Statistics on received applications for authorisation and review reports

The placing on the market and use of Substances of Very High Concern included in the Authorisation List requires an authorisation. Manufacturers, importers, only representatives or downstream users can apply for an authorisation. Applications for authorisation are submitted to ECHA. At the end of the authorisation process, which includes a consultation and the development of opinions by ECHA's Committees on Risk Assessment and Socio-economic Analysis, the European Commission decides on the granting or refusing of authorisations.

All authorisation decisions have a time-limited review period. In order to continue using the substance in question after the end of the review period the authorisation holders may submit a review report. The tables below provide statistics related to applications for authorisation and review reports per year and per substance.

 

Status of pre-submission activities and received applications for authorisation per year.

yearly pre-submissions and received afa

Status of received review reports per year.

Yearly received review reports

  Received notifications to submit Information sessions held
(link to details)
Received1 applications (applicants) Number of uses RAC
and
SEAC opinions per use2
RAC
and
SEAC opinions per use and per applicant3
Commission decisions per use and per applicant4

Status of received applications for authorisation per substance.

Received afa per substance

  Received notifications to submit Information sessions held
(link to details)
Received1 applications (applicants) Number of uses RAC
and
SEAC opinions per use2
RAC
and
SEAC opinions per use and per authorisation holder3
Commission decisions per use and per authorisation holder4

Status of received review reports per substance:

received review reports per substance

Substance Number of received1 applications (applicants) Number of uses RAC and SEAC opinions per use2 RAC and SEAC opinions per use and per applicant3 Commission decisions per use and per applicant4

1 An application/review report is received in terms of Article 64(1) of REACH when ECHA has received the application fee.

2 One opinion refers to a compiled version of the final opinions of RAC and SEAC for each use.

3 This refers to compiled final opinions of RAC and SEAC for each use and applicant/authorisation holder. For instance, if one application has been submitted by 3 applicants/authorisation holders for 1 substance and 2 uses there will be (3×1×2=) 6 RAC and SEAC opinions and subsequent Commission decisions. If another application/review report is submitted by 1 applicant/authorisation holder for 1 substance and 3 uses, there will be (1×1×3=) 3 RAC and SEAC opinions and Commission decisions. In total there would be 9 RAC and SEAC opinions and 9 Commission decisions.

4 Final decisions for each use and applicant/authorisation holder.

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Substance Number of received1 applications (authorisation holders) Number of uses RAC and SEAC opinions per use2 RAC and SEAC opinions per use and per authorisation holder3 Commission decisions per use and per authorisation holder4