Wednesday, December 23, 2009

European Chemicals Agency (ECHA) Ready for 2010 Chemical Registration Deadlines - They Hope!

The European Chemicals Agency (ECHA) in Helsinki, Finland, is working hard to get prepared for the expected onslaught of registration dossiers that will be submitted in 2010. ECHA is putting some contingency plans into place as the first deadline for registrations - for high volume and high hazard chemicals - comes due on November 30, 2010.

While that seems like a long time from now, it isn't. Companies have been working hard for the last 2 years trying to get organized and coordinate with other companies that manufacture or import the same chemicals into Europe.

Two of the contingencies are a "back-up" IT system and a task force to monitor SIEF activity.

Currently all legal entities are required to submit their dossiers through ECHA's online REACH-IT system. Given that the system became overloaded and hard to access during the pre-registration period in 2008, where 2.4 million pre-registrations were received when only about 400,000 were expected, a back-up system is probably a good idea. ECHA has invited bids from three consortia for a contract to develop the back-up in the event of a total collapse of its REACH-IT system.

Another contingency is to appoint a team to monitor the activity of lead registrants and substance information exchange forums (SIEFs). SIEFs are the forums mandated by REACH in which all manufacturers, importers, and "only representatives" are required to work together to share data so as to limit unnecessary animal testing. Once hired and trained, the team will assess various scenarios ranging from a low number of submissions to a very high number of submissions. They will also be empowered to deal with any problems arising in the SIEFs that might endanger successful registrations by the deadlines. Given the ongoing problems many SIEFs have had getting organized and forming consortia, a little help from ECHA is likely to be very much appreciated by industry. In fact, industry has been pushing for more help in meeting deadlines for a long time.

Another welcome sight was last week's release of much anticipated "technical completeness check tool." The TCC tool will enable registrants who have prepared the data in the IUCLID5 database to run the same automated check that ECHA will run once the registration dossier is submitted. To date, many of the early registration dossiers have failed to pass the completeness check, which automatically rejects dossiers even for minor deviations. Pre-checking with the TCC should mean most dossiers will pass the ECHA check quickly, and minimize any bottle-necking as companies find that everyone else is also trying to submit their dossiers at the last minute.

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