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).

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Use this format to prepare your Summary of risk management measures (RMMs) and operational conditions (OCs).

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Chemical safety report

This document contains instructions on how to organise and present your Chemical safety report.

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Use the CSR format if you need to generate a new Chemical safety report. You can also use the IUCLID CSR plug-in and the Chesar tool.

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Analysis of alternatives

This document contains instructions on how to organise and present your Analysis of alternatives.

If you wish to document this together with Socio-economic analysis, use the format which is given below.

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Use this format to prepare your Analysis of alternatives.

If you wish to document this together with Socio-economic analysis, use the format which is given below.

Download
Socio-economic analysis

This document contains instructions on how to organise and present your Socio-economic analysis.

If you wish to document this together with Analysis of alternatives, use the format which is given below.

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Use this format to prepare your Socio-economic analysis.

If you wish to document this together with Analysis of alternatives, use the format which is given below.

Download

Analysis of Alternatives

and

Socio-economic analysis

This document contains instructions on how to organise and present your Analysis of alternatives and Socio-economic analysis in one document. You may use this approach instead of preparing two separate documents (which are listed above).

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Use this format to prepare your Analysis of alternatives and Socio-economic analysis in one document.

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Substitution plan This document contains instructions on how to organise and present your Substitution plan. Download
Use this format to prepare your 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

 

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