REACH Application Evaluation Process

Sistem Patent Kalite can share these details on the REACH application evaluation process.

Dossiers registered under REACH are analyzed based on the following:

Compliance Review

A review of the quality of information submitted by industry. The European Chemicals Agency (ECHA) in Helsinki runs this process on samples drawn from registered dossiers across each tonnage band (at a rate of at least 5 percent).

Dossier Evaluation

For substances registered at higher tonnage levels (100 tonnes/year), the registrant submits a testing proposal for required standard tests that involve animal testing. These testing proposals are reviewed to avoid unnecessary animal testing.

Substance Evaluation

This step is run by the competent authorities of Member States for substances that require regulatory measures based on hazardous properties. All dossiers go through a completeness check on submitted information. This completeness check does not assess the adequacy or quality of the information submitted.