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

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 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 tomato containing predominantly phytoene plus phytofluene (PE/PF) at up to 10% of the NF, as well as a lesser amount of zeta-carotene (≤ 5%), beta-carotene (≤ 0.5%) and lycopene (≤ 0.4%). The NF is produced from the tomato pulp using supercritical CO₂ extraction. The applicant proposes to use the NF in food supplements (FS) for adults only at a maximum daily dose of 100 mg. The intake of lycopene from such FS would correspond to 0.4 mg/day which corresponds to 5.7 μg/kg body weight and day for an adult weighing 70 kg. This is approximately 1.1% of the acceptable daily intake (ADI) for lycopene established by EFSA (i.e. 0.5 mg/kg body weight), which does not raise safety concerns. According to the exposure assessment performed by EFSA, which included all population age groups, the highest mean and highest P95 intakes/kg bw estimates for PE/PF from the background diet of infants and toddlers are higher than the combined exposure of adults from the background diet and the NF under its proposed use and use levels in food supplements. Noting that the main sources for PE/PF are commonly and regularly consumed also by the youngest age groups and that PE/PF exposure from the background diet does not raise safety concern, the Panel considers that the NF is nutritionally not disadvantageous at the proposed intake of the NF of up to 100 mg/day used in FS in adults. The Panel concludes that the NF, yellow tomato extract, is safe under the proposed conditions of use.