Since 1 July 2026, Ireland applies an amended Listeria monocytogenes food-safety criterion to certain ready-to-eat foods that can support its growth. If the food business cannot demonstrate, to the competent authority’s satisfaction, that the food will stay at or below 100 colony-forming units per gram (CFU/g) throughout shelf life, L. monocytogenes must be “not detected in 25g” while the product is on the market throughout that shelf life.
The answer in 30 seconds
The rule is not a general instruction to test every deli item every day, and it is not a new temperature limit. It changes the microbiological criterion for ready-to-eat foods in category 1.2 of Regulation (EC) No 2073/2005: foods able to support the growth of L. monocytogenes, other than foods intended for infants or special medical purposes.
If your business produces a food in scope, confirm the product category, review the shelf life, and make sure the supporting evidence exists before a positive result or incident occurs. Evidence may include product characteristics, scientific literature, predictive modelling, durability studies or challenge studies, as appropriate, together with effective hygiene, temperature and environmental controls.
TapTick can help teams keep routine controls, exceptions, corrective actions and verification evidence connected across sites. It does not replace product classification, laboratory work or competent technical advice. See the TapTick features.
What changed on 1 July 2026?
Commission Regulation (EU) 2024/2895 amended the L. monocytogenes criterion in food category 1.2 of Regulation (EC) No 2073/2005. The amendment applies from 1 July 2026.
Before that date, the “not detected in 25g” criterion applied before the food left the immediate control of the food business that produced it. Once the food had left that immediate control, the operator could rely on the 100 CFU/g limit during shelf life even where it had not demonstrated in advance that the limit would not be exceeded.
That gap has closed. FSAI explains that, from 1 July 2026, “not detected in 25g” applies to products placed on the market throughout shelf life when the operator has not demonstrated, to the satisfaction of the competent authority, that the product will stay within 100 CFU/g throughout shelf life.
This is a legal change already in force in Ireland. It is not a proposal, voluntary standard or future deadline. It does not mean that 100 CFU/g is acceptable in every ready-to-eat food: different criteria apply to foods intended for infants or special medical purposes and to ready-to-eat foods unable to support growth. Correct classification comes first.
Which businesses and foods need attention?
The amended criterion concerns ready-to-eat foods able to support the growth of L. monocytogenes, other than those intended for infants and for special medical purposes. Ready-to-eat means food intended for direct human consumption without cooking or another treatment effective at eliminating or reducing the microorganism to an acceptable level.
Do not decide scope from the product name alone. Whether a food supports growth can depend on factors such as pH, water activity, formulation, processing, packaging, storage temperature and shelf life. FSAI directs operators to the European Commission guidance for determining the applicable category and demonstrating compliance.
A business should review the issue if it:
- manufactures or prepares chilled ready-to-eat food and assigns a shelf life;
- changes a recipe, process, pack, storage instruction or durability date;
- repackages or relabels a product under its own responsibility;
- produces centrally for distribution to other sites or customers;
- has assumed a food cannot support growth without documented evidence; or
- relies on the 100 CFU/g limit but cannot promptly retrieve the evidence supporting that reliance.
The regulation and guidance are technical. A small kitchen, deli or central production unit should not invent its own category decision or laboratory plan. Where scope is uncertain, obtain advice from the environmental health officer, competent food-safety adviser or appropriately experienced laboratory.
What does this mean for retailers and caterers?
The practical responsibility depends on what the business actually does.
Receiving sealed supplier-branded food
Where a site only receives and sells a sealed product within the supplier’s labelled shelf life, the supplier or producer will normally hold the product-specific validation. The retailer still needs to maintain the labelled storage conditions, date control and traceability; use an approved supplier; keep product and batch information; and act immediately on a withdrawal, recall or safety instruction.
If a supplier cannot answer a reasonable question about classification, storage or shelf-life evidence, escalate it through the business’s supplier-approval process rather than creating an unsupported local assurance.
