Selection of 222 authorized claims between 2006 – 2012 from 44.000 claims sent in by MS Many claims rejected but claims re. botanicals still pending > of interest for neutraceuticals NB List with general claims is dynamic: 7 claims added since 2012
Examples of other DRR-claims relate to vitamin D (reduces risk of falling > fallling is risk factor for bone fractures), plant stanol esters (lower blood cholesterol > risk factor for coranary heart diseases) and xylitol (reduces dental plaque > risk factor of development of caries in children).
the German company Innova Vital had promoted a Vitamin D3 product to medical doctors, stating that it would contribute to the prevention of diseases that are linked to a lack of Vitamin D, such as osteoporosis and diabetis mellitus. These are not authorized claims and the German consumer organization involved had argued that Innova therefore had violated the Claims Regulation10 . In defense, Innova had stated that the Claims Regulation only applies to final consumers, whereas health care professionals could not be considered as such.
Conclusion AG: the arguments of Innova Vital were rejected based on the text and the intention of the Claims Regulation. Firstly, the European legislator did not make a distinction in the addressee of any health claims (for instance consumers / (health care) professionals). Only the commercial character of the communication in which the health claims are used, has been clearly addressed. Secondly, one of the purposes of the Health Claim Regulation is to ensure a high level of consumer protection. Allowing the use of health claims in the context of communication with health care professionals could endanger this purpose, as it could result in targeting consumers via health care providers. In conclusion, the Advocate General states that the Health Claim Regulation is also applicable to claims with respect to food products that are to be delivered indirectly (that is: via health care providers) to the final consumer
Art. 1.2 Medicianal Products Directive Defintiie naar aandiening (by presentation) Definitie naar werking/toediening (by function) Art. 2.2. Medicinal Prouct Directive: in cases of doubt,where, taking into account all its characteristics, a product may fall within the definition of a ‘medicinal product’ and within the definition of a product covered by other Community legis lation the provisions of this Directive shall apply.
Pharmacological properties if only small quantity of API with no effect on fysiological functions > no medicinal product Starting point: use according to prescription. Not relevant if higher dosage produces relevant fysiological effect
Risks implied in the use Forms relevant factor in product qualification, but mere risk does not render product automatically a medicinal product “Safe upper limits” (art. 5.a Directive 2002/46) does not play decisive role in qualification
NB Presentation criterion broadly interpreted for protection of public health
Zie Rb. R’dam 14 maart 2014: http://uitspraken.rechtspraak.nl/inziendocument?id=ECLI:NL:RBROT:2014:1615
https://www.peptan.com/science/health-benefits/healthy-aging/ Claims back by research on beneficial effects on bone health / muscle mass / joint function
Amongst the Foods for Special Groups can be disinguised (1) Foods for special medical purposes, (2) foods for infants and young children and (3) total diet replacement. It is prohibited to make nutrition and health claims for FSMP’s > Art. 7 Regulation 2016/128
Ad # 1: Despite 8 different clinical trials, EFSA considered the evidence provided insufficient to substantiate this claim. Ad # 2: Claim was granted for water-soluble tomato concentrate Ad # 3: Aspirin works as a anti-coagulation means; Fruitflow has comparable effect. Difference: chemical vs. natural source
Vitafoods B2C communication in the funtional food
IN THE FUNCTIONAL FOOD
Geneva, 11 May 2016
• Nutrition and Health Claims (Regulation 1924/2006)
• Medical claims (Directive 2001/83)
• Food Information to Consumers
• Quiz with practical examples
• Amsterdam based law firm with international focus
• Fully dedicated to life sciences, familiar with food business
• Assisting high tech companies bringing innovative food products to the
• International network through European Alliance of Life Sciences Law
• Reporting current food law developments at blog FoodHealthLegal
Legal framework health and
nutrition claims (1)
Notion of “claim” is pretty broad:
• any message or representation
• which is not mandatory under EU or national legislation
• in any form (including text but also pictorial or symbolic messages)
• that states, suggests or implies that a food has particular characteristics
• nutrition claim
• health claim
Legal framework health and
nutrition claims (2)
Nutrition claim vs. health claim
• Nutrition claim: claim that states / implies that a food has particular
beneficial nutritional properties in terms of energy and / or nutrients
“What’s in the product?”
