Demandes d'informations complémentaires
An evaluation process may conclude that additional information is needed either to decide on a testing proposal, to clarify a concern on a substance or to bring a registration dossier into compliance with REACH. In the cases of compliance checks and testing proposal examinations, ECHA will draft a decision to request further information from registrants. In the substance evaluation process, the evaluating Member State will draft the decision.
Throughout the process, ECHA will ensure that the decision is finalised via the decision making procedure established by REACH and that a harmonised approach is maintained for all evaluation cases.
The procedure also ensures that testing is tailored to real information needs. Therefore, the registrant should not commence any testing or submit any new testing proposals until the decision on substance evaluation is finalised. However, if ECHA has taken or takes other parallel decisions as a result of dossier evaluation, registrants must perform the requested tests by the deadline given in the decisions.
Once a draft decision to request for further information is submitted, registrants can comment on it within 30 days after being informed by ECHA. During this time, registrants can also update their dossiers with information relevant to the concern or fill the data gaps detailed within the draft decision.
The evaluating Member State or ECHA will take the comments and updated dossiers into account and may amend the draft decision accordingly. It may also consider that no additional information is required and the evaluation process may finish.
Following this, the other Member States and ECHA, in the case of substance evaluation, will review the updated draft decision and the registrants' comments and will have 30 days to propose further amendments.
If other Member States, and ECHA, in the case of substance evaluation, propose amendments to the draft decision, the registrants have the opportunity to comment on these amendments.
The evaluating Member State or ECHA may then modify the draft decision accordingly and forward it to ECHA's Member State Committee.
When the Members States and ECHA do not propose amendments to the draft decision, ECHA can take the final decision accordingly without the involvement of the Member State Committee.
Member State Committee
The Member State Committee (MSC) will examine the draft decision, the registrants' comments, and any proposals for amendments from the other Member States and ECHA. It will then try to reach an agreement on the final decision.
An involved registrant or a representative of a group of affected registrants may be admitted to the meeting as an observer when their specific case is addressed by the Committee.
The Committee must seek agreement on the draft decision within 60 days. If it reaches unanimous agreement, ECHA will take the final decision accordingly. If there is disagreement amongst the MSC members, the matter is referred to the European Commission and the decision will be made under the examination procedure [under Articles 5 and 13(1)(c) of Regulation 182/2011].
The adopted ECHA decision requires registrants to submit the requested information by updating their registration dossiers within the specified deadlines.
Registrants can appeal against this decision to ECHA's Board of Appeal within three months of receiving the notification of the decision.
The non-confidential versions of ECHA decisions originating from compliance checks and examination of testing proposals are published on the ECHA website on the Evaluation decisions page.
After the substance evaluation, the evaluating Member State will examine the information provided by the registrants and may then, if needed, draft a new decision to request more information within a further 12 months if the concern is still not clarified or new information raises further concerns. Or else, it can consider that the initial concern has been removed or confirmed and that no further information is required.
In compliance check and testing proposal cases, ECHA will examine the information provided by the registrant in the dossier update and consider whether the information complies with the REACH requirements and whether it is sufficient for the purposes of classification and labelling and risk assessment. If the information is deemed noncompliant or the new information causes further standard information needs, ECHA may prepare another draft decision to request for appropriate information.