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. 

 
4,4'- Diaminodiphenylmethane (MDA) 202-974-4 101-77-9 Germany Carcinogenic (Article 57a) 30/06/2008 14/08/2008
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
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
Anthracene 204-371-1 120-12-7 Germany PBT (Article 57 d) 30/06/2008 14/08/2008
Benzyl butyl phthalate (BBP) 201-622-7 85-68-7 Austria Toxic for reproduction (Article 57 c) 30/06/2008 14/08/2008
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(tributyltin) oxide (TBTO) 200-268-0 56-35-9 Norway PBT (Article 57 d) 30/06/2008 14/08/2008
Cobalt dichloride 231-589-4 7646-79-9 France Carcinogenic (Article 57a); Toxic for reproduction (Article 57 c) 30/06/2008 14/08/2008
Cyclododecane 206-033-9 294-62-2 France PBT (Article 57 d) 30/06/2008 14/08/2008
Diarsenic pentaoxide 215-116-9 1303-28-2 France Carcinogenic (Article 57a) 30/06/2008 14/08/2008
Diarsenic trioxide 215-481-4 1327-53-3 France Carcinogenic (Article 57a) 30/06/2008 14/08/2008
Dibutyl phthalate 201-557-4 84-74-2 Austria Toxic for reproduction (Article 57 c) 30/06/2008 14/08/2008
Hexabromocyclododecane (HBCDD) 247-148-4 25637-99-4 Sweden PBT (Article 57 d) 30/06/2008 14/08/2008
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
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
Triethyl arsenate 427-700-2 15606-95-8 Norway Carcinogenic (Article 57a) 30/06/2008 14/08/2008
2,4-Dinitrotoluene 204-450-0 121-14-2 Spain Carcinogenic (Article 57a) 31/08/2009 15/10/2009
Acrylamide 201-173-7 79-06-1 Netherlands Carcinogenic (Article 57a); Mutagenic (Article 57b) 31/08/2009 15/10/2009
Aluminosilicate, Refractory Ceramic Fibres - - Germany Carcinogenic (Article 57a) 31/08/2009 15/10/2009
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
Diisobutyl phthalate 201-553-2 84-69-5 Germany Toxic for reproduction (Article 57 c) 31/08/2009 15/10/2009
Lead chromate 231-846-0 7758-97-6 France Carcinogenic (Article 57a); Toxic for reproduction (Article 57 c) 31/08/2009 15/10/2009
Lead chromate molybdate sulphate red (C.I. Pigment Red 104) 235-759-9 12656-85-8 France Carcinogenic (Article 57a); Toxic for reproduction (Article 57 c) 31/08/2009 15/10/2009
Lead sulfochromate yellow (C.I. Pigment Yellow 34) 215-693-7 1344-37-2 France Carcinogenic (Article 57a); Toxic for reproduction (Article 57 c) 31/08/2009 15/10/2009
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
Tris(2-chloroethyl)phosphate 204-118-5 115-96-8 Austria Toxic for reproduction (Article 57 c) 31/08/2009 15/10/2009
Zirconia 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
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
Disodium tetraborate, anhydrous 215-540-4
1303-96-4
1330-43-4
12179-04-3
Denmark 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
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
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
Tetraboron disodium heptaoxide, hydrate 235-541-3 12267-73-1 Denmark Toxic for reproduction (Article 57 c) 08/03/2010 22/04/2010
Trichloroethylene 201-167-4 79-01-6 France Carcinogenic (Article 57a) 08/03/2010 22/04/2010
1,2,3 Trichlorobenzene 201-757-1 87-61-6 Germany PBT like substance (equivalent level of concern) 30/08/2010 14/10/2010
1,2,4 Trichlorobenzene 204-428-0 120-82-1 Germany Equivalent level of concern having probable serious effects to human health and environment (Article 57 f) 30/08/2010 14/10/2010
1,3,5 Trichlorobenzene 203-608-6 108-70-3 Germany PBT like substance (equivalent level of concern) 30/08/2010 14/10/2010
2-Ethoxyethanol 203-804-1 110-80-5 Austria Toxic for reproduction (Article 57 c) 30/08/2010 14/10/2010
2-Methoxyethanol 203-713-7 109-86-4 Austria Toxic for reproduction (Article 57 c) 30/08/2010 14/10/2010
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
Chromium trioxide 215-607-8 1333-82-0 Germany Carcinogenic (Article 57a); Mutagenic (Article 57b) 30/08/2010 14/10/2010
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
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
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



* 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