申请人应如何解读和使用“经济可行性”标准？

申请人应如何解读和使用“经济可行性”标准？

How should the "economic feasibility" criteria be interpreted and used by the applicants?

根据 REACH 法规第 60(4) 条和第 64(4)(b) 条，社会经济分析委员会 (SEAC) 需要在其意见中说明所申请物质的替代品是否合适。经济可行性是适用性的一个方面。SEAC 关于经济可行性的说明讨论了经济可行性的概念。本问答通过描述 SEAC 当前的评估实践对该说明进行了补充，并包含在 ECHA 网站上提供的更新版说明中。技术可行性和经济可行性是相互关联的概念。技术上不可行的替代品不能被视为经济可行。申请人只需证明技术或经济上的不可行性，即可证明替代品不适合申请人（或相关的下游用户）。采用替代品的影响可能多种多样，例如从使用替代物质的成本增加到申请人的运营停止。使用替代方案的成本以及未经授权对申请人运营的相关影响（例如搬迁或关闭）都可能与评估经济可行性有关。一般来说，经济可行性和不可行性之间的合理“临界点”可以是公司对在欧盟开展替代活动和停止活动无所谓的点。在某些情况下，即使替代方案不会导致在欧盟的活动停止，SEAC 也可能认为替代方案在经济上不可行，这取决于成本增加或利润损失的幅度。这将根据具体情况进行评估。没有设定阈值，超过该阈值的任何与替代方案相关的成本增加都会被判定为对申请人在经济上不可行。请注意，此评估应在特定用途层面进行，不考虑申请人（或相关的下游用户）整体上是否能够吸收增加的成本和/或利润损失（例如，通过将替代物与与关注物质无关的其他业务中获得的利润进行交叉补贴）。除了证明在截止日期或意见采纳时不存在合适的替代品外，经济不可行性也可用于证明审查期的长短。如果替代品不适用的主要原因是经济不可行性，SEAC 将考虑该替代品在申请的整个审查期内是否可能仍然不可行。

Based on Articles 60(4) and 64(4)(b) of the REACH Regulation, the Committee for Socio-economic Analysis (SEAC) needs to state in its opinion if the alternatives to the substance that is applied for are suitable. Economic feasibility is one aspect of suitability. SEAC’s note on economic feasibility discusses the concept of economic feasibility. This Q&A complements that note by describing SEAC’s current practice on its evaluation and it is included in the updated version of the note available on ECHA’s website.Technical and economic feasibility are interlinked concepts. Technically infeasible alternatives cannot be considered economically feasible. It is sufficient for applicants to demonstrate either technical or economic infeasibility to demonstrate that an alternative is not suitable for the applicant (or to downstream users when relevant).The impacts of adopting an alternative may vary e.g. from increased cost of using alternative substances to a shutdown of the applicant’s operations. Both the cost of using alternatives and the related impacts of non-authorisation on applicants’ operations (e.g. relocation or shutdown) may be relevant for assessing economic feasibility. As a general rule of thumb, a reasonable “tipping point” between economic feasibility and infeasibility can be the point at which a company becomes indifferent between undertaking a substitution activity and ceasing activity in the EU. In some instances, SEAC may consider an alternative economically infeasible even if this alternative would not lead to a cessation of activity in the EU, depending on the magnitude of the increased costs or profits lost. This will be assessed on a case-by-case basis. There is no set threshold above which any increase in costs associated with an alternative would be judged economically infeasible for the applicant. Note that this assessment should be made at the level of the particular use in question and does not consider whether the applicant (or downstream user when relevant) overall could absorb increased costs and/or profit losses (e.g. by cross-subsidising the substitution with profits obtained in other operations not related to the substance of concern).In addition to demonstrating that suitable alternatives do not exist by the sunset date or adoption of an opinion, economic infeasibility can be used to justify the length of the review period. If the main reason for unsuitability of an alternative is economic infeasibility of an alternative, SEAC will consider whether it is likely to remain infeasible throughout the review period requested.