Nanotechnology Lawyer & Attorney : Bergeson & Campbell Law Firm : Nanotechnology Law Blog

On March 1, 2010, the European Commission (EC) issued a request, via the accelerated procedure, for a scientific opinion on the scientific basis for the definition of the term “nanomaterial” from the Scientific Committee on Emerging and Newly Identified Health Risks (SCENIHR). According to the EC, its services “urgently need to elaborate a working definition of the term ‘nanomaterials’ to ensure the consistency of forthcoming regulatory developments to guide, as appropriate, the effective implementation of existing regulation, and to contribute to international work and dialogue on nanotechnology definitions.” The EC states that it needs “clarification on the size ranges and other relevant characteristics and corresponding metrics reported in the scientific literature, the types of physical and chemical properties particular to nanomaterials, the relevant thresholds, as well as the most appropriate metrics to express such thresholds.” The deadline is May 2010.

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On November 11, 2009, the European Commission (EC) began a public consultation to receive input from all people and organizations involved or interested in nanosciences and nanotechnologies research in Europe, including researchers, policy makers, industry, media, and civil society organizations. The EC adopted on February 7, 2008, a Recommendation for a Code of Conduct for Responsible Nanosciences and Nanotechnologies Research, followed on September 26, 2008, by Council Conclusions on Responsible Nanosciences and Nanotechnologies. Both documents suggested that the EC Recommendation and Code of Conduct should be revised after two years. The EC intends to make these revisions in February 2010, and states that the results of the consultation will contribute to that. The Code of Conduct is intended to frame future research development within a set of general principles on which member states are invited to take concrete action to ensure that nanotechnologies are developed in a safe manner. The online consultation ends on January 3, 2010.

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On October 29, 2009, the European Commission (EC) adopted a Communication entitled Nanosciences and Nanotechnologies: An Action Plan for Europe 2005-2009. Second Implementation Report 2007-2009. The Communication outlines the key developments during 2007-2009 in each policy area of the Nanotechnology Action Plan 2005-2009, identifies current challenges, and draws conclusions relevant to the future European nanotechnology policy. According to the Communication, the EC has made significant progress on all points in the Action Plan. The Communication notes that, “[a]s a general remark, the past two years have seen a substantial development of nanotechnology, supported by a further growth in research funding and the active development of policy. . . . In view of this, efforts to address societal and safety concerns must be continued to ensure the safe and sustainable development of nanotechnology.” The Communication states that the EC “is considering proposing a new Nanotechnology Action Plan that would be one of the driving forces of the European Research Area and address important societal and environmental issues.”

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In an October 9, 2009, speech at the stakeholder conference concerning nanomaterials on the market, Stavros Dimas, European Commissioner for the Environment, stated that the European Commission (EC) “will review all relevant legislation within two years to ensure safety for all applications of nanomaterials in products with potential health, environmental, or safety impacts over their life cycle.” The EC’s review is in response to an April 24, 2009, resolution adopted by the European Parliament that questions whether current legislation covers the relevant risks relating to nanomaterials and asks the EC to consider whether revisions are necessary to address nanomaterials.  Dimas stated that the EC “has not made up its mind on how precisely to get the information needed.” The EC intends to look at measures taken by member states and non-European Union (EU) countries, including voluntary reporting programs.

Dimas examined whether the existing regulatory framework of the Registration, Evaluation, Authorization and Restriction of Chemicals (REACH) program is sufficient to ensure “a high level of protection of health, safety and the environment” from nanotechnology products. Dimas stated that nanomaterials are covered by REACH under the definition of a chemical substance, and the general obligations therefore apply as for any other substance. According to Dimas, the “important” question to ask is whether the one tonne threshold used by REACH is appropriate for nanomaterials. Dimas stated:

Once we have a better idea of the scope and nature of nanomaterials on the European market we can then take a step back and go through the rules.  We will need to consider whether registration of the majority of nanomaterials will take place in 2010 or only at the end of the registration timetable in 2018 and if there are some nanomaterials that will not be registered under REACH.  We will also need to look at other key provisions in REACH to see if they are adequate for nanomaterials.

