Qualified presumption of safety (QPS)

The European Food and Safety Authority (EFSA) is requested to assess the safety of biological agents in the applications it receives for market authorisation of feed additives, food additives, food enzymes, food flavourings, novel foods, and plant protection products (“regulated products”).

The system of assigning a qualified presumption of safety (QPS) status to taxonomic units (TUs) of microorganisms (MOs) ( QPS Uznane domniemanie bezpieczeństwa (QPS) to procedura oceny bezpieczeństwa drobnoustrojów w łańcuchu żywnościowym. QPS wykorzystuje zgromadzoną wiedzę na temat bezpieczeństwa określonych drobnoustrojów w celu odróżnienia tych niebudzących obaw (którym można nadać status QPS) od tych, które mogą powodować ryzyko i powinny zostać poddane pełnej ocenie bezpieczeństwa. assessment) that are notified to EFSA is part of a simplified safety assessment used by EFSA. It was implemented in 2007 with the aim of facilitating the safety assessment of application dossiers for market authorisation through a simplified evaluation of microbial strains belonging to a TU with a QPS-status.

Who can trigger a QPS assessment?

The QPS assessment process is only triggered internally by EFSA after receiving an application for market authorisation. It cannot be triggered directly by an applicant.

Applications sent to EFSA arrive first at the Front-Desk where they are checked for completeness before being distributed to the relevant EFSA Unit(s). Simultaneously, a list with all notified applications that include a microorganism (MO) is prepared and shared monthly with the Biological Hazards (BIOHAZ) Team, responsible for coordinating all activities related to the QPS process.

The list ”Microbial species as notified to EFSA” compiles all MOs notified to EFSA from the beginning of the QPS exercise in 2007.

The QPS list (“Updated list of QPS-recommended microorganisms for safety risk assessments carried out by EFSA”)  is a “positive list” containing only the taxonomic units (TUs) notified to EFSA for which QPS status has been granted. If a MO has never been notified to EFSA, it will not be in the QPS list.

More information here.

What is assessed within the QPS process?

During the QPS assessment of a microorganism (MO), the following are assessed at a taxonomic unit (TU) level:

• taxonomic identity
• body of knowledge

• potential safety concerns (including knowledge of relevant acquired antimicrobial resistance - for bacteria).

If a hazard related to a TU that can be tested at the strain or product level is identified, a ”qualification” to exclude that hazard may be established during the QPS assessment. The subject of these qualifications for the microbial strain under investigation is evaluated by the EFSA Unit tasked with carrying out the safety assessment for market authorisation (which is independent of the QPS assessment).

For genetically modified microorganisms (GMM), the QPS approach can be extended to genetically modified production strains, biomass or active agents as long as:

• the species of the parental/recipient strain has QPS status, and

• the genetic modification does not raise safety concerns (assessed during the safety assessment for market authorisation).

Some biological groups are excluded from QPS assessment based on an ambiguous taxonomic position or the possession of potentially harmful traits and it is considered unlikely that any MOs within these groups would be granted QPS status in the foreseeable future.

What is not assessed in the QPS process?

The following safety aspects are not covered by the QPS concept:

• type and level of exposure of users handling the product (e.g., dermal contact, ingestion, inhalation);
• potential allergenicity to microbial residual components;
• hazards linked to the formulation or other aspects of the processing of those products.

EFSA assesses these aspects separately in its safety assessments for market authorisation of regulated products. Please visit here to get details on how to submit and monitor an application.

How can QPS status affect a future market authorisation application process?

The QPS assessment  is conducted separately and independently of the safety assessment of a regulated product proposed for market authorisation. Therefore, it does not necessarily lead to its market authorisation.

However, for microorganisms (MOs) with QPS status, a simplified safety assessment (evaluation) may be done, as reflected in the specific sectorial EFSA guidance. This requires less data on potential risks as compared to MOs without QPS status.

The QPS status of a certain taxonomic unit (TU) is granted through the QPS assessment  at species level for bacteria, yeasts and microalgae/protists and at family level for viruses, while the safety assessment of a MO notified through an application for market authorisation is done at strain level.

Strains belonging to a certain TU recommended for the QPS list still require:

• the confirmation of the taxonomic identity of the strain;
• the confirmation that the QPS qualifications assigned during the QPS assessment  are met;
• for genetically modified microorganisms (GMM), a confirmation of the safety of the genetic modification;

• a safety assessment based on a specific data package as requested by the respective Regulation and EFSA guidance documents for the application areas of the requested product authorisation.

Strains belonging to a specific TU not recommended for the QPS list may still be considered safe at the strain level:

• after a full safety assessment, based on a specific data package as requested by the respective Regulation and EFSA guidance documents for the application areas of the requested product authorisation.

List of microorganisms with QPS status (QPS list) and list of notifications

The following are published on the EFSA Knowledge Junction:

• 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 6 months after publication of a Biological Hazards (BIOHAZ) Panel Statement: these statements review relevant scientific literature on the safety of all taxonomic units (TUs) on the QPS list and assess new notifications. A Scientific Opinion is published every 3 years that provides more detail on the QPS assessment .