2. Methods for the detection and quantitative analysis of nanomaterials which in a large number of cases may not involve the use of nanomaterials.

Seeking inputs from various stakeholders is noble idea which is encouraged.

Good luck,

• characterise nanomaterials in a standardised way

• test nanomaterials in appropriate manners and relevant test systems

• monitor quantities and effects of nanomaterials entering the environment (particularly water, sediments, soils and biota).

Environmental monitoring is stated to be an integral objective underpinning regulation, and was highlighted in the Royal Commission on Environmental Pollution’s report as an obligation that should fall to the Environment Agency in England and Wales. However, there appear to be no current proposals as to how this might be achieved other than work within the Environmental Nanoscience Initiative, which is funded at a relatively modest level given the enormity of the task, in the UK. While the work to develop standards is welcome, we believe major research into monitoring tools should be initiated as soon as possible regardless of which body will monitor the environment for nanomaterials. There are very few, if any, techniques for monitoring nanomaterials in the environment beyond the coupling of simple chemical analysis and sophisticated laboratory imaging techniques. We do not believe this approach is a practical way forward.

We do not have the resources to develop and undertake monitoring programmes for a wide range of different nanomaterials. We believe monitoring should be prioritised on those materials likely to pose the greatest hazard and/or risk to the environment. This requires knowledge on the types of materials being produced and released – see our earlier comments on “Anticipating Opportunities and Concerns” and “Managing Risks and Uncertainties”). In addition, we believe current monitoring programmes are likely to require considerable modification to detect even a small range of different nanomaterials. This will have significant cost implications, above and beyond the investment required to develop and validate the monitoring tools themselves.

We believe that a significant uncertainty is the lack of understanding of the breadth of nanomaterial developments and uses within industry. There is a risk that research initiatives will, therefore, be unco-ordinated and/or that any prioritisation of research or regulatory development may be based on assumptions regarding the types, volumes and uses (and hence routes of release to the environment) rather than actual information. We believe this in turn promotes a disjointed approach to research and one which is driven primarily by the individual research priorities of individual institutes, rather than an overall strategic view of which nanomaterials require the most urgent attention.

The UK’s industrial heritage has left us with significant challenges from land and water affected by contamination, much as a result of the limited understanding of the impacts of releasing materials into the environment. We believe it is critical that a strategic approach is developed to ensure that nanotechnology does not contribute to this. Specifically, with respect to the prospective use of nanomaterials in environmental remediation, we believe the strategy should support, and raise awareness of, the Government’s moratorium on the deliberate release of manufactured nanoparticles until there is sufficient evidence that the benefits outweigh any adverse effects.

We support the importance that the consultation gives to the environment and health and safety aspects of the responsible implementation of this technological area and its associated materials. We also agree that mechanisms to ensure the safe manufacture, use and disposal of nanomaterials must be appropriate and proportional to any risk.

The Environment Agency recognises that the qualification and quantification of the risks that nanomaterials may pose presents complex and technical challenges. We believe that work in this area will be best provided through international collaboration and support the UK’s ongoing input into international research, and believe the government should continue and further this approach.

The Environment Agency also supports the ongoing investment into the development of a UK research community, advancing basic science and evaluating the potential risks and uncertainties associated with nanomaterials for the environment and human health. We believe this should be undertaken in a strategic way.

Because of the variety in chemical and physical form and application, we do not believe that nanomaterials can be grouped as a simple class for safety assessment purposes. We believe it is critical to have a full understanding of the range of nanomaterials (and their uses) on the UK market and their potential for environmental release before work on detection, standards and hazard/risk assessment can be prioritised.

We agree with the Royal Commission on Environmental Pollution’s report on novel materials, that there is a key research need to develop predictive models based on functionality, and for research to be prioritised on those nanomaterials likely to pose the greatest risk. We believe the Environmental Nanoscience Initiative may provide results towards this end. However, a good understanding of the full range of nanomaterials is critical to allow any such prioritisation to be effective.

