The European Food Safety Authority has today published a guidance document for the risk assessment of engineered nanomaterial (ENM) applications in food and feed. The guidance is the work of the Authority’s Scientific Committee and is the first of its kind to give practical guidance for addressing potential risks arising from applications of nanoscience and nanotechnologies in the food and feed chain. The guidance covers risk assessments for food and feed applications including food additives, enzymes, flavourings, food contact materials, novel foods, feed additives and pesticides.
The EFSA guidance, prepared in response to a request from the European Commission, sets out the considerations for risk assessment of ENM that may arise from their specific characteristics and properties. Importantly, the ENM guidance complements existing guidance documents for substances and products submitted for risk assessment in view of their possible authorisation in food and feed. It stipulates the additional data needed for the physical and chemical characterisation of ENM in comparison with conventional applications and outlines different toxicity testing approaches to be followed by applicants.
Commenting on the publication of the EFSA guidance, Professor Vittorio Silano, Chair of EFSA’s Scientific Committee explained, “A thorough characterisation of the engineered nanomaterials followed by adequate toxicity testing is essential for the risk assessment of these applications. Yet we recognise uncertainties related to the suitability of certain existing test methodologies and the availability of data for ENM applications in food and feed. The guidance makes recommendations about how risk assessments should reflect these uncertainties for food and feed applications.”
To assist with the practical use of the guidance, six scenarios are presented which outline different toxicity testing approaches. For each scenario, the guidance indicates the type of testing required.
EFSA conducted a public consultation on its preparatory work, acknowledging the importance of developing risk assessment methodologies in this field to support innovation whilst ensuring the safety of food and feed. In total 256 comments were received from 36 organisations spanning from academia, NGOs, industry to Member State and international authorities. All of these contributions were considered and incorporated into the guidance document where appropriate.
Risk assessment of engineered nanomaterials is under fast development and consequently, in keeping with EFSA’s commitment to review its guidance for risk assessment on an ongoing basis, this work will be revised as appropriate.
- Guidance on the risk assessment of the application of nanoscience and nanotechnologies in the food and feed chain
- Outcome of the public consultation on the draft scientific opinion on Guidance on risk assessment concerning potential risks arising from applications of nanoscience and nanotechnologies to food and feed