Contents
Regulation (EU) 2024/2895 entered into effect on 11 December 2024 and will apply in practice to operators from 1 July 2026. For businesses producing ready-to-eat foods (RTE), this is not a minor administrative update: it is a paradigm shift in how the control of Listeria monocytogenes is defined, documented and demonstrated throughout the production chain.
Why this regulation, and why now?
Listeria monocytogenes is not a new issue for food safety professionals. However, epidemiological data from European surveillance authorities now provide a clear picture of the scale of the challenge.
According to the ECDC’s Annual Epidemiological Report on Listeriosis, published in March 2025:
- In 2023, 2,993 confirmed cases of listeriosis were reported in the EU/EEA. This is the highest annual figure since EU/EEA-wide surveillance began.
- The notification rate reached 0.67 cases per 100,000 population.
- The highest incidence was among people aged 64 and over (2.2 cases per 100,000 population).
- Listeriosis has the highest hospitalisation and case-fatality rates among the zoonoses monitored in Europe.
The joint EFSA/ECDC One Health 2024 report on zoonoses, published in December 2025, confirms this trend: over 3,000 Listeria infections were recorded in 2024, of which around 70% required hospitalisation, and one in twelve people died.
It is against this epidemiological backdrop that the European Commission adopted Regulation (EU) 2024/2895, published in the Official Journal of the EU on 20 November 2024, which entered into force on 11 December 2024 and applies to all food business operators from 1 July 2026.
Understanding the pathogen: why Listeria is particularly difficult to control
Before examining the regulatory changes, it is essential to understand why Listeria monocytogenes poses specific challenges that other foodborne pathogens do not present in the same way.
A psychrotrophic pathogen
Listeria monocytogenes is a psychrotrophic pathogen capable of multiplying at refrigeration temperatures, including down to 0°C. This is a key characteristic: maintaining the cold chain does not prevent its growth throughout a product’s shelf life.
This property is particularly critical for ready-to-eat foods (RTE), which are consumed without further heat treatment. A product that leaves the production facility with very low levels of contamination can reach concerning concentrations by the end of its shelf life if the potential for growth is not sufficiently controlled.
Persistence in the production environment
Listeria monocytogenes is a ubiquitous bacterium with an exceptional ability to persist in production environments. It can survive for months, or even years, in drains, on equipment surfaces and within biofilms that are resistant to standard cleaning and disinfection protocols.
This persistence explains why contamination in a production facility is not an isolated incident; it is a risk that requires continuous and systematic monitoring.
What Regulation (EU) 2024/2895 changes
The legislative loophole has been closed
Regulation (EC) No 2073/2005 lays down the microbiological criteria applicable to foodstuffs in the EU. However, it contained a significant loophole: for Category 1.2 RTEs (those allowing the growth of Listeria monocytogenes), no criteria applied once the product had left the immediate control of the operator who had produced it, in cases where the operator could not demonstrate that the limit of 100 CFU/g would not be exceeded throughout the shelf life.
In practice, a manufacturer could demonstrate compliance at the time of dispatch without being responsible for what happens throughout the product’s shelf life in the distribution chain.
Regulation (EU) 2024/2895 closes this loophole.
The fundamental change
From 1 July 2026, compliance with food safety requirements will no longer be assessed at a specific point in time. Manufacturers must demonstrate that their products remain safe throughout their shelf life, including during distribution and up to the use-by date.
The three product categories
Annex I to Regulation (EC) No 2073/2005 distinguishes between three categories of infant formula:
Category 1.1: Infant formula intended for infants or for special medical purposes: not detected in 25g throughout the shelf life.
Category 1.2: RTEs in which Listeria monocytogenes can grow (other than 1.1): subject to the new requirements from 1 July.
Category 1.3: RTEs in which Listeria monocytogenes cannot grow: criterion ≤ 100 CFU/g throughout the shelf life.
Automatic classification in category 1.3
Products are automatically classified in category 1.3 (not supporting growth) when they meet at least one of the following physicochemical conditions, as defined in footnote 8 of Annex I:
- pH ≤ 4.4
- Water activity (aw) ≤ 0.92
- Combination: pH ≤ 5.0 and aw ≤ 0.94
- Shelf life of less than 5 days
Important point: other products may also be classified in category 1.3 subject to scientific justification, for example via challenge tests or predictive modelling. Products that do not meet these automatic thresholds are not necessarily in category 1.2 if a study demonstrates that they do not support growth.
