The food enzyme prolyl oligopeptidase (EC 3.4.21.26) is produced with the genetically modified Aspergillus niger strain NZYM-MR by Novozymes A/S. The genetic modifications do not give rise to safety concerns. The food enzyme was considered free from viable cells of the production organism and its DNA. It is intended to be used in three food manufacturing processes. Since residual amounts of food enzyme—total organic solids (TOS) are removed in one process, dietary exposure was calculated for the remaining two food manufacturing processes. It was estimated to be up to 0.557 mg TOS/kg body weight (bw) per day in European populations. Genotoxicity tests did not indicate a safety concern. The systemic toxicity was assessed by means of a repeated dose 90-day oral toxicity study in rats. The panel identified a no observed adverse effect level of 1488 mg TOS/kg bw per day, the highest dose tested, which when compared with the estimated dietary exposure, resulted in a margin of exposure of at least 2671. A search for the homology of the amino acid sequence of the prolyl oligopeptidase to known allergens was made, and no match was found. The Panel considered that a risk of allergic reactions upon dietary exposure to the food enzyme cannot be excluded, but that the likelihood is low. Based on the data provided, the panel concluded that this food enzyme does not give rise to safety concerns, under the intended conditions of use.
Following a request from the European Commission, the EFSA Panel on Nutrition, Novel Foods and Food Allergens (NDA) was asked to deliver an opinion on the extension of use of galacto-oligosaccharides (GOS) as a novel food (NF) pursuant to Regulation (EU) 2015/2283. The NF is produced from milk-derived lactose using β-galactosidases. The applicant proposed to extend the use of GOS to several food categories (non-alcoholic beverages, confectionery, chewing gum, cocoa and chocolate-based products and protein products). The target population is the general population. GOS is already authorised and included in the Union list of NFs for use in several foods, including infant formula, and in food supplements. The Panel estimated that the proposed extension of use would result in a highest 95th percentile intake of GOS from all food uses, of up to 48.5 g/day in adults. As compared to the exposure to GOS from the currently authorised food uses (at the highest P95), the proposed extension of use is expected to result in an increase in intake of GOS of up to 17%. The information provided on the proposed use levels and anticipated intake does not raise safety concerns. The Panel concludes that the proposed extension of use of GOS is safe under the proposed conditions of use.
Following a request from the European Commission, the Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) was asked to deliver a scientific opinion on the safety and efficacy of perlite as a technological feed additive for all terrestrial animal species. The FEEDAP Panel concluded that perlite is considered safe at 20,000 mg/kg complete feed for the use in feed for poultry for fattening or reared for laying/reproduction, ornamental birds, piglets (suckling and weaned) and pigs for fattening. No conclusion could be drawn on the safety of the product for the rest of terrestrial species/categories. The Panel concluded that the use of perlite is safe for the consumers and the environment. The Panel also concluded that the additive is not irritant to skin or eyes, but it is considered a dermal and respiratory sensitiser. Exposure by dermal and inhalation routes is considered a risk and should be minimised. The FEEDAP Panel concluded that perlite is efficacious as an anticaking agent in feed for terrestrial animal species.
Animal welfare is a recognised and important issue within the European Union, addressed through comprehensive regulations such as Regulations 1/2005 and 1099/2009, which emphasise the necessity to respect and protect the welfare of animals, particularly during transport and slaughter procedures. These legislative measures are part of an ongoing European commitment to ensure ethical treatment and minimise suffering for food-producing animals, aligning with broader food safety and public health goals. This project aimed to create a prototype of an updated cattle path designed to minimise stress and reduce reliance on coercive means such as electric prods, while also decreasing the risk of injury due to trauma or falls. The approach focused on implementing evidence-based methods and integrating preventative design features that support both animal behaviour and safety in handling environments. The ultimate goal was to guarantee the welfare and protection of animals as specified in European guidelines, while also achieving improvements in meat quality. By advancing these objectives, the project demonstrates how compliance with animal welfare standards can be harmonised with operational efficiency and product quality, benefitting both animals and consumers across the European Union.
Understanding the minimum inhibitory concentration (MIC) of antibiotics is crucial for developing targeted strategies to combat antimicrobial resistance (AMR) in the food chain. Traditional MIC testing methods provide a single and deterministic value without taking into account the inherent inter-individual variability in the response of foodborne pathogens to antimicrobials. A more accurate representation of the complex interactions influencing AMR in foodborne pathogens could be probabilistic MIC modelling. The incorporation of probabilistic MIC modelling into a classic quantitative microbiological risk assessment (QMRA) of AMR for food pathogens could provide a more realistic risk estimate. The EU-FORA fellowship's objective was to develop a probabilistic QMRA for an antimicrobial-resistant foodborne pathogen in a food product, incorporating the variability of the MIC of individual bacterial cells. The project involved the collection of data on Listeria monocytogenes in ready-to-eat (RTE) cooked ham, the selection of an appropriate growth model, the conducting of MIC assessment laboratory experiments for ampicillin based on the plate-count agar method and Monte Carlo analysis. The QMRA model was constructed using the R programming language. The final outputs obtained were a total of 1000 simulated doses of L. monocytogenes in servings of cooked ham at the time of consumption, as well as the maximum and 95th percentile of single-cells MIC values of ampicillin for each dose. Moreover, a sensitivity analysis was conducted.