We believe the Voluntary Reporting Scheme for nanomaterials was a potentially useful attempt to characterise the range of nanomaterials being used/produced and could have provided a significant first step in enabling the development of a strategic framework for resolving research and regulatory priorities. The lack of support for this initiative by industry is unfortunate and likely to delay the formulation of a more integrated research strategy for nanomaterials. This is an area which needs to be addressed as a matter of urgency as we believe that a mandatory reporting scheme would be more efficient in gathering information on nanomaterials on the UK market. Such a scheme, even with only basic information requirements, might fill the gap until mandatory reporting is in place. This is likely to be introduced under amended EU chemicals legislation. Public attitudes may be important determinants in the approach taken to any successor of the first reporting scheme.

This is in our view a problematic position, which Government and research funders have yet to tackle. While the public might perceive a strong role for government in funding, regulating, and ensuring appropriate uses of new technologies, the reality of our current model of R&D gives the most significant decisions about applications to the private sector. And despite the existence of CSR policies, the best intentions of the researchers themselves and the work that the research councils and government departments are doing to assess and regulate the risk and to discuss these issues more widely, already the first applications employing these technologies to come on the market don’t go near to solving the big challenges facing society.

While we do not want to argue against market economics (indeed the public in our studies were keen on the potential of the technologies to generate wealth and jobs), the evidence from the introduction of previous controversial technologies and our research suggests that dissatisfaction and distrust are likely to arise when the government and scientific community fails to meet expectations around the way in which the technologies are used – arguably what happened in the GM debate.

It’s a huge challenge, but there are lots of ideas about the levers available to government to start to bridge this ‘valley of death’ between R&D and the prizes will be big – no room here though.

best wishes

In line with our Responsible Care commitments the chemical industry strives to optimise the benefits of engineered nanomaterials and nanotechnologies and ensure the safety of its employees, the public and also the environment. The safety of our products, the protection of consumers and our workforce is our top priority.

The UK has a great potential to develop nanotechnologies to remain one of the key global players. It is however essential that both the European regulatory framework and UK Government funding and tax regime be adequate to allow this to happen. It is also important to reach global agreements on standards (e.g. test methods and definitions) to ensure fair competition globally.

CTPA is supportive of having an open dialogue on nanotechnology and welcomes the development of a UK strategy for nanotechnologies. We wish to congratulate the Department for Business Innovation and Skills for this positive website and we are appreciative that the information on the site provides a balanced account of nanotechnology in the cosmetics sector.

We also welcome this opportunity to provide more information on the types of nanomaterials used in cosmetic products. These are nanoparticles (predominantly nanopigments at present) and nanosomes/nanoemulsions: CTPA members do not use fullerenes in cosmetic products.

The types of nanomaterials developed on the nanometric scale in one industry are generally very different from nanomaterials used in other industrial sectors. They differ in their form and their molecular structure, their mode of use and the way they interact with the environment. We feel that this should be taken into account when developing a strategy for nanotechnologies. In particular, that strategy should be focused on the specific properties of individual nanomaterials. Of course, key to any such discussion is having widely agreed definitions of what is meant by nanomaterials, nanoparticles etc.

We are aware that concern has been expressed about the possible absorption of nanoparticles. In practice, cosmetic products are carefully formulated to ensure ingredients are delivered to the appropriate site on the skin or on the hair, and knowledge of the potential absorption of ingredients is essential in this regard.

The skin is an effective barrier against penetration. Indeed a number of scientific studies have consistently shown that nanoparticles (including nanopigments) in current cosmetic use are non-toxic and do not penetrate into or through human skin. Studies undertaken within the framework of the European Union research programme, Nanoderm, as well as the US FDA and independent researchers showed that nanoparticles do not cross the skin barrier, even in cases where the skin is compromised, such as psoriasis, sunburned skin and stripped skin (removal of the horny layer).

The basic premise of the European Cosmetics Directive (76/768/EEC) is that a cosmetic product must not cause harm to human health when applied under normal or reasonably foreseeable conditions of use. This legislation requires that all cosmetic products are the subject of a robust safety assessment before being placed on the market. Part of this assessment will address the safety of the ingredients actually used including the ingredients’ particle size. Consequently, any potential health risks must be understood and assessed before a new technology may be introduced in cosmetic products.

