Nano and Other Emerging Chemical Technologies Law Blog: Lawyer & Attorney : Bergeson & Campbell Law Firm : Nanotech and Chemical Legal Developments

The European Commission (EC) adopted on October 18, 2011, a Recommendation on the definition of a nanomaterial. The Recommendation “invites” member states, European Union agencies, and economic operators to use the following definition of nanomaterial “in the adoption and implementation of legislation and policy and research programmes concerning products of nanotechnologies”:

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

In specific cases and where warranted by concerns for the environment, health, safety or competitiveness the number size distribution threshold of 50 % may be replaced by a threshold between 1 and 50 %.

3.         By derogation from point 2, fullerenes, graphene flakes and single wall carbon nanotubes with one or more external dimensions below 1 nm should be considered as nanomaterials.

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During the September 23, 2011, Registration, Evaluation, Authorization and Restriction of Chemicals (REACH) conference organized by the European Chemicals Agency (ECHA) and European Commission (EC), Astrid Schomaker, Directorate-General (DG) Environment, stated that the EC has been working on a definition of nanomaterials, and that it “should be coming after the summer.” The EC previously stated in a letter to the Dutch Environment Ministry that it would publish a definition by the end of June. Karl Falkenberg, Director-General for DG Environment, stated that the issue is “triangular -- we have to put together environmental, trade and health perspectives.” Conference delegates disagreed whether nanomaterials are appropriately addressed under REACH. According to Alexander Nies, Deputy Director-General for Germany’s Federal Ministry for the Environment, Nature Conservation and Nuclear Safety, ECHA has found only three cases where substances qualify as nanomaterials, even though there are “more than 900 companies in Germany that produce nanomaterials.” Nies urged the EC to adapt REACH to deal with the specific features of nanomaterials. Adrian Harris, Director-General for the European Engineering Industries Association, responded that the Association supports “rationalization” rather than increasing demands under the registration process. Harris stated that “REACH in its present form is fit to address nanotechnology.”

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On April 21, 2011, the United Kingdom’s (UK) Food Standards Agency (FSA) published a report of consumers’ views on the use of nanotechnology in food and food packaging. FSA convened a focus group in late 2010 and early 2011, and asked participants about their views on nanotechnology. According to FSA, the main findings are that:

• Participants’ reactions to nanotechnology and food reflected a variety of concerns. These included whether this was a necessary development, whose interests it would serve, and whether the benefits outweighed the perceived risks;
• Acceptance around the use of nanotechnology was conditional. For instance, participants were more positive about the use of nanotechnology to reduce the salt or fat content of foods without adversely affecting the taste or texture. Participants were negative towards the use of nanotechnology for what they perceived to be “trivial” purposes, however, such as using nanotechnology to develop new flavors and textures;
• Participants were relatively more open to the use of nanotechnology in food packaging and readily identified the potential benefits of extended shelf life and waste reduction. Participants questioned, however, whether consumers would receive the benefits of nanotechnology or whether these developments would be of most benefit to the food industry;
• The current way of regulating nanotechnologies in foods, the European Novel Foods Regulation, provided participants with a degree of confidence that the framework in place ensured the safety of nanotechnology in foods. Questions were raised, however, about the ability to predict long-term health effects of nanotechnology in food and whether wider social and environmental implications would be taken into account; and
• To provide further confidence in the use of nanotechnology in foods, participants wanted transparency about the developments, including providing them with more information. A register of foods that use nanotechnology, established by a body independent from industry and government, was received positively. The introduction of an “n” label for nanotech foods was also proposed, although participants recognized that consumers might not use or understand this information without complementary education and awareness raising.

 

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On April 12, 2011, the German Federal Institute for Risk Assessment (BfR) issued a statement entitled “Safety of Nano Silver in Consumer Products: Many Questions Remain Open,” which reports BfR’s conclusions from a February 2011 workshop discussing existing risks and possible options for comprehensive consumer protection from nanosilver. According to BfR, “the situation continues to be characterised by the fact that not enough secured scientific findings about the specific effects of nano-sized silver particles are available.” BfR states: “Articles of daily use and consumer products may not constitute any health risk based on statutory provisions during proper use or foreseeable misuse. Since no final safety assessment for man and the environment is available so far for nanoscale forms of silver due to the missing data, BfR continues to advise against a broad use of nano silver in consumer products.”

