The application of synthetic biology in food production continues to deepen. In response to this trend, the European Food Safety Authority (EFSA) has updated its guidance for novel food applications, further refining requirements for products derived from synthetic biology (Find details on Novel Food Applications for Synthetic Biology-Derived Products Under the New EU Regulations here).
Within the updated guidance, EFSA frequently references the Qualified Presumption of Safety (QPS) list in its requirements for microorganisms. To address key industry concerns, CIRS provides a focused introduction to the QPS framework to assist companies in navigating regulatory requirements.
What is the QPS list?
The QPS is a system implemented by the EU in 2007 to assess the safety of biological agents in the applications submitted to EFSA for market authorization of food and feed substances. Microorganisms that EFSA concludes to be safe will be included in the “QPS list”, which is a positive list updated every six months.
What is assessed within the QPS process?
During the QPS assessment process, experts assess the taxonomic identity of the microorganism, the related body of knowledge, and potential safety concerns. A QPS status is the result of the pre-assessment that covers safety concerns for humans, animals, and the environment.
How can QPS status accelerate market access？
Inclusion in the QPS list signifies that a microorganism’s safety has been pre-assessed and endorsed by EFSA. Consequently, if an applicant uses a microorganism with a QPS-status as a production strain, a simplified safety assessment may be done with fewer data requirements.
Case A: Novel Food Application
In January 2025, EFSA published its scientific opinion on the safety of oil from Schizochytrium limacinum (strain ATCC-20889) for use in infant and follow-on formula as a novel food. According to the opinion, no toxicological studies were performed with this novel food substance (NF). However, based on multiple safety datasets (including the available toxicological data on oils derived from Schizochytrium sp., and the QPS status of the Schizochytrium limacinum), EFSA concluded that there were no concerns with regard to the toxicity of the NF.
Notably, the applicant had previously submitted this NF application in 2019. However, as the production strain of the NF is not characterized at a species level, EFSA could not confirm the QPS applicability of the production strain, and the concern that this strain has the potential to produce toxins remains. As a result, EFSA considered that available toxicological data on oils derived from other strains of Schizochytrium sp. cannot be used to establish the safety of this NF.
Case B: Food Enzyme Application
According to the scientific guidance for food enzyme applications published by EFSA, toxicological studies may be exempted if the production strain is included in the QPS list and complies with QPS requirements.
Who can apply for QPS status?
The QPS assessment process is only triggered internally by EFSA after receiving an application for market authorization. It cannot be triggered directly by an applicant.
Can QPS status be applied to genetically modified microorganisms (GMM)?
The QPS status can be extended to GMM as long as:
- the species of the parental/recipient strain has QPS status, and
- the genetic modification does not raise safety concerns.
Summary
In summary, an applicant cannot apply for QPS status for microorganisms directly, however, using production strains with QPS status can facilitate standardized EFSA technical evaluation, which significantly reduces documentation demands, shortens approval timelines, lowers compliance costs, and accelerates product commercialization.
CIRS offers professional technical support services for inquiries regarding specific microorganisms’ QPS status or optimization of application strategies.
About CIRS Food Division
Established in 2012, the Food Business Division of CIRS Group has helped over 1,000 food companies globally in achieving one-stop compliance solutions. CIRS offers a full range of regulatory services covering China novel food applications, synthetic biology-derived foods, US GRAS notifice, EU novel food application, health food registration, and food for special medical purposes (FSMP).
If you need any assistance or have any questions, please get in touch with us via service@cirs-group.com.
