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Does REACH provide sufficient information to regulate mutagenic and carcinogenic substances?
Human and Ecological Risk Assessment ( IF 3.0 ) Pub Date : 2018-08-01 , DOI: 10.1080/10807039.2018.1480351
Marjolijn Woutersen 1 , Martijn Beekman 1 , Marja E. J. Pronk 1 , Andre Muller 1 , Joop A. de Knecht 1 , Betty C. Hakkert 1
Affiliation  

The REACH (Registration, Evaluation, Authorisation and Restriction of Chemicals) data requirements for mutagenicity and carcinogenicity have been compared to the criteria for classification under Classification, Labelling and Packaging (CLP) and the studies used as key evidence by Committee for Risk Assessment (RAC) in drafting its opinions on the appropriate classification. This comparison revealed that the REACH information requirements will not provide sufficient information to conclude a substance is a Cat 1B mutagen and/or carcinogen. In addition, requiring such information via a substance evaluation under REACH requires a large investment from the Member States and takes years. Classification and labeling is essential in the communication of the hazardous properties of substances and mixtures and is amongst others an important first step in the identification of a substance as a Substance of Very High Concern (SVHC). REACH will hardly generate sufficient information for classification of substances as category 1B for mutagenicity and carcinogenicity. Therefore, indications of very severe hazards of substances are missed and health risks could occur. There are various ways to deal with this problem, however as most of these require adaptation of regulations this will cost considerable time and political will. This study is a first step to raise awareness for the problem and to start a discussion to search for a sustainable solution.



中文翻译:

REACH是否提供足够的信息来调节诱变和致癌物质?

致突变性和致癌性的REACH(化学品注册,评估,授权和限制)数据要求已与分类,标签和包装(CLP)下的分类标准以及风险评估委员会(RAC)用作关键证据的研究进行了比较。 )起草有关适当分类的意见。该比较表明,REACH信息要求将无法提供足够的信息来推断物质为Cat 1B致突变剂和/或致癌物。此外,要通过REACH的物质评估要求提供此类信息,需要成员国投入大量资金,并且需要花费数年时间。分类和标签对于传达物质和混合物的危险特性至关重要,在确定物质是否为高度关注物质(SVHC)方面,这是重要的第一步。REACH几乎不会生成足够的信息来将物质分类为1B类致突变性和致癌性。因此,遗漏了非常严重的物质危害迹象,可能会危害健康。有多种方法可以解决此问题,但是,由于大多数方法都需要对法规进行修改,因此这将花费大量时间和政治意愿。这项研究是提高对问题的认识并开始讨论以寻求可持续解决方案的第一步。REACH几乎不会产生足够的信息来将物质分类为1B类致突变性和致癌性。因此,遗漏了非常严重的物质危害迹象,可能会危害健康。有多种方法可以解决此问题,但是,由于大多数方法都需要对法规进行修改,因此这将花费大量时间和政治意愿。这项研究是提高对问题的认识并开始讨论以寻求可持续解决方案的第一步。REACH几乎不会生成足够的信息来将物质分类为1B类致突变性和致癌性。因此,遗漏了非常严重的物质危害迹象,可能会危害健康。有多种方法可以解决此问题,但是,由于大多数方法都需要对法规进行修改,因此这将花费大量时间和政治意愿。这项研究是提高对这一问题的认识并开始讨论以寻求可持续解决方案的第一步。但是,由于大多数法规都需要修改法规,因此这将花费大量时间和政治意愿。这项研究是提高对问题的认识并开始讨论以寻求可持续解决方案的第一步。但是,由于大多数法规都需要修改法规,因此这将花费大量时间和政治意愿。这项研究是提高对这一问题的认识并开始讨论以寻求可持续解决方案的第一步。

更新日期:2018-08-01
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