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. The EFSA GMO Panel concluded that the available scientific literature shows that plants containing the types and numbers of genetic modifications used as criteria to identify category 1 NGT plants in the European Commission proposal do exist as the result of spontaneous mutations or random mutagenesis. Therefore, it is scientifically justified to consider category 1 NGT plants as equivalent to conventionally bred plants with respect to the similarity of genetic modifications and the similarity of potential risks. The EFSA GMO Panel did not identify any additional hazards and risks associated with the use of NGTs compared to conventional breeding techniques in its previous Opinions.

New developments in biotechnology applied to microorganisms.

EFSA was requested by the European Commission (in accordance with Article 29 of Regulation (EC) No 178/2002) to provide a scientific opinion on the application of new developments in biotechnology (new genomic techniques, NGTs) to viable microorganisms and products of category 4 to be released into the environment or placed on the market as or in food and feed, and to non-viable products of category 3 to be placed on the market as or in food and feed. A horizon scanning exercise identified a variety of products containing microorganisms obtained with NGTs (NGT-Ms), falling within the remit of EFSA, that are expected to be placed on the (EU) market in the next 10 years. No novel potential hazards/risks from NGT-Ms were identified as compared to those obtained by established genomic techniques (EGTs), or by conventional mutagenesis. Due to the higher efficiency, specificity and predictability of NGTs, the hazards related to the changes in the genome are likely to be less frequent in NGT-Ms than those modified by EGTs and conventional mutagenesis. It is concluded that EFSA guidances are 'partially applicable', therefore on a case-by-case basis for specific NGT-Ms, fewer requirements may be needed. Some of the EFSA guidances are 'not sufficient' and updates are recommended. Because possible hazards relate to genotypic and phenotypic changes introduced and not to the method used for the modification, it is recommended that any new guidance should take a consistent risk assessment approach for strains/products derived from or produced with microorganisms obtained with conventional mutagenesis, EGTs or NGTs.

Applying different levels of practice variability for motor learning: More is not better.

Background: Variable practice is a broadly used tool to improve motor learning processes. However, controversial results can be found in literature about the success of this type of practice compared to constant practice. This study explored one potential reason for this controversy: the manipulation of variable practice load applied during practice and its effects according to the initial performance level and the initial intrinsic variability of the learner. Method: Sixty-five participants were grouped into four practice schedules to learn a serial throwing task, in which the training load of variable practice was manipulated: one constant practice group and three groups with different variable practice loads applied. After a pre-test, participants trained for 2 weeks. A post-test and three retests (96 h, 2 weeks and 1 month) were carried out after training. The participants' throwing accuracy was assessed through error parameters and their initial intrinsic motor variability was assessed by the autocorrelation coefficient of the error. Results: The four groups improved their throwing performance. Pairwise comparisons and effect sizes showed larger error reduction in the low variability group. Different loads of variable practice seem to induce different performance improvements in a throwing task. The modulation of the variable practice load seems to be a step forward to clarify the controversy about its benefits, but it has to be guided by the individuals' features, mainly by the initial intrinsic variability of the learner.

Analysis of Concentric and Eccentric Power in Flywheel Exercises Depending on the Subjects' Strength Level and Body Mass.

