A new definition for nanomaterials
On June 10, 2022, the revision of the recommendation for the definition of a nanomaterial C (2022)3689 was finally published by the European Commission. This revision, which had been awaited since 2014, would harmonize the term "nanomaterial" across all European cross-sectoral or sectoral regulations. Thus, it would help to standardize EU legislation across all sectors and better define the scope of the definition.
According to the new definition, a nanomaterial is defined as :
"A natural, incidental, or manufactured material consisting of solid particles that are present, either alone or as identifiable constituent particles in aggregates or agglomerates, and where 50% or more of such particles in the number-based size distribution meet at least one of the following conditions:
- one or more external dimensions of the particle are in the size range of 1 nm to 100 nm ;
- the particle has an elongated shape, such as a rod, fiber, or tube, where two external dimensions are less than 1 nm and the other dimension is greater than 100 nm;
- the particle has a plate-like shape, where one external dimension is less than 1 nm and the other dimensions are greater than 100 nm."
Until now, the threshold could fluctuate from 1 to 50% because there was no scientific evidence to determine whether the threshold could be increased or decreased. The new definition sets a default threshold of 50%, and removes the possibility of variation.
The Commission stated that this decision stems from the desire to ensure "regulatory consistency, and to avoid a situation where a specific nanomaterial is considered a nanomaterial in one regulatory framework but not in another."
However, the new definition does not significantly change the previous version and retains the key features. The Commission shared a document to describe the revision process and justify the changes made.
Industry was satisfied with the revision, as it brought clarity and harmonization. The NGOs, on the other hand, were not satisfied with the result. The new definition seems to them very limited and some points seem unjustified (such as the deletion of the threshold from 1 to 50%).
A long overdue revision
In 2017, a first public consultation on a new definition had been launched by the Commission. This consultation was already 3 years late and planned a revision only in 2020, questioning the real will to regulate nanoforms.
Since January 1, 2020, manufacturers or importers must register nanoforms under the REACH annexes, to provide specific information:
- characterization of the nanoforms or sets of nanoforms that are covered by the registration (Annex VI);
- chemical safety assessment (Annex I);
- information requirements for registration (Annexes III and VII-XI); and
- obligations of the downstream user (Annex XII).
On the one hand, the definition of nanomaterials as "materials with at least one dimension between about 1 and 100 nanometers in size or structure" was very broad. This definition did not distinguish between process-related and intentionally manufactured nanomaterials.
On the other hand, there was no real distinction between nanomaterials and nanoforms. Moreover, the size of nanomaterials was a real problem for the analysis tools.
It was therefore important for manufacturers or importers to have clarification on the definition of nanomaterials.
Regulations applied to nanomaterials
Nanomaterials are subject to numerous regulations (REACH, CLP, Biocides, Cosmetics, etc.). As part of the revision of the definition of a nanomaterial, any regulation will have to update its definition, taking into account the new version.
The various regulations will include the issue of the definition of a nanomaterial during revisions scheduled for 2022:
- Public consultation on the revision of the cosmetic products regulation - closing date June 21, 2022
- Revision of REACH according to CSS (Chemicals Strategy for Sustainability) - proposal expected by end 2022
The Commission stated that for each new scientific evidence or regulatory experience that challenges the definition of a nanomaterial, a new definition will be provided.
The European Union Observatory for Nanomaterials (EUON) launches 3 studies per year to deepen the knowledge on nanomaterials and fill the gaps. The studies address issues related to the health and safety aspects of nanomaterials. The EUON is accepting proposals for studies until July 18, 2022.
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