Proposals to identify Substances of Very High Concern previous consultations

In the framework of the authorisation process, Member States Competent Authorities or the European Chemicals Agency (ECHA), on request of the European Commission, may prepare Annex XV dossiers for the identification of Substances of Very High Concern (SVHC). SVHC are defined in Article 57 of Regulation (EC) No 1907/2006 ("the REACH Regulation") and include substances which are:

  • Carcinogenic, Mutagenic or toxic to Reproduction (CMR), meeting the criteria for classification in category 1 or 2 in accordance with Directive 67/548/EEC. This directive was replaced in beginning of 2009 by the new EU regulation (EC) No 1272/2008 on classification, labelling and packaging of chemical substances and mixtures, the so-called CLP Regulation. According to the new CLP Regulation these substances shall be classified as 1a or 1b.
  •  Persistent, Bioaccumulative and Toxic (PBT) or very Persistent and very Bioaccumulative (vPvB) according to the criteria in Annex XIII of the REACH Regulation,
  •  Identified, on a case-by-case basis, from scientific evidence as causing probable serious effects to human health or the environment of an equivalent level of concern as those above (e.g. endocrine disrupters)

The Annex XV reports, prepared by a Member State or the Agency, are available in the table below for information. Interested parties have 45 days from the date of publication to provide comments to the Agency on the identification of the substance as SVHC as well as further information related to use, exposure, alternatives and risks. 

There are currently no ongoing consultations.
 
(±)-1,7,7-trimethyl-3-[(4-methylphenyl)methylene]bicyclo[2.2.1]heptan-2-one covering any of the individual isomers and/or combinations thereof (4-MBC) - - Denmark Endocrine disrupting properties (Article 57(f) - human health) 03/09/2021 18/10/2021 Details
(±)-1,7,7-trimethyl-3-[(4-methylphenyl)methylene]bicyclo[2.2.1]heptane-2-one (4-methylbenzylidene camphor) 253-242-6 36861-47-9 Germany Equivalent level of concern having probable serious effects to the environment (Article 57 f) 29/02/2016 14/04/2016 Details
1,1'-[ethane-1,2-diylbisoxy]bis[2,4,6-tribromobenzene] 253-692-3 37853-59-1 Spain vPvB (Article 57e) 02/09/2022 17/10/2022 Details
1,2,3 Trichlorobenzene 201-757-1 87-61-6 Germany PBT like substance (equivalent level of concern) 30/08/2010 14/10/2010 Details
1,2,3-trichloropropane 202-486-1 96-18-4 ECHA Carcinogenic (Article 57a); Toxic for reproduction (Article 57 c) 21/02/2011 07/04/2011 Details
1,2,4 Trichlorobenzene 204-428-0 120-82-1 Germany Equivalent level of concern having probable serious effects to human health and environment (Article 57 f) 30/08/2010 14/10/2010 Details
1,2-benzenedicarboxylic acid, di-C6-10-alkyl esters; 1,2-benzenedicarboxylic acid, mixed decyl and hexyl and octyl diesters with ≥ 0.3% of dihexyl phthalate (EC No. 201-559-5)
271-094-0
272-013-1
68515-51-5
68648-93-1
Sweden Toxic for Reproduction (Article 57 c) 02/03/2015 16/04/2015 Details
1,2-Benzenedicarboxylic acid, di-C6-8-branched alkyl esters, C7-rich 276-158-1 71888-89-6 ECHA Toxic for reproduction (Article 57 c) 21/02/2011 07/04/2011 Details
