The final deadline for registration of existing substances used in low volumes
(1–100 tonnes per year) as part of REACH (Registration, Evaluation, Authorisation and Restriction of Chemicals) is Thursday 31st May 2018.
Although the aspiration for REACH is to create ‘the most comprehensive chemicals database in the world’1 by gathering data on chemical substances used across European markets, the task is immense for both manufacturers and regulators. There have already been two previous phases of registration under REACH, both of which have come and gone without drama. However, the May 2018 deadline is considerably different in terms of the number of registrations and the type of registrants.
ECHA (European Chemicals Agency) estimates that there will be up to 60,000 registrations for up to 25,000 substances – this is three times more than either of the previous deadlines.1 As of 27th March 2017 there have been 8,547 registrations of 4,257 unique substances for the REACH 2018 deadline, so there is still some way to go.2 The scale of this registration phase is starting to cause some concerns, as manufacturers and regulators realise that there may not be capacity within contract research organisations to support the data generation that is required.
ECHA response to capacity issues in research organisations
Recent briefings from the ECHA 12th Stakeholder meeting in Helsinki3 stated that the ECHA are considering the situation and liaising with Member States and industry to establish any capacity issues and to assess the true scale of the problem should it exist. The ECHA have stated that if they find that capacity is a major problem limiting dossier completion, they will instigate appropriate steps to allow the submission of dossiers containing data ‘gaps’. A similar process was implemented for the previous REACH deadline.
While there was no official process in the two previous deadlines, it is likely the process will follow the best practice that was observed in those previous registration phases. If a registrant knows that they will not have complete test data in time for the deadline, they should contact the ECHA via a webform and provide detailed documentary evidence showing that they have acted in good faith and commissioned the necessary study, or studies, in good time. If the ECHA deem that this is the case, the registrant will be issued with a token (code number) that will allow them to submit the dossier to REACH-IT with data gaps, on the express understanding that the missing data will be added at the earliest possible point. The token means that the dossier would not fail the manual verification which checks for data gaps.
Who will this apply to?
If this approach is deployed it is unlikely it will be open to all registrants – only to those who can demonstrate that their dossiers are incomplete as a direct result of delays in conducting studies due to capacity limitations in contract research organisations, rather than due to a lack of planning for these studies on the part of the registrant. Registrants will need to show that they have commissioned studies in a timely fashion and not at the last minute, for example, the commissioning of a 6-month study later than October 2017 will likely be perceived as poor planning, with any subsequent capacity issue being irrelevant. How many registrants will be asking for this flexibility in dossier submission is, as yet, unclear.
So, if you are registering a substance for the May 2018 deadline, review your plans and timelines now and, if your data will not be available until after the deadline through no fault of your own, contact the ECHA.
Envigo have supported importers and manufacturers through this and previous REACH registrations, so to discuss your REACH registration, no matter what stage of the process it is at, please contact kate.newell@envigo.com.
Envigo provides essential research services, models and products for pharmaceutical, crop protection, biocides and chemical companies, as well as universities, governments, and other research organisations.
References
1. ECHA. REACH 2018 – registration deadline for low-volume chemicals. https://echa.europa.eu/press/press-material/pr-for-reach-2018
2. ECHA. Registration Statistics deadline 2018: All EU countries. https://echa.europa.eu/documents/10162/13629/reach_2018_result_stats_en.pdf
3. Musset C. Questions and answer session. ECHA. REACH 12th Stakeholders Day, 5th April 2017. http://qsb.webcast.fi/e/echa/echa_2017_0405_stakeholders_day_part3/#/webcast
