Prioritisation of pesticides and target organ systems for dietary cumulative risk assessment based on the 2019-2021 monitoring cycle.

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.

The 2021 European Union report on pesticide residues in food.

Under European Union legislation (Article 32, Regulation (EC) No 396/2005), EFSA is to provide an annual report assessing the pesticide residue levels in foods on the European market. In 2021, 96.1% of the overall 87,863 samples analysed fell below the maximum residue level (MRL), 3.9% exceeded this level, of which 2.5% were non-compliant, i.e. samples exceeding the MRL after accounting for the measurement uncertainty. For the EU-coordinated multiannual control programme subset, 13,845 samples were analysed of which 2.1% exceeded the MRL and 1.3% 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 (HBGVs). A new pilot methodology based on probabilistic assessment was introduced to provide the probability of subjects being expose to an exceedance of the HBGV. Recommendations to risk manager are given to increase the effectiveness of European control systems and to ensure a high level of consumer protection throughout the EU.

Dietary exposure to heavy metals and iodine intake via consumption of seaweeds and halophytes in the European population.

EFSA assessed the relevance of seaweed and halophyte consumption to the dietary exposure to heavy metals (arsenic, cadmium, lead and mercury) and the iodine intake in the European population. Based on sampling years 2011-2021, there were 2,093 analytical data available on cadmium, 1,988 on lead, 1,934 on total arsenic, 920 on inorganic arsenic (iAs), 1,499 on total mercury and 1,002 on iodine. A total of 697 eating occasions on halophytes, seaweeds and seaweed-related products were identified in the EFSA Comprehensive European Food Consumption Database (468 subjects, 19 European countries). From seaweed consumption, exposure estimates for cadmium in adult 'consumers only' are within the range of previous exposure estimates considering the whole diet, while for iAs and lead the exposure estimates represent between 10% and 30% of previous exposures from the whole diet for the adult population. Seaweeds were also identified as important sources of total arsenic that mainly refers, with some exceptions, to organic arsenic. As regards iodine, from seaweed consumption, mean intakes above 20 µg/kg body weight per day were identified among 'consumers only' of Kombu and Laver algae. The impact of a future increase in seaweed consumption ('per capita') on the dietary exposure to heavy metals and on iodine intake will strongly depend on the seaweeds consumed. The exposure estimates of heavy metals and iodine intakes in 'consumers only' of seaweeds were similar to those estimated in a replacement scenario with selected seaweed-based foods in the whole population. These results underline the relevance of the current consumption of seaweeds in the overall exposure to different heavy metals and in the intake of iodine. Recommendations are provided for further work needed on different areas to better understand the relationship between seaweed consumption and exposure to heavy metals and iodine intake.

Risk Assessment of Combined Exposure to Multiple Chemicals at the European Food Safety Authority: Principles, Guidance Documents, Applications and Future Challenges.

Human health and animal health risk assessment of combined exposure to multiple chemicals use the same steps as single-substance risk assessment, namely problem formulation, exposure assessment, hazard assessment and risk characterisation. The main unique feature of combined RA is the assessment of combined exposure, toxicity and risk. Recently, the Scientific Committee of the European Food Safety Authority (EFSA) published two relevant guidance documents. The first one "Harmonised methodologies for the human health, animal health and ecological risk assessment of combined exposure to multiple chemicals" provides principles and explores methodologies for all steps of risk assessment together with a reporting table. This guidance supports also the default assumption that dose addition is applied for combined toxicity of the chemicals unless evidence for response addition or interactions (antagonism or synergism) is available. The second guidance document provides an account of the scientific criteria to group chemicals in assessment groups using hazard-driven criteria and prioritisation methods, i.e., exposure-driven and risk-based approaches. This manuscript describes such principles, provides a brief description of EFSA's guidance documents, examples of applications in the human health and animal health area and concludes with a discussion on future challenges in this field.

Retrospective cumulative dietary risk assessment of craniofacial alterations by residues of pesticides.

