Regulatory Updates

The European Commission updates the definition of nanomaterial

The European Commission has updated, as of 10 June 2022, the Recommendation 2011/696/EU on the definition of nanomaterial that supports a coherent EU regulatory framework for nanomaterials:

‘Nanomaterial’ means a natural, incidental or manufactured material consisting of solid particles that are present, either on their own or as identifiable constituent particles in aggregates or agglomerates, and where 50 % or more of these particles in the number-based size distribution fulfil at least one of the following conditions:
(a) one or more external dimensions of the particle are in the size range 1 nm to 100 nm;
(b) the particle has an elongated shape, such as a rod, fibre or tube, where two external dimensions are smaller than 1 nm and the other dimension is larger than 100 nm;
(c) the particle has a plate-like shape, where one external dimension is smaller than 1 nm and the other dimensions are larger than 100 nm.
In the determination of the particle number-based size distribution, particles with at least two orthogonal external dimensions larger than 100 μm need not be considered. 
However, a material with a specific surface area by volume of < 6 m2/cm3 shall not be considered a nanomaterial.

Following the adoption of the new Recommendation, it is expected the different individual sectors, as REACH, Biocidal Products Regulation and Medical Devices, will update their internal definition, replacing the old with the new one. Relevant uptake information available:

  • review of regulation on cosmetic products – public consultation including question related to the definition of nanomaterial (closes 21 June 2022);
  • preparation of the revision of REACH as announced in the Chemicals Strategy for Sustainability -proposal expected by end 2022, and the Commission is planning to include update of the definition of nanoform as part of the revision proposal.

What are the main features?

  1. Change from ‘contain’ to ‘consist’ “Nanomaterial means a … material consisting of solid particles…’
    Why? Increased clarity. ‘Material’ is a generic term for what is evaluated in specific legislation (as chemical substance, cosmetic ingredient etc.), and it should be evaluated based on what it mainly “consists of” – without taking into account other components that may be present such as impurities, additives or stabilisers.
  1. Different particle aspects, including consideration of particles with dimensions outside 1-100 nm and generalization from current derogation of fullerens, single wall carbon nanotubes and graphene flakes.

    Change A. “…material consisting of solid particles…’
    Why? Increased clarity. The term “Solid” is here used in its meaning as one of the four fundamental states of matter, characterized by structural rigidity and resistance to changes of shape or volume, considered in this context under normal conditions. This excludes emulsions (liquid particles dispersed in liquid media) and micelles with variable boundaries.

    Change B. “particles, in an unbound state or as that are either present on their own or as identifiable constituent particles in aggregates…’
    Why? The qualifying term ‘constituent’ for particles in aggregates and agglomerates should eliminate doubts to which particles the definition refers (i.e. regarding sizing, counting).

    Change C. Restriction of the particles to be considered: particles with at least two orthogonal external dimensions larger than 100 micrometres shall not be counted for the purpose of the number size distribution.
    Why? It can address some of the practical measurement issues, and it can also help to avoid in practice any potential ambiguity in differentiating between a particle and a larger solid product such as a large material sheet that should not be covered by the definition. 

    Change D. Sub-definition of a particle: ‘Single molecules are not considered particles.‘
    Why? It is in line with the current interpretation of the Recommendation 2011/696/EU as laid down in the European Commission’s Questions&Answers and the JRC Report EUR 29647 EN “An overview of concepts and terms used in the European Commission’s definition of nanomaterial”. 

    Change E: Delete derogation for specific carbon-based materials, and include additional conditions b) and c) in the definition.
    Why? Generalization of an existing derogation. Ideally, a definition would cover all materials using one straightforward rule, without the need for derogations. 
  1. Flexibility of the particle number concentration threshold: “Removal of flexibility, leaving only default threshold of 50%”.
    Why? In Recommendation 2011/696/EU, a certain flexibility was introduced as a safeguard in the light of the uncertainties and lack of knowledge on nanomaterials at the time. However, it may create confusion among business operators, consumers and regulators. 
  1. Application of VSSA (Volume Specific Surface Area).

Mérieux NutriSciences Expertise in Nanomaterials

Thanks to the high experience in nanotechnologies, our experts have developed a multistep multi-technique approach to detect, characterize and quantify nanomaterials in different products in order to provide:

  1. Qualitative screening
  2. Size distribution and morphology
  3. Chemical identification
  4. Quantification
  5. Risk assessment