Advancing the Regulatory Mechanisms for Nanomaterials
The Blue Frog led consortium and ECHA funded project 'Nanomaterial Risk Assessment: A Regulatory Way Forward for Sameness & Grouping Approaches' has come to a close.
The project was led by Dr. Kai Paul, Principal Regulatory Consultant and Head of NAMs & Nanomaterials at Blue Frog Scientific.
Kai will be attending ToxExpo in San Diego to present a poster and disseminate the findings in full.
Poster Title
A Regulatory Framework for Assessing the Variability & Safety of Nanoforms in the EU to Reduce Industry and Animal Burden
Wednesday 1:45 - 4:15pm
ToxExpo, Hall B
Poster Board K692
Abstract Number 5138
Nanoform 'Sameness' & 'Similarity'
The project purpose was to expedite the understanding of nanoform 'sameness' and 'similarity' assessments to advance the regulatory mechanisms for nanomaterials under Regulation (EC) No. 1907/2206 (herein: REACH).
At the outset of the project the main goals were:
Identify cut-off criteria for nanoform characterisers to inform the registrant of boundary compositions setting:
a. These rules (e.g. cut-offs, fold-differences, thresholds) must lead to the nanoforms having the 'same' profile.
b. This framework is for identifying groups of nanoforms so similar they can be considered a single nanoform, or be used to develop nanoform Substance Identity Profiles (nanoSIPs).
- Develop a systematic framework and/or rules for clearer registrant requirements and evaluation criteria for sets of similar nanoforms
This poster will compare the non-nanoform regulatory compliance mechanisms with that of the nanoforms, to highlight aspects missing for nanoforms. We'll then explore how the project has addressed this by developing the aforementioned framework based on current state of research and applying three case studies to explore the validity of a decision tree framework for 'sameness', and supporting possible 'sameness' algorithms from mathematical approaches. The comparative strength of each assessed in the context of regulatory preparedness.
The poster will provide a whistle-stop tour of the project, highlight regulatory and scientific gaps and present aspects of the applied methods, with Kai on hand to field any questions.
If you have interest in the topic, but can't be there on Wednesday, Kai will be attending the conference and will be found at booth 2543. Or call or email and speak with Kai directly anytime.
