Search

Abstract Microorganisms, genetically modified or not, may be used in the food chain either as active agents, biomasses or as production organisms of substances of interest. The placement of such microorganisms or their derived substances/products in the European market may be subject to a premarket authorisation process. The authorisation process requires a risk assessment in order to establish the safety and/or the efficacy of the microorganism(s) when used in the food chain as such, as biomasses or as production strains. This includes a full molecular characterisation of the microorganism(s) under assessment. For certain regulated products, the use of whole genome sequence (WGS) data of the microorganism is established as a requirement for the risk assessment. In this regard, data obtained from WGS analysis can provide information on the unambiguous taxonomic identification of the strains, on the presence of genes of concern (e.g. those encoding virulence factors, resistance to antimicrobials of clinical relevance for humans and animals, production of harmful metabolites or of clinically relevant antimicrobials) and on the characterisation of genetic modification(s) (where relevant). This document provides recommendations to applicants on how to describe and report the results of WGS analyses in the context of an application for market authorisation of a regulated product. Indications are given on how to perform genome sequencing and the quality criteria/thresholds that should be reached, as well as the data and relevant information that need to be reported, if required. This updated document replaces the EFSA 2021 Statement and reflects the current knowledge in technologies and methodologies to be used to generate and analyse WGS data for the risk assessment of microorganisms.

Abstract The conclusions of EFSA following the peer review of the initial risk assessments carried out by the competent authority of the rapporteur Member State Belgium for the pesticide active substance Pythium oligandrum strain B301 and the considerations as regards the inclusion of the substance in Annex IV of Regulation (EC) No 396/2005 are reported. The context of the peer review was that required by Regulation (EC) No 1107/2009 of the European Parliament and of the Council. The conclusions were reached on the basis of the evaluation of the representative uses of Pythium oligandrum strain B301 as a resistance inducer/elicitor to control trunk diseases on grapevines. The reliable endpoints, appropriate for use in regulatory risk assessment, are presented. Missing information identified as being required by the regulatory framework is listed. Concerns are reported where identified.

Abstract According to Article 12 of Regulation (EC) No 396/2005, EFSA has reviewed the maximum residue levels (MRLs) currently established at European level for the pesticide active substance difenoconazole. To assess the occurrence of difenoconazole residues in plants, processed commodities, rotational crops and livestock, EFSA considered the conclusions derived in the framework of Council Directive 91/414/EEC, the MRLs established by the Codex Alimentarius Commission as well as the European authorisations reported by Member States and the UK (including the supporting residues data). Based on the assessment of the available data, MRL proposals were derived, and a consumer risk assessment was carried out. Some information required by the regulatory framework was missing and a possible acute risk to consumers was identified. Hence, the consumer risk assessment is considered indicative only, some MRL proposals derived by EFSA still require further consideration by risk managers and measures for reduction of the consumer exposure should also be considered.

Abstract The conclusions of the European Food Safety Authority (EFSA) following the peer review of the initial risk assessments carried out by the competent authority of the rapporteur Member State The Netherlands for the pesticide active substance 1‐methylcyclopropene are reported. The context of the peer review was that required by Regulation (EC) No 1107/2009 of the European Parliament and of the Council for an amendment in approval conditions. The current approval of 1‐methylcyclopropene includes the specific provision ‘Only uses as plant growth regulator for post‐harvest storage in sealable warehouse may be authorised’. The applicant AgroFresh Holding France SAS submitted, in accordance with Article 7 of Reg. (EC) 1107/2009, an application to remove this specific provision in order to allow member states to authorise the use of products containing 1‐methylcyclopropene on outdoor crops pre‐harvest. The conclusions were reached on the basis of the evaluation of the representative use(s) of 1‐methylcyclopropene as a plant growth regulator via spray application on pome fruit. The reliable endpoints, appropriate for use in regulatory risk assessment are presented. Missing information identified as being required by the regulatory framework is listed. Concerns are reported where identified.

Abstract Following a request from the European Commission, the European Food Safety Authority (EFSA) assessed the 2022 post‐market environmental monitoring (PMEM) report on the cultivation of Cry1Ab‐expressing maize event MON 810. Overall, the 2022 PMEM report provides no evidence of adverse effects of maize MON 810 cultivation. It shows a high level of compliance with refuge requirements by Spanish and Portuguese farmers growing maize MON 810, but uncertainty remains on compliance in areas where the clustered surface of maize MON 810 farms exceeds 5 ha. There are no signs of practical resistance to Cry1Ab in the field in corn borer populations collected in north‐eastern Spain in 2022, although a decrease in Cry1Ab susceptibility in Mediterranean corn borer populations from this area cannot be excluded. Information retrieved through farmer questionnaires in Spain and from the scientific literature reveals no unanticipated adverse effects on human and animal health or the environment arising from the cultivation of maize MON 810. Uncertainties remain on whether ‘very highly’ and ‘extremely’ sensitive non‐target lepidoptera are potentially exposed to harmful amounts of MON 810 pollen. EFSA notes that several recommendations made in the frame of the assessment of previous PMEM reports remain unaddressed and identified additional shortcomings in the 2022 PMEM report that require further consideration by the consent holder in future annual PMEM reports. Particularly, EFSA emphasises the urgent need to increase the sensitivity of the insect resistance monitoring strategy and implement mitigation measures to ensure that the exposure of non‐target lepidoptera to maize MON 810 pollen is reduced to levels of no concern.

Abstract The conclusions of the European Food Safety Authority (EFSA) following the peer review of the initial risk assessments carried out by the competent authority of the rapporteur Member State, The Netherlands for the pesticide active substance Phthorimaea operculella granulovirus are reported. The context of the peer review was that required by Regulation (EC) No 1107/2009 of the European Parliament and of the Council. The conclusions were reached on the basis of the evaluation of the representative uses of Phthorimaea operculella granulovirus as an insecticide on tomato (field and greenhouse uses) and on potato (field use) via spraying (tractor drawn or knapsack sprayers) or overhead irrigation. The reliable endpoints, appropriate for use in regulatory risk assessment are presented. Missing information identified as being required by the regulatory framework is listed.

Abstract The adverse outcome pathway (AOP) framework serves as a practical tool for organising scientific knowledge that can be used to infer cause–effect relationships between stressor events and toxicity outcomes in intact organisms. However, a major challenge in the broader application of the AOP concept within regulatory toxicology is the development of a robust AOPs that can withstand peer review and acceptance. This is mainly due to the considerable amount of work required to substantiate the modular units of a complete AOP, which can take years from inception to completion. The methodology used here consisted of an initial assessment of a single chemical hazard using the Integrated Approach to Testing and Assessment (IATA) framework. An evidence‐based approach was then used to gather empirical evidence combining systematic literature review methods with expert knowledge to ensure the effectiveness of the AOP development methodology. The structured framework used assured transparency, objectivity and comprehensiveness, and included expert knowledge elicitation for the evaluation of key event relationships (KERs). This stepwise approach led to the development of an AOP that begins with binding of chemicals to Voltage Gate Sodium Channels (VGSC/Nav) during mammalian development leading to adverse consequences in neurodevelopment evidenced as deficits in cognitive functions. Disruption of the formation of precise neural circuits by alterations in VGSC kinetics during the perinatal stages of brain development may also underlie neurodevelopmental disorders. Gaps in our understanding include the specific critical developmental windows and the quantitative relationship of binding to VGSC and subsequent disruption and cognitive function. Despite the limited quantitative information at all KER levels, regulatory applications of this AOP for DNT assessment have been identified.

