Statistics on received applications

The placing on the market and use of Substances of Very High Concern included in the Authorisation List requires an authorisation. A manufacturer, an importer or a downstream user can apply for an authorisation. Applications for authorisation are submitted to ECHA. At the end of the authorisation process, which includes a public 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.

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

 

  Received notifications to submit Pre-submission information sessions held Received1 applications (applicants) Number of uses RAC-SEAC opinions2 Commission decisions3 Substances concerned
Per use and applicant4
2012 5 1 0 (0) 0 0 0 n/a
2013 11 9 8 (10) 17 1 0

 

2

Bis(2-ethylhexyl)
phthalate (DEHP)

Dibutyl phthalate (DBP)

2014* 168 13 19 (33) 38 21 1

 

5

Lead sulfochromate yellow (C.I. Pigment Yellow 34)

Lead chromate molybdate sulphate red (C.I. Pigment Red 104)

Diarsenic trioxide

Hexabromocyclododecane (HBCDD)

Trichloroethylene

Total 184 23 27 (43) 55 22 1  

*) Situation as of 11 December 2014.

1 An application 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 and applicant
3 Final decisions for each use and applicant.
4 This is the total number of opinions and decisions. For instance, if one application has been submitted by 3 applicants for 1 substance and 2 uses there will be (3x1x2=) 6 RAC-SEAC opinions and Commission decisions. If another application is submitted by 1 applicant for 1 substance and 3 uses, there will be (1x1x3=) 3 RAC-SEAC opinions and Commission decisions. In total there would be 9 RAC-SEAC opinions and 9 Commission decisions.

Status of received applications for authorisation per substance is given below.

 

Substance Number of received1 applications (appplicants) Number of uses RAC-SEAC opinions2 Commission decisions3
Per use and applicant4
Bis(2-ethylhexyl)
phthalate (DEHP)
5 (7) 10 11 1
Dibutyl phthalate (DBP) 2 (2) 4 4  

Bis(2-ethylhexyl)
phthalate (DEHP) and Dibutyl phthalate (DBP)

1 (1) 3 3  
Lead sulfochromate yellow (C.I. Pigment Yellow 34) and
Lead chromate molybdate sulphate red (C.I. Pigment Red 104)
1 (1) 12    
Hexabromocyclododecane (HBCDD) 1 (13) 2    
Diarsenic trioxide 4 (4) 5 4  
Trichloroethylene 13 (15) 19    
Total 27 (43) 55 22 1

*) Situation as of 11 December 2014.

1 An application 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 and applicant.
3 Final decisions for each use and applicant.
4 This is the total number of opinions and decisions. For instance, if one application has been submitted by 3 applicants for 1 substance and 2 uses there will be (3x1x2=) 6 RAC-SEAC opinions and Commission decisions. If another application is submitted by 1 applicant for 1 substance and 3 uses, there will be (1x1x3=) 3 RAC-SEAC opinions and Commission decisions. In total there would be 9 RAC-SEAC opinions and 9 Commission decisions.

After the submission of an application, ECHA performs the technical checks and prepares the "Broad Information on Uses" package for public consultation. Upon the completion of these checks it will also send an invoice to the applicant.  As soon as the Agency has received the payment of the application fee the public consultation on the Broad information on Uses will start. At that stage the Agency intends to disclose further details, such as the identity of the substance, the uses applied for, the public version of the analysis of alternatives  as well as the name of the applicant. The public consultation is launched two and a half to three months after the submission.

Public consultations on alternatives