ETUC Passes Resolution on Nanotechnologies and Nanomaterials

Posted on July 7, 2008 by Lynn L. Bergeson
On June 26, 2008, the European Trade Union Confederation (ETUC) passed a resolution on nanotechnologies and nanomaterials, which calls for the application of the precautionary principle. The resolution states that application of the precautionary principle is necessary to avoid “past mistakes [made] with putatively ‘miracle’ technologies and materials. According to ETUC, the number of workers coming into contact with nanomaterials will increase sharply as nanotechnologies are applied to difference industry sectors, including the chemical, pharmaceutical, and electronics industries. The ETUC urges the European Commission (EC) to amend the Registration, Evaluation, Authorization, and Restriction of Chemicals (REACH) regulation “so as to give better and wider coverage to all potentially manufacturable nanomaterials.” Because nanomaterials are manufactured or imported below the threshold of one tonne per year and may evade the REACH registration requirements, “ETUC demands that different thresholds and/or units (e.g., surface area per volume) are used for registration of nanomaterials under REACH.”

The resolution sets out a series of demands in different areas related to nanotechnology development:

  • Marketing:
  • REACH’s “no data, no market” principle must apply: nanometer forms of chemicals should not be allowed on the market unless sufficient data are supplied to show no harmful effect for human health and the environment;
  • All nanomaterials, including those produced or imported in quantities below one tonne per year, must come within the REACH registration requirements; and
  • A chemical safety report must be produced for all REACH-registered substances for which a nanometer scale use has been identified.
  • Worker protection:
  • Amend Chemical Agents Directive 98/24/EC to require employers to implement risk reduction measures for substances not proven to be harmless;
  • Involve workers and their representatives in the assessment and reduction of nanomaterial-related risks;
  • Improve worker information about nanomaterials that may be present in products to which they are exposed: safety data sheets must state whether nanomaterials are present; and
  • Provide training and health surveillance for workers exposed to nanomaterials.
  • Research and Development:
  • Earmark at least 15 percent of public research budgets for health and environmental aspects; and
  • Make health and safety at work aspects a compulsory part of all research projects.
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European Commission Begins Public Dialogue on Nanotechnologies

Posted on June 18, 2008 by Lynn L. Bergeson

On June 17, 2008, the European Commission (EC) issued a press release entitled “Commission starts public dialogue on nanotechnologies -- tapping economic and environmental potential through safe products.” According to the EC, while current European Union (EU) legislation “covers in principle” the environment, health, and safety issues concerning nanomaterials, “there is further need for research and international cooperation.” EC will begin a consultation with stakeholders and member states that it intends “to increase knowledge and awareness about the potential of nanotechnologies and to continue to ensure an adequate protection of nature, environment and health.” Under “Next Steps,” the EC states:

Knowledge about the characterisation of nanomaterials, hazard and exposure needs to be improved. The Commission is therefore backing targeted actions in a number of areas and at different levels, particularly in the field of research and development under the Research Framework Programmes FP6 and FP7 and the Commission’s Joint Research Centre.) Such activities are coordinated and discussed with stakeholders and in the framework of the [Organization for Economic Cooperation and Development (OECD)] and the International Standardisation Organisation (ISO) and through international cooperation.

The Commission will also engage in an open dialogue with citizens and stakeholders at large to accompany the correct application of existing legislation to the new products arriving on the market.
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EC Will Hold Workshop on Research on the Safety of Nanomaterials

Posted on March 14, 2008 by Lynn L. Bergeson

On April 17-18, 2008, the European Commission (EC) will hold a workshop on research on the safety of nanomaterials. The main objectives of the workshop are:

  • To increase interactions between researchers to enhance networking, sharing of outcomes of the research projects, and boosting synergies between research groups across Europe and abroad;
  • To improve communication of the results of research to risk assessment bodies and other interested parties, providing sound science-based data for informing opinions and scientific advice to policy makers; and
  • To examine the current knowledge to review, if need be, the priorities in safety of nanomaterials’ research.
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SCCP Releases Opinion on Safety of Nanomaterials in Cosmetic Products

