Sunday, February 28, 2010

European Chemicals Agency Gives Strategies for Improving Acceptance of REACH Dossiers

With the first major deadline for high volume and "substances of very high concern" registration dossiers rapidly approaching, the European Chemicals Agency (ECHA) has offered some help in a new report. The "Evaluation Under REACH: Progress Report 2009" (PDF) was published on Thursday and includes detailed recommendations for REACH registrants based on problems identified in the dossiers ECHA has reviewed so far.

The most common reasons for registration dossiers failing to pass the completeness and compliance checks, ECHA says, include:

* The identity of the registered substance and the substance used for testing were not clearly described (precise composition and impurities)

* Testing was omitted based on inappropriate or poorly justified scientific arguments

* The summaries of test reports did not include enough detailed information

* Shortcomings related to the risk assessment and the recommended risk management measures

* Omission of the classification and labelling information specified by the CLP Regulation

Registrants still working on their dossiers but that plan to submit them by the November 30, 2010 deadline will find some useful advice on how to avoid these problems.

According to ECHA, in 2009 the Agency:

* received 409 complete registration dossiers and initiated evaluation of 35 of these, 27 of which were compliance checks and 8 examinations of testing proposals

* took a decision for one testing proposal

* concluded 14 compliance checks resulting in seven 'quality observation letters' and three draft decisions being sent to companies

According to ECHA estimates, somewhere on the order of 9000 dossiers are expected to be submitted by November 30th of this year. So whereas they have been doing compliance checks on most of the dossiers received to date, they clearly will not be able to do that for all the new dossiers. The REACH regulation stipulates that ECHA should review 5% of the dossiers from each tonnage band, so in theory only about 450 of the new ones will receive a prompt and thorough review, though ECHA could choose to review more if it is capable of doing so.

All of this has ramifications for TSCA reform in the United States. It is likely that the new TSCA will have enough flexibility to utilize the data and dossiers submitted under the REACH program for chemicals that are manufactured or imported in Europe. The new TSCA should also be flexible enough to be informed by the recent Canadian assessment program.

As I noted Friday, the House will hold a hearing next week on TSCA reform and, pending Senator Lautenberg's chemotherapy schedule, I would expect the new bill to be introduced sometime in March. I'm guessing that Senator Klobuchar will co-sponsor with Lautenberg, or at the very least take over the responsibility for shepherding it through the committee process.

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