LEGAL DO S & DON TS OF B2C COMMUNICATION IN THE FOOD SECTOR Food Valley Expo Wageningen, 13 October 2015 Karin Verzijden www.axonlawyers.com
Agenda Nutrition and Health Claims (Regulation 1924/2006) Medical claims (Directive 2001/83) Food Information to Consumers (Regulation 1169/2011) Quiz with practical examples 2
Introduction Axon Lawyers 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 market International network through European Alliance of Life Sciences Law Firms Reporting current food law developments at blog FoodHealthLegal 3
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 Distinction between: nutrition claim health claim 4
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? 5
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 physiological effect. Claimed nutrient is present in the end product that will produce the claimed effect. 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. 6
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 use. 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 provided by proteins. is 7
Legal framework health and nutrition claims (5) 3 types health claims: (1) general function claims (2) disease risk reduction claims (3) Claims related to children s development and health 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 heart disease. Ad (3) Iron contributes to normal cognitive development of children. 8
Legal framework health and nutrition claims (6) Pursuant to Regulation 1924/2006 ( Claims Regulation ), only the use of authorized claims is permitted. 16 May 2012: Commission publishes 222 authorized generic claims. Between 2006 and 2012: selection made from 44.000 claims sent in by the Member States and evaluated by EFSA. Many claims rejected, but a number are still in the pipeline, e.g. claims re. botanical substances (food or pharmaceutical?) 222-list is dynamic: 7 claims added since 2012. Currently 14 authorized DRR claims en 11 children s claims. 9
Legal framework health and nutrition claims (7) 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 Amongst final consumer: should a distinction be applied between regular consumer and professional? ECJ, Case C-19/15 d.d. 19 January 2015 Verband Sozialer Wettbewerb / Innova Vital Gmbh Publicity targeted at professionals allowed? 10
Medical claims (1) Medical claims: claims directed at the prevention or treatment of a disease è covered by Medicinal Products Directive and subsequent national legislation. Example: Dutch Act on Medicinal products distinguishes publicity aimed at general public / publicity aimed at professionals In as far as publicity aimed at general public is allowed è clear statement this relates to medicinal product. Use of medical claims for food product is not allowed. Distinction between medicinal product / food product not always clear è in cases of doubt legislation on medicinal products > any other legislation. Test applied: medicine by presentation / by function? 11
Medical claims (2) Dutch examples: consequences of using medical claims for food products District Court Rotterdam 23 January 2014: fine of 150K for unauthorized publicity re. medicinal product for which no marketing authorisation was granted (art. 84 Dutch Act on Medicinal Products) Fine related to communications around the product (website/handbook). Claims made: lowers cholesterol and beneficial for blood pressure. Pro-activ products considered medicinal products by presentation. 12
Medical claims (3) 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 also led the authorities to believe that product qualified as medicinal product by presentation. Criterion broadly interpreted for consumer protection. Learning: in the Netherlands DDR-claims that deviate from authorized wording quickly qualify as medical claims. 13
Medical claims (4) 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 14
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 legislation: Additional requirements re. list of ingredients and language requirements; Detailed requirements re. legibility; Nutrition declaration compulsory as of 13 December 2016. However, when health claims are used, nutrition declaration must also be applied. 15
Food information (2) Language requirements 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 of weight; 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. 16
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. 17
Food information (4) Legibility Where should mandatory food information be mentioned? Pre-packed food products: directly on the package or on the label attached thereto; 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 cm 2. 18
Food information (5) Nutrition declaration 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 è provided that portion is quantified and number of portions mentioned. Presentation: 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. 19
Quiz (1) Do these pictures contain nutrition and/or health claims? If so, what type of claims? 20
Quiz (2) Do you see a health or nutrition claim here? 21
Quiz (3) And how about this logo? 22
Quiz (4) Below are 2 claims applied for by 2 different companies. Which one was authorized you think? (1) Activated charcoal contributes to reducing excessive flatulence after eating (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 23
Quiz (5) Claim (2) was not authorized è evidence provided was not substantial enough to characterize the claimed effect. Claim (1) Activated charcoal contributes to reducing excessive flatulence after eating was authorized and the product belonging thereto are already marketed. Conditions of use Food must contain 1 g activated charcoal per quantified portion. 24
Quiz (6) 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. 25
Quiz (7) Claim # 1: helps to maintain a healthy blood flow and benefits circulation. Claim # 2 Helps maintain normal platelet aggregation, which contributes to a normal bloodflow. Claim # 3: Fruitflow as a natural alternative to Aspirin. NB Aspirine works as a anti-coagulation means; Fruitflow has comparable effect. Difference: chemical vs. natural source. Which one do you think was granted? 26
C Conclusie A Distinguish between mandatory and voluntary information in B2C communication re. food products; 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. 27