- 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.
There are currently no ongoing consultations.
| (±)-1,7,7-trimethyl-3-[(4-methylphenyl)methylene]bicyclo[2.2.1]heptan-2-one covering any of the individual isomers and/or combinations thereof (4-MBC) | - | - | Denmark | Endocrine disrupting properties (Article 57(f) - human health) | 03/09/2021 | 18/10/2021 | Details |
| 1,6,7,8,9,14,15,16,17,17,18,18-Dodecachloropentacyclo[12.2.1.16,9.02,13.05,10]octadeca-7,15-diene (“Dechlorane Plus”™) | - | - | United Kingdom | vPvB (Article 57e) | 05/09/2017 | 20/10/2017 | Details |
| 2,3,3,3-tetrafluoro-2-(heptafluoropropoxy)propionic acid, its salts and its acyl halides (covering any of their individual isomers and combinations thereof) | - | - | Netherlands |
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) |
13/03/2019 | 29/04/2019 | Details |
| 2-(4-tert-butylbenzyl)propionaldehyde and its individual stereoisomers | - | - | Sweden | Toxic for reproduction (Article 57c) | 09/03/2021 | 23/04/2021 | 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 |
| 5-sec-butyl-2-(2,4-dimethylcyclohex-3-en-1-yl)-5-methyl-1,3-dioxane [1], 5-sec-butyl-2-(4,6-dimethylcyclohex-3-en-1-yl)-5-methyl-1,3-dioxane [2] [covering any of the individual isomers of [1] and [2] or any combination thereof] | - | - | Netherlands | vPvB (Article 57 e) | 02/03/2015 | 16/04/2015 | Details |
| Aluminosilicate Refractory Ceramic Fibres (RCF) | - | - | Germany | Carcinogenic (Article 57a) | 29/08/2011 | 13/10/2011 | Details |
| Aluminosilicate, Refractory Ceramic Fibres | - | - | Germany | Carcinogenic (Article 57a) | 31/08/2009 | 15/10/2009 | Details |
| Bis(2-ethylhexyl) tetrabromophthalate covering any of the individual isomers and/or combinations thereof | - | - | Sweden | vPvB (Article 57e) | 02/09/2022 | 17/10/2022 | Details |
| Dioctyltin dilaurate, stannane, dioctyl-, bis(coco acyloxy) derivs., and any other stannane, dioctyl-, bis(fatty acyloxy) derivs. wherein C12 is the predominant carbon number of the fatty acyloxy moiety | - | - | Sweden | Toxic for reproduction (Article 57c) | 01/09/2020 | 16/10/2020 | 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 |
| n-pentyl-isopentyl phthalate | - | 776297-69-9 | Germany | Toxic for reproduction (Article 57 c) | 03/09/2012 | 18/10/2012 | 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 |
| 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 |
| 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 |
| 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 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 |
| 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 |
| Zirconia Aluminosilicate Refractory Ceramic Fibres | - | - | Germany | Carcinogenic (Article 57a) | 31/08/2009 | 15/10/2009 | Details |
| Zirconia Aluminosilicate Refractory Ceramic Fibres (Zr-RCF) | - | - | Germany | Carcinogenic (Article 57a) | 29/08/2011 | 13/10/2011 | Details |
| Benzo[def]chrysene (Benzo[a]pyrene) | 200-028-5 | 50-32-8 | Germany |
Carcinogenic (Article 57 a) Mutagenic (Article 57 b) Toxic for reproduction (Article 57 c) PBT (Article 57 d) vPvB (Article 57 e) |
29/02/2016 | 14/04/2016 | Details |
| Bis(tributyltin) oxide (TBTO) | 200-268-0 | 56-35-9 | Norway | PBT (Article 57 d) | 30/06/2008 | 14/08/2008 | Details |
| Benz[a]anthracene | 200-280-6 | 56-55-3 | Germany |
Carcinogenic (Article 57a) PBT (Article 57d) vPvB (Article 57e) |
05/09/2017 | 20/10/2017 | Details |
