- ECHA
- Consultations
- Substances of very high concern identification
- Proposals to identify Substances of Very High Concern previous consultations
Proposals to identify Substances of Very High Concern previous consultations
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.
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