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. 

There are currently no ongoing consultations.
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Showing 1 - 50 of 263 results.
Name
EC Number
CAS Number
Proposing authority
Reason for proposing
Date of publication
Deadline for commenting
 
Bis(α,α-dimethylbenzyl) peroxide 201-279-3 80-43-3 Norway Toxic for reproduction (Article 57c) 01/03/2024 15/04/2024 Details
Triphenyl phosphate 204-112-2 115-86-6 France Endocrine disrupting properties (Article 57(f) – environment) 01/03/2024 15/04/2024 Details
2,4,6-tri-tert-butylphenol 211-989-5 732-26-3 Belgium Toxic for reproduction (Article 57c);
PBT (Article 57d);
vPvB (Article 57e) 		01/09/2023 16/10/2023 Details
2-(2H-benzotriazol-2-yl)-4-(1,1,3,3-tetramethylbutyl)phenol 221-573-5 3147-75-9 Germany vPvB (Article 57e) 01/09/2023 16/10/2023 Details
2-(dimethylamino)-2-[(4-methylphenyl)methyl]-1-[4-(morpholin-4-yl)phenyl]butan-1-one 438-340-0 119344-86-4 Austria Toxic for reproduction (Article 57c) 01/09/2023 16/10/2023 Details
Bumetrizole 223-445-4 3896-11-5 Germany vPvB (Article 57e) 01/09/2023 16/10/2023 Details
Dibutyl phthalate 201-557-4 84-74-2 Netherlands Endocrine disrupting properties (Article 57(f) – environment) 01/09/2023 16/10/2023 Details
Oligomerisation and alkylation reaction products of 2-phenylpropene and phenol 700-960-7 - Denmark vPvB (Article 57e) 01/09/2023 16/10/2023 Details
bis(4-chlorophenyl) sulphone 201-247-9 80-07-9 Austria vPvB (Article 57e) 17/02/2023 03/04/2023 Details
Diphenyl(2,4,6-trimethylbenzoyl)phosphine oxide 278-355-8 75980-60-8 Sweden Toxic for reproduction (Article 57c) 17/02/2023 03/04/2023 Details
1,1'-[ethane-1,2-diylbisoxy]bis[2,4,6-tribromobenzene] 253-692-3 37853-59-1 Spain vPvB (Article 57e) 02/09/2022 17/10/2022 Details
2,2',6,6'-tetrabromo-4,4'-isopropylidenediphenol 201-236-9 79-94-7 Norway Carcinogenic (Article 57a) 02/09/2022 17/10/2022 Details
4,4'-sulphonyldiphenol 201-250-5 80-09-1 Belgium Toxic for reproduction (Article 57c); Endocrine disrupting properties (Article 57(f) – environment); Endocrine disrupting properties (Article 57(f) – human health) 02/09/2022 17/10/2022 Details
Barium diboron tetraoxide 237-222-4 13701-59-2 Sweden Toxic for reproduction (Article 57c) 02/09/2022 17/10/2022 Details
Bis(2-ethylhexyl) tetrabromophthalate covering any of the individual isomers and/or combinations thereof - - Sweden vPvB (Article 57e) 02/09/2022 17/10/2022 Details
Isobutyl 4-hydroxybenzoate 224-208-8 4247-02-3 Denmark Endocrine disrupting properties (Article 57(f) – human health) 02/09/2022 17/10/2022 Details
Melamine 203-615-4 108-78-1 Germany Equivalent level of concern having probable serious effects to human health (Article 57(f) - human health); Equivalent level of concern having probable serious effects to the environment (Article 57(f) - environment) 02/09/2022 17/10/2022 Details
Perfluoroheptanoic acid and its salts - - Netherlands Toxic for reproduction (Article 57c); PBT (Article 57d); vPvB (Article 57e); Equivalent level of concern having probable serious effects to human health (Article 57(f) - human health); Equivalent level of concern having probable serious effects to the environment (Article 57(f) - environment) 02/09/2022 17/10/2022 Details
reaction mass of 2,2,3,3,5,5,6,6-octafluoro-4-(1,1,1,2,3,3,3-heptafluoropropan-2-yl)morpholine and 2,2,3,3,5,5,6,6-octafluoro-4-(heptafluoropropyl)morpholine 473-390-7 - Belgium vPvB (Article 57e) 02/09/2022 17/10/2022 Details
N-(hydroxymethyl)acrylamide 213-103-2 924-42-5 Sweden Carcinogenic (Article 57a); Mutagenic (Article 57b) 04/03/2022 19/04/2022 Details
(±)-1,7,7-trimethyl-3-[(4-methylphenyl)methylene]bicyclo[2.2.1]heptan-2-one covering any of the individual isomers and/or combinations thereof (4-MBC) - - Denmark Endocrine disrupting properties (Article 57(f) - human health) 03/09/2021 18/10/2021 Details
6,6'-di-tert-butyl-2,2'-methylenedi-p-cresol (DBMC) 204-327-1 119-47-1 Denmark Toxic for reproduction
(Article 57 c) 		03/09/2021 18/10/2021 Details
S-(tricyclo[5.2.1.0'2,6]deca-3-en-8(or 9)-yl) O-(isopropyl or isobutyl or 2-ethylhexyl) O-(isopropyl or isobutyl or 2-ethylhexyl) phosphorodithioate 401-850-9 255881-94-8 Belgium PBT (Article 57 d) 03/09/2021 18/10/2021 Details
tris(2-methoxyethoxy)vinylsilane 213-934-0 1067-53-4 Austria Toxic for reproduction
(Article 57 c) 		03/09/2021 18/10/2021 Details
1,4-dioxane 204-661-8 123-91-1 Germany Equivalent level of concern having probable serious effects on the environment (Article 57f)
Equivalent level of concern having probable serious effects on human health (Article 57f) 		09/03/2021 23/04/2021 Details
