Clasado Bioscience lands EFSA positive opinion on Bimuno prebiotic novel food status

04 May 2022 --- Clasado Biosciences has received European Food Safety Authority (EFSA) approval extending the novel food status for galactooligosaccharides (GOS) as a novel food in food for special medical purposes (FSMP) across the EU.

EFSA’s approval paves the way for Clasado’s Bimuno GOS to be used in future FSMPs for the nutritional management of hospitalized patients with impaired gastrointestinal problems. This is in collaboration with GLNP Life Sciences, a specialist FSMP producer in Europe.

“The opinion published in the EFSA Journal centers around indirectly tackling malnutrition in hospitalized patients where gut microbiome dysbiosis is a common factor; fiber content is key and as a prebiotic substrate, Bimuno GOS certainly fits the bill,” says Per Rehné, CEO of Clasado Biosciences.

Feeling impact of authorization
EFSA’s approval follows the opinion released earlier this year titled “Safety of the extension of the use of galactooligosaccharides as a novel food in food for specific medical purposes under Regulation (EU) 2015/2283”.

The EU food authority examined the safety of prebiotic GOS, in this case, Bimuno GOS, as a new product with the goal of using it in FSMP applications after receiving a request from the European Commission.

“Following an eventual authorization from the Commission, we can hopefully affect more positive change across the spectrum of health and well-being,” adds Rehné. “This positive opinion is a fantastic step forward, whereby we appreciate GLNP’s efforts in helping to unlock Bimuno GOS potential in FSMPs.”

Bimuno GOS potential explored
According to Glasado, Bimuno GOS is backed by research, including more than 20 clinical trials and provides maximum stability for formulators. Bifidobacteria, a beneficial bacteria found in the gut microbiome, are linked to essential physical and mental health aspects.

The EFSA opinion may result in the Commission’s approval of Bimuno GOS use in FSMPs soon.“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,” adds Rehné.

“Bimuno is already building a firm name for itself in the global health supplement and functional food market as consumers worldwide look to the importance of rebalancing their gut microbiome due to various causes of dysbiosis backed by credible scientific and clinical evidence.”

Using prebiotics in the FSMP category is a good prospect for prebiotics to play a vital role in the European market, explains Gijs Roozendaal, general manager at GLNP Food Sciences.

“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.”

Prebiotics have so much potential to positively affect public and patient health, and we’re delighted to be leading the charge,” adds Rehné.

Prebiotic potential proliferates
Emphasizing the rise in prebiotic use, Rehné says: “When we consider that the gut bacteria are connected with areas such as digestive health, immunity and cognition, it’s no surprise that prebiotics is coming into focus.”

A Clasado exec previously told NutritionInsight that the North American food manufacturing sector brings abundant prebiotics possibilities, especially in functional foods. The prebiotic company also noted that gut-health-focused athletic supplements are becoming an “entirely new” segment within sports and nutrition products.

A previous study conducted by the University of Nottingham unveiled that Clasado’s Bimuno prebiotic could lower the severity of Hyperpnoea-Induced Bronchoconstriction (EIB), a frequent health concern for athletes.

By Nicole Kerr