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1.
EFSA J ; 22(7): e8844, 2024 Jul.
Article in English | MEDLINE | ID: mdl-38957748

ABSTRACT

The European Commission asked EFSA for a risk assessment on small organoarsenic species in food. For monomethylarsonic acid MMA(V), decreased body weight resulting from diarrhoea in rats was identified as the critical endpoint and a BMDL10 of 18.2 mg MMA(V)/kg body weight (bw) per day (equivalent to 9.7 mg As/kg bw per day) was calculated as a reference point (RP). For dimethylarsinic acid DMA(V), increased incidence in urinary bladder tumours in rats was identified as the critical endpoint. A BMDL10 of 1.1 mg DMA(V)/kg bw per day (equivalent to 0.6 mg As/kg bw per day) was calculated as an RP. For other small organoarsenic species, the toxicological data are insufficient to identify critical effects and RPs, and they could not be included in the risk assessment. For both MMA(V) and DMA(V), the toxicological database is incomplete and a margin of exposure (MOE) approach was applied for risk characterisation. The highest chronic dietary exposure to DMA(V) was estimated in 'Toddlers', with rice and fish meat as the main contributors across population groups. For MMA(V), the highest chronic dietary exposures were estimated for high consumers of fish meat and processed/preserved fish in 'Infants' and 'Elderly' age class, respectively. For MMA(V), an MOE of ≥ 500 was identified not to raise a health concern. For MMA(V), all MOEs were well above 500 for average and high consumers and thus do not raise a health concern. For DMA(V), an MOE of 10,000 was identified as of low health concern as it is genotoxic and carcinogenic, although the mechanisms of genotoxicity and its role in carcinogenicity of DMA(V) are not fully elucidated. For DMA(V), MOEs were below 10,000 in many cases across dietary surveys and age groups, in particular for some 95th percentile exposures. The Panel considers that this would raise a health concern.

2.
Ethn Health ; : 1-25, 2024 Jun 12.
Article in English | MEDLINE | ID: mdl-38867355

ABSTRACT

OBJECTIVES: Inequitable pregnancy care experiences and outcomes disproportionately affect refugee background women in Australia. Culturally safe care is essential for achieving health equity, however, cultural safety can only be determined by the person receiving care. To our knowledge, women of refugee background in Australia are yet to be asked what culturally safe pregnancy care is to them. Specifically, this study aimed to explore what culturally safe pregnancy care is to Karen women (from Burma) of refugee background. DESIGN: A photovoice study founded on community-based participatory research principles was undertaken with a Karen community of refugee background living in Victoria, Australia. A community advisory group was established, guiding study design and conduct. Five S'gaw Karen-speaking women with experience of pregnancy care in Australia were invited to take photos within their community. Participants shared their photos and stories with each other in four online discussion groups. RESULTS: Reflexive thematic analysis guided by a critical constructionist lens developed three themes: Building foundations for belonging; cultivating reciprocal curiosity; and storytelling as an expression of self and shared power. These themes sit within the overarching theme When I can be my whole authentic self, I feel safe and know that I belong. CONCLUSION: When Karen women can embrace their cultural and spiritual identity without fear of discrimination, including racism, culturally safe pregnancy care is possible. This study contributes to the design and delivery of maternity services by providing insights that can enhance equitable and culturally safe pregnancy care for Karen women of refugee background.

