BASF SE, Carl-Bosch-Strasse 38, D-67056 Ludwigshafen, Germany.
Toxicol Lett. 2013 Dec 16;223(3):310-4. doi: 10.1016/j.toxlet.2013.03.027. Epub 2013 Apr 1.
The European regulation on plant protection products (1107/2009) and the Biocidal Products Regulation (EC Regulation 528/2012) only support the marketing and use of chemicals if they do not cause endocrine disruption in humans or wildlife species. Also, substances with endocrine properties are subject to authorization under the European regulation on the registration, evaluation, authorization and restriction of chemicals (REACH; 1907/2006). Therefore, the regulatory consequences of identifying a substance as an endocrine disrupting chemical are severe. In contrast to that, basic scientific criteria, necessary to define endocrine disrupting properties, are not described in any of these legislative documents. Thus, the European Center for Ecotoxicology and Toxicology of Chemicals (ECETOC) established a task force to provide scientific criteria for the identification and assessment of chemicals with endocrine disrupting properties that may be used within the context of these three legislative texts (ECETOC, 2009a). In 2009, ECETOC introduced a scientific framework as a possible concept for identifying endocrine disrupting properties within a regulatory context (ECETOC, 2009b; Bars et al., 2011a,b). The proposed scientific criteria integrated, in a weight of evidence approach, information from regulatory (eco)toxicity studies and mechanistic/screening studies by combining evidence for adverse effects detected in apical whole-organism studies with an understanding of the mode of action (MoA) of endocrine toxicity. However, since not all chemicals with endocrine disrupting properties are of equal hazard, an adequate concept should also be able to differentiate between chemicals with endocrine properties of low concern from those of higher concern (for regulatory purposes). For this purpose, the task force refined this part of their concept. Following an investigation of the key factors at a second workshop of invited regulatory, academic and industry scientists, the guidance was advanced further. For human health assessments it is based on the relevance to humans of the endocrine mechanism of toxicity, the specificity of the endocrine effects with respect to other toxic effects, the potency of the chemical to induce endocrine toxicity and consideration of exposure levels.
欧洲植保产品法规（1107/2009）和《生物杀灭剂法规》（EC 法规 528/2012）仅支持在化学品不会对人类或野生动物物种造成内分泌干扰的情况下进行市场营销和使用。此外，具有内分泌特性的物质根据欧洲关于化学品注册、评估、授权和限制的法规（REACH；1907/2006）进行授权。因此，将某种物质确定为内分泌干扰化学物质的监管后果是严重的。与此相反，在这些立法文件中都没有描述定义内分泌干扰特性所需的基本科学标准。因此，欧洲生态毒理学和化学毒物学中心（ECETOC）成立了一个特别工作组，为可能在这三个立法案文范围内使用的具有内分泌干扰特性的化学品的识别和评估提供科学标准（ECETOC，2009a）。2009 年，ECETOC 引入了一个科学框架，作为在监管背景下识别内分泌干扰特性的可能概念（ECETOC，2009b；Bars 等人，2011a，b）。该提议的科学标准采用证据权重方法，将来自监管（生态）毒性研究和机制/筛选研究的信息整合在一起，将在整体生物体研究中检测到的不良影响的证据与对内分泌毒性作用模式（MoA）的理解结合起来。然而，由于并非所有具有内分泌干扰特性的化学品都具有同等危害，因此，该概念还应能够区分具有低关注内分泌特性的化学品和具有更高关注内分泌特性的化学品（用于监管目的）。为此，特别工作组对其概念的这一部分进行了细化。在对受邀监管、学术和行业科学家的第二次研讨会的关键因素进行调查之后，该指导意见得到了进一步推进。对于人类健康评估，它基于内分泌毒性作用机制对人类的相关性、内分泌效应相对于其他毒性效应的特异性、化学物质诱导内分泌毒性的效力以及考虑暴露水平。