Abstract The conclusions of the European Food Safety Authority (EFSA) following the peer review of the initial risk assessments carried out by the competent authorities of the rapporteur Member State Poland and co‐rapporteur Member State Hungary for the pesticide active substance triclopyr (variant triclopyr‐butotyl) and the assessment of applications for maximum residue levels (MRLs) are reported. The context of the peer review was that required by Commission Implementing Regulation (EU) No 844/2012, as amended by Commission Implementing Regulation (EU) No 2018/1659. The conclusions were reached on the basis of the evaluation of the representative uses of triclopyr (variant triclopyr‐butotyl) as a herbicide on established pasture and non‐recreational amenity grassland (field use). MRLs were assessed in rice. The reliable end points, appropriate for use in regulatory risk assessment and the proposed MRLs, are presented. Missing information identified as being required by the regulatory framework is listed. Concerns are reported where identified.

Abstract In accordance with Article 6 of Regulation (EC) No 396/2005, the Federal Public Service (FPS) Health, Food chain Safety and Environment submitted a request on behalf of Belgium (evaluating Member State, EMS) to modify the existing maximum residue level (MRL) for the active substance methoxyfenozide in aubergines/eggplants. The data submitted in support of the request were found to be sufficient to derive an MRL proposal for aubergines/eggplants. Adequate analytical methods for enforcement are available to control the residues of methoxyfenozide in the commodity under consideration at the validated limit of quantification (LOQ) of 0.01 mg/kg. Based on the risk assessment results, the EFSA concluded that the short‐term and long‐term intake of residues resulting from the indoor use of methoxyfenozide according to the reported agricultural practice is unlikely to present a risk to consumer health.

Abstract This report comprises the 14th assessment of the Echinococcus multilocularis surveillance scientific reports, provided by Finland, Ireland, United Kingdom (Northern Ireland) and Norway on their respective surveillance programmes. Every year since 2012, EFSA presents the assessment to the European Commission in which the sampling strategy, data collection and detection methods used by these countries are evaluated. More specifically, the surveillance programmes of these four countries are evaluated by checking the information submitted by each of them and verifying that the technical requirements are fulfilled as laid down in Commission Delegated Regulation (EU) 2018/772 of 21 November 2017 supplementing Regulation (EU) No 576/2013 of the European Parliament and of the Council with regard to preventive health measures for the control of Echinococcus multilocularis infection in dogs, and repealing Delegated Regulation (EU) No 1152/2011. The information is divided into four different categories for assessment: the type and sensitivity of the detection method, the selection of the target population, the sampling strategy and the methodology. For each category, the main aspects that need to be considered in order to accomplish the technical requirements of the legislation are checked against compliance of several criteria. The countries participating in this surveillance (Finland, Ireland, the United Kingdom (Northern Ireland) and Norway) succeeded in the fulfilment of the technical legal requirements foreseen in Commission Delegated Regulation (EU) 2018/772 concerning these four different categories. None of the four countries recorded positive samples in the 12‐month reporting period.

Abstract The European Commission asks scientific and technical assistance from EFSA to determine the impact of the revision of the Australian monitoring programme on its ability to detect microbiological contamination. Considering that, in 2010, the European Commission determined the current Australian monitoring programme to be equivalent to the EU requirements for microbiological monitoring further to an EFSA scientific assessment, the current and proposed programmes were described and the total number of alerts was compared using a probabilistic modelling approach. In the current programme, only beef and sheep carcasses are monitored using three‐class moving window sampling plans, while in the proposed programme, carcass, bulk meat, primal and offal are monitored using four two‐class sampling plans and Salmonella testing is excluded. The models revealed that the current programme provides a higher number of alerts for APC, while the proposed monitoring programme provides a higher number of alerts for E. coli. For APC and E. coli combined, the mean, 5th and 95th centiles of the uncertainty distribution of the total number of alerts in the current and the proposed monitoring programme are 201 [179, 227] and 172 [149, 194] for beef, and 199 [175, 222] and 2897 [2795, 3008] for sheep, respectively. For Salmonella, there are no alerts for the proposed programme since sampling is excluded while for the current programme, the estimated mean, 5th and 95th centiles of the uncertainty distribution of the number of alerts for a 5‐year period were 143 [126, 144] for heifer/steer, 1.6 [0, 4] for cow/bull and 0 [0, 0] for lamb/sheep. Overall, for APC and E. coli, the estimated total number of alerts was similar (beef) or higher (sheep) for the proposed compared to the current programme. In contrast, Salmonella sampling is excluded from the proposed programme and thus cannot detect the number of current alerts.

Abstract The conclusions of the European Food Safety Authority (EFSA) following the peer review of the initial risk assessments carried out by the competent authorities of the rapporteur Member State, Greece, and co‐rapporteur Member State, France, for the pesticide active substance paraffin oil are reported. The context of the peer review was that required by Commission Implementing Regulation (EU) No 844/2012, as amended by Commission Implementing Regulation (EU) No 2018/1659. The conclusions were reached on the basis of the evaluation of the representative uses of paraffin oil as an acaricide and insecticide on potatoes, ornamentals (flower bulbs) and orchards (pear/apple), on pome fruit and stone fruit, on field and permanent protected fruiting vegetables and on field and permanent protected roses and on citrus. The reliable end points appropriate for use in regulatory risk assessment are presented. Missing information identified as being required by the regulatory framework is listed. Concerns are reported where identified.

Abstract This scientific report provides an update of the Xylella spp. host plant database, aiming to provide information and scientific support to risk assessors, risk managers and researchers dealing with Xylella spp. Upon a mandate of the European Commission, EFSA created and regularly updates a database of host plant species of Xylella spp. The current mandate covers the period 2021–2026. This report is related to the 10th version of the database published in Zenodo in the EFSA Knowledge Junction community, covering literature published from 1 July 2023 up to 31 December 2023, and recent Europhyt outbreak notifications. Informative data have been extracted from 39 selected publications. Sixteen new host plants, five genera and one family were identified and added to the database. They were naturally infected by X. fastidiosa subsp. fastidiosa or unknown either in Portugal or the United States. No additional data were retrieved for X. taiwanensis, and no additional multilocus sequence types (STs) were identified worldwide. New information on the tolerant/resistant response of plant species to X. fastidiosa infection were added to the database. The Xylella spp. host plant species were listed in different categories based on the number and type of detection methods applied for each finding. The overall number of Xylella spp. host plants determined with at least two different detection methods or positive with one method either by sequencing or pure culture isolation (category A), reaches now 451 plant species, 204 genera and 70 families. Such numbers rise to 712 plant species, 312 genera and 89 families if considered regardless of the detection methods applied (category E).

