- ECHA
- Konsultationen
- Identifizierung besonders besorgniserregender Stoffe
- 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.
| 2,2'-dichloro-4,4'-methylenedianiline (MOCA) | 202-918-9 | 101-14-4 | ECHA | Carcinogenic (Article 57a) | 29/08/2011 | 13/10/2011 | Details |
| 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 | 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 |
| 4,4'-bis(dimethylamino)benzophenone (Michler’s ketone) | 202-027-5 | 90-94-8 | ECHA | Carcinogenic (Article 57a) | 27/02/2012 | 12/04/2012 | Details |
| 4,4'-methylenedi-o-toluidine | 212-658-8 | 838-88-0 | ECHA | Carcinogenic (Article 57a) | 03/09/2012 | 18/10/2012 | 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 |
| 4-Aminoazobenzene | 200-453-6 | 60-09-3 | ECHA | Carcinogenic (Article 57a) | 03/09/2012 | 18/10/2012 | Details |
| 4-methyl-m-phenylenediamine (toluene-2,4-diamine) | 202-453-1 | 95-80-7 | ECHA | Carcinogenic (Article 57a) | 03/09/2012 | 18/10/2012 | Details |
| 6-methoxy-m-toluidine (p-cresidine) | 204-419-1 | 120-71-8 | ECHA | Carcinogenic (Article 57a) | 03/09/2012 | 18/10/2012 | 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 |
| [4-[[4-anilino-1-naphthyl][4-(dimethylamino)phenyl]methylene]cyclohexa-2,5-dien-1-ylidene] dimethylammonium chloride (C.I. Basic Blue 26) [with ≥ 0.1% of Michler's ketone (EC No. 202-027-5) or Michler's base (EC No. 202-959-2)] | 219-943-6 | 2580-56-5 | ECHA | Carcinogenic (Article 57a) | 27/02/2012 | 12/04/2012 | Details |
| [Phthalato(2-)]dioxotrilead | 273-688-5 | 69011-06-9 | ECHA | Toxic for reproduction (Article 57 c) | 03/09/2012 | 18/10/2012 | Details |
| Acetic acid, lead salt, basic | 257-175-3 | 51404-69-4 | ECHA | Toxic for reproduction (Article 57 c) | 03/09/2012 | 18/10/2012 | Details |
| Biphenyl-4-ylamine | 202-177-1 | 92-67-1 | ECHA | Carcinogenic (Article 57a) | 03/09/2012 | 18/10/2012 | Details |
| Diethyl sulphate | 200-589-6 | 64-67-5 | ECHA | Carcinogenic (Article 57a); Mutagenic (Article 57b) | 03/09/2012 | 18/10/2012 | Details |
| 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 |
| Dioxobis(stearato)trilead | 235-702-8 | 12578-12-0 | ECHA | Toxic for reproduction (Article 57 c) | 03/09/2012 | 18/10/2012 | 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 |
| Furan | 203-727-3 | 110-00-9 | ECHA | Carcinogenic (Article 57a) | 03/09/2012 | 18/10/2012 | Details |
| Hydrazine | 206-114-9 |
302-01-2 7803-57-8 |
ECHA | Carcinogenic (Article 57a) | 21/02/2011 | 07/04/2011 | 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 cyanamidate | 244-073-9 | 20837-86-9 | ECHA | Toxic for reproduction (Article 57 c) | 03/09/2012 | 18/10/2012 | 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