Steps

The adoption of a new restriction on the manufacturing, placing on the market or use of substances involves the following main steps:

1. Preparatory work

A Member State, the European Commission or ECHA may have a concern that a certain substance poses a risk to human health or the environment. If so, it would undertake preparatory work to investigate the problem further.

2. Notify the intention to prepare a restriction dossier

If the Member State, the Commission or ECHA 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 interested parties to prepare their contributions to the process.

3. Prepare the restriction dossier

The restriction dossier will include information on hazards and risks, available information on alternatives and a justification for restrictions at EU-wide level. The dossier needs to show that a restriction is the most appropriate risk management instrument to address 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 to REACH. The dossier needs to be submitted within 12 months of the notification in the Registry of Intentions.

4. Submit the restriction dossier

Currently Member States can submit restriction proposals by e-mail or through CIRCA BC.

5. Check conformity

The Committees check whether the submitted restriction dossier conforms with the requirements of Annex XV to REACH.

6. Public consultation on the restriction report

Conforming restriction reports will be published on ECHA's website, excluding any confidential information. Interested parties may submit comments on the restriction report and supporting documents within six months of the date of their publication.

7. Advice from the Forum

The Forum may provide advice to RAC and SEAC on the enforceability of the proposed restriction.

8. Prepare and adopt the opinion of RAC

Within nine months of the date of the publication of the restriction report, RAC prepares and adopts an opinion based on the restriction dossier and comments received during the public consultation.

9. Prepare and agree on the draft opinion of SEAC

Within nine months of the date of the publication of the restriction report, SEAC prepares and agrees on a draft opinion based on the restriction dossier, the socio-economic impacts, and the comments and socio-economic information received during the public consultation

10. Public consultation on SEAC draft opinion

The draft opinion of SEAC and the final opinion of RAC will be placed on ECHA's website. Interested parties may submit comments on the SEAC draft opinion within 60 days from publication.

11. Prepare and adopt the opinion of SEAC

SEAC prepares and adopts the final opinion taking into account the comments on its draft opinion.

12. Send the opinions to the Commission

ECHA sends the opinions of RAC and SEAC along with relevant background documents to the European Commission. These are also published on ECHA's website.

13. Prepare and adopt the restriction decision

Within three months of receiving the committees' opinion, the Commission prepares a draft amendment of the list of restrictions.

If the Council or the European Parliament do not oppose to the restriction, the Commission adopts it. The decision to restrict is published in the Official Journal as an amendment Annex XVII of the REACH.

14. Comply with restriction

Once the substance restriction has been adopted industry needs to comply with it. Industry refers to anyone addressed in the restriction, such as manufacturers, importers, distributors, downstream users or retailers.

15. Enforce the restriction

The Member States are responsible for enforcing the restriction.

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