EFSA’s OpenFoodTox: An open source toxicological database on chemicals in food and feed and its future developments

Dorne, Jean‐Lou; Richardson, Jane; Livaniou, A.; Carnesecchi, Edoardo; Ceriani, Lidia; Baldin, Rossella; Kovarich, Simona; Pavan, Manuela; Saouter, Erwan; Biganzoli, Fabrizio; Pasinato, Luca; Jeddi, Maryam Zare; Robinson, Tobin; Kass, George E.N.; Liem, A.K.D.; Toropov, Andrey A.; Toropova, Alla P.; Yang, Chihae; Tarkhov, Aleksey; Georgiadis, Nikolaos; Nicola, Matteo Riccardo Di; Mostrąg, Aleksandra; Verhagen, Hans; Roncaglioni, Alessandra; Benfenati, Emilio; Bassan, Arianna

doi:10.1016/j.envint.2020.106293

Cited by 43 publications

(33 citation statements)

References 27 publications

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“…For example, the food risk component database (FRCD) is a comprehensive open-source database that provides information about more than 10.000 substances obtained from more than 150.000 literature reports and several databases (Zhang et al 2020). Additionally, EFSA initialized the publicly available OpenFoodTox database on toxicological properties of substances in food and feed evaluated by EFSA (Dorne et al 2021). Since the obtained data are not exclusively relevant for food risk databases, toxicology studies frequently provide important additional information for databases in other research areas.…”

Section: Resultsmentioning

confidence: 99%

Alternative model organisms for toxicological fingerprinting of relevant parameters in food and nutrition

Sandner

König

Wallner

et al. 2021

Critical Reviews in Food Science and Nutrition

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In the field of (food) toxicology, there is a strong trend of replacing animal trials with alternative methods for the assessment of adverse health effects in humans. The replacement of animal trials is not only driven by ethical concerns but also by the number of potential testing substances (food additives, packaging material, contaminants, and toxicants), which is steadily increasing. In vitro 2D cell culture applications in combination with in silico modeling might provide an applicable first response. However, those systems lack accurate predictions of metabolic actions. Thus, alternative in vivo models could fill the gap between cell culture and animal trials. In this review, we highlight relevant studies in the field and spotlight the applicability of alternative models, including C. elegans, D. rerio, Drosophila, HET-CAM and Lab-on-a-chip.

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Section: Resultsmentioning

confidence: 99%

Alternative model organisms for toxicological fingerprinting of relevant parameters in food and nutrition

Sandner

König

Wallner

et al. 2021

Critical Reviews in Food Science and Nutrition

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“…Substances for which an FCM number has been allocated (according to the Union list of FCM substances in Table 1, Annex I of Regulation (EU) No 10/2011) were checked against the following sources of information, based on the packaging material reference number (Ref. No) and/or the FCM number or the CAS number: Synoptic Document (European Commission, 2005) reports and opinions from the SCF 20 EFSA’s OpenFoodTox 21 (Dorne et al, 2021 ). …”

Section: Data and Methodologiesmentioning

confidence: 99%

Identification and prioritisation for risk assessment of phthalates, structurally similar substances and replacement substances potentially used as plasticisers in materials and articles intended to come into contact with food

Lambré¹,

Baviera²,

Bolognesi³

et al. 2022

EFS2

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The EFSA Panel on Food Contact Materials, Enzymes and Processing Aids was requested by the European Commission to re‐evaluate the risks to public health related to the presence of plasticisers such as phthalates, structurally similar substances and replacement substances, as a consequence of migration from food contact materials (FCMs). As the first part of the two‐part mandate, EFSA was tasked with identifying and prioritising those plasticisers used in FCMs that may warrant further data collection and eventual risk assessment. Close collaboration with the European Chemicals Agency (ECHA) was requested in the mandate. Substances potentially used as plasticisers were identified using Annex II of the mandate, ECHA’s PLASI inventory, the Plastics Regulation and the Regenerated Cellulose Film Directive, the ECHA database, the ECHA grouping approach, and consultation with the Member States. Only substances authorised for FCMs at EU or at national level were prioritised. Five substances classified either as carcinogenic, mutagenic, toxic to reproduction Cat. 1 (under CLP) or as endocrine disruptors, persistent, bioaccumulative and toxic, very persistent/very bioaccumulative (under REACH) were placed into an ‘exclusion group’. Prioritisation was based on the date of the most recent risk assessment in the context of FCM, with substances assessed before 2001 being placed in the high‐priority group, substances assessed between 2001 and 2011 in the medium‐priority group and substances assessed after 2011 in the low‐priority group. For the EU stream, the 76 substances were split into 59 high‐, 14 medium‐ and 3 low‐priority substances. For the nationally authorised stream, the split of the 72 substances is 66, 3 and 3, respectively. The outcome of follow‐up calls for data in support of the exposure assessment will be used for a final ranking.

