Restriction process
Restriction process
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I PHASE: PREPARATION AND SUBMISSION OF A RESTRICTION PROPOSAL
STARTING THE RESTRICTION PROCESS
The restriction process can be initiated in one of five ways:
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A Member State starts to prepare a restriction dossier.
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The European Commission asks ECHA to prepare a restriction dossier.
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ECHA prepares a restriction dossier on its own initiative, for a substance in the Authorisation List which it sees as not being adequately controlled when used in articles. Learn more
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If urgent action is needed under REACH, there is a safeguard clause that allows Member States to take provisional measures to protect human health and the environment. The Member State prepares a restriction dossier if the Commission authorises these measures.Learn more
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The European Commission proposes a restriction for a carcinogenic, mutagenic or reprotoxic (CMR) substance, on its own, in mixtures or in articles, without involving ECHA.Learn more
NOTIFICATION OF INTENTION TO SUBMIT A RESTRICTION PROPOSAL
A Member State, the Commission or ECHA may have a concern that a substance poses a risk to human health or the environment. If so, preparatory work is undertaken to investigate the problem.
If a Member State, the Commission or ECHA concludes that a restriction is the best way forward, it has to notify its intention to prepare a restriction dossier 12 months before the dossier is submitted.
If the safeguard clause is used, Member States must submit the restriction dossier within three months from the Commission's decision.
ECHA sets a specific timeline for submitting restriction proposals to establish an effective plan for the work of its Committees. ECHA contacts the notifier with information on the support that can be provided.
REGISTRY OF INTENTIONS
ECHA maintains a public Registry of Intentions (RoI), which indicates when a new restriction dossier is being planned to be submitted to ECHA for a particular substance. Learn more
It enables interested parties – citizens, organisations, companies and authorities – to plan for and contribute to the consultations in the restriction process.
The public activities coordination tool (PACT) provides an overview of the substance-specific activities by authorities under REACH and CLP
PREPARATION OF THE RESTRICTION DOSSIER
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.
It has to show that a restriction is the most appropriate risk management measure to address the identified risks. It may also include an analysis of the socio-economic impacts.
ECHA and other Member States may provide support to the Member State being a dossier submitter while the restriction dossier is being prepared. ECHA may also launch a call for comments and evidence, or publicise one on behalf of the Member State.
Submission and Conformity Check
Member States and ECHA can submit their restriction dossiers through the same web form used to notify the intention. The non-confidential restriction report is published as soon as ECHA receives it so that interested parties have more time to prepare for consultation.
Within 30 days of the submission, ECHA’s Committee for Risk Assessment (RAC) and Committee for Socio-economic Analysis (SEAC) check whether the submitted restriction dossier conforms with REACH requirements. If it does, a consultation is launched on the restriction report.
ECHA provides the Committees with scientific, technical and regulatory support throughout the process.