2,2-bis(bromomethyl)propane1,3-diol (BMP)
2,2-dimethylpropan-1-ol, tribromo derivative/3-bromo-2,2-bis(bromomethyl)-1-propanol (TBNPA)
2,3-dibromo-1-propanol (2,3-DBPA) 		221-967-7 253-057-0 202-480-9 3296-90-0 36483-57-5 1522-92-5 96-13-9 Norway Carcinogenic (Article 57a) 09/03/2021 23/04/2021 Details
2-(4-tert-butylbenzyl)propionaldehyde and its individual stereoisomers - - Sweden Toxic for reproduction (Article 57c) 09/03/2021 23/04/2021 Details
4,4'-(1-methylpropylidene)bisphenol; (bisphenol B) 201-025-1 77-40-7 France Endocrine disrupting properties (Article 57(f) - environment AND human health 09/03/2021 23/04/2021 Details
Glutaral 203-856-5 111-30-8 Sweden Respiratory sensitising properties (Article 57(f) - human health) 09/03/2021 23/04/2021 Details
Medium-chain chlorinated paraffins (MCCP) [UVCB substances consisting of more than or equal to 80% linear chloroalkanes with carbon chain lengths within the range from C14 to C17] - - ECHA PBT (Article 57d)
vPvB (Article 57e 		09/03/2021 23/04/2021 Details
Orthoboric acid, sodium salt 237-560-2 13840-56-7 Sweden Toxic for reproduction (Article 57c) 09/03/2021 23/04/2021 Details
Phenol, alkylation products (mainly in para position) with C12-rich branched or linear alkyl chains from oligomerisation, covering any individual isomers and/ or combinations thereof (PDDP) - - Germany Toxic for reproduction (Article 57c)
Endocrine disrupting properties (Article 57(f) – human health)
Endocrine disrupting properties (Article 57(f) – environment) 		09/03/2021 23/04/2021 Details
bis(2-(2-methoxyethoxy)ethyl) ether 205-594-7 143-24-8 Austria Toxic for reproduction (Article 57c) 01/09/2020 16/10/2020 Details
Dioctyltin dilaurate, stannane, dioctyl-, bis(coco acyloxy) derivs., and any other stannane, dioctyl-, bis(fatty acyloxy) derivs. wherein C12 is the predominant carbon number of the fatty acyloxy moiety - - Sweden Toxic for reproduction (Article 57c) 01/09/2020 16/10/2020 Details
1-vinylimidazole 214-012-0 1072-63-5 Sweden Toxic for reproduction (Article 57c) 03/03/2020 17/04/2020 Details
2-methylimidazole 211-765-7 693-98-1 Sweden Toxic for reproduction (Article 57c) 03/03/2020 17/04/2020 Details
Butyl 4-hydroxybenzoate 202-318-7 94-26-8 Denmark Endocrine disrupting properties (Article 57(f) – human health) 03/03/2020 17/04/2020 Details
Dibutylbis(pentane-2,4-dionato-O,O')tin 245-152-0 22673-19-4 Sweden Toxic for reproduction (Article 57c) 03/03/2020 17/04/2020 Details
Resorcinol 203-585-2 108-46-3 France Endocrine disrupting properties (Article 57(f) – human health) 03/03/2020 17/04/2020 Details
2-benzyl-2-dimethylamino-4'-morpholinobutyrophenone 404-360-3 119313-12-1 Austria in cooperation with Slovakia Toxic for reproduction (Article 57c) 03/09/2019 18/10/2019 Details
2-methyl-1-(4-methylthiophenyl)-2-morpholinopropan-1-one 400-600-6 71868-10-5 Austria in cooperation with Slovakia Toxic for reproduction (Article 57c) 03/09/2019 18/10/2019 Details
Diisohexyl phthalate 276-090-2 71850-09-4 Sweden Toxic for reproduction (Article 57c) 03/09/2019 18/10/2019 Details
Perfluorobutane sulfonic acid (PFBS) and its salts - - Norway Equivalent level of concern having probable serious effects on the environment (Article 57f)
Equivalent level of concern having probable serious effects on human health (Article 57f) 		03/09/2019 18/10/2019 Details
2,3,3,3-tetrafluoro-2-(heptafluoropropoxy)propionic acid, its salts and its acyl halides (covering any of their individual isomers and combinations thereof) - - Netherlands Equivalent level of concern having probable serious effects on the environment (Article 57f)
Equivalent level of concern having probable serious effects on human health (Article 57f) 		13/03/2019 29/04/2019 Details
2-methoxyethyl acetate 203-772-9 110-49-6 Sweden Toxic for reproduction (Article 57c) 13/03/2019 29/04/2019 Details
Tris(4-nonylphenyl, branched and linear) phosphite (TNPP) with ≥ 0.1% w/w of 4-nonylphenol, branched and linear (4-NP) - - France Endocrine disrupting properties (Article 57(f) – environment) 13/03/2019 29/04/2019 Details
2,2-bis(4'-hydroxyphenyl)-4-methylpentane 401-720-1 6807-17-6 Sweden Toxic for reproduction (Article 57c) 04/09/2018 19/10/2018 Details
Benzo[k]fluoranthene 205-916-6 207-08-9 Belgium Carcinogenic (Article 57a)
PBT (Article 57d)
vPvB (Article 57e) 		04/09/2018 19/10/2018 Details
Fluoranthene 205-912-4 206-44-0 Belgium PBT (Article 57d)
vPvB (Article 57e) 		04/09/2018 19/10/2018 Details
Phenanthrene 201-581-5 85-01-8 France vPvB (Article 57e) 04/09/2018 19/10/2018 Details
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* 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