Conclusions reached by the Panel put to bed previous concerns its use could increase diabetes mellitus risk and inflammatory disorders such as Crohn's disease and rheumatoid arthritis.
In its latest evaluation, EFSA stated that “based on the overall toxicological data the no-observed-adverse-effect level (NOAEL) of 800 mg/kg bw per day pertains to pregnant and breastfeeding women as well as to young children (i.e. toddlers) and infants.”
Maximum anticipated daily intakes of consuming l-ergothioneine as a novel food, in addition to the background diet, were also calculated: 2.82 milligrams per kilogram body weight per day (mg/kg/bw/day) for infants, 3.39 mg/kg bw per day for toddlers and 1.31 mg/kg bw per day for adults including pregnant and breastfeeding women.
The decision follows concerns raised earlier this year by some Member States, regarding the potential for exposure of the excluded population subgroups to the novel food (NF).
They argued that in real life situations it would be difficult to ensure that those products (e.g. chocolate, dairy products) would not be consumed by the excluded subgroups.
EFSA referred back to a novel food approval submitted back in November 2016 by French firm Tetrahedron for its antioxidant marketed under the name Ergoneine.
EFSA found “no relationships” between consuming l-ergothioneine supplements and fortified foods and the risk of developing diabetes mellitus, Crohn's disease or rheumatoid arthritis.
The Dietetic Products, Nutrition and Allergies (NDA) panel expressed no concerns regarding genotoxicity at the proposed daily doses of 30 mg per day for adults and 20 mg per day for children in food supplements and foods like non-alcoholic drinks, cereal bars, milk, fresh dairy and chocolate.
Building on this finding, the Panel’s latest assessment concluded that “These population groups (infants, young children (i.e. toddlers) and pregnant and breastfeeding women) can reasonably be expected not to consume the NF as a food supplement owing to labelling provisions”.
L-ergothioneine was first extracted as a natural compound from the fungi rye ergot (Claviceps purpurea) in 1909. It is naturally present in small amounts in food sources like mushrooms, some varieties of black and red beans (Phaseolus vulgaris) and cereals.
Speaking to NutraIngredients-USA back in January, Jan Trampota, CEO of L-ergothioneine (aka EGT) supplier Mironova Labs described the compound as “uniquely powerful and versatile”, explaining that the EGT-transporter is expressed in cells and tissues sensitive to aging forces such as inflammation and free radical damage.
“This indicates that EGT’s antioxidant protection in those cells is critically important to their survival,”he added.
Spokesperson for Tetrahedron Benoit Turpin, also added to the discussions anticipating that as formulators and end users became more knowledgeable about its physiological benefits, “it will start getting used in body system specific formulations such cardiovascular, cognitive, sports, joints, anti-aging, eye health and skin health products”.
Research into this ingredient has been steadily gathering over the past ten years with a notable review published last year suggesting that ergothioneine build up in the body was a way of minimising oxidative damage.
More research put forward the notion that ergothioneine levels seen in elderly populations may be a risk factor for neurodegeneration.
“Following absorption via a specific transporter, OCTN1, ergothioneine (ET) may accumulate preferentially in tissues predisposed to higher levels of oxidative stress and inflammation,” the researchers wrote.
“We found that whole blood ET levels in elderly individuals decline significantly beyond 60 years of age. Additionally, a subset of these subjects with mild cognitive impairment had significantly lower plasma ET levels compared with age-matched subjects.
“This decline suggests that deficiency in ET may be a risk factor, predisposing individuals to neurodegenerative diseases.”