Regulatory stakeholders workshop

“Guiding Industry in the Nanoform Registration Process: An overview of the requirements by the different regulatory bodies & available infrastructure for safety assessment”

2 June 2022

The workshop scope aimed to provide an overview of actual and future regulations related to engineered nanomaterials (ENMs). The workshop took place at a crucial time as new directives (how REACH is addressing nanoforms and the recommendations from the EC on the nanomaterial definition) are emerging, and the first presentations aimed to give an overview of the different steps to be implemented in a regulatory framework covering NMs. A second set of presentations at the workshop was then intended to provide insight on the data that companies need to provide regarding ENMs in articles in order to comply with regulations and on the most appropriate methodologies to use in order to generate this data. Finally, the workshop presented knowledge resources, tools, and models available within the NanoCommons Knowledge Infrastructure for the different actors of the nanotechnology sector.

June 2nd, 2022 (10:00h - 13:30h)- Virtual Workshop

First Part: The regulatory framework

  1. Introduction: NanoCommons Knowledge Base Infrastructure
  2. Nanomaterial definition and key phys-chem properties for RA purposes
  3. Key requirements for nanomaterials human and environmental RA along the life cycle
  4. Non-nano parameters and nano-specific parameters required by REACH and other regulatory frameworks

Second Part: Methodology for data/information acquisition

  1. Gathering phys-chem information for regulatory requirements
  2. Exposure Assessment - Methodologies and Tools
  3. Hazard Assessment – Methodologies and Tools (grouping approaches)
  4. Usability of NanoCommons Knowledge Base Infrastructure to support industry
  5. Virtual lab tour

Main Discussion points after the presentations:

  • NM definition Recommendation is just out for its consideration by all the regulatory bodies. It is again a recommendation and therefore not legally binding, so each sector specific regulation could adapt to the new recommendation or not (not an obligation), however the regulatory bodies have to ensure that materials put in the market will be safe.
  • There are some key properties of the materials that are required to be reported for Risk Assessment under REACH. The corresponding testing methods to be used were presented and some specific ones were discussed since their applicability is not completely clear in some cases. One of these properties, which is quite critical for RA purposes, was “reactivity or surface functionalization or surface chemistry or surface coating”. The current suggested testing methods are suggested in the REACH Guidelines. However, their application requires additional information that has to be determined by other test methods, which are still not defined or cannot be applied to all types of NMs. The importance of the ontological work initiated already in previous and running projects was stressed in the discussion. Data needs to be provided in a harmonised way to be able to involve as many data producers as possible, so that we all agree on how to differentiate between all the terms used to describe what is on the surface of the NPs.
  • There was a discussion on the usability of data and the still existing issues of how to use the data of projects that produced data and store the data in different warehouses. The need to solve the problem with the project embargos was raised, which in some cases are long. It was concluded that, as a community producing data on nanosafety, we are all responsible for generating FAIR data and that the discussion needs to be continued at the Nano-week data round table to engage the community even more broadly.

Main outcomes from the workshop:

  • Industry awareness of the scientific developments on nanosafety and how they are aligned with the regulatory requirements towards the production of safer NMs
  • Industry awareness of the data and tools infrastructure provided by NanoCommons via the NanoCommons KB
  • Identification of areas, in which the Community should concentrate their efforts on, to be able to provide industry with highly predictable models and tools by linking those to high quality and FAIR data.
  • The need for harmonisation of terminology, which at the moment is also progressing well in the nanosafety community but needs to continue in the future.