New factsheet explaining the follow-up to dossier evaluation decisions

New factsheet explaining the follow-up to dossier evaluation decisions

ECHA/NA/13/35

Dossier evaluation covers compliance checks and testing proposal examinations. Both processes may lead to ECHA decisions requesting further information from registrants. In the  follow-up to these decisions ECHA assesses whether the registrants provided the requested information by the deadline set in the decision and whether this new information should lead to further actions. A new factsheet has been published clarifying this follow-up stage.

Helsinki, 15 October 2013 – Once a dossier evaluation decision has been issued and no appeal has been submitted, the decision is legally binding. ECHA expects to receive the information requested at the latest by the deadline set via an update of the registration dossier. Examining the dossier updates and any new information contained in them is, therefore, the final element of the dossier evaluation process.

The purpose of the follow-up examinations is to ensure that the registrant complies with the requests in the dossier evaluation decision. Moreover, the purpose is to identify and possibly address issues arising from the new information submitted.

Once the dossier evaluation is completed and all information requested in the decision has been provided, ECHA will notify the Member State Competent Authorities and the Commission of the information obtained and any conclusions made. The Member States may use the new information for substance evaluation, restriction, authorisation or harmonised classification and labelling.  

If the registrant did not provide all or any of the requested information by the deadline, ECHA informs the appropriate authorities of the Member States, since the responsibility for enforcement is on the Member States. The national authorities are asked to address the issues identified by ECHA in their own competence and, if found appropriate, to adopt enforcement measures.

The fact sheet describes the process steps and the possible outcome documents. Communciation issues after the decision has been received are also addressed. The fact sheet includes also useful reminders for registrants.