The 31st May 2018 may seem a distant date right now but for those stakeholders who bear a REACH registration obligation for this date it is just around the corner.
The first registration deadline realised 3400 phase-in substances having been registered representing greater than 20000 dossiers. The second registration deadline brought about approximately a further 3000 substance registrations represented by approximately 9000 dossiers. However, for the 2018 deadline it is expected that 25000 substances will need to be registered, covered by an estimated 70000 dossiers. This represents an extraordinary challenge for both industry and the European Chemicals Agency alike.
The biggest concern is that many parties involved will be first time registrants and may well be unaware of the urgency to act now. Experience to date has highlighted a number of difficulties for registrants. Notable examples are substance identity and substance sameness, data and cost sharing, dossier preparation, use patterns and extended safety data sheets to name but a few. With the greatly enhanced number of registrations expected for 2018 these difficulties and others are likely to be repeated many times over. This is indeed a daunting prospect for first time registrants, especially small and medium enterprises (SMEs), who perhaps, to date, have not engaged with the REACH registration process.
In addition, given the current timeline, there exists a serious concern that there may be insufficient testing laboratory capacity to conduct any necessary studies in time for 2018 given the high number of substances involved. It is imperative that those first time registrants recognise that they have obligations and to act now. Although there is lots of guidance, help desks and consultants available to assist first time registrants these companies somehow need to find sufficient internal resource to address their obligations and not suspect that those obligations will somehow “take care of themselves” or be met by other parties. This is in addition to budgeting for the undoubted costs that will be incurred.
Once this is understood, the pressing need is to evaluate the substance inventory of the organisation. Whilst this may be straightforward for simple mono constituent substances supplied in neat form, the supply of multi constituent or UVCB substances brings enhanced complexities, which may be compounded should those substances be imported as finished products in the form of complex mixtures. Thereafter, the organisation needs to pre-register these phase-in substances as soon as possible in order to begin engagement with the Substance Information Exchange Forums (SIEFs). Although companies should have pre-registered the majority of substances in their product portfolio by the end of 2008, pragmatic strategies are still available to facilitate continued supply up until the registration process is complete.
Once engagement with the SIEFs has been established and the substance sameness has been determined, the discussions can begin about data availability, data gaps and costs. From this point there are a number of scenarios that the newcomer may face:
- For a substance that has already been registered in either 2010 or 2013, the process may not be so onerous. In this eventuality the pertinent data should already be available and the majority of the regulatory work completed. In addition, if there are a large number of SIEF members the overall costs of the letters of access may be considerably reduced since the overall cost of generating the original data package will be divided by a large number of registrants. This scenario is probably the best that the first time registrant can expect but even then complications can occur should the substance fall under additional REACH compliance issues such as substance or dossier evaluation or even authorisation.
- If the substance has yet to be registered then a lead registrant needs to be appointed. The presence of an experienced company may help, and realistically, the newcomer is unlikely to wish to take this role. However, if other SIEF members are also newcomers, or unwilling to accept the mantle of lead registrant there is a dilemma to resolve and completing the registration process will likely require external assistance. Thereafter, data availability and data gaps need to be quickly determined and a strategy agreed and implemented to fill those gaps, which may mean placing studies. As the data package is developed the dossier needs to be prepared in IUCLID and if applicable a Chemical Safety Report prepared.
Other scenarios can of course arise, e.g. the substance is unique to the new registrant although the two described above are the most likely scenarios the first time registrant is likely to face. However, in essence, first time registrants need to engage with the REACH process now in order to determine quickly what scenario awaits them in their respective SIEFs and to ensure they meet their obligations by the 2018 deadline. Failure to act now may result in companies facing non-compliance issues and ultimately having to withdraw substances from the EU market so it is vital to implement a REACH plan without delay.
Dr John Weetman
Exponent International Ltd
+44 (0)1332 868004
jweetman@exponent.com
Dr John Weetman has worked in the field of regulatory affairs for over 20 years and has supported the notification and registration of chemicals in markets across the globe. John has extensive experience as a consultant, offering strategic advice and registration services to the chemicals industry.
