New EU Guidance on Listeria monocytogenes in Ready-to-Eat Foods

Commission Regulation (EU) 2024/2895, which amends Commission Regulation (EC) No 2073/2005 regarding Listeria monocytogenes is set to come into effect on 1 July 2026. To assist food businesses in meeting this new requirements, the European Commission recently published a new GUIDANCE DOCUMENT on Listeria monocytogenes monitoring and shelf-life studies for ready-to-eat foods under Commission Regulation (EC) No 2073/2005 of 15 November 2005 on microbiological criteria for foodstuffs. 

Purpose and scope

This guidance is primarily directed at food business operators (FBOp) who produce ready-to-eat (RTE) foods and conduct related L. monocytogenes shelf-life studies in accordance with Article 3(2) and Annex II of Commission Regulation (EC) No 2073/2005 on microbiological criteria for foodstuffs. Beyond manufacturers, it can also assist competent authorities conducting official controls on these food business operators and serve as a resource for third parties laboratories or consultants involved in performing L. monocytogenes shelf-life studies.

Closing the Legislative Gap

Under the current framework, Commission Regulation (EC) No 2073/2005 does not establish a specific limit for L. monocytogenes in Category 1.2 ready-to-eat foods that are able to support the growth of L. monocytogenes if they are sampled after they have left the immediate control of the food business operator that produced them, and when the operator cannot demonstrate that the limit of 100 cfu/g will not be exceeded throughout the product's shelf life.

To address this legislative gap, Commission Regulation (EU) 2024/2895 extends the criterion limit of "L. monocytogenes not detected in 25 g" for "ready-to-eat foods able to support the growth of L. monocytogenes, other than those intended for infants and for special medical purposes” as laid down under food category 1.2 in Commission Regulation (EC) No 2073/2005.

Compliance and Shelf-Life Validation

Food businesses that produce ready-to-eat foods capable of supporting the growth of L. monocytogenes, and which do not undergo heat treatment or other processes capable of eliminating L. monocytogenes during production, must be able to demonstrate that their products will remain compliant with the requirements of Commission Regulation (EC) No 2073/2005 throughout the shelf-life of the product. To support food business operators in understanding the growth behaviour of L. monocytogenes in the ready-to-eat foods they produce in order to set a safe shelf-life for their products, the new guidance document provides recommendations on:

• to classify and adequately label their food products as RTE or non-RTE foods,
• to determine which Lm food safety criterion applies to their food products,
• to decide on when and which shelf-life studies are needed with respect to Lm to demonstrate that their food products will comply with the Lm criteria until the end of the shelf-life,
• to validate, verify (initial verification and regular verification) and document that such shelf life studies are adequate to respect the applicable Lm food safety criterion,
• the options to collaborate in conducting such shelf-life studies.