31 May 2013 is the next deadline for industry to register all phase-in substances manufactured or imported in the EU above 100 tonnes a year under REACH.

REACH promotes innovation in the evaluation of chemical substances and foresees the use of alternative non-testing methods to meet information gaps. However, industry has been cautious in accepting the use of such methods, e.g. QSAR or in silico methods (computer modelling) and appears reluctant to replace their traditional test methods, with what is perceived as an unsubstantiated result with a level of regulatory risk.

With an increased number of registrants expected in 2013, it is critical that industry shed its concerns and embrace alternative testing as the smart thing to do. Besides the obvious benefit of reducing the number of in vivo studies, in- silico testing can significantly reduce the testing timelines and costs associated with animal experiments. It is expected that there will be a shortage of laboratories, significant delays in testing and increased charges as 2013 approaches. In addition, with more 2013 registration to manage, in-silico methods can help predict risk and to prioritize the experimental testing that must be done.

There are many valid and suitable models available today, e.g. OECD toolbox and ECHA has stepped up its efforts to promote their use and regulatory acceptance. It is important that QSAR is used and applied correctly and ECHA will expect you to demonstrate that the application to a particular chemical is scientifically justified, that the results are acceptable, and that appropriate documentation is included. Hence, most registrants will need the assistance of a knowledgeable person with experience in the use and limitations of the models.

With 2013 fast approaching, now is the time to plan. As a registrant needing to meet the extensive testing requirements, whether as a lead or joint registrant, you can’t afford not to consider the use of alternative testing methods for select endpoints.

Joint Registration: Lessons learned from 2010

For the Tier 1 deadline, roughly 5,000 unique substances had registration dossiers submitted to the European Chemicals Agency. This equated in total to approximately 25,000 registration submissions; on average 5 per substance. Despite the initial concerns, it appears that for the most part the SIEF process worked effectively and that Joint registrations were the preferred option for registrants to fulfil their registration obligations.

Looking forward to 2013, there should be less uncertainty about the Joint Registration process as companies are more knowledgeable about the key tasks and timelines for registration. However, companies should apply any lessons learned from 2010 to ensure a smooth path towards 2013.

Contact H2 Compliance today to let us guide you through your compliance issues.