Younes Maged, Aggett Peter, Aguilar Fernando, Crebelli Riccardo, Dusemund Birgit, Filipič Metka, Frutos Maria Jose, Galtier Pierre, Gundert-Remy Ursula, Kuhnle Gunter Georg, Lambré Claude, Leblanc Jean-Charles, Lillegaard Inger Therese, Moldeus Peter, Mortensen Alicja, Oskarsson Agneta, Stankovic Ivan, Waalkens-Berendsen Ine, Woutersen Rudolf Antonius, Wright Matthew, Herman Lieve, Tobback Paul, Pizzo Fabiola, Smeraldi Camilla, Tard Alexandra, Papaioannou Adamantia, Gott David
EFSA J. 2017 Dec 1;15(12):e05064. doi: 10.2903/j.efsa.2017.5064. eCollection 2017 Dec.
The present scientific opinion deals with the safety of the extension of use of lycopene (E 160d) in certain meat preparations, meat products and fruit and vegetable preparations. Lycopene (E 160d) is an authorised food additive in the EU for use in several food categories and an acceptable daily intake (ADI) of 0.5 mg/kg body weight (bw) per day was established. In the present opinion, the Panel decided that a comparison of the exposure resulting from the current uses and use levels with the exposure resulting from this additional proposed extension of uses would be sufficient to address the safety of lycopene. The Panel calculated that, considering the current maximum permitted levels (MPLs) and the proposed extension of uses and use levels, the mean dietary exposure to lycopene (E 160d) in the total population ranged from 0.01 mg/kg bw per day in infants to 0.82 mg/kg bw per day in toddlers. At the high level, dietary exposure to lycopene (E 160d) ranged from 0.03 mg/kg bw per day in infants to 1.39 mg/kg bw per day in toddlers. The Panel concluded that the proposed extension of uses of lycopene (E 160d) as a food additive in meat preparations, meat products and fruit and vegetable preparations up to 60 mg/kg would not add significantly to the intake of the food additive at its current MPL. However, the Panel noted that the overall intake at the MPL scenario would exceed the currently established ADI. The Panel acknowledged the uncertainties in the current estimates which could result in an overestimation of the exposure to lycopene (E 160d) as a food additive in European countries and therefore concluded that a refined exposure estimate would be recommended focusing on food categories contributing the most to its estimates, in order to decrease uncertainties in its current estimates.
本科学意见涉及番茄红素（E 160d）在某些肉类制品、肉制品以及水果和蔬菜制品中扩大使用范围的安全性。番茄红素（E 160d）是欧盟批准用于多个食品类别的食品添加剂，已确定每日可接受摄入量（ADI）为0.5毫克/千克体重（bw）。在本意见中，专家小组决定，将当前使用情况和使用水平所导致的暴露量与此次提议的扩大使用范围所导致的暴露量进行比较，足以解决番茄红素的安全性问题。专家小组计算得出，考虑到当前的最大允许水平（MPL）以及提议的使用范围和使用水平扩大情况，总体人群中番茄红素（E 160d）的膳食暴露量范围为：婴儿每日0.01毫克/千克体重，幼儿每日0.82毫克/千克体重。在高暴露水平下，番茄红素（E 160d）的膳食暴露量范围为：婴儿每日0.03毫克/千克体重，幼儿每日1.39毫克/千克体重。专家小组得出结论，提议将番茄红素（E 160d）作为食品添加剂在肉类制品、肉制品以及水果和蔬菜制品中的使用范围扩大至最高60毫克/千克，在当前MPL水平下不会显著增加该食品添加剂的摄入量。然而，专家小组指出，在MPL情况下的总体摄入量将超过目前确定的ADI。专家小组承认当前估计存在不确定性，这可能导致对欧洲国家作为食品添加剂的番茄红素（E 160d）暴露量的高估，因此得出结论，建议针对对估计贡献最大的食品类别进行更精确的暴露量估计，以减少当前估计中的不确定性。
