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Stavros DIMAS

European Commissioner for the environment

Nanotechnologies…challenges for the future

Figures and graphics available in PDF and WORD PROCESSED

Stakeholder Conference on Nanomaterials on the market

Brussels, 9 October 2009

Good morning ladies and gentlemen, let me first of all welcome you to this conference on nanomaterials, a very important and challenging topic that I am pleased to introduce. Before doing so, let me also thank the Swedish presidency for their help in organising this event where I am pleased to see many policymakers, public authorities and NGOs represented here today.

It is a fact that nanomaterials can already be found in many products on the market – from the infamous nano-silver socks to tennis rackets and printing inks for instance.

Nanotechnology carries many promises: not only to create new products that will make positive changes to our lives but also to boost the competitiveness of EU industry.

Europe is among the leaders in this area. The EU has expanded its spending on Research and Development on nanotechnology in the last decade with some €3.4 billion available under the Seventh Framework Programme 2007 to 2013, not including spending in the area of nano-electronics

But this is not only a pure research issue that could reach our daily lifes in a couple of decades: nanomaterials are already on the market and it is clear that the world market for nanotechnology is growing very rapidly. As more and more products using nanomaterials are placed on the market, a number of important and legitimate questions are being raised: what are these nanomaterials that are already being used, how many are available on the EU market and what are their specific characteristics.

Today we will look at the information gaps that need to be filled and linked to this, the extent to which the EU chemicals legislation REACH is providing the answers. In other words, is REACH an adequate tool to assess and manage the risks that may be associated with nanomaterials.

New technology – new challenges

Ladies and gentlemen,

We live in a dynamic world in which we see an ever-increasing stream of new inventions, technologies and products. This is something we welcome as they generally bring benefits. This is particularly true for chemicals, where old substances known to be hazardous should be replaced with new less hazardous ones.

There is no doubt that nanotechnology is an exciting new area of science with promising benefits for manufacturers, consumers, employers, patients and the environment.

As Commissioner for the environment, I believe that any technology that can help us respond to the many environmental pressures we face must be embraced and become part of our toolbox.

Nanotechnology may help us reduce energy consumption, increase the effectiveness of renewable energy sources and treat polluted water, air and soil. These are just a few examples of areas in which we hope to see nanotechnology produce concrete benefits.

However, and as any other new technology, this may also bring potential new risks. Nanomaterials have specific characteristics and novel properties, which need to be considered carefully in order to minimise any potential risk, notably to health and the environment.

At this point in time little is known about the potential effects of nanomaterials and there are still many uncertainties about the health and safety aspects of nanotechnologies. And this is my concern and responsibility as Commissioner responsible for the environment to find out about these uncertainties.

The regulatory challenge is to ensure that society benefits from novel applications of nanotechnologies, while ensuring a high level of protection of health, safety and the environment.

Is the existing regulatory framework suitable?

Nanotechnology and the products that are made possible through the use of this technology are a good example of how new innovative technologies can challenge our existing regulatory framework.

Today the EU has by far the most advanced chemicals legislation in the world – REACH.

REACH is there to ensure a safe use of all chemicals, including nanomaterials. Nanomaterials are, as a matter of principle, covered by REACH under the definition of a chemical substance. The general obligations in REACH therefore apply as for any other substance, even if there are no provisions referring explicitly to nanomaterials.

REACH therefore provides an effective legal framework in principle to ensure that chemicals, including a priori nanomaterials, are not harmful to human health and the environment.

During the decision process for REACH, the feasibility and cost of its implementation were discussed at length. A fair balance was struck between the administrative cost for the companies and the level of environmental protection.

One of the key elements in this balance was setting the volume threshold for registrations at 1 tonne – significantly higher than the old legislation which made notification of new substances mandatory from 10 kg.

The important question to ask, and this is particularly relevant for nanomaterials, is whether what falls below the threshold may represent a risk to health and the environment. For standard chemicals the tonnage threshold is, I believe, appropriate, but the question is whether this is equally true for nanomaterials.

The discussion can easily become driven by assumptions. But what matters is to be pragmatic and be driven by the need for information, which is crucial since our responsibility as policy-makers is to take risk management decision allowing for a high level of protection. Today's conference is an effort by the Commission's Directorate General for the Environment to discuss the issues based on the search of the facts and data that are necessary to best inform decision-makers about the scope and nature of the issues at stake. Getting better information about the use and characteristics of nanomaterials is the very first but necessary step towards an informed and effective decision-making and risk management. We are convinced that the best long-term results are achieved if we keep an open mind, gather data and information and – in an open process – consider the options.

The scope of the issue

Firstly, we need to understand the scale of nanotechnology in the EU in terms of the number of nanomaterials that are produced today and how many we can expect to see in the near future.

It is not easy to gather such information as there is no single register. To make matters more difficult, there is not even full agreement about the definition of a nanomaterial.

Today's meeting is therefore a good first occasion to start the work of finding this out.

Once we have a better idea of the scope and nature of nanomaterials on the European market we can then take a step back and go through the rules. We will need to consider whether registration of the majority of nanomaterials will take place in 2010 or only at the end of the registration timetable in 2018 and if there are some nanomaterials that will not be registered under REACH. We will also need to look at other key provisions in REACH to see if they are adequate for nanomaterials.

The European Parliament intervened in this discussion with the adoption of a Resolution on 24 April this year, which is a very welcome contribution to the open debate we should be having on these issues. The Parliament acknowledges that nanotechnologies carry important benefits and can contribute to the competitiveness of the European Union. On the other hand, it recognises that nanomaterials may potentially present new risks and that the current discussion about nanomaterials is characterised by a significant lack of knowledge and information.

The Parliament questions whether our legislation covers the relevant risks relating to nanomaterials in the absence of any specific nano-provisions or appropriate data and methods to assess the risks. Consequently, it has invited the Commission to consider whether regulatory change is necessary to address risks in relation to nanomaterials in an appropriate way. It considers particularly important to address nanomaterials explicitly within the scope of legislation on chemicals, food, waste, air and water and worker protection.

In response, the Commission will review all relevant legislation within two years to ensure safety for all applications of nanomaterials in products with potential health, environmental or safety impacts over their life cycle.

Many different Commission services must contribute in response to the broad range of requests. Therefore today's conference is only a first and limited step in trying to address some of the questions that are relevant to ensure the greatest protection for citizens' health and the environment. It is our ambition that it can help start a discussion that the Commission can benefit from in its future work.

When discussing these issues today, it will also be important to look at measures already being used by some Member States and non-EU countries in their quest for more information about nanomaterials. This is part of the picture and of what we need to bear in mind, not least as an illustration of concerns on the part of some Member States and their citizens regarding the use of nanomaterials.

For example, some Member States have initiated with industry voluntary reporting schemes to allow public authorities, in cooperation with the industry, to have better knowledge about nanotechnologies being used and put on the market.

The Commission has not made up its mind on how precisely to get the information needed. Today's event will contribute to our reflexion on finding the best way to gather this information in the short run while we carefully review the adequacy of the regulatory framework.

Ladies and Gentlemen,

REACH set out to fill the huge information gap that existed on thousands of chemical substances. The process of doing this is already underway.

A s technology advances, it offers new solutions. But it also raises new questions about safety and it is our duty to address these issues and ensure the highest level of protection for citizens and the environment, in accordance with a fundamental principle enshrined in the EU Treaty, namely the precautionary principle.

I look forward to a fruitful discussion today which will take this debate forward. As we can see there is much ground to cover and I wish all participants a good conference.

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