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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.
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