Health claim on water drowns – Decision of the General Court in case T-17/12
Recently, the General Court has decided a dispute concerning a health claim on water, explaining the concept of a disease risk reduction claim as defined by art. 14 (1) of the Health Claim Regulation. More specifically, the Court has clarified that indicating a ‘risk factor’ is mandatory in order to acquire authorisation for such claim. According to the grapevine, this was a test case for the working of the EU food and advertising rules, which has been much criticised. Anticipating the EU elections, EU criticism is not rare to find. Below you will read however, how this case has contributed to clarification of the notion of a disease risk reduction claim.
Cause of the case
The case was initiated by two German individuals, Moritz Hagenmeyer and Andreas Hahn (“the Claimants”), both food law academics, who submitted an application for authorisation of a health claim via the German Federal Office for Consumer Protection and Food Safety. The claim at stake was ‘Regular consumption of significant amounts of water can reduce the risk of development of dehydration and of concomitant decrease of performance‘. Although the claim seems uncontroversial, EFSA delivered a negative opinion. According to EFSA, the application did not provide a ‘risk factor’ for a human disease that would significantly be reduced by the consumption of water. The Commission followed EFSA’s advice and issued Regulation 1170/2011 refusing the claim applied for. In line with EFSA, the Commission held that the proposed risk factors are measures of water depletion and thus are measures of the disease. Accordingly, as a risk factor in the development of a disease is not shown to be reduced, the claim does not comply with the requirements of the Health Claim Regulation and cannot be authorized.
Continuing their experiment, the Claimants requested the Court to annul the part of Regulation 1170/2011 that refused the authorisation of their claim. To support their action, nine pleas of law were provided. In response, the European Commission pleaded for inadmissibility of the claim, and alternatively for its lacking justification. The Court however, decided to address the matter on admissibility in final judgment, forcing the Commission to take position on the reasons of justification of the claim. In its defence the Commission enjoyed the support of the Council of the European Union, as the application for intervention was admitted. The majority of the pleas brought before the Court regarded the procedural aspects of the claim authorisation procedure. The material dispute, however, focussed on the risk factor and whether this factor was dispensable.
Broad interpretation of “disease risk reduction claim”?
With their first plea, the Claimants argued that according to the Health Claim Regulation, it is not mandatory to provide for a risk factor in the application for a disease risk reduction claim. In support, they relied, inter alia, on previous case law from the European Court of Justice on health claims. In the first place, they argued that it follows from Green Swan, C-299/12 that in order to qualify as a disease risk reduction claim, such claim does not have to state that the consumption of a particular food significantly reduces the development of a certain disease. In the second place, they deduced from Deutsches Weintor, C-544/10 that the link between the consumption of a particular food and the effect on health, should be interpreted broadly. Even if the Court seems to acknowledge this concept, the Court disagreed, explaining that the concept of a disease risk reduction claim is defined by art. 2 (2)(6) of the Health Claim Regulation, and should be interpreted in this context. Therefore, there can be no distinction between the risk factor of art. 2(2)(6) and the term ‘disease risk’ in art. 14 (1). An indication of one, or multiple risk factors in the development of a human disease is, therefore mandatory for the authorisation of a disease risk reduction claim.
In rejection of the subsequent pleas, the Court emphasized the importance of the risk factor as component of the disease risk reduction claim. Without an indication for a disease or a risk factor for a disease, the Commission cannot judge the beneficial physiological effect that is required by the Regulation for the claim to be permitted. The Court further explained that it is sufficient when the application implies a risk factor instead of a providing a specific indication (see consideration 92 of the decision) thereof. However “water loss in tissues” or “reduced water content in tissues” indicated by the Claimant when requested for clarification could not be interpreted as the required risk factors. The Court, following the reasoning of the Commission and the EFSA advice decided that these alleged risk factors should be considered as a measures of dehydration rather than risk factors for developing such disease.
Although the claim chosen for this experiment may give rise to hilarity and the length of proceedings to process it may criticised, this case further tightens up the body of case law around disease risk reduction claims. That is a welcome development. As a general rule, health claims should contribute to properly inform the consumer about the characteristics of food and they should not be misleading. Now imagine the situation that this claim had been authorised and was subsequently used by many food business operators for mineral waters. That would be stating the obvious and not really add to any specific consumer information. After all, the Commission did not deny that scientific evidence had shown the link between dehydration and decrease of performance (see consideration 81 of the decision). It simply clarified the requirements for a disease risk reduction claim and more specifically, the mandatory ‘risk factor’. Those requirements prevented stating the obvious in this case. Cheers!
The author is grateful to Lisanne van Kouterik, intern at Axon Lawyers, for her valuable contribution to this post.