Following on from our last blog about ECHA-instigated updates to REACH registration dossiers (e.g. following an ECHA Evaluation (draft) decision), it’s worth taking a look at the update process more generally: Why are updates so important and how should we go about actioning them?

A 2017 external report on dossier updates (commissioned by ECHA) indicated, somewhat alarmingly, that over 60% of the registration dossiers submitted since 2008 have not been updated. In the eyes of ECHA, registrants are “duty-bound” to keep dossier content up to date, with the requirement to report any new relevant available information concerning their registration “without undue delay”. In this regard, a REACH registration should be viewed as an ongoing process, and proactive reassessment and spontaneous updates are recommended to keep the dossier of high quality and current, prior to ECHA scrutiny.

Dossier updates are an integral component of the overall chemical assessment process; robust and up-to-date data provide the most relevant information in assessing the safety of substances and for risk management purposes, resulting in more appropriate protection of human health and the environment. It is therefore key that registrants conduct comprehensive periodic literature searches in combination with company data-gathering exercises, to ensure that any recent data of relevance to an update are identified and incorporated into IUCLID dossiers.

It’s worth noting that ECHA publicly disseminates a large chunk of the REACH registration data on its website (with plans to extend this drive for transparency further still). A good quality dossier, produced on the basis of high-quality and current data, can therefore be important for how your company and business is perceived in terms of its regulatory/safety responsibilities.

Revisions to the REACH Standard Information Requirements (SIRs) in recent years along with the rollout of IUCLID version 6, provide extra drivers for dossier updates. One key point to flag up concerns the way that alternative approaches to testing (e.g. in vitro test methods and read-across) are now handled or presented. For endpoints where validated in vitro approaches have been developed (e.g. skin irritation), the individual Endpoint Study Records (ESRs) in IUCLID have been tailored accordingly. In cases where existing in vivo data enable a confident conclusion on the hazard potential of a chemical for a particular endpoint, a justification for not providing in vitro test data should be included in the dossier as a data waiver. Following publication of the ECHA (2017) Read-Across Assessment Framework (RAAF), where read-across is used in a registration, the extent of justification expected by ECHA is now much greater than in previous years. Attaching a separate read-across justification report in IUCLID provides a neat way of achieving this. In all cases involving non-animal approaches, registrants should strive to ensure that there is appropriate, adequate reporting and scientific basis in the updated version of IUCLID.

Perhaps of most importance to any update, would be the inclusion of novel hazard data which may act as a trigger for changes to the documented classification & labelling and/or the dose-response characterisation for human health or the environment (e.g. the calculation of DNELs/PNECs), and also new uses and novel exposures, since these would have direct consequences for the chemical safety assessment. It is critical that all registrants endeavour to ensure that the information provided is up-to-date and that human health and the environment are adequately protected.

The bibra team are experts in searching for, identifying and critically evaluating data of relevance to REACH submissions. If you would like to discuss how we can help with updating registration dossiers, or with any other REACH-related enquiries, please drop us a line.

 

 

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