The European Food Safety Authority (EFSA) is currently tasked with reviewing a multitude of health claim applications and giving its opinion to the European Commission, as per the new Health Claim Regulation that came into effect in 2007. The authority bases its opinions on the submitted substantiating evidence—the applicants’ tasks being to submit the entire body of evidence in literature, along with substantiating clinical trials done on the respective products.

The points EFSA evaluates include: whether the product or substance in question is sufficiently characterized; whether the claimed effect is beneficial to human health; whether the submitted evidence is relevant; and whether a cause and effect relationship has been established between the evidence and the claim.

Since EFSA has been reviewing applications, it has become apparent that it is using demanding criteria, comparably stringent to those used in evaluating drug claims. As a result, it has issued hundreds of rejections—some of which are being appealed by manufacturers—as well as some downright strange decisions.

One such strange decision was made February 23, 2011, when EFSA rejected a claim for water and dehydration. The claim was submitted by two German professors as a test case, and not really meant in earnest, but EFSA treated it as earnest. It was an article 14 claim (a risk-reduction claim), worded “regular consumption of significant amounts of water can reduce the risk of development of dehydration and of concomitant decrease of performance,” which sounds pretty straightforward at first glance.

The main point of a risk-reduction claim application is proving that using the product in question could reduce the risk of developing a disease. Again, no problem there, right? Drinking water certainly reduces the risk of becoming dehydrated.

According to the regulation, risk-reduction claims are defined as claims, which state that the consumption of a food “significantly reduces a risk factor in the development of a human disease.” But what, precisely, are the risk factors for dehydration? And which factors must be reduced in order to prevent the disease “dehydration?”

There was some back-and-forth between EFSA and the two professors, which led to the proposal that the risk factors for dehydration were “water loss in tissues” or “reduced water content in tissues.” EFSA disagreed, finding instead that these points were “measures of water depletion and thus are measures of the disease.” In other words, consuming water would reduce the disease, not the risk factor. The risk factors, according to the panel, include things such as “lack of water” or “heat” or other external factors facilitating dehydration. These, however, cannot be reduced by consuming water. EFSA then ruled that the water-dehydration claim is outside the scope of the EU nutrition and health claim regulation, and rejected the application. If the European Commission adopts EFSA’s opinion, it would basically mean that no company could make a claim linking water consumption and dehydration.

This is yet another sign of how absurd this evaluation process has become. There is significant confusion that exists about the difference between “disease risk reduction” and “disease risk factor reduction.” This confusion, according to claim applicants, may also be the reason why EFSA took almost 2.5 years to reach this decision. They say that they are likely to sue EFSA over the rejection of their application, but are not overly optimistic about the outcome.

Other experts state that this decision illustrates the many inherent faults in EFSA’s evaluation framework. If dehydration is a disease because it does not fall within the scope of the health claim regulations for foodstuffs, does this mean that water is a drug because it is something that cures a disease?

Rejections on the basis that the application in question does not fall within the scope of the regulation are rare. In most cases, applications are rejected because of methodological flaws in substantiating clinical trials, or because of a complete lack of evidence. However, the fact remains that the number of rejections far outweighs that of accepted claims, and occasionally, EFSA’s ruling is surprising and unacceptable for manufacturers and other stakeholders, who subsequently start lobbying for a changed decision.

Many stakeholders believe EFSA is using a drug measuring stick on food claims. Or, to put it differently, it is applying drug standards to functional food claims. The discussion about risk factors is symptomatic for this need to measure acceptable markers. In a way, it is easier to prove drug efficacy, since the trials can be conducted on patients, with the effect being the curing of a disease. In a food, the study population must be healthy volunteers, since the study population must be equal to the target population, which is assumed to be the general population. Proving a health effect in an already healthy study group is difficult and even more so if you’re working alone.