Bijeenkomst 12 november Leergang Functional Food

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s.nl www.syntens Powered by: www.agrofood-community.nl Workshop Workshop 2 2 12 november 12 november 2009 2009

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Bijeenkomst 12 november

Transcript of Bijeenkomst 12 november Leergang Functional Food

Page 1: Bijeenkomst 12 november Leergang Functional Food

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Powered by: www.agrofood-community.nl

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

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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?

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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

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- 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

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- Presentation- Advertising - Brand names- Trademarks

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General principles EU Regulation 1924/2006

- Claims ≠ false, misleading

- Claims ≠ prevent, treat or cure disease

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- 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?

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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

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Ingredients:

--------

--------

--------

True claim -wrong message

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Nutrient Profiling:

“Categorization of foods

for specific purposes

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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

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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

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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 ….

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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

Sou

rce:

EU

Foo

d La

w 2

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Feb

2009

National Institutefor Public Healthand the Environment

Sou

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EU

Foo

d La

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Page 47: Bijeenkomst 12 november Leergang Functional Food

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

Page 48: Bijeenkomst 12 november Leergang Functional Food

Nutritionclaims

What it contains

EU Regulation 1924/2006

Light

National Institutefor Public Healthand the Environment

claims

• content claims• Comparative claims

+ Vit C

In future?

Page 49: Bijeenkomst 12 november Leergang Functional Food

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

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• 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

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- ‘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

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• 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

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• 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

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• 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

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- 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

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- 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%

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- 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

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• 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”

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• “HIGH OMEGA -3 FATTY ACIDS”

• “HIGH MONO UNSATURATED FAT”

• “HIGH POLY UNSATURATED FAT”

• “HIGH UNSATURATED FAT”

EU Regulation 1924/2006

Page 59: Bijeenkomst 12 november Leergang Functional Food

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

Page 60: Bijeenkomst 12 november Leergang Functional Food

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

Page 61: Bijeenkomst 12 november Leergang Functional Food

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

Page 63: Bijeenkomst 12 november Leergang Functional Food

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

Page 65: Bijeenkomst 12 november Leergang Functional Food

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”

Page 70: Bijeenkomst 12 november Leergang Functional Food

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

Page 73: Bijeenkomst 12 november Leergang Functional Food

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

Page 74: Bijeenkomst 12 november Leergang Functional Food

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

Page 75: Bijeenkomst 12 november Leergang Functional Food

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

Page 76: Bijeenkomst 12 november Leergang Functional Food

•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

Page 77: Bijeenkomst 12 november Leergang Functional Food

Claims Claims receivedreceived byby categorycategory

Foods8%

Macronutrients9%

Minerals5%

Vitamins5%

Probiotics8%

Diets1%

Fibre3%

8%Botanicals45%

Other substances16%

Page 78: Bijeenkomst 12 november Leergang Functional Food

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

Page 79: Bijeenkomst 12 november Leergang Functional Food

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

Page 80: Bijeenkomst 12 november Leergang Functional Food

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

Page 81: Bijeenkomst 12 november Leergang Functional Food

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

Page 82: Bijeenkomst 12 november Leergang Functional Food

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

Page 83: Bijeenkomst 12 november Leergang Functional Food

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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Page 86: Bijeenkomst 12 november Leergang Functional Food

National Institutefor Public Healthand the Environment

Page 87: Bijeenkomst 12 november Leergang Functional Food

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 ….

Page 88: Bijeenkomst 12 november Leergang Functional Food

• 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

Page 89: Bijeenkomst 12 november Leergang Functional Food

• 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

Page 90: Bijeenkomst 12 november Leergang Functional Food

National Institutefor Public Healthand the Environment

Page 91: Bijeenkomst 12 november Leergang Functional Food

National Institutefor Public Healthand the Environment

Page 92: Bijeenkomst 12 november Leergang Functional Food

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

Page 93: Bijeenkomst 12 november Leergang Functional Food

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

Page 94: Bijeenkomst 12 november Leergang Functional Food

Nutrition claims

Significant scientific agreement

Moderate LowExtremely

low

Consumer understanding

Function claims

Reduction risk of disease

claims

Page 95: Bijeenkomst 12 november Leergang Functional Food

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

Page 96: Bijeenkomst 12 november Leergang Functional Food

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

Page 97: Bijeenkomst 12 november Leergang Functional Food

�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

Page 98: Bijeenkomst 12 november Leergang Functional Food

• 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

Page 99: Bijeenkomst 12 november Leergang Functional Food

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

Page 100: Bijeenkomst 12 november Leergang Functional Food

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

Page 101: Bijeenkomst 12 november Leergang Functional Food

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

Page 102: Bijeenkomst 12 november Leergang Functional Food

Questions ?

