In a statement, the Iowa-based firm revealed details of the motion, which includes a five-year exclusivity on sales of the product ‘BetaVia Complete’ within the European Union.
“EFSA conducted a rigorous evaluation of the safety data on BetaVia Complete,” says Pedro Vieira, Vice President – Europe and Latin America, Kemin Human Nutrition and Health.
“This achievement demonstrates the strength of the Novel Food dossier Kemin Human Nutrition and Health submitted to the European Commission.
"We are 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."
BetaVia Complete is the firm’s algae-sourced beta-glucan ingredient that is manufactured through a patented process using a proprietary strain of algae, Euglena gracilis ATCC PTA-123017.
The ingredient is said to offer immune support as Kemin submitted plans to the EC for dried whole cell Euglena gracilis to be used in food supplements and in total diet replacement for weight control in adults.
Maximum levels permitted by the EC includes 375 milligrams per day (mg/day) for adults, 100mg/day for young children, 150mg/day for children from 3 to 9 years of age, 225mg/day for children from 10 years of age and adolescents to 17 years of age.
The submitted plans to the EC for dried whole cell Euglena gracilis also include use in food categories that include breakfast, granola and protein bars; yoghurt; yoghurt beverages; fruit juices, smoothies and nectars, vegetable juices; fruit-flavoured drinks; meal replacement beverages.
"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," adds Filipa Quintela, Marketing Manager – Europe, Kemin Human Nutrition and Health.
The EC’s decision brings the application process to a successful conclusion after EFSA provided its positive Novel Food opinion for the ingredient back in May of this year.
The Novel Food is essentially the dried biomass of the microalga Euglena gracilis, that is produced by fermentation of which its major constituent (over 50%) is a β‐glucan polysaccharide.
Further nutritional analysis of the ingredient found that along with the high content of β‐1,3‐glucan it contains protein (about 20%), fat (about 8%), ash (about 4%) and moisture (about 4%).
Kemin also provided information on sugar profiles and concentrations of vitamins (C, E, D2, D3, K) and minerals, fatty acids, carotenoids and amino acids.
The Panel considers that taking into account the composition of the NF and the proposed conditions of use the consumption of the NF is not ‘nutritionally disadvantageous.’