Has anyone looked into the application of current laws to nano?
Yes, current laws have been reviewed by a number of different groups.
In 2004 the Royal Society and Royal Academy of Engineering published a landmark report, recommending that UK regulatory authorities consider whether existing laws are able to protect humans and the environment from hazards associated with nano.
In response, several UK government departments have published reports on the application of existing laws to nano. The European Commission has also examined the matter and published a report last year. To see the reports, click on the following links:
- Department for Environment, Food & Rural Affairs (Defra)
- Department of Trade & Industry (DTI)
- Food Standards Agency (FSA)
- Health & Safety Executive (HSE)
- European Commission
What did the reviews find?
The general conclusion to be drawn from the reports is that existing laws are on the whole capable of controlling nano, but there may be instances in which they prove to be inadequate and need to be improved.
Some reports, however, are more critical than others. Those published by the DTI and Defra (see above) point out that even though current laws cover nanomaterials, they were not designed with nanomaterials in mind and as such fail to address their novel properties.
They also stress that better regulation depends on improving our understanding of the nature and effects of nanomaterials as well as developing detection and monitoring tools so that laws can be effectively enforced.
The European Parliament’s Environment Committee has recently adopted a much more critical stance, calling the European Commission to fundamentally rethink its approach to regulating nanomaterials.
In what ways could existing laws be inadequate?
Nano and novelty
One of the explanations for these inadequacies is that laws do not distinguish between materials at conventional- and nano- scale. This means that laws apply in the same way to both types of material.
Some people think this could be a problem because materials at nano-scale can behave very differently from the same materials in bulk-form. They argue that some laws should be changed to reflect these differences.
There is also some concern relating to laws which require novel materials to be registered or authorised before they are marketed. New nanomaterials will be covered by these laws. However, when a company produces nano-versions of existing materials, it is not always clear whether the laws on novel materials will apply.
Lack of information and risk assessment methods
Another explanation is that information on the effects of nanomaterials is lacking, which can make it difficult for companies producing or selling nano-based products confidently to fulfill the relevant legal requirements.
As well as significant knowledge gaps, there are concerns that the methods currently used to assess risks are unsuitable for testing nano.
The laws on consumer products, for example, say that companies can only place products on the market if they are safe. Without appropriate information and methods of assessing risks, it may not always be easy to determine whether a particular nano-based product poses a danger.
The European Scientific Committee on Emerging and Newly Identified Health Risks published a report in January 2009 which found that methods for evaluating the potential risks of nanomaterials may need to be further developed.
The European Parliament has also recently expressed concerns that the test methods currently available are not adequate for assessing risks associated with nanomaterials.
The UK government is funding and co-ordinating research in an attempt to fill these information and assessment gaps (see below).
For related information, see:
What about reviews outside the EU?
A great deal of work has been carried out in other countries. The Project on Emerging Nanotechnologies has published numerous studies on the regulation of nanomaterials in the United States. One such study (Nanotechnology Oversight) concludes that existing laws and institutions for dealing with nano in the US are weak and inadequate, and that many of these laws need to be changed. Another study (Regulating the Products of Nanotechnology) makes the point that the US Food and Drug Administration is not ‘nano ready’ because it lacks the resources to develop its own safety testing methods and evaluate new nano products.
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