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.

Assessment of genetically modified maize DP910521 (application GMFF-2021-2473).

Genetically modified (GM) maize DP910521 was developed to confer resistance against certain lepidopteran insect pests as well as tolerance to glufosinate herbicide; these properties were achieved by introducing the expression cassettes. The molecular characterisation data and bioinformatic analyses did not identify issues requiring food/feed safety assessment. None of the identified differences in the agronomic/phenotypic and compositional characteristics tested between maize DP910521 and its conventional counterpart needs further assessment except for the levels of iron in grain, which do not raise safety and nutritional concerns.

Assessment of genetically modified maize MON 95275 (application GMFF-2022-5890).

Genetically modified maize MON 95275 was developed to confer protection to certain coleopteran species. These properties were achieved by introducing the , and expression cassettes. The molecular characterisation data and bioinformatic analyses reveal similarity to known toxins, which was further assessed.

Scientific opinion on the ANSES analysis of Annex I of the EC proposal COM (2023) 411 (EFSA-Q-2024-00178).

EFSA was asked by the European Parliament to provide a scientific opinion on the analysis by the French Agency for Food, Environmental and Occupational Health & Safety (ANSES) of Annex I of the European Commission proposal for a regulation 'on plants obtained by certain new genomic techniques (NGTs) and their food and feed, and amending regulation (EU) 2017/625'. The Panel on genetically modified organisms (GMO) assessed the opinion published by ANSES, which focuses on (i) the need to clarify the definitions and scope, (ii) the scientific basis for the equivalence criteria and (iii) the need to take potential risks from category 1 NGT plants into account. The EFSA GMO Panel considered the ANSES analysis and comments on various terms used in the criteria in Annex I of the European Commission proposal and discussed definitions based on previous EFSA GMO Panel opinions.

Assessment of genetically modified maize MON 89034 × 1507 × MON 88017 × 59122 and 8 out of 10 of its subcombinations for renewal authorisation under Regulation (EC) No 1829/2003 (dossier GMFF-2022-9170).

Following the joint submission of dossier GMFF-2022-9170 under Regulation (EC) No 1829/2003 from Bayer Agriculture B.V. and Corteva Agriscience Belgium B.

Assessment of genetically modified maize MON 94804 (application GMFF-2022-10651).

Genetically modified (GM) maize MON 94804 was developed to achieve a reduction in plant height by introducing the suppression cassette. The molecular characterisation and bioinformatic analyses do not identify issues requiring food/feed safety assessment. None of the agronomic/phenotypic and compositional differences identified between maize MON 94804 and its conventional counterpart needs further assessment, except for ear height, plant height and levels of carbohydrates in forage, which do not raise safety or nutritional concerns.

Assessment of genetically modified maize MON 89034 × 1507 × NK603 for renewal authorisation under Regulation (EC) No 1829/2003 (application GMFF-2022-3670).

Following the submission of dossier GMFF-2022-3670 under Regulation (EC) No 1829/2003 from Corteva Agriscience Belgium BV and Bayer Agriculture BV, 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 and insect-resistant genetically modified maize MON 89034 × 1507 × 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, a systematic search and evaluation of literature, updated bioinformatic analyses and a search for additional documents or studies performed by or on behalf of the applicant. 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 DP202216 for food and feed uses, under Regulation (EC) No 1829/2003 (application EFSA-GMO-NL-2019-159).

Genetically modified maize DP202216 was developed to confer tolerance to glufosinate-ammonium-containing herbicides and to provide an opportunity for yield enhancement under field conditions. 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.

Core Outcome Set for IgE-mediated food allergy clinical trials and observational studies of interventions: International Delphi consensus study 'COMFA'.

Background: IgE-mediated food allergy (FA) is a global health concern with substantial individual and societal implications. While diverse intervention strategies have been researched, inconsistencies in reported outcomes limit evaluations of FA treatments. To streamline evaluations and promote consistent reporting, the Core Outcome Measures for Food Allergy (COMFA) initiative aimed to establish a Core Outcome Set (COS) for FA clinical trials and observational studies of interventions.

Assessment of genetically modified maize DP915635 for food and feed uses, under regulation (EC) No 1829/2003 (application EFSA-GMO-NL-2020-172).

Genetically modified maize DP915635 was developed to confer tolerance to glufosinate herbicide and resistance to corn rootworm pests. 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 cotton COT102 for food and feed uses, under Regulation (EC) No 1829/2003 (application EFSA-GMO-DE-2017-141).

Genetically modified cotton COT102 was developed to confer resistance against several lepidopteran species. The molecular characterisation data and bioinformatic analyses do not identify issues requiring food/feed safety assessment. None of the differences in the agronomic-phenotypic and compositional characteristics between cotton COT102 and its non-GM comparator needs further assessment, except for levels of acid detergent fibre, which do not raise safety or nutritional concerns.

