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. 

 
2-Ethoxyethanol 203-804-1 110-80-5 Austria Toxic for reproduction (Article 57 c) 30/08/2010 14/10/2010
2-Methoxyethanol 203-713-7 109-86-4 Austria Toxic for reproduction (Article 57 c) 30/08/2010 14/10/2010
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
Benzyl butyl phthalate (BBP) 201-622-7 85-68-7 Austria Toxic for reproduction (Article 57 c) 30/06/2008 14/08/2008
Bis(2-methoxyethyl) ether 203-924-4 111-96-6 Austria Toxic for reproduction (Article 57 c) 29/08/2011 13/10/2011
Diazene-1,2-dicarboxamide (C,C`-azodi(formamide)) (ADCA) 204-650-8 123-77-3 Austria Equivalent level of concern having probable serious effects to human health (Article 57 f) 03/09/2012 18/10/2012
Dibutyl phthalate 201-557-4 84-74-2 Austria Toxic for reproduction (Article 57 c) 30/06/2008 14/08/2008
Diisopentylphthalate 210-088-4 605-50-5 Austria Toxic for reproduction (Article 57 c) 03/09/2012 18/10/2012
Dioctyltin bis(2-ethylhexyl mercaptoacetate), 2-Ethylhexyl 10-ethyl-4,4- dioctyl-7-oxo-8-oxa-3,5-dithia- 4-stannatetradecanoate 239-622-4 15571-58-1 Austria Toxic for Reproduction (Article 57 c) 01/09/2014 16/10/2014
Nitrobenzene 202-716-0 98-95-3 Austria Toxic for reproduction (Article 57 c) 31/08/2015 15/10/2015
Reaction mass of 2-ethylhexyl 10-ethyl-4,4-dioctyl-7-oxo-8-oxa-3,5-dithia-4-stannatetradecanoate and 2-ethylhexyl 10-ethyl-4-[[2-[(2-ethylhexyl)oxy]-2-oxoethyl]thio]-4-octyl-7-oxo-8-oxa-3,5-dithia-4-stannatetradecanoate (reaction mass of DOTE and MOTE) - - Austria Toxic for Reproduction (Article 57 c) 01/09/2014 16/10/2014
Tris(2-chloroethyl)phosphate 204-118-5 115-96-8 Austria Toxic for reproduction (Article 57 c) 31/08/2009 15/10/2009
Trixylyl phosphate 246-677-8 25155-23-1 Austria Toxic for reproduction (Article 57 c) 02/09/2013 17/10/2013
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-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
2-Ethoxyethyl acetate 203-839-2 111-15-9 Belgium Toxic for reproduction (Article 57 c) 21/02/2011 07/04/2011
Pitch, coal tar, high temp. 266-028-2 65996-93-2 Commission Carcinogenic (Article 57a); PBT (Article 57 d); vPvB (Article 57 e) 31/08/2009 15/10/2009
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
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
Bis(2-ethylhexyl) phthalate (DEHP) 204-211-0 117-81-7 Denmark Equivalent level of concern having probable serious effects to human health and the environment(Article 57 f) 01/09/2014 16/10/2014
Dibutyl phthalate (DBP) 201-557-4 84-74-2 Denmark Equivalent level of concern having probable serious effects to human health and the environment (Article 57 f) 01/09/2014 16/10/2014
Diisobutyl phthalate (DIBP) 201-553-2 84-69-5 Denmark Equivalent level of concern having probable serious effects to human health and the environment (Article 57 f) 01/09/2014 16/10/2014
Disodium tetraborate, anhydrous 215-540-4
1303-96-4
1330-43-4
12179-04-3
Denmark Toxic for reproduction (Article 57 c) 08/03/2010 22/04/2010
Sodium perborate,perboric acid, sodium salt
239-172-9
234-390-0
15120-21-5 Denmark Toxic for reproduction (Article 57 c) 03/03/2014 17/04/2014
Sodium peroxometaborate 231-556-4 7632-04-4 Denmark Toxic for reproduction (Article 57 c) 03/03/2014 17/04/2014
Tetraboron disodium heptaoxide, hydrate 235-541-3 12267-73-1 Denmark Toxic for reproduction (Article 57 c) 08/03/2010 22/04/2010
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-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
1,3-propanesultone 214-317-9 1120-71-4 ECHA Carcinogenic (Article 57 a) 31/08/2015 15/10/2015
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
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'-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-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
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
Acetic acid, lead salt, basic 257-175-3 51404-69-4 ECHA Toxic for reproduction (Article 57 c) 03/09/2012 18/10/2012
Biphenyl-4-ylamine 202-177-1 92-67-1 ECHA Carcinogenic (Article 57a) 03/09/2012 18/10/2012
Diethyl sulphate 200-589-6 64-67-5 ECHA Carcinogenic (Article 57a); Mutagenic (Article 57b) 03/09/2012 18/10/2012
Dimethyl sulphate 201-058-1 77-78-1 ECHA Carcinogenic (Article 57a) 03/09/2012 18/10/2012
Dinoseb (6-sec-butyl-2,4-dinitrophenol) 201-861-7 88-85-7 ECHA Toxic for reproduction (Article 57 c) 03/09/2012 18/10/2012
Dioxobis(stearato)trilead 235-702-8 12578-12-0 ECHA Toxic for reproduction (Article 57 c) 03/09/2012 18/10/2012
Fatty acids, C16-18, lead salts 292-966-7 91031-62-8 ECHA Toxic for reproduction (Article 57 c) 03/09/2012 18/10/2012



* 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