Rethinking Nanoform Regulation: Towards a More Proportionate, Science-Based Framework

Nanomaterials are at the heart of modern innovation – but regulating them remains one of the most complex challenges in chemical safety.

Under current frameworks, a simple reality exists... each nanoform is treated as different by default.

But what if that assumption is holding us back?

At SETAC EU 2026, Kai Paul and collaborators present a new approach designed to bring greater clarity, proportionality, and scientific rigour to nanoform assessment.

Poster Presentation

“A Regulatory Framework for Assessing the Variability & Safety of Nanoforms”
Presentation ID: 4.08.P-We341
Blue Frog Scientific – Booth 79

The Problem with “Everything is Different”

Under EU REACH:

• Each nanoform is typically treated as a separate entity.
• “One Substance, One Registration” (OSOR) principles are not upheld.
• Companies may face multiple dossiers for the same substance family.

As highlighted on the poster, this creates:

• Significant cost and time burdens.
• Barriers to innovation – especially for SMEs.
• Extensive duplication of testing, including animal studies.

In extreme cases, a single registrant with multiple nanoforms could face millions of euros in testing costs.

A New Way Forward: Defining “Acceptable Variation”

This research explores a critical question:

Can we define when different nanoforms are “similar enough” to be assessed together?

The answer proposed is a Decision Tree Framework built on:

• Established regulatory principles (REACH Annex VI, CLP concepts).
• Analysis of ~1,500 scientific studies (refined to ~200).
• Key nanoform characteristics:
  • Size
  • Shape
  • Surface area
  • Crystallinity
  • Surface treatment / functionalisation

How the Framework Works

As shown in the poster (decision tree diagrams and schematic on page 1):

• Each characteristic is assessed through structured decision trees.
• All criteria must align to conclude “acceptable variation”.
• Statistical thresholds support decision-making
  • e.g. ~2-fold variation in surface area.
  • ~1.5-fold variation in diameter.

Importantly, this is not grouping or read-across, it is a controlled, evidence-based assessment of variability.

What This Enables

The framework demonstrates:

• A proof of concept for science-based nanoform assessment.
• A pathway toward:
  • Reduced duplication of testing
  • Greater regulatory consistency
  • Improved proportionality in decision-making
  • Alignment with the 3Rs (Replacement, Reduction, Refinement) in animal testing
     

Challenges Still to Address

The research also highlights important gaps:

• Limited long-term environmental data.
• Need for broader validation across nanoforms.
• Inconsistent data generation and sharing.
• Lack of established mechanisms to maintain and evolve frameworks.

Looking Ahead

To fully realise this approach, the poster points to key priorities:

• Integration of New Approach Methodologies (NAMs).
• Greater international alignment (OECD, ISO).
• Continued development of data-sharing frameworks.

Together, these could form the basis of a more modern, proportionate regulatory model for nanomaterials.

More Than Just Meeting Requirements

If you work with nanomaterials, this goes to the heart of:

• Cost vs compliance.
• Innovation vs regulation.
• Science vs practicality.

If you have any interest in nanomaterials and their regulation, come and meet Kai and our regulatory experts at Booth 79.
 

Download a copy of Kai's poster here...