New EFSA opinion offers future FSMP application potential for Bimuno® prebiotic ingredient

Clasado Biosciences ('Clasado'), a global leader in the development of clinically proven prebiotic ingredient and product solutions for the human gut microbiome, announces that the European Food Safety Authority (EFSA) has given a positive opinion on the extension of use of galactooligosaccharises (GOS) as a novel food in food for special medical purposes (‘FSMP’) in the EU in collaboration with partner GLNP Life Sciences BV (‘GNLP’), a specialist FSMP producer in Europe.

The opinion, ‘Safety of the extension of use of galactooligosaccharides (GOS) as a novel food in food for special medical purposes pursuant to Regulation (EU) 2015/2283’, was published on 30 March 2022. Following a request from the European Commission, EFSA reviewed the safety of prebiotic GOS, in this case Bimuno® GOS, as a novel food with the intention of use in FSMP applications.

Significantly, the EFSA opinion marks the beginning of an exciting journey for Bimuno GOS, which the business hopes will see it approved for use in FSMPs by the Commission in due course. The acknowledgement from EFSA paves the way for Bimuno GOS to be used in FSMPs intended for the dietary management of impaired gastrointestinal issues in hospitalised patients.

Per Rehné, CEO of Clasado Biosciences, explains: “Exploring the potential of Bimuno GOS in the FSMP category presents an exciting opportunity for us, and as the most comprehensively studied prebiotic GOS in the market, it’s a logical development. Bimuno is already building a very strong name for itself in the global health supplement and functional food market as consumers around the world look to the importance of rebalancing their gut microbiome due to various causes of dysbiosis backed by credible scientific and clinical evidence. When we consider that our gut bacteria are connected with areas such as digestive health, immunity and cognition, it’s no surprise that prebiotics are coming into focus.

“With the EFSA positive opinion on the use of GOS in FSMP applications, this presents the opportunity to embark on a brand-new and promising journey for the business. The opinion published in the EFSA Journal centres around indirectly tackling malnutrition in hospitalised patients where gut microbiome dysbiosis is a common factor; fibre content is key and as a prebiotic substrate, Bimuno GOS certainly fits the bill. Following an eventual authorisation from the Commission, we can hopefully affect more positive change across the spectrum of health and wellbeing. This positive opinion is a fantastic step forward, whereby we appreciate GLNP’s efforts in helping to unlock Bimuno GOS potential in FSMP’s.”

Gijs Roozendaal, General Manager at GLNP Food Sciences BV, added “Using prebiotics within the FSMP category represents an exciting opportunity where prebiotics can potentially play a key role within the European market. Working with a leading prebiotic ingredient developer like Clasado, that focuses on strong scientific backing, is an essential step in accelerating our understanding of gut-mediated health, and crucially, turning that knowledge into action and solutions that make a difference.” 

Bimuno GOS is designed to be the optimal blend of science and versatility. Alongside offering supreme stability for formulators, the ingredient is backed by over 100 studies, including more than 20 clinical trials. The ingredient nourishes bifidobacteria, a beneficial bacteria in the gut microbiome that is connected with key areas of physical and mental health.

Per concludes: “As our business continues to grow and evolve, we are looking to where we can take the technology next that can make a positive impact on health, as well as establishing prosperous partnerships along the way. With an active healthcare professional engagement programme as a core part of our business, the time is right for us to explore this channel further. Prebiotics have so much potential to positively affect public and patient health, and we’re delighted to be leading the charge.”

To find out more about Clasado Biosciences, please visit www.clasado.com