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)

• CELEX: Regulation (EC) No 258/97
• Articles: 5

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.

Schedules & Appendices

ANNEX SPECIFICATION OF CITICOLINE

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