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On February 17, 2011, the U.S. Environmental Protection Agency (EPA) announced that it awarded $5.5 million to three consortia to support innovative research on nanotechnology. EPA states that, in collaboration with the United Kingdom's (UK) Natural Environment Research Council, it is leading this scientific research effort to understand better the potential risks to people’s health and the environment. The grants EPA awarded are intended to help researchers determine whether certain nanomaterials can leach out of products such as paints, plastics, and fabrics when they are used or disposed of and whether they could become toxic to people and the environment.  According to EPA, the U.S. Consumer Product  Safety Commission (CPSC) has also contributed $500,000 through a new research partnership between the two agencies.  Grant awards were made to three consortia consisting of researchers from the U.S. and the UK Each U.S. team of researchers received $2 million from EPA and CPSC, for a total of $6 million. Each UK team will also receive $2 million from the UK agencies, resulting in a grand total of $12 million to conduct the research.

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On January 25, 2011, the European Agency for Safety and Health at Work (EU-OSHA) announced that French Agency for Environmental and Occupational Health Safety (ANSES) experts have developed a control banding tool specific to nanomaterials that can potentially be used in any work environment in which nanomaterials are manufactured or used. With control banding, new products are classified into “bands,” which are defined after comparison with the hazard level of known and/or similar products, while taking into account the assessment of exposure at the work station. The process combines a qualitative risk assessment with a risk control band and proposes minimum collective preventive measures to be implemented that are consistent with the estimated level of risk.  EU-OSHA notes that, “[i]n particular, the proposed tool is especially adapted to [small- and medium-sized enterprises (SME)] which do not necessarily have at their disposal the metrological characterisation equipment or detailed toxicological studies required for a proper risk assessment process.”

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On November 24, 2010, the European Parliament (EP) overwhelmingly approved the proposed recast of the Restriction of Hazardous Substances (RoHS) Directive, which restricts the use of certain hazardous substances in electronic and electrical equipment (EEE). The EP passed by a vote of 640 to 3, with 12 abstentions, legislation that would extend the Directive to most EEE, unless specifically excluded. The legislation calls for a review of the Directive after three years, at which time new substances may be added. Exemptions for banned substances would be allowed only if they are in the interest of consumer health and safety and no alternatives are available. Proposed restrictions on additional substances, including nanosilver and long multi-walled carbon nanotubes, were not supported by the European Union (EU) Council and are not included in the version of the legislation passed by both the EU Council and EP. The EP press release notes that “nanomaterials are cited as due for further scientific scrutiny” when RoHS is reviewed in three years.

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On October 21, 2010, the European Commission (EC) began a consultation on its proposal for a definition of the term “nanomaterial” that the it intends to use as “an overarching, broadly applicable reference term” for any European Union (EU) communication or legislation addressing nanomaterials. The EC states that the definition of the term “nanomaterial” should be based on available scientific knowledge and should be used for regulatory purposes.  The definition should determine when a material should be considered as a nanomaterial for legislative and policy purposes in the EU. The EC proposes to define as a nanomaterial any material meeting at least one of the following criteria:

• Consists of particles, with one or more external dimensions in the size range 1 nanometer (nm)-100 nm for more than one percent of their number size distribution;
• Has internal or surface structures in one or more dimensions in the size range 1 nm-100 nm; or
• Has a specific surface area by volume greater than 60 m²/cm³, excluding materials consisting of particles with a size lower than 1 nm.

The EC states that it intends to carry out a public consultation by 2012 and, if appropriate, review the adequacy of the definition “taking into account experience gained, scientific knowledge and the technological development.”

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During a September 14, 2010, conference on nanomaterials management, Paul Magnette, the Belgian Minister for Energy, Environment, Sustainable Development, and Consumer Protection, proposed to create a specific register for nanomaterials under the Registration, Evaluation, Authorisation and Restriction of Chemical Substances (REACH) program and to implement mandatory labeling for nanomaterials used in consumer products. According to Magnette, the next European Environment and Health Action Plan is expected to address the challenge of nanomaterials among its priority areas. In 2011, the European Commission (EC) must also respond to the April 2009 European Parliament (EP) resolution on the regulatory aspects of nanomaterials. The resolution calls for various “ambitious” measures to ensure safety with regard to nanomaterials and nanotechnology. Magnette put forward five proposals from the Belgian Presidency of the European Union (EU) that are intended to respond to consumer needs while ensuring their safety:

1. Define the obligation to inform the consumer of the presence of nanomaterials in consumer products;
2. Ensure the traceability of the chain so as to be able to return to the source, if necessary.  Regarding this aspect, it would be obligatory to maintain a register of nanomaterials;
3. Identify the most appropriate regulatory path at the EU level for risk evaluation and management;
4. Encourage member states, during this transitory period, to take up the responsibility and draw up integrated national strategies and concrete measures in favor of risk management, information, and monitoring; and
5. Regulate the claims made on labels of products containing nanomaterials.