Posted on March 5, 2008 by Lynn L. Bergeson
The European Commission’s (EC) Scientific Committee on Consumer Products (SCCP) released on March 3, 2008, a document entitled Opinion on Safety of Nanomaterials in Cosmetic Products (Opinion). In its Opinion, the SCCP divides nanoparticles into two groups: 1) soluble and/or biodegradable nanoparticles; and 2) insoluble particles. The SCCP states that, for the soluble and/or biodegradable group, “conventional risk assessment methodologies based on mass metrics may be adequate, whereas for the insoluble particles other metrics, such as the number of particles, and their surface area as well as their distribution are also required.” According to the SCCP, when assessing possible risks associated with nanoparticles, it is crucial to consider their uptake, and that it is primarily for the insoluble particles that health concerns related to possible uptake may arise. The SCCP concludes that, at present, there is inadequate information on: hazard identification; exposure assessment; uptake; the role of physico-chemical parameters of nanoparticles determining absorption and transport across membranes in the gut and lungs; the role of physico-chemical parameters of nanoparticles in systemic circulation determining biokinetics and accumulation in secondary target organs; possible health effects; and translocation of nanoparticles via the placenta to the fetus. The Opinion states that review of the safety of the insoluble nanomaterials presently used in sunscreens is required.
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EC Announces Increases in Industrial Research in Nanoelectronics

Posted on February 28, 2008 by Lynn L. Bergeson
On February 22, 2008, the European Commission (EC) announced the European Nanoelectronics Initiative Advisory Council (ENIAC) Joint Technology Initiative (JTI), which is endorsed by the Council of Ministers and by the European Parliament. Over the next ten years, € 3 billion will be invested in nanoelectronics.  The ENIAC JIT is a public-private partnership that targets nanoelectronics.  Under the ENIAC JIT, the EC and European Union (EU) member states who wish to participate will pool their public funding with universities and industry, including many innovative small- and medium-sized enterprises (SME), by setting up public-private partnerships. According to the EC, while research funding in nanoelectronics so far tends to be fragmented in small projects funded by individual member states and agencies, the ENIAC JIT will allow member states and the EC “to co-operate and co-finance pan-European research initiatives focus[]ed on a strategic agenda set by Industry itself.” The following member states participate in ENIAC: Austria, Belgium, Czech Republic, Estonia, France, Germany, Greece, Ireland, Italy, the Netherlands, Poland, Portugal, Spain, Sweden, and the United Kingdom.  The Governing Boards of the ENIAC JIT held its first meeting on February 22, 2008.
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EC Asks for Scientific Opinion on Risk Assessment of Products of Nanotechnologies

Posted on February 26, 2008 by Lynn L. Bergeson
The European Commission (EC) asked its Scientific Committee on Emerging and Newly Identified Health Risks (SCENIHR) for a scientific opinion on the risk assessment of products of nanotechnologies. The request asks SCENIHR to identify and assess new information and update its opinions on the potential risks of products of nanotechnologies, “in particular, with respect to characterisation, eco-toxicology and toxicology as well as exposure assessments.” The EC’s request for an opinion states that the update “should be done in a step-wise manner taking into account the upcoming risk assessment demands related to specific nanomaterials and the evolving scientific information from various sources, including results from scientific research projects and activities of the European Technology Platforms related to the safety of nanomaterials. The deadline for the opinion is November 2008.
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European Commission Adopts Code of Conduct for Responsible Nanosciences and Nanotechnologies Research

Posted on February 14, 2008 by Lynn L. Bergeson
On February 8, 2008, the European Commission (EC) announced the adoption of a code of conduct for responsible nanosciences and nanotechnologies (N&N) research. The EC recommends that member states adopt codes of conduct to govern N&N research.  The EC code of conduct is based on seven general principles that address issues such as sustainability, precaution, inclusiveness, and accountability. The code of conduct also provides guidelines that implement these principles under good governance of research; due respect of precaution; and dissemination and monitoring of the code of conduct. The EC invites member states to take concrete action involving universities, research institutes, and companies for the safe development and use of nanotechnologies.

