- ECHA
- Documents et informations d'appui
- Autorisation
- Comment présenter une demande d’autorisation
- Débutez la préparation de votre demande
- Formats pour demandes d’autorisation
Formats pour demandes d’autorisation
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Comment présenter une demande d’autorisation
- L'autorisation vous concerne-t-elle?
- Élaborez une stratégie pour déposer une demande
- Débutez la préparation de votre demande
- Notifiez l'ECHA et demandez une séance d'information préalable à la soumission
- Finalisez votre demande
- Soumettez votre demande
- Participez à l'élaboration de l'avis
- Respectez vos obligations
- Soumettez un rapport d’examen si vous avez toujours besoin d’utiliser la substance
- Interrogez l'ECHA sur les demandes d'autorisation
Formats pour demandes d’autorisation
Create the following documents using 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). |
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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. |
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(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. |
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Use this format (without instructions) to present your analysis of alternatives and socio-economic - and where needed - a substitution plan in one document. |
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| 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