As early as the research and development stage, company experts systematically evaluate new products, not only in terms of identifying any potential risks but also assessing their ecological and toxicological properties. For example, one nanomaterial used in sun protection products is titanium dioxide. When formulated into a sun protection product, nano titanium dioxide is present in large clusters of particles reaching sizes much greater than 100 nanometres to ensure optimal protection of the skin surface. Studies carried out in the US by the FDA and in Europe, have demonstrated that even in the case where titanium dioxide nanoparticles are not clustered and are injected under the skin or into the blood stream, no adverse effects are observed. These results were confirmed by independent studies in Europe and in Japan.

Consumer safety is the first priority of the European cosmetics industry but it is also committed to innovation. The cosmetics industry will follow scientific progress in the area of nanotechnology and will continue to ensure that all ingredients used in cosmetics comply with the high safety standards expected by the public, consumers and competent health authorities.

We provide further information on nanotechnology, as well as many other issues, on our consumer website http://www.thefactsabout.co.uk .

Our Centre for nanotechnology, Biomaterials & Tissue Engineering has over 7 postdoctoral and 30 PhD students working on development biomedical product using nanotechnology and stem cells. In addition this year we are running a MSc in Nanotechnology & Regenerative Medicine.

Therefore I would be very much interested to be involve in this initiative.

Prof Alexander Seifalian
Professor of Nanotechnology & Regenerative Medicine

At BRE we have been working with Aerogel manufacturers and other large Corporates to get some of these products into the marketplace; to enable a step-change in the refurbishment arena via our National Exemplar projects. (We are working on these in conjunction with the Housing Market Renewal Agencies to demonstrate “hands-on” what can be done).

The opportunites are vast for the sector and should not be underestimated. Whilst I am not an authority on this particular topic, I feel sure that the likes of Aspen (Aerogels) would welcome an opportunity from BIS to discuss these particular issues.

Voluntary disclosure of research is obviously pitifully inadequate to counter such threats to the general health and welfare of the human race by unscrupulous organizations, governments and individuals.

The threat to the natural environment, flora and fauna is just as real. We have through toxic farming and industrial pollution bought this planet to its knees. Will we now compound that by introducing such time bombs as “smart” delayed release insecticides, pesticides and herbicides, sitting unseen, unpredictable and unrecallable in the environment, out of all control? We have to work with nature not invent new ways of polluting and destroying natural systems of balance, essential for the future of us all on the planet.

Science can produce all sorts of novel solutions to apparent problems, but are they wise and advised and will they stand the test of time to produce the best possible result for all concerned? It is time to be very careful in devising strategy going forward, as history has shown us, mankind can only too easily abuse and pervert. We are creating all our futures – lets make it a good one.

Nanoparticles 2009 Conference, 2-4/September/2009,

University of Liverpool, UK

Please see this link:

http://www.soci.org/General-Pages/Display-Event?EventCode=COLL066

If you want to know what it covers, do a search for jobs on the new scientist website of nature with the keyword “formulation”…Recruiters and employers know what they are looking for…

It is also our experience that some of the fundamental technologies we have developed have poterntial application outside of our existing ability to explore and exploit. In our case there are fields of thermal fluid use that we have simply not had sufficient time and resources to pursue; a clearly stated UK nano stratgey would help us to identify the most valuable of these themes, partners and routes to market within a context of national support and funding opportunities.

Finally, we will be pleased to take part in this initiative as we see no difference between the development and promotion of the industry in the UK and the success of our own company which is seeking to be part of it.

Space was conquered because the generation that time took the risk. Its our turn now. But definitely Neil we need to be understand enough to make the “giant leap”

I hope you can get significant input from the industry sectors, it would be very helpful to get more detailed information on what is really happening and what they would find useful to help them deliver responsible nano.

The downside of this is everyone is expecting a fabulous strategy to be developed out of this – good luck on that one!

It has long been considered an art, and as rightly pointed out by Automaxion above, that the science of formulation is a critical enabling technology for nano-materials processing that must be developed.

Nano-materials are not new. nature has been making nano-scale materials for millenium. However, man is now finding ways to make other materials and handle them to our advantage but still, they need to be made into forms that can be delivered and perform. So, as with other ingredients, the science of formulating nano-materials must be developed.

Formulation?

If so, why is it important?

Marks & Spencer wishes to play its part in informing and directing policy and research and will do what it can to support this process.