The Challenges of Regulating Nanomaterials

The Challenges of Regulating Nanomaterials

Author: Vera Köster

Dr. Otto Linher is Deputy Head of the Chemicals Industry Unit,
European Commission, DG Enterprise and Industry, Brussels, Belgium. He deals with competitiveness aspects of the chemical industry, including emission trading and nanomaterials.

Here, he talks to Dr. Vera Koester for ChemViews magazine about the challenges of defining and regulating nanomaterials and where legislation is heading.

Since when has the European Commission been dealing with nanomaterials?

It all started with an action plan to promote nanotechnology. Then more and more concerns about health and safety arose. So today there is an interservice group in the Commission dealing with nanomaterials led by DG Research and Innovation with strong involvement from DG Environment, DG Enterprise, and DG Health and Consumer Affairs.

Nanomaterials is such a huge field, ranging in applications from pharmaceuticals to paints. How can you get regulation that covers all nanomaterials under one umbrella?

It’s not at all easy. It’s a very, very complex field. It was already difficult for the Commission to define nanomaterials. Then the next question is how to regulate them.

What are the main challenges?

In our work on the Second Regulatory Review on Nanomaterials we discovered that nanomaterials are much more common and normal than we would have expected from previous debate. Many known nanomaterials that have been there for decades, such as carbon black and synthetic amorphous silica, are widespread in many applications. Also, if objective criteria are applied, such as particle distribution in a size range of 1–100 nanometres, many more common materials may actually be nanomaterials, even those that have traditionally not been identified as nanomaterials.

What definition of nanomaterials did the Comission agree upon?

We started to use the ISO definition, the international standardized definition, but found that that was too broad. It covers too many materials, even many more than the EU definition does, and would have been even more challenging to enforce.

For example, we needed to define a minimum threshold on how many nanoparticles need to be in a material to make it a nanomaterial, because nanoparticles are everywhere and without such a threshold we would have covered almost all solid materials. We took a figure of 50 % of particles to be as practical as possible but we are far from claiming that this is a perfect and scientifically unequivocal value. We will have a review of the nanomaterial definition in the next year.

We also excluded nanostructured materials, that means materials with surface structures or pores in the nano range because most real-life materials have in one way or the other such structures. Defining a minimum threshold on how many and which structures would be needed to characterize a nanostructured material would have been an almost impossible task.

Where do you gain your knowledge about nanoparticles from?

There are different aspects to how we do that. On the one hand, we follow the ongoing research on nanomaterials, in terms of market developments and innovation, as well as safety assessment. Quite a lot of research programs and publications are in that field.

On the other hand, we are involved in legislation. While we were discussing what exactly could be characterized as a nanomaterial, we’ve learned a lot. Earlier definitions, as were introduced, for example, in the cosmetics legislation, were limited to intentionally manufactured nanomaterials. However, the intention to manufacture is a rather subjective notion, and it is hard to see in what way intentionally manufactured nanoparticles would have different properties and risks compared to those that were produced unintentionally or those naturally present or those resulting from milling or combustion processes.

So that means that the short-term vision is to have different regulations for, for example, the cosmetics and the paint industry?

We have two layers of existing legislation. If you look at nanomaterials as substances or mixtures, then REACH comes into the game. Here our objective is to make the rules clear and to get more information into the REACH registration dossiers ensuring the safe use of those nanomaterials.

The other is the legislation for specific products that require particular attention because of their field of application, for example, the close contact consumers have with those applications. This covers, for example, cosmetics, food labeling, and biocides. For these areas, we already have specific legislation, which now needs to be implemented.

There is, maybe, a third emerging layer relating to information on nanomaterials on the market. This is where we have the debate on a possible registry of nanomaterials and products containing nanomaterials.

Are you concerned that the public’s good perception of nanomaterials might be lost due to legislation activities? Maybe comparable to the perception of plant biotech?

The characteristics of nanomaterials are different from GMOs because there is no real ethical dimension and no change in genetics.

The real difference compared to conventional solid chemicals is that nanoparticles can under certain circumstances pass through membranes and reach target organs, where they may, or may not, be accumulated. Available evidence, however, indicates that despite this possibility, as a group of substances, nanomaterials are not particularly hazardous, and that effects, if there are any at all, tend to occur only at high or very high doses. Where nanomaterials have been on the market for a long time, we are not aware of any major hazardous effects of those substances, including on workers who have been intensively in contact with the substances.

