Office of Environmental Health Hazard Assessment, California Environmental Protection Agency, 1515 Clay St, Oakland CA, and 1001 I St, Sacramento, California, USA.
Center for Environmental Research and Community Health, School of Public Health, University of California, 2121 Berkeley Way, Berkeley, California, USA.
Environ Health. 2022 Apr 29;21(1):45. doi: 10.1186/s12940-022-00849-9.
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.
人们担心合成食用色素可能会影响儿童的行为，这促使加利福尼亚州环境健康危害评估办公室（OEHHA）对其进行审查。OEHHA 对合成食用色素与儿童神经行为结果的流行病学研究（特别是注意力和活动）进行了系统回顾。我们还对动物毒理学文献进行了检索，以确定研究实验室动物暴露于合成食用色素的神经行为影响的研究。最后，我们对食用色素消费的潜在神经行为影响进行了危害特征描述。在本次审查中，我们确定了 27 项针对儿童暴露于合成食用色素的临床试验，其中 25 项为挑战研究。所有研究均采用交叉设计，大多数为双盲设计，且交叉设计为随机设计。在 25 项挑战研究中，有 16 项（64%）确定了一些阳性关联的证据，其中 13 项（52%）的关联具有统计学意义。这些研究支持食用色素暴露与儿童不良行为结果之间存在关联。动物毒理学文献为行为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了合成食用色素与儿童行为影响之间的关联。目前，美国食品和药物管理局（FDA）的每日允许摄入量是基于未设计用于评估儿童观察到的行为影响的旧研究制定的。对于四种有足够的动物和人类研究剂量-反应数据的染料，在测量暴露于合成食用色素后行为或大脑影响的研究中，有效剂量的比较表明，ADI 的基础可能不足以保护易受影响的儿童的神经行为。有必要重新评估儿童的暴露情况，并开展更多的研究，为建立保护神经行为的 ADI 提供更完整的数据库。
