At the end of May, EFSA (the European Food Safety Authority) published a positive opinion on the safety of the novel food paramylon, paving the way for the authorisation of this microalgae-derived beta-glucan polymer for the European market.
This is the second positive novel food opinion relating to the safety of Euglena gracilis – a beta-glucan polysaccharide and single-cell microalgae that occurs widely in nature and is commonly found in freshwater habitats.
In 2020, EFSA assessed the safety of this microalgae as a dried, whole-cell biomass. The panel concluded that it was safe for use as a food supplement and food ingredient in a number of foods.
This latest assessment relates to paramylon, which is a linear, unbranched beta‐1,3‐glucan polymer that is isolated from E. gracilis.
Immunity-boosting supplements are driving demand for beta-glucan ingredients, with the majority of this demand being met by ingredients that are derived from baker’s yeast (Saccharomyces cerevisiae). These ingredients are a highly purified beta-1,3/1,6-glucan (which is different from the 1,3/1,4 structure of the cholesterol-lowing oat beta-glucan). Algae potentially offers a more concentrated source of beta-glucan (up to 95%, compared with 60-80% for purified yeast).
Both assessments were carried out in response to novel food applications submitted by Kemin Foods, which produces a line of E. gracilis algae beta-1,3-glucan ingredients. The EFSA opinion granted Kemin a five-year exclusivity period for the European market, on the grounds that it could not have reached the conclusion on the safety of the novel food without certain data claimed as proprietary by Kemin.
While algae is commonly grown in open ponds, the algae that was the subject of the novel food assessments is grown in a controlled, closed system with no organic solvents.
An optimised, vertically integrated and patented fermentation process produces beta-glucan at concentrations of greater than 50% (or 95% for high-purity lines). This algae also has the capacity for storing energy in free-floating granules called paramylon, made exclusively of beta-1,3-glucans.
Paramylon's technical attributes and health benefits
The beta-glucan structure is said to be uniform and stable, meaning it can be added to many applications where high temperatures and pressures are used, such as gummy manufacturing or tableting, as well as more traditional capsules and powdered drink mixes.
In a 2019 study published in the journal Nutrients, researchers concluded that supplementation with a proprietary E. gracilis fermentate containing greater than 50% beta-1,3-glucan may reduce and prevent upper respiratory tract infection (URTI) symptoms, providing immune support and protecting overall health.
Thirty-four healthy, active adults took part in the randomised, double-blind, placebo-controlled 90-day trial. Those who took the E. gracilis supplement reported 3.3 fewer sick days, 70% fewer upper respiratory tract infection (URTI) symptoms, 10 fewer URTI symptom days, and 80% significantly lower overall severity of URTI symptoms compared with the placebo group.
Other preclinical studies and unpublished clinical studies have also indicated potential benefits for immunity and digestive health.
Which applications offer the greatest market potential?
E. gracilis has a history of use in food in China, Japan, and the USA. In Japan, for example, it is marketed as an ingredient in cookies, cereal bars, and nutritional drinks.
The EFSA opinion relates to the use of paramylon in cereal bars, yoghurt and yoghurt drinks, fruit and vegetable juices and nectars, soft drinks (with minor amounts of fruit or flavourings), meal replacement beverages, and food supplements.
Given that most functional ingredients become established via the supplements route before progressing into food products, it looks likely that immunity and/or digestive supplements will be one of the main applications for the ingredient – initially at least.
