- 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.
| Dimethyl sulphate | 201-058-1 | 77-78-1 | ECHA | Carcinogenic (Article 57a) | 03/09/2012 | 18/10/2012 | Details |
| Dinoseb (6-sec-butyl-2,4-dinitrophenol) | 201-861-7 | 88-85-7 | ECHA | Toxic for reproduction (Article 57 c) | 03/09/2012 | 18/10/2012 | Details |
| Dioctyltin bis(2-ethylhexyl mercaptoacetate), 2-Ethylhexyl 10-ethyl-4,4- dioctyl-7-oxo-8-oxa-3,5-dithia- 4-stannatetradecanoate | 239-622-4 | 15571-58-1 | Austria | Toxic for Reproduction (Article 57 c) | 01/09/2014 | 16/10/2014 | 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 |
| Dioxobis(stearato)trilead | 235-702-8 | 12578-12-0 | ECHA | Toxic for reproduction (Article 57 c) | 03/09/2012 | 18/10/2012 | Details |
| Dipentyl phthalate (DPP) | 205-017-9 | 131-18-0 | Poland | Toxic for reproduction (Article 57 c) | 04/03/2013 | 18/04/2013 | Details |
| Diphenyl(2,4,6-trimethylbenzoyl)phosphine oxide | 278-355-8 | 75980-60-8 | Sweden | Toxic for reproduction (Article 57c) | 17/02/2023 | 03/04/2023 | Details |
| 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 | Details |
| 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 | Details |
| Disodium octaborate | 234-541-0 | 12008-41-2 | Sweden | Toxic for reproduction (Article 57c) | 08/03/2018 | 23/04/2018 | 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 |
| Dodecamethylcyclohexasiloxane (D6) | 208-762-8 | 540-97-6 | ECHA |
PBT (Article 57d) vPvB (Article 57e) |
08/03/2018 | 23/04/2018 | Details |
| Ethylenediamine | 203-468-6 | 107-15-3 | ECHA | Respiratory sensitising properties (Article 57(f) - human health) | 08/03/2018 | 23/04/2018 | Details |
| Fatty acids, C16-18, lead salts | 292-966-7 | 91031-62-8 | ECHA | Toxic for reproduction (Article 57 c) | 03/09/2012 | 18/10/2012 | Details |
| Fluoranthene | 205-912-4 | 206-44-0 | Belgium |
PBT (Article 57d) vPvB (Article 57e) |
04/09/2018 | 19/10/2018 | Details |
| Formaldehyde, oligomeric reaction products with aniline (technical MDA) | 500-036-1 | 25214-70-4 | Germany | Carcinogenic (Article 57a) | 29/08/2011 | 13/10/2011 | Details |
| Formamide | 200-842-0 | 75-12-7 | Germany | Toxic for reproduction (Article 57 c) | 27/02/2012 | 12/04/2012 | Details |
| Furan | 203-727-3 | 110-00-9 | ECHA | Carcinogenic (Article 57a) | 03/09/2012 | 18/10/2012 | Details |
| Glutaral | 203-856-5 | 111-30-8 | Sweden | Respiratory sensitising properties (Article 57(f) - human health) | 09/03/2021 | 23/04/2021 | Details |
| Henicosafluoroundecanoic acid | 218-165-4 | 2058-94-8 | Germany | vPvB (Article 57 e) | 03/09/2012 | 18/10/2012 | Details |
| Heptacosafluorotetradecanoic acid | 206-803-4 | 376-06-7 | Germany | vPvB (Article 57 e) | 03/09/2012 | 18/10/2012 | Details |
| Hexabromocyclododecane (HBCDD) | 247-148-4 | 25637-99-4 | Sweden | PBT (Article 57 d) | 30/06/2008 | 14/08/2008 | Details |
| Hexahydromethylphthalic anhydride [1], Hexahydro-4-methylphthalic anhydride [2], Hexahydro-1-methylphthalic anhydride [3], Hexahydro-3-methylphthalic anhydride [4] [The individual isomers [2], [3] and [4] (including their cis- and trans- stereo isomeric forms) and all possible combinations of the isomers [1] are covered by this entry] |
247-094-1 243-072-0 256-356-4 260-566-1 |
25550-51-0 19438-60-9 48122-14-1 57110-29-9 |
Netherlands | Equivalent level of concern having probable serious effects to human health (Article 57 f) | 03/09/2012 | 18/10/2012 | 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 |
| Hydrazine | 206-114-9 |
302-01-2 7803-57-8 |
ECHA | Carcinogenic (Article 57a) | 21/02/2011 | 07/04/2011 | Details |
| Imidazolidine-2-thione (2-imidazoline-2-thiol) | 202-506-9 | 96-45-7 | Sweden | Toxic for reproduction (Article 57 c) | 02/09/2013 | 17/10/2013 | Details |
| Isobutyl 4-hydroxybenzoate | 224-208-8 | 4247-02-3 | Denmark | Endocrine disrupting properties (Article 57(f) – human health) | 02/09/2022 | 17/10/2022 | Details |
| Lead | 231-100-4 | 7439-92-1 | Sweden | Toxic for reproduction (Article 57c) | 08/03/2018 | 23/04/2018 | Details |
| Lead bis(tetrafluoroborate) | 237-486-0 | 13814-96-5 | ECHA | Toxic for reproduction (Article 57 c) | 03/09/2012 | 18/10/2012 | 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 cyanamidate | 244-073-9 | 20837-86-9 | ECHA | Toxic for reproduction (Article 57 c) | 03/09/2012 | 18/10/2012 | Details |
| Lead di(acetate) | 206-104-4 | 301-04-2 | Netherlands | Toxic for reproduction (Article 57 c) | 02/09/2013 | 17/10/2013 | 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 dinitrate | 233-245-9 | 10099-74-8 | ECHA | Toxic for reproduction (Article 57 c) | 03/09/2012 | 18/10/2012 | Details |
| Lead dipicrate | 229-335-2 | 6477-64-1 | ECHA | Toxic for reproduction (Article 57 c) | 29/08/2011 | 13/10/2011 | Details |
| Lead hydrogen arsenate | 232-064-2 | 7784-40-9 | Norway | Carcinogenic (Article 57a); Toxic for reproduction (Article 57 c) | 30/06/2008 | 14/08/2008 | 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 |
| Lead oxide sulfate | 234-853-7 | 12036-76-9 | ECHA | Toxic for reproduction (Article 57 c) | 03/09/2012 | 18/10/2012 | Details |
| Lead styphnate | 239-290-0 | 15245-44-0 | 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 |
| Lead titanium trioxide | 235-038-9 | 12060-00-3 | 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(II) bis(methanesulfonate) | 401-750-5 | 17570-76-2 | Netherlands | Toxic for reproduction (Article 57 c) | 27/02/2012 | 12/04/2012 | 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 |
| 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 |
| Methoxyacetic acid | 210-894-6 | 625-45-6 | Sweden | Toxic for reproduction (Article 57 c); equivalent level of concern having probable serious effects to human health and environment (Article 57 f) | 03/09/2012 | 18/10/2012 | Details |
| Methyloxirane (Propylene oxide) | 200-879-2 | 75-56-9 | ECHA | Carcinogenic (Article 57a); Mutagenic (Article 57b) | 03/09/2012 | 18/10/2012 | 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 |
| N,N-Dimethylacetamide (DMAC) | 204-826-4 | 127-19-5 | ECHA | Toxic for reproduction (Article 57 c) | 29/08/2011 | 13/10/2011 | 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