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Milk is a complete and highly nutritious source of food for human beings. However, in many developing countries, including Ethiopia, the quality of milk products has become a major health concern for consumers, particularly for infants and children. Therefore, the aim of the present study was to assess the quality of raw and pasteurized milk marketed in Gondar city, Northwest Ethiopia. A laboratory-based cross-sectional study was conducted on 90 milk samples. The samples were chosen using a simple random sampling technique. For statistical analysis, ANOVA and the Pearson correlation coefficient were used. The specific gravity of pasteurized milk, farm milk, and milk vendors were found to be 1.021, 1.027, and 1.026, respectively. Farm milk, milk vendors, and pasteurized milk had fat contents of 3.38%, 3.22%, and 3.09%, respectively. The total bacterial count in pasteurized milk, farm milk, and milk vendors was found to be 7.08, 6.73, and 6.94 log10 CFU/mL, respectively. In raw milk, hydrogen peroxide (7.7%), formalin (7.7%), and water (3.8%) were found, whereas in pasteurized milk, hydrogen peroxide (50%), formalin (50%), and water (19.8%) were found. Based on the findings of this study, the quality of both raw and pasteurized milk was found to be poor as per the milk quality standards. This may cause significant public health-related problems. Therefore, an appropriate intervention should be conducted to improve the quality of milk.

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One route of human exposure to environmental chemicals is oral uptake. This is primarily true for chemicals that may leach from food packaging materials, such as bisphenols and phthalate esters. Upon ingestion, these compounds are transported along the intestinal tract, from where they can be taken up into the blood stream or distributed to mucosal sites. At mucosal sites, mucosal immune cells and in the blood stream peripheral immune cells may be exposed to these chemicals potentially modulating immune cell functions. In the present study, we investigated the impact of three common bisphenols and two phthalate esters on mucosal-associated invariant T (MAIT) cells in vitro, a frequent immune cell type in the intestinal mucosae and peripheral blood of humans. All compounds were non-cytotoxic at the chosen concentrations. MAIT cell activation was only slightly affected as seen by flow cytometric analysis. Phthalate esters did not affect MAIT cell gene expression, while bisphenol-exposure induced significant changes. Transcriptional changes occurred in ∼ 25 % of genes for BPA, ∼ 22 % for BPF and ∼ 8 % for BPS. All bisphenols down-modulated expression of CCND2, CCL20, GZMB and IRF4, indicating an effect on MAIT cell effector function. Further, BPA and BPF showed a high overlap in modulated genes involved in cellular stress response, activation signaling and effector function suggesting that BPF may not be safe substitute for BPA.

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In 2005 and 2010, the European Commission (EC) published two subsequent 'Road Maps' to provide options for relaxation of the bans on the application of animal proteins in feed. Since then, the food production system has changed considerably and demands for more sustainability and circularity are growing louder. Many relaxations envisioned in the second Road Map have by now been implemented, such as the use of processed animal proteins (PAPs) from poultry in pig feed and vice versa. However, some legislative changes, in particular concerning insects, had not been foreseen. In this article, we present a new vision on legislation for increased and improved use of animal by-products. Six current legislative principles are discussed for the bans on animal by-products as feed ingredients: feed bans; categorization of farmed animals; prohibition unless explicitly approved; approved processing techniques, the categorization of animal by-products, and monitoring methods. We provide a proposal for new guiding principles and future directions, and several concrete options for further relaxations. We argue that biological nature of farmed animals in terms of dietary preferences should be better recognised, that legal zero-tolerance limits should be expanded if safe, and that legislation should be revised and simplified.

