A Member State, or ECHA on request of the European Commission, can start the restriction procedure when they have a concern that a certain substance poses an unacceptable risk to human health or the environment. ECHA can also propose a restriction on articles containing substances that in the Authorisation list (Annex XIV).
The intention to prepare a restriction proposal is made public in the registry of intentions before the proposal file itself is prepared so as to give advance warning.
The dossier proposing the restriction contains background information such as the identity of the substance and justifications for the proposed restrictions. It includes the identified risks, any information on alternatives to the substance and the costs, as well as the environmental and human health benefits, resulting from the restriction.
The dossier needs to be prepared according to the REACH Regulation (Annex XV) and it has to be submitted to ECHA within twelve months after the intention to prepare the proposal was notified.
Upon receiving the dossier the ECHA Committees check whether the proposal conforms to the requirements of Annex XV. If it does, the dossier will be made publicly available for consultation (excluding any commercially confidential information). Interested parties can then comment on the restriction within six months of its publication on the ECHA website.
Within nine months of that same publication date, ECHA's Risk Assessment Committee (RAC) will give its opinion as to whether the suggested restriction is appropriate in reducing the risk to human health or the environment based on the dossier and the comments received during the public consultation.
At the same time, the Committee for Socio-economic Analysis (SEAC) prepares an opinion about the socio-economic impacts of the suggested restrictions, taking into account the comments and socio-economic analyses submitted by interested parties. All comments on the SEAC draft opinion should be submitted within 60 days of its publication. SEAC will then adopt its final opinion, taking the comments into account, within 12 months of the start of the first public consultation on the restriction proposal.
Besides the two groups above the Forum of enforcement authorities from the Member States may provide advice to the Committees on the enforceability of the proposed restriction.
The two opinions of the ECHA Committees contribute to the decision of the European Commission, who will then take a balanced view of the identified risks and of the benefits and costs of the proposed restriction.
Within three months of receipt of the two Committees' opinions, the Commission will provide a draft amendment of the list of restrictions in Annex XVII of REACH. The final decision is taken in a comitology procedure with scrutiny involving the Member States and the European Parliament.
Once the substance restriction has been adopted, industry must comply. That means all including manufacturers, importers, distributors, downstream users and retailers.
The Competent Authorities in the Member States are responsible for enforcing the restriction.
Restriction procedure steps
- Notification of intention to submit a proposal to restrict a chemical
- Submission of the proposal
- Checking of its conformity
- Public consultation (6 months)
- Advice on enforceability by Forum
- Opinion by RAC and draft opinion by SEAC
- Public consultation on the SEAC draft opinion (2 months)
- Opinion by SEAC
- Draft amendment of Annex XVII by the Commission
- EU Decision