Workshop on risk assessment of nanomaterials and materials containing small/nanoparticles in the food and feed chain
Background
In August 2021, the EFSA Scientific Committee published two guidance documents:
- Guidance on Particle Technical Requirements for assessing small particles, including nanoparticles, in food and feed.
- Guidance on Nanomaterial Risk Assessment for human and animal health.
These documents aim to assess the health risks of nanomaterials and small/nano particles in the food and feed chain. Since publication, EFSA has worked to ensure their smooth and harmonised implementation across all relevant areas within its remit. Through stakeholder consultations and case evaluations, several recurring issues have been identified. Although EFSA has published additional clarifications, further action is needed to improve the guidance for both applicants and risk assessors.
As a result, EFSA initiated a new self-task mandate (M-2024-00062)[1]. to develop an updated guidance document for the risk assessment of nanomaterials and materials containing small/nano particles in the food and feed chain.
To enhance international cooperation and stakeholder interaction, a series of engagement activities are being planned. A stepwise approach is being implemented to ensure constructive dialogue and alignment of scientific requirements. The process began with an initial consultation to collect input on the mandate objectives and Terms of Reference. This informed the development of a scoping paper, which outlines the proposed strategy for updating the guidance. The paper includes a draft structure for the new consolidated guidance and highlights key content areas to be addressed in the revised document[2]. It was published for public consultation and discussed during a dedicated workshop.
Objectives of the meeting
The aim of the workshop was to gather inputs on the proposed approach for updating the EFSA Nano Guidance documents and to engage stakeholders and other regulatory agencies in discussing fundamental scientific aspects.
The event presented the proposed strategy to merge the two existing documents into a single, comprehensive guidance on risk assessment for nanomaterials and small/nanoparticles in the food and feed chain.
It provided an open platform for discussing key issues, exploring approaches to address them, and ensuring the revised guidance reflects the latest scientific developments. Stakeholders were encouraged to share their experiences and collaborate with regulators to help shape the updated guidance.
We are, in the meantime, drafting a more detailed event report, which will provide a comprehensive summary of the discussions, stakeholder input, and next steps.
Contact
Do not hesitate to contact the organising committee at events [at] efsa.europa.eu for more information.
Documents
- Agenda
- Scoping paper on the update of EFSA’s guidance on risk assessment of nanomaterials and materials containing small/nano particles in the food chain
- Guidance on Particle Technical Requirements for assessing small particles, including nanoparticles, in food and feed.
- Guidance on Nanomaterial Risk Assessment for human and animal health
Presentations
SESSION 1 Existing guidance, frameworks and relevant activities on nanotechnologies and nanoparticles risk assessment
- Chaudhry and Astuto_Update of EFSA guidance and activities
- Hubert Rauscher_Identifying nanomaterials and counting particles
- Emily Hams_Guideline on the safety of nanoparticles
- V.Unamuno Rodriguez_Nanomaterials under REACH_Regulatory Framework and Evaluation of Nanoforms
- Gonzalez_OECD work on nanomaterials
SESSION 2 Technical aspects of nanomaterials and small/nanoparticles risk assessment
- Marie Rouault_Nanoparticles risk assessment of novel foods
- Federico Benetti_ Approaches to identify small particles and nanomaterials
- Nolde-Drexel_ EFSA Dispersion Protocol for sample preparation_Industry learnings
- David Esdaile_Nanomaterial testing
- Blanco-Bose and Faigt_Toward Scientifically Grounded Criteria for Accepting Historical Toxicology
- Haase_Implementing NAMs in risk assessment for NMs