EFSA’s warning takes into account its 2017’s decision that concludes betaine as a novel food (NF) is safe to be used at a maximum intake level of six milligrams per kilogram (mg/kg) body weight per day.
EFSA’s Panel on Nutrition, Novel Foods and Food Allergens (NDA) ruled this value is in addition to the intake from the background diet.
“The intake assessment of betaine based on the new proposed uses and use levels indicated that the mean and high‐level (95th percentile) estimated intakes of betaine for the general population do not exceed the safe level of intake as previously established by the NDA Panel.
“The Panel considers the NF as safe, at the new proposed uses and use levels in the general population.”
Sports nutrition supplements
The main issue stems from the Panel’s observations noting consumption of some of the food supplements containing betaine currently on the EU market could, on their own, result in intakes of betaine higher than those considered safe by the Panel.
These sports-nutrition supplements include protein and cereal bars targeted to athletes (500mg/100g), total diet replacement foods for weight control (500g (bar) and foods for Special Medical Purposes, excluding foods for infants and young children (400 mg/day).
“Regarding ‘Foods for Special Medical Purposes’, the Panel considers that the proposed maximum daily intake of 400 mg/day is safe for adults only, as for individuals below 18 years of age the proposed maximum daily intake exceeds the safe level of 6 mg/kg body weight (bw),” the document stated.
Background to decision
According to EFSA, On DuPont Nutritional Biosciences submitted a request on 2 November 2018 to the European Commission requesting betaine be placed on the EU market as a NF.
The application contains revised use and intake concentrations for betaine as a NF aligned with the maximum level of 400 mg/day deemed to be safe by EFSA. Here, the European Commission asked EFSA to provide its scientific opinion.
This latest action follows a request in 2015, in which DuPont asked Finnish authorities to place betaine on the EU market as a NF ingredient. Similarly, the Commission requested EFSA to assess the safety of betaine as a NF ingredient.
EFSA concluded on 25 October 2017, that betaine posed no safety concerns if the total daily intake from all uses did not exceed 400 mg/day.
