ECHA has published an updated format for Authorization Application on 15t September, by which companies can use this when applying for authorization to use substances of very high concern (SVHC). The new format looks easier to fill in – combining the analysis of alternatives, the socio-economic analysis, and when relevant, a substitution plan into a single document.
Simultaneously, the opinion format for the Committees for Risk Assessment Committee (RAC) and Socio-Economic Analysis (SEAC) has been revised to take the General Court’s judgments in two authorization cases into account. The judgments concerned situations where suitable alternatives are available in general, and the applicants would need to give a substitution plan.
As requested by the European Commission, the opinion format now 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 instructions on confidentiality have also been updated. The revision of this format was done with the help of stakeholders and committee members said ECHA.
Applicants should start using these formats at once. However, applications may be given in the old format until the end of 2021 if applicants have already completed or are close to finishing the content of their application. RAC and SEAC will also use the new opinion format from now on.
New Authorization Application Format link: https://echa.europa.eu/applying-for-authorisation/preparing-applications-for-authorisation
Evaluating application document link: https://echa.europa.eu/applying-for-authorisation/evaluating-applications
Reference: https://echa.europa.eu/
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