‘The Great Illusion’ is the term that best describes the collapse of the European regime for nutrition and health claims regarding food. After the EC’s tightening up (1) of the criteria for the evaluation of the scientific validity of health claims relating to food, it now risks falling under the axe of the EU Court of Justice. In case C-19/15, the Advocate General is reconsidering the scope of application of the regulation (EC) No. 1924/2006, extending it to include information addressed to professionals. On what basis, and with what outcome?
‘The Great Illusion’, regulation (EC) No. 1924/06
The European nutrition and health claims regulation – published in the Official Gazette after 5 years in the making – had finally made it possible to inform consumers about the recognised nutritional and health benefits of food and drink, their various categories, and the substances they contain, but only under specific conditions, in order to guarantee the practical relevance of the aforementioned nutrition claims and the “generally accepted” scientific validity of the health claims.
With a heated debate between Rome and Brussels, the interpretative stringency of both the Commission and the European Food Safety Authority (EFSA) kicked into touch not only the extensive list of health information proposed by the member states, but even the more restricted list devised by international experts, who had selected the health claims on the basis of criteria already in use in other parts of the world (eg the USA, Japan), criteria previously revised as part of a dedicated European research project (2).
The excessively onerous conditions for obtaining authorisation for new health claims forced not only SMEs to desist, but also large industrial groups, causing the collapse of funding for public and private research on functional foods, and, more generally, of the connection between the consumption of certain foods – including traditional ones – and health.
The current regime only allows the use of nutritional information provided on the definitive list in the Appendix of regulation (EC) 1924/2006, and the appendix to regulation (UE) 432/2012 and its subsequent modifications, which contains the list of the only health claims permitted. In contrast to the previous chaos of conflicting rules of the various member states, often too lenient or unregulated, there is now extreme stringency which effectively prevents information concerning the values of certain foods from reaching the consumer, each with their own needs. And excluding any news based on several levels of scientific evidence (3).
As a consequence of this restriction, European Research and Development companies have had to entrust their economic survival to two commercial channels:
– a legal classification of the products as food supplements, under certain conditions and following the appropriate procedures. The Health Minister can authorise references to specific nutritional and physiological functions (4) beyond the strict European framework on nutrition and health claims, regarding certain substances and within certain limits (conditions of use, standardisation of active ingredients, maximum daily dose etc).
– commercial information aimed at professionals and not intended for the final consumer. Business to business promotion and advertising, directed for example to mass retail buyers, health stores and over-the-counter drugstores, sports centres and health farms, medical staff, nutritionists etc.
Indeed, the scope of application of the claims regulation is in fact limited to information directed to the final consumer: “This Regulation shall apply to nutrition and health claims made in commercial communications, whether in the labelling, presentation or advertising of foods to be delivered as such to the final consumer.
This Regulation shall also apply in respect of foods intended for supply to restaurants, hospitals, schools, canteens and similar mass caterers.” (5)
Vitamin D for discord
In November 2013 Innova Vital GmbH, a German producer of food supplements, distributed a letter to doctors advertising the alleged ability of one of its vitamin D3 based products (Innova Mulsin ® Vitamin D3) to reduce the risk of various diseases:
“The situation is clear: 87% of children in Germany have a vitamin D blood level of less than 30 ng/ml. According to the German Society for Nutrition [Deutsche Gesellschaft für Ernährung], the ideal level should be between 50 and 75 ng/ml. As has been shown in numerous studies, vitamin D plays a considerable part in the prevention of various diseases such as atopic dermatitis, osteoporosis, diabetes mellitus and MS [multiple sclerosis]. According to these studies, low levels of vitamin D in childhood could cause these diseases to appear later on in life.”
The trade association Verband Sozialer Wettbewerb immediately sued the company in the Bavarian regional court for unfair competition, claiming that the advertising violated the letter and spirit of the law of regulation EC 1924/06 concerning nutrition and claims. And the judges in Munich did not hesitate to refer the question to the European Union Court of Justice, with a preliminary ruling, asserting themselves that the legislation did not explicitly exclude indirect commercial communication from its scope of application, such as those aimed at medical professionals.
Making a hash of it. From Munich to Luxembourg: “Must Article 1(2) of Regulation (EC) No 1924/2006 be interpreted as meaning that the provisions of that regulation apply also to nutrition and health claims made in commercial communications in advertisements for foods to be delivered as such to the final consumer if the commercial communication or advertisement is addressed exclusively to the professional sector?” On close inspection, the literal and logical interpretation of the regulation leaves no room for doubt: it refers to information intended for, quite simply, the end user, the ordinary consumer (6). The German question should therefore have been resolved through other legal channels, rather than allowing the situation to precipitate.
The Court blunder, from EU law to the Bavarian suit
It is worth remembering that the European Union Court of Justice “shall have jurisdiction to give preliminary rulings concerning: (a) the interpretation of the Treaties; (b) the validity and interpretation of acts of the institutions, bodies, offices or agencies of the Union.
Where such a question is raised before any court or tribunal of a Member State, that court or tribunal may, if it considers that a decision on the question is necessary to enable it to give judgement, request the Court to give a ruling thereon.” (7)
The Court is the only institution – beyond European legislation – able to offer an official interpretation on common law, and must strictly comply with it. But in this Brexit-fever Europe where each is trying to make space for himself, even the Court’s Advocate General (8) has strayed somewhat.