The seven principles are:

  1. Meaning:  N&N research activities should be comprehensible to the public.  They should respect fundamental rights and be conducted in the interest of the well-being of individuals and society in their design, implementation, dissemination, and use.
  2. Sustainability:  N&N research activities should be safe, ethical, and contribute to sustainable development.  They should not harm or threaten people, animals, plants, or the environment, at present or in the future.
  3. Precaution:  N&N research activities should be conducted in accordance with the precautionary principle, anticipating potential environmental, health, and safety impacts of N&N outcomes and taking due precautions, proportional to the level of protection, while encouraging progress for the benefit of society and the environment.
  4. Inclusiveness:  Governance of N&N research activities should be guided by the principles of openness to all stakeholders, transparency, and respect for the legitimate right of access to information.  It should allow the participation in decision-making processes of all stakeholders involved in or concerned by N&N research activities.
  5. Excellence:  N&N research activities should meet the best scientific standards, including integrity of research and good laboratory practices.
  6. Innovation:  Governance of N&N research activities should encourage maximum creativity, flexibility, and planning ability for innovation and growth.
  7. Accountability:  Researchers and research organizations should remain accountable for the social, environmental, and human health impacts of their work.
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EFSA Calls for Data on Applications of Nanotechnology and Nanomaterials Used in Food and Feed

Posted on February 13, 2008 by Lynn L. Bergeson
On January 23, 2008, the European Food Safety Authority (EFSA) issued a notice entitled “Call for Scientific Data on Applications of Nanotechnology and Nanomaterials used in Food and Feed.” According to the notice, EFSA is seeking data that could be useful as it prepares an initial scientific opinion for the European Commission (EC) regarding the risks arising from nanoscience and nanotechnologies on food and feed safety and the environment. The EC asked EFSA to identify the nature of the possible hazards associated with actual and foreseen applications in the food and feed area, and to provide general guidance on data needed for the risk assessment of such technologies and applications. EFSA intends to release a draft of its opinion in July 2008. Data submissions to EFSA are due March 28, 2008.

EFSA requests data on the following issues:

  • Data on the safety of nanomaterials used in food and feed;
  • Food and feed applications and products containing or consisting of nanomaterials or produced by nanotechnology;
  • Methods, procedures, and performance criteria used to analyze nanomaterials in food and feed;
  • Use patterns and exposure to humans and environment;
  • Risk assessments performed on nanomaterials used in food and feed;
  • Toxicological data on nanomaterials used in food and feed;
  • Environmental studies performed on nanotechnologies and nanomaterials used in food and feed; and
  • Other data of relevance for risk assessment of nanotechnology and nanomaterials in food and feed.
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EC Provides Overview of Past and Ongoing R&D

Posted on February 8, 2008 by Lynn L. Bergeson
In a January 28, 2008, report entitled EU Nanotechnology R&D in the Field of Health and Environmental Impact of Nanoparticles, the European Commission (EC) provides an overview of past and ongoing research projects funded by the Framework Programmes (FP), EU member states, candidate countries, and countries associated to FP6 or FP7 in the area of possible impacts in health, environment, and safety of nanoparticles. The report has information on 106 projects, 14 of which are from the FPs, which provide around 32 million € in grants. The other 92 projects are from the EU members states, which spent around 47 million € in grants. The EC states that the “information may well be incomplete” and asks all interested parties to send additional information on research projects funded through national funding schemes. The EC intends to update the information regularly.
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EFSA Begins Review of Nanotechnology

Posted on November 26, 2007 by Lynn L. Bergeson
The European Food Safety Authority (EFSA) met the week of November 19, 2007, to begin reviewing the regulation and risk assessment of nanotechnology. The European Commission (EC) issued a mandate for a complete evaluation by March 31, 2008, but EFSA responded that, because of the range of differing properties and safety profiles, it will not be able to complete its review by this deadline. EFSA instead proposed to issue an initial scientific opinion by Summer 2008. EFSA intends to create a working group of 10 to 15 scientific experts. The Scientific Committee held its first discussion on the EFSA working strategy on November 19-20, 2007.
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First Annual Nanotechnology Safety for Success Dialogue Held in October

Posted on November 13, 2007 by Lynn L. Bergeson

On October 25-26, 2007, the European Commission (EC) held the First Annual Nanotechnology Safety for Success Dialogue. Presentations included:

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Reader-Friendly Version of 2006 EC Report Available

Posted on August 30, 2007 by Lynn L. Bergeson
The European Commission (EC) Directorate General for Health and Consumer Protection retained GreenFacts to summarize the EC’s 2006 report entitled Modified Opinion (After Public Consultation) on the Appropriateness of Existing Methodologies to Assess the Potential Risks Associated with Engineered and Adventitious Products of Nanotechnologies. According to GreenFacts, the EC’s Scientific Committee on Emerging and Newly Identified Health Risks (SCENIHR) wrote its Opinion for a scientific audience. GreenFacts prepared its summary for a broader audience.

