From 1st July 2026, Regulation (EU) 2024/2895 will come into force, updating the microbiological criteria for Listeria monocytogenes in ready-to-eat (RTE) foods. The new regulatory framework requires food business operators (FBOs) to provide scientific validation of shelf-life, introduce intermediate control limits, and train staff.
Competent authorities will need to verify the robustness of technical evidence and strengthen cold chain surveillance, whilst consumers are called upon to store products more consciously. This represents a strategic shift towards a more scientific, documented, and preventive European food safety system.
Listeria monocytogenes: a global threat
Listeria monocytogenes is recognised as one of the most dangerous foodborne pathogens for public health. Its ability to proliferate even at low temperatures, including refrigeration temperatures, makes it particularly insidious for the safety of ready-to-eat (RTE) products, often consumed without further heat treatment. The resulting listeriosis presents fatality rates that can reach 30% in the most vulnerable subjects (EFSA, 2025).
The danger of L. monocytogenes lies in its ability to survive in difficult environments and adapt to a wide range of foods, from fishery products (e.g. smoked salmon) to dairy products, and pre-packaged vegetables. Self-monitoring requires an integrated approach that combines prevention, surveillance, and control throughout the entire supply chain.
Microbiological criteria: international scenario
At international level, the microbiological criteria for Listeria monocytogenes show substantial convergence:
- Codex Alimentarius distinguishes between foods that favour pathogen proliferation (absence in 25 g prescribed) and those that do not favour it (concentration < 100 colony-forming units per gramme, cfu/g, tolerated) (Codex Alimentarius Commission, 2007);
- Food and Drug Administration (FDA, USA) requires total absence in 25 grammes of food (FDA, 2017);
- Health Canada prescribes absence in 25 g for at-risk products, allowing concentrations up to 100 cfu/g for non-risk products only in the presence of scientific demonstrations of microbiological stability (Health Canada, 2023);
- Food Standards Australia New Zealand (FSANZ) prescribes absence in 25 g for products intended for infants and immunocompromised individuals, allowing concentrations up to 100 cfu/g for foods not intended for vulnerable groups (FSANZ, 2018);
- People’s Republic of China maintains a strict zero-tolerance policy for L. monocytogenes in ready-to-eat (RTE) foods. The National Food Safety Standard for Pathogen Limits (GB 29921-2021) stipulates that L. monocytogenes must not be detected in 25 g samples of specified RTE foods. This applies to a defined range of products, including cold-prepared dishes, RTE meat products, and RTE aquatic products (National Health Commission of China, 2021);
- Japan also enforces a strict standard for L. monocytogenes in RTE foods. In accordance with the Food Sanitation Act, the standard requires the pathogen to be ‘not detected’ in 25 g of sample for a wide array of RTE foods, particularly those consumed without further cooking, such as cheese, sliced meats, and salads (Ministry of Health, Labour and Welfare of Japan, 2018);
- European Union, with Regulation (EU) 2024/2895, establishes absence in 25 grammes, or a limit of 100 cfu/g only for products that operators demonstrate do not support pathogen growth.
Codex Alimentarius: work in progress
In March 2024, at the 54th session of the Food Hygiene Commission of the Codex Alimentarius, representatives from Canada, France, and the United States proposed revising the Guidelines on the Application of General Principles of Food Hygiene to the Control of Listeria monocytogenes in Foods (CXG 61-2007). Whilst the fundamental principles contained in the original version of the text are destined to remain largely unchanged, the update of the guidelines will enable continued provision of updated guidance to governments on a reference framework for the control of Listeria monocytogenes.
The new work will need to consider several factors relevant to pathogen control, including:
- activities in the primary production phase;
- new and relevant information to be integrated throughout the entire supply chain up to the consumption phase, relating to resource management, time and temperature control, and environmental hygiene practices;
- microbiological monitoring methods, particularly approaches based on molecular or genomic techniques, as a complement to traditional culture methods;
- consumer practices and the relevance of factors influencing listeriosis risk in different regions of the world;
- other recently available scientific information.
