Evaluación de la sustancia
Member States evaluate certain substances to clarify whether their use poses a risk to human health or the environment. The objective is to request further information from the registrants of the substance to verify the suspected concern, if necessary.
The evaluation may in the end conclude that the risks are sufficiently under control with the measures already in place. Otherwise, it may lead to the proposal of EU-wide risk management measures such as restrictions, identification of substances of very high concern, harmonised classification or other actions outside the scope of REACH.
In cooperation with the Member States, ECHA defines risk-based criteria and then selects the substances that are to be evaluated. The selected substances are listed by ECHA in the community rolling action plan (CoRAP) following the opinion of the Member State Committee. An evaluating Member State will be designated for each substance on the final CoRAP.
The initial reason for selecting a substance for the CoRAP is not limiting the scope of the evaluation. During the evaluation, the Member State may identify other concerns that need clarification in order to conclude whether a substance is of concern or not. However, the Member State may focus the evaluation more upon certain aspects of the substance.
The substance evaluation process assesses all registration dossiers from all registrants specific to the same substance, i.e. in order to take into account the combined exposure. Other available sources of information are also considered.
The evaluating Member State has 12 months from the publication of the CoRAP to decide whether it needs to request further information from the registrants to clarify the concern. This request might go beyond the standard information requirements of REACH (Annexes VII to X) and may pertain to the intrinsic properties of the substance or its exposure. For example, registrants may need to provide studies on mode of action or monitoring of concentration levels in organisms or the environment.
The view that further information is needed is shared with all the other Member States and ECHA to achieve a general agreement. ECHA takes the decision to request for further information should this be necessary.