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ECHA Publishes Report on Evaluation in 2010
Press Release
ECHA/PR/11/05
Media enquiries: ECHA Press
The Evaluation Report describes ECHA's work in evaluating REACH registration dossiers in 2010. The report also provides recommendations to registrants.
Helsinki, 28 February 2011 - The report presents details and figures on the different REACH evaluation activities and their respective output. In 2010, ECHA examined 273 dossiers for evaluation: 151 compliance checks and 123 examinations of testing proposals. Seventy of these compliance checks and seven testing proposals were completed in 2010. The remaining dossiers are still being worked on.
The report concludes that ECHA identified quality problems in a considerable proportion of dossiers in 2010. It is, however, too soon to draw firm conclusions on the quality of dossiers registered by the first registration deadline as most of dossier evaluation work is still to come.
The report lists the most common shortcomings found in the dossiers evaluated and gives specific recommendations for registrants of which the most important are:
- The identity of the registered substance needs to be clearly described;
- Any adaptation to the standard testing regime must meet the conditions set out in Annexes VII to XI of the REACH Regulation, and a clear justification for any adaptation must be provided;
- The robust study summaries should contain enough detail to allow an independent assessment of the information provided;
- Classification and labelling should be in line with the hazards identified or with the harmonized classification and labelling of the substance;
- A proposal to do testing must be submitted first (for tests under Annex IX and X) before the test is done. Doing a test before getting ECHA's decision may lead to legal action;
- Registrants have an obligation to share data resulting from animal tests and to share the costs before submitting the dossier.
Registrants are encouraged to take a pro-active approach and update their dossiers taking into account these recommendations.
Further information
REACH provides for three different evaluation processes, namely the compliance check, the examination of testing proposals and the substance evaluation. In a compliance check the Agency examines the quality and adequacy of data provided by the registrant and may require further information to bring the dossier in compliance with information requirements in REACH. Examination of testing proposals aims to check that adequate and reliable data are produced and to avoid unnecessary animal testing. The Agency decides whether testing is necessary and may then provide permission for the tests to be performed. The third evaluation process, substance evaluation, is launched when there is a suspicion that certain uses of a substance may cause harm to human health or the environment. The Member States carry out the scientific assessment required for substance evaluation.
Pursuant to Article 54 of the REACH Regulation, ECHA publishes a report on evaluation by the end of February each year.
Evaluation under REACH Progress Report 2010 [PDF]
Evaluation under REACH Progress Report 2009 [PDF]