Prepared June 2013
The first and perhaps most obvious lesson is not to leave everything to the last minute. Although there were few examples of potential registrants missing deadlines, there are many examples of dossiers being submitted that had been rushed; to be fair to those compiling these dossiers, the individuals involved (consultants, technical staff etc) were not always given satisfactory information with which to work.
Either way, do not delay if heading for the next deadline.
The other main lesson that seemed to have been learnt quickly by those working on registrations is that organisations that cooperate and try to resolve issues efficiently for the common good, without personal agendas, end up with an easier time. Those (fortunately limited) cases where some registrants attempted to profit from others ended up in a mess with higher costs for everyone.
About 4500 substances were registered in the first phase of > 1000 t substances (2010 deadline) and if already registered, the lead registrant (or SIEF manager / consortium manager) should have already been in touch at some point. If there has been no contact with other potential registrants, the first thing to do is check the list of registered substances on the ECHA web site (disseminated dossiers). More registrations were made in 2013.
Either way, it is important for 2018 registrants to be pro-active and not to wait for existing registrants to get in contact. In many cases, potential registrants will be contacted by the existing lead registrant and an offer made to buy into an existing registration by way of a letter of access. In doing so, you will be a ‘joint registrant’; whether what you pay for access is fair or not is up to debate.
The most contentious issue is the payment for access. REACH legal text states that cost sharing and compensation for costs of data generated previously should be ‘fair and equitable’. What is fair for one organisation is very likely not going to be fair for another. There needs to be flexibility in cost sharing and lessons from 2013 demonstrate that disputes can cost more in legal fees and management time than the letter of access costs.
If buying a ‘letter of access’, the key item is the ‘token’. The electronic token to allow access to joint submissions is provided by ECHA and is obtained by the lead registrant.
If not already registered and the 2018 registration needs to be started from scratch, the lessons learned can be put into practice. In addition, more data are now available for read-across from substances already registered. Many existing registrants will also be registering in 2018 and they will have gained experience, and even if not wanting to take the lead themselves, those new to registration should listen to experiences from first time around.
The endpoints that need to be addressed for registrations in the 1 – 100 t band is described in Annex VII and VIII of REACH. Even though this is a shorter list than Annex IX, this is still a significant set of endpoints and if performing tests for all endpoints, the cost would be up to €200 000. Fortunately, as with the high band registration, it is possible to cover many endpoints by using read-across or modelling or justify not testing by requesting a waiver.
In a surprisingly large number of cases, the amount of testing required can be quite low thanks to alternatives to testing. Guidance provided by ECHA describes the ‘intelligent’ testing strategy to reduce the burden of testing and to specifically avoid animal experiments. Denehurst can provide support on waivers and testing if needed.
Working with others
When working in a SIEF , it is important to ensure that a balance is struck between constructive cooperation and caution. Those joining in an existing consortium or existing SIEF (or Joint Submission if already registered) may find established rules, systems and relationships. However, any new member has the same rights as existing members with respect to REACH and data sharing and can also attempt to make changes to existing systems; the commercial part of SIEFs, Joint Submissions and consortia are subject to the same rules as any other industry group.
However, it is recommended to try to fit into existing frameworks where possible, remembering time and effort (and perhaps legal costs) making changes to agreements diverts resources away from the more pressing need to register and assess safety of substances.
Taking the lead puts you in control of the registration and means that you can set the pace and ensure that the registration is to your standards on time and the extra work in doing this may be worth the effort if the success of the registration is an important business issue. Many lead registrants though find themselves in this position because no one else has volunteered or if they are in a SIEF of one.
Joint registrant – active
If taking an active role, the registrant will be contributing to debate on matters such as the SIEF agreement, data evaluation, classification, dossier preparation, cost control etc.
Joint registrant – passive
Taking a passive role may seem attractive, but by not getting involved in decision processes or meetings, there is less control. For substances that are not critical for your business or if there is a high level of confidence in the others working for registration (for example, if in the hands of a consortium) then letting others get on with it may be an advantage.
Even if ‘passive’ it is strongly recommended that you continue to check on progress and perhaps be ready to take a more active role if it is thought that progress is slow.
Once submitted, successful registrants passing the technical completeness checks and business rules will received through REACH IT a ‘reference number’ starting 01-. This is the registration number and the last four digits are unique to the registrant. Substances are being slowly reviewed, but it is very likely that registrants (either for newly registered substances or if joint registrants joining an existing registration) will hear nothing about their registration for a long time. The majority of issues arising are following checks on substance identity and sameness within the SIEF.
Even 2018, is not the end of the registration process. There will potentially be new joint registrants beyond that and after 2018, it is important to remember that any new manufacturer or importer will need to register and therefore obtain a letter of access. Data access will be free 12 years after it is submitted to ECHA, but there may still be some cost sharing issues for access to additional data, collective exposure scenarios etc. Any SIEF or Joint Submission agreement should take into account future activities and refunds may be applicable as new income from later registrants is disbursed among earlier registration – check these details in any agreement.
Denehurst Chemical Safety Ltd
REACH Registration in 2018
After the initial phase of registrations in 2010 and 2013, many lessons have been learned. However, for many registrants, the 2018 deadline for substances manufactured or imported in the range 1 – 100 t will be their first experience with registration under REACH.
One key lesson from the first round of registrations was that it is perhaps not as scary as first thought and the costs have so far been below those predicted by industry groups. Again, contrary to the fears of many, industry has worked well in handling of SIEFs and consortia and in many cases (but not all) cost sharing has been fair and transparent.
Denehurst can help by providing support and training to help industry help themselves for registration and if necessary, provide expert support for data analysis, test programmes, classification, CSR etc. Although, under exceptional circumstances, Denehurst can prepare registration dossiers, we will typically encourage industry to attempt this themselves, under supervision if needed.
Support is also offered with SIEF agreements and fair sharing costs. Guidance on cost sharing is provided.
Those due to register need to determine whether the substance has already been registered; if it is a phase-in substance and the new registrant has pre-registered, there should have been communications in the SIEF already.
If there has been no contact yet from other potential SIEF members, you must initiate contact now as time is running out
You may find yourself the only registrant !