Nanomaterials: EU clarifies definition in Recommendation 2022/C229/01

Throughout the 21st century, the nanomaterials and the nanotechnology have revolutionised the world of science as we knew it. Thanks to the emergence of this new technology, a vast field of research is opening up across a range of sectors, including physics, chemistry, engineering, mechanics and medicine.

 

The nanomaterials These are materials composed of molecules of very small size, created through science and technology. In recent years, they have been used to develop, amongst other consumer goods, a large number of cosmetic products. Although nanomaterials are invisible to the naked eye, it has been demonstrated through the use of microscopes that, when examining a material from the nanometre scale, it is possible to create materials with properties that are very different from those exhibited by the same material in the macroscale which we usually use to work with them. What’s more, existing materials can be modified and shaped so that they offer new applications in his field. 

 

As this is a very new field of study – one which has been constantly evolving since its inception – it is necessary for the authorities to describe and explain certain concepts, such as, for example, the nanomaterialsthe nanotechnology or the nanoparticles. And back in 2011, the European Commission began work on a common definition for all these terms. 

 

However, as is the nature of any rapidly evolving field of science, this common definition has evolved and needed to be adapted to the changing times. For this reason, the European Commission has published a ‘clarification’ of the definition of nanomaterials, which is included in the Commission Recommendation 2022/C229/01 of 10 June 2022 on the definition of nanomaterials.

Recommendation 2022/C229/0 on the definition of nanomaterials

On 10 June, the European Commission published the Commission Recommendation 2022/C229/01 of 10 June 2022 on the definition of nanomaterials, amending the definition of the term ‘nanomaterials’ for EU Member States. Until now, there had been a single definition of this term across the EU, which appeared in the Recommendation 2011/696/EU published in 2011 and which has been obsolete since last June.

The new Recommendation 2022/C229/0 It consists of a 24-point document setting out the information that the European Commission has assessed in relation to nanomaterials and their definition. Following this overview, the Commission publishes a further four points containing specific recommendations that serve to define and contextualise the nanomaterials. 

This new definition of nanomaterials, which replaces the one adopted by the European Commission in 2011, introduces significant changes in relation to three key points:

1. 1. For the first time The dimensional requirements for nanomaterials have been set out. In other words, a minimum and maximum size, which will make it possible to distinguish them from other particles.
   2. In the new definition, Nanomaterials are limited solely to solid particles, excluding liquid particles in emulsions or gaseous particles. Furthermore, individual molecules are not regarded as particles.
   3. It has been replaced in the definition «contains» for «consists of", so that the term now refers to a material in its own right, rather than to ingredients or parts of other materials. To put it another way: the European Commission clarifies that nanomaterials do not contain nanoparticles, but are themselves made up of nanoparticles.

What risks do nanotechnologies pose to people? And to the environment?

By working with materials at the nanoscale, we obtain nanomaterials, which have properties that differ from those found in the same material at the macroscale. And whilst these different properties can sometimes be very beneficial, they may also carry risks that we are not yet aware of.

In this regard, the work carried out by the CScientific Committee on Emerging and Recently Identified Health Risks (CCRSERI) -also known by its English acronym SCENIHR-, a committee of experts set up in 2004 by the European Commission to assess emerging risks arising from new technologies.

The fact is that SCENIHR is a scientific committee, comprising 13 members and 6 associate members – who are professionals from the sector and health authorities – and whose remit includes, amongst other functions, the monitoring and assessment of the risks posed by nanomaterials to human health and the environment. It must also submit the findings of these assessments to the European Commission in a timely manner, and respond to any questions put to it by the Commission.

Here are some questions put to SCENIHR by the European Commission at the start of the 21st century regarding nanomaterials:

• What are the direct or indirect risks associated with current and planned applications of nanomaterials?

• How can testing methods be improved, and what new methods can be used to address the specific aspects of nanotechnology?

• How can the assessment of exposure to nanomaterials be improved, and what specific exposures should be investigated?

• What further research is needed to improve our understanding of the potential risks posed by nanotechnology products?

It is worth noting that the CScientific Committee on Emerging and Recently Identified Health Risks (CCRSERI) It is also the European body responsible for devising a methodology that enables to assess the risks posed by nanomaterials to human health and the environment. And that presents its own challenges, as it requires the development of methods that enable the measurement of the exhibition nanomaterials and iIdentify hazards. 

In this regard, SCENIHR is investigating the potential hazards of nanomaterials in both urban and natural environments. It identifies risks to human health, as well as to that of other animals and living organisms, and to the environment as a whole. So if you still have any doubts about the safety of nanomaterials available on the European market, you can consult the Spanish-language website of the CScientific Committee on Emerging and Recently Identified Health Risks (CCRSERI).