Making or repacking ready-to-eat food
If a site or central kitchen makes ready-to-eat food and determines how long it may be sold, the business may carry the producer’s responsibilities for that food. The same concern arises where the business changes the formulation, process, packaging or shelf life in a way not covered by the supplier’s evidence.
A label printed in-store does not validate a shelf life. The business needs a reasoned classification and evidence that matches the actual recipe, process, pack, temperature and reasonably foreseeable distribution, storage and use.
What evidence should exist?
FSAI says operators should review the shelf life of foods in category 1.2 and ensure compliance throughout that shelf life. Annex II of Regulation (EC) No 2073/2005 describes shelf-life studies that must be carried out as necessary. The evidence must reflect reasonably foreseeable conditions of distribution, storage and use.
Depending on the food and the technical assessment, the evidence may draw on:
- the product specification, formulation, pH and water activity;
- relevant scientific literature and research data;
- predictive mathematical modelling;
- durability studies that evaluate the organism in the food over shelf life;
- challenge studies assessing growth potential or maximum growth rate;
- processing, packaging and storage conditions;
- reasonably foreseeable temperature variation in distribution and use; and
- results from product, process and environmental monitoring.
Not every business needs every type of study. The method must be appropriate to the product and the question being answered. Laboratory sampling by itself is not a substitute for a valid study design, and one satisfactory end-product result does not prove that every future batch will remain within the limit for its full shelf life.
Evidence must pre-date the incident
FSAI states that, if L. monocytogenes is detected in a category 1.2 ready-to-eat food, the business is expected to have existing evidence showing that 100 CFU/g will not be exceeded through shelf life. It is not appropriate to try to generate that evidence retrospectively during an active incident.
Which operating controls support compliance?
Shelf-life evidence only remains meaningful when day-to-day production matches the conditions on which it was based. A change in recipe, equipment, pack, supplier, sanitation, storage temperature or distribution route can make old evidence unreliable.
Review the controls that prevent introduction, survival and growth of L. monocytogenes:
- approved ingredients and supplier specifications;
- separation of raw materials from ready-to-eat food and areas;
- validated processing steps where applicable;
- cleaning and disinfection, including difficult-to-access equipment niches;
- control of condensation, standing water, drains and damaged surfaces;
- personal hygiene and movement of people, tools and equipment;
- chilled storage, distribution temperature and time control;
- packaging integrity and prevention of post-process contamination;
- environmental sampling where necessary to verify hygiene and process controls;
- product testing at a frequency justified by the HACCP-based system; and
- defined action limits, escalation and corrective action.
Regulation (EC) No 2073/2005 does not set one universal sampling frequency for every operator. FSAI says businesses decide appropriate frequencies in the context of their HACCP-based procedures and good hygiene practice, unless a specific frequency is set. The decision should be risk-based, technically justified and reviewed when the food or process changes.
What if Listeria is detected?
Do not wait for the entire investigation before controlling potentially affected food. The immediate response should follow the site’s incident and traceability procedure and the facts of the result.
- Identify the exact result: food or environmental sample, organism, quantitative or presence/absence result, sample point, batch and date.
- Hold affected food: stop release, use or sale of implicated stock while the responsible person assesses the result.
- Define scope: identify related batches, production dates, lines, sites, ingredients and customers using traceability records.
- Notify internally: escalate to the named food-safety and management contacts without delay.
- Contact the competent authority: report a food incident to FSAI or the relevant official route where the result may represent a food-safety threat, and follow the authority’s direction.
- Apply withdrawal or recall controls: where unsafe or potentially unsafe food has left control, follow the approved incident procedure and regulatory advice.
- Investigate the source: review the environment, equipment, hygiene, process, ingredients, temperatures and recent changes.
- Verify corrective action: do not close the incident because cleaning was assigned; retain evidence that the action was completed and effective.
The correct response depends on the food category, result, existing shelf-life evidence, distribution status and competent-authority assessment. Do not use this article as a release decision for a specific batch.
