The Dutch probiotic firm has developed the first probiotic strain that can carry an EFSA approved claim without the need for other added ingredients - by naturally producing high levels of vitamin B12.
The fact that the Propionibacterium freudenreichii strain itself produces a natural version of the vitamin means it stands out from other products that add vitamins to final formulations to gain an EFSA claim and means that the strain itself – or products containing the strain – could be allowed to carry the eight EFSA approved claims granted for vitamin B12, said Marco van Es, director of business development at Winclove.
“It is known that gut bacteria produce vitamins and other metabolites, it is one of the key roles in the microbiome,” said van Es. “It is also known that Propionibacterium freudenreichii, which a lot of people already have in their intestines, is able to produce vitamin B12.”
No loopholes?
By altering and upgrading the fermentation process for the bacteria, Winclove says the strain now produces enough vitamin B12 to be able to make EFSA approved claims relating to the vitamin.
“When you look at vitamin B12, it has some nice claims that are close to what science has suggested probiotics can do. For example, contributing to the normal function of the immune system and reducing tiredness and fatigue. Those sorts of claims, you could say, are in a similar league to where some probiotics have evidence of efficacy,” said van ES.
“It can support probiotic evidence which is already out there, but could now be EFSA claimable without using loopholes like adding in extra vitamins,” he added.
When asked how the new development differs from current industry tactics of simply adding vitamins into finished formulation, van Es said that in terms of labelling, the essence could be very similar. However, he noted that the firm have not yet checked on the exact wording of the claim, and whether it could now include the word 'probiotic'.
"We think there is a key difference in that it’s not a synthetic form of B12 that is added in," he commented.
“It is the natural bacteria which naturally produces this and this is a step closer what you could consider a true probiotic claim,” he said – adding that while the exact wording of how a claim might look, and how it could show that the vitamin was naturally produced by the bacteria, has not yet been figured out, the firm is confident that claims can be made.
Bringing back ‘probiotic’ wording…
The probiotic expert also noted that the fact that the bacteria itself contains the vitamins, and could itself be claimable, might open up the possibility of using the word ‘probiotic’ – which is currently banned from use because it is classed as an implied health claim.
"From what I understand from EFSA, the case is that because probiotics do not have an accepted health claim, the word probiotic itself is also banned. So our question is could this also be an opening to bring back the word probiotic?" he questioned.
“I’m not a lawyer and we have not looked into that, but I can imagine that it might be a possibility.”
New way of working
The idea has been in development with the Dutch probiotic firm’s fermentation team for around two years. Now van Es and his colleagues want to get feedback from existing partners and the wider market to judge how to further develop the idea.
“We are very curious as to whether this will get a lot of interest. For us this is a novel way of working too, it is the first time we have worked on a single strain, it is also the first time we have looked at the issue of claims,” van ES told NutraIngredients – adding that Winclove is also discussing ‘whether and how’ to add the vitamin B12 -rich strain to its own multi-strain formulations.
“From safety, production, and that sort of point of view, all the hurdles have been tackled,” he said. “We have been able to make it, to reproduce it, and make it stable.”
“It is very shelf stable and people are able to claim throughout the shelf life.”
Further research … and development
van ES confirmed that the next step for Winclove is to listen to feedback and begin to co-develop with new partners to produce new products and formulations that contain the ‘upgraded’ Propionibacterium freudenreichii.
A trial is also in the planning stages, which he confirmed will look at issues of bioavailability and how intake of the probiotic influences blood markers of vitamin B12 status.
“Up to now we have focused on the innovation to get the amount of B12 at the moment of administration,” said van Es. “As far as we have interpreted the EFSA legislation, that is what you need to be able to make the claim.”
“We have not yet extended to see whether it keeps on producing in the intestine. This is a next stop which is currently under investigation.”
He told us that a new trial is currently ‘at the design table’.
“That is a proof of principle that we are going to do,” he told us – adding that while such studies ‘always take a long time’, he hopes to see research completed within two years.