Regulatory safety assessment of nanoparticles for the food chain in Europe

Schoonjans, Reinhilde; Castenmiller, Jacqueline; Chaudhry, Qasim; Cubadda, Francesco; Daskaleros, Takis; Franz, Roland; Gott, David Michael; Mast, Jan; Mortensen, Alicja; Oomen, Agnes G.; Rauscher, Hubert; Weigel, Stefan; Astuto, Maria Chiara; Cattaneo, Irene; Barthélémy, Eric; Rincón, Ana María; Tarazona, José V.

doi:10.1016/j.tifs.2023.01.017

Cited by 23 publications

(16 citation statements)

References 40 publications

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“…EFSA has recently drafted two guides on the risk assessment of nanomaterials that outline (i) the technical requirements for establishing the presence of small particles and (ii) the scientific risk assessment and the necessary testing for evaluating the safety to protect consumers [127,128]. The regulatory safety assessment of nanoparticles in foods has been recently discussed in depth by Schoonjans and co-workers [129].…”

Section: Nanoceutical Application In the Food Sector: Safety Issues A...mentioning

confidence: 99%

Combination of Nanodelivery Systems and Constituents Derived from Novel Foods: A Comprehensive Review

Truzzi,

Bertelli,

Bilia

et al. 2023

Pharmaceutics

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Novel Food is a new category of food, regulated by the European Union Directive No. 2015/2283. This latter norm defines a food as “Novel” if it was not used “for human consumption to a significant degree within the Union before the date of entry into force of that regulation, namely 15 May 1997”. Recently, Novel Foods have received increased interest from researchers worldwide. In this sense, the key areas of interest are the discovery of new benefits for human health and the exploitation of these novel sources of materials in new fields of application. An emerging area in the pharmaceutical and medicinal fields is nanotechnology, which deals with the development of new delivery systems at a nanometric scale. In this context, this review aims to summarize the recent advances on the design and characterization of nanodelivery systems based on materials belonging to the Novel Food list, as well as on nanoceutical products formulated for delivering compounds derived from Novel Foods. Additionally, the safety hazard of using nanoparticles in food products, i.e., food supplements, has been discussed in view of the current European regulation, which considers nanomaterials as Novel Foods.

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Section: Nanoceutical Application In the Food Sector: Safety Issues A...mentioning

confidence: 99%

Combination of Nanodelivery Systems and Constituents Derived from Novel Foods: A Comprehensive Review

Truzzi,

Bertelli,

Bilia

et al. 2023

Pharmaceutics

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“…Notably, certain studies have harnessed machine learning algorithms, such as artificial neural networks and support vector machines, to build more accurate and predictive Nano-QSAR models for nanomaterials in agriculture . Another area of active research in Nano-QSAR for agriculture is the development of high-throughput screening methods that can rapidly test large numbers of nanomaterials for their possible toxicity . This approach relies on the integration of experimental data with computational modeling to predict the toxicity of nanomaterials based on their physicochemical properties, thereby reducing the need for expensive and time-consuming in vitro and in vivo experiments. , Despite the benefits of Nano-QSAR discussed above, ethical and regulatory challenges persist in the use of nanomaterials in agriculture .…”

Section: Introductionmentioning

confidence: 99%

Harmonization Risks and Rewards: Nano-QSAR for Agricultural Nanomaterials

Singh,

Shelar,

Rai

et al. 2024

J. Agric. Food Chem.

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This comprehensive review explores the emerging landscape of Nano-QSAR (quantitative structure−activity relationship) for assessing the risk and potency of nanomaterials in agricultural settings. The paper begins with an introduction to Nano-QSAR, providing background and rationale, and explicitly states the hypotheses guiding the review. The study navigates through various dimensions of nanomaterial applications in agriculture, encompassing their diverse properties, types, and associated challenges. Delving into the principles of QSAR in nanotoxicology, this article elucidates its application in evaluating the safety of nanomaterials, while addressing the unique limitations posed by these materials. The narrative then transitions to the progression of Nano-QSAR in the context of agricultural nanomaterials, exemplified by insightful case studies that highlight both the strengths and the limitations inherent in this methodology. Emerging prospects and hurdles tied to Nano-QSAR in agriculture are rigorously examined, casting light on important pathways forward, existing constraints, and avenues for research enhancement. Culminating in a synthesis of key insights, the review underscores the significance of Nano-QSAR in shaping the future of nanoenabled agriculture. It provides strategic guidance to steer forthcoming research endeavors in this dynamic field.

