Winclove Steers Around Health Claims Minefield With Vitamin Containing Probiotic Strain

14 Mar 2017 --- The first probiotic with a European health claim is now a fact, according to Dutch probiotic researcher and manufacturer Winclove Probiotics. Winclove’s upgraded Propionibacterium freudenreichii W200 contains adequate amounts of vitamin B12 to make an EFSA approved health claim.

Geline Ormel of Winclove’s marketing team tells NutritionInsight: “It is among the first probiotic strains where you can make a claim, because we were able to upgrade it so that it has sufficient levels of vitamin B12. Via this route is able to have the first claim for a probiotic in that sense.”

She explains: “In the body, vitamin B12 is produced by bacteria among which is the strain that we used. We have upgraded the fermentation process of the Propionibacterium freudenreichii in such a way that the bacteria produces vitamin B12 in high amounts. This bacteria is already known for producing small amounts of vitamin B12, but we have upgraded the fermentation process, so that this upgraded bacteria produces an adequate amount, so you can make a vitamin B claim.”

With their upgraded Propionibacterium freudenreichii W200 the following 8 EFSA health claims can be made:
• Vitamin B12 contributes to normal energy-yielding metabolism.
• Vitamin B12 contributes to normal functioning of the nervous system.
• Vitamin B12 contributes to normal homocysteine metabolism.
• Vitamin B12 contributes to normal psychological function.
• Vitamin B12 contributes to normal red blood cell formation.
• Vitamin B12 contributes to the normal function of the immune system.
• Vitamin B12 contributes to the reduction of tiredness and fatigue.
• Vitamin B12 has a role in the process of cell division.

It is therefore not a “probiotic” claim as such, but as Ormel explains, it does have benefits from a marketing perspective: “It is unique in a way that you do not have to supplement with vitamin B12, as it is there itself. It is a bit of a different route than how companies are normally taking to be able to put a claim on the package, such as probiotic clinical trials, big randomized studies, but we have thought of another way to make a claim, by adjusting the bacteria.”

It is effectively another strategy to achieve a claim and steer around the health claims regulations. “It is a completely different way to trying to receive a claim,” she notes.

Marco van Es, Director Business Development at Winclove: “Stringent probiotic regulations drive the market to innovation. We have succeeded in optimizing the fermentation process of Propionibacterium freudenreichii W200 in such a way that it now produces substantial amounts of vitamin B12. It is the first probiotic in Europe that allows EFSA approved health claims. W200 opens up new opportunities for dietary supplement marketers to promote the health benefits of probiotics to health care professionals and consumers.” 

According to the WHO probiotics are defined as “live micro-organisms which, when administered in adequate amounts, confer a health benefit on the host". Although this definition is widely adopted, European national regulatory authorities forbid the use of the word “probiotic” since it embeds a non-validated health claim. So far, EFSA has rejected all submitted health claims for probiotics. The upgraded Propionibacterium freudenreichii W200 would be the first strain with an approved health claim, implying the first probiotic that can truly be called a probiotic. 

Vitamin B12, a water-soluble vitamin also called cobalamin, is involved in the metabolism of every cell of the human body and is only produced through a bacterial fermentation-synthesis. Propionibacteria are already known for producing vitamin B12, however in small amounts. 

Ormel notes: “We are able to deliver this bacteria and are very interested in getting in contact with brand owners who are interested in putting it into their formulation. We have the probiotic available and it is accessible for the market. It’s a new strain and you can put it in every product you like. We usually develop multi-species probiotic species, but you can also put it as a single strain.” 

The product is available already and Ormel hopes that a commercial launch will take place this year. “We are discussing with partners to add to existing formulations. What they find especially interesting is that it is a natural source of vitamin B12. It is not like adding vitamin B12 to your probiotic formulations. We see that the market is very interested in those kind of natural sources of vitamins and we have some enthusiastic customers already and are discussing how we should further develop their probiotics.”

Beyond supplements, dairy could be an interesting future application route too. Research work into this space is also ongoing with another high vitamin containing probiotic already in development, although Ormel was coy on details. “We are busy with working on a different vitamin producing strain and are still in the development phase. This is a very interesting way to look at bacteria and how to upgrade the capacities to make them even more probiotic and better exert their health effects in the body,” she concludes.

Winclove has over 25 years of experience in researching, developing and manufacturing evidence-based probiotics. The company offers an extensive portfolio ranging from probiotics for traditional gastrointestinal disorders to innovative mental health solutions.

By Robin Wyers