National Institutefor Public Healthand the Environment

Page 103: Bijeenkomst 12 november Leergang Functional Food

©=============================================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============================================

Page 104: Bijeenkomst 12 november Leergang Functional Food

Alternatieven voor claims

10 manieren om je product te 10 manieren om je product te positioneren zonder te claimen

Quirien Veldman – Syntens12 november 2009

Page 105: Bijeenkomst 12 november Leergang Functional Food

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

Page 106: Bijeenkomst 12 november Leergang Functional Food

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.

Page 107: Bijeenkomst 12 november Leergang Functional Food

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.

Page 108: Bijeenkomst 12 november Leergang Functional Food

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.

Page 109: Bijeenkomst 12 november Leergang Functional Food

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

Page 110: Bijeenkomst 12 november Leergang Functional Food

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.

Page 111: Bijeenkomst 12 november Leergang Functional Food

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

Page 112: Bijeenkomst 12 november Leergang Functional Food

Veldman’s Regenwormgehakt

Regenwormgehakt – Proteïne - Spieropbouw

Veldman’s regenwormgehakt

Page 113: Bijeenkomst 12 november Leergang Functional Food

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

Page 114: Bijeenkomst 12 november Leergang Functional Food

Superioriteitsclaim

Georgina is zo dom nog niet!

BEVAT MEER PROTEÏNE

DAN ALLE ANDERE

LEVENSMIDDELEN

Veldman’s regenwormgehakt

Page 115: Bijeenkomst 12 november Leergang Functional Food

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

Page 116: Bijeenkomst 12 november Leergang Functional Food

Gelijkheid aan de top-claimBodybuilders kennen de kracht van regenwormgehakt

NIETS BEVAT MEER

PROTEÏNE

Veldman’s regenwormgehakt

Page 117: Bijeenkomst 12 november Leergang Functional Food

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

Page 118: Bijeenkomst 12 november Leergang Functional Food

Zelfrefererende claimSonja Bakker eet het ook

VELDMAN’S

EFFICIENTSTE GEHAKT

OOIT

Page 119: Bijeenkomst 12 november Leergang Functional Food

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

Page 120: Bijeenkomst 12 november Leergang Functional Food

Geen wonder dat ze lacht!

Superioriteitsclaim met beperking

HET MEESTE PROTEÏNE

VAN ALLE WEEKDIER-

VLEESWAREN

Veldman’s regenwormgehakt

Page 121: Bijeenkomst 12 november Leergang Functional Food

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

Page 122: Bijeenkomst 12 november Leergang Functional Food

Ook je oma denkt weer aan vroeger

Uniekheids-claim

GEHAKT ZOALS GEHAKT

BEDOELD IS

Veldman’s regenwormgehakt

Page 123: Bijeenkomst 12 november Leergang Functional Food

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

Page 124: Bijeenkomst 12 november Leergang Functional Food

Intentie-claimArnold zweert erbij

ONTWIKKELD OM

SPIEROPBOUW TE

VERSNELLEN

Veldman’s regenwormgehakt

Page 125: Bijeenkomst 12 november Leergang Functional Food

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

Page 126: Bijeenkomst 12 november Leergang Functional Food

Statistische claim

Paris is wel in voor een feestje

WORDT AL OP 78% VAN

ALLE FEESTJES

GESERVEERD

Veldman’s regenwormgehakt

Page 127: Bijeenkomst 12 november Leergang Functional Food

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

Page 128: Bijeenkomst 12 november Leergang Functional Food

Claim met open einde

Tiesto pompt het volume op

WERKTEN ALLE

PROTEINEPRODUCTEN

MAAR ZO….

Veldman’s regenwormgehakt

Page 129: Bijeenkomst 12 november Leergang Functional Food

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

Page 130: Bijeenkomst 12 november Leergang Functional Food

Hoe Amy erbovenop komt in rehab

De Vraag

WIE WIL ER NOU NIET

AANSTERKEN?

Veldman’s regenwormgehakt

Page 131: Bijeenkomst 12 november Leergang Functional Food

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

Page 132: Bijeenkomst 12 november Leergang Functional Food

De ondersteunde claim

Het gehakt van de toekomst!

GETEST DOOR

WETENSCHAPPERS

Veldman’s regenwormgehakt

Page 133: Bijeenkomst 12 november Leergang Functional Food

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!