Control of Listeria Monocytegenes in Ready-To Eat-Food (RTE), Guidance for Industry – FDA / EU Regulation 2024 / 2895

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The FDA guidance document on listeria control is intended for food manufacturers who are making RTE products and are subject to 21 CFR 117.

Listeria monocytogenes is an environmental pathogen that can contaminate foods and cause a mild non-invasive illness called listerial gastroenteritis or a severe invasive illness called listeriosis. Listeriosis is characterised by a relatively high mortality rate compared to illnesses caused by most other foodborne pathogens (20% compared to less than 1% for salmonella or E.Coli 0157). Persons who are at greatest risk of experiencing Listeriosis due to consumption of food contaminated by L. Monocytegenes are pregnant women and their foetuses, the elderly and persons with weakened immune systems. Foods that have caused outbreaks are typically contaminated from the environment during manufacturing, processing or packaging.

Although temperatures below freezing prevent the growth of L. mono it can multiply slowly at refrigeration temperatures (will grow at -0.4° C). As a result refrigeration is less effective as a control measure for L. mono than other food borne pathogens.

Listeriosis is largely associated with RTE foods. It is well established that the foods which pose the greatest risk of foodborne Listeriosis are those ready to eat foods that have intrinsic characteristics such as pH & Aw that support growth. To control L mono an FBO must first understand the bacteria itself and then how to control the environment that it can be found in. The FDA guidance document is very well designed to logically address the L. mono challenge.

Within Europe, the recent amendments to 2073/2005 – 2024/2895 (Commission Regulation (EU) 2024/2895 of 20 November 2024 amending Regulation (EC) No 2073/2005 as regards Listeria monocytogenes) comes into effect on July 1^st 2026. This amendment introduces a change to the criterion for Listeria monocytogenes in RTE foods. The new EU rules will focus on RTE foods that support the growth of L.mono.

Introduction and background

Regulatory framework

US - CFR 117
EU – 2073/2005 – 2024/2895

Risk Related Factors

The Nature of the Hazard
The Nature of the Food
The Nature of Consumer Use

Characteristics of L monocytogenes

Risk management framework

Tools
Process
Communication

EMP Team

Seven Step Process

L Mono Controls

Control of personnel
Design and construction of premises
Design and construction of equipment
Sanitation
Control of Raw Materials
Process Controls based on RTE Formulation
- Intrinsic characteristics - pH, Aw,
- Extrinsic factors – kill temperature
- Listericidal “Management Components”
1) Monitoring
2) Corrective action
3) Verification
Storage practices & Temperature / Time Control
Transportation

Environmental monitoring programmes (EMP)

Sampling and testing of RTE Foods
Analysis of data
Training – EMP Team – Seven Step Process

Workshops

Contamination scenario
Plant design
Cleaning schedules
EMP sampling
EMP Team

EMP Team Members
Food Safety Team Leaders
Laboratory Personnel
HACCP Team Member
Operations Leadership
Engineering / Maintenance Personnel
Supply Chain Personnel

Participants achieve the following learning outcomes from the programme;

Understand the upcoming EU legislation change – 2024/2895
Understand the seven step process when developing an EMP Team
Understand how to design and execute an effective EMP for L. mono
Be familiar with the FDA guidance document for listeria monocytogenes control
Understand the intrinsic and extrinsic factors that affect L. mono growth
Understand the regulation framework for L. mono in the EU and USA
Understand the critical L. mono controls in the processing environment
Understand how to validate and verify L. mono control procedures
Understand the three elements of the management components for L. mono control

In-House Courses
For In-House courses, the Tutor will contact the Course Organiser in advance to discuss the programme in more detail in order to tailor it specifically to the organisation.

Course Manual
Delegates will receive a very comprehensive course manual.

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Snapshot

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Course Code

FS050

Duration

2 training days

Public Price

Virtual Training: £645

Delivery Mode

This programme is delivered by Classroom, or In-Company training

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Control of Listeria Monocytegenes in Ready-To Eat-Food (RTE), Guidance for Industry – FDA / EU Regulation 2024 / 2895

Introduction

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