Evaluation
Evaluation is a process by which registration dossiers and risks of substances can be examined. It may result in a request for further information on substances from the registrant. There are two types of evaluation with different aims:
Dossier evaluation (i.e., per individual registration):
- Checking of testing proposals to prevent unnecessary animal testing, i.e., the repetition of existing tests, and poor quality or unnecessary tests. The Agency will be responsible for checking the testing proposals under annexes VII and VIII submitted as part of the registrations before the tests are performed;
- Compliance check: The Agency will check the compliance of, a minimum of 5%, registration dossiers with the registration requirements. National enforcement action is possible as a result.
Substance evaluation (i.e., per substance):
The Agency, in conjunction with MS Authorities, may clarify suspicions of risks to human health or the environment by requesting further information from industry on particular substances. The process aims to clarify whether a substance falls under the scope of SVHC. Any costs incurred should be shared amongst registrants of the substance within the contest of Substance Information Exchange Fora (SIEFs). Substance evaluation will be prioritized on the basis of risk following guidance to be developed by the Agency. The first community action rolling plan will be published by 1 December 2011 by ECHA. This action rolling plan will list the substances subject to evaluation. Member State Competent Authorities and ECHA will be in charge to comply with this task.
Evaluation may lead to the conclusion that action needs to be taken under the restrictions or authorisation procedures, or that information needs to be passed on to other authorities responsible for other relevant legislation. The evaluation process should ensure that reliable and useful data is provided and made available to the relevant bodies by the Agency.
|
