Scientific Opinion on the Safety of “Citicoline” as a Novel Food Ingredient1

EFSA Journal 2013;11(10):3421

SCIENTIFIC OPINION

Scientific Opinion on the safety of “citicoline” as a Novel Food ingredient1

EFSA Panel on Dietetic Products, Nutrition and Allergies (NDA)2, 3

European Food Safety Authority (EFSA), Parma, Italy

ABSTRACT

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.

© European Food Safety Authority, 2013

KEY WORDS

citicoline, CDP-choline, novel food, ingredient

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On request from the European Commission, Question No EFSA-Q-2013-00080, adopted on 10 October 2013.

Panel members:...