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Follow up to dossier evaluation decisions

The global situation due to Covid-19 has caused delays and we cannot provide the information requested in the adopted ECHA decision by the set deadline. Can ECHA grant an extension?

ECHA appreciates that the current global emergency has affected several registrants in the EU. For this reason, ECHA extended certain deadlines in the registration and evaluation processes, for a limited period of time, to take account of the current global situation (see more here).

However, the Agency is not in a position to alter the final deadlines set in adopted decisions. This is because these are decisions that have been agreed in close consultation with the Member States.

As usual, ECHA will initiate the follow-up evaluation of the updated registration dossier for the substance subject to dossier evaluation process that you mentioned in your document when the deadline in the decision has passed. Then, ECHA will establish whether the new information submitted in an updated dossier corresponds to the requests in the decision.

If you think you will not be able to provide all the information requested in the decision by the deadline set, we advise you to anyway update your registration dossier by the deadline and, if necessary, include all relevant explanations and proof concerning the status of ongoing tests and the reasons for the delay, including the expected submission date. As soon as the missing information becomes available to you, you should update your registration dossier again.

According to Article 42(1), ECHA needs to examine all of the information submitted as a response to a testing proposal and compliance check decision. The Agency also has to draft any appropriate decisions, if necessary.

If the information provided in the dossier update does not fulfil the information requirements, the Member State competent authorities will be informed. They will then have to consider your argumentation and decide on any enforcement actions, where appropriate.

For further information on the follow-up to dossier evaluation decisions, please see the steps in the Evaluation process and the answers to the most frequently asked questions on Evaluation on the ECHA website.

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