May 21, 2024 by Becky Marks
The long-awaited consultation on the Alternative Transitional Registration model (ATRm) under UK REACH is now open, with two of the key takeaways from the new proposals being:
- Reduced hazard requirements for transitional substances, with only classification, PBT (persistence, bioaccumulation and toxicity) conclusions, PNECs (predicted no effect concentrations) and DNELs (derived no effect levels) required, plus some phys-chem and environmental fate data if exposure and risk assessment is triggered.
- Enhanced use and exposure data requirements, at three different levels depending on tonnage and hazard classification.
Having carried out an initial review of the proposals, and with wca colleagues recently attending talks from Defra and HSE representatives at the recent ChemUK trade event, there is clearly a balance to be struck between protection of human health and the environment, and minimising excessive costs to industry (which could potentially lead to a reduction in chemicals on the UK market). At wca, we have spent many years working with clients to help them negotiate the practical aspects of EU (and now UK) REACH and can already foresee some potential issues that would need to be ironed out if these ATRm proposals are to be adopted. For example, the proposals (presumably) remove the need for UK REACH registrants to purchase access to full EU REACH datasets for the purpose of registration, significantly reducing the financial burden on UK companies. However, data access issues may still remain if EU REACH DNELs and PNECs are used for UK REACH registration. What is more, if DNEL and PNEC values are taken directly from EU REACH dossiers, without access to the supporting studies that underpin them, verifying the suitability of these values for risk assessment purposes will not be possible. Additionally, best practice for EU REACH requires dossiers to be continually updated, as new data become available and guidance changes. If UK REACH registrants reference PBT conclusions, DNELs and PNECs based on EU REACH dossiers, there would be a need to stay on top of any changes or risk being ‘left behind’. Consideration should also be given to the perception by EU REACH registrants if these conclusions are referenced without paying for access to the test data, as EU registrants will have spent significant sums of money on testing.
wca will continue to consider the proposals in order to explore how they may work in practice, and we will be responding to the consultation questions. Ultimately, we hope that a registration approach can be implemented that provides a workable solution for all stakeholders, so that we can support our clients with the next steps in the UK REACH registration process.
If you have any questions on UK REACH, or the ATRm proposals, please contact us.