Guidance on risk assessment of nanomaterials to be applied in the food and feed chain: human and animal health
Simon J. More, Vasileios Bampidis, Diane Benford, Claude Bragard, Þórhallur I. Halldórsson, Antonio F. Hernández, Susanne Hougaard Bennekou, Kostas Koutsoumanis, Claude Lambré, Kyriaki Machera, Hanspeter Naegeli, Søren Saxmose Nielsen, Josef Schlatter, Dieter Schrenk, Vittorio Silano, Dominique Turck, Maged Younes, Jacqueline Castenmiller, Qasim Chaudhry, Francesco Cubadda, Roland Franz, David Michael Gott, Jan Mast, Alicja Mortensen, Agnes G. Oomen, Stefan Weigel, Eric Barthélemy, Ana María Rincón, José Tarazona, Reinhilde Schoonjans
Abstract
degradation, toxicokinetics, genotoxicity, local and systemic toxicity as well as general issues relating to testing of nanomaterials are described. Depending on the initial tier results, additional studies may be needed to investigate reproductive and developmental toxicity, chronic toxicity and carcinogenicity, immunotoxicity and allergenicity, neurotoxicity, effects on gut microbiome and endocrine activity. The possible use of read-across to fill data gaps as well as the potential use of integrated testing strategies and the knowledge of modes or mechanisms of action are also discussed. The Guidance proposes approaches to risk characterisation and uncertainty analysis.