PDF(Pubmed)
Abstract：
This opinion addresses the re-evaluation of erythritol (E 968) as food additive and an application for its exemption from the laxative warning label requirement as established under Regulation (EU) No 1169/2011. Erythritol is a polyol obtained by fermentation with Moniliella pollinis BC or Moniliella megachiliensis KW3-6, followed by purifications and drying. Erythritol is readily and dose-dependently absorbed in humans and can be metabolised to erythronate to a small extent. Erythritol is then excreted unchanged in the urine. It does not raise concerns regarding genotoxicity. The dataset evaluated consisted of human interventional studies. The Panel considered that erythritol has the potential to cause diarrhoea in humans, which was considered adverse because its potential association with electrolyte and water imbalance. The lower bound of the range of no observed adverse effect levels (NOAELs) for diarrhoea of 0.5 g/kg body weight (bw) was identified as reference point. The Panel considered appropriate to set a numerical acceptable daily intake (ADI) at the level of the reference point. An ADI of 0.5 g/kg bw per day was considered by the Panel to be protective for the immediate laxative effect as well as potential chronic effects, secondary to diarrhoea. The highest mean and 95th percentile chronic exposure was in children (742 mg/kg bw per day) and adolescents (1532 mg/kg bw per day). Acute exposure was maximally 3531 mg/kg bw per meal for children at the 99th percentile. Overall, the Panel considered both dietary exposure assessments an overestimation. The Panel concluded that the exposure estimates for both acute and chronic dietary exposure to erythritol (E 968) were above the ADI, indicating that individuals with high intake may be at risk of experiencing adverse effects after single and repeated exposure. Concerning the new application, the Panel concluded that the available data do not support the proposal for exemption.
摘要：
该意见涉及赤藓糖醇（E968）作为食品添加剂的重新评估，以及根据法规（EU）No1169/2011对其免除泻药警告标签要求的申请。赤藓糖醇是一种多元醇，它是通过用传粉念珠菌BC或巨大念珠菌KW3-6发酵，然后纯化和干燥而获得的。赤藓糖醇在人体中容易且剂量依赖性地吸收，并且可以在很小的程度上代谢为红呢。然后赤藓糖醇在尿液中排泄不变。它不会引起对遗传毒性的担忧。评估的数据集由人类介入研究组成。小组认为赤藓糖醇有可能导致人类腹泻，这被认为是不利的，因为它可能与电解质和水的不平衡有关。对于0.5g/kg体重（bw）的腹泻，未观察到的不良反应水平（NOAEL）范围的下限被确定为参考点。小组认为在参考点水平上设定可接受的每日摄入量（ADI）是适当的。专家小组认为每天0.5g/kgbw的ADI可保护即时泻药效应和潜在的慢性效应。继发于腹泻。儿童（742mg/kgbw/天）和青少年（1532mg/kgbw/天）的平均和第95百分位数慢性暴露最高。第99百分位儿童的急性暴露量最大为每餐3531mg/kgbw。总的来说,专家组认为这两种饮食暴露评估都是高估.小组的结论是，赤藓糖醇的急性和慢性膳食暴露（E968）的暴露估计值均高于ADI，这表明高摄入量的个体在单次和重复暴露后可能有经历不良反应的风险。关于新的申请，小组的结论是，现有数据不支持豁免建议。
