Tag Archives: Center for International Environmental Law

Nanomaterials and safety: Europe’s non-governmental agencies make recommendations; (US) Arizona State University initiative; and Japan’s voluntary carbon nanotube management

I have three news items which have one thing in common, they concern nanomaterials and safety. Two of these of items are fairly recent; the one about Japan has been sitting in my drafts folder for months and I’m including it here because if I don’t do it now, I never will.

First, there’s an April 7, 2014 news item on Nanowerk (h/t) about European non-governmental agencies (CIEL; the Center for International Environmental Law and its partners) and their recommendations regarding nanomaterials and safety. From the CIEL April 2014 news release,

CIEL and European partners* publish position paper on the regulation of nanomaterials at a meeting of EU competent authorities

*ClientEarth, The European Environmental Bureau, European citizen’s Organization for Standardisation, The European consumer voice in Standardisation –ANEC, and Health Care Without Harm, Bureau of European Consumers

… Current EU legislation does not guarantee that all nanomaterials on the market are safe by being assessed separately from the bulk form of the substance. Therefore, we ask the European Commission to come forward with concrete proposals for a comprehensive revision of the existing legal framework addressing the potential risks of nanomaterials.

1. Nanomaterials are different from other substances.

We are concerned that EU law does not take account of the fact that nano forms of a substance are different and have different intrinsic properties from their bulk counterpart. Therefore, we call for this principle to be explicitly established in the REACH, and Classification Labeling and Packaging (CLP) regulations, as well as in all other relevant legislation. To ensure adequate consideration, the submission of comprehensive substance identity and characterization data for all nanomaterials on the market, as defined by the Commission’s proposal for a nanomaterial definition, should be required.

Similarly, we call on the European Commission and EU Member States to ensure that nanomaterials do not benefit from the delays granted under REACH to phase-in substances, on the basis of information collected on their bulk form.

Further, nanomaterials, due to their properties, are generally much more reactive than their bulk counterpart, thereby increasing the risk of harmful impact of nanomaterials compared to an equivalent mass of bulk material. Therefore, the present REACH thresholds for the registration of nanomaterials should be lowered.

Before 2018, all nanomaterials on the market produced in amounts of over 10kg/year must be registered with ECHA on the basis of a full registration dossier specific to the nanoform.

2. Risk from nanomaterials must be assessed

Six years after the entry into force of the REACH registration requirements, only nine substances have been registered as nanomaterials despite the much wider number of substances already on the EU market, as demonstrated by existing inventories. Furthermore, the poor quality of those few nano registration dossiers does not enable their risks to be properly assessed. To confirm the conclusions of the Commission’s nano regulatory review assuming that not all nanomaterials are toxic, relevant EU legislation should be amended to ensure that all nanomaterials are adequately assessed for their hazardous properties.

Given the concerns about novel properties of nanomaterials, under REACH, all registration dossiers of nanomaterials must include a chemical safety assessment and must comply with the same information submission requirements currently required for substances classified as Carcinogenic, Mutagenic or Reprotoxic (CMRs).

3. Nanomaterials should be thoroughly evaluated

Pending the thorough risk assessment of nanomaterials demonstrated by comprehensive and up-to-date registration dossiers for all nanoforms on the market, we call on ECHA to systematically check compliance for all nanoforms, as well as check the compliance of all dossiers which, due to uncertainties in the description of their identity and characterization, are suspected of including substances in the nanoform. Further, the Community Roling Action Plan (CoRAP) list should include all identified substances in the nanoform and evaluation should be carried out without delay.

4. Information on nanomaterials must be collected and disseminated

All EU citizens have the right to know which products contain nanomaterials as well as the right to know about their risks to health and environment and overall level of exposure. Given the uncertainties surrounding nanomaterials, the Commission must guarantee that members of the public are in a position to exercise their right to know and to make informed choices pending thorough risk assessments of nanomaterials on the market.

Therefore, a publicly accessible inventory of nanomaterials and consumer products containing nanomaterials must be established at European level. Moreover, specific nano-labelling or declaration requirements must be established for all nano-containing products (detergents, aerosols, sprays, paints, medical devices, etc.) in addition to those applicable to food, cosmetics and biocides which are required under existing obligations.

5. REACH enforcement activities should tackle nanomaterials

REACH’s fundamental principle of “no data, no market” should be thoroughly implemented. Therefore, nanomaterials that are on the market without a meaningful minimum set of data to allow the assessment of their hazards and risks should be denied market access through enforcement activities. In the meantime, we ask the EU Member States and manufacturers to use a precautionary approach in the assessment, production, use and disposal of nanomaterials

This comes on the heels of CIEL’s March 2014 news release announcing a new three-year joint project concerning nanomaterials and safety and responsible development,

Supported by the VELUX foundations, CIEL and ECOS (the European Citizen’s Organization for Standardization) are launching a three-year project aiming to ensure that risk assessment methodologies and risk management tools help guide regulators towards the adoption of a precaution-based regulatory framework for the responsible development of nanomaterials in the EU and beyond.