Abstract The conclusions of the EFSA following the peer review of the initial risk assessment carried out by the competent authority of the rapporteur Member State, Spain, for the pesticide active substance difenoconazole are reported. The context of the peer review was that requested by the European Commission following the submission and evaluation of confirmatory information with regard to the consumer risk assessment. The conclusions were reached on the basis of the evaluation of the representative uses of difenoconazole as a fungicide on pome fruit, carrot, wheat, barley, triticale, rye and oats. The reliable endpoints concluded as being appropriate for use in regulatory risk assessment, derived from the available studies and/or literature in the dossier peer reviewed, are presented. Concerns were not identified.

Abstract The conclusions of the EFSA following the peer review of the initial risk assessments carried out by the competent authorities of the rapporteur Member State, Finland, and co‐rapporteur Member State, Estonia, for the pesticide active substance mepiquat (evaluated variant mepiquat chloride) are reported. The context of the peer review was that required by Commission Implementing Regulation (EU) No 844/2012, as amended by Commission Implementing Regulation (EU) No 2018/1659. The conclusions were reached on the basis of the evaluation of the representative uses of mepiquat chloride as a plant growth regulator on cereals and grass (field uses). The reliable end points, appropriate for use in regulatory risk assessment, are presented. Missing information identified as being required by the regulatory framework is listed. Concerns are identified.

Abstract The European Commission requested scientific and technical assistance in the preparation of a EU‐wide baseline survey of antimicrobial resistance (AMR) in bacteria from aquaculture animals. It is recommended that the survey would aim at estimating the occurrence of AMR in Aeromonas spp. isolated from Atlantic Salmon (Salmo salar), European seabass (Dicentrarchus labrax) and trout (Salmo trutta, Salvelinus fontinalis, Oncorhynchus mykiss) intended to consumption, at harvesting (at farm/slaughter), at the EU level and in addition, at estimating the occurrence and diversity of AMR of Escherichia coli, Enterococcus faecium, Enterococcus faecalis, Vibrio parahaemolyticus and Vibrio alginolyticus in blue mussel (Mytilus edulis) and Mediterranean mussel (Mytilus galloprovincialis) from production areas and at dispatch centres at the EU level. These technical specifications define the target populations, the sample size for the survey, sample collection requirements, the analytical methods (for isolation, identification, phenotypic susceptibility testing and further genotypic analysis of some of the bacteria targeted) and the data reporting requirements. The data to be reported by the EU Member States to support this baseline survey are presented in three data models. The results of the survey should be reported using the EFSA reporting system.

Abstract The conclusions of the European Food Safety Authority (EFSA) following the peer review of the initial risk assessments carried out by the competent authorities of the rapporteur Member State, Belgium, and co‐rapporteur Member State, Austria, for the pesticide active substance lenacil are reported. The context of the peer review was that required by Commission Implementing Regulation (EU) No 844/2012, as amended by Commission Implementing Regulation (EU) No 2018/1659. The conclusions were reached on the basis of the evaluation of the representative uses of lenacil as a herbicide on sugar and fodder beet (field use). The reliable end points, appropriate for use in regulatory risk assessment, are presented. Missing information identified as being required by the regulatory framework is listed. Concerns are reported where identified.

Abstract In accordance with Article 43 of Regulation (EC) No 396/2005, EFSA received a mandate from the European Commission to perform a targeted risk assessment for residues of lambda‐cyhalothrin in poultry products (meat/muscle, fat, liver, kidney, edible offal) and bird's eggs. EFSA performed the acute (short‐term) and chronic (long‐term) dietary risk assessment considering the lambda‐cyhalothrin exposure via residues in food commodities from poultry and birds' eggs at the levels of the proposed temporary maximum residue level (MRL) of 0.03 mg/kg and 0.02 mg/kg, respectively. These temporary MRLs were derived by the European Commission from monitoring data provided by EU member States and compiled by EFSA in a central database. Based on the risk assessment results, EFSA concluded that the proposed temporary MRL is unlikely to pose a risk to consumer health.

Abstract In 2023, 14 Member States were affected by African swine fever (ASF), including Croatia and Sweden where ASF emerged (wild boar outbreaks only) and Greece where ASF re‐emerged after being free since 2021. The number of ASF outbreaks among domestic pigs in the EU was five times higher than in 2022, reaching a similar magnitude to that in 2019. This was predominantly driven by the introduction and subsequent spread of ASF in Croatia and its resurgence in Romania, representing 96% of the EU outbreaks. ASF outbreaks in domestic pigs were clearly seasonal in all countries, with 88% of outbreaks reported between July and October. Most of the ASF outbreaks among domestic pigs were detected through clinical suspicion (94%), followed by tracing from affected establishments (3%), and the weekly testing of at least two dead pigs in establishments (3%). In wild boar, a 10% increase in the number of notified outbreaks was observed in the EU in comparison with 2022, with considerable variations between countries. A winter peak was observed only in Poland, Slovakia and Hungary. The epidemiological situation in wild boar improved in Germany and Hungary, as suggested by the decrease in the number of outbreaks and in the proportions of PCR‐positive samples from dead wild boar. Overall, 31% of wild boar carcasses found during passive surveillance tested positive by PCR, representing 69% of the ASF outbreaks in wild boar in the EU. In contrast, 0.4% of hunted wild boar tested positive, representing 31% of the outbreaks. Despite the introduction of ASF into new countries and the increase in the number of outbreaks, the size of restricted zones in the EU remained stable, due to the highly clustered outbreaks in Croatia, and the reduction of restricted zones in Poland, Slovakia and Bulgaria (in domestic pigs), and Hungary (in wild boar).

Abstract Carbendazim (CBZ) is an active substance in plant protection products that is no longer authorised within the European Union. CBZ is classified according to Regulation (EC) No 1272/2008 as mutagenic, category 1B and toxic for reproduction, category 1B. In 2010, EFSA established consumers' health‐based guidance values (HBGVs) for CBZ (ADI and ARfD). In compliance with Article 43 of Regulation (EC) No 396/2005, the European Commission asked EFSA on 1 March 2024 to carry out a follow‐up qualitative assessment of the data gaps that were identified in the studies used in the framework of the assessment of the HBGVs for CBZ, in order to confirm the reliability of the existing toxicological studies and their impact for the setting of the HBGVs. By considering missing information in the extensive database and the reliability of the available toxicological studies, EFSA concluded that missing information does not prevent setting of HBGVs and that the critical effects of CBZ were investigated in studies of sufficient reliability and acceptability. Therefore, the HBGVs derived in 2010 are protective for the consumers.

