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. 

 
1,3-propanesultone 214-317-9 1120-71-4 ECHA Carcinogenic (Article 57 a) 31/08/2015 15/10/2015
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
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
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
1,2-Dichloroethane (EDC) 203-458-1 107-06-2 Slovakia Carcinogenic (Article 57a) 29/08/2011 13/10/2011
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-Dinitrotoluene 204-450-0 121-14-2 Spain Carcinogenic (Article 57a) 31/08/2009 15/10/2009
2-Methoxyaniline,o-Anisidine 201-963-1 90-04-0 Germany Carcinogenic (Article 57a) 29/08/2011 13/10/2011
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-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
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
Aluminosilicate Refractory Ceramic Fibres (RCF) - - Germany Carcinogenic (Article 57a) 29/08/2011 13/10/2011
Aluminosilicate, Refractory Ceramic Fibres - - Germany Carcinogenic (Article 57a) 31/08/2009 15/10/2009
Arsenic acid 231-901-9 7778-39-4 Norway Carcinogenic (Article 57a) 29/08/2011 13/10/2011
Biphenyl-4-ylamine 202-177-1 92-67-1 ECHA Carcinogenic (Article 57a) 03/09/2012 18/10/2012
Calcium arsenate 231-904-5 7778-44-1 Norway Carcinogenic (Article 57a) 29/08/2011 13/10/2011
Diarsenic pentaoxide 215-116-9 1303-28-2 France Carcinogenic (Article 57a) 30/06/2008 14/08/2008
Diarsenic trioxide 215-481-4 1327-53-3 France Carcinogenic (Article 57a) 30/06/2008 14/08/2008
Dichromium tris(chromate) 246-356-2 24613-89-6 France Carcinogenic (Article 57a) 29/08/2011 13/10/2011
Dimethyl sulphate 201-058-1 77-78-1 ECHA Carcinogenic (Article 57a) 03/09/2012 18/10/2012
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
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
Formaldehyde, oligomeric reaction products with aniline (technical MDA) 500-036-1 25214-70-4 Germany Carcinogenic (Article 57a) 29/08/2011 13/10/2011
Furan 203-727-3 110-00-9 ECHA Carcinogenic (Article 57a) 03/09/2012 18/10/2012
Hydrazine 206-114-9
302-01-2
7803-57-8
ECHA Carcinogenic (Article 57a) 21/02/2011 07/04/2011
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
o-aminoazotoluene 202-591-2 97-56-3 ECHA Carcinogenic (Article 57a) 03/09/2012 18/10/2012
o-Toluidine 202-429-0 95-53-4 ECHA Carcinogenic (Article 57a) 03/09/2012 18/10/2012
Pentazinc chromate octahydroxide 256-418-0 49663-84-5 France Carcinogenic (Article 57a) 29/08/2011 13/10/2011
Phenolphthalein 201-004-7 77-09-8 ECHA Carcinogenic (Article 57a) 29/08/2011 13/10/2011
Potassium hydroxyoctaoxodizincatedichromate 234-329-8 11103-86-9 France Carcinogenic (Article 57a) 29/08/2011 13/10/2011
Strontium chromate 232-142-6 7789-06-2 France Carcinogenic (Article 57a) 21/02/2011 07/04/2011
Trichloroethylene 201-167-4 79-01-6 France Carcinogenic (Article 57a) 08/03/2010 22/04/2010
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
Triethyl arsenate 427-700-2 15606-95-8 Norway Carcinogenic (Article 57a) 30/06/2008 14/08/2008
Zirconia Aluminosilicate Refractory Ceramic Fibres - - Germany Carcinogenic (Article 57a) 31/08/2009 15/10/2009
Zirconia Aluminosilicate Refractory Ceramic Fibres (Zr-RCF) - - Germany Carcinogenic (Article 57a) 29/08/2011 13/10/2011
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
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
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
Cadmium oxide 215-146-2 1306-19-0 Sweden Carcinogenic (Article 57a); Equivalent level of concern having probable serious effects to human health (Article 57 f) 04/03/2013 18/04/2013
Cadmium sulphide 215-147-8 1306-23-6 Sweden Carcinogenic (Article 57a); Equivalent level of concern having probable serious effects to human health (Article 57 f) 02/09/2013 17/10/2013
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



* 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

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