Upcoming EU Listeria Regulation: What global food manufacturers and exporters need to know

There's a significant regulatory shift on the EU landscape regarding the microbiological criteria for Listeria monocytogenes. The European Union has introduced Regulation (EU) 2024/2895, an amendment that took effect on December 11th, 2024, and will apply from July 1st, 2026. This regulation reinforces the microbiological criteria for L. monocytogenes across the food supply, particularly for ready-to-eat (RTE) products, ensuring a higher and more consistent level of consumer protection across the entire food chain.

Regulatory context 

This change does not come out of the blue, but it is a response to genuine public concern. Recent data from the European Centre for Disease Prevention and Control (ECDC) and the European Food Safety Authority (EFSA) indicate a concerning increase in listeriosis cases within the EU. In 2023, there were 2,952 reported cases, the highest since the EU-level surveillance began, with 335 associated deaths. This uptick is largely attributed to Europe's aging population. Whilst for most healthy individuals Listeria food poisoning would be mild, for vulnerable groups - pregnant women, infants, the elderly, and then immunocompromised – it is a very serious illness with a very high mortality rate compared to some of the other foodborne pathogens.  RTE foods, such as cold smoked salmon, meat products, and dairy items, are common sources of contamination.

This amendment to the long-standing Regulation (EC) No 2073/2005 on microbiological criteria for foodstuffs with its now active status and 2026 application date, divides foodstuffs into three categories. For foods intended for special medical purposes or for infants, as well as for foods that will not support the growth of Listeria (due to intrinsic factors like low pH and water activity), there is no change in the legislation. The change primarily impacts category 1.2, i.e.  RTE foods that can support the growth of L. monocytogenes. 

What does it change for food manufacturers?

The main changes and implications for the food manufacturers can be summarized as follows:

• Previously, for these RTE foods, the criterion of "not detected in 25g" for L. monocytogenes was critical before the food left the producer's immediate control, while a limit of 100 CFU/g was generally permissible on the market throughout the shelf-life if the manufacturer could ensure it. Going forward, the new criterion is "not detected in 25g" throughout the entire shelf-life, unless the producer can demonstrate, to the satisfaction of the competent authority, that the product will not exceed the 100 CFU/g limit throughout its shelf-life.
• If a producer or an exporter wants to rely on that 100 CFU/g limit, robust scientific evidence is needed. This means comprehensive challenge tests or predictive microbiology studies specifically tailored to each product and its conditions. Compliance will now need to be demonstrated throughout the entire food chain. Without this validated proof, the default expectation is the absence of L. monocytogenes in 25g of product across its entire life on the market.

The change will demand more from RTE food manufacturers. Enhanced validation is non-negotiable. If they plan to work with 100 CFU/g limit, they need to invest and have access to solid scientific studies. And these studies must account for any foreseeable storage and shelf-life conditions. Temperature abuse scenarios during summer, delays and disruptions in chilled transport, and the reality of the consumer’s underperforming home fridge. This critical shift, from a primary focus on testing at the manufacturing stage to continuous verification along the supply chain, demands that all food safety and quality management protocols be rigorously examined and updated. Preventing contamination in the first place becomes even more critical. A constant re-evaluation of sanitation and environmental monitoring programs within the plant, as well as further investment in employee training, will be needed to effectively minimize any contamination risks.

There are still some open questions relating to the new legislation. The phrase "to the satisfaction of competent authority" is key. At the moment, there is no harmonized guidance across the food inspection authorities of all EU member states on what constitutes acceptable demonstration. For instance, Dutch authorities accept and encourage the usage of the Food Spoilage and Safety Predictor (FSSP) by manufacturers, a predictive microbiology tool assessing the effect of constant or fluctuating temperature storage conditions on product shelf-life. We expect that with the new legislation entering into effect, predictive models potentially powered by newer technologies such as Artificial Intelligence will be developed and adopted by manufacturers and authorities alike. Furthermore, while manufacturers bear significant responsibility, Listeria control is a total supply chain issue. This raises concerns about whether the regulation sufficiently addresses these wider responsibilities and could create significant tensions with aspects of the EU’s Farm to Fork strategy, particularly its goals for food waste reduction and sustainable food systems. If these new burdens aren't managed holistically there is a valid concern about having products in the market with shorter shelf-lives leading to increased food waste.

This new regulation is a significant development. It underscores the EU's commitment to public health and safe food systems, but it also presents clear operational and technical hurdles for the food industry. By understanding the nuances, staying closely in touch with microbiology experts, and preparing proactively, manufacturers and food exporters can navigate these changes. The businesses that act now and not in 2026 will be the ones best positioned to stay compliant, competitive, and credible in the eyes of EU regulators and consumers.