 

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On June 10, 2010, the Federal Institute for Risk Assessment (BfR) issued a press release entitled “Nanosilver has no place in food, textiles or cosmetics,” which states “BfR currently advises against using nanoscale silver ions in consumer products.” According to BfR, manufacturers of consumer products “have made use of the antimicrobial properties of silver ions for some time now,” and “silver particles in the nanorange have likewise been used.” BfR states: “It is not possible at the present time to determine in a definitive manner whether nanosilver constitutes a health risk for consumers,” and “we recommend that manufacturers refrain from using nanosilver in consumer products.” The press release states:

BfR feels there is a need for research to elucidate the fundamental issues in conjunction with the use of nanoscale silver as an antimicrobial material. On what scale do consumers come into contact with nanoscale particles? How big is the danger of resistance development?

BfR recommends refraining from using any nanoscale silver in consumer products until a definitive safety assessment becomes available. In any case nanoscale additives in food require approval. Nanosilver has not been approved for use in food. BfR welcomes this in the context of the yet to be answered questions about risk assessment.

BfR has published an Opinion on this subject.

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On March 18, 2010, the United Kingdom (UK) Department for Business, Innovation and Skills (BIS) announced publication of UK Nanotechnologies Strategy: Small Technologies, Great Opportunities, which sets out how the government intends to take action to ensure that everyone safely benefits from the societal and economic opportunities that these technologies offer, while addressing the challenges that they might present. The Strategy includes the following key actions:

• Government chief scientific advisers to review coordination of nanotechnologies research across government, including research on safety issues;
• A new website to keep the public informed about government work on nanotechnologies;
• A new Nanotechnologies Collaboration Group to facilitate ongoing communication and collaboration between government, academia, industry, and other interested parties;
• A new Ministerially led Nanotechnologies Leadership Group to address barriers to commercial growth in this area; and
• Government to explore a new industry reporting scheme with a broader scope covering nanomaterials, as well as products containing them.

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On January 8, 2010, the United Kingdom (UK) House of Lords Science and Technology Committee announced the availability of its report entitled Nanotechnologies and Food, which criticizes the food industry for failing to be transparent about its research into the uses of nanotechnologies and nanomaterials. In its report, the Committee urges the Government and Research Councils to fund research into potential health and safety risks arising from the use of nanomaterials in the food sector. The Committee recommends that the Food Standards Agency maintain a publicly available register of food and food packaging containing nanomaterials, and suggests that the register be made available online. The Committee calls for nanomaterials to be defined clearly in food legislation to ensure that all uses of nanomaterials in food are subject to appropriate risk assessment procedures. According to the Committee, regulatory definitions should use a change in functionality, i.e. how a substance interacts with the body, as the criterion that distinguishes a nanomaterial from its larger form, to ensure that any nano-sized materials with novel properties are included. The Committee also recommends that the UK work with other European Union (EU) nations to clarify what is meant by the phrase “properties that are characteristic to the nanoscale” in the draft definition proposed for the revised Novel Foods Regulation, by the inclusion in legislation of a more detailed list of what these properties comprise. The Committee also raises concerns about the potential for the illegal importation of food products containing nanomaterials not approved for use in food in the EU.

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On June 2, 2009, the United Kingdom (UK) released its response to the Royal Commission on Environmental Pollution (RCEP) Report entitled Novel Materials in the Environment: The Case of Nanotechnology. The RCEP looked at the properties of nanomaterials and the potential pathways by which they could enter and present potential hazards to the environment and people. The UK states that it shares RCEP’s “understanding that there is no evidence of actual harm resulting from the use of nanotechnologies, but accepts that this is a possibility and that there is a need to develop our understanding further.” The UK intends to develop a “UK Strategy for nanotechnologies,” which “will build on previous and existing activities and review the UK’s priorities and strategic direction.” The UK intends to begin in Summer 2009 an “evidence gathering exercise” with stakeholders to inform development of the Strategy.

