Home Authority & Legal Europe: EC approves sale of Kemin Industries’ algae-sourced beta-glucan ingredient

Europe: EC approves sale of Kemin Industries’ algae-sourced beta-glucan ingredient

The European Commission has approved BetaVia Complete to be placed on the market in the European Union with five-year exclusivity on sales of the product.

The product by Kemin Industries is an algae-sourced beta-glucan ingredient for year-round immune support that is manufactured through a patented process using a proprietary strain of algae, Euglena gracilis ATCC PTA-123017.

It is reportedly the first and only ingredient derived from this strain to be approved as a novel food in Europe.

In late 2018, Kemin Human Nutrition and Health submitted a Novel Food dossier for BetaVia Complete to the European Commission.

The submission included exclusive data generated by and belonging to Kemin that demonstrated the safety of BetaVia Complete, which was crucial in the European Food Safety Authority (EFSA) positively assessing the safety of BetaVia Complete (dried Euglena gracilis algae) as a novel food pursuant to Regulation (EU) 2015/2283. EFSA’s positive opinion was published in May 2020.

On December 2, 2020, following discussion and a favorable vote on September 21, from all member states at the Standing Committee on Plants, Animals, Food and Feed, the European Commission published the implementing regulation that authorizes BetaVia Complete to be placed on the market in the European Union and grants Kemin five-year exclusivity on sales of BetaVia Complete in the European Union.

The Commission Implementing Regulation includes usage for a range of age groups – from young children one year of age and up to adulthood – and allows for dried Euglena gracilis to be used as a novel food in food supplements, diet replacements for weight control and a number of food categories for the general population.

These food categories include breakfast, granola and protein bars, yoghurt beverages and meal-replacement beverages.

BetaVia Complete contains more than 50% beta 1,3 glucan, as well as proteins, fatty acids, vitamins, minerals and carotenoids, supporting the immune system in three ways:

– Priming innate immune cells, the body’s first line of natural defense
– Fueling the growth of beneficial “good bacteria” – including Lactobacillus and Bifidobacteria – in the gut microbiota, which hosts most of the body’s immune cells
– Protecting the health of intestinal cells, which are essential in maintaining the integrity of the gastrointestinal tract so it can act as a protective physical barrier and immune shield

These beneficial immune effects are supported by clinical and preclinical research on the respiratory and gastrointestinal tract.