Diets are evolving to cope with the ecological transition and reduce the environmental impact of agri-food systems. The alternatives currently available will influence the nutritional content of diets and will also change consumers' exposure to microbiological and chemical hazards. Health impacts need to be considered to suggest safe, nutritious and sustainable alternatives. Quantifying this overall health impact is now possible using methods of food risk–benefit assessment (RBA), a recognised and well-established approach that integrates scientific knowledge on nutrition, toxicology, microbiology and human epidemiology. The Risk–Benefit Assessment for Sustainable Dietary Shift (RBA4SDS) project aimed to train a fellow to analyse the overall health impacts of dietary transitions towards more climate-friendly diets. This included performing RBA and applying the necessary quantitative tools to evaluate nutritional, microbiological and toxicological risks and benefits. The present project focused on a practical case considering the substitution of meat by insects and plant-based alternatives including lentil and red kidney bean for Croatia, France and Greece. As part of the programme, the fellow was involved in the following activities: (i) understanding key steps of food health RBA, with a focus on nutrition, microbiology and toxicology; (ii) defining and characterising various sustainable diet alternatives, including meat, insect-based and plant-based options; (iii) identifying available and missing data inputs needed for RBA of selected alternative scenarios; (iv) applying RBA methods to assess a chosen alternative scenarios; (v) identifying strategies for further development of RBA methodologies. Within the research group, multi-criteria decision analysis (MCDA) tool was used to rank sustainable options for alternative scenarios. The project enabled the fellow to define different sustainable food alternatives and to identify both available and missing inputs required to perform RBA and to suggest strategies to develop further RBA methodology.
New approach methodologies (NAMs) are gaining increasing attention within the scientific community as strategies to reduce the use of animal testing. Their integration into regulatory frameworks for chemical hazard and risk assessment in food and feed would directly support the goals of the European Food Safety Authority (EFSA). Within the framework of the EU-FORA fellowship programme, this study investigated the use of metabolomic approaches to evaluate cellular responses to genotoxic agents, serving as a proof of concept for the development, standardisation and future regulatory application of metabolomics in genotoxicity testing. Human liver-derived cells (HepRG) were exposed to two well-characterised genotoxicants, and both intracellular (endometabolome) and extracellular (exometabolome) metabolites were extracted and analysed using gas chromatography–mass spectrometry (GC–MS). Metabolites associated with energy metabolism, sugar metabolism and antioxidant capacity were identified, and both multivariate and univariate statistical analyses were applied to characterise metabolic profiles. Results obtained under the experimental conditions tested in this pilot study, do not highlight significant differences between exposed and control cultures. Nevertheless, the findings demonstrate the potential of metabolomics to capture biologically relevant pathways, supporting its future application in genotoxicity assessment under alternative experimental conditions and designs.
We are happy to introduce this Special Issue of the EFSA Journal, dedicated to the eighth cohort of the EU-FORA Fellowship Programme. It provides an insight of the work programmes and activities performed by our fellows in relevant areas of food risk assessment. Each report tells a story of professional growth, collaboration, networking and scientific curiousness.
To the fellows: Congratulations on your accomplishments. Together with my team, we hope you expand your networks, share the knowledge, build upon the experience gained during this year and continue to invest in the EU-FORA Community as Alumni.
Finally, we would like to thank everyone who was involved and contributed to yet another cycle of this well-established and welcome initiative, extending our gratitude to EFSA's Management and Staff, Member States and competent organisations, and our training consortium for shaping it.
On behalf of the EU-FORA Programme,
Victoria Villamar
Before we delve into the scientific articles in this special issue of the EFSA Journal, it is only fitting that we pay tribute to our late esteemed colleague and friend Dr. Konstantinos (Kostas) Koutsoumanis who acted as mentor and tutor for many of the fellows who have participated in EFSA's EU-FORA programme over the years. His untimely passing earlier this year has greatly saddened his many colleagues in EFSA and the wider European food safety community. A prominent researcher in food microbiology, teacher and global advocate for food safety, Kostas passed away on 25th of February at the age of just 52. His passing leaves an irreplaceable void in the field of food microbiology and a profound sense of loss among those whose lives he touched through his commitment to food safety research and policy.
In addition to his academic career at Aristotle University, he found time to collaborate widely across Europe and well beyond, encompassing not just EFSA but also the Food and Agriculture Organization (FAO) and the World Health Organization (WHO). Over the course of his distinguished career, he authored more than 250 peer-reviewed articles, 15 book chapters and 150 conference proceedings, making him one of the most cited academics on food safety of his generation.
He first began to contribute to EFSA in 2007 and over the years held a number of key positions: as a member and Chair of EFSA's Panel on Biological Hazards and more recently as Vice-Chair of its Scientific Committee. His expertise was greatly appreciated on the Editorial Advisory Board of this Journal. Those of us who had the good fortune to work with Kostas remember him for his dedication and collaborative nature. He always found time to support colleagues and nowhere was this more evident than in his collaboration with the EU-FORA Programme, a vital platform for preparing the next generation of European food risk assessors.
Colleagues at EFSA remember Kostas not only for what he achieved but for how he did it, with compassion and an unwavering commitment to science. While he received numerous awards throughout his distinguished career, perhaps the most meaningful testament to his work lies in the improved safety of food systems around the world and in the generations of professionals who continue to build on his legacy.
All involved in the EU-FORA programme offer their sincere condolences to Kostas’ family and his wide circle of friends.
May he rest in eternal peace.
Arthur Healy
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