Tag Archives: REACH

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.

What do you do with a problem like regulating nanotechnology risks?

You get points for recognizing the “Sound of Music’ reference. Of course, the points aren’t useful for anything, which leads me in a roundabout way to Michael Berger’s fascinating May 28, 2013 Nanowerk Spotlight article, Does the EU’s chemical regulation sufficiently address nanotechnology risks? It’s a digest of a discussion, published in Nature Nanotechnology’s May 2013 issue, about nanotechnology regulations in light of the European Commission’s (EC; a unit in the European Union structure) Second Regulatory Review on Nanomaterials.

Berger summarizes Steffen Foss Hansen’s The European Union’s chemical legislation needs revision (article is behind a paywall) and Antonio Tajani’s response to Hansen, Substance identification of nanomaterials not key to ensuring their safe use (article is behind a paywall; Note: Links have been removed from the following excerpt),

The European Union’s chemical legislation known as REACH needs revision argues Steffen Foss Hansen, Associate Professor at DTU Environment, Technical University of Denmark. In a correspondence to the Editor of Nature Nanotechnology (“The European Union’s chemical legislation needs revision”), Hansen argues that REACH needs to be revised in three major areas.

First of all, a distinction needs to be made in the legal text of REACH between the bulk and the nano form of a given material and Hansen argues that the European Commission should acknowledge that nanomaterials cannot be identified solely by chemical composition. Additional main identifiers (such as primary particle size distribution, shape – including aspect ratio – specific surface area and surface treatment) are needed as this is the only manner in which it can be made clear that the properties and behavior of nanomaterials differ fundamentally from each other and from the bulk material.

In a response to Hansen’s Correspondence, Antonio Tajani, Vice-President of the European Commission and Commissioner for Industry and Entrepreneurship, writes that substance identification of nanomaterials is not key to ensuring their safe use (“Substance identification of nanomaterials not key to ensuring their safe use”).

Tajani argues that substance identification is only one element and that trying to identify unambiguous rules for substance identification is probably elusive and might result in ever more complex rules on what is considered as the same substance as opposed to different substances, without necessarily resulting in more safety of nanomaterials. Instead, Tajani and the European Commission wish to focus on clarifying what is needed to demonstrate the safe use while also noting that the implementation of regulatory changes would take several years and hence is not desirable.

As per my Oct. 25, 2011 posting (Nanoparticle size doesn’t matter), my thinking on environmental, health, and safety issues regarding engineered nanomaterials has been in the process of change and I note that focusing on the size, shape, and other factors would make regulation next to impossible. So, I’m inclined to agree with Tajani’s arguments that trying to develop “unambiguous rules for substance identification” is not a worthwhile approach to dealing with any EHS issues that nanomaterials may present and will likely prove futile in the same way as gaining points for recognizing my attempted ‘Sound of Music’ reference.

I assume that Tajani and Hansen are referring to engineered nanomaterials as opposed to naturally occurring nanomaterials. (I too forget to specify but unless otherwise noted I’m usually referring to engineered nanomaterials.)

For me, two of the most compelling issues that Hansen presents revolve around a lack of data and standardized testing (from Hansen’s article in Nature),

… there are few measured exposure data and that few environmental fate and behaviour studies are available. …

… there are currently no standardized (eco)toxicity test guidelines in use …

I do wonder how many the word ‘few’ represents as I’m reminded of the plethora of studies on silver nanoparticles and on long, multi-walled carbon nanotubes. Certainly, they are attempting to address the situation regarding consistent testing protocols in the US as per my May 8, 2013 post about the NanoGo Consortium. Perhaps the EC folks could consider using these protocols as a model for a European version?  I assume that Hansen is commenting on a broader, European-inflected picture rather than the piecemeal, ‘globalish’ picture I have formed from my meanderings in the nanosphere.

