For many companies handling chemicals in the EU, pre-registration in REACH IT between June and December 2008 may seem like a distant memory.
At that time, with the final phase-in deadline a decade into the future, industry could have been forgiven for thinking that there was plenty of time to complete their joint registrations. The reality is, the half-way point is almost upon us.
Initially, over 2 million pre-registrations for over 150,000 phase-in substances were submitted by Industry; however, the European Chemicals Agency (ECHA) later estimated the total number of substances to be registered by 2018 would be a more conservative 30,000. To date, just under 12,500 unique substances have been registered representing almost 50,000 industry submissions. ECHA has yet to officially estimate the remaining number of substances to be registered but this data suggests that at a minimum a further 17,500 substances equating to 70,000 industry dossiers (based on an average of 4 member registrants per substance) will be prepared and submitted to ECHA by the deadline. ECHAs forecast for submitted registrations for 2013 was only marginally away from what was actually received. Therefore it is reasonable to expect that that 2018 will not be different. It is also widely accepted that registrations for this deadline, (>1tonne per year) will largely be submitted by Small Medium Enterprise (SME) and this presents many new challenges. It is time to consider your registration strategy and plan for 2018.
Industry must work with, not against time
While the data requirements for member dossiers are not extensive, there are many external factors that could impact upon a submission. At the onset, a member dossier cannot be submitted without a lead dossier in place. Many Substance Information Exchange Forums (SIEFs) have yet to appoint a Lead registrant and in many other cases the lead has resigned in the period since the initial submission. Contractual arrangements within the SIEFs need to be in place well in advance of any submission. It is important for potential registrants to stay informed about the activity within the SIEFs, be aware of the status of both the lead registrant and lead dossier. ECHAs dossier evaluation decisions may already be impacting the lead dossier and therefore may impact on a members ability to submit on time.
ECHA has always specified that consistent substance identification is the foundation of REACH. In order to ensure that the correct data sharing arrangements are in place within the SIEF, each registrant must submit a unique set of analytical data for the substance as manufactured or imported. Recent reports from the Agency cite substance identification as one of the most commonly detected inconsistencies within registration dossiers. Moves are afoot to ensure submissions contain accurate analytical data and correct substance identifiers prior to submission. Where such inconsistencies are encountered during compliance checks, registrants have been requested to update their data. It is important therefore that this data is accurate the first time. The projected number of registrations has the potential to place enormous pressure on industrys capacity to complete or have this testing completed ahead of the 2018 deadline.
Lessons and best practices learned
Since the beginning of the REACH registration process, many hard lessons have been learned as industry grappled with IUCLID 5, substance identification, SIEFs and substance sameness rules.
With ongoing updates to registration rules and ECHAs IT tools, failure in some cases of the Lead to submit the dossier on time and requests for further information from the regulatory authorities, compliance may seem like a moving target.
In these dynamic times, we at H2 Compliance are confident that our Registration team with over 6 year’s registration experience can support your registration needs to 2018 and beyond.
Speak to us about tailored registration programmes, laboratory testing oversight, substance identification and sameness determination and dossier build services.
It’s time to REACH for 2018.
