Define and Disclose: The EU moves forward with nanomaterial regulation

Over the last few months, the debate around nanomaterials has matured. The policy initiatives of the European Union and France regarding nanomaterials, presented in the September 2010 issue of the Flash, have turned into concrete proposals. Determining the real nano-effects, as a result of improved scientific data and research, appears to be the key for effective regulation of nanomaterials.

The European Commission has decided to first define nanomaterials to ensure harmonization for future regulation. In October 2010, a definition of the term nanomaterial was proposed in a draft Recommendation. A Recommendation would not give this definition the full force of law but it would contribute to the development of new EU policies and regulatory developments and the implementation of existing regulations. “Nanomaterial” would be defined as any material which meets at least one of the following criteria:

  • consists of particles, with one or more external dimensions in the size range 1 nanometre (nm) to 100 nm for more than 1 per cent of their number size distribution;
  • has internal or surface structures in one or more dimensions in the size range 1 nm – 100 nm; or
  • has a specific surface area by volume greater than 60 m2/cm3, excluding materials consisting of particles with a size lower than 1 nm.

However, uncertainty about the definition may remain. The draft definition of nanomaterials is the outcome of scientific research, studies, opinions and consultations at the European level, and specifically the Opinion of the Scientific Committee on Emerging and Newly Identified Risks (SCENIHR). According to the results of the stakeholder consultation carried out by the SCENHIR and published in March 2011, the definition of nanomaterials suffers from a lack of agreement: while certain stakeholders favour a definition based on the weight of the particle, others favour one based on the number of particles. A final definition has not yet been issued by the European Commission and could undergo further amendments to gain wider agreement.

At the same time, attempts to improve our understanding and knowledge of nanotechnology continue. From a consumer perspective, the Belgian Presidency of the EU proposed in late 2010 to ensure the traceability of nanomaterials through a register of nanotechnology and to strengthen the information provided to consumers on the presence of nanomaterials in everyday products. The register of nanomaterials could be the first step to assess the risks nanoparticles present. The European Commission Joint Research Centre also launched the first European Repository of Reference Nanomaterials. The Repository contains 25 types of different nanomaterials as a representative range, in order to enhance the safety assessment and standardization of nanomaterials. The repository aims to further study the impact of nanomaterials, by addressing those mostly used in consumer products such as titanium dioxide, silver nanoparticles or carbon nanotubes. Aside from these proposals, the European Commission is examining how to better address nanomaterials within the existing REACH requirements without having to introduce specific nano-requirements therein.

Meanwhile, in January 2011 France moved on with its innovative approach

requiring compulsory declaration of nanomaterials by issuing a detailed proposal. Prior to the proposal, all that was known was that manufacturers, importers, or persons that place on the market nanoparticulate substances, including mixtures, would be required to periodically declare the identity, quantities and uses of these substances, as well as the identity of the professional users they supplied them to. This requirement would apply to various products containing nanoparticulates such as medicinal products, cosmetics, or plant protection products. Nanomaterials falling under the scope of the declaration, thresholds and reporting periods had not been previously defined.

In the proposal, the French Government avoided the complex job of defining nanomaterials by using the definition prepared at EU level and clarified that the declaration would concern aggregates, agglomerates, compounds, nanotubes, nanothreads, nanolayers, quantum dots and dendrimers. The declaration would be required as long as at least 10 grams of nanomaterials would be manufactured, imported or placed on the market in France. The declaration would have to be done electronically at the latest before the first of May for the nanomaterials placed on the market the previous year. If the declaration was deemed incomplete or insufficient, the competent authority would be able to request the declarant to provide further information. An exception for the protection of national defence would be applicable on specific request.

The proposal indicates a research purpose for the declaration, as the collected data would be transferred to French public agencies in charge of environmental and safety research or surveillance for the development of further studies on the risks of nanomaterials for the environment or human health and safety. Although this text has not yet been adopted and other implementing measures are not yet drafted, France demonstrates its willingness to handle and regulate the presence of nanomaterials on its territory in a precautionary manner.

The regulatory activity on nanomaterials in France and the European Union are just two examples. Several other countries are issuing policies to avoid negative impacts of the growing presence of nanomaterials in everyday life. Germany is for instance considering developing a nanomaterials’ register, and Switzerland authorities have issued guidelines on how to take into account the unique properties of nanoparticles in material safety data sheets.  If you are concerned by the upcoming regulations and policy developments on nanotechnology, it is one of the many issues that Enhesa keeps track of global level with its monitoring service.

The way forward in the debate over nanomaterials will necessarily require a definition of the real risks they present for the environment and for human health, which might trigger a global search for scientific and technical data.

Flore Cognat

EHS Consultant

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