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. 

 
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
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
6-methoxy-m-toluidine (p-cresidine) 204-419-1 120-71-8 ECHA Carcinogenic (Article 57a) 03/09/2012 18/10/2012
[4-[4,4'-bis(dimethylamino) benzhydrylidene]cyclohexa-2,5-dien-1-ylidene]dimethylammonium chloride (C.I. Basic Violet 3) [with ≥ 0.1% of Michler's ketone (EC No. 202-027-5) or Michler's base (EC No. 202-959-2)] 208-953-6 548-62-9 ECHA Carcinogenic (Article 57a) 27/02/2012 12/04/2012
[4-[[4-anilino-1-naphthyl][4-(dimethylamino)phenyl]methylene]cyclohexa-2,5-dien-1-ylidene] dimethylammonium chloride (C.I. Basic Blue 26) [with ≥ 0.1% of Michler's ketone (EC No. 202-027-5) or Michler's base (EC No. 202-959-2)] 219-943-6 2580-56-5 ECHA Carcinogenic (Article 57a) 27/02/2012 12/04/2012
[Phthalato(2-)]dioxotrilead 273-688-5 69011-06-9 ECHA Toxic for reproduction (Article 57 c) 03/09/2012 18/10/2012
Acetic acid, lead salt, basic 257-175-3 51404-69-4 ECHA Toxic for reproduction (Article 57 c) 03/09/2012 18/10/2012
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
Acrylamide 201-173-7 79-06-1 Netherlands Carcinogenic (Article 57a); Mutagenic (Article 57b) 31/08/2009 15/10/2009
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
Aluminosilicate Refractory Ceramic Fibres (RCF) - - Germany Carcinogenic (Article 57a) 29/08/2011 13/10/2011
Aluminosilicate, Refractory Ceramic Fibres - - Germany Carcinogenic (Article 57a) 31/08/2009 15/10/2009
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
Ammonium pentadecafluorooctanoate (APFO) 223-320-4 3825-26-1 Germany Toxic for reproduction (Article 57 c); PBT (Article 57 d) 04/03/2013 18/04/2013
Anthracene 204-371-1 120-12-7 Germany PBT (Article 57 d) 30/06/2008 14/08/2008
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
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
Anthracene oil, anthracene paste, anthracene fraction 295-275-9 91995-15-2 Germany Carcinogenic (Article 57a); Mutagenic (Article 57b); PBT (Article 57 d); vPvB (Article 57 e) 31/08/2009 15/10/2009
Anthracene oil, anthracene paste, distn. Lights 295-278-5 91995-17-4 Germany Carcinogenic (Article 57a); Mutagenic (Article 57b); PBT (Article 57 d); vPvB (Article 57 e) 31/08/2009 15/10/2009
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
Arsenic acid 231-901-9 7778-39-4 Norway Carcinogenic (Article 57a) 29/08/2011 13/10/2011
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
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
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
Benzo[ghi]perylene 205-883-8 191-24-2 Denmark PBT (Article 57 d); vPvB Art.57(e) 08/03/2018 23/04/2018
Benzyl butyl phthalate (BBP) 201-622-7 85-68-7 Austria Toxic for reproduction (Article 57 c) 30/06/2008 14/08/2008
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
Biphenyl-4-ylamine 202-177-1 92-67-1 ECHA Carcinogenic (Article 57a) 03/09/2012 18/10/2012
Bis (2-ethylhexyl)phthalate (DEHP) 204-211-0 117-81-7 Sweden Toxic for reproduction (Article 57 c) 30/06/2008 14/08/2008
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
Bis(2-methoxyethyl) ether 203-924-4 111-96-6 Austria Toxic for reproduction (Article 57 c) 29/08/2011 13/10/2011
Bis(2-methoxyethyl) phthalate 204-212-6 117-82-8 Germany Toxic for reproduction (Article 57 c) 29/08/2011 13/10/2011
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
Bis(tributyltin) oxide (TBTO) 200-268-0 56-35-9 Norway PBT (Article 57 d) 30/06/2008 14/08/2008
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
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
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
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
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
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
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
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
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
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
Calcium arsenate 231-904-5 7778-44-1 Norway Carcinogenic (Article 57a) 29/08/2011 13/10/2011
Chromium trioxide 215-607-8 1333-82-0 Germany Carcinogenic (Article 57a); Mutagenic (Article 57b) 30/08/2010 14/10/2010
Chrysene 205-923-4 218-01-9 Germany Carcinogenic (Article 57a)
PBT (Article 57d)
vPvB (Article 57e)
05/09/2017 20/10/2017
Cobalt dichloride 231-589-4 7646-79-9 France Carcinogenic (Article 57a); Toxic for reproduction (Article 57 c) 30/06/2008 14/08/2008
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
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



* 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

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