The summary includes the following conclusion:

Conclusion -- Are existing methodologies to assess the potential human health and environmental risks associated with products of nanotechnology appropriate?

To the question: “Are existing methodologies appropriate to assess potential and plausible risks associated with different kinds of nanotechnologies and processes associated with nanosized materials as well as the engineered and adventitious products of nanotechnologies?,” the SCENIHR is of the opinion that:

  • Although the existing methods are appropriate to assess many of the hazards associated with the products and processes involving nanoparticles, they may not be sufficient to address all the hazards.
  • More specifically, the mode of delivery of the nanoparticle to the test system should adequately reflect the exposure scenarios. Additional tests may be needed.
  • Expressing the dose of exposure in terms of mass alone is not sufficient; it also needs to be expressed in terms of total surface area, number of particles, or a combination of the two.
  • Also, the existing methods used for environmental exposure assessment are not necessarily appropriate.
  • Therefore, the current risk assessment procedures require modification for nanoparticles.

To the question: “If existing methodologies are not appropriate to assess the hypothetical and potential risks associated with certain kinds of nanotechnologies and their engineered and adventitious products, how should existing methodologies be adapted and/or completed?,” the SCENIHR is of the opinion that:

Existing methodologies need to be modified or new ones developed so that they are able:

  • To determine the physical and chemical properties of nanoparticles routinely.
  • To measure the representative exposure to free nanoparticles in air, soil, water.
  • To better assess the potential hazard of nanoparticles, including whether or not they can exacerbate pre-existing medical conditions.
  • To better detect the movement of nanoparticles inside living systems.

More specifically, these methodologies need to provide information on how nanoparticles distribute in human tissues and in the environment.

To the question: “In general terms, what are the major gaps in knowledge necessary to underpin risk assessment in the areas of concern?,” the SCENIHR is of the opinion that:

The major gaps in knowledge that need to be filled to allow for satisfactory risk assessments for humans and ecosystems to be performed include:

  • The mechanisms and the rate at which nanoparticles are released from products and processes.
  • The actual levels of exposure to nanoparticles, both for humans and the environment.
  • The extent to which it is possible to calculate the toxicology of nanoparticles from the knowledge on the same chemicals in larger physical forms.
  • The movement of nanoparticles inside the body, the effects that nanoparticles cause at cellular level, and how target organs respond to different doses of nanoparticles.
  • The exposure and related health effects of workers involved in the production and processing of nanoparticles.
  • The behaviour of nanoparticles in the environment, how they are distributed, if they persist in it, and whether they accumulate in different species, including micro-organisms.
  • The effects of nanoparticles on various environmental species.
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EC Committee Recommends Revisions to Technical Guidance Documents to Address Risk Assessment of Nanomaterials

Posted on August 16, 2007 by Lynn L. Bergeson
On August 8, 2007, the European Commission (EC) released the scientific opinion of the Scientific Committee on Emerging and Newly Identified Health Risks (SCENIHR) on the appropriateness of the risk assessment methodology in accordance with the European Union’s (EU) technical guidance documents for new and existing substances for assessing the risks of nanomaterials. SCENIHR concluded that modifications to the existing technical guidance documents are necessary because special characterization of nanomaterial properties, which potentially differ considerably from conventional chemicals, is needed. Furthermore, the toxicological behavior and effects on health and the environment need to be assessed properly.  The opinion states that, due to the lack of common rules for the toxicology of nanomaterials, the risk assessment of nanomaterials should be done on a case-by-case basis. SCENIHR identified issues requiring improvements in the technical guidance and methodologies, and proposed a staged strategy for the risk assessment of nanomaterials. Special consideration is required for the assessment of the potential translocation of nanoparticles in humans and other species, and potential adverse effects, for example, within the cardiovascular system or following passage across the blood-brain barrier.
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European Commission Publishes Results of Intellectual Property Rights Workshop

