The EFSA QPS update is here, and it brings important changes for businesses involved in food and feed safety. As the European Food Safety Authority (EFSA) continuously evaluates microorganisms intentionally added to food and feed, this new update reflects the most recent findings and safety considerations.
Whether you’re a producer, importer, or distributor in the food and feed industries, staying informed about the QPS list changes is crucial for ensuring compliance and maintaining safety standards.
Let’s dive into what this update means for your business and how it might affect your operations.
What Is the Qualified Presumption of Safety (QPS)?
The Qualified Presumption of Safety (QPS) is a process developed by EFSA to evaluate microorganisms intentionally added to food and feed. By identifying taxonomic units (TUs) that are generally considered safe, EFSA helps businesses streamline safety assessments, reducing the need for exhaustive individual evaluations. This list is updated regularly based on new research.
EFSA introduced the QPS approach in 2004, following a Scientific Opinion that built on a 2003 working document titled “On a generic approach to the safety assessment of microorganisms used in feed/food and feed/food production.”
This document was developed by a specialized working group, including experts from the Scientific Committee on Animal Nutrition, the Scientific Committee on Food, and the Scientific Committee on Plants of the European Commission. Establishing QPS status is based on four key criteria:
- Taxonomic identification – The microorganism must be classified under a clearly defined taxonomic unit (TU).
- Body of knowledge – Sufficient scientific data must be available to assess human and animal exposure through food and feed.
- Safety concerns – The microorganism must not contain known safety risks.
- Intended use – The assessment considers how the microorganism will be used in food or feed production.
By following these strict scientific principles, EFSA ensures a transparent, consistent, and efficient evaluation process for microorganisms in the food and feed industry.
Key Changes in the EFSA 2025 QPS Update
The 2025 update introduces several important changes that could impact your business:
1. New Microorganisms Assessed for QPS Status
In the latest update, Lacticaseibacillus huelsenbergensis has been granted QPS status, owing to its close relation to other safe Lacticaseibacillus species. This is good news for businesses using Lacticaseibacillus strains in their products.
2. Exclusions and Safety Concerns
EFSA also identified microorganisms that pose safety risks. For example, Bacillus thuringiensis was excluded from the QPS list due to its potential to produce harmful toxins. Businesses working with Bacillus species should ensure that their products meet safety standards.
3. Verification of Previously Approved Microorganisms
The update also verifies the safety of microorganisms that are already on the QPS list. Most previously approved taxonomic units remain on the list, offering stability for businesses using these microorganisms.
How This Affects Your Business
For businesses in the food and feed sectors, the EFSA QPS update provides a clear framework for ensuring that your products are safe for consumers. By using microorganisms approved for QPS status, you meet regulatory requirements and ensure safety.
If you’re involved in product development, the QPS list can guide ingredient selection. With Lacticaseibacillus huelsenbergensis now on the list, you may consider it for use in your products.
The update also helps you manage risks. For instance, the exclusion of Bacillus thuringiensis due to safety concerns means you need to avoid using strains that could compromise product safety.
Next Steps for Your Business
To stay compliant with EFSA’s regulations, you can:
- Review the QPS list: Check whether the microorganisms used in your products are on the latest QPS list.
- Collaborate with suppliers: Ensure your suppliers are aware of the new updates and use compliant ingredients.
- Consult experts: If you need clarification on the QPS status of specific microorganisms, reach out to regulatory experts for guidance.
The EFSA 2025 QPS update is a vital development for ensuring food and feed safety across Europe. By staying informed about the changes and aligning your processes with the updated list, you can maintain compliance, mitigate risks, and foster innovation in your business.
If you need to get expert advice, contact us at Quality Smart Solutions. For more information on the latest updates, read EFSA’s article.
FAQs
What is the Qualified Presumption of Safety (QPS)?
The QPS is a process by the European Food Safety Authority (EFSA) used to pre-evaluate microorganisms intentionally added to food and feed. If a taxonomic unit (TU) meets certain criteria clear taxonomy, sufficient scientific data, lack of safety concerns, and defined intended use it can be placed on the QPS list. This helps streamline safety assessments for businesses by reducing requirements for individual risk evaluations.
What are the criteria EFSA uses to grant QPS status?
EFSA evaluates microorganisms under four key criteria:
Taxonomic identification: The microorganism must be properly classified under an accepted taxonomic unit.
Body of knowledge: There must be sufficient published or scientific data about human and/or animal exposure.
Safety concerns: The microorganism must not show known harmful traits or produce toxins under intended use.
Intended use: The proposed usage (in food/feed) is evaluated to ensure no undue risk under that use.
What are the key changes in the 2025 EFSA QPS update?
Addition: Lacticaseibacillus huelsenbergensis has been granted QPS status due to its close relation to other safe species in the Lacticaseibacillus genus.
Exclusion: Bacillus thuringiensis has been removed/excluded from the QPS list because of safety concerns, notably its potential to produce harmful toxins.
Verification of existing members: Most microorganisms already on the QPS list have been re-assessed (or verified) and remain; this provides stability for businesses relying on those microorganisms.
How might this update affect your business in food or feed industries?
If your product uses microorganisms, you should check whether they are now included in (or excluded from) the QPS list to ensure compliance. Using a newly QPS-approved TU (like L. huelsenbergensis) may open up new options.
If you use organisms like Bacillus thuringiensis, you may need to review or modify your formulations, supplier sources, or production processes to avoid safety or regulatory issues.
Collaborate with suppliers to ensure microorganisms used are compliant with the latest scientific assessments. Importers, producers and distributors will need to update their compliance checks.
What steps should companies take to stay compliant with the EFSA QPS update?
Review the updated EFSA QPS list and compare with your current microorganism strains or species used.
Audit supplier documentation to confirm the taxonomic identity and safety data of any microorganisms. Ensure they meet EFSA’s QPS criteria.
Avoid usage of microorganisms excluded from QPS unless additional individual safety assessments are done.
Seek expert regulatory advice if uncertain about the status of particular microbial strains.
Monitor EFSA publications for further updates as science evolves.