1,2-Benzenedicarboxylic acid, di-C7-11-branched and linear alkyl esters 271-084-6 68515-42-4 Denmark Toxic for reproduction (Article 57 c) 21/02/2011 07/04/2011 Details
1,2-Benzenedicarboxylic acid, dihexylester, branched and linear 271-093-5 68515-50-4 Sweden Toxic for reproduction (Article 57 c) 03/03/2014 17/04/2014 Details
1,2-Benzenedicarboxylic acid, dipentylester, branched and linear 284-032-2 84777-06-0 Germany Toxic for reproduction (Article 57 c) 03/09/2012 18/10/2012 Details
1,2-bis(2-methoxyethoxy)ethane (TEGDME,triglyme) 203-977-3 112-49-2 Belgium Toxic for reproduction (Article 57 c) 27/02/2012 12/04/2012 Details
1,2-Dichloroethane (EDC) 203-458-1 107-06-2 Slovakia Carcinogenic (Article 57a) 29/08/2011 13/10/2011 Details
1,2-Diethoxyethane 211-076-1 629-14-1 Slovakia Toxic for reproduction (Article 57 c) 03/09/2012 18/10/2012 Details
1,2-dimethoxyethane,ethylene glycol dimethyl ether (EGDME) 203-794-9 110-71-4 Belgium Toxic for reproduction (Article 57 c) 27/02/2012 12/04/2012 Details
1,3,5 Trichlorobenzene 203-608-6 108-70-3 Germany PBT like substance (equivalent level of concern) 30/08/2010 14/10/2010 Details
1,3,5-Tris(oxiran-2-ylmethyl)-1,3,5-triazinane-2,4,6-trione (TGIC) 219-514-3 2451-62-9 Netherlands Mutagenic (Article 57b) 27/02/2012 12/04/2012 Details
1,3,5-tris[(2S and 2R)-2,3-epoxypropyl]-1,3,5-triazine-2,4,6-(1H,3H,5H)-trione (β-TGIC) 423-400-0 59653-74-6 Netherlands Mutagenic (Article 57b) 27/02/2012 12/04/2012 Details
1,3-propanesultone 214-317-9 1120-71-4 ECHA Carcinogenic (Article 57 a) 31/08/2015 15/10/2015 Details
1,4-dioxane 204-661-8 123-91-1 Germany Equivalent level of concern having probable serious effects on the environment (Article 57f)
Equivalent level of concern having probable serious effects on human health (Article 57f)
09/03/2021 23/04/2021 Details
1,6,7,8,9,14,15,16,17,17,18,18-Dodecachloropentacyclo[12.2.1.16,9.02,13.05,10]octadeca-7,15-diene (“Dechlorane Plus”™) - - United Kingdom vPvB (Article 57e) 05/09/2017 20/10/2017 Details
1,7,7-trimethyl-3-(phenylmethylene)bicyclo[2.2.1]heptan-2-one (3-benzylidene camphor) 239-139-9 15087-24-8 Germany Equivalent level of concern having probable serious effects to the environment (Article 57 f) 29/02/2016 14/04/2016 Details
1-bromopropane (n-propyl bromide) 203-445-0 106-94-5 ECHA Toxic for reproduction (Article 57 c) 03/09/2012 18/10/2012 Details
1-Methyl-2-pyrrolidone (NMP) 212-828-1 872-50-4 ECHA Toxic for reproduction (Article 57 c) 21/02/2011 07/04/2011 Details
1-vinylimidazole 214-012-0 1072-63-5 Sweden Toxic for reproduction (Article 57c) 03/03/2020 17/04/2020 Details
2,2',6,6'-tetrabromo-4,4'-isopropylidenediphenol 201-236-9 79-94-7 Norway Carcinogenic (Article 57a) 02/09/2022 17/10/2022 Details
2,2'-dichloro-4,4'-methylenedianiline (MOCA) 202-918-9 101-14-4 ECHA Carcinogenic (Article 57a) 29/08/2011 13/10/2011 Details
2,2-bis(4'-hydroxyphenyl)-4-methylpentane 401-720-1 6807-17-6 Sweden Toxic for reproduction (Article 57c) 04/09/2018 19/10/2018 Details
2,2-bis(bromomethyl)propane1,3-diol (BMP)
2,2-dimethylpropan-1-ol, tribromo derivative/3-bromo-2,2-bis(bromomethyl)-1-propanol (TBNPA)
2,3-dibromo-1-propanol (2,3-DBPA)
