# Commission Decision of 28 April 2009 authorising the placing on the market of lycopene from Blakeslea trispora as a novel food ingredient under Regulation (EC) No 258/97 of the European Parliament and of the Council (notified under document number C(2009) 3039) (Only the Spanish text is authentic) (2009/365/EC), Introduction: Introductory text

Extent: E+W+S+N.I.

Commission Decision
of 28 April 2009
authorising the placing on the market of lycopene from Blakeslea trispora as a novel food ingredient under Regulation (EC) No 258/97 of the European Parliament and of the Council
(notified under document number C(2009) 3039)
(Only the Spanish text is authentic)
(2009/365/EC)
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, and in particular Article 7 thereof,
Whereas:
(1)
On 30 August 2007 the company Vitatene made a request to the competent authorities of the United Kingdom to place lycopene from Blakeslea trispora on the market as a novel food ingredient; on 17 October 2007 the competent food assessment body of the United Kingdom issued its initial assessment report. In that report it came to the conclusion that, in the light of other pending applications concerning 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.
(2)
The Commission forwarded the initial assessment report to all Member States on 11 February 2008.
(3)
The European Food Safety Authority was consulted and issued its opinion on 4 December 2008.
(4)
In its opinion EFSA came to the conclusion, because lycopene may undergo oxidative changes, it needs to be formulated as suspensions in edible oils, directly compressible or water dispersible powders. Sufficient antioxidative protection has to be ascertained.
(5)
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 also 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.
(6)
On the basis of the scientific assessment, it is established that the lycopene from Blakeslea trispora complies with the criteria laid down in Article 3(1) of Regulation (EC) No 258/97.
(7)
The company Vitatene agreed that Commission Decision 2006/721/EC will be repealed.
(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:

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Source: https://www.legislation.gov.uk/eudn/2009/365/introduction (the official version)
Page: https://openlegislation.uk/eu-decision-2009-365/introduction
Contains public sector information licensed under the Open Government Licence v3.0. Source: legislation.gov.uk, The National Archives.