Substances of very high concern identification

Substances that may have serious and often irreversible effects on human health and the environment can be identified as substances of very high concern (SVHCs). If a substance is identified as an SVHC, it will be added to the Candidate List for eventual inclusion in the Authorisation List.

 

Participate in the public consultation

Member States or the European Chemicals Agency (ECHA), on request of the European Commission, may propose a substance to be identified as an SVHC by preparing a dossier in accordance with the requirements set out in Annex XV to REACH. The Annex XV reports can be found by selecting the "Details" button in the table listing the substances that are proposed. All interested parties are invited to submit comments on such reports during the public consultation.

 

Making comments

The SVHC identification is based on the hazard properties of a substance. Comments are particularly welcome on:

  • the identity of the substance (i.e. on the substance name/EC number/CAS number/molecular structure etc.)
  • PBT or vPvB properties and on properties giving rise to an equivalent level of concern.

SVHC proposals based on harmonised classifications and labelling (CLH) included in the CLP Regulation cannot be challenged in the SVHC identification process. Therefore, comments questioning CLH will not be considered in this context.

Comments and further information related to uses, volumes per use, exposure, alternatives and risks of the substance are also welcome from all interested parties. This further information will not be used to confirm the SVHC identification but during the next step in the authorisation process, to help ECHA decide if the substance should be recommended for inclusion in the Authorisation List. Registration dossiers are however the main source of information for the recommendation of substances from the Candidate List to the Authorisation List.

The Member State who submitted the SVHC proposal or ECHA will respond to any comments received. Comments relevant for the identification of the substance as an SVHC will be forwarded to the Member State Committee (MSC) which will assess whether the substance should be identified as an SVHC.

 

Confidentiality

Comments provided are normally considered non-confidential and will be made available to the public on the ECHA website. There is, however, an opportunity to attach confidential details. In this case, justification must be provided by the submitting person/party explaining why the information is considered confidential. Such confidential information will only be used by ECHA, including its Committees, the proposing Member State competent authorities and the European Commission.

ECHA would be grateful if, where possible, interested parties could submit their comments in English. Please note that it is your responsibility to ensure that no confidential information is included in the public version of the comments (including the name of your organisation/attachment file names etc.). Please also refer to the page number in the Annex XV report in your comment (e.g. p.12 the conclusion on…). Comments received after the relevant deadline will not be taken into account.

Substance Name EC Number CAS Number Proposing authority Reason for proposing Date of publication Deadline for commenting  
2-(2H-benzotriazol-2-yl)-4,6-ditertpentylphenol (UV-328) 247-384-8 25973-55-1 Germany PBT (Article 57 d);
vPvB (Article 57 e)
01/09/2014 16/10/2014
2-benzotriazol-2-yl-4,6-di-tert-butylphenol (UV-320) 223-346-6 3846-71-7 Germany PBT (Article 57 d);
vPvB (Article 57 e)
01/09/2014 16/10/2014
2-ethylhexyl 10-ethyl-4,4-dioctyl-7-oxo-8-oxa-3,5-dithia-4-stannatetradecanoate (DOTE) 239-622-4 15571-58-1 Austria Toxic for Reproduction (Article 57 c) 01/09/2014 16/10/2014
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
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
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 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
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
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
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
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