Evaluation process
Evaluation process
Phase 3 – Follow-up to ECHA’s decision
Follow-up to dossier evaluation decision
ECHA starts the follow-up to dossier evaluation decision once the deadline for updating the registration dossier with the requested information has passed.
This deadline is set in the ECHA’s decision.
ECHA evaluates the latest submission of the registration dossier.
ECHA evaluates whether the information requested in the decision has been provided.
If the requirements are met, ECHA informs the registrants, the Member State competent authorities and the European Commission of any conclusion made and that the dossier evaluation process is complete.
The conclusions obtained from dossier evaluation can be used to address substances under other processes – substance evaluation, harmonised classification and labelling, identification of substances of very high concern or restriction.
ECHA informs the relevant Member States and national enforcement authorities of any cases where registrants do not provide the requested information by the set deadline.
ECHA informs them also if the registrants provide, for example, irrelevant studies or manifestly unreasonable adaptations.
If necessary, the Member States and enforcement authorities will address non-compliance by applying enforcement measures.
The national enforcement authority informs ECHA of any enforcement actions taken and the date by when the registrant will provide the missing information.
The national enforcement authority informs ECHA of any enforcement actions taken and the date by when the registrant will provide the missing information.
When a registrant provides new information which does not comply with the request in the decision, ECHA issues a new draft decision stating the reasons for the non-compliance and sends it to the registrants.
FOLLOW-UP TO SUBSTANCE EVALUATION DECISION
The follow-up assessment by the eMSCA of the substance evaluation decision starts once all information is submitted or when the deadline set in ECHA’s decision for updating the dossier has passed.
ECHA informs the eMSCA when the registrant provides an updated version of the registration dossier.
The eMSCA evaluates whether the information included in the updated registration dossier meets all the requirements in ECHA’s decision and whether the concern is clarified.
Within 12 months of the submission of the update:
If the concern is still not clarified, for example, due to sequential testing being used, or the submitted information raises new concerns, the eMSCA prepares a new draft decision requesting additional information.
If the available information is sufficient to address the concern, the eMSCA ends the substance evaluation by preparing a conclusion document.
The eMSCA notifies ECHA:
If the registrants do not provide the requested information by the set deadline and the eMSCA is unable to conclude on the concern and on the appropriate risk management measures.
If the registrants provide, for example, irrelevant studies or manifestly unreasonable adaptations.
In many cases, the registrants are not based in the territory of the evaluating Member State. ECHA then informs the enforcement authorities of the relevant Member States about the eMSCA’s findings.
If necessary, the enforcement authorities will address non-compliance by applying enforcement measures.
The national enforcement authority informs ECHA and the eMSCA of any enforcement actions taken and the date by when the registrant will provide the missing information.
If the eMSCA confirms the concerns about the substance, it may propose further regulatory risk management measures, such as identification of substances of very high concern, restriction, harmonised classification and labelling, occupational exposure limits or measures under other legislation.
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