Readers' guide for preparing an application for authorisation : version 1.1.
Date: 2018-09-19
Institutions: European Chemicals Agency
Subjects: administrative formalities, chemical industry, chemical product, dangerous substance, legislation, regulation (EU), research report, toxic substance, user guide

european chemicals agency

ECHA-18-H-22-EN

Version 1.1. 

July 2018

Readers’ guide for preparing an 
application for authorisation

The purpose of the readers’ guide

1.   

OVERVIEW

The purpose of this readers’ guide is to give 
potential applicants, and their consultants, 
an overview of the existing documents 
that should be read before preparing and 
submitting an application for authorisation, 
including information on how applications 
are assessed by the Committee for Risk 
Assessment (RAC) and the Committee for 
Socio-economic Analysis (SEAC).

A lot of material is available, including two 
guidance documents, over 10 documents 
on how applications are evaluated by our 
scientific committees and over 70 questions 
and answers on specific topics. These are 
spread out across several different web pages. 

This readers’ guide is intended to be adapted 
in the future based on readers’ needs. If you 
think that any useful information or documents 
have been omitted, or if you have any 
questions or suggestions for improvement, 
please let us know by emailing us at: 
application-authorisation@echa.europa.eu

For a quick overview of the application process, visit 
our support page on how to apply for authorisation.

The guidance on the preparation of an application 
for authorisation gives an overview of the 
authorisation process and describes the main 
elements of an application for authorisation.

2.   

DEVELOPING THE ASSESSMENT  
REPORTS

An authorisation is always use-specific and a 
key step in the preparation of the application is 
therefore the description of the use(s) applied for. 
The guidance on how to develop the description of 
uses provides further information on this process. 

2.1 

Chemical safety report

The chemical safety report covers the risks to human 
health and/or the environment from the use of the 
substance arising from its intrinsic properties specified 
in Annex XIV. The guidance on information requirements 
and chemical safety assessment provides generic 
guidance on how to prepare a chemical safety report. 
For some applicants, the guidance on occupational 
exposure estimation and on preparing a downstream 

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user chemical safety report may also be relevant. 

3.   

EVALUATION OF APPLICATIONS

If the applicant uses the reference derived no-effect 
levels (DNEL) and dose-response relationships 
published by RAC, it does not need to provide the 
hazard data necessary to derive DNELs or dose-
response relationships.

2.2 

Analysis of alternatives and socio-economic  
analysis

Information about how applications are assessed 
by RAC and SEAC can be found in the note on the 
common approach of RAC and SEAC in opinion 
development on applications for authorisation, the 
working procedure for RAC and SEAC for developing 
opinions on applications for authorisation and 
the note on the opinions of RAC and SEAC on 
applications for authorisation. 

In the analysis of alternatives, the applicant analyses 
the technical feasibility, economic feasibility, 
availability and risk reduction potential of alternative 
substances or technologies. Section 3 of the guidance 
on the preparation of an application for authorisation 
gives further technical information on this. SEAC’s 
note on how it assesses economic feasibility in 
applications for authorisation is also relevant.

The note on publication of information on 
applications during the opinion-making process 
outlines what information will be made publicly 
available, while the note on participation of 
applicants, third parties and stakeholder observers 
in the application for authorisation process 
describes the roles of the various actors in the 
opinion-making process. 

The socio-economic analysis describes what would 
happen if the applicant was not able to continue 
using the substance, and what costs and benefits 
this would create for society. The guidance on the 
preparation of a socio-economic analysis provides 
more information on this. In order to estimate the 
human health benefits, applicants can also use the 
findings of an ECHA study published in 2015 on 
willingness-to-pay to avoid certain health impacts. 

The impact of substances identified as persistent, 
bioaccumulative and toxic (PBT) or very persistent 
very bioaccumulative (vPvB) are usually not 
possible to monetise. Applicants applying for these 
substances should read SEAC’s note on the evaluation 
of applications for PBT and vPvB substances.  

We have selected examples of socio-economic 
analyses and analyses of alternatives from received 
applications that could be read by future applicants. 
These examples are illustrative in terms of the 
clarity of reporting, the coverage of the key issues 
as well as the extent to which the analyses are 
evidence-based and referenced.

For information about RAC’s and SEAC’s experience 
so far we recommend reading previous opinions, as 
well as the presentations made by RAC’s Chairman 
and SEAC’s Chairman at the Conference on Lessons 
Learnt on Applications for Authorisation held in 
February 2015 and the Workshop on Streamlining 
Applications for Authorisation of November 2015. 

All authorisation decisions have a time-limited 
review period. A note published by RAC and SEAC 
further explains how the length of the proposed 
review period is determined.

4.   

QUESTIONS AND ANSWERS AND   
FREQUENTLY ASKED QUESTIONS

We have developed an extensive series of questions 
and answers to frequently asked questions on 
applications for authorisation.   

5.   

PRESENTATIONS IN SEMINARS,  

  WORKSHOPS

Presentations given in events related to applications 
for authorisation are accessible from our website.

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