Abstract The applicant Corteva Agriscience submitted a request to the competent national authority in Austria to evaluate the confirmatory data that were identified for myclobutanil in the framework of the MRL review under Article 12 of Regulation (EC) No 396/2005 as not available. To address the data gap related to the lack of information on the triazole derivative metabolites (TDMs), new residue trials analysing for TDMs were submitted on apples, grapes, strawberries, tomatoes and melons. Following the assessment of the submitted data, EFSA concluded that Article 12 confirmatory data gaps are considered addressed for pome fruits, grapes, cucurbits with inedible peel, strawberries and tomatoes. The new information provided required the assessment of consumer exposure to TDMs, which identified no consumer intake concerns for the crops under consideration. No information was provided to address the Article 12 confirmatory data referred to in Regulation (EU) 2020/770 for blackberries, gooseberries, bananas, aubergines/eggplants, lamb's lettuces/corn salads, beans (with pods), globe artichokes, hops, sugar beet roots and products of animal origin. For these commodities, the existing EU MRL could be lowered to the enforcement limit of quantification (LOQ). For kaki/Japanese persimmon and azararoles/mediterranean medlars, the existing EU MRL is set on the basis of Codex MRL in pome fruits. The applicant did not request maintaining a Codex MRL in these commodities, but should risk managers decide otherwise, the Article 12 data gap is considered addressed for kaki/Japanese persimmon while for azaroles/Mediterranean medlars, a risk management decision might be required. No consumer intake concerns were identified.

Abstract Avian influenza viruses (AIV) remain prevalent among wild bird populations in the European Union and European Economic Area (EU/EEA), leading to significant illness and mortality of birds. Transmission between bird and mammal species has been observed, particularly in fur animal farms, where outbreaks have been reported. While transmission from infected birds to humans is rare, there have been instances of exposure to these viruses since 2020 without any symptomatic infections reported in the EU/EEA. However, these viruses continue to evolve globally, and with the migration of wild birds, new strains carrying potential mutations for mammalian adaptation could be selected. If avian A(H5N1) influenza viruses acquire the ability to spread efficiently among humans, large‐scale transmission could occur due to the lack of immune defences against H5 viruses in humans. The emergence of AIV capable of infecting mammals, including humans, can be facilitated by various drivers. Some intrinsic drivers are related to virus characteristics or host susceptibility. Other drivers are extrinsic and may increase exposure of mammals and humans to AIV thereby stimulating mutation and adaptation to mammals. Extrinsic drivers include the ecology of domestic and wild host species, human activities like farming practices and the use of natural resources, climatic and environmental factors. One Health measures to mitigate the risk of AIV adapting to mammals and humans focus on limiting exposure and preventing spread. Key options for actions include enhancing surveillance targeting humans and animals, ensuring access to rapid diagnostics, promoting collaboration between animal and human sectors, and considering the implementation of preventive measures such as vaccination of poultry. Effective communication to different target audiences should be emphasised, as well as strengthening veterinary infrastructure, enforcing biosecurity measures at farms, and reducing wildlife contact with domestic animals. Careful planning of poultry and fur animal farming, especially in areas with high waterfowl density, is essential for effective risk reduction.

Abstract The conclusions of the EFSA following the peer review of the initial risk assessments carried out by the competent authority of the rapporteur Member State, Malta, for the pesticide active substance clove oil are reported. The context of the peer review was that required by Regulation (EC) No 1107/2009 of the European Parliament and of the Council. The conclusions for the amendment of approval were reached on the basis of the evaluation of the representative use of clove oil as a preharvest nematicide on tomatoes and cucumbers (permanent greenhouse use). The representative use evaluated for the renewal of approval of clove oil was as post‐harvest fungicide and bactericide on apples, pears and peaches (indoor uses). The reliable endpoints appropriate for use in regulatory risk assessment are presented. Endpoints not relevant to the scope of the proposed amendment of approval conditions will be addressed in the context of the renewal of approval procedure of clove oil running in parallel (AIR IV, EFSA Q‐2016‐00809). Missing information identified as being required by the regulatory framework is listed. Concerns are reported where identified.

Abstract As part of the risk assessment (RA) requirements for genetically modified (GM) plants, according to Regulation (EU) No 503/2013 and the EFSA guidance on the RA of food and feed from GM plants (EFSA GMO Panel 2011), applicants need to perform a molecular characterisation of the DNA sequences inserted in the GM plant genome. This Technical Note to the applicants puts together requirements and recommendations for the quality assessment of the methodology, analysis and reporting when DNA sequencing is used for the molecular characterisation of GM plants. In particular, it applies to the use of Sanger sequencing and next‐generation sequencing for the characterisation of the inserted genetic material and its flanking regions at each insertion site, the determination of the copy number of all detectable inserts and the analysis of the genetic stability of the inserts. This updated document replaces the EFSA 2018 Technical Note and reflects the current knowledge in scientific‐technical methods for generating and verifying, in a standardised manner, DNA sequencing data in the context of RA of GM plants. It does not take into consideration the verification and validation of the detection method which remains under the remit of the Joint Research Centre (JRC).

Abstract Under European Union legislation (Article 32, Regulation (EC) No 396/2005), the European Food Safety Authority provides an annual report assessing the pesticide residue levels in foods on the European market. In 2022, 96.3% of the overall 110,829 samples analysed fell below the maximum residue level (MRL), 3.7% exceeded this level, of which 2.2% were non‐compliant, i.e. results in a given sample exceeded the MRL after taking into account the measurement uncertainty. For the EU‐coordinated multiannual control programme subset, 11,727 samples were analysed of which 0.9% were non‐compliant. To assess acute and chronic risk to consumer health, dietary exposure to pesticide residues was estimated and compared with available health‐based guidance values (HBGV). Continuation of the probabilistic assessment methodology was consolidated to all pesticides listed in the 2022 EU Regulation providing the probability of a consumer being exposed to an exceedance of the HBGV. Overall, the assessed risk to EU consumer's health is low. Recommendations to risk managers are given to increase the effectiveness of European control systems and to ensure a high level of consumer protection throughout the EU.

Abstract The conclusions of the EFSA following the peer review of the initial risk assessments carried out by the competent authorities of the rapporteur Member State, Ireland, and co‐rapporteur Member State, Poland, for the pesticide active substance dichlorprop‐P and the variant dichlorprop‐P‐2‐ethylhexyl and the assessment of applications for maximum residue levels (MRLs) are reported. The context of the peer review was that required by Commission Implementing Regulation (EU) No 844/2012. The conclusions were reached on the basis of the evaluation of the representative uses of dichlorprop‐P as a herbicide on cereals, grassland and grass seed crops and of the variant dichlorprop‐P‐2‐ethylhexyl as a plant growth regulator on citrus. MRLs were assessed in mandarin and lemon. The conclusions from 2018 were updated in 2024 following the request from the European Commission with regard to the endocrine‐disrupting properties. The reliable end points, appropriate for use in regulatory risk assessment and the proposed MRLs, are presented. Missing information identified as being required by the regulatory framework is listed. Concerns are reported where identified.

Abstract EFSA updated its previous work on the establishment of specific effects that are considered relevant for grouping pesticide residues targeting the thyroid and for performing the retrospective assessment of dietary cumulative risk (CRA). The two specific effects already selected in 2019 leading to the two cumulative assessment groups (CAGs) ‘hypothyroidism’ and ‘C‐cell hypertrophy, hyperplasia and neoplasia’ were reconfirmed. Compared to 2019, the list of indicators that can be used to identify these specific effects was refined to only include histopathological changes. In a second phase of the work, data will be extracted on indicators of the specific effects from the dossiers on active substances (a.s.) used as plant protection products. The criteria for including a.s. into CAGs were also updated, together with the hazard characterisation methodology and the lines of evidence for assessing CAG‐membership probabilities. The tasks related to the data extraction and the establishment of the CAGs on hypothyroidism and on C‐cell hypertrophy, hyperplasia and neoplasia are beyond the scope of this report. This part of the CRA process has been outsourced and will be the subject of a separate report.

