Nanoparticulate materials and regulatory policy in Europe: An analysis of stakeholder perspectives

Abstract

The novel properties of nanoparticulate materials (NPM) and the rapid development of NPM based products have raised many unanswered questions and concerns by different stakeholders over its consequences for the environment and human health. These concerns have led to an increasing discussion in both the US and Europe about possible regulatory policies for NPM. In this article a comparative study of stakeholdersÕ perceptions on regulatory policy issues with NPM in Europe is presented. It was found that industry wants to regulate this area if the scientific evidence demonstrates that NPM are harmful, but also that the regulatory bodies do not find it necessary at this point of time to regulate until scientific evidence demonstrates that NPM are harmful. This research therefore shows that there will most likely not be any regulatory interventions until there is an established and convincing scientific knowledge base demonstrating that NPM can be hazardous. It is furthermore discussed in this article the different roles and responsibilities of the stakeholders in financing the research required to establish the necessary level of fundamental scientific evidence. It was also found that the activity of the regulatory bodies on this issue differ between the European countries.

Expert perspectives on potential environmental risks from nanomedicines and adequacy of the current guideline on environmental risk assessment

“…Beaudrie et al 52 in their survey of 254 US-based scientists, decisionmakers, and environmental health and safety (EHS) scientists reported that regulatory scientists did not consider themselves fully prepared to manage risks from nanotechnology applications whereas scientists and EHS experts perceived regulators to be more prepared (than the regulators' self-assessment) for managing risks from nanotechnologies. A similar uncertainty on the part of the regulators was reported in their survey of experts from both the US and Canada, 53 and also by Helland et al, 58 who gathered perceptions of experts from academic, health and safety agency and industry. Another interesting outcome observed from the interviews across the spectrum of expertise was that the questions from one area could promote discussion or even follow-up questions to colleagues from different disciplines.…”

“…For example, the findings are related to outcomes from quantitative studies on expert judgements on risks from chemicals, [45][46][47][48][49] expert perception on nanomaterial regulations, risks, and benefits, [50][51][52][53][54][55] and surveys related to perceptions of risks related to nanomaterials and nanotechnology by industry and other stakeholders. [56][57][58] Given our objectives, a purely qualitative research design was deemed most appropriate for our study, and the findings presented here reflects this approach. Generally, qualitative inquiries are an entry when a field is emerging and little research has been done and there are very few hypothesis to enable influence research policies.…”

Behavior of Ag nanoparticles in soil: Effects of particle surface coating, aging and sewage sludge amendment

“…The growth of nanotechnology has raised public concern about potential environmental and human health effects of manufactured nanoparticles (MNPs) released to the environment (Helland et al, 2006;Wiesner et al, 2006). Production of consumer products containing MNPs continues to increase despite the lack of sufficient knowledge concerning how they may affect the environment (Luoma, 2008;Project on Emerging Nanotechnologies, 2008).…”

The survey on use of photo-catalytic nanoparticles in Korea

“…The toxicity of TiO 2 nanoparticles has been increasingly reported that the cytotoxicity and genotoxicity in various lines of cultured cells as well as acute toxicity in mice [14][15][16][17][18] . As a result, the discussion about potential risks of nanoparticles has a high priority in governments and the public [19][20][21] .…”