With tighter regulations coming in and compliance under scrutiny, it is time to take a closer look at your REACH dossiers. Chris Hughes, Principal Consultant at the National Chemical Emergency Centre (NCEC), shares his thoughts based on many years’ experience supporting organisations with their REACH regulations.
REACH requires the manufacturers or importers of substances to submit a dossier documenting the identity and properties of a substance, and how it is used safely. It is a legal requirement of REACH Article 22 for registrants to maintain compliant dossiers and update them in the light of new relevant information.
In 2018, the German Federal Institute for Risk Assessment (BfR) and the German environment Agency (UBA) published a report claiming that only one-third of the approximately 3,800 REACH registered dossiers that were investigated met the information requirements. The remaining two-thirds were split 50/50 between those that were non-compliant and those where more investigation was required to confirm compliance.
The European Chemicals Agency (ECHA) and the European Commission (EC) have since created a Joint Action Plan to address the lack of compliance with the information requirements in dossiers. Industry associations, such as the European Chemicals Industry Council (Cefic) and Eurometaux, have also launched initiatives to promote the improvement of dossier quality among their members.
ECHA conducts automated and manual completeness checks on both new and updated dossiers. International Uniform ChemicaL Information Database (IUCLID) software is used when submitting information to ECHA and using the automated ‘Validation Assistant’ plug-in is useful to show if your dossier is technically complete. However, it does not include aspects of ECHA’s manual checks. The manual checks cover aspects such as substance identification, justification for waiving standard information requirements, testing proposals on vertebrate animals, chemical safety reports (or justification for waiving these) and specific requirements for nanoforms.
A complete dossier is essential, but it is also vital to ensure that your dossiers are compliant with the information requirements, including scientifically robust justification of any adaptations from the test endpoints used. This extends to checking if new evidence relating to your substance(s) or new guidance recommended by ECHA has been published since submitting your dossier.
Particular issues to be aware of include:
Around 20% of registered substances are known as substances of unknown or variable composition, complex reaction products or of biological materials (UVCBs). These complex substances are particularly challenging to characterise and to assess their hazards and risks, and are a common source of issues when checking the compliance of registration dossiers.
Read-across is an application of the grouping concept, whereby existing data from one or more analogous substances (‘source chemicals’) can be used to fill a data gap for an endpoint of another substance (‘target chemical’). While read-across has been employed extensively in some dossiers, guidance provided by ECHA has evolved, meaning that early justifications may no longer be compliant.
QSAR models are used to predict properties of substances based on their chemical structure. These models can sometimes be used in place experimental data, for example to reduce animal testing. However, they require a robust scientific justifications and many dossiers are lacking this information. Accepted QSAR models are generally not available for complex toxicological endpoints.
It is also important to ensure that test information remains up to date and is appropriate. Using tests not suitable for the substance affects the quality and validity of the data, which could trigger unnecessary further testing and/or further regulatory risk management.
If one or more of the information requirements is deemed to be non-compliant by ECHA, then the registrants will receive decision letters requesting additional information. In April 2020, an amendment to REACH was adopted requiring ECHA to increase the number of checks it carries out from 5% to 20% of dossiers to improve the compliance of REACH registrations. In addition, it has committed to screen all dossiers in the tonnage band of over 100 tonnes/year by 2023 and for the tonnage bands 1-100 tonnes/year by 2027.
REACH Article 22, requires registrants to update their dossiers ‘without delay’ when new and relevant information becomes available. A new implementing regulation has clarified the deadlines for updating different types of information. This regulation imposes legally binding deadlines of between 3 and 12 months to update dossiers, depending on the circumstances and type of information. Failure to comply with these timelines would mean the dossier is non-compliant and could lead to fines or other enforcement action being taken against offenders.
A proactive approach to dossier compliance can reduce the risks of unexpected costs and disruption from urgent regulatory demands for data and leads to lower costs of REACH compliance.
By conducting a manual review of your dossiers, you can demonstrate that you are complying with the requirements of REACH and with industry standards to update and maintain your registration dossier. By putting the time in now, you can save time, costs and disruption in the long run.
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