Decision under dossier evaluation

If ECHA considers that your registration dossier is not compliant with the information required for your substance at the tonnage band registered, it will issue a decision. This decision obliges you to submit the required information.

ECHA will also issue a decision to inform you about the outcome of our examination of a testing proposal you have submitted.

ECHA’s dossier evaluation decision is based on the registration dossier available in ECHA’s systems at the time the draft decision is issued to the registrants for comments. Therefore, any subsequent updates of the registration dossier will not be taken into account in the evaluation decision-making process leading to the final decision. 

During the decision-making process, ECHA is only required to take into account registrants’ comments to the draft decision and registrants’ comments to any proposal for amendment submitted by the competent authorities. Such comments must be provided in the format specified by ECHA.

 

React in a timely manner to a draft decision
  • Check your REACH-IT account regularly for messages from ECHA.
  • Agree on procedures/ timelines with your co-registrants to be prepared to react to a draft decision and during the subsequent steps of the decision-making process.
  • You have 30 days to provide comments on a draft decision.
  • Get organised and communicate with the other co-registrants to agree on a consolidated set of comments.
  • Focus your comments on the content of the draft decision; for example, inform ECHA by commenting that you may have new data which would remove a request from the decision, and submit that data with your comments. ECHA will take these comments into account in its evaluation decision. As part of your obligations under Article 22 of REACH you must also provide the new information in a dossier update.
  • If as part of your comments, you request ECHA to extend the deadline of the decision, provide clear reasons for the request. If lack of laboratory capacity is the sole basis for the request, you must include a statement from your selected laboratory as an attachment.
  • In the decision-making process, ECHA notifies the draft decision to the Member State competent authorities. You will be invited to comment on any proposals for amendment submitted by the competent authorities.
  • You have 30 days to provide comments on a proposal for amendment by a competent authority. Get organised and communicate with the other co-registrants to agree on a consolidated set of comments.
  • If the Member State competent authorities do not propose any amendments to the draft decision, or if the Member State Committee has unanimously agreed on a draft decision, ECHA will issue the adopted decision.
  • An adopted decision includes deadlines by which you are required to provide the requested information.
  • ECHA will evaluate any new information submitted in a dossier update only after the deadline in the adopted decision has passed.
  • If you change the status of your registration dossier from active to inactive in REACH-IT to inform ECHA about cease of manufacture after receiving a draft decision but before the decision is adopted, your registration will be revoked and no longer be valid.

 

After receiving the adopted decision
  • Discuss and agree with the recipients of the decision how to fulfil the requests in the decision.
  • Decide who will perform the requested tests, and inform ECHA within 90 days of receiving the decision. Otherwise, ECHA will nominate one of the co-registrants to carry out the tests.
  • Make sure that your studies and data are ready before you submit your dossier – ECHA cannot extend the deadline set in the adopted decision.
  • Agree on who will prepare the robust study reports in IUCLID format.
  • Report the studies comprehensively so that ECHA can make an independent assessment: submit the data in a robust study summary.
  • Report data which is adequate for classification and labelling or risk assessment.
  • Remember that any adaptation to the requested information is your responsibility. ECHA will assess the validity of these adaptations.
  • If you inform ECHA of cease of manufacture after a dossier evaluation decision has been adopted, you still have to fulfil the requests in the decision.

 

Review the non-confidential version of ECHA’s decision
  • Review the non-confidential version of the adopted decision by the indicated deadline (21 days after receipt) to ensure that ECHA will not publish any confidential information on its website.
  • Note that if you do not comment by the deadline, ECHA will proceed with publishing the decision.

 

Update your dossier by the deadline, even if one or more of your studies are delayed
  • ECHA will start the follow-up evaluation process when the deadline in the decision has passed, regardless of whether you have provided reasons for not being able to meet the deadline.
  • If you do not have all the data available by the deadline, include all relevant explanations and proof about the status of the ongoing tests, the reasons for delay and the expected submission date of the test results. This information can be taken into account by the national enforcement authorities when they decide on possible enforcement actions. As soon as the missing information becomes available, update your dossier again and inform your national enforcement authorities.
  • During the follow-up evaluation, ECHA will assess whether the new information submitted corresponds to the requests in the decision and complies with the information requirements.
  • If ECHA finds that some or all of the requested information is missing during the follow-up evaluation, the national enforcement authorities will be informed.

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