Hong Kong Trader, 4 Nov 2011 –
The Official Journal of the EU published, on 20 October 2011, a Recommendation from the European Commission regarding a common definition of “nanomaterials”. Hong Kong companies will already be familiar with this generic term: nanomaterials are currently used in hundreds of consumer products including cosmetics, clothes and electronic goods as well as in numerous industrial applications, but there is still some uncertainty as to potential risks of such materials.
The new definition is intended to be primarily used to provide clear and unambiguous criteria to identify nanomaterials. This in turn would mean that certain policy provisions and legislation (concerning for example risk assessment or ingredient labelling) will be given greater legal clarity by the incorporation of a commonly agreed definition.
Hong Kong companies may be aware that large parts of the nano-technology sector are rapidly developing, and as a result nanomaterials are increasingly used in both industrial and consumer products. This new definition could therefore have a potentially major significance for Hong Kong businesses as it will be incorporated into a wide range of policy objectives, including consumer protection, workplace safety and environmental standards.
The Commission’s definition of nanomaterials is based purely on size. The Recommendation states that “nanomaterial” means a natural, incidental or manufactured material containing particles where, for 50% or more of the particles, one or more external dimensions is in the size range 1 nm-100 nm (i.e., between 1 and 100 billionth of a meter).
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 of between 1 and 50%. Exceptionally, fullerenes, graphene flakes and single wall carbon nanotubes with one or more external dimensions below 1 nm should be considered as nanomaterials.
The Commission considers that size is the only universally applicable and measurable criterion which can be used to identify nanomaterials. Furthermore, even though nanomaterials are not considered intrinsically hazardous, there is a need to take into account the specific scientific considerations which may apply regarding the potentially dangerous or undesired effects caused by the use of nanomaterials.
Hong Kong traders should know that the potential consequences of the new definition, whilst bringing greater coherence and legal precision for all parties dealing with nanomaterials, will also lead to new regulatory and information obligations imposed on those trading in such materials within the EU. Janez Potocnik, Environment Commissioner to the EU, stated that the definition has brought about a major step towards a “clear and coherent regulatory framework for industry and for consumers to derive accurate information about possible risk for the environment and human health.”
Nanomaterials are currently broadly governed by a variety of legislative instruments at EU level (e.g., the REACH Regulation, but only generally, and the Regulation on cosmetic products). Definitions have been developed on a case-by-case basis leading to different definitions being applied within different sectors of industry as well as among Member States.
Despite the fact that the new definition is thought to bring greater legal clarity in respect of the use of nanomaterials, the Commission’s definition has been criticised by both chemical groups and industry associations. ChemSec – a chemical campaign group – has denounced the 50% particle threshold of the definition. It argues that this “falls far below expectations as to the recommended ratio of particles which need to be ‘nano’ before the definition applies.”
ChemSec points to the fact that other bodies such as the EU’s own Scientific Risk Assessment Committee (SCHENIR) believes a safer recommendation would be far lower at 0.15%, and even the Commission itself advised on a 1% threshold in an earlier draft of the definition. The 50% threshold finally adopted by the Commission is thought to be a compromise with certain industry groups who felt that a lower threshold would be too restrictive. Nevertheless, the European Chemical Industry Council (CEFIC) warned against such a compromise arguing that the “lower threshold was abandoned despite scientific opinions to the contrary and a lack of awareness surrounding [nanomaterials’] harmful effects.”
CEFIC also criticised the definition’s upper limit of 100 nm as too narrow, with regard to size of nanomaterials and that it may lead to potentially hazardous bigger nanoparticles avoiding regulation.
Hong Kong manufacturers may also want to be aware of CEFIC’s more general criticism of such a scientific definition. It argues that “implementing the proposed definition will add unnecessary burdens for companies leading to added costs and less efficient use of resources.”
In light of these numerous criticisms and the fact that nano-technology is still in a nascent state of development, the Commission will review the scope of the definition in 2014 with regard to the technical and scientific progress made, and any risks that may arise.
The Recommendation, published on 20 October 2011, can be found at: