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Scientific Committee on Emerging and Newly Identified Health Risks (SCENHIR)


Report Title: Scientific Basis for the Definition of the Term "Nanomaterial"
Report ID: 522
Date: 7/6/2010
Report Type: Scientific Opinion Report
URL: [scenihr_o_030.pdf]
Country: European Union
Organization: Scientific Committee on Emerging and Newly Identified Health Risks (SCENHIR)
Summary: This opinion provides advice on the scientific elements of a definition for "nanomaterial." Many current definitions lack scientific support. At present, there is no scientific evidence in favor of a single upper size limit for nanoparticles, but an upper limit of 100 nm is commonly used. While size is the predominant feature in classifying nanoparticles, internal size must be considered as well. Some aggregates and complex multi-component nanomaterials with external dimensions in excess of an upper size limit still have internal structures with nanomaterial dimensions. Other criteria to use include measuring the volume specific surface area (VSSA) of a particle, and considering the size distribution. While this opinion concludes that size is the most suitable measurand for determining nanoparticles, other properties such as crystalline phase and water solubility can be secondarily useful. SCENIHR suggests that size, characteristics, physico-chemical properties, and thresholds be taken into account when setting nanomaterial definitions.
Archived Copy: scenihr_o_030 definition_522_6136.pdf



Report Title: The Synthesis Report on the public consultation of the SCENIHR opinion on "The appropriateness of existing methodologies to assess the potential risks associated with engineered and adventitious products of nanotechnologies"
Report ID: 448
Date: 6/1/2006
Report Type: General Report
URL: [synth_report.pdf]
Country: European Union
Organization: Scientific Committee on Emerging and Newly Identified Health Risks (SCENHIR)
Summary: The Scientific Committee on Emerging and Newly Identified Health Risks (SCENHIR)'s opinion on the appropriateness of existing methodologies to assess the potential risks associated with nanotechnology (see report ID 69) was adopted in 2005 and subsequently modified after public consultation from October 20 to December 16, 2005; it was adopted in modified form in March 2006. This document is the Synthesis Report presenting the overall results from the public consultation and SCENHIR's response to the public comments. Responding stakeholders included representatives of manufacturers, research institutions, NGOs, and individuals. Overall, respondents agreed with SCENHIR's assessment of risk assessment methodologies and the need for case by case evaluation of risks. Issues raised that were outside of the SCENHIR scope included the need for better EU and international coordination, international consensus of testing and risk assessment methodologies, and integration of the risk assessment demands of nanotechnology products into the existing legal frameworks. Areas of public disagreement largely were over the appropriateness of existing testing methods. SCENHIR's response to the public comments emphasizes that its call for development of new methodologies was not meant to neglect current methodologies. Both the public and SCENHIR agree that actions must be pragmatic and there is value in case by case risk assessment.
Archived Copy: synth_report_448_2212.pdf



Report Title: Scientific Committee on Emerging and Newly Identified Health Risks (SCENIHR) Modified Opinion (after Public Consultation) on the Appropriateness of Existing Methodologies to Assess the Potential Risks Associated With Engineered and Adventitious Products of Nanotechnologies
Report ID: 205
Date: 3/10/2006
Author: Scientific Committee on Emerging and Newly Identified Health Risks (SCENIHR)
Report Type: Scientific Opinion Report
URL: [scenihr_o_003b.pdf]
Country: European Union
Organization: Scientific Committee on Emerging and Newly Identified Health Risks (SCENHIR)
Summary: Following from the conclusions of the Council of the European Union on the European strategy for nanotechnologies which highlighted the importance of the "assessment of potential risks throughout the life cycle of nanotechnology based products" and the nanotechnologies action plan, the European Commission asked the independent experts of the Scientific Committee on Emerging and Newly Identified Health Risks for a scientific opinion on the appropriateness of existing methodologies to assess the potential risks of nanotechnologies. The committee issued a report that complements current scientific background and contains an assessment of the gaps in knowledge required to address the risks of nanotechnologies and an examination of regulatory aspects related to risk assessment. In particular, the committee concludes that current risk assessment methodologies require some modification in order to deal with the hazards associated with nanotechnology, and in particular that existing toxicological and ecotoxicological methods may not be sufficient to address all of the issues arising with nanoparticles. It furthermore points to major gaps in the knowledge necessary for viable risk assessment.

Archived Copy: scenihr_o_003b_205_5616.pdf



Report Title: Request for a Scientific Opinion on the Appropriateness of the Risk Assessment Methodology in Accordance With the Technical Guidance Documents for New and Existing Substances for Assessing the Risks of Nanomaterials
Report ID: 175
Date: 1/1/2006
Author: SCENHIR
Report Type: Request for Opinion
Publication: Request for a Scientific Opinion on the Appropriateness of the Risk Assessment Methodology in Accordance With the Technical Guidance Documents for New and Existing Substances for Assessing the Risks of Nanomaterials
Country: European Union
Organization: Scientific Committee on Emerging and Newly Identified Health Risks (SCENHIR)
Summary: The European Commission requested that the Scientific Committee on Emerging and Newly Identified Health Risks (SCENIHR) form an opinion on the appropriateness of existing risk assessment methodologies for determining nanomaterial safety to humans and the environment. That opinion concluded the methodologies required adjustment in order to adequately address the new concerns of nanoparticles. This document is another request from the Commission to again assess the appropriateness of existing risk assessment methodologies as described in the Technical Guidance Documents. Specifically, SCENIHR is asked to perform this assessment as well as provide concrete suggestions for improvement of the methodology. Additionally, SCENIHR is requested to provide practical examples of how risk assessment of nanomaterials can be performed. The deadline for this opinion is December 2006.
Archived Copy: Michael Vincent (SCENIHR) 2006, Request for a scientific opinion in accordance with the TGD_175_4714.pdf