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On May 28, 2009, during the Helsinki Chemicals Forum organized by the European Commission (EC) and European Chemicals Agency (ECHA), governmental spokespersons said that the way the Registration, Evaluation, Authorization and Restriction of Chemicals (REACH) program applies to nanoscale substances is being reconsidered. ECHA Executive Director Geert Dancet stated that specific regulation of nanomaterials could be considered when the EC reviews REACH, which it is required to do by June 1, 2012. According to Dancet, the review could cover both the scope and implementation of REACH. Dancet stated that “nanomaterials will be covered in a more systematic way” following the review. European Union (EU) Environment Commissioner Stavros Dimas stated that “further work needs to be done to consider if further legislation is needed” to regulate nanomaterials. After the Forum, Dimas stated that separate legislation could be necessary to ensure to protect the environment and human health. According to Dimas, ECHA could manage nanomaterials, or EU legislation concerning fine particles could be used to regulate nanomaterials. The fine particle legislation concerns particles in air rather than in products, however, and a spokesperson for Dimas stated that the EC is “looking at all sorts of possibilities” and that specific approaches are “unexplored as yet.”

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The European Commission (EC) will hold a scientific hearing on nanotechnology on September 10, 2009. The hearing will focus on the scientific aspects of the issues covered in the nanotechnology opinions issued by the Scientific Committee on Emerging and Newly Identified Health Risks (SCENIHR) and the Scientific Committee on Consumer Products (SCCP) (which is now replaced by the Scientific Committee on Consumer Safety (SCCS)). To prepare for the hearing, the EC is launching a public consultation relating to the three main objectives to be addressed:

• Identification of any possible topics which have not been covered in the opinions from the relevant European Union (EU) risk assessment committees and bodies;
• Identification of what are -- according to current scientific knowledge -- the main potential risks that could emerge from the use of nanomaterials in the future; and
• Identification of the issues to be discussed at the hearing, including provision of background information and comments on those issues.

The outcome of the consultation will be presented at the scientific hearing.  Comments are due June 19, 2009.

 

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In an April 24, 2009, press release, the European Parliament (EP) calls for the provision of information to consumers on the use of nanomaterials in consumer products. According to the EP, all ingredients present in the form of nanomaterials in substances, mixtures, or articles should be clearly indicated in the product labeling. The press release also specifically calls for the European Commission (EC) to evaluate the need to review the Registration, Evaluation, Authorization and Restriction of Chemicals (REACH) concerning:

• Simplified registration for nanomaterials manufactured or imported below one tonne;
• Consideration of all nanomaterials as new substances;
• A chemical safety report with exposure assessment for all registered nanomaterials; and
• Notification requirements for all nanomaterials placed on the market on their own, in preparations, or in articles.

The EP also calls for the EC to evaluate the need to review worker protection legislation concerning:

• The use of nanomaterials only in closed systems or in other ways that exclude exposure of workers as long as it is not possible to detect reliably and control exposure;
• A clear assignment of liability to producers and employers arising from the use of nanomaterials; and
• Whether all exposure routes (inhalation, dermal, and other) are addressed.

 

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On March 31, 2009, the European Parliament (EP) Committee on Environment, Public Health, and Food Safety amended and adopted a report on the regulatory aspects of nanomaterials. The January 2009 draft report was prepared by Swedish Green EP Member Carl Schlyter and urges tighter controls on nanotechnology. The report calls on the European Commission (EC) to review all relevant legislation to implement the principle “no data, no market” for all applications of nanomaterials in products with potential health, environmental, or safety impacts over their life cycle. The report reiterates the Committee’s call for labeling of consumer products containing nanomaterials, and recommends development of testing protocols and metrology standards to assess the hazard of, and exposure to, nanomaterials over their entire life cycle, using a multi-disciplinary approach. The report was adopted by a vote of 21-14.

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On March 24, 2009, the European Parliament (EP) approved an update of European Union (EU) legislation on cosmetics. The new regulation is intended to remove legal uncertainties and inconsistencies, while increasing the safety of cosmetics. The regulation would replace 27 different regulations. The new regulation addresses nanomaterials used as cosmetics ingredients. As requested by the EP, the new regulation introduces a safety assessment procedure for all products containing nanomaterials, which could lead to a ban on a substance if there is a risk to human health. The EP also succeeded in requiring that any nanomaterials present in cosmetics be mentioned in the list of ingredients on the packaging. The new regulation also includes a definition of nanomaterials, which must be adapted by the European Commission (EC) in line with scientific and technological advances. Under the new regulation, nanomaterial would be defined as “an insoluble or bioresistant and intentionally manufactured material with one or more external dimensions, or an internal structure, on the scale from 1 to 100 nm.”