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Background: This study aims to assess factors associated with food security and dietary diversity among poor urban households of western Oromia, Ethiopia, after the outbreak of the Covid-19 pandemic. Method: A cross-sectional, community-based study was conducted in May to June 2021 with 361 poor urban households in the Horo Guduru Wollega zone, western Oromia, Ethiopia. A pre-tested structured questionnaire was used to collect primary data. Twenty-four hour reminder points were used to assess household dietary diversity, and household food security was assessed using the Household Food Insecurity Access Scale tool. Data were evaluated using the statistical software SPSS version 25.0. Results: This study showed a prevalence of food insecurity in households of 59.6%. The mean and standard deviation of household dietary diversity values were 4.19 ± 1.844. Family size (AOR = 8.5; 95% CI:3.295-21.92), monthly income (AOR = 3.52; 95% CI; 1.771-6.986), dietary diversity (AOR = 8.5; 95% CI; 3.92-18.59), knowledge (AOR = 3.0, 95% CI = 1.08-)8.347), attitude (AOR = 8.35, 95% CI:3.112-22.39) and practices against Covid-19 (AOR = 2.12; 95% CI:1.299-11.4) were factors significantly associated with food insecurity. Variables like educational status (AOR = 3.46; 95% CI:1.44-8.312), increased family size after the Covid-19 pandemic (AOR = 2.26; 95% CI:1.02-5.04), food security (AOR = 6.7; 95% CI:4.01-19.01), knowledge (AOR = 3.96; 95% CI:1.57-10.0), attitude (AOR = 3.9; 95% CI:1.75-8.82) and practices toward coronavirus (AOR = 2.23; 95% CI:2.18-23.95) were predictors significantly associated with dietary diversity. Conclusion: This study concluded that family size, monthly income, and dietary diversity were factors contributed to household food security. On the other hand, variables such as educational status, family size, and food security were highly relevant factors for dietary diversity after the outbreak of the Covid-19 pandemic. Knowledge, attitudes, and practices were also variables related to both household food security and dietary diversity. Therefore, immediate interventions such as nutrition-specific interventions can be suggested to address food insecurity and problems of inadequate food intake in poor urban households. In addition, governmental and non-governmental organizations should raise awareness and policies to support those at higher risk by developing affordable, sustainable and targeted social protection systems that ensure food security and adequate dietary intake at the household level.

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The EU In-Vitro Diagnostic Device Regulation (IVDR) aims for transparent risk-and purpose-based validation of diagnostic devices, traceability of results to uniquely identified devices, and post-market surveillance. The IVDR regulates design, manufacture and putting into use of devices, but not medical services using these devices. In the absence of suitable commercial devices, the laboratory can resort to laboratory-developed tests (LDT) for in-house use. Documentary obligations (IVDR Art 5.5), the performance and safety specifications of ANNEX I, and development and manufacture under an ISO 15189-equivalent quality system apply. LDTs serve specific clinical needs, often for low volume niche applications, or correspond to the translational phase of new tests and treatments, often extremely relevant for patient care. As some commercial tests may disappear with the IVDR roll-out, many will require urgent LDT replacement. The workload will also depend on which modifications to commercial tests turns them into an LDT, and on how national legislators and competent authorities (CA) will handle new competences and responsibilities. We discuss appropriate interpretation of ISO 15189 to cover IVDR requirements. Selected cases illustrate LDT implementation covering medical needs with commensurate management of risk emanating from intended use and/or design of devices. Unintended collateral damage of the IVDR comprises loss of non-profitable niche applications, increases of costs and wasted resources, and migration of innovative research to more cost-efficient environments. Taking into account local specifics, the legislative framework should reduce the burden on and associated opportunity costs for the health care system, by making diligent use of existing frameworks.

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Background: EU enlargement after 2004 was a major factor in increasing Eastern European migration to the UK. This population requires access to high quality public services generally, and ambulance services more specifically. To understand how Eastern European migrants use ambulance care, this study explored the perceptions and experiences of ambulance staff and the Eastern European patients themselves. Methods: We undertook qualitative semi-structured interviews across Lincolnshire. Purposive and maximum variation sampling ensured that participants were knowledgeable about Eastern European patients' use of ambulance care and were demographically diverse. Data were analysed using framework analysis. Results: There were interviews with 15 ambulance staff and 12 Eastern European patients. A staff interviewee problematised "Health Tourism", which suggests that migrants deliberately exploit state-funded healthcare. However, most disagreed. Patient interviewees often undertook medical travel to access healthcare in response to perceived healthcare problems in the UK. Medical travel increased the likelihood of ambulance staff encountering foreign medication. Variable quality of, and access to, professional interpreters prompted patients to rely instead on informal interpreters. Patients did not register with GPs perhaps due to limited understanding of how the NHS worked. This led to inappropriate use of ambulance services. Recommendations for service delivery improvements included: Eastern European language information on how and when to use ambulance care; improving GP registration; and greater engagement between the ambulance service and Eastern European communities. Conclusions: Frequent medical travel can limit how Eastern Europeans acculturate to the NHS and anchor roots in the UK. Acculturation is about how migrant cultures adjust to the host country. This is not assimilation, where they dilute their cultural identity. Language and communication barriers, as well as inadequate availability and quality of interpreting services, can impede patient-staff dialogue in time-critical emergencies.

