- How to apply for authorisation
- Are you affected by authorisation?
- Develop an application strategy
- Start preparing your application
- Notify ECHA and request a teleconference based information session
- Finalise your application
- Submit your application
- Engage during the opinion development
- Fulfil your obligations
- Submit a review report if you still need to use the substance
- Ask ECHA about authorisation applications
Formats for applications for authorisation
Create the following documentsusing the available formats as necessary.
| Document | Description | |
|---|---|---|
| Summary of risk management measures (RMMs) and operational conditions (OCs) | This document contains information on how to organise and present your Summary of risk management measures (RMMs) and operational conditions (OCs). | |
Use this format to prepare your Summary of risk management measures (RMMs) and operational conditions (OCs). | Download | |
| Chemical safety report | This document contains instructions on how to organise and present your Chemical safety report. | |
(and - where needed - a substitution plan) | This format contains instructions on how to organise and present your analysis of alternatives, and socio-economic analysis – and where needed - a substitution plan in one document. | |
Use this format (without instructions) to present your analysis of alternatives and socio-economic - and where needed - a substitution plan in one document. | ||
| Note of the Commission of 27 May 2020 “Suitable alternative available in general & Requirement for a substitution plan | Download | |
| Explanatory note | Use this format to prepare your Explanatory note as part of a review report | Download |
| Argumentation for substance grouping | There is currently no specific format. However, you may find support in: | |
| Guidance on information requirements and chemical safety assessment, Chapter R6: QSARs and grouping of chemicals and | Download | |
| Practical guide 6: How to report read-across and categories | Download | |
| Justification for not considering certain risks | There is currently no specific format. However, you may find support in the Guidance on the preparation of an application for authorisation. | Download |
| Simplified analysis of alternatives and Socio-economic analysis to produce legacy spare parts or to repair articles and complex products no longer produced | Use this format to prepare your analysis of alternatives and Socio-economic analysis when submitting an application for authorisation or review report to produce legacy spare parts or to repair articles and complex products no longer produced. | Download |
- How to describe uses in the context of Authorisation[PDF] [EN]
- Guidance on the preparation of an Application for Authorisation[PDF] [EN]
- Guidance on Socio-Economic Analysis – Authorisation[PDF] [EN]
- Manual on How to prepare an application for authorisation
- ECHA Fee calculator [XLS]
A tool provided by ECHA to estimate the possible amount of a fee related to a given application for authorisation under REACH