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. 

 
Dibutyl phthalate 201-557-4 84-74-2 Austria Toxic for reproduction (Article 57 c) 30/06/2008 14/08/2008
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
Dibutyltin dichloride (DBTC) 211-670-0 683-18-1 Sweden Toxic for reproduction (Article 57 c) 03/09/2012 18/10/2012
Dichromium tris(chromate) 246-356-2 24613-89-6 France Carcinogenic (Article 57a) 29/08/2011 13/10/2011
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
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
Diethyl sulphate 200-589-6 64-67-5 ECHA Carcinogenic (Article 57a); Mutagenic (Article 57b) 03/09/2012 18/10/2012
Dihexyl phthalate 201-559-5 84-75-3 Germany Toxic for reproduction (Article 57 c) 02/09/2013 17/10/2013
Diisobutyl phthalate 201-553-2 84-69-5 Germany Toxic for reproduction (Article 57 c) 31/08/2009 15/10/2009
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
Diisopentylphthalate 210-088-4 605-50-5 Austria Toxic for reproduction (Article 57 c) 03/09/2012 18/10/2012
Dimethyl sulphate 201-058-1 77-78-1 ECHA Carcinogenic (Article 57a) 03/09/2012 18/10/2012
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
Dioctyltin bis(2-ethylhexyl mercaptoacetate), 2-Ethylhexyl 10-ethyl-4,4- dioctyl-7-oxo-8-oxa-3,5-dithia- 4-stannatetradecanoate 239-622-4 15571-58-1 Austria Toxic for Reproduction (Article 57 c) 01/09/2014 16/10/2014
Dioxobis(stearato)trilead 235-702-8 12578-12-0 ECHA Toxic for reproduction (Article 57 c) 03/09/2012 18/10/2012
Dipentyl phthalate (DPP) 205-017-9 131-18-0 Poland Toxic for reproduction (Article 57 c) 04/03/2013 18/04/2013
Disodium 3,3'-[[1,1'-biphenyl]-4,4'-diylbis(azo)]bis(4-aminonaphthalene-1-sulphonate) (C.I. Direct Red 28) 209-358-4 573-58-0 Netherlands Carcinogenic (Article 57a) 02/09/2013 17/10/2013
Disodium 4-amino-3-[[4'-[(2,4-diaminophenyl)azo][1,1'-biphenyl]-4-yl]azo] -5-hydroxy-6-(phenylazo)naphthalene-2,7-disulphonate (C.I. Direct Black 38) 217-710-3 1937-37-7 Netherlands Carcinogenic (Article 57a) 02/09/2013 17/10/2013
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
Fatty acids, C16-18, lead salts 292-966-7 91031-62-8 ECHA Toxic for reproduction (Article 57 c) 03/09/2012 18/10/2012
Formaldehyde, oligomeric reaction products with aniline (technical MDA) 500-036-1 25214-70-4 Germany Carcinogenic (Article 57a) 29/08/2011 13/10/2011
Formamide 200-842-0 75-12-7 Germany Toxic for reproduction (Article 57 c) 27/02/2012 12/04/2012
Furan 203-727-3 110-00-9 ECHA Carcinogenic (Article 57a) 03/09/2012 18/10/2012
Henicosafluoroundecanoic acid 218-165-4 2058-94-8 Germany vPvB (Article 57 e) 03/09/2012 18/10/2012
Heptacosafluorotetradecanoic acid 206-803-4 376-06-7 Germany vPvB (Article 57 e) 03/09/2012 18/10/2012
Hexabromocyclododecane (HBCDD) 247-148-4 25637-99-4 Sweden PBT (Article 57 d) 30/06/2008 14/08/2008
Hexahydromethylphthalic anhydride [1], Hexahydro-4-methylphthalic anhydride [2], Hexahydro-1-methylphthalic anhydride [3], Hexahydro-3-methylphthalic anhydride [4] [The individual isomers [2], [3] and [4] (including their cis- and trans- stereo isomeric forms) and all possible combinations of the isomers [1] are covered by this entry]
247-094-1
243-072-0
256-356-4
260-566-1
25550-51-0
19438-60-9
48122-14-1
57110-29-9
Netherlands Equivalent level of concern having probable serious effects to human health (Article 57 f) 03/09/2012 18/10/2012
hexamethylene diacrylate (hexane-1,6-diol diacrylate) 235-921-9 13048-33-4 Sweden Equivalent level of concern having probable serious effects to human health (Article 57 f) 31/08/2015 15/10/2015
Hydrazine 206-114-9
302-01-2
7803-57-8
ECHA Carcinogenic (Article 57a) 21/02/2011 07/04/2011
Imidazolidine-2-thione (2-imidazoline-2-thiol) 202-506-9 96-45-7 Sweden Toxic for reproduction (Article 57 c) 02/09/2013 17/10/2013
Lead bis(tetrafluoroborate) 237-486-0 13814-96-5 ECHA Toxic for reproduction (Article 57 c) 03/09/2012 18/10/2012
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 cyanamidate 244-073-9 20837-86-9 ECHA Toxic for reproduction (Article 57 c) 03/09/2012 18/10/2012
Lead di(acetate) 206-104-4 301-04-2 Netherlands Toxic for reproduction (Article 57 c) 02/09/2013 17/10/2013
Lead diazide, Lead azide 236-542-1 13424-46-9 ECHA Toxic for reproduction (Article 57 c) 29/08/2011 13/10/2011
Lead dinitrate 233-245-9 10099-74-8 ECHA Toxic for reproduction (Article 57 c) 03/09/2012 18/10/2012
Lead dipicrate 229-335-2 6477-64-1 ECHA Toxic for reproduction (Article 57 c) 29/08/2011 13/10/2011
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
Lead monoxide (lead oxide) 215-267-0 1317-36-8 ECHA Toxic for reproduction (Article 57 c) 03/09/2012 18/10/2012
Lead oxide sulfate 234-853-7 12036-76-9 ECHA Toxic for reproduction (Article 57 c) 03/09/2012 18/10/2012
Lead styphnate 239-290-0 15245-44-0 ECHA Toxic for reproduction (Article 57 c) 29/08/2011 13/10/2011
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
Lead titanium trioxide 235-038-9 12060-00-3 ECHA Toxic for reproduction (Article 57 c) 03/09/2012 18/10/2012
Lead titanium zirconium oxide 235-727-4 12626-81-2 ECHA Toxic for reproduction (Article 57 c) 03/09/2012 18/10/2012
Lead(II) bis(methanesulfonate) 401-750-5 17570-76-2 Netherlands Toxic for reproduction (Article 57 c) 27/02/2012 12/04/2012
Methoxyacetic acid 210-894-6 625-45-6 Sweden Toxic for reproduction (Article 57 c); equivalent level of concern having probable serious effects to human health and environment (Article 57 f) 03/09/2012 18/10/2012
Methyloxirane (Propylene oxide) 200-879-2 75-56-9 ECHA Carcinogenic (Article 57a); Mutagenic (Article 57b) 03/09/2012 18/10/2012
N,N,N',N'-tetramethyl-4,4'-methylenedianiline (Michler’s base) 202-959-2 101-61-1 ECHA Carcinogenic (Article 57a) 27/02/2012 12/04/2012
N,N-Dimethylacetamide (DMAC) 204-826-4 127-19-5 ECHA Toxic for reproduction (Article 57 c) 29/08/2011 13/10/2011



* 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