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On March 6, 2009, the United Kingdom (UK) Health and Safety Executive (HSE) published an information sheet on the risk management of carbon nanotubes (CNT). According to HSE, the information sheet “is specifically about the manufacture and manipulation of carbon nanotubes and has been prepared in response to emerging evidence about the toxicology of these materials. However, the risk management principles detailed here are equally applicable to other nanodimensioned bio-persistent fibres with a similar aspect ratio.” HSE cites as “new evidence” a recent study by the University of Edinburgh, which “found that long, straight [multi-walled CNTs] with a high aspect ratio produced a marked inflammatory reaction and the formation of granulomas when injected into the abdominal cavity of mice.”

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On November 12, 2008, the United Kingdom (UK) Royal Commission on Environmental Pollution (RCEP) published a report entitled Novel Materials in the Environment: The Case of Nanotechnology, which examines issues related to innovation in the materials sector and the challenges and benefits arising from the introduction of nanomaterials. According to RCEP, there is an “urgent need for more testing, extending existing governance arrangements and creating new arrangements concerning nanomaterials.”  The report was prompted by concerns about potential releases to the environment from industrial applications of metals and minerals that have not previously been widely used. The RCEP states that, as the majority of the evidence it received was almost entirely focused on manufactured nanomaterials, it decided to focus on this sector as an exemplar. The report includes recommendations on how to address “ignorance and uncertainty in this area, which could also be applied to other areas of fast-paced technological development.”

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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.

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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.”

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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 May 19, 2008, the Department for Environment, Food, and Rural Affairs (DEFRA) posted its sixth quarterly report on the Voluntary Reporting Scheme (VRS) for engineered nanoscale materials. According to the report, DEFRA received no new submissions this quarter, and to date has received only nine submissions since the VRS’s launch in September 2006:  seven from industry, and two from academia. The report states that DEFRA, in partnership with the United Kingdom Technology Strategy Board, is funding a telephone survey of selected companies and researchers.  DEFRA intends the survey, to be undertaken between May and August 2008, to find out more about the nature of these companies/researchers’ activities in the field of nanotechnologies.  As part of this process, DEFRA will offer assistance to those wishing to submit data to the VRS, in the form of telephone advice or site visits.  All information collected as part of this process will be treated as confidential unless the data owner advises to the contrary.

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On March 11, 2008, the German Chemical Industry Association (VCI) released a report entitled Responsible Production and Use of Nanomaterials, which is a series of documents intended to provide guidance on all aspects of a good product stewardship on nanomaterials. The documents include joint papers prepared by VCI and the German Federal Institute for Occupational Safety and Health (BAuA) and the German Society for Chemical Engineering and Biotechnology (DECHEMA). The report includes the following documents:

Principles Document:

• Implementing Responsible Care® for a Responsible Production and Use of Nanomaterials

Regulatory Documents:

• Requirements of the REACH Regulation on Substances Which Are Manufactured or Imported also as Nanomaterials
• Guidance for a Tiered Gathering of Hazard Information for the Risk Assessment of Nanomaterials
• Guidance for Handling and Use of Nanomaterials at the Workplace
• Guidance for the Passing on of Information along the Supply Chain in the Handling of Nanomaterials via Safety Data Sheets
• Strategy Paper of the German Chemical Industry on the Standardization of Nanomaterials

Documents on Safety Research:

• Roadmap for Safety Research on Nanomaterials
• Environmental Aspects of Nanoparticles

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On March 12, 2008, the Department for Environment, Food and Rural Affairs (DEFRA) released a supplementary guidance document for the Voluntary Reporting Scheme (VRS). DEFRA prepared the supplementary guidance document to complement the existing VRS guidance. Chapter 2 describes the rationale and benefits of the VRS. Chapter 3 provides a specific list of the relevant physical, chemical, toxicological, and ecotoxicological data to include when reporting under the VRS, and the relevant hazard, exposure, and risk context for the information requested.  Chapter 4 sets out a context and summary for nanomaterial hazard and risk to human health and the environment. DEFRA intends the VRS to develop a better understanding of the properties and characteristics of different engineered nanoscale materials, so enabling potential hazard, exposure, and risk to be considered.  According to DEFRA, “[b]uilding an evidence-base in this way will allow for a more informed debate about the nature of appropriate controls.”