Together with our project partner the German Öko-Institut, CIEL and ECOS will participate in the work of the standardization organizations Comité Européen de Normalisation and International Standards Organization, and this work of the OECD [Organization for Economic Cooperation and Development], especially related to health, environmental and safety aspects of nanomaterials and exposure and risk assessment. We will translate progress into understandable information and issue policy recommendations to guide regulators and support environmental NGOs in their campaigns for the safe and sustainable production and use of nanomaterials.

The VILLUM FOUNDATION and the VELUX FOUNDATION are non-profit foundations created by Villum Kann Rasmussen, the founder of the VELUX Group and other entities in the VKR Group, whose mission it is to bring daylight, fresh air and a better environment into people’s everyday lives.

Meanwhile in the US, an April 6, 2014 news item on Nanowerk announces a new research network, based at Arizona State University (ASU), devoted to studying health and environmental risks of nanomaterials,

Arizona State University researchers will lead a multi-university project to aid industry in understanding and predicting the potential health and environmental risks from nanomaterials.

Nanoparticles, which are approximately 1 to 100 nanometers in size, are used in an increasing number of consumer products to provide texture, resiliency and, in some cases, antibacterial protection.

The U.S. Environmental Protection Agency (EPA) has awarded a grant of $5 million over the next four years to support the LCnano Network as part of the Life Cycle of Nanomaterials project, which will focus on helping to ensure the safety of nanomaterials throughout their life cycles – from the manufacture to the use and disposal of the products that contain these engineered materials.

An April 1, 2014 ASU news release, which originated the news item, provides more details and includes information about project partners which I’m happy to note include nanoHUB and the Nanoscale Informal Science Education Network (NISENet) in addition to the other universities,

Paul Westerhoff is the LCnano Network director, as well as the associate dean of research for ASU’s Ira A. Fulton Schools of Engineering and a professor in the School of Sustainable Engineering and the Built Environment.

The project will team engineers, chemists, toxicologists and social scientists from ASU, Johns Hopkins, Duke, Carnegie Mellon, Purdue, Yale, Oregon’s state universities, the Colorado School of Mines and the University of Illinois-Chicago.

Engineered nanomaterials of silver, titanium, silica and carbon are among the most commonly used. They are dispersed in common liquids and food products, embedded in the polymers from which many products are made and attached to textiles, including clothing.

Nanomaterials provide clear benefits for many products, Westerhoff says, but there remains “a big knowledge gap” about how, or if, nanomaterials are released from consumer products into the environment as they move through their life cycles, eventually ending up in soils and water systems.

“We hope to help industry make sure that the kinds of products that engineered nanomaterials enable them to create are safe for the environment,” Westerhoff says.

“We will develop molecular-level fundamental theories to ensure the manufacturing processes for these products is safer,” he explains, “and provide databases of measurements of the properties and behavior of nanomaterials before, during and after their use in consumer products.”

Among the bigger questions the LCnano Network will investigate are whether nanomaterials can become toxic through exposure to other materials or the biological environs they come in contact with over the course of their life cycles, Westerhoff says.

The researchers will collaborate with industry – both large and small companies – and government laboratories to find ways of reducing such uncertainties.

Among the objectives is to provide a framework for product design and manufacturing that preserves the commercial value of the products using nanomaterials, but minimizes potentially adverse environmental and health hazards.

In pursuing that goal, the network team will also be developing technologies to better detect and predict potential nanomaterial impacts.

Beyond that, the LCnano Network also plans to increase awareness about efforts to protect public safety as engineered nanomaterials in products become more prevalent.

The grant will enable the project team to develop educational programs, including a museum exhibit about nanomaterials based on the LCnano Network project. The exhibit will be deployed through a partnership with the Arizona Science Center and researchers who have worked with the Nanoscale Informal Science Education Network.

The team also plans to make information about its research progress available on the nanotechnology industry website Nanohub.org.

“We hope to use Nanohub both as an internal virtual networking tool for the research team, and as a portal to post the outcomes and products of our research for public access,” Westerhoff says.

The grant will also support the participation of graduate students in the Science Outside the Lab program, which educates students on how science and engineering research can help shape public policy.

Other ASU faculty members involved in the LCnano Network project are:

• Pierre Herckes, associate professor, Department of Chemistry and Biochemistry, College of Liberal Arts and Sciences
• Kiril Hristovski, assistant professor, Department of Engineering, College of Technology and Innovation
• Thomas Seager, associate professor, School of Sustainable Engineering and the Built Environment
• David Guston, professor and director, Consortium for Science, Policy and Outcomes
• Ira Bennett, assistant research professor, Consortium for Science, Policy and Outcomes
• Jameson Wetmore, associate professor, Consortium for Science, Policy and Outcomes, and School of Human Evolution and Social Change

I hope to hear more about the LCnano Network as it progresses.

