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.
 
bis(2-(2-methoxyethoxy)ethyl) ether 205-594-7 143-24-8 Austria Toxic for reproduction (Article 57c) 01/09/2020 16/10/2020 Details
Bis(2-ethylhexyl) phthalate (DEHP) 204-211-0 117-81-7 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
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
Bis(2-methoxyethyl) ether 203-924-4 111-96-6 Austria Toxic for reproduction (Article 57 c) 29/08/2011 13/10/2011 Details
Bis(2-methoxyethyl) phthalate 204-212-6 117-82-8 Germany Toxic for reproduction (Article 57 c) 29/08/2011 13/10/2011 Details
bis(4-chlorophenyl) sulphone 201-247-9 80-07-9 Austria vPvB (Article 57e) 17/02/2023 03/04/2023 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
Bis(tributyltin) oxide (TBTO) 200-268-0 56-35-9 Norway PBT (Article 57 d) 30/06/2008 14/08/2008 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
Boric acid
233-139-2
234-343-4
10043-35-3
11113-50-1
Germany Toxic for reproduction (Article 57 c) 08/03/2010 22/04/2010 Details
Bumetrizole 223-445-4 3896-11-5 Germany vPvB (Article 57e) 01/09/2023 16/10/2023 Details
Butyl 4-hydroxybenzoate 202-318-7 94-26-8 Denmark Endocrine disrupting properties (Article 57(f) – human health) 03/03/2020 17/04/2020 Details
Cadmium 231-152-8 7440-43-9 Sweden Carcinogenic (Article 57a); Equivalent level of concern having probable serious effects to human health (Article 57 f) 04/03/2013 18/04/2013 Details
Cadmium nitrate 233-710-6 10325-94-7 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
Cadmium carbonate 208-168-9 513-78-0 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
Cadmium chloride 233-296-7 10108-64-2 Sweden Carcinogenic (Article 57a); Mutagenic (Article 57(b); Toxic for Reproduction (Article 57(c); Equivalent level of concern having probable serious effects to human health (Article 57 f) 03/03/2014 17/04/2014 Details
Cadmium fluoride 232-222-0 7790-79-6 Sweden Carcinogenic (Article 57 a);
Mutagenic (Article 57 b);
Toxic for Reproduction (Article 57 c);
Equivalent level of concern having probable serious effects to human health (Article 57 f)
01/09/2014 16/10/2014 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
Cadmium oxide 215-146-2 1306-19-0 Sweden Carcinogenic (Article 57a); Equivalent level of concern having probable serious effects to human health (Article 57 f) 04/03/2013 18/04/2013 Details
Cadmium sulphate 233-331-6
10124-36-4
31119-53-6
Sweden Carcinogenic (Article 57 a);
Mutagenic (article 57 b);
Toxic for Reproduction (Article 57 c);
Equivalent level of concern having probable serious effects to human health (Article 57 f)
01/09/2014 16/10/2014 Details
Cadmium sulphide 215-147-8 1306-23-6 Sweden Carcinogenic (Article 57a); Equivalent level of concern having probable serious effects to human health (Article 57 f) 02/09/2013 17/10/2013 Details
Calcium arsenate 231-904-5 7778-44-1 Norway Carcinogenic (Article 57a) 29/08/2011 13/10/2011 Details
Chromium trioxide 215-607-8 1333-82-0 Germany Carcinogenic (Article 57a); Mutagenic (Article 57b) 30/08/2010 14/10/2010 Details
Chrysene 205-923-4 218-01-9 Germany Carcinogenic (Article 57a)
PBT (Article 57d)
vPvB (Article 57e)
05/09/2017 20/10/2017 Details
Cobalt dichloride 231-589-4 7646-79-9 France Carcinogenic (Article 57a); Toxic for reproduction (Article 57 c) 30/06/2008 14/08/2008 Details
Cobalt(II) carbonate 208-169-4 513-79-1 Netherlands Carcinogenic (Article 57a); Toxic for reproduction (Article 57 c) 30/08/2010 14/10/2010 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
Cobalt(II) dinitrate 233-402-1 10141-05-6 Netherlands Carcinogenic (Article 57a); Toxic for reproduction (Article 57 c) 30/08/2010 14/10/2010 Details
Cobalt(II) sulphate 233-334-2 10124-43-3 Netherlands Carcinogenic (Article 57a); Toxic for reproduction (Article 57 c) 30/08/2010 14/10/2010 Details
Cyclododecane 206-033-9 294-62-2 France PBT (Article 57 d) 30/06/2008 14/08/2008 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
Decamethylcyclopentasiloxane (D5) 208-764-9 541-02-6 Germany PBT (Article 57d); vPvB (Article 57e) 08/03/2018 23/04/2018 Details
Diarsenic pentaoxide 215-116-9 1303-28-2 France Carcinogenic (Article 57a) 30/06/2008 14/08/2008 Details
Diarsenic trioxide 215-481-4 1327-53-3 France Carcinogenic (Article 57a) 30/06/2008 14/08/2008 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
Diboron trioxide 215-125-8 1303-86-2 Germany Toxic for reproduction (Article 57 c) 27/02/2012 12/04/2012 Details
Dibutyl phthalate 201-557-4 84-74-2 Austria Toxic for reproduction (Article 57 c) 30/06/2008 14/08/2008 Details
Dibutyl phthalate 201-557-4 84-74-2 Netherlands Endocrine disrupting properties (Article 57(f) – environment) 01/09/2023 16/10/2023 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
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
Dibutyltin dichloride (DBTC) 211-670-0 683-18-1 Sweden Toxic for reproduction (Article 57 c) 03/09/2012 18/10/2012 Details
Dichromium tris(chromate) 246-356-2 24613-89-6 France Carcinogenic (Article 57a) 29/08/2011 13/10/2011 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
Diethyl sulphate 200-589-6 64-67-5 ECHA Carcinogenic (Article 57a); Mutagenic (Article 57b) 03/09/2012 18/10/2012 Details
Dihexyl phthalate 201-559-5 84-75-3 Germany Toxic for reproduction (Article 57 c) 02/09/2013 17/10/2013 Details
Diisobutyl phthalate 201-553-2 84-69-5 Germany Toxic for reproduction (Article 57 c) 31/08/2009 15/10/2009 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
Diisohexyl phthalate 276-090-2 71850-09-4 Sweden Toxic for reproduction (Article 57c) 03/09/2019 18/10/2019 Details
Diisopentylphthalate 210-088-4 605-50-5 Austria 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