ECHA

We can all recognise quality when we see it. There is a sense that expertise and appropriate resources have been employed in a focused and considered way. The result feels substantial and secure.

And so it is with REACH. ECHA has been making a lot of noise in recent months about the quality of registrations. Striving towards improved standards in the information provided by registrants, it is offering various forms of help and advice. At bibra, we think this should be applauded.

If this complex and challenging piece of legislation is going to be effective, then those evaluating and using the information need to be confident that the details can be relied upon. In ECHA's own words: REACH is about making Europe healthier, safer and more prosperous; knowing more about the chemicals we use is crucial to this.

There is much help available – including guidance, webinars, plug-ins and national helpdesks – and experience with the 2010 and 2013 deadlines has highlighted a number of key areas where further improvement can be made.

In March of this year, ECHA published its annual progress report (2013) on evaluation under REACH, which made for some rather disappointing reading on quality. By the end of 2013, ECHA had evaluated 1 130 of the registration dossiers submitted for the 2010 registration deadline – exceeding the 5 % target set out in REACH. Of the 928 evaluations concluded in 2013, ECHA found that 61 % of the dossiers did not comply with one or more REACH information requirements and sent draft decisions to registrants for more information or improvement.

Perhaps this high proportion of non-compliance is not that surprising, given the complexity and technical expertise that is required by industry to manage REACH. Indeed, many of the registrants that we work with have had no, or little, direct experience of putting together a registration dossier. Like any technical skill, it is continual hands-on practice and the knowledge that comes with this that can make achieving a satisfyingly high level of quality part of routine work.

One thing is for sure: ensuring high quality takes planning, good organisation and an awareness of timelines. It is surprising how lengthy a process it can be to put together a satisfactory registration dossier, particularly when you need to consider all stakeholders.

Although the resources needed can be somewhat daunting, REACH does provide many opportunities to maximise the use of existing information and make reasoned arguments for non-testing.

Like ECHA, we would encourage companies to conduct comprehensive and ongoing literature searches to make sure they always have the most robust data at their fingertips, and to keep their dossiers up-to-date. This is a relatively straightforward and cost-effective first step to ensuring quality.

Bibra is fortunate in this regard, as we have been searching and collating physical-chemical and (eco)toxicity data on chemicals for over 50 years, and this has given us a good insight into the pitfalls and limitations of the numerous available data sources. Indeed, over 25 years ago we designed our own in-house toxicity database, TRACE, which is listed in ECHA's guidance on information gathering as a valuable source of toxicity data. Since then, we have been maintaining, updating and populating this resource.

Our experience has shown the importance of good data searching for high quality dossier submission. In one example, pre-neoplastic lesions were observed in a repeated dose toxicity study with a substance intended for registration in 2010. Inclusion of a testing proposal in the dossier for a carcinogenicity study was recommended by the members of the consortium as they had failed to identify a long-term study. However, further searches were suggested. This was agreed and we identified an early, published, two-year carcinogenicity study in the TRACE database. Inclusion of this reliable study enabled a successful registration in 2010, without the need for a testing proposal or a possible future (costly and animal-intensive) trip to the testing laboratory.

ECHA highlights that registrants still have difficulty in robustly substantiating any adaptations of the standard testing regimes using waivers, (Q)SAR and grouping or read-across approaches. Although the Agency has provided guidance, this is by no means straightforward and expert knowledge is a prerequisite.

Any move away from the standard REACH approach or guidance needs to be fully justified, using clear, scientifically-sound explanations. For example, in the absence of reliable and relevant data on the substance intended for REACH registration, reading across endpoint-specific data from a suitable surrogate (or group of surrogates) is possible. The choice of appropriate read-across candidate(s), assessment of the suitability of the data and provision of a robust read-across justification (including generation of a comprehensive data matrix) requires considerable expertise. Indeed, ECHA has warned registrants that they will be asked to improve dossiers that lack a robust read-across justification.

But it can be done. We have been involved in a number of REACH registration projects that have included detailed read-across justifications for the 2010 and 2013 deadlines. This has enabled registrants to submit a scientifically robust registration dossier for their substance, with peace-of-mind and without the need to resort to testing. It is our expectation that an even greater reliance on adaptations of the standard testing regimes (including read-across data) will be a feature of the lower-tonnage substances at the 2018 deadline.

It is clear from ECHA that these are the areas where particular focus on quality is needed and it is here that companies are likely to fall short of ECHA's ever rising bar.

Philip Copestake, Principal Toxicologist at bibra
Richard Young, Senior Toxicologist at bibra
Chris Waine, Toxicologist at bibra

Bibra toxicology advice & consulting provides expert support in all aspects of chemical hazard and risk assessment.

Philip Copestake.	Richard Young.	Chris Waine.

All images: bibra