reachFactsheet

ECHA-13-FS-04-EN

Applications for authorisation under REACH

Authorisation is one of the REACH
processes for managing the risksof hazardous substances. It aims toensure that risks from substancesof very high concern (SVHCs) areproperly controlled and that thesesubstances are progressively replacedby suitable alternatives, without
introducing unwanted disruptions to

the functioning of the internal market.
Therefore, it is possible to apply for anauthorisation for a substance includedin the Authorisation List (i.e. Annex
XIV of the REACH Regulation).
The Authorisation procedure isdescribed in Title VII of the REACH
Regulation (EC) No. 1907/2006.

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THE AUTHORISATION PROCEDURE

The Commission decides on the granting or refusingof authorisations. For that, ECHA’s Committees
for Risk Assessment (RAC) and Socio-economic
Analysis (SEAC) provide the Commission withopinions on applications for authorisation.

• If a manufacturer or an importer applies:
The authorisation can cover the manufacturer’s orimporter’s downstream uses of the substance forits customers base (“top-down” coverage).
• If a downstream user applies:
The authorisation has a limited coverage. It covers
the applicant itself, its customers (down the supplychain) and its immediate supplier (one level up
in the supply chain) if this one is only placing thesubstance on the market (not using the substanceitself). A downstream user cannot therefore coveractors up its supply chain other than the substancemanufacturer or importer, this one being its
immediate supplier.

The up-to-date Authorisation List is available on
ECHA’s website.

THE IMPORTANCE OF DOWNSTREAM USERS AND
SUPPLY CHAIN COMMUNICATION

SUPPLY CHAIN CONSIDERATIONS

Compared to manufacturers or importers,
downstream users may have a greater interest inensuring that an authorisation is granted if they
depend on particular substances being available. This
does not automatically mean that all downstream
users should apply for an authorisation themselves.
However, it does imply that manufacturers anddownstream users of chemicals should set up supply
chain communication from the outset to share
information (including the chemical safety report)
and discuss the most efficient form of cooperation.
In the authorisation process, communication along
the supply chain is a key function.

The uses of substances on the Authorisation list on
the EU market are suspended after the so-called
sunset date which is set on a case-by-case basis foreach substance. Unless an exception applies, thesesubstances may only be placed on the market if anauthorisation has been granted for a specific use.

A manufacturer, an importer or a downstream
user of a substance on the Authorisation List may
prepare an application for authorisation for its ownuses or for the uses for which they intend to place
the substance on the EU market. A duly mandated
only representative of a non-EU manufacturer canalso submit an application.
The supply chain coverage of an authorisation isimportant to consider:

Manufacturer/Importer(applicant)Formulator 1

Formulator 2

End user

Manufacturer/Importer

Formulator 1(applicant)Formulator 2

End user

Manufacturer/Importer

Formulator 1

Formulator 2(applicant)End user

Applicant’s immediate supplier.
M/I has no use itself.

Figure 1. Authorisation: supply chain coverage. The arrows indicate authorisation coverageannankatu 18 , p.o. box 400, fi - 00121 helsinki, finland | echa.europa.eu

HOW IS AN AUTHORISATION GRANTED OR
REFUSED?
The criteria for granting an authorisation are definedin Art. 60 of REACH:• Under the “adequate control route” (Art. 60(2)) an
application shall be granted if the risk to human healthand the environment from the use of the substancearising from the intrinsic properties specified in theAuthorisation List is adequately controlled.
• Under the “socio-economic route” (Art. 60(4)), an
authorisation may be granted if it is shown that (i)the socio-economic benefits outweigh the risk tohuman health and the environment from the use of
the substance and (ii) there is no suitable alternative
substances or technologies.
The factors to be taken into account for assessing
the availability of suitable alternatives aredescribed in Art. 60(5) and in the Guidance on
Applications for Authorisation.
The Committees prepare their draft opinions forthe application for authorisation within 10 monthsof receipt of the application. The opinions arebased on the application, as well as any information
received during the public consultation onpossible alternatives run by ECHA, and any further
information on alternatives that the applicant orinterested parties have provided, based on requestfrom the Committee for Socio-Economic Analysis.
Applicants can comment on the draft opinions
before they are adopted by the Committees.
Within three months of receipt of the Committees’
opinions, the Commission prepares a draft decision
as to whether or not the authorisation should begranted. Subsequently, the Commission adopts thedecision granting or refusing the authorisation.
PREPARING APPLICATIONS FOR AUTHORISATIONECHA's guidance and manuals illustrate how to apply
for an application for authorisation and explain how
to prepare the different parts of an application:• Guidance on the preparation of an Application forAuthorisation• Guidance on Socio-Economic Analysis:
Authorisation• Guidance on information requirements andchemical safety assessment• How to describe uses in the context ofAuthorisation

