conveying food innovations by health claims

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CONVEYING FOOD INNOVATIONS BY HEALTH CLAIMS HollandBio – Food Innovations 10 October 2014 Karin Verzijden en www.axonadvocaten.nl

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Conveying Food Innovations by Health Claims - presentation for HollandBio on 10 October 2014

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Page 1: Conveying food innovations by health claims

CONVEYING FOOD INNOVATIONSBY HEALTH CLAIMS

HollandBio – Food Innovations10 October 2014

Karin Verzijden en www.axonadvocaten.nl

Page 2: Conveying food innovations by health claims

Agenda

• Legal framework health and nutrition claims

• Conveying food innovations by claims in practice

• Quizzzz

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Page 3: Conveying food innovations by health claims

Legal framework nutrition and health claims (1)

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Notion of “claim” is pretty broad:

• any message or representation• which is not mandatory under Community or national legislation• in any form, including pictorial, graphic or symbolic representation• which states, suggests or implies that a food has particular

characteristics

Distinction between:

• nutrition claim• health claim

Page 4: Conveying food innovations by health claims

Legal framework nutrition and health claims (2)

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• Claim: any message stating that a food has particular characteristics

• Nutrition claim: any message stating that a food has particular nutritional properties

“What is in the product?”

• Health claim: any message stating that a relationship exists between the consumption of a food and health

“What does the product do?”

Page 5: Conveying food innovations by health claims

Legal framework nutrition and health claims (3)

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Both nutrition and health claims can only be used if:

• The presence of a nutrient in a food in respect of which the claim is made has shown to have a beneficial nutritional or physiological effect;

• The nutrient for which the claim is made is contained in the final product in a quantity that will produce the claimed effect;

• The nutrient covered by the claim is available to be used by the body;

• The quantity of the food that can be reasonably expected to be consumed provides a significant quantity of the nutrient to which the claim relates.

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Legal framework nutrition and health claims (4)

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• Nutrition claims are aimed at certain nutritional properties, in terms of the energy the food provides and the nutrients the food contains.

• Currently: 29 authorised nutritions claims, subject of specific conditions of use – for example:

Claim: High fiber Condition of use: product should contain at least 6 g of fibre per 100 gram or at least 3 g of fiber per 100 kcal.

Claim: Source of proteinCondition of use: at least 12 % of the energy value of the food is provided by protein

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Legal framework nutrition and health claims (5)

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3 types of health claims:

(1) General function claims(2) Disease risk reduction claims(3) Claims re. children’s health and development

ExamplesAd (1) “Carbohydrates contribute to the maintenance of normal brain function.”Ad (2) “Plant stanol esters have been shown to lower/reduce blood cholesterol. High cholesterol is a risk factor in the development of coronary heart diseases.”Ad (3) “Essential fatty acids are needed for normal growth and development of children.”

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Legal framework nutrition and health claims (6)

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• Claims can be used either from list of authorized claims or on the basis of individual authorization procedure.

• 16 May 2012: Commission publishes 222 authorized general function claims.

• Result of mass procedure ran between 2006 and 2012: 44.000 claims submitted by Member States and evaluated by EFSA.

• Many claims were rejected but some are still in the pipeline, e.g. botanical substances (food or pharmaceutical?)

• 222-list is dynamic: 7 claims were added since 2012. Furthermore: 9 authorized DRR claims and 11 authorized CHD claims

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Conveying food innovations by claims in practice (1)

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“Plant sterols have been shown to lower / reduce blood cholesterol. High cholesterol is a risk factor in the development of coronary heart disease”

Proprietary disease risk reduction claim applied for by Unilever and authorized by the Commission in 2010.

Main challenges for Unilever: (i) scientific substantiation and (ii) communication to conumsers

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Conveying food innovations by claims in practice (2)

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Scientific substantion of BECEL health claim

Evidence should demonstrate that:

• food (component) is sufficiently characterized• effect is beneficial for human health• a cause and effect relationship should be established based on human /

non-human data• quantity of the food and pattern of consumption could be reasonably

achieved as part of a balanced diet• study groups are representative of target population

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Conveying food innovations by claims in practice (3)

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Communication to consumers of BECEL health claim

• Claim should be worded in simple and clear non-technical language.• Claim should be understood by average consumer….• ….even if in certain situations a particular group is targeted.• In some countries, claims may be interpreted differently than in others.• Many countries (including NL) offer flexibility in wording….• … but each country enforces acceptable wording differently.

Keuringsraad KOAG/KAG Indicatieve lijst gezondheidsaanprijzingenDatabase ingrediënten + claims

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Conveying food innovations by claims in practice (4)

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“Helps maintain normal platelet aggregation, which contributes to a normal bloodflow”

• DSM product with first proprietary (13.5) health claim re. positive effect of lycopene extracted from tomatos.

