From 2019 to 2023, confirmed listeriosis cases in the EU rose consistently, reaching 2,993 in 2023 - the highest annual figure since EU-wide surveillance began. Nearly all cases required hospitalisation, and the mortality rate exceeded 19%. The primary transmission route, according to EFSA and ECDC, is contaminated ready-to-eat food. Regulation (EU) 2024/2895, applicable from 1 July 2026, is the EU's direct regulatory response: the first substantive change to Listeria criteria in twenty years. For manufacturers of certain RTE foods, it changes not just what is tested, but when and where compliance must be demonstrated. 

From 1 July 2026, Regulation (EU) 2024/2895 introduces important changes to EU Listeria criteria for certain ready‑to‑eat (RTE) foods. While the amendment is limited to a specific product category, its practical impact on compliance, shelf-life validation and environmental monitoring programmes is significant. 

This article explains what has changed, which products are affected, and what it means in practice. 

Regulation (EU) 2024/2895 amends Regulation (EC) No 2073/2005 by extending the “not detectable in 25g” requirement for Listeria monocytogenes beyond the manufacturing stage. 

From July 2026, the criterion applies throughout the entire shelf life and distribution chain for certain RTE foods. 

Why this matters: 
Products that were previously compliant at the point of leaving the manufacturing site may no longer meet food safety criteria once placed on the market, unless the manufacturer can demonstrate that Listeria levels will remain controlled throughout shelf life. 

Listeriosis cases in the EU have increased consistently over the past five years, driven in part by an ageing population and the continued prevalence of contaminated RTE foods. Under the previous framework, a regulatory gap meant that Category 1.2 RTE foods - those able to support the growth of Listeria monocytogenes - had no applicable criterion once they left the manufacturing site, unless the producer could demonstrate growth would stay below 100 CFU/g throughout shelf life. Where that demonstration was absent, no further limit applied - even if growth beyond that threshold before the use-by date was possible 

The amendment closes this regulatory gap by extending the applicable criterion to products placed on the market throughout their shelf life. 

The change applies exclusively to Category 1.2 ready‑to‑eat foods, defined as RTE foods that can support the growth of Listeria monocytogenes. 

This covers a broad range of commonly produced RTE foods - including chilled meat and fish products, soft and semi-soft cheeses, and other products where pH and water activity do not inherently limit Listeria growth. If your product reaches the consumer without a formulation barrier against Listeria, Category 1.2 is the likely classification. 

Category 1.3 products are not affected. 

Products remain in Category 1.3 (not supporting Listeria growth) if they meet any of the following conditions set out in Regulation (EC) No 2073/2005, Footnote 8: 

• pH ≤ 4.4, or 
• Water activity (aw) ≤ 0.92, or 
• pH ≤ 5.0 and aw ≤ 0.94, or 
• Shelf life < 5 days 

Practical implication: 
Where technologically and sensorially feasible, reformulation to meet Category 1.3 criteria is often the most robust and cost‑effective long‑term compliance option and the one that removes ongoing shelf-life validation burden entirely. 

Manufacturers have three main pathways: 

Adjusting pH, water activity, or shelf life to reclassify the product as Category 1.3. Where formulation constraints allow, this is the most definitive route - it moves the product out of scope entirely. For many established products, sensory or functional requirements will make this impractical. 

Demonstrating, to the satisfaction of the competent authority, that Listeria monocytogenes will not exceed 100 CFU/g throughout shelf life. 

• Typically involves challenge testing or predictive microbiology 
• Estimated cost: €2,000–3,000 per product category 
• Availability of specialised laboratories may be limited 

Where this route is taken, the regulation also requires manufacturers to set intermediate control limits within their HACCP plans - checkpoints during shelf life, not just at the end - to demonstrate that the 100 CFU/g limit will hold. Access to laboratories qualified to conduct this work varies across the EU. 

For manufacturers with multi-product portfolios, the full compliance picture - including what validation is needed and how monitoring programmes need to change - is covered in detail in our regulatory overview. 

Applying “not detectable in 25g” at the end of shelf life, based on five subsamples. 

This is the most operationally demanding route. It requires contamination to be effectively prevented at source - which places environmental monitoring at the centre of compliance, not as a supporting activity. 

Under the revised framework, environmental contamination with Listeria monocytogenes can affect product compliance after market placement, not just during manufacturing. 

For RTE foods, post-process contamination from the processing environment is the primary Listeria risk. Under the new criteria, a contamination event that previously had limited regulatory consequence - because the product had already left the manufacturer's control - now has direct compliance implications throughout shelf life. This raises the operational stakes for environmental monitoring programmes that are infrequent, narrowly scoped, or slow to return results. 

Manufacturers should review sampling zones, testing frequency, and result turnaround time well ahead of July 2026 - particularly in high-risk RTE production areas. 

The practical starting point is product classification: understanding whether your products fall under Category 1.2 or 1.3 determines everything that follows. From there, shelf-life validation status and the adequacy of current environmental monitoring programmes are the two areas where most manufacturers will need to take action before July 2026. 

Shelf-life validation and monitoring programme redesign both take time. Neither can be implemented after the fact. 

Manufacturers working through the implications of Regulation (EU) 2024/2895 face practical decisions that go beyond reading the regulation - product classification, monitoring programme adequacy, and detection capability all need to be assessed in context. Romer Labs works with RTE food manufacturers on environmental monitoring and rapid Listeria detection, and has covered the full compliance picture - including the category framework, validation pathways, and monitoring implications - in a detailed regulatory overview on the Romer Labs website. 

If you are assessing your position ahead of July 2026, read the full article here or get in touch with the Romer Labs team directly.