The European Food Safety Authority published two guidance documents, one on technical requirements for regulated food and feed product applications to establish the presence of small particles including nanoparticles and another on risk assessment of nanomaterials to be applied in the food and feed chain for human and animal health.
In the first document, EFSA, following a mandate from the Commission, sets out criteria for assessments, as well as information requirements for applications in the regulated food and feed product areas (e.g. novel food, food/feed additives, food contact materials (FCM) and pesticides. The guidance outlines appraisal criteria that applicants may follow to confirm that a fraction of small particles is either not present or covered by the conventional risk assessment, or to assess whether conventional risk assessment should be complemented with nano-specific considerations. These considerations refer to three aspects: (1) solubility and dissolution rate as the main properties to assess whether consumers will be exposed to particles; (2) information requirements for assessing whether the conventional material contains a fraction or consists of small particles, and its characterisation; and (3) the information to be presented for existing safety studies to demonstrate that the fraction of small particles has been properly evaluated.
The second document updates a previous guidance and, together with the first one, elaborates on physico-chemical characterisation, as well as methods and techniques that can be used for the characterisation of nanomaterials and their determination in complex matrices.
~sThe National Law Review, 10 September 2021