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By Stephen Gardner
BRUSSELS—Evaluation of substance registration dossiers submitted under the European Union's REACH law and assessments of related chemical safety testing proposals continue to be affected by quality problems, the European Chemicals Agency (ECHA) said in a progress report published Feb. 27.
ECHA Executive Director Geert Dancet said the report should be a “call to action” to companies registering their substances under REACH (Regulation No. 1907/2006 on the registration, evaluation, and authorization of chemicals).
In particular, companies planning to submit registration dossiers by the next deadline should pay attention to the progress report so that they avoid the mistakes found in registration dossiers evaluated in 2011, Dancet said. The next deadline is May 31, 2013, and applies to chemicals imported into, or manufactured in, the European Union in annual volumes of 100-1,000 metric tons.
ECHA said that the most common shortcomings in registration dossiers were confusion about substance identity, insufficient scientific justification for hazard assessments, and deficiencies “in all parts” of chemical safety reports, including incorrect classification and labeling and missing safe-use information, ECHA said in the report, Evaluation Under REACH, Progress Report 2011.
Under REACH, the European Chemicals Agency is required to check 5 percent of the registration dossiers it receives for compliance with REACH information requirements.
ECHA must also evaluate by Dec. 1, 2012, all the testing proposals it received in registration dossiers submitted by Dec. 1, 2010, which was the first REACH registration deadline, for high volume substances.
The agency said it expected to evaluate a total of about 565 testing proposals by Dec. 1, though the number might fluctuate if proposals are withdrawn or modified by registrants.
ECHA finalized checks on 146 registration dossiers for compliance with REACH in 2011 and concluded the examination of 216 testing proposals, according to the progress report.
But due to missing or unclear information, only 12 of the 146 compliance-checked dossiers were approved without sending notifications to registrants requesting them to upgrade their dossiers, ECHA said.
The agency also said it fell short of a self-imposed target to make draft decisions on 250 testing proposals, in part because the substances for which tests were proposed were not clearly identified in their registration dossiers, and it was “not possible to conclude on a testing proposal without knowing precisely the substance concerned,” the progress report said.
This problem affected 67 testing proposals, ECHA said. Testing proposals must be approved by ECHA before going ahead in a bid to minimize animal tests.
The shortcomings found in the REACH registration dossiers examined during 2011 were similar to problems found during 2010, the first year of compliance checks, when about two-thirds of dossiers were judged inadequate (34 INER 214, 3/2/11).
For 105 out of the 146 compliance-checked dossiers in 2011, ECHA issued legally binding decisions that require the registrants to provide additional information.
For 29 of the 146 dossiers, ECHA either sent advisory letters requesting registrants to make certain upgrades to their dossiers or approved the dossiers after additional information was received before a legally binding decision was issued.
ECHA spokesman Mikko Väänänen said the agency received a “generally high” level of cooperation from registrants when problems with their dossiers were highlighted.
Compliance shortcomings were “partly due to misunderstanding” of the REACH requirements, and registrants should make use of ECHA's advisory services to clarify issues, Väänänen said.
The Evaluation Under REACH, Progress Report 2011 is available at http://echa.europa.eu/documents/10162/17221/evaluation_report_en.pdf.
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