Dossier evaluation decisions

 

In dossier evaluation, ECHA checks if the information submitted in your registration meets the requirements set in REACH for your substance and tonnage band. If your dossier does not meet the requirements, you will receive a dossier evaluation decision and you need to submit all information requested in the decision to ECHA.

If you have submitted a testing proposal, you will receive a decision after our examination is finalised.

First, you will receive a draft decision, to which you have the right to comment by the given deadline. After decision-making process is over, you will receive an adopted decision and you must provide the requested data by the given deadline. You need to agree with your co-registrants how to organise the work to meet these deadlines.

Dossier evaluation is carried out based on the registration data available in ECHA’s registration database at the time a draft decision is sent to registrants for comments.

During decision-making, ECHA is required to consider comments on the draft decision and on any proposal for amendment submitted by the Member State competent authorities. Such comments must be provided in the format specified by ECHA.

The scope of your comments should address ECHA’s assessment of your dossier or the proposals for amendments by the competent authorities and should not be used as a channel to submit e .g new or revised adaptations, (revised) testing strategies or plans on fulfilling the requests in the decision. ECHA cannot advise on acceptability of future adaptation strategies.

If new information becomes available after you have received a draft evaluation decision, you must submit it as part of your comments within the 30-day commenting period using the webform indicated in the decision notification letter.

 

 

React timely to a draft decision
  • Check REACH-IT regularly.
  • Agree on procedures and 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 compile your comments to the draft decision and send them to ECHA.
  • Start by contacting your co-registrants and agreeing how to collect and consolidate all comments into one response.
  • Focus your comments on the content of the draft decision; for example, possible errors or inaccuracies in ECHA’s assessment. ECHA will take these comments into account in its evaluation decision.
  • If you request ECHA to extend the deadline of the decision in your comments, provide clear reasons and documentary evidence for your request. For example, if there is a lack of laboratory capacity, you must include a statement from your selected laboratory.
  • 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 comment on the proposals for amendment . Get organised with the other co-registrants and agree on a consolidated set of comments. ECHA only considers comments related to the proposals for amendment at this step of decision-making. Comments on other elements of the draft decision are not considered.
  • ECHA will issue the adopted decision if the competent authorities do not propose any amendments to the draft decision or the Member State Committee unanimously agrees on the draft decision.
  • If you inform ECHA that you have ceased the manufacture or import of the substance after receiving a draft evaluation decision but before the decision is adopted, your registration will be invalidated. The decision making process will be stopped for you, but it will continue for the other recipients of the decision, if applicable.
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After receiving the adopted decision
  • Discuss and agree with all recipients how to fulfil the requests in the decision.
  • Decide who will perform the requested tests on behalf of all recipients and send this information to ECHA within 90 days of receiving the decision. Otherwise, ECHA will nominate one of the recipients to carry out the tests.
  • Make sure your studies and data are ready before you submit your update – ECHA cannot extend the deadline set in the adopted decision and will evaluate any new information only after the deadline in the adopted decision has passed.
  • Agree who will update the dossier in IUCLID format and send it to ECHA.
  • Make sure the information about the studies is comprehensive so that ECHA can make an independent assessment: submit the data in a robust study summary.
  • Report data that is adequate for classification and labelling or risk assessment.
  • Remember that any adaptation to the requested information is your responsibility. ECHA will assess their validity.
  • If you inform ECHA that you have ceased manufacture or import after the dossier evaluation decision has been adopted, you will still have to fulfil the requests in the decision.
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Review non-confidential version of ECHA’s decision
  • Review the non-confidential version of the adopted decision by the deadline (21 days after receipt) to avoid ECHA publishing confidential information on its website.

 

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 given in the decision has expired. This will be done even if you have provided reasons for not being able to meet the deadline.
  • During the follow-up evaluation, ECHA will assess whether the new information 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, it notifies the national enforcement authorities. You will receive a copy of the notification.
  • If you do not have all the data available by the deadline, include all relevant explanations and proof about the status of ongoing tests, reasons for delay and expected submission date of the test results in your dossier update.
  • National enforcement authorities can take this into account when they decide on possible enforcement actions. As soon as the missing information is available, update your dossier again and inform your national enforcement authorities.
  • If the national enforcement authorities have been informed of the incompliance, you must agree on a dossier update with the national authorities. ECHA will only evaluate an updated dossier if agreed with the national authorities.