Dietary exposure to lycopene from background diet, novel foods and food additive use in the European population

Abstract In 2023, EFSA adopted a scientific opinion on the safety of yellow/orange tomato extract as a novel food pursuant to Regulation (EU) 2015/2283, concluding that its safe use could not be established under the proposed conditions and estimated intakes could lead to an exceedance of the acceptable daily intake for lycopene when considering combined exposure from natural occurrence and food additive uses. Consequently, EFSA was requested to carry out a dietary exposure assessment of lycopene considering combined intakes from the background diet and from its authorised uses as food additive and as novel food. For the refined scenarios, use level data were collected from industry for food additive and novel food uses, while occurrence data for naturally occurring lycopene were extracted from the literature. Food consumption data were obtained from EFSA's Comprehensive European Food Consumption Database. Five exposure scenarios were assessed: a regulatory maximum level scenario, a refined non‐brand‐loyal scenario, a food supplements consumers only scenario, a scenario for infants and toddlers consuming foods for special medical purposes, and a scenario for infants below 16 weeks consuming such foods. In the regulatory maximum level scenario, the highest combined mean and 95th percentile exposures were observed in toddlers with 1.2 and 2.52 mg/kg bw per day, respectively. In the refined non‐brand‐loyal scenario, highest mean exposure was in toddlers at 0.36 mg/kg bw per day and P95 exposure in infants at 0.97 mg/kg bw per day. Naturally occurring lycopene was the predominant contributor to total exposure in the refined non‐brand‐loyal scenario. In the scenario for food supplements consumers, novel food use in food supplements contributed significantly to the background exposure, leading to a twofold increase. Novel food use in foods for special medical purposes for infants and toddlers contributed to much smaller extent compared to food supplements in the previous scenario.