Food Pathogens: Listeria Monocytogenes Management in the EU

The EU Commission guidance document addressing the risk management of Listeria Monocytogenes in ready-to-eat (**RTE**) foods has just been republished and updated. The revision and update of the version published in 2013 reflect advancements in scientific knowledge and practical regulatory experience.

Its objective is to assist Food Business Operators (FBOs) in assessing microbial behavior and validating shelf-life pursuant to Regulation (EC) No 2073/2005.

It emphasizes the pathogen’s public health significance, given its ubiquitous nature in the environment and its ability to survive and proliferate under adverse conditions — such as low temperatures, reduced water activity, and modified atmospheres — posing heightened risks to vulnerable populations.

For those not acquainted with Listeria, it can survive in frozen foods at -18 °C and still proliferates during ordinary refrigeration, and once it enters a production facility, it can produce biofilms and persists for years.

The highest risk is associated with Ready-to-Eat (RTE) foods that are not cooked before consumption, like:

• Meat Products: Sliced meats, cold cuts, pâtés, hamburgers, sausages and hot dogs.
• Dairy: Soft cheeses (Brie, Camembert, Queso Fresco) and unpasteurized (raw) milk cheese and cheese products.
• Seafood: Cold-smoked fish (like smoked salmon) and shellfish.
• Produce: Pre-cut vegetables, raw sprouts, and pre-packaged salads.
• Frozen food: Ice cream

But we also had outbreaks from infant formula,

The disease, Listeriosis, manifests in two ways:

• Non-invasive: A mild “flu-like” illness with fever, muscle aches, and occasionally diarrhea.
• Invasive: The bacteria enter the bloodstream or central nervous system. This leads to sepsis, meningitis, or encephalitis.
• Pregnancy Outcomes: For the mother, symptoms are often mild. However, for the fetus, it is catastrophic, leading to miscarriage, stillbirth, premature delivery, or severe infection in the newborn.

Listeria is rare compared to Salmonella, but it is the deadliest common foodborne pathogen.

• General Case Fatality: Typically ranges between 15% and 30% for invasive cases.
• EU Context (2025/2026): Recent reports (e.g., EFSA 2025) indicate that while it represents a small fraction of total foodborne illnesses, it accounts for the highest proportion of hospitalizations and deaths among reported zoonotic diseases.

The guidance text reaffirms the primary responsibility of FBOs to ensure product safety throughout the entire commercial shelf-life, within a management system based on Good Hygiene Practices (GHP) and HACCP. The proper application of microbiological criteria necessitates the correct classification of foods as either RTE or non-RTE, alongside an assessment of the product’s ability to support the growth of the microorganism.

To this end, FBOs must take into account product characteristics (pH, water activity, storage and packaging conditions, and competitive flora), historical data, and scientific literature, utilizing tools such as predictive modeling, challenge tests, and durability studies where necessary.

Specific focus is placed on defining ‘worst-case’ scenarios, ensuring batch representativeness, and 𝐝𝐨𝐜𝐮𝐦𝐞𝐧𝐭𝐢𝐧𝐠 𝐭𝐡𝐞 𝐞𝐯𝐢𝐝𝐞𝐧𝐜𝐞 𝐫𝐞𝐪𝐮𝐢𝐫𝐞𝐝 𝐭𝐨 𝐝𝐞𝐦𝐨𝐧𝐬𝐭𝐫𝐚𝐭𝐞 𝐜𝐨𝐦𝐩𝐥𝐢𝐚𝐧𝐜𝐞 𝐰𝐢𝐭𝐡 𝐭𝐡𝐞 𝟏𝟎𝟎 𝐂𝐅𝐔/𝐠 𝐥𝐢𝐦𝐢𝐭 𝐭𝐡𝐫𝐨𝐮𝐠𝐡𝐨𝐮𝐭 𝐭𝐡𝐞 𝐬𝐡𝐞𝐥𝐟-𝐥𝐢𝐟𝐞; 𝐟𝐚𝐢𝐥𝐢𝐧𝐠 𝐭𝐡𝐢𝐬, 𝐭𝐡𝐞 ‘𝐚𝐛𝐬𝐞𝐧𝐜𝐞 𝐢𝐧 𝟐𝟓𝐠’ 𝐜𝐫𝐢𝐭𝐞𝐫𝐢𝐨𝐧 𝐬𝐡𝐚𝐥𝐥 𝐚𝐩𝐩𝐥𝐲.