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22 July 2010

An expert group appointed by the Commission proposes a definition of nanomaterials based on size factor

The current nanotechnology talks in the European Union focus mainly on defining the term ‘nanomaterials’. Because this term has such a broad meaning, this causes tension among environmental NGOs, the industry, scientists, trade unions, the civil society and regulatory bodies. Consequently, if a unanimous definition of this term is found, the regulatory process will be easier.

The Joint Research Centre is a reference centre of science and technology for the European Commission. In July 2010, the JRC published the report titled ‘Considerations on a definition of nanomaterials for regulatory purposes’, to answer questions asked by the European Parliament.
The EP believes that the relevant risks related to nanomaterials should be covered in the current community legislation. It has asked the Commission to review the existing legislation and to find a comprehensive scientifically-based definition of nanomaterials that could serve the regulatory purposes of the current and future legislation.
Since a global or an EU definition has not yet been agreed upon, the aim of the report is to gather elements that could define the terms nanomaterial and nanoscale.
Since we have, on the one hand, a horizontal legislation that encompasses the chemical legislation, worker protection and environmental legislation and on the other, legislation for specific sectors such as cosmetics, food and biocidal products, the solution is either to find a harmonized definition or else a definition tailored to each sector.
Various definitions of nanomaterials were proposed by Australia, Canada, Denmark, the United Kingdom, the United Stated and other international organisations and committees. Instead of adopting the same pattern, the JRC recommended that a single definition be found and accepted by all Member States.
A science-based definition would be widely applicable to the EU legislation. It should be clear, unambiguous, enforceable and easy to implement. It should also be suited to all relevant regulation policies. Ideally, it would be in line with other international legislations within the framework of organizations such as the ISO or the OECD. And it should be in the interest of stakeholders such as scientists, industries, environmental NGOs, trade unions and the civil society.
The JRC proposes the term ‘particulated nanomaterial’, which is in line with the existing ISO definition of the term ‘particle’. It requires the introduction of practical norms such as a nanoscale size range with lower limits of 1nm and upper limits of 100nm or greater, and applications of those limits for nanoscale materials with size distributions.
As any other material, nanomaterials are characterized by their physico-chemical properties. A crucial factor for the upper size limit is that some of those properties scale are in proportion to the size. This means that they change continuously and smoothly with size (scalable) while others can change dramatically when the size becomes too small (non-scalable).
As the JRC Report explains, ‘the size at which genuinely nanoscale properties are observed depends strongly on the material’. Therefore, case by case studies are needed for every type of material. Another relevant factor to take into consideration is the matrix effect, “when physicochemical properties of the surrounding environment of nanomaterial can have a substantial impact on a material behavior”.
Moreover, in order to formulate a definition of nanomaterials, it is essential to list nanoscale properties and to differentiate them from the bulk properties, to stipulate their nature, their occurrence and the measurement processes to determine them.

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