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 ‘List of restrictions' 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:
- 2 October 2015
- 8 January 2016
- 1 April 2016
- 15 July 2016
- 7 October 2016
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.
ECHA and its Committees have prepared a series of documents that clarify the restrictions process. The documents will help Member States to better understand how their proposals will be treated and evaluated during ECHA's opinion-making process.
|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 and SEAC|
|Framework for RAC and SEAC in checking conformity and developing opinions on restriction proposals||Describes the principles of how the Committees handle the restriction dossiers. Implements the recommendations made by the restriction efficiency task force.||Framework for conformity check and opinion development|
|Conformity check template and template for recommendations||Conformity check template describes the content of the conformity check conducted by RAC and SEAC. The template for recommendations regarding the Annex XV dossier is used to give information that is relevant for the opinion development to the dossier submitter.|| Conformity check template |
Template for recommendations
|Opinion template||Opinion template describes the structure and the content of the opinion and justification provided by RAC and SEAC on restriction proposals.||Opinion template|
|How to evaluate PBT and vPvB substances in SEAC?||Describes a consistent approach for evaluating restriction reports and applications for authorisation for PBT and vPvB substances in SEAC.||SEAC|
|Recommendations by the Restriction Efficiency Task Force||Describes the recommendations to the dossier submitter, ECHA, RAC and SEAC and the Commission on how to improve the preparation of the restriction dossier and how to make the procedure of handling the dossier more efficient.||RETF Recommendations|
- 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
- Practical guides
- Information requirements and chemical safety assessment
- Member State competent authorities
- ECHA's Risk Management Implementation Unit
- Questions and answers on restrictions
- COM DG GROWTH
- COM DG ENVIRONMENT
- Restriction process
- Substance identity
- Committee for Risk Assessment
- Committee for Socio-economic Analysis
- Enforcement Forum
- Public Activities Coordination Tool (PACT)