• Open Access

Scientific Opinion on the safety of “citicoline” as a Novel Food ingredient


  • EFSA Panel on Dietetic Products, Nutrition and Allergies (NDA)

  • Panel members: Carlo Agostoni, Roberto Berni Canani, Susan Fairweather-Tait, Marina Heinonen, Hannu Korhonen, Sébastien La Vieille, Rosangela Marchelli, Ambroise Martin, Androniki Naska, Monika Neuhäuser-Berthold, Grażyna Nowicka, Yolanda Sanz, Alfonso Siani, Anders Sjödin, Martin Stern, Sean (J.J.) Strain, Inge Tetens, Daniel Tomé, Dominique Turck and Hans Verhagen
  • Correspondence: nda@efsa.europa.eu
  • Acknowledgement: The Panel wishes to thank the members of the Working Group on Novel Foods: Paul Brantom, Karl-Heinz Engel, Marina Heinonen, Hannu Korhonen, Rosangela Marchelli, Bevan Moseley, Monika Neuhäuser-Berthold, Annette Pöting, Morten Poulsen, Seppo Salminen, Josef Schlatter, Hendrik Van Loveren and Hans Verhagen for the preparatory work on this scientific opinion.
  • Adoption date: 10 October 2013
  • Published date: 24 October 2013
  • Question number: EFSA-Q-2013-00080
  • On request from: European Commission


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.