community list of article 14 claims National Institute for Public Health and the Environment
EFSA health claims evaluation status (30 October 2009) Claim type Children (Art. 14)
Received
Withdrawn
Adopted 45 opinions
In progress
213
23
Disease risk reduction (Art. 14)
47
3
14
4**
New science/ proprietary (Art. 13.5)
23
6
14
2***
283
32
73 covering 80
12
Total
covering 52 applications
applications
6*
* 2 in clock stop ** 2 in clock stop *** 0 in clock stop
63
21 August 2008: EFSA adopts first opinions on health claims made on foods relating to disease risk reduction and children’s health
National Institute for Public Health and the Environment
EFSA Opinions article 14 – August 2008 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 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
National Institute for Public Health and the Environment
EFSA verdicts on food claims send shockwaves through the industry
National Institute for Public Health and the Environment
EFSA health claim rejections 'shock' industry
National Institute for Public Health and the Environment
National Institute for Public Health and the Environment
Industry: “EFSA verdicts on food claims send shockwaves through the industry” Consumer organizations: “welcomes EFSA approach” Scientists: “generally support for EFSA opinions” National Institute for Public Health and the Environment
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 lowfat foods such as milk and yoghurt), in the target population, concerning the LDL-cholesterol lowering effect: consistent results, dose-response. Cause-effect relationship established No studies demonstrating that plant sterols reduce the risk of coronary heart disease.
EFSA: ÂŤ Plant sterols have been shown to lower/reduce blood cholesterol. Blood cholesterol may reduce the risk of coronary disease Âť. Should be consumed only by people who want to lower their blood cholesterol. Patients on cholesterol lowering medication should only consume the product under medical supervision.
Example: Regulat.pro.kid BRAIN Fermented vegetables/fruits with probiotics, lecithin and Rhodiola rosea exact Claimed effect: Contribute to mental and cognitive development Target: children 3-6 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
National Institute for Public Health and the Environment
October 2009: Regulations on articel 14/13.5 claims
•EU Regulation 983/2009: claims •EU Regulation 984/2009: claims
7 permitted claims; 14 rejected 2 rejected
•EU Regulation 1024/2009: 2 permitted claims; 14 rejected claims •EU Regulation 1025/2009: 2 rejected claims National Institute for Public Health and the Environment
Menu 1. 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 National Institute for Public Health and the Environment
EU Regulation 1924/2006 What it does
a) growth, development and the functions of the body b) psychological and behavioral functions c) claims related to slimming, bodyweight control
National Institute for Public Health and the Environment
Weight reduction
Health claims Function claims Based on generally accepted scientific data
Based on newly developed scientific data
Article 13 Calcium: good for bones
Article 13.1
EU Regulation 1924/2006: List of Article 13 claims
“Dossiers”
papers etc
•Member States send to EC lists by 31 Jan 2008
total ~ 44.000 • EC: Compilation > 4.000 • EFSA
Opinion
• EC to adopt list by 31 Jan 2010 National Institute for Public Health and the Environment
Claims received by category
Vitamins 5%
Minerals 5%
Macronutrients 9% Foods 8%
Botanicals 45%
Diets 1% Fibre 3% Other substances 16%
Probiotics 8%
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 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 78
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) • 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
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
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 ‘09 – approx. 2,000 under evaluation by EFSA – approx. 2,000 require further clarification by EC/MS (ongoing) – Updated EC consolidated list - EFSA to by end of 09 (taking into account missing/misplaced claims) – List of references – EFSA published in Sep 09 81
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 thoughout 2010 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
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 Cardiovascular Health Bone, dental health, connective tissue Weight management, satiety, physical performance Mental health, CNS, vision Miscellaneous Characterisation of Botanicals
National Institute for Public Health and the Environment
3 levels of evidence: • a cause and effect has been established • a cause and effect has not been established • Insufficient evidence for cause and effect ….
