Yellow tomato extract as a novel food in food supplements for adults, 100 mg a day: carotenoids 10–13 g/100 g, of which phytoene and phytofluene 7–10 g/100 g, with a carotenoid profile by HPLC-DAD and glycoalkaloids by LC-MS/MS in the EFSA data
Commission Implementing Regulation (EU) 2025/2242, published on 10 November 2025, adds to the Union list of novel foods yellow tomato extract — a carotenoid-rich extract from the pulp of ripe yellow tomatoes (Lycopersicon esculentum Mill.) obtained by supercritical CO₂ extraction — for use in food supplements for adults at up to 100 mg a day. For 5 years from 30 November 2025 only Lycored Ltd of Beer Sheva may place it on the market, because EFSA’s conclusions rest on protected data from an Ames test and a micronucleus test in human lymphocytes.
- Specification: viscous dark brown liquid; moisture < 0.5 %, proteins 0.2–0.6 %, total lipids > 95 % (saturated 12–25 %, monounsaturated 17–30 %, polyunsaturated 50–65 %, trans ≤ 2 %), unsaponifiable matter < 20 %, acid value < 5 mg KOH/g, peroxide value ≤ 15 mEq O2/kg (according to the Codex Alimentarius guidelines for concentrated oils). Total carotenoids 10–13 g/100 g: phytoene and phytofluene 7–10, ζ-carotene 2–4, β-carotene 0.1–0.5, lycopene 0.1–0.4 g/100 g.
- EFSA data (opinion e9373) for 5 batches: total carotenoids 10.1–12.1 %, phytoene with phytofluene 7.4–8.9 %, ζ-carotene 2.0–2.7 %, lycopene 0.1–0.2 %, β-carotene 0.1–0.3 % — determined by HPLC with diode array detection (HPLC-DAD); lipids 96.6–99.3 %, moisture by Karl Fischer titration, phytosterols about 1 % (stigmasterol, β-sitosterol, campesterol).
- Natural toxins: tomatidine 0.050–0.128 mg/kg, while tomatine, α-solanine, α-chaconine and solanidine were < 0.01 mg/kg in each of the 5 batches (LC-MS/MS). Heavy metals were determined by ICP-MS; the specification sets lead, cadmium and arsenic ≤ 1 mg/kg and mercury ≤ 0.1 mg/kg. Microbiology: total aerobic microbial count ≤ 1000 cfu/g, E. coli and S. aureus not detected in 10 g, Salmonella in 25 g, yeasts and moulds ≤ 100 cfu/g.
- At 100 mg of extract a day, lycopene intake would be 0.4 mg/day, i.e. 5.7 µg/kg bw for a person weighing 70 kg — about 1.1 % of the ADI set by EFSA (0.5 mg/kg bw). The supplement label states that it is intended for adults only. Three of the five batches had already been assessed by EFSA in its 2023 opinion on yellow/orange tomato extract.