The restrictions of substances under REACH may be initiated by Members States or ECHA (following a request from the Commission).
When a substance poses an unacceptable risk to human health or the environment a Member State, or following a request from the European Commission, ECHA may consider submitting a restriction proposal on the manufacturing, placing on the market or the use of that substance, after investigating the EU-wide basis.
A Member State or ECHA (on behalf of the Commission) could conclude that restriction is the best risk management option during the authorisation process in cases where restriction of a substance of very high concern (SVHC) at the EU level would be more appropriate than its inclusion on the authorisation list (Annex XIV of REACH). Furthermore, a follow-up to substance evaluation may also trigger a restriction process carried out by a Member State.
After the sunset date for a substance listed in Annex XIV, ECHA will consider whether the use of that substance in articles poses an inadequately controlled risk to human health or the environment and subsequently prepare an Annex XV dossier for a restriction proposal.
In addition, the Commission can also propose a restriction for CMR category 1 and 2 substances without the involvement of ECHA's Committees.
The restriction proposal may end up as a new entry or as an amendment of the current entry in Annex XVII of REACH containing the list of restrictions of certain dangerous substances, mixtures and articles for their marketing and use on the European market.
ECHA establishes specific timelines for submitting restriction proposals due to procedure practicalities.
The following dates to submit Annex XV restriction dossiers have been set in order to establish a better plan for the work of the Committees:
- 17 April 2015
- 17 July 2015
- 02 October 2015
- 08 January 2016
- 08 April 2016
- 15 July 2016
- 07 October 2016
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.
Notify your intention to prepare a restriction dossier 12 months before the submission date using the web form. You might be contacted by the ECHA secretariat in order to clarify the substance identity or to clarify the information you have provided together with the notification.
Confirmed intentions are published in the RoI. If a restriction dossier does not conform to the requirements even after the resubmission of the dossier after the 60 days, the process is terminated and a new notification of intention needs to be submitted if you wish to submit a new revised proposal.
The restriction dossier must include information as indicated in Annex XV of REACH.
The restriction dossier has to include information on hazards and risks, available information on alternatives and a justification for restrictions at an EU-wide level. The dossier needs to demonstrate that restriction is the most appropriate risk management instrument for addressing the identified 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.
ECHA provides a service for Member States to carry out the assessment of 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.
Furthermore, ECHA provides support in the methodological development and use of socio-economic analysis. Other Member States may also provide you support during the preparation of the restriction proposal.
Currently, Member States can submit restriction proposals by email or through CIRCA BC. Submission of Annex XV restriction dossiers through REACH-IT is under development.
ECHA and its Committees have prepared a series of documents for clarifying the process. The documents will help Member States to better understand how their proposals will be treated and evaluated during the opinion making process of ECHA.
|Working procedure for RAC and SEAC on conformity check||Describes the main roles and tasks of the (co-)rapporteurs, the members of RAC and SEAC, and the ECHA secretariat as well as the timelines related to the conformity check of the restriction dossiers||RAC and SEAC|
|Working procedure for Forum||Describes the main roles, tasks and timelines of Forum, also covering the restriction dossiers||Forum|
|Working procedures for RAC and SEAC for developing opinions||Describes the main roles and tasks of the (co-)rapporteurs, the members of RAC and SEAC, and the ECHA secretariat as well as the timelines related to the opinion-making process|| RAC |
|How to evaluate PBT and vPvB substances in SEAC?||Describes a consistent approach for evaluation of restriction reports and applications for authorisation for PBT and vPvB substances in SEAC.||SEAC|
- Guidance for the preparation of an Annex XV dossier for restrictions [PDF][EN]
- Guidance for Socio-economic analysis – Restrictions [PDF][EN]
- Addendum: Calculation of compliance costs [PDF][EN]
- Substances identification and naming [PDF][EN]
- Format of Annex XV Restriction report [DOC]
- Practical guides
- Information requirements and chemical safety assessment