Updated application for authorisation formats

ECHA/NR/21/23

ECHA has published an updated format for companies to use when applying for authorisation to use substances of very high concern. The new format combines the analysis of alternatives, the socio-economic analysis and, when relevant, a substitution plan into a single document. 

Helsinki, 15 September 2021 - The new format is easier for applicants to fill in. The possibility to submit separate documents has been removed making the application process more efficient and the documents more coherent. The instructions on confidentiality have also been updated.

At the same time, the opinion format for the Committees for Risk Assessment (RAC) and for Socio-Economic Analysis (SEAC) has been revised to take the General Court’s judgments in two authorisation cases into account. The judgments concerned situations where suitable alternatives are available in general and the applicants would need to submit a substitution plan. As requested by the European Commission, the opinion format also includes “a conclusion on whether or not the applicant has shown that the benefits for society from using the substance outweigh the risk to human health or the environment”.

The revision of formats was done in cooperation with stakeholders and committee members.

Applicants should start using these formats immediately. However, applications may be submitted in the old format until the end of 2021 if applicants have already finalised or are close to finalising the content of their application. RAC and SEAC will also use the new opinion format from now on.

更新的申请授权格式
ECHA / NR / 21/23
ECHA已经发布了一份更新的格式，供公司在申请许可使用非常受关注的物质时使用。新的格式将替代方案的分析、社会经济分析和相关时的替代计划合并成一个单独的文件。
赫尔辛基，2021年9月15日—新的格式更容易让申请人填写。取消了提交单独文件的可能性，使申请过程更有效率，文件更连贯。有关保密的说明也已更新。
同时，对风险评估委员会(RAC)和社会经济分析委员会(SEAC)的意见格式进行了修订，以考虑到普通法院在两个授权案件中的判决。判决涉及的情况是，一般情况下有合适的替代方案，申请人需要提交替代计划。按照欧洲联盟委员会的要求，意见格式还包括"关于申请人是否已证明使用该物质对社会的好处大于对人类健康或环境的风险的结论"。
格式的修订是与利益相关者和委员会成员合作完成的。
申请人应立即开始使用这些格式。然而，如果申请人已经完成或即将完成其申请内容，那么在2021年底之前，申请人可以按照旧格式提交申请。从现在开始，RAC和SEAC也将使用新的意见格式。

更多信息请点击：https://echa.europa.eu/de/home

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