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Advice for food businesses on the new criterion for L. monocytogenes in ready-to-eat food

What is Listeria monocytogenes and why do food businesses need to control it?

Listeria monocytogenes (L. monocytogenes) is a bacterium that is primarily transmitted through contaminated food. It can cause a serious illness in humans known as listeriosis. Vulnerable populations, including pregnant women, infants, older adults, and people with weakened immune systems, are at a higher risk of developing severe illness and associated complications from listeriosis.

How does Listeria monocytogenes contaminate food?

Listeria monocytogenes is ubiquitous.  It is found in soil, water, sewage, vegetation, and animals.  It can therefore be present in raw food ingredients. Handling and processing of contaminated ingredients can result in contamination of the processing environment and subsequent cross-contamination of ready-to-eat foods. L. monocytogenes is killed by thorough cooking (i.e. core temperature of 75 °C or an equivalent time temperature combination) but if food is handled after cooking, L. monocytogenes can be transferred from contaminated equipment, surfaces, or hands. 

Which foods are at higher risk of causing listeriosis?

Ready-to-eat foods pose a higher risk for L. monocytogenes contamination because they are consumed without additional cooking, which would eliminate the pathogen. Foods that support the growth of L. monocytogenes pose a higher risk, particularly if storage conditions (such as temperature and shelf-life duration) provided on product labels are not properly followed. L. monocytogenes can grow slowly at refrigeration temperatures, this means that chilled ready-to-eat foods with a long shelf-life are a particular risk if the properties of the food allow for growth.  If present in such foods, L. monocytogenes could reach levels that can cause illness during refrigeration storage.

What is the legal definition of ‘ready-to-eat’ foods? 

Ready-to-eat food are defined’ in legislation as: ‘ …food intended by the producer or the manufacturer for direct human consumption without the need for cooking or other processing effective to eliminate or reduce to an acceptable level micro-organisms of concern’ (Commission Regulation (EC) No 2073/2005, as amended).

What legal controls are in place before the 1 July 2026 that specifically address the risk of L. monocytogenes in foods?

European food safety legislation establishes microbiological criteria for foodstuffs under Commission Regulation (EC) No 2073/2005, as amended. It includes criteria that set limits for L. monocytogenes in specified categories of ready-to-eat foods. Food business operators are obliged to perform testing as appropriate against the criteria, when they are validating or verifying the correct functioning of their procedures based on Hazard Analysis and Critical Control Point (HACCP) principles and good hygiene practice. 

The Regulation also requires, where appropriate, shelf-life studies to be conducted to determine whether a food supports the growth of L. monocytogenes and to demonstrate compliance with the relevant food safety criteria throughout shelf-life. It further requires sampling of processing areas and equipment for L. monocytogenes, where necessary, to verify the effectiveness of hygiene and process controls.

What changed on the 1 July 2026?

From the 1 July 2026, Commission Regulation (EU) 2024/2895 amends the microbiological limit for ready-to-eat food products that can support the growth of L. monocytogenes (food category 1.2). 

Under the amended rule, a limit of ‘not detected in 25g’ applies to products placed on the market throughout their shelf-life, where the food business operator has not been able to demonstrate, to the satisfaction of the competent authority, that the level of L. monocytogenes will not exceed the limit of 100 colony forming units per gram (CFU/g) throughout its shelf-life. Before the 1 July 2026, the criterion of ‘not detected in 25g’ applied only before the food had left the immediate control of the manufacturer.

What actions should food business operators take to comply with this change?

Food business operators are obliged to apply the revised microbiological criteria from 1 July 2026. They should review the shelf-life of ready-to-eat food falling into food category 1.2 under Commission Regulation (EC) No 2073/2005 to ensure that it remains compliant with the relevant limits for L. monocytogenes throughout its shelf-life. Annex II of the Regulation describes the shelf-life studies that the food business operator shall conduct, as necessary, to demonstrate compliance. Under Article 3.1 of the Regulation, these studies must be carried out under reasonably foreseeable conditions of distribution, storage and use. 

If L. monocytogenes is detected in a ready-to-eat food falling under food category 1.2, food businesses are expected to have existing evidence to demonstrate to the satisfaction of the relevant competent authority, that the product will not exceed the limit of 100 CFU/g throughout its shelf-life. It is not appropriate for food businesses to attempt to generate such evidence retrospectively during an active incident. 

Control of L. monocytogenes is required at all stages in the food chain. An integrated approach is required to prevent the growth of this pathogen in the final product. The challenges for controlling L. monocytogenes are considerable given its ubiquitous nature, high resistance to heat, salt and acidic pH, and its ability to grow and survive at or below normal refrigeration temperatures. 

The following general recommendations apply to all sectors of the food chain:

  • Implementation of prerequisite programmes (PRPs). These are good hygiene practices that are the basic conditions and activities necessary to maintain a hygienic environment.
  • Implementation of a food safety management system based on the principles of HACCP.
  • Testing against microbiological criteria, as appropriate, when validating and verifying the correct functioning of the HACCP-based procedures and other hygiene control measures.
  • Implementation of a robust Listeria Environmental Monitoring (LEM) programme to detect, investigate, manage and/or eliminate potential sources of L. monocytogenes contamination in the environment of a ready-to-eat food business operation.

Why was it necessary to change the criterion?

The previous food safety criterion for food category 1.2 did not specify a legal limit for L. monocytogenes in ready-to-eat foods once they had left the immediate control of the manufacturer that produced it, where the manufacturer was not able to demonstrate that L. monocytogenes, if present in the food product, would not exceed the limit of 100 CFU/g throughout its shelf-life. 

This caused a legislative gap in cases where it was not assured that the growth of L. monocytogenes in contaminated ready-to-eat food placed on the market would not go above the 100 CFU/g limit. Scientific evidence indicates that exposure to L. monocytogenes at levels below 100 CFU/g present a low risk of contracting listeriosis for healthy adults, with levels lower than 100 CFU/g possibly causing illness in the more vulnerable populations. In the interests of public health, a new more stringent limit has been set to bridge this legislative gap.

What impact will the new criterion have on food businesses and consumers?

As the new L. monocytogenes criterion limit is more stringent than the current limit of 100 CFU/g in place for food category 1.2 ready-to-eat foods placed on the market, it can be expected that there may be an increase in non-compliance for certain ready-to-eat food products. This is more likely to occur if food businesses do not have robust procedures in place for effectively managing the risk of L. monocytogenes cross-contamination and growth in the ready-to-eat foods they manufacture and/or place on the market. However, while the new rules are stricter for food businesses, they will ultimately ensure that consumers, particularly those who are most vulnerable, are better protected overall from the risk of listeriosis.

Additional resources

Food businesses can find more information and specific guidance on how to comply with the new rules on L. monocytogenes in ready-to-eat foods in the following documents: