Safety of yellow/orange tomato extract as a novel food pursuant to Regulation ( EU ) 2015/2283

EFSA Journal · 29 authors

AI SUMMARY

FIDELITY 100%

POPULATIONEU general population and individuals above 15 years of age (for food supplement use)

INTERVENTIONYellow/orange tomato extract (carotenoid-rich extract containing predominantly phytoene and phytofluene, with lesser beta-carotene, zeta-carotene, and lycopene) proposed at up to 100 mg/day as a food supplement and as an ingredient in cereal bars and functional drinks

COMPARISONEstablished acceptable daily intake (ADI) for lycopene of 0.5 mg/kg body weight per day and existing lycopene exposure from food additive use and natural occurrence

This summary was generated by AI from a single paper. It has not been reviewed by a clinician and is not clinical advice. Verify against the source before acting on it.

AGENT 01 · STRUCTURED SUMMARY

TRACE TO SOURCE

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TL;DR

The EFSA NDA Panel assessed a carotenoid-rich extract from yellow/orange tomato proposed for use in cereal bars, functional drinks, and food supplements, and concluded that safety could not be established under the proposed conditions of use due to potential exceedance of the lycopene acceptable daily intake and a lack of safety data on phytoene and phytofluene.

Full summary

877 CHARS

The EFSA NDA Panel conducted a regulatory safety assessment of a yellow/orange tomato extract produced by supercritical CO2 extraction, containing over 96% lipids of which 10–30% are carotenoids, predominantly phytoene and phytofluene (6–16%), with smaller amounts of beta-carotene (0.1–0.2%), zeta-carotene (2–6%), and lycopene (0.1–5%). Dietary exposure estimates for the novel food were derived using the EFSA Comprehensive European Food Consumption Database for cereal bars and functional drinks, with food supplement use proposed for individuals above 15 years at up to 100 mg/day. However, when combined with existing lycopene exposure from food additive use and natural occurrence, the ADI of 0.5 mg/kg bw per day would be exceeded across all population groups assessed. Furthermore, no safety data were available for phytoene and phytofluene intake from the novel food.

PICO

PPOPULATION

EU general population and individuals above 15 years of age (for food supplement use)

IINTERVENTION

Yellow/orange tomato extract (carotenoid-rich extract containing predominantly phytoene and phytofluene, with lesser beta-carotene, zeta-carotene, and lycopene) proposed at up to 100 mg/day as a food supplement and as an ingredient in cereal bars and functional drinks

OOUTCOME

Dietary exposure estimates of the novel food and its constituent lycopene relative to the ADI across EU population groups

STUDY TYPE

guidelines

SPECIALTY

nutrition

SUMMARISED BY

AI pipeline

FIDELITY CHECK

100% · A

ORIGINAL PAPER

PMC10190518

Safety of yellow/orange tomato extract as a novel food pursuant to Regulation ( EU ) 2015/2283

EFSA Journal

READ THE FULL PAPER

ABSTRACT

Abstract Following a request from the European Commission, the EFSA Panel on Nutrition, Novel Foods and Food Allergens (NDA) was asked to deliver an opinion on yellow/orange tomato extract used as a novel food (NF) pursuant to Regulation (EU) 2283/2015. The NF which is the subject of the application is a carotenoid‐rich extract from the yellow/orange tomato containing predominantly phytoene and phytofluene, as well as a lesser amount of beta‐carotene, zeta‐carotene and lycopene. The NF is produced from the tomato pulp using supercritical CO 2 extraction. The applicant proposes the use of the NF in cereal bars, functional drinks and as a food supplement in individuals above 15 years of age. For the use of the NF in cereal bars and functional drinks, the Panel considers, the target population is the general population. According to EFSA's latest exposure assessment for lycopene as a food additive (EFSA ANS Panel, 2017), the highest P95 intakes for children (< 10 and 10–17 years) and adults when combined to the use of lycopene as a food colour from natural occurrence would exceed the established acceptable daily intake (ADI) for lycopene (0.5 mg/kg body weight (bw) day). The estimated intakes of the NF would lead to an exceedance of the ADI when considering natural occurrence and exposure to lycopene when used as a food additive. Due to the absence of safety data regarding phytoene and phytofluene intake from the NF, and the contribution of the NF to the estimated high daily intakes of lycopene, the Panel considers that it cannot be established whether or not the consumption of the NF is nutritionally disadvantageous. The Panel concludes that the safety of the NF has not been established under the proposed conditions of use.

CITATION EXPORT

Dominique Turck, Torsten Bohn, Jacqueline Castenmiller et al.. Safety of yellow/orange tomato extract as a novel food pursuant to Regulation (EU) 2015/2283. EFSA Journal. (2023). https://doi.org/10.2903/j.efsa.2023.7994

AUTHORS

29 · 0 CENTRES

Dominique Turck, Torsten Bohn, Jacqueline Castenmiller, Stefaan De Henauw, Karen Ildico Hirsch‐Ernst, Alexandre Maciuk, Inge Mangelsdorf, Harry J. McArdle, Androniki Naska, Carmen Pelaez, Kristina Pentieva, Alfonso Siani, Frank Thies, Sophia Tsabouri, Marco Vinceti, Margarita Aguilera‐Gómez, Francesco Cubadda, Thomas Frenzel, Marina Heinonen, Rosangela Marchelli, Monika Neuhäuser‐Berthold, Morten Poulsen, Miguel Prieto Maradona, Josef Rudolf Schlatter, Henk van Loveren, Wolfgang Gelbmann, Katerina Gerazova‐Efremova, Ruth Roldán‐Torres, Helle Katrine Knutsen