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On February 18, 2009, the European Commission (EC) Scientific Committee on Emerging and Newly Identified Health Risks (SCENIHR) published its opinion on the most recent developments in the risk assessment of nanomaterials.  In its opinion, SCENIHR indicates that methodologies to assess exposure to manufactured nanomaterials to humans and the environment and the identification of potential hazards require further development.  For lack of a general approach, SCENIHR maintains its earlier recommendation to perform risk assessment case-by-case for each nanomaterial.

The Opinion identifies the following issues:

• Characterization of manufactured nanomaterials: There is currently a need for reference nanomaterials.  The absence of well-defined parameters to measure and of standardized test protocols is identified as a major obstacle for reference material production.  It should be noted that for use in biological systems certain compounds need to be added, which may have an effect on nanomaterial composition and properties resulting in changes in (toxic) behavior.
• Human exposure: Exposure estimates for consumers from food and consumer products remains difficult. Information on the presence of manufactured nanomaterials solely relies on information provided by manufacturers.  In addition, exposure estimation is also hampered by lack of information on product use and use of multiple products containing manufactured nanomaterials.  The main issues may be summarized as problems in replicating actual exposure conditions in laboratory tests and the lack of general availability of robust and specific measurement methods.  Exposure assessment needs to consider each stage in the life-cycle.
• Human hazard: The main issues for human hazard identification may be summarized as a need to ensure that each test system is appropriate for nanomaterials and to ensure that endpoints of potential particular concern (e.g., cardio-vascular effects) are properly addressed.
• Environmental exposure: The main issues may be summarized as the development of suitable methods to assess the distribution of nanomaterials in the environment and the lack of portable monitoring equipment to measure levels of nanomaterials in different environmental media. In addition, for many manufactured nanomaterials the methods currently used (carbon dioxide production, integration into biomass) for determining biological degradation will not be applicable.
• Environmental hazard: The main issues for environmental hazard assessment may be summarized as the need for validation of laboratory test systems for characterizing the effects of nanomaterials and the need for studies of the impacts of specific nanomaterials on ecosystems.
• Risk assessment: Health and environmental hazards have been demonstrated for a variety of manufactured nanomaterials.  It should be noted that not all nanomaterials induce toxic effects, however. As there is not yet a generally applicable paradigm for nanomaterial hazard identification, a case-by-case approach for the risk assessment of nanomaterials is still recommended.

 

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On October 17, 2008, the European Food Safety Authority (EFSA) began a public consultation on its draft scientific opinion in relation to nanoscience and nanotechnologies and food and feed safety.  EFSA’s draft opinion focuses on engineered nano materials (ENM) that could be deliberately introduced into the food chain and elaborates on approaches to risk assessment. EFSA states that it “is not an assessment of any specific application of ENM.” According to EFSA, the European Commission (EC) requested the opinion “as a first step because consideration needs to be given as to whether existing risk assessment approaches can be appropriately applied to this new technology.”  EFSA states that its final opinion “will then help the EC to explore appropriate measures, assess existing legislation and determine the scope of possible further requests for scientific opinions from EFSA in this field.” Comments are due December 1, 2008.

Key conclusions of the draft opinion include:

• Established international approaches to risk assessment currently used for non nano chemicals can also be applied to ENM;
• It is currently not possible to satisfactorily extrapolate scientific data on non nano chemicals and apply it to their nano-sized versions.  Consequently specific case-by-case risk assessments should be performed when assessing their safety, based on specific data from relevant safety tests applicable to the particular application;
• Possible risks arise because ENM have particular characteristics, due in part to their small size and high surface area.  Small size increases their ability to move around in the body in ways that other substances do not, while their high surface area increases their reactivity; and
• Additional limitations and uncertainties exist, particularly in relation to characterizing, detecting and measuring ENM in food, feed, or the body.  There is also limited information on absorption, distribution, metabolism, and excretion, as well as the toxicity of ENM.

