Nine groups and individuals submitted comments and questions on the opinion to the European Commission’s Basil Mathioudakis that included whether or not the opinion meant all hydration-based claims would be banned in the EU because EFSA considered dehydration a disease and not a risk factor of disease as required in the nutrition and health claims regulation (NHCR).
Dr Moritz Hagenmeyer, the German lawyer who submitted the claim along with professor of nutrition, Dr Andreas Hahn, welcomed the comments from the likes of the European Nutraceutical Association (ENA), Cognis and the Dutch Health FoodAssociation (NPN ).
Water loss in tissues
Dr Hagenmeyer has indicated it is likely he will mount legal action against the opinion and he told NutraIngredients: “The opinion is unfounded and unjustified. In the case of xylitol chewing gums and the claim ‘reduced the risk of caries’, EFSA found the specific risk factor to be unclear, but nonetheless gave a positive opinion and even proposed a wording of a claim – naturally without a risk factor. Furthermore EFSA already accepted the scientific rationale behind the application as essentially undisputed in its own opinion on dietary reference values for water.”
After dialogue with EFSA’s Panel on Dietetic Products, Nutrition and Allergies (NDA) to clarify the disease risk reduction factors, the professors proposed, “water loss in tissues” or “reduced water content in tissues” as risk factors in the development of dehydration.
But in ruling the claim outside the scope of the NHCR, the Panel found these were, “measures of water depletion and thus are measures of the disease (dehydration).”
Dr Hagenmeyer disputed this by observing there existed no necessity in the NHCR to, “mention a separate disease risk reduction factor”.
“The application has nonetheless mentioned a disease risk reduction factor, namely ‘water loss in tissue’, as suggested by the competent German Federal Office for Consumer Protection and Food Safety (BVL). The Regulation does not provide for an arbitrary classification of this factor by EFSA as a ‘measure of disease’, a term unknown to the NHCR. This is even more so as EFSA has not directed its opinion at the correct disease ‘dehydration and concomitant decrease of performance’, but rather at ‘dehydration’, which is not the subject matter of the application.”
Cognis chemist in its product safety and regulation team, Dr Horst Messinger, wrote: “There is no doubt that there is an established risk relation between water consumption and dehydration as a disease state and therefore it is somewhat surprising that EFSA still fails to find a ‘risk factor’.”
ENA president Dr Peter Prock wrote: “We cannot behave in any other way but to seriously question this entire process…We would like to call upon healthy common sense for something to be done here so that efforts to establish health claims, the credibility of institutions such as EFSA and nutritional research are not all harmed.”
The opinion can be found here.
The NDA has however issued a positive article 13 opinion linking consumption of 2 litres of water per day and normal physical and cognitive functions and the maintainenance of thermoregulation.
That opinion can be found here.