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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.

The General Summary states:

It is the opinion of the working group that research, development and application of nanotechnology are covered by existing legislation.  In view of this, the working party does not consider there to be a need for special nano-legislation.

However, the working group also considers that there will continue to be a need, determined by future development, to assess and if necessary adapt rules and executive orders etc. within the framework of existing legislation. Work is in progress in a number of national and international forums to create the necessary conditions for such adaptation, in part by establishing standards and limit values.

The [European Union (EU)] and the [Organization for Economic Cooperation and Development (OECD)] are playing a key role in connection with risk assessment of nanotechnology, in part through the EU’s [Scientific Committee on Emerging and Newly Identified Health Risks (SCENIHR) and Scientific Committee on Consumer Products (SCCP)].  It is therefore important to keep an eye out for recommendations and assessments issued by the EU and the OECD, as it will be possible to use these actively in connection with the adjustment of Danish rules and executive orders.

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.