Introductory text

THE COMMISSION OF THE EUROPEAN COMMUNITIES,

Having regard to the Treaty establishing the European Community,

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^f1, and in particular Article 7 thereof,

Whereas:

On 18 July 2008 the company DSM Nutritional Products Ltd. made a request to the competent authorities of Ireland to place synthetic lycopene on the market as a novel food ingredient; on 6 October 2008 the competent food assessment body of Ireland issued its initial assessment report. In that report it came to the conclusion that, in the light of other pending applications concerning lycopene, for synthetic lycopene an additional assessment is required in order to assure that an authorisation for use of the different lycopenes as novel food ingredients is granted under the same terms.

The Commission forwarded the initial assessment report to all Member States on 22 October 2008.

On 4 December 2008 EFSA adopted the ‘Scientific Opinion of the Scientific Panel on dietetic Products, Nutrition and Allergies on a request from the Commission related to the safety of lycopene from Blakeslea trispora Cold Water Dispersion (CWD)’. This opinion came to the conclusions that lycopene preparations intended for use in foods and food supplements are formulated as suspensions in edible oils, direct compressible or water-dispersible powders. As lycopene may undergo oxidative changes in such formulations, sufficient antioxidative protection should be ascertained.

EFSA also concluded that the consumption of lycopene by the average user will stay below the Acceptable Daily Intake (ADI), but that some users of lycopene may exceed the ADI. Therefore, it appears appropriate to collect intake data for a number of years following the authorisation in order to review this authorisation in the light of any further information on the safety of lycopene and its consumption. Particular attention should be given to the collection of data regarding levels of lycopene in breakfast cereals. However, this requirement under the present Decision, applies to the use of lycopene as a novel food ingredient and not to the use of lycopene as a food colour, that falls within the scope of Council Directive 89/107/EEC of 21 December 1988 on the approximation of the laws of the Member States concerning food additives authorised for use in foodstuffs intended for human consumption^f2.

On the basis of the scientific assessment, it is established that the synthetic lycopene complies with the criteria laid down in Article 3(1) of Regulation (EC) No 258/97.

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: