- 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.
| 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 |
| Cyclohexane-1,2-dicarboxylic anhydride [1], cis-cyclohexane-1,2-dicarboxylic anhydride [2], trans-cyclohexane-1,2-dicarboxylic anhydride [3] [The individual cis- [2] and trans- [3] isomer substances and all possible combinations of the cis- and trans-isomers [1] are covered by this entry] |
201-604-9 236-086-3 238-009-9 |
85-42-7 13149-00-3 14166-21-3 |
Netherlands | Equivalent level of concern having probable serious effects to human health (Article 57 f) | 03/09/2012 | 18/10/2012 | 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| Benzyl butyl phthalate (BBP) | 201-622-7 | 85-68-7 | Denmark | Equivalent level of concern having probable serious effects to human health and the environment (Article 57 f) | 01/09/2014 | 16/10/2014 | Details |
| Dibutyl phthalate (DBP) | 201-557-4 | 84-74-2 | Denmark | Equivalent level of concern having probable serious effects to human health and the environment (Article 57 f) | 01/09/2014 | 16/10/2014 | Details |
| Diisobutyl phthalate (DIBP) | 201-553-2 | 84-69-5 | Denmark | Equivalent level of concern having probable serious effects to human health and the environment (Article 57 f) | 01/09/2014 | 16/10/2014 | 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 |
| 1,7,7-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 |
| 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 |
| 4-(1,1,3,3-tetramethylbutyl)phenol, ethoxylated [covering well-defined substances and UVCB substances, polymers and homologues] | - | - | Germany | Equivalent level of concern having probable serious effects to the environment (Article 57 f) | 03/09/2012 | 18/10/2012 | Details |
| 4-Heptylphenol, branched and linear [substances with a linear and/or branched alkyl chain with a carbon number of 7 covalently bound predominantly in position 4 to phenol, covering also UVCB- and well-defined substances which include any of the individual isomers or a combination thereof] | - | - | Austria | Equivalent level of concern having probable serious effects to the environment (Article 57 f) | 06/09/2016 | 21/10/2016 | Details |
| 4-Nonylphenol, branched and linear [substances with a linear and/or branched alkyl chain with a carbon number of 9 covalently bound in position 4 to phenol, covering also UVCB- and well-defined substances which include any of the individual isomers or a combination thereof] | - | - | Germany | Equivalent level of concern having probable serious effects to the environment (Article 57 f) | 03/09/2012 | 18/10/2012 | Details |
| 4-Nonylphenol, branched and linear, ethoxylated | - | - | Germany | Equivalent level of concern having probable serious effects to the environment (Article 57 f) | 04/03/2013 | 18/04/2013 | Details |
| 4-tert-butylphenol | 202-679-0 | 98-54-4 | Germany | Equivalent level of concern having probable serious effects to the environment (Article 57 f) | 06/09/2016 | 21/10/2016 | Details |
| p-(1,1-dimethylpropyl)phenol | 201-280-9 | 80-46-6 | Germany | Equivalent level of concern having probable serious effects to the environment (Article 57 f) | 06/09/2016 | 21/10/2016 | Details |
| 1,3,5-Tris(oxiran-2-ylmethyl)-1,3,5-triazinane-2,4,6-trione (TGIC) | 219-514-3 | 2451-62-9 | Netherlands | Mutagenic (Article 57b) | 27/02/2012 | 12/04/2012 | Details |
| 1,3,5-tris[(2S and 2R)-2,3-epoxypropyl]-1,3,5-triazine-2,4,6-(1H,3H,5H)-trione (β-TGIC) | 423-400-0 | 59653-74-6 | Netherlands | Mutagenic (Article 57b) | 27/02/2012 | 12/04/2012 | Details |
| Anthracene | 204-371-1 | 120-12-7 | Germany | PBT (Article 57 d) | 30/06/2008 | 14/08/2008 | Details |
| Bis(tributyltin) oxide (TBTO) | 200-268-0 | 56-35-9 | Norway | PBT (Article 57 d) | 30/06/2008 | 14/08/2008 | Details |
| Cyclododecane | 206-033-9 | 294-62-2 | France | PBT (Article 57 d) | 30/06/2008 | 14/08/2008 | Details |
| Hexabromocyclododecane (HBCDD) | 247-148-4 | 25637-99-4 | Sweden | PBT (Article 57 d) | 30/06/2008 | 14/08/2008 | 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 |
| 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 |
| 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-benzotriazol-2-yl-4,6-di-tert-butylphenol (UV-320) | 223-346-6 | 3846-71-7 | Germany |
PBT (Article 57 d); vPvB (Article 57 e) |
01/09/2014 | 16/10/2014 | 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 |
| 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 |
| Pyrene | 204-927-3 | 129-00-0 | France |
PBT (Article 57d) vPvB (Article 57e) |
04/09/2018 | 19/10/2018 | Details |
| Decamethylcyclopentasiloxane (D5) | 208-764-9 | 541-02-6 | Germany | PBT (Article 57d); vPvB (Article 57e) | 08/03/2018 | 23/04/2018 | 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 |
| Dodecamethylcyclohexasiloxane (D6) | 208-762-8 | 540-97-6 | ECHA |
PBT (Article 57d) vPvB (Article 57e) |
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 |
| Octamethylcyclotetrasiloxane (D4) | 209-136-7 | 556-67-2 | Germany |
PBT (Article 57d) vPvB (Article 57e) |
08/03/2018 | 23/04/2018 | Details |
| 1,2,3 Trichlorobenzene | 201-757-1 | 87-61-6 | Germany | PBT like substance (equivalent level of concern) | 30/08/2010 | 14/10/2010 | Details |
| 1,3,5 Trichlorobenzene | 203-608-6 | 108-70-3 | Germany | PBT like substance (equivalent level of concern) | 30/08/2010 | 14/10/2010 | Details |
| Ethylenediamine | 203-468-6 | 107-15-3 | ECHA | Respiratory sensitising properties (Article 57(f) - human health) | 08/03/2018 | 23/04/2018 | Details |
| Glutaral | 203-856-5 | 111-30-8 | Sweden | Respiratory sensitising properties (Article 57(f) - human health) | 09/03/2021 | 23/04/2021 | Details |
| 2-(4-tert-butylbenzyl)propionaldehyde and its individual stereoisomers | - | - | Sweden | Toxic for reproduction (Article 57c) | 09/03/2021 | 23/04/2021 | Details |
| Orthoboric acid, sodium salt | 237-560-2 | 13840-56-7 | Sweden | Toxic for reproduction (Article 57c) | 09/03/2021 | 23/04/2021 | 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 |
| 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 |
| 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 |
| 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, dipentylester, branched and linear | 284-032-2 | 84777-06-0 | Germany | 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