Safety Regulations Research Articles

Regulatory decentralization and food safety: evidence from China

AbstractIt is not clear, a priori, whether a centralized or decentralized institutional arrangement is better at providing public goods. This study investigates how decentralization of regulatory authority affects public good provision, focusing on food safety. Using a natural experiment that transfers food safety regulatory authority over the food processing and manufacturing sector from provincial to city‐level governments, we find a 51% decrease in the average number of food safety incidents within cities that experienced the decentralization reform. Decentralization reduces food safety incidents by rectifying information asymmetry in food safety regulations and by increasing local food safety laws and regulations. Additional analyses show that decentralization primarily improves the food safety of larger and more experienced firms, and it has not harmed the total revenue of large‐scale food processing and manufacturing firms. Our study demonstrates the importance of information available to regulatory authorities in food safety regulation and highlights the role of local information in the decentralized provision of public goods.

Ensuring safety and efficacy in combination products: regulatory challenges and best practices.

Combination products, amalgamating drugs, biologics, and medical devices, have revolutionized the healthcare landscape with their potential for innovative therapies. However, the intersection of diverse components within these products presents a complex regulatory environment, demanding rigorous attention to safety and efficacy. This article delves into the intricate landscape of regulatory considerations, safety, and efficacy assessments pertaining to combination products-a category at the intersection of drugs, devices, and biologics. The regulatory framework, primarily governed by the U.S. Food and Drug Administration (FDA), necessitates a nuanced classification determining the regulatory pathway. Collaboration between diverse regulatory centers, such as the Center for Drug Evaluation and Research (CDER) and the Center for Devices and Radiological Health (CDRH), underscores the integrated approach required for these innovative healthcare solutions. Safety considerations unravel the potential risks and adverse events associated with combining diverse components, emphasizing the need for robust risk assessment and mitigation strategies. The evaluation of efficacy involves sophisticated methodologies, clinical trials, and post-market surveillance, with recent advancements incorporating digital technologies. This comprehensive exploration aims to contribute to the evolving understanding and best practices in the regulatory and scientific realms, fostering collaboration and innovation in the development and assessment of combination products.

P-081 A first in class potentiating therapeutic antibody as a new male fertility treatment

Abstract Study question Can we improve spermatogenesis in male by increasing FSH activity with a potentiating antibody? Summary answer IGYXOS developed a first in class potentiating therapeutic antibody that is able to stimulate spermatogenesis better than gonadotropins only as demonstrated in animal models. What is known already Idiopathic male infertility, including oligozoospermia, oligoasthenoteratospermia (OATS) and azoospermia, accounts for at least 75% of infertile men population, and no treatment is available at the moment for them. IGYXOS developed a monoclonal antibody directed against human FSH. IGX12 is a humanized IgG4 and it is able to potentiate FSH activity in vitro and in vivo in several animal models. Study design, size, duration IGX12 was tested in azoospermic rat and mouse models. The first model was created by treating Wistar Han rats with a GnRH antagonist. Gonadotropin treatment started after full inhibition of spermatogenesis. Four rats per group were treated with FSH+hCG regimen alone or in combination with IGX12. The second model was hpg mice that are congenitally hypogonadal because of their inability to synthetize GnRH. Seven mice per group were treated with FSH only or FSH+IGX12. Participants/materials, setting, methods IGX12 was tested in vitro on HEK293 cells and in vivo in Steelman and Pohley bioassay. The potentiating effect was investigated in azoospermic rats, that were treated for 8 weeks with FSH+hCG or FSH+hCG+IGX12. Hpg mice were treated with Gonal-f or Gonal-f+IGX12 for 7 weeks, followed by a treatment with Menopur or Menopur+IGX12 for a further 7 weeks. At the end of treatment, sperm counts in the testes and in the epididymides were assessed. Main results and the role of chance In vitro on HEK 293 cells expressing the human FSH receptor, IGX12 combined to FSH improved both the potency (EC50) and the efficacy (Emax) of FSH by increasing the cyclic AMP production at all tested FSH concentrations. The potentiating activity was confirmed in vivo in the Steelman and Pohley bioassay. Ovaries weight of immature female rats was increased significantly in the group treated with hCG/FSH+IGX12 compared to hCG/FSH only. To further analyze the potential benefit of IGX12 on male fertility, its effect was investigated in azoospermic rodent models. In rats with acquired azoospermia, treatment with FSH+hCG reached ∼50% of spermatogenesis of wild-type (WT) animals. Doubling the dose of gonadotropins did not improve their effect, whereas the addition of IGX12 on top of FSH+hCG treatment during one spermatogenesis cycle only (8 weeks) significantly improved sperm count in the testes and in the epididymides, reaching the level of WT animals. In hpg mice with congenital azoospermia, sperm count in the testis was 3.6 times higher and the sperm count in the epididymides was 6 times higher in the group treated with IGX12+FSH compared with FSH only (p < 0.05). In conclusion, IGX12 combined to a standard treatment stimulated spermatogenesis better than standard gonadotropin treatment. Limitations, reasons for caution After several proofs of concept and regulatory safety and toxicology evaluation in different animal models, IGX12 safety and tolerability is now assessed in a randomized, double blinded clinical phase I study on healthy men and women volunteers. Wider implications of the findings This first in class potentiating antibody IGX12 represents an innovative and promising new therapy to treat male patients with idiopathic infertility, especially with oligozoospermia. Trial registration number not applicable