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“…The opposite might happen if NC is used as the sole (or main component), e.g., in tablets. Insufficient information exists in this respect and consideration of worst-case scenarios in terms of particle agglomeration is warranted in risk assessment (EFSA Scientific Committee, 2021;Schoonjans et al, 2023).…”

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confidence: 99%

“…The absence of suitable dispersion protocols violates the basic principle that the test conditions must ensure worst case scenarios, which means exposure to the most dispersed form. This principle is embedded in regulatory data requirements for proper and fresh dispersion of the material before testing, as well as confirmation thereof (EFSA Scientific Committee, 2021;Schoonjans et al, 2023). The use of unrealistically high concentrations with no confirmation of cellular exposure, especially in case of negative results (i.e.…”

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confidence: 99%

“…no adverse effects detected), is a shortcoming due to the fact that the degree of NC agglomeration increases with increasing concentrations. A proper dispersion is difficult to attain and to keep stable at higher doses and extensive agglomeration generally translates into a decrease in cell uptake, for which size threshold exists (EFSA Scientific Committee, 2021;Schoonjans et al, 2023). This is why in vitro studies with exposure concentrations >100 μg/mL are considered inappropriate for hazard characterisation of inorganic nanomaterials, whereas for light (carbonaceous) materials such as NC even a lower threshold appears to be appropriate in order to expose cells to comparable particle number concentrations.…”

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confidence: 99%

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EFSA Project on the use of New Approach Methodologies (NAMs) for the hazard assessment of nanofibres. Lot 1, nanocellulose oral exposure: gastrointestinal digestion, nanofibres uptake and local effects

Vincentini,

Blier,

Bogni

et al. 2023

EFS3

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Nanocellulose (NC) is an emerging material in the food sector with several prospective application areas. Three main types of NC exist, i.e. bacterial NC (BNC), nanofibrillated cellulose (NFC), and cellulose nanocrystals (CNC). The biological sources and processing conditions affect several physicochemical parameters of NC. In the present project, a NAM‐based IATA for addressing data gaps in the assessment of potential hazards associated to NC oral exposure was considered. This IATA focused on three main pillars, i.e. (i) assessment of the uptake and potential crossing of the intestinal barrier by NC, (ii) assessment of local effects, including inflammation and genotoxicity, on the gastrointestinal epithelia, and (iii) assessment of any digestion or degradation of NC by the human microbiome. Eight NC samples belonging to the three NC types, plus a comparator in the micro‐range, were selected as study materials and submitted to a thorough physicochemical characterisation. A battery of in vitro tests was used to provide insight into NC hazard and mode of action according to a tiered approach, which lead to selection of three materials belonging to the three main NC types for in depth‐testing. Cell uptake of these materials was demonstrated, and such uptake was greater in a triculture model, which better simulates the barrier properties of the human intestinal epithelium, as compared to Caco‐2 monolayers. Uptake was the greatest in repeated exposure conditions, in which intestinal barrier crossing was demonstrated for CNC. Pro‐inflammatory responses accompanied by massive NC uptake in macrophages, indicative for potential immunotoxicological effects, and barrier function impairment were observed, whereas no indications for genotoxicity were obtained. Finally, no formation of smaller particles following colonic fermentation of NC was observed. For the integration of these results in regulatory hazard assessment of NC after oral exposure, prospective use of NC as novel food or as food additive was considered.

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Regulatory safety assessment of nanoparticles for the food chain in Europe

Cited by 23 publications

References 40 publications

Combination of Nanodelivery Systems and Constituents Derived from Novel Foods: A Comprehensive Review

Combination of Nanodelivery Systems and Constituents Derived from Novel Foods: A Comprehensive Review

Harmonization Risks and Rewards: Nano-QSAR for Agricultural Nanomaterials

EFSA Project on the use of New Approach Methodologies (NAMs) for the hazard assessment of nanofibres. Lot 1, nanocellulose oral exposure: gastrointestinal digestion, nanofibres uptake and local effects

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