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.
 
Trilead dioxide phosphonate 235-252-2 12141-20-7 ECHA Toxic for reproduction (Article 57 c) 03/09/2012 18/10/2012 Details
α,α-Bis[4-(dimethylamino)phenyl]-4 (phenylamino)naphthalene-1-methanol (C.I. Solvent Blue 4) [with ≥ 0.1% of Michler's ketone (EC No. 202-027-5) or Michler's base (EC No. 202-959-2)] 229-851-8 6786-83-0 ECHA Carcinogenic (Article 57a) 27/02/2012 12/04/2012 Details
Terphenyl hydrogenated 262-967-7 61788-32-7 Finland vPvB Art.57(e) 08/03/2018 23/04/2018 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'-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’-isopropylidenediphenol (bisphenol A) 201-245-8 80-05-7 France Toxic for reproduction (Article 57 c) 06/09/2016 21/10/2016 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
Cobalt dichloride 231-589-4 7646-79-9 France Carcinogenic (Article 57a); Toxic for reproduction (Article 57 c) 30/06/2008 14/08/2008 Details
Cyclododecane 206-033-9 294-62-2 France PBT (Article 57 d) 30/06/2008 14/08/2008 Details
Diarsenic pentaoxide 215-116-9 1303-28-2 France Carcinogenic (Article 57a) 30/06/2008 14/08/2008 Details
Diarsenic trioxide 215-481-4 1327-53-3 France Carcinogenic (Article 57a) 30/06/2008 14/08/2008 Details
Dichromium tris(chromate) 246-356-2 24613-89-6 France Carcinogenic (Article 57a) 29/08/2011 13/10/2011 Details
Lead chromate 231-846-0 7758-97-6 France Carcinogenic (Article 57a); Toxic for reproduction (Article 57 c) 31/08/2009 15/10/2009 Details
Lead chromate molybdate sulphate red (C.I. Pigment Red 104) 235-759-9 12656-85-8 France Carcinogenic (Article 57a); Toxic for reproduction (Article 57 c) 31/08/2009 15/10/2009 Details
Lead sulfochromate yellow (C.I. Pigment Yellow 34) 215-693-7 1344-37-2 France Carcinogenic (Article 57a); Toxic for reproduction (Article 57 c) 31/08/2009 15/10/2009 Details
Pentazinc chromate octahydroxide 256-418-0 49663-84-5 France Carcinogenic (Article 57a) 29/08/2011 13/10/2011 Details
Phenanthrene 201-581-5 85-01-8 France vPvB (Article 57e) 04/09/2018 19/10/2018 Details
Potassium chromate 232-140-5 7789-00-6 France Carcinogenic (Article 57a); Mutagenic (Article 57b) 08/03/2010 22/04/2010 Details
Potassium dichromate 231-906-6 7778-50-9 France Carcinogenic (Article 57a); Mutagenic (Article 57b); Toxic for reproduction (Article 57 c) 08/03/2010 22/04/2010 Details
Potassium hydroxyoctaoxodizincatedichromate 234-329-8 11103-86-9 France Carcinogenic (Article 57a) 29/08/2011 13/10/2011 Details
Pyrene 204-927-3 129-00-0 France PBT (Article 57d)
vPvB (Article 57e)
04/09/2018 19/10/2018 Details
Resorcinol 203-585-2 108-46-3 France Endocrine disrupting properties (Article 57(f) – human health) 03/03/2020 17/04/2020 Details
Sodium chromate 231-889-5 7775-11-3 France Carcinogenic (Article 57a); Mutagenic (Article 57b); Toxic for reproduction (Article 57 c) 08/03/2010 22/04/2010 Details
Sodium dichromate, dihydrate 234-190-3 7789-12-0 France Carcinogenic (Article 57a); Mutagenic (Article 57b); Toxic for reproduction (Article 57 c) 30/06/2008 14/08/2008 Details
Strontium chromate 232-142-6 7789-06-2 France Carcinogenic (Article 57a) 21/02/2011 07/04/2011 Details
Trichloroethylene 201-167-4 79-01-6 France Carcinogenic (Article 57a) 08/03/2010 22/04/2010 Details
Triphenyl phosphate 204-112-2 115-86-6 France Endocrine disrupting properties (Article 57(f) – environment) 01/03/2024 15/04/2024 Details
Tris(4-nonylphenyl, branched and linear) phosphite (TNPP) with ≥ 0.1% w/w of 4-nonylphenol, branched and linear (4-NP) - - France Endocrine disrupting properties (Article 57(f) – environment) 13/03/2019 29/04/2019 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
1,2,3 Trichlorobenzene 201-757-1 87-61-6 Germany PBT like substance (equivalent level of concern) 30/08/2010 14/10/2010 Details
1,2,4 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, dipentylester, branched and linear 284-032-2 84777-06-0 Germany Toxic for reproduction (Article 57 c) 03/09/2012 18/10/2012 Details
1,3,5 Trichlorobenzene 203-608-6 108-70-3 Germany PBT like substance (equivalent level of concern) 30/08/2010 14/10/2010 Details
1,4-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
1,7,7-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
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-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-(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) 04/03/2013 18/04/2013 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-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-Methoxyaniline,o-Anisidine 201-963-1 90-04-0 Germany Carcinogenic (Article 57a) 29/08/2011 13/10/2011 Details
4,4'- Diaminodiphenylmethane (MDA) 202-974-4 101-77-9 Germany Carcinogenic (Article 57a) 30/06/2008 14/08/2008 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-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



* 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