Finally, there was this Nov. 12, 2013 news item on Nanowerk about instituting  voluntary safety protocols for carbon nanotubes in Japan,

Technology Research Association for Single Wall Carbon Nanotubes (TASC)—a consortium of nine companies and the National Institute of Advanced Industrial Science and Technology (AIST) — is developing voluntary safety management techniques for carbon nanotubes (CNTs) under the project (no. P10024) “Innovative carbon nanotubes composite materials project toward achieving a low-carbon society,” which is sponsored by the New Energy and Industrial Technology Development Organization (NEDO).

Lynn Bergeson’s Nov. 15, 2013 posting on nanotech.lawbc.com provides a few more details abut the TASC/AIST carbon nanotube project (Note: A link has been removed),

Japan’s National Institute of Advanced Industrial Science and Technology (AIST) announced in October 2013 a voluntary guidance document on measuring airborne carbon nanotubes (CNT) in workplaces. … The guidance summarizes the available practical methods for measuring airborne CNTs:  (1) on-line aerosol measurement; (2) off-line quantitative analysis (e.g., thermal carbon analysis); and (3) sample collection for electron microscope observation. …

You can  download two protocol documents (Guide to measuring airborne carbon nanotubes in workplaces and/or The protocols of preparation, characterization and in vitro cell based assays for safety testing of carbon nanotubes), another has been published since Nov. 2013, from the AIST’s Developing voluntary safety management techniques for carbon nanotubes (CNTs): Protocol and Guide webpage., Both documents are also available in Japanese and you can link to the Japanese language version of the site from the webpage.

The French and others weigh in on the European nanomaterials definition (included here)

The responses to the announcement of the nanomaterials definition for Europe are coming fast and furious now. A summary from L’Association de Veille et d’Information Civique sur les Enjeux des Nanosciences et des Nanotechnologies (L’Avicenn) is available in an Oct. 20, 2011 news item on Nanowerk (French language version is available here),

Avicenn offers a first insight into the politics hidden behind this supposedly neutral and “scientific” definition, the next obstacles and important meetings, and then concludes on the suspense surrounding the definition that France will finally adopt for the annual mandatory declaration of nanomaterials it is implementing.

In a self-applauding press release, the European Commission announced yesterday that it finally published “a clear definition (of nanomaterials) to ensure that the appropriate chemical safety rules apply”. Nanomaterial is defined as:

  • “a natural, incidental or manufactured material
  • containing particles, in an unbound state or as an aggregate or as an agglomerate
  • and where, for 50% or more of the particles in the number size distribution, one or more external dimensions is in the size range 1 nm – 100 nm.”

Here’s a list of the responding organizations (from the Oct. 20, 2011 news item on Nanowerk),

After the release of this new definition, the most active “stakeholders” have already formally responded: among them, on the side of CSOs, the European Environmental Bureau (BEE) – the federation of 140+ environmental organisations in 31 countries, Friends of the Earth Australia (FoE Australia), the Center for International Environmental Law (CIEL), the European Consumers’ Organisation (BEUC) or the European consumer voice in standardisation (ANEC); on the industrial side, the European Chemical Industry Council (CEFIC).

I posted European nanomaterials definition not good enough about the response from the European Environmental Bureau yesterday (Oct. 19, 2011). So this may seem mildly repetitive (from English language tranaslation on the Avicenn website),

  • The new 100 nm upper limit

Friends of the Earth Australia, ANEC and BEUC denounce the adoption of the upper limit of 100 nm that they consider too restrictive: these CSOs would have preferred a higher threshold limit, that would have encompassed more materials. They refer to the Scientific Committee on Emerging and Newly Identified Health Risks (SCENIHR)’s highlight of the lack of scientific basis for this 100nm limit, and to results of toxicology studies on toxicity of submicron particles over 100 nm.
As illustrated by Foe Australia, “if this definition were applied to regulation, it would mean that where 45% of particles are 95nm in size and 55% particles are 105nm in size, substances would not be regulated as nano”at the expense of consumers and workers exposed to these substances and over whom will therefore keep hanging the threat of a risk that is assumed but not evaluated.
In response to EC consultation on its draft definition in 2010, many CSOs [civil society organizations] had argued for a threshold of 300 nm.
FoE Australia alerts to the fact that “some European cosmetics companies and North American bioactive manufacturers are reformulating their products to exploit the novel optical, chemical and biological properties of larger nanomaterials (ie >100nm) while escaping the labelling and safety assessment requirements that were anticipated for materials 1-100nm in size”.