3.
Regul Toxicol Pharmacol ; 151: 105652, 2024 Jun 03.
Article in English | MEDLINE | ID: mdl-38839030

ABSTRACT

BACKGROUND: Few methods are available for transparently combining different evidence streams for chemical risk assessment to reach an integrated conclusion on the probability of causation. Hence, the UK Committees on Toxicity (COT) and on Carcinogenicity (COC) have reviewed current practice and developed guidance on how to achieve this in a transparent manner, using graphical visualisation. METHODS/APPROACH: All lines of evidence, including toxicological, epidemiological, new approach methodologies, and mode of action should be considered, taking account of their strengths/weaknesses in their relative weighting towards a conclusion on the probability of causation. A qualitative estimate of the probability of causation is plotted for each line of evidence and a combined estimate provided. DISCUSSION/CONCLUSIONS: Guidance is provided on integration of multiple lines of evidence for causation, based on current best practice. Qualitative estimates of probability for each line of evidence are plotted graphically. This ensures a deliberative, consensus conclusion on likelihood of causation is reached. It also ensures clear communication of the influence of the different lines of evidence on the overall conclusion on causality. Issues on which advice from the respective Committees is sought varies considerably, hence the guidance is designed to be sufficiently flexible to meet this need.

4.
EFSA J ; 22(3): e8640, 2024 Mar.
Article in English | MEDLINE | ID: mdl-38476320

ABSTRACT

EFSA was asked for a scientific opinion on the risks for animal and human health related to the presence of polychlorinated naphthalenes (PCNs) in feed and food. The assessment focused on hexaCNs due to very limited data on other PCN congeners. For hexaCNs in feed, 217 analytical results were used to estimate dietary exposures for food-producing and non-food-producing animals; however, a risk characterisation could not be performed because none of the toxicological studies allowed identification of reference points. The oral repeated dose toxicity studies performed in rats with a hexaCN mixture containing all 10 hexaCNs indicated that the critical target was the haematological system. A BMDL20 of 0.05 mg/kg body weight (bw) per day was identified for a considerable decrease in the platelet count. For hexaCNs in food, 2317 analytical results were used to estimate dietary exposures across dietary surveys and age groups. The highest exposure ranged from 0.91 to 29.8 pg/kg bw per day in general population and from 220 to 559 pg/kg bw per day for breast-fed infants with the highest consumption of breast milk. Applying a margin of exposure (MOE) approach, the estimated MOEs for the high dietary exposures ranged from 1,700,000 to 55,000,000 for the general population and from 90,000 to 230,000 for breast-fed infants with the highest consumption of breast milk. These MOEs are far above the minimum MOE of 2000 that does not raise a health concern. Taking account of the uncertainties affecting the assessment, the Panel concluded with at least 99% certainty that dietary exposure to hexaCNs does not raise a health concern for any of the population groups considered. Due to major limitations in the available data, no assessment was possible for genotoxic effects or for health risks of PCNs other than hexaCNs.

5.
EFSA J ; 22(1): e8528, 2024 Jan.
Article in English | MEDLINE | ID: mdl-38205503

ABSTRACT

This statement provides scientific guidance on the information needed to support the risk assessment of the detoxification processes applied to products intended for animal feed in line with the acceptability criteria of the Commission Regulation (EU) 2015/786.

6.
EFSA J ; 22(1): e8488, 2024 Jan.
Article in English | MEDLINE | ID: mdl-38239496

ABSTRACT

The European Commission asked EFSA to update its 2009 risk assessment on arsenic in food carrying out a hazard assessment of inorganic arsenic (iAs) and using the revised exposure assessment issued by EFSA in 2021. Epidemiological studies show that the chronic intake of iAs via diet and/or drinking water is associated with increased risk of several adverse outcomes including cancers of the skin, bladder and lung. The CONTAM Panel used the benchmark dose lower confidence limit based on a benchmark response (BMR) of 5% (relative increase of the background incidence after adjustment for confounders, BMDL05) of 0.06 µg iAs/kg bw per day obtained from a study on skin cancer as a Reference Point (RP). Inorganic As is a genotoxic carcinogen with additional epigenetic effects and the CONTAM Panel applied a margin of exposure (MOE) approach for the risk characterisation. In adults, the MOEs are low (range between 2 and 0.4 for mean consumers and between 0.9 and 0.2 at the 95th percentile exposure, respectively) and as such raise a health concern despite the uncertainties.

