EFSA Consults on Draft Guidance on Technical Requirements for Regulated Food and Feed Product Applications to Establish the Presence of Small Particles, Including Nanoparticles

The European Food Safety Authority (EFSA) has begun a public consultation on a draft document entitled “EFSA Guidance on Technical Requirements for Regulated Food and Feed Product Applications to Establish the Presence of Small Particles Including Nanoparticles.”  The draft Guidance sets out information requirements for applications in the regulated food and feed product areas and establishes criteria for assessing the presence of a fraction of small particles.  EFSA states that these requirements apply to particles requiring specific assessment at the nanoscale in conventional materials that do not meet the definition of engineered nanomaterial as set out in the Novel Food Regulation (EU) 2015/2283.  The draft Guidance outlines appraisal criteria, grouped in three sections, to confirm whether the conventional risk assessment should be complemented with nanospecific considerations.  The first group addresses solubility and dissolution rate as key physicochemical properties to assess whether consumers will be exposed to particles.  The second group establishes the information requirements for assessing whether the conventional material contains a fraction or consists of small particles, and its characterization.  The third group describes the information to be presented for existing safety studies to demonstrate that the fraction of small particles, including particles at the nanoscale, has been properly evaluated.  In addition, to guide the appraisal of existing safety studies, the draft Guidance provides recommendations for fulfilling the data gaps while minimizing the need for conducting new animal studies.  EFSA states that the draft Guidance complements the “Guidance on Nanoscience and Nanotechnology” adopted by the EFSA Scientific Committee in 2018.  It advises applicants to consult both guidance documents before conducting new studies.  Comments are due September 9, 2020.