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Qualified presumption of safety (QPS)

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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 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.

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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 notrecommended 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:

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.

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Microorganisms (MOs) in QPS

This section provides information on the steps that should be followed for a market authorisation application.

 
QPS species virulence body of knowledge taxonomic units (TUs) QPS assessment
1

What does it mean if a microorganism (MO) has QPS status?

It means that all microbial strains belonging to that QPS taxonomic unit (TU) (at species level for bacteria, yeasts, and microalgae/protists and family level for viruses), included in an application for market authorisation, also have the same QPS status. A “qualified presumption of safety” (QPS) status provides a harmonized safety assessment approach used by EFSA that covers safety concerns for human, animals and the environment.

2

How does this affect my application?

Whenever foreseen by the specific sectorial EFSA guidance document, a simplified evaluation can be done with fewer requirements in relation to the risks that might be associated with the microorganism (MO). Strains belonging to QPS taxonomic units (TUs) still require a safety assessment based on a specific data package to be carried out by EFSA’s scientific Panels; however QPS status facilitates a simplified evaluation. Requirements for the different regulated products can be found here.

3

How do I proceed?

The requirements for the preparation of an application for the authorisation of a regulated product, including the characterisation of microorganisms (MOs), depend on applicable sectorial Regulation and EFSA guidance documents.

More information is available here.

In case further clarifications are needed, ask a question here.

 

1

Reasons for excluding a microorganism (MO) from future QPS assessment

Some microbial groups can be excluded from the QPS assessment because of an ambiguous taxonomic position or the possession of potentially harmful traits by some strains (e.g., pathogenicity, presence of virulence factors or production of biologically active toxic secondary metabolites) and it is considered unlikely that any MOs within these groups would be granted QPS status in the foreseeable future.

2

What does it mean when a microorganism (MO) is excluded from the QPS list?

This does not mean that a product containing such a MO will not be granted market authorisation. It means that a full safety assessment by EFSA will be required.

3

How do I proceed?

The requirements for the preparation of an application for the authorisation of a regulated product, including the characterisation of microorganisms (MOs), depend on applicable sectorial Regulation and EFSA guidance documents.

Detailed information can be found in the dedicated EFSA section here.

In case further clarifications are needed, ask a question here.

1

Reasons a microorganism (MO) is not in the QPS list

A MO is not in the QPS list either because it was never assessed before or because following its QPS assessment, QPS status was not granted.

  • MO has no QPS status because it has never been assessed:

EFSA initiates the QPS process only upon receipt of an application for market authorisation, i.e., MOs that are not notified, are not assessed.

  • MO assessed and no QPS status is granted:

There are three main reasons why following to an QPS assessment a MO is not granted QPS status:

  1. Ambiguous taxonomic position:

    The first step of the QPS assessment consists in checking if the name of the MO to be assessed exists as an official TU in accordance with recent international taxonomical insights. If it does not exist, QPS status cannot be granted to that MO.

  2. Lack of a sufficient body of knowledge:

    This means that there are no studies/articles published related to the MO (no body of knowledge including history of use).

    If a new notification of the same MO is received after publication of the last Biological Hazards (BIOHAZ) Panel opinion, the QPS assessment is repeated. If in the meantime new studies are published validating the safety of the MO in question, QPS status is granted if all the other criteria are met.

  3. Potentially harmful traits (e.g., pathogenicity, presence of virulence factors or production of biologically active toxic secondary metabolites):

    These MOs require a full safety assessment at strain level by EFSA. If EFSA considers unlikely that any TUs within these groups would be granted QPS status in the near future, it may recommend that these microbial groups are excluded from the QPS process.

2

What does it mean when a microorganism (MO) does not have QPS status?

This does not mean that a product containing such a MO will not be granted market authorisation. It means that a full safety assessment by EFSA is always required.

3

How do I proceed?

The requirements for the preparation of an application for the authorisation of a regulated product, including the characterisation of microorganisms (MOs), depend on applicable sectorial Regulation and EFSA guidance documents.

Detailed information can be found in the dedicated EFSA section here.

In case further clarifications are needed, ask a question here.

QPS genus species enzyme exposure body of knowledge risk assessment nutrition efficacy QPS assessment

QPS FAQs

QPS status is granted independently of the concentration levels in the product. Possible risks linked to the formulation or processing of the regulated products are not covered by the QPS status assessment and must be assessed separately, where applicable, by the EFSA panel responsible for assessing the application for market authorisation. In some cases, it is included the qualification “for production purposes only” which implies the absence of viable production organisms in the final product.
QPS status is granted independently of the culture medium used to grow a certain microorganism. Possible risks linked to the formulation or processing of the regulated products are not covered by the QPS status assessment and must be assessed separately, where applicable, by the EFSA panel responsible for assessing the application for market authorisation.
In principle, strains belonging to a taxonomic unit (TU) with QPS status can be mixed with a TU that does not have QPS status. However, this does not mean that the QPS status is extended to the mixture. The safety of the other(s) TUs in the mixture is assessed independently by the EFSA panel responsible for assessing the application for market authorisation. Be aware that possible risks linked to the formulation or processing of the regulated products are not covered by the QPS assessment and must be assessed separately, where applicable, also by the EFSA panel responsible for assessing the application.