7.
EFSA J ; 22(1): e8497, 2024 Jan.
Article in English | MEDLINE | ID: mdl-38269035

ABSTRACT

The European Commission asked EFSA to update its 2011 risk assessment on polybrominated diphenyl ethers (PBDEs) in food, focusing on 10 congeners: BDE-28, -47, -49, -99, -100, -138, -153, -154, -183 and ­209. The CONTAM Panel concluded that the neurodevelopmental effects on behaviour and reproductive/developmental effects are the critical effects in rodent studies. For four congeners (BDE-47, -99, -153, -209) the Panel derived Reference Points, i.e. benchmark doses and corresponding lower 95% confidence limits (BMDLs), for endpoint-specific benchmark responses. Since repeated exposure to PBDEs results in accumulation of these chemicals in the body, the Panel estimated the body burden at the BMDL in rodents, and the chronic intake that would lead to the same body burden in humans. For the remaining six congeners no studies were available to identify Reference Points. The Panel concluded that there is scientific basis for inclusion of all 10 congeners in a common assessment group and performed a combined risk assessment. The Panel concluded that the combined margin of exposure (MOET) approach was the most appropriate risk metric and applied a tiered approach to the risk characterisation. Over 84,000 analytical results for the 10 congeners in food were used to estimate the exposure across dietary surveys and age groups of the European population. The most important contributors to the chronic dietary Lower Bound exposure to PBDEs were meat and meat products and fish and seafood. Taking into account the uncertainties affecting the assessment, the Panel concluded that it is likely that current dietary exposure to PBDEs in the European population raises a health concern.

8.
EFSA J ; 22(1): e8496, 2024 Jan.
Article in English | MEDLINE | ID: mdl-38264299

ABSTRACT

The European Commission requested EFSA to provide an update of the 2012 Scientific Opinion of the Panel on Contaminants in the Food Chain (CONTAM) on the risks for animal health related to the presence of ergot alkaloids (EAs) in feed. EAs are produced by several fungi of the Claviceps and Epichloë genera. This Opinion focussed on the 14 EAs produced by C. purpurea (ergocristine, ergotamine, ergocornine, α- and ß-ergocryptine, ergometrine, ergosine and their corresponding 'inine' epimers). Effects observed with EAs from C. africana (mainly dihydroergosine) and Epichloë (ergovaline/-inine) were also evaluated. There is limited information on toxicokinetics in food and non-food producing animals. However, transfer from feed to food of animal origin is negligible. The major effects of EAs are related to vasoconstriction and are exaggerated during extreme temperatures. In addition, EAs cause a decrease in prolactin, resulting in a reduced milk production. Based on the sum of the EAs, the Panel considered the following as Reference Points (RPs) in complete feed for adverse animal health effects: for pigs and piglets 0.6 mg/kg, for chickens for fattening and hens 2.1 and 3.7 mg/kg, respectively, for ducks 0.2 mg/kg, bovines 0.1 mg/kg and sheep 0.3 mg/kg. A total of 19,023 analytical results on EAs (only from C. purpurea) in feed materials and compound feeds were available for the exposure assessment (1580 samples). Dietary exposure was assessed using two feeding scenarios (model diets and compound feeds). Risk characterisation was done for the animals for which an RP could be identified. The CONTAM Panel considers that, based on exposure from model diets, the presence of EAs in feed raises a health concern in piglets, pigs for fattening, sows and bovines, while for chickens for fattening, laying hens, ducks, ovines and caprines, the health concern related to EAs in feed is low.

