- 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.
| α,α-Bis[4-(dimethylamino)phenyl]-4 (phenylamino)naphthalene-1-methanol (C.I. Solvent Blue 4) [with ≥ 0.1% of Michler's ketone (EC No. 202-027-5) or Michler's base (EC No. 202-959-2)] | 229-851-8 | 6786-83-0 | ECHA | Carcinogenic (Article 57a) | 27/02/2012 | 12/04/2012 | Details |
| Zirconia Aluminosilicate Refractory Ceramic Fibres (Zr-RCF) | - | - | Germany | Carcinogenic (Article 57a) | 29/08/2011 | 13/10/2011 | Details |
| Zirconia Aluminosilicate Refractory Ceramic Fibres | - | - | Germany | Carcinogenic (Article 57a) | 31/08/2009 | 15/10/2009 | 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 |
| Trixylyl phosphate | 246-677-8 | 25155-23-1 | Austria | Toxic for reproduction (Article 57 c) | 02/09/2013 | 17/10/2013 | Details |
| Tris(4-nonylphenyl, branched and linear) phosphite (TNPP) with ≥ 0.1% w/w of 4-nonylphenol, branched and linear (4-NP) | - | - | France | Endocrine disrupting properties (Article 57(f) – environment) | 13/03/2019 | 29/04/2019 | 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 |
| Tris(2-chloroethyl)phosphate | 204-118-5 | 115-96-8 | Austria | Toxic for reproduction (Article 57 c) | 31/08/2009 | 15/10/2009 | Details |
| Triphenyl phosphate | 204-112-2 | 115-86-6 | France | Endocrine disrupting properties (Article 57(f) – environment) | 01/03/2024 | 15/04/2024 | Details |
| Trilead dioxide phosphonate | 235-252-2 | 12141-20-7 | ECHA | Toxic for reproduction (Article 57 c) | 03/09/2012 | 18/10/2012 | Details |
| Trilead diarsenate | 222-979-5 | 3687-31-8 | Norway | Carcinogenic (Article 57a); Toxic for reproduction (Article 57 c) | 29/08/2011 | 13/10/2011 | Details |
| Trilead bis(carbonate) dihydroxide | 215-290-6 | 1319-46-6 | ECHA | Toxic for reproduction (Article 57 c) | 03/09/2012 | 18/10/2012 | Details |
| Triethyl arsenate | 427-700-2 | 15606-95-8 | Norway | Carcinogenic (Article 57a) | 30/06/2008 | 14/08/2008 | Details |
| Tricosafluorododecanoic acid | 206-203-2 | 307-55-1 | Germany | vPvB (Article 57 e) | 03/09/2012 | 18/10/2012 | 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 |
| Trichloroethylene | 201-167-4 | 79-01-6 | France | Carcinogenic (Article 57a) | 08/03/2010 | 22/04/2010 | Details |
| Tetralead trioxide sulphate | 235-380-9 | 12202-17-4 | ECHA | Toxic for reproduction (Article 57 c) | 03/09/2012 | 18/10/2012 | Details |
| Tetraethyllead | 201-075-4 | 78-00-2 | 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 |
| 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 |
| Strontium chromate | 232-142-6 | 7789-06-2 | France | Carcinogenic (Article 57a) | 21/02/2011 | 07/04/2011 | Details |
| Sodium peroxometaborate | 231-556-4 | 7632-04-4 | Denmark | Toxic for reproduction (Article 57 c) | 03/03/2014 | 17/04/2014 | 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 |
| Sodium dichromate, dihydrate | 234-190-3 | 7789-12-0 | France | Carcinogenic (Article 57a); Mutagenic (Article 57b); Toxic for reproduction (Article 57 c) | 30/06/2008 | 14/08/2008 | Details |
| Sodium chromate | 231-889-5 | 7775-11-3 | France | Carcinogenic (Article 57a); Mutagenic (Article 57b); Toxic for reproduction (Article 57 c) | 08/03/2010 | 22/04/2010 | Details |
| Silicic acid, lead salt | 234-363-3 | 11120-22-2 | ECHA | Toxic for reproduction (Article 57 c) | 03/09/2012 | 18/10/2012 | 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 |
| S-(tricyclo[5.2.1.0'2,6]deca-3-en-8(or 9)-yl) O-(isopropyl or isobutyl or 2-ethylhexyl) O-(isopropyl or isobutyl or 2-ethylhexyl) phosphorodithioate | 401-850-9 | 255881-94-8 | Belgium | PBT (Article 57 d) | 03/09/2021 | 18/10/2021 | Details |
