29-Feb-2012 - European Chemicals Agency (ECHA)

ECHA Publishes the Evaluation Report 2011

The Evaluation report presents details and figures on ECHA’s REACH dossier evaluation activities and their respective output. In 2011, ECHA issued 187 draft or final decisions on testing proposals. In 2011, ECHA adopted 22 final decisions on testing proposals, and closed the examination of 58 cases that were either inadmissible or withdrawn by the registrant. A significant share of the proposals could not be examined or properly concluded due to substance identity problems.

In 2011, ECHA completed 146 compliance checks. Of the 146 completed dossiers, 134 resulted in ECHA requesting the registrant to provide further information. Ten of the cases were already closed after the registrant had updated his dossier with the information required, and in twelve cases no action was needed.

Given the high proportion of compliance checks where action was required, the report concludes that while registrants strived to fulfil their obligations regarding information requirements under REACH, in many cases further improvement is required from registrants, thereby giving the perception of insignificant quality of registrations overall.

“This report is essential reading for registrants preparing for the 2013 REACH deadline and should be a call for action for companies who have already registered”, says ECHA’s Executive Director Geert Dancet in the foreword of the report.

The report lists the most common shortcomings found in the dossiers and gives specific recommendations for registrants of which the most important are:

  • Substance Identity: Registrants are urged to precisely identify their substances. The identity and composition specified in the registration needs to be supported by appropriate analytical information on the substance as manufactured. Ambiguous identity of the substance not only may signal that the dossier contains more than one substance but also undermines the pertinence of the hazard information and consequently the information on how to use the substance(s) safely.
  • Testing proposals and hazard assessment: Read across approaches require that the information needs are covered as they would be with a standard test on the substance. As such, read across approaches need to be based on scientific evidence and this verifiable evidence needs to be provided in the registration dossier.
  • Chemical Safety Report (CSR): Deficiencies have been observed in all parts of the CSRs. If the CSR has missing information on the hazards, uses or potential exposures, the risks are not adequately identified and inappropriate risk management measures are recommended. In such cases, REACH’s ultimate aim, the safe use of chemicals, cannot be achieved. Companies are therefore urged to improve and update CSRs and to ensure proper communication on how to safely use the substances to customers.

The report contains recommendations to registrants with regard to the relevance of particular tests, the test material for the specific substance, substance identity and reproductive toxicity testing. There are also tips to avoid shortcomings in the chemical safety assessment, hazard assessment, PBT assessment, exposure assessment and its scope, risk characterisation and classification and labelling.

Facts, background information, dossiers
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