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如果总体上存在合适的替代方案——但对于申请人来说在技术上或经济上不可行——因此提交了替代计划,那么是否可以根据社会经济路线获得授权?

问题(中文)
如果总体上存在合适的替代方案——但对于申请人来说在技术上或经济上不可行——因此提交了替代计划,那么是否可以根据社会经济路线获得授权?
Question (EN)
If a suitable alternative is available in general -- but not technically or economically feasible for the applicant -- and it therefore submits a substitution plan, can an authorisation be granted under the socio-economic route?
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)
是的,在某些条件下。根据普通法院的判决(案件 T 837/16,瑞典诉欧盟委员会),如果普遍存在合适的替代品,申请人必须制定替代计划(参见委员会 2020 年 5 月 27 日的说明)。根据社会经济途径,如果证明 (i) 这些替代品对申请人而言在技术或经济上不可行,并且 (ii) 社会经济效益大于使用该物质对人类健康或环境造成的风险,则在这种情况下仍可授予授权。RAC 和 SEAC 将对替代计划的可信度及其与替代品分析和社会经济评估的一致性进行评估,以便委员会决定是否授予授权。ECHA 已根据法院的解释调整了替代计划的格式,并更新了关于如何组织和提交替代计划的说明。
Answer (EN)
Yes, under certain conditions. Pursuant the General Court’s judgment (Case T 837/16, Sweden vs European Commission), the applicant is required to prepare a substitution plan if there are suitable alternatives available in general (see the Commission’s note of 27 May 2020). Under the socio-economic route, an authorisation may still be granted in such cases if it is shown (i) that those alternatives are not technically or economically feasible for the applicant and (ii) that the socio-economic benefits outweigh the risk to human health or the environment arising from the use of the substance. RAC and SEAC will provide their assessment of the credibility of the substitution plan and of its consistency with the analysis of alternatives and the socio-economic assessment, so that the Commission can decide on the granting of the authorisation. ECHA has adapted the format for the substitution plan to take into account the Court’s interpretation and updated its instructions on how to organise and present the substitution plan.