ABSTRACT: Asencio, P, García-Valverde, A, Albaladejo-García, C, Beato, M, Moreno-Hernández, FJ, and Sabido, R. Analysis of concentric and eccentric power in flywheel exercises depending on the subjects' strength level and body mass. J Strength Cond Res XX(X): 000-000, 2024-The objective of this study is to describe how flywheel exercise mechanical outputs are affected by the athletes' body mass (BM) and strength level and by the exercise type. Forty-six recreational athletes came to a laboratory 3 times. On the first day, descriptive data, squat (1 repetition maximum: 1RM) and flywheel familiarization were performed. After a second day of familiarization, subjects performed a randomized flywheel exercise-testing protocol of squat and split squat exercises. The variables used for data analysis were peak concentric power and peak eccentric power, eccentric/concentric ratio, and their relationship with 1RM/BM. Subjects were assigned to a stronger or weaker group according to their 1RM/BM ratio. Group differences were found in absolute values of eccentric overload (EOL) (p < 0.01; effect size [ES] = 0.51) and EOL/BM (p < 0.01; ES = 0.46) only in the split squat. Absolute power values in the concentric phase showed differences between inertial load (p < 0.01; ES = 0.41). The stronger group did not present significant differences between inertial loads during squat (p < 0.01; ES = 0.46), but they showed different ratios with light inertias in comparison with the weaker group (p < 0.01; ES = 0.46). There were significant differences between groups with light inertias in split squat (nondominant) and squat exercises (p < 0.05; ES = 0.29) in the eccentric and concentric phases (p < 0.116; ES = 0.20). Squat and split squat exercises present different profiles depending on the training level. In conclusion, it is recommended that practitioners perform a test to understand the inertial load-power profile (concentric, eccentric, and their ratio) for each exercise and also consider the user's strength level for selection of the inertial load and for the exercise to use in training.

Effects of variable intensity and constant intensity flywheel resistance training programs on specific soccer players' performance.

Resistance training programs play a crucial role in optimizing soccer performance. The aim of this study is to compare performance outcomes in sport-specific tasks after implementing two different flywheel resistance training (FRT) programs: variable intensity (VI) and constant intensity (CI). Seventeen (n = 17) amateur footballers were divided into VI and CI groups with the same training volume. For the VI group, a decrease in inertial load was implemented every four sessions, whereas the CI group maintained a constant load during the entire program. After different familiarization sessions and testing (sprint, change of direction, jump, one-repetition maximum and flywheel strength variables), ten sessions of FRT were performed over 5 weeks. Both groups showed similar improvements in the one-repetition maximum (p < 0.01) but the CI group had significant improvements in the 10-m sprint (p = 0.04; ES = 0.72), emphasizing the potential benefits of medium inertial loads to maximize power and specificity in sport tasks. However, no significant differences were observed in the countermovement jump, change of direction and 30-m sprint, possibly attributed to neuromuscular fatigue from a high-volume training schedule and friendly matches. The study highlights the importance of considering training load distribution in FRT programs. The findings emphasize the need for complementary training to maximize the jump and change of direction abilities and caution against high-volume training and friendly match scenarios. In conclusion, FRT programs, whether varying in intensity or not, can yield medium-term performance improvements for soccer players.

Liver Histopathological and Immunohistochemical Evaluation from Fasciola hepatica Experimentally Infected and Reinfected Sheep.

Fasciolosis is an important economic disease of livestock. There is a global interest in the development of protective vaccines since the current anthelmintic therapy is no longer sustainable. A better knowledge of the host-parasite interaction is needed to design effective vaccines. To date, few studies have evaluated host-parasite interaction by comparing infected and reinfected animals. The present study evaluates the microscopical hepatic lesions in sheep infected and reinfected with Fasciola hepatica during the acute and chronic stages of infection. The histopathological study revealed the presence of necrotizing foci (NF1) associated with larvae migration during the early stages of infection in the primoinfected (PI) and reinfected (RI) groups. In the late stages of infection of the PI group and at the early and late stages of infection in the RI groups, extensive necrotizing/hemorrhagic foci (NF2) were found in the vicinity of enlarged bile ducts, some containing adult flukes, suggesting parasites may have caused NF2 while feeding. The immunohistochemical study revealed an increase in Foxp3+ T cells in both PI and RI groups with respect to the UC group and in the infiltrates adjacent to NF1 in the RI groups with respect to the PI group, suggesting the F. hepatica induce Foxp3 T cell expansion to facilitate parasite survival. In addition, in both the PI and RI groups, and during acute and chronic stages of the infection, a poor expression of iNOS was found accompanied by a strong expression of CD163, suggesting a marked M2 activation of macrophages in the hepatic lesions, which may be related with healing processes, and it also may facilitate parasite survival. The main differences between PI and RI animals were the more severe infiltration of eosinophils and Foxp3+ T cells, whereas RI did not modify M2 activation of macrophages which occurs since the early stages of primoinfection.

Prevalence of Gastrointestinal Parasites in Small Ruminant Farms in Southern Spain.

