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.
Day 1 - 31 March
Presentations Day 1
- Introduction to the Stakeholder Workshop 2022
- EFSA‘s catalogue of support initiatives
- Overview of the EFSA Guidance on Particle – Technical Requirements
- Examples related to the assessment of solubility/dissolution and particle size distribution
- Examples related to other considerations
- Challenges faced by companies - Amazentis SA
- Physicochemical characterization of novel foods: the ECAMRICERT SRL testing lab facility experience
- Application of EFSA nano Guidance in the E171 opinion: a TDMA perspective
Day 2 - 1 April
Presentations Day 2
- Wrap up of Session 1 and introduction to Session 2
- Overview of the EFSA Guidance on Nano Risk Assessment
- Examples related to the assessment of existing safety studies
- EFSA Project on the use of New Approaches Methodologies (NAMs) for the hazard assessment of nanocellulose
- IHAT (Iron Hydroxyde Adipate Tartrate): the first EFSA approved Novel Food in nanoparticulate form
- ESEM-EDS-BASED Approach to assess nanoparticles for food safety and environmental control
- Take-home messages and closing remarks