annankatu 18, p.o. box 400, fi - 00121 helsinki, finland | echa.europa.eu Follow up to dossier evaluation decisions ECHA-17-FS-01-EN Through dossier evaluation, ECHA gains further information on registrations which do not yet comply with the REACH Regulation. In a dossier evaluation decision, registrants have to provide further information on their substance by a deadline. Examining these registration updates is the final step of dossier evaluation. The follow-up evaluation ensures that registrants comply with the issues addressed by the dossier evaluation decision. It also identifies and possibly addresses issues arising from the new information that the registrants submit. Both compliance checks and testing proposal examinations may lead to decisions where ECHA asks registrants for more information. ECHA expects to receive this information in a registration update by the set deadline and then examines it. In Brief
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annankatu 18, p.o. box 400, fi-00121 helsinki, finland | echa.europa.eu
Follow up to dossier evaluation decisionsECHA-17-FS-01-EN
Through dossier evaluation, ECHA gains further information on registrations which do not yet comply with the REACH Regulation. In a dossier evaluation decision, registrants have to provide further information on their substance by a deadline. Examining these registration updates is the final step of dossier evaluation.
The follow-up evaluation ensures that registrants comply with the issues addressed by the dossier evaluation decision. It also identifies and possibly addresses issues arising from the new information that the registrants submit.
Both compliance checks and testing proposal examinations may lead to decisions where ECHA asks registrants for more information. ECHA expects to receive this information in a registration update by the set deadline and then examines it.
In Brief
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Once the dossier evaluation is complete, ECHA notifies the Commission and Member State competent authorities about the information obtained and the conclusions made. The registrant receives a copy of the notification letter.
HOW DOES THE PROCESS GO?
ECHA starts the follow-up evaluation when the deadline of the dossier evaluation decision has expired. The Agency checks if the registrant has provided the requested information in the latest dossier update and whether the corresponding information requirement is fulfilled.
ECHA’s dossier evaluation decisions specify the methods and conditions for how information requirements should be fulfilled.
For example, if the registrant provides a study, ECHA assesses whether it has been performed according to the specified test method, with the requested substance, and whether a proper (robust) study summary has been provided. ECHA also checks whether the conclusions are reasonable, based on the new information.
Once ECHA concludes whether the registrant has provided the requested information, it records the outcome in the appropriate outcome documents.
POSSIBLE OUTCOME
a) Requested information provided
If the registrant complies with ECHA’s decision and provides the requested information, ECHA sends an Article 42(2) notification to the Member State competent authorities (MSCAs) and to the European Commission, with a copy to the registrant. The evaluation process is closed.
b) Deviation from the decision
If the registrant deviates from the request, but provides information resulting from alternative methods (e.g. read-across) or another adaptation argument (e.g. test not technically possible) that are still compliant with REACH, ECHA may consider the deviation as acceptable (see under “Reminders for registrants” for the documentation needed) and issue an Article 42(2) notification, as above. The evaluation process is closed.
c) No update
If ECHA does not receive any relevant update, it sends a “statement of non-compliance following a dossier evaluation decision” (SONC) to the relevant Member State with a copy to the registrant. A SONC records ECHA’s finding that a registrant did not comply with the decision’s information requests within the set deadline.
A SONC consists of:• a notification letter addressing the legal background and the assessment that the information request was partly or not fulfilled; • an attachment with the scientific facts; • the original notification and decision; and • any relevant communication with the registrant after the decision was submitted.
The Article 42(2) notification is kept on hold until the registrant has satisfactorily addressed all of the decision’s requests.
d) Insufficient information provided
If ECHA receives a relevant update but it does not comply with the information request, a SONC is normally issued as described above.
However, under certain circumstances, ECHA will prepare a new draft decision1. This happens if the registrant provides new and substantial information that requires scientific assessment by ECHA, but does not comply with the information request. In such cases, ECHA prepares a follow-up draft decision and notifies the registrant of it.
The draft decision refers to the original evaluation decision, addresses the information which the registrant has subsequently provided, and assesses why the information request has not been fulfilled. The adoption of the follow-up decision follows the procedure described in Articles 50 and 51 as with any other evaluation decision.
