Qualified presumption of safety (QPS)

Introduction

Qualified presumption of safety (QPS)

Microorganisms (such as bacteria, yeasts and viruses), also called biological agents, have been used since ancient times for the production of food and feed. Some have a long history of safe use, while the safety of others still needs to be assessed.

The qualified presumption of safety (QPS) is an assumption of safety based on reasonable evidence. If an assessment of a group of microorganisms concludes that they do not raise safety concerns, the group is granted “QPS status”. Any microorganism that is assigned to that group does not need to undergo the full 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 if they pose safety concern to humans, animals or the environment are not considered suitable for QPS status and must undergo a full safety assessment.

Once EFSA grants a microorganism a QPS status, it is included in the “QPS list”, which is available on the EFSA website.

EFSA’s Panel on Biological Hazards will adopt a scientific opinion on the maintenance of the list of biological agents with QPS status in December 2019.

2016 EFSA’s Panel on Biological Hazards (BIOHAZ) adopts a scientific opinion on the maintenance of the list of Qualified Presumption of Safety biological agents with the “2016 updated list of QPS status recommended biological agents for safety risk assessments carried out by EFSA scientific Panels and Units” (2016 QSP list).

2014 As a follow-up of a recommendation of the EFSA’s Scientific Committee, the BIOHAZ Panel decides that from now on the overall assessment of the QPS list will be carried out every three years (see section EFSA role).

EFSA Scientific Committee recommends that the QPS approach (initially developed for the assessment of microorganisms added to the food and feed) is also applied to the assessment of botanicals or botanical preparations.

2013 BIOHAZ Panel adopts a scientific opinion on the update of the list of QPS-recommended biological agents intentionally added to food or feed as notified to EFSA.

2009, 2010, 2011, 2012 BIOHAZ Panel updates the list of biological agents intentionally added to food and feed for which a QPS status is recommended:

2008 EFSA’s Panel on Biological Hazards publishes the first review of the list of QPS microorganisms and updates the antimicrobial resistance criteria used to assess the safety microorganism used in food and feed.

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 a 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 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 establish a generic approach that would 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 a literature search every six months to ensure that the list is up to date. If new information is discovered that might change the QPS status of a microorganism, 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 updated list is published as an appendix to the 2016 scientific opinion and is also available on the Knowledge Junction. The six-monthly Panel statements include:

  • New information that might change the QPS status of a microorganism that is already on the list or its qualifications.
  • The evaluation of microbiological agents notified to EFSA to be assessed for their use in food or feed additives, food enzymes, flavourings, novel foods or pesticides.
  • Recommendations for the attribution of new QPS status.