• Health claim: claim that states / implies there is a relationship between
food and health
“What does the product do?”
Legal framework health and
nutrition claims (3)
General conditions for use of nutrition and health claims
• Claimed nutrient has been shown to have a beneficial nutritional or
• Claimed nutrient is present in the end product that will produce the
• Claimed nutrient is present in a form that is available to be used by the
human body (“bio available”).
• The quantity of the product that can reasonably
be expected to be consumed provides a
significant quantity of the claimed nutrient.
Legal framework health and
nutrition claims (4)
• Nutrition claims are directed at particular nutritional effects: how much
energy does a foodstuff provide and / or which nutrients does it contain?
• Currently: 30 authorized nutrition claims, subject to specific conditions of
Claim: High fibre
Product contains at least 6 g of fibre/100 g or
at least 3 g of fibre/100 kcal.
Claim: Source of protein
At least 12% of the energy value of the food is
provided by proteins.
Legal framework health and
nutrition claims (5)
3 types health claims:
(1) general function claims (222+)
(2) disease risk reduction claims (14)
(3) Claims related to children’s development and health (11)
Ad (1) “Calcium contributes to the normal function of digestive enzymes.”
Ad (2) “Barley beta-glucans has been shown to lower/reduce blood
cholesterol. High cholesterol is a risk factor in the development of coronary
Ad (3) “Iron contributes to normal cognitive development of children.”
Legal framework health and
nutrition claims (6)
Scope Claims Regulation
Concerns use of nutrition and and health claims in all commercial
communication re. food products to be delivered to final consumer
• Labelling, presentation, advertising
• not applicable in exclusively scientific communication
• Final consumer: distinction between regular consumer and professional?
ECJ, Case C-19/15 dated 19 January 2015
Verband Sozialer Wettbewerb / Innova Vital Gmbh
Advocate General 16 February 2016:
No distinction between professional / regular consumer
Medical claims (1)
Medical claims: claims directed at the prevention or treatment of a disease
covered by Medicinal Products Directive (2001/83) and subsequent
• Use of medical claims for food product is not allowed.
• Distinction between medicinal product / food product not always clear
in cases of doubt legislation on medicinal products > any other
legislation. Test applied: medicine by presentation / by function?
• Examples: krill oil and magnesium based food supplements were
considered medicinal products by presentation.
• Sales perceived as marketing of medicinal product without required
market authorization > sanctioned by considerable fine.
Medical claims (2)
Food or pharmaceutical? Relevant factors according to EU case law:
(1) Characteristics of the product: form & composition (product and
packaging) and pharmacological properties
• If only small quantity of API with no effect on physiological functions > no
• Starting point: use according to prescription. Not relevant if higher
dosage produces relevant physiological effect
(2) Risks implied in the use
• Forms relevant factor in product qualification, but mere risk does not
render product automatically a medicinal product
• “Upper safe levels” (art. 5.a Directive 2002/46) does not play decisive
role in qualification
Medical claims (3)
Landmark case European Court of Justice: van Bennekom (227/82)
> Defines dividing line between medicinal products and food
• Large quantity of (multi) vitamin preparations traded by Dutch national
van Bennekom was seized > contrary to Medicinal Products Supply Act.
• Preparations in pharmaceutical form and highly concentrated.
• Van Bennekom did not meet registrations & authorization requirements.
• According to him, products were foodstuffs, not medicinal products.
• Concept of “presentation” broadly construed > consumer protection.
• No benchmark for vitamins to qualify as a medicinal product >
evaluation on case-by-case basis.
• Under certain circumstances, MS may stop imports of products at stake.
