Prebiotic & botanical health claims withdrawn from EFSA
EFSA was due to deliver opinions on the three claims filed by Specialised Nutrition Europe (SNE) and the Chios Mastiha Growers Association but both parties withdrew their dossiers, which all date back to 2008.
NutraIngredients understands the dossiers had been subject to the stop-the-clock procedure, which allows firms time to gather additional information requested by EFSA.
SNE filed its prebiotic claim under its former moniker IDACE.
The claim read: “Non digestible oligosaccharide fibers (FOS/inulin, GOS and a mixture of FOS/inulin and GOS) are prebiotics that promote a healthy gut as clinically shown by an increase in beneficial bacteria.”
No longer considered a health claim
SNE executive director Aurélie Perrichet said since 2008 EFSA had further detailed its requirements on the substantiation of health claims, and this meant its application included statements no longer regarded as specific health claim for example a ‘shift in gut microbiota composition’.
“However, we believe in the health benefits of non-digestible fibers, and we are very confident that the investment effort of our industry in research will in time be conclusive and comply with the very high standards of EFSA assessment,” she told us.
Last year German supplier Beneo secured a health claim for its prebiotic chicory inulin and better bowel function.
Data concerns
Meanwhile Greece-based Chios Mastiha Growers Association withdrew its application for two claims concerning the plant resin Chios mastiha.
The dossiers were for an article 13.5 claim for the “improvement of gastric discomfort” and an article 14.1 claim for the “reduction of Helicobacter pylori which is a risk factor for the development of stomach ulcers”.
Dr Ilias Smyrnioudis, R&D manager at the association, told us both claims had been accompanied by “strong scientific studies conducted in numerous universities and institutes around the globe”.
However the applications had been withdrawn because of EFSA’s concerns over the methodology used in the studies including statistical methods.
It was also awaiting the results of ongoing studies on gastric discomfort and H.pylori from the University in Athens and a hospital on the Greek island of Chios as well clinical trials from the ‘MAST4HEALTH’ project co-financed by the EU's Horizon 2020 initiative.
“Therefore, owing to the aforementioned reasons, we deliberately reached the conclusion that both applications should be withdrawn, in order to strengthen the dossiers.”
Communication breakdown
Asked what the group’s impression of the application process was, Smyrnioudis said despite being 10 years old, the 2006 nutrition and health claims regulation (NHCR) still had a long way to go.
“[W]e think that communication between EFSA and the applicant is still in its infancy and should become more active through the years, so that the applicant can obtain more information during the assessment.”
He said the stop-the-clock period was “extremely limited” if more research was needed.
In 2014 EFSA published new guidelines on the procedure, which aimed to increase efficiency, clarity and consistency.
Health without a health claim
Smyrnioudis told us since it applied for the food health claims, Chios has been officially assigned an EU herbal monograph by the European Medicines Agency (EMA), which contains a scientific opinion on safety and efficacy data about a herbal substance and its preparations intended for medicinal use.
Chios' herbal monograph refers to use in mild dyspeptic disorders and for the symptomatic treatment of minor inflammations of the skin and as an aid in healing of minor wounds.
Smyrnioudis said while it still had food supplements in sight, this monograph also opened up the ‘pharma world’.
“Undoubtedly, the horizons of Chios Mastiha were widely broadened after the monograph was obtained.”
Non-EU markets would also continue to be a focus.
