- Posted by: Marta
- Categories: Insights, News
'The Great Illusion' is the epithet that best describes the collapse of the European regime nutrition & health claims related to food. After the tightening of the screw by the European Commission (1) on the criteria for assessing the scientific substantiation of health claims relating to foods, the EU Court of Justice is in danger of falling. The Advocate General, in case C-19/15, in fact, has come to deny the field of application of Regulation (EC) no. 1924/2006, citing its extension to information addressed to professional operators. On what basis, and towards what horizons?
Premise. 'The Great Illusion', Regulation (EC) no. 1924/06
The European regulation on nutrition & health claims - published in the Official Gazette after a gestation that lasted over 5 years - had finally introduced the possibility of communicating to consumers the recognized virtues, linked to nutrition and health, of food and beverages, their categories and substances contained therein. Upon the occurrence of precisely defined conditions, to ensure the concrete relevance of the so-called nutrition claims and the 'generally recognized' scientific validity of the so-called health claims.
The Commission's interpretative rigor and European Food Safety Authority (Efsa), in a lively table tennis of controversies between Rome and Brussels, had already put out not only the huge list of health claims proposed by the Member States, but also the short list drawn up by internationally renowned experts who had selected i claim on the basis of the criteria already adopted in other areas of the planet (eg USA, Japan), already revised as part of a specific European research project (2).
The severe conditions of access to the authorization procedures of new ones health claims had forced not only SMEs to desist, but also large industrial groups, thus causing the collapse of funding for public and private research on the so-called functional foods and, more generally, on the relationship between the consumption of certain foods - including traditional ones - and health.
The regime today only allows the use of indications nutritional requirementsThe exhaustive list of which in Annex of the reg. CE 1924/2006, the accompanying health claims to reg. EU 432/2012 and subsequent amendments, which contains note the positive list dethe only ones health claims admittedi. From the primordial chaos of disharmonious rules in the various Member States, sometimes too permissive or in any case lacking in controls, we have reached the absolute rigor which in fact denies consumers the possibility of receiving useful information to understand the values of some foods with respect to the needs of each one. . Excluding any news based on different levels of scientific evidence (3).
Outside the narrow funnel, European companies engaged in R&D (research and development) have therefore entrusted their economic survival to two different commercial channels:
- legal framework dand products like integratori alimentari, where the conditions are met and the appropriate procedures are followed. Il Ministry of Health can intrue authorize the reference to need features nutritive and physiological (4) outside the strict European context di nutrition & health claims, in relation to some substances efromntro determinatthe limits (method of use, standardization of active ingredients, maximum daily limitsi, ..);
- commercial information reserved for professional users, therefore not directed to the final consumer. Promotion epB2B advertising (business to business), addressed for example to the buyer of large-scale distribution, herbalists and para-pharmacies, sports, beauty centers and wellness, medical personnel, nutritionists, etc.
The field of application of the so-called regulation claims it is in fact limited to information directed to the final consumer"This Regulation applies to nutrition and health claims appearing in commercial communications, both on the labeling and in the presentation or advertising of food products supplied to the final consumer, including those marketed unpackaged or offered in bulk.
It also applies to food products intended for restaurants, hospitals, schools, canteens and similar community catering services."(5)
Vitamin D of Discord
A German manufacturer of food supplements, Innova Vital GmbH, in November 2013 sent a letter to a number of doctors promoting the alleged ability of its vitamin D3 product (Innova Mulsin® Vitamin D3) to reduce the risks of various diseases:
«You know the situation: 87% of children in Germany have a blood vitamin D level below 30 ng / ml. According to the German Nutrition Society [Deutsche Gesellschaft für Ernährung], this value should rather lie between 50 and 75 ng / ml. As already shown by numerous studies, vitamin D plays a significant role in the prevention of various diseases such as atopic dermatitis, osteoporosis, diabetes mellitus and MS [multiple sclerosis]. According to these studies, a too low level of vitamin D already in childhood contributes to causing the subsequent appearance of the aforementioned pathologies."
The trade association Verband Sozialer Wettbewerb immediately sued the aforementioned company for unfair competition, at the Bavarian regional court, alleging that this letter violated the dictates and the spirit of the EC regulation 1924/06 on nutrition & claims. And the judges of Monaco did not hesitate to refer the question to the Court of Justice of the European Union, with a preliminary reference, asserting in turn that the common legislation was not explicit in excluding indirect commercial communications from its scope of application, as indeed those addressed to medical personnel.
The Bavarian mess. From Monaco to Luxembourg, "The Court is called, for the first time, to determine whether the requirements of that regulation apply where nutrition and health claims relating to a food product supplied as such to consumers appear in commercial communications addressed not to consumers but to professionals only. .”The literal and logical interpretation of the regulation under examination leaves no room for doubt, it refers to information directed to the final user, the citizen consumer, full stop (6). The Bavarian question therefore had to be resolved with other legal instruments, but no, the affair has precipitated.
The Court's fall in style, from EU law to Bavarian merit
The Court of Justice of the European Union, it is worth remembering, "it has jurisdiction to give a preliminary ruling on: a) the interpretation of the treaties; b) the validity and interpretation of acts carried out by the institutions, bodies, offices or agencies of the Union.
When such a question is raised before a court of one of the Member States, that court may, if it deems it necessary to give its judgment a decision on this point, ask the Court to rule on the matter.. ” (7)
The Court is the only institution - beyond the European legislator - to be able to offer official interpretations on common law, and must strictly adhere to this. But in this feverish Europe where everyone is looking for new spaces, even the Advocate General (8) at the Court has digressed a bit.