P-654 A first in class potentiating therapeutic antibody as a new treatment for female fertility

Abstract Study question Can we improve controlled ovarian stimulation (COS) outcome in female by increasing FSH activity with a potentiating antibody? Summary answer IGYXOS developed a first in class potentiating antibody that improves COS treatments’ outcome by increasing FSH efficacy in vivo as demonstrated in non-human primates (NHP). What is known already For a COS in IVF cycles, FSH-containing preparations are injected to patients in order to obtain mature and fertilizable oocytes. However, the efficacy of these treatments is still limited and several attempts are needed before reaching a pregnancy and a live birth. One of the parameters that could be improved to avoid several attempts is the number of mature and thus fertilizable oocytes. It was previously demonstrated that breeding animals treated with gonadotropins could develop anti-gonadotropin antibodies that enhance their bioactivity instead of inhibiting it. These females had a high kidding rate and were hyperprolific. Study design, size, duration IGYXOS developed a monoclonal antibody (mAb) IGX12, a humanized IgG4, directed against human FSH. IGX12 was selected based on its ability to increase FSH activity in vitro and in vivo in rat., It was tested in mature cynomolgus female monkeysthat were treated as women undergoing ovarian stimulation for IVF with FSH alone or in combination with IGX12. Participants/materials, setting, methods IGX12 was tested in vitro on HEK 293 cells expressing the human FSH receptor. In vivo, the mAb was tested according to the Steelman and Pohley protocol. The potentiating effect was further investigated in NHP treated with mAb combined to a standard FSH treatment, under an agonist protocol. After hCG injection, oocytes were retrieved and their quality was analyzed. Blood was collected for hormonal assessments. Main results and the role of chance In vitro on HEK 293 cells expressing the human FSH receptor, IGX12 combined to FSH improves both the potency (EC50) and the efficacy (Emax) of FSH by increasing the cyclic AMP production at all tested FSH concentrations. The potentiating activity was confirmed in vivo in the Steelman and Pohley bioassay. Immature female rats received hCG+FSH alone or combined to mAb, twice a day, during 3 days. The animals were sacrificed the fourth day of treatment and the weight of the ovaries was compared. Ovaries weight was increased significantly in the group treated with hCG/FSH+IGX12 compared to hCG/FSH only. To further analyze the potential benefit of a IGX12 on human fertility, its effect was investigated in mature cynomolgus monkeys. IGX12 combined to a standard FSH treatment stimulated the follicular growth better than FSH only, and tripled the number of collected mature oocytes. Improved follicular growth correlated well with increased estradiol secretion during follicular phase and progesterone secretion during luteal phase. Limitations, reasons for caution After several proofs of concept and regulatory safety and toxicology evaluation in different animal models, IGX12 safety and tolerability is now assessed in a randomized, double blinded clinical phase I study on healthy men and women volunteers. Wider implications of the findings This first in class potentiating antibody IGX12 represents an innovative and promising new therapy to better stimulate patients with limited response to classical FSH treatments in order to improve the outcome of COS, and for normo-responders to avoid repetition of treatments. Trial registration number not applicable