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Introduction: Autologous chondrocytes (ACs) are Human cell/tissue-based products used for the treatment of joint cartilage defects. Regulatory agencies have established regulations related to ACs to ensure their safety and efficacy. This study investigated the status and characteristics of ACs approved worldwide. Furthermore, the AC-related regulations were compared by country to provide reference materials for the development of product approval procedures. Methods: This study reviewed the current status of global AC products over the past 20 years by referring to the AC approval list provided on the International Society for Cell & Gene Therapy (ISCT) website. Based on the review report provided by the regulatory agencies that approved the products, major nonclinical/clinical data and product characteristics were reviewed; and the classification and definition of ACs and the approval review procedures were compared through the regulatory agencies' websites. The development status of ACs was also analyzed using a clinical trial registration site. Results: Eight ACs were approved during the study period in Europe, the US, Japan, Australia, and Korea. Two products were withdrawn owing to marketability problems. Human cell/tissue-based products in each country are classified and defined distinguished from biopharmaceuticals, but the approval process for both products is the same. The approval period differs by country, with an average of 282.4 days and the shortest being in Korea (115 days). On Clinical Trials.gov, we screened 46 clinical trials related to ACs, which were conducted in Europe (41%), Korea (20%), and the US (17%). The knee accounted for the largest portion of the indication (37/46, 80%), followed by the ankle or hip joints. Measurements of improvements in function and pain were the main endpoints used to evaluate the efficacy of ACs. Observational studies were conducted to confirm the long-term safety of these products. Conclusions: This is the first study comparing the current status and characteristics of globally approved AC products, as well as their classification and definition by country. In the past two decades, clinical trials have been conducted on the application of ACs in tissue engineering to treat joint cartilage defects. ACs are expected to be used for the treatment of cartilage defect diseases.

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Currently, many institutions and academics are working to establish strategies of economic recovery with the aim of mitigating the short- and long-term impacts of the COVID-19 crisis. The main aim of this study is to analyze how this crisis has impacted Spanish SMEs, considering their operating, financial, and investment activities. We also analyze the initiatives or public policies that SME managers consider necessary in order to face the effects of COVID-19. To do this, an empirical study has been carried out based on information from 612 Spanish SMEs, estimating a PLS research model and multigroup analysis that considers the activity sector as a moderating variable. The results are useful to companies and different economic and social agents, providing information to facilitate decision-making to overcome pandemic crisis mainly in the economic and strategic spheres.

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To date, skin wounds are still an issue for healthcare professionals. Although numerous approaches have been developed over the years for skin regeneration, recent advances in regenerative medicine offer very promising strategies for the fabrication of artificial skin substitutes, including 3D bioprinting, electrospinning or spraying, among others. In particular, skin sprays are an innovative technique still under clinical evaluation that show great potential for the delivery of cells and hydrogels to treat acute and chronic wounds. Skin sprays present significant advantages compared to conventional treatments for wound healing, such as the facility of application, the possibility to treat large wound areas, or the homogeneous distribution of the sprayed material. In this article, we review the latest advances in this technology, giving a detailed description of investigational and currently commercially available acellular and cellular skin spray products, used for a variety of diseases and applying different experimental materials. Moreover, as skin sprays products are subjected to different classifications, we also explain the regulatory pathways for their commercialization and include the main clinical trials for different skin diseases and their treatment conditions. Finally, we argue and suggest possible future trends for the biotechnology of skin sprays for a better use in clinical dermatology.

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Energy and power system models have become necessary tools that provide challenges and technical and economic solutions for integrating high shares of Variable Renewable Energy. Models are focused on analysing strategies of power systems to achieve their decarbonisation targets. The data presented in this paper includes the model algorithm, inputs, equations, modelling assumptions, supplementary materials, and results of the simulations supporting the research article titled "Facing the high share of variable renewable energy in the power system: flexibility and stability requirements". The analysis is based on data from the system operator of one of the European Union member states (Spain). The developed model allows making projections and calculations to obtain the power generation of each technology, the international interconnections, inertia, emissions, system costs and flexibility requirements of new technologies. These data can be used for energy policy development or decision making on power capacity and the balancing needs of the future power system.

