European Chemicals Agency Says Review of REACH Dossiers Shows Quality Problems

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BRUSSELS--Almost two-thirds of chemical registration dossiers checked for compliance in 2010 under the European Union’s REACH law were sent back to registrants with requests for clarification or further information, according to the European Chemicals Agency (ECHA).

Of the 70 dossiers for which compliance checks were completed in 2010, 25 were judged complete, 33 needed clarification on certain points, and 12 did not provide adequate information, according to figures published Feb. 28 by ECHA in the Evaluation Under REACH Progress Report 2010.

However, ECHA said it is “too soon to draw firm conclusions” about the quality of approximately 21,600 registration dossiers submitted by a deadline of Nov. 30, 2010, and for which registration numbers had been issued by the end of the year.

In February, ECHA Executive Director Geert Dancet told BNA that quality shortcomings could affect a considerable portion of dossiers submitted under REACH (Regulation No. 1907/2006 on the registration, evaluation, and authorization of chemicals).

“Too many companies started too late with the preparation activities for registration,” Dancet said (30 DEN B-1, 2/14/11).

The most common problems affecting registration dossiers were lack of clarity on the identity of the registered substance, insufficient information about substance studies, mismatches between substance classification and labeling and the identified hazards of the substance, and technical shortcomings relating to the testing of substances, ECHA said.

ECHA Approval Required for Animal Tests.

The agency also said that, in cases when it was necessary to obtain more information about the properties of a substance, animal tests should not be carried out until approval from ECHA had been obtained. “Doing a test before getting ECHA’s decision may lead to legal action,” the agency said.

ECHA added that when clarification was needed for a registration dossier’s contents, the registrant was sent a quality observation letter requesting the revision and resubmission of the dossier.

When insufficient information was provided, legally binding requests were sent to registrants asking for the missing information to be provided by a specified date, ECHA said.

ECHA said it also completed four evaluations of proposals for animal tests, approving three of them without modification and requesting modifications to the tests in one case. A further three testing proposals were withdrawn by the registrants.

Increased Workload in 2011.

ECHA’s evaluation workload will increase considerably in 2011. It must evaluate 1,171 proposals for animal tests by a deadline of Dec. 1, 2012, and it is required to perform quality checks on a sample comprising at least 5 percent of registration dossiers.

ECHA said that during 2010, in addition to the evaluations completed, it started a further 81 dossier compliance checks and moved forward with another 116 animal testing proposals.

By Stephen Gardner


The ECHA Evaluation Under REACH Progress Report 2010 is available at http://echa.europa.eu/doc/evaluation_under_reach_progress_report_2010.pdf.