Cocoa Farmer's Use Of Approved Pesticides And Compliance With Safety Standards In Obuasi Municipality, Ghana

Amidst the agricultural landscape of Ghana lies a complex interplay of practices governing the use of approved pesticides and adherence to safety standards among farmers. By analysing data gleaned from 400 farmers through the multistage sampling technique, our aim is reveal the multifaceted influences that shape farmers' decisions in the use of approved pesticides and safety compliance. Age, education, marital status, farm ownership, experience, farm size, access to equipment and services, cooperative membership, secondary occupations, and income, significantly influence farmers' choices in the use of approved pesticides. Furthermore, compliance with safety protocols is found to be influenced by factors such as farm size, access to extension services, and the perceived relative advantage of pesticides. We advocate for policies that promote the use of approved pesticides and prioritise safety standards in agricultural practices. This may include strengthening regulatory frameworks, incentivising sustainable farming practices, and enforcing penalties for non-compliance with safety regulations.

The role of trust in occupational safety: research results

This article presents the concept and results of a study on the effects of organizational trust on the safety level in an enterprise. The research results presented provide valid and reliable statistical evidence that employees’ trust in management is an important factor that significantly affects safety in a company. In particular, the research findings prove that employees’ trust in management affects safety outcomes indirectly (full mediation), due to the improvement in their engagement in safety citizenship behaviour (SCB); but also that better engagement in SCB should directly or indirectly contribute to the reduction of accident event occurrence through improvement in employees’ health and safety (H&S) regulation compliance (partial mediation). Moreover, the research findings prove that improvement in perceived management commitment in H&S will additionally strengthen positive relationships between trust in management and SCB engagement (interaction effect).

Identification of key factors influencing unsafe behavior of decoration workers

This study explores the factors influencing unsafe behaviors among decorators. The study begins with a literature review on unsafe behaviors among construction workers, compiling a checklist of factors specific to decorators. Utilizing exploratory factor analysis (EFA), a measurement scale for these factors is developed. Subsequently, stepwise regression analysis (SRA) is conducted to validate relationships and identify crucial factors. Results categorize influencing factors into three dimensions: personal, organizational and environmental. Non-compliance with safety procedures and protocols is found to correlate directly with increased unsafe behavior at an individual level. Additionally, internal safety regulations within companies are identified as having a direct negative impact on unsafe behaviors at the organizational level. This study enhances our understanding of unsafe behaviors among decorators and offers recommendations for mitigation.

Evaluating Environmental Health and Safety Practices among Fuel Station Operators in Ghana’s Petroleum (Downstream) Sector

The study assesses service operators’ role and awareness level in environmental health and safety practices in the petroleum (downstream) sector / Fuel Service Station (FSS) in Adentan Municipality in Ghana. A total of 50 managers and workers were used as the sample size for the study, of which 18 were female and 32 were male. The study was a descriptive survey, with a questionnaire as the instrument for data gathering. The final data were analyzed using descriptive statistics like percentages and frequencies through SPSS IBM 27. The two main objectives of the study were to examine the role of operators in participating in environmental health and safety in fuel service stations and to establish the level of awareness of the operators about environmental health and safety. The study revealed that operators of FSS within the petroleum downstream sector have major roles to play in environmental health and safety by enforcing health and safety policies established by law and regulations for Health, Safety, and Environment (HSE). The findings again showed that the level of awareness of the operators on environmental health and safety is very high and paramount in the FSS, as they showed positive concern about worker Personal Protective Equipment (PPE) provision and standardized procedures for investigating and reporting accidents.

