Formats for applications for authorisation

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).

Download

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.

Download


Analysis of Alternatives

and

Socio-economic analysis

(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. 

Download (Version 3.1)

Use this format (without instructions) to present your analysis of alternatives and socio-economic - and where needed - a substitution plan in one document.

Download (Version 3)

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