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

  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
2012 5 1 0 (0) 0 0 0 0
2013 11 9 8 (10) 17 1 1 0
2014 170 14 19 (33) 38 30 34 2
2015 72 33 7 (20) 13 25 51 10
2016 17 10 77 (132) 112 63 175 52
2017 6 6 10 (13) 16 58 74 46
2018 71 22 5 (7) 5 22 26 72
2019 27 38 62 (87) 95 13 17 45
2020 17 10 31 (50) 53 96 171 108
2021 2 3 (5) 3 1
Total 398 143 222 (357) 352 308 549 336

*) Situation as of 17 February 2021

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 authorisation holder3		 Commission decisions per use and per authorisation holder4
2017 2 2 2 (2) 4
2018 2 2 1 (1) 1 4 4
2019 2 1 1 1
2020 1 4 4
2021 2 (2) 2
Total 6 6 9 (9) 11 5 5

*) Situation as of 17 February 2021

Status of received applications for authorisation per substance.

Received afa 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
Bis(2-ethylhexyl) phthalate (DEHP) 5 (7) 10 10 14 7
Dibutyl phthalate (DBP) 3 (3) 5 5 5 5
Bis(2-ethylhexyl) phthalate (DEHP) and Dibutyl phthalate (DBP) 1 (1) 3 3 3 3
Lead sulfochromate yellow (C.I. Pigment Yellow 34) and Lead chromate molybdate sulphate red (C.I. Pigment Red 104) 1 (1) 12 12 12 12
Hexabromocyclododecane (HBCDD) 1 (13) 2 2 26 26
Diarsenic trioxide 4 (4) 5 5 5 5
Trichloroethylene 13 (15) 19 19 21 21
Lead chromate 1 (1) 1 1 1 1
Chromium trioxide 47 (93) 75 56 127 92
Sodium dichromate 21 (27) 27 27 39 38
Chromium trioxide, Sodium dichromate and Potassium dichromate 1 (6) 3 3 18 18
Chromium trioxide, Sodium dichromate 2 (3) 2 1 2
Sodium chromate 3 (5) 4 4 7 8
Sodium chromate; Potassium chromate 1 (1) 4 4 4 4
1,2-Dichloroethane (EDC) 16 (18) 20 20 22 22
Potassium dichromate 4 (4) 7 7 7 7
Ammonium dichromate 3 (5) 4 4 5 5
Dichromium tris(chromate) 2 (3) 3 3 5 5
Chromium trioxide; Dichromium tris(chromate); 1 (2) 4 4 5 5
Strontium chromate 2 (13) 3 3 23 23
Potassium hydroxyoctaoxodizincatedichromate 1 (5) 2 2 10 10
Bis(2-methoxyethyl) ether (Diglyme) 10 (10) 12 10 10 8
Arsenic acid 1 (1) 1 1 1 1
Chromic acid 1 (1) 1 1 1 1
Formaldehyde, oligomeric reaction products with aniline (technical MDA) 1 (1) 2 2 2 2
2,2'-dichloro-4,4'-methylenedianiline (MOCA) 2 (2) 2 1 1
Pentazinc chromate octahydroxide 2 (3) 4 4 6 6
4-(1,1,3,3-tetramethylbutyl)phenol, ethoxylated 51 (70) 77 65 90
4-Nonylphenol, branched and linear, ethoxylated 6 (8) 7 6 8
4-(1,1,3,3-tetramethylbutyl)phenol, ethoxylated; 4-Nonylphenol, branched and linear, ethoxylated 6 (22) 21 15 61
Pitch, coal tar, high-temp. 4 (4) 4 4 4 1
Pitch, coal tar, high-temp.; Anthracene oil 4 (4) 4 4 4
Total 221 (356) 351 308 549 336

*) Situation as of 17 February 2021

Status of received review reports per substance:

received review reports per substance

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
Bis(2-ethylhexyl) phthalate (DEHP) 2 (2) 4 4 4
Trichloroethylene 3 (3) 3 1 1
1,2-dichloroethane (EDC) 2 (2) 2
Sodium dichromate 1 (1) 1
Chromium Trioxide 1 (1) 1
Total 9 (9) 11 5 5

*) Situation as of 17 February 2021

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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