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.

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

  Received applications Applicants Number of uses RAC
and
SEAC opinions		 Commission decisions
2013 8 10 17 1
2014 20 34 38 32 2
2015 7 20 14 23 10
2016 77 133 118 70 14
2017 10 13 16 58 38
2018 5 8 5 22 42
2019 62 86 115 14 41
2020 31 48 70 124 36
2021 16 30 19 50 11
2022 49 77 66 34 73
2023 42 69 52 59 82
Total 327 528 530 487 349

*) Situation as of 31/12/2023

Status of received review reports per year.

Status of received review reports per year.

  Received applications Applicants Number of uses RAC
and
SEAC opinions		 Commission decisions
2017 2 2 4
2018 1 1 1 4
2019 1
2020 4 4 4
2021 4 4 4 5 1
2022 1 1 1 3 1
2023 14 55 30 1 5
Total 26 67 44 14 7

*) Situation as of 31/12/2023

Status of received applications for authorisation per substance.

Status of received applications for authorisation per substance:

Substance Annex XIV entry Number of uses received 1 Committee opinions adopted (per use)2 Commission decision (per use)3
hexabromocyclododecane (hbcdd) 3 2 2 2
bis(2-ethylhexyl) phthalate 4 14 11 4
dibutyl phthalate 6 7 7 7
diarsenic trioxide 8 5 5 5
lead chromate 10 1 1 1
lead sulfochromate yellow 11 6 6 6
lead chromate molybdate sulfate red 12 6 6 6
trichloroethylene 15 19 19 19
chromium trioxide 16 193 163 67
acids generated from chromium trioxide and their oligomers 17 2 1 1
chromic acid 17 1 1
sodium dichromate 18 40 36 29
potassium dichromate 19 12 9 9
ammonium dichromate 20 4 4 4
potassium chromate 21 2 2 2
sodium chromate 22 7 7 7
formaldehyde, oligomeric reaction products with aniline 23 2 2 2
arsenic acid 24 1 1 1
bis(2-methoxyethyl) ether 25 12 12 12
1,2-dichloroethane 26 20 20 20
4,4'-methylenebis[2-chloroaniline] 27 4 4
dichromium tris(chromate) 28 5 5 4
strontium chromate 29 3 3 3
potassium hydroxyoctaoxodizincatedichromate(1-) 30 2 2 2
pentazinc chromate octahydroxide 31 4 4 4
anthracene oil 40 4 4 4
pitch, coal tar, high-temp. 41 8 8 8
4-(1,1,3,3-tetramethylbutyl)phenol, ethoxylated 42 113 113 98
4-nonylphenol, branched and linear, ethoxylated 43 28 27 19
trixylyl phosphate 47 2 2
Tetraehyllead 55 1
Total 530 487 349

*) Situation as of 31/12/2023

Status of received review reports per substance:

Status of received review reports per substance:

Substance Annex XIV entry Number of uses received 1 Committee opinions adopted (per use)2 Commission decision (per use)3
bis(2-ethylhexyl) phthalate 4 4 4
trichloroethylene 15 5 5 5
chromium trioxide 16 12 1 1
sodium dichromate 18 8 1 1
potassium dichromate 19 4
sodium chromate 22 2
bis(2-methoxyethyl) ether 25 1 1
1,2-dichloroethane 26 2 2
dichromium tris(chromate) 28 1
4-(1,1,3,3-tetramethylbutyl)phenol, ethoxylated 42 3
4-nonylphenol, branched and linear, ethoxylated 43 2
Total 44 14 7

*) Situation as of 31/12/2023

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