The proposed timeline envisages a two- or three-year work cycle, considering the scope and importance of the document. The preliminary working group (pWG) has accepted the request from several countries to also update the scope and objectives of the document, so that it applies to both governments and food business operators (FBOs).
European Union: epidemiological picture and regulatory evolution
In 2023, the 30 countries of the EU and European Economic Area reported 2,993 confirmed cases of listeriosis, the highest annual number since the beginning of EU/EEA-level surveillance, with an incidence of 0.67 cases per 100,000 inhabitants (ECDC, 2025). The most affected countries were Germany, France, and Spain, but the increase in cases was widespread.
The most vulnerable categories include the elderly over 64 years of age, with an incidence of 2.2 cases per 100,000 people, pregnant women and newborns, subjects at high perinatal risk, and immunocompromised individuals, in whom even low bacterial loads can be fatal.
The foods most often associated with contamination are: smoked fish, pâté, cold meats, soft cheeses, pre-packaged vegetables, and other refrigerated RTE products. The absence of obvious signs of deterioration can mislead the consumer, accentuating domestic risk (EFSA, 2025).
Evolution of European regulations
Regulation (EC) No. 2073/2005 represented the European reference on microbiological criteria applicable to foods for nearly two decades. The threshold of 100 cfu/g was permitted provided that the operator was able to demonstrate, to the satisfaction of the authorities, that the product would not exceed it during shelf-life.
The increase in listeriosis cases and the critical issues identified in validations carried out by operators have, however, necessitated a substantial update. Regulation (EU) 2024/2895 introduces a more rigorous approach based on scientific evidence:
- the limit of 100 cfu/g is confirmed only for products whose microbiological stability is demonstrated through challenge tests and recognised predictive models;
- in the absence of the aforementioned evidence, the more restrictive criterion of absence in 25 grammes applies;
- operators must also define intermediate control limits in HACCP plans throughout the shelf-life and subject their monitoring plans to periodic validation.
Responsibility profiles
Food business operators (FBOs) are required to demonstrate the safety of their products through solid scientific evidence. They must validate shelf-life through experimental tests and predictive models, update HACCP plans with intermediate control limits, and ensure continuous staff training.
Competent authorities must instead overcome the permissive approach that, under the validity of Regulation (EC) 2073/2005, had led to the acceptance of theoretical or incomplete validations, insufficient post-marketing control, and underestimation of constantly growing epidemiological data (ECDC, 2025).
Cold chain and traceability
A particularly critical element concerns the cold chain, often monitored discontinuously. The absence of thermal traceability along the distribution chain has favoured episodes of microbial proliferation even in products that were compliant at the time of leaving the establishment.
Regulation (EU) 2024/2895 therefore provides for strengthened temperature controls and the adoption of digital traceability systems, defining surveillance as a shared responsibility. The consumer is also an integral part of the system: proper food storage and compliance with expiry dates are essential to reduce domestic risks.
Scientific evidence and predictive tools
The analysis and management of risk linked to Listeria monocytogenes requires a scientific approach based on predictive models and digital surveillance tools. In this context, the EFSA ListeriaPredict Project (Butler et al., 2023) has developed a quantitative modelling platform that enables food business operators to simulate pathogen growth in different food matrices and environmental conditions. Such models prove fundamental for shelf-life validation, allowing the integration of experimental data with reliable mathematical predictions.
A complementary contribution comes from the study by Yangchen and colleagues (2025) published in Foods, which illustrates the effectiveness of multi-hurdle technologies – that is, the combined use of multiple physical, chemical, and biological barriers – to inhibit the growth of Listeria monocytogenes in ready-to-eat (RTE) foods.
Among the most innovative tools, the EFSA Dashboard today represents a strategic resource for competent authorities, operators, and researchers. It is an interactive, publicly accessible platform that integrates data from European microbiological surveillance systems, RASFF notifications, and monitoring conducted by Member States. Through dynamic visualisations, graphs, and maps, the Dashboard enables real-time analysis of Listeria monocytogenescontamination trends, identification of emerging trends, and correlation of data with specific foods or countries of origin. This integrated analysis capability supports a proactive approach to food safety, facilitating timely and evidence-based interventions.
