Commission Regulation (EU) 2024/2895 of 20 November 2024 amending Regulation (EC) No 2073/2005 as regards Listeria monocytogenes
Date: 2024-11-20
Institutions: Directorate-General for Health and Food Safety, European Commission
Subjects: agri-foodstuffs, food contamination, food inspection, food safety, food-borne disease, foodstuff, health control, human nutrition, labelling, microorganism




L_202402895EN.000101.fmx.xml












Official Journal of the European Union


EN
L series













2024/2895


21.11.2024







            COMMISSION REGULATION (EU) 2024/2895
of 20 November 2024
         
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:







(1)


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.












(2)


In particular, Regulation (EC) No 2073/2005 lays down food safety criteria, which define the acceptability of a product, or a batch of foodstuff applicable to products placed on the market. That Regulation provides for food safety criteria for Listeria monocytogenes, which is a major foodborne pathogen posing serious risk to public health due to its high fatality rate. In its latest report on zoonoses (3), the European Food Safety Authority (the ‘Authority’) observed that the number of cases of listeriosis in humans in the Union was 15.9 % higher in 2022 than in 2021 and the number of deaths from foodborne outbreaks and caused by Listeria monocytogenes in the Union in 2022 was one of the highest numbers ever reported to the Authority in the last ten years. In view of this upsurge of listeriosis cases in the Union, it is crucial that food safety criteria for Listeria monocytogenes can offer a high and consistent level of protection of consumers throughout the food chain.












(3)


The risk of contracting listeriosis through food is influenced by both the individual susceptibility of the consumer and the ability of the contaminated food to support the growth of Listeria monocytogenes to high levels. Infants and consumers with weakened immune defences because they are suffering diseases, disorders or medical conditions are highly susceptible to Listeria monocytogenes and cannot be exposed to food containing this pathogen at any concentration. For other consumers, it is scientifically recognised that only ingestion of food containing concentration of Listeria monocytogenes over the limit of 100 cfu/g is potentially injurious to health. Therefore, ready-to-eat foods, other than those intended for infants and for special medical purposes, which are able to support the growth of Listeria monocytogenes beyond the limit of 100 cfu/g throughout their shelf-life represent a sensitive food commodity group on which risk mitigation measures should be focused.












(4)


Pursuant to Regulation (EC) No 2073/2005 the presence of Listeria monocytogenes is not to be detected in 25g of ready-to-eat foods able to support the growth of Listeria monocytogenes, other than those intended for infants and for special medical purposes, before they have left the immediate control of the producing food business operator where that food business operator is not able to demonstrate, to the satisfaction of the competent authority, that the level of Listeria monocytogenes will not exceed the limit of 100 cfu/g throughout the shelf-life of the foods concerned. However, Regulation (EC) No 2073/2005 does not provide for a criterion which applies to those foods once they have left the immediate control of the producing food business operator while it is still not possible to ensure that the limit of 100 cfu/g will not be exceeded throughout their shelf-life.












(5)


In order to guarantee the same level of public health protection from production to distribution for ready-to-eat foods other than those intended for infants and for special medical purposes that are able to support the growth of Listeria monocytogenes, the food safety criterion ‘Listeria monocytogenes not detected in 25 g’ should apply to all situations where those foods are placed on the market during their shelf-life and for which the producing food business operator has not been able to demonstrate, to the satisfaction of the competent authority, that the level of Listeria monocytogenes will not exceed the limit of 100 cfu/g throughout their shelf-life.












(6)


To allow food business operators sufficient time to adapt their practices and procedures to the new requirement, this Regulation should not apply before 1 July 2026.












(7)


Regulation (EC) No 2073/2005 should therefore be amended accordingly.












(8)


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 that of its publication in the Official Journal of the European Union.

It shall apply from 1 July 2026.




This Regulation shall be binding in its entirety and directly applicable in all Member States.
Done at Brussels, 20 November 2024.


For the Commission


The President

Ursula VON DER LEYEN
            





(1)  
            OJ L 139, 30.4.2004, p. 1., ELI: http://data.europa.eu/eli/reg/2004/852/oj.

(2)  Commission Regulation (EC) No 2073/2005 of 15 November 2005 on microbiological criteria for foodstuffs (OJ L 338, 22.12.2005, p. 1., ELI: http://data.europa.eu/eli/reg/2005/2073/oj).

(3)  
            https://doi.org/10.2903/j.efsa.2023.8442.




ANNEX
In Annex I to Regulation (EC) No 2073/2005, Chapter 1 (Food safety criteria) is amended as follows:






(1)


entry 1.2 is replaced by the following:












Food category


Micro-organisms/their toxins, metabolites


Sampling plan


Limits


Analytical reference method


Stage where the criterion applies




n


c


m


M










‘1.2


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 


0 


100 cfu/g 
 (*1)



EN/ISO 11290-2 
 (*2)



Products placed on the market during their shelf-life




5 


0 


Not detected in 25 g 
 (*3)



EN/ISO 11290-1


Products placed on the market during their shelf-life














(2)


in the notes on the interpretation of the 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 the following:

                        ‘
                        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 bacterium is not detected in any of the sample units,










—


unsatisfactory, if the presence of the bacterium is detected in any of the sample units.’
                           










(*1)  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 the limit 100 cfu/g throughout the shelf-life of the food. The operator may fix intermediate limits during the process that must be low enough to guarantee that the limit of 100 cfu/g is not exceeded at the end of shelf-life of the food.

(*2)  1 ml of inoculum is plated on a Petri dish of 140 mm diameter or on three Petri dishes of 90 mm diameter.

(*3)  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.’;



ELI: http://data.europa.eu/eli/reg/2024/2895/oj
ISSN 1977-0677 (electronic edition)