- 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.
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
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