Schrenk Dieter, Bignami Margherita, Bodin Laurent, Chipman James Kevin, Del Mazo Jesús, Grasl-Kraupp Bettina, Hogstrand Christer, Hoogenboom Laurentius Ron, Leblanc Jean-Charles, Nebbia Carlo Stefano, Nielsen Elsa, Ntzani Evangelia, Petersen Annette, Sand Salomon, Schwerdtle Tanja, Vleminckx Christiane, Dusemund Birgit, Hart Andrew, Mulder Patrick, Viviani Barbara, Anastassiadou Maria, Cascio Claudia, Riolo Francesca, Wallace Heather
EFSA J. 2023 Mar 2;21(3):e07866. doi: 10.2903/j.efsa.2023.7866. eCollection 2023 Mar.
The European Commission asked EFSA for a scientific opinion on the risks for human health of the presence of grayanotoxins (GTXs) in 'certain honey' from Ericaceae plants. The risk assessment included all structurally related grayananes occurring with GTXs in 'certain' honey. Oral exposure is associated with acute intoxication in humans. Acute symptoms affect the muscles, nervous and cardiovascular systems. These may lead to complete atrioventricular block, convulsions, mental confusion, agitation, syncope and respiratory depression. For acute effects, the CONTAM Panel derived a reference point (RP) of 15.3 μg/kg body weight for the sum of GTX I and III based on a BMDL for reduced heart rate in rats. A similar relative potency was considered for GTX I. Without chronic toxicity studies, an RP for long-term effects could not be derived. There is evidence for genotoxicity in mice exposed to GTX III or honey containing GTX I and III, showing increased levels of chromosomal damage. The mechanism of genotoxicity is unknown. Without representative occurrence data for the sum of GTX I and III and consumption data from Ericaceae honey, acute dietary exposure was estimated based on selected concentrations for GTX I and III reflecting concentrations measured in 'certain' honeys. Applying a margin of exposure (MOE) approach, the estimated MOEs raised health concerns for acute toxicity. The Panel calculated the for GTX I and III below which no acute effects would be expected following 'certain honey' consumption. The Panel is 75% or more certain that the of 0.05 mg for the sum of GTX I and III per kg honey is protective for all age groups regarding acute intoxications. This value does not consider other grayananes in 'certain honey' and does not cover the identified genotoxicity.
欧盟委员会要求欧洲食品安全局就杜鹃花科植物“特定蜂蜜”中存在的灰安毒素（GTXs）对人体健康的风险提供科学意见。风险评估涵盖了“特定”蜂蜜中与GTXs同时出现的所有结构相关的灰安烷类。经口接触与人类急性中毒有关。急性症状会影响肌肉、神经和心血管系统。这些可能导致完全性房室传导阻滞、惊厥、精神错乱、烦躁不安、晕厥和呼吸抑制。对于急性影响，CONTAM小组基于大鼠心率降低的基准剂量下限（BMDL）得出GTX I和III总量的参考点（RP）为15.3μg/kg体重。对GTX I也考虑了类似的相对效力。由于缺乏慢性毒性研究，无法得出长期影响的RP。有证据表明，暴露于GTX III或含有GTX I和III的蜂蜜的小鼠存在遗传毒性，表现为染色体损伤水平升高。遗传毒性的机制尚不清楚。由于缺乏GTX I和III总量的代表性出现数据以及杜鹃花科蜂蜜的消费数据，基于反映“特定”蜂蜜中测得浓度的GTX I和III选定浓度来估计急性膳食暴露量。采用暴露边际（MOE）方法，估计的MOE引发了对急性毒性的健康担忧。该小组计算了GTX I和III的含量，低于此含量食用“特定蜂蜜”后预计不会产生急性影响。该小组有75%或更高的把握确定，每千克蜂蜜中GTX I和III总量为0.05mg的含量对所有年龄组预防急性中毒具有保护作用。该值未考虑“特定蜂蜜”中的其他灰安烷类，也未涵盖已确定的遗传毒性。
