The following main steps are involved in the application for authorisation and the subsequent decision-making process on granting an authorisation for the placing on the market or use of a substance on the Authorisation List (i.e. Annex XIV) to the REACH Regulation:
1. Prepare an application for authorisation
A manufacturer, an importer or a downstream user of the substance on the Authorisation list may prepare an application for authorisation for his own use(s) or for uses for which he intends to place the substance on the market.
2 Notification and pre-submission information sessions
Applicants are requested to notify ECHA well in advance of their intentions to submit an application.
When notifying or later, future applicants can request a pre-submission information session with ECHA to clarify regulatory and procedural issues related to the authorisation application process.
3. Submit the application
Applicants submit their applications for authorisation to ECHA.
4. Prepare the invoice
ECHA checks that the application is complete and can be processed so that it can prepare and send an invoice.
5. Pay the invoice
The applicants need to pay the invoice. Once ECHA has received the payment by the specified deadline the application is considered received and the Committees can start their work.
6. Check conformity
The Committees, supported by the Secretariat, check whether the application conforms with the information requirements of Article 62 of the REACH Regulation. The Committees may jointly require additional information to bring the application into conformity with the Regulation.
7. Public consultation on the uses applied for
ECHA will publish broad information on the uses applied for on its website inviting interested parties to submit information on possible alternative substances or techniques for these uses.
8. Require additional information on alternatives
SEAC may require the applicant or third parties to submit additional information on alternatives within a specified timeline.
9. Prepare draft opinions of RAC and SEAC
The Committees prepare and adopt their draft opinions for the application for authorisation within 10 months of receipt of the application. The opinions are based on the application, any information received during the public consultation, and any further information on alternatives that the applicant or interested parties have provided based on SEAC's request.
10. Comment draft opinions
The applicant has the possibility to comment on the draft opinions within two months of the receipt.
11. Adopt RAC and SEAC final opinions
RAC and SEAC adopt their final opinions taking into account the possible comments made by the applicant on the draft opinions. The Secretariat sends the opinions to the European Commission, the Member States and the applicant. Non-confidential versions of the opinions will be published on ECHA's website.
12. Prepare, adopt and publish the authorisation decision
Within three months of receipt of the Committees' opinions, the Commission prepares a draft decision as to whether or not the authorisation should be granted. Subsequently the Commission adopts the decision granting or refusing the authorisation under the regulatory committee procedure.
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. The authorisation is subject to a time-limited review period (see Review of the authorisation).
Review of the authorisations
Authorisations are valid until the Commission decides to withdraw or amend the authorisation in the context of a review. All authorisation decisions will define a time-limited review period. Holders of authorisations must submit a review report at least 18 months before the expiry of the time-limited review period.
In addition, an authorisation may be reviewed 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; or
- new information on possible substitutes becomes available.
13. Comply with the authorisation
Holders of an authorisation and downstream users using an authorised substance must comply with the requirements of the authorisation decision when marketing and/or using the substance.
Holders of an authorisation (i.e. manufacturers, importers and/or downstream users) need to include the authorisation number on the label before they place the substance or a mixture containing the substance on the market. This shall be done without delay once the authorisation number has been made publicly available (see step 12).
14. Register of the notifications of Downstream users
Downstream users of an authorised substance shall notify ECHA within three months of the first supply of the substance.
ECHA will keep a register of the Downstream User notifications (see step 13) and grant access to this register to the competent authorities of the Member States.