Report Title: Request for a Scientific Opinion: on the Appropriateness of Existing Methodologies to Assess the Potential Risks Associated With Engineered and Adventitious Products of Nanotechnologies
Report ID: 174
Date: 1/1/2004
Report Type: Request for Opinion
Publication: SCENHIR
Country: European Union
Organization: Scientific Committee on Emerging and Newly Identified Health Risks (SCENHIR)
Summary: The market for nanotechnologies is estimated at $1 trillion by 2015 according to the National Science Foundation. The European Community wishes to ensure that the EU participates in this enormous market. However, nanoparticles raise significant health and environmental concerns due to their miniature size. Existing toxicological and exposure data are not applicable to nano-forms of existing chemical substances. This document is a request to the Scientific Committee on Emerging and Newly Identified Health Risks (SCENIHR) for an assessment of methodologies and gaps in current knowledge which endanger the safe development of nanotechnology. Three problems were posed to the Committee: finding the efficacy of existing risk assessment methodologies, determining if any adaptations of or additions to existing methodologies are required for the safe development of nanotechnology, and identifying current knowledge gaps which undermine effective risk assessment.
Archived Copy: Michael Vincent (SCENIHR) 2004, Request for a scientific opinion on adventitious_174_7951.pdf



Report Title: Opinion on the Scientific Aspects of the Existing and Proposed Definitions to Relation to Products on Nanonscience and Nanotechnologies
Report ID: 110
Date: 11/1/2007
Report Type: Opinion for Definitions
URL: [risk_en.htm]
Country: Other
Organization: Scientific Committee on Emerging and Newly Identified Health Risks (SCENHIR)
Summary: This document establishes a framework for relevant definitions concerned with nanoscience, nanotechnologies, and the products of nanotechnology. The opinion also considered various definitions previously published or currently in use when forming the definitions. Also, the opinion stated that the purpose for creating these definitions was to generate consistency through standardization, and to create standard definitions with risk assessment strategies in mind. Furthermore, the opinion noted that these definitions are based primarily on physical, chemical, and biological properties. Although many of the nanosubstances are created naturally, the opinion discussed how the significant increase in manufactured and engineered products requires the need for new words and definitions to establish accurate safety measures. In addition, the opinion said that the criteria for terms selected for definitions included scientific validity, clarity and their ability to stand alone. Finally, the opinion reported that the definitions required for risk assessment purposes must include those that refer to qualitative and quantitative description of the size and shape of products of nanotechnologies and to relevant features of their behavior.



Report Title: Risk assessment of products of nanotechnologies
Report ID: 72
Date: 1/19/2009
Report Type: Committee Report
URL: [risk_assessment_products_nanotechnologies_sce.....]
Country: European Union
Organization: Scientific Committee on Emerging and Newly Identified Health Risks (SCENHIR)
Summary: This document is the fourth in a series of written opinions by the independent scientific committee SCENIHR to the European Commission regarding nanomaterials. Previous opinions identified free and low solubility nanoparticles as posing the greatest human and environmental risks. This opinion highlights solubility as the single most important determinant of environmental and human risk, as a result of its impact on concentration levels within cells and water sources. Difficulty in determining the presence and size of nanoparticles creates a lack of high-quality toxicological data set for risk assessment. Interactions between nanoparticles and biological proteins are also a poorly researched contribution to toxicity. The opinion supports case by case assessment of nanomaterials as the best way to ensure human and environmental safety.



Report Title: The appropriateness of the risk assessment methodology in accordance with the Technical Guidance Documents for new and existing substances for assessing the risks of nanomaterials
Report ID: 70
Date: 6/22/2007
Report Type: Committee Report
URL: [scenihr_o_010.pdf]
Country: European Union
Organization: Scientific Committee on Emerging and Newly Identified Health Risks (SCENHIR)
Summary: The European Union Scientific Committee on Emerging and Newly-Identified Health Risks (SCENHIR) investigated the appropriateness of current risk assessment methodologies for their applicability to nanomaterials. This document contains the Committee's findings and recommendations. The lack of published standards for toxicity testing remains a significant problem. The Committee suggested that exposure and dose-rate models require adaptation because of the slowly changing properties of nanoparticles over time as degradation occurs. It also found that traditional measurements of concentration involving mass are not useful due to the small size of nanoparticles. Agglomerations of and impurities within nanoparticles also play a role in determining toxicity. Once inside the human body, the biological role of nanoparticles remains unknown. It is theorized that nanoparticles may be able to be readily transported throughout cells in the body. The Committee suggests in vitro tests for determining such conditions. It discusses inhalation risks and stresses that caution is needed when developing nanoparticles. This document describes in detail the requirements of a new methodology for performing such human risk tests on nanomaterial products.



Report Title: Scientific Committee on Emerging and Newly Identified Health Risks (SCENHIR), modified Opinion (after public consultation) on the appropriateness of existing methodologies to assess the potential risk associated with engineered and adventitious products of nanotechnologies
Report ID: 69
Date: 3/10/2006
Report Type: Committee Report
URL: [scenihr_o_003b.pdf]
Country: European Union
Organization: Scientific Committee on Emerging and Newly Identified Health Risks (SCENHIR)
Summary: The European Union Scientific Committee on Emerging and Newly Identified Health Risks (SCENHIR) was asked to provide opinions on the suitability of existing methodologies for assessing human risks from nanotechnology. This document assesses the toxicology of nanoparticles and existing risk assessment methods. It describes the properties and sources of nanoparticles. It identifies methods of detection and risk assessment, and details potential exposure scenarios and methods of toxicology. The Report also recommends changes in existing regulations as necessary to address additional risks of nanotechnologies.



 
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