European Union

German officials are leading a push for a major revision of the European Union's REACH regulation as it deals with nanomaterials due to continued concerns over their potential hazard to humans and the environment.

The EU Commission's Second Regulatory Review on Nanomaterials, published in October 2012, said nanosubstances do not require a special regulatory framework and their risks can largely be addressed through REACH.   But REACH does not set out any specific requirements for nanosubstances.

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REACH, the European Union's primary regulation on chemicals is failing to identify or control nanomaterials. That is the conclusion of "Just Out of REACH: How REACH is failing to regulate nanomaterials and how it can be fixed," a report published February 6, 2012, by the nonprofit Center for International Environmental Law (CIEL).

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A project funded by the Danish Environmental Protection Agency (EPA), has resulted in the development of a new nanomaterial risk assessment tool called NanoRiskCat (NRC). The project's aim was to identify, categorize, and rank exposures and effects of nanomaterials used in consumer and industrial products based on data available in the peer-reviewed scientific literature and other regulatory relevant sources of information and data. The primary focus was on nanomaterials relevant for professional end-users and consumers, as well as nanomaterials released into the environment. The tool is a valuable step but needs to be further validated and tested on a series of various nano products in order to adjust and optimize the concept.

The project report, NanoRiskCat - A Conceptual Decision Support Tool for Nanomaterials, is 268-pages long.  I've provided what I hope is a succinct, but still sufficiently robust, summary of the NRC project and report below, from the report's Executive Summary. 

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On November 24, 2011, the EU's SAFENANO and ObservatoryNANO published an excellent new resource, the “Nanotechnology EHS Landscape” report.   I recommend a review by anyone with an interest in nanosafety and risk issues.

SAFENANO continues to offer great up-to-date information on nano safety issues and is one of my "must-read" sites on a regular basis.

The new report provides a map and concise overview of key organizations and their activities in nanotechnology Environment, Health and Safety (EHS) issues.  Activity in this sector has been growing for a decade, with multiple position papers, roadmaps, standardization committees, research groups, and significant research conducted. The literature has grown exponentially in the past 3 years in particular.

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SAFENANO, Europe's Centre of Excellence on Nanotechnology Hazard and Risk, along with the Institute of Occupational Medicine (IOM), have announced the official launch of the European Research project MARINA (MAnaging RIsks of NAnoparticles).

While there are standard procedures for product life cycle analysis, exposure, hazard, and risk assessment for traditional chemicals, it is not yet clear how these procedures need to be modified to address all the novel properties of nanomaterials. There is still an acute need to develop specific reference methods for all the main steps in managing the potential risk of ENM. The aim of MARINA is to develop such methods.

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A recent document from the Organization for Economic Co-operation and Development (OECD), “Current Developments/Activities on the Safety of Manufactured Nanomaterials,” provides an update on current developments and activities regarding the safety of manufactured nanomaterials in OECD member countries, and other delegations that attended the 8th meeting of the OECD’s Working Party on Manufactured Nanomaterials, held in Paris, France from March 16 to 18, 2011. 

 

The document includes written reports on current activities related to nanotechnologies and nanomaterials in other international organizations, such as the International Organization for Standardization, the Food and Agriculture Organization of the United Nations, and the World Health Organization.  This resource is intended to provide delegations and other stakeholders with a “snapshot” (current to March 2011) of information on activities related to manufactured nanomaterials, as well as other nanotechnology activities, at the national and international level.

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The recent EU Cosmetic Products Regulation includes a labeling obligation for nanomaterials in the list of ingredients, in order to allow consumers to make a choice.  Similar provisions are now being considered for other regulations/ directives, e.g. the Novel Foods Regulation. Also the European chemicals legislation REACH may need adjustments to address and control the potential risk of nanomaterials.

The introduction of these provisions specific to nanomaterials requires the adoption of a definition of the term ‘nanomaterial’. This need is also acknowledged by a European Parliament resolution from 20090 which has called for a comprehensive science-based definition in Community legislation.

An excellent discussion of the subject, and real progress on the issue, is reflected in a new European Commission Reference Report, “Considerations on a Definition of Nanomaterial for Regulatory Purposes.”

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On May 10, 2011, the European Food Safety Authority (EFSA) published a guidance document for the risk assessment of engineered nanomaterial (ENM) applications in food and feed  in response to a request from the European Commission,

 

“Guidance on the risk assessment of the application of nanoscience and nanotechnologies in the food and feed chain” is the work of the EFSA’s Scientific Committee and is the first of its kind to give practical guidance for addressing potential risks arising from applications of nanoscience and nanotechnologies in the food and feed chain. The guidance covers risk assessments for food and feed applications including food additives, enzymes, flavorings, food contact materials, novel foods, feed additives and pesticides.

 

The EFSA guidance sets out the considerations for risk assessment of ENM that may arise from their specific characteristics and properties.