To prepare an application for authorisation in IUCLID:• Data submission manual – part 22: How toprepare and submit an application for authorisation
using IUCLID
Format and templates
The format for an application for authorisation isa IUCLID dossier, to which assessment reports andsupporting documents need to be attached. Theseare summarised below. All the formats and detailed
instructions are available on ECHA’s website.
ECHA provides templates to be used by applicants
for authorisation as necessary and applicable:• Chemical safety report: documenting thechemical safety assessment of the substance anddemonstrating the adequate control or minimisationof the risk arising from the use of the substanceapplied for.
• Analysis of alternatives: showing whether
there are any suitable alternative substance(s) ortechnology(ies) to the substance(s) for the uses
applied for.
• Socio-economic analysis: gathering socioeconomic arguments in support of the applicationfor each use of the substance applied for.
• Concordance table: specifying where in theapplication is discussed important issues forthe formulation of the opinion on granting theauthorisation.
For threshold substances where adequate control
is demonstrated and where suitable alternative(s)is(are) available to the user:• Substitution plan: showing the applicant’scommitment to take the actions needed tosubstitute the substance with suitable alternativesubstance(s) or technology(ies) for the use(s)applied for within a specified timetable.
Notification of intent and pre-submission
information session
ECHA invites the potential applicants to notify wellin advance their intention to submit an application.
ECHA also gives the opportunity to future applicants
to ask for a pre-submission information session with
ECHA staff members to ask case-specific questions
regarding the regulatory and procedural aspects of
the application for authorisation process.
Pre-submission information sessions should be held
the latest about six months before the submission of
the application for authorisation.

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Payinvoice

Prepare application

Additional
information

Comment

ComplyApplicant
ECHA

NotifySubmitCheckconformity

Committees
RAC and SEAC
Secretariat

Pre-submission
information session

Preparedraft opinions of
RAC and SEAC

Adopt RAC
and SEAC
opinions

Register ofnotifications

Preparebroad
information
on uses andinvoice

Interested parties

Public consultation

European Commission

Prepare and adopt decision
Publish in Official Journal(with regulatory committee)

Downstream users

ComplyFigure 2. The application for authorisation process: actors and steps

Submission windows
ECHA establishes specific windows for submitting
applications for authorisation (see ECHA website).
Submitting the applications within these windows
ensures the minimum processing time for theapplications by ECHA and its Committees.
Fees and reductions for small and medium-sizedenterprises
A fee has to be paid to ECHA for the development of
the opinion by ECHA’s Committees. The level of thefee depends on the number of uses and exposure
scenarios, substances and applicants covered by
the application. However, small and medium-sizedenterprises (SMEs) can get up to 90% reduction on
the application fee provided that they qualify for this.

ECHA has made available a Fee Calculator on its
website. This is a very useful tool to estimate the fee
before submission.
PUBLIC CONSULTATION ON ALTERNATIVES
The purpose of public consultation is to gather
additional, relevant and meaningful information
on possible alternatives for the uses applied for. It
offers the opportunity for public engagement in theFor each combination of applicant/substance/use
applied for, a public consultation on alternatives
will be launched. The consultation lasts eightweeks, starting from the publication on ECHA’s
website of the “broad information on uses” package
which consists of:• The name of the applicant• “Brief wording”:•• Name of the use•• Conditions of use (exposure, functionalrequirements)•• List of use descriptors (codes, function)• Public version of the Exposure Scenario• Public version of the Analysis of Alternatives• Public summary of the Socio-economic Analysis• Public summary of the Substitution Plan
FURTHER INFORMATION
More information is available in the ECHA website at:
http://echa.europa.eu/addressing-chemicals-of-concern
http://echa.europa.eu/applying-for-authorisation© European Chemicals Agency - November 2013

annankatu 18 , p.o. box 400, fi - 00121 helsinki, finland | echa.europa.eu

ED-03-13-510-EN-N - DoI: 10.2823/18266 - ISBN: 978-92-9244-072-5

ECHA will verify the SME status of all applicants.
If it concludes that the size of a company is larger
than claimed when applying for authorisation, theapplicant needs to pay the difference in authorisation
fee as well as an administrative charge.

regulatory process. ECHA's scientifc committees take
into account the information submitted by interested
third parties in the development of their opinions.