One of the founders of the group, Ger Rijkers, PhD, from the University Medical Center in Utrecht, in the Netherlands, said the group is preparing to send versions of the open letter that appears on its website to MEPs, as it takes an increasingly political role.
This has happened due to the large number of academics that have registered their disillusionment with the course of the 2006 nutrition and health claims regulation (NHCR). Since the EU Gut Health group was formed three months ago by Professor Rijkers, Professor Bruno Pot, PhD from the Lille Institut Pasteur in France, and Stephan Bischoff, PhD, professor and chair at the Department of Nutritional Medicine at the University of Hohenheim, 149 academics from 30 countries have signed up.
“Our legal advice says the most effective way to change the regulation that is killing the science of probiotics is to approach the MEPs and the member state governments so that is what we are doing,” Professor Rijkers told NutraIngredients today.
“But we know this is a difficult task because the argument we, as scientists, our argument is somewhat technical and scientific, so we have to think about the best way to present our position so that the message doesn’t get diluted to the point where it gets lost.”
He said letters would also be sent to relevant committee members at the European Commission.
The point that Professor Rijker’s group makes is that the criteria by which gut health claim dossiers are judged is not clear, and that the restriction on the use of clinical endpoints as validated biomarkers, “scientifically doesn’t make sense and promotes bad science”.
An example of such an endpoint is diarrhoea, something the European Food safety Authority (EFSA) health claims panel considers as a disease, not a disease risk reduction factor.
He said advances in clinical endpoints in the immunity area that offered hope for the gut health area.
“What we want is that the regulation could allow clinical endpoints as primary endpoints in gut health,” he said.
Probiotics are not botanicals
He reiterated calls for an “interim period” to halt further opinions given that EFSA’s Panel on Dietietic Products, Nutrition and Allergies (NDA) had itself said it was engaged in a learning process about the best way to scrutinise dossiers under the NHCR.
“If there is a learning process, does that mean the first dossiers to be assessed were not treated fairly? There needs to be a break so that these biomarker and criteria issues can be debated.”
His colleague Professor Pot added that the group did not seek to have probiotic science treated in the same way as botanicals – which the EC removed from the NHCR process until the best way to approach them can be formulated – but noted the fact the NHCR in its current form was deemed inappropriate for them, was applicable to probiotics.
Professor Pot said such a hiatus would allow for dialogue with EFSA and the EC.
“The lack of this interaction seems to be the biggest frustration amongst the scientific community involved in probiotic/prebiotic research as well as in the many other domains of nutrition where EFSA has been publishing negative opinions,” he said.
Pre- and Probiotics virtual conference
Professor Pot will be speaking at the Pre- & Probiotics virtual conference where we will discuss some of the latest developments in immune and gut health science.
To find out more and attend this free event click here.