National Institute for Public Health and the Environment
• • • • • • • • • •
Calcium & bones Calcium, vitD & bones Fluoride & teeth Magnesium & energy, cell division, electrolyte Biotin, niacin & energy Selenium & antioxidant, immune, …. VitC & antioxidant Sugar-free chewing gum & teeth Betaglucans & cholesterol …… etc
National Institute for Public Health and the Environment
• Probiotics ≠ strengthen immune system • >100 probiotics insufficiently characterised • Botanicals ≠ characterised, poor data • Taurine ≠ energy, performance • Glucosamine, shark cartilage ≠ joint health • …… etc National Institute for Public Health and the Environment
National Institute for Public Health and the Environment
National Institute for Public Health and the Environment
Menu 1. 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 National Institute for Public Health and the Environment
Consumer understanding
consumer understanding not assessed by EFSA
However 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 93
Consumer understanding Significant scientific Moderate agreement
Nutrition claims
Function claims Reduction risk of disease claims
Low
Extremely low
Significant scientific Moderate agreement
Nutrition claims
Function claims Reduction risk of disease claims
Low
Extremely low
Little effect of claim strength level (more for personal relevance)
Netherlands: Van Kleef, van Trijp et al, 2005
Significant scientific Moderate agreement
Nutrition claims
Structure function claims
Low
Extremely low
Consumers do not clearly distinguish between: Nutrient content claims
Health claims
Structure function claims Health claims Australia: P. Williams, 2005
Significant scientific Moderate agreement
Low
Extremely low
Nutrition claims Little
Function claims
distinction between level A through D claims
Reduction risk of disease claims
USA: FDA 2005
EU Regulation 1924/2006: Consumer understanding
• Is mentioned in Regulation 1924/2006 • No requirements by EFSA in dossier (except examples of wording)
• EC/MS: enforcement on consumer understanding
National Institute for Public Health and the Environment
Menu 1. 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 National Institute for Public Health and the Environment
Health claims Health claims should be should be substantiated substantiated
scientists
consumers
authorities industry National Institute for Public Health and the Environment
EU Regulation 1924/2006 What it does
What it contains
Nutrition claims • content claims • Comparative claims
National Institute for Public Health and the Environment
Health claims Function claims Based on generally accepted scientific data
Based on newly developed scientific data
Reduction of disease risk claims + claims growth and development of children
Questions ?
National Institute for Public Health and the Environment
Š ============================================= Dr. Hans Verhagen Head, Centre for Nutrition and Health National Institute for Public Health and the Environment (RIVM) PO Box 1 3720 BA Bilthoven The Netherlands Tel +31 30 274 3391 Secretariat +31 30 274 3318 Fax +31 30 274 4466 Hans.Verhagen@rivm.nl http://www.rivm.nl/en/aboutrivm/organization/vgc/cvg/index.jsp ============================================
National Institute for Public Health and the Environment
Alternatieven voor claims 10 manieren om je product te positioneren zonder te claimen
Quirien Veldman – Syntens 12 november 2009
Claim: Een bewering over je product die je gebruikt om de beoogde klant te overtuigen
Overtuigen: 1) met wetenschappelijk onderbouwde claims 2) door aan te spreken op emotie
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 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.
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. 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.
Product - Ingrediënt - Functie Groenten Eieren Boter / vis Melk Yoghurt Actimel Olijfolie Volkorenbrood Streekbrood ….
Biologisch ScharrelOmega 3 Calcium Rechtsdraaiend melkzuur Bifidus ActiRegularis cultuur Onverzadigde vetten Vezels Van het land ….
Natuurlijk Diervriendelijk Verbetert geheugen Sterke botten Licht verteerbaar Stoelgang Hart en bloedvaten Darmwerking Lekkerder ….
Bijvoorbeeld: Actimel bevat de BAR cultuur, de BAR cultuur is goed voor de stoelgang, dus Actimel is goed voor de stoelgang.
