2009/355/EC: Commission Decision of 28 April 2009 authorising the placing on the market of lycopene oleoresin from tomatoes as novel food ingredient under Regulation (EC) No 258/97 of the European Parliament and of the Council (notified under document number C(2009) 3036)

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⁽¹⁾, and in particular Article 7 thereof,

Whereas:

1. On 7 September 2004 the company Ottaway & Associates Ltd. on behalf of the company LycoRed made a request to the competent authorities of the United Kingdom to place lycopene oleoresin from tomatoes on the market as a novel food ingredient; on 30 June 2005 the competent food assessment body of the United Kingdom issued its initial assessment report, in which it came to the conclusion that lycopene oleoresin from tomatoes is acceptable to be used in the proposed range of foodstuffs.

2. The Commission forwarded the initial assessment report to all Member States on 9 August 2005.

3. Within the 60-day period laid down in Article 6(4) of Regulation (EC) No 258/97 reasoned objections to the marketing of the product were raised in accordance with that provision; therefore the European Food Safety Authority (EFSA) was consulted on 13 September 2006 and issued its opinion on 24 April 2008.

4. In that opinion, EFSA came to the conclusion that lycopene may be safely used as a food ingredient for the proposed use; however, EFSA 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.

5. Meanwhile, following other requests for other uses of lycopene as novel food ingredient, EFSA came to the same conclusion; therefore, it appears appropriate to establish a list of foods acceptable for the addition of lycopene.

6. 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 the 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 laws of the Member States concerning food additives authorised for use in foodstuffs intended for human consumption⁽²⁾.

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

8. 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: