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是否有明确的标准作为意见的依据,并且可以为申请结果提供更多确定性?
问题(中文)
是否有明确的标准作为意见的依据,并且可以为申请结果提供更多确定性?
Question (EN)
Are there clear criteria on which the opinions will be based and which could provide more certainty about the outcome of the application?
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)
REACH法规第60条明确规定了授权标准:根据“充分控制途径”(第60(2)条),如果附件XIV中规定的物质固有特性导致的使用对人类健康和环境的风险得到充分控制,则申请应予批准。根据“社会经济途径”(第60(4)条),如果证明(i)社会经济效益大于使用该物质对人类健康和环境的风险,并且(ii)没有合适的替代物质或技术,则可以授予授权。评估合适替代品可用性时需要考虑的因素在第60(5)条和《授权申请指南》中进行了说明。此外,还有两份重要文件描述了RAC和SEAC计划如何评估申请:RAC和SEAC计划如何评估申请[PDF] [EN] RAC和SEAC意见报告格式[PDF] [EN]
Answer (EN)
The criteria for granting an authorisation are clearly defined in Art. 60 of REACH: under the "adequate control route" (Art. 60(2)) an application shall be granted if the risk to human health and the environment from the use of the substance arising from the intrinsic properties specified in Annex XIV is adequately controlled.
Under the "socio-economic route" (Art. 60(4)), an authorisation may be granted if it is shown that (i) the socio-economic benefits outweigh the risk to human health and the environment from the use of the substance and (ii) there is no suitable alternative substances or technologies.
The factors to be taken into account for assessing the availability of suitable alternatives are described in Art. 60(5) and in the Guidance on Applications for Authorisation.
Also, two important documents describe how RAC and SEAC intend to evaluate the applications:
How RAC and SEAC intend to evaluate the applications [PDF] [EN]
Reporting format for the RAC and SEAC opinions [PDF] [EN]