The genus Lactobacillus has been recently divided into 25 new genera, based on phylogenetic, phenotypical and habitat differences shown by its 261 member species, while their species names are retained. Consequently, the 37 species that have QPS status were reclassified into 13 genera.

All strains belonging to a previous designed Lactobacillus species were transferred to the new species.

It is suggested to use the most recent nomenclature, however, former taxonomic classifications can be specified as well.

You may find the previous and current designations of the QPS Lactobacillus species here:

https://efsa.onlinelibrary.wiley.com/doi/epdf/10.2903/j.efsa.2020.6174

Bacilli are an extremely heterogeneous group within the phylum Firmicutes, exhibiting great phylogenetic and phenotypic diversity. The species traditionally included important agents in industrial microbiology (antibiotic and enzyme producers), food (pathogens, spoilage, and fermentation agents), feed additives and plant protection products. The systematics of the genus Bacillus have been recently revised and several changes have been proposed to clarify the evolutionary relationships and taxonomic structure.

It is suggested to use the most recent nomenclature, however, former taxonomic classifications can be specified as well.

You may find the previous and current designations of the QPS Bacillus species here:

https://efsa.onlinelibrary.wiley.com/doi/epdf/10.2903/j.efsa.2022.7045

The QPS status of a microbial taxonomic unit (TU) provides a simplified safety assessment of microbial strains belonging to that TU. Examples are strains used as zootechnical additives and food and feed additives, but also their enzymes and compounds used as flavourings. If residues, impurities, or degradation products linked to the total production process of these products do not give rise to concern, data on the safety of the target organism and toxicological data would not be required. Strains belonging to QPS status TU still require an assessment based on a specific data package as is requested by the respective guidance documents for the different application areas (e.g., data confirming the taxonomic identification as belonging to the QPS TU and data confirming that eventual qualifications are met).

Specific information on applications and updated guidance documents for each regulated product area can be found here: https://www.efsa.europa.eu/en/applications

In case further clarifications are needed, ask a question here: https://www.efsa.europa.eu/en/applications/askaquestion

For some taxonomic unit (TUs), data are lacking on the direct exposure of humans and animals to viable cells, while there is a documented body of knowledge on the safety of their fermentation products and/or their biomasses in the food and/or feed chain. This qualification implies the absence of viable production organisms in the final product and is also applicable to food and feed products based on the non-viable biomass of the microorganism. The qualification needs to be met by delivering data confirming the absence of viable cells of the microorganism being considered in the application.

EFSA guidance on how to assess the microbiological requirements to undertake the risk assessment approach based on QPS is available at:

https://efsa.onlinelibrary.wiley.com/doi/epdf/10.2903/j.efsa.2018.5206https://efsa.onlinelibrary.wiley.com/doi/epdf/10.2903/j.efsa.2021.6851https://efsa.onlinelibrary.wiley.com/doi/epdf/10.2903/j.efsa.2021.6506

The “list of microorganisms with QPS status” first established in 2007, has been revised and updated annually until 2014 via QPS Opinions; since 2014 the updates are carried out and published every 3 years. If new information is retrieved from extended literature searches (ELS) that would change the QPS status of a taxonomic unit (TU) or its qualifications, this is also published in the QPS Panel Statement (PS) covering a previous 6-month period.

The PS also includes the evaluation of microbiological agents notified to EFSA within the 6-month period for possible QPS status, for applications for market authorisation of feed additives, food additives, food enzymes, food flavourings, novel foods, and plant protection products (“regulated products”).

In the “Virtual issue” dedicated to QPS, you may find more information: https://efsa.onlinelibrary.wiley.com/doi/toc/10.1002/(ISSN)1831-4732.QPS

In the “Topics” section dedicated to QPS, you may find the latest publications on QPS assessment as well general information: https://www.efsa.europa.eu/en/topics/topic/qualified-presumption-safety-qps

The current valid “list of microorganisms with QPS status” can be found here: https://doi.org/10.5281/zenodo.1146566

The list of “microbiological agents as notified to EFSA” can be found here: https://doi.org/10.5281/zenodo.3607183

Products composed of viable microorganisms intended to be used in animal feed (including the so-called “probiotics”) according to Regulation (EC) 1831/2003 on additives for use in animal nutrition, require an EFSA risk assessment and are, on receipt of the application at EFSA, assessed for possible introduction to the QPS list. Human “probiotics” are not regulated as such and would not be QPS assessed when they are not introduced as a novel food or as a genetically modified microorganism. In the framework of Regulation (EC) No 1924/2006 on health claims made on foods (including microorganisms (e.g., bacteria and yeast), the Panel on Nutrition, Novel Foods and Food Allergens (NDA) is responsible for verifying the scientific substantiation (efficacy assessment) of submitted health claims based on data made available to EFSA (i.e., the applications provided by applicants). Under this framework, it should be noted that a safety assessment is not foreseen. However, where relevant, the NDA Panel may recommend restrictions of use based on safety considerations. Decisions regarding the authorisation of health claims, including the final wording and the conditions/restrictions of use, are taken by risk managers (i.e. the European Commission and Member States). In order to make such decisions, risk managers may take into account other legitimate factors, such as safety aspects (e.g. to modify the conditions/restrictions of use), in addition to EFSA’s scientific evaluation.

You may find more information at:

https://www.efsa.europa.eu/en/efsajournal/pub/6553https://www.efsa.europa.eu/en/applications/nutrition

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