The novel food authorization, effective from April 30, follows a positive opinion granted by the European Food Safety Authority (EFSA) last June and covers use in food supplements for a range of age groups as well as within diet replacements for weight control and cereal bars for the general population.
The US-based global ingredient manufacturer uses a patented process to produce the algae strain with 95% beta 1,3 glucan (paramylon) for immune and gut support.
Claimed to be the highest purity beta-glucan currently available on the market, the ingredient offers a neutral odor and color and a small recommended dose for inclusion in numerous finished-product formats.
The firm said that its comprehensive proprietary data generated to establish the safety of BetaVia Pure led to a five-year exclusivity in the European Union market.
“The European Food Safety Authority conducted an extremely rigorous evaluation of the safety data on BetaVia Pure, and now receiving approval is a tremendous achievement that demonstrates the strength of the Novel Food dossier Kemin Human Nutrition and Health submitted to the European Commission,” said Pedro Vieira, vice president for Europe at Kemin Human Nutrition and Health. “We are extremely excited to see the Commission Implementing Regulation published, which finally allows us to offer BetaVia Pure to the European Union, one of the key markets for Kemin Human Nutrition and Health.”
History of regulation
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 microalgae. 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 novel food status for its Pure ingredient in 2019 for use in food supplements, as an ingredient added to a number of food categories (yogurts, cereal bars, juices, soft drinks and meal replacement beverages) and in foods for total diet replacement for weight control.
In the United States, it has been marketed since 2019 as a food supplement and food ingredient. Sales figures were provided for 2020 and 2021. In 2021, it received authorization as novel food from 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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