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Silvia Carnio – Regional Marketing Manager, EU
Jeroen Bursens – Senior Scientific Affairs Manager
The regulatory landscape in food microbiology is shifting and changing as our collective understanding of pathogens and their effects on health and the economy develops. Recently, a significant change for EU countries has been the introduction of EU Regulation 2024/2463. This new regulation builds on existing frameworks and opens the door for innovation; specifically, the use of alternative testing methods by official laboratories. But what does this mean for food safety labs and the wider industry?
Understanding the landscape
Codex Alimentarius |
Regulation - 2073/2005 - EN - EUR-Lex |
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Principles for the Establishment and Application of Microbiological Criteria for Foods (CAC/GL 21-1997)Objective: To ensure food safety and protect consumer health. Scope: Establishes microbiological criteria for food products.
Key Elements:
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Microbiological Criteria for FoodstuffsObjective: To ensure that foodstuffs comply with microbiological safety standards within the EU. Scope: Applies to food business operators at all stages of production, processing, and distribution. Key Elements:
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ISO 17025:2017 |
ISO 16140 |
General Requirements for the Competence of Testing and Calibration LaboratoriesObjective: To ensure the competence, impartiality, and consistent operation of laboratories. Scope: Applies to all organizations performing laboratory activities.
Key Elements:
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Microbiology of the Food Chain — Method Validation
Objective: To provide guidelines for the validation of microbiological methods. Scope: Applies to the validation of alternative (proprietary) methods against a reference method.
Key Elements:
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What’s changing?
Under the previous regulatory structure, Regulation (EU) 2017/625 and Regulation (EC) 2073/2005, official laboratories were required to use reference methods listed in Annex I of 2073/2005 when verifying food safety compliance. These reference methods, while scientifically robust, are often time-consuming and resource-intensive.
With the introduction of Regulation (EU) 2024/2463, official laboratories now have the option to use alternative or proprietary methods for detection and confirmation, provided these methods have been validated according to ISO 16140-2 against the relevant reference methods.
Additionally, ISO 16140-3 plays a critical role in this context by defining the requirements for method verification in individual laboratories. Once an alternative method is validated (Part 2), labs must verify its performance in-house using ISO 16140-3 to ensure it works reliably under their specific conditions.
This is a major development. Elaborates Jeroen Bursens, “It opens the door for official laboratories to move towards easier and faster methods, without compromising on reliability.”
What is an official laboratory?
In the context of EU food safety regulations, an official laboratory is a testing facility designated by national authorities to verify compliance with food law. These labs carry out analyses and tests on samples taken during official controls, such as inspections or monitoring programs, as defined in Regulation (EU) 2017/625.
Historically, official labs were required to use reference methods listed in Annex I of Regulation (EC) 2073/2005. However, under Regulation (EU) 2024/2463, they may now use validated alternative or proprietary methods—provided they meet the strict validation (ISO 16140-2) and verification (ISO 16140-3) criteria, and are certified by a third party.
Regulation EU - 2017/625 |
Regulation EU - 2024/2463 |
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This regulation stipulates that EU member states must verify compliance to food safety regulations pertaining to producing, processing, and distributing food.
In this document, countries have the right/obligation to mandate official laboratories to conduct lab tests on samples taken as part of the compliance verification.
Per EN 2073/2005, official laboratories that test food products are required to use the reference methods in Annex I of that same norm. |
This “new” ordinance confirms that official labs described in 2017/625 need to use reference methods described in Annex I of 2073/2005, BUT can now seek approval from the food authorities to use alternative/proprietary analytical methods for both detection and confirmation, provided they were validated by ISO 16140-2 against the reference methods from 2073/2005, for either the specific food group or a ‘broad range of food’ as is defined in ISO16140.
IF the official lab under 2017/625 uses an alternative/proprietary method, they must themselves be certified by an independent certification body, by
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Download the eBook: A Guide to Efficiently Implementing Alternative Food Testing Methods in the Lab for Compliant Adoption under ISO 16140-3
Our comprehensive eBook, "A guide to efficiently implementing a new, alternative food testing method in accordance with ISO 16140 – Part 3" is your roadmap to navigating, selecting, and verifying alternative workflows in line with an internationally recognized standard.
What does this mean for your lab?
If you are part of the network of official food testing labs in the EU, you can now request approval from your food authority to adopt validated alternative methods. However, there are critical requirements:
- Compliance with ISO 16140-2: Any alternative method must be validated against the ISO reference method using ISO 16140-2 standards.
- Verification with ISO 16140-3: The validated method must then be verified in-house to demonstrate consistent performance under local lab conditions.
- Third-party certification: Your lab must be certified by an independent certification body, using the validation results and demonstrating a quality management process for the method used.
- Documentation and Quality Assurance: A declaration of the method's quality control and traceability must be available to support its application.
Why it matters
This regulatory update allows official labs to upgrade workflows and operations, reduce turnaround times, and potentially lower operational costs without compromising accuracy or compliance. As Silvia Carnio emphasizes, “We don't expect a sudden fundamental change in the market - however, at Thermo Fisher Scientific we always aim to be prepared and proactive in understanding these regulatory dynamics so we can remain the trusted source of education and support to our customers whether they are looking for advice or solutions.”
Your next step
As regulations evolve, so should the tools we use in the lab. Whether you run a public or private lab, choosing alternative methods isn’t just about compliance; it’s about prioritizing productivity first and foremost without compromising compliance. Alternative methods can offer faster results, simplified workflows, and increased confidence in your decision making while maintaining the rigor needed for regulatory approval if you choose the right methods.
PCR adoption and workflow considerations in food safety testing
PCR-based methods are often top of mind when we discuss rapid, alternative methods. They combine speed with sensitivity, making them an excellent choice for high-throughput, time-sensitive environments, or difficult and complex matrices. Learn more about selecting the right PCR method for your lab in our eBook.
Coloring the path to food safety: A guide to chromogenic media
For labs looking to streamline visual confirmation without implementing PCR, chromogenic media can offer clarity and convenience. Learn more about this in our eBook.
Connect with your Thermo Fisher Scientific representative to explore the best-fit solutions for your lab and take the next step in modernizing your testing workflows.
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