Nanomaterials: where are we and where are we going?

The 22nd and 23rd meetings of the European Chemicals Agency's Nanomaterials Expert Group (ECHA-NMEG) were held in November 2025 and May 2026, respectively. Below is an overview of some of the topics covered by ECHA, Member State representatives, the European Commission, industry stakeholder organizations, and NGOs

REACH compliance and implementation

As of April 23, 2026, 1109 registration dossiers had been correctly submitted in accordance with the updated requirements of the REACH Regulation (CE) 1907/2000, for a total of 186 registered nanoform substances; these numbers demonstrate the progressive maturation of the registration system.

ECHA announced that compliance checks under Annex VI are continuing for three substances: zinc oxide, graphene oxide and Pigment Red 112. Follow-up actions are also ongoing for Synthetic Amorphous Silica (SAS) and Titanium dioxide (TiO2).

A critical issue under discussion concerns the registration of alloys produced at the nanoscale. In this regard, a white paper is being finalized by ECHA to clarify terminology (definition of alloy vs. nano-alloy) and ensure that the nano-specific properties of these materials are acknowledged under REACH.

International Standardization of Test Methods (OECD & CEN)

Work continues to provide valuable guidance.

In October 2025, the third edition of the OECD guidance on the grouping of chemicals was published, including, for the first time, a section dedicated to nanomaterials.

In December 2025, the OECD guidance document on sample preparation and dosimetry was published, providing a foundation for consistent safety testing.

The Netherlands (RIVM) and the United Kingdom (UKHSA) are co-leading the development of an OECD guidance document on the toxicokinetics of (nano)particles. The document covers dosing regimens, post-exposure period duration, time points for measuring organ/tissue burdens, and analytical methods for both inhalation and oral exposure routes. Approval is expected in 2026.

Italy, meanwhile, led the development of the OECD guidance document on in vitro testing of the intestinal fate of ingested nanomaterials, which outlines an approach using in chemico dissolution and intestinal barrier models to assess the fate of ingested nanomaterials. Official publication is expected in Q3 2026.

Two new standards are under development by the Technical Committee of the European Committee for Standardization (CEN/TC): one relating to the Safe-by-Design (SbD) concept; the other is a quick-start guide for health and safety risk management of nano-objects and their aggregates and agglomerates (NOAA).

Regarding workplace exposure, the finalized versions of EN 15051 (Measurement of the Dustiness of Bulk Materials) and EN 17199-5 (Dustiness of Bulk Materials that Contain or Release Respirable NOAA - Vortex Shaker) have also been published. The EN 13205 series on sampler performance for airborne particle concentration measurement and EN 481 (Size Fraction Definitions for Airborne Particles) are also under revision.

Furthermore, to support practical implementation of the revised Asbestos at Work Directive (EU) 2023/2668 - which lowers occupational exposure limit values and strengthens protection for workers exposed to asbestos -, the European Commission developed comprehensive guidelines.

New Methodologies and Grouping Strategies

A key issue remains the challenge of reducing animal testing and grouping nanoforms. In this regard, several crucial projects are underway:

• NanoSet, commissioned by EFSA, aims to develop a framework for justifying sets of nanoforms using statistical evidence to prove that variations within a set do not impact hazard or risk;
• NAMS4Nano aims to build experience with New Approach Methodologies (NAMs) for nanomaterials and develop Integrated Approaches for Testing and Assessment (IATAs);
• iNAMS4NGRA, connected toNAMS4Nan, also commissioned by EFSA, focuses on developing guidance for NAMs data integration and implementing Next Generation Risk Assessment (NGRA) in the food and feed chain with a specific nanotechnology focus.
  
  

Advanced Materials (AdMa) and New Frontiers of Risk

The regulatory focus is expanding toward more complex materials and proactive safety.

There is an ongoing discussion led by Germany to restrict substances in critical fibre form (biopersistent and respirable) based on their morphology rather than just their chemistry (i.e. "Fiber Paradigm").

An interesting aspect concerns the definition of guiding values: the concept of Health-based Nano Reference Values (HNRVs), introduced in 2022, is replaced by the concept has now been updated to Health-based Nanomaterial Guidance Values (HNGVs) to distinguish from existing pragmatic Nano Reference Values. A group of European experts worked to an HNGV value definition for occupational exposure to spheroidal biodurable engineered nanomaterials of relatively low substance-specific toxicity, recommending 4 μg/m3 averaged over an 8-h work shift.

Tools like Early4AdMa are being used to identify safety and sustainability issues early in the development of materials like MXenes and Graphene.

Specific discussion panels were organized to address the challenges of risk assessment of nanometric transport systems, NanoCarriers (e.g. pharmaceutical or cosmetic products), where changes in behaviour, fate, kinetics, and effects of the active ingredient can result from encapsulation in or attachment to the carrier. 

Safety, Sustainability and Social Issues

Multiple European projects, such as IRISS and MACRAMÉ, are working to integrate safety and sustainability throughout the material life cycle (Safe-and-Sustainable-by-Design). The Netherlands establish a national expertise centre to help companies in these processes. CHIASMA is, instead, a project that focuses on the development and application of testing strategies for risk assessment, integrating computational and experimental approaches in a SSbD framework to support REACH and CLP.

There is no shortage of sector-specific projects: EU project PLANETS demonstrates SSbD in industrial applications by co-developing alternative plasticisers, flame retardants and surfactants with industry; while CIRCULAR-C project aims to deploy cost-effective, sustainable and circular biobased formulations for construction panels.

In conclusion, the near future is shaping up to be marked by the revision of the REACH regulation, by the consolidation of new international standards (OECD and CEN), and a decisive transition toward the management of advanced materials (AdMa) by integrating safe-and-sustainable-by-design (SSbD) criteria.