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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. Continue Reading...

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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. Continue Reading...

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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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According to a report recently released by the Danish Ministry of Health and Prevention, nanotechnology research, development, and applications are covered by existing legislation. The report, which includes an English summary, reviews existing national and international legislation in the areas of foods, medicines, the environment, chemicals, and the working environment in relation to current knowledge of nanotechnological products and processes.  The report also includes a chapter on national and international research policy activities, and describes the initiatives, working groups, and network groups the relevant government departments are taking part in, both nationally and internationally. The working group that prepared the report included representatives from the Ministry of the Interior and Health, the Danish Board of Health, the Danish Environmental Protection Agency, the Danish Medicines Agency, the Danish Veterinary and Food Administration, the National Food Institute at the Technical University of Denmark, the Danish Agency for Science, Technology, and Innovation, the Danish Working Environment Authority, and Danish Standards. Continue Reading...

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According to the December 22, 2007, fifth quarterly report for the Department for Environment, Food, and Rural Affairs’ (DEFRA) Voluntary Reporting Scheme (VRS) for engineered nanoscale materials, DEFRA received no new submissions since publication of the previous quarterly report in September 2007. DEFRA is in the process of updating the VRS documentation to clarify the purpose and aims of the VRS and provide supplementary guidance for anyone submitting data. DEFRA intends to publish the revised guidance in early February 2008. DEFRA will include a letter to relevant stakeholders in the industry and research communities, restating the strategic importance of the VRS.

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On 3 January 2008, Lloyd’s released a report entitled Nanotechnology: Recent Developments, Risks and Opportunities, which examines the potential risks and opportunities in the emerging field of nanotechnology. Lloyd’s states that nanotechnology “promises to improve many industries including medicine, food technology, textiles, materials, cosmetics, defence and more, but the risks are still not fully understood.” Continue Reading...

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On December 19, 2007, the Department for Environment, Food and Rural Affairs (DEFRA) published a report entitled Characterising the Potential Risks Posed by Engineered Nanoparticles: A Second UK Government Research Report, which follows up on DEFRA’s 2005 report and 2006 progress report. The report reviews the status of research pertaining to the environmental, health, and safety (EHS) issues relating to engineered nanoparticles, and places the United Kingdom’s (UK) research program in an international context. DEFRA is collaborating with international partners, particularly the Organization for Economic Cooperation and Development (OECD) and the International Standards Organization (ISO), to share data and experiences. In this way, according to the report, DEFRA will be able to maximize the effectiveness and speed with which potential risks may be identified and managed.

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The Swedish Chemicals Agency (KemI) recently released a report entitled Nanotechnology -- Large Risks with Tiny Particles? Although the report is in Swedish, it includes a summary in English. According to the report, the rapid development of new fields of application and a lack of knowledge call for caution. The report states that companies are responsible for ensuring that human health and the environment are not damaged and that legislation needs to be extended to cover nanomaterials. Continue Reading...

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The Federal Institute for Occupational Safety and Health (Bundesanstalt für Arbeitsschutz und Arbeitsmedizin/BAuA) (FIOSH) and the German Chemical Industry Association (Verband der Chemischen Industrie/VCI) (GCIA) have issued draft document entitled Guidance for Handling and Use of Nanomaterials at the Workplace. The Guidance is intended to provide an overview of occupational health and safety measures in the production and use of nanomaterials. The basis for the Guidance is a survey FIOSH and GCIA conducted in 2006 regarding occupational health and safety measures for handling and using nanomaterials. The Guidance provides recommendations for workers’ protection measures in the handling and use of nanomaterials, based on hazard assessments. The Guidance discusses the state of methods available for measuring nanoparticles and provides a flowchart that recommends specific hazard assessment activities based on the responses to flowchart questions. The Guidance will be developed further by mid-2008 to meet the advancing state of knowledge of nanoparticles.