9.
EFSA J ; 21(12): e8430, 2023 Dec.
Article in English | MEDLINE | ID: mdl-38125972

ABSTRACT

This opinion addresses the re-evaluation of erythritol (E 968) as food additive and an application for its exemption from the laxative warning label requirement as established under Regulation (EU) No 1169/2011. Erythritol is a polyol obtained by fermentation with Moniliella pollinis BC or Moniliella megachiliensis KW3-6, followed by purifications and drying. Erythritol is readily and dose-dependently absorbed in humans and can be metabolised to erythronate to a small extent. Erythritol is then excreted unchanged in the urine. It does not raise concerns regarding genotoxicity. The dataset evaluated consisted of human interventional studies. The Panel considered that erythritol has the potential to cause diarrhoea in humans, which was considered adverse because its potential association with electrolyte and water imbalance. The lower bound of the range of no observed adverse effect levels (NOAELs) for diarrhoea of 0.5 g/kg body weight (bw) was identified as reference point. The Panel considered appropriate to set a numerical acceptable daily intake (ADI) at the level of the reference point. An ADI of 0.5 g/kg bw per day was considered by the Panel to be protective for the immediate laxative effect as well as potential chronic effects, secondary to diarrhoea. The highest mean and 95th percentile chronic exposure was in children (742 mg/kg bw per day) and adolescents (1532 mg/kg bw per day). Acute exposure was maximally 3531 mg/kg bw per meal for children at the 99th percentile. Overall, the Panel considered both dietary exposure assessments an overestimation. The Panel concluded that the exposure estimates for both acute and chronic dietary exposure to erythritol (E 968) were above the ADI, indicating that individuals with high intake may be at risk of experiencing adverse effects after single and repeated exposure. Concerning the new application, the Panel concluded that the available data do not support the proposal for exemption.

10.
EFSA J ; 21(11): e08375, 2023 Nov.
Article in English | MEDLINE | ID: mdl-37942224

ABSTRACT

In 2004, the EFSA Panel on Contaminants in the Food Chain (CONTAM) adopted a Scientific Opinion on the risks to animal health and transfer from feed to food of animal origin related to the presence of ochratoxin A (OTA) in feed. The European Commission requested EFSA to assess newly available scientific information and to update the 2004 Scientific Opinion. OTA is produced by several fungi of the genera Aspergillus and Penicillium. In most animal species it is rapidly and extensively absorbed in the gastro-intestinal tract, binds strongly to plasma albumins and is mainly detoxified to ochratoxin alpha (OTalpha) by ruminal microbiota. In pigs, OTA has been found mainly in liver and kidney. Transfer of OTA from feed to milk in ruminants and donkeys as well as to eggs from poultry is confirmed but low. Overall, OTA impairs function and structure of kidneys and liver, causes immunosuppression and affects the zootechnical performance (e.g. body weight gain, feed/gain ratio, etc.), with monogastric species being more susceptible than ruminants because of limited detoxification to OTalpha. The CONTAM Panel considered as reference point (RP) for adverse animal health effects: for pigs and rabbits 0.01 mg OTA/kg feed, for chickens for fattening and hens 0.03 mg OTA/kg feed. A total of 9,184 analytical results on OTA in feed, expressed in dry matter, were available. Dietary exposure was assessed using different scenarios based on either model diets or compound feed (complete feed or complementary feed plus forage). Risk characterisation was made for the animals for which an RP could be identified. The CONTAM Panel considers that the risk related to OTA in feed for adverse health effects for pigs, chickens for fattening, hens and rabbits is low.

