Safety of citicoline

Following a request from the European Commission, the EFSA Panel on Dietetic Products, Nutrition and Allergies (NDA) was asked to deliver a scientific opinion on citicoline as a novel food ingredient in the context of Regulation (EC) No 258/97. The novel food ingredient (NFI), citicoline, is choline cytidine 5’-pyrophosphate (C14H26N4O11P2) with a minimum purity of 98.0 %. The stability, specification and production process of the NFI do not raise safety concerns. Citicoline is intended to be used in food supplements aimed at a target population of middle-aged to elderly adults, at a maximum level of 500 mg/day, and in foods for particular nutritional uses, specifically foods for special medical purposes, at a maximum level of 250 mg/serving, and with a maximum daily intake from these types of foods of 1 000 mg/day. Citicoline is readily hydrolysed on ingestion, breaking down to choline and cytidine, which are normal body constituents that then undergo further metabolism and incorporation into normal pathways of metabolism. The Panel considers that consumption of the NFI is not nutritionally disadvantageous. Available human studies do not raise safety concerns under the proposed conditions of use. The additional data presented by the applicant on safety in laboratory animals, although incomplete by modern standards, provides further reassurance on the safety of the NFI. The Panel concludes that the NFI, citicoline, is safe under the proposed uses and use levels.