221-967-7 253-057-0 202-480-9 3296-90-0 36483-57-5 1522-92-5 96-13-9 Norway Carcinogenic (Article 57a) 09/03/2021 23/04/2021 Details
2,3,3,3-tetrafluoro-2-(heptafluoropropoxy)propionic acid, its salts and its acyl halides (covering any of their individual isomers and combinations thereof) - - Netherlands Equivalent level of concern having probable serious effects on the environment (Article 57f)
Equivalent level of concern having probable serious effects on human health (Article 57f)
13/03/2019 29/04/2019 Details
2,4,6-tri-tert-butylphenol 211-989-5 732-26-3 Belgium Toxic for reproduction (Article 57c);
PBT (Article 57d);
vPvB (Article 57e)
01/09/2023 16/10/2023 Details
2,4-di-tert-butyl-6-(5-chlorobenzotriazol-2-yl)phenol (UV-327) 223-383-8 3864-99-1 Germany vPvB (Article 57 e) 31/08/2015 15/10/2015 Details
2,4-di-tert-butyl-6-(5-chlorobenzotriazol-2-yl)phenol (UV-327) 223-383-8 3864-99-1 Germany vPvB (Article 57 e) 04/03/2013 18/04/2013 Details
2,4-Dinitrotoluene 204-450-0 121-14-2 Spain Carcinogenic (Article 57a) 31/08/2009 15/10/2009 Details
2-(2H-benzotriazol-2-yl)-4,6-ditertpentylphenol (UV-328) 247-384-8 25973-55-1 Germany PBT (Article 57 d);
vPvB (Article 57 e)
01/09/2014 16/10/2014 Details
2-(2H-benzotriazol-2-yl)-4-(1,1,3,3-tetramethylbutyl)phenol 221-573-5 3147-75-9 Germany vPvB (Article 57e) 01/09/2023 16/10/2023 Details
2-(2H-benzotriazol-2-yl)-4-(tert-butyl)-6-(sec-butyl)phenol (UV-350) 253-037-1 36437-37-3 Germany vPvB (Article 57 e) 31/08/2015 15/10/2015 Details
2-(2H-benzotriazol-2-yl)-4-(tert-butyl)-6-(sec-butyl)phenol (UV-350) 253-037-1 36437-37-3 Germany vPvB (Article 57 e) 04/03/2013 18/04/2013 Details
2-(4-tert-butylbenzyl)propionaldehyde and its individual stereoisomers - - Sweden Toxic for reproduction (Article 57c) 09/03/2021 23/04/2021 Details
2-(dimethylamino)-2-[(4-methylphenyl)methyl]-1-[4-(morpholin-4-yl)phenyl]butan-1-one 438-340-0 119344-86-4 Austria Toxic for reproduction (Article 57c) 01/09/2023 16/10/2023 Details
2-benzotriazol-2-yl-4,6-di-tert-butylphenol (UV-320) 223-346-6 3846-71-7 Germany PBT (Article 57 d);
vPvB (Article 57 e)
01/09/2014 16/10/2014 Details
2-benzyl-2-dimethylamino-4'-morpholinobutyrophenone 404-360-3 119313-12-1 Austria in cooperation with Slovakia Toxic for reproduction (Article 57c) 03/09/2019 18/10/2019 Details
2-Ethoxyethanol 203-804-1 110-80-5 Austria Toxic for reproduction (Article 57 c) 30/08/2010 14/10/2010 Details
2-Ethoxyethyl acetate 203-839-2 111-15-9 Belgium Toxic for reproduction (Article 57 c) 21/02/2011 07/04/2011 Details
2-Methoxyaniline,o-Anisidine 201-963-1 90-04-0 Germany Carcinogenic (Article 57a) 29/08/2011 13/10/2011 Details
2-Methoxyethanol 203-713-7 109-86-4 Austria Toxic for reproduction (Article 57 c) 30/08/2010 14/10/2010 Details
2-methoxyethyl acetate 203-772-9 110-49-6 Sweden Toxic for reproduction (Article 57c) 13/03/2019 29/04/2019 Details
2-methyl-1-(4-methylthiophenyl)-2-morpholinopropan-1-one 400-600-6 71868-10-5 Austria in cooperation with Slovakia Toxic for reproduction (Article 57c) 03/09/2019 18/10/2019 Details
2-methylimidazole 211-765-7 693-98-1 Sweden Toxic for reproduction (Article 57c) 03/03/2020 17/04/2020 Details
3-ethyl-2-methyl-2-(3-methylbutyl)-1,3-oxazolidine 421-150-7 143860-04-2 ECHA Toxic for reproduction (Article 57 c) 03/09/2012 18/10/2012 Details