| Resorcinol | 203-585-2 | 108-46-3 | France | Endocrine disrupting properties (Article 57(f) – human health) | 03/03/2020 | 17/04/2020 | Details |
| Reaction products of 1,3,4-thiadiazolidine-2,5-dithione, formaldehyde and 4-heptylphenol, branched and linear (RP-HP) [with ≥0.1% w/w 4-heptylphenol, branched and linear] | - | - | Austria | Endocrine disrupting properties (Article 57(f) – environment) | 05/09/2017 | 20/10/2017 | Details |
| Reaction mass of 2-ethylhexyl 10-ethyl-4,4-dioctyl-7-oxo-8-oxa-3,5-dithia-4-stannatetradecanoate and 2-ethylhexyl 10-ethyl-4-[[2-[(2-ethylhexyl)oxy]-2-oxoethyl]thio]-4-octyl-7-oxo-8-oxa-3,5-dithia-4-stannatetradecanoate (reaction mass of DOTE and MOTE) | - | - | Austria | Toxic for Reproduction (Article 57 c) | 01/09/2014 | 16/10/2014 | Details |
| reaction mass of 2,2,3,3,5,5,6,6-octafluoro-4-(1,1,1,2,3,3,3-heptafluoropropan-2-yl)morpholine and 2,2,3,3,5,5,6,6-octafluoro-4-(heptafluoropropyl)morpholine | 473-390-7 | - | Belgium | vPvB (Article 57e) | 02/09/2022 | 17/10/2022 | Details |
| Pyrochlore, antimony lead yellow | 232-382-1 | 8012-00-8 | ECHA | Toxic for reproduction (Article 57 c) | 03/09/2012 | 18/10/2012 | Details |
| Pyrene | 204-927-3 | 129-00-0 | France |
PBT (Article 57d) vPvB (Article 57e) |
04/09/2018 | 19/10/2018 | Details |
| Potassium hydroxyoctaoxodizincatedichromate | 234-329-8 | 11103-86-9 | France | Carcinogenic (Article 57a) | 29/08/2011 | 13/10/2011 | Details |
| Potassium dichromate | 231-906-6 | 7778-50-9 | France | Carcinogenic (Article 57a); Mutagenic (Article 57b); Toxic for reproduction (Article 57 c) | 08/03/2010 | 22/04/2010 | Details |
| Potassium chromate | 232-140-5 | 7789-00-6 | France | Carcinogenic (Article 57a); Mutagenic (Article 57b) | 08/03/2010 | 22/04/2010 | 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 |
| Phenolphthalein | 201-004-7 | 77-09-8 | ECHA | Carcinogenic (Article 57a) | 29/08/2011 | 13/10/2011 | Details |
| Phenol, alkylation products (mainly in para position) with C12-rich branched or linear alkyl chains from oligomerisation, covering any individual isomers and/ or combinations thereof (PDDP) | - | - | Germany |
Toxic for reproduction
(Article 57c) Endocrine disrupting properties (Article 57(f) – human health) Endocrine disrupting properties (Article 57(f) – environment) |
09/03/2021 | 23/04/2021 | Details |
| Phenanthrene | 201-581-5 | 85-01-8 | France | vPvB (Article 57e) | 04/09/2018 | 19/10/2018 | 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 |
| Perfluorohexane-1-sulphonic acid and its salts | 206-587-1 | 355-46-4 | Sweden | vPvB (Article 57e) | 09/03/2017 | 24/04/2017 | Details |
| Perfluoroheptanoic acid and its salts | - | - | Netherlands | Toxic for reproduction (Article 57c); PBT (Article 57d); vPvB (Article 57e); 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 |
| Perfluorobutane sulfonic acid (PFBS) and its salts | - | - | Norway |
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) |
03/09/2019 | 18/10/2019 | Details |
| Pentazinc chromate octahydroxide | 256-418-0 | 49663-84-5 | France | Carcinogenic (Article 57a) | 29/08/2011 | 13/10/2011 | Details |
| Pentalead tetraoxide sulphate | 235-067-7 | 12065-90-6 | ECHA | Toxic for reproduction (Article 57 c) | 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 |
| Pentacosafluorotridecanoic acid | 276-745-2 | 72629-94-8 | Germany | vPvB (Article 57 e) | 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