Differences between Advanced Materials and Nanomaterials
Advanced materials (AdMat) are materials designed to offer superior properties to conventional materials. They are defined by their performance and functionality and are distinguished by:
- Their specific composition (complex alloys, hybrid composites, smart polymers, nanostructures, etc.)
- Their controlled microstructure (grain size, crystal orientation, multi-scale organization)
- Their unique functionalities (conductivity, mechanical strength, shape memory, self-repair, response to external stimuli, etc.).
Nanomaterials are defined by their size (less than 100 nm in at least one dimension) and their properties emerge from surface effects. Nanomaterials therefore constitute a specific subcategory of AdMats.
A strategic class of materials
Smart coatings, nanocarriers, bio-based polymers, and metamaterials: these advanced materials are driving innovation in the energy, mobility, construction, healthcare, electronics, and many other sectors.
Demand for AdMat is expected to grow significantly in the coming years, and these materials are set to play a key transformative role in the European Union’s (EU) ecological and digital transitions.
However, as science progresses and their complexity increases, regulatory challenges are multiplying.
What about regulation?
Concerns about the bioavailability and toxicity of nanomaterials have led to the introduction of dedicated regulations (e.g., REACh) over many years.
Although the term “advanced materials” is increasingly used in political circles and in EU research and innovation (R&I) groups, it does not have a harmonized definition in EU legislation.
The OECD, ISO, and national authorities such as the BfR and BAuA in Germany have each proposed nuanced working definitions, converging around materials rationally designed to exhibit new or enhanced properties and functionalities. However, their diversity in terms of structure, function, and composition makes them difficult to regulate under a single framework. This heterogeneity also complicates a harmonized approach to risk assessment.
However, since 2006, the OECD Working Party on Manufactured Nanomaterials (WPMN), initially dedicated to manufactured nanomaterials, has broadened its scope to include advanced materials and their potential risks to human health and the environment.
For chemical manufacturers, formulators, and technology providers, this lack of regulatory clarity creates a grey area:
- Are their materials subject to specific rules for nanomaterials?
- What data is needed to demonstrate their safety and sustainability?
- How can they position their innovation while remaining compliant?
Ultimately, this ambiguity creates uncertainty regarding market access, product classification, and risk communication, which can slow down time to market and complicate dialogue with customers.
European coordination
European regulators are taking action to remedy this situation, especially since AdMats are among the ten critical technology areas for the economic security of the European Union.
The OECD, the European Commission, and consortia such as the Malta Initiative[1] are therefore actively working to define, prioritize, and create testing methods and governance strategies tailored to AdMats.
At the same time, the EU’s chemical strategy for sustainability and Safe-and-Sustainable-by-Design (SSbD[2]) policies are driving the search for materials that are not only innovative, but also safe and sustainable, from the laboratory to the market.
Materials covered, but not explicitly
Many AdMats fall within the scope of existing EU legislation on chemicals (e.g., nanomaterials): REACH, CLP, Biocidal Products Regulation, or Cosmetics Regulation, among others. However, these frameworks do not generally deal explicitly with advanced materials and do not include provisions specific to AdMats, leading to uncertainty and potential gaps in their safety management. Only nanomaterials receive specific attention, for example through updates to the REACH annexes.
Furthermore, the assessment of AdMats faces real operational challenges, such as data requirements and testing protocols that are not adapted to these complex or multifunctional materials. The consequence is, once again, potential gaps in registration, authorization, or defense dossiers.
A common European approach to AdMat governance is both a regulatory necessity to ensure safety and a strategic imperative to promote innovation within the EU. This approach must strike a balance between innovation, safety, and sustainability.
EquiTox closely monitors regulatory developments and changes in testing methodologies for chemicals, including advanced materials.
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[1] https://malta-initiative.org/what/
[2] https://research-and-innovation.ec.europa.eu/research-area/industrial-research-and-innovation/chemicals-and-advanced-materials/safe-and-sustainable-design_en