Abstract The conclusions of the European Food Safety Authority (EFSA) following the peer review of the initial risk assessments carried out by the competent authorities of the rapporteur Member State, Spain, and co‐rapporteur Member State, the Netherlands, for the pesticide active substance quinolin‐8‐ol are reported. The context of the peer review was that required by Commission Implementing Regulation (EU) No 844/2012. The conclusions were reached on the basis of the evaluation of the representative use of quinolin‐8‐ol as a fungicide and bactericide against soil‐borne pathogens in tomato cultivation in permanent greenhouses applied by drip irrigation. The reliable end points, appropriate for use in regulatory risk assessment are presented. Missing information identified as being required by the regulatory framework is listed. Concerns are reported where identified.

Abstract The applicant Arysta Life Science Great Britain Limited submitted a request to the competent national authority in Croatia to evaluate the confirmatory data that were identified for quizalofop‐P‐tefuryl in the framework of the maximum residue level (MRL) review under Article 12 of Regulation (EC) No 396/2005 as not available. Since Article 12 data gaps were also set for the two other quizalofop‐P variants sharing the same residue definitions for risk assessment and monitoring, EFSA included in the present assessment all quizalofop‐P variants: quizalofop‐P‐ethyl, quizalofop‐P‐tefuryl and propaquizafop. Moreover, in the application submitted to Croatia, the applicant also included a request to modify the existing MRLs for quizalofop‐P‐tefuryl in grapes, sunflower seeds and soyabeans in accordance with Article 6 of Regulation (EC) No 396/2005. To address the data gaps, new data on hydrolysis efficiency of quizalofop‐P‐tefuryl, quizalofop acid, quizalofop‐pentanoic acid and quizalofop‐P‐glycerate in different matrices of animal origin in accordance with the guidance document SANTE/2020/12830 Rev.1 were submitted, along with a validated analytical method for animal commodities. EFSA concluded that the data gap on validation of the efficiency of the extraction and hydrolysis included in the enforcement method of residues in livestock animal commodities was only fully addressed for muscle, poultry liver and eggs. Regarding plant commodities, the remaining data gaps were not addressed. EFSA also considered data gaps for quizalofop‐p‐ethyl in caraway as sufficiently addressed in the context of a previous MRL application. In general, the new information provided required a revision of the existing MRLs for several commodities of plant and animal origin. Further risk management considerations are required. Based on the risk assessment results, EFSA concluded that the short‐term and long‐term intake of residues resulting from the use of quizalofop‐P‐tefuryl according to the reported agricultural practices is unlikely to present a risk to consumer health.

Abstract The fourth joint inter‐agency report on integrated analysis of antimicrobial consumption (AMC) and the occurrence of antimicrobial resistance (AMR) in bacteria from humans and food‐producing animals (JIACRA) addressed data obtained by the Agencies' EU‐wide surveillance networks for 2019–2021. The analysis also sought to identify whether significant trends in AMR and AMC were concomitant over 2014–2021. AMC in both human and animal sectors, expressed in mg/kg of estimated biomass, was compared at country and European level. In 2021, the total AMC was assessed at 125.0 mg/kg of biomass for humans (28 EU/EEA countries, range 44.3–160.1) and 92.6 mg/kg of biomass for food‐producing animals (29 EU/EEA countries, range 2.5–296.5). Between 2014 and 2021, total AMC in food‐producing animals decreased by 44%, while in humans, it remained relatively stable. Univariate and multivariate analyses were performed to study associations between AMC and AMR for selected combinations of bacteria and antimicrobials. Positive associations between consumption of certain antimicrobials and resistance to those substances in bacteria from both humans and food‐producing animals were observed. For certain combinations of bacteria and antimicrobials, AMR in bacteria from humans was associated with AMR in bacteria from food‐producing animals which, in turn, was related to AMC in animals. The relative strength of these associations differed markedly between antimicrobial class, microorganism and sector. For certain antimicrobials, statistically significant decreasing trends in AMC and AMR were concomitant for food‐producing animals and humans in several countries over 2014‐2021. Similarly, a proportion of countries that significantly reduced total AMC also registered increasing susceptibility to antimicrobials in indicator E. coli from food‐producing animals and E. coli originating from human invasive infections (i.e., exhibited ‘complete susceptibility’ or ‘zero resistance’ to a harmonised set of antimicrobials). Overall, the findings suggest that measures implemented to reduce AMC in food‐producing animals and in humans have been effective in many countries. Nevertheless, these measures need to be reinforced so that reductions in AMC are retained and further continued, where necessary. This also highlights the importance of measures that promote human and animal health, such as vaccination and better hygiene, thereby reducing the need for use of antimicrobials.

Abstract In compliance with Article 43 of Regulation (EC) No 396/2005, EFSA received from the European Commission in 2020 a mandate to provide its reasoned opinion on the toxicological properties and maximum residue levels (MRLs) for the benzimidazole substances carbendazim and thiophanate‐methyl. Specifically, EFSA was asked to assess whether thiophanate‐methyl or carbendazim has clastogenic potential and, in case clastogenic potential can be excluded, to derive toxicological reference values necessary for consumer risk assessment and assessment of maximum residue levels (MRLs). Although these active substances are no longer authorised within the European Union, MRLs were established by the Codex Alimentarius Commission (codex maximum residue limits; CXLs), and import tolerances are in place. Based on the assessment of the available data, toxicological reference values and MRL proposals were derived and a consumer risk assessment was carried out. Some information required by the regulatory framework was found to be missing and a possible acute risk to consumers was identified. Hence, the consumer risk assessment was considered indicative only and all MRL proposals derived by EFSA still require further consideration by risk managers. In October 2022, to ensure that MRLs derived by EFSA in its assessment of 2021 are safe for consumers also in view of endocrine‐disrupting properties, EFSA was requested to carry out a follow‐up assessment taking into account the scientific criteria for identifying endocrine disruptors (ED). Based on the outcome of the assessment, the experts agreed that the reference values are also covering the concern related to the identified hazards indicative of endocrine disruption for thiophanate‐methyl. No further considerations on the impact of the ED assessment on the current reference values were needed for carbendazim since the ED criteria are not met for this substance. Therefore, the risk assessment and the MRL recommendations derived in 2021 are confirmed.

