There are three areas under REACH which are focused on Evaluation:
At least 5% of all dossiers received by ECHA, within each tonnage band has a compliance check initiated. The decision as to which dossiers will be subject to a compliance check and whether all or part of the dossier is to be checked is by ECHA. The criteria for selection of the dossiers follows those set out in REACH, however additional criteria are also used in the random selection of dossiers. A compliance check can start at any time in respect of any dossier.
In order to meet the data requirements for REACH registration, it is sometimes required for testing on vertebrate animals to be completed. However, this is thought as a last resort to fill data gaps, therefore all proposals for certain testing described in Annexes IX and X of the Regulation are checked for reliability and adequacy of the data being generated in order to ensure the testing is required.
For every testing proposal on vertebrate animals that is submitted, ECHA publishes the information and invites third parties to submit any scientific information (including studies and hazard endpoints) so that ECHA has all of the information required to prepare the decision on the submitted testing proposal.
A substance may be placed on a list of substances to be evaluated which is called the Community rolling action plan (CoRAP) and is adopted on the basis of the opinion of the Member State Committee. A designated Member State performs the substance evaluation and, if necessary, prepares a draft decision within one year of the publication of the CoRAP.
When substances are chosen for Substance Evaluation, the Member States examine and assess the information within the registration dossiers in detail, to ensure the completeness and quality of the data, the appropriateness of the testing studies or proposals, and the hazard and risk conclusions contained within the dossier. Further information may be required to be submitted (both data or testing proposals) by the registrants, following the completion of the substance evaluation process.
For further information relating to the three options of Evaluation, please visit the ECHA website.
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