The European Food Safety Authority published in August 2021 the “Guidance on technical require-ments for regulated food and feed product applications to establish the presence of small particles including nanoparticles” (Guidance on Particle – Technical Requirements (TR)) and an updated ver-sion of the “Guidance on risk assessment of nanomaterials to be applied in the food and feed chain: human and animal health” (Guidance on Nano – Risk Assessment (RA)).
These guidance documents update the information requirements for applicants that seek market approval or renewal of a product in the areas under EFSA’s remit, such as food/feed additives, food contact materials, novel foods, and pesticide active substances.
It should be noted that EFSA may receive two types of applications: 1) materials that meet the definition of engineered nanomaterials or nanoforms; 2) conventional materials that do not meet the definition of engineered nanomaterial or nanoforms but may contain small particles including particles at the nanoscale.
The new Guidance on Particle – Technical Requirements supports the applicant in demonstrating that the material does not contain a fraction of nanoparticles, or, if a fraction is detected, in decid-ing whether or not the material requires specific assessment of properties at the nanoscale. The guidance gives appraisal routes that confirm if a conventional risk assessment is sufficient or a nanospecific risk assessment should be performed according to the updated version of the Guid-ance on Nano-RA.
The workshop is aimed particularly at stakeholders and experts who are preparing dossiers on food/feed additives, food contact materials, novel foods and pesticides to be assessed by EFSA and regulatory risk assessors.
EFSA invites applicants, interested parties, laboratories conducting the studies, consultants, and other stakeholders to actively participate in the discussion, sharing their experiences and discuss-ing best practices for implementing the new requirements of the guidances in a cost-effective way.
An online workshop of two half-days where participants can raise specific issues, follow presentations, provide input related to generic issues or specific cases, and discuss with EFSA scientists their ex-periences, anticipated issues and possible concerns in implementing the guidance documents. Par-ticipants interested in presenting specific cases are encouraged to contact EFSA (see details below) to discuss the details.
The first half-day is dedicated to conventional materials (i.e. those that are not nanoengineered), and will cover the 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 frac-tion is covered by existing safety studies.
The second half-day is dedicated to the specific considerations for the assessment of engineered nanomaterials and conventional materials containing a fraction of nanoparticles requiring assess-ment at the nanoscale.
The event is intended for all applicants and interested parties submitting information to EFSA on chemical substances and other materials in the area of food and feed, as well as experts involved in the design and conduction of safety studies, and assessors.
The second half-day is especially relevant for stakeholders that are using nanoscience and nano-technologies, and those with expertise and interest in the area of nanospecific considerations for the risk assessment of applications in the food and feed chain.
The registration form is available here.
Please note that registration closes on 7 March (midnight).
After closure of registration, potential participants will be informed whether or not they have been se-lected for participation.
The meeting will take place online between 31 March 2022, from 09:00 to 13:00, and 1 April 2022, from 09:00 to 13:00. Further details on the logistics will be communicated to selected participants following the closure of registrations. The event will be conducted in English; no translation will be provided.
There is no participation fee involved.
Do not hesitate to contact Jose Tarazona (scientific issues) at [email protected] or Francesco Amoretti (organisational issues) at [email protected].