EFSA guidances on nanomaterials in food chain
On August 3rd, the EFSA published 2 guidances: one on the technical requirements to establish the presence of small particles in food products and another one on the risk assessments of nanomaterials in the food chain.
The guidance on technical requirements defines the criteria for assessing the presence of a fraction of small particles, and sets out information requirements for applications in the regulated food and feed product areas (e.g. novel food, food/feed additives, food contact materials and pesticides). It applies 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. It outlines appraisal criteria grouped in three sections, to confirm whether or not the conventional risk assessment should be complemented with nanospecific considerations:
- The first section addresses solubility and dissolution rate as key physicochemical properties to assess whether consumers will be exposed to particles.
- The second one establishes the information requirements for assessing whether the conventional material contains a fraction or consists of small particles, and its characterisation.
- 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, in order to guide the appraisal of existing safety studies, recommendations for closing the data gaps while minimizing the need for conducting new animal studies are provided.
The guidance on risk assessment measures the exposure to nanomaterials from food and hazard identification and characterization. It covers the application areas within EFSA’s remit, including novel foods, food contact materials, food/feed additives and pesticides. The updated guidance, now Scientific Committee Guidance on nano risk assessment (SC Guidance on Nano‐RA), has taken account of relevant scientific studies that provide insights to physico‐chemical properties, exposure assessment and hazard characterization of nanomaterials and areas of applicability.
The two guidance documents were finalized after a public consultation period from July 9th to September 9th, 2020. A report on the comments received and how the Working Group on Nanotechnologies addressed them was published together with the guidance documents.
To know more, read:
EFSA (August 3, 2021). “Guidance on technical requirements for regulated food and feed product applications to establish the presence of small particles including nanoparticles.” EFSA Journal.
EFSA (August 3, 2021). “Guidance on risk assessment of nanomaterials to be applied in the food and feed chain: human and animal health.” EFSA Journal.
EFSA (August 3, 2021). “Outcome of the public consultation on the draft Guidance on technical requirements for regulated food and feed product applications to establish the presence of small particles including nanoparticles.” EFSA Journal.