Europe unveils risk assessment guidance for engineered nanomaterials used in food chain.

E774 CMAJ, September 6, 2011, 183(12) © 2011 Canadian Medical Association or its licensors With food additives, flavourings, enzymes and other socalled “engineered nanomaterials” becoming altogether more common in products on market shelves, the Parma, Italy-based European Food Safety Authority has issued the world’s first guidance on determining the potential health risks they pose. The “Guidance on the risk assessment of the application of nanoscience and nanotechnologies in the food and feed chain,” prepared at the request of the European Commission, sketches the parameters for scientific risk assessments to be made of engineered nanomaterials, including their identification, chemical characterization and toxicity (www .efsa.europa.eu/en /efsa journal/doc /2140.pdf). The guidance includes recommendations regarding “the physico-chemical characterisation requirements of engineered nanomaterials used e.g. as food additives, enzymes, flavourings, food contact materials, novel foods, feed additives and pesticides and; testing approaches to identify and characterise hazards arising from the nanoproperties which, in general, should include information from in vitro genotoxicity, absorption, distribution, metabolism and excretion and repeated dose 90-day oral toxicity studies in rodents.” The guidance essentially proposes different levels of toxicity testing and reporting depending on the level of exposure to engineered nanomaterials. In cases where people will digest nanomaterials, it recommends that toxicity tests be done through both in-vitro and in-vivo experiments to determine the estimated safe level of human consumption. Experimental data show that engineered nanomaterials seem to accumulate mainly in the mononuclear phagocyte system tissues, particularly the spleen, liver and the gastrointestinal tract.