Preparing applications for authorisation

Step 1

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 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. Download
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.

Download

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.

Download

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).

Download

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

Download
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
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
Concordance table To further simplify the preparation of applications for authorisation, ECHA no longer requires concordance tables. Any reference to the concordance table in the manuals can therefore be ignored.   

 

Step 2

Create your IUCLID 5 substance data set, and attach the documents listed above to it.

Detailed instructions can be found in the Data Submission Manual Part 22.

If you do not have IUCLID 5 installed, you can also use a release of IUCLID 5 that has been specially created for the process of application for authorisation. This release, Preconfigured IUCLID 5 for AfA, allows you to run IUCLID 5 locally on any Microsoft Windows computer without making a formal installation, and without having to configure it or install any other software. Partially pre-filled substance datasets for the substances in the Authorisation List are supplied pre-loaded into the software. Note that the Preconfigured IUCLID 5 for AfA is intended as a supplementary means of support. It is not intended to replace the most recent version of IUCLID 5 or existing installations, which can still be used to prepare dossiers for applications for authorisation, if the user so prefers.
 
The hardware and software requirements for Preconfigured IUCLID 5 for AfA are a computer running Microsoft Windows with 1.25 GB of free hard-drive space. It can be downloaded free of charge from the IUCLID 5 website. To download any IUCLID 5 software from the IUCLID site requires that the user be signed in to an account on the site. Support for using this release of IUCLID 5 is included in the download package and can also be found under "Related documents" (above, right).
 
 
 

Step 3

Once you are ready to submit your application to ECHA, follow the steps described here.

 

Joint Applications

An application can be submitted by one applicant or a group of applicants (i.e. joint application). Due to the possible complexity and technical issues of joint applications, ECHA recommends that you develop and submit a joint application preferably when (i) all co-applicants of the group apply for all uses in the joint application for authorisation, and (ii) they have found an acceptable way to share all information provided in the application. In complex cases, it may be preferable for each co-applicant to submit their own application separately.

SME verification

The application for authorisation process follows the same SME verification conditions as the registration process. After receiving the payment of the authorisation fee, ECHA will verify the size category of companies who claim to be eligible for a fee reduction. ECHA will collect an administrative charge from any registrant who wrongly claimed to be entitled to a fee reduction. If ECHA concludes that the size of a company is larger than claimed when applying for authorisation under REACH, the company will have to pay the difference in authorisation fee and an administrative charge.