Chris Waine , senior toxicologist at Bibra Toxicology Advice & Consulting , discusses the importance of updating your REACH registration dossier before an ECHA evaluation is under way
Improving REACH dossier quality prior to evaluation
Chris Waine , senior toxicologist at Bibra Toxicology Advice & Consulting , discusses the importance of updating your REACH registration dossier before an ECHA evaluation is under way
By now , we are all probably more familiar with the ‘ R ’ of REACH than we would ever have wanted to be . More than five years have now passed since the final tonnage-driven registration deadline and ECHA continue to ramp up its work on the ‘ E ’ – Evaluation .
Evaluation in REACH
A registrant will encounter two forms of evaluation . The first is substance evaluation , which is led by member states and looks at all registrations submitted for a particular compound or element . The focus is on the possible risks to human health and the environment associated with the substance ’ s manufacture and uses .
The Community Rolling Action Plan ( CoRAP1 ) provides a three-year warning for substances for which an evaluation is forthcoming , with those considered of very high concern given priority . A new aspect , driven by ECHA ’ s Chemicals Strategy for Sustainability , is the Assessment of Regulatory Needs ( ARN ) documents .
These assessments group , sometimes controversially , structurally similar compounds to be evaluated together . Dossier evaluation is led by ECHA itself and focuses on compliance with the standard information requirements
( SIRs ) in a particular registration . It also looks at testing proposals , data waivers and other adaptations used within the dossier .
In 2022 , over 80 % ( 277 ) of the 330 compliance checks carried out by ECHA resulted in additional information being requested from the registrant by a specific deadline . 2 Meeting compliance check deadlines is often challenging , especially when additional in vivo testing is requested . This is one reason why it is so important to keep a dossier up to date .
Figure 1 - Common causes of non-compliance in ECHA evaluation decisions
Non-compliance
What might lead to a finding of non-compliance under evaluation ? The most straightforward answer is that information has simply not been included . That is to say that , for a given endpoint , a registrant has not included a study or a waiver or other adaptation . As far as compliance checks go , this is an open and shut case .
Sometimes there can be a lack of documentation . All adaptations to the SIRs have to be justified correctly and robustly . This is especially the case when the adaptation is not one of the standard options within IUCLID . ( Q ) SAR predictions used to fill data gaps need to be supported by detailed descriptions of the model used and the prediction results . Similarly , readacross approaches need to be supported carefully if they are to be accepted by ECHA . The third common pitfall is a lack of detail . This is particularly common with dossiers that were first prepared early in the REACH process , as ECHA ’ s expectations have certainly increased over time . The overarching principle is that IUCLID-robust study summaries need to have sufficient detail to enable an ECHA evaluator to come to an independent conclusion on whether or not a study fulfils the relevant information
34 SPECIALITY CHEMICALS MAGAZINE ESTABLISHED 1981