The European Commission (EC) has asked for this opinion as a first step because consideration needs to be given as to whether existing risk assessment approaches can be appropriately applied to this new technology. When finalised, EFSA’s opinion will then help the EC to explore appropriate measures, assess existing legislation and determine the scope of possible further requests for scientific opinions from EFSA in this field.

EFSA’s Scientific Committee (SC), which includes the chairs of all of EFSA’s Panels, is leading this work as it has a multi-disciplinary character and is relevant to a number of the Panels’ respective areas of expertise. They are being assisted by a Working Group of scientists with relevant expertise.

Key conclusions of the draft opinion include:

• Established international approaches to risk assessment[1] currently used for non nano chemicals can also be applied to ENM
• It is currently not possible to satisfactorily extrapolate scientific data on non nano chemicals and apply it to their nano-sized versions. Consequently specific case by case risk assessments should be performed when assessing their safety, based on specific data from relevant safety tests applicable to the particular application
• Possible risks arise because ENM have particular characteristics, due in part to their small size and high surface area. Small size increases their ability to move around in the body in ways that other substances do not, while their high surface area increases their reactivity
• Additional limitations and uncertainties exist, particularly in relation to characterising, detecting and measuring ENM in food, feed or the body. There is also limited information on absorption, distribution, metabolism and excretion, as well as the toxicity of ENM

Recommendations are made in the draft opinion for further data, research and investigations to address uncertainties and limitations and therefore strengthen the understanding, evidence base and methodologies to be applied in assessing the risk of ENMs. The opinion also gives an indication to potential applicants of the data they would need to provide to allow for a risk assessment.

Comments on the draft opinion can be submitted until 1st December 2008, via the EFSA website. EFSA will also meet with stakeholders to discuss the draft opinion and engage with EU Member States (MS) through its Advisory Forum.

The Working Group and the SC will consider comments and contributions made during the consultation. The final opinion will be adopted, considering the comments received, after the public consultation.

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