‘Citicoline’ and support of the memory function: Evaluation of a health claim pursuant to Article 13(5) of Regulation (EC) No 1924/2006

AbstractFollowing an application from Egde Pharma Sp. z o.o, submitted for authorisa-tion of a health claim pursuant to Article 13(5) of Regulation (EC) No 1924/2006via the Competent Authority of Poland, the EFSA Panel on Nutrition, Novel Foodsand Food Allergens (NDA) was asked to deliver an opinion on the scientific sub-stantiation of a health claim related to citicoline and memory. The Panel considersthat the food, citicoline (cytidine 5-diphosphocholine, CDP- Choline) inner salt, issufficiently characterised. Improvement, maintenance or reduced loss of memoryis a beneficial physiological effect for middle-aged or elderly adults encounter-ing age-associated subjective memory impairment. The applicant identified threepertinent human intervention studies in healthy individuals that investigated theeffect of citicoline on memory. In weighing the evidence, the Panel took into ac-count that only one randomised controlled trial in healthy participants showed abeneficial effect of citicoline on episodic memory when consumed at doses of 500mg/day for 12 weeks, whereas this effect has not been observed in another studyusing citicoline at doses of 1 g/day for 3 months or supported by data obtainedin patients with dementia using doses of 1 g/day for 12 weeks and 12 months. Noconvincing evidence of a plausible mechanism by which citicoline or any of itscomponents (in addition to their endogenous synthesis) could exert an effect onmemory in humans has been provided. The Panel concludes that a cause-and-effect relationship has not been established between the consumption of citico-line (CDP- Choline) inner salt and improvement, maintenance or reduced loss ofmemory in middle-aged or elderly adults encountering age-associated subjectivememory impairment.