EFSA assesses the safety of microorganisms in the applications it receives for market authorisation of feed additives, food additives, food enzymes, food flavourings, novel food, and plant protection products (“regulated products”).
A Qualified Presumption of Safety (QPS) status is the result of a pre-assessment that covers safety concerns for humans, animals and the environment. During this process, experts assess the taxonomic identity of the microorganism, the related body of knowledge and potential safety concerns.
Microorganisms that are not well defined, for which some safety concerns are identified or for which it is not possible to conclude whether they pose a safety concern to humans, animals or the environment are not considered suitable for QPS status and must undergo a full safety assessment.
Have a look at this interactive multimedia tool for more information about how the QPS process is carried out at EFSA.
List of microorganisms with QPS status (QPS list) and list of notifications
The following two lists are available on the EFSA website:
- The QPS list (“Updated list of QPS-recommended microorganisms for safety risk assessments carried out by EFSA”)
- The list of “Microbiological agents as notified to EFSA”, through an application for market authorisation
Both lists are updated every six months after publication of a Biological Hazards (BIOHAZ) panel statement. The statements review relevant scientific literature on the safety of all microorganisms on the QPS list and assess new microorganisms notified to EFSA for a possible QPS status.
A scientific opinion that provides more detail on the QPS assessment is published every three years. The latest scientific opinion updating the QPS list was published in January 2023, based on the biannual assessments carried out by the BIOHAZ Panel.
EFSA publishes the latest scientific opinion on the maintenance of the list of microorganisms with QPS status (2022 QPS updated list). The opinion covers the previous three-year period (2020-2022), following the previous scientific opinions published in 2016 and 2019.
The 2019 QPS updated list, the overall list of notifications received by EFSA, the extensive literature search protocol, and respective search strategies are all published on the Knowledge Junction community of EFSA on Zenodo.
The Virtual issue on QPS is published. It includes all the QPS scientific opinions and the assessments of proposed microbiological agents to add to the QPS list.
The search and revision of the possible safety concerns linked to microorganisms included in the list starts to be done every six months, based on the evaluation of extensive literature searches. The evaluation of new microbiological agents notified to EFSA, to be assessed for use in food or feed additives, food enzymes, flavourings, novel foods or pesticides, for a possible QPS status is also done every six months. Both assessments are published in every panel statement, published every six months.
The BIOHAZ Panel decides that the overall assessment of the microorganisms included in the QPS list will be carried out every three years rather than every year.
EFSA’s Scientific Committee recommends that the QPS approach (initially developed for the assessment of microorganisms added to food and feed) be applied to the assessment of botanicals or botanical preparations.
The BIOHAZ Panel publishes the first review of the list of QPS microorganisms and updates the antimicrobial resistance criteria used to assess the safety of microorganisms used in food and feed. Between 2009 and 2013 the list is updated every year.
EFSA’s Scientific Committee proposes a strategy for the introduction of an assessment system based on the QPS concept and publishes the first list of microorganisms proposed for QPS status. The QPS approach will allow risk assessors to focus on biological agents that pose the greatest risks or uncertainties. It is to be used for pre-market safety assessment of notified microorganisms by all EFSA’s scientific units and panels.
EFSA’s Scientific Committee concludes that the introduction of a QPS system for microorganisms would help set priorities and avoid long investigations on the safety of microorganisms known not to cause concern.
EFSA assesses the safety of microorganisms used in feed additives, food additives, food enzymes, food flavourings, novel food, and plant protection products (“regulated products”) before they are authorised for use in the European market. The concept of qualified presumption of safety (QPS) was introduced in 2007 to facilitate the safety assessment of a regulated product proposed for market authorisation.
The QPS assessment is conducted separately from and independently of the safety assessment of a regulated product proposed for market authorisation. Therefore, it does not necessarily lead to its market authorisation.