ECHA

A total of 571 dossiers with 1 184 individual testing proposals have been examined. Of these, 445 dossiers had proposals to test on vertebrate animals covering 770 endpoints. The other testing proposals concerned environmental studies, in vitro human health studies, or even simple physical chemical studies such as dissociation constant or viscosity. Draft decisions were issued in 436 cases, of which 146 have already resulted in a final decision. Nearly 130 cases were terminated due to the withdrawal of the proposals, testing already being initiated or for other reasons.

 

"For the first registration deadline the registrants had to assess whether they needed more experimental studies on the so called higher tier information requirements set out in Annexes IX and X of REACH. If they identified a data gap, they submitted a testing proposal to ECHA. So, the 571 dossiers with testing proposals submitted to ECHA reflect the status of registrants' understanding of the information gaps in their dossiers," says Leena Ylä-Mononen, Director of Evaluation, explaining the background.

 

By examining the testing proposals, ECHA ensures that the tests proposed are necessary and adequate for meeting the REACH information requirements. This is an important step forward in filling the data gaps and getting more information about the old, phase-in chemicals that have been on the market for a long time already. However, the process is long. "We are still quite far from having received the test data. Once the study is available the registrant submits a dossier update where the study is to be reflected. They might also need to update their chemical safety assessment and report and even change the self-classification. Ultimately, we should have significantly more information on chemicals helping the registrants to decide what measures need to be taken to ensure the safe use," Ms Ylä-Mononen says.

 

 

Challenges with substance identity and analogue approaches

 

Examining the testing proposals is a new process introduced by REACH and therefore has never been done before. The big wave of dossiers arriving for the first deadline and the two-year window for processing, created a considerable challenge for ECHA's scientists. "We began by screening the dossiers. Early on, we tried to identify the dossiers where the substance identity information was not sufficient to allow a meaningful examination of the testing proposals. In 25 % of the cases we actually had to open a compliance check first in order to clarify the identity of the substance. I was not expecting so many cases with ambiguous substance identity. Clearing the substance identity required a lot more work than expected and caused a slowing up of the whole process," says Leena Ylä-Mononen.

 

Another challenge was the testing proposals built on read across or category approaches. This means that the testing proposal was not about testing the registered substance but another substance - an analogue or a member of a wider category or group. "In these cases, the registrant needs to present a more thorough assessment. It is not enough to assess whether testing is necessary but also whether the hypothesis for the read across or analogue approach is acceptable and sufficiently justified. Unfortunately, in most cases we found that the justifications were not adequate for accepting the testing strategy or approach proposed by the registrants." Cases proposing read across, category or grouping approaches are very complex and therefore mainly still in the draft decision phase. "In many cases ECHA has had to reject the approach and simply request a test on the registered substance(s)," Ms Ylä-Mononen clarifies.

 

ECHA encourages registrants to improve their justifications and the substance identity information. "The ball is, in many cases, thrown back to the registrant. Hopefully they can make a better justification for their approach so that we can avoid any unnecessary animal testing."