Abstract This report by the European Food Safety Authority and the European Centre for Disease prevention and Control, provides an overview of the main findings of the 2021–2022 harmonised Antimicrobial Resistance (AMR) monitoring in Salmonella spp., Campylobacter jejuni and C. coli from humans and food‐producing animals (broilers, laying hens and fattening turkeys, fattening pigs and cattle under one year of age) and relevant meat thereof. For animals and meat thereof, AMR data on indicator commensal Escherichia coli, presumptive extended‐spectrum beta‐lactamases (ESBL)‐/AmpC beta‐lactamases (AmpC)−/carbapenemase (CP)‐producing E. coli, and the occurrence of methicillin‐resistant Staphylococcus aureus (MRSA) are also analysed. Generally, resistance levels differed greatly between reporting countries and antimicrobials. Resistance to commonly used antimicrobials was frequently found in Salmonella and Campylobacter isolates from humans and animals. In humans, increasing trends in resistance to one of two critically antimicrobials (CIA) for treatment was observed in poultry‐associated Salmonella serovars and Campylobacter, in at least half of the reporting countries. Combined resistance to CIA was however observed at low levels except in some Salmonella serovars and in C. coli from humans and animals in some countries. While CP‐producing Salmonella isolates were not detected in animals in 2021–2022, nor in 2021 for human cases, in 2022 five human cases of CP‐producing Salmonella were reported (four harbouring bla OXA‐48 or bla OXA‐48‐like genes). The reporting of a number of CP‐producing E. coli isolates (harbouring bla OXA‐48, bla OXA‐181, bla NDM‐5 and bla VIM‐1 genes) in fattening pigs, cattle under 1 year of age, poultry and meat thereof by a limited number of MSs (5) in 2021 and 2022, requires a thorough follow‐up. The temporal trend analyses in both key outcome indicators (rate of complete susceptibility and prevalence of ESBL‐/AmpC‐producers in E. coli) showed an encouraging progress in reducing AMR in food‐producing animals in several EU MSs over the last 7 years.

Abstract On 24 July 2020, the EFSA conclusion on the peer review of the pesticide risk assessment of the active substance captan drawn in the context of the renewal of approval of the active substance captan conducted in accordance with Commission Implementing Regulation (EC) No 844/2012 was approved. In December 2023, the European Commission asked EFSA to provide a statement on its view as regards the RMS's revised environmental risk assessment concerning some uses in pome fruits and cherries and the potential impact of the recent new classification recommended by RAC on the toxicological reference values of captan stated in the EFSA Conclusion. The current statement contains the conclusions of the considerations related to the environmental revised risk assessment performed by the RMS, Austria, and to the new classification proposed by RAC on the toxicological reference values.

Abstract Aiming at accelerating the implementation of cumulative risk assessment to pesticide residues, this report describes a two‐step prioritisation analysis, on individual pesticides and on target organ systems, that allows to identify (i) low‐priority substances expected to have a marginal contribution to cumulative risk, and (ii) high priority organ systems to be addressed in future cumulative risk assessments. The analysis encompassed 350 substances and 36 raw primary commodities of plant origin surveyed in the monitoring cycle 2019–2021, carried out in 30 population groups, covering 3 age classes, and 17 EU countries. Probabilistic exposure calculations, for chronic and acute effects, were executed on the occurrence and consumption data by a two‐dimensional procedure, modelling variability and uncertainty. In the first step, the prioritisation method adopted allowed to reduce the number of substances by about 80%. These substances were in turn grouped based on their capacity to cause toxicological effects on common organ systems and, as second step, probabilistic combined exposure calculations were carried out for 16 target organ systems. This step allowed to identify the organ systems that need further assessment, reducing their initial number by about 70%. The organ systems would need to be prioritised as follows: reproductive and developmental toxicity, liver, kidney, male reproductive system, and haematopoietic system and haematology. The sources of uncertainty stemming from the modelling procedure and from methodological assumptions were discussed and their impact qualitatively assessed. Overall, it was concluded that the risk estimates for the different organ systems were more likely to be overestimated than underestimated.

Abstract The applicant Detia Freyberg GmbH submitted to the competent national authority in Germany two requests to evaluate the confirmatory data that were identified for tree nuts, oilseeds, cereals and commodities of animal origin in the framework of the maximum residue level (MRL) review under Article 12 of Regulation (EC) No 396/2005 as not available and two requests in accordance with Article 6 of Regulation (EC) No 396/2005 to increase the existing MRL for the active substance aluminium phosphide in peanuts, barley, oat, rye, rice and wheat, roots of herbal infusions, cocoa beans and seed spices and for the active substance magnesium phosphide in oilseeds (except peanuts) and pistachios. The four applications were combined by EFSA under the current assessment. To address the data gaps, validation data for the method of analysis for enforcement of phosphide in high‐oil content commodities and new residue trials were submitted. The data gaps on additional residue trials supporting authorisations on oilseeds and cereal grains, on clarifications regarding the discrepancies observed in the residue trial results for pistachios, and on data confirming the negligible occurrence of phosphane and its oxidation products in livestock products were considered addressed. The data gap on independent laboratory validation (ILV) and a confirmatory method for monitoring of phosphide in high‐oil content commodities was considered not fully addressed. The information provided justified a lowering of the current tentative MRLs for the whole group of cereals (except rice and ‘others’), an increase of the current tentative MRLs for pistachios, the whole group of oilseeds, rice and ‘other’ cereals, herbal infusions from roots, cocoa beans and seed spices, and a revision of the risk assessment performed for phosphane and its phosphide salts. Based on the risk assessment results, EFSA concluded that the short‐term and long‐term intake of residues resulting from the use of AlP and Mg3P2 according to the reported agricultural practices is unlikely to present a risk to consumer health. Further risk management considerations are required.

Abstract EFSA was asked by the European Commission to provide scientific assistance with respect to the EFSA adopted scientific opinion on ‘Safety of calcidiol monohydrate produced by chemical synthesis as a novel food pursuant to Regulation (EU) 2015/2283’, including its bioavailability as a metabolite of vitamin D3 when added for nutritional purposes to food supplements. On 5 July 2023, EFSA adopted the ‘Scientific opinion on the tolerable upper intake level for vitamin D, including the derivation of a conversion factor for calcidiol monohydrate’. This opinion concerns an updated exposure assessment for vitamin D and proposes a conversion factor for calcidiol monohydrate into vitamin D3 of 2.5 for labelling purposes. In addition, in reference to the EFSA opinion on the safety of calcidiol monohydrate, the Commission had received a letter from the pharmaceutical company EirGen Pharma Ltd requesting a revision of this opinion based on new data concerning calcidiol. Based on the information and data considered in this scientific technical report, EFSA concludes that the novel food calcidiol monohydrate proposed for use in food supplements is a bioavailable source of the biologically active metabolite of vitamin D, i.e. 1,25‐dihydroxyvitamin D, that a conversion factor of 2.5 reflects the relative bioavailability of calcidiol vs vitamin D3 under the proposed conditions of use and use levels, and that it is safe under the proposed conditions of use and use levels, i.e. up to 10 μg/day for children ≥ 11 years old and adults, including pregnant and lactating women, and up to 5 μg/day for children 3–10 years of age.

Abstract In accordance with Article 6 of Regulation (EC) No 396/2005, the applicant Corteva Agriscience International Sàrl submitted a request to the competent national authority in Finland to modify the existing maximum residue levels (MRLs) for the active substance clopyralid in honey. The data submitted in support of the request were found to be sufficient to derive MRL proposals for honey. Adequate analytical methods for enforcement are available to control the residues of clopyralid (including potential conjugates) in honey at the validated limit of quantification (LOQ) of 0.001 mg/kg. Based on the risk assessment results, EFSA concluded that the short‐term and long‐term intake of clopyralid residues in honey, resulting from the authorised use of clopyralid on oilseed rape notified in the present MRL assessment, is unlikely to present a risk to consumer health.