11.
Midwifery ; 125: 103807, 2023 Oct.
Article in English | MEDLINE | ID: mdl-37660539

ABSTRACT

OBJECTIVE: Midwifery graduates may experience transition shock that makes them question their fit for their workplace and the profession and in extreme cases, may lead to them leaving. Understanding graduate midwives' worldviews, job intentions and work experiences is important to inform retention strategies. Factors such as having a strong professional identity and experiencing strong job satisfaction are important for midwife retention. Conversely, stress, trauma and work-life imbalances are examples of factors that lead to attrition from midwifery. Transition shock experienced by some graduates can exacerbate these factors if not managed effectively. This study aimed to identify causes and impact of any changes in graduate and early career midwives' philosophy, practice, and intention to stay in the profession. DESIGN, SETTING AND PARTICIPANTS: We invited the 2021 and 2022 cohorts of graduating midwifery students from all educational pathways in Victoria, Australia to participate in a longitudinal descriptive study using a questionnaire with both closed and open -ended questions. This paper reports the findings from 16 participants that completed the first survey of a five-year longitudinal descriptive study. FINDINGS: The sixteen participants predominantly held a woman centred philosophy and ideally wanted to work in a midwife-led model of care. Although excited about moving into practice, they also disclosed a sense of needing to 'survive' in a maternity care system that their beliefs were not fully in alignment with. KEY CONCLUSIONS: The hopes, expectations and concerns of midwifery students who are anticipating moving into practice in this study resonate with those previously reported and demonstrate the need to consider personality-job fit in supporting this vulnerable group to transition. IMPLICATIONS FOR PRACTICE: This study provides insights into graduating midwives' hopes for, expectations of, and concerns about transitioning into practice that may inform the design of transition programs and support expansion of midwifery led models of care.


Subject(s)
Maternal Health Services , Midwifery , Nurse Midwives , Female , Pregnancy , Humans , Midwifery/education , Intention , Surveys and Questionnaires , Victoria , Philosophy , Students , Qualitative Research
12.
EFSA J ; 21(9): e08215, 2023 Sep.
Article in English | MEDLINE | ID: mdl-37711880

ABSTRACT

Mineral oil hydrocarbons (MOH) are composed of saturated hydrocarbons (MOSH) and aromatic hydrocarbons (MOAH). Due to the complexity of the MOH composition, their complete chemical characterisation is not possible. MOSH accumulation is observed in various tissues, with species-specific differences. Formation of liver epithelioid lipogranulomas and inflammation, as well as increased liver and spleen weights, are observed in Fischer 344 (F344) rats, but not in Sprague-Dawley (SD) rats. These effects are related to specific accumulation of wax components in the liver of F344 rats, which is not observed in SD rats or humans. The CONTAM Panel concluded that F344 rats are not an appropriate model for effects of MOSH with wax components. A NOAEL of 236 mg/kg body weight (bw) per day, corresponding to the highest tested dose in F344 rats of a white mineral oil product virtually free of wax components, was selected as relevant reference point (RP). The highest dietary exposure to MOSH was estimated for the young population, with lower bound-upper bound (LB-UB) means and 95th percentiles of 0.085-0.126 and 0.157-0.212 mg/kg bw per day, respectively. Considering a margin of exposure approach, the Panel concluded that the present dietary exposure to MOSH does not raise concern for human health for all age classes. Genotoxicity and carcinogenicity are associated with MOAH with three or more aromatic rings. For this subfraction, a surrogate RP of 0.49 mg/kg bw per day, calculated from data on eight polycyclic aromatic hydrocarbons, was considered. The highest dietary exposure to MOAH was also in the young population, with LB-UB mean and 95th percentile estimations of 0.003-0.031 and 0.011-0.059 mg/kg bw per day, respectively. Based on two scenarios on three or more ring MOAH contents in the diet and lacking toxicological information on effects of 1 and 2 ring MOAH, a possible concern for human health was raised.

