Microplastics: State of the Evidence on Health Effects and Public Perception.

Background: Microplastics, i.e., plastic particles ranging from 1 μm to 5 mm in size, are ubiquitous in the environment.

Assessment of genetically modified T25 maize for renewal authorisation under Regulation (EC) No 1829/2003 (dossier GMFF-2024-22651).

Following the submission of dossier GMFF-2024-22651 under Regulation (EC) No 1829/2003 from BASF Agricultural Solutions Seed US LLC, the Panel on genetically modified organisms of the European Food Safety Authority was asked to deliver a scientific risk assessment on the data submitted in the context of the renewal of authorisation application for the herbicide-tolerant genetically modified maize T25, for food and feed uses, excluding cultivation within the European Union. The data received in the context of this renewal application contained post-market environmental monitoring reports, an evaluation of the literature retrieved by a scoping review, a search for additional studies performed by or on behalf of the applicant and updated bioinformatics analyses. The GMO Panel assessed these data for possible new hazards, modified exposure or new scientific uncertainties identified during the authorisation period and not previously assessed in the context of the original application.

Assessment of genetically modified cotton GHB614 × LLCotton25 for renewal authorisation under regulation (EC) No 1829/2003 (dossier GMFF-2024-21890).

Following the submission of dossier GMFF-2024-21890 under Regulation (EC) No 1829/2003 from BASF Agricultural Solutions Seeds US LLC, the Panel on Genetically Modified Organisms of the European Food Safety Authority was asked to deliver a scientific risk assessment on the data submitted in the context of the renewal of authorisation application for the herbicide-tolerant genetically modified cotton GHB614 × LLCotton25, for food and feed uses, excluding cultivation within the European Union. The data received in the context of this renewal application contained post-market environmental monitoring reports, an evaluation of the literature retrieved by a scoping review, a search for additional studies performed by or on behalf of the applicant and updated bioinformatics analyses. The GMO Panel assessed these data for possible new hazards, modified exposure or new scientific uncertainties identified during the authorisation period and not previously assessed in the context of the original application.

New developments in biotechnology applied to animals: An assessment of the adequacy and sufficiency of current EFSA guidance for animal risk assessment.

EFSA was requested by the European Commission to provide a scientific opinion on new developments in biotechnology, including new genomic techniques, as applied to animals for food, feed and other agricultural uses. A horizon-scanning exercise identified a variety of animals obtained with new genomic techniques, with the potential to reach the EU market in the short, medium and long term. No novel hazards have been identified that are linked to either the modification process or the newly introduced trait, when SDN-1, SDN-2 and comparable techniques (e.

Assessment of genetically modified cotton T304-40 for renewal authorisation under Regulation (EC) No 1829/2003 (dossier GMFF-2024-23010).

Following the submission of dossier GMFF-2024-23010 Regulation (EC) No 1829/2003 from BASF Agricultural Solutions Seed US LLC, the Panel on Genetically Modified Organisms of the European Food Safety Authority was asked to deliver a scientific risk assessment on the data submitted in the context of the renewal of authorisation application for the insect resistant and herbicide tolerant genetically modified cotton T304-40, for food and feed uses, excluding cultivation within the European Union. The data received in the context of this renewal application contained post-market environmental monitoring reports, an evaluation of the literature retrieved by a scoping review, a search for additional studies performed by or on behalf of the applicant and updated bioinformatics analyses. The GMO Panel assessed these data for possible new hazards, modified exposure or new scientific uncertainties identified during the authorisation period and not previously assessed in the context of the original application.

Discovery of PXR Antagonist MI891 and PXR Degrader MI1013 and Their Roles in Hepatic Gene Regulation.

The pregnane X receptor (PXR) is an important regulator of hepatic metabolism, yet mechanistic insights into the effects of pharmacological inhibition using PXR inverse agonists or antagonists on critical genes involved in both xenobiotic and endobiotic metabolism remain limited. Here, we discovered a novel PXR inverse agonist/antagonist, MI891, which binds to the ligand-binding domain of PXR. Furthermore, we computationally designed and synthesized the proteolysis-targeting chimera molecule, MI1013, based on the PXR antagonist SPA70, which degrades PXR in HepaRG hepatic cells.

Assessment of genetically modified soybean DBN9004 (application EFSA-GMO-BE-2019-165).

Genetically modified soybean DBN9004 was developed to confer tolerance to glufosinate-ammonium- and glyphosate-containing herbicides. These properties were achieved by introducing the and expression cassettes. The molecular characterisation data and bioinformatic analyses do not identify issues requiring food/feed safety assessment.

Assessment of genetically modified maize NK603 for renewal authorisation under Regulation (EC) No 1829/2003 (dossier GMFF-2023-21250).

