By Gill Dando, RQA Group Technical Director and Dr. Nicola Wilson, RQA Principal Consultant
Changes to food safety legislation can sometimes create more noise than clarity, particularly when they relate to a pathogen as serious as Listeria monocytogenes. The upcoming amendment to Regulation 2073/2005 is a good example. For some businesses, the headline may sound like a major new technical requirement. In practice, the position is more nuanced.
This is not a complete rewrite of how ready-to-eat food businesses should manage Listeria risk. The core expectations remain familiar: understand whether the product can support growth, have robust HACCP-based controls, maintain good hygiene and manufacturing practices, support shelf life with appropriate evidence, and be able to demonstrate that the food will remain within the required microbiological criteria throughout its life.
What is changing is the consequence where that evidence is not available, not accepted, or not sufficiently robust. From July 2026, for relevant ready-to-eat foods in the EU and in jurisdictions applying EU law, including Northern Ireland, competent authorities will have a clearer route to apply a “not detected in 25g” expectation during shelf life where the food business operator cannot demonstrate that L. monocytogenes will remain below 100 cfu/g.
That distinction matters. For well-controlled businesses with appropriate product knowledge, environmental monitoring, shelf-life evidence, cleaning controls and documentation, this may not require a dramatic change in approach. For others, it may expose gaps that were already present but not fully tested.
It also means businesses should be cautious about jumping straight to expensive or unnecessary testing simply because the regulation has changed. Additional analysis, challenge testing or shelf-life work may be appropriate in some cases, but it should follow a proper review of the product, process, existing evidence and risk profile. Testing should support a clear technical question, not become a default response to regulatory concern.
In the article below, our microbiology specialist, Dr Nicola Wilson, sets out what the amendment changes, how it fits alongside the existing criteria, and what food business operators should consider when reviewing their Listeria controls.
Ensuring the safety of ready-to-eat foods: L. monocytogenes and Regulation 2073/2005
Regulation 2073/2005 on microbiological criteria for foodstuffs helps protect consumers from L. monocytogenes in ready-to-eat foods by requiring food business operators to control contamination risks through personnel, raw materials, process controls and environmental controls.
This article summarises the 2026 amendment to Criterion 1.2b of Regulation 2073/2005[1], explains why the change was introduced, and sets out the practical implications for food business operators managing L. monocytogenes risk in ready-to-eat foods.
On 3rd July 2024, the Standing Committee on Plants, Animals, Food and Feed (SCOPAFF) adopted a revision to L. monocytogenes Criterion 1.2b in Regulation 2073/2005. This change came about partly due to a complex domestic court case in Estonia involving Listeria and fish which resulted in a dispute between the Estonian authorities and a fish producer. The European Court of Justice found that the zero-tolerance limit on Listeria monocytogenes cannot be applied to food which has left the control of the producer and is already on the market.
EFSA reported that in 2024, Listeria caused the highest proportion of hospitalisations and deaths among all foodborne infections reported in the European Union.[2] The European commission also justified the regulation change on the back of these rises in Listeriosis cases within the EU in recent years.
From 1st July 2026, the amendment to Criterion 1.2b of Regulation 2073/2005 will apply in the EU and in other jurisdictions applying EU law, including Northern Ireland. They will not apply to food businesses in Great Britain unless they are exporting relevant foods to the EU or moving them to NI.
The revised wording is significant because it changes the point at which the not detected in 25g requirement can apply. It extends the ‘not detected in 25g’ limit to products placed on the market throughout their shelf life, not only at the point they are placed on the market. The Competent Authority (CA) can, in the absence of acceptable evidence presented by the Food Business Operator (FBO) of compliance with Criterion 1.2a, require L. monocytogenes to be ‘not detected’ in 25g before the food has left the immediate control of the FBO (Criterion 1.2b).
The table below summarises the amended Criterion 1.2b that will apply from 1st July 2026.
