Evaluation
The Agency and the Member States Competent Authorities will carry out different types of evaluations to determine the need for further information on the registered substance.
There are three types of evaluation, covering three different objectives:
- Dossier evaluation: The Agency will perform the following checks of the registration dossiers:
- Compliance check: The Agency may select any registration dossier to check whether the appropriate information is available and has been adequately reported. The registrant may be asked to submit further information if necessary.
- Checking of testing proposals: for chemicals manufactured or imported in a quantity of 100 tonnes or more, no testing shall be conducted for the information specified in Annexes IX and X of the REACH Regulation. Instead a testing proposal must be submitted in the registration dossier. The Agency shall then evaluate whether the testing proposal is adequate before such a test is performed. The objective of this procedure is to prevent unnecessary animal testing, i.e. the repetition of existing tests, and poor quality tests.
- Substance evaluation: When the Agency or a Member State Competent Authority has an indication that a substance may pose a risk to human health or the environment, the Agency will include that substance on a list for “substance evaluation”. For each substance on this list, one Member State shall evaluate in more detail whether further information is needed and in that case the registrant(s) will be requested to provide such information.
Substance evaluation may lead to conclusions such as:
- action needs to be taken under the restriction or authorisation procedures
- classification and labelling needs harmonising under REACH
- information needs to be given to other authorities to take appropriate action under other legislation.