With effect from July 1, 2026, Regulation (EC) No 2073/2005 will be amended by Regulation (EU) 2024/2895. This revision serves to tighten the microbiological criteria for Listeria monocytogenes in ready-to-eat (RTE) foods. Consequently, it brings about a redefinition of the requirements for demonstrating food safety.
What is Listeria monocytogenes?
Listeria monocytogenes is a gram-positive, rod-shaped, non-spore-forming bacterium belonging to the family Listeriaceae. Its exceptional adaptability makes this organism ubiquitous, meaning it occurs in soil, water, vegetation, as well as in the intestinal tracts of animals.
For the food industry, Listeria monocytogenes represents a constant challenge due to two primary characteristics:
- Although the optimal growth temperature for Listeria ranges between 30 – 39°C, its high resilience allows it to proliferate at refrigeration temperatures (2 – 4°C) as well as under oxygen-deficient conditions.
- Listeria is highly salt-tolerant and acidoresistant. Their capacity to form biofilms render them remarkably resistant to cleaning and disinfection.
Listeria monocytogenes is a foodborne pathogen that is transmitted through contaminated food and a severe threat to public health. High-risk food matrices include smoked fish, raw milk, raw milk products, cheese, cold cuts, pre-packaged salads, and raw minced meat.
Medical relevance: Low incidence – high mortality rate
In healthy individuals, an infection with Listeria – known as listeriosis – is mostly asymptomatic or presents as a mild, flu-like illness with gastrointestinal symptoms. The pathogen is a significant cause of mortality for elderly, immunocompromised individuals, and pregnant women, often resulting in severe illness or even fatality. Across Europe, the case-fatality rate for severe courses of the disease is approximately 20 – 30%.
amendments: which products are affected?
The core change of the regulation targets Food Category 1.2: Ready-to-eat foods able to support the growth of Listeria monocytogenes, other than those intended for infants and for special medical purposes.
Until now, the regulation has distinguished between products that are still in the manufacturing stage and those that are already in the distribution stage. This distinction is now being abolished, and the new requirements will apply across the entire supply chain.
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The Core Change: The strict limit of “Absence in 25 g” will apply throughout the entire shelf-life of the food product.
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The Derogation: Challenge Testing – A deviation to the limit of 100 cfu/g is only permissible if the manufacturer can demonstrate through scientific studies that this threshold will not be exceeded at any point during the product’s shelf-life.
A challenge test is a standardized laboratory procedure in which the ready-to-eat product is inoculated in the laboratory with a defined concentration of Listeria monocytogenes to monitor the pathogen’s behavior under realistic storage conditions throughout its entire shelf-life. A product is classified as safe if the growth potential does not exceed the regulatory limit over time.
If the challenge tests are not performed, the strict limit of “Absence in 25 g” must be maintained.
Impact on food manufacturers and contract laboratories
The amendment to the EU Listeria regulation impacts both food producers and contract laboratories. In particular, contract laboratories face significant operational challenges:
Key challenges for analytical testing laboratories include:
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Increased sample throughput
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Rapid sample analysis
What do laboratories require to meet these challenges?
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Highly reliable and sensitive detection kits for Listeria
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Rapid and reliable results
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Suitable technical laboratory equipment
Detection of Listeria monocytogenes in enriched food
Our SureFast® real-time PCR kits for the detection of Listeria monocytogenes support laboratories in implementing the requirements of the revised EU Regulation 2024/2895 reliably, rapidly, and efficiently.
CONGEN offers a comprehensive portfolio for the direct, qualitative detection of specific Listeria DNA sequences in enriched food samples:
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F5113 SureFast® Listeria monocytogenes PLUS
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F5117 SureFast® Listeria Screening PLUS
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F5175 SureFast® Foodborne Pathogens 4plex
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F5217 SureFast® Listeria 3plex ONE (AOAC and MicroVal certified)
The corresponding real-time PCR assays and the product-related documents can be found here: www.congen.de/en/food-analysis/food-microbiology/