EFSA Journal最新文献

The EFSA Panel on Food Contact Materials (FCM) assessed the safety of the recycling process EREMA Vacurema Basic (EU register number RECYC 336). The input is washed and dried poly(ethylene terephthalate) (PET) flakes mainly originating from collected post-consumer PET containers, with below 5% PET from non-food consumer applications. The flakes are heated in a continuous flake reactor (step 2) under vacuum before being extruded. Having examined the challenge test provided, the Panel concluded that step 2 is critical in determining the decontamination efficiency of the process. The operating parameters to control the efficiency are the temperature, the pressure (vacuum) and the residence time. It was demonstrated that this recycling process ensures that the level of migration of potential unknown contaminants into food is below the conservatively modelled migration of 0.0481 or 0.0962 μg/kg food, depending on the molar mass of the contaminant substance. Therefore, the Panel concluded that the recycled PET obtained from this process is not of safety concern, when used at up to 100% for the manufacture of materials and articles for contact with all types of foodstuffs, including drinking water, and used for long-term storage at room temperature or below, with or without hot-fill. Articles made of this recycled PET are not intended to be used in microwave and conventional ovens and such uses are not covered by this evaluation.

The present work, developed within the EU-FORA fellowship programme, assessed the risk assessment of vegetable by-product extracts as natural alternatives to synthetic preservatives in food formulations. Extracts were obtained from onion peel (Allium cepa L.), zucchini (Cucurbita pepo L.) and kale (Brassica oleracea L. var. acephala), which represent abundant residues with limited commercial value but high potential for valorisation. Suitable extraction techniques were applied to each matrix, and the resulting extracts were characterised through phenolic profiling, antioxidant activity, cytocompatibility and pesticide residue analysis. Onion peel extract was rich in quercetin glycosides and showed strong antioxidant activity, while zucchini and kale extracts contained quercetin or kaempferol derivatives with moderate effects. Cytocompatibility assays demonstrated acceptable safety margins at lower concentrations, though dose-dependent toxicity appeared at higher levels, particularly in hepatic cells. Pesticide residues were mostly absent or present only at trace levels in zucchini and kale extracts. In onion peel extract, hexachlorobenzene and β-HCH were detected, but remained below EU maximum residue limits (MRLs). Overall, the findings suggest that the benefits of these extracts, including preservative potential and sustainable waste valorisation, outweigh the identified risks.

Anthropogenic activities, such as industrial processes, urban development, intensive agriculture and waste disposal, have significantly contributed to the continuous introduction and accumulation of a wide array of xenobiotic compounds into natural ecosystems. Among them, emerging contaminants (ECs) such as pharmaceuticals, endocrine-disrupting chemicals (EDCs), and per- and polyfluoroalkyl substances (PFAS) are of increasing concern due to their persistence, bioactivity and limited regulation. ECs enter ecosystems through diverse pathways including wastewater discharge, agricultural runoff and atmospheric deposition. Once released, many of these xenobiotics can bioaccumulate in organisms and enter the food chain, posing serious risks to food safety and public health. Traditional physico-chemical remediation methods are often insufficient or environmentally taxing, prompting a shift toward bio-based alternatives like bioremediation. These approaches, which rely on the activity of microbial communities to degrade pollutants, offer more sustainable solutions but require further interdisciplinary research to optimise their use. The One Health framework provides an effective model for addressing the complex risks posed by xenobiotics. This research programme aims to harmonise methodologies for cumulative dietary risk assessment across Europe and explore microbial strategies for xenobiotic degradation. By integrating microbiomics, toxicology, environmental science and food safety, this approach supports the development of safer food systems and more effective pollution management in line with the ‘farm to fork’ and One Health principles.

Food safety is a key concern in the European Union, with the harmonisation of risk assessment methodologies being a strategic priority. The EU-FORA programme, coordinated by EFSA, promotes standardised approaches to microbial risk assessment across Europe. Metagenomic sequencing has advanced the understanding of microbial ecosystems in food production, with Illumina (short-reads) and Oxford Nanopore Technologies (ONT) (long-reads) playing significant roles in detecting pathogens and characterising microbial communities. These technologies differ in accuracy, read length and resolution, potentially influencing risk profiles when used in quantitative microbiological risk assessment (QMRA). This fellowship, conducted at UPCT in Spain and IBPRS-PIB in Poland, compares the two platforms in assessing microbial populations in Polish and Spanish dairy chains. It explores how sequencing strategy affects hazard identification and QMRA outcomes, while also demonstrating how metagenomic data can enhance predictive modelling and support practical improvements in food safety management.