The primary population of small ruminants in Spain is concentrated in the southern region, a critical area for the country's livestock production. Indirect economic losses can occur when this livestock is affected by gastrointestinal parasites. This study aimed to determine the prevalence of these parasites in small ruminant herds (159 sheep and 39 goats) through coprological analyses and conducted a survey on farmers' management practices related to gastrointestinal parasite control. The survey results revealed some important aspects: monitoring through coprological analyses is not a common practice; veterinarians are not typically involved in deworming plans; anthelmintic treatment in adults is often applied twice a year in sheep and once a year in goats; and finally, drug rotation was higher in sheep farms. Coprological analyses showed Eimeria spp. as the most common parasitic infection, followed by Strongyles infection. Other parasites like Moniezia spp., Trichuris spp., and D. dendriticum were less important, although their prevalence was higher in sheep than goats. This constitutes the first report on the epidemiological status of gastrointestinal parasites in small ruminants in southern Spain. Based on the survey findings, the introduction of certain management measures on farms could potentially mitigate parasite infections.

Assessment of visuospatial functions in post-Covid 19 patients: Beyond the traditional paradigm.

Several studies indicate that some cognitive changes occur after COVID-19. Visuospatial alterations have been reported in 24-40 %. These alterations may be useful as early biomarkers of neurodegenerative disease. Thus, we can emphasize the importance of visuospatial processes in cognition through quantitative and qualitative analysis of performance on the Clock Test (CDT) and the Rey-Osterrieth Complex Figure (FCRO). Our objective was to describe the performance of post COVID 19 patients in visuospatial tests, with different degrees of respiratory impairment and to perform a qualitative analysis of the performance to check its relationship with alterations in attention and executive functions. This will allow highlighting the executive component of the performance of the CDT and ROCF and differentiate patients with possible cognitive impairment. 77 patients with SARS-CoV-2 infection were evaluated (3 months post-infection) with a complete neuropsychological battery and MRI. Overall, there is a significant difference between FCRO and CDT, with FCRO having only 9 % change and CDT having 51.9 % change. Regarding the correlations observed between groups (VM Inv, VM non I and non hospitalized) the highest correlations were observed between Boston with FCRO copy (r=0.497; p=0.001) and with FCRO memory (r=0.429; p=0.001). Comparing the performance between groups by severity, significant differences were observed only in the TMT A (13.706 p=0.001) and B (9.583 p=0.008) tests and in the phonological fluency letter A (13.445 p=0.001), we observed that the group of non-hospitalized patients had a better performance. Neuropsychological deficits often have a direct impact on daily life by affecting the ability to learn and adapt. Thus, a useful strategy for the neuropsychological characterization of post-COVID-19 patients is the qualitative analysis of visuospatial abilities in conjunction with executive functions that cannot be analyzed in isolation.

Comparison of baseline clinical characteristics among people with type 2 diabetes on second-line therapy previously added with dapagliflozin or another oral glucose-lowering drug: AGORA study.

