Citicoline: authorised novel food in the EU

Conditions of use and maximum levels

Table 1, column "Conditions under which the novel food may be used", as written:

• Food Supplements as defined in Directive 2002/46/EC: 500 mg/day
• Foods for special medical purposes as defined in Regulation (EU) No 609/2013: 250 mg per serving and a maximum daily consumption level of 1 000 mg

Additional specific labelling requirements

1. The designation of the novel food on the labelling of the foodstuffs containing it shall be ‘Citicoline’ 2. The labelling of foods containing citicoline shall bear a statement that the product is not intended to be consumed by children

Specification (Table 2)

Table 2 of the Annex, row with the same name, as written:

Description/Definition:

Citicoline is produced by a microbial process.

Citicoline is composed of cytosine, ribose, pyrophosphate and choline.

White crystalline powder

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/mol

CAS No.: 987-78-0

pH (sample solution of 1 %): 2,5-3,5

Purity:

Assay value: ≥ 98 % of dry matter

Loss on drying (100 °C for 4 hours): ≤ 5,0 %

Ammonium: ≤ 0,05 %

Arsenic: Not more than 2 ppm

Free phosphoric acids: ≤ 0,1 %

5′-Cytidylic acid: ≤ 1,0 %

Microbiological criteria:

Total plate count: ≤ 103 CFU/g

Yeast and moulds: ≤ 102 CFU/g

Escherichia coli: Absence in 1 g

Source and version

Implementing Regulation (EU) 2017/2470, Annex, Union list of novel foods, Table 1. Consolidated text of 10 August 2026. The text above is copied from that document without change except that amendment markers are removed. It is not advice and it does not decide whether a particular product is covered.

• Consolidated text on EUR-Lex

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