Source

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)

Regulation (EC) No 258/97 · Decision · 5 articles

Data as of 2026-07-04 · Compiled from an official source version. Later amendments or repeals may not be reflected; the official text prevails. · Read the official text ↗

Article 1

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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

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The designation of citicoline authorised by this Decision on the labelling of the foodstuffs containing it shall be ‘citicoline’.

Article 3

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Information shall be given to the consumer that foods containing citicoline are not intended to be consumed by children.

Article 4

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This Decision is addressed to Kyowa Hakko Europe GmbH, Am Wehrhahn 50, 40211 Düsseldorf, Germany.

Supplementary provisions

SPECIFICATION OF CITICOLINE

ANNEXSupplementary provisions

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ANNEX SPECIFICATION OF CITICOLINE Definition : Citicoline 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: C 14 H 26 N 4 O 11 P 2 Molecular weight: 488,32 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 (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

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Source: EUR-Lex (Publications Office of the EU), © European Union, reuse permitted under Commission Decision 2011/833/EU.

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