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 opinions2
Commission decisions on RAC and SEAC opinions3
2012 5 1 0 (0) 0 0 0
2013 11 9 8 (10) 17 1 0
2014 170 14 19 (33) 38 30 2
2015 72 33 7 (20) 13 23 10
2016 17 10 77 (133) 112 63 22
2017 6 6 10 (13) 14 58 36
2018 71 22 5 (8) 5 20 37
2019 27 38 62 (86) 95 13 39
2020 16 10 31 (48) 53 96 37
2021 59 11 16 (30) 18 42 12
2022 28 13(15) 17 4 4
Total 444 154 248 (396) 382 352 199

*) Situation as of 15 March 2022

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 opinions2
Commission decisions on RAC and SEAC opinions3
2017 2 2 2 (2) 4
2018 2 2 1 (1) 1 4
2019 2 1 1
2020 2 1 4 (4) 4
2021 2 1 4 (4) 4 5 1
2022
Total 10 7 11 (11) 13 8 1

*) Situation as of 15 March 2022

Status of received applications for authorisation per substance.

Received afa per substance

Substance Number of received1 applications (applicants) Number of uses RAC and SEAC opinions2 Commission decisions on RAC and SEAC opinions3
Bis(2-ethylhexyl) phthalate (DEHP) 5 (7) 10 10 3
Dibutyl phthalate (DBP) 3 (3) 5 5 5
Bis(2-ethylhexyl) phthalate (DEHP) and Dibutyl phthalate (DBP) 1 (1) 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
Hexabromocyclododecane (HBCDD) 1 (13) 2 2 2
Diarsenic trioxide 4 (4) 5 5 5
Trichloroethylene 13 (15) 19 19 19
Lead chromate 1 (1) 1 1 1
Chromium trioxide 66 (114) 100 78 43
Sodium dichromate 22 (29) 28 27 24
Chromium trioxide, Sodium dichromate and Potassium dichromate 1 (6) 3 3 3
Sodium chromate 3 (5) 4 4 3
Sodium chromate; Potassium chromate 1 (1) 2 2 2
1,2-Dichloroethane (EDC) 16 (19) 20 20 20
Potassium dichromate 4 (4) 7 7 7
Ammonium dichromate 3 (5) 4 4 5
Dichromium tris(chromate) 3 (4) 4 4 3
Chromium trioxide; Dichromium tris(chromate); 1 (2) 4 4 4
Strontium chromate 2 (13) 3 3 3
Potassium hydroxyoctaoxodizincatedichromate 1 (5) 2 2 2
Bis(2-methoxyethyl) ether (Diglyme) 10 (10) 12 12 12
Arsenic acid 1 (1) 1 1 1
Chromic acid 2 (2) 2 1 1
Formaldehyde, oligomeric reaction products with aniline (technical MDA) 1 (1) 2 2 2
2,2'-dichloro-4,4'-methylenedianiline (MOCA) 3 (14) 4 3
Pentazinc chromate octahydroxide 2 (3) 4 4 6
4-(1,1,3,3-tetramethylbutyl)phenol, ethoxylated 53 (72) 79 77 10
4-Nonylphenol, branched and linear, ethoxylated 7 (9) 8 6
4-(1,1,3,3-tetramethylbutyl)phenol, ethoxylated; 4-Nonylphenol, branched and linear, ethoxylated 7 (21) 22 21
Pitch, coal tar, high-temp. 4 (4) 4 4 1
Pitch, coal tar, high-temp.; Anthracene oil 4 (4) 4 4 0
Chromium trioxide, Sodium dichromate 2 (3) 2 2
Total 248 (396) 382 352 199

*) Situation as of 15 March 2022

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 opinions2 Commission decisions on RAC and SEAC opinions3
Bis(2-ethylhexyl) phthalate (DEHP) 2 (2) 4 4
Trichloroethylene 5 (5) 5 3 1
1,2-dichloroethane (EDC) 2 (2) 2 1
Sodium dichromate 1 (1) 1 1
Chromium Trioxide 1 (1) 1 1
Total 11 (11) 13 10 1

*) Situation as of 15 March 2022

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 The commission takes only one decision on each opinion of the RAC and SEAC opinion regardless of the number of applicants involved