Model‐Based Systems Engineering (MBSE) Application in Nuclear Power Plants (NPP)

AbstractCompanies in the nuclear power sector are constantly being challenged to improve their safety and reliability due to increasing complexity arise from evolving safety regulations, long production life, interdisciplinary collaboration, and the need for analyzing the impact of the changes in an operational life cycle. Recognizing these challenges, the paper proposes a transition to Model‐Based Systems Engineering (MBSE) as a transformative solution to improve the management of such complex systems. With this objective, this paper presents a workflow implementation that demonstrates the MBSE methodologies to define a concept model, system architecture, impact analysis, safety and reliability analysis, and operational decision‐making of Nuclear Power Plants (NPP). The paper concludes that MBSE provides a potent approach to managing NPP by employing graphical models to develop interrelated systems that has strong adaptability to heterogeneous environments and regulatory changes. The simulation results demonstrated an NPP life cycle, impact analysis, and a test case for model‐based safety and reliability analysis for regulatory compliance, operational efficiency, balance safety, and informed decision‐making in NPP. The study also leads to a number of interesting directions of future work such as synchronization through Product Lifecycle Management, integration with Building Information Modeling, Model‐Based Commissioning/Decommissioning, and Model‐Based Cyber System Security tailored for nuclear power systems.

Subchronic oral toxic effects of 2,4-dinitroaniline in wistar rats: A comprehensive toxicity evaluation

2,4-dinitroaniline (2,4-D), a widely used dye intermediate, is one of the typical pollutants, and its potential health risks and toxicity are still largely unknown. To explore its subchronic oral toxicity, Wistar rats (equal numbers of males and females) were used as test animals, and a 90-day oral dosing experiment was conducted, divided into control group, low-dose group (0.055 mg/kg), medium-dose group (0.22 mg/kg), medium-high dose group (0.89 mg/kg), and high-dose group (3.56 mg/kg). The body weight data, clinical appearance, and drug reactions of each test rat within 90 days of dosing were recorded; morning urine samples were collected four times to test for eight urinary indicators; blood samples were collected to test for nineteen hematological indicators and sixteen biochemical indicators; tissue samples were collected for pathological analysis; moreover, the no-observed-adverse-effect level (NOAEL) was determined, and the benchmark dose method was used to support this determination and provide a statistical estimate of the dose corresponding. The results indicated that the chronic toxicity of 2,4-dinitroaniline showed certain gender differences, with the eyes, liver, and kidneys being the main potential target organs of toxicity. Moreover, the subchronic oral NOAEL for 2,4-dinitroaniline was determined to be 0.22 mg/kg body weight (0.22 mg/kg for males and 0.89 mg/kg for females), and a preliminary calculation of the safe exposure limit for human was 0.136 mg/kg. The research results greatly enriched the safety evaluation data of 2,4-dinitroaniline, contributing to a robust scientific foundation for the development of informed safety regulations and public health precautions.

Guided Wave Behavior in Type IV Composite Overwrapped Pressure Vessels Under Fatigue Loading

Innovative Ultrasonic Guided Wave Approach for Structural Health Monitoring of Type IV Composite Overwrapped Pressure Vessels Seyedreza Hashemi, Jan Heimann, Amir Charmi, Eric Duffner, Jens Prager Abstract: The digitalization of quality control processes and the use of digital data infrastructures is a novel idea that can be applied for ensuring the operational safety and reliability of pressure vessels, particularly in the context of hydrogen storage at high pressure. Despite the critical role these pressure vessels play, current safety regulations lack an established concept for Structural Health Monitoring (SHM). This research addresses this gap by presenting a study on the application of ultrasonic guided waves (GWs) for SHM of Type IV Composite Overwrapped Pressure Vessels (COPVs). The study focuses on the development of a reliable measurement system to transition from conventional periodic inspections to SHM and predictive maintenance, prolonging the remaining lifetime of the vessels. A sensor network is employed, consisting of fifteen piezoelectric wafers arranged in three rings, which are mounted on the outer surface of the COPV. Deploying GWs, known for their long-distance propagation and ability to cover complex structures, the study explores GW behavior under different environmental and operational conditions, including periodic pressure fluctuations and temperature loadings. Meticulous analysis of GW signals by utilizing various features and damage indices, underscores their suitability for an effective SHM under realistic working conditions. The project aims to localize defects by considering temperature, and internal pressure. Mimicking the continuous monitoring of Type IV COPVs in H2 refueling gas stations under authentic operational conditions, the COPV underwent thousands of pressure load cycles in our special test facility . The implemented methodology facilitates early damage detection, showcasing the efficacy of the designed method in effective safety assurance.

