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Description
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New Approach Methodologies (NAMs) show great potential in advancing risk assessment (RA). However, their regulatory implementation is still limited. The EFSA Guidance on RA of nanomaterials promotes nano-specific RA through Integrated Approaches to Testing and Assessment (IATA) with NAMs, as the first choice to generate new information. Integrating NAMs in RA promises several advantages such as a better human focus, a stronger emphasis on molecular mechanisms and a higher efficacy. Applying NAMs to nanomaterials (NMs) offers further advantages (e.g. uptake/barrier crossing studies are technically easier to be run in vitro) but also poses considerable challenges such as issues related to dispersion and dosimetry. Within the EFSA-funded project NAMs4NANO we have conducted a review of NAMs which are potentially useful for application in RA of NMs in the food and feed sector. Furthermore, we proposed a generic framework for a NAMs qualification system (QS), based on existing prototypes developed by FDA (2020) and EMA (2008) in the pharmaceutical domain. However, the proposed QS is distinct from the existing systems as it is specifically designed to evaluate NAMs that can be applied for RA in the food and feed sector, in alignment with the existing EFSA guidance documents. The QS can be regarded as a practical tool allowing regulators to a) evaluate NAMs regarding adequacy for a specific context-of-use, b) support the optimisation of submitted NAMs and c) ultimately facilitate their regulatory implementation for chemical RA in the food and feed sector as well as facilitate validation at e.g. OECD level via the gained experience in optimisation. Herein, NM RA is the initial application area of the QS.In the present, provisional proposal of the QS, the NAMs are assessed through method readiness criteria structured into three overarching sections, namely i) detailed test method description covering three pillars (i.e. set-up of the NAM, its application and evaluation phase), ii) relevance and iii) reliability in the context of the regulatory application.Based on the EFSA Guidance on Nano-RA, the qualification programme will initially be applied on “NAMs for nano”, covering NAMs for a) NM physicochemical characterisation; b) in chemico characterisation of NM in relevant biological fluids (e.g., to assess solubility, dissolution/degradation rate, other relevant particle transformations that have an impact on the assessments); c) toxicity screening (specifically involving intestinal uptake/crossing, genotoxicity, cytotoxicity, reactivity/ oxidative stress, (pro-)inflammatory responses and barrier impairment). Currently, the QS is being tested on selected NAMs as applied in relevant case studies.This research is performed via EU funding through a grant of the European Food Safety Authority (GP/EFSA/MESE/2022/01). This communication reflects only the author's view and EFSA is not responsible for any use that may be made of the information it contains. (2025-01-01)
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