A relatively small amendment to the EU's microbiological criteria became applicable on 1 July 2026, but for producers of chilled ready-to-eat foods its consequences are significant.
The change concerns Listeria monocytogenes and, more specifically, ready-to-eat (RTE) foods that are able to support its growth.
One point is worth clearing up at the outset: the 100 CFU/g criterion has not disappeared.
A producer may still rely on a limit of 100 CFU/g for an RTE food that supports Listeria growth where it can demonstrate, to the satisfaction of the competent authority, that the organism will not exceed that level at any point during the product's shelf life.
Where that assurance cannot be provided, however, the position is now stricter: Listeria monocytogenes must not be detected in 25 g throughout the product's shelf life while it is on the market.
That is the practical significance of Regulation (EU) 2024/2895, which amends Regulation (EC) No 2073/2005 and applies from 1 July 2026.
What actually changed?
Before July 2026, an RTE food capable of supporting Listeria monocytogenes growth was already subject to strict controls.
Where the producer could not demonstrate that the product would remain at or below 100 CFU/g throughout shelf life, Listeria monocytogenes had to be absent in 25 g before the food left the immediate control of the producing food business.
The regulatory weakness was what happened afterwards.
Once the product had left the producer's immediate control, Regulation 2073/2005 did not provide the same “not detected in 25 g” criterion for a product where the producer still could not demonstrate that 100 CFU/g would not be exceeded during shelf life.
Regulation 2024/2895 closes that gap.
From 1 July 2026, where adequate assurance of compliance with 100 CFU/g cannot be provided, the not-detected-in-25-g criterion follows the product throughout its shelf life while it is on the market.
| RTE food category | Criterion from 1 July 2026 |
|---|---|
| Intended for infants or special medical purposes | L. monocytogenes not detected in 25 g |
| Able to support growth, with satisfactory evidence that 100 CFU/g will not be exceeded throughout shelf life | Maximum 100 CFU/g throughout shelf life |
| Able to support growth, without satisfactory evidence that 100 CFU/g will not be exceeded | Not detected in 25 g throughout shelf life |
| Unable to support growth | Maximum 100 CFU/g throughout shelf life |
For adult RTE foods in categories 1.2 and 1.3, the sampling plan specified in the Regulation is generally n=5, c=0. For RTE foods intended for infants and for special medical purposes, it is n=10, c=0.
It is also worth remembering that “not detected in 25 g” is an analytical criterion. It should not be interpreted as a claim that a food contains mathematically zero bacterial cells.
The first question is not “What is my limit?”
It is “Which category does my product belong to?”
That distinction matters more than ever.
For RTE foods other than those intended for infants or for special medical purposes, products are normally regarded as unable to support the growth of Listeria monocytogenes where they have:
- pH ≤ 4.4
- aw ≤ 0.92
- pH ≤ 5.0 and aw ≤ 0.94
- a shelf life of less than five days
These foods normally fall within category 1.3 and remain subject to the 100 CFU/g criterion throughout shelf life. The competent authority may nevertheless require the food business operator to conduct studies under Article 3(2) where it considers this appropriate. Other products can also be shown to be unable to support growth, but that classification needs an appropriate scientific basis.
The vulnerable-population category takes precedence: an RTE food intended for infants or for special medical purposes remains in category 1.1 even if it meets one of the pH, water-activity or shelf-life conditions above. It must meet the not-detected-in-25-g criterion, with the category 1.1 sampling plan of n=10, c=0.
Product names alone are therefore not enough.
Soft cheeses, cooked sliced meats, smoked fish, prepared salads, sandwiches, sushi, cooked shellfish and cut fruit are all product groups in which Listeria control frequently deserves close attention. But a particular product cannot be classified simply because it is “smoked salmon” or “soft cheese”.
Its formulation, pH, water activity, preservatives, packaging, processing conditions, storage temperature and shelf life all matter.
That is an important distinction when reviewing an existing HACCP plan: classification needs to be based on the actual product, not on a generic food category.
The 100 CFU/g route is still available — but you need evidence
This is probably the most easily misunderstood part of the new rules.
A growth-supporting RTE product does not automatically have to meet “not detected in 25 g”.
The producer can apply the 100 CFU/g criterion where it can demonstrate, to the satisfaction of the competent authority, that Listeria monocytogenes will not exceed 100 CFU/g throughout the product's shelf life.
The important word here is demonstrate.
It is not enough to say that the business has never had a high result, or that routine finished-product testing has historically been satisfactory.
The December 2025 European guidance identifies several types of information that can contribute to shelf-life assessment, including the physico-chemical characteristics of the product, scientific literature, historical data, predictive microbiology, challenge tests and durability studies.
The evidence needs to make sense for the product being manufactured and for the conditions it is reasonably expected to encounter between production and consumption.
That includes realistic storage temperatures—not simply the most favourable temperature written on the label.
Where challenge testing fits in
Challenge testing becomes particularly useful where the growth behaviour of Listeria monocytogenes cannot be established confidently from the product's intrinsic characteristics or other available evidence.