 

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On October 8, 2008, the European Commission (EC) published a regulation amending the Registration, Evaluation, Authorization, and Restriction of Chemicals (REACH) Annex IV to remove carbon and graphite. Although the substances were originally listed in Annex IV, meaning they were exempt from REACH requirements because they were considered to be of minimum risk because of their intrinsic properties, a European Union (EU) expert committee delisted the substances in June 2008. According to the regulation, there is insufficient information for carbon and graphite to be listed in Annex IV, “in particular due to the fact that the concerned EINECS and/or CAS numbers are used to identify forms of carbon or graphite at the nano-scale, which do not meet the criteria for inclusion in this Annex.”

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On September 10, 2008, the European Commission (EC) requested companies to submit data “with regard to all substances used at nano-scale and the final [cosmetic] products in which they are used.” Citing the December 18, 2007, opinion of the Scientific Committee on Consumer Products concerning the safety of nanomaterials in cosmetic products and the June 22, 2007, opinion of the Scientific Committee on Emerging and Newly-Identified Health Risks regarding the appropriateness of the risk assessment methodology in assessing the risks of nanomaterials, the EC states that “there is an urgent need for closing the information gap and even the methodological gap with regard to nanomaterials in cosmetics.  Without these gaps being closed, it will, in the medium term, be hardly defendable for industry and authorities to assert that cosmetic products containing nanomaterials are safe.”

 

The EC seeks data concerning:

• The chemical composition, the chemical impurities, the form and its flexibility, the agglomeration and coalescence behavior, the stability, the surface reactivity, the biodegradability, and the solubility of the nanoparticles;
• The storage conditions of the particles prior to the manufacturing of the cosmetic product, and the molecules with which the particles come into contact;
• The proportion of nanoparticles in the final product (in mass concentration, number concentration, and surface area);
• The other components of the final product;
• Modification of the particles occurring within the cosmetic product during or after the manufacturing process; and
• The interaction between the various factors for each of the products on which data are provided.

Comments are due December 31, 2008.

 

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

• Food applications of nanoscience and nanotechnologies -- Ms. Sue O’Hagan, Confederation of the Food and Drink Industries of the European Union (CIAA);
• Consumer products applications of nanoscience and nanotechnologies -- Dr. Michael Holman, Lux Research;
• Health applications of nanoscience and nanotechnologies -- Dr. Carole Moquin-Pattey, European Science Foundation (ESF);
• Nanotechnology risk assessment: Knowns and unknowns -- Mr. Herman B.W.M. Koëter, Deputy Executive Director and Director of Science, European Food Safety Authority (EFSA);
• Nanoparticle toxicology: Scientific state-of-the-art -- Professor Ken Donaldson, University of Edinburgh;
• Nanomaterials. Risk assessment needs -- Professor Jim Bridges, Chair, Scientific Committee on Emerging and Newly Identified Health Risks (SCENIHR);
• The EU perspective on policy and regulatory aspects -- Mr. Kees Brekelmans; Enterprise and Industry Directorate General, “Consumer Goods” Directorate;
• Nanotechnology and the Food and Drug Administration:  Science and Policy -- Dr. Richard Canady, U.S. Food and Drug Administration (FDA); and
• The consumer perspective on applications of nanoscience and nanotechnologies -- Dr. Sue Davies, Chief Policy Advisor, Which?.

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Environment Canada (EC) and Health Canada (HC) have released a document entitled Proposed Regulatory Framework for Nanomaterials Under the Canadian Environmental Protection Act, 1999 (Proposed Framework). EC/HC will hold a public workshop for stakeholders regarding the Proposed Framework on September 27, 2007, in Toronto. At the workshop, EC/HC will gather comments from participating stakeholders through discussion groups and plenary sessions. EC/HC will invite all stakeholders to provide additional written comments the weeks following the meeting. Click here to request a copy of Bergeson & Campbell, P.C.’s memorandum on the Proposed Framework.

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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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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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The proceedings of the June 19-21, 2007, EuroNanoForum 2007 are available. According to the European Commission (EC), they “provide an overview of the state-of-the-art in nanotechnology for industrial applications, presented by selected international top speakers to open up new perspectives in Europe for coming years.”

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On July 19, 2007, the European Commission (EC) issued a press release entitled “Commission launches consultation on responsible research in Nanosciences and Nanotechnologies.” The press release states: “The European Commission has today announced a public consultation on responsible nanosciences and nanotechnologies research.  The consultation will provide input for a Recommendation to the Member States on a possible Code of Conduct for this emerging area of science, which the Commission will put forward later this year.  Contributions are expected from a broad cross-section of European society, including the scientific community, industry, civil society, policy-makers, media and the general public.”

