2014/423/EU: Commission Implementing Decision of 1 July 2014 authorising the placing on the market of citicoline as a novel food ingredient under Regulation (EC) No 258/97 of the European Parliament and of the Council (notified under document C(2014) 4252)
Data as of 2026-07-04 Β· Compiled from an official source version. Later amendments or repeals may not be reflected; the official text prevails. Β· Read the official text β
Citicoline as specified in the Annex may be placed on the market in the Union as a novel food ingredient in food supplements with a maximum dose of 500 mg per day and in dietary foods for special medical purposes with a maximum dose of 250 mg per serving and with a maximum daily consumption level of 1Β 000 mg from these types of foods without prejudice to Directive 1999/21/EC and Directive 2002/46/EC. Citicoline shall not be used in foods intended to be consumed by children.
The designation of citicoline authorised by this Decision on the labelling of the foodstuffs containing it shall be βciticolineβ.
Information shall be given to the consumer that foods containing citicoline are not intended to be consumed by children.
This Decision is addressed to Kyowa Hakko Europe GmbH, Am Wehrhahn 50, 40211 DΓΌsseldorf, Germany.
SPECIFICATION OF CITICOLINE
ANNEX SPECIFICATION OF CITICOLINE Definition : Citicoline is composed of cytosine, ribose, pyrophosphate and choline. Chemical name: Choline cytidine 5β²-pyrophosphate, Cytidine 5β²-(trihydrogen diphosphate) Pβ²-[2-(trimethylammonio)ethyl]ester inner salt Chemical formula: C 14 H 26 N 4 O 11 P 2 Molecular weight: 488,32Β g/mol Description : White crystalline powder. Identification : CAS No 987-78-0 pH (sample solution of 1 %) 2,5-3,5 Purity : Assay value Not less than 98 % of dry matter Loss on drying (100Β Β°C for 4 hours) Not more than 5,0 % Ammonium Not more than 0,05 % Total heavy metals (as Pb) Not more than 10 ppm Arsenic Not more than 2 ppm Free phosphoric acids Not more than 0,1 % 5β²-Cytidylic acid Not more than 1,0 % Microbiological criteria : Total plate count Not more than 1Β 000 cfu/g Yeast and moulds Not more than 100 cfu/g Escherichia coli Absent in 1 g
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