Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
. 2018 Jan 24;16(1):e05131.
doi: 10.2903/j.efsa.2018.5131. eCollection 2018 Jan.

Update of the list of QPS-recommended biological agents intentionally added to food or feed as notified to EFSA 7: suitability of taxonomic units notified to EFSA until September 2017

EFSA Panel on Biological Hazards (BIOHAZ); Antonia Ricci, Ana Allende, Declan Bolton, Marianne Chemaly, Robert Davies, Rosina Girones, Konstantinos Koutsoumanis, Roland Lindqvist, Birgit Nørrung, Lucy Robertson, Giuseppe Ru, Pablo Salvador Fernández Escámez, Moez Sanaa, Marion Simmons, Panagiotis Skandamis, Emma Snary, Niko Speybroeck, Benno Ter Kuile, John Threlfall, Helene Wahlström, Pier Sandro Cocconcelli, Luisa Peixe, Miguel Prieto Maradona, Amparo Querol, Juan Evaristo Suarez, Ingvar Sundh, Just Vlak, Fulvio Barizzone, Sandra Correia, Lieve Herman

Update of the list of QPS-recommended biological agents intentionally added to food or feed as notified to EFSA 7: suitability of taxonomic units notified to EFSA until September 2017

EFSA Panel on Biological Hazards (BIOHAZ) et al. EFSA J. .

Abstract

The qualified presumption of safety (QPS) concept was developed to provide a harmonised generic pre-evaluation to support safety risk assessments of biological agents performed by EFSA's scientific Panels. The identity, body of knowledge, safety concerns and antimicrobial resistance of valid taxonomic units were assessed. Safety concerns identified for a taxonomic unit are, where possible and reasonable in number, considered to be 'qualifications' which should be assessed at the strain level by the EFSA's scientific Panels. No new information was found that would change the previously recommended QPS taxonomic units and their qualifications. The BIOHAZ Panel confirms that 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. Between April and September 2017, the QPS notification list was updated with 46 applications for market authorisation. From these, 14 biological agents already had QPS status and 16 were not included as they are filamentous fungi or enterococci. One notification of Streptomyces K-61 (notified as former S. griseoviridis) and four of Escherichia coli were not considered for the assessment as they belong to taxonomic units that were excluded from further evaluations within the current QPS mandate. Eight notifications of Bacillus thuringiensis and one of an oomycete are pending the reception of the complete application. Two taxonomic units were evaluated: Kitasatospora paracochleata, which had not been evaluated before, and Komagataella phaffii, previously notified as Pichia pastoris included due to a change in the taxonomic identity. Kitasatospora paracochleata cannot be granted QPS status due to lack of information on its biology and to its possible production of toxic secondary metabolites. The species Komagataella phaffii can be recommended for the QPS list when used for enzyme production.

Keywords: Kitasatospora paracochleata; Komagataella phaffii; QPS; bacteria; safety; yeast.

PubMed Disclaimer

References

    1. Chessa R, Landolfo S, Ciani M, Budroni M, Zara S, Ustun M, Cakar ZP and Mannazzu I, 2017. Biotechnological exploitation of Tetrapisispora phaffii killer toxin: heