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

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Article
Panel on Dietetic Products, Nutrition and Allergies
EFSA Journal
EFSA Journal 2015;13(1):3955 [11 pp.].
doi
10.2903/j.efsa.2015.3955
Panel members at the time of adoption
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.
Acknowledgements

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

Contact
Type
Opinion of the Scientific Committee/Scientific Panel
On request from
European Commission
Question Number
EFSA-Q-2014-00301
Adopted
9 December 2014
Published
9 January 2015
Affiliation
European Food Safety Authority (EFSA), Parma, Italy
Note
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Abstract

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.

Summary

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 (Decisions 2009/348/EC and 2009/362/EC), lycopene oleoresin from tomatoes (Decision 2009/355/EC) and lycopene from Blakeslea trispora (Decision 2009/365/EC) as a novel food ingredient (NFI) in several foodstuffs.

In 2008, EFSA Panel on Food Additives, Flavourings, Processing Aids and Materials in Contact with Food (AFC) assessed the safety of lycopene from B. trisporaas a food colouring in the food categories and at the use levels proposed by an applicant. The AFC Panel concluded that high intake estimates of lycopene, mainly from non-alcoholic, flavoured beverages, by pre-school and school children may exceed the Acceptable Daily Intake (ADI) of 0.5 mg/kg body weight (bw) per day established by the Panel. Intake of lycopene as a NFI was not considered by the AFC Panel in the intake assessment.

In its assessment of three novel food applications related to synthetic lycopene, lycopene oleoresin from tomatoes and cold water-dispersible lycopene products from B. trispora,the NDA Panel took into account lycopene intakes from natural occurrence, from its use as a food colouring and when used as a NFI in accordance with the intended uses and use levels as proposed in the three applications. High percentile lycopene intakes from natural sources, food colourings and NFIs were summed up to derive a high intake scenario. In its three opinions on lycopene as a NFI, the NDA Panel concluded that, for the average user, consumption of lycopene as a NFI and from all other sources would be below the ADI, but that some consumers of all considered age groups might exceed the ADI of 0.5 mg/kg bw/day.

In 2010, following a request from the European Commission, the EFSA Panel on Food Additives and Nutrient Sources (ANS) carried out a revised exposure assessment for children and adults (EFSA, 2010). EFSA should take into account the exposure to lycopene from natural occurrence and from its use as a food colouring at revised proposed maximum and typical use levels according to a range of scenarios defined in the terms of reference. The Commission asked EFSA to consider six different exposure scenarios: dietary intake of lycopene from natural occurrence, dietary intake from natural sources and colouring uses excluding all non-alcoholic, flavoured drinks, dietary intake from natural occurrence (5 mg/L) and colouring uses (12 mg/L) including selected non-alcoholic, flavoured drinks and the last two scenarios plus dietary intakes of lycopene as a NFI by considering the maximum content of lycopene for food categories. The ANS Panel concluded that only in the two scenarios when exposure to lycopene from its use as a NFI were also taken into account did the total exposure exceeded the ADI in all population groups studied. The ANS Panel noted that these estimates were based on several conservative assumptions and might overestimate the potential intake.

As a consequence, the Commission Decisions authorising the use of lycopene as a NFI imposed authorisation holders to collect information for the period from 1 July 2009 to 30 June 2012 on the quantities of lycopene sold to producers of final food products. In addition, authorisation holders should provide an updated intake assessment and, if available, new scientific information for a reconsideration of the maximum safe intake levels of lycopene. According to these Commission Decisions, the Commission shall consult EFSA to review the information provided by industry.

The marketing authorisation holders for the use of lycopene as a NFI jointly prepared and submitted a dossier which was forwarded by the European Commission to EFSA. The dossier contains sales data, product launch data, an intake estimate conducted by the manufacturers and toxicological information.

The total amounts of lycopene sold within these three years, from mid-2009 to mid-2012, were low. The manufacturers of lycopene also provided information on new lycopene product launches derived from query of the Mintel Group’s Global New Products Database (GNPD) to characterise the lycopene market for each of these three years, and also an update for 2013. The information from this research indicates that most uses of lycopene concerned food supplements. Very few food products from each of the food categories, non-alcoholic beverages, chewing gum, prepared meal, meal replacements, bakery and dairy products chocolate confectionery and meat substitute, also contained added lycopene. The information derived from the GNPD indicates that lycopene used as a NFI in food supplements is, for the most part, marketed with recommend dose levels between 1 and 10 mg lycopene per day, which is below maximum levels (15 mg per day) considered by the NDA Panel in its intake estimates in 2008. The GNPD also indicated that a few food supplements are marketed with recommended daily doses between 20 and 30 mg, which are above the level authorised by the European Commission of 15 mg per day.

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.

The Panel considers that data provided by the manufacturers indicate that actual intakes of lycopene are below the estimates for lycopene (which are overestimations, because they considered that lycopene would be added to all permitted food categories at maximum permitted levels).

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.

Keywords
lycopene, novel food ingredient, post-marketing monitoring
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Number of Pages
11