- 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.
| 1,2,4 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 |
| 2,4-Dinitrotoluene | 204-450-0 | 121-14-2 | Spain | Carcinogenic (Article 57a) | 31/08/2009 | 15/10/2009 | 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 |
| 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 |
| Dipentyl phthalate (DPP) | 205-017-9 | 131-18-0 | Poland | Toxic for reproduction (Article 57 c) | 04/03/2013 | 18/04/2013 | 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 |
| bis(2-(2-methoxyethoxy)ethyl) ether | 205-594-7 | 143-24-8 | Austria | Toxic for reproduction (Article 57c) | 01/09/2020 | 16/10/2020 | Details |
| Benzo[ghi]perylene | 205-883-8 | 191-24-2 | Denmark | PBT (Article 57 d); vPvB Art.57(e) | 08/03/2018 | 23/04/2018 | Details |
| Fluoranthene | 205-912-4 | 206-44-0 | Belgium |
PBT (Article 57d) vPvB (Article 57e) |
04/09/2018 | 19/10/2018 | Details |
| Benzo[k]fluoranthene | 205-916-6 | 207-08-9 | Belgium |
Carcinogenic (Article 57a) PBT (Article 57d) vPvB (Article 57e) |
04/09/2018 | 19/10/2018 | Details |
| Chrysene | 205-923-4 | 218-01-9 | Germany |
Carcinogenic (Article 57a) PBT (Article 57d) vPvB (Article 57e) |
05/09/2017 | 20/10/2017 | Details |
| Cyclododecane | 206-033-9 | 294-62-2 | France | PBT (Article 57 d) | 30/06/2008 | 14/08/2008 | Details |
| Lead di(acetate) | 206-104-4 | 301-04-2 | Netherlands | Toxic for reproduction (Article 57 c) | 02/09/2013 | 17/10/2013 | Details |
| Hydrazine | 206-114-9 |
302-01-2 7803-57-8 |
ECHA | Carcinogenic (Article 57a) | 21/02/2011 | 07/04/2011 | Details |
| Undecafluorohexanoic acid and its ammonium salt |
206-196-6 244-479-6 |
307-24-4 21615-47-4 |
Germany | Equivalent level of concern having probable serious effects to human health and environment (Article 57f) | 04/09/2018 | 19/10/2018 | Details |
| Tricosafluorododecanoic acid | 206-203-2 | 307-55-1 | Germany | vPvB (Article 57 e) | 03/09/2012 | 18/10/2012 | Details |
| Pentadecafluorooctanoic acid (PFOA) | 206-397-9 | 335-67-1 | Germany | Toxic for reproduction (Article 57 c); PBT (Article 57 d) | 04/03/2013 | 18/04/2013 | Details |
| Nonadecafluorodecanoic acid (PFDA) and its sodium and ammonium salts |
206-400-3 - 221-470-5 |
335-76-2 3830-45-3 3108-42-7 |
Sweden | Toxic for reproduction (Article 57 c); PBT (Article 57 d) | 06/09/2016 | 21/10/2016 | Details |
| Perfluorohexane-1-sulphonic acid and its salts | 206-587-1 | 355-46-4 | Sweden | vPvB (Article 57e) | 09/03/2017 | 24/04/2017 | Details |
| Perfluorononan-1-oic acid (2,2,3,3,4,4,5,5,6,6,7,7,8,8,9,9,9-heptadecafluorononanoic acid and its sodium and ammonium salts | 206-801-3 |
375-95-1 21049-39-8 4149-60-4 |
Sweden | Toxic for reproduction (Article 57 c); PBT (Article 57 d) | 31/08/2015 | 15/10/2015 | Details |
| Heptacosafluorotetradecanoic acid | 206-803-4 | 376-06-7 | Germany | vPvB (Article 57 e) | 03/09/2012 | 18/10/2012 | Details |
| Cadmium carbonate | 208-168-9 | 513-78-0 | 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 |
| Cobalt(II) carbonate | 208-169-4 | 513-79-1 | Netherlands | Carcinogenic (Article 57a); Toxic for reproduction (Article 57 c) | 30/08/2010 | 14/10/2010 | Details |
| Dodecamethylcyclohexasiloxane (D6) | 208-762-8 | 540-97-6 | ECHA |
PBT (Article 57d) vPvB (Article 57e) |
08/03/2018 | 23/04/2018 | Details |
| Decamethylcyclopentasiloxane (D5) | 208-764-9 | 541-02-6 | Germany | PBT (Article 57d); vPvB (Article 57e) | 08/03/2018 | 23/04/2018 | Details |
| [4-[4,4'-bis(dimethylamino) benzhydrylidene]cyclohexa-2,5-dien-1-ylidene]dimethylammonium chloride (C.I. Basic Violet 3) [with ≥ 0.1% of Michler's ketone (EC No. 202-027-5) or Michler's base (EC No. 202-959-2)] | 208-953-6 | 548-62-9 | ECHA | Carcinogenic (Article 57a) | 27/02/2012 | 12/04/2012 | Details |
| Benzene-1,2,4-tricarboxylic acid 1,2-anhydride (trimellitic anhydride) | 209-008-0 | 552-30-7 | Netherlands | Equivalent level of concern having probable serious effects to human health (Article 57 f) | 06/09/2016 | 21/10/2016 | Details |
| Octamethylcyclotetrasiloxane (D4) | 209-136-7 | 556-67-2 | Germany |
PBT (Article 57d) vPvB (Article 57e) |
08/03/2018 | 23/04/2018 | Details |
| 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 | 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 |
| Diisopentylphthalate | 210-088-4 | 605-50-5 | Austria | Toxic for reproduction (Article 57 c) | 03/09/2012 | 18/10/2012 | 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 |
| 1,2-Diethoxyethane | 211-076-1 | 629-14-1 | Slovakia | Toxic for reproduction (Article 57 c) | 03/09/2012 | 18/10/2012 | Details |
| Dibutyltin dichloride (DBTC) | 211-670-0 | 683-18-1 | Sweden | Toxic for reproduction (Article 57 c) | 03/09/2012 | 18/10/2012 | Details |
| 2-methylimidazole | 211-765-7 | 693-98-1 | Sweden | Toxic for reproduction (Article 57c) | 03/03/2020 | 17/04/2020 | Details |
| 2,4,6-tri-tert-butylphenol | 211-989-5 | 732-26-3 | Belgium |
Toxic for reproduction (Article 57c); PBT (Article 57d); vPvB (Article 57e) |
01/09/2023 | 16/10/2023 | Details |
| 4,4'-methylenedi-o-toluidine | 212-658-8 | 838-88-0 | ECHA | Carcinogenic (Article 57a) | 03/09/2012 | 18/10/2012 | Details |
| 1-Methyl-2-pyrrolidone (NMP) | 212-828-1 | 872-50-4 | ECHA | Toxic for reproduction (Article 57 c) | 21/02/2011 | 07/04/2011 | Details |
| N-(hydroxymethyl)acrylamide | 213-103-2 | 924-42-5 | Sweden | Carcinogenic (Article 57a); Mutagenic (Article 57b) | 04/03/2022 | 19/04/2022 | 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-vinylimidazole | 214-012-0 | 1072-63-5 | Sweden | Toxic for reproduction (Article 57c) | 03/03/2020 | 17/04/2020 | Details |
| 1,3-propanesultone | 214-317-9 | 1120-71-4 | ECHA | Carcinogenic (Article 57 a) | 31/08/2015 | 15/10/2015 | 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 |
| 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 |
| 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 |
* 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