INTRODUCTION: Type 2 diabetes mellitus (T2D) has acquired epidemic proportions worldwide. In recent years, new oral glucose-lowering drugs (OGLD) have emerged that improve the cardiovascular-kidney-metabolic control in T2D people. OBJECTIVES: To compare the baseline clinical-biological characteristics among T2D people to whom had added-on dapagliflozin (DAPA group) or another OGLD (SOC group) second-line hypoglycaemic therapies among the AGORA study population. METHODS: This is a multicentre cross-sectional observational study of the baseline characteristics of T2D people recruited through competitive sampling among 46 primary care health centres in Spain for the AGORA study. The inclusion and exclusion criteria of participants, and justification of the sample size are reported. After verifying the data necessary to be evaluated and informed consent, 317 subjects were included to the DAPA group and 288 to the SOC group. Both categorical and continuous variables were analysed and compared with the usual statistics. Cohen's d was used to assess the standardised difference in means. RESULTS: Six hundred and five patients with T2D were assessed (mean age 63.5 [SD±8.1] years, 61.8% men), whom 17.4% were smokers, 47.6% had obesity, 74.8% hypertension, 87.3% dyslipidaemia, and 41.7% reported physical inactivity, with no significant differences between both comparison groups. The mean (SD) evolution time of T2D was 10.1 (5.6) years. Most baseline clinical-biological characteristics at recruitment were similar in both groups. However, DAPA group was younger (2.9 years), and had lower systolic blood pressure (SBP) (2.8mmHg), higher body weight (BW) (3.7kg), and higher glycated haemoglobin A1c (HbA1c) (0.3%) than SOC group. Only 11.5% of participants had poor glycaemic control (HbA1c>8%) at recruitment, 54.9% had good glycaemic control (HbA1c<7%), being significantly lower in the DAPA group (47.3%) than in the SOC group (63.4%). The percentage of T2D patients with high vascular risk (VR) was 46.3%, and 53.7% with very high VR, being significantly higher in the DAPA group (57.4%) than in the SOC group (49.6%). CONCLUSIONS: Most baseline cardiovascular-kidney-metabolic characteristics were similar in T2D patients whom had added dapagliflozin on second-line hypoglycaemic therapy as those whom had added-on another OGLD. However, patients whom had added-on dapagliflozin had higher VR, lower SBP, higher BW, and slightly worse HbA1c control. Future research is necessary to explain the causes of these differences in cardiometabolic control.

NP-12 peptide functionalized nanoparticles counteract the effect of bacterial lipopolysaccharide on cultured osteoblasts.

OBJECTIVE: To evaluate whether nanoparticles (NPs) functionalized with Tideglusib (TDg, NP-12), and deposited on titanium surfaces, would counteract the effect of bacterial lipopolysaccharide (LPS) on osteoblasts. METHODS: Experimental groups were: (a) Titanium discs (TiD), (b) TiD covered with undoped NPs (Un-NPs) and (c) TiD covered with TDg-doped NPs (TDg-NPs). Human primary osteoblasts were cultured onto these discs, in the presence or absence of bacterial LPS. Cell proliferation was assessed by MTT-assay and differentiation by measuring the alkaline phosphatase activity. Mineral nodule formation was assessed by the alizarin red test. Real-time quantitative polymerase chain reaction was used to study the expression of Runx-2, OSX, ALP, OSC, OPG, RANKL, Col-I, BMP-2, BMP-7, TGF-ß1, VEGF, TGF-ßR1, TGF-ßR2, and TGF-ßR3 genes. Osteoblasts morphology was studied by Scanning Electron Microscopy. One-way ANOVA or Kruskal-Wallis and Bonferroni multiple comparisons tests were carried out (p < 0.05). RESULTS: TDg-NPs enhanced osteoblasts proliferation. Similarly, this group increased ALP production and mineral nodules formation. TDg-NPs on titanium discs resulted in overexpression of the proliferative genes, OSC and OSX, regardless of LPS activity. In the absence of LPS, TDg-NPs up-regulated Runx2, COL-I, ALP, BMP2 and BMP7 genes. OPG/RANKL gene ratios were increased about 2500 and 4,000-fold by TDg-NPs, when LPS was added or not, respectively. In contact with the TDg-NPs osteoblasts demonstrated an elongated spindle-shaped morphology with extracellular matrix production. SIGNIFICANCE: TDg-NPs on titanium discs counteracted the detrimental effect of LPS by preventing the decrease on osteoblasts proliferation and mineralization, and produced an overexpression of proliferative and bone-promoting genes on human primary osteoblasts.

Factor structure and measurement invariance of the Patient Health Questionnaire-4 among the Chilean population.

BACKGROUND: The PHQ-4 is an ultrabrief screening test for depression and anxiety symptoms. The psychometric properties of this test among the population in Chile are unknown. This study was aimed to determine the factor structure of the PHQ-4 in the adult population in Chile, and to assess its measurement invariance across different groups. METHODS: The study considered a nationally representative sample of 10921 people aged 18 and above, in Chile in 2021. Exploratory and confirmatory factor analysis were conducted, and configural, metric, scalar, and strict measurement invariance were assessed. RESULTS: The two-factor structure of the PHQ-4 supported the two underlying constructs of depression and anxiety. This model explained 67% of the variance and had excellent fit (CFI: 0.9999; TLI: 0.9994; RMSEA: 0.0107; SRMR: 0.0022). Strict measurement invariance held across gender, age, area of residence, household income quintile, immigrant or host population, and indigenous or non-indigenous population (ΔCFI<0.01). CONCLUSION: The PHQ-4 can be used to assess depressive and anxiety symptoms in population studies, and as a screening test for depression and anxiety in public mental health programs in Chile.

