ECHA is sounding the alarm over critical gaps in analytical methods for nanomaterials, warning that without urgent action the foundations of chemical safety regulation could be undermined.
The agency is pressing for faster completion of OECD test method revisions under the Malta Initiative, flagging the work as overdue and essential to keeping regulation functional.
Key unresolved areas include toxicokinetic characterisation, biodegradation, bioaccumulation, and long-term effects on soils and sediments, alongside the validation of new approach methodologies for regulatory acceptance.
ECHA Highlights Regulatory Challenges and Research Needs for Nanomaterials
Summary
In June 2024 ECHA published a document highlighting research needs to ensure that the regulatory frameworks remain robust and effective for the chemical safety assessment. The document also included nanomaterials, acknowledges the vast amount of research performed on the adaptation of testing guidelines and guidance for nanomaterials but still highlights that there is a lack of information as well as availability of analytical methods to ensure a proper assessment and these issues could challenge the efficiency of chemical management. The document highlights the missing methods as critical and reports a need for New Approach Methodology (NAMs) validation, so they can be regulatory accepted. Physico-chemical characterisation methodologies to support toxicokinetic assessment, as well as biodegradation, bioaccumulation and long-term effects on sediments and soils are presented as regulatory needs. ECHA highlights the critical need to urgently finalise the ongoing OECD test methods and guidelines revisions under the Malta Initiative as well as the Malta initiative priority list.