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.
 
Acids generated from chromium trioxide and their oligomers. Names of the acids and their oligomers: Chromic acid, Dichromic acid, Oligomers of chromic acid and dichromic acid.
231-801-5
236-881-5
7738-94-5
13530-68-2
Germany Carcinogenic (Article 57a) 30/08/2010 14/10/2010 Details
Lead chromate 231-846-0 7758-97-6 France Carcinogenic (Article 57a); Toxic for reproduction (Article 57 c) 31/08/2009 15/10/2009 Details
n-pentyl-isopentyl phthalate - 776297-69-9 Germany Toxic for reproduction (Article 57 c) 03/09/2012 18/10/2012 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
Arsenic acid 231-901-9 7778-39-4 Norway Carcinogenic (Article 57a) 29/08/2011 13/10/2011 Details
Calcium arsenate 231-904-5 7778-44-1 Norway 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
Lead hydrogen arsenate 232-064-2 7784-40-9 Norway Carcinogenic (Article 57a); Toxic for reproduction (Article 57 c) 30/06/2008 14/08/2008 Details
Potassium chromate 232-140-5 7789-00-6 France Carcinogenic (Article 57a); Mutagenic (Article 57b) 08/03/2010 22/04/2010 Details
Strontium chromate 232-142-6 7789-06-2 France Carcinogenic (Article 57a) 21/02/2011 07/04/2011 Details
Ammonium dichromate 232-143-1 7789-09-5 France Carcinogenic (Article 57a); Mutagenic (Article 57b); Toxic for reproduction (Article 57 c) 08/03/2010 22/04/2010 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
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
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
Pyrochlore, antimony lead yellow 232-382-1 8012-00-8 ECHA Toxic for reproduction (Article 57 c) 03/09/2012 18/10/2012 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
4,4'-methylenedi-o-toluidine 212-658-8 838-88-0 ECHA Carcinogenic (Article 57a) 03/09/2012 18/10/2012 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
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
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
Dihexyl phthalate 201-559-5 84-75-3 Germany Toxic for reproduction (Article 57 c) 02/09/2013 17/10/2013 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
Phenanthrene 201-581-5 85-01-8 France vPvB (Article 57e) 04/09/2018 19/10/2018 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
Benzyl butyl phthalate (BBP) 201-622-7 85-68-7 Austria Toxic for reproduction (Article 57 c) 30/06/2008 14/08/2008 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
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
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-Methyl-2-pyrrolidone (NMP) 212-828-1 872-50-4 ECHA Toxic for reproduction (Article 57 c) 21/02/2011 07/04/2011 Details
Dinoseb (6-sec-butyl-2,4-dinitrophenol) 201-861-7 88-85-7 ECHA Toxic for reproduction (Article 57 c) 03/09/2012 18/10/2012 Details
2-Methoxyaniline,o-Anisidine 201-963-1 90-04-0 Germany Carcinogenic (Article 57a) 29/08/2011 13/10/2011 Details
4,4'-bis(dimethylamino)benzophenone (Michler’s ketone) 202-027-5 90-94-8 ECHA Carcinogenic (Article 57a) 27/02/2012 12/04/2012 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



* 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