- 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.
| Lead titanium trioxide | 235-038-9 | 12060-00-3 | ECHA | Toxic for reproduction (Article 57 c) | 03/09/2012 | 18/10/2012 | Details |
| Pentalead tetraoxide sulphate | 235-067-7 | 12065-90-6 | ECHA | Toxic for reproduction (Article 57 c) | 03/09/2012 | 18/10/2012 | Details |
| Trilead dioxide phosphonate | 235-252-2 | 12141-20-7 | ECHA | Toxic for reproduction (Article 57 c) | 03/09/2012 | 18/10/2012 | Details |
| Tetralead trioxide sulphate | 235-380-9 | 12202-17-4 | ECHA | Toxic for reproduction (Article 57 c) | 03/09/2012 | 18/10/2012 | Details |
| Tetraboron disodium heptaoxide, hydrate | 235-541-3 | 12267-73-1 | Denmark | Toxic for reproduction (Article 57 c) | 08/03/2010 | 22/04/2010 | Details |
| Dioxobis(stearato)trilead | 235-702-8 | 12578-12-0 | 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 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 |
| 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 |
| Lead diazide, Lead azide | 236-542-1 | 13424-46-9 | ECHA | Toxic for reproduction (Article 57 c) | 29/08/2011 | 13/10/2011 | Details |
| Barium diboron tetraoxide | 237-222-4 | 13701-59-2 | Sweden | Toxic for reproduction (Article 57c) | 02/09/2022 | 17/10/2022 | Details |
| Lead bis(tetrafluoroborate) | 237-486-0 | 13814-96-5 | ECHA | Toxic for reproduction (Article 57 c) | 03/09/2012 | 18/10/2012 | Details |
| Orthoboric acid, sodium salt | 237-560-2 | 13840-56-7 | Sweden | Toxic for reproduction (Article 57c) | 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 |
| Sodium perborate,perboric acid, sodium salt |
239-172-9 234-390-0 |
15120-21-5 | Denmark | Toxic for reproduction (Article 57 c) | 03/03/2014 | 17/04/2014 | Details |
| Lead styphnate | 239-290-0 | 15245-44-0 | ECHA | Toxic for reproduction (Article 57 c) | 29/08/2011 | 13/10/2011 | 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 |
| Lead cyanamidate | 244-073-9 | 20837-86-9 | ECHA | Toxic for reproduction (Article 57 c) | 03/09/2012 | 18/10/2012 | Details |
| Cadmium hydroxide | 244-168-5 | 21041-95-2 | 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 |
| Dibutylbis(pentane-2,4-dionato-O,O')tin | 245-152-0 | 22673-19-4 | Sweden | Toxic for reproduction (Article 57c) | 03/03/2020 | 17/04/2020 | Details |
| Dichromium tris(chromate) | 246-356-2 | 24613-89-6 | France | Carcinogenic (Article 57a) | 29/08/2011 | 13/10/2011 | Details |
| Trixylyl phosphate | 246-677-8 | 25155-23-1 | Austria | Toxic for reproduction (Article 57 c) | 02/09/2013 | 17/10/2013 | 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 |
| Hexabromocyclododecane (HBCDD) | 247-148-4 | 25637-99-4 | Sweden | PBT (Article 57 d) | 30/06/2008 | 14/08/2008 | 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-(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-(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 |
| (±)-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 |
| 1,1'-[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 | Details |
| Pentazinc chromate octahydroxide | 256-418-0 | 49663-84-5 | France | Carcinogenic (Article 57a) | 29/08/2011 | 13/10/2011 | 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 |
| Terphenyl hydrogenated | 262-967-7 | 61788-32-7 | Finland | vPvB Art.57(e) | 08/03/2018 | 23/04/2018 | Details |
| Sulfurous acid, lead salt, dibasic | 263-467-1 | 62229-08-7 | ECHA | Toxic for reproduction (Article 57 c) | 03/09/2012 | 18/10/2012 | Details |
| Pitch, coal tar, high temp. | 266-028-2 | 65996-93-2 | Commission | Carcinogenic (Article 57a); PBT (Article 57 d); vPvB (Article 57 e) | 31/08/2009 | 15/10/2009 | Details |
| 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 | Details |
| 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 | Details |
| 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 | Details |
|
Silicic acid (H2Si2O5), barium salt (1:1), lead-doped [with lead (Pb) content above the applicable generic concentration limit for ’toxicity for reproduction’ Repr. 1A (CLP) or category 1 (DSD),the substance is a member of the group entry of lead compounds, with index number 082-001-00-6 in Regulation (EC) No 1272/2008] |
272-271-5 | 68784-75-8 | ECHA | Toxic for reproduction (Article 57 c) | 03/09/2012 | 18/10/2012 | Details |
| [Phthalato(2-)]dioxotrilead | 273-688-5 | 69011-06-9 | ECHA | Toxic for reproduction (Article 57 c) | 03/09/2012 | 18/10/2012 | Details |
| Diisohexyl phthalate | 276-090-2 | 71850-09-4 | Sweden | Toxic for reproduction (Article 57c) | 03/09/2019 | 18/10/2019 | Details |
| 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 | Details |
| Pentacosafluorotridecanoic acid | 276-745-2 | 72629-94-8 | Germany | vPvB (Article 57 e) | 03/09/2012 | 18/10/2012 | 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 |
| 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 |
| Alkanes, C10-13, chloro (Short Chain Chlorinated Paraffins) | 287-476-5 | 85535-84-8 | United Kingdom | PBT (Article 57 d); vPvB (Article 57 e) | 30/06/2008 | 14/08/2008 | Details |
| Anthracene oil | 292-602-7 | 90640-80-5 | Germany | Carcinogenic (Article 57a); PBT (Article 57 d); vPvB (Article 57 e) | 31/08/2009 | 15/10/2009 | Details |
| Anthracene oil, anthracene paste | 292-603-2 | 90640-81-6 | Germany | Carcinogenic (Article 57a); Mutagenic (Article 57b); PBT (Article 57 d); vPvB (Article 57 e) | 31/08/2009 | 15/10/2009 | Details |
| Anthracene oil, anthracene-low | 292-604-8 | 90640-82-7 | Germany | Carcinogenic (Article 57a); Mutagenic (Article 57b); PBT (Article 57 d); vPvB (Article 57 e) | 31/08/2009 | 15/10/2009 | 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 |
| Anthracene oil, anthracene paste, anthracene fraction | 295-275-9 | 91995-15-2 | Germany | Carcinogenic (Article 57a); Mutagenic (Article 57b); PBT (Article 57 d); vPvB (Article 57 e) | 31/08/2009 | 15/10/2009 | 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