Evaluation

Evaluation is an element of REACH in which both ECHA and National Competent Authorities are involved. There are two types of evaluation which can be carried out; dossier evaluation and substance evaluation.

Evaluation Flow Chart

Under dossier evaluation, ECHA conducts the following tasks:

  • Compliance check: ECHA may select any registration dossier to check if the appropriate information has been provided in the dossier. This will be carried out on at least 5% of dossiers submitted at each tonnage level.
  • Testing proposal examination:This applies only to substances registered at 100 tonnes or more. The registrant will have to propose which animal tests he considers necessary amongst those laid out in Annex IX and X. ECHA will evaluate whether the proposal is adequate before such a test is performed. The objective of this is to prevent unnecessary animal testing.

 

Substance evaluation is undertaken by Member State Competent Authorities (MSCAs) The evaluation aims to clarify the initial concern that the manufacture and/or use of certain substances could pose a risk to human health or the environment. The substances to be evaluated are listed on ECHA’s community rolling action plan (CoRAP). In addition to the names of the substances to be evaluated, the CoRAP indicates the Member State that will complete the evaluation and when. It is a three year rolling plan and is updated each year in March. Following evaluation by the MSCA, further information may be requested from the registrant(s) to clarify a suspected risk. Alternatively, it may be concluded that the substance does not constitute a risk and that no further data is needed.

 

The latest CoRAP and further details on substance evaluation including a questions and answers document and a fact sheet can be obtained from ECHA’s website.