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In this paper a novel holistic approach to assess the performance of waste management systems (WMSs) is presented. The so called WMS development stage concept (WMS-DSC) can be used by practitioners or decision makers to assess primarily the WMS at the municipal level. The WMS categorization into development stages notably enables a clear identification of symptoms, the causes of possible waste mismanagement and potential measures for improvement. The concept can be used to (i) assess the status quo of a WMS and, based on this, identify possible measures for implementation; (ii) check whether relevant system conditions to implement a specific measure are met; (iii) monitor the progress of a WMS; and (iv) compare the WMSs of different cities. The concept consists of five development stages: stage 1 - absence or lack of essential elements of waste management; stage 2 - reliable collection and improved landfill sites; stage 3 - separate collection and sorting; stage 4 - expansion of the recycling industry; and stage 5 - circular economy (CE), waste as a resource. While stage 1 describes the absence of or a very immature and malfunctioning WMS, stage 5 stands for a fully implemented CE. By equating the highest stage to the objectives that have evolved today globally for a sustainable CE, this concept can be used to identify targets and the most suitable steps for an individual WMS towards a future best practice of CE.•A holistic approach to assess waste management systems' performance is presented.•A benchmarking tool to estimate the circular economy (CE) evolvement in cities.•Usable for cities both in the Global North and South to identify CE potentials.

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Authentication of seafood products by means of molecular techniques has relevance for food sustainability and security, as well as international trade regulation, linked to transparency in food manufacturing. We focus on the molecular detection of the depleted European eel Anguilla anguilla, a species for which strict international trade regulations are in place since 2010, in studies conducted outside Europe. We found thirteen studies from nine countries (Canada, China, Japan, Malaysia, Peru, Singapore, South Korea, Taiwan, and USA) for which, on average, 59 ± 28% of the 330 sequenced eel samples comprised European eel. Only China, Japan, South Korea, and USA reported the import of European eel in the years prior to sampling. The authentication of eel products demonstrates a global, in part illegal, trade in European eel, covered up by incomplete or fraudulent labelling. This calls into question the compliance with existing national and international trade regulations and its implications for food safety and sustainability.

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This study aimed to investigate the nonclinical safety of lincomycin and spectinomycin hydrochloride (LC-SPH) intramuscular (i.m) doses on target animals (chickens) to provide guidelines for dose level design and side effect monitoring in clinical trials. A total of 80 healthy Arbor Acres plus broiler chicks were completely randomized and blindly divided into four treatment groups (control, one-time dose, three-time dose, and five-time dose) of 20 chicks each (20 chickens per group). At the age of day 15, all chickens (except the control group) were administered LC-SPH intramuscularly (chest muscles) at different doses of 20 mg/kg.bw, 60 mg/kg.bw, and 100 mg/kg.bw respectively for 9 consecutive days recommended by veterinary international cooperation on harmonization (VICH) guidelines. The chickens had ad libitum access to antibiotic-free feed and water. Feeding chickens were observed twice a day throughout the study. The drug safety was evaluated by complete blood count, biochemical parameters, histopathological, clinical signs, body weight gain, and feed conversion ratio (FCR). Hence, considering the minor toxicity of 60 mg/kg, our results reveal that intramuscular injection of at least 20 mg/kg body weight has no effects on growth performance, clinical blood parameters, organ coefficient, and histopathological parameters. Thus, a combination of LC-SPH 20 mg/kg body weight i.m injection investigated safe followed daily administration for nine consecutive days in healthy chickens. It is concluded that the experimental results support the safety of 20 mg/kg body weight in combination for the further clinical research study.