Forecasting Road Accident Deaths in India Using SARIMA

Road accidents are one of the leading causes of death worldwide. The present study analysed the pattern of road accident deaths in India from the year 2014 till the year 2022. The data was taken from the government website, and we have split it into training and testing datasets. The training dataset was from the year 2014 to 2020, and the forecasting was done for the years 2021 and 2022. We have used the SARIMA model to forecast the number of road accidents in India for the years 2021 and 2022. The accuracy of the SARIMA model in forecasting the number of road accidents in India is also established in the present study. The study has insights for policymakers and administrators. Some of the policies that can be enforced to decrease the number of road accidents in India are better road infrastructure for vehicles across India, enforcement of safety regulations, easy access to trauma care centres, strictly following the speed limits on the road and so on.

Analysis of refrigerants used in supermarket commercial equipment and the potential for increasing energy efficiency and reducing environmental impact

Refrigerants used in the commercial equipment of supermarkets are the object of the research. The Montreal Protocol calls for a complete phase-out of hydrochlorofluorocarbons (HCFCs) by 2030, and the Kigali Amendment regulates the use of hydrofluorocarbons (HFCs) from 2019. Developed countries began phasing out HFC use in 2019, while developing countries plan to freeze HFC consumption from 2024. These global efforts are aimed at reducing the depletion of the ozone layer and combating climate change. The number of supermarkets in the world varies greatly: in Europe they number from 110 thousand to 115 thousand, and in China – from 65 thousand to 70 thousand, which reflects various needs in refrigeration equipment. Stringent environmental regulations are forcing the commercial refrigeration sector to remain globally competitive. Modernization of supermarkets using natural refrigerants is important for solving emerging challenges. The results of the study show significant improvements in energy efficiency ratio (EER) and coefficient of performance (COP) when using a mixture of hydrocarbons (R290: 85 %, R600a: 15 %) compared to traditional refrigerants R404a, R449a and R502. Specifically, at the evaporation temperature of Tevap=–10 °C, EER increased by 38–44 % and COP by 26–31 % compared to R404a and R449a, respectively. At Tevap=–25 °C, EER increased by 17–34 % and COP by 2–22 % compared to R404a and R449a. Additionally, compared to R502, the hydrocarbon blend showed a 38–44 % increase in EER and 28–31 % COP at Tevap=–10 °C, and a 17–34 % increase in EER and 5–22 % COP at Tevap=–25 °C. These results highlight the advantages of the hydrocarbon mixture at different evaporation temperatures, indicating its potential to improve energy efficiency in refrigeration applications. The obtained data suggest the possibility of a wider application of the mixture of hydrocarbons in commercial refrigeration plants, offering both improved performance and compliance with safety regulations.

Food Safety Risk Analysis of Songkem Duck Using Failure Mode and Effect Analysis (FMEA) Method

Food safety is an essential aspect of human health. Food processed without paying attention to food safety regulations can harm consumer health. This research aims to 1) identify activities with food safety risks, 2) determine the sequence of food safety risks that will be followed up, and 3) determine appropriate food safety risk mitigation. This research uses the Failure Mode and Effect Analysis (FMEA) method and fishbone diagrams. A case study was conducted on the Songkem pak Soleh Bangkalan duck supply chain. The research results show that activities that pose a food safety risk include receiving raw materials, storing raw material stocks, using raw materials and BTP, sanitizing production facilities, and storing finished products. The priority order of food safety risks in the Songkem duck supply chain is based on the FMEA method: storage of finished products, sanitation of production facilities, and storage of raw material stocks. Risk mitigation can be done to prevent food safety risks in storing raw material stocks and storing finished products, namely by controlling water activity (aw) and acidity factor (pH); and controlling the room's atmosphere. Meanwhile, to prevent risks due to sanitation hygiene, namely holding training to increase awareness of the importance of sanitation hygiene for restaurant employees monitoring and maintaining sanitation hygiene in the production environment.

