The update has been published in EFSA’s latest QPS (qualified presumption of safety) update, which evaluated more than 300 notifications between 2022 and 2025.
One of the most notable additions to the positive list is Bacteriophages, which were previously ineligible for the QPS status, but are now deemed to be safe at the species level.
Research shows that Bacteriophages—viruses that attack and kill specific bacteria—can survive oral administration, avoid antibiotic resistance and eliminate a certain strains of unwanted bacteria without disrupting the rest of the microbiome, opening significant opportunities for innovation.
What is the QPS list?
The QPS is a positive list of microbes which EFSA has evaluated for safety purposes. EFSA conducts safety assessments on microbes which were submitted to the agency as part of technical dossiers for safety assessments.
These notifications are not requests for QPS status specifically, but are formal applications from companies seeking market authorization to use a microorganism in the food or feed chain.
The QPS approach assesses the taxonomic identity, body of relevant knowledge, and safety concerns of microorganisms. The list helps to streamline further safety assessments, allowing applicants to achieve a fast-tracked assessment if the ingredient is included on the positive list.
“QPS means that EFSA, under certain conditions, considers a micro-organism safe,” explained regulatory expert Luca Bucchini, managing director at Hylobates Consulting. “Whether it can be used depends on individual application. For example, if a product made with Microchloropsis gaditana is a novel food for which an application is pending, once the novel food is approved than Microchloropsis gaditana can be used to produce it."
“In practice, many consider QPS as a reference point for safety,” he added. “So, even internationally, in the context of submissions in the U.S. or elsewhere, QPS status is a positive factor for applications.”
If a microbe has not been granted QPS status, it does not necessarily mean it is unsafe, but rather that there is insufficient data to clarify its safety. Companies who submit applications for such ingredients will therefore be subjected to a more rigorous safety assessment to determine whether it can be used in food and feed in Europe.
Key changes and implications
Microbes which have achieved QPS status include Chlamydomonas reinhardtii, Microchloropsis Gaditana, Candida oleophila, Vibrio natriegens and Agrobacterium radiobacter, all with the qualification for ‘production purposes only’, implying that there must be no live cells left in the final food.
The microalga Microchloropsis gaditana is of particular interest to the dietary supplement industry since it is a rich source of polyunsaturated fatty acids (PUFAs) and has high levels of vitamin D3, Bucchini said.
“Of more interest to the nutraceutical industry, Aurantiochytrium acetophilum, a protist used for its capacity to accumulate lipids and in particular DHA, was denied the QPS status due to a limited body of knowledge, in particular safety data,” he added.
In addition, Bacillus thuringiensis did not achieve QPS status due to unresolved safety concerns and Bacillus thermoamylovorans was also denied due to a lack of data.
Companies seeking to use these microbes in food and feed products will therefore need to provide additional data in their applications to prove their safety for humans, animals and the environment.
Importantly, EFSA also published new guidance on antimicrobial resistance genes and genetically modified microorganisms (GMMs).
The QPS concept is now applicable to strains developed through new genetic techniques, such as GMMs. This means QPS status can be extended to these strains is the parental strain is already on the QPS list and the modification does not raise further safety concerns.
However, EFSA maintains a zero-tolerance approach to antimicrobial resistance and applicants must now demonstrate that any antimicrobial resistance found is a natural, non-transferable feature of that species rather than a gene picked up from the environment or other bacteria.
