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.
 
1,3-propanesultone 214-317-9 1120-71-4 ECHA Carcinogenic (Article 57 a) 31/08/2015 15/10/2015 Details
Cadmium sulphate 233-331-6
10124-36-4
31119-53-6
Sweden Carcinogenic (Article 57 a);
Mutagenic (article 57 b);
Toxic for Reproduction (Article 57 c);
Equivalent level of concern having probable serious effects to human health (Article 57 f)
01/09/2014 16/10/2014 Details
Cadmium fluoride 232-222-0 7790-79-6 Sweden Carcinogenic (Article 57 a);
Mutagenic (Article 57 b);
Toxic for Reproduction (Article 57 c);
Equivalent level of concern having probable serious effects to human health (Article 57 f)
01/09/2014 16/10/2014 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
1,2-Dichloroethane (EDC) 203-458-1 107-06-2 Slovakia Carcinogenic (Article 57a) 29/08/2011 13/10/2011 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(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
2,4-Dinitrotoluene 204-450-0 121-14-2 Spain Carcinogenic (Article 57a) 31/08/2009 15/10/2009 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'-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'-methylenedi-o-toluidine 212-658-8 838-88-0 ECHA Carcinogenic (Article 57a) 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-methyl-m-phenylenediamine (toluene-2,4-diamine) 202-453-1 95-80-7 ECHA Carcinogenic (Article 57a) 03/09/2012 18/10/2012 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
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
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
Arsenic acid 231-901-9 7778-39-4 Norway Carcinogenic (Article 57a) 29/08/2011 13/10/2011 Details
Biphenyl-4-ylamine 202-177-1 92-67-1 ECHA Carcinogenic (Article 57a) 03/09/2012 18/10/2012 Details
Calcium arsenate 231-904-5 7778-44-1 Norway Carcinogenic (Article 57a) 29/08/2011 13/10/2011 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
Dimethyl sulphate 201-058-1 77-78-1 ECHA Carcinogenic (Article 57a) 03/09/2012 18/10/2012 Details
Disodium 3,3'-[[1,1'-biphenyl]-4,4'-diylbis(azo)]bis(4-aminonaphthalene-1-sulphonate) (C.I. Direct Red 28) 209-358-4 573-58-0 Netherlands Carcinogenic (Article 57a) 02/09/2013 17/10/2013 Details
Disodium 4-amino-3-[[4'-[(2,4-diaminophenyl)azo][1,1'-biphenyl]-4-yl]azo] -5-hydroxy-6-(phenylazo)naphthalene-2,7-disulphonate (C.I. Direct Black 38) 217-710-3 1937-37-7 Netherlands Carcinogenic (Article 57a) 02/09/2013 17/10/2013 Details
Formaldehyde, oligomeric reaction products with aniline (technical MDA) 500-036-1 25214-70-4 Germany Carcinogenic (Article 57a) 29/08/2011 13/10/2011 Details
Furan 203-727-3 110-00-9 ECHA Carcinogenic (Article 57a) 03/09/2012 18/10/2012 Details
Hydrazine 206-114-9
302-01-2
7803-57-8
ECHA Carcinogenic (Article 57a) 21/02/2011 07/04/2011 Details
N,N,N',N'-tetramethyl-4,4'-methylenedianiline (Michler’s base) 202-959-2 101-61-1 ECHA Carcinogenic (Article 57a) 27/02/2012 12/04/2012 Details
o-aminoazotoluene 202-591-2 97-56-3 ECHA Carcinogenic (Article 57a) 03/09/2012 18/10/2012 Details
o-Toluidine 202-429-0 95-53-4 ECHA Carcinogenic (Article 57a) 03/09/2012 18/10/2012 Details
Pentazinc chromate octahydroxide 256-418-0 49663-84-5 France Carcinogenic (Article 57a) 29/08/2011 13/10/2011 Details
Phenolphthalein 201-004-7 77-09-8 ECHA Carcinogenic (Article 57a) 29/08/2011 13/10/2011 Details
Potassium hydroxyoctaoxodizincatedichromate 234-329-8 11103-86-9 France Carcinogenic (Article 57a) 29/08/2011 13/10/2011 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
Tricobalt tetraoxide containing ≥ 0.1% w/w nickel oxides 215-157-2 1308-06-1 Netherlands Carcinogenic (Article 57a) 05/09/2017 20/10/2017 Details
Triethyl arsenate 427-700-2 15606-95-8 Norway Carcinogenic (Article 57a) 30/06/2008 14/08/2008 Details
Zirconia Aluminosilicate Refractory Ceramic Fibres - - Germany Carcinogenic (Article 57a) 31/08/2009 15/10/2009 Details
Zirconia Aluminosilicate Refractory Ceramic Fibres (Zr-RCF) - - Germany Carcinogenic (Article 57a) 29/08/2011 13/10/2011 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
Cadmium chloride 233-296-7 10108-64-2 Sweden Carcinogenic (Article 57a); Mutagenic (Article 57(b); Toxic for Reproduction (Article 57(c); Equivalent level of concern having probable serious effects to human health (Article 57 f) 03/03/2014 17/04/2014 Details
N-(hydroxymethyl)acrylamide 213-103-2 924-42-5 Sweden Carcinogenic (Article 57a); Mutagenic (Article 57b) 04/03/2022 19/04/2022 Details
Cadmium 231-152-8 7440-43-9 Sweden Carcinogenic (Article 57a); Equivalent level of concern having probable serious effects to human health (Article 57 f) 04/03/2013 18/04/2013 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