2013 Is Soon - Imagine this scenario: The Reach 2010 registration deadline has successfully passed for the company, and everyone puts Reach aside and returns to their previous roles. Or, consider this scenario: A downstream user receives a new extended safety data sheet and doesn't understand what they are expected to do with it. Or, a final scenario: A company holds a kick-off meeting for Reach and only one person has knowledge about the regulation, and the project team's aim is 2013 registration.

It is fair to say that people have put a lot of time and energy into understanding and applying Reach. Is this effort over once the first registration has been completed?

What Now?

For companies who have complied with their registration in 2010, what comes next? Companies need to integrate Reach compliance into their daily work routine. For example, taking data from the IUCLID database and using this in their management systems to ensure volume tracking is assured at a substance level while still working with their downstream users at a product level. The next regulatory phase is evaluation - which means manufacturers and importers need to make sure they have Reach fully integrated into their processes to monitor the continuity of production and imports to be sure the registrants are ready for evaluation by the regulatory authorities whenever that may be.

Downstream Users

Manufacturers, importers and only representatives (OR) need to ensure that downstream users receive the right information in a timely manner via the extended safety data sheets (eSDS) wthin their supply chain. The existing safety data sheets have to be modified to reflect the amendments due to Reach and CLP (Classification, Labeling and Packaging) regulations and the extension to include the exposure scenarios. This document should be provided in the necessary languages of the EU appropriate for the downstream users. Downstream users who are waiting anxiously for confirmation that their supplier registered the substance need to be satisfied that their uses have been registered - downstream users need to receive the new eSDS. The downstream users need to fall into line with guidelines of the revised eSDS, which may result in changing their current operating conditions or applying new risk management measures. In cases where uses have not been registered, the downstream users may well have to notify the European Chemicals Agency(ECHA) of these uses and prepare chemical safety reports (CSR) if appropriate. All this has to be done within a defined time period.

SIEFs

For each existing Substance Information Exchange Forum (SIEF), there are several tasks still to be considered that will add to the workload of the lead registrant (LR). Dossiers submitted in 2010 with testing proposals will need to be examined. Once permission has been granted for the test to be carried out, the workload will continue for these substances. The LR or a service provider will need to update the dossier - including in particular the CSR - to reflect the results of the new tests. The management of the SIEF will also continue. The lead registrant needs to continue monitoring new companies coming into the SIEF who want to register the substance. These newcomers will require a token number - which is a requirement to be able to submit a dossier if you want to be a part of a join submission -by purchasing a letter of access.

For some SIEFS, it is possible that the cost of a letter of access will be reevaluated based on the number of registrations recorded in 2010. This is necessary to establish the cost of the letter of access for companies wishing to register as a consequence of their lower tonnage band. This whole process could result in reimbursements for early registrants based on the agreements reached in each SIEF.

Companies with substances on the candidate list for authorization need to prepare for this next step to allow them to continue manufacturing or importing that substance. For substances listed for authorization, the companies have to start to carry out social economic analysis. This is new for everyone and the guidance documents are slowly taking shape to help industry.

Looking Beyond 2010

Up until now, the tasks that will befall the existing registrants of 2010 have been the focus of attention. Looking to the future, there will be a new wave of activities for new substances that will need their first registration in 2013. For these companies, the registration process may have begun when Reach came into force. However, many companies will be waiting to review the ways of working during the first wave of registrations before launching themselves into the Reach process. The process is likely to begin in earnest from January 2011 - forming SIEFs, agreeing on substance sameness, identifying the lead registrant, launching supply chain communication. The current impression is that more companies will be acting on their own as lead registrants and not in a consortium in this second wave of registrations.

What support will these individual companies have and from whom? First of all, the newcomers need to become familiar very quickly with the Reach legislation and the latest guidance documents that have supplemented and interpreted the legal text.
For the 2013 registration, consider the following three deadlines:

• June 1, 2012 for downstream users to declare their identified uses to their suppliers and for
  for late pre-registration of the substance for first time manufacturers or importers ;
• June 1, 2013 for the registration deadline of the tonnage band 100-1000 tons/year.

It is true to say that a lot is being learned during the first registration period: who does what, when and how. It is wise to acknowledge that there will not be a consortium for all substances. As a result, this knowledge and experience should filter through for the preparations leading to the next registration deadline. To begin with, the SIEF formation facilitator (SFF) should initiate the discussion rounds for the substance sameness and nominations to be a lead registrant. In parallel, the SFF should carry out the SIEF survey to identify the active SIEF members from the dormant ones.

Lead Registrants Should Come Forward

Companies who have to take the lead for the next registration should make themselves known as soon as possible to initiate the registration process. There may not be big multinationals coming forward to take on the role. Medium- sized companies could be expected to come forward as nominees for the role of lead registrant. When it comes to the gathering of data studies that exist, this whole exercise is time consuming - but imperative. There could be a considerable lack of data for substances with 2013 registration deadline which will mean alternative testing strategies should be considered to find supporting evidence for end point studies.

Service Providers Still Relevant

There is a need for continued support from the service providers who have demonstrated their competency and professionalism in assisting companies over the past two or three years. These service providers will be relied upon to keep things moving under Reach for potential newcomers. This is where a company such as ReachCentrum can really add value and support as they have been active since 2007 in setting up consortium services, lead registrant support and - equally important -an effective SIEF communication solution.

In conclusion, therefore, for those who have registered in 2010, Reach needs to become embedded into their current processes and continual tracking needs to be done at substance level from now on. The next registration phase will have a higher number of substances with fewer companies actively participating in SIEFs. It is evident the lessons learned from the 2010 that registrations will mean acting smarter and more effectively to improve the way SIEFs operate and prepare their registrations.

Reach has had a dramatic impact in Europe and throughout the world up to 2010. It will continue to do so, bringing with it more reviews of the existing technical guidance documents and upgrades to the IT solutions.
In short, there is no respite for companies.