Post-registration support

Regulatory review and voluntary updates

The registrant’s responsibilities do not end once the registration has been completed. The registration dossiers may be evaluated by the regulatory authorities and if any deficiency or uncertainty is identified, the registrant receives a letter setting out the required information, with a deadline for compliance. Registrants are not normally informed in advance that compliance checks are in progress, and a draft decision letter may arrive unexpectedly.

Further information may be requested on a wide range of simple and complex issues, but a common issue seems to be the ‘higher-tier’ study endpoints, particularly when studies are waived without robust justification. Following receipt of a decision letter, the best strategy is to take the opportunity for discussion with ECHA, before the regulatory decision is finalised, but the time window is short and registrants need to be prepared to act quickly.

If the registered substance is selected for substance evaluation, this tends to be a much more far-reaching evaluation and typically a wide range of separate information requirements appear in the resulting decision.

The data set and chemical safety assessment can be improved on the basis of better understanding or availability of new information. Registrants should therefore plan towards a voluntary update of their dossiers where appropriate. The benefit of this approach is that it meets the registrant’s obligation to keep their dossiers updated and it should help to limit further information requests from ECHA.  

PFA can support registrants by:

  • Preparing the required additional material to fulfil the requirements issued by ECHA and meeting the specified deadlines.
  • Advising on the strengths and weakness of different options to fulfil the identified data need using a different approach than that required in the (draft) decision – e.g. possible alternatives to conducting further testing.
  • Pro-actively reviewing a dossier to identify weaknesses in advance of any letter from ECHA, allowing registrants to plan ahead and consider taking action.
  • We can also assist with voluntary updates, for example if there is a change to the supply volume or use pattern of a substance after registration.