Assessment of genetically modified maize Bt11 × MIR162 × MIR604 × MON 89034 × 5307 × GA21 and 30 subcombinations, for food and feed uses, under Regulation (EC) No 1829/2003 (application EFSA-GMO-DE-2018-149).

Genetically modified maize Bt11 × MIR162 × MIR604 × MON 89034 × 5307 × GA21 was developed by crossing to combine six single events: Bt11, MIR162, MIR604, MON 89034, 5307 and GA21, the GMO Panel previously assessed the 6 single maize events and 27 out of the 56 possible subcombinations and did not identify safety concerns. No new data on the single maize events or the assessed subcombinations were identified that could lead to modification of the original conclusions on their safety. The molecular characterisation, comparative analysis (agronomic, phenotypic and compositional characteristics) and the outcome of the toxicological, allergenicity and nutritional assessment indicate that the combination of the single maize events and of the newly expressed proteins in the six-event stack maize does not give rise to food and feed safety and nutritional concerns.

Assessment of genetically modified oilseed rape MS8, RF3 and MS8 × RF3 for renewal authorisation under Regulation (EC) No 1829/2003 (application EFSA-GMO-RX-024).

Following the submission of application EFSA-GMO-RX-024 under Regulation (EC) No 1829/2003 from BASF Agricultural Solutions Seed US LLC, the Panel on Genetically Modified Organisms of EFSA 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 MS8, RF3 and MS8 × RF3, 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, a systematic search and evaluation of literature, updated bioinformatic analyses, and additional documents or studies performed by or on behalf of the applicant. 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.

Risk assessment of additional information on maize MIR162.

The European Commission requested the Panel on Genetically Modified Organisms of the European Food Safety Authority (EFSA GMO Panel) to assess new scientific information on maize MIR162, and to indicate whether the previous conclusions on the safety of maize MIR162 as a single event and as a part of stacked events remain valid. The new information is included in a European patent that reports a decrease in male fertility in some MIR162 inbred lines, pointing to a potential link between such decrease and the Vip3 protein expressed by maize MIR162. The EFSA GMO Panel evaluated the data provided by the patent owner and found scarce support for a causal link between Vip3 and decreased fertility.

Animal Models for the Study of Food Allergies.

In the last decades there has been a parallel increase in the incidence of food allergies and the development of experimental mouse models. These models have improved our understanding of the disease but do have limitations. For instance, they do not entirely reproduce human pathophysiology; moreover, validated and predictive models are absent.

Assessment of genetically modified maize GA21 × T25 for food and feed uses, under Regulation (EC) No 1829/2003 (application EFSA-GMO-DE-2016-137).

Genetically modified maize GA21 × T25 was developed by crossing to combine two single events: GA21 and T25. The GMO Panel previously assessed the two single maize events and did not identify safety concerns. No new data on the single maize events were identified that could lead to modification of the original conclusions on their safety.

Assessment of genetically modified maize MON 87419 for food and feed uses, under Regulation (EC) No 1829/2003 (application EFSA-GMO-NL-2017-140).

Genetically modified maize MON 87419 was developed to confer tolerance to dicamba- and glufosinate-based 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.

Animal dietary exposure in the risk assessment of feed derived from genetically modified plants.

EFSA carries out the risk assessment of genetically modified plants for food and feed uses under Regulation (EU) No 503/2013. Exposure assessment - anticipated intake/extend of use shall be an essential element of the risk assessment of genetically modified feeds, as required by Regulation (EU) No 503/2013. Estimates of animal dietary exposure to newly expressed proteins should be determined to cover average consumption across all the different species, age, physiological and productive phases of farmed and companion animals, and identify and consider particular consumer groups with expected higher exposure.

Proteomic Profiling of Major Peanut Allergens and Their Post-Translational Modifications Affected by Roasting.

Post-translational modifications (PTMs) are covalent changes occurring on amino acid side chains of proteins and yet are neglected structural and functional aspects of protein architecture. The objective was to detect differences in PTM profiles that take place after roasting using open PTM search. We conducted a bottom-up proteomic study to investigate the impact of peanut roasting on readily soluble allergens and their PTM profiles.

Assessment of genetically modified soybean MON 87701 for renewal authorisation under Regulation (EC) No 1829/2003 (application EFSA-GMO-RX-021).

Following the submission of application EFSA-GMO-RX-021 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 insect-resistant genetically modified soybean MON 87701, 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, a systematic search and evaluation of literature, updated bioinformatic analyses and additional documents or studies performed by or on behalf of the applicant. 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.