13.
EFSA J ; 21(7): e08102, 2023 Jul.
Article in English | MEDLINE | ID: mdl-37448443

ABSTRACT

The European Commission requested EFSA to provide an assessment of the processing conditions which make Ambrosia seeds non-viable in feed materials and compound feed. This assessment also includes information on a reliable procedure to verify the non-viability of the seeds. Ambrosia seeds are known contaminants in feed with maximum levels set in the Directive 2002/32/EC. The manufacturing processes and processing conditions applied to the feed may affect the viability of the Ambrosia seeds. Therefore, the CONTAM Panel compared these conditions with conditions that have been shown to be sufficient to render Ambrosia seeds non-viable. The Panel concluded with a certainty of 99-100% that solvent extraction and toasting of oilseed meals at temperatures of 120°C with steam injection for 10 min or more will make Ambrosia seeds non-viable. Since milling/grinding feed materials for compound feed of piglets, aquatic species and non-food producing animals would not allow particles of sizes ≥1 mm (the minimum size of viable Ambrosia seeds) passing the grinding process it was considered very likely (with ≥ 90% certainty) that these feeds will not contain viable Ambrosia seeds. In poultry, pig, and possibly cattle feed, particle sizes are ≥ 1 mm and therefore Ambrosia seeds could likely (66-90% certainty) survive the grinding process. Starch and gluten either from corn or wheat wet milling would not contain Ambrosia seeds with 99-100% certainty. Finally, ensiling fresh forages contaminated with A. artemisiifolia seeds for more than 3 months is very likely to render all seeds non-viable. The Panel concluded that a combination of the germination test and a subsequent triphenyl-tetrazolium-chloride (TTC) test will very likely (with ≥ 90% certainty) verify the non-viability of Ambrosia seeds. The Panel recommends that data on the presence of viable Ambrosia seeds before and after the different feed production processes should be generated.

14.
Am J Med Qual ; 38(3): 154-159, 2023.
Article in English | MEDLINE | ID: mdl-37125671

ABSTRACT

The authors hypothesize that standardized telehealth (TH) scheduling processes will improve TH utilization without increasing adverse events. Fifty visits preimplementation and 67 visits postimplementation were audited from June 2021 to January 2022. Both leadership and frontline stakeholders were engaged to identify current workflows and potential interventions targeting outpatient elective procedures. Process mapping outlined current TH scheduling workflows. Outcomes related to TH completion, cost, and TH scheduling were collected after implementation. Preimplementation TH scheduling rate was 32%. The intervention required TH postoperative appointments to be scheduled in clinic at the time of surgery scheduling with TH being the default postsurgical appointment for a standardized list of eligible procedures. Following implementation, 95% of patients undergoing eligible procedures had TH follow-up. This provided improved access to surgical follow-up care, by reducing travel needs to the Veterans Affairs facility. Secondarily, this intervention increased clinic appointment availability and resulted in possible increased revenue for billable visits. Standardizing TH scheduling based on the procedure improves the utilization of TH resulting in improved clinic efficiency and increased revenue, without increasing adverse events.


Subject(s)
Appointments and Schedules , Telemedicine , Humans , Ambulatory Care Facilities , Time Factors , Efficiency, Organizational
15.
EFSA J ; 21(3): e07866, 2023 Mar.
Article in English | MEDLINE | ID: mdl-36875862

ABSTRACT

The European Commission asked EFSA for a scientific opinion on the risks for human health of the presence of grayanotoxins (GTXs) in 'certain honey' from Ericaceae plants. The risk assessment included all structurally related grayananes occurring with GTXs in 'certain' honey. Oral exposure is associated with acute intoxication in humans. Acute symptoms affect the muscles, nervous and cardiovascular systems. These may lead to complete atrioventricular block, convulsions, mental confusion, agitation, syncope and respiratory depression. For acute effects, the CONTAM Panel derived a reference point (RP) of 15.3 µg/kg body weight for the sum of GTX I and III based on a BMDL10 for reduced heart rate in rats. A similar relative potency was considered for GTX I. Without chronic toxicity studies, an RP for long-term effects could not be derived. There is evidence for genotoxicity in mice exposed to GTX III or honey containing GTX I and III, showing increased levels of chromosomal damage. The mechanism of genotoxicity is unknown. Without representative occurrence data for the sum of GTX I and III and consumption data from Ericaceae honey, acute dietary exposure was estimated based on selected concentrations for GTX I and III reflecting concentrations measured in 'certain' honeys. Applying a margin of exposure (MOE) approach, the estimated MOEs raised health concerns for acute toxicity. The Panel calculated the highest concentrations for GTX I and III below which no acute effects would be expected following 'certain honey' consumption. The Panel is 75% or more certain that the calculated highest concentration of 0.05 mg for the sum of GTX I and III per kg honey is protective for all age groups regarding acute intoxications. This value does not consider other grayananes in 'certain honey' and does not cover the identified genotoxicity.

