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我应该使用哪个 DNEL?
Question (EN)
Which DNEL should I use?
中文内容由 Google Cloud Translation 自动生成,仅供参考;请以英文原文为准。问答资料来自欧盟化学品管理局(ECHA)官方网站。
答案(中文)
授权申请的化学品安全报告 (CSR) 中应证明已充分控制或将风险降至最低。REACH 附件 I 定义了衍生无效应水平 (DNEL),即人类接触的暴露水平不得超过该水平,并规定了基于 DNEL(如果可以确定 DNEL)对人群进行风险表征的方式。因此,根据欧洲化学品管理局 (ECHA) 指南得出的 DNEL 是证明已充分控制的参考数据。需要注意的是,风险评估委员会 (RAC) 已为附件 XIV 中的某些物质得出参考 DNEL,并计划继续为其他附件 XIV 物质提供此类参考 DNEL。更多详情,请参阅:信息要求指南和 CSA 剂量[浓度]-人体健康反应表征(第 R.8 章)[PDF] [EN] 评估申请网页
Answer (EN)
The demonstration of adequate control or minimisation of the risks should be made in the Chemical Safety Report (CSR) of the application for authorisation. REACH Annex I defines the Derived No-Effect Level (DNEL), i.e. the level of exposure above which humans should not be exposed and the way the risk characterisation for the human population should be performed, based on the DNEL (if a DNEL can be determined). DNELs derived according to the ECHA guidance are therefore the reference data for the demonstration of adequate control.
It should be noted that the Committee for Risk Assessment (RAC) has derived reference DNELs for some substances on Annex XIV and intends to continue doing so for other Annex XIV substances.
For more details, see:
Guidance on information requirement and CSA
Characterisation of dose [concentration] - response for human health (Chapter R.8) [PDF] [EN]
Evaluating applications web page