Abstract In accordance with Article 6 of Regulation (EC) No 396/2005, the applicant ISK Biosciences Europe N.V. submitted two requests to the competent national authority in Finland and Belgium, respectively, to modify the existing maximum residue levels (MRLs) for the active substance flonicamid in potatoes and in various crops. The data submitted in support of the requests were found to be sufficient to derive MRL proposals for potatoes, lettuces and salad plants, spinaches and similar leaves, beans (without pods), cardoons, celeries, Florence fennels and rhubarbs. Adequate analytical methods for enforcement are available to control the residues according to the residue definition as of the sum of flonicamid, TFNA and TFNG, expressed as flonicamid in the plant matrices under consideration at the validated limit of quantification (LOQ) of 0.01 mg/kg for each compound. Based on the risk assessment results, EFSA concluded that the short‐term and long‐term intake of residues resulting from the uses of flonicamid according to the reported agricultural practices is unlikely to present a risk to consumer health.

Abstract Regulation (EC) No 396/2005 establishes the rules governing the setting and the review of pesticide maximum residue levels (MRLs) at European level. According to Article 12(1) of Regulation (EC) No 396/2005, EFSA shall provide within 12 months from the date of the inclusion or non‐inclusion of an active substance in Annex I to Directive 91/414/EEC a reasoned opinion on the review of the existing MRLs for that active substance. Among the active substances that need to be reviewed under Article 12(1), EFSA identified two active substances for which a review of MRLs is no longer considered necessary. EFSA prepared a statement explaining the reasons why a review of MRLs for these substances became obsolete. The relevant question numbers are considered addressed by this statement.

Abstract The conclusions of the EFSA following the peer review of the initial risk assessments carried out by the competent authority of the rapporteur Member State, France, and co‐rapporteur Member State, Austria, for the pesticide active substance pydiflumetofen and the assessment of applications for maximum residue levels (MRLs) are reported. The context of the peer review was that required by Regulation (EC) No 1107/2009 of the European Parliament and of the Council. The conclusions were reached on the basis of the evaluation of the representative uses of pydiflumetofen as a fungicide field application on pome fruits, grapes, potato, fruiting vegetables, cucurbits and Brassica vegetables and updated following the request from Commission to consider additional information submitted and review the risk assessment. The reliable endpoints, appropriate for use in regulatory risk assessment and the proposed MRLs, are presented. Missing information identified as being required by the regulatory framework is listed. Concerns are reported where identified.

Abstract This report by the European Food Safety Authority and the European Centre for Disease Prevention and Control presents the results of the zoonoses monitoring and surveillance activities carried out in 2022 in 27 Member States (MSs), the United Kingdom (Northern Ireland) and 11 non‐MSs. Key statistics on zoonoses and zoonotic agents in humans, food, animals and feed are provided and interpreted historically. In 2022, the first and second most reported zoonoses in humans were campylobacteriosis and salmonellosis, respectively. The number of cases of campylobacteriosis and salmonellosis remained stable in comparison with 2021. Nineteen MSs and the United Kingdom (Northern Ireland) achieved all the established targets in poultry populations for the reduction of Salmonella prevalence for the relevant serovars. Salmonella samples from carcases of various animal species, and samples for Campylobacter quantification from broiler carcases, were more frequently positive when performed by the competent authorities than when own checks were conducted. Yersiniosis was the third most reported zoonosis in humans, followed by Shiga toxin‐producing Escherichia coli (STEC) and Listeria monocytogenes infections. L. monocytogenes and West Nile virus infections were the most severe zoonotic diseases, with the most hospitalisations and highest case fatality rates. In 2022, reporting showed an increase of more than 600% compared with 2021 in locally acquired cases of human West Nile virus infection, which is a mosquito‐borne disease. In the EU, the number of reported foodborne outbreaks and cases, hospitalisations and deaths was higher in 2022 than in 2021. The number of deaths from outbreaks was the highest ever reported in the EU in the last 10 years, mainly caused by L. monocytogenes and to a lesser degree by Salmonella. Salmonella and in particular S. Enteritidis remained the most frequently reported causative agent for foodborne outbreaks. Norovirus (and other calicivirus) was the agent associated with the highest number of outbreak human cases. This report also provides updates on brucellosis, Coxiella burnetii (Q fever), echinococcosis, rabies, toxoplasmosis, trichinellosis, infection with Mycobacterium tuberculosis complex (focusing on Mycobacterium bovis and Mycobacterium caprae) and tularaemia.

Abstract According to Article 12 of Regulation (EC) No 396/2005, EFSA has reviewed the maximum residue levels (MRLs) currently established at European level for the pesticide active substance zoxamide. To assess the occurrence of zoxamide residues in plants, processed commodities, rotational crops and livestock, EFSA considered the conclusions derived in the framework of Regulation (EC) No 1107/2009, the MRLs established by the Codex Alimentarius Commission and the European authorisations reported by Member States and the UK (including the supporting residues data). Based on the assessment of the available data, MRL proposals were derived, and a consumer risk assessment was carried out. Although no apparent risk to consumers was identified, some information required by the regulatory framework was missing. Hence, the consumer risk assessment is considered indicative only and some MRL proposals derived by EFSA still require further consideration by risk managers. Furthermore, in accordance with Article 6 of Regulation (EC) No 396/2005, the Applicant Gowan Crop Protection Ltd, submitted a request to the competent national authority in Latvia to set an import tolerance for zoxamide in onions (extrapolated to garlic and shallots) based on the use authorised in USA. The data submitted in support of the request were found to be sufficient to derive MRL proposals for all crops under assessment. Based on the risk assessment results, EFSA concluded that the short‐term and long‐term intake of residues resulting from the use of zoxamide according to the agricultural practices on onions, garlic and shallots is unlikely to present a risk to consumer health.

Abstract In accordance with Article 6 of Regulation (EC) No 396/2005, the applicant Syngenta Crop Protection AG submitted a request to the competent national authority in the Netherlands to modify the existing maximum residue level (MRL) for the active substance mandipropamid in radish leaves (classified under the subgroup of kales), based on an intended indoor use on radishes. The residue data in radish leaves submitted in support of the request were found to be sufficient to derive an MRL proposal for this commodity. Adequate analytical methods for enforcement are available to control the residues of mandipropamid on the commodity under consideration at the validated limit of quantification (LOQ) of 0.01 mg/kg. Based on the risk assessment results, EFSA concluded that long‐term intake of residues resulting from the use of mandipropamid according to the reported agricultural practice is unlikely to present a risk to consumer health. The reliable end points, appropriate for use in regulatory risk assessment are presented.

Abstract In accordance with Article 43 of Regulation (EC) 396/2005, EFSA received a request from the European Commission to review the existing maximum residue levels (MRLs) for the non‐approved active substance chlorfenapyr in view of the possible lowering of the MRL set for tea. This current EU MRL is based on an import tolerance established in 2007. EFSA reviewed the toxicological data assessed by other scientific bodies, proposing toxicological reference values to be used for an indicative risk assessment, noting that the values are affected by additional, non‐standard uncertainties. According to the indicative chronic and acute dietary risk assessment the existing MRL for tea does not pose an unacceptable risk for consumers. Further risk management discussions are required to decide which of the risk management options proposed by EFSA should be implemented in the EU MRL legislation.

