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.
Page 1 of 3
100 Items per Page
Showing 1 - 100 of 263 results.
Name
EC Number
CAS Number
Proposing authority
Reason for proposing
Date of publication
Deadline for commenting
 
(±)-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 Details
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 Details
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 Details
2-(4-tert-butylbenzyl)propionaldehyde and its individual stereoisomers - - Sweden Toxic for reproduction (Article 57c) 09/03/2021 23/04/2021 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-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 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
5-sec-butyl-2-(2,4-dimethylcyclohex-3-en-1-yl)-5-methyl-1,3-dioxane [1], 5-sec-butyl-2-(4,6-dimethylcyclohex-3-en-1-yl)-5-methyl-1,3-dioxane [2] [covering any of the individual isomers of [1] and [2] or any combination thereof] - - Netherlands vPvB (Article 57 e) 02/03/2015 16/04/2015 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
Bis(2-ethylhexyl) tetrabromophthalate covering any of the individual isomers and/or combinations thereof - - Sweden vPvB (Article 57e) 02/09/2022 17/10/2022 Details
Dioctyltin dilaurate, stannane, dioctyl-, bis(coco acyloxy) derivs., and any other stannane, dioctyl-, bis(fatty acyloxy) derivs. wherein C12 is the predominant carbon number of the fatty acyloxy moiety - - Sweden Toxic for reproduction (Article 57c) 01/09/2020 16/10/2020 Details
Medium-chain chlorinated paraffins (MCCP) [UVCB substances consisting of more than or equal to 80% linear chloroalkanes with carbon chain lengths within the range from C14 to C17] - - ECHA PBT (Article 57d)
vPvB (Article 57e 		09/03/2021 23/04/2021 Details
Oligomerisation and alkylation reaction products of 2-phenylpropene and phenol 700-960-7 - Denmark vPvB (Article 57e) 01/09/2023 16/10/2023 Details
Perfluorobutane sulfonic acid (PFBS) and its salts - - Norway 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) 		03/09/2019 18/10/2019 Details
Perfluoroheptanoic acid and its salts - - Netherlands Toxic for reproduction (Article 57c); PBT (Article 57d); vPvB (Article 57e); Equivalent level of concern having probable serious effects to human health (Article 57(f) - human health); Equivalent level of concern having probable serious effects to the environment (Article 57(f) - environment) 02/09/2022 17/10/2022 Details
Phenol, alkylation products (mainly in para position) with C12-rich branched or linear alkyl chains from oligomerisation, covering any individual isomers and/ or combinations thereof (PDDP) - - Germany Toxic for reproduction (Article 57c)
Endocrine disrupting properties (Article 57(f) – human health)
Endocrine disrupting properties (Article 57(f) – environment) 		09/03/2021 23/04/2021 Details
reaction mass of 2,2,3,3,5,5,6,6-octafluoro-4-(1,1,1,2,3,3,3-heptafluoropropan-2-yl)morpholine and 2,2,3,3,5,5,6,6-octafluoro-4-(heptafluoropropyl)morpholine 473-390-7 - Belgium vPvB (Article 57e) 02/09/2022 17/10/2022 Details
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 Details
Reaction products of 1,3,4-thiadiazolidine-2,5-dithione, formaldehyde and 4-heptylphenol, branched and linear (RP-HP) [with ≥0.1% w/w 4-heptylphenol, branched and linear] - - Austria Endocrine disrupting properties (Article 57(f) – environment) 05/09/2017 20/10/2017 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
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
Boric acid
233-139-2
234-343-4
10043-35-3
11113-50-1
 Germany Toxic for reproduction (Article 57 c) 08/03/2010 22/04/2010 Details
Lead dinitrate 233-245-9 10099-74-8 ECHA Toxic for reproduction (Article 57 c) 03/09/2012 18/10/2012 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
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
