Nanotechnologies are everywhere, from the medicines we take to the food we eat, but what do we really know about the potential effects when they come into contact with complex matrices and how do we ensure that nanoproducts are safe?
The global market for nanomaterials is estimated by the European Commission to be 11 million tonnes at a market value of €20 billion, and products underpinned by nanotechnology are forecast to grow from a global volume of €200 billion in 2009 to €2 trillion by 2015.
We know that the properties of nanomaterials can change significantly when they are used in complex matrices, such as biological systems, potentially affecting functionality and behaviour. It is these changes that are exploited in nanobiotechnology or nanomedical applications. For example, in some therapeutic applications, protein coated nanoparticles (apolipoprotein E coatings) can target specific locations, such as the brain.
However, there may be other currently unknown biological interactions which could pose a potential risk to human health. These risks are compounded by a lack of robust methods to characterise nanomaterials in complex biological matrices.
This was the challenge behind a three-year multi-national project, ‘Chemical and Optical Characterisation of Nanomaterials in Biological Systems’ (NanoChOp), which finished last month. The project is led by the international life sciences company LGC, which is the UK’s designated National Measurement Institute for chemical and bio- measurement, and involves a consortium of European partners.
Dr Heidi Goenaga-Infante, NanoChOp project coordinator and principal scientist for Inorganic Analysis at LGC, said: “The benefits of nanotechnology can only be fully realised if nanomaterials, particularly those for use in nanomedicine applications and consumer products, are shown to be non-toxic. Generally, nanomaterials are characterised in their pure form or in simple idealised matrices. However, if we are to understand the evolution of nanomaterials, it is important to be able to measure their physicochemical properties not only in a simple water environment but also within more complex biological matrices. This is a particularly challenging task, since matrix components are likely to interfere with numerous techniques and assays, leading to ambiguous readouts.”
To address this challenge, the project partners have developed methods to characterise nanomaterials for their physical, chemical and optical properties in biological matrices. They have also developed a series of nanoparticle quality control (QC) materials composed of metal oxide materials (which enable the development of methods for physical and chemical characterization), fluorescently labelled metal oxide materials (which allow nanomaterials tracking within biological systems), and a quantum dot nanomaterial (to enable the development of methods for the optical characterisation of fluorescent nanomaterials).
Goenaga-Infante said: “The traceable methods developed in the NanoChOp project will lead to a reduction in the uncertainty of measurements used to characterize nanomaterials in terms of their size, zeta potential, elemental composition, fluorescence etc. Such methods will be invaluable to evaluate the potential changes that nanomaterials may undergo due to interactions with biological systems.”
This new breakthrough will be welcome news to regulatory bodies who have been voicing concerns over the regulation of nanotechnologies for several years.
In 2009, the European Scientific Committee on Emerging and Newly Identified Health Risks published a report highlighting concerns about the methods for evaluating the potential risks of nanomaterials. It highlighted the need for further research to develop validated and standardised methodology for assessing risks associated with nanomaterials. The UK Nanotechnologies Strategy was launched in 2010 with the challenge of ensuring that society can benefit from novel applications of nanotechnology, while a high level of protection of health, safety and the environment is maintained.
Legislation has been introduced, albeit in a piecemeal fashion, which place restrictions on the use of nanomaterials. For example, the REACH (Registration, Evaluation, Authorisation and Restriction of Chemicals) Regulation (EC No. 1907/2006) provides an over-arching legislation applicable to the manufacture, placing on the market and use of substances on their own, in preparations or in articles. Nanomaterials are covered by the definition of a ‘substance’ in REACH even though there is no explicit reference to nanomaterials. The Cosmetic Regulation (EU No 1223/2009) was one of the first to be introduced and states that all ingredients present as nanomaterials must be clearly indicated with the term ‘nano’ in the ingredients list on the product packaging. Others include the Biocidal Products Regulation (EU No 528/2012) and there are additional areas of legislation where proposals are being made including controlling the use of nanomaterials including in medical devices.
The new methods and QC materials from the NanoChop project will assist in providing regulatory bodies and legislators with coherent and comparable data from which to formulate policy, enabling manufacturers of nanomaterials to operate under a fit for purpose regulatory framework.
Goenaga-Infante said: “Ultimately, the NanoChOp project will help to alleviate public concern regarding the safety of many applications of nanoparticles by providing the nanobiotechnology and the nanomedicine sectors with validated protocols to perform their analysis. In turn, this will lead to regulatory and legislative bodies being equipped with reliable data upon which to make more informed decisions.”
The NanoChOp project is funded by the European Metrology Research programme (EMRP).