替代方案分析和社会经济分析的范围是什么？是申请人的视角还是整个社会？

替代方案分析和社会经济分析的范围是什么？是申请人的视角还是整个社会？

What is the scope of the Analysis of Alternatives and the Socio-economic Analysis? The applicant's perspective or the society as a whole?

申请人和社会的视角都与申请相关。替代方案分析中，申请人的视角与评估申请人采用任何可用替代方案的可行性相关。这包括完全停止使用该物质的替代方案。该分析可用于识别如果未获得授权，将适用的不使用情景。应从社会视角评估使用和不使用情景，以基于授权效益与风险的比较，从社会角度评估授权是否合理。申请人应进行替代方案分析，假设其在日落日期之后将无法使用该物质，即假设其授权申请未获批准。因此，替代方案分析的范围应为申请人在其业务中选择替代物质或技术时通常会使用的范围。但前提是，公众咨询中可能会提出申请人之前未曾知晓或通常不会考虑的替代方案。因此，他可能希望扩大其分析的正常范围，以应对这种情况。社会经济分析的确切范围无法一概而论，因为这会因具体情况而异。原则是，所有因素都应纳入考虑范围，直至其可能对结论产生实质性影响。采用迭代分析方法，并咨询社会经济分析专家并征求意见，有助于在任何特定情况下确定适当的范围。更多详情，请参阅授权申请研讨会演示文稿：http://echa.europa.eu/addressing-chemicals-of-concern/authorisation/applications-for-authorisation/afa

Both the applicant's and society's perspectives are relevant in the application. The applicant's perspective is relevant in the Analysis of Alternatives to assess how feasible it would be for the applicant to adopt any alternatives which are available to him. This would include the alternative of ceasing use of the substance altogether. This analysis can be used to identify the non-use scenario(s) which would pertain, if authorisation is not granted. The use and non-use scenarios should be assessed from society's perspective to provide an assessment of whether authorisation is justified from a social perspective or not, based on a comparison of the benefits of authorisation and the risks. 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 scope should be whatever the applicant would normally use when choosing alternative substances or technologies in his business. One qualification to this is that alternatives might be suggested through the public consultation of which the applicant was previously unaware or would not normally consider. He might wish, therefore, to extend the normal scope of his analysis in anticipation of this. It is not possible to generalise about the exact scope of the socio-economic analysis, as this will vary on a case-by-case basis. The principle is that all factors should be incorporated to the extent that they might make a material difference to the conclusions. An iterative approach to developing the analysis, as well as consultation and input from socio-economic analysis experts, can be helpful in establishing the appropriate scope in any given situation. More details in the presentations of the seminars on application for authorisation: http://echa.europa.eu/addressing-chemicals-of-concern/authorisation/applications-for-authorisation/afa