Restrictions of substances under REACH may be initiated by Members States, the Commission or ECHA when it is assessed that a substance is not adequately controlled and needs to be addressed on a Union-wide basis. The Commission together with the Member States then decides if the risk is unacceptable.
The process starts when:
- a Member State sends a notification of intention to ECHA to prepare a dossier for a restriction proposal;
- the Commission requests ECHA to prepare a dossier for a restriction proposal;
- ECHA decides to prepare a dossier on its own initiative, for substances listed on Annex XIV where it considers the use in articles not to be adequately controlled; or
- a Member State starts preparing an Annex XV restriction proposal if an urgent action is necessary under REACH (Safeguard clause).
In addition, the Commission can also propose a restriction for substances classified as carcinogenic, germ cell mutagenic and toxic to the reproduction (CMR) categories 1A and 1B without the involvement of ECHA's Committees.
Some of these restrictions are the result of risk management option analyses (RMOAs): please see the Public Activities Coordination Tool (PACT) for further information.
The existing restrictions are listed in Annex XVII to REACH. ECHA has prepared specific webpages ‘Substances restricted under REACH' where these restrictions and related information can be found.
ECHA establishes specific timelines for submitting restriction proposals due to procedure practicalities.
The following dates to submit Annex XV restriction dossiers have been set to establish an effective plan for the work of the Committees:
- 15 July 2016
- 7 October 2016
- 13 January 2017
- 7 April 2017
- 14 July 2017
- 6 October 2017
The intention to prepare a restriction dossier has to be notified to ECHA. ECHA maintains a Registry of Intentions (RoI) which is publicly available on ECHA's website.
The intention to prepare a restriction dossier should to be notified 12 months before the submission date using the specific web form. The ECHA Secretariat may contact the notifier to clarify the substance identity or to clarify the information provided. Confirmed intentions are published in the RoI.
Once a confirmed intention is received, ECHA provides a number of services to potential dossier submitters to help them prepare their dossier. These services include:
- A pre-restriction information meeting (PRIM) to discuss the dossier preparation as a whole and any identified challenges;
- Helping to publicise a call for comments and evidence on behalf of the Member State and
- Providing substance identity advice.
These services and other supporting activities offered by ECHA, are described in the information letter that ECHA sends to the notifier, once the intention is confirmed.
If a restriction dossier does not conform to the requirements given in Annex XV to REACH even after the resubmission of the dossier within 60 days (following the second conformity check made by the Committees), the process is terminated, the relevant RoI entry is removed and placed in the withdrawn RoI, and a new notification of intention will need to be submitted.
The dossier needs to be submitted within 12 months of the notification in the Registry of Intentions. The proposal needs to be prepared according to the requirements given in Annex XV to REACH.
The restriction dossier has to include information on hazards and risks, available information on alternatives (substances and/or processes) and a justification for restrictions at a Union-wide level.
The dossier needs to show 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. ECHA can provide support as mentioned above as well as in the methodological development and use of socio-economic analysis. Other Member States may also provide support during the preparation of the restriction proposal.
Currently, Member States can submit restriction proposals through CIRCA BC and notify ECHA by email that this has been done (Annex XV functional mailbox). Work is under development to allow Member States to submit Annex XV restriction dossiers through REACH-IT.
Member States will receive a communication from ECHA shortly after the start of the public consultation with the relevant links. The public consultation is the only official channel to deliver comments including additional information to be taken into account by the Committees for Risk Assessment (RAC) and Socio-economic Analysis (SEAC) during the opinion-making process. ECHA welcomes any initiative by Members States to promote the public participation in the consultation at a national level, involving stakeholders from industry, local authorities and experts from the academic sector, NGOs and individual citizens.