With not a single health claim application for probiotics approved, some have concluded that it is simply impossible to get such a dossier past EFSA scrutiny.
This summer the EU authority rejected Swedish supplier Probi’s article 13.5 health claim for a probiotic strain and improved iron absorption.
The rejection was the 310th such disappointment for the probiotics industry since the creation of the EU’s Nutrition and Health Claims Regulation (NHCR) in 2006.
The company’s CEO Peter Nählstedt told us that if it failed to overturn the rejection in an appeals process, it would have to be assumed that getting a health claim for probiotics is an impossible task.
“Should this conclusion persist – the conclusion would have to be that it can’t be possible to get a health claim for probiotics,” he said.
We asked IPA Europe executive director Carine Lambert if she agreed.
She told us if EFSA continued to use a pharmaceutical approach of “one molecule, one end point, one effect” to look at probiotic dossiers, “it will never be possible to claim”.
‘It has been rendered in a way impossible’: IPA Europe
Yet she said the problem was the approach of EFSA, not the science of the probiotics industry.
“It’s not impossible because of our science, because it’s obviously possible everywhere else in the world, except in Europe. So we believe in our
science and this must be clearly, clearly stated,” she said.
“It has been rendered in a way impossible because of the whole technical approach and the way EFSA evaluates. It’s not because we have a lack of science.”
She said there had been more than 11,000 probiotic papers published in journals over the last 50 years.
But there are countless other claims approved under the same system, so what is it about probiotics?
“Probiotics are live microorganisms intervening in several mechanisms and pathways of the body so it’s quite complex, and much more so than vitamins and minerals or fibres or whatever,” she said.
The cost of confusion
Lambert said the situation had already hit market confidence, with a noticeable reluctance to invest in research.
Euromonitor International calculates the de facto ban on the term ‘probiotic’ in the EU will cost the probiotic yoghurt market about €2.5 billion between 2012 and 2020 in lost revenue.
Dr Luca Bucchini, managing director of Rome-based Hylobates Consulting, echoed this.
“It is true that trust has been eroded, resources for research have diminished as industry has suffered so many setbacks and restrictions in the market place due to the NHCR and, since putting together a successful application is likely to require massive resources, with no certainty of a positive outcome, it has all become very difficult.”
In the past companies have estimated it costs between one and two million euros to gather enough evidence for a successful health claim application.
Yet Lambert conceded that many of the early dossiers counted in the 310 list of rejections were far from perfect.
Indeed some of these early applications didn’t have strain numbers.
Bucchini agreed: “I think it is not fair to put all the rejected probiotic claims in the same basket. Most applications (especially the earlier ones, which count for most) had several flaws.”
“It was not all down to applicants, and EFSA could not be faulted: the NHCR had to be implemented too quickly, and there was insufficient time for a dialogue in which EFSA could define and explain its requirements.”
He said by contrast recent applications like Probi’s were “successful in most respects”, including characterisation and type of effect.
“So, yes, I think that now there is sufficient understanding of how EFSA is going to assess a probiotic claim to make a successful application. At the same time, I do understand the frustration of the applicants, and their arguments.”
He remained optimistic about a future probiotic claim win, and urged industry to keep applying.
He called for industry with a presence in Italy to take a particular interest. Unlike the rest of Europe, in Italy the term probiotics is not considered a health claim needing approval.
Key to any EU-level progress would be dialogue beyond stakeholder conferences to address scepticism and produce clear guidance, both Bucchini and Lambert said.
Dr Mark Tallon, managing director at UK-based consultancy firm Legal Foods, said dialogue would incentivise investment.
“A solution would be an ability to submit to EFSA a proposed study design and claim. If the study yields a significant effect the claim can be used. Such an assessment would give certainty to companies that investment in research is worth the risk.”
He said without this certainty companies may not see the value of playing by the NHCR rules.
“Food businesses are ultimately ignoring the health claims regulation and making more non-authorised claims to connect to their consumers.
“In most member states non-compliance and fines are cheaper than trying to get ‘consumer friendly’ health claims authorised.”
The bigger picture
Beyond dialogue, Lambert said IPA Europe was calling for movement on the de facto ban of the term probiotic.
They also want a basic definition of probiotics.
Specific regulation on probiotics would help regulate labelling, quality, concentration.
The lack of any standard here has led to a situation whereby probiotic is a term banned on food and food supplement packs, but allowed on toilet cleaners.
“All in all the situation is really not viable anymore,” said Lambert.