Reports

NIA Meeting Report on the ECHA Nanomaterial Expert Group 19

NIA Meeting Report on the 25th MEETING OF THE WORKING PARTY ON MANUFACTURED NANOMATERIALS (OECD)

MXenes are emerging as a major regulatory blind spot, with critical data gaps on pulmonary toxicity, genotoxicity, and environmental fate, and serious questions about whether existing test methods can handle their unique properties at all.The long-awaited OECD guidance on sample preparation and dosimetry for nanomaterial safety testing has been approved for release, updating a framework last revised in 2012.3D printing is now on the OECD's radar as a nanomaterial exposure concern, with emissions of VOCs, particulates, and free radicals flagged as particular risks in consumer and educational settings.A new ring trial planned for 2026 will test whether a standardized bioaccumulation protocol for nanomaterials can hold up across multiple laboratories, a prerequisite for any future OECD test guideline.Six consumer exposure models have been put through practical case studies, revealing significant usability gaps and highlighting that no single tool works across all nanomaterial scenarios.

NIA Meeting Report on the CEN/TC 352 Nanotechnologies 37th meeting

The Safe-by-Design standard for nanomaterials has been put on hold, with progress now contingent on the European Commission's JRC updating its SSbD framework, expected by end of 2025.Two significant standards covering nanoobject characterization in food products and aggregation state determination are both advancing to formal vote, running from August 2025 through March 2026.Nanoplastics and 2D materials including graphene are emerging as new standardization targets, signaling where the next wave of technical work is headed.

NIA Meeting Report on the ECHA Nanomaterial Expert Group 20 08 November 2024, online

Grouping nanoforms under REACH remains deeply uncertain, with no agreed cut-off criteria and registrants left navigating a framework still under construction.Nanoalloys present a live regulatory gap: they likely qualify as nanomaterials under EU definitions but fall outside the current alloy definition, leaving duty holders without clear obligations.OCSiAl's lifecycle exposure data on its SWCNT product showed no detectable release above NIOSH limits across abrasion, recycling, and incineration scenarios, a notable data point for the industry.ECHA is commissioning new studies on surface-treated nanomaterials and nanomaterial flame retardants in consumer products, flagging these as the next priority knowledge gaps.Researchers tested ChatGPT for screening ecotoxicity study quality, with mixed results that raise questions about AI reliability in regulatory data assessment.

NIA Meeting Report on the ECHA Nanomaterial Expert Group 21

Synthetic amorphous silica has been officially classified as STOT RE 1 by RAC, a decision with direct compliance consequences for industries using SAS across food, cosmetics, and industrial applications.Nanoalloys sit in a regulatory vacuum under REACH, with no agreed definition and unresolved questions about whether they should be treated as alloys, mixtures, or something else entirely.Nearly 1,000 REACH registration dossiers now cover nanomaterials, but Germany's five-year review found data quality remains poor and evaluation timelines unworkably long.A new framework for determining nanoform "sameness" is being stress-tested through case studies, with the outcome set to shape how grouping and registration obligations work in practice.Detecting carbon-based nanomaterials like CNTs and graphene in real-world environmental and biological samples remains largely unsolved, with current methods falling short of the sensitivity regulators need.

NIA Meeting Report on the MEETING OF THE WORKING PARTY ON MANUFACTURED NANOMATERIALS (OECD)

The OECD is advancing a pipeline of over a dozen test guidelines and guidance documents for nanomaterials, with several due for approval in 2025 covering everything from toxicokinetics to intestinal fate after oral ingestion.Graphene is emerging as a priority focus, with urgent gaps identified in characterization parameters and existing test methods found to be inadequate for graphene-specific properties.No legally binding occupational exposure limits exist for nano-objects in any jurisdiction, and measurement instruments for workplace exposure show inconsistent results even across the same model, leaving a critical gap in worker protection.South Korea has proposed a new multi-year project to develop dedicated testing guidelines for nanoplastics, with completion targeted for 2029.AI is being explored as a tool to support exposure modelling for nanomaterials in occupational and environmental settings.

NIA Meeting Report on the Technology Council for Advanced Materials

The NIA has secured a seat on the European Commission's high-level Technology Council for Advanced Materials, giving the nanomaterials sector a direct voice in shaping EU strategy.Over €1.7 billion has been invested in advanced materials under Horizon 2020 and Horizon Europe combined, yet industry flagged persistent barriers including scarce venture capital, high energy costs, and fragmented regulations.The Commission is planning a new shared digital infrastructure for materials data under the 2025 Horizon Europe work programme, with IP protection and trust cited as make-or-break conditions for industry buy-in.NIA will push to join subgroups on both industrial uptake and future priorities, with SME needs and nanomaterials competitiveness at the top of its agenda.

NIA Meeting Report on the CEN/TC 352 Nanotechnologies, 19-21 March 2024

Three proposed new work items failed to gain enough country support to proceed, exposing a persistent participation gap in nanotechnology standardization.Graphene is emerging as a priority area, with multiple characterization standards in parallel development across CEN and ISO.Two analytical technologies from the NanoPAT project are being positioned as candidates for standardization, offering faster and more cost-efficient alternatives to existing nanoparticle characterization methods.

​​NIA Meeting Report​ on the CEN/TC 352 Nanotechnologies​, ​​8-10th October 2024

Key nanotechnology standards are at risk of cancellation, with two CEN/TC 352 projects needing activation deadlines met to survive.A new project group is being formed to tackle graphene characterization by chemical vapour deposition, reflecting growing regulatory interest in graphene-specific standards.Leadership changes and a proposed scope amendment signal a broader reshaping of how CEN/TC 352 operates going forward.