EN   EN 
 
 
 EUROPEAN  
COMMISSION   
Brussels, XXX   
SANTE -2021 -10580  
[…](2023) XXX  draft  
 
COMMISSION REGULATION (EU) …/…  
of XXX  
amending Regulation (EC) No 2073/2005 as regards Listeria monocytogenes  
(Text with EEA relevance)   EN 1  EN COMMISSION REGULATION (EU) …/…  
of XXX  
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 foodstuffs1, and in particular Article 4(4) thereof , 
Whereas:  
(1) Commission Regulation (EC) N o 2073/20052 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 (E C) 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. Th at 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 zoonoses3, the European Food 
Safety Authority ( the ‘A uthority’ ) 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 num bers 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 consumer s throug hout 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 defence s 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 consume rs, 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 . 
 
1  OJ L 139, 30.4.2004 , p. 1., ELI: http://data.europa.eu/eli/reg/2004/852/oj . 
2 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   EN 2  EN (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 in fants and for special medical purposes,  
before the y have left the immediate control of the producing food business operator 
where th at food business operator is not able to demonstrate , to the satisfaction of the 
competent authority, that the level of Listeria monocytogenes  will not exceed th e limit 
of 100 cfu/g throughout the s helf-life of the food s 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 produ ction 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” shoul d 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 January 
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, An imals, 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 January 2026.  
This Regulation 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