In case C-19/15 the Luxembourg legal expert seems to identify with the Munich magistrates, entering into the ongoing battle between drug and supplement manufacturers in order to find a practical, common sense solution. It took the heat off the local judges without putting competing manufacturers or medical professionals in a difficult position, but in doing so has distorted the application of a regulation that is crucial for the continent’s leading manufacturing sector.
In the EU Court’s Advocate General‘s conclusions, it was stressed that it is not possible to attribute the ability to prevent and cure diseases to foods, but merely the reduction of the factors contributing to disease, and therefore the claims made by Innova Vital GmbH are illegitimate. And no-one could have disagreed, given the evident conflict both with the general regulation concerning information about food aimed at the consumer (10) and with that concerning nutrition and health claims.
Secondly, it was decided that it was not possible to exclude commercial communications from the application of Regulation (EC) No. 1924/06 in that it refers to the product itself, and not to the type of recipient.
“It is therefore the product itself which is necessarily destined for the consumer, and not the communication of which it is the subject”, stated the Advocate General. The concise definition of the scope of application of the claims regulation ends up being broadly and creatively interpreted (11) to the point that it implies that all commercial communications are to be included – i.e. those “with economic ends” – regardless of the type of recipient.
Risks and outlook
If the Court decides to follow the interpretation proposed by the Advocate General (12), it will throw into disarray commercial practices that have been built up over the years with the backing of the administrative institutions. B2B information actually operated on two levels in the sector:
– indications authorised under regulation EC 1924/06 and amendments, to be used on product labels and to be distributed to consumers via promotional material, websites, and social networks
– information and brochures intended only for professionals, a more thorough and complete communication for better understanding and differentiation of single references, evidence for the qualities of each SKU, sharing of research and development and new products. In line with the needs of professionals, medical and otherwise, to have access to the latest news and keep up to date with issues relevant to their field.
This second level of information is essential to those businesses investing in R&D and who have no other means of communicating their values and investments.
While still hoping that the Court of Justice will disregard the conclusions of its legal expert, we must prepare to face the worst-case scenario, since its decisions concerning the application of the regulation will take immediate and mandatory effect in the member states’ law. The legislator should therefore intervene immediately and clarify what, up until now, had been considered self-evident.
In the meantime on a practical level, our team at FARE – Food & Agricultural Requirements has devised a contingency plan for its clients.
(1) Note that reg. EC 353/08 introduced evaluation criteria for claims about food that were much more stringent than those for medication – exceptionally so for those set out for traditional medicines of plant origin under Directive 2004/24/EC – going so far as to demand double-blind placebo-controlled clinical trials on healthy individuals, published in respected scientific journals. That is, fiendish requirements the burden of which has caused the collapse of research into probiotics and functional foods in Europe.
-> Video “Innovating Food Innovating the Law – Part 6 – Dario Dongo” https://vimeo.com/31033738
(2) There were 44,000 claims proposed by Health Ministers from the various member states, 3000 selected by experts in the sector, and 222 those approved for Reg (UE) 432/2012 (95% of which concerned only micronutrients, vitamins and minerals)
(3) The good example of the USA has been to no avail, where news based on experience and ongoing research is allowed, for the express purpose of promoting nutritional education and improving public health, albeit with a disclaimer to clarify that this information is not “set in stone”. Cf http://www.fda.gov/Food/GuidanceRegulation/GuidanceDocumentsRegulatoryInformation/LabelingNutrition/ucm064908.htm
(4) Cf Directive 2002/46/EC concerning food supplements, Ministerial Decree 9.7.2012 (as modified by Ministerial Decree 27.2.14) – “Regulations concerning the use of herbal substances and preparations in food supplements”, Decree 31.7.07, “Commission Directive 2006/37/EC amending Annex II to Directive 2002/46/EC of the European Parliament and of the Council as regards the inclusion of certain substances”, Decree 27.3.14, Annex 1- “Plants and herbal extracts”
(5) Reg. (EC) No. 1924/06, article 1, paragraph 2
(6) In line with general regulations concerning consumer information about food products (reg. EU no. 1169/11, where the extensions are clearly defined) and with the same directive about unfair commercial practices, Dir. 2005/29/EC
(7) TFUE, art. 267
(8) The Advocate General’s institutional role is to closely analyse the legal aspects of the dispute and impartially propose an answer to the court that is deemed appropriate to the issue presented
(10) Reg. (EU) no. 1169/11, as in Dir. 2000/13/EC and previously Dir. 1979/112/EEC
(11) a “teleological” interpretation, as acknowledged by the author (conclusions, point 35)
(12) Hence, the Advocate’s ruling proposed to the Court: “Article 1, paragraph 2 of European Parliament and Council regulation (EC) no. 1924/2006 of December 20th 2006, concerning nutrition and health claims made on foodstuffs, must be interpreted as meaning that the provisions of this regulation shall apply to nutrition and health claims on foodstuffs supplied as such to the end consumer, made in commercial communications, where such communications are addressed exclusively to professionals but have the ultimate aim of reaching, indirectly through the latter, the consumer.”