Safety of L-alpha-glycerylphosphorylcholine (L-alpha-GPC) from soya phospholipids (lecithin) as a novel food pursuant to Regulation (EU) 2015/2283

Following a request from the European Commission, the EFSA Panel on Nutrition, Novel Foods and Food Allergens (NDA) was asked to deliver an opinion on L-alpha-glycerylphosphorylcholine (L-alpha-GPC) as a novel food (NF) pursuant to Regulation (EU) 2015/2283. The NF subject of the application is L-alpha-GPC produced by chemical means starting from phosphatidylcholine (PC) enriched soya lecithin and is available in two forms: a viscous liquid GPC 85% and a powder Alpha Size 100P. The identity, production process, composition and specifications of the NF do not raise safety concerns. The NF is proposed to be used in food supplements at a maximum use level of 203.7 mg/day, corresponding to 82.5 mg/day of choline. The target population comprises individuals above 3 years of age, including pregnant and lactating women. L-alpha-GPC is an endogenous metabolite of phosphatidylcholine, is rapidly absorbed and serves as source of choline. The Panel considers that consumption of the NF is not nutritionally disadvantageous. The safety data in laboratory animals submitted by the applicant show several limitations; however, a no observed adverse effect level (NOAEL) of 1000 mg/kg bw per day for a 90-day study and for maternal toxicity in a teratogenicity study could be derived from published studies. Based on the nature and absorption, distribution, metabolism and excretion (ADME) of the NF, the proposed use levels, the human data provided and the margin of Exposure (MoE), derived from the 90-day study and the teratogenicity study, for children > 3 years of age (111) and for adults (345), which the Panel considers as sufficient in this case, the Panel concludes that the NF does not raise safety concerns under the proposed conditions of use.