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THE COMMISSION OF THE EUROPEAN COMMUNITIES,
Having regard to the Treaty establishing the Europeån 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 30 October 2003 Vitatene Antibiotics SAU made a request to the competent authorities of the United Kingdom to place lycopene from Blakeslea trispora on the market as a novel food or novel food ingredient.
(2) On 6 April 2004 the competent food assessment body of the United Kingdom issued its initial assessment report. In that report it came to the conclusion that the proposed uses for lycopene from Blakeslea trispora are safe for human consumption.
(3) The Commission forwarded the initial assessment report to all Member States on 27 April 2004.
(4) 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.
(5) Consequently, the European Food Safety Authority (EFSA) was consulted on 22 November 2004.
(6) On 21 April 2005 EFSA adopted the ‘Opinion of the Scientific Panel on Dietetic Products, Nutrition and Allergies on a request from the Commission related to an application on the use of α-tocopherol-containing oil suspension of lycopene from Blakeslea trispora as a novel food ingredient’.
(7) The opinion came to the conclusion that the requested levels of use of lycopene from Blakeslea trispora would lead to an additional intake of up to about 2 mg/day. It also concluded that this additional intake was not of concern from the safety point of view.
(8) Food additives falling 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), are excluded from the scope of Regulation (EC) No 258/97. This Decision does therefore not constitute authorisation to use lycopene from Blakeslea trispora as a food colour.
(9) On the basis of the scientific assessment, it is established that lycopene from Blakeslea trispora in an α-tocopherol containing suspension complies with the criteria laid down in Article 3(1) of Regulation (EC) No 258/97.
(10) 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:
OJ L 43, 14.2.1997, p. 1. Regulation as last amended by Regulation (EC) No 1882/2003 of the European Parliament and of the Council (OJ L 284, 31.10.2003, p. 1).
OJ L 40, 11.2.1989, p. 27. Directive as last amended by Regulation (EC) No 1882/2003.
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