A Member State or the European Commission may have a concern that a certain substance poses a risk to human health or the environment. If so, it would undertake preparatory work to investigate the problem further.
Notifying the intention to prepare a restriction dossier
If the Member State or the Commission concludes that a restriction appears to be the best way forward, it has to notify its intention to prepare a restriction dossier. ECHA maintains a Registry of Intentions (RoI) which is publicly available on ECHA's website. It enables the stakeholders to prepare their contributions to the process.
Preparing a restriction dossier
The restriction dossier shall include information on hazards and risks, available information on alternatives and a justification for restrictions at EU-wide level. The dossier needs to demonstrate that the restriction is the most appropriate risk management instrument to address the identified risk or risks. The restriction dossier may also include an analysis of the socio-economic impacts. The proposal needs to be prepared according to the requirements given in Annex XV of REACH. The dossier needs to be submitted within 12 months of the notification in the Registry of Intentions.
Furthermore, ECHA provides support in the methodological development and use of socio-economic analysis.
Carrying out a substance identification check
ECHA provides a service to Member States to carry out the check of the substance identification during the preparation of restriction dossiers. Thus, any issues relating to substance identification can be cleared before the submission of the dossier. If you wish to use this service please contact the Risk Management Implementation Unit of ECHA.
Submitting the restriction dossier
Currently Member States can submit restriction proposals by e-mail or via CIRCA. Submission of Annex XV restriction dossiers through REACH-IT is under development.
The following dates to submit Annex XV restriction dossiers have been established:
- 18 January 2013
- 19 April 2013
- 2 August 2013
- 18 October 2013
- 17 January 2014
- 22 April 2014
- 1 August 2014
- 17 October 2014