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 competent authority 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.
  • If the decision requires you to submit the full study report, report the studies comprehensively so that the evaluating competent authority 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.

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