Qualified presumption of safety (QPS)

Introduction

The qualified presumption of safety (QPS) is based on reasonable evidence. If an assessment concludes that a group of microorganisms does not raise safety concerns, the group is granted “QPS status”.

No microorganism belonging to that group needs to undergo a full safety assessment.

QPS list

Once EFSA grants a microorganism QPS status, it is included in the list of QPS status recommended biological agents for safety risk assessments or “QPS list”.

A list of all notifications received by EFSA since 2007 in the context of technical dossiers submitted by applicants and considered for possible inclusion in the QPS list is also available.

A QPS assessment is done when EFSA receives an application for market authorisation of a regulated product that requires a safety assessment.

To be granted QPS status, a microorganism must meet the following criteria:

  • Its taxonomic identity must be well defined.
  • The available body of knowledge must be sufficient to establish its safety.
  • The lack of pathogenic properties must be established and substantiated.
  • Its intended use must be clearly described.

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.

Latest

The publication of the next scientific opinion updating the QPS list is planned for December 2022, based on the 6-month assessments carried out by the BIOHAZ Panel.

Milestones

2019 EFSA’s Panel on Biological Hazards (BIOHAZ) adopts a scientific opinion on the maintenance of the list of biological agents with QPS status. 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.

2018 The Virtual issue on QPS is published. It includes all the QPS Opinions and the assessments of proposed microbiological agents to add to the QPS list.

As of 2017 The search and revision of the possible safety concerns linked to these biological agents starts to be done every six months, based on the evaluation of extensive literature searches.

2016 EFSA’s Panel on Biological Hazards (BIOHAZ) adopts a scientific opinion on the maintenance of the list of QPS biological agents

2014 The BIOHAZ Panel decides that the overall assessment of the biological agents included in the QPS list will be carried out every three years (see section: EFSA’s role) rather than every year.

2013 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.

2008 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.

2007 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 biological agents by all EFSA’s scientific units and panels.

2005 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 organisms known not to cause concern.

EFSA’s role

EFSA assesses the safety of microorganisms used in food and feed, before they are authorised for use in the European market. The Authority introduced the concept of qualified presumption of safety (QPS) to harmonise the safety evaluation of microorganisms used as food or feed additives, food enzymes, novel foods or pesticides.

The first list of biological agents with QPS status was established in 2007 and is updated in the form of a scientific opinion from the BIOHAZ Panel every three years.

EFSA also carries out an extensive literature search every six months to ensure that the list is up to date. If new information that might change the QPS status of a microorganism is discovered, this is published in a BIOHAZ Panel statement. The statements also include the evaluation of microbiological agents notified to EFSA within each six-month period to be assessed for use in food or feed additives, food enzymes, flavourings, novel foods or pesticides.

The six-monthly BIOHAZ Panel statements include:

  • new information that might change the QPS status of a microorganism that is already on the list or its qualifications;
  • evaluation of microbiological agents notified to EFSA for a possible recommendation for the QPS status.

Every three years the statements are summarised in a scientific opinion and the updated QPS list serves as a reference for the subsequent three-year updates.

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