To begin with, can you tell us a bit about your background?
I was previously an academic. I used to work at Cambridge University, where I finished my PhD and Post Doctorate. I then moved into other research at Lancaster University, before I set up my own company in 2007. I left the university in 2009 and then worked with companies directly. There were a lot of startups and larger companies that required help with understanding nanotechnology and how it can apply to their products. They also wanted to know the best application and market for their inventions and whether there was any competition.
In recent years, I've gotten very much into standards and regulation for nanomaterials. At the moment I'm leading the Global ISO Standard Committee, ISO/TC 229 (Nanotechnologies). It's rather rewarding because industry is now coming to the point where it becomes a necessity to specify a material according to international standards. In the past, people sold nanomaterials and said, “Oh, it's a fantastic nanomaterial. Just take it.”. But these days, there are so many suppliers and so many refined requirements that there is a need for tighter specifications.
Graphene is another hot area at the moment, and you can buy it in whatever form you like. You can buy samples of nearly pure carbon black or thick graphite sheets, all the way up to nearly single-sheet, well-defined graphene.
There are several organizations for standards, and each has various committees, but here we are talking about standards for nanotechnology.
Our committee, ISO/TC 229 (Nanotechnologies), was formed in 2005 by Dr. Peter Hatto from the United Kingdom. The UK has held chairmanship of the committee since then, and it has the biggest following compared to other nanotechnology standards committees. There are 33 countries fully engaged and also 19 that are observing. We have between 150-200 experts, sent from all over the world to our meetings; held twice a year. The committee sets the terminology and definitions, measurement and characterization, health and safety guidlines, materials specifications and application specifications for nanomaterials and their applications.
The terminology is important for the industry. As we've learnt from the past, ignoring terminology would actually destroy the future of the industry. If you start producing bicycles and call them 4x4s, at some point somewhere, somebody having bought that bicycle instead of a 4x4, would realize that it is not the same product. This is obviously an exaggerated example, but a lot of things like that do happen at the moment in various nanomaterial areas. The terminology is extremely important, but once the terminology's set, how do you prove that you've got what you say you have? You need to have characterization, measurements and all the other tools that would verify your statements.
If you say you have graphene or single-walled carbon nanotubes or other nanomaterials, it's important for you to have a measurement and specification process that is accepted across the world. The process needs to be done in the same way universally. Therefore, the results of the measurements and research would be comparable. If you purchase a nanomaterial and its parameters are specified according to ISO norm, there is a way to reproduce or even correct them in your own lab or company. Without such norms any value specified by the manufacturer may be misinterpreted. This approach gives us a way of tracing down the values and it's very important for the industry and consumers.
Over the years there were some concerns for health and safety of nanomaterials. ISO TC229 also covers that. A working group under ISO TC 229 (Working Group 3) is looking at health and safety and how this is managed or tested. For example, testing if a nanomaterial has an effect on the environment, the human body or cells. There's then a fourth working group (WG4) that looks at nanomaterials’ specifications. The main aim of such standards developed under WG4 is to clarify the specifications of nanomaterials along the supply chain. Working Group 5 (WG5), which was just recently created, actually tells people what nanomaterials are doing in products, and how are they enhancing their capability or functionality. In each case, we distinguish between nano-enhanced and nano-enabled products - nano-enhanced is an improvement from the existing product that does not use nanotechnology, while nano-enabled products do not exist without the use of nanomaterials.
ISO also has a formal link with OECD-WPMN, which is the Working Party on Manufactured Nanomaterials. We work in partnership with them because they then take our standards and develop them into international regulatory guidelines. The guidelines that they produce are used by national bodies such as EPA and DEFRA.
The scope of the TC 229 committee is quite broad. But there are other committees too. There is the IEC/TC 113 that looks at the electro-technical applications of nanotechnology. There is also the European CEN/TC 352 that looks at all aspects of nanotechnology and is predominately linked with European definitions of nanomaterials and regulators.
How has ISO changed over the years?
Egorov Artem / Shutterstock
The committee actually started about 2005, and back then we were anticipating problems rather than solving existing ones. The main concern at the time was to sort out the terminology. What do we mean by a nano-object, nanostructure or nanomaterial? There were lots of very fundamental discussions. By 2015, we came to a stage where we were comfortable with the internationally accepted terminology. By then, we published most of the terminology standards and got to revise and consolidate existing documents.
At the moment, we have an explosion of activity in measurement and characterization, because everyone wants to know whether we actually have nanomaterials and what they do. There's a huge number of documents specifying how to detect, count, size and characterize nanomaterials as powders, aerosols and dispersions.
The requirements on such measurements are often quite tough too. For a standard to be even considered for development under ISO TC229, it has to be based on an existing well-established technology. It can't just be an academic publication that would not be reproducible or even accepted by half of the community; even if people are excited about it. We require a lot more than one, two or even ten publications – it requires well-accepted science, a lot of crosschecking and in many cases inter-laboratory studies to confirm it.
From the beginning, we also had a lot of concerns about health and safety, so our health and safety group has been very busy. It was driven originally by anticipatory evaluation of risks. Now, we are being asked directly by various stakeholders to help them to solve testing problems for regulatory and policy developments. For example, the EU’s REACH regulation was recently modified to accommodate nanomaterials and many test guidelines are still under development.