Two options for Category 1.2 products
For Category 1.2 RTEs, two options are available under the amended regulations. The applicable criterion depends entirely on the evidence the operator can provide:
With verified evidence
The operator may demonstrate, to the satisfaction of the competent authority, that Listeria monocytogenes will not exceed 100 CFU/g throughout the product’s shelf life.
In this case, the criterion of ≤ 100 CFU/g applies throughout the shelf life.
Without validated evidence
The operator cannot provide this scientific evidence. In this case, the stricter criterion applies: not detected in 25g, throughout the entire shelf life of the product placed on the market.
The fundamental change concerns the scope: previously, the ‘not detected in 25g’ requirement applied only whilst the product was under the direct control of the manufacturer. From 1 July 2026, it will apply throughout the shelf life, wherever the product is in the supply chain.
Operational implications for operators
Lifetime studies and stress tests
Opting for Route A requires robust scientific evidence. The European Commission has published an updated guidance document (DG SANTE, December 2025), and the EU Reference Laboratory for Listeria monocytogenes (EURL Lm, hosted by ANSES) published an updated version of its Technical Guidance Document (TGD) in February 2026, dealing specifically with challenge tests and shelf-life studies.
These studies must be designed to reflect adverse production and storage scenarios, taking into account variations in temperature, handling practices and the intrinsic characteristics of the product. Historical data alone is generally insufficient as validation evidence.
Environmental Monitoring Plan: Review and Enhancement
The regulation emphasizes the importance of systematic environmental monitoring in production facilities, particularly in post-heat-treatment areas, where cross-contamination is most likely to occur. Sampling plans must be revised to ensure adequate coverage of critical points where Listeria monocytogenes can establish itself and persist.
Review of HACCP plans
The existing HACCP documentation must be revised to include the requirement for control through the end of the shelf life as a control point. Critical limits and corrective action procedures must reflect the new regulatory scope.
Compilation of the evidence file
The European Commission’s updated guidance document and the EURL Lm TGD provide the technical framework for structuring the evidence dossiers that competent authorities are entitled to request. Operators must ensure that their validation dossiers are structured, traceable, and accessible.
The Role of Molecular Detection in Compliance
The ability to meet these requirements depends directly on the quality, frequency, and speed of detection throughout the production and monitoring process.
The LoopDeetect method offers significant operational advantages for environmental monitoring and product control:
- Shorter turnaround times compared to traditional culture methods, enabling faster decision-making.
- High sensitivity to low levels of contamination: critical for detecting Listeria monocytogenes before it reaches concerning concentrations.
- Ability to integrate into high-frequency routine monitoring plans without disrupting production flows.
At Loop Dee Science, LoopDeetect reagents are designed for this type of routine, high-frequency molecular detection, providing reliable and traceable results within the timeframes required by environmental monitoring and industrial control programs.
Key Dates
- November 20, 2024 – Publication of Regulation (EU) 2024/2895 in the Official Journal of the EU
- December 11, 2024 – Entry into force of the Regulation
- December 2025 – Publication of the updated guidance document from the European Commission (DG SANTE)
- February 2026 – Publication of the updated version of the EURL Lm technical document
- July 1, 2026 – Effective application to food business operators
Conclusion
Regulation (EU) 2024/2895 represents a structural shift in how food safety responsibility is defined for RTEs in the European Union. The compliance window is no longer limited to the production facility; it now extends throughout the product’s commercial life.
For quality managers, site directors, and food safety teams, the practical implications are clear: shelf-life studies must be validated or revalidated, environmental monitoring plans must be strengthened, and HACCP documentation must be updated to reflect the new scope.
The deadline is set for July 1, 2026. The question today is no longer whether action is needed, but whether the evidence is already in place.
Sources :
- ECDC. Annual Epidemiological Report – Listériose 2023. Stockholm : ECDC ; mars 2025.
Règlement (UE) 2024/2895 – EUR-Lex.
Règlement (CE) n°2073/2005.
Rapport épidémiologique annuel ECDC 2023.
Rapport EFSA One Health 2024.
Document technique EURL Lm, février 2026.
- EFSA/ECDC. The European Union One Health 2024 Zoonoses Report. Décembre 2025.
Académie nationale de médecine (Rosset, 2019) – ScienceDirect.
Institut Pasteur, Caractéristiques et sources de Listeria monocytogenes.
PROFEL / DG SANTE. Guidance document on Listeria monocytogenes. Commission européenne, 2020.