Van functie naar ziektebeeld: niet toegestaan
Verbetert geheugen Sterke botten Licht verteerbaar Hart en bloedvaten
Tegen dementie Voorkomt artrose Geneest spastiche darm Voorkomt hart- en vaatziekten
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.
10 typen claims 1. 2. 3. 4. 5. 6. 7. 8. 9. 10.
Superioriteits-claim Gelijk aan de top-claim Zelfreferentie-claim Superioriteitsclaim met beperking Uniekheids-claim Intentie-claim Statistische claim Claim met open einde De Vraag Ondersteunde claim
Veldman’s Regenwormgehakt Regenwormgehakt – Proteïne - Spieropbouw
Veldman’s regenwormgehakt
1. Superioriteitsclaim 1. 2.
3. 4.
5. 6. 7. 8. 9. 10.
Het makkelijkst te onthouden en veruit het meest effectief. Als je superioriteit kunt claimen: doe het!
Superioriteitsclaim Gelijkheid aan de topclaim Zelfrefererende claim Superioriteitsclaim met beperking Uniekheids-claim Intentie-claim Statistische claim Claim met open einde De Vraag Ondersteunde claim
Formuleer in overtreffende trap: beste, snelste, grootste, gladste, makkelijkste, duurzaamste, goedkoopste, schoonste, hoogste… ●
Samsung, ‘s werelds kleinste printer
●
Durex, the best there is
Superioriteitsclaim Georgina is zo dom nog niet!
Veldman’s regenwormgehakt
BEVAT MEER PROTEÏNE DAN ALLE ANDERE LEVENSMIDDELEN
2. Gelijkheid aan de top-claim 1.
2.
3.
4.
5. 6. 7. 8.
9. 10.
Klinkt als superioriteit, maar is dat het echt? Zolang je aan kunt tonen dat geen ander superieur is kun je dit gebruiken.
Superioriteits-claim
Gelijkheid aan de toptop-claim Zelfrefererende claim Superioriteitsclaim met beperking Uniekheids-claim Intentie-claim Statistische claim Claim met open einde De Vraag Ondersteunde claim
●
Miele, er is geen betere
●
Er gaat niets boven Groningen
●
Geen dagcreme haalt meer rimpels weg
Gelijkheid aan de top-claim Bodybuilders kennen de kracht van regenwormgehakt
Veldman’s regenwormgehakt
NIETS BEVAT MEER PROTEÏNE
3. Zelfrefererende claim 1. 2.
3.
4.
5. 6. 7. 8.
9. 10.
Je claimt superioriteit, maar ten opzichte van je eigen producten.
Superioriteits-claim Gelijkheid aan de top-claim
Zelfrefererende claim Superioriteitsclaim met beperking Uniekheids-claim Intentie-claim Statistische claim Claim met open einde De Vraag Ondersteunde claim
●
Het beste stoomstrijkijzer, van Philips
●
Geen Ariel waspoeder verwijdert zoveel vlekken
●
●
Verbeterd! Absorbeert 20% meer vocht dan voorheen. Gilette’s beste scheerresultaat
Zelfrefererende claim Sonja Bakker eet het ook
VELDMAN’S EFFICIENTSTE GEHAKT OOIT
4. Superioriteitsclaim met beperking 1. 2.
3.
4.
5. 6. 7. 8. 9. 10.
Je claimt superioriteit maar bouwt een beperking in. Je beperkt je vergelijking tot een subcategorie van het concurrerende veld.
Superioriteits-claim Gelijkheid aan de topclaim Zelfrefererende claim
Superioriteitsclaim met beperking Uniekheids-claim Intentie-claim Statistische claim Claim met open einde De Vraag Ondersteunde claim
●
●
●
De beste waskracht van een vloeibaar wasmiddel Reedyk: de grootste hijskracht die door een deur kan Het beste scheerresultaat met 4 mesjes
Superioriteitsclaim met beperking Geen wonder dat ze lacht!
