The guidance document, prepared by the Scientific Committee in response to a request from the European Commission, outlines that in this evolving area of science, it remains essential to adequately characterise the ENM following classical risk assessment practices; hazard identification and hazard characterisation followed by exposure assessment and risk characterisation. The EFSA guidance sets out for applicants, the data needed to understand the specific properties of the ENM, allowing a risk assessment to be carried out.
The draft guidance also recognises several uncertainties related to test methodologies and the availability of data and makes recommendations about how risk assessments should reflect such uncertainties.
Commenting on the launch of the public consultation, Professor Vittorio Silano, Chair of EFSA's Scientific Committee explained: "Building on EFSA's previous scientific opinions in the area of nanotechnologies, we are now in the position to provide practical guidance on the risk assessment process. EFSA recognises the importance of developing risk assessment methodologies in this area of science, supporting innovation whilst ensuring the safety of food and feed. This is the first time that risk assessment guidance on nanotechnologies related to the food chain has been developed, making this public consultation very important to EFSA. We look forward to reviewing the contributions."
Comments on the draft opinion can be submitted until 25 February 2011. In addition to the public consultation, EFSA will meet with EU Member State representatives to discuss the draft guidance document.
The final guidance document will be adopted by EFSA's Scientific Committee, which will consider the comments received, following the public consultation.
For further information on the public consultation, click here.
