
Article 1 
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 1 000 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.
Article 2 
The designation of citicoline authorised by this Decision on the labelling of the foodstuffs containing it shall be ‘citicoline’.
Article 3 
Information shall be given to the consumer that foods containing citicoline are not intended to be consumed by children.
Article 4 
This Decision is addressed to Kyowa Hakko Europe GmbH, Am Wehrhahn 50, 40211 Düsseldorf, Germany.
Done at Brussels, 1 July 2014.
For the Commission
Tonio BORG
Member of the Commission
ANNEX

DefinitionCiticoline is composed of cytosine, ribose, pyrophosphate and choline.
Chemical name: Choline cytidine 5′-pyrophosphate, Cytidine 5′-(trihydrogen diphosphate) P′-[2-(trimethylammonio)ethyl]ester inner salt
Chemical formula: C14H26N4O11P2
Molecular weight: 488,32 g/molDescriptionWhite crystalline powder.Identification
CAS No 987-78-0
pH (sample solution of 1 %) 2,5-3,5Purity
Assay value Not less than 98 % of dry matter
Loss on drying (100 °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 %
5′-Cytidylic acid Not more than 1,0 %Microbiological criteria
Total plate count Not more than 1 000 cfu/g
Yeast and moulds Not more than 100 cfu/g
Escherichia coli Absent in 1 g
