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. 

Showing 1 - 50 of 186 results.
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Name EC Number CAS Number Proposing authority Reason for proposing Date of publication Deadline for commenting  
(±)-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
1,2,3 Trichlorobenzene 201-757-1 87-61-6 Germany PBT like substance (equivalent level of concern) 30/08/2010 14/10/2010
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
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
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
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
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
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
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
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
1,2-Dichloroethane (EDC) 203-458-1 107-06-2 Slovakia Carcinogenic (Article 57a) 29/08/2011 13/10/2011
1,2-Diethoxyethane 211-076-1 629-14-1 Slovakia Toxic for reproduction (Article 57 c) 03/09/2012 18/10/2012
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
1,3,5 Trichlorobenzene 203-608-6 108-70-3 Germany PBT like substance (equivalent level of concern) 30/08/2010 14/10/2010
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
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
1,3-propanesultone 214-317-9 1120-71-4 ECHA Carcinogenic (Article 57 a) 31/08/2015 15/10/2015
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
1-bromopropane (n-propyl bromide) 203-445-0 106-94-5 ECHA Toxic for reproduction (Article 57 c) 03/09/2012 18/10/2012
1-Methyl-2-pyrrolidone (NMP) 212-828-1 872-50-4 ECHA Toxic for reproduction (Article 57 c) 21/02/2011 07/04/2011
2,2'-dichloro-4,4'-methylenedianiline (MOCA) 202-918-9 101-14-4 ECHA Carcinogenic (Article 57a) 29/08/2011 13/10/2011
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
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
2,4-Dinitrotoluene 204-450-0 121-14-2 Spain Carcinogenic (Article 57a) 31/08/2009 15/10/2009
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
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
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
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
2-Ethoxyethanol 203-804-1 110-80-5 Austria Toxic for reproduction (Article 57 c) 30/08/2010 14/10/2010
2-Ethoxyethyl acetate 203-839-2 111-15-9 Belgium Toxic for reproduction (Article 57 c) 21/02/2011 07/04/2011
2-Methoxyaniline,o-Anisidine 201-963-1 90-04-0 Germany Carcinogenic (Article 57a) 29/08/2011 13/10/2011
2-Methoxyethanol 203-713-7 109-86-4 Austria Toxic for reproduction (Article 57 c) 30/08/2010 14/10/2010
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
4,4'- Diaminodiphenylmethane (MDA) 202-974-4 101-77-9 Germany Carcinogenic (Article 57a) 30/06/2008 14/08/2008
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
4,4'-bis(dimethylamino)benzophenone (Michler’s ketone) 202-027-5 90-94-8 ECHA Carcinogenic (Article 57a) 27/02/2012 12/04/2012
4,4'-methylenedi-o-toluidine 212-658-8 838-88-0 ECHA Carcinogenic (Article 57a) 03/09/2012 18/10/2012
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
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
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
4-Aminoazobenzene 200-453-6 60-09-3 ECHA Carcinogenic (Article 57a) 03/09/2012 18/10/2012
4-methyl-m-phenylenediamine (toluene-2,4-diamine) 202-453-1 95-80-7 ECHA Carcinogenic (Article 57a) 03/09/2012 18/10/2012
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
4-Nonylphenol, branched and linear, ethoxylated [substances with a linear and/or branched alkyl chain with a carbon number of 9 covalently bound in position 4 to phenol, ethoxylated covering UVCB- and well-defined substances, polymers and homologues, which include any of the individual isomers and/or combinations thereof] - - Germany Equivalent level of concern having probable serious effects to the environment (Article 57 f) 04/03/2013 18/04/2013
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
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
6-methoxy-m-toluidine (p-cresidine) 204-419-1 120-71-8 ECHA Carcinogenic (Article 57a) 03/09/2012 18/10/2012
[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
[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
[Phthalato(2-)]dioxotrilead 273-688-5 69011-06-9 ECHA Toxic for reproduction (Article 57 c) 03/09/2012 18/10/2012
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* 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