Expectations are that nanomaterials will be critical to the UK and Europe’s long-term growth and sustainability. Many expect they will underpin major technological advances in automotive, aerospace, communications, energy products, medicines food and consumer goods. Remediation of land is a further example where nanomaterials have the potential to provide a highly effective solution to addressing the issue of soil contamination. The safety of such materials to humans and the environment is therefore of paramount importance. Dr. Roger Pullin, Head of Health at the Chemical Industries Association in the UK provides a brief insight into some of the regulatory challenges currently facing industry and policy makers.
For the past decade, the debate on nanomaterials with regards to their safe use and whether they need to be managed differently to standard sized chemicals has been steadily growing. Some deem this to be a new emerging technology whilst others see this as a simple renaming of what was previously known as ‘ultrafines’. What is definite though, is that the word nanomaterial is here to stay.
Industry contributes to this debate and is working with national and European authorities. It also works with international bodies including the Organization for Economic Co-operation and Development (OECD) and many other stakeholders to demonstrate the safety of chemical substances defined as nanomaterials. Industry is building up evidence to show that nanomaterials can be produced and used responsibly under current existing EU legislation.
EU policy makers are giving careful consideration to the following challenges:
- Around the difficulties of identifying whether a substance is a nanomaterial;
- Ensuring testing requirements in the REACH (Registration, Evaluation and Authorisation of Chemicals) Annexes covering nanomaterials; and
- Whether consumer transparency needs to go further than that needed for other chemical substances.
First of all what qualifies as a nanomaterial? This is not as straightforward to define as we might think. Due to diverging scientific opinions, international bodies such as International Standards Organisation (ISO), the European Commission and EU Member States have different views on how this should be defined. An easier place to start is what is meant by the term nanoscale i.e. this being 10-9 or 1 nanometre (nm) is one billionth of a metre. In terms of nanomaterials, it is generally agreed that they are substances with a size in the range of 1-100 nm; in comparison, a human hair has a typical diameter of between 80,000-100,000 nm. In October 2011, the European Commission adopted a recommendation for a definition of a nanomaterial and agreed that this would be reviewed during the course of 2014 to evaluate whether it remains fit for purpose. The Review of the recommended definition is now in progress; the 2011 definition can be found on the Commission website at: http://ec.europa.eu/environment/chemicals/nanotech/faq/definition_en.htm. Prior to this the ISO published its own definition, yet this differs to the one from the European Commission. There are also differences between the definitions used within EU Member State reporting schemes, these being those in France, Belgium and Denmark.
Industry has reservations over the definition due to its impracticality in the absence of standard and certified measurement techniques for determining the metric number size distribution of particles. A practical universal definition that is related to the normal mode of use would be welcomed, as in its view the EU definition is currently too broad. In 2015, it will be interesting to see what the Review concludes and as a consequence if any changes will be made.
As nanomaterials are chemical substances, the European Commission is pressing ahead to integrate their management under the existing horizontal REACH Regulation; the purpose of which is to ensure the safety of producers and users, as well as the environment, of chemical substances on the European market.
Stakeholders recognise and accept that some adjustments will be needed, yet how does the Commission do this. In line with the conclusion of the REACH Review, amendments to the REACH Annexes are currently under discussion. Industry believes the implementation of a concern-driven integrated approach would be the most effective whereby a substance is first checked to see it meets the nanomaterial definition and if so, whether the physicochemical properties together with information on use and exposure give any cause for potential concern. Identified nanomaterials with a potential concern would then be required to undergo further tiered and targeted testing. A legislative proposal for amending the REACH Annexes is expected later in 2014.
Some stakeholders call for more transparency on the use of nanomaterials through the development of national registers/inventories and more recently the idea of an EU inventory is being explored. Industry fully supports openness and transparency, believing that an ‘Observatory’ approach to be the most beneficial way forward to bringing reassurance to all stakeholders. This would be achieved by expanding the existing European Commission’s Joint Research Centre web platform on nanomaterials to include information in the public domain for notifications of nanomaterials to all current regulatory schemes. It would include information on nanomaterials used in food, cosmetics, medical devices, biocidal products as well as substances submitted under REACH and CLP (Classification, Labelling and Packaging). Industry believes that with this in place, there would be no need for establishing a separate EU register, or national inventories, on top of existing regulatory requirements. It is likely that the debate on how to manage the information on nanomaterials will continue for some time.
Whatever the outcome of the discussions, future regulatory decisions need to be pragmatic and not only protect human health and the environment, but also allow competitiveness and innovation in the UK and Europe to not be hampered. This can be achieved and achieving it will enable society to enjoy current and future benefits from these novel materials called nanomaterials; these may very well underpin the next generation of things we take today for granted such as cars, aeroplanes, communication devices, water treatment, energy production, medical provision and food preservation.