16.
Plants (Basel) ; 12(5)2023 Mar 02.
Article in English | MEDLINE | ID: mdl-36904007

ABSTRACT

Breast cancer (BC) is known to be the most common malignancy among women throughout the world. Plant-derived natural products have been recognized as a great source of anticancer drugs. In this study, the efficacy and anticancer potential of the methanolic extract of Monotheca buxifolia leaves using human breast cancer cells targeting WNT/ß-catenin signaling was evaluated. We used methanolic and other (chloroform, ethyl acetate, butanol, and aqueous) extracts to discover their potential cytotoxicity on breast cancer cells (MCF-7). Among these, the methanol showed significant activity in the inhibition of the proliferation of cancer cells because of the presence of bioactive compounds, including phenols and flavonoids, detected by a Fourier transform infrared spectrophotometer and by gas chromatography mass spectrometry. The cytotoxic effect of the plant extract on the MCF-7 cells was examined by MTT and acid phosphatase assays. Real-time PCR analysis was performed to measure the mRNA expression of WNT-3a and ß-catenin, along with Caspase-1,-3,-7, and -9 in MCF-7 cells. The IC50 value of the extract was found to be 232 µg/mL and 173 µg/mL in the MTT and acid phosphatase assays, respectively. Dose selection (100 and 300 µg/mL) was performed for real-time PCR, Annexin V/PI analysis, and Western blotting using Doxorubicin as a positive control. The extract at 100 µg/mL significantly upregulated caspases and downregulated the WNT-3a and ß-catenin gene in MCF-7 cells. Western blot analysis further confirmed the dysregulations of the WNT signaling component (*** p< 0.0001). The results showed an increase in the number of dead cells in methanolic extract-treated cells in the Annexin V/PI analysis. Our study concludes that M. buxifolia may serve as an effective anticancer mediator through gene modulation that targets WNT/ß-catenin signaling, and it can be further characterized using more powerful experimental and computational tools.

17.
EFSA J ; 21(3): e07884, 2023 Mar.
Article in English | MEDLINE | ID: mdl-36999063

ABSTRACT

EFSA was asked for a scientific opinion on the risks to public health related to the presence of N-nitrosamines (N-NAs) in food. The risk assessment was confined to those 10 carcinogenic N-NAs occurring in food (TCNAs), i.e. NDMA, NMEA, NDEA, NDPA, NDBA, NMA, NSAR, NMOR, NPIP and NPYR. N-NAs are genotoxic and induce liver tumours in rodents. The in vivo data available to derive potency factors are limited, and therefore, equal potency of TCNAs was assumed. The lower confidence limit of the benchmark dose at 10% (BMDL10) was 10 µg/kg body weight (bw) per day, derived from the incidence of rat liver tumours (benign and malignant) induced by NDEA and used in a margin of exposure (MOE) approach. Analytical results on the occurrence of N-NAs were extracted from the EFSA occurrence database (n = 2,817) and the literature (n = 4,003). Occurrence data were available for five food categories across TCNAs. Dietary exposure was assessed for two scenarios, excluding (scenario 1) and including (scenario 2) cooked unprocessed meat and fish. TCNAs exposure ranged from 0 to 208.9 ng/kg bw per day across surveys, age groups and scenarios. 'Meat and meat products' is the main food category contributing to TCNA exposure. MOEs ranged from 3,337 to 48 at the P95 exposure excluding some infant surveys with P95 exposure equal to zero. Two major uncertainties were (i) the high number of left censored data and (ii) the lack of data on important food categories. The CONTAM Panel concluded that the MOE for TCNAs at the P95 exposure is highly likely (98-100% certain) to be less than 10,000 for all age groups, which raises a health concern.

