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Posted: Jul 04, 2012

Paralysis by analysis - European Commission appears to be stuck in perpetual review mode on nanosilver

(Nanowerk Spotlight) A commentary by Steffen Foss Hansen and Anders Baun in this week's Nature Nanotechnology ("When enough is enough") pointedly asks "when will governments and regulatory agencies stop asking for more reports and reviews, and start taking regulatory action?"
Hansen and Baun, both from the Technical University of Denmark's Department of Environmental Engineering, take issue with yet another scientific opinion on nanosilver that has been requested by the European Commission in late 2011: "SCENIHR – Request for a scientific opinion on Nanosilver: safety, health and environmental effects and role in antimicrobial resistance" (pdf). Specifically, the EC wants SCENIHR to answer four questions under the general heading of ‘Nanosilver: safety, health and environmental effects, and role in antimicrobial resistance’.
"Most of these questions – and possibly all of them – have already been addressed by no less than 18 review articles in scientific journals, the oldest dating back to 2008, plus at least seven more reviews and reports commissioned and/or funded by governments and other organizations" Hansen tells Nanowerk. "Many of these reviews and reports go through the same literature, cover the same ground and identify many of the same data gaps and research needs."
Since many of the reviews on nanosilver that have been published since 2008 have already addressed the four questions on the environmental, health and safety aspects of nanosilver that the SCENIHR has been asked to review, the outcome is entirely predictable, say the two DTU scientists. They lists several of their "predictions" in their commentary.
For instance, Hansen and Baun predict that the SCENIHR's upcoming review will consist of five main sections summarizing: "the properties and uses of nanosilver; human and environmental toxicity; microbial resistance; risk assessment; and research needs."
"We also predict that the SCENIHR’s report will say something along the following lines: 'Nanosilver is reportedly one of the most widely used nanomaterials in consumer products today but the scale of production and use is unknown. The antibacterial properties of nanosilver are exploited in a very diverse set of products and applications including dietary supplements, personal care products, powdered colors, textile, paper, kitchenware and food storage'" they add.
And like many previous reviews and reports, the new report is likely to cite the all-time classic when it comes to mentioning nanotechnology consumer products: the Consumer Product Inventory compiled by the Project on Emerging Nanotechnologies, complete with its 21 different antibacterial socks, 30 pairs of stainless pants, and numerous facial creams.
Since the SCENIHR report is not due for at least another year (by August 2013) it appears unlikely that the European Commission will take any regulatory steps before then.
"Given the many high-profile reviews already available, we find it unlikely that the scientific committee will reach any significant new insights" says Hansen. "One wonders, therefore, why the European Commission has asked for yet another review on this topic. Although it may be common practice for regulators to ask for ‘their own review’ from a scientific advisory group, rather than acting on reviews published as scientific papers, it seems that many of these reviews have been commissioned by regulators with a purpose of delaying decisions on regulatory measures that should be implemented. It would not be the first time that regulators are ‘buying time’ before making difficult decisions that will be against the interests of certain stakeholders."
Although it won't be an easy task to regulate the use of nanosilver – given the sometimes opposing positions of various stakeholders (e.g. NGOs versus industry), the complex regulatory landscape in Europe, and the numerous actual and potential applications of nanosilver – some of the reviews already published offer plenty of recommendations on actions that could be taken.
Hansen and Baun cite one particular example in their commentary: "Back in 2008, for example, Luoma sketched out a multi-faceted strategy ("Silver Nanotechnologies and the Environment: Old Problems or New Challenges" (pdf)) that included: (1) the development of clear rules defining the ingredients of a product using the unique physical and chemical attributes of the ingredients to track production, use and environmental release/dispersal data; (2) the assessment of what information is needed to oversee safe use of nanosilver; (3) the evaluation of the relevance and shortcomings of current silver-relevant regulations."
They also cite recommendations made by DEFRA in the UK and the BfR in Germany. However, little progress has been made in implementing any of these recommendations.
"Given the extensive nature of existing literature, we do not see the need for further reviews" the two scientists conclude their commentary. "It is time for the European Commission to decide on the regulatory measures that are appropriate for nanosilver. These measures should then be implemented wholeheartedly and their effectiveness monitored."
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