Study of the Scope of a Belgian National Register for Nanomaterials and Products containing Nanomaterials

Final Report

Nanotechnology is considered as one of the key enabling technologies of this century and offers a wide variety of potential uses that that should be considered from the point of view of their economic, health and environmental impacts and applications.
The use of nanomaterials may lead to products with new or improved properties and many nanotechnology enabled products have already been commercialized, ranging from sun-screen (titanium dioxide) over sports equipment (carbon nanotubes) to food packaging (nanoclay).

At the same time, several institutions and stakeholders stress the need for action to address regulatory and knowledge gaps with regards to potential effects of nanomaterials -and products using or containing them- on human health and environment. While there is no indication that all nanomaterials are dangerous, the European Commission highlighted that a substance may present a different danger profile depending on its presence as a nanomaterial or as bulk. Potential risks should therefore be identified at an early stage to be able to develop a culture of sustainable innovation. However, the risk assessment approach could have limits, and it is in that sense that we interpret a statement of Pr. K.A. Dawson at a recent conference organized by the EU Commission, when he highlighted that "the pace of innovation in nanomaterials design far outpaces our capacity to 'be sure' ".

Until now, at the European level, the chemicals industry sees the existing risk assessment paradigm and regulatory framework as a solid basis for ensuring that nanomaterials are produced, used and disposed of in a safe and sustainable way, and highlights particularly the role of REACH (see "Nanomaterials - Safe and Innovative", CEFIC).

The provision of clear and unambiguous criteria to identify nanomaterials for regulatory purposes is a prerequisite for the implementation of any legislation by enabling a coherent cross-cutting reference. In this sense, the recommendation on the definition of a nanomaterial published by the European Commission on 18 October 2011 marked an important step forward, and states that a nanomaterials is:

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 %. By derogation from the above, fullerenes, graphene flakes and single wall carbon nanotubes with one or more external dimensions below 1 nm should be considered as nanomaterials. Specific provisions on nanomaterials have been introduced at the EU level, for biocides, cosmetics, food additives, food labelling and materials in contact with foodstuff. Although there are no explicit requirements for nanomaterials under REACH or CLP, they meet the regulations' substance definition and therefore their provisions apply.

However, regarding REACH, a number of shortcomings have been reported for nanomaterials. For instance, because most nanomaterials currently on the market are derived from "parent substances" that benfit from a phase-in status, the many nanomaterials currently marketed benefit from delayed registration deadlines in direct contradiction with the "no data, no market" principle underlying REACH. In addition, nanomaterials that are produced or imported at smaller quantities are not subject to registration. And eventually, there are controversial debates surrounding the identification and characterization of nanomaterials. Discussions on the adaptation of REACH annexes to better address nanomaterials are currently on-going.

However, despite this approach and notwithstanding the rapid increase of the market for nanotechnology products, exposure monitoring and assessment is very difficult or impossible at present for nanomaterials as authorities and most enterprises have no means to obtain sufficiently reliable information. Besides the approach of adapting REACH annexes and other regulations to better address nanomaterials, many EU Member States and the EU Parliament support the introduction of databases or registries for gathering necessary information on (products with) nanomaterials to address current regulatory shortcomings.In this regard, a number of approaches to reporting, either voluntary or mandatory, have been proposed (including by Belgium) or implemented. Within the European Union, France has become the first country to require manufacturers to identify uses of substances in nanoform in the frame of a mandatory reporting scheme. Various NGO's and companies constituted their own databases, including claims about the exposure risk and possible hazards the nanomaterials may pose for humans and the environment.