Stakeholder workshop on small particles and nanoparticles in food

Summary

An online workshop of two half-days was held to present to stakeholders and experts involved in the field of nanoscience and nanotechnologies the two recently published EFSA Nano Guidances, showing the information requirements for applicants that seek market approval or renewal of a product in the areas under EFSA’s remit.

As introduction, EFSA provided an overview of the available services and supporting tools for applicants that are preparing dossiers to be assessed by EFSA.

The first half-day was dedicated to the presentation of the “Guidance on technical requirements for regulated food and feed product applications to establish the presence of small particles including nanoparticles” for conventional materials (i.e. those that are not nanoengineered). This Guidance covers different appraisal routes that applicants and other interested parties may use for demonstrating that their material does not contain a fraction of nanoparticles or that the fraction is covered by existing safety studies. The members of the EFSA Working Group on Nanotechnologies (WG Nano) presented an insight on some examples related to key physico-chemical elements of the assessment, as solubility, dissolution rate, and particle size distribution and to specific elements and peculiarities of nanomaterial’s risk assessment.

The second half-day was dedicated to the update of the “Guidance on risk assessment of nanomaterials to be applied in the food and feed chain: human and animal health”. This second Guidance provides specific considerations for the assessment of engineered nanomaterials, nanostructured materials, nanocarriers, and conventional materials containing a fraction of nanoparticles requiring assessment at the nanoscale. The WG Nano gave presentations on examples related to the assessment of existing safety studies. An additional presentation regarding an ongoing case study on the use of New Approach Methodologies for the hazard assessment of nanofibers, using nanocellulose as model, was provided by the responsible of the project.

During both sessions, a number of Stakeholders gave presentations on their experience in the implementation of the Guidances, opening the floor to a fruitful discussion and sharing their views.

All participants had the opportunity of asking questions and clarifications on the implementation of the Guidances, sharing their experiences and challenges. Two Q&A dedicated sessions were organised each day, and EFSA has pledged to produce and publish a comprehensive document with responses to the more relevant generic questions.

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