In case C-19/15 the Luxembourg lawyer seems to have identified with the Munich magistrates, entering into the ongoing battle between the manufacturers of drugs and supplements to find a concrete and common sense solution. He has removed the chestnuts from the fire of the local judges without causing embarrassment between the competing producers and the medical profession, but in doing so he has effectively upset the application of a regulation that is strategic for the main manufacturing sector of the continent.
In his conclusions (9) to the EU Court, the Advocate General first of all he took care to clarify that it is not possible to attribute to foods the properties of prevention and treatment of diseases, but only, if anything, of reducing the risk factors of diseases, and therefore the claim experienced by Innova Vital GmbH are illegitimate. And no one would have ever thought otherwise, given the clear contrast both with the general legislation providing information to consumers on food (10), and with that relating to nutrition & health claims.
Secondly, the Court's consultant felt that he could not rule out the application of Regulation (EC) No. 1924/06 from commercial communications as they refer to the product as such rather than to the type of recipient.
"It is therefore the product itself which must necessarily be intended for consumers, and not the communication to which it is the subject“, Asserted the Advocate General. The concise definition of the scope of the regulation claims is in fact interpreted in an extensive and creative sense (11) to the point of inferring that it includes all commercial communications - that is, those "with economic purposes"- regardless of the characteristics of their recipients.
Risks and prospects
If the Court decides to follow the interpretation proposed by the Advocate General (12), there will be serious turmoil with respect to the commercial practices that have consolidated over the years, with the understandable endorsement of the administrative institutions. B2B information has indeed been articulated by sector operators on two levels:
- indications authorized pursuant to reg. CE 1924/06 and subsequent ones, to be used on product labels and disclosed to consumers with advertising material, websites website e social networks,
- information e brochure reserved for professionals, with more complete communication objectives for a better understanding and differentiation of individual references, evidence of the prerogatives of each SKU, sharing on the development of research and new products. In line with the needs of the professionals themselves, medical and non-medical, to have further news and to be updated on topics relevant to their activities.
The second level of information is essential for companies that invest in R&D and do not have other tools to communicate their values and investments.
Without ceasing to hope that the Court of Justice can disregard the conclusions of its jurisperist, we must already prepare to face the worst hypothesis, as its judgments which interpret European Union regulations have immediate and necessary application in the law of the Member States. The legislator should therefore intervene immediately and clarify even better what everyone up to now had considered self-evident.
On an operational level, our FARE team - Food & Agriculture Requirements has meanwhile developed a contingency plan for its customers.
(1) The reg. CE 353/08, it is recalled, introduced criteria for the evaluation of claim on foods much stricter than those required for drugs - extraordinarily stricter than those established for traditional drugs of plant origin referred to in Directive 2004 / 24 / EC - reaching the point of demanding double-blind clinical studies against placebo on healthy individuals published in high impact factor scientific journals. Namely, devilish trials whose extreme onerousness caused the collapse of research in Europe on probiotics and functional foods
-> Video "Innovating Food Innovating the Law - Part 6 - Dario Dongo" https://vimeo.com/31033738
(2) 44.000 were i claim proposed by the Ministries of Health of the member countries, 3.000 those selected by the industrial experts, 222 those admitted in regulation (EU) 432/2012 (95% of which related only to micronutrients, vitamins and minerals)
(3) The positive example of the USA was of no avail, where for the express purpose of promoting nutritional education and the improvement of public health it is possible to communicate news based on traditional experience and ongoing research, albeit with a disclaimer aimed precisely at clarifying that it is not a question of 'biblical truth'. See http://www.fda.gov/Food/GuidanceRegulation/GuidanceDocumentsRegulatoryInformation/LabelingNutrition/ucm064908.htm
(4) Cf. dDirective 2002/46 / EC on food supplements, DM 9. 7.2012 (as amended by Ministerial Decree 27.2.14) - "Discipline of the use of vegetable substances and preparations in food supplements", Ministerial Decree 31.7.07,"Rules for the implementation of Directive 2006/37 / EC, which amends Annex II of Directive 2002/46 / EC as regards the inclusion of certain substances", Ministerial Decree 27.3.14, Annex 1 - "Herbal substances and preparations"
(5) Reg. (EC) no. 1924/06, article 1, paragraph 2
(6) In line with the general rules on consumer information relating to food products (EU regulation no. 1169/11, where the extensions are clearly defined) and with the same directive on unfair commercial practices, dir. 2005/29 / EC
(7) TFEU, art. 267
(8) The Advocate General has the institutional role of analyzing in detail the legal aspects of the dispute and, in full independence, propose to the Court the answer it deems necessary to provide to the problem raised
(10) Reg. (EU) no. 1169/11, as already the dir. 2000/13 / CE and before that the dir. 1979/112 / EEC
(11) A "teleological" interpretation, as recognized by its author (conclusions, paragraph 35)
(12) Thus, the ruling proposal formulated by the lawyer to the Court: "Article 1 (2) of Regulation (EC) No. 1924/2006 of the European Parliament and of the Council, of 20 December 2006, relating to nutrition and health claims made on food, must be interpreted as meaning that the provisions of this regulation apply to nutrition and health claims relating to food provided as such to the final consumer, formulated in commercial communications, if said communications are addressed exclusively to professionals but have the aim of indirectly reaching consumers, through the latter."