The European Food Safety Authority (EFSA ) plays a crucial role in ensuring the safety of the food and feed supply chain. A key element in this process is the Qualified Presumption of Safety (QPS) list.
This list streamlines the safety assessment of microorganisms used in food and feed production. When compiling a safety dossier (whether for Food Enzymes, Feed Additives or Novel Food), a thorough understanding of the QPS list is essential for efficient product development and regulatory compliance. GenoScreen, with its expertise in microbial genomics applied to regulatory dossiers, supports companies in navigating the QPS process and ensuring the safety of their products.
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What is the purpose of the QPS list?
The QPS list serves as a tool to simplify and expedite the safety assessment of certain microorganisms (like bacteria, yeasts, and molds) that are intended for production of active ingredient or as ingredient in food and feed. Instead of evaluating the safety of each microorganism from scratch, those included on the QPS list are presumed to be safe based on a history of safe use and well-established safety profiles.
What are the criteria for inclusion on the QPS list?
Taxonomic Identity: The microorganism must be well-characterized and classified in a clear taxonomic group
Safety Concerns: The microorganism should have a history of safe use in food or feed, with no known harmful effects to humans, animals, or the environment
Absence of Pathogenicity: It should not have any pathogenic potential that could cause disease
The EFSA's Panel on Biological Hazards (BIOHAZ Panel) is responsible for the scientific assessment and updates of the QPS list. They proceed in parallel with the EFSA application assessment.
What are the benefits of the QPS list?
Simplification: Microorganisms on the QPS list do not require a full safety assessment, saving time and resources for both regulators and companies
Transparency & Consistency: The list provides clear criteria and is regularly updated, ensuring that safety assessments are consistent and based on the latest scientific knowledge
Can I apply for my strain to be included in the QPS list?
No,
The integration process of new species in the QPS list is an autonomous process, not submitted to application. The BIOHAZ panel decides alone whether a microorganism is to be added in the list. However, by proving the safety of your strain, you add proves that its species is safe, and it is possible that by adding proves, it one day permit thesaid specie to be included in the updates QPS list. So, you cannot apply for the inclusion of a strain, but you could indirectly contribute to its future addition in the list.
My strain species is in the list, is it sufficient to be considered as QPS?
No,
You first need to prove that your strain is from claimed species, you do so by running whole genome sequencing analysis and genome assembly. Once you have proofs that you strain is from species enlisted in the QPS list, then you have to answer to one or several qualifications. These qualifications are microorganism ‘specific. It can be for example to use the strain as a production strain only, to show that it harbours no acquired antimicrobial resistance (AMR) genes, that it has no toxigenic activity … One the needed qualifications are met, then your strain qualifies for the QPS status.
My strain is genetically modified but its species is in the QPS list, can It still be qualified for the QPS status?
Yes,
According to EFSA BIOHAZ Panel 2017, ‘the QPS approach can be extended to a genetically modified production strain if the recipient strain qualifies for the QPS status, and if the genetic modification does not indicate a concern.’.
Source: EFSA BIOHAZ Panel (EFSA Panel on Biological Hazards), Ricci A, Allende A,Bolton D, Chemaly M, Davies R, Girones R, Koutsoumanis K, Lindqvist R, Nørrung B, Robertson L, Ru G,Fernandez Escamez PS, Sanaa M, Simmons M, Skandamis P, Snary E, Speybroeck N, Ter Kuile B, Threlfall J,Wahlstr€om H, Cocconcelli PS, Peixe L, Maradona MP, Querol A, Suarez JE, Sundh I, Vlak J, Barizzone F,Correia S and Herman L, 2018. Statement on the update of the list of QPS-recommended biological agentsintentionally added to food or feed as notified to EFSA 7: suitability of taxonomic units notified to EFSAuntil September 2017. EFSA Journal 2018;16(1):5131, 43 pp
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