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2 2 Is Regulation (EC) No 1924/2006 on nutrition and health claims applied to commercial communications addressed exclusively to the professional sector (B2B)? Luis González Vaqué 1 This doubt has arisen regarding case C 19/15 ( Verband Sozialer Wettbewerb e.v. v Innova Vital GmbH ) which the ECJ has not yet resolved; however, the Advocate General HENRIK SAUGMANDSGAARD ØE presented his Opinion 2 mid-february in which it appeared that he chose to respond affirmatively to the statement put forward in the heading of this note. Although the suggestions of the Advocate General are not binding upon the EJC, I feel it is appropriate to analyse his arguments in this respect whilst we await a firm judgment to be dictated on the corresponding request for a preliminary ruling from the Landgericht München I (Munich Regional Court I, Germany) relating to the interpretation of article 1.2 of Regulation (EC) No 1924/2006 on nutrition and health claims made on foods 3. Said request stems from a dispute between an association protecting the commercial interests of its members and an undertaking selling a nutritional supplement, and concerned some statements made in advertising mail sent by the latter exclusively to doctors. In these a requested was made to ECJ, «for the first time, to determine whether the requirements under that regulation are applicable where nutrition and health claims on foods to be delivered as such to consumers are made in commercial communications addressed not directly to consumers but exclusively to professionals» 4. The origin of this conflict can be found in the correspondence sent in November 2013, by the director of Innova Vital 5 of a written communication exclusively to named 1 gonzalu70@outlook.es. 2 Available at: 3 OJ L 404, , p. 9. That regulation has been the subject of a corrigendum (OJ 2007 L 12, p. 3) and was last amended by Commission Regulation (EU) No 1047/2012 of 8 November 2012 with regard to the list of nutrition claims (OJ 2012 L 310, p. 36). 4 See paragraph two of the Opinion of the Advocate General HENRIK SAUGMANDSGAARD 5 A German undertaking the director of which is a doctor, markets an emulsion containing vitamin D which is administered in the form of drops and is called «Innova Mulsin Vitamin D3».

3 3 doctors 6 stating that that nutritional supplement helped to prevent diseases caused by vitamin D deficiency. It was worded as follows: «You are aware of the situation: 87% of children in Germany have blood vitamin D levels below 30 ng/ml. According to the German Food Association (Deutsche Gesellschaft für Ernährung, DGE), that level should be approximately 50 to 75 ng/ml. As has already been demonstrated in numerous studies, vitamin D plays an important role in the prevention of several illnesses, such as atopic dermatitis, osteoporosis, diabetes mellitus and MS [multiple sclerosis]. According to those studies, vitamin D deficiency in childhood is partly responsible for the subsequent development of those illnesses. [...] As a doctor specialising in immunology, I considered this issue and developed a vitamin D3 emulsion (Innova Mulsin D3) which can be administered in the form of drops. [...] Benefits of Mulsin emulsions: [ ] Rapid prevention or elimination of nutritional deficiencies (80% of the population is described as being vitamin D3-deficient in winter) [...] You can find out how to place direct orders and obtain free information material for your surgery by calling... [...]». Verband Sozialer Wettbewerb e.v. 7 brought before the mentioned Landgericht München I an action for a prohibitory injunction against Innova Vital pursuant to the German Law on Unfair Competition (Gesetz gegen den unlauteren Wettbewerb 8 ). That action was based on an infringement of Regulation No 1924/2006, with particular emphasis on two of the abovementioned statements 9. 6 Sic in paragraph Nº 16 of the Opinion of the Advocate General HENRIK SAUGMANDSGAARD 7 A registered German association, one of the statutory duties of which is to protect the commercial interests of its members, and in particular to ensure compliance with the rules of fair competition. 8 In accordance with the first sentence of Article 8(1) of the German Law on Unfair Competition, in the version applicable to the dispute in the main proceedings, an action for a prohibitory injunction may be brought against any person who engages in an unlawful commercial practice under Articles 3 and 7 of the same Law. 9 Namely, first: «as has already been demonstrated in numerous studies, vitamin D plays an important role in the prevention of several illnesses, such as atopic dermatitis, osteoporosis, diabetes mellitus and MS [multiple sclerosis]. According to those studies, vitamin D deficiency in childhood is partly responsible for the subsequent development of those illnesses»; and secondly: «rapid

4 4 In support of his claim Verband Sozialer Wettbewerb e.v. sustained that the provisions of Regulation (EC) No 1924/2006 are applicable to publicity directed to both professionals as non-professionals. As the main argument he sustained that health claims are prohibited under Article 10(1) of that Regulation unless they have been authorised in accordance with the Regulation and are included in the list of authorised claims provided for in Article 13, which is not the case with the affirmations put forward. He added that, given the composition and efficacy of the nutritional supplement in question, it does not fulfil the general conditions provided for in Article 5(1) of that Regulation. In the alternative, it argued an infringement of Article 10(2) of the same Regulation on the ground that the advertisement at issue does not include the information which is mandatory under that provision. Innova Vital GmbH sustained, on the contrary, that Articles 5 and 10 of Regulation No 1924/2006 are not applicable to the statements made in the communication at issue, since it was addressed exclusively to doctors, and that that regulation cannot be applied to advertisements directed at professionals. In that context, by decision of 16 December 2014, the Landgericht München I decided to stay the proceedings and to refer the following question to the ECJ for a preliminary ruling: «Must Article 1(2) of Regulation 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?» It should be noted that the Advocate General HENRIK SAUGMANDSGAARD ØE proposed that the ECJ answer the question referred to for a preliminary ruling as follows: «Article 1(2) of Regulation (EC) No 1924/2006 of the European Parliament and of the Council of 20 December 2006 on nutrition and health claims made on foods must be interpreted as meaning that the provisions of that regulation apply to nutrition and health claims made in commercial communications on foods to be delivered as such to the final consumer if those communications are addressed exclusively to the professional sector but are intended to be targeted indirectly at consumers, via the professional sector». Brevitatis causae, I cannot here list all the considerations that led the Advocate General HENRIK SAUGMANDSGAARD ØE to formulate his final conclusion; however, I can highlight what he took into consideration: «that, according to the referring court, it has been established that, under the conditions for application set out in Article 1(2) of [the Regulation No 1924/2006], first, the product referred to in the written communication at issue in the main proceedings constitutes a food to be delivered as such to the final consumer and, secondly, the communication from Innova Vital was intended as advertising for that food» 10 ; prevention or elimination of nutritional deficiencies (80% of the population is described as being vitamin D 3 -deficient in winter)». 10 See paragraph Nº 24 of the Opinion of the Advocate General HENRIK SAUGMANDSGAARD

