Concern that synthetic food dyes may impact behavior in children prompted a review by the California Office of Environmental Health Hazard Assessment (OEHHA). OEHHA conducted a systematic review of the epidemiologic research on synthetic food dyes and neurobehavioral outcomes in children with or without identified behavioral disorders (particularly attention and activity). We also conducted a search of the animal toxicology literature to identify studies of neurobehavioral effects in laboratory animals exposed to synthetic food dyes. Finally, we conducted a hazard characterization of the potential neurobehavioral impacts of food dye consumption. We identified 27 clinical trials of children exposed to synthetic food dyes in this review, of which 25 were challenge studies. All studies used a cross-over design and most were double blinded and the cross-over design was randomized. Sixteen (64%) out of 25 challenge studies identified some evidence of a positive association, and in 13 (52%) the association was statistically significant. These studies support a relationship between food dye exposure and adverse behavioral outcomes in children. Animal toxicology literature provides additional support for effects on behavior. Together, the human clinical trials and animal toxicology literature support an association between synthetic food dyes and behavioral impacts in children. The current Food and Drug Administration (FDA) acceptable daily intakes are based on older studies that were not designed to assess the types of behavioral effects observed in children. For four dyes where adequate dose-response data from animal and human studies were available, comparisons of the effective doses in studies that measured behavioral or brain effects following exposure to synthetic food dyes indicate that the basis of the ADIs may not be adequate to protect neurobehavior in susceptible children. There is a need to re-evaluate exposure in children and for additional research to provide a more complete database for establishing ADIs protective of neurobehavioral effects.

中文翻译：

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合成食用染料对儿童活动和注意力的潜在影响：人类和动物证据综述

对合成食用染料可能影响儿童行为的担忧促使加州环境健康危害评估办公室 (OEHHA) 进行了审查。OEHHA 对有或没有已确定行为障碍（特别是注意力和活动）的儿童的合成食用染料和神经行为结果的流行病学研究进行了系统评价。我们还对动物毒理学文献进行了搜索，以确定对暴露于合成食用染料的实验动物的神经行为影响的研究。最后，我们对食用染料消费对神经行为的潜在影响进行了危害表征。我们在本综述中确定了 27 项儿童接触合成食用染料的临床试验，其中 25 项是挑战研究。所有研究都使用交叉设计，大多数是双盲的，交叉设计是随机的。25 项挑战研究中有 16 项 (64%) 确定了一些正相关的证据，13 项 (52%) 的相关性具有统计学意义。这些研究支持食用染料暴露与儿童不良行为结果之间的关系。动物毒理学文献为对行为的影响提供了额外的支持。人类临床试验和动物毒理学文献共同支持合成食用染料与儿童行为影响之间的关联。当前食品和药物管理局 (FDA) 可接受的每日摄入量是基于较早的研究，这些研究并非旨在评估在儿童中观察到的行为影响类型。对于从动物和人类研究中获得足够剂量反应数据的四种染料，在测量暴露于合成食用染料后的行为或大脑影响的研究中比较有效剂量表明 ADI 的基础可能不足以保护神经行为在易感儿童中。有必要重新评估儿童的暴露情况并进行更多研究，以提供更完整的数据库来建立 ADI 保护神经行为影响。