Kemin's BetaVia Pure gains positive EFSA opinion

06-Jun-2023 - Last updated on 06-Jun-2023 at 14:37 GMT

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The positive opinion from the European Food Safety Authority​, which also granted Kemin a five-year exclusivity in the European market, brings the BetaVia Pure closer to final Novel Food approval by the European Commission.

The BetaVia ingredient line, for immune support, is derived from the beta-glucan-rich Euglena gracilis​ algae, grown through a patented, sustainable fermentation process. The firm claims BetaVia Pure is the highest purity of beta-glucan currently available on the market, with greater than 95% beta 1,3 glucans.

BetaVia products are available globally, in the US, China and Japan, as well as in Brazil, Australia and Thailand where novel food authorisations have been also achieved.

Chris Sadewasser, global product manager at Kemin, says: "We are very pleased with the result of over 3 years of the extensive work done by our Regulatory and R&D teams which allows us to take a leading position in Europe's algae beta glucans market.

"Kemin finally achieved this remarkable milestone of having a positive novel food opinion on BetaVia Pure which would not have been possible without Kemin's proprietary safety data, granting us exclusivity in the European market for this product."

Filipa Quintela, Kemin's marketing manager EMEA, adds: "With the opinion, the full BetaVia product line will soon be available for the European market. BetaVia Pure and its water-dispersible form open the opportunity to formulate a new generation of postbiotics for immune and gut support with an ingredient that is neutral in terms organoleptic characteristics and requires a lower inclusion rate."

In 2019, E. gracilis was attributed the qualified presumption of safety (QPS) status with the qualification ‘for production purposes only’, which includes food products based on microbial biomass of the microalga. Based on the information provided, E. gracilis is not expected to survive the manufacturing process. The submitted toxicity studies did not raise safety concerns.

In 2020, BetaVia Complete was granted Novel Food status, making it the first and only ingredient derived from this strain to be approved as a novel food in Europe.

Kemin applied for NF status for its Pure ingredient in 2019, proposing to use the ingredient in food supplements, as an ingredient added to a number of food categories (yoghurts, cereal bars, juices, soft drinks, and meal replacement beverages) and in foods for total diet replacement for weight control.

In the USA, the ingredient has been marketed since 2019 as a food supplement and food ingredient. Sales figures were provided for 2020 and 2021. In 2021, the NF was authorised to be put on the market by the Brazilian Health Regulatory Agency (ANVISA).

Providing its scientific opinion to the European Commission, EFSA reported no adverse effects were observed in the subchronic toxicity studies, up to the highest dose tested, i.e. 5,000 mg NF/kg body weight per day.

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