The immune ingredient Yestimun® Beta-Glucan finally achieved a new regulatory status. After being sold for 15 years officially as normal food ingredient, the regulatory status now changed to “Novel Food”.
During the last years some beta-glucans have been sold as normal food while others have been categorized as Novel Food ingredient. This caused lots of regulatory discrepancies and discussions with authorities and customers. To have an equal competition with other Novel Food registered beta-glucans and to make the regulatory aspects easier and better understandable, Leiber GmbH finally decided to make a Novel Food application for Yestimun® as well.
“There have been several reasons for making an own full application and not just a substantial equivalence”, explained Eike Hagemann, Business Unit Director Health at Leiber GmbH. “The most important aspect was to expand the use levels and food categories for Yestimun® in comparison to already authorized yeast beta-glucans.”
The own Novel Food application for Yestimun® includes use levels up to 1500 mg per day in food supplements. These dosages are safe and give more possibilities for different product concepts. “The new Novel Food approval will make regulatory issues easier for our customers, especially in countries, where the authority’s opinion has been a big challenge before”, says Hagemann.
Now the regulatory status is officially confirmed by the European Authorities and should be accepted everywhere (Commission Implementing Decision (EU) 2017/2078). Furthermore the process of Novel Food Authorization also included a complete safety assessment of Yestimun® and confirms the high quality and safety of the ingredient for functional food and supplement applications. In combination with the ongoing interest and trend to immune supporting products we can look forward to new interesting products including the immune ingredient Yestimun® from brewers’ yeast.
Willows Ingredients are the Authorized Distributor for Yestimun® in the UK and Ireland.