Decision under substance evaluation

Substance evaluation is carried out by the EU Member States. It aims to clarify concerns related to the safe use of a substance. The evaluating competent authority may request information beyond the standard information requirements to determine whether using the substance poses a risk to human health or the environment. The evaluation may lead to regulatory risk management measures.

 

Facilitate the substance evaluation process
  • Update your registration dossier as early as possible if you see that your substance is scheduled for substance evaluation. See the Community rolling action plan (CoRAP) for the substances to be evaluated over a period of three years.
  • Avoid submitting dossier updates after the evaluating Member State has started the 12-month evaluation period.
  • If the evaluation has already started but new information needs to be included in the dossier, agree with the evaluating Member State first whether and how a new dossier update can be considered.
  • Aim to speak with one voice: one single contribution on behalf of all registrants of a substance makes for a smoother decision-making process.
  • When preparing the CoRAP, ECHA may indicate similarities between substances to ensure consistency between evaluations which may be performed by the same Member State. Registrants may consider coordinating interaction between themselves.
  • During the decision-making process, ECHA and evaluating Member States are 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
  • If the decision requires you to submit the full study report, report the studies comprehensively so that the evaluating Member State can make an independent assessment. Always submit the data in the form of a robust study summary.
  • Note that evaluating competent authority will initiate a follow-up evaluation of the updated registration dossier.
  • The competent authority will assess whether the new information corresponds to the requests in the decision and clarifies the concerns.

 

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.

 

Follow up evaluation and update your dossier by the deadline, even if one or more of your studies are delayed
  • Note that the evaluating Member State will start a follow-up evaluation when all requested information is submitted in the updated registration dossier.
  • The evaluating Member State will assess whether the new information corresponds to the requests in the decision and clarifies the concerns or whether further information should be requested in a subsequent substance evaluation decision.
  • You are advised to communicate to the evaluating Member State and ECHA about the difficulties to meet the deadline set in the decision as soon as you realise that you cannot realistically meet the deadline.When 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, at the latest by the deadline in your dossier update.
  • The evaluating Member State may ask ECHA to notify the national enforcement authorities because of missing information. The explanations in your dossier update 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 as well as the evaluating Member State.

Categories Display

Tagged as:

(click the tag to search for relevant content)