Table 1: Criterion 1.2b from 1st July 2026 in the EU and other jurisdictions applying EU law
|
Criterion no |
Food Category |
Sampling plan |
Limits |
Where the criterion applies |
|
|
n |
c |
||||
|
1.2b |
RTE foods able to support the growth of L. monocytogenes, other than those intended for infants and for special medical purposes |
5 |
0 |
Not detected in 25g1 |
Products placed on the market during their shelf life |
1 This criterion shall apply where the producing 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 cfu/g throughout the shelf life of the food.
Understanding how the amended 1.2b criterion fits alongside the existing criteria is important, because the practical impact depends on whether the product can support the growth of L. monocytogenes and whether the food business operator can demonstrate control throughout shelf life.
There have been no changes to Criterion 1.1, 1.2a or 1.3. Criterion 1.1: L. monocytogenes must not be detected in 25g in RTE food which is intended for consumption by infants or for special medical purposes when placed on the market, during their shelf life. Criterion 1.2a: applies to foods that are not intended for infants or RTE food for special medical purposes, which support the growth of L. monocytogenes. This criterion requires the FBO to have evidence to demonstrate to the CA that 100 cfu/g will not be exceeded when placed on the market and during shelf life. This is provided by data which supports the correct functioning of the HACCP system. Criterion 1.3: For food not intended for infants or RTE food for special medical purposes. This criterion applies to foods that are unable to support the growth of L. monocytogenes. This is provided by physicochemical data demonstrating L. monocytogenes will not grow and exceed 100 cfu/g during the products whole life and historical data demonstrating that HACCP is functioning correctly.
The 2026 amendment does not change how a business determines a product shelf- life, but strengthens the consequences if the CA is not satisfied with the evidence provided for the length of shelf-life for a product which supports the growth of Listeria monocytogenes.[3]
The management of Listeria monocytogenes risk therefore still relies on HACCP-based principles, good data to back up product shelf life, understanding intrinsic product controls, good hygienic practice and good manufacturing practice. Clear documentation must be evidenced showing system compliance and the proper functioning of HACCP, all of which will demonstrate strong food safety management systems and management of risk.
The change in the regulation could increase vulnerability to recalls for products falling into criterion 1.2b in the Foodstuffs Regulation 2073/2005 where RTE products have a shelf life of 4 days or more, but only when there is no evidence of robust HACCP and Listeria management programs.
Before deciding what action is needed, it is worth being clear on which products (if any) are actually in scope.
|
Product type |
Broad position |
|
RTE foods for infants or special medical purposes |
Covered by Criterion 1.1, with separate stricter requirements. |
|
RTE foods able to support the growth of Listeria monocytogenes |
The main category affected by the amended Criterion 1.2b. |
|
RTE foods unable to support the growth of Listeria monocytogenes |
Covered by Criterion 1.3, supported by evidence that growth will not occur during shelf life. |
|
Non-ready-to-eat foods |
Not the focus of this specific Criterion 1.2b amendment, although wider food safety duties still apply. |
For many businesses, the most useful next step will not be to commission new testing immediately, but to understand whether the existing evidence is sufficient. That means reviewing the product category, shelf-life rationale, physicochemical characteristics, environmental monitoring, historical results, cleaning controls, zoning, HACCP documentation and how clearly the business can demonstrate ongoing control.
RQA does not provide laboratory testing, and our role is not to sell unnecessary analysis. We can, however, help businesses take a practical and independent look at their current position. That may include reviewing existing procedures, shelf-life evidence, environmental monitoring programmes, HACCP documentation and incident or recall vulnerability to identify whether there are any gaps against the amended requirements.
Where further work is genuinely needed, we can help define what that should be and why. Where existing controls and evidence are already strong, we can help businesses document that position clearly and proportionately.
If you are unsure how the amendment applies to your products, or whether your current Listeria controls and supporting evidence are robust enough, RQA can help you review the position before you commit to unnecessary activity or cost.
Click here to get in touch with the RQA team.
Sources:
[1] Regulation – 2073/2005 – EN – EUR-Lex
[2] Serious Listeria infections rising in Europe, EU report warns | EFSA