Hansen also points this out in his Nature article (Note: Footnotes have been removed),

Another disturbing aspect of the Second Regulatory Review on Nanomaterials is that it focuses only on first-generation nanomaterials (that is, passive nanostructures such as nanoparticles). The Staff Working Paper acknowledges that second- and third-generation nanomaterials (for example, targeted drug-delivery systems and novel robotic devices) are entering early stages of market development, …

I’m beginning to find the discussion about definitions and resultant regulations wearing and am coming to the conclusion that the focus should be on bringing the information already gathered together, standardizing tests, determining what is  known and not known, and establishing some forward momentum.

Webinar featuring REACH and JRC perspectives on the European Union’s definition of nanomaterials

NanoSight is once more hosting a webinar on the European Union’s definition of nanomaterials (the first nanomaterials definitiion webinar was mentioned in my March 6, 2012 posting).  Here’s more about their latest nanomaterials definition webinar,  from NanoSight’s webinar registration page,

Update on the EU Nanomaterials Definition: Impact of Recent EU and JRC [European Commission's Joint Research Centre] Publications

Wednesday, 14th November 2012
Live at 15:00 GMT (16:00 CET, 07:00 PST, 10:00 EST)
Repeated Live at 17:00 GMT (18:00 CET, 09:00 PST, 12:00 EST)

Dr Denis Koltsov is an international nanotechnology legislation and control expert. He is Director and Principal Consultant at BREC Solutions offering technology consulting services. He also holds a lectureship in the Department of Engineering at Lancaster University.
Dr Matteo Della Valle is from the REACH Centre, an organization that provides the highest quality advice on the many regulatory, technical and commercial aspects of REACh and other chemical regulations.

During the 30 minute interactive presentations, the speakers will

  • Review the JRC methods document and dicuss the key conclusions and the challenges presented
  • Outline the EU’s Second Regulatory Review and forthcoming legislation where it will have most impact with particular emphasis on the REACh [European Community's (Registration, Evaluation, Authorisation and restriction of CHemicals] registration process
  • Report on the USA perspective concerning regulation of nanomaterials. This reporting will include matters tabled as SENN2012 – International Congress on Safety of Engineered Nanoparticles and Nanotechnologies, at the end of this month in Helsinki

As part of this fully interactive presentation you will be able to put your question to both myself and Denis, so please take advantage of this opportunity to clarify any queries you may have.

H/T to Azonano’s Nov. 2, 2012 news item.

Bureaucratic incomprehensibility: REACH Nanomaterials Implementation Projects

This looks to be one of those announcements made by an organization that is simply going through the motions or perhaps they’ve forgotten that no one understands bureaucratese unless they’re intimately involved.

This first bit isn’t so bad, from the Oct.19, 2011 news item on Nanowerk,

Final reports have been published from two REACH Implementation Projects on Nanomaterials (RIP-oN 2&3). Commissioned by the JRC’s Institute for Health & Consumer Protection, the projects intended to develop specific advice on the implementation of REACH for nanomaterials. The outputs from the projects have been developed over a period of 12-16 months in consultation with a range of stakeholders. The reports have scoped the current state-of-the-science regarding assessment of nanomaterials in the context of REACH, and provide recommendations to the European Commission on how the REACH Guidance on Information Requirements and Chemical Safety Assessment could be further developed to better address nanomaterials.

So we have two final reports. Here’s the description of the reports,

The RIP-oN 2 project has addressed the REACH information requirements on intrinsic properties of nanomaterials, and the information needed for safety evaluation of nanomaterials. The RIP-oN 3 project has addressed exposure assessments and hazard and risk characterisation for nanomaterials within the REACH context.

Not the most informative description I’ve ever read. And as it turns out, there’s a third report,

Under a separate process, a third report from the RIPoN activity relating to Substance Identity (Rip-oN 1) has also been published. This report is also available online, however, according to the Commission it was not possible to reach consensus amongst the experts on the recommendations, therefore further work of the Commission, in collaboration with CARACAL, is required before recommendations can be forwarded to ECHA

Maybe a government bureaucrat understands some of this?