4,4'- Diaminodiphenylmethane (MDA) 202-974-4 101-77-9 Germany Carcinogenic (Article 57a) 30/06/2008 14/08/2008 Details
4,4'-(1-methylpropylidene)bisphenol; (bisphenol B) 201-025-1 77-40-7 France Endocrine disrupting properties (Article 57(f) - environment AND human health 09/03/2021 23/04/2021 Details
4,4'-bis(dimethylamino)-4''-(methylamino)trityl alcohol [with ≥ 0.1% of Michler's ketone (EC No. 202-027-5) or Michler's base (EC No. 202-959-2)] 209-218-2 561-41-1 ECHA Carcinogenic (Article 57a) 27/02/2012 12/04/2012 Details
4,4'-bis(dimethylamino)benzophenone (Michler’s ketone) 202-027-5 90-94-8 ECHA Carcinogenic (Article 57a) 27/02/2012 12/04/2012 Details
4,4'-isopropylidenediphenol (bisphenol A; BPA) 201-245-8 80-05-7 France Endocrine disrupting properties (Article 57(f) - human health) 09/03/2017 24/04/2017 Details
4,4'-methylenedi-o-toluidine 212-658-8 838-88-0 ECHA Carcinogenic (Article 57a) 03/09/2012 18/10/2012 Details
4,4'-oxydianiline and its salts 202-977-0 101-80-4 ECHA Carcinogenic (Article 57a); Mutagenic (Article 57b) 03/09/2012 18/10/2012 Details
4,4'-sulphonyldiphenol 201-250-5 80-09-1 Belgium Toxic for reproduction (Article 57c); Endocrine disrupting properties (Article 57(f) – environment); Endocrine disrupting properties (Article 57(f) – human health) 02/09/2022 17/10/2022 Details
4,4’-isopropylidenediphenol (bisphenol A) 201-245-8 80-05-7 France Toxic for reproduction (Article 57 c) 06/09/2016 21/10/2016 Details
4,4’-isopropylidenediphenol (bisphenol A; BPA) 201-245-8 80-05-7 Germany Endocrine disrupting properties (Article 57(f) – environment) 05/09/2017 20/10/2017 Details
4-(1,1,3,3-tetramethylbutyl)phenol, (4-tert-Octylphenol) 205-426-2 140-66-9 Germany Equivalent level of concern having probable serious effects to the environment (Article 57 f) 29/08/2011 13/10/2011 Details
4-(1,1,3,3-tetramethylbutyl)phenol, ethoxylated [covering well-defined substances and UVCB substances, polymers and homologues] - - Germany Equivalent level of concern having probable serious effects to the environment (Article 57 f) 03/09/2012 18/10/2012 Details
4-Aminoazobenzene 200-453-6 60-09-3 ECHA Carcinogenic (Article 57a) 03/09/2012 18/10/2012 Details
4-Heptylphenol, branched and linear [substances with a linear and/or branched alkyl chain with a carbon number of 7 covalently bound predominantly in position 4 to phenol, covering also UVCB- and well-defined substances which include any of the individual isomers or a combination thereof] - - Austria Equivalent level of concern having probable serious effects to the environment (Article 57 f) 06/09/2016 21/10/2016 Details
4-methyl-m-phenylenediamine (toluene-2,4-diamine) 202-453-1 95-80-7 ECHA Carcinogenic (Article 57a) 03/09/2012 18/10/2012 Details
4-Nonylphenol, branched and linear [substances with a linear and/or branched alkyl chain with a carbon number of 9 covalently bound in position 4 to phenol, covering also UVCB- and well-defined substances which include any of the individual isomers or a combination thereof] - - Germany Equivalent level of concern having probable serious effects to the environment (Article 57 f) 03/09/2012 18/10/2012 Details
