On 19 June 2009, EPHA responded to the public consultation from DG SANCO on the risk assessment of nanomaterials. Please find the EPHA response below.
Adequate and effective regulation of nanomaterials and nanotechnology represents a current need for the health sector. Such regulation is vital to ensure that products containing manufactured nanoparticles are safe and beneficial to consumers and do not lead to new human health and environmental risks.
Inadequate funding and the lack of governmental emphasis on the potential human health risks associated with nanotechnology has led to a situation where, despite the lack of testing methods and technology to adequately assess the long-term health impact, there are hundreds of consumer products on the market that either contain nanomaterials or are made using nanotechnology . In light of the mounting evidence highlighting the potential for significant health risks, the European Commission should convene consultations among the relevant regulatory bodies to exchange data and establish an improved approach to assessing and preventing risks.
Such an approach would involve a broadening of the regulatory systems in order to address the specific characteristics of nanomaterials. New regulations are required to manage nanomaterials; a 2008 survey showed that industry was failing to undertake adequate risk assessments on a voluntary basis . The European Commission and its advisory committees, including the Scientific Committee on Emerging and Newly Identified Health Risks (SCENIHR) and the Scientific Committee on Consumer Products (SCCP), should endeavour to identify the key risks and address the issue of significant knowledge gaps. In its 2006 report , the EU Scientific Committee on Emerging and Newly Identified Health Risks (SCENIHR) recognised the systemic failure of existing chemicals regulatory frameworks to manage the risks of nanomaterials.
A strong precautionary approach to manage nanotechnology is recommendable:
Mandatory safety testing of nanomaterials prior to their inclusion in commercial products- these assessments should be carried out by independent scientific committees.
The EU should establish a mandatory reporting scheme to keep track of the introduction of manufactured nanomaterials into the marketplace. In addition, the EU should establish a public inventory of all current and forthcoming nanomaterials used in products on the market.
Requirements for product labels to indicate the presence of manufactured nanomaterials/particles- in particular those products with which consumers come in direct, close or regular contact such as food, medicines and cosmetics.
Agreement on definitions of nanomaterials and nanotechnologies- the lack of definitions leads to legal uncertainties and can delay the establishment of effective regulation.
Existing European legislation relevant to nanotechnologies should be adapted in order to safeguard public health and safety.
Public participation in decision-making regarding nanotechnology’s introduction and in determining priorities for public spending on nanotechnology research and development.
 "Principles for the Oversight of Nanotechnologies and Nanomaterials", NanoAction
 Siegrist M, Wiek A, Helland A, Kastenholz H (2007). “Risks and nanotechnology: the public is more concerned than experts and industry”. Nature 2:67
 SCENIHR (2006). “Scientific Committee on Emerging and Newly Identified Health Risks: The appropriateness of existing methodologies to assess the potential risks associated with engineered and adventitious products of nanotechnologies”, European Commission