Authorisation process

Phase III: Application for authorisation

This phase consists of the following steps:

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Companies that want to continue using a substance included in the Authorisation List after the sunset date need to prepare an application for authorisation and submit it before the latest application date. The latest application date and the sunset date are specified in the Authorisation List.

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Preparation of the application

An application for authorisation can be submitted for:

  • one or several uses
  • one or a group of (similar) substances

Applicants may apply for authorisation for their own use or uses for which they intend to place the substance on the market.

If the conclusion is to continue using the substance or placing it on the market after the sunset date, then the company should apply for authorisation.

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Notification and teleconference based information sessions

Finalisation of application

Applicants should be transparent and avoid any unnecessary confidentiality claims in the public versions of the reports. Justifications will need to be provided for any information claimed confidential.

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Submission of the application to ECHA

Applicants submit their applications for authorisation to ECHA. Learn more

Consultation

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Opinion development Questions to applicant from rapporteurs

The Committees for Risk Assessment (RAC) and Socio-economic Analysis (SEAC) will prepare their draft opinion, including on whether the application contains all the necessary information specified in Article 62 of REACH, within 10 months of receiving the application.

The opinions are based on:

  • the application;
  • any information received during the consultation; and
  • any further information that the applicant or interested parties have provided.

The committees may request additional information from the applicant or third parties within a specified timeline.

Opinion development Possible trialogue between applicants, RAC and SEAC, and any relevant third parties

A trialogue may also be organised with the applicant, the RAC and SEAC rapporteurs and any third parties that have submitted information on alternatives in the consultation.

The trialogue is an opportunity for the rapporteurs to discuss, in an interactive manner, the applicability of the suggested alternatives and, if necessary, any other technical and scientific issues related to the application for authorisation.

Opinion development RAC and SEAC opinion

Draft opinion by RAC and SEAC

The applicant may comment on the draft opinion within two months of receiving the draft opinion.

Final opinion by RAC and SEAC

RAC and SEAC adopt their final opinions taking into account the possible comments made by the applicant on the draft opinions. If the applicant provides comments on the draft opinion, the final opinion is ready approximately four months after the draft opinion.

ECHA sends the opinions to the European Commission, the Member States and the applicant. Non-confidential versions of the opinions are published on ECHA's website.

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Decision

This step consists of the following substeps:

  • Draft decision by the European Commission.
  • REACH Committee vote and adoption of decision.

The European Commission prepares a draft decision on whether or not the authorisation should be granted within three months of receiving the opinions. Following the draft decision, a minimum of three months is needed for the vote in the REACH Committee and the subsequent adoption procedure, including translations, in the Commission.

Once the European Commission adopts the decision granting or refusing the authorisation, a summary of the decision is published in the Official Journal (OJ) of the European Union, and made publicly available through a database maintained by ECHA.


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The authorisation is subject to a time-limited review period.

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Implementation Compliance by authorisation holders and downstream users

If the authorisation is granted by the European Commission, it is subject to the conditions described in the chemical safety report submitted in the application. The authorisation decision may stipulate additional conditions. The authorisation holder should also continue efforts to find safer alternatives after the decision.

Holders of an authorisation must:

Comply with the requirements of the authorisation decision when marketing and/or using the substance; and

Include the authorisation number on the label before they place the substance or a mixture containing the substance on the market (if they are manufacturers, importers or only representatives).

This has to be done without delay once the authorisation number has been made publicly available.

Downstream users covered by an authorisation granted to an actor up their supply chain must comply with the conditions of the decision and notify ECHA within three months of the first supply of the substance.

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ECHA keeps a register of the downstream user notifications and grants access to this register to the competent authorities of the Member States.

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Implementation Enforcement by Member State Competent Authorities

The national authorities are responsible for enforcing REACH authorisation.

The Commission may review an authorisation at any time if:

  • the circumstances have changed so as to affect the risk to human health or the environment, or the socio-economic impact;
  • new information on possible substitutes becomes available.

Review report
if the company needs to continue using the SVHC after the review period

If the authorisation holder needs to continue using the SVHC after the review period, they must submit a review report. A review may also be triggered if the circumstances of the original authorisation have changed or new information on possible substitutes becomes available.

During the time-limited review period, authorisation holders must continue looking for a suitable alternative substance or technology that would make the use of the SVHC un-necessary.

If authorisation holders need to continue using the SVHC after the end of the review period, they must submit a review report to ECHA at least 18 months before the expiry of the review period.

A review may also be triggered if the circumstances of the original authorisation have changed or new information on possible substitutes becomes available.

As part of the review reports, the authorisation holders should update all documents submitted in the original application that have changed and submit any other elements required by the conditions or monitoring arrangements of the authorisation decision.

The process for submitting and handling a review report (including the consultation) is the same as for the initial application for authorisation.

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