EFSA established cumulative assessment groups and conducted retrospective cumulative risk assessments for two types of craniofacial alterations (alterations due to abnormal skeletal development, head soft tissue alterations and brain neural tube defects) for 14 European populations of women in childbearing age. Cumulative acute exposure calculations were performed by probabilistic modelling using monitoring data collected by Member States in 2017, 2018 and 2019. A rigorous uncertainty analysis was performed using expert knowledge elicitation. Considering all sources of uncertainty, their dependencies and differences between populations, it was concluded with varying degrees of certainty that the MOET resulting from cumulative exposure is above 100 for the two types of craniofacial alterations. The threshold for regulatory consideration established by risk managers is therefore not exceeded. Considering the severity of the effects under consideration, it was also assessed whether the MOET is above 500. This was the case with varying levels of certainty for the head soft tissue alterations and brain neural tube defects. However, for the alterations due to abnormal skeletal development, it was found about as likely as not that the MOET is above 500 in most populations. For two populations, it was even found more likely that the MOET is below 500. These results were discussed in the light of the conservatism of the methodological approach.

Cumulative dietary risk assessment of chronic acetylcholinesterase inhibition by residues of pesticides.

A retrospective cumulative risk assessment of dietary exposure to pesticide residues was conducted for chronic inhibition of acetylcholinesterase. The pesticides considered in this assessment were identified and characterised in a previous scientific report on the establishment of cumulative assessment groups of pesticides for their effects on the nervous system. The exposure assessments used monitoring data collected by Member States under their official pesticide monitoring programmes in 2016, 2017 and 2018, and individual food consumption data from 10 populations of consumers from different countries and from different age groups. Exposure estimates were obtained by means of a two-dimensional probabilistic model, which was implemented in SAS ® software. The characterisation of cumulative risk was supported by an uncertainty analysis based on expert knowledge elicitation. For each of the 10 populations, it is concluded with varying degrees of certainty that cumulative exposure to pesticides contributing to the chronic inhibition of acetylcholinesterase does not exceed the threshold for regulatory consideration established by risk managers.

Comparison of cumulative dietary exposure to pesticide residues for the reference periods 2014-2016 and 2016-2018.

Retrospective dietary exposure assessments were conducted for pesticides that have chronic effects on the thyroid and pesticides that have acute effects on the nervous system. Exposure assessments were performed using monitoring data collected by Member States under their official pesticide monitoring programmes in 2016, 2017 and 2018. Exposure estimates were obtained for 10 populations of consumers (i.e. from different countries and from different age groups) by means of a two-dimensional probabilistic model. Results were compared to those previously obtained for the years 2014, 2015 and 2016, and exposure did not change significantly over time. However, an increase of the sampling uncertainty was identified for one pesticide in a specific food commodity. Strategies are therefore recommended to reduce the sampling uncertainty and to anticipate potential problems before initiating a cumulative risk assessment.

Guidance Document on Scientific criteria for grouping chemicals into assessment groups for human risk assessment of combined exposure to multiple chemicals.

This guidance document provides harmonised and flexible methodologies to apply scientific criteria and prioritisation methods for grouping chemicals into assessment groups for human risk assessment of combined exposure to multiple chemicals. In the context of EFSA's risk assessments, the problem formulation step defines the chemicals to be assessed in the terms of reference usually through regulatory criteria often set by risk managers based on legislative requirements. Scientific criteria such as hazard-driven criteria can be used to group these chemicals into assessment groups. In this guidance document, a framework is proposed to apply hazard-driven criteria for grouping of chemicals into assessment groups using mechanistic information on toxicity as the gold standard where available (i.e. common mode of action or adverse outcome pathway) through a structured weight of evidence approach. However, when such mechanistic data are not available, grouping may be performed using a common adverse outcome. Toxicokinetic data can also be useful for grouping, particularly when metabolism information is available for a class of compounds and common toxicologically relevant metabolites are shared. In addition, prioritisation methods provide means to identify low-priority chemicals and reduce the number of chemicals in an assessment group. Prioritisation methods include combined risk-based approaches, risk-based approaches for single chemicals and exposure-driven approaches. Case studies have been provided to illustrate the practical application of hazard-driven criteria and the use of prioritisation methods for grouping of chemicals in assessment groups. Recommendations for future work are discussed.

Cumulative dietary risk characterisation of pesticides that have acute effects on the nervous system.

