# 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) (Only            the German text is authentic) (2014/423/EU)         

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U.K.

# 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)*

# (Only the German text is authentic)

# (2014/423/EU)

THE EUROPEAN COMMISSION,

Having regard to the Treaty on the Functioning of the European Union,

Having regard to Regulation (EC) No 258/97 of the European Parliament and of the Council of 27 January 1997 concerning novel                           foods and novel food ingredients(1), and in particular Article 7 thereof,                        

Whereas:

(1)On 29 March 2012, the company Kyowa Hakko Europe GmbH made a request to the competent authorities of Ireland to place citicoline                              on the market as a novel food ingredient.

(2)On 2 June 2012, the competent food assessment body of Ireland issued its initial assessment report. In that report it came                              to the conclusion that citicoline for use in certain foods at the levels proposed by the applicant meets the criteria set                              out in Article 3(1) of Regulation (EC) No 258/97.

(3)On 10 July 2012, the Commission forwarded the initial assessment report to the other Member States.

(4)Reasoned objections were raised within the 60-day period laid down in the first subparagraph of Article 6(4) of Regulation                              (EC) No 258/97. In addition, some Member States explained in their objections that they consider products containing citicoline                              sodium salt to be a medicinal product.

(5)On 27 November 2012, the applicant informed the Commission that its application was modified to seek only approval for the                              use of citicoline in food supplements at a maximum level of 500 mg/day, and in food for particular nutritional uses, specifically                              foods for special medical purposes, at a maximum level of 250 mg/serving and a maximum daily consumption level of 1 000 mg                              from these types of foods. These products are aimed at adults and are not intended to be consumed by children.

(6)On 15 January 2013, the Commission consulted the European Food Safety Authority (EFSA) asking it to carry out an additional                              assessment for citicoline as food ingredient in accordance with Regulation (EC) No 258/97.

(7)On 10 October 2013, EFSA adopted a Scientific Opinion on the safety of ‘citicoline’ as a Novel Food ingredient(2), concluding that it is safe under the proposed uses and use levels.

(8)The opinion gives sufficient grounds to establish that citicoline in the proposed uses and use levels complies with the criteria                              laid down in Article 3(1) of Regulation (EC) No 258/97.

(9)In its opinion, EFSA also considered that citicoline may interact with specific medicines and should therefore not be administered                              together with those medicines. Directive 2001/83/EC of the European Parliament and of the Council(3) applies where a product, taking into account all its characteristics, may fall both within the definition of ‘medicinal product’                              as laid down in Article 1(2) of that Directive and within the definition of a product covered by Regulation (EC) No 258/97.                              In that respect, where a Member State establishes in accordance with Directive 2001/83/EC that a product is a medicinal product,                              it may restrict the placing on the market of that product in accordance with Union law.

(10)Commission Directive 1999/21/EC(4) lays down requirements on dietary foods for special medical purposes. The use of citicoline should be authorised without                              prejudice to the requirements of that legislation.

(11)Directive 2002/46/EC of the European Parliament and of the Council(5) lays down requirements on food supplements. The use of citicoline should be authorised without prejudice to the requirements                              of that legislation.

(12)The measures provided for in this Decision are in accordance with the opinion of the Standing Committee on the Food Chain                              and Animal Health,

HAS ADOPTED THIS DECISION:

# Article 1U.K.

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 2U.K.

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

# Article 3U.K.

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

# Article 4U.K.

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*                            

## ANNEXU.K.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: C14H26N4O11P2                      

Molecular weight: 488,32 g/mol

**Description**

:

White crystalline powder.

**Identification**

:

**Purity**

:

**Microbiological criteria**

:

1

OJ L 43, 14.2.1997, p. 1.                           

2

EFSA Journal 2013; 11(10):3421.

3

Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to medicinal                              products for human use (OJ L 311, 28.11.2001, p. 67).                           

4

Commission Directive 1999/21/EC of 25 March 1999 on dietary foods for special medical purposes (OJ L 91, 7.4.1999, p. 29).                           

5

Directive 2002/46/EC of the European Parliament and of the Council of 10 June 2002 on the approximation of the laws of the                              Member States relating to food supplements (OJ L 183, 12.7.2002, p. 51).