"Companies should set up a process to address the legal requirement to keep dossiers updated and to demonstrate that they take chemical safety seriously." ECHA
NCEC’s Chris Hughes attended the REACH dossier compliance workshop, hosted by the Bundesinstitut für Risikobewertung (BfR) and co-organised by German Environment Agency (Umweltbundesamt – UBA) and European Chemicals Agency (ECHA). Here are some of his reflections.
This workshop was a fascinating 2-day deep dive into the regulation, focusing on the state of current REACH registration dossiers, the effectiveness and deficiencies of current regulatory processes and instruments, the legal requirements and the available policy options. Issues such as the ECHA target of evaluating 5% of REACH registration dossiers (per Article 41) and the current (dis)incentives for registrants to update their dossiers were key topics of discussion.
The meeting was well-attended, with representatives from national and EU regulatory bodies, industry and NGOs, and brought into sharp focus the divergence of views on how industry has been doing with respect to keeping its dossiers up to date and what constitutes compliance.
Results of BfR/UBA dossier compliance project
A major focus of the meeting was to disseminate the findings from a joint BfR/UBA project investigating the state of compliance of REACH registration dossiers. The study looked at around 4000 substance dossiers from the >1000 and 100-1000 tonnage bands and covered selected health and environmental hazard endpoints from the standard information requirements Annex VII-X, plus aspects of consumer and environmental exposure assessment. Compliance of endpoints was assessed based on whether a relevant study was presented, or whether approaches to adapt the standard information requirements were in accordance with Annex XI, or with endpoint-specific “column 2" criteria.
Overall the results of this investigation were that only 31% and 44% of endpoints checked were found to be “compliant” for the > 1000 tpa and 100-1000 tpa substances, respectively. The remainder were found either to be “non-compliant” or “complex”. A conclusion of “complex” meant that they could not be concluded within the scope of the project and included examples such as where read-across was used, and where references to the chemical safety assessment were made. It is perhaps important to highlight that these assessments did not include an evaluation of the scientific validity of either the studies presented or the justifications used for adapting the standard testing requirements, and hence the results could be subject to change following a more detailed investigation.
In addition to the results, a series of recommendations were included as to how the quality of information could be improved, and dossiers made more compliant. These included providing documentation to support the use of QSARs (QMRF/QPRFs) and read-across justifications in line with the ECHA read-across assessment framework (RAAF). These could be seen as ‘low hanging fruits’ to improve dossier compliance without having to resort to further testing.
Industry gave a good account of itself at this meeting, with CEFIC highlighting the joint agreement it signed with ECHA to improve the implementation of REACH, and the enormous effort industry has already made to get to where it has with the preparation and submission of registration dossiers by the various phase-in deadlines. CEFIC was also keen to remind that by 2005 it had committed to help REACH to work “as well as possible” and has since contributed much to the development of guidance, tools and approaches to support its implementation, such as the guidance on substance identity profiles (SIPs), which is now adopted by ECHA.
In response to the outcome of the BfR/UBA project, industry was of the view that the majority of registration dossiers that had been submitted were robust. It was suggested that a possible reason for the rather stark results of the project was a difference in the interpretation of what is acceptable within the scope of options described in Annex XI. I have to say I have some sympathy with this viewpoint, having worked on the preparation of dossiers for the 2010 phase-in deadline. During that time my colleagues and I were certainly of the view that the dossiers we were preparing were scientifically sound and in accordance with the requirements set out in REACH.
There was disappointment expressed by some that there had not been more dialogue with industry to understand these results before presenting them in the context of whether the legal requirement to evaluate at least 5% of dossiers should be revised. From my perspective, it seems like a more detailed, collaborative look at dossiers to address the approaches applied by industry is needed, and this could be used to establish clearer guidance and examples of what is acceptable and what is not in terms of justifications to adapt the standard testing requirements.
On the topic of the Article 22 requirement of registrants to update their dossiers when new information becomes available, again issues of interpretation were highlighted. For example, does new information need to be added when it does not alter the hazard classification or outcome of the chemical safety assessment? Also, the quality of new information can sometimes be problematic, particularly when compared against OECD tests conducted in accordance with good laboratory practice (GLP). It was concluded that the necessity to update dossiers needs to be considered on a case-by-case basis.
A further ‘pain point’ was pointed out during discussions that dossiers submitted in 2010 would not pass the completeness checks of IUCLID6 in their current forms, and this makes any update far more onerous than simply updating the endpoint in question. A means to make this process easier might encourage more proactive dossier updating.
ECHA took the opportunity in the meeting to take stock of the situation having now passed the 2018 REACH registration deadline, and to outline its vision for the coming years. They reminded everyone that registration was only the start of the REACH journey and announced a number of planned changes to the evaluation process to address the outcome of the latest REACH Review.
ECHA's feedback and vision for the future
Although fewer 1-100 tpa REACH registrations had been received than was expected, they are still continuing to come in after the May deadline, and the number of submissions received overall is now getting close to initial estimates and similar to the number of substances understood to be on the US market. It was stressed that those who have not yet registered should bring themselves into compliance ASAP. ECHA’s aim is to disseminate the information in this latest batch of registration documents by the end of 2018. They also intend to assess confidentiality claims and verify the status of all SME registrations in the near term.
ECHA signalled its intention to target dossiers that had not been updated since 2010 for evaluation (67% of all dossiers have never been updated). Since 2016 it has been running enhanced completeness checks and these have shown that, with ECHA’s encouragement, registrants have been able to fulfil the information requirements through testing or improved justifications. However, in a few cases ECHA has actually used its powers to revoke REACH registrations due to unacceptable dossiers. They pointed out that results of compliance checks (CCH) are visible on the ECHA website, from which the names of registrants and the frequency at which they have updated their dossiers is visible to the public. ECHA CCHs also have fixed binding timelines, which can cause significant unplanned disruption. These were some of the reasons why timely proactive updating should be preferable to receiving CCH decision letters according to ECHA. It was suggested that companies should set up a process to address the legal requirement to keep dossiers updated and to demonstrate that they take chemical safety seriously.
Announced changes to ECHA’s evaluation processes included applying substance and dossier evaluation processes in parallel to improve efficiency, using grouping approaches for substance evaluation where possible, and expanding decision letters to all members of joint submissions. The latter point is perhaps the most immediately relevant as a procedural change and would mean that all members of a joint registration would be equally responsible for addressing the issues raised, and equally liable for enforcement action should they fail to do so. This is intended to support continued collaboration now that SIEFs no longer exist and is also expected to improve overall levels of dossier quality. The grouping of substances for evaluation is also interesting and might help to address some of the perceived issues around fairness and the appropriate generation and use of data in the current process.
These changes are likely to raise a lot of questions and bring some added complexity, and ECHA is planning a webinar in September to provide clarity around this.
Finally, ECHA’s objective for the near term was to address the World Summit on Sustainable Development (WSSD) 2020 goals. For chemicals ECHA sees success factors for this as:
• Robust data available on all chemicals in Europe
• Putting in place effective regulatory risk management of the most dangerous chemicals
• Effective communications take place about safe use up and down supply chain
In addition to this aspiration, ECHA’s focus will also be to implement the actions from the REACH review, and to continue to push to get REACH recognised around the world as the best-in-class for regulation of chemicals.
Overall, I would say that this was a very well-organised meeting where useful information was disseminated and that, whilst heated at times, ultimately it seemed to be a well-balanced debate.
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