Following the submission of dossier GMFF-2023-21250 under Regulation (EC) No 1829/2003 from Bayer CropScience LP, the Panel on Genetically Modified Organisms of the European Food Safety Authority was asked to deliver a scientific risk assessment on the data submitted in the context of the renewal of authorisation application for the herbicide-tolerant genetically modified maize NK603, for food and feed uses, excluding cultivation within the European Union. The data received in the context of this renewal application contained post-market environmental monitoring reports, an evaluation of the literature retrieved by a scoping review, a search for additional studies performed by or on behalf of the applicant and updated bioinformatics analyses. The GMO Panel assessed these data for possible new hazards, modified exposure or new scientific uncertainties identified during the authorisation period and not previously assessed in the context of the original application.

Assessment of genetically modified cotton MON 88913 for renewal authorisation under Regulation (EC) No 1829/2003 (dossier GMFF-2023-21234).

Following the submission of dossier GMFF-2023-21234 under Regulation (EC) No 1829/2003 from Bayer CropScience LP, the Panel on genetically modified organisms of the European Food Safety Authority was asked to deliver a scientific risk assessment on the data submitted in the context of the renewal of authorisation application for the herbicide-tolerant genetically modified cotton MON 88913, for food and feed uses, excluding cultivation within the European Union. The data received in the context of this renewal application contained post-market environmental monitoring reports, an evaluation of the literature retrieved by a scoping review, a search for additional studies performed by or on behalf of the applicant and updated bioinformatics analyses. The GMO Panel assessed these data for possible new hazards, modified exposure or new scientific uncertainties identified during the authorisation period and not previously assessed in the context of the original application.

Assessment of genetically modified maize MON 87427 for renewal authorisation under Regulation (EC) No 1829/2003 (dossier GMFF-2023-21254).

Following the submission of dossier GMFF-2023-21254 under Regulation (EC) No 1829/2003 from Bayer CropScience LP, the Panel on Genetically Modified Organisms of the European Food Safety Authority was asked to deliver a scientific risk assessment on the data submitted in the context of the renewal of authorisation application for the of tissue-selective herbicide-tolerant genetically modified maize MON 87427, for food and feed uses, excluding cultivation within the European Union. The data received in the context of this renewal application contained post-market environmental monitoring reports, an evaluation of the literature retrieved by a scoping review, a search for additional studies performed by or on behalf of the applicant and updated bioinformatics analyses. The GMO Panel assessed these data for possible new hazards, modified exposure or new scientific uncertainties identified during the authorisation period and not previously assessed in the context of the original application.

Assessment of genetically modified soybean MON 87708 for renewal authorisation under Regulation (EC) No 1829/2003 (dossier GMFF-2023-21237).

Following the submission of dossier GMFF-2023-21237 under Regulation (EC) No 1829/2003 from Bayer CropScience LP, the Panel on Genetically Modified Organisms of the European Food Safety Authority was asked to deliver a scientific risk assessment on the data submitted in the context of the renewal of authorisation application for the herbicide tolerant genetically modified soybean MON 87708, for food and feed uses, excluding cultivation within the European Union. The data received in the context of this renewal application contained post-market environmental monitoring reports, an evaluation of the literature retrieved by a scoping review, a search for additional studies performed by or on behalf of the applicant and updated bioinformatics analyses. The GMO Panel assessed these data for possible new hazards, modified exposure or new scientific uncertainties identified during the authorisation period and not previously assessed in the context of the original application.

Assessment of genetically modified oilseed rape MON 88302 for renewal authorisation under Regulation (EC) No 1829/2003 (dossier GMFF-2023-21220).

Following the submission of dossier GMFF-2023-21220 under Regulation (EC) No 1829/2003 from Bayer CropScience LP, the Panel on Genetically Modified Organisms of the European Food Safety Authority was asked to deliver a scientific risk assessment on the data submitted in the context of the renewal of authorisation application for the herbicide-tolerant genetically modified oilseed rape MON 88302, for food and feed uses, excluding cultivation within the European Union. The data received in the context of this renewal application contained post-market environmental monitoring reports, an evaluation of the literature retrieved by a scoping review, a search for additional studies performed by or on behalf of the applicant and updated bioinformatics analyses. The GMO Panel assessed these data for possible new hazards, modified exposure or new scientific uncertainties identified during the authorisation period and not previously assessed in the context of the original application.

Assessment of genetically modified sugar beet KWS20-1 (application GMFF-2023-14732).

Genetically modified sugar beet KWS20-1 was developed to confer tolerance to glyphosate-, dicamba- and glufosinate-ammonium-based herbicides. These properties were achieved by introducing the , and expression cassettes. The molecular characterisation data and bioinformatic analyses do not identify issues requiring further safety assessment.

Towards understanding particle-protein complexes: Physicochemical, structural, and cellbiological characterization of β-lactoglobulin interactions with silica, polylactic acid, and polyethylene terephthalate nanoparticles.

Nanoplastic particles and their additives are increasingly present in the food chain, interacting with biomacromolecules with not yet known consequences. A protein corona forms around the particles in these usually complex matrices, primarily with a first contact at surface-active proteins. However, systematic studies on the interactions between the particles and proteins -especially regarding protein affinity and structural changes due to surface properties like polarity - are limited.

