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答案(中文)
欧盟委员会于去年 6 月公布了根据农药和生物杀灭剂法规确定内分泌干扰物的科学标准。虽然 REACH 法规没有专门用于识别内分泌干扰物的标准,但目前仍根据 WHO/IPCS 定义逐案识别。根据欧盟委员会内分泌干扰物专家咨询组 (ED EAG) 的建议,可以考虑使用严重程度、不可逆性、铅毒性和效力等因素来表征内分泌干扰物的潜在危害,例如在评估某种物质是否符合监管要求时。因此,根据 WHO/IPCS 定义,可以寻找某种物质可能具有内分泌活性和/或可能引起由内分泌作用方式介导的不良影响的迹象,并且 REACH 法规缺乏标准并不是推迟筛选活动的理由。就筛查而言,即使某些情况下怀疑存在因勃起功能障碍 (ED) 作用机制而可能引起的不良反应,算法也能识别内分泌活性物质,这已足够。之后,我们将对这些物质进行人工筛查,并仔细检查任何 ED 活性和/或不良反应。请参阅筛查定义文档,了解更多关于我们目前在常见筛查算法中识别潜在 ED 物质的方法的详细信息。
Answer (EN)
The European Commission announced last June scientific criteria to determine what is an endocrine disruptor under the pesticides and biocides regulations. Although there are no criteria for identifying endocrine disruptors under REACH, at the moment they are identified case-by-case based on the WHO/IPCS definition.
According to the recommendation of the EU Commission's Endocrine Disruptor Expert Advisory Group (ED EAG), factors such as severity, irreversibility, lead toxicity and potency can be considered to characterise the hazard potential of an endocrine-disrupting substance, e.g. when assessing the relevance of a substance for consideration in regulatory terms.
Therefore, on the basis of the WHO/IPCS definition, it is possible to search for indications that a substance may be endocrine active and/or elicit adverse effects that are (potentially) mediated by endocrine modes of action and the lack of criteria under REACH is not a reason to postpone screening activities.
For the purposes of screening, it is sufficient if algorithms identify endocrine active substances although some scenarios provide suspicion of adverse effects potentially caused due to an ED mode of action. The substances will then be manually screened and any ED activity and/or adverse effects will be scrutinised.
Please refer to the screening definition document for more details on our current approach in identifying potential ED substances in common screening algorithms.