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According to the fourth quarterly report for the UK’s Voluntary Reporting Scheme (VRS) for Manufactured Nanomaterials, the Department for Environment, Food, and Rural Affairs (DEFRA) received no new submissions during the most recent quarter. Since the VRS began in September 2006, DEFRA has received a total of nine submissions, seven from industry and two from academia. In late July 2007, the Advisory Committee on Hazardous Substances (ACHS) reported the findings of its review of the VRS. ACHS concluded that improvements to the VRS guidance documents were needed to increase participation levels and enhance the quality and relevance of data submitted. ACHS recommended changes to the scheme literature to make its purpose clearer and make the specific data requested from industry more explicit. The report states that DEFRA will publish revised guidance shortly. The VRS is scheduled to end in September 2008, at which time DEFRA will evaluate its success and consider alternatives, including compulsory data submissions, if necessary.

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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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On July 23, 2007, the United Kingdom (UK) Royal Society issued a press release entitled “’Responsible NanoCode’ for business to be developed.” The press release states: “An initiative to develop a ‘Responsible NanoCode' for businesses working with nanotechnologies has been launched by the Royal Society, Insight Investment, the Nanotechnology Industries Association and the Nanotechnology Knowledge Transfer Network today.” The Code is intended to establish a set of internationally relevant principles that outline good practice for businesses involved in all aspects of these emerging technologies and their applications including research, development, manufacturing, distribution, and retailing. An open consultation will take place in Autumn 2007 when a draft code will be available for comment.  The working group aims to publish the Code early in 2008.

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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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On May 17, 2005, the United Kingdom’s (UK) Department for Environment, Food, and Rural Affairs (DEFRA) released a report entitled Environmentally Beneficial Nanotechnologies: Barriers and Opportunities, which provides the results of a study exploring ways in which nanotechnology could reduce the use of non-renewable energy sources and greenhouse gas emissions. The study investigated the opportunities and potential obstacles to adoption of a number of environmentally beneficial nanotechnologies. The resulting report explores the application of nanoscience in the areas of insulation, photovoltaics, electricity storage, engine efficiency, and the hydrogen economy.

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On May 11, 2007, the United Kingdom (UK) Health & Safety Executive (HSE) published its first bulletin on nanotechnology research. The bulletin is intended to provide an overview of published studies that have examined the exposure and potential health effects of nanomaterials, particularly in the occupational setting. According to HSE, inevitably there will be some overlap between studies of exposure of other groups (i.e. consumers).  HSE screened the literature search results to ensure that the studies listed are relevant to HSE and its responsibility to manage health and safety in the workplace. The first bulletin reviews literature published in 2000-2006. According to HSE, subsequent bulletins will summarize publications from the previous four-month period. The bulletins will summarize the range of studies that have been published in two areas of interest: measurement, characterization, and control of exposure to nanoparticles; and potential for toxic effects of nanoparticles in humans.

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Environmental Defense (ED) will hold a webcast regarding its recent report, Not That Innocent: A Comparative Analysis of Canadian, European Union and United States Policies on Industrial Chemicals, on May 24, 2007, from 3:00 p.m. to 4:30 p.m. (EDT). The webcast will include a 45-minute presentation and a question and answer period. Dr. Richard Denison, Senior Scientist at ED, will present the findings and discuss his report, which compares the European Union’s new Registration, Evaluation, and Authorization of Chemicals (REACH) regulation, the Toxic Substances Control Act (TSCA), and the Canadian Environmental Protection Act (CEPA). Continue Reading...

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On May 4, 2007, the European Commission (EC) released a document entitled Strategy for Communication Outreach in Nanotechnology, which is a working paper from the EC’s February 6, 2007, workshop. The paper includes recommendations for future European funding on appropriate communication and innovative approaches to engage the European civil society in a dialogue on nanotechnology, including:  surveying the public; developing new models and tools for communication; developing the role of choice-making process; and ensuring access to reliable information. Comments on the paper are due June 30, 2007. Continue Reading...

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On April 3, 2007, the United Kingdom’s (UK) Department of Environment, Food, and Rural Affairs (DEFRA) released its second quarterly update on the Voluntary Reporting Scheme (VRS) for engineered nanoscale materials. According to the update, DEFRA has received a total of six submissions since VRS’s launch in September 2006, four of which were from industry and two from academia. DEFRA has liaised with groups representing the UK nanotechnologies industry and has made direct contact with companies involved in the sector. From these contacts, DEFRA believes that “a number of VRS submissions are being prepared and will be delivered” in the near future. During discussions with industry, DEFRA sought feedback on VRS, and industry raised the following issues: uncertainty regarding the scope of VRS; resources; and confidentiality issues. The next update will be published in June 2007.

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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. Continue Reading...

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