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Two Sections of the American Bar Association are presenting a half-day program that may be of interest to you. “Nano Governance: The Current State of Federal, State, and International Regulation,” is being presented as a webinar and for attendance at several host sites on Thursday, May 19, 2011, at 1:00 p.m. – 5:30 p.m. Eastern Time.

A number of knowledgeable experts have been lined up to speak by the co-sponsoring Section of Science and Technology Law: Nanotechnology Committee (of which this blogger is a member) , and Section of Environment, Energy, and Resources: Pesticides, Chemical Regulation and Right-to-Know Committee.

The program brochure is available here.   A program overview and educational objectives are shown below.

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SAFETY ISSUES OF NANOMATERIALS ALONG THEIR LIFE CYCLE is a two day Symposium that will be held on May 4-5, 2011, at LEITAT Technological Center, Barcelona (Spain).  It is jointly organized by the coordinators of three European Community nanotechnology safety research projects: NANOPOLYTOX, NEPHH and HINAMOX.  

The aim of the Symposium is to discuss the human and environmental impacts of nanomaterials along their life cycle from their production through their processing, use, and end of life (recycling and/or disposal).   Therefore, the tools and methodologies proposed for the risk assessment (RA) and Life Cycle Assessment (LCA) of nanomaterials will be one of the main topics of discussion in this symposium.

A panel of international experts have been invited as speakers and the lectures will be organized into six different sessions:

Session 1. International, national and regional initiatives on Nanotechnology / Nanosafety
Session 2. Nanomaterials: Synthesis, characterization and applications
Session 3. Human health impact of Nanomaterials
Session 4. Environmental impact of Nanomaterials
Session 5. Risk assessment of Nanomaterials
Session 6. Life cycle assessment of Nanomaterials

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A joint workshop between the United States and the European Union will be held from March 10-11, 2011 in Washington, DC, in an effort to promote more effective collaboration between the two entities.

The purpose of the workshop, "The US and EU: Bridging NanoEHS Research Efforts", is to: Engage in an active discussion about Environmental Health and Safety questions for nano-enabled products; Encourage joint programs of work that would leverage resources; and, Establish communities of practice, including identification of key points of contact/interest groups/themes between key U.S. and EU researchers and key U.S. and EU funding sources for near-term and future collaborations.

Sponsors include the U.S. National Nanotechnology Initiative (NNI), the European Commission, the American Association for the Advancement of Science, and the U.S. Environmental Protection Agency.

The full program can be viewed online at the link below.
http://www.nano.gov/html/meetings/us-eu/index.html

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An October 25, 2010, joint press release from Europe’s two largest consumers umbrella groups, BEUC and ANEC, is entitled “ANEC/BEUC inventory exposes a game of roulette.”

"Nano whitening"

"Using the newest Nanotechnological ingredients"

"Uses the Nano Silver technology which protects the baby's skin"

Consumer products containing a number of nanomaterials are already widely available on the European market and these are just some of the come-ons used in stores or online.

In 2009 the European Consumers' Organization (BEUC) and its sister organization, ANEC, started to monitor the availability of consumer products containing nanomaterials. The initial 2009 inventory listed 151 products, while in 2010 the number rose to 475. The BEUC inventory has product categories representing those most often consumed in everyday life such as child products, food & drink, cosmetics, products for cars and electronic devices.

The inventory and explanatory leaflet can be found on the BEUC website.

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The European Food Safety Authority (EFSA) and Belgian Federal Agency for the Safety of the Food Chain are hosting an International Symposium on Nanotechnology in the Food Chain, to be held in Brussels, Belgium on November 24, 2010.

Nanotechnology has many promising applications emerging for the areas of agriculture and food (smart packaging, agrochemicals, etc.). It has the potential to bring significant benefits to the agriculture and food industries and to consumers, but may also introduce potential risks for human health and the environment.

The Symposium will present the current knowledge regarding the applications, opportunities and risks of nanotechnology in the food chain.  It will also consider the gaps in knowledge, legislation and control methods, in order to inform an international audience of policy makers, consumers, researchers, industrial representatives, etc.

Complete information on the Symposium and the program may be found on this site:
http://www.favv-afsca.fgov.be/nanotechnology/information/

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Ahead of the EU Commission’s nanotechnology regulatory review next year, several EU members are advocating the creation of a specific register for nanomaterials under the EU’s REACH (Registration, Evaluation, and Authorization of Chemicals) chemicals regulation. There are also calls for mandatory labeling of the presence of nanomaterials in consumer products sold in the EU.

Most recently, on September 14, 2010, the Belgian EU Presidency proposed those nanotechnology regulatory measures at the opening of an EU workshop on the traceability of nanomaterials. "Nanomaterials are increasingly present in consumer products and everyday items we use, and yet we don't know a lot about them," said Paul Magnette, the Belgian minister in charge of consumer protection and environment. He also argued that "the current development approach for nanomaterials without prior notification of their presence or labelling of their characteristics or potential toxicity is not acceptable".