According to the ‘EFSA-SANTE Action Plan on Cumulative Risk Assessment for pesticides residues’, EFSA, with the support of a working group, undertook the identification of specific effects on male and female reproductive function, including fertility, that are considered relevant for grouping pesticide residues and for assessing retrospectively the cumulative risk (CRA) deriving from consumers' dietary exposure. In this first report, two specific effects leading to two correspondent cumulative assessment groups (CAGs) were identified for male reproduction, namely, (1) altered mating performance and (2) decreased fertility. Four distinct CAGs were proposed for grouping chemicals affecting female reproduction: (1) altered mating performance, (2) decreased fertility, (3) altered gestation and (4) altered parturition. EFSA also defined the list of indicators (i.e. toxicological endpoints measurable in regulatory studies) describing each specific effect. Qualitative and quantitative information on these indicators will be collected from the toxicological assessment reports on individual pesticide active substances: indicators will be used to determine the inclusion of prioritised active substances and their metabolites into the respective CAG and to estimate the no observed adverse effect level (NOAEL) and lowest observed adverse effect level (LOAEL) of each chemical in relation to the given specific effect. Additional endpoints (named ancillary findings), not sufficiently informative to define a specific effect but contributing to the overall evidence, will be collected for a limited number of substances identified as risk drivers, based on hazard and exposure considerations, to support the estimation of CAG-membership probabilities. Additional criteria for including active substances into CAGs, the hazard characterisation methodology and the lines of evidence for assessing CAG-membership probabilities are detailed in this report, which was sent for public consultation. The process of data extraction and actual establishment of the CAGs are instead beyond the scope of this report. This part of the CRA process was outsourced and will be dealt with in a separate report.

The project Computational characterisation of ecological hazard and risk of environmental mixtures focused on two key priorities in advancing a next-generation risk assessment (NGRA) workflow: (i) transitioning to assessing mixtures and (ii) utilising mechanism-based hazard assessment based on new approach methodology (NAM) data. Through a case study, an enhanced component-based mixture risk assessment (CBMRA) framework, integrating high-throughput-screening (HTS) bioactivity data combined with a quantitative adverse outcome pathway (qAOP) approach for hazard and risk assessment was demonstrated. The case study utilised a previously published qAOP based on the proposed AOP-Wiki AOP#245 ‘Uncoupling of photophosphorylation leading to reduced ATP production associated growth inhibition’ (Xie et al., 2018), which models growth inhibition via uncoupling of mitochondrial oxidative phosphorylation from a reference chemical on a model aquatic plant (Moe et al., 2021). It used pesticide monitoring data from the European Environmental Agency's Pesticide Indicator dataset (WISE statistics – Pesticides) in freshwater environments (European Environment Agency, 2023). Relevant bioactivity data from ToxCast and Tox21 were mapped to the target pesticides to derive equipotent mixture compared to the reference chemical used to parametrised the qAOP (i.e. 3,5-dichlorophenol), enabling assessment of the potential initiation of the AOP cascade. In silico methods were used to fill bioactivity data gaps and probabilistic modelling using a Bayesian network (BN) was designed to incorporate various uncertainties into the current NGRA workflow. The study assessed the strengths and limitations of a NAM-based CBMRA, with a particular attention on equipotency assessment as a means to extend the chemical domain of qAOPs for mechanistic ecological risk assessment. It highlighted both conceptual and technical innovations and identified research needs to improve the approach towards future regulatory adoption.

The European Union (EU) food safety legislative framework is designed to guarantee the safety of the entire food production chain through a comprehensive ‘from farm to fork’ approach. Chemical safety of the food production chain, encompassing contaminants, veterinary drugs and pesticide residues, food/feed additives, is further regulated by a specific legislative framework. Regulation (EU) 2017/625 requires each Member State to ensure that official controls are carried out to verify compliance with food, feed and animal health laws. These controls are to be performed in a risk-based manner through specifically designed multi-annual national control plans. In Norway, where aquaculture represents a highly developed sector, systematic monitoring of chemical contaminants throughout the aquaculture production chain is essential to safeguard food safety and identify potential risks to both public and animal health. Therefore, the present work programme was focused on the development and subsequent application of a ranking methodology for the prioritisation of chemical contaminants to be included in the Norwegian national monitoring programmes for the aquaculture production chain of Atlantic salmon (Salmo salar) fillet and complete feed for salmonids. The fellow was involved in the identification of the assessment criteria to be included in the semi-quantitative methodology, the selection of appropriate metrics for each criterion and testing the methodology on the selected contaminants relevant for Norwegian farmed fish production chain. The developed methodology systematically incorporates the assessment of contaminants present in feed materials, fish feed and fish fillet and is intended to provide documented basis for risk-based prioritisation of contaminants for monitoring plans.

