European Commission, Joint Research Centre (JRC) , Ispra , Italy.
Crit Rev Toxicol. 2019 Feb;49(2):174-189. doi: 10.1080/10408444.2019.1579169. Epub 2019 Apr 1.
This paper summarizes current challenges, the potential use of novel scientific methodologies, and ways forward in the risk assessment and risk management of mixtures. Generally, methodologies to address mixtures have been agreed; however, there are still several data and methodological gaps to be addressed. New approach methodologies can support the filling of knowledge gaps on the toxicity and mode(s) of action of individual chemicals. (Bio)Monitoring, modeling, and better data sharing will support the derivation of more realistic co-exposure scenarios. As knowledge and data gaps often hamper an in-depth assessment of specific chemical mixtures, the option of taking account of possible mixture effects in single substance risk assessments is briefly discussed. To allow risk managers to take informed decisions, transparent documentation of assumptions and related uncertainties is recommended indicating the potential impact on the assessment. Considering the large number of possible combinations of chemicals in mixtures, prioritization is needed, so that actions first address mixtures of highest concern and chemicals that drive the mixture risk. As chemicals with different applications and regulated separately might lead to similar toxicological effects, it is important to consider chemical mixtures across legislative sectors.
本文总结了当前混合物风险评估和风险管理所面临的挑战、新型科学方法的潜在用途以及前进方向。通常，已经就解决混合物的方法达成了一致；然而，仍有几个数据和方法上的差距需要解决。新的方法学可以支持填补关于个别化学物质毒性和作用模式的知识空白。（生物）监测、建模和更好的数据共享将支持更真实的共同暴露场景的推导。由于知识和数据差距常常阻碍对特定化学混合物的深入评估，因此简要讨论了在单项物质风险评估中考虑可能的混合物效应的选项。为了使风险管理者能够做出明智的决策，建议透明地记录假设和相关不确定性，以表明其对评估的潜在影响。考虑到混合物中可能存在大量的化学物质组合，需要进行优先级排序，以便首先针对最受关注的混合物和驱动混合物风险的化学物质采取行动。由于具有不同应用且分开监管的化学物质可能会导致类似的毒理学效应，因此有必要跨立法部门考虑化学混合物。