ANALYSIS OF RADIOECOLOGICAL MONITORING CONCEPTS IN AREAS OF NUCLEAR ENERGY FACILITIES

This article presents an analysis of international documents on the justification of monitoring systems in areas where nuclear facilities are located. The main international organization that regulates radiation safety, including requirements for the organization of radiation control and monitoring of radioactive contamination of the environment, is the International Atomic Energy Agency (IAEA). The IAEA Statute authorizes the Agency to establish safety standards to protect health and minimize the consequences to life and property of activities involving the use of radiation technologies. The IAEA safety standards must be used in its own work, and IAEA member states can apply them by incorporating them into their nuclear and radiation safety regulations. Regularly reviewed IAEA safety standards are a key element of the global regime for the protection of people and the environment.

인공발 제품의 사용적합성 평가 지침 개발 및 시험적용

Artificial foot is an assistive device worn by calf or thigh amputees to enable walking. Orthotic prosthesis including artificial foot are internationally classified as medical devices, but in Korea, they are still classified as assistive devices for the disabled rather than medical devices. All medical devices under the the Ministry of Food and Drug Safety regulation are required to conform to the international standard IEC 62366-1 since 2021. However, prosthetic orthotic products such as artificial foot are not classified as medical devices, so their usability test requirement has not yet been mandated. In this study, four prosthetic orthosis experts formed an advisory committee and applied IEC 62366-1, an international standard for medical device usability evaluation, to develop the usage scenarios for artificial foot products, in indoor and outdoor environments. After selecting 16 tasks in usage environments, we developed guidelines consisting of 52 questionnaires to determine the product's usability, including safety, effectiveness, and satisfaction. Three lower-leg amputees participated in the test application and responded to the survey of the guidelines for a prosthetic foot product while performing 16 tasks. this product received an average score of 3.42 out of 5, and the usability evaluation score was lower on unpaved roads and slippery tiles than on flat surfaces. It is expected that the experience in developing user suitability evaluation guidelines for artificial feet developed in this study can be usefully applied to the development of usability evaluation guidelines for other prosthetic and orthotic products.

Safety Aspects of In-Vehicle Infotainment Systems: A Systematic Literature Review from 2012 to 2023

This systematic literature review investigates the safety aspects of in-vehicle infotainment systems (IVISs) from 2012 to 2023, analyzing 96 studies. IVISs have significantly evolved, incorporating technologies such as navigation systems, parking assistance, and video games. However, these innovations introduce safety concerns like driver distraction and cognitive overload. This review identifies six primary safety issues: driving distraction, situational awareness, cognitive load, driving performance, interaction success, and emotional state. Head-down displays and touchscreens often have negative safety implications, while speech-based interfaces and Bluetooth-integrated systems are generally considered safer. Suggested improvements include enhancing interface design for touchscreens and exploring gesture-based alternatives. Despite these developments, significant gaps remain in real-world evaluations and studies in diverse driving conditions, highlighting the need for standardized manufacturing norms. Addressing these issues is essential for creating future IVIS that are both reliable and safe. This review serves as a foundation for future research, safety regulations, and design principles aimed at improving IVIS safety. Overcoming these challenges will require a multi-faceted approach that considers user-friendly design, adaptive technologies, and predictive analytics. The goal is to balance technological advancements with road safety, ensuring that IVISs contribute to a safer driving experience without compromising convenience and functionality.

