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.
 
(±)-1,7,7-trimethyl-3-[(4-methylphenyl)methylene]bicyclo[2.2.1]heptan-2-one covering any of the individual isomers and/or combinations thereof (4-MBC) - - Denmark Endocrine disrupting properties (Article 57(f) - human health) 03/09/2021 18/10/2021
(±)-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
1,1'-[ethane-1,2-diylbisoxy]bis[2,4,6-tribromobenzene] 253-692-3 37853-59-1 Spain vPvB (Article 57e) 02/09/2022 17/10/2022
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
1,4-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
1,6,7,8,9,14,15,16,17,17,18,18-Dodecachloropentacyclo[12.2.1.16,9.02,13.05,10]octadeca-7,15-diene (“Dechlorane Plus”™) - - United Kingdom vPvB (Article 57e) 05/09/2017 20/10/2017
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
1-vinylimidazole 214-012-0 1072-63-5 Sweden Toxic for reproduction (Article 57c) 03/03/2020 17/04/2020
2,2',6,6'-tetrabromo-4,4'-isopropylidenediphenol 201-236-9 79-94-7 Norway Carcinogenic (Article 57a) 02/09/2022 17/10/2022
2,2'-dichloro-4,4'-methylenedianiline (MOCA) 202-918-9 101-14-4 ECHA Carcinogenic (Article 57a) 29/08/2011 13/10/2011
2,2-bis(4'-hydroxyphenyl)-4-methylpentane 401-720-1 6807-17-6 Sweden Toxic for reproduction (Article 57c) 04/09/2018 19/10/2018
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
2,3,3,3-tetrafluoro-2-(heptafluoropropoxy)propionic acid, its salts and its acyl halides (covering any of their individual isomers and combinations thereof) - - Netherlands 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)
13/03/2019 29/04/2019
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) 04/03/2013 18/04/2013
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-(4-tert-butylbenzyl)propionaldehyde and its individual stereoisomers - - Sweden Toxic for reproduction (Article 57c) 09/03/2021 23/04/2021
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-benzyl-2-dimethylamino-4'-morpholinobutyrophenone 404-360-3 119313-12-1 Austria in cooperation with Slovakia Toxic for reproduction (Article 57c) 03/09/2019 18/10/2019
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
2-methoxyethyl acetate 203-772-9 110-49-6 Sweden Toxic for reproduction (Article 57c) 13/03/2019 29/04/2019
2-methyl-1-(4-methylthiophenyl)-2-morpholinopropan-1-one 400-600-6 71868-10-5 Austria in cooperation with Slovakia Toxic for reproduction (Article 57c) 03/09/2019 18/10/2019
2-methylimidazole 211-765-7 693-98-1 Sweden Toxic for reproduction (Article 57c) 03/03/2020 17/04/2020
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'-(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
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



* 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