The European Food Safety Authority (EFSA) published a ‘Draft Opinion of the Scientific Committee on the Potential Risks Arising from Nanoscience and Nanotechnologies on Food and Feed Safety’, which had been requested by the European Commission in June 2007; due to the multidisciplinary nature of the subject, EFSA subsequently assigned the task to the EFSA Scientific Committee.

• Formulation at the nanosize changes the physico-chemical characteristics of materials as compared to the dissolved and macroscale forms of the same substance. Their small size, high surface-to-mass ratio and surface reactivity are important properties, both for new applications and in terms of the associated potential health and environmental risks.
• […] Specific uncertainties apply to the difficulty to characterize, detect and measure ENM in food/feed and biological matrices and the limited information available in relation to aspects of toxicokinetics and toxicology.
• There is limited knowledge of (likely) exposure from possible applications and products in the food and feed area or of environmental impacts of such applications and products.
• The current usage levels of ENM in the food and feed area is unknown. […]
• Whilst recognising these limitations, the currently used risk assessment paradigm (hazard identification, hazard characterization, exposure assessment and risk characterization) is considered applicable for ENM.
• Risk assessment of ENM in the food and feed area should consider the specific properties of ENM in addition to those common to the equivalent non-nanoforms. […]
• Current toxicity testing approaches used for conventional materials are a suitable starting point for case-by-case risk assessment of ENMs.
• […] the adequacy of currently existing toxicological tests to detect all aspects of potential toxicity of ENM has yet to be established. […] There may also be additional toxic effects caused by ENM that are not readily detectable by current standard protocols. Additional endpoints not routinely addressed and pharmacological endpoints may need to be considered in addition to traditional endpoints.
• For hazard characterization, the relationship of any toxicity to the various dose metrics that may be used is currently discussed and several dose metrics may need to be explored in addition to mass.
• The different physicochemical properties of ENM compared to conventional dissolved and macroscale chemical counterparts imply that their toxicokinetic and toxicity profiles cannot be fully inferred by extrapolation from data on their equivalent non-nanoforms. Thus, the risk assessment of ENM has to be performed on a case-by-case basis. […]

• Monitor current and future commercial applications of ENM in the food and feed sectors and developments of nanotechnologies[…].

• Determine the effects of size of ENM on physicochemical properties, compared to those of the dissolved chemical or macroscale materials.
• Investigate the interaction and stability of ENM in the presence of components in food and feed matrices, in the GI tract and biological tissues.
• Develop and validate routine methods to detect, characterize and quantify ENM in FCM, food and feed matrices and in biological tissues.
• Generate information on the effects of processing on the characteristics of ENM.

• Generate information on the amount and form (dispersed or aggregated) of ENM content in food and feed, and the bioavailability of the nanoform following ingestion.
• Generate information on consumption of products containing ENM.
• Determine migration of different ENM from FCM into food and feed.

• Generate information on toxicokinetic properties of ENM after oral exposure. […]
• Generate information on the bioavailability from food and feed of a range of ENM […].
• Develop, improve and validate in silico, in vitro and in vivo (in particular oral) test methodologies to assess toxicity of ENM (including reliability and relevance of the test methods).
• Develop understanding of the toxicity (including chronic exposure and carcinogenicity) following oral intake […].
• Develop understanding on whether ENM interact with biomolecules (e.g. enzymes), nutrients and foreign compounds (“Trojan horse effect”), and the significance of such interactions for human and animal health.
• […] Oral toxicity studies materials with a fully characterised size range should be performed [on substances approved for use in food and feed (e.g., MnO, SiO2), which have been claimed to also be available in nanoscale dimensions].
• Generate information on the efficacy of applications which claim antimicrobial activity.