Substance evaluation decisions

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

 

Be active in the substance evaluation process
  • Monitor the Community rolling action plan (CoRAP), listing the substances to be evaluated over a period of three years, and update your registration dossier as early as possible if your substance is listed on the CoRAP.
  • Avoid submitting a dossier update after the 12-month evaluation period of the evaluating Member State has started, unless you have agreed with the evaluating Member State.
  • After ECHA has sent you the draft decision, you have the possibility to provide comments:
    1. Aim to speak with one voice: collect and consolidate the comments from all registrants into one response.
    2. ECHA and the evaluating Member States will only consider your comments which relate directly to the assessment of your dossier (or if they address any proposals for amendment made later by the other competent authorities).
    3. Check if ECHA has indicated similarities in the CoRAP list between substances evaluated by the same Member State. Where useful, communicate with the registrants of all similar substances when coordinating your response.

 

After receiving the adopted decision
  • Discuss and agree with all recipients how to best fulfil the requests in the decision.
  • Decide who will perform the requested tests and send this information to ECHA within 90 days of receiving the decision. Otherwise, ECHA will nominate one of the addressees of the decision to carry out the tests.
  • ECHA cannot extend the deadline set in the adopted decision, so:
    1. Make sure that your studies and data are ready before the deadline set in the decision.
    2. Agree who will report the studies in the IUCLID format.
    3. Submit your dossier update timely and the data in the form of a robust study summary. If the decision requires you to submit the full study report, attach the report in the updated dossier.
    4. Make sure the information about the studies is comprehensive so that the evaluating competent authority can make an independent assessment. Also make sure it is adequate for classification and labelling or risk assessment.
  • If you inform ECHA that you cease manufacture after the substance evaluation decision has been adopted, you will 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 to ensure ECHA will not publish any confidential information.
  • If you do not comment, ECHA will publish the non-confidential version of the adopted decision on its website.

 

Follow up evaluation – update your dossier by the deadline, even if one or more of your studies are delayed
  • The evaluating competent authority will start a follow-up evaluation when all requested information is submitted in the updated registration dossier.
  • Communicate with the evaluating competent authority and ECHA as soon as you realise any difficulties to meet the deadline set in the decision.
  • If you do not have all the data available by the deadline set in the decision, 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 in your dossier update.
  • The evaluating competent authority may ask ECHA to notify the national enforcement authorities if there is any missing information. National enforcement authorities may take your explanations into account when deciding on possible enforcement actions. Update your dossier and inform your national enforcement authorities as well as the evaluating competent authority, as soon as the missing information becomes available.
  • The evaluating competent authority will assess whether the new information corresponds to the requests in the decision and clarifies the potential risks. It may then conclude on whether the concerns are clarified, or decide to request further information in a subsequent substance evaluation decision.

The substance evaluation is closed when the evaluating competent authority has completed their conclusion report, which ECHA then publishes on its website.

Categories Display

Tagged as:

(click the tag to search for relevant content)