Safety of betaine as a novel food pursuant to Regulation (EC) No 258/97

Abstract

Following a request from the European Commission, the EFSA Panel on Dietetic Products, Nutrition and Allergies (NDA) was asked to deliver an opinion on betaine as a novel food (NF) pursuant to Regulation (EC) No 258/97. The information provided on the composition, the specifications, the batch-to-batch variability, stability and production process of the NF is sufficient and does not raise concerns about the safety of the NF. The NF is proposed to be used in foods intended to meet additional requirements for intense muscular effort with a maximum intake of 2.5 g/day of betaine for sports people above 10 years of age. Based on the lowest BMDL 05 , which was derived from a chronic toxicity study in rats in which a dose-related increase in platelet counts was observed, and the anticipated daily intake of the NF in the target population, the Margins of Exposure are 3.6 and 5, which are generally regarded as not sufficient. However, the total exposure to betaine from the diet (about 830 mg/day) is not known to be associated with adverse effects. Moreover, no adverse effects on platelet counts were noted in human intervention studies with exposure levels of 4 g/day of betaine for up to 6 months. A significant increase in total and low-density lipoprotein (LDL)-cholesterol concentrations was noted at intakes of 4 g/day of betaine in overweight subjects with metabolic syndrome but not in healthy subjects, nor at intakes of 3 g/day. Thus, considering 4 g/day of betaine as a reference point and applying an uncertainty factor of 10 to account for interindividual variability, an amount of 400 mg/day of betaine in addition to the background exposure is considered as safe. The Panel considers that the NF is safe to be used at maximum intake of 400 mg/day in the target population.

Safety of betaine as a novel food pursuant to Regulation (EU) 2015/2283

“…In 2017, in its scientific opinion on betaine, the Panel concluded that an amount up to 6 mg/kg bw per day of betaine in addition to the intake from the background diet is considered safe (EFSA NDA Panel, 2017).…”

“…The Panel notes 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, i.e. 6 mg/kg bw per day in addition to the intake from the background diet (EFSA NDA Panel, 2017).…”

“…On 25 October 2017, the EFSA NDA Panel adopted the scientific opinion on the safety of betaine as a NF when added to a variety of foods (EFSA NDA Panel, 2017). In that scientific opinion, the Panel concluded that an amount up to 6 mg/kg bw per day of betaine in addition to the intake from the background diet is considered as safe.…”

“…6 mg/kg bw per day in addition to the intake from the background diet (EFSA NDA Panel, 2017). 6 mg/kg bw per day in addition to the intake from the background diet (EFSA NDA Panel, 2017).…”

In Vitro Genotoxicity Assessment of Functional Ingredients: Betaine, Choline, and Taurine

“…Regarding betaine, addition to beverages, cereal products, confectionary, or dairy products in the EU was firstly intended fifteen years ago, but the available data were not sufficient to rule out the safety concerns (Table 2) [19]. Nonetheless, recent scientific opinions of the European Food Safety Authority (EFSA) expressed no safety concerns to the addition of betaine in novel foods for intense muscular effort, foods for sportsmen, weight control, and special medical purposes, under determined conditions (Table 2) [2,20]. This has led to its inclusion in the positive list of authorized novel foods [21].…”