Posted on May 17, 2007 by Lynn L. Bergeson
On May 10, 2007, the European Commission (EC) announced the availability of the results of its April 16, 2007, workshop on intellectual property rights (IPR) in nanotechnology. The objective of the workshop was to identify specific IPR issues for nanotechnology and to discuss possible consequences for patent offices, policy makers, patent consultants, and the research community.  Ongoing academic and political discussions have identified many aspects, such as the costs of patenting and the accessibility of patents for small- and medium-sized enterprises (SME) or developing countries; the need for a transparent and clearly defined scope of patent protection; the implications of “nanopatent land grab” and “patent thickets”; “nanotech patent battles”; and “second nature” and “monopoly patent.”  The discussions were aiming at possible actions specific for nanotechnology, i.e., the need for a better patent monitoring system of nanotechnology for patent application and examining, technology analysis, and policy advice purposes, the possible need for harmonization between the European Union (EU), the U.S., and Japan, the need for a new nanotechnology patent regime, the development of guidelines for the protection of IPR and models for consortium and licensing agreements, lessons for collaborative research projects, and other research collaborations.
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PEN Releases LCA Report

Posted on March 22, 2007 by Lynn L. Bergeson
On March 20, 2007, the Woodrow Wilson International Center for Scholars Project on Emerging Nanotechnologies (PEN) released a report entitled Nanotechnology and Life Cycle Assessment: A Systems Approach to Nanotechnology and the Environment, which summarizes the results of the October 2-3, 2006, workshop organized by PEN and the European Commission on life cycle assessment (LCA). LCA is a cradle-to-grave analysis of how a material affects ecosystems and human health. According to the report, the purpose of the October 2-3, 2006, workshop was to determine whether existing LCA tools and methods are adequate to use on a new technology. The report provides an overview of LCA and nanotechnology, discusses the current state of the art, identifies current knowledge gaps that may prevent the proper application of LCA in this field, and offers recommendations on the application of LCA for assessing the potential environmental impacts of nanotechnology, nanomaterials, and nanoproducts.

The report offers the following main conclusions identified by the workshop participants:

  • There is no generic LCA of nanomaterials, just as there is no generic LCA of chemicals.
  • The International Organization for Standardization (ISO) framework for LCA (ISO 14040:2006) is fully suitable to nanomaterials and nanoproducts, even if data regarding the elementary flows and impacts might be uncertain and scarce. Since environmental impacts of nanoproducts can occur in any life cycle stage, all stages of the life cycle of nanoproducts should be assessed in an LCA study.
  • While the ISO 14040 framework is appropriate, a number of operational issues need to be addressed in more detail in the case of nanomaterials and nanoproducts. The main problem with LCA of nanomaterials and nanoproducts is the lack of data and understanding in certain areas.
  • While LCA brings major benefits and useful information, there are certain limits to its application and use, in particular with respect to the assessment of toxicity impacts and of large-scale impacts.
  • Within future research, major efforts are needed to assess fully potential risks and environmental impacts of nanoproducts and materials (not just those related to LCA).
  • There is a need for protocols and practical methodologies for toxicology studies, fate and transport studies, and scaling approaches.
  • International cooperation between Europe and the U.S., together with other partners, is needed to address these concerns.
  • Further research is needed to gather missing relevant data and to develop user-friendly eco-design screening tools, especially ones suitable for use by small and medium sized enterprises.

The report also offers specific recommendations in the following areas:

  • Case-studies/prioritizing efforts: With limited resources, a case-study research approach could be adopted to enhance significantly knowledge on environmental impacts of nanomaterials and nanoproducts.
  • LCA studies and presentations of results: Any LCA study on nanoproducts and nanomaterials most likely suffers from high uncertainty issues.
  • Approaches.
  • Actions from stakeholders: Different stakeholders/authorities can potentially support the application and use of LCA for nanoproducts and nanomaterials through a large set of actions.
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