AutoRepo: A general framework for multimodal LLM-based automated construction reporting

Ensuring the safety, quality, and timely completion of construction projects is critical, and construction inspections play an important role in achieving these objectives. Nevertheless, the predominantly manual approach to inspections frequently results in inefficiencies and inadequate information management. These methods often fail to provide a comprehensive and detailed assessment, resulting in regulatory oversight and potential safety hazards. To address this issue, this paper presents a novel framework named AutoRepo for automated generation of construction inspection reports. In AutoRepo, the unmanned vehicles efficiently perform construction inspections and collect scene information, while the multimodal large language model (LLM) is used to automatically generate the inspection reports. The framework was applied and tested on a real-world construction site, demonstrating its potential to speed up the inspection process, significantly reduce waste of resource, and generate high-quality inspection reports that meet regulatory standards. Thus, this research highlights the great potential of multimodal LLMs in revolutionizing construction inspection practices, signaling a significant leap forward towards a more efficient and safer construction management paradigm.

Integration of Postbiotics in Food Products through Attenuated Probiotics: A Case Study with Lactic Acid Bacteria in Bread.

The study examines the integration of postbiotics in food products through the use of attenuated probiotics, specifically lactic acid bacteria (LAB) in bread. Postbiotics, non-viable microorganisms or their metabolites, offer health benefits similar to probiotics without the risks associated with live bacteria. This research evaluates the regulatory aspects and safety of LAB in sourdough bread production, highlighting their historical and significant use in Europe before 1997. The study includes microbial quantification and Next-Generation Sequencing (NGS) to identify LAB in traditional sourdough, comparing them with historical and current EFSA Qualified Presumption of Safety (QPS) lists. Findings show that the LAB present in sourdough have been extensively and safely used in bread making, supporting their classification as non-novel foods under EU regulations. The stability and consistency of LAB metabolites in sourdough bread are also confirmed, ensuring quality and safety in each batch. The study concludes that LAB in sourdough, when inactivated through bread-making processes, are not considered novel foods, aligning with historical, scientific, and regulatory evidence.

Nanofillers in Novel Food Packaging Systems and Their Toxicity Issues.

Background: Environmental concerns about petroleum-based plastic packaging materials and the growing demand for food have inspired researchers and the food industry to develop food packaging with better food preservation and biodegradability. Nanocomposites consisting of nanofillers, and synthetic/biopolymers can be applied to improve the physiochemical and antimicrobial properties and sustainability of food packaging. Scope and approach: This review summarized the recent advances in nanofiller and their applications in improved food packaging systems (e.g., nanoclay, carbon nanotubes), active food packaging (e.g., silver nanoparticles (Ag NPs), zinc oxide nanoparticles (ZnO NPs)), intelligent food packaging, and degradable packaging (e.g., titanium dioxide nanoparticles (e.g., TiO2 NPs)). Additionally, the migration processes and related assessment methods for nanofillers were considered, as well as the use of nanofillers to reduce migration. The potential cytotoxicity and ecotoxicity of nanofillers were also reviewed. Key findings: The incorporation of nanofillers may increase Young's modulus (YM) while decreasing the elongation at break (EAB) (y = -1.55x + 1.38, R2 = 0.128, r = -0.358, p = 0.018) and decreasing the water vapor (WVP) and oxygen permeability (OP) (y = 0.30x - 0.57, R2 = 0.039, r = 0.197, p = 0.065). Meanwhile, the addition of metal-based NPs could also extend the shelf-life of food products by lowering lipid oxidation by an average of approx. 350.74% and weight loss by approx. 28.39% during the longest storage period, and significantly increasing antibacterial efficacy against S. aureus compared to the neat polymer films (p = 0.034). Moreover, the migration process of nanofillers may be negligible but still requires further research. Additionally, the ecotoxicity of nanofillers is unclear, as the final distribution of nanocomposites in the environment is unknown. Conclusions: Nanotechnology helps to overcome the challenges associated with traditional packaging materials. Strong regulatory frameworks and safety standards are needed to ensure the appropriate use of nanocomposites. There is also a need to explore how to realize the economic and technical requirements for large-scale implementation of nanocomposite technologies.