Identifikation af stoffer, som vækker meget store betænkeligheder
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. More details of the SVHC identification process can be found under the Regulations tab.
Preparing and submitting an SVHC dossier
The SVHC dossier must be prepared in an IUCLID file that contains an annexed report in accordance with the requirements given in Annex XV to REACH. Member States can submit SVHC proposals via CIRCABC. There are two submission windows per year for the submission of Annex XV SVHC dossiers. The following dates by which to submit Annex XV SVHC dossiers in 2016 have been established:
- 07 February 2018
- 06 August 2018
An annotated Annex XV report template has been developed to assist Member States in preparing Annex XV reports.
Further guidance and support is provided at the links below including ECHA guidance documents and practical guides. Links to ECHA's general approach papers which aim to present the latest understanding of the subject in question are also provided.
All current ECHA guidance documents are available on ECHA's website. The following documents are particularly relevant to those preparing a proposal to identify a substance as an SVHC:
- Guidance for the preparation of an Annex XV dossier on the identification of substances of very high concern [PDF] [EN]
- Guidance for identification and naming of substances under REACH and CLP [PDF] [EN]
- Guidance on information requirements and chemical safety assessment Chapter R.11: PBT and vPvB Assessment [PDF] [EN] 1
General approach papers
Addressing Chemicals of Concern