Medical claims (4)
District Court Rotterdam 14 March 2014: fine of > € 30K for marketing of
food supplements containing vitamin D, Krill oil and magnesium
• Information provided on the benefits of the supplements led the
authorities to believe that product qualified as medicinal product by
• Criterion broadly interpreted for protection of public health.
Learning: in the Netherlands DDR-claims that deviate from authorized
wording quickly qualify as medical claims.
Medical claims (5)
Medical claims: What are the possibilities re. health products?
• Grey area between medical claims / nutrition and health claims
• Useful tool Dutch self-regulatory body: Indicative List Health
Recommendation accessible by keyword and indication
• Similar initiatives in other EU Member States
Food information (1)
On 13 December 2014: Entry into force of Regulation 1169/2001 re. Food
Information to Consumers. New elements in comparison to previous
• Additional requirements re. list of ingredients and language
• Detailed requirements re. legibility;
• Nutrition declaration compulsory as of 13 December 2016. However,
when health claims are used, nutrition declaration must also be applied.
Also explicit prohibition that food information shall not attribute to any food
the property of preventing, treating or curing a human disease.
Food information (2)
• Mandatory information should be in a language that is easily understood
by the consumer of the MS where product is marketed.
• MS may stipulate that mandatory information is in one or more of the
official EU languages re. food products marketed in their territory.
List of ingredients
• Heading “ingredients” followed by list of ingredients in descending order
• Ingredients that may cause allergies/intolerances should be emphasised
through a specific type set;
• QUID when ingredient is contained in name of the product
or otherwise emphasized to characterize the product.
Food information (3)
List of ingredients in relation to pictures on product packaging
ECJ, case C-195/14, 4 June 2015
Verbraucherzentrale Bundesverband e.V. v Teekanne GmbH & Co. KG
• German Company Teekanne marketed a fruit tea called Felix raspberry
and vanilla adventure.
• Packaging contained pictures of raspberry and vanilla, but none of these
ingredients were specified in the list of ingredients.
• ECJ: even if list of ingredients is correct, it cannot be excluded that
consumer will be misled.
Food information (4)
Where should mandatory food information be mentioned?
• Pre-packed food products: directly on the package or on the label
• Non pre-packed food products: MS can take national measures re.
communication of materials causing allergens/intolerances.
How should the mandatory information be shaped?
• Easily visible and clearly legible;
• Minimum font size1.2 mm or 0.9 mm when packaging < 80 cm2.
Food information (5)
Energy value and nutrients:
• relate to the food as sold or after preparation, provided that sufficiently
clear instructions for preparation are provided;
• are expressed per 100 g or 100 ml;
• only in addition thereto expression per portion / consumption unit
provided that portion is quantified and number of portions mentioned.
• in tabular format (if space does not permit: in linear format);
• different forms of expression permitted when supported by wide range
of stake holders and not misleading for the consumer.
Do these pictures contain nutrition and/or health claims?
If so, what type of claims?
How do you assess this health claim: authorized / not authorized?
“Compound X is a bioactive protein supporting healthy aging”
What type of claims can be made for these types of products, if any?
” What health claim for FruitFlow?
• DSM was one of the first companies to obtain authorization for a 13.5
health claim re. positive effect van lycopene extracted from tomato's.
• Product Fruitflow is offered in powder and
in liquid format.
• Active dose: 3 g / 250 ml drink or
150 mg / daily dose or portion.
• Claim # 1: “helps to maintain a healthy blood flow and benefits
• Claim # 2 “Helps maintain normal platelet aggregation, which contributes
to a normal bloodflow”.
• Claim # 3: “Fruitflow as a natural alternative to Aspirin”.
Which one do you think was granted?
• Distinguish between mandatory and voluntary information in B2C
communication re. functional food & nutraceuticals; make sure that
mandatory information complies with applicable legal framework.
• When using voluntary information: expressions quickly qualify as a
nutrition or health claim. Know the rules!
• Only use authorized claims in B2C communication and avoid medical
claims in combination with food products.