4-Nonylphenol, branched and linear, ethoxylated - - Germany Equivalent level of concern having probable serious effects to the environment (Article 57 f) 04/03/2013 18/04/2013 Details
4-tert-butylphenol 202-679-0 98-54-4 Germany Equivalent level of concern having probable serious effects to the environment (Article 57 f) 06/09/2016 21/10/2016 Details
5-sec-butyl-2-(2,4-dimethylcyclohex-3-en-1-yl)-5-methyl-1,3-dioxane [1], 5-sec-butyl-2-(4,6-dimethylcyclohex-3-en-1-yl)-5-methyl-1,3-dioxane [2] [covering any of the individual isomers of [1] and [2] or any combination thereof] - - Netherlands vPvB (Article 57 e) 02/03/2015 16/04/2015 Details
5-tert-butyl-2,4,6-trinitro-m-xylene (Musk xylene) 201-329-4 81-15-2 Netherlands vPvB (Article 57 e) 30/06/2008 14/08/2008 Details
6,6'-di-tert-butyl-2,2'-methylenedi-p-cresol (DBMC) 204-327-1 119-47-1 Denmark Toxic for reproduction
(Article 57 c)
03/09/2021 18/10/2021 Details
6-methoxy-m-toluidine (p-cresidine) 204-419-1 120-71-8 ECHA Carcinogenic (Article 57a) 03/09/2012 18/10/2012 Details
[4-[4,4'-bis(dimethylamino) benzhydrylidene]cyclohexa-2,5-dien-1-ylidene]dimethylammonium chloride (C.I. Basic Violet 3) [with ≥ 0.1% of Michler's ketone (EC No. 202-027-5) or Michler's base (EC No. 202-959-2)] 208-953-6 548-62-9 ECHA Carcinogenic (Article 57a) 27/02/2012 12/04/2012 Details
[4-[[4-anilino-1-naphthyl][4-(dimethylamino)phenyl]methylene]cyclohexa-2,5-dien-1-ylidene] dimethylammonium chloride (C.I. Basic Blue 26) [with ≥ 0.1% of Michler's ketone (EC No. 202-027-5) or Michler's base (EC No. 202-959-2)] 219-943-6 2580-56-5 ECHA Carcinogenic (Article 57a) 27/02/2012 12/04/2012 Details
[Phthalato(2-)]dioxotrilead 273-688-5 69011-06-9 ECHA Toxic for reproduction (Article 57 c) 03/09/2012 18/10/2012 Details
Acetic acid, lead salt, basic 257-175-3 51404-69-4 ECHA Toxic for reproduction (Article 57 c) 03/09/2012 18/10/2012 Details
Acids generated from chromium trioxide and their oligomers. Names of the acids and their oligomers: Chromic acid, Dichromic acid, Oligomers of chromic acid and dichromic acid.
231-801-5
236-881-5
7738-94-5
13530-68-2
Germany Carcinogenic (Article 57a) 30/08/2010 14/10/2010 Details
Acrylamide 201-173-7 79-06-1 Netherlands Carcinogenic (Article 57a); Mutagenic (Article 57b) 31/08/2009 15/10/2009 Details
Alkanes, C10-13, chloro (Short Chain Chlorinated Paraffins) 287-476-5 85535-84-8 United Kingdom PBT (Article 57 d); vPvB (Article 57 e) 30/06/2008 14/08/2008 Details
Aluminosilicate Refractory Ceramic Fibres (RCF) - - Germany Carcinogenic (Article 57a) 29/08/2011 13/10/2011 Details
Aluminosilicate, Refractory Ceramic Fibres - - Germany Carcinogenic (Article 57a) 31/08/2009 15/10/2009 Details
Ammonium dichromate 232-143-1 7789-09-5 France Carcinogenic (Article 57a); Mutagenic (Article 57b); Toxic for reproduction (Article 57 c) 08/03/2010 22/04/2010 Details
Ammonium pentadecafluorooctanoate (APFO) 223-320-4 3825-26-1 Germany Toxic for reproduction (Article 57 c); PBT (Article 57 d) 04/03/2013 18/04/2013 Details
Anthracene 204-371-1 120-12-7 Germany PBT (Article 57 d) 30/06/2008 14/08/2008 Details
Anthracene oil 292-602-7 90640-80-5 Germany Carcinogenic (Article 57a); PBT (Article 57 d); vPvB (Article 57 e) 31/08/2009 15/10/2009 Details
