On March 31 and April 1, 2022, the European Food Safety Authority (EFSA) held an online stakeholder workshop on small particles and nanoparticles in food to present and discuss the “Guidance on technical requirements for regulated food and feed product applications to establish the presence of small particles including nanoparticles” published in August 2021, as well as the “Guidance on risk assessment of nanomaterials to be applied in the food and feed chain: human and animal health” updated at the same time (FPF reported).
The two 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.” The workshop aimed to clarify dossier requirements and provide an opportunity for the stakeholders preparing dossiers to ask EFSA questions directly. Between 200 and 300 participants attended the online workshop.
In their welcome speech, Jose Tarazona and Claudia Roncancio Peña from EFSA laid out that nanoparticles have been identified in various foods (FPF reported and here) and that the two complementary guidance documents seek to provide science-based protection. Sara De Berardis (EFSA) presented the agency’s catalog of support initiatives that can assist applicants. The catalog includes initiatives that are currently implemented by EFSA during the entire life cycle of applications for regulated products.
The rest of the first half-day was dedicated to the technical guidance on particles. This guidance applies to all conventional (not nanoengineered) chemical substances and materials requiring EFSA assessment, including previously assessed materials already on the market. Maria Chiara Astuto (EFSA) presented the different appraisal routes applicants can choose to demonstrate that their material is free of nanoparticles or that consumer safety is sufficiently covered by sectoral guidance. The appraisal routes and their objectives are (i) solubility and (ii) dissolution rate to demonstrate that consumers will not be exposed to small particles, (iii) screening and (iv) quantification of particle size to show the absence and quantity of small particles in properly dispersed samples, as well as (v) coverage by existing studies to demonstrate that the fraction of small particles is properly covered by existing safety studies. For substances in food contact materials (FCMs), a specific provision sets 60 mg/L as a generic upper migration limit, thus, if exceeding that limit, the material does not comply with legislation irrelevant of whether the substance is in its solubilized or particle form.
If the outcome of the assessment indicates that the material has any properties at the nanoscale (e.g., large specific surface area), applicants must follow the nano-specific risk assessment guidance, which was the focus of the second day. The guidance is applicable to engineered nanomaterials, nanoforms, conventional materials with a fraction of nanoparticles, nanostructured materials, and nanocarriers. Irene Carraneo from EFSA first clarified that the updated guidance maintained its original focus but was refined by recent scientific knowledge and through the experiences gained with actual cases.
Subsequently, Carraneo explained the tiered steps to go through the guidance. She especially focused on the identification of materials and their physicochemical characterization, in vitro and in vivo testing, oral exposure assessment, as well as hazard identification and characterization. A specific consideration for FCMs in oral exposure assessments is to measure transfer by migration or physical release. EFSA emphasized that applicants can and should use already available studies and complement them when needed. OECD test guidelines and other testing protocols would require specific adaptions to cover nanomaterials. Furthermore, Carraneo highlighted that engineered nanomaterials and nanoforms make extensive physicochemical characterization necessary and that their level of dispersion and agglomeration should be considered in the design and reporting.
Throughout the workshop, Tarazona and others from EFSA highlighted that science and consumer protection comes above all. On both days, stakeholders presented examples of the practical applicability of the two guidance documents as well as shared applied methods, challenges, and best practices. On the first day, it was also outlined why and which specific considerations apply for nanomaterial risk assessment since a chemical in nanoparticle form has not only a chemical nature (e.g., functional groups, solubility) but also a particle nature (e.g., particle size, surface characteristics, solubility/dissolution rate, dustiness) and kinetic/functionals aspects (e.g., potential to cross membrane barriers) that need to be considered. Moreover, it was clarified that nanomaterials may also be composed of organic substances (besiedes inorganic ones), such as vitamins, antioxidants, nutraceuticals, and certain food supplements, but even with a natural origin a nanomaterial cannot automatically be claimed to be “safe.”
On the second day, Francesco Cubadda, coordinator of EFSA‘s NANOCELLUP project, presented how they design and conduct new approaches methodologies (NAMs)-based studies to address current data gaps on the hazards of nanocellulose. Nanocellulose is an emerging material in the food sector used in food packaging or incorporated into food as a thickener, binder, or texture modifier, but its hazards upon ingestion are insufficiently characterized. The project’s results are expected to be available in 2023 and will be openly accessible.
Furthermore, all workshop participants were given the opportunity to ask questions, and EFSA announced it would prepare and publish a publicly available FAQ document as a follow-up.
References
EFSA Scientific Committee (August 2021). “Guidance on technical requirements for regulated food and feed product applications to establish the presence of small particles including nanoparticles.” EFSA Journal. DOI: 10.2903/j.efsa.2021.6769
EFSA Scientific Committee (August 2021). “Guidance on risk assessment of nanomaterials to be applied in the food and feed chain: human and animal health.” EFSA Journal. DOI: 10.2903/j.efsa.2021.6768
EFSA (March 2021). “EFSA’s Catalogue of support initiatives during the life‐cycle of applications for regulated products (update 2021).” EFSA Journal. DOI: 10.2903/sp.efsa.2021.EN-6472
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EFSA (March 31 and April 1, 2022). “Stakeholder workshop on small particles and nanoparticles in food.”