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In Germany the early detection of health risks in consumer-related areas is the responsibility of the Federal Institute for Risk Assessment (BfR). In this context it has developed, together with the Federal Institute for Occupational Safety and Health (BAuA) and the Federal Environmental Agency (UBA), a research strategy to identify the potential risks of nanotechnology. The goal of this research strategy is to structure this research area, to develop methods for the measurement and characterization of nanoparticles, to collect information on exposure, toxicological and eco-toxicological effects, and to promote the development of a risk–based test and evaluation strategy.

When questions about the safety and the potential risks of nanotechnology were becoming increasingly pressing, the BfR in 2006 began to carry out the interdisciplinary research project “Delphi Study on Nanotechnology - Expert Survey of the Use of Nanomaterials in Food and Consumer Products.”  Parts of the study were undertaken in cooperation with the Centre for Interdisciplinary Risk Research and Sustainable Technology Development (ZIRN) of Stuttgart University. The goal of this project was to lay the foundations for future BfR risk assessments of nanotechnology applications.

In September 2010 the results of the BfR Nano Delphi study were published, offering a detailed discussion of each of the basic nanostructured substances currently on the market, as well as across a variety of product uses.   This work is very helpful for those currently tasked with assessing and managing the likely future risks associated with nanomaterial usage.

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. . . then you simply must start becoming knowledgeable, if not expert, on the uses of nanotechnology in agriculture and food production, food products, food processing, and food packaging. It is going to be a significant growth area and an expected litigation field within the food safety/toxic exposure arena.

I'd suggest you might do a couple things to get started:

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A new UK-based nanoparticle risk research center was launched this week.  

Edinburgh (Scotland) Napier University's new Centre for Nano Safety has been set up to identify whether a variety of nanoparticles can enter the human body – as well as other species such as bacteria, insects and plants – and cause harm.   The Centre's mission is to study the possible toxicity of nanoparticles, both biotoxocity and ecotoxicity.

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On October 26, 2009, The Advisory Committee on Hazardous Substances to the United Kingdom's Department of Environment, Food and Rural Affairs (Defra), issued a "Report on Nanosilver.”  The Report warns that more information on both the hazards of and exposure to nanosilver is urgently required, and recommended to British agencies that they gather information about products containing nanosilver. read more

 A symposium, “Approaches to Safe Nanotechnology: A Global Perspective,” was held at the XVIII World Congress on Safety and Health at Work in Seoul, Korea.  That brought together speakers/scientists from seven countries to discuss the topic, including those from the United States, Japan, Korea, Australia, Germany, France, and Italy.  The lessons learned and the importance of global collaboration on nanotechnology safety and health research were discussed.  A report of the symposium proceedings was recently published by the United States participant, the National Institute for Occupational Safety and Health (NIOSH), “A Global Perspective on Safe Nanotechnology,” NIOSH Publication No. 2009-130. read more

An October 21, 2009, paper by Germany's Federal Environment Agency (Umweltbundesamt, UBA) triggered fearful headlines in some of the country's biggest newspapers and in the blogosphere:

"German Environment Agency: Don’t use nano-materials!”

“Nanotechnology can make you sick”

“The German Environment Agency warns against nanotechnology”

The paper, "Nanotechnology for Humans and the Environment: Increasing Chances, Minimizing Risks," certainly expresses reservations about nanotechnology. For example, the UBA calls for a register of nanotechnology products and consumer product labeling indicating that a product contains nano-particles. But the paper is cautious in its criticism and certainly not anything close to the near hysteria expressed by some respectable German newspapers and others that have picked up those stories.

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Concerns have been raised about whether workers exposed to engineered nanoparticles are at increased risk of adverse health effects. The current body of evidence about the possible health risks of occupational exposures to engineered nanoparticles is quite small, and uncertainty means risk.

A new Canadian study to appear in a forthcoming issue of the International Journal of Nanotechnology suggests that current protective equipment used for existing chemicals may not offer adequate protection for workers handling nanomaterials. The study, by engineers in the Department of Mechanical Engineering at Montreal’s School of Higher Technology, suggests that urgent research is necessary into the risks associated with the growing field of nanotechnology manufacture so that appropriate protective equipment can be developed. Prevention of harmful exposures from ingestion, inhalation, and dermal absorption are the reason that protective clothing and gloves, in addition to respirators, are often an essential and common sight in the chemical industry. However, the Canadian researchers wonder if standard protection against chemical risks is enough for workers who are handling nanomaterials. read more

The Age of Nanotechnology is here. Welcome to the Nanotort Law Blog.  

The Nanotort Law Blog aims to be a useful resource for lawyers and risk managers. It will help you stay abreast of the current state of hazard assessment knowledge, pertinent governmental regulation, industry and NGO standards and guidelines, and other important information germane to environmental, health, and safety risks and potential liabilities. The Nanotort Law Blog will also offer ideas and links to other helpful resources to help you monitor, understand and manage the potential - and as yet unkown - liability risks of Nanotechnologies.

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