Following a compliance check under the dossier evaluation procedure, ECHA issued a final decision requiring the Appellant to conduct tests to satisfy certain information requirements and to submit a robust study summary for a test already conducted.
During the course of the decision-making process, after a draft decision was sent to the Member State Competent Authorities (MSCAs), the Appellant updated its registration dossier to include the robust study summary requested and an exposure-based waiving strategy addressing the information requirements. As the registration dossier update was received after the draft decision had been sent to the MSCAs it was not taken into consideration by ECHA for the purposes of its final decision.
The Board of Appeal found that in this particular case ECHA had infringed the principle of legal certainty as it had not clearly and precisely indicated to the Appellant, in due time, that registration dossier updates will not be taken into account for the purposes of a final decision if they are submitted after the draft decision has been sent to the MSCAs for their comments.
European Chemicals Agency
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