| 4-Aminoazobenzene | 200-453-6 | 60-09-3 | 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 |
| N,N-dimethylformamide | 200-679-5 | 68-12-2 | Sweden | Toxic for reproduction (Article 57 c) | 03/09/2012 | 18/10/2012 | Details |
| Cobalt(II) diacetate | 200-755-8 | 71-48-7 | Netherlands | Carcinogenic (Article 57a); Toxic for reproduction (Article 57 c) | 30/08/2010 | 14/10/2010 | Details |
| Formamide | 200-842-0 | 75-12-7 | Germany | Toxic for reproduction (Article 57 c) | 27/02/2012 | 12/04/2012 | Details |
| Methyloxirane (Propylene oxide) | 200-879-2 | 75-56-9 | ECHA | Carcinogenic (Article 57a); Mutagenic (Article 57b) | 03/09/2012 | 18/10/2012 | Details |
| Phenolphthalein | 201-004-7 | 77-09-8 | ECHA | Carcinogenic (Article 57a) | 29/08/2011 | 13/10/2011 | Details |
| 4,4'-(1-methylpropylidene)bisphenol; (bisphenol B) | 201-025-1 | 77-40-7 | France | Endocrine disrupting properties (Article 57(f) - environment AND human health | 09/03/2021 | 23/04/2021 | Details |
| Dimethyl sulphate | 201-058-1 | 77-78-1 | ECHA | Carcinogenic (Article 57a) | 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 |
| Trichloroethylene | 201-167-4 | 79-01-6 | France | Carcinogenic (Article 57a) | 08/03/2010 | 22/04/2010 | Details |
| Acrylamide | 201-173-7 | 79-06-1 | Netherlands | Carcinogenic (Article 57a); Mutagenic (Article 57b) | 31/08/2009 | 15/10/2009 | Details |
| N-methylacetamide | 201-182-6 | 79-16-3 | ECHA | Toxic for reproduction (Article 57 c) | 03/09/2012 | 18/10/2012 | Details |
| 2,2',6,6'-tetrabromo-4,4'-isopropylidenediphenol | 201-236-9 | 79-94-7 | Norway | Carcinogenic (Article 57a) | 02/09/2022 | 17/10/2022 | Details |
| 4,4'-isopropylidenediphenol (bisphenol A; BPA) | 201-245-8 | 80-05-7 | France | Endocrine disrupting properties (Article 57(f) - human health) | 09/03/2017 | 24/04/2017 | Details |
| 4,4’-isopropylidenediphenol (bisphenol A) | 201-245-8 | 80-05-7 | France | Toxic for reproduction (Article 57 c) | 06/09/2016 | 21/10/2016 | Details |
| 4,4’-isopropylidenediphenol (bisphenol A; BPA) | 201-245-8 | 80-05-7 | Germany | Endocrine disrupting properties (Article 57(f) – environment) | 05/09/2017 | 20/10/2017 | Details |
| bis(4-chlorophenyl) sulphone | 201-247-9 | 80-07-9 | Austria | vPvB (Article 57e) | 17/02/2023 | 03/04/2023 | Details |
| 4,4'-sulphonyldiphenol | 201-250-5 | 80-09-1 | Belgium | Toxic for reproduction (Article 57c); Endocrine disrupting properties (Article 57(f) – environment); Endocrine disrupting properties (Article 57(f) – human health) | 02/09/2022 | 17/10/2022 | Details |
| Bis(α,α-dimethylbenzyl) peroxide | 201-279-3 | 80-43-3 | Norway | Toxic for reproduction (Article 57c) | 01/03/2024 | 15/04/2024 | 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 |
| 5-tert-butyl-2,4,6-trinitro-m-xylene (Musk xylene) | 201-329-4 | 81-15-2 | Netherlands | vPvB (Article 57 e) | 30/06/2008 | 14/08/2008 | Details |
| Dicyclohexyl phthalate | 201-545-9 | 84-61-7 | Sweden | Toxic for reproduction (Article 57 c); Equivalent level of concern having probable serious effects to human health and the environment (Article 57 f) | 31/08/2015 | 15/10/2015 | Details |
| Dicyclohexyl phthalate (DCHP) | 201-545-9 | 84-61-7 | Sweden |
Toxic for reproduction (Article 57 c) Equivalent level of concern having probable serious effects to human health and the environment (Article 57 f) |
29/02/2016 | 14/04/2016 | 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