amending Regulation (EC) No 2073/2005 as regards Listeria monocytogenes (Text with EEA relevance)
THE EUROPEAN COMMISSION
Having regard to the Treaty on the Functioning of the European Union,
Having regard to Regulation (EC) No 852/2004 of the European Parliament and of the Council of 29 April 2004 on the hygiene of foodstuffs[1], and in particular Article 4(4) thereof,
Whereas:
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Commission Regulation (EC) No 2073/2005[2] lays down the microbiological criteria for certain micro‑organisms and the implementing rules to be complied with by food business operators in respect of the general and specific hygiene requirements referred to in Article 4 of Regulation (EC) No 852/2004.
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Regulation (EC) No 2073/2005 defines food‑safety criteria for Listeria monocytogenes, a major food‑borne pathogen. In its latest report on zoonoses[3], the European Food Safety Authority observed that the number of listeriosis cases in humans in the Union was 15.9 % higher in 2022 than in 2021, and the number of deaths from food‑borne outbreaks caused by L. monocytogenes in 2022 was one of the highest reported in the last ten years.
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The risk of contracting listeriosis is influenced by the consumer’s susceptibility and the ability of contaminated food to support growth of L. monocytogenes to high levels. Infants and immunocompromised individuals are highly susceptible and must not be exposed to any concentration of the pathogen. For other consumers, ingestion of food containing L. monocytogenes above 100 cfu/g is potentially injurious to health. Ready‑to‑eat foods (other than those intended for infants or special medical purposes) that can support growth of L. monocytogenes beyond this limit throughout their shelf‑life represent a sensitive commodity group requiring risk‑mitigation measures.
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Pursuant to Regulation (EC) No 2073/2005, L. monocytogenes must not be detected in 25 g of ready‑to‑eat foods able to support its growth (excluding foods for infants or special medical purposes) before they leave the immediate control of the producing food business operator, unless the operator can demonstrate to the competent authority that the level will not exceed 100 cfu/g throughout the product’s shelf‑life. The same criterion does not currently apply once the food has left the operator’s immediate control.
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To guarantee the same level of public‑health protection from production to distribution for these ready‑to‑eat foods, the criterion “Listeria monocytogenes not detected in 25 g” should apply wherever the foods are placed on the market during their shelf‑life and the operator cannot demonstrate compliance with the 100 cfu/g limit.
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To allow food business operators sufficient time to adapt, this Regulation shall not apply before 1 January 2026.
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Regulation (EC) No 2073/2005 should therefore be amended accordingly.
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The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on Plants, Animals, Food and Feed.
HAS ADOPTED THIS REGULATION
Article 1
Annex I to Regulation (EC) No 2073/2005 is amended in accordance with the Annex to this Regulation.
Article 2
This Regulation shall enter into force on the twentieth day following its publication in the Official Journal of the European Union.
It shall apply from 1 January 2026.
It shall be binding in its entirety and directly applicable in all Member States.
Done at Brussels,
For the Commission
The President
Ursula von der Leyen
ANNEX
In Annex I to Regulation (EC) No 2073/2005, Chapter 1 (Food safety criteria) is amended as follows:
- Entry 1.2 is replaced by the following table:
| Food category | Micro‑organisms / their toxins, metabolites | Sampling plan | Limits | Analytical reference method | Stage where the criterion applies |
|---|---|---|---|---|---|
| Ready‑to‑eat foods able to support the growth of L. monocytogenes, other than those intended for infants and for special medical purposes | Listeria monocytogenes | 5 n / 0 c / m / M | 100 cfu/g (*) | EN/ISO 11290‑2 () | Products placed on the market during their shelf‑life |
| 5 n / 0 c / m / M | Not detected in 25 g (***) | EN/ISO 11290‑1 | Products placed on the market during their shelf‑life |
- () This criterion shall apply if the producing food business operator has been able to demonstrate, to the satisfaction of the competent authority, that the level of L. monocytogenes* will not exceed 100 cfu/g throughout the food’s shelf‑life. The operator may set intermediate limits during processing that must be low enough to guarantee the final limit is not exceeded.
() 1 ml of inoculum is plated on a Petri dish of 140 mm diameter or on three Petri dishes of 90 mm diameter.
() 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 100 cfu/g throughout the food’s shelf‑life.
- In the notes on the interpretation of test results, the entry:
“L. monocytogenes in ready‑to‑eat foods able to support the growth of L. monocytogenes before the food has left the immediate control of the producing food business operator when he is not able to demonstrate that the product will not exceed the limit of 100 cfu/g throughout the shelf‑life: – satisfactory, if all the values observed indicate the absence of the bacterium, – unsatisfactory, if the presence of the bacterium is detected in any of the sample units.”
is replaced by:
“L. monocytogenes in ready‑to‑eat foods able to support the growth of L. monocytogenes if 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 foods: – satisfactory, if all the values observed indicate the absence of the bacterium, – unsatisfactory, if the presence of the bacterium is detected in any of the sample units.”