19.
EFSA J ; 21(2): e07806, 2023 Feb.
Article in English | MEDLINE | ID: mdl-36751491

ABSTRACT

In 2017, the EFSA Panel on Contaminants in the Food Chain (CONTAM) adopted a Scientific Opinion on the risks for animal health related to the presence of deoxynivalenol (DON) and its acetylated and modified forms in food and feed. No observed adverse effect levels (NOAELs) and lowest observed adverse effect levels (LOAELs) were derived for different animal species. For horses, an NOAEL of 36 mg DON/kg feed was established, the highest concentration tested and not showing adverse effects. For poultry, an NOAEL of 5 mg DON/kg feed for broiler chickens and laying hens, and an NOAEL of 7 mg DON/kg feed for ducks and turkeys was derived. The European Commission requested EFSA to review the information regarding the toxicity of DON for horses and poultry and to revise, if necessary, the established reference points (RPs). Adverse effect levels of 1.9 and 1.7 mg DON/kg feed for, respectively, broiler chickens and turkeys were derived from reassessment of existing studies and newly available literature, showing that DON causes effects on the intestines, in particular the jejunum, with a decreased villus height but also histological damage. An RP for adverse animal health effects of 0.6 mg/kg feed for broiler chickens and turkeys, respectively, was established. For horses, an adverse effect level of 5.6 mg DON/kg feed was established from studies showing reduced feed intake, with an RP for adverse animal health effects of 3.5 mg/kg feed. For ducks and laying hens, RPs remain unchanged. Based on mean and P95 (UB) exposure estimates performed in the previous Opinion, the risk of adverse health effects of feeds containing DON was considered a potential concern for broiler chickens and turkeys. For horses, the risk for adverse health effects from feed containing DON is low.

20.
Womens Health (Lond) ; 19: 17455057221150098, 2023.
Article in English | MEDLINE | ID: mdl-36692031

ABSTRACT

BACKGROUND: Over the past 50 years, the content and structure of antenatal education classes have varied to reflect social norms of the time, the setting and context in which they have been held and who has facilitated them. In recent times, antenatal and parenting education classes have become a smorgasbord of information, offering a range of diverse content. Where and how parents-to-be may access formal antenatal and parenting education classes are also varied. Even before the lockdown challenges of the Covid-19 pandemic, many antenatal and parenting education classes had become available and accessible online. While the flexibility and accessibility of this option are apparent, scant research to date has reported on parents' experiences of undertaking online antenatal education. OBJECTIVES: The objectives of this study were to explore new parents' experiences of engaging in online antenatal education, and to discover how consumers of online antenatal education perceive it should be designed and delivered. DESIGN/METHODS: A mixed-methods design was used for this study, which was conducted with 294 past enrolees in a range of online antenatal and early parenting education programmes delivered by one private provider in Australia. The past enrolees were invited to participate in the study by email, wherein a link to an online information sheet and survey containing closed- and open-ended questions was provided. The responses to the open-ended questions that are reported in this article were analysed using a thematic approach that involved coding, sub-categorizing and then categorizing the data. RESULTS: A total of 108 participants provided qualitative data about the delivery and design of online antenatal education and information. The data were captured in three themes: video control and content, accessibility and pre-/intra-programme support. CONCLUSIONS: The results of this study provide important insights for the development of online antenatal education programmes and courses that will be of interest to antenatal educators, maternity services and maternity care policy developers. Specifically, millennial parents want trustworthy and accurate antenatal education that is delivered in a framework that aligns with and builds on adult-learning principles. The diversity of families and of expectant parents' learning styles is also important to recognize in antenatal education curricula.


Subject(s)
COVID-19 , Maternal Health Services , Adult , Female , Humans , Pregnancy , Retrospective Studies , Parenting , Pandemics , Communicable Disease Control , Parents , Education, Nonprofessional
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