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Environment Canada (EC) recently posted a New Substances Program Advisory Note entitled “Requirements for nanomaterials under the New Substances Notification Regulations (Chemicals and Polymers).” The Advisory Note was signed in June 2007 and states that the Canadian Environmental Protection Act, 1999 (CEPA) and the New Substances Notification Regulations (Chemicals and Polymers) (Regulations) “apply to new nanomaterials just as any other substance, whether a chemical or a polymer.

The Note includes the following questions and answers:

What are the requirements under the Regulations for nanomaterials which are manufactured or imported?

Nanomaterials which are manufactured in or imported into Canada are subject to the same regulatory requirements as chemicals and polymers, and notifiers must submit a New Substances Notification package prior to the manufacture in or import into Canada of the new substance.

Although not required, Environment Canada and Health Canada recommend notifiers request a Pre-notification Consultation (PNC) during the planning or preparation of a notification. For example, a notifier can request a PNC to assist with determining whether the substance is notifiable, as well as to clarify notification procedures or information requirements, and to determine the acceptability of waiver requests and/or test protocols.

What nanomaterials are subject to the Regulations?

Nanomaterials which are manufactured in or imported into Canada that are not listed on the Domestic Substances List (DSL) are considered new. The nanoscale form of a substance on the DSL is considered a “new” substance if it has unique structures or molecular arrangements. New nanomaterials are subject to notification under the Regulations. For example, the nanomaterial fullerene (CAS No. 99685-96-8) is not listed on the DSL and is considered a “new” substance under the Regulations.

What nanomaterials are not subject to the Regulations?

Substances listed on the DSL whose nanoscale forms do not have unique structures or molecular arrangements are considered existing. Existing nanomaterials are not subject to the Regulations and do not require notification. For example, titanium dioxide (CAS No. 13463-67-7) is listed on the DSL and since its nanoscale form does not have unique structures or molecular arrangements, it is not subject to the Regulations.

In addition, incidentally produced or naturally occurring nanomaterials are not subject to notification.

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Until September 6, 2007, the European Commission (EC) Scientific Committee on Consumer Products (SCCP) is accepting comments on its Preliminary Opinion on the Safety of Nanomaterials in Cosmetic Products. According to the SCCP, traditional risk assessment methods -- hazard identification, hazard characterization, and exposure assessment -- may not be suitable for nanomaterials in cosmetics.  The SCCP suggests that either a new method should be developed, or the existing methodologies for hazard characterization and exposure assessment should be validated.  The SCCP recommends that the risk assessment of nanoparticles in cosmetics should be carried out on a case-by-case basis, taking into account the specific physical, chemical, and surface area characteristics of nanomaterials.  Previous safety evaluations on nanomaterials used in cosmetics would also need to be revised.

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The July 2007 issue of Regulatory Toxicology and Pharmacology includes an article entitled “Limits and Prospects of the ‘Incremental Approach’ and the European Legislation on the Management of Risks Related to Nanomaterials.” According to the authors, the European Commission (EC) has adopted an incremental approach, focusing on adopting existing laws to regulate nanotechnologies. The authors concluded that the current regulations fail to address the environmental, health, and safety risks posed by nanomaterials and recommended specific revisions to European regulatory policies and the information on which they are based.

The authors analyzed in a life cycle perspective three commercially available products containing fullerenes to map current applicable regulations, determine their applicability to nanomaterials, identify their gaps, and suggest proper solutions. After mapping the life cycle of the three products, the authors reviewed applicable regulations in the order in which they became relevant in their life cycle, i.e.:

• The Safety at Workplace Directives;
• Directive 61/1996 on the Integrated Pollution Prevention and Control;
• The European Union’s Directive on the Registration, Evaluation, Authorization and Restriction of Chemicals (REACH); and
• The Waste Management Directives.

The authors concluded that the applicability of environmental laws is limited due to difficulties in generating sufficient data on the nanomaterials residing in the products according to their life cycles.  Further, metrology tools, which measure nanoparticles in the environment or at the work site, are unavailable; thresholds are not tailored to the nanoscale and are based on ecotoxicological and toxicological data from larger chemicals; and occupational exposure limits cannot be established with existing methodologies.  According to the authors, the incremental approach can be applicable only with the implementation of due amendments.

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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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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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