4,4'- Diaminodiphenylmethane (MDA) 202-974-4 101-77-9 Germany Carcinogenic (Article 57a) 30/06/2008 14/08/2008 Details
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 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
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
Cobalt(II) sulphate 233-334-2 10124-43-3 Netherlands Carcinogenic (Article 57a); Toxic for reproduction (Article 57 c) 30/08/2010 14/10/2010 Details
Cobalt(II) dinitrate 233-402-1 10141-05-6 Netherlands Carcinogenic (Article 57a); Toxic for reproduction (Article 57 c) 30/08/2010 14/10/2010 Details
Cadmium nitrate 233-710-6 10325-94-7 Sweden Carcinogenic (Article 57a)
Mutagenic (Article 57b)
Specific target organ toxicity after repeated exposure (Article 57(f) - human health) 		05/09/2017 20/10/2017 Details
1-bromopropane (n-propyl bromide) 203-445-0 106-94-5 ECHA Toxic for reproduction (Article 57 c) 03/09/2012 18/10/2012 Details
tris(2-methoxyethoxy)vinylsilane 213-934-0 1067-53-4 Austria Toxic for reproduction
(Article 57 c) 		03/09/2021 18/10/2021 Details
1,2-Dichloroethane (EDC) 203-458-1 107-06-2 Slovakia Carcinogenic (Article 57a) 29/08/2011 13/10/2011 Details
Ethylenediamine 203-468-6 107-15-3 ECHA Respiratory sensitising properties (Article 57(f) - human health) 08/03/2018 23/04/2018 Details
1-vinylimidazole 214-012-0 1072-63-5 Sweden Toxic for reproduction (Article 57c) 03/03/2020 17/04/2020 Details
Resorcinol 203-585-2 108-46-3 France Endocrine disrupting properties (Article 57(f) – human health) 03/03/2020 17/04/2020 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
Melamine 203-615-4 108-78-1 Germany Equivalent level of concern having probable serious effects to human health (Article 57(f) - human health); Equivalent level of concern having probable serious effects to the environment (Article 57(f) - environment) 02/09/2022 17/10/2022 Details
2-Methoxyethanol 203-713-7 109-86-4 Austria Toxic for reproduction (Article 57 c) 30/08/2010 14/10/2010 Details
Furan 203-727-3 110-00-9 ECHA Carcinogenic (Article 57a) 03/09/2012 18/10/2012 Details
2-methoxyethyl acetate 203-772-9 110-49-6 Sweden Toxic for reproduction (Article 57c) 13/03/2019 29/04/2019 Details
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 Details
2-Ethoxyethanol 203-804-1 110-80-5 Austria Toxic for reproduction (Article 57 c) 30/08/2010 14/10/2010 Details
2-Ethoxyethyl acetate 203-839-2 111-15-9 Belgium Toxic for reproduction (Article 57 c) 21/02/2011 07/04/2011 Details
Glutaral 203-856-5 111-30-8 Sweden Respiratory sensitising properties (Article 57(f) - human health) 09/03/2021 23/04/2021 Details
Bis(2-methoxyethyl) ether 203-924-4 111-96-6 Austria Toxic for reproduction (Article 57 c) 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
Silicic acid, lead salt 234-363-3 11120-22-2 ECHA Toxic for reproduction (Article 57 c) 03/09/2012 18/10/2012 Details
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 Details
1,3-propanesultone 214-317-9 1120-71-4 ECHA Carcinogenic (Article 57 a) 31/08/2015 15/10/2015 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(2-chloroethyl)phosphate 204-118-5 115-96-8 Austria Toxic for reproduction (Article 57 c) 31/08/2009 15/10/2009 Details
Bis(pentabromophenyl) ether (decabromodiphenyl ether) (DecaBDE) 214-604-9 1163-19-5 United Kingdom PBT (Article 57 d); vPvB (Article 57 e) 03/09/2012 18/10/2012 Details
Bis (2-ethylhexyl)phthalate (DEHP) 204-211-0 117-81-7 Sweden Toxic for reproduction (Article 57 c) 30/06/2008 14/08/2008 Details
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 Details
Bis(2-methoxyethyl) phthalate 204-212-6 117-82-8 Germany Toxic for reproduction (Article 57 c) 29/08/2011 13/10/2011 Details
6,6'-di-tert-butyl-2,2'-methylenedi-p-cresol (DBMC) 204-327-1 119-47-1 Denmark Toxic for reproduction
(Article 57 c) 		03/09/2021 18/10/2021 Details
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 Details