A retrospective acute cumulative risk assessment of dietary exposure to pesticide residues, supported by an uncertainty analysis based on expert knowledge elicitation, was conducted for two effects on the nervous system: brain and/or erythrocyte acetylcholinesterase inhibition, and functional alterations of the motor division. The pesticides considered in this assessment were identified and characterised in the scientific report on the establishment of cumulative assessment groups of pesticides for their effects on the nervous system. Cumulative exposure assessments were conducted through probabilistic modelling by EFSA and the Dutch National Institute for Public Health and the Environment (RIVM) using two different software tools and reported separately. These exposure assessments used monitoring data collected by Member States under their official pesticide monitoring programmes in 2014, 2015 and 2016 and individual consumption data from 10 populations of consumers from different countries and different age groups. This report completes the characterisation of cumulative risk, taking account of the available data and the uncertainties involved. For each of the 10 populations, it is concluded with varying degrees of certainty that cumulative exposure to pesticides that have the acute effects on the nervous system mentioned above does not exceed the threshold for regulatory consideration established by risk managers.

Cumulative dietary risk characterisation of pesticides that have chronic effects on the thyroid.

A retrospective chronic cumulative risk assessment of dietary exposure to pesticide residues, supported by an uncertainty analysis based on expert knowledge elicitation, was conducted for two effects on the thyroid, hypothyroidism and parafollicular cell (C-cell) hypertrophy, hyperplasia and neoplasia. The pesticides considered in this assessment were identified and characterised in the scientific report on the establishment of cumulative assessment groups of pesticides for their effects on the thyroid. Cumulative exposure assessments were conducted through probabilistic modelling by EFSA and the Dutch National Institute for Public Health and the Environment (RIVM) using two different software tools and reported separately. These exposure assessments used monitoring data collected by Member States under their official pesticide monitoring programmes in 2014, 2015 and 2016 and individual consumption data from 10 populations of consumers from different countries and different age groups. This report completes the characterisation of cumulative risk, taking account of the available data and the uncertainties involved. For each of the 10 populations, it is concluded with varying degrees of certainty that cumulative exposure to pesticides that have the chronic effects on the thyroid mentioned above does not exceed the threshold for regulatory consideration established by risk managers.

Guidance on harmonised methodologies for human health, animal health and ecological risk assessment of combined exposure to multiple chemicals.

This Guidance document describes harmonised risk assessment methodologies for combined exposure to multiple chemicals for all relevant areas within EFSA's remit, i.e. human health, animal health and ecological areas. First, a short review of the key terms, scientific basis for combined exposure risk assessment and approaches to assessing (eco)toxicology is given, including existing frameworks for these risk assessments. This background was evaluated, resulting in a harmonised framework for risk assessment of combined exposure to multiple chemicals. The framework is based on the risk assessment steps (problem formulation, exposure assessment, hazard identification and characterisation, and risk characterisation including uncertainty analysis), with tiered and stepwise approaches for both whole mixture approaches and component-based approaches. Specific considerations are given to component-based approaches including the grouping of chemicals into common assessment groups, the use of dose addition as a default assumption, approaches to integrate evidence of interactions and the refinement of assessment groups. Case studies are annexed in this guidance document to explore the feasibility and spectrum of applications of the proposed methods and approaches for human and animal health and ecological risk assessment. The Scientific Committee considers that this Guidance is fit for purpose for risk assessments of combined exposure to multiple chemicals and should be applied in all relevant areas of EFSA's work. Future work and research are recommended.

Cumulative dietary exposure assessment of pesticides that have chronic effects on the thyroid using SAS® software.