Conclusions
The new European Union regulations require FBOs to determine shelf-life with a scientific approach, periodic validation, updating of HACCP systems, and adequate staff training. Control authorities must in turn verify the methodological robustness of validations, challenge any non-compliance, and strengthen cold chain surveillance.
This regulatory update represents a decisive step towards a food safety culture based on prevention, scientific rigour, and shared responsibility. Only consistent application of these principles can structurally reduce the incidence of listeriosis in the Old Continent, whose population is moreover increasingly vulnerable due to demographic ageing (WHO, 2025).
Dario Dongo e Claudio Biglia
References
- Butler, F., Hunt, K., Redmond, G., d’Onofrio, F., Gonzales Barron, U., Fernandes, S., Cadavez, V., Iannetti, L., Centorotola, G., Pomilio, F., Valero Diaz, A., Pérez Rodríguez, F., & Bonilla Luque, O. M. (2023). Application of novel predictive microbiology techniques to shelf-life studies on Listeria monocytogenes in ready-to-eat foods (ListeriaPredict). EFSA Supporting Publication, 20(12), EN-8418. https://doi.org/10.2903/sp.efsa.2023.EN-8418
- Codex Alimentarius Commission. (2007). Guidelines on the Application of General Principles of Food Hygiene to the Control of Listeria monocytogenes in Foods (CXG 61-2007). FAO/WHO. https://www.fao.org/fao-who-codexalimentarius
- Commission Regulation (EU) 2024/2895 of 20 November 2024 amending Regulation (EC) No 2073/2005 as regards Listeria monocytogenes. Official Journal of the European Union. http://data.europa.eu/eli/reg/2024/2895/oj
- European Centre for Disease Prevention and Control. (2025). Listeriosis – Annual Epidemiological Report for 2023. ECDC. https://www.ecdc.europa.eu/en/publications-data/listeriosis-annual-epidemiological-report-2023
- European Food Safety Authority. (2025). Listeria monocytogenes – Topic page. EFSA. https://www.efsa.europa.eu/en/topics/topic/listeria
- European Food Safety Authority. (n.d.). Listeria Dashboard. https://www.efsa.europa.eu/en/microstrategy/listeria-dashboard
- Food and Drug Administration. (2017). Draft Guidance for Industry: Control of Listeria monocytogenes in Ready-to-Eat Foods. U.S. Department of Health and Human Services. https://www.fda.gov
- Food Standards Australia New Zealand. (2018). Food Standards Code – Standard 1.6.1: Microbiological Limits for Food. FSANZ. https://www.foodstandards.gov.au
- Health Canada. (2023). Policy on Listeria monocytogenes in Ready-to-Eat Foods. Canadian Food Inspection Agency. https://inspection.canada.ca
- Ministry of Health, Labour and Welfare (MHLW) of Japan. (2018). Specifications and Standards for Foods, Food Additives, etc. under the Food Sanitation Act (Abstract) – Section 3. Microbiological Standards. Notice No. 195.
- National Health Commission of the People’s Republic of China. (2021). National Food Safety Standard – Limit of Pathogens in Food (GB 29921-2021).
- World Health Organisation (WHO) Europe. (2025). Development of the Strategy: Ageing is Living. https://www.who.int/europe/teams/policy-and-governance-for-health-through-the-life-course/development-of-the-strategy–ageing-is-living
- Yangchen, T., Li, Q., & Zhang, H. (2025). Multi-hurdle technologies for Listeria monocytogenes control in ready-to-eat foods. Foods, 14(2), 220–234. https://doi.org/10.3390/foods14213664
Dario Dongo, lawyer and journalist, PhD in international food law, founder of WIISE (FARE - GIFT - Food Times) and Égalité.
Veterinary surgeon, specializing in the inspection of food of animal origin. Since 1982 he has been a public veterinarian, since 1990 he has taught at the Universities of Turin and Teramo. He is the author of over seventy scientific publications and co-author of various texts on microbiology, radiocontamination of food, surveillance, health and food law, trade in public areas and communication in health emergencies.