Abstract In accordance with Article 6 of Regulation (EC) No 396/2005, the applicant Bayer AG, Crop Science Division submitted a request to the competent national authority in the Netherlands to modify the existing maximum residue levels (MRL) and to set import tolerances for flupyradifurone and its metabolite difluoroacetic acid (DFA) in various plant commodities. The data submitted in support of the request were found to be sufficient to derive MRL proposals for flupyradifurone and DFA in avocados, mangoes, papayas, asparagus, sesame seeds, sunflower seeds, sugar beet roots and chicory roots. Adequate analytical methods for enforcement are available to control the residues of flupyradifurone and DFA in plant matrices under consideration at the validated limits of quantification (LOQs) of 0.01 and 0.007 mg/kg, respectively. Based on the risk assessment results, EFSA concluded that the short‐term and long‐term intake of flupyradifurone and DFA residues resulting from the use of flupyradifurone according to the reported agricultural practices is unlikely to present a risk to consumer health.

Abstract In accordance with Article 6 of Regulation (EC) No 396/2005, the Federal Public Service (FPS) Health, Food chain Safety and Environment submitted a request on behalf of Belgium (evaluating Member State, EMS) to modify the existing maximum residue levels (MRL) in okra/lady's fingers and various leaf vegetables, herbs and edible flowers. The data submitted in support of the request were found to be sufficient to derive MRL proposals for all crops under assessment. Adequate analytical methods for enforcement are available to control the residues of sulfoxaflor in plant matrices under consideration at the validated limit of quantification (LOQ) of 0.01 mg/kg. Based on the risk assessment results, EFSA concluded that the short‐term and long‐term intake of residues resulting from the use of sulfoxaflor according to the reported agricultural practices is unlikely to present a risk to consumer health.

Abstract All European Union (EU) Member States (MSs) are required to implement surveillance for avian influenza (AI) in poultry and wild birds and (i) to notify the outbreaks, when relevant and (ii) to report the results to the responsible authority. In addition, Iceland, Norway, Switzerland and the United Kingdom (Northern Ireland) also implement ongoing surveillance programmes to monitor occurrences of avian influenza viruses (AIVs) in poultry and wild birds. EFSA received a mandate from the European Commission to collate, validate, analyse and summarise the data resulting from these AI surveillance programmes in an annual report. The present report summarises the results of the surveillance activities carried out in MSs, Iceland, Norway, Switzerland and the United Kingdom (Northern Ireland) in 2022. Overall, the 31 reporting countries (RCs) sampled 22,171 poultry establishments (PEs) during the 2022 surveillance activity: 18,490 PEs were sampled for serological testing and 3775 were sampled for virological testing. Some PEs were therefore sampled for both type of analytical methods. Out of the 18,490 PEs sampled for serological testing, 15 (0.08%) were seropositive for influenza A(H5) viruses. Out of the 3775 PEs sampled for virological testing, 74 PEs (1.96%) were positive to the virological assay for influenza A(H5) viruses. Seropositive PEs were found in four RCs (Belgium, Poland, Spain and Sweden) and as in previous years, the highest percentages of seropositive PEs were found in PEs raising breeding geese and waterfowl game birds. Out of these 15 seropositive PEs, 3 also tested positive by polymerase chain reaction (PCR) for influenza A (H5) viruses – 2 for highly pathogenic avian influenza virus (HPAIV) and 1 low pathogenic avian influenza (LPAI) (H5N3). In relation to the virological surveys, 10 RCs (32%) out of the 31 reported the detection of A (H5) viruses in 74 PEs, covering 12 different poultry categories. More specifically, 54 reported HPAIV A(H5N1), 17 HPAIV (H5N8), 2 AIV (H5N1) with unknown virus pathogenicity and 1 low pathogenic avian influenza (LPAI) (H5N3). Additionally, six PEs tested positive for undefined AIVs in three RCs. A total of 32,143 wild birds were sampled, with 4163 (12.95%) wild birds testing positive for HPAIVs by PCR, from 25 RCs. In contrast to previous years, out of the 4163 wild birds testing positive for HPAIv, subtype A(H5N1) virus was the main influenza A virus subtype identified among the wild bird testing positive for HPAIVs (3942; 95%). In addition, RCs also reported 984 wild birds testing positive for low pathogenic avian influenza (LPAI). Out of those, for 660 (67%) it was ascertained that the subtype was non‐A(H5/H7); 260 (26%) wild birds tested positive for LPAIv of A(H5 or H7) subtypes and the remaining 64 (7%) LPAI viruses were belonging to other H‐subtypes.

Abstract In accordance with Article 43 of Regulation (EC) 396/2005, EFSA received a request from the European Commission to review the existing maximum residue levels (MRLs) for the non‐approved active substance profenofos in view of the possible lowering of the MRL. EFSA investigated the origin of the current EU MRLs. Existing EU MRLs are based on Codex Maximum Residue Limits still in place or reflect temporary MRLs set from monitoring data. EFSA performed an indicative chronic and acute dietary risk assessment for the list of MRLs to allow risk managers to take the appropriate decisions. For some commodities, further risk management discussions are required to decide which of the risk management options proposed by EFSA should be implemented in the EU MRL legislation.

Abstract Following a request from the European Commission, the European Food Safety Authority (EFSA) assessed the 2021 post‐market environmental monitoring (PMEM) report on the cultivation of Cry1Ab‐expressing maize event MON 810. Evidence provided in the PMEM report shows that farmers growing maize MON 810 in Spain complied partially with refuge requirements, while full compliance was achieved in Portugal. Cry1Ab susceptibility tests performed on European and Mediterranean corn borer populations collected from north‐eastern Spain in 2021 indicated no symptoms of resistance evolution to maize MON 810. However, unexpected damage to maize MON 810 plants was observed in a field trial in the province of Girona (north‐eastern Spain), which may point to the presence of resistance alleles in this region. Information retrieved through farmer questionnaires and the scientific literature reveals no unanticipated adverse effects on human and animal health or the environment arising from the cultivation of maize MON 810. Overall, EFSA concludes that the evidence reported in the 2021 PMEM report does not invalidate its previous conclusions on the safety of maize MON 810. The possible presence of Cry1Ab resistance alleles at frequencies leading to damage to maize MON 810 plants in Girona requires twofold actions: (1) increase monitoring efforts in this area; and (2) implement remedial measures to limit the suspected evolution and spread of resistance. As in previous years, EFSA identified shortcomings on resistance monitoring that need revision. In particular, full refuge compliance must be achieved in Spain. Moreover, the sensitivity of the monitoring plan must be increased, which can be achieved by replacing the current susceptibility assays by periodic F2 screens. EFSA also recommends the consent holder to revise the farmer questionnaires to account for the emergence of teosinte as a noxious agricultural weed in maize MON 810‐growing areas in Spain.