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BACKGROUND: Numerous countries have imposed strict travel restrictions during the COVID-19 pandemic, contributing to a large socioeconomic burden. The long quarantines that have been applied to contacts of cases may be excessive for travel policy. METHODS: We developed an approach to evaluate imminent countrywide COVID-19 infections after 0-14-day quarantine and testing. We identified the minimum travel quarantine duration such that the infection rate within the destination country did not increase compared to a travel ban, defining this minimum quarantine as "sufficient." FINDINGS: We present a generalised analytical framework and a specific case study of the epidemic situation on November 21, 2021, for application to 26 European countries. For most origin-destination country pairs, a three-day or shorter quarantine with RT-PCR or antigen testing on exit suffices. Adaptation to the European Union traffic-light risk stratification provided a simplified policy tool. Our analytical approach provides guidance for travel policy during all phases of pandemic diseases. INTERPRETATION: For nearly half of origin-destination country pairs analysed, travel can be permitted in the absence of quarantine and testing. For the majority of pairs requiring controls, a short quarantine with testing could be as effective as a complete travel ban. The estimated travel quarantine durations are substantially shorter than those specified for traced contacts. FUNDING: EasyJet (JPT and APG), the Elihu endowment (JPT), the Burnett and Stender families' endowment (APG), the Notsew Orm Sands Foundation (JPT and APG), the National Institutes of Health (MCF), Canadian Institutes of Health Research (SMM) and Natural Sciences and Engineering Research Council of Canada EIDM-MfPH (SMM).

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This data article refers to the paper "Assessing Nearly zero energy buildings (NZEBs) development in Europe" [1]. Data linked with this article relate to collected best practices NZEBs throughout Europe. Data on building geometry, year of construction or renovation, primary energy consumption, saving percentages, renewable production, heating demand are provided. Data allow an overview of the status of most commonly implemented efficiency measures and renewables in NZEBs. In particular, data are available in relation technologies, such as heating, domestic hot water, lighting, renewable sources, ventilation, cooling. Heat recovery efficiency data are also collected. U-values are detailed for roofs, walls, floors, windows. Further data can be visualized in relation to technologies costs, cost of construction and maintenance.

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Digitalization of any manufacture industry is a key step in any progress of the production process. The process of digitalization includes both increased use of robotics, automatization solutions and computerization, thereby allowing to reduce costs, to improve efficiency and productivity, and to be flexible to changes. Pharmaceutical Industry (PI) has however been resistant to digitalization, mainly due to fair experience and complexity of the entailed development and manufacture processes. Nevertheless, there is a clear need to digitalize PI as the demand in both traditional and new drugs is constantly growing. Contract Development Manufacture Organizations (CDMOs) have a special digitalizing challenge. Digitalization of PI, and CDMO precisely, should be tightly related to the main aspects of Good Manufacture Practice (GMP), and, to succeed in PI digitalizing requires constant focus on GMP. Close collaboration with constantly changing stakeholders is another important factor which should be in focus during digitalization of CDMO. This paper represents an overview over the main aspects of CDMO digitalization and discusses both the opportunities and challenges of the process, focusing on the practical solutions for successive digital implementation.

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BACKGROUND: One in seven people living in the United Kingdom (UK) is an international migrant, rendering migrants an important population group with diverse and dynamic health and healthcare needs. However, there has been no attempt to map contemporary trends within migration health research conducted in the UK. The aim of this scoping review was to describe trends within migration health research and identify gaps for future research agendas. METHODS: PubMed and Embase were systematically searched for empirical research with a primary focus on the concepts "health" and "migrants" published between 2001 and 2019. Findings were analysed using the UCL-Lancet Commission on Migration and Health Conceptual Framework for Migration and Health. RESULTS: In total, 399 studies were included, with almost half (41.1%; 164/399) published in the last five years of the study period between 2015 and 2019 and a third (34.1%; 136/399) conducted in London. Studies included asylum seekers (14.8%; 59/399), refugees (12.3%; 49/399), and undocumented migrants or migrants with insecure status (3.5%; 14/399), but most articles (74.9%; 299/399) did not specify a migrant sub-group. The most studied health topics were specific disease outcomes such as infectious diseases (24.1% of studies) and mental health (19.1%) compared to examining systems or structures that impact health (27.8%), access to healthcare (26.3%), or specific exposures or behaviours (35.3%). CONCLUSIONS: There has been a growing interest in migration health. Ensuring a diverse geographic distribution of research conducted in the UK and disaggregation by migrant sub-group is required for a nuanced and region-specific understanding of specific health needs, interventions and appropriate service delivery for different migrant populations. More research is needed to understand how migration policy and legislation intersect with both the social determinants of health and access to healthcare to shape the health of migrants in the UK.

