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EU chemicals policy - REACH

Questions and answers: Evaluation
 
What is ‘Evaluation’?

Evaluation is a process by which registration dossiers 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 and substance evaluation

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 IX and X submitted as part of the registrations before the tests are performed;
  • Compliance check: The Agency will check the compliance of a minimum of 5% of 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. Any costs incurred should be shared amongst registrants of the substance. Substance evaluation will be prioritised on the basis of risk following guidance to be developed by the Agency.

Evaluation may lead to the conclusion that action needs to be taken under the restrictions or authorisation procedures, or that information should 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.

 
Which substances will be subject to substance evaluation?

The Agency will develop a Community rolling action plan covering a three year period with substances prioritised on the basis of available information, the hazard posed (this may take account of analogues for example), exposure information and tonnage (including aggregating the quantities from all registrants of the same substance). The Agency will be responsible for coordinating this process, relying on the Member State competent authorities to carry out much of the work.  The competent authorities may  in turn, appoint another body to work on their behalf.

 
Will there be a fee for evaluations?

No. The fees submitted with registrations will cover the cost of evaluations. It would be unreasonable to charge an evaluation fee when some dossier evaluations are random and substance evaluations may result in no further action being required. Registrants or downstream users will have to pay for and carry out any further testing required as a result of evaluation.

 

Page published:11 May 2007

Department for Environment, Food and Rural Affairs