• Product comes in liquid form and in powder format.

• Active dose: 3 g / 250 ml drink or 150 mg / daily dose or portion

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Conveying food innovations by claims in practice (5)

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• Initial suggested wording of claim: “helps to maintain a healthy blood flow and benefits circulation”.

• However, EFSA considered this claim was not reflect scientific evidence.

• In total, DSM conducted 8 different clinical trials to establish the required cause and effect relationship.

• Despite positive effects established (and claim granted) this is just the beginning. Explaining health claims requires communication to

• health care professionals media• consumers media, advertising, websites, phone, product

packaging…..

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Conveying food innovations by claims in practice (6)

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• Recently the Kenniscentrum Plantenstoffen initiated an investigation on the use of nutrition claims in the horticultural sector.

• Rationale: companies in horticultural sector focus their marketing more and more at their end users: you and me!

• Twofold interest: claims offer opportunity to provide detailed information about nutrients contained in product. Also: use of nutrition claim can offer incentive for product improvement.

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Conveying food innovations by claims in practice (7)

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Results of investigation by Kenniscentrum Plantenstoffen:

• List of selected nutrition claims (13/29) + conditions of use + selection of crops for which they could be used.

• List of permitted vitamins and minerals

e.g. “high on vitamin A” + selection of crops for which they could be used (per 100 g /p per portion).

• For summary of this project see http://foodhealthlegal.com/?p=528

Page 16: Conveying food innovations by health claims

Quiz (1)

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Do these pictures contain any nutrition / health claims?If so, what type of claims?

Page 17: Conveying food innovations by health claims

Quiz (2)

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Is this a nutrion / health claim and if so, what type?

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Quiz (3) What type of claims are these?

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“Help Replenish Bifido Lost with Age” “Restores natural balance of good bacteria in digestive tract”

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Quiz (4)

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Claim: “Activated charcoal contributes to reducing excessive flatulence after eating”

Is this an existing claim or a fancy one?

Page 20: Conveying food innovations by health claims

Quiz (5)

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Actually, this is a real one! And there are also products targeting this inconvenience….

Claim: “Activated charcoal contributes to reducing excessive flatulence after eating”Condition of use: food should contain 1 g of activated charcoal per quantifed portion.

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Quiz (6)

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What type of claims could you imagine for food supplements?

What ingredients do you think those claims would be linked to?

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Quiz (7)

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See here some examples for food supplements

Claim: creatine increases physical performance in successive bursts of short-term, high intensity exercise.Condition of use: mention that beneficial effect is obtained with a daily intake of 3 g creatine

Claim: protein contributes to a growth in muscle massCondition of use: At least 12 % of the energy value of the food is provided by protein

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Quiz (8)

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Do you think the claim “high in Vitamin C” would be allowed for peppers?

Would it be of any use to boost the pepper sales?

Would any additional info be desirable, e.g. InfoProvided by Voedingscentrum – see below.

“Vitamine C heeft een antioxidantfunctie en beschermt daardoor de lichaamcellen tegen oxidatieve schade. Oxidatieve schade ontstaat als gevolg van blootstelling aan vrije radicalen. Vitamine C is onder meer nodig voor de vorming van bindweefsel, de opname van ijzer en het in stand houden van de weerstand.”

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Quiz (8)

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Do you think this claim would be allowed in NL / EU?

“Fruitflow as a natural alternative to Aspirin”

Background info: aspirin is advocated to operate as an anti-coagulant.It could be argued that Fruitflow has a similar effect. Its source is however not a chemical, but a natural one.

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Quiz (9)

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Which one of these two claims have been authorized?

(1) “Chewing gum sweetened with 100% xylitol has been shown to reduce dental plaque. High content/level of dental plaque is a risk factor in the development of caries in children.”

(2) “Fermented milk containing the probiotic Lactobacillus casei DN-114 001 and yoghurt symbiosis decreases presence of Clostridium difficile toxins in the gut (of susceptible ageing people). Presence of Clostridium difficile toxins is associated with the incidence of acute diarrhoea”

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Quiz (10)

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Authorized claim (1)

“Chewing gum sweetened with 100% xylitol has been shown to reduce dental plaque. High content/level of dental plaque is a risk factor in the development of caries in children.”

Condition of useInformation to the consumer that the beneficial effect is obtained with a consumption of 2-3g of chewing gum sweetened with 100% xylitol at least 3 times per day after the meals

Claim (2) not authorized because evidence provided was insufficient to characterize claimed effect.

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AThank you

Karin [email protected]

Axon Advocatenwww.axonlawyers.com / www.axonadvocaten.nl