EU Approach to Nanomaterials

The risk assessment of nanomaterials should be carried out on a case-by-case basis, using strategies based on indications of potential risks, says the Commission.

A web platform with references to provide information sharing on nanomaterials should also be established.

These are the main points of a Communication on the second regulatory review on nanomaterials. Nanotechnology - the manipulation of matter at an atomic and molecular scale – promises major breakthroughs in numerous industrial fields, and the Commission wants to ensure that the risk assessment procedures covering this technology are as effective and efficient as possible.

This, it says, will ensure that European businesses and citizens can fully benefit.

The Communication

The Communication evaluates the adequacy and implementation of current EU legislation on nanomaterials, outlines follow-up action and addresses issues raised by other EU Institutions.

It is a follow-up of the 2008 Communication on the regulatory review on nanomaterials, and adjusts for technological breakthroughs and safety concerns. It also responds to concerns and issues raised by the 2009 European Parliament Resolution, the 2010 Council call and the 2009 Opinion of the European Economic and Social Committee.

The Communication focuses on:
• The security aspects regarding nanomaterials
• The application of the REACH and CLP (Classification, Labelling, and Packaging) Regulations to nanomaterials
• The developments as regards the EU framework on health, safety and environment protection 
• The need for better accessible information on nanomaterials

The definition of nanomaterials

There is no legal definition of nanomaterials. Only the 2011 Commission Recommendation defines nanomaterials as natural, incidental or manufactured materials containing particles where one or more external dimensions are in the size range 1 nm-100nm.

There will be no changes to this definition at this stage, and the definition will be integrated into EU legislation where appropriate. A review of this definition is planned in 2014 in view of scientific and technological developments.

There are three main groups of nanomaterials:
• Traditional high volume nanomaterials -  carbon black and synthetic amorphous silica - which are produced in quantities above 1 tonne per year
• Nanomaterials that have been recently developed and are attracting attention - nano-titanium dioxide, nano-zinc oxide, fullerenes, carbon nanotubes and nanosilver. These are produced in smaller quantities
• Other nanomaterial substances which are being developed rapidly in specialised technical applications, with high innovation potential and limited exposure to consumers

The benefits of nanomaterials

Nanomaterials are part of fast-growing high-end innovative sector that produces an estimated 11 million tonnes globally, with a market value of €20 billion. Carbon black and amorphous silica represent 97% of nanomaterials on the market in terms of volume.

Nanomaterials are currently used in catalysts, electronics, solar panels, batteries and biomedical applications such as diagnostics and tumour therapies. The Commission forecasts the nanotechnology sector as whole to increase from €200 billion in 2009 to €2 trillion by 2015. This potential has been recognised by the Commission, when it identified nanotechnology as one of the Key Enabling Technologies (KET).

Safety aspects

Natural and incidental man-made nanoparticles are omnipresent in the human environment. Their presence and effects on humans are generally known and understood. However, there is limited information on manufactured nanoparticles in the workplace and environment.

Based on scientific research, the specific nature of nanomaterials still requires more development, even though current risk assessment methodologies for substances are generally applicable to nanomaterials. The same applies for risk assessment in the food sector for nanomaterial applications in the food and feed chain.

This is one reason why the Commission believes that risk assessments should be carried out on a case by case basis.

REACH and CLP

The REACH Directive requires chemical substances, imported or manufactured in the EU, for which all or some forms are nanomaterials, to be registered with the European Chemicals Agency (ECHA) in order to demonstrate their safe use.

The CLP Regulation (Classification, Labelling, and Packaging) obliges actors to notify to the ECHA substances in the forms as placed on the market (including nanomaterials), which meet the criteria to be considered hazardous.

Registration of a substance under REACH requires that all forms of a substance are stated, but the safety of a substance has to be ensured as a whole. This does not necessitate stating and testing of all forms of a substance in the registration. As of February 2012, seven substance registrations and 18 CLP notifications had stated nanomaterial as the form of substance in a voluntary field.

The Commission Recommendation on a definition of nanomaterial will clarify terminology, but will not provide clarity for the registrants on how to address nanomaterials in REACH registrations. This is foreseen to be done by way of amending REACH Annexes.

ECHA will provide guidance on treating nanomaterials as forms of a bulk substance or as distinct substances based on further experience from evaluation of REACH registrations by 2013.

Even though REACH provides for suitable framework for nanomaterials, the overall goal is to improve assessment and reporting of nanomaterials in REACH registrations.

Health, safety and environmental protection

The Communication also notes that work is currently underway to assess the impact of nanomaterials on health and safety at work. A final assessment on a review of occupational health and safety legislation will be done by 2014.

In the area of consumer product safety legislation, work is also being done on:
• Adapting the relevant legislation to transpose the horizontal definition and to introduce specific provisions on nanomaterials
• Updating the relevant risk assessment processes
• Strengthening market surveillance 
• Improving information and labelling requirements
Environmental aspects of nanomaterials are covered by all environmental legislation, in principle. However, no nanomaterials-specific provisions have yet been established in EU environmental legislation controlling hazardous pollutants under CLP.

The Commission believes that potential environmental risks are best covered upstream by REACH and product legislation. Remaining implementation gaps in the legislation are being addressed.

More accessible information

The Commission will however create a web platform with references to all relevant national and sectoral information sources as soon as possible. At the same time, the Commission plans to conduct an impact assessment to develop the most adequate means to increase transparency and ensure regulatory oversight.

Next Steps

The European Parliament and the Council may formally respond to the Communication in the coming months. The Commission will prepare the next review within three years.