分析替代方案需要什么程度的详细程度？

分析替代方案需要什么程度的详细程度？

What is the level of details needed for the analysis of alternatives?

申请人应进行替代品分析，假设其在日落日期之后将无法使用相关物质，即其授权申请未获批准。因此，详细程度应与申请人在其业务中选择替代物质或技术时通常使用的程度相同。然而，正如授权申请指南中所述：“强烈建议申请人证明已对替代品进行了全面且充分的评估。这是因为，化学品局在其意见中以及委员会在评估是否存在合适的替代品时，将考虑“所有相关方面”{第60(5)条}，包括利害关系第三方提交的信息。” 然而，关于替代品使用风险的评估以及将这些风险与附件XIV物质使用风险进行比较，“申请人无需为每种替代品生成新的危害数据或提供化学安全评估。也无需对替代物质或技术的风险进行与附件XIV物质风险相同的详细评估。”总之，对替代方案的分析需要付出的努力程度将由申请人自行判断，并且应达到申请人能够轻松地在 ECHA 委员会面前捍卫其分析的程度。

The applicant should undertake an Analysis of Alternatives as if they will be unable to use the substance in question beyond the sunset date, that is, as if their application for authorisation is not granted. Thus, the level of detail should be whatever the applicant would normally use when choosing alternative substances or technologies in his business. However, as stated in the guidance on applications for authorisation: "It is strongly recommended that the applicant demonstrates that a comprehensive and adequate assessment of alternatives has been done. This is because the Agency in its opinions and the Commission in its assessment of whether suitable alternatives are available will take "all relevant aspects" into account {Art. 60(5)}, including information submitted by interested third parties." However, regarding the assessment of the risks arising from the use of the alternative and the comparison of these risks with the ones arising from the use of the Annex XIV substance "the applicant is not required to generate new hazard data or provide a chemical safety assessment for each of the alternatives. Nor is it required that the risks associated with alternative substances or technologies are assessed in the same detail as the risks associated with the Annex XIV substance." In conclusion, the level of effort that needs to be put into the analysis of alternatives will be a matter of judgment for the applicant and should reach a point where the applicant is comfortable in defending its analysis in front of the ECHA Committees.