Turck Dominique, Bohn Torsten, Castenmiller Jacqueline, De Henauw Stefaan, Hirsch-Ernst Karen Ildico, Maciuk Alexandre, Mangelsdorf Inge, McArdle Harry J, Naska Androniki, Pelaez Carmen, Pentieva Kristina, Siani Alfonso, Thies Frank, Tsabouri Sophia, Vinceti Marco, Aguilera-Gómez Margarita, Cubadda Francesco, Frenzel Thomas, Heinonen Marina, Marchelli Rosangela, Neuhäuser-Berthold Monika, Poulsen Morten, Prieto Maradona Miguel, Schlatter Josef Rudolf, van Loveren Henk, Gelbmann Wolfgang, Gerazova-Efremova Katerina, Roldán-Torres Ruth, Knutsen Helle Katrine
EFSA J. 2023 May 17;21(5):e07994. doi: 10.2903/j.efsa.2023.7994. eCollection 2023 May.
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 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.
应欧盟委员会的要求，欧洲食品安全局（EFSA）营养、新型食品及食品过敏原专家小组（NDA）被要求根据欧盟法规（EU）2283/2015，就用作新型食品（NF）的黄/橙色番茄提取物发表意见。该申请所涉及的新型食品是一种富含类胡萝卜素的黄/橙色番茄提取物，主要含有八氢番茄红素和六氢番茄红素，以及少量的β-胡萝卜素、ζ-胡萝卜素和番茄红素。该新型食品是使用超临界CO萃取法从番茄果肉中提取的。申请人提议将该新型食品用于谷物棒、功能性饮料，并作为15岁以上人群的食品补充剂。对于在谷物棒和功能性饮料中使用该新型食品，专家小组认为，目标人群为普通人群。根据欧洲食品安全局对番茄红素作为食品添加剂的最新暴露评估（EFSA ANS专家小组，2017年），儿童（<10岁和10-17岁）和成年人在将番茄红素作为天然存在的食用色素使用时的最高P95摄入量将超过番茄红素既定的每日可接受摄入量（ADI）（0.5毫克/千克体重（bw）天）。考虑到天然存在的情况以及用作食品添加剂时番茄红素的暴露量，该新型食品的估计摄入量将导致超过ADI。由于缺乏关于从该新型食品中摄入八氢番茄红素和六氢番茄红素的安全性数据，以及该新型食品对估计的番茄红素高每日摄入量的贡献，专家小组认为无法确定食用该新型食品是否在营养上不利。专家小组得出结论，在所提议的使用条件下，该新型食品的安全性尚未确立。