Retrospective dietary exposure assessments were conducted for two groups of pesticides that have chronic effects on the thyroid: hypertrophy, hyperplasia and neoplasia of C-cells, and hypothyroidism. The pesticides considered in this assessment were identified and characterised in the scientific report on the establishment of cumulative assessment groups of pesticides for their effects on the thyroid. The exposure assessments used monitoring data collected by Member States under their official pesticide monitoring programmes in 2014, 2015 and 2016, and individual food consumption data from 10 populations of consumers from different countries and from different age groups. Exposure estimates were obtained for each group of pesticides by means of a 2-dimensional probabilistic model, which was implemented in SAS ® software. Results were validated against exposure estimates obtained by the Dutch National Institute for Public Health and the Environment (RIVM) using the Monte Carlo Risk Assessment (MCRA) software. Both tools produced nearly identical results and minor differences were mainly attributed to the random effect of probabilistic modelling. The exposure estimates obtained in this report are used in the final scientific report on the cumulative dietary risk characterisation of pesticides that have chronic effects on the thyroid. The latter combines the hazard assessment and exposure assessment into a consolidated risk characterisation including all uncertainties.

Cumulative dietary exposure assessment of pesticides that have acute effects on the nervous system using SAS® software.

Retrospective dietary exposure assessments were conducted for two groups of pesticides that have acute effects on the nervous system: brain and/or erythrocyte acetylcholinesterase inhibition, and functional alterations of the motor division. The pesticides considered in this assessment were identified and characterised in the scientific report on the establishment of cumulative assessment groups of pesticides for their effects on the nervous system. The exposure assessments used monitoring data collected by Member States under their official pesticide monitoring programmes in 2014, 2015 and 2016 and individual food consumption data from 10 populations of consumers from different countries and from different age groups. Exposure estimates were obtained for each group of pesticides by means of a 2-dimensional Monte Carlo simulation, which was implemented in SAS ® software. Results were validated against exposure estimates obtained by the Dutch National Institute for Public Health and the Environment (RIVM) using the Monte Carlo Risk Assessment (MCRA) software. Both tools produced nearly identical results and minor differences were mainly attributed to the random effect of probabilistic modelling. The exposure estimates obtained in this report are used in the final scientific report on the cumulative dietary risk characterisation of pesticides that have acute effects on the nervous system. The latter combines the hazard assessment and exposure assessment into a consolidated risk characterisation including all related uncertainties.

Effect on public health of a possible increase of the maximum level for 'aflatoxin total' from 4 to 10 µg/kg in peanuts and processed products thereof, intended for direct human consumption or use as an ingredient in foodstuffs.

EFSA was asked to deliver a scientific opinion regarding the effect on public health of a possible increase of the maximum level (ML) for 'aflatoxin total' (AFT; sum of aflatoxin B1, aflatoxin B2, aflatoxin G1 and aflatoxin G2) from 4 to 10 µg/kg in peanuts and processed products thereof. Aflatoxins are genotoxic and cause hepatocellular carcinomas in humans. The Panel on Contaminants in the Food Chain (CONTAM Panel) evaluated 8,085 samples of peanuts and 472 samples of peanut butter, with > 60% left-censored. The mean concentration of AFT in peanuts was 2.65/3.56 µg/kg (lower bound (LB)/upper bound (UB)) with a maximum of 1,429 µg/kg. The mean concentration in peanut butter was 1.47/1.92 µg/kg (LB/UB) with a maximum of 407 µg/kg. Peanut oil was not included since all data were left-censored and the ML does not apply for oil. Exposure was calculated for a 'Current ML' and 'Increased ML' scenario, and mean chronic exposure estimates for consumers only, amounted to 0.04-2.74 ng/kg body weight (bw) per day and 0.07-4.28 ng/kg bw per day, respectively. The highest exposures were calculated for adolescents and other children. The CONTAM Panel used the cancer potencies estimated by the Joint FAO/WHO Expert Committee on Food Additives for the risk characterisation. Under the scenario of the current ML, the cancer risk was estimated to range between 0.001 and 0.213 aflatoxin-induced cancers per 100,000 person years. Under the scenario of the increased ML, it ranged between 0.001 and 0.333 aflatoxin-induced cancers per 100,000 person years. Comparing these data calculated under the current ML scenario with the yearly excess cancer risk of 0.014 shows a higher risk for consumers of peanuts and peanut butter in some surveys. The calculated cancer risks indicate that an increase of the ML would further increase the risk by a factor of 1.6-1.8.

Scientific opinion on pesticides in foods for infants and young children.