5 5 that «it is true that [the Regulation No 1924/2006] contains numerous references to consumers, and, in particular, the perception of nutrition and health claims which the average consumer is likely to have is used as a point of reference several times in that regulation 11» 12 (however, in light of the text of article 1, paragraph 2 and remaining provisions of the oft mentioned Regulation No 1924/2006, it cannot be ruled out that that regulation may govern both commercial communications addressed directly to consumers and communications which, although addressed exclusively to professionals, are in fact intended to be targeted indirectly at the consumers who may purchase the food concerned 13 ); that The legislature has made no distinction based on the capacity of the addressee of communications containing the nutrition and health claims covered by the Regulation No 1924/2006: «the only requirements laid down in the regulation concern the purpose and nature of those communications [given that] first they must relate to foods to be delivered to a final consumer 14 and, secondly, they must be of a commercial nature, whether they take the form of the labelling or presentation of such foods, or as in the dispute in the main proceedings the advertising of those foods 15» 16, and, finally, «it is [ ] the product itself, and not the communication of which it is the subject matter, which must necessarily be aimed at consumers» 17 ; and that, it is necessary to consider that the objective of the Regulation in question is «ensur[ing] the effective functioning of the internal market» (by, inter alia, «creating equal conditions of competition» for product promotion) and providing «a high level of consumer protection» 18 ; and that is achieved primarily by enabling consumers to make informed dietary choices thanks to objective information and based on evidence. 11 See recital 16 and articles 5, paragraph 2, and 13, paragraph 1, in fine, of the (see also point 17 of the explanatory memorandum and recital 10 and Article 2(8), Article 5(2), Article 9(1) and Article 12(1) of Proposal COM(2003) 424 final). 12 See paragraph Nº 37 of the Opinion of the Advocate General HENRIK SAUGMANDSGAARD 13 Ibidem, paragraph Nº Those foods are «delivered as such» either directly to the final consumer (see recital 3 and the first subparagraph of Article 1(2) of Regulation No 1924/2006) or indirectly in the context of supply to restaurants, hospitals, schools, canteens and similar mass caterers (see the third subparagraph of Article 1(2) of that regulation). 15 See recital 4 and the first subparagraph of Article 1(2) of Regulation No 1924/2006. As pointed out by the Advocate General HENRIK SAUGMANDSGAARD ØE that requirement was not set out in Proposal COM(2003) 424 final. 16 See paragraph Nº 39 of the Opinion of the Advocate General HENRIK SAUGMANDSGAARD 17 Ibidem. 18 See recitals 1, 2, 9 and 36 and Article 1(1) of Regulation No 1924/2006. See, also, paragraphs 2, 6, 12 and 33 of the explanatory memorandum of Proposal COM(2003) 424 final.

6 6 Therefore it is necessary to opt for «an interpretation of the scope of application of Regulation No 1924/2006 broad enough to ensure that the fulfilment of those objectives and observance of those principles are not compromised, in accordance with the approach that the Court has taken to date in respect of food industry operators attempting to limit the material scope of that regulation 19» 20 and, more specifically estimate that in the case object of the preliminary of Landgericht München I, since the consumers are not «expressly designated as the only potential addressees, [the Regulation No 1924/2006] should [ ] be considered as also being applicable to a commercial communication, such as that at issue in the main proceedings, addressed exclusively to professionals, which satisfies the other conditions set out in that instrument 21» 22. Now we shall have to wait for the ECJ to accept or not the arguments of the Advocate General which, as I have said, are not binding Accepted Article (Accepted, unedited articles published online and citable. The final edited and typeset version of record will appear in future.) 19 On this issue please see: Nihoul, P.and Van Nieuwenhuyze, E., «Allégations nutritionnelles y de santé: quelques stratégies juridiques utilisées par les entreprises pour échapper à la réglementation», Revue européenne de droit de la consommation, 2014, No. 1, pp See paragraph Nº 48 of the Opinion dof the Advocate General HENRIK SAUGMANDSGAARD 21 The cursive is ours. 22 See also paragraph Nº 48 of the Opinion of the Advocate General HENRIK SAUGMANDSGAARD

COMMISSION DELEGATED REGULATION (EU) /... of XXX

EUROPEAN COMMISSION Brussels, XXX SANTE/11481/2018 CIS (POOL/E1/2018/11481/11481-EN CIS.doc) [ ](2018) XXX draft COMMISSION DELEGATED REGULATION (EU) /... of XXX amending Commission Delegated Regulation