MEETING STANDARDS

FOR

COGNITIVE CLAIMS

Food Matters Live London, 22 November 2017

Karin Verzijden www.axonlawyers.com

Introduction Axon Lawyers

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• Amsterdam based law firm with international focus

• Fully dedicated to life sciences, well acquainted with food business

• Assisting high tech companies marketing innovative food products

• International network: EU Alliance of Life Sciences Law Firms

• Reporting current food law developments at blog FoodHealthLegal

Agenda

Meeting standards for cognitive claims

1. General framework applicable to health claims

2. Cognitive claims + conditions of use

3. Examples from practice

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General framework health claims (1)

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Food Information to Consumers (FIC) Regulation (1169/2011)

General framework for for food information embodying principle of “fair

information practices” > food information should:

• not be misleading, as to the characteristics of the food or by attributing

to the food effects it does not possess;

• be accurate, clear and easy to understand for the consumer;

• not make a medical allusion by attributing to any food the property of

preventing, treating or curing a human disease.

General framework health claims (2)

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Claims Regulation (1924/2006) introduces concept of health claim

• Any message or representation,

• which is not mandatory under EU or national legislation,

• in any form (both text and images),

• that states, suggest or implies that food has particular characteristics.

In sum: claim stating that there is a relation between food and health

“What does the product do?”

General framework health claims (3)

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Claims Regulation distinguishes 3 types of claims

• general function claims (229)

“Iodine contributes to normal cognitive function”

• disease risk reduction claims (14)

“Plant stanol esters have been shown to lower/reduce blood cholesterol.

High cholesterol is a risk factor in the development of coronary heart

disease.”

• claims related to children’s health and development (12)

“Iron contributes to normal cognitive development of children”

General framework health claims (4)

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Scope of Claims Regulation

Concerns the use of health claims in all commercial communications re.

food products to be delivered to the final consumer.

• labelling, presentation, advertising

• not applicable in exclusively scientific communications

• final consumer: also includes professional?

ECJ 14 July 2016, case C-19/15

Verband Sozialer Wettbewerb / Innova Vital GmbH:

No distinction should be made between health professional

and final consumer

General framework health claims (5)

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Avoid the use of medical claims for food products

• Medical claim: any claim targeted at the prevention or treatment of a

disease / communications claiming that product X improved health

problem Y.

• In the field of functional foods > distinction between food products and

medicinal products is not always clear. Test applied: medicine by

function or by presentation?

• Use of medical claims for food products is strictly prohibited.

General framework health claims (6)

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Health claims can only be made with regard to a particular nutrient that

• has been shown to have a beneficial nutritional or physiological effect;

• is present in the end product that will produce the claimed effect;

• is present in a form that is available to the human body to be used (“bio

available”).

The quantity of the product that can reasonably be expected to be

consumed provides provides a significant quantity of the claimed nutrient.

What nutrients are specifically linked to cognition?

Legal framework cognitive claims (1)

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Authorized claims for cognitive function

Iodine

• contributes to normal cognitive function

• contributes to normal functioning of the nervous system

Iron

• contributes to normal cognitive function

• contributes to normal cognitive development of children

Zinc

• contributes to normal cognitive function

Water

• contributes to the maintenance of normal physical and cognitive

functions

Legal framework cognitive claims (2)

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Conditions of use for cognitive claims

• Are calculated on the basis of the Reference Intakes (RI) applicable to

each vitamin and mineral.

• Should contain at least “a significant amount” of ingredient at stake.

• Distinction is being made between food and beverages:

Significant amount for food: 15 % RI / 100 g

Significant amount for beverages: 7,5 % RI / 100 ml

Legal framework cognitive claims

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Legal framework cognitive claims (4)

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Conditions of use for claim “contributes to normal cognitive function”

and variants

Iodine 22,5 ug / 100 g or 11.25 g / 100 ml

Iron 2.1 mg / 100 g or 1.05 mg / 100 ml

Zinc 1.5 mg / 100 g or 0,75 mg / 100 ml

Water In order to obtain the claimed effect, at least 2,0 L of water should

be consumed per day. The claim may be used only on water

complying with the Drinking Water Directives.

NB Claim should refer to food ready for consumption in accordance with

manufacturer’s instructions.

Examples from practice (1)

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Food supplement marketed by

Canadiann Canadian company Flora Health,

claiming:

“Helps to enhance cognitive function

and o and memory in an aging population”

“Extract manufactured at world-class

European facilities in Italy”

“Clinically supported with safety,

toxicity and efficacy data”

Examples from practice (2)

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Food supplement offered by US company

Bio Fusion consisting of “unique

blend of natural ingredients” (vitamins,

minerals, green tea extract).

“Improves mind focus and concentration

instantly”

“Promotes cognitive health”

Examples from practice (3)

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“Combination of 2 Sage species, specifically

developed for people wishing to improve

their cognitive faculties”

5 clinical studies re. Spanish sage and

Garden Sage proving positive effects

on memory and cognitive performance

Marketed by French company Nexira

Examples from practice (4)

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“Neuravena is a green oat

extract sourced from Avena

Sativa L known for its positive

effect on cognitive markers”

“Five clinical studies confirm

Neuravena benefits to cognitive

function”.

Manufacturer: Frutarom Health

with offices in both US and EU

Examples from practice (5)

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In a non-commercial, purely scientific environment, the Claims Regulation

is not applicable.

In such an environment, other scientific results for the cognition function

than those linked to iron, zinc and iodine can be communicated.

Examples from practice (6)

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Variations on authorized wording on a country-by-country basis

Zinc: contributes to a regular problem solving ability / contributes to regular

memory

Iodine: contributes to the maintenance of cognitive functions / plays an

important role in mental activity

Iron: contributes to regular intelligence / Iron keeps your mind clear

C Conclusion

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• Currently, only six cognition claims related to iron, zinc, iodine and water

have been authorized in the EU. Strict conditions of use are applicable.

• Slight variations on authorized wording permitted provided that essence

of claim is maintained.

• In purely scientific communications the Claims Regulation is not

applicable. In such context scientific results on cognition relating to other

ingredients can be communicated.

karin.verzijden@axonlawyers.com