Tuesday, March 1, 2011

European Chemicals Agency Publishes Evaluation of REACH Chemical Registrations

By now readers should know that REACH is the EU's chemical control law, the Registration Evaluation Authorization (and Restriction) of Chemicals regulation.  November 30, 2010 was the deadline for manufacturers and importers to register their hazardous or high production volume chemicals.  And now the European Chemicals Agency (ECHA) has released a report evaluating registration dossiers, as well as substance evaluations.  The goal is to summarize progress to date and provide useful feedback to future REACH dossier submitters.

There are actually three different evaluation processes. One is the "compliance check," in which ECHA "examines the quality and adequacy of data provided by the registrant." The second is examination of "testing proposals," in which ECHA "decides whether testing is necessary and may then provide permission for the tests to be performed." The third is "substance evaluation," in which the Member States prepare a dossier on chemicals they believe "there is a suspicion that certain uses of a substance may cause harm to human health or the environment."

The Evaluation report concludes that there were "quality problems in a considerable proportion of dossiers in 2010," though ECHA is still in the early stages of review. In an effort to improve future submissions, the gives specific recommendations for registrants, including:
  • 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.
The full Evaluation progress report for 2010 can be downloaded as a PDF file here.

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