Dossiers submitted to the Agency at registration will be subject to evaluation by the Agency and the Member State Competent Authorities (MS CA). There are three types of evaluation, as follows:
• Compliance checking: The Agency is likely to select a 5% sample of registration dossiers to check the scope and quality of information submitted. The registrant may be asked to submit further information if necessary.
• Dossier evaluation: The Agency will assess the testing proposals and data waiver arguments for non-testing for the information requirements specified in Annexes IX and X of REACH. The Agency shall then evaluate whether the testing proposal is adequate before any of the higher tier tests are performed. The objective is to prevent unnecessary animal testing and to reduce the overall burden on industry.
• Substance evaluation: The MS CA will evaluate substances that have been prioritised for potential regulatory action due to concerns over their hazardous properties and their potential risks to human health or the environment. Such substances are included on a list for ‘substance evaluation’ and each substance on the list will be evaluated by a MS CA to check whether any further information is needed to control the risks perceived. Outcomes of substance evaluation could lead to the substance being added to the priority list for authorisation, a proposal to change the classification and labelling or a request for further test information from industry. The MS CA may also request that other authorities take appropriate action under other legislation where appropriate.
Further information on evaluation can be found on the ECHA website.