What records should be kept?
An inspector or incident team should be able to see how the product was classified, how the shelf life was supported and whether routine production matched the validated conditions. Keep the current controlled version of:
- product specification, recipe and process flow;
- ready-to-eat category assessment and technical rationale;
- shelf-life protocol, study report, assumptions and approval;
- pH, water-activity, modelling, durability or challenge-study evidence used;
- supplier specifications and supporting assurances;
- HACCP review and prerequisite controls;
- cleaning, disinfection and hygiene verification records;
- environmental and product sampling plans, results and trend reviews;
- chilled storage and distribution evidence;
- deviations, holds, releases, corrective actions and verification;
- batch and distribution traceability; and
- change-control and review records.
Keep superseded evidence where it is needed to explain food already produced. A new report should not erase the assumptions and controls that applied to an earlier batch.
How should multi-site operators respond?
Do not ask every outlet to interpret microbiological legislation independently. Assign product classification, shelf-life validation and technical approval to a competent central owner. Give sites simple operating controls that match the approved evidence.
A multi-site review should answer:
- Which products are made centrally, locally or supplied ready for sale?
- Who owns the category decision and shelf-life evidence for each product?
- Are recipes, packs, labels and storage instructions consistent with the evidence?
- Can each site retrieve batch, supplier and distribution information quickly?
- Are temperature, cleaning and date-control exceptions visible to the technical owner?
- Which changes require reassessment before rollout?
- Can affected sites place food on hold and confirm stock within a defined time?
Standardise the evidence structure, not the scientific conclusion. Two similar sandwiches or deli products can require different assessments because formulation, processing, packaging and shelf life differ.
What is law and what is guidance?
- Law: Regulation (EC) No 2073/2005, as amended by Commission Regulation (EU) 2024/2895, contains the microbiological criteria. The amendment applies from 1 July 2026.
- Law: operators must comply with the applicable criterion and conduct the Annex II studies as necessary, under reasonably foreseeable conditions of distribution, storage and use.
- Official guidance: FSAI’s advice explains the change and the actions expected of Irish food businesses.
- Technical guidance: the European Commission’s guidance explains monitoring, product categorisation and shelf-life studies. It supports application of the law but does not replace the regulation.
- Business procedure: the operator converts the applicable requirements and technical evidence into product controls, monitoring, responsibilities, records and incident actions.
This article is labelled Ireland because the cited EU amendment applies there. Do not copy its legal explanation into a Great Britain procedure without checking the rules and official guidance that apply in that jurisdiction.
Practical review checklist
- List every ready-to-eat food the business produces or repacks.
- Identify who owns the product classification and shelf-life decision.
- Confirm which foods fall within category 1.2.
- Check that evidence supports compliance throughout the full shelf life.
- Confirm the evidence reflects foreseeable distribution, storage and use.
- Review recipes, packs, labels, processes and temperatures against the approved study.
- Document the sampling plan and the reason for its frequency.
- Review environmental monitoring where necessary.
- Define hold, escalation, reporting, withdrawal and recall actions.
- Make sure evidence can be retrieved during an incident.
- Set change triggers that require technical reassessment.
- Record management verification before closing gaps.
Official sources
- Food Safety Authority of Ireland: Advice for food businesses on the new criterion for L. monocytogenes in ready-to-eat food
- EUR-Lex: Commission Regulation (EU) 2024/2895
- European Commission: Guidance on L. monocytogenes monitoring and shelf-life studies for ready-to-eat foods
- Food Safety Authority of Ireland: Listeria monocytogenes factsheet
- Food Safety Authority of Ireland: Sampling frequency
- Food Safety Authority of Ireland: Report a food incident
Disclaimer: This article is general operational guidance, not product-specific scientific or legal advice. Food classification, shelf-life studies, sampling and batch decisions require competent assessment of the actual product, process and evidence.