2-(dimethylamino)-2-[(4-methylphenyl)methyl]-1-[4-(morpholin-4-yl)phenyl]butan-1-one 438-340-0 119344-86-4 Austria Toxic for reproduction (Article 57c) 01/09/2023 16/10/2023 Details
Anthracene 204-371-1 120-12-7 Germany PBT (Article 57 d) 30/06/2008 14/08/2008 Details
6-methoxy-m-toluidine (p-cresidine) 204-419-1 120-71-8 ECHA Carcinogenic (Article 57a) 03/09/2012 18/10/2012 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
Disodium octaborate 234-541-0 12008-41-2 Sweden Toxic for reproduction (Article 57c) 08/03/2018 23/04/2018 Details
Lead oxide sulfate 234-853-7 12036-76-9 ECHA Toxic for reproduction (Article 57 c) 03/09/2012 18/10/2012 Details
Lead titanium trioxide 235-038-9 12060-00-3 ECHA Toxic for reproduction (Article 57 c) 03/09/2012 18/10/2012 Details
Pentalead tetraoxide sulphate 235-067-7 12065-90-6 ECHA Toxic for reproduction (Article 57 c) 03/09/2012 18/10/2012 Details
2,4-Dinitrotoluene 204-450-0 121-14-2 Spain Carcinogenic (Article 57a) 31/08/2009 15/10/2009 Details
Trilead dioxide phosphonate 235-252-2 12141-20-7 ECHA Toxic for reproduction (Article 57 c) 03/09/2012 18/10/2012 Details
Tetralead trioxide sulphate 235-380-9 12202-17-4 ECHA Toxic for reproduction (Article 57 c) 03/09/2012 18/10/2012 Details
Tetraboron disodium heptaoxide, hydrate 235-541-3 12267-73-1 Denmark Toxic for reproduction (Article 57 c) 08/03/2010 22/04/2010 Details
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 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
Dioxobis(stearato)trilead 235-702-8 12578-12-0 ECHA Toxic for reproduction (Article 57 c) 03/09/2012 18/10/2012 Details
Lead titanium zirconium oxide 235-727-4 12626-81-2 ECHA Toxic for reproduction (Article 57 c) 03/09/2012 18/10/2012 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
N,N-Dimethylacetamide (DMAC) 204-826-4 127-19-5 ECHA Toxic for reproduction (Article 57 c) 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
Diarsenic pentaoxide 215-116-9 1303-28-2 France Carcinogenic (Article 57a) 30/06/2008 14/08/2008 Details
Diboron trioxide 215-125-8 1303-86-2 Germany Toxic for reproduction (Article 57 c) 27/02/2012 12/04/2012 Details
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 Details
hexamethylene diacrylate (hexane-1,6-diol diacrylate) 235-921-9 13048-33-4 Sweden Equivalent level of concern having probable serious effects to human health (Article 57 f) 31/08/2015 15/10/2015 Details
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 Details
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 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
Dipentyl phthalate (DPP) 205-017-9 131-18-0 Poland Toxic for reproduction (Article 57 c) 04/03/2013 18/04/2013 Details
Orange lead (lead tetroxide) 215-235-6 1314-41-6 ECHA Toxic for reproduction (Article 57 c) 03/09/2012 18/10/2012 Details
Lead monoxide (lead oxide) 215-267-0 1317-36-8 ECHA Toxic for reproduction (Article 57 c) 03/09/2012 18/10/2012 Details
Trilead bis(carbonate) dihydroxide 215-290-6 1319-46-6 ECHA Toxic for reproduction (Article 57 c) 03/09/2012 18/10/2012 Details
Diarsenic trioxide 215-481-4 1327-53-3 France Carcinogenic (Article 57a) 30/06/2008 14/08/2008 Details
Chromium trioxide 215-607-8 1333-82-0 Germany Carcinogenic (Article 57a); Mutagenic (Article 57b) 30/08/2010 14/10/2010 Details
Lead diazide, Lead azide 236-542-1 13424-46-9 ECHA Toxic for reproduction (Article 57 c) 29/08/2011 13/10/2011 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
Barium diboron tetraoxide 237-222-4 13701-59-2 Sweden Toxic for reproduction (Article 57c) 02/09/2022 17/10/2022 Details
Lead bis(tetrafluoroborate) 237-486-0 13814-96-5 ECHA Toxic for reproduction (Article 57 c) 03/09/2012 18/10/2012 Details
Orthoboric acid, sodium salt 237-560-2 13840-56-7 Sweden Toxic for reproduction (Article 57c) 09/03/2021 23/04/2021 Details
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* 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