Veldman’s regenwormgehakt
HET MEESTE PROTEÏNE VAN ALLE WEEKDIERVLEESWAREN
5. Uniekheids-claim 1. 2.
3.
4.
5. 6. 7. 8.
9. 10.
Superioriteits-claim Gelijkheid aan de top-claim Zelfrefererende claim Superioriteitsclaim met beperking
UniekheidsUniekheids-claim Intentie-claim Statistische claim Claim met open einde De Vraag Ondersteunde claim
Als eerste of als enige creëer je een vergelijking 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?
Uniekheids-claim Ook je oma denkt weer aan vroeger
Veldman’s regenwormgehakt
GEHAKT ZOALS GEHAKT BEDOELD IS
6. Intentie-claim
5.
Superioriteits-claim Gelijkheid aan de top-claim Zelfrefererende claim Superioriteitsclaim met beperking Uniekheids-claim
6.
IntentieIntentie-claim
1. 2.
3.
4.
7. 8.
9. 10.
Statistische claim Claim met open einde De Vraag Ondersteunde claim
Ook al kun je van een eigenschap niet bewijzen 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
Intentie-claim Arnold zweert erbij
Veldman’s regenwormgehakt
ONTWIKKELD OM SPIEROPBOUW TE VERSNELLEN
7. Statistische claim
6.
Superioriteits-claim Gelijkheid aan de top-claim Zelfrefererende claim Superioriteitsclaim met beperking Uniekheids-claim Intentie-claim
7.
Statistische claim
1. 2.
3.
4.
5.
8.
9. 10.
Claim met open einde De Vraag Ondersteunde claim
Je product hoeft niet technisch beter te zijn, je 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
Statistische claim Paris is wel in voor een feestje
Veldman’s regenwormgehakt
WORDT AL OP 78% VAN ALLE FEESTJES GESERVEERD
8. Claim met open einde 1. 2.
3.
4.
5. 6. 7.
8.
9. 10.
Superioriteits-claim Gelijkheid aan de top-claim Zelfrefererende claim Superioriteitsclaim met beperking Uniekheids-claim Intentie-claim Statistische claim
Door een ‘vergrotende trap’ formulering te 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
Claim met open einde De Vraag Ondersteunde claim
●
Rizla 3x beter. Rolt beter, plakt beter, brandt beter.
Claim met open einde Tiesto pompt het volume op
Veldman’s regenwormgehakt
WERKTEN ALLE PROTEINEPRODUCTEN MAAR ZO….
9. De Vraag 1. 2.
3.
4.
5. 6. 7. 8.
Superioriteits-claim Gelijkheid aan de top-claim Zelfrefererende claim Superioriteitsclaim met beperking Uniekheids-claim Intentie-claim Statistische claim Claim met open einde
9.
De Vraag
10.
Ondersteunde claim
Een vraag suggereert dat jouw product het 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?
De Vraag Hoe Amy erbovenop komt in rehab
Veldman’s regenwormgehakt
WIE WIL ER NOU NIET AANSTERKEN?
10. De ondersteunde claim 1. 2.
3.
4.
5. 6. 7. 8.
9.
10.
Superioriteits-claim Gelijkheid aan de top-claim Zelfrefererende claim Superioriteitsclaim met beperking Uniekheids-claim Intentie-claim Statistische claim Claim met open einde De Vraag
Ondersteunde claim
Ondersteuning door een ‘kenner’ werkt goed om de geloofwaardigheid van je producten te versterken ●
Oral B. Poets als een tandarts.
●
Pedigree. Aanbevolen door topfokkers.
De ondersteunde claim Het gehakt van de toekomst!
Veldman’s regenwormgehakt
GETEST DOOR WETENSCHAPPERS
Samenvatting
• Kies je ingrediënt en functie • Bepaal wat je wilt claimen • Zoek een formulering die past
Proost! Veldman’s regenwormgehakt