European Chemicals Agency

Substances of Very High Concern: Annex XV reports to be commented by Interested Parties

In the framework of the authorisation process, Member States Competent Authorities or the European Chemicals Agency (ECHA), on a request by the Commission, may prepare Annex XV dossiers for the identification of substances of very high concern (SVHC).
Substances of very high concern 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,
  • Persistent, Bioaccumulative and Toxic (PBT) or very Persistent and very Bioaccumulative (vPvB) according to the criteria in Annex XIII of the REACH Regulation, and/or
  • 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 report prepared by a Member State or the Agency is available in the table below in order to inform interested parties. The interested parties have 45 days from this publication to give scientific comments on the identification of the substance as SVHC as well as further information related to exposures, alternatives substances and risks and send their comments to the Agency. It would facilitate the evaluation process of comments to receive them in English.

The interested party is requested to provide a non-confidential version of the information which ECHA may make available to the public. There is an opportunity to submit confidential details to support the non-confidential information (see detailed instructions below). A justification must be given by the submitting party to explain why the information is confidential. Such confidential information will only be used by ECHA, including its Committees.

In case you want to submit comments, please use the link to the submission form given in the table before the indicated deadline.
 

Substance identification Authority Reason for proposing Date of publication Deadline for commenting Link to the Annex XV report Link to commenting form
Substance name CAS number EC number
Anthracene120-12-7 204-371-1 Germany PBT 30/06/08 14/08/08 pdf Anthracene
4,4'- Diaminodiphenylmethane101-77-9 202-974-4 Germany CMR 30/06/08 14/08/08 pdf 4,4'- Diaminodiphenylmethane
Dibutyl phthalate 84-74-2 201-557-4 Austria CMR 30/06/08 14/08/08 pdf Dibutyl phthalate
Cyclododecane 294-62-2 206-33-9 France PBT 30/06/08 14/08/08 pdf Cyclododecane
Cobalt dichloride 7646-79-9 231-589-4 France CMR 30/06/08 14/08/08 pdf Cobalt dichloride
Diarsenic pentaoxide 1303-28-2 215-116-9 France CMR 30/06/08 14/08/08 pdf Diarsenic pentaoxide
Diarsenic trioxide 1327-53-3 215-481-4 France CMR 30/06/08 14/08/08 pdf Diarsenic trioxide
Sodium dichromate, dihydrate 7789-12-0   France CMR 30/06/08 14/08/08 pdf Sodium dichromate, dihydrate
5-tert-butyl-2,4,6-trinitro-m-xylene (musk xylene) 81-15-2 201-329-4 Netherlands vPvB 30/06/08 14/08/08 pdf 5-tert-butyl-2,4,6-trinitro-m-xylene (musk xylene)
Bis (2-ethyl(hexyl)phthalate) (DEHP) 117-81-7 204-211-0 Sweden CMR 30/06/08 14/08/08 pdf Bis (2-ethyl(hexyl)phthalate) (DEHP)
Hexabromocyclododecane (HBCDD) 25637-99-4 247-148-4 Sweden PBT 30/06/08 14/08/08 pdf Hexabromocyclododecane (HBCDD)
Alkanes, C10-13, chloro (Short Chain Chlorinated Paraffins) 85535-84-8 287-476-5 United Kingdom PBT 30/06/08 14/08/08 pdf Alkanes, C10-13, chloro (Short Chain Chlorinated Paraffins)
Bis(tributyltin)oxide 56-35-9 200-268-0 Norway PBT 30/06/08 14/08/08 pdf Bis(tributyltin)oxide
Lead hydrogen arsenate 7784-40-9 232-064-2 Norway CMR 30/06/08 14/08/08 pdf Lead hydrogen arsenate
Triethyl arsenate 15606-95-8 427-700-2 Norway CMR 30/06/08 14/08/08 pdf Triethyl arsenate
Benzyl butyl phthalate 85-68-7 201-622-7 Austria CMR 30/06/0814/08/08 pdf Benzyl butyl phthalate

Last update 1/7/2008 15:47 (EET)