Anthracene oil, anthracene paste 292-603-2 90640-81-6 Germany Carcinogenic (Article 57a); Mutagenic (Article 57b); PBT (Article 57 d); vPvB (Article 57 e) 31/08/2009 15/10/2009 Details
Anthracene oil, anthracene paste, anthracene fraction 295-275-9 91995-15-2 Germany Carcinogenic (Article 57a); Mutagenic (Article 57b); PBT (Article 57 d); vPvB (Article 57 e) 31/08/2009 15/10/2009 Details
Anthracene oil, anthracene paste, distn. Lights 295-278-5 91995-17-4 Germany Carcinogenic (Article 57a); Mutagenic (Article 57b); PBT (Article 57 d); vPvB (Article 57 e) 31/08/2009 15/10/2009 Details
Anthracene oil, anthracene-low 292-604-8 90640-82-7 Germany Carcinogenic (Article 57a); Mutagenic (Article 57b); PBT (Article 57 d); vPvB (Article 57 e) 31/08/2009 15/10/2009 Details
Arsenic acid 231-901-9 7778-39-4 Norway Carcinogenic (Article 57a) 29/08/2011 13/10/2011 Details
Barium diboron tetraoxide 237-222-4 13701-59-2 Sweden Toxic for reproduction (Article 57c) 02/09/2022 17/10/2022 Details
Benz[a]anthracene 200-280-6 56-55-3 Germany Carcinogenic (Article 57a)
PBT (Article 57d)
vPvB (Article 57e)
05/09/2017 20/10/2017 Details
Benzene-1,2,4-tricarboxylic acid 1,2-anhydride (trimellitic anhydride) 209-008-0 552-30-7 Netherlands Equivalent level of concern having probable serious effects to human health (Article 57 f) 06/09/2016 21/10/2016 Details
Benzo[def]chrysene (Benzo[a]pyrene) 200-028-5 50-32-8 Germany Carcinogenic (Article 57 a)
Mutagenic (Article 57 b)
Toxic for reproduction (Article 57 c)
PBT (Article 57 d)
vPvB (Article 57 e)
29/02/2016 14/04/2016 Details
Benzo[ghi]perylene 205-883-8 191-24-2 Denmark PBT (Article 57 d); vPvB Art.57(e) 08/03/2018 23/04/2018 Details
Benzo[k]fluoranthene 205-916-6 207-08-9 Belgium Carcinogenic (Article 57a)
PBT (Article 57d)
vPvB (Article 57e)
04/09/2018 19/10/2018 Details
Benzyl butyl phthalate (BBP) 201-622-7 85-68-7 Austria Toxic for reproduction (Article 57 c) 30/06/2008 14/08/2008 Details
Benzyl butyl phthalate (BBP) 201-622-7 85-68-7 Denmark Equivalent level of concern having probable serious effects to human health and the environment (Article 57 f) 01/09/2014 16/10/2014 Details
Biphenyl-4-ylamine 202-177-1 92-67-1 ECHA Carcinogenic (Article 57a) 03/09/2012 18/10/2012 Details
Bis (2-ethylhexyl)phthalate (DEHP) 204-211-0 117-81-7 Sweden Toxic for reproduction (Article 57 c) 30/06/2008 14/08/2008 Details



* The Annex XV reports for 'Disodium tetraborate, anhydrous' and 'Tetraboron disodium heptaoxide, hydrate' are identical because these substances form the same compounds in aqueous solution and can be utilised for similar uses.

1) Index number in Annex VI of Regulation (EC) No 1272/2008 of the European Parliament and of the Council of 16 December 2008 on classification, labelling and packaging of substances and mixtures, amending and repealing Directives 67/548/EEC and 1999/45/EC, and amending Regulation (EC) No 1907/2006

2) European Chemicals Agency on request of the European Commission

3) In collaboration with Austria and Poland

4) Due to an administrative mistake the public consultation for the identification of cobalt dichloride as 'toxic for reproduction 1B' had to be re-launched for a new period of 45 days