BetaVia™ Complete from Kemin Granted Novel Food Approval in the European Union

The motion allows the first algae-sourced beta-glucan product for immunity to enter the marketplace in Europe

10-Dec-2020 - USA

Kemin Industries, a global ingredient manufacturer that strives to sustainably transform the quality of life every day for 80 percent of the world with its products and services, has announced that 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.

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BetaVia Complete 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, making it 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.

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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
Yoghurt beverages
Fruit and vegetable juices, nectars and fruit/vegetable blend juices (smoothies)
Fruit-flavoured drinks
Meal-replacement beverages
Food supplements

"With consumers adopting a holistic approach to health and becoming more prone to make diet and lifestyles changes in order to improve immunity, we are thrilled to now have BetaVia Complete officially available in Europe," said Filipa Quintela, Marketing Manager – Europe, Kemin Human Nutrition and Health.

BetaVia Complete contains greater than 50 percent beta 1,3 glucan, as well as proteins, fatty acids, vitamins, minerals and carotenoids, supporting the immune system in three distinct 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.

"EFSA conducted an extremely rigorous evaluation of the safety data on BetaVia Complete, and this tremendous achievement demonstrates the strength of the Novel Food dossier Kemin Human Nutrition and Health submitted to the European Commission," said Pedro Vieira, Vice President – Europe and Latin America, Kemin Human Nutrition and Health. "We are extremely excited to see the Commission Implementing Regulation published, which finally allows us to offer BetaVia Complete to the European market, one of the key markets for Kemin Human Nutrition and Health."

https://www.yumda.com/en/news/1169055/betavia-complete-from-kemin-granted-novel-food-approval-in-the-european-union.html