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Regulation of nanotechnology 4/6 https://en.wikipedia.org/wiki/Regulation_of_nanotechnology reference science, encyclopedia 2026-05-05T04:27:37.701684+00:00 kb-cron

Wide use of the term nanotechnology in recent years has created the impression that regulatory frameworks are suddenly having to contend with entirely new challenges that they are unequipped to deal with. Many regulatory systems around the world already assess new substances or products for safety on a case by case basis, before they are permitted on the market. These regulatory systems have been assessing the safety of nanometre scale molecular arrangements for many years and many substances comprising nanometre scale particles have been in use for decades e.g. Carbon black, Titanium dioxide, Zinc oxide, Bentonite, Aluminum silicate, Iron oxides, Silicon dioxide, Diatomaceous earth, Kaolin, Talc, Montmorillonite, Magnesium oxide, Copper sulphate. These existing approval frameworks almost universally use the best available science to assess safety and do not approve substances or products with an unacceptable risk benefit profile. One proposal is to simply treat particle size as one of the several parameters defining a substance to be approved, rather than creating special rules for all particles of a given size regardless of type. A major argument against special regulation of nanotechnology is that the projected applications with the greatest impact are far in the future, and it is unclear how to regulate technologies whose feasibility is speculative at this point. In the meantime, it has been argued that the immediate applications of nanomaterials raise challenges not much different from those of introducing any other new material, and can be dealt with by minor tweaks to existing regulatory schemes rather than sweeping regulation of entire scientific fields. A truly precautionary approach to regulation could severely impede development in the field of nanotechnology safety studies are required for each and every nanoscience application. While the outcome of these studies can form the basis for government and international regulations, a more reasonable approach might be development of a risk matrix that identifies likely culprits.

== Response from governments ==

=== United Kingdom === In its seminal 2004 report Nanoscience and Nanotechnologies: Opportunities and Uncertainties, the United Kingdom's Royal Society concluded that:

Many nanotechnologies pose no new risks to health and almost all the concerns relate to the potential impacts of deliberately manufactured nanoparticles and nanotubes that are free rather than fixed to or within a material... We expect the likelihood of nanoparticles or nanotubes being released from products in which they have been fixed or embedded (such as composites) to be low but have recommended that manufacturers assess this potential exposure risk for the lifecycle of the product and make their findings available to the relevant regulatory bodies... It is very unlikely that new manufactured nanoparticles could be introduced into humans in doses sufficient to cause the health effects that have been associated with [normal air pollution]. but have recommended that nanomaterials be regulated as new chemicals, that research laboratories and factories treat nanomaterials "as if they were hazardous", that release of nanomaterials into the environment be avoided as far as possible, and that products containing nanomaterials be subject to new safety testing requirements prior to their commercial release. The 2004 report by the UK Royal Society and Royal Academy of Engineers noted that existing UK regulations did not require additional testing when existing substances were produced in nanoparticulate form. The Royal Society recommended that such regulations were revised so that “chemicals produced in the form of nanoparticles and nanotubes be treated as new chemicals under these regulatory frameworks” (p.xi). They also recommended that existing regulation be modified on a precautionary basis because they expect that “the toxicity of chemicals in the form of free nanoparticles and nanotubes cannot be predicted from their toxicity in a larger form and... in some cases they will be more toxic than the same mass of the same chemical in larger form.” The Better Regulation Commission's earlier 2003 report had recommended that the UK Government:

enable, through an informed debate, the public to consider the risks for themselves, and help them to make their own decisions by providing suitable information; be open about how it makes decisions, and acknowledge where there are uncertainties; communicate with, and involve as far as possible, the public in the decision making process; ensure it develops two-way communication channels; and take a strong lead over the handling of any risk issues, particularly information provision and policy implementation. These recommendations were accepted in principle by the UK Government. Noting that there was “no obvious focus for an informed public debate of the type suggested by the Task Force”, the UK government's response Archived September 29, 2011, at the Wayback Machine was to accept the recommendations. The Royal Society's 2004 report identified two distinct governance issues:

the “role and behaviour of institutions” and their ability to “minimise unintended consequences” through adequate regulation and the extent to which the public can trust and play a role in determining the trajectories that nanotechnologies may follow as they develop.