Statement on the post-marketing monitoring of the use of lycopene


Panel on Dietetic Products, Nutrition and Allergies
EFSA Journal
EFSA Journal 2015;13(1):3955 [11 pp.].
Panel Members
Carlo Agostoni, Roberto Berni Canani, Susan Fairweather-Tait, Marina Heinonen, Hannu Korhonen, Sébastien La Vieille, Rosangela Marchelli, Ambroise Martin, Androniki Naska, Monika Neuhäuser-Berthold, Grażyna Nowicka, Yolanda Sanz, Alfonso Siani, Anders Sjödin, Martin Stern, Sean (J.J.) Strain, Inge Tetens, Daniel Tomé, Dominique Turck and Hans Verhagen.

The Panel wishes to thank the members of the Working Group on Novel Foods, Paul Brantom, Karl-Heinz Engel, Marina Heinonen, Hannu Korhonen, Rosangela Marchelli, Monika Neuhäuser-Berthold, Annette Pöting, Morten Poulsen, Seppo Salminen, Josef Schlatter, Hendrik Van Loveren and Hans Verhagen, for the preparatory work on this scientific opinion, and EFSA staff Wolfgang Gelbmann for the support provided to this scientific opinion

Opinion of the Scientific Committee/Scientific Panel
On request from
European Commission
Question Number
9 December 2014
Published in the EFSA Journal
9 January 2015
European Food Safety Authority (EFSA), Parma, Italy

Following a request from the European Commission, the Panel on Dietetic Products, Nutrition and Allergies (NDA) was asked to provide an update of its exposure assessment on lycopene as a novel food ingredient in the context of Regulation (EC) No 258/97 taking into account the new additional information from the post-marketing monitoring programme imposed by the Commission Decisions authorising the use of synthetic lycopene, lycopene oleoresin from tomatoes and lycopene from Blakeslea trispora as a novel food ingredient in several foodstuffs. The marketing authorisation holders for the use of lycopene as a novel food ingredient jointly prepared and submitted a dossier containing sales data, product launch data, an intake estimate and toxicological information. On the basis of information on sales and new product launch data for the period from July 2009 to June 2012 provided by the lycopene manufacturers, food supplements appear to be the main source of lycopene after intake from natural occurrence. Since no new toxicological studies became available, there is no scientific basis on which the ADI established by EFSA in 2008 could be reconsidered. On the basis of previous intake assessments performed by EFSA and data on sales and product launch data provided for the period from July 2009 to June 2012, the Panel concludes that intakes of naturally occurring lycopene and from its use as a food colouring and as a novel food ingredient at permitted use levels do not lead to intakes above the ADI of 0.5 mg/kg bw/day.

lycopene, novel food ingredient, post-marketing monitoring
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