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. 

 
1,6,7,8,9,14,15,16,17,17,18,18-Dodecachloropentacyclo[12.2.1.16,9.02,13.05,10]octadeca-7,15-diene (“Dechlorane Plus”TM) [covering any of its individual anti- and syn-isomers or any combination thereof] - - United Kingdom vPvB (Article 57e) 05/09/2017 20/10/2017
4-(1,1,3,3-tetramethylbutyl)phenol, ethoxylated [covering well-defined substances and UVCB substances, polymers and homologues] - - Germany Equivalent level of concern having probable serious effects to the environment (Article 57 f) 03/09/2012 18/10/2012
4-Heptylphenol, branched and linear [substances with a linear and/or branched alkyl chain with a carbon number of 7 covalently bound predominantly in position 4 to phenol, covering also UVCB- and well-defined substances which include any of the individual isomers or a combination thereof] - - Austria Equivalent level of concern having probable serious effects to the environment (Article 57 f) 06/09/2016 21/10/2016
4-Nonylphenol, branched and linear [substances with a linear and/or branched alkyl chain with a carbon number of 9 covalently bound in position 4 to phenol, covering also UVCB- and well-defined substances which include any of the individual isomers or a combination thereof] - - Germany Equivalent level of concern having probable serious effects to the environment (Article 57 f) 03/09/2012 18/10/2012
4-Nonylphenol, branched and linear, ethoxylated [substances with a linear and/or branched alkyl chain with a carbon number of 9 covalently bound in position 4 to phenol, ethoxylated covering UVCB- and well-defined substances, polymers and homologues, which include any of the individual isomers and/or combinations thereof] - - Germany Equivalent level of concern having probable serious effects to the environment (Article 57 f) 04/03/2013 18/04/2013
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
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
N-pentyl-isopentylphthalate - 776297-69-9 Germany Toxic for reproduction (Article 57 c) 03/09/2012 18/10/2012
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
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
Zirconia Aluminosilicate Refractory Ceramic Fibres - - Germany Carcinogenic (Article 57a) 31/08/2009 15/10/2009
Zirconia Aluminosilicate Refractory Ceramic Fibres (Zr-RCF) - - Germany Carcinogenic (Article 57a) 29/08/2011 13/10/2011
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
Bis(tributyltin) oxide (TBTO) 200-268-0 56-35-9 Norway PBT (Article 57 d) 30/06/2008 14/08/2008
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
4-Aminoazobenzene 200-453-6 60-09-3 ECHA Carcinogenic (Article 57a) 03/09/2012 18/10/2012
Diethyl sulphate 200-589-6 64-67-5 ECHA Carcinogenic (Article 57a); Mutagenic (Article 57b) 03/09/2012 18/10/2012
N,N-dimethylformamide 200-679-5 68-12-2 Sweden Toxic for reproduction (Article 57 c) 03/09/2012 18/10/2012
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
Formamide 200-842-0 75-12-7 Germany Toxic for reproduction (Article 57 c) 27/02/2012 12/04/2012
Methyloxirane (Propylene oxide) 200-879-2 75-56-9 ECHA Carcinogenic (Article 57a); Mutagenic (Article 57b) 03/09/2012 18/10/2012
Phenolphthalein 201-004-7 77-09-8 ECHA Carcinogenic (Article 57a) 29/08/2011 13/10/2011
Dimethyl sulphate 201-058-1 77-78-1 ECHA Carcinogenic (Article 57a) 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
Trichloroethylene 201-167-4 79-01-6 France Carcinogenic (Article 57a) 08/03/2010 22/04/2010
Acrylamide 201-173-7 79-06-1 Netherlands Carcinogenic (Article 57a); Mutagenic (Article 57b) 31/08/2009 15/10/2009
N-methylacetamide 201-182-6 79-16-3 ECHA Toxic for reproduction (Article 57 c) 03/09/2012 18/10/2012
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
4,4’-isopropylidenediphenol (bisphenol A) 201-245-8 80-05-7 France Toxic for reproduction (Article 57 c) 06/09/2016 21/10/2016
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
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
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
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
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
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
Dihexyl phthalate 201-559-5 84-75-3 Germany Toxic for reproduction (Article 57 c) 02/09/2013 17/10/2013
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
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
1,2,3 Trichlorobenzene 201-757-1 87-61-6 Germany PBT like substance (equivalent level of concern) 30/08/2010 14/10/2010
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
2-Methoxyaniline,o-Anisidine 201-963-1 90-04-0 Germany Carcinogenic (Article 57a) 29/08/2011 13/10/2011
4,4'-bis(dimethylamino)benzophenone (Michler’s ketone) 202-027-5 90-94-8 ECHA Carcinogenic (Article 57a) 27/02/2012 12/04/2012
Biphenyl-4-ylamine 202-177-1 92-67-1 ECHA Carcinogenic (Article 57a) 03/09/2012 18/10/2012
o-Toluidine 202-429-0 95-53-4 ECHA Carcinogenic (Article 57a) 03/09/2012 18/10/2012
4-methyl-m-phenylenediamine (toluene-2,4-diamine) 202-453-1 95-80-7 ECHA Carcinogenic (Article 57a) 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

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