Article 1
Synthetic lycopene, hereinafter called the product, as specified in Annex I may be placed on the market in the Community as a novel food ingredient to be used in the foods listed in Annex II.
2009/362/EC: Commission Decision of 30 April 2009 authorising the placing on the market of lycopene as novel food ingredient under Regulation (EC) No 258/97 of the European Parliament and of the Council (notified under document number C(2009) 3149)
2009/362/EC: Commission Decision of 30 April 2009 authorising the placing on the market of lycopene as novel food ingredient under Regulation (EC) No 258/97 of the European Parliament and of the Council (notified under document number C(2009) 3149)
Data as of 2026-07-04 · Compiled from an official source version. Later amendments or repeals may not be reflected; the official text prevails. · Read the official text ↗
Article 2
The designation of the novel food ingredient authorised by this Decision on the labelling of the foodstuff containing it shall be ‘lycopene’.
Article 3
The company DSM Nutritional Products Ltd shall establish a monitoring programme accompanying the marketing of the product. This programme shall encompass information about use levels of lycopene in foods as specified in Annex III. The data collected shall be made available to the Commission and Member States. In the light of new information and a report of EFSA, at the latest in the year 2014 the use of lycopene as an ingredient to foods shall be reviewed.
Article 4
This Decision is addressed to DSM Nutritional Products Ltd, Wurmis 576, CH – 4363 Kaiseraugst, Switzerland.
Supplementary provisions
ANNEX ISupplementary provisions
ANNEX I Specifications of synthetic lycopene DESCRIPTION Synthetic lycopene is produced by the Wittig condensation of synthetic intermediates commonly used in the production of other carotenoids used in food. Synthetic lycopene consists of ≥ 96 % lycopene and minor quantities of other related carotenoid components. Lycopene is presented either as a powder in a suitable matrix or an oily dispersion. The colour is dark red or red-violet. Antioxidative protection has to be assured. SPECIFICATION Chemical name : Lycopene C.A.S. number : 502-65-8 (all trans lycopene) Chemical formula : C 40 H 56 Structural formula : Formula weight : 536,85
ANNEX IISupplementary provisions
ANNEX II List of foods to which synthetic lycopene may be added Food category Maximum content of lycopene Fruit/vegetable juice-based drinks (including concentrates) 2,5 mg/100 g Drinks intended to meet the expenditure of intense muscular effort especially for sportsmen 2,5 mg/100 g Foods intended for use in energy-restricted diets for weight reduction 8 mg/meal replacement Breakfast cereals 5 mg/100 g Fats and dressings 10 mg/100 g Soups other than tomato soups 1 mg/100 g Bread (including crispy breads) 3 mg/100 g Dietary foods for special medical purposes In accordance with the particular nutritional requirements Food supplements 15 mg per daily dose as recommended by the manufacturer
ANNEX IIISupplementary provisions
ANNEX III Post launch monitoring of synthetic lycopene INFORMATION TO BE COLLECTED Quantities of synthetic lycopene provided by DSM Nutritional Products Ltd. to their customers for the production of final food products to be placed on the market in the European Union. Results of data base searches on product launches of foods with added lycopene, including fortification levels and portion sizes per launched food by Member State. REPORTING OF THE INFORMATION The information above shall be reported to the European Commission annually for the years 2009 to 2012. For the first time on 31 October 2010 for the reporting period 1 July 2009 to 30 June 2010; and then with the same yearly reporting period for the following two years. ADDITIONAL INFORMATION Where appropriate and available to DSM Nutritional Products Ltd. also the same information on intakes of lycopene used as food colour should be reported. Where available, DSM Nutritional Products Ltd. shall provide new scientific information for a reconsideration of the maximum safe intake levels of lycopene. ASSESSMENT OF INTAKE LEVELS OF LYCOPENE Based on the collected and reported information above, DSM Nutritional Products Ltd. shall carry out an updated intake assessment. REVIEW The Commission shall consult EFSA in 2013 to review the information provided by industry.
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Source: EUR-Lex (Publications Office of the EU), © European Union, reuse permitted under Commission Decision 2011/833/EU.
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