Once the follow-up decision is adopted and the appeal period has passed, ECHA will inform the Member State competent authorities and the national enforcement authorities of the decision and invites them to consider enforcement actions. The Article 42(2) notification is kept on hold until the
1 According to Article 42(1).
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registrant has satisfactorily addressed all of the decision’s requests.
e) Other concerns
If the registrant complies with ECHA’s decision, but ECHA or the registrant identify other concerns regarding the same information requirement, the Agency may issue a new dossier evaluation decision.
MEMBER STATE ACTIONS
The Article 42(2) notification informs the Member States and the Commission of the dossier evaluation results. The MSCAs shall use this information for other REACH or CLP processes, such as substance evaluation, authorisation, restriction, or harmonised classification and labelling.
The Member States are solely responsible for enforcement. If the registrant does not address the issues covered by the decision by the deadline, ECHA informs the relevant national enforcement authority (NEA) and the MSCA through a SONC or a follow-up evaluation decision. The purpose of these documents is to support national enforcement actions. The national authorities are asked to address the issues identified by ECHA in their own competence and, if appropriate, to adopt enforcement measures. The registrant is notified for the sake of transparency.
Once the case is handed over to the national authorities, ECHA expects that any further communication on it will be between them and the registrant. A communication system allows ECHA and the Member States to exchange information on such cases. This allows ECHA to examine dossier updates in the appropriate time once the registrant has provided the missing information.
COMMUNICATION WITH REGISTRANTS
If a registrant seeks to clarify their obligations related to the decision, ECHA can provide contextual guidance. They should contact ECHA’s Helpdesk with concrete questions. However, the Agency cannot change the content (including the deadline) of the decision, since the decision has been agreed by the Member State Committee.
In some cases, registrants might wish to discuss with authorities whether the way they want to fulfil
the information requirements is acceptable, for example, by using general or specific adaptations. ECHA cannot provide advice or comments on any alternative strategies or approaches that the registrant considers using. The Agency only starts to assess the compliance of the updated registration dossier when the deadline has passed. The assessment is based on the latest update of the dossier.
Once a SONC has been sent or a follow-up evaluation decision has been adopted, the registrant should communicate with the national authorities. In such cases, ECHA communicates with the registrant only in agreement with the national authorities.
REMINDERS FOR REGISTRANTS
Registrants must submit the requested information by the deadline set.
If the decision requests the generation of new hazard information, the information must comply with Article 10 of REACH - submission of (robust) study summaries. The update must also include any changes to the registration dossier that follow from
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Registrants may cease to manufacture or import the registered substance after the evaluation decision is adopted. Such a cessation falls under Article 50(2) of REACH, and in practice means no further decisions will be adopted, unless the registrant restarts manufacturing or importing. However, any decisions adopted before the manufacture or import ceases are still valid and need to be complied with. Therefore, cessation is not a way to avoid the obligations resulting from an evaluation decision.
LINKS
Evaluation and its stepshttps://echa.europa.eu/regulations/reach/evaluation/steps
Questions and answershttps://echa.europa.eu/support/qas-support/qas
National helpdeskshttps://echa.europa.eu/support/helpdesks
this new information required – for example, with regard to classification and labelling, the chemical safety report, or submission of testing proposals.
Registrants may, under their own responsibility and risk, and notwithstanding the dossier evaluation decision, seek to fulfil the information gap identified by ECHA by providing adaptations of the standard information requirements. For instance, they might predict the results of the requested study by using information from a structurally similar substance (read-across).
When using such adaptations, registrants must fulfil the rules outlined in Annexes VI to X or the general rules in Annex XI to REACH. Any adaptation needs to be accompanied by sound scientific reasoning and documented comprehensively and transparently. If these conditions are not met, ECHA does not accept the adaptation and would issue either a SONC or a follow-up evaluation decision.
If registrants encounter difficulties to submit the requested information in due time, they are encouraged to update the dossier by the deadline in any case, and include any relevant explanations and proof concerning the status and timing of pending information requirements. The relevant NEAs can then consider these explanations.
