EU Report on NanoSafety – Risk governance of manufactured nano-particles
The EU Parliament’s Science and Technology Option’s Assessment unit (STOA) has published a new report on “NanoSafety – Risk governance of manufactured nano-particles” and is highlighting the difficulties in regulating nanotechnology. TextileFuture has in past reported repeatedly on the challenges and difficulties to define uniform regulatory rules for nano-technology, e.g. on December 5, 2011 “Nano-technology is not without risk”on TextileFuture’s website http://www.textile-future.com , make use of the search function!) The study was requested by MEP European Parliament member Malcolm Harbour in 2009 and was presented to MEP’s on July 10, 2012.
Nanotechnology deals with the manipulation of materials at molecular, atomic and macromolecular scale. Nano-particles are attractive because they exhibit new or improved properties which can have a variety of applications. Silver particles are used, for example for their antimicrobial applications in socks, bandages, bay-changing facilities and refrigerators. There exists an immense variety of products making use of engineered nano-particles (smaller than 100 nm) and among these we find paints, industrial lubricants, advanced tyres, cosmetics, sunscreens, coatings for beverage containers, printin inks and nano-medicines as well as a broad spectrum of functional textiles and clothing. Their use for the improvement of fuel cells and rechargeable batteries is also under investigation.
As we stated and reported before, the lack of adequate scientific definition for nano-material is non-existing. The EU Commission announced a year ago its Recommendation on the definition of nano-material, however only based on the size of particles and delivers the definition that nano-material means a natural, incidental or manufactured material containing particles where, for 50 % or mor of the particles, one or more external dimensions is in the range of 1 nm – 100 nm.
According to the newest EU study it is a confirmed fact that nano-scale implies not only new material properties, but entails novel environmental and health risks and the experts state that nano-particles have the potential to cause toxicological effects to individual cells. Further the difficulties in studying the toxicological effects because of the vast number of manufactured particulate nano materials and each size and form has to be studied individually.
The study proves that MPN’s can be removed by clearance mechanisms and the immune system, however, these mechanism are less effective with decreasing particle sizes. It these are deposited into a certain area of the lung they can accumulate, pass membrane barriers and even enter individual cells causing biological or toxicological effect.
Also the assessment of toxicity is limited by technology and therefore scientists do not yet know of the effects of nano-particle delivery from products during their life cycle. The report concludes that the risk assessment methodology is inadequate to support political decisions about the regulation of nano-materials. And therefore it is unclear what the STOA favours, either a precautionary approach, or an approach whereby nano-materials are earmarked to have proven negative effects. It is also not clear by which legal framework nano-materials should be regulated (existing legislation such as REACH or a completely new regulatory framework specific to nanomaterials, the later would have to be adopted. It seems that REACH might not be the firsthand choice because it was not designed for nano-materials.