Siderophores and competition for iron govern myxobacterial predation dynamics.

Bacterial predators are decisive organisms that shape microbial ecosystems. In this study, we investigated the role of iron and siderophores during the predatory interaction between two rhizosphere bacteria: Myxococcus xanthus, an epibiotic predator, and Sinorhizobium meliloti, a bacterium that establishes nitrogen-fixing symbiosis with legumes. The results show that iron enhances the motility of the predator and facilitates its predatory capability, and that intoxication by iron is not used by the predator to prey, although oxidative stress increases in both bacteria during predation. However, competition for iron plays an important role in the outcome of predatory interactions. Using combinations of predator and prey mutants (non-producers and overproducers of siderophores), we have investigated the importance of competition for iron in predation. The results demonstrate that the competitor that, via the production of siderophores, obtains sufficient iron for growth and depletes metal availability for the opponent will prevail in the interaction. Consequently, iron fluctuations in soils may modify the composition of microbial communities by altering the activity of myxobacterial predators. In addition, siderophore overproduction during predation can alter soil properties, affecting the productivity and sustainability of agricultural operations.

Attitudes towards seeking psychological help among community dwelling older adults enrolled in primary care in Chile.

BACKGROUND: Depression and anxiety are common mental disorders among older adults, but they are frequently underdiagnosed. Attitudes towards seeking professional mental health care is one of the barriers to access to treatment. This study was aimed at assessing the attitudes towards seeking psychological help among older adults who are enrolled in primary care in Chile, and to determine the associated factors. METHODS: This cross-sectional study recruited 233 primary care users aged 65 or more years. The Attitudes Towards Seeking Professional Psychological Help was used. Reliability and factor analysis of this scale were carried out. The average scores of the scale and factors were calculated and compared, by selected variables. Multivariate linear regression was estimated to determine factors associated with attitudes towards seeking psychological help. RESULTS: Three factors were identified in the attitudes towards seeking psychological help: confidence in psychologists, coping alone with emotional problems, and predisposition to seek psychological help. On average, participants had a favorable attitude towards seeking psychological help, compared with previous research. Lower level of education, and risk of social isolation were inversely associated with these attitudes. CONCLUSION: Strategies to improve mental health literacy and social connection among older adults, could have an impact on factors that mediate the access to mental health care, such as attitudes towards seeking psychological help, among people who have a lower level of education or are at risk of social isolation.

Analysis of the Prognostic Factors That Influence the Outcome of Periapical Surgery, including Biomimetic Membranes for Tissue Regeneration: A Review.

The objective of this study was to analyze the prognostic factors that influence the outcome of periapical surgery. A systematic search of the literature was carried out using PubMed and Scopus databases between January 2000 and December 2023 with no language limitations. The PICO question of the present systematic review was: What prognostic factors may influence the outcome of periapical surgery? The most relevant randomized controlled clinical trials (RCTs), prospective clinical trials, retrospective studies, and meta-analyses (n = 44) were selected from 134 articles. The reviewed literature evidenced that bone-lesion healing could significantly be improved by the absence of deep periodontal pockets (>4 mm), localization in anterior teeth, the absence of pain and/or preoperative symptoms, a size of bone lesion < 5 mm, the use of ultrasound, the correct placement of retrograde filling material, and the use of different biomimetic membranes for guided tissue regeneration (GTR). Some preoperative and intraoperative factors could significantly improve the prognosis of periapical surgery. However, these results were not conclusive, and further high-quality research is required.

A novel membrane-based process to concentrate nutrients from sidestreams of an Urban Wastewater Treatment Plant through captured carbon dioxide from biogas.