Following a request from the European Commission, the EFSA Panel on Plant Protection Products and their Residues (PPR Panel) prepared a scientific opinion to provide a comprehensive evaluation of pesticide residues in foods for infants and young children. In its approach to develop this scientific opinion, the EFSA PPR Panel took into account, among the others, (i) the relevant opinions of the Scientific Committee for Food setting a default maximum residue level (MRL) of 0.01 mg/kg for pesticide residues in foods for infants and young children; (ii) the recommendations provided by EFSA Scientific Committee in a guidance on risk assessment of substances present in food intended for infants below 16 weeks of age; (iii) the knowledge on organ/system development in infants and young children. For infants below 16 weeks of age, the EFSA PPR Panel concluded that pesticide residues at the default MRL of 0.01 mg/kg for food for infants and young children are not likely to result in an unacceptable exposure for active substances for which a health-based guidance value (HBGV) of 0.0026 mg/kg body weight (bw) per day or higher applies. Lower MRLs are recommended for active substances with HBGVs below this value. For infants above 16 weeks of age and young children, the established approach for setting HBGVs is considered appropriate. For infants below 16 weeks of age the approach may not be appropriate and the application of the EFSA guidance on risk assessment of substances present in food intended for infants below 16 weeks of age is recommended. The contribution of conventional food to the total exposure to pesticide residues is much higher than that from foods intended for infants and young children. Because of the increased intake of conventional food by young children, these have the highest exposure to pesticide residues, whereas infants 3-6 months of age generally have lower exposure. The impact of cumulative exposure to pesticide residues on infants and young children is not different from the general population and the EFSA cumulative risk assessment methodology is also applicable to these age groups. Residue definitions established under Regulation (EC) No 396/2005 are in general considered appropriate also for foods for infants and young children. However, based on a tier 1 analysis of the hydrolysis potential of pesticides simulating processing, the particular appropriateness of existing residue definitions for monitoring to cover processed food, both intended for infants and young children as well as conventional food, is questionable.

Risks for public health related to the presence of furan and methylfurans in food.

The European Commission asked EFSA for a scientific evaluation on the risk to human health of the presence of furan and methylfurans (2-methylfuran, 3-methylfuran and 2,5-dimethylfuran) in food. They are formed in foods during thermal processing and can co-occur. Furans are produced from several precursors such as ascorbic acid, amino acids, carbohydrates, unsaturated fatty acids and carotenoids, and are found in a variety of foods including coffee and canned and jarred foods. Regarding furan occurrence, 17,056 analytical results were used in the evaluation. No occurrence data were received on methylfurans. The highest exposures to furan were estimated for infants, mainly from ready-to-eat meals. Grains and grain-based products contribute most for toddlers, other children and adolescents. In adults, elderly and very elderly, coffee is the main contributor to dietary exposure. Furan is absorbed from the gastrointestinal tract and is found in highest amounts in the liver. It has a short half-life and is metabolised by cytochrome P450 2E1 (CYP2E1) to the reactive metabolite, cis-but-2-ene-1,4-dialdehyde (BDA). BDA can bind covalently to amino acids, proteins and DNA. Furan is hepatotoxic in rats and mice with cholangiofibrosis in rats and hepatocellular adenomas/carcinomas in mice being the most prominent effects. There is limited evidence of chromosomal damage in vivo and a lack of understanding of the underlying mechanism. Clear evidence for indirect mechanisms involved in carcinogenesis include oxidative stress, gene expression alterations, epigenetic changes, inflammation and increased cell proliferation. The CONTAM Panel used a margin of exposure (MOE) approach for the risk characterisation using as a reference point a benchmark dose lower confidence limit for a benchmark response of 10% of 0.064 mg/kg body weight (bw) per day for the incidence of cholangiofibrosis in the rat. The calculated MOEs indicate a health concern. This conclusion was supported by the calculated MOEs for the neoplastic effects.

Guidance on the assessment of the safety of feed additives for the consumer.

[Table: see text]. ABSTRACT: This guidance document is intended to assist the applicant in the preparation and the presentation of an application, as foreseen in Article 7.6 of Regulation (EC) No 1831/2003, for the authorisation of additives for use in animal nutrition. It specifically covers the assessment of the safety for the consumer.

Access to Treatment for Diabetes and Hypertension in Rural Cambodia: Performance of Existing Social Health Protection Schemes.

