BSI would like to draw your attention to a recently published final opinion on nanosilver: safety, health and environmental effects and role in antimicrobial resistance. The European Commission’s non-food Scientific Committee on Emerging and Newly Identified Health Risks (SCENIHR) has produced the opinion on the safe use and health risks associated with the increasing use of nanosilver.
The committee assessed whether the use of nanosilver, in particular in medical care and in consumer products, could result in additional risks compared to more traditional uses of silver and whether the use of nanosilver to control bacterial growth could result in resistance of micro-organisms.
The final opinion has been published, following a public consultation that was open between 13th December 2013 and 2nd February 2014. The full details of the public consultation can be found on the European Commission website.
The opinion concludes:
“Regarding the hazard associated with the dissemination of the resistance mechanism following the use of silver nanoparticles, no studies are available at this moment, representing a serious gap of knowledge. Since other nanoparticles have been shown to substantially increase the horizontal gene transfer between bacteria – which is extremely relevant for developing resistance – the potential of silver nanoparticles to induce similar effects should be given particular attention. More data are needed to better understand bacterial response to ionic silver and silver nanoparticles exposure. Since the mechanisms resulting in silver nanoparticles resistance are not well understood, it is not possible to estimate at this time whether or not resistance of microorganisms will increase and spread in view of a more widespread use of silver nanoparticles in products.”
How will this influence the Medical Device Directives?
BSI will not be altering its technical reviews to the Medical Device Directives until there is further clarification on the use of nanosilver in medical devices.
Will this influence the use of ALL nanomaterial in Medical Devices?
The European Commission and the SCENIHR have launched a separate public consultation on the Preliminary Opinion ‘Guidance on the Determination of Potential Health Effects of Nanomaterials Used in Medical Devices’. You can comment on the consultation before the 3rd October 2014 on the European Commission website.
If you have further questions regarding the use of nanosilver or the wider discussion regarding nanomaterials, please contact your Scheme Manager directly.