The decision is a disappointment for the Swedish probiotic firm, whose efforts in establishing a cause and effect relationship began in 2009 with an unsuccessful application to the European Food and Safety Authority (EFSA).
Probi’s persistence in getting the strain recognised was further tested as this latest decision took into account the unfavourable opinion expressed by EFSA in June 2016.
“We addressed the Commission as Probi believed that the evaluation showed that LP299V did enhance non-haem iron absorption, within reasonable doubt,” said Peter Nählstedt, CEO of Probi.
“We pointed out that some of the considerations made by the panel might have been based on mistakes in the interpretations of the dossier.
Along with the Commission and the Member States, all three decision makers concluded that the evidence was “insufficient to establish a cause and effect relationship between the consumption of Lactobacillus plantarum 299v (Lp299v) and an increase of non-haem iron absorption”.
“Accordingly, as the claim does not comply with the requirements of Regulation (EC) No 1924/2006, it should not be authorised.”
“As Probi is convinced that we have actually shown that our bacteria, LP299V, does increase the absorption of non-haem iron, we have instead performed additional studies,” said Nählstedt.
“These studies show positive results and have now been included in the dossier and re-submitted as a new application for the same claim. This new application is currently being evaluated by the NDA panel.”
L. plantarum 299v’s highly adaptive nature means it is found in fermented foods such as kimchi, sauerkraut, pickles, olives, and sourdough.
As a result, L. plantarum strains are found in the gastro-intestinal tract and are linked to such conditions as Irritable Bowel Syndrome (IBS), Inflammatory Bowel Disease (IBD), and Antibiotic-Associated Diarrhoea.
Probi’s venture in this research area has not proved fruitful either with EFSA rejecting health claims for a probiotic strain effect on potentially harmful gut pathogens in the gut.
When asked whether Probi would continue to pursue probiotic health applications in the future, Nählstedt said it was a question worth considering.
“We will for sure continue to carry out relevant, high quality clinical studies to support effective probiotics, but if we do not get a positive opinion on the present application it is questionable if we will make the effort of applying for health claim in Europe again.
“But that of course, also depends on the nature and details of such opinion – we remain hopeful though that our new application will result in a positive opinion.“
Regulatory process more “user friendly”
Despite the strength of scientific studies, there are currently no approved claims for probiotics in the EU. The term ‘probiotic’ itself is classed as an unauthorised health claim and thus not allowed to be featured on pack.
The majority of EU manufacturers now resort to listing bacterial strains on the product label and leave consumers to draw their own conclusions regarding the health benefits.
“We do believe that the regulatory landscape in Europe is highly complex, and will continue to be so if the NDA panel at EFSA will continue to require proof beyond any doubt, not only beyond reasonable doubt, to publish a positive opinion on a health claim application on probiotics,” said Nählstedt.
“We do however believe that the system has gradually become more “user-friendly”, as the guidelines for beneficial health effects, study designs etc. are becoming more and more detailed.”