Ramboll US Consulting Inc., Monroe, LA, 71201, USA.
Ramboll US Consulting Inc., Monroe, LA, 71201, USA.
Food Chem Toxicol. 2021 May;151:112097. doi: 10.1016/j.fct.2021.112097. Epub 2021 Mar 4.
California's Office of Environmental Health Hazard Assessment was tasked with conducting risk assessments for United States Food and Drug Administration-approved food dyes relative to neurobehavioral concerns. The purpose of this assessment was to evaluate the evidence for neurodevelopment effects based on three streams of evidence: 1) studies identified by OEHHA for consideration in a quantitative risk assessment; 2) studies relevant to understanding mechanisms of neurobehavioral effects; 3) an in silico assessment of the bioavailability of USFDA-approved food dyes. The results indicate a lack of adequate or consistent evidence of neurological effects, supported by a lack of bioavailability and brain penetration predicted by the in silico assessment. Further, the mechanistic evidence supports a lack of activity from in vitro neurotransmitter assays, and a lack of evidence to support molecular initiating events or key events in adverse outcome pathways associated with neurodevelopmental effects, supporting a lack of biological plausibility for neurobehavioral effects following food exposures to colors. These conclusions are consistent with other authoritative bodies, such as JECFA and EFSA, that have determined (i) other effects are more appropriate for estimating acceptable daily intakes and (ii) evidence from the neurobehavioral studies lack the strength to be relied upon for quantitative risk assessment.
加利福尼亚州环境健康危害评估办公室承担了对美国食品和药物管理局批准的食用色素进行神经行为相关风险评估的任务。这项评估的目的是根据三方面的证据来评估神经发育影响的证据：1）OEHHA 确定的定量风险评估研究；2）与理解神经行为影响机制相关的研究；3）美国食品和药物管理局批准的食用色素的生物利用度的计算机评估。结果表明，缺乏充分或一致的神经影响证据，这是由计算机评估预测的生物利用度和脑穿透不足所支持的。此外，机制证据支持体外神经递质测定无活性，并且缺乏证据支持与神经发育影响相关的不良结局途径中的分子起始事件或关键事件，这支持了在食用色素暴露后神经行为影响缺乏生物学合理性。这些结论与其他权威机构（如 JECFA 和 EFSA）一致，这些机构确定（i）其他影响更适合估计可接受的每日摄入量，以及（ii）神经行为研究的证据缺乏强度，无法依赖于定量风险评估。