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“…It is foreseen that in the future in vitro comparative metabolism data for pesticide active substances will be included and can support inputs for modelling pesticide active substance kinetics using generic PBK models within the TK plate of EFSA. In silico models using OpenFoodTox have been developed for ecological risk assessment (bees and rainbow trout) and human risk assessment (rat toxicological data) (Dorne et al, 2021 ). These in silico models provide alternative means to animal experiments for the hazard identification and characterisation of chemicals, and are becoming of increasing interest in the risk assessment community to deliver the 3Rs (replacement, reduction, refinement) (particularly since the banning of animal testing for the approval of cosmetics as consumer products (Regulation (EC) No.…”

Section: Appendix F – Openfoodtoxmentioning

confidence: 99%

Scientific Opinion of the Scientific Panel on Plant Protection Products and their Residues (PPR Panel) on testing and interpretation of comparative in vitro metabolism studies

Hernández‐Jerez¹,

Adriaanse²,

Aldrich³

et al. 2021

EFS2

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EFSA asked the Panel on Plant Protection Products and their residues to deliver a Scientific Opinion on testing and interpretation of comparative in vitro metabolism studies for both new active substances and existing ones. The main aim of comparative in vitro metabolism studies of pesticide active substances is to evaluate whether all significant metabolites formed in the human in vitro test system, as a surrogate of the in vivo situation, are also present at comparable level in animal species tested in toxicological studies and, therefore, if their potential toxicity has been appropriately covered by animal studies. The studies may also help to decide which animal model, with regard to a particular compound, is the most relevant for humans. In the experimental strategy, primary hepatocytes in suspension or culture are recommended since hepatocytes are considered the most representative in vitro system for prediction of in vivo metabolites. The experimental design of 3 9 3 9 3 (concentrations, time points, technical replicates, on pooled hepatocytes) will maximise the chance to identify unique (UHM) and disproportionate (DHM) human metabolites. When DHM and UHM are being assessed, test item-related radioactivity recovery and metabolite profile are the most important parameters. Subsequently, structural characterisation of the assigned metabolites is performed with appropriate analytical techniques. In toxicological assessment of metabolites, the uncertainty factor approach is the first alternative to testing option, followed by new approach methodologies (QSAR, read-across, in vitro methods), and only if these fail, in vivo animal toxicity studies may be performed. Knowledge of in vitro metabolites in human and animal hepatocytes would enable toxicological evaluation of all metabolites of concern, and, furthermore, add useful pieces of information for detection and evaluation of metabolites in different matrices (crops, livestock, environment), improve biomonitoring efforts via better toxicokinetic understanding, and ultimately, develop regulatory schemes employing physiologically based or physiology-mimicking in silico and/or in vitro test systems to anticipate the exposure of humans to potentially hazardous substances in plant protection products.

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EFSA’s OpenFoodTox: An open source toxicological database on chemicals in food and feed and its future developments

Cited by 43 publications

References 27 publications

Alternative model organisms for toxicological fingerprinting of relevant parameters in food and nutrition

Alternative model organisms for toxicological fingerprinting of relevant parameters in food and nutrition

Identification and prioritisation for risk assessment of phthalates, structurally similar substances and replacement substances potentially used as plasticisers in materials and articles intended to come into contact with food

Scientific Opinion of the Scientific Panel on Plant Protection Products and their Residues (PPR Panel) on testing and interpretation of comparative in vitro metabolism studies

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