Dutch firm upgrades EU probiotic (medical devices) claim

By Shane STARLING contact

- Last updated on GMT

Related tags: Lactic acid, Lactobacillus, Bacteria

Dutch firm upgrades EU probiotic (medical devices) claim
A probiotics specialist in the Netherlands has won a second claim for a multi-strain probiotic blend targeting vaginal health under European Union medical devices legislation.

Dutch firm Winclove Probiotics previously won a vaginal infection claim for its Ecologic ​FEMI+ product under the same route in 2009, but the product has not yet been commercialised.

Winclove researcher Yorick Tromp told us the company re-applied for the claim through Dutch authorities about a year ago as the blend had been altered to boost shelf life and stability.

“We replaced two of the Lactobacillus strains with two others from the same family and this has meant the shelf life of the product has been increased from one to two years,” ​Tromp said.

“We also changed the excipient.”

Tromp said the firm had to answer many ‘mechanism of action’ and other questions from the Dutch agency, DEKRA (formerly KEMA), in winning the medical devices authorisation that applies across the EU’s 28 member states.

The route has permitted other claims denied under the EU nutrition and health claims regulation (NHCR) such as for cranberry (urinary tract infections) and chitosan (cholesterol management). See more on that here​.

The product is said to be applied topically and was backed by in vitro ​studies.

Strains in the blend include: L. plantarum, L. salivarius​, Bifidobacterium bifidum​, L. brevis​ and L. acidophilus​.

The official claim

“Winclove Ecologic® FEMI+ is a medical device, containing a number of beneficial lactic acid producing bacteria, for topical vaginal application, which is intended to enhance the natural vaginal flora by preventing or alleviating any imbalance in this flora, thus inhibiting the growth of pathogens and thereby preventing the occurrence or recurrence of vaginal infections such as vaginosis and vaginitis.

“It achieves this principally by promoting the formation of lactic acid, the production of hydrogen peroxide, and competition with potential pathogens for space and substrate.”

Winclove said the blend had been shown to:

  • inhibit growth of C. albicans​ (two different strains) and C.glabrata
  • promote production of hydrogen peroxide (H2​O2​)
  • promote lactic acid production.

Vaginosis can lead to vaginal infection which can result in unpleasant odours as well as itching, swelling, irritation and stomach cramps.

Probiota 2014

Invested in pre- and probiotics? Probiota 2014 will explore the prebiotic-probiotic scientific frontier, its evolution and commercial application in food, nutraceuticals, pharmaceuticals and cosmetics across the globe.

The 2-day, 2-stream event – formerly Probiotech and Microbiota - will be held in Amsterdam on February 4-5 this year. Will you be joining your peers there?

To know more click here​.

Related news

Show more

Related products

show more

Next-wave sports nutrition innovation today

Next-wave sports nutrition innovation today

ADM | 05-Oct-2020 | Technical / White Paper

Today’s consumers are passionate about embracing health in many aspects of their lives, starting with customizing their nutrition. Rooted in proprietary...

Pycnogenol® Improves Fitness and Muscle Recovery

Pycnogenol® Improves Fitness and Muscle Recovery

Horphag Research | 28-Sep-2020 | Technical / White Paper

Published studies show daily supplementation of Pycnogenol® is effective in boosting muscle performance, increasing endurance and reducing cramping and...

Time to rethink your probiotics for infant use

Time to rethink your probiotics for infant use

Morinaga Milk Industry Co., Ltd. | 17-Sep-2020 | Technical / White Paper

Undoubtedly, probiotics-fortified infant nutrition products have hit the mainstream, and a baby-friendly concept is on the consumer radar. Morinaga's...

Exploring life to improve living

Exploring life to improve living

Gnosis by Lesaffre | Recorded the 07-Oct-2020 | Webinar

Let’s discover how biotransformation processes can lead to a better living! At Gnosis by Lesaffre, we harness the power of microorganisms and biotransformation...

Register for free

Related suppliers

Follow us


View more