Among the challenges that wastewater treatment plants face in the path towards sustainability, reducing CO2 emissions and decrease the amount of waste highlight. Within these wastes, those that can cause eutrophication, such as nutrients (nitrogen and phosphorous) are of great concern. Herein we study a novel process to concentrate nutrients via membrane technology. In particular, we propose the use of forward osmosis, applying the carbonated solvent which contains the CO2 captured from the biogas stream as draw solution. This carbonated solvent has a high potential osmotic pressure, which can be used in forward osmosis to concentrate the nutrients stream. To this end, we present the results of an experimental plan specifically designed and performed to evaluate two main parameters: (1) nutrients concentration; and (2) water recovery. The process designed involves pH adjustment, membrane filtration to separate solids, pH reduction and forward osmosis concentration of nutrients. With this process, concentrations factor for nutrients in between 2 and 2.5 and water recovery of approximately 50 % with water flux of 7 to 8 L/(m2h) can be achieved.

Aqueous mineral carbonation of three different industrial steel slags: Absorption capacities and product characterization.

Heavy carbon industries produce solid side stream materials that contain inorganic chemicals like Ca, Na, or Mg, and other metals such as Fe or Al. These inorganic compounds usually react efficiently with CO2 to form stable carbonates. Therefore, using these side streams instead of virgin chemicals to capture CO2 is an appealing approach to reduce CO2 emissions. Herein, we performed an experimental study of the mineral carbonation potential of three industrial steel slags via aqueous, direct carbonation. To this end, we studied the absorption capacities, reaction yields, and physicochemical characteristics of the carbonated samples. The absorption capacities and the reaction yields were analyzed through experiments carried out in a reactor specifically designed to work without external stirring. As for the physicochemical characterization, we used solid-state Fourier Transform Infrared Spectroscopy (FTIR), X-ray diffraction (XRD), and scanning electron microscope (SEM). Using this reactor, the absorption capacities were between 5.8 and 35.3 g/L and reaction yields were in the range of 81-211 kg CO2/ton of slag. The physicochemical characterization of the solid products with solid FTIR, XRD and SEM indicated the presence of CaCO3. This suggests that there is potential to use the carbonated products in commercial applications.

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. Under the assumption that the DNA sequences of the events in maize MON 89034 × 1507 × NK603 considered for renewal are identical to the sequences of the originally assessed events, the GMO Panel concludes that there is no evidence in renewal dossier GMFF-2022-3670 for new hazards, modified exposure or scientific uncertainties that would change the conclusions of the original risk assessment on maize MON 89034 × 1507 × NK603.

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 GA20ox_SUP 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. The Panel on Genetically Modified Organisms (GMO Panel) does not identify safety concerns regarding the toxicity and allergenicity of the GA20ox_SUP precursor-miRNA and derived mature miRNA as expressed in maize MON 94804 and finds no evidence that the genetic modification would change the overall allergenicity of maize MON 94804. In the context of this application, the consumption of food and feed from maize MON 94804 does not represent a nutritional concern in humans and animals. The GMO Panel concludes that maize MON 94804 is as safe as the conventional counterpart and non-GM maize varieties tested, and no post-market monitoring of food/feed is considered necessary. In the case of accidental release of viable maize MON 94804 grains into the environment, this would not raise environmental safety concerns. The post-market environmental monitoring plan and reporting intervals are in line with the intended uses of maize MON 94804. The GMO Panel concludes that maize MON 94804 is as safe as its conventional counterpart and the tested non-GM maize varieties with respect to potential effects on human and animal health and the environment.

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.V., 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 × MON 88017 × 59122 and 8 out of 10 of its subcombinations, 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. Under the assumption that the DNA sequences of the events in maize MON 89034 × 1507 × MON 88017 × 59122 and 8 out of 10 of its subcombinations considered for renewal are identical to the sequences of the originally assessed events, the GMO Panel concludes that there is no evidence in renewal dossier GMFF-2022-9170 for new hazards, modified exposure or scientific uncertainties that would change the conclusions of the original risk assessment on maize MON 89034 × 1507 × MON 88017 × 59122 and 8 out of 10 of its subcombinations.