Therefore, we do not see a reason to suspect major problems collectively with nanomaterials. This said, we should, of course, undertake all efforts to identify any possible health and environmental issues. To do this, we should focus our efforts on those substances and nanoforms where we have most doubts, and investigate whether those doubts are justified, and what we can learn for the risk assessment and management for other substances, for example, by better understanding the drivers of toxicity in those areas. We should do that on a case by case basis instead of trying to cover the whole range of nanomaterials, which in the end is not really worth spending too much time on.

How can such a case-by-case study happen?

That’s basically the system we have in REACH. It is, if you want, a sort of screening system. Producers have certain obligations to provide information. When there are indications that something might be critical, REACH provides the possibility to go into more detail, for example, in substance evaluation.

So you work closely together with REACH?

REACH is the main tool to identify risks and to make sure that those risks are adequately addressed, in the first place by the manufacturers. But we also see a subsidiary obligation for the authorities to evaluate the dossiers and raise critical questions. ECHA does this through compliance checks. That is a more formal check. Member States have the possibility to do substance evaluation and can ask for more information from companies if they feel that the dossier is not strong enough.

Then what separates your work from ECHA’s work?

The work of the Commission is to set the framework. ECHA is there to implement the framework, but that also goes together with the work of the Member States.

So nanomaterials will stay within the domain of REACH or are there plans for a separate legislation like for biocides?

REACH is the centerpiece, but there are specific pieces of legislation around this, some of which build directly or indirectly on REACH, or what has been done in REACH, and set more specific rules when a substance is used in a particular application, for example, when it’s particularly critical for consumers. So anything you eat or you put on your skin, requires specific precautions. Also, there may be specific considerations for worker protection that should be addressed in the context of worker protection legislation or its implementation.

Is there a vision for international harmonization of the regulation of nanoparticles?

There’s a lot of cooporation in the risk assessment of nanomaterials, mainly in OECD. We also have a specific dialogue with our colleagues in the US, but I think we have to be aware that we have two completely different systems of chemicals legislation. In the EU we have rules applying to all nanomaterials, whereas the US system is based on identifying individual substances, which may also be nanomaterials, for further scrutiny.

What are the next goals?

We have three main areas to work on: One priority is to work on measurement methods for nanomaterials. There are still a lot of methodological problems that cause unclarity for companies.

Then, there will be an Annex Review on REACH. This is intended to clarify the application of the REACH rules to nanomaterials, generating more information on which nanomaterials have been registered and improving their risk assessment. The Commission intends to come up with a proposal within the coming year.

The third main area we’re working on is registries. You’re probably aware of the system in France where manufacturers or distributors of nanomaterials on their own, or in a mixture, or under certain conditions in a finished product, have to declare to the authorities which nanomaterials they put on the market, and in what quantity. There have been calls to create such a system at the European level. So far, we have not taken a decision on this. But we are doing an impact assessment, which is something that the Commission has to do on every proposal. Whether this is going to come or not is a political decision that will be taken by Commissioners, although probably not under the current Commission, but rather under the next, which is going to start at the end of 2014.

So will we only see huge changes, if there will be any, in 2014?

Concerning the registries, there will be a decision at the end of 2014 or beginning of 2015. We still need to be aware that it will take several years until this could be in place because of the duration of the legislative process and the time needed to implement the legislation. So I think that we won’t have a community registration system for such products before 2017 or 2018, whether or not we take the decision to do something along the lines of the French system at EU level.

Concerning the REACH Annexes it’s probably sooner than that. We aim at being ready with a Commission proposal by the end of this year.

And a final question. Can you tell us a bit about how your career has developed?

I’ve been a Commission official since 1996. In the beginning, I worked in the DG Enterprise on environmental issues. Then I spent seven years in DG Environment on waste issues and since 2006 I’ve been working on chemicals, first on REACH. Since 2010, I’ve been Deputy Head of Unit of the chemicals industry unit in DG Enterprise. Here, I’ve been involved in competitiveness issues and all general issues for the chemical industry, from economic analysis to competition and trade.

Since I have been working on REACH, I have had a special pet subject: nanomaterials.

Thank you very much for the interview.

Dr. Otto Linher studied biology and history at the University of Vienna, Austria, and then studied at the Diplomatic Academy in Vienna and the Ecole Nationale d’Administration in Paris and Strasbourg, France. He joined the European Comission in 1996 and has held several positions within the Comission since then. Currently, he is Deputy Head of the Chemicals Industry Unit, European Comission, DG Enterprise and Industry, Brussels, Belgium.

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