Health claims and risk factors: the General Court of the EU sets some playing field limits

31 July 2014

Nicolas Carbonnelle

In early 2012, two professors of the Leibniz University in Hanover filed an application for annulment of Regulation No 1170/2011 "refusing to authorise certain health claims made on foods and referring to the reduction of disease risk"[1].  On 30 April 2014, the General Court of the EU dismissed their action (T-17/12).

The facts that gave rise to this case date back to 2008, when the two professors submitted a health claim for approval to the German Bundesamt für Verbraucherschuts und Lebensmittelsicherheit, i.e., the German competent authority for the authorisation of health claims.  The claim they submitted was: "regular consumption of significant amounts of water can reduce the risk of development of dehydration and of concomitant decrease of performance".  The scope of the application was proposed to fall under a health claim referring to disease risk reduction, with the general population as the target population of the claim.

After some delay, the EFSA issued a scientific opinion on the claim on 28 January 2011, which held that the Regulation (EC) No 1924/2006 (the "Regulation") defined reduction of disease risk claims as claims which state that the consumption of a food “significantly reduces a risk factor in the development of a human disease”.  As a consequence, the beneficial physiological effect must result from the reduction of a risk factor for the development of a human disease.  The EFSA noted that dehydration was identified as the disease by the applicants and that the proposed risk factors (“water loss in tissues” or “reduced water content in tissues”) were measures of water depletion and thus are measures of the disease, not risk factors per se.  The Panel therefore considered that the proposed claim did not comply with the requirements for a disease risk reduction claim pursuant to Article 14 of the Regulation.

The Commission adopted the EFSA's opinion (see Regulation No 1170/2011), and refused to include the claim in the list of authorised claims.

In support of the action they brought before the GC, the German professors relied on nine pleas in law, four of which were based on breach of EU law, four alleged infringements of essential procedural requirements and the last one claimed that Regulation No 1170/2011 was based on erroneous grounds.

Inter alia, the applicants argued that no obligation resulted from the Regulation for a "risk factor" to be named in the application and that the Commission had infringed essential procedural requirements in that, instead of issuing a decision, as provided for in the Regulation, it issued a regulation.

The Commission raised grounds of inadmissibility of the application for annulment, and notably held that the professors did not have standing under the Regulation to make the proposal of the claim because they would have only a theoretical interest in the Regulation.  The Court however admitted that the legislature intended to permit any natural or legal person to file an application for authorisation however, and it did not restrict the circle of applicants for authorization (see paragraph 44).

On the merits, the Court however found none of the nine pleas in law raised by the applicants well-founded.  First, the Court confirmed that a risk factor for disease development must be designated in order to support the application for authorisation of a claim referring to disease risk reduction.  Second, while the claimants alleged that a risk factor had actually been submitted – referring to "water loss in tissues" and "reduced water content in tissues" - the court considered that these could not be interpreted as risk factors, and held that they should be considered as measures of dehydration rather than risk factors for developing such disease.  This is in line with the statements made by EFSA and the Commission in the course of the examination of the application for a health claim.  The Court held that it was not disproportionate of the Commission to reject the health claim.  The absence of sufficient legal basis for the regulation rejecting the health claim was also considered not founded, because Regulation No 1170/2011 was based on the authorisation procedure provided for by Article10(1), Article 14(1)(a) and Article 17(1) of the Regulation – and that legal basis was not found inappropriate by the Court.

[1] O.J., 17 November 2011.