Chemical Companies Register Thousands of Chemicals Under REACH - Now What?

The first 25,000 registration dossiers under REACH - for nearly 3,400 chemicals - were submitted to the European Chemicals Agency (ECHA) by the November 30, 2010 deadline.  Over 3.1 million classification and labeling notifications were received by the January 3, 2011 deadline.  The next tier registration deadline is not until June of 2013.  So now what?  A lot, so while many companies are feeling a sense of relief from meeting the deadlines they should not get too comfortable.

ECHA has a statutory requirement to review a minimum of 5% of the REACH registration dossiers submitted.  Sure, that's only about 1,250 dossiers, right?  Not so fast.  The 5% figure is a minimum.  ECHA could conceivably review 100% of the dossiers if they wanted to, assuming they could come up with the time and manpower resources (which is highly unlikely).  But many of the dossiers submitted contain "Annex IX and X testing proposals."  For those less familiar with REACH there are a series of Annexes that list the various test endpoints for which data must be provided.  The endpoints listed in Annexes VII and VIII were required to be provided, including testing if necessary, along with the registration.  But for Annexes IX and X, which include most of the longer-term, animal-intensive, test methods, registrants were required only to provide results they already had in-house but were banned from conducting any additional animal testing prior to submission.  Instead they provided "testing proposals" indicating what additional Annex IX and X tests they planned to conduct.

What all this means is that ECHA must review all of the dossiers that include testing proposals in order to determine whether or not the proposed studies will actually inform their decision-making process.  They will not allow animal testing if they think it will not change their decision.  They also will insist that any testing be conducted in collaboration with other registrants in order to minimize animal testing.  To do this they will publish a list of substances proposing testing and ask for anyone with available data to come forward.  These third parties then have 45 days to provide valid data to address the endpoint, and assuming it fulfills the data requirement the registrants will have to pay the data holder for use of the existing data.

ECHA has until December of 2012 to respond to testing proposals received by the first registration deadline. Companies then will have a set period of time in which they must conduct the studies and update their registration dossier.  The time frames will vary depending on the type and amount of testing since some studies could take 2 to 3 years to conduct.