I anticipate a further increase in the number of standards being developed in nanomaterial and product specification areas. These are handled by the later working groups 4 and 5. The materials specifications working group doubled the amount of documents they are working on over the last two years, extending the technical negotiations late into the night at all our meetings. With a wide development of nano-enabled and nano-enhanced products, we are seeing an increased interest in performance-based standards for such products. This area of standardization is driven by Working Group 5.
How do you think Nanotechnology will develop in the future?
There are many visions of this horizontal technology development. I guess it is easier to deal with examples. Graphene is probably the most recent golden egg of nanotechnology and research. We've heard a lot about its potential capability, but what I'm a little bit skeptical about at the moment, is graphene's real ability to solve the problems that people claim it can. There were lots of claims about global-impact applications such as desalination of water, remediation of land, drug delivery, etc. But surprisingly the global demand of graphene remains low in volume. There are also a lot of companies that claim that they can produce tons of graphene a year. I'm just a little bit worried that we are not going fast enough in graphene applications and usage.. There are some applications that are very smart and very good, but they are actually using very little graphene.
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In the absence of sustained demand we may go into a spiral of of price competition. There is another issue of going down the path of reduced value - cheaper, larger-scale material, which may or may not even be graphene. There is a clear need to keep the quality of what we actually call graphene high, because otherwise what we will do is dilute or destroy the definition of graphene and people wouldn't trust it. The lack of trust would slow down material uptake and development of applications.
There is a trend for producing nanomaterials at the larger scale - not only graphene. Here you may have a variation between the batches within the same supplier, and that needs to be verified because customers often need that consistency in their applications. There is also a lot of uncertainty with the regulation. European regulation seems to be the toughest at the moment, but the U.S. is quite strict in some cases. We anticipate more reporting and safety test requirements from regulators in the coming years.
There is a lot of fundamental research in nanotechnology across Europe, but the national government initiatives in support of industry have now moved away from funding pure nanotechnology for its own right. The funding calls tend to include nanotechnology as a key enabling technology in support of sector-specific calls like renewable energy, light aircraft, future transport, bio-medical applications, etc. In some areas of EU-funded research, we see a lot of activity in health and safety and regulatory compliance, but no significant technology development..
In other parts of the world, China is steaming ahead like there is no tomorrow. They are drafting, and they are publishing their own standards. They are supporting their industry in a very big way and they will definitely be a power not only to reckon with, but to work with. They claim they're already producing 60 % of the global supply in graphene. Whether it's verifiable or not is a different question, but I am aware of very large-scale investments in that area. China is a place to watch - there's a lot of very talented people there and they are not shy in recruiting talent from all over the world.
There are other countries too - Iran has an interesting nanotechnology community. They have been doing well and they're very well-funded. Other promising countries include Malaysia, Thailand and Korea. Japan are less funded, but they have an outstanding track record of nanotechnology research. Russia has funding and are now telling the world that they have actually got some revenue back with nanotechnology, which is very encouraging as well.
We're heading into a new area where interestingly enough, nanotechnology research is not only focused in U.S. and Europe - it is very much distributed among a lot of players. This is reflected again at our ISO TC229 committee, where the contributions are coming from very diverse points of view. There are very strong delegations from the U.S., Canada, Iran, South Africa, Mexico, Germany, the U.K., the Netherlands, France and obviously Asian countries such as China, Korea, Japan, Malaysia and India. We would welcome more too, as this is an incredibly diverse area where politics is stopped in its tracks to give way to pragmatic technical discussions. Every country and expert is listened to and respected.
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Is there anything else you’d like to share with our readers?
It’s important to really drive home the notion of why these standards are important. I've tried to describe a few times what the impact of lack of standards is, but a lot of companies say, "Well, it's very difficult for us to see the dollar at the end of that. Do we actually get engaged? What do we get out of it?" The companies quite often miss that critical point, because generally what they have is knowledge and a technology that they spent a lot of time developing. People miss the point that the standard isn't really the text that is on the screen or on the paper, it is actually the common understanding of a certain specification (measurement method or material specification, etc). So, the ISO committee are actually creating the standard as they discuss things and throughout this conversation they convince each other to put this on the paper in one way or another.
This is more valuable than people realize. For a company to have their technology bashed about and then accepted as an international standard, in the minds of all metrology experts and all the experts in the field, is invaluable. You can't even put the price tag on this. That's why they should be there if they have something to share. What happens if somebody else develops a standard that may exclude your technology all together? Since you were not there, you didn't comment on documents, you didn't contribute and nobody heard your opinion. This situation is lose-lose for everyone.
That applies to small companies, medium companies, and definitely larger corporations because they already have set policies and set procedures, that may be actually valuable to ISO. On the other hand, adjusting internal procedures to external guidelines may be costly and time consuming. It's much easier to send a representative through a national standards committee to debate that in the open. That's what ISO TC229 actually offers - an international nanotechnology standards forum.
GiroScience / Shutterstock
About Denis Koltsov
Denis Koltsov, PhD. is the Chairman of ISO TC299 (Nanotechnologies) at the International Organization for Standardization. He has a background in Physics and Engineering at the University of Cambridge and also works as a nanotechnology consulting professional. He is currently the Director of BREC Solutions Limited.
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