Hazard characterization of the mycotoxins enniatins and beauvericin to identify data gaps and improve risk assessment for human health.

Enniatins (ENNs) and beauvericin (BEA) are cyclic hexadepsipeptide fungal metabolites which have demonstrated antibiotic, antimycotic, and insecticidal activities. The substantial toxic potentials of these mycotoxins are associated with their ionophoric molecular properties and relatively high lipophilicities. ENNs occur extensively in grain and grain-derived products and are considered a food safety issue by the European Food Safety Authority (EFSA).

Molecular heaters: a green route to boosting crop yields?

Food production and food security are fast becoming some of the most pressing issues of the 21st century. We are developing environmentally responsible molecular heaters to help boost crop growth and expand geographic areas capable of supporting growth. Sinapic diacid (SDA) is such a molecule, that can act as a light-to-heat agent, converting solar energy into heat delivered to the plant.

Risk assessment considerations for RNAi-based genetically modified plants.

The risk assessment (RA) requirements for genetically modified plants (GMPs) are defined in Regulation (EU) No 503/2013 and the EFSA guidance on the RA of food and feed from GM plants (EFSA GMO Panel, 2011). When a GMP is developed to silence transcripts by RNA interference (RNAi), some specific additional analysis needs to be provided by the applicant. This guidance describes the requirements and recommendations for the GMP applications submitted to EFSA.

Assessment of genetically modified maize DAS1131 (application GMFF-2021-1530).

Genetically modified maize DAS1131 was developed to confer resistance to certain susceptible lepidopteran pests, as well as tolerance to glyphosate herbicide, these properties were achieved by introducing the and expression cassettes. The molecular characterisation data and bioinformatic analyses do not identify issues requiring food/feed safety assessment. None of the identified differences in the agronomic/phenotypic and compositional characteristics tested between maize DAS1131 and its conventional counterpart needs further assessment, except for crude fat in grain which does not raise safety and nutritional concerns.

NAM-based analysis of contaminant short-term organ toxicity in HepaRG and RPTEC/TERT1 cells.

New Approach Methodologies (NAMs), including cell culture and multi-level omics analyses, are promising alternatives to animal testing. To become useable for risk assessment purposes, they have to be applicable for different substance groups. One important group of substances is food contaminants, including synthetic chemicals, such as perfluorooctanesulfonic acid (PFOS) and perfluorooctanoic acid (PFOA), and natural compounds, such as mycotoxins and pyrrolizidine alkaloids.

Improved identification of human hepatotoxic potential by summary variables of gene expression.

Prediction of hepatotoxicity in humans remains an unresolved challenge. Recently, an in vitro/in silico method was established to predict blood concentrations of test compounds with an increased risk of causing human hepatotoxicity. In the present study, we addressed the question whether gene expression data can improve the quality of hepatotoxicity prediction compared to cytotoxicity analysis alone.

A group of novel polyfluoroether substances affects lipid metabolism in human hepatocyte HepaRG cells less than classic perfluoroalkyl compounds.

Per- and polyfluoroalkyl substances (PFAS) are used for numerous industrial applications including the production of fluorosurfactants. Some prominent PFAS, e.g.

Impact of Short-Chain Perfluoropropylene Oxide Acids on Biochemical and Behavioural Parameters in (Savigny, 1826).

Per- and polyfluoroalkyl substances (PFAS) are a class of persistent organic pollutants that pose a growing threat to environmental and human health. Soil acts as a long-term reservoir for PFAS, potentially impacting soil biodiversity and ecosystem function. Earthworms, as keystone species in soil ecosystems, are particularly vulnerable to PFAS exposure.

Assessment of soy leghemoglobin produced from genetically modified , under Regulation (EC) No 1829/2003 (application EFSA-GMO-NL-2019-162).

Genetically modified strain MXY0541 was developed to produce soy leghemoglobin by introducing the coding sequence encoding leghemoglobin from soybean (). The molecular characterisation data and bioinformatic analyses do not raise any safety concerns. The safety of soy leghemoglobin as a food additive has already been assessed by the EFSA FAF Panel (EFSA-Q-2022-00031).

Assessment of genetically modified maize DP51291 (application GMFF-2021-0071).

Genetically modified maize DP51291 was developed to confer control against susceptible corn rootworm pests and tolerance to glufosinate-containing herbicide; these properties were achieved by introducing the and expression cassettes. The molecular characterisation data and bioinformatic analyses do not identify issues requiring food/feed safety assessment. None of the identified differences in the agronomic/phenotypic and compositional characteristics tested between maize DP51291 and its conventional counterpart needs further assessment, except for phosphorus in forage and manganese, proline, oleic acid (C18:1) and linoleic acid (C18:2) in grain, which do not raise safety and nutritional concerns.