BACKGROUND: Non-communicable diseases (NCD) pose challenges to Cambodia's health system. Medicines for NCD are on the National Essential Medicines List but no clinical guidelines support their utilization. Two social health protection schemes aimed at the informal sector population exist (Health Equity Funds and Insurance) together with two disease-specific interventions (a Peer Educator Network and Chronic Diseases Clinics) targeted at NCD patients. This study examines performance of these various schemes in relation to NCD. METHODS: Cross-sectional household survey among 709 individuals self-reporting diabetes and/or hypertension in three geographical locations in rural Cambodia using a structured questionnaire investigating diagnostic and treatment pathways, health seeking behaviour, health expenditures, and financial coping mechanisms. RESULTS: Two third of respondents with NCD were female and 55% did not belong to any scheme. The majority (59%) were diagnosed in the private sector and only 56% were on allopathic treatment that was mainly sought in the private sector (49%). Outpatient treatment cost was higher in the private sector and when using multiple providers of care. The majority were indebted, 11% due to health-related expenses. Contrary to social health protection schemes, disease-specific interventions offered better access to allopathic treatment and provided medicines in accordance with NEML. CONCLUSION: The benefit packages of existing social health protection schemes and services in the public health sector should be adjusted to cater for the needs of people living with NCD in rural Cambodia. Initiatives that offer active disease management strategies and promote patients and community participation appear more successful in increasing treatment adherence and decreasing the risk of financial hardship.

[Health workers' involvement for data quality improvement in Benin]. / Implication des agents de santé dans la conception des outils de collecte de données au Bénin.

OBJECTIVE: In developing countries, the poor quality of data derived from Health Information Systems constitutes a problem that limits use of these data and contributes to the recurrent difficulties of health system management. The low level of involvement of health workers directly responsible for data may contribute to this poor quality. This study documents a Health Information System collection tool design experience by health workers and assesses its effect on data quality. METHODS: Eighty health workers responsible for clinical statistics in public health centres participated in this study. The two tools used for clinical data collection were modified by a group of 6 volunteer health workers. Monitoring indicators, data entry time, percentage exhaustiveness and quality of data were assessed before and after using the new tools. Data were compared by Wilcoxon's test for paired data and Mc Nemar's chi-square test. RESULTS: Between the two assessments, the data entry time increased from 28.7 to 22.5 seconds by reported case (p=0.153), the exhaustiveness of the reports increased from 16% to 89% (p<0.001) and the proportion of reports with sufficient data quality increased from 18.8% to 45.8% (p=0.002). CONCLUSION: The positive course of the indicators shows that increased involvement of health workers in key stages such as the design of data collection tools can help improve data quality.

Consequences of severe obstetric complications on women's health in Morocco: please, listen to me!

OBJECTIVE: In Morocco, medical care for women with severe obstetric complications (near-miss cases) ends at discharge from the hospital. Little information exists regarding what happens after returning home. The aim of the study was to assess the physical and mental health consequences of near-miss events on Moroccan women 8 months after childbirth. METHODS: A prospective cohort study of 76 near-miss women was conducted in three hospitals. For every case, we recruited at least two women from the same hospital who had uncomplicated deliveries (n = 169). We used a mixed-methods approach. For the quantitative part, we analysed sociodemographic characteristics collected via a questionnaire and medical complications extracted from the medical records during a medical consultation at 8 months post-partum. Forty in-depth interviews were also conducted with 20 near-miss cases and 20 women with uncomplicated deliveries. RESULTS: The near-miss women were poorer and less educated than those who had uncomplicated deliveries. The proportion of physical consequences (serious illness) was higher among near-miss cases (22%) than uncomplicated deliveries (6%, P = 0.001). The risk of depression was significantly higher among near-miss cases with perinatal death (OR = 7.16; [95% CI: 2.85-17.98]) than among those who had an uncomplicated delivery. Interviews revealed that the economic burden of near-miss care contributed to social problems among the women and their households. CONCLUSION: A near-miss event has consequences that go beyond the first days after delivery. Developing new mechanisms for maternal and newborn health follow-up is essential and should address the mother's physical and mental health problems and involve husbands and family members.