In a growth-potential challenge test, the organism is deliberately introduced into representative product samples and its behaviour is followed under defined storage conditions.
The current European guidance uses a growth potential, Δ, of 0.5 log10 CFU/g as the classification point:
- Δ > 0.5 log10 indicates that the food is able to support growth;
- Δ ≤ 0.5 log10 indicates that the food is unable to support growth.
Challenge testing can also be used for another purpose: in a product that does support growth, it can help quantify how much growth could occur and support the calculation of an initial or intermediate limit capable of keeping the finished product below 100 CFU/g at the end of shelf life.
That distinction is useful. A challenge test is not simply a pass/fail exercise; depending on its design, it can answer different questions about the behaviour of Listeria in the product.
And the test conditions matter. The European guidance specifically stresses that storage during the study should reflect reasonably foreseeable conditions throughout the cold chain, including retail and consumer storage. Using unrealistically favourable temperatures can underestimate growth and overestimate safe shelf life.
Finished-product testing is only one part of Listeria control
It is tempting to respond to a tighter microbiological criterion by simply increasing finished-product testing.
That would miss much of the point.
Listeria monocytogenes contamination can be sporadic. A set of satisfactory finished-product results provides useful verification, but it does not by itself prove that a process or shelf life is safe.
For producers of higher-risk RTE foods, control needs to work across the system: hygienic design, zoning, cleaning and disinfection, environmental monitoring, control of post-process contamination, temperature management, validated shelf life and an appropriate sampling programme.
The European guidance likewise places shelf-life studies within the wider food safety management system rather than treating microbiological testing as a standalone control.
What should food businesses review now?
For businesses producing RTE foods, the most useful response is not simply to change a laboratory specification from “100 CFU/g” to “absence in 25 g”.
Start with the product portfolio.
Identify which products are RTE and determine which of the three regulatory categories applies. For category 1.2 products that support growth, review the evidence behind the shelf life and ask a harder question: could we demonstrate to the competent authority that this product will remain at or below 100 CFU/g throughout its shelf life?
Where the answer is uncertain, the shelf-life evidence needs attention.
Businesses should also review whether:
- product specifications accurately reflect pH, aw, formulation, packaging, storage conditions and shelf life;
- existing challenge or durability studies remain representative of the current recipe and process;
- realistic cold-chain conditions were considered when the shelf life was validated;
- environmental monitoring is suitable for the Listeria risk posed by the process;
- HACCP studies and hazard analyses reflect the current microbiological criterion;
- sampling plans and laboratory specifications use the correct criterion;
- customer and supplier specifications have been updated where necessary.
A formulation change, a longer shelf life, different packaging or a change in storage conditions may also invalidate assumptions made when an older study was carried out.
What about Great Britain and Northern Ireland?
The jurisdiction matters.
In the European Union, Regulation (EU) 2024/2895 applies from 1 July 2026.
The Food Standards Agency states that the amendment also applies in Northern Ireland from 1 July 2026 under the applicable post-Brexit arrangements.
The position in Great Britain — England, Scotland and Wales — is different. Directly applicable new EU legislation does not automatically become GB law. Businesses operating solely under the GB regime should therefore work from the current assimilated version of Regulation 2073/2005 and relevant FSA/FSS requirements rather than assuming that Regulation 2024/2895 applies automatically.
Businesses manufacturing in Great Britain for export to the EU, or supplying markets where the EU requirements apply, need to consider the EU criterion as part of their market-access and product-compliance arrangements.
A few common questions
Has the 100 CFU/g limit been abolished?
No. This is probably the most important misconception to avoid. It remains the applicable criterion for RTE foods unable to support Listeria growth and can also apply to growth-supporting RTE foods where the producer provides satisfactory evidence that 100 CFU/g will not be exceeded throughout shelf life.
Do I automatically need a challenge test?
Not necessarily. Some foods automatically fall into the non-growth category because of their pH, aw or shelf life. Other scientific information may also contribute to the assessment. Challenge testing becomes particularly valuable where the growth behaviour of the product cannot otherwise be established adequately.
Does a historical record of negative finished-product tests prove that my product does not support growth?
No. Historical data can form part of the evidence, but whether Listeria can grow is fundamentally related to the characteristics of the product and the conditions it encounters throughout shelf life. Historical testing should be considered alongside the wider scientific evidence.
What is the first thing I should review?
Your RTE product classification and the evidence supporting it.
For many businesses, that exercise will quickly identify whether the July 2026 amendment requires a substantive change—or simply stronger documentation of controls that are already working.
Need help applying the new criterion to a product?
Ask PinkPepper about your product's formulation, shelf life and storage conditions to understand which Listeria monocytogenes criterion may be relevant and what evidence you should review.
This article provides general food-safety information and is not legal advice. Product classification and shelf-life validation should be assessed against the current legislation, applicable official guidance and, where appropriate, the position of the competent authority.