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BACKGROUND & AIMS: Non-alcoholic fatty liver disease (NAFLD), which is closely associated with obesity, metabolic syndrome, and diabetes, is a highly prevalent emerging condition that can be optimally managed through a multidisciplinary patient-centred approach. National preparedness to address NAFLD is essential to ensure that health systems can deliver effective care. We present a NAFLD Preparedness Index for Europe. METHODS: In June 2019, data were extracted by expert groups from 29 countries to complete a 41-item questionnaire about NAFLD. Questions were classified into 4 categories: policies/civil society (9 questions), guidelines (16 questions), epidemiology (4 questions), and care management (12 questions). Based on the responses, national preparedness for each indicator was classified into low, middle, or high-levels. We then applied a multiple correspondence analysis to obtain a standardised preparedness score for each country ranging from 0 to 100. RESULTS: The analysis estimated a summary factor that explained 71.3% of the variation in the dataset. No countries were found to have yet attained a high-level of preparedness. Currently, the UK (75.5) scored best, although falling within the mid-level preparedness band, followed by Spain (56.2), and Denmark (43.4), whereas Luxembourg and Ireland were the lowest scoring countries with a score of 4.9. Only Spain scored highly in the epidemiology indicator category, whereas the UK was the only country that scored highly for care management. CONCLUSIONS: The NAFLD Preparedness Index indicates substantial variation between countries' readiness to address NAFLD. Notably, even those countries that score relatively highly exhibit deficiencies in key domains, suggesting that structural changes are needed to optimise NAFLD management and ensure effective public health approaches are in place. LAY SUMMARY: Non-alcoholic fatty liver disease (NAFLD), which is closely associated with obesity, metabolic syndrome, and diabetes, is a highly prevalent condition that can be optimally managed through a multidisciplinary patient-centred approach. National preparedness to address NAFLD is essential to allow for effective public health measures aimed at preventing disease while also ensuring that health systems can deliver effective care to affected populations. This study defined preparedness as having adequate policies and civil society engagement, guidelines, epidemiology, and care management. NAFLD preparedness was found to be deficient in all 29 countries studied, with great variation among the countries and the 4 categories studied.

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The wind energy sector has seen an increasing growth in the last decade and this is foreseen to continue in the next years. This has posed several challenges in terms of skilled and prepared professionals that have always to be up to date in an industry that is constantly changing. Thus, teaching tools have gained an increasing interest. The present research reviewed the state of the art in terms of digital interactive training tools pinpointing that the existing options do not feature the user involvement in the development of the training material. Hence, the main aim of this paper is to develop and test an innovative method based on gamification to increase wind energy sector industrial skills, providing a digital interactive environment in the form of a new user-friendly software that can allow its users to train and contribute to the teaching and learning contents. The first methodological step deals with the associated background studies that were required at strategy implementation and development stages, including market analysis and technology trade-offs, as well as the general structure and the implementation steps of the software design. Obtained results pinpointed that with minimal use of web-based database and network connectivity, a mobile phone application could work in the form of a time-scored quiz application that remotely located staff at wind energy farms could benefit from. The technological innovation brought by this research will substantially improve the service of training, allowing a more dynamic formative management contributing to an improvement in the competitiveness and a step towards excellence for the whole sector.

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The quantitative determination of multiple pesticide residues in food is an iterative process given the frequent changes in monitoring specifications set by regulatory authorities, introduction of new pesticide active ingredients, variety of commodities encountered and advances in the capability of analytical instrumentation and software platforms. The method described here:•replaces our previous methodology [1] that was based on an ethyl acetate extraction [2], two different sample extract clean-up regimes depending on the commodity; either Gel Permeation Chromatography (GPC) or Solid Phase Extraction (SPE) and GC/MSMS analysis using cool on-column injection and permits higher throughput using the same QuEChERS extraction method used for LCMS/MS analysis [3]•uses PTV injection incorporating a deactivated (baffled) injection liner required to improve performance for 'difficult to analyse' pesticides e.g. captan, dichlofluanid, folpet, tolylfluanid.•has been validated for the quantitative determination of 113 different pesticides and their metabolites in a range of fruit and vegetables of high water content and high acid and high water content i.e. cabbage, lemon, pepper, plum and spinach and complies with requirements of European Commission guidance document on Analytical Quality Control and Method Validation Procedures for Pesticides Residues Analysis in food and feed - SANTE/12682/2019 [4].