The fellowship, titled ‘Integrating quantitative chemical and microbial risk assessments to optimize the disinfection of fresh products’ was implemented at the National and Kapodistrian University of Athens (Greece). The fellowship aimed to provide practical training on the quantitative chemical risk assessment of emulsified nano-components used for washing fresh vegetables. This is motivated by the fact that, although a washing step is essential for the safety of fresh vegetables, chlorine-based solutions may have negative effects on the health of workers and consumers. Nanoemulsified d-limonene can thus present an alternative solution with fewer side effects. The fellowship focused in the chemical risk assessment of d-limonene residues after washing. This fellowship provided the fellow with the necessary skills in risk assessment and taught him mass spectrometry techniques for sample analysis.

Next-generation sequencing (NGS) has become an essential tool for antimicrobial resistance (AMR) surveillance, enabling comprehensive detection of AMR determinants in both bacterial isolates and complex microbial communities. Metagenomic sequencing enables culture-independent profiling of antimicrobial resistance genes (ARGs) in different environments, while whole-genome sequencing (WGS) is widely used in AMR surveillance laboratories to predict phenotypic resistance in major food-borne pathogens. AMR risk assessment usually considers factors such as the pathogenicity of the ARG-carrying bacterial host, the abundance of ARGs and their mobility potential inferred from association with plasmids or other mobile genetic elements that facilitate horizontal gene transfer. Clinical relevance of antimicrobials and the severity of clinical outcomes can further be implemented in AMR risk assessment. Exposure assessment contextualises hazards within real-world scenarios by estimating consumer exposure to AMR bacteria or their ARGs through food or other routes. Despite challenges in fully quantitative assessments, the integration of NGS-based surveillance with risk modelling represents a critical step towards proactive AMR risk management. In this study, broiler samples from different stages of a Slovenian and a Spanish slaughterhouse were analysed using conventional microbiology, shotgun metagenomic sequencing and WGS of isolates of selected pathogenic species. A modular, semi-quantitative risk assessment model was developed that combines (meta)genomic data with key risk factors and, where available, exposure assessment. This approach prioritises AMR risks in broiler meat processing and supports evidence-based decision-making in the areas of food safety and public health.

EFSA assessed the risk of introducing viral haemorrhagic septicaemia virus (VHSV), infectious haematopoietic necrosis virus (IHNV) and highly polymorphic region-deleted infectious salmon anaemia virus (HPR-deleted ISAV) into free areas through movement of fertilised eggs and gametes. No evidence of true vertical transmission of these viruses was found. However, viral contamination of the surface of fertilised eggs and gametes cannot be ruled out. Assuming full compliance with the recommendations in the new draft 4.Z chapter of the Aquatic Animal Health Code of the World Organisation for Animal Health, including individual testing of broodfish at stripping, the median probability of introduction following importation of fertilised eggs was 0.36% for VHSV and IHNV, and 0.4% for HPR-deleted ISAV. The median probabilities were reduced to 0.02% and 0.01%, respectively, if fertilised eggs were disinfected twice (as green and as eyed eggs) at origin. Additional disinfection upon arrival in the importing establishment reduced the median probability to 0.02% for all viruses with one disinfection at the origin, and to virtually zero when two disinfections were applied at the origin. The assessment also evaluated probability of introduction when only population testing before stripping is applied. Two disinfections at the origin plus one at destination also resulted in virtually zero probability of introduction. For gametes, individual testing of broodfish at stripping, along with the other risk mitigation measures recommended in the new chapter resulted in a probability of introduction ranging from 0% to 0.3%. Implementation of the measures included in the new draft 4.Z chapter is recommended to prevent the introduction of VHSV, IHNV and HPR-deleted ISAV when moving gametes and fertilised eggs from non-free to free areas. In addition, it is recommended that fertilised eggs are disinfected twice before being traded and, to further reduce the risk, also disinfected at the establishment receiving the imported materials.