Brussels, 16 February 2021 – A workshop organised by the Centre for chemical safety assessment (ECETOC) has recommended improving the EU’s REACH legislation legal text to enable more chemicals to be assessed via exposure-based adaptations (EBA).
REACH requires companies to provide information on the properties of substances through testing or by other means. But in situations where there is no human or environmental exposure to a
chemical, or it is so low that additional data will not lead to improvement of risk management, it is possible to waive some information requirements for registering the substance, so avoiding
unnecessary animal testing.
Participants from ECETOC’s EBA Taskforce, the European Commission (DG GROW), European Chemicals Agency (ECHA) and RIVM (Dutch National Institute for Public Health and the Environment) compared their experiences of EBA and how its use was often limited by ambiguous legal terminology. They then explored how to modify the legislation using a ‘threshold of toxicological concern’ to help define what should be considered ‘low’ or ‘negligible’ exposure conditions.
The ECETOC Taskforce was set up to assess the use of EBA under REACH, as well as how it could be done in a scientifically robust manner. This included the criteria for exposure and toxicity data and
how to document the case. Meanwhile, the European petroleum refining association (Concawe) has run a case-study project to evaluate whether and what EBA approaches could be practically applied to complex petroleum substances.
The workshop used the results and recommendations from both project teams as a basis for reviewing EBA procedures and reaching an understanding on how to make the best use of them without compromising the core goals of REACH, namely protection of human health and the environment. Participants also exchanged ideas to feed into the REACH Annex XI amendment proposal document for regulators and provide a platform for further discussion.
The workshop participants concluded that to improve EBA, there must be a change to the REACH legal text as well as improvements in the guidance and clarification of vague terminology. In addition, improvements in exposure information, coupled with more rigorous ways of expressing it (eg. exposure categories) would help address fears about EBA’s robustness. Finally, they said there must be a ‘change in mindset’ about relying on animal studies – instead using non-animal tests, or ‘new approach methodologies’ (NAMs), to address any concerns.
The workshop’s conclusions represented the participants’ views, rather than that of their respective organisations. The conclusions will be consolidated into an ECETOC technical report which will form the basis for future scientific and advocacy work relating to the use and improvement of EBA.
Download the report here.