6 Oct 2017
European Commission Opens Public Consultation on Further Defining Nanomaterials for Application in Future Laws to Regulate Them
With a view to preparing a revised Recommendation which it intends to adopt, the European Commission called for public feedback on the EU’s existing Recommendation on the Definition of Nanomaterial on 15 September 2017. The Commission’s objective is to avoid confusion and to ease implementation and consistent application across all EU legislation.
Nanomaterials technology is developing very dynamically and with rapid progress. Nanomaterials are already used in the manufacture of a wide range of products which Hong Kong traders will be familiar with. These include cosmetics, stain-repellent fabrics, carbon nanotubes to make lightweight sports equipment, scratchproof eyeglasses, crack-resistant paints, anti-graffiti coatings for walls, transparent sunscreens, self-cleaning windows, ceramic coatings for solar cells and drug delivery agents.
The current definition of nanomaterials dates back to 2011. According to that Commission Recommendation, “Nanomaterial” is defined as a “natural, incidental or manufactured material containing particles, in an unbound state or as an aggregate or as an agglomerate and where, for 50 % or more of the particles in the number size distribution, one or more external dimensions is in the size range 1 nm-100 nm. In specific cases and where warranted by concerns for the environment, health, safety or competitiveness the number size distribution threshold of 50 % may be replaced by a threshold between 1 and 50 %.”
Scientists have argued that the existing definition is based only on the size of the constituent particles of a material, without regard to hazard or risk. The issue of lack of clarity has also been raised. Moreover, the definition poses several implementation challenges, e.g., the measurement of the size of constituent particles inside aggregates.
The current process aims to provide minor clarifications in the text of the Recommendation and ways to facilitate its implementation. The main elements of the nanomaterial definition, i.e. the use of particle size distributions based on the numbers of particles, and not on the mass or volume of the particles, as the main classification feature are planned to remain the same.
Interestingly, the Roadmap dated 15 September 2017 and titled “Review and potential revision of the EU Recommendation on the Definition of Nanomaterial” states that “specific regulatory provisions targeting nanomaterials appear inevitable” as “some nanomaterials, compared to any other material or product even when made of the same chemical, may have different (positive or negative) environmental impacts or interact with the biosphere in a specific way, e.g., reaching different cells and organs.”
Although not intrinsically hazardous per se, the risk assessment of nanomaterials therefore has to follow different patterns, which would take into account their specific properties.