  • 50% threshold

Some organizations – including CIEL and ANEC – applaud the choice of particle number (i.e. the number of particles) rather than mass as a measuring unit for size distribution of a nanomaterial product ; in contrast, CEFIC (which had strongly advocated using weight concentration rather than particle number distribution to determine the cut-off criterion for nanomaterials) is concerned that the adoption of this definition will add unnecessary burden for companies, leading to added costs and less efficient use of resources. The Commission followed by the recommendations of SCENIHR, which had been particularly supported by ANEC in 2010.
The Commission, however, largely raised the proportion of nano-sized materials required to qualify as nanomaterial compared to what was expected: 50% or more of the particles in the number size distribution is 50 times higher than the one that was proposed by DG Environment and supported by civil society (1%) and 333 times greater than that recommended by SCENIHR (0.15%) and supported by DG Sanco.
CSOs have expressed their surprise, incomprehension and hostility to such a high threshold. For example CIEL pinpoints that even the German industry had not been so demanding: it had campaigned for a rate of 10% “only”. However, the Commission provided that “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 between 1 and 50 %”. While CIEL or ClientEarth welcome this opportunity, FoE Australia deplores that it puts a huge burden of proof on to the CSOs to demonstrate not only that certain nanomaterials can cause harm but that certain they do so as a specific proportion of particles in a sample. Showing that some nanomaterials can cause damage in itself is already very difficult by the uncertainties, the gaps in the safety science, the variability of nanomaterials and the lack of information about real life exposure. But making the same demonstration by identifying the fraction of nanoparticles in a sample that cause such harm is even more difficult, actually well beyond current scientific knowledge.

  • The inclusion of aggregate and agglomerate

CIEL appreciates the inclusion of aggregate and agglomerate within the definition. CEFIC believes that this measure will make any European legislation on nanomaterials too restrictive.

The apparent technical nature of these debates and, ultimately, the arbitrary selection of thresholds illustrate the strong political dimension at work behind the decisions made by the EC : granted, the European authorities have had to make a decision based on “sound science” – backed by consultation of scientific experts – but in the end, they mainly had to come up with a trade-off between conflicting interests of stakeholders.

Here’s how they hope the French government will respond to all of this (from the English translation on the Avicenn website),

As far as France is concerned, it is not clear at present whether the decree on the annual declaration of “substances with nanoparticle status” will use the new definition of the European Commission. In its decree, the French government might try to maintain a larger definition than the definition adopted by the Commission. CSOs are turning with hope towards French choice which will be determinant for the future: if the adopted definition is larger than that of the Commission and therefore more in line with the precautionary principle, it could serve as an example and be followed in other countries.

For anyone who may not be familiar with some recent French nanotechnology history, in the Spring of 2010 there were major nanotechnology protests in France during a series of public debates.  You can read more about them in my Jan. 26, 2011 posting, Feb. 26, 2010 posting, and followup March 10 , 2010 posting, which includes details about a French-language podcast with two Québec academics discussing the French protests.

This does clear up one question I had about European Commission (EC) jurisdictions and national jurisdictions. It seems that countries can choose to create their own definitions although I imagine they cannot be at cross-purposes with the EC definition.

On an almost final note, here’s Dexter Johnson (Nanoclast blog for the Institute of Electrical and Electronics Engineers [IEEE]) in his Oct. 19, 2011 posting,

The definition itself…well, I don’t see how it helps to narrow anything, which I understand to be one of the main purposes of definitions. It would seem that the nanoparticles that are given off when your car’s tires roll along the pavement are now up for regulatory policy (“Nanomaterial” means a natural, incidental or manufactured material containing particles…”). And due to the lack of distinction between “hard” and “soft” nanoparticles in the definition, Andrew Maynard points out that “someone needs to check the micelle size distribution in homogenized milk.”

So what is the fallout from this definition? It would seem to be somewhat less than had been anticipated earlier in the year when worries surrounded getting the definition just right because it would immediately dictate policy.

So basically they have created a class of materials that at the moment are not known to be intrinsically hazardous, but if someday they are they now have a separate class for them. While some may see as this as making some sense, it eludes me.

As for me, I think much depends on future implementations. After all, you can have the best system possible but if it’s being run by fools, you have a big problem. That said, I take Dexter’s point about establishing a class of materials ‘just in case there could be a problem’. I really must take another look at the Health Canada nanomaterials definition.

Note: I removed footnotes from the Avicenn material; these can easily be found by viewing either the Oct. 20, 2011 news item on Nanowerk or the material on the Avicenn site.

ETA Oct. 20, 2011 1500 hours: I forgot to include a link to the ANEC response in this Oct. 20, 2011 news item on Nanowerk.