ECHA

Summary

Substances in the Authorisation List require an authorisation before they can be placed in the market or used. You can prepare an application for authorisation following the steps below.

Prepare your application with the latest version of IUCLID 5, attach the relevant documents to your IUCLID dataset, and submit your dossier to ECHA via the specific web form.

Preparing an application

1. Create the following documents using the available templates as necessary.

Concordance table
Specify here where in the application dossier the important issues are for the formulation of the opinion on granting an authorisation.

Concordance table

 [DOC] [EN]

Chemical Safety Report
You can use the CSR template and the IUCLID CSR plug-in and the Chesar tool, if you need to generate a new chemical safety report.

Chemical Safety Report template

 [DOC] [EN]

Analysis of Alternatives
This template will guide you on how to organise and present the analysis of alternatives.

Analysis of Alternatives

 [DOC] [EN]

Substitution Plan
This template will guide you on how to organise and present the substitution plan.

Substitution Plan

 [DOC] [EN]

Socio-Economic Analysis
This template will guide you on how to organise and present the socio-economic analysis.

Socio-Economic Analysis

 [DOC] [EN]

Argumentation for substance grouping
There is currently no specific template. However, you may find support in the Practical guide 6: How to report read-across and categories.

Practical guide 6: How to report read-across and categories

 [PDF]

 

 

Justification for not considering certain risks
There is currently no specific template. However, you may find support in the Guidance on the preparation of an Application for Authorisation.

Guidance on preparation of an Application for Authorisation

 [PDF] [EN]

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 - How to Prepare and Submit an Application for Authorisation using IUCLID 5

 [PDF] [EN]

3. Sign-up in REACH-IT

Note: ECHA will use the company size stated in the REACH-IT account to determine the fee for your application. For small and medium-sized enterprises (SMEs), the application for authorisation process follows the same verification conditions as the registration process. ECHA will verify the SME status of applicants after it has received the fee. 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 which has been defined by Management Board decision MB/D/29/2010. More information on our SME web pages.

Submission dates

To better plan the committees' workload, ECHA establishes specific periods for submitting applications for authorisation. Uploading your application within these periods can ensure the minimum processing time for your application by ECHA and its Committees.

• 16 February - 1 March 2012
• 18 May - 1 June 2012
• 20 August - 3 September 2012
• 19 November - 3 December 2012 (advised latest submission window for substances with latest application date on 21 February 2013, i.e. musk xylene and MDA)
• 15 February - 1 March 2013
• 20 May - 3 June 2013 (advised latest submission window for substances with latest application date on 21 August 2013, i.e. DEHP, BBP, DBP and DIBP)
• 19 August - 2 September 2013 (advised latest submission window for substances with latest application date on 21 November 2013, i.e. diarsenic trioxide, diarsenic pentaoxide, lead chromate, lead sulfochromate yellow (C.I. pigment yellow 34) and lead chromate molybdate sulphate red (C.I. pigment red 104))
• 18 November - 2 December 2013 (advised latest submission window with latest application date on 21 February 2014, i.e. HBCDD, TCEP and 2,4-Dinitrotoluene)

Tip: Submit your application during the first days of these windows to reduce the risk of missing a specific period's deadline due to failing the business rules check, which could result in a delay up to three months before the invoice can be issued.  The Business Rules are a set of pre-requisites that must be fulfilled before ECHA can establish that the dossier can be handled properly and that the required regulatory processes can be successfully carried out. Passing the business rules check, only provides a confirmation that the dossier can be accepted for processing and not that the dossier is complete. 

The invoice for the authorisation application fee will be established and sent to the applicant after these checks have been performed. Therefore, in order to be able to pay the fee before the latest application date for the substance applied for, and receive from ECHA the "date of receipt" for the application, an applicant should submit to ECHA an application for authorisation dossier sufficiently in advance, which is currently estimated at 2,5 to 3 months.

ECHA's activities in support of preparations for applications for authorisation

Notification and pre-submission information sessions

You are invited to notify ECHA well in advance of the date you intend to submit an application so that ECHA can ensure a proper resource planning and a smooth processing of all incoming applications for authorisation. Please indicate the substance and provide a general description of the uses for which an authorisation will be sought.

Send notification

 

When notifying ECHA, you may also request a pre-submission information session with ECHA representatives to ask case-specific questions regarding the regulatory and procedural aspects of the authorisation application process. If your request is accepted, you will be asked to provide ECHA with some background information before the session. Pre-submission information sessions should be held the latest about six months before the submission of the application for authorisation. 

Request a pre-submission information session