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. 

 
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
Zirconia Aluminosilicate Refractory Ceramic Fibres (Zr-RCF) - - Germany Carcinogenic (Article 57a) 29/08/2011 13/10/2011
Zirconia Aluminosilicate Refractory Ceramic Fibres - - Germany Carcinogenic (Article 57a) 31/08/2009 15/10/2009
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
Trixylyl phosphate 246-677-8 25155-23-1 Austria Toxic for reproduction (Article 57 c) 02/09/2013 17/10/2013
Tris(2-chloroethyl)phosphate 204-118-5 115-96-8 Austria Toxic for reproduction (Article 57 c) 31/08/2009 15/10/2009
Trilead dioxide phosphonate 235-252-2 12141-20-7 ECHA Toxic for reproduction (Article 57 c) 03/09/2012 18/10/2012
Trilead diarsenate 222-979-5 3687-31-8 Norway Carcinogenic (Article 57a); Toxic for reproduction (Article 57 c) 29/08/2011 13/10/2011
Trilead bis(carbonate) dihydroxide 215-290-6 1319-46-6 ECHA Toxic for reproduction (Article 57 c) 03/09/2012 18/10/2012
Triethyl arsenate 427-700-2 15606-95-8 Norway Carcinogenic (Article 57a) 30/06/2008 14/08/2008
Tricosafluorododecanoic acid 206-203-2 307-55-1 Germany vPvB (Article 57 e) 03/09/2012 18/10/2012
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
Trichloroethylene 201-167-4 79-01-6 France Carcinogenic (Article 57a) 08/03/2010 22/04/2010
Tetralead trioxide sulphate 235-380-9 12202-17-4 ECHA Toxic for reproduction (Article 57 c) 03/09/2012 18/10/2012
Tetraethyllead 201-075-4 78-00-2 ECHA Toxic for reproduction (Article 57 c) 03/09/2012 18/10/2012
Tetraboron disodium heptaoxide, hydrate 235-541-3 12267-73-1 Denmark Toxic for reproduction (Article 57 c) 08/03/2010 22/04/2010
Terphenyl hydrogenated 262-967-7 61788-32-7 Finland vPvB Art.57(e) 08/03/2018 23/04/2018
Sulfurous acid, lead salt, dibasic 263-467-1 62229-08-7 ECHA Toxic for reproduction (Article 57 c) 03/09/2012 18/10/2012
Strontium chromate 232-142-6 7789-06-2 France Carcinogenic (Article 57a) 21/02/2011 07/04/2011
Sodium peroxometaborate 231-556-4 7632-04-4 Denmark Toxic for reproduction (Article 57 c) 03/03/2014 17/04/2014
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
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
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
Silicic acid, lead salt 234-363-3 11120-22-2 ECHA Toxic for reproduction (Article 57 c) 03/09/2012 18/10/2012
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
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
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
Pyrochlore, antimony lead yellow 232-382-1 8012-00-8 ECHA Toxic for reproduction (Article 57 c) 03/09/2012 18/10/2012
Pyrene 204-927-3 129-00-0 France PBT (Article 57d)
vPvB (Article 57e)
04/09/2018 19/10/2018
Potassium hydroxyoctaoxodizincatedichromate 234-329-8 11103-86-9 France Carcinogenic (Article 57a) 29/08/2011 13/10/2011
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
Potassium chromate 232-140-5 7789-00-6 France Carcinogenic (Article 57a); Mutagenic (Article 57b) 08/03/2010 22/04/2010
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
Phenolphthalein 201-004-7 77-09-8 ECHA Carcinogenic (Article 57a) 29/08/2011 13/10/2011
Phenanthrene 201-581-5 85-01-8 France vPvB (Article 57e) 04/09/2018 19/10/2018
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
Perfluorohexane-1-sulphonic acid and its salts 206-587-1 355-46-4 Sweden vPvB (Article 57e) 09/03/2017 24/04/2017
Pentazinc chromate octahydroxide 256-418-0 49663-84-5 France Carcinogenic (Article 57a) 29/08/2011 13/10/2011
Pentalead tetraoxide sulphate 235-067-7 12065-90-6 ECHA Toxic for reproduction (Article 57 c) 03/09/2012 18/10/2012
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
Pentacosafluorotridecanoic acid 276-745-2 72629-94-8 Germany vPvB (Article 57 e) 03/09/2012 18/10/2012
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
Orange lead (lead tetroxide) 215-235-6 1314-41-6 ECHA Toxic for reproduction (Article 57 c) 03/09/2012 18/10/2012
Octamethylcyclotetrasiloxane (D4) 209-136-7 556-67-2 Germany PBT (Article 57d)
vPvB (Article 57e)
08/03/2018 23/04/2018
o-Toluidine 202-429-0 95-53-4 ECHA Carcinogenic (Article 57a) 03/09/2012 18/10/2012
o-aminoazotoluene 202-591-2 97-56-3 ECHA Carcinogenic (Article 57a) 03/09/2012 18/10/2012
Nonadecafluorodecanoic acid (PFDA) and its sodium and ammonium salts
206-400-3
-
221-470-5
335-76-2
3830-45-3
3108-42-7
Sweden Toxic for reproduction (Article 57 c); PBT (Article 57 d) 06/09/2016 21/10/2016
Nitrobenzene 202-716-0 98-95-3 Austria Toxic for reproduction (Article 57 c) 31/08/2015 15/10/2015
N-pentyl-isopentylphthalate - 776297-69-9 Germany Toxic for reproduction (Article 57 c) 03/09/2012 18/10/2012
N-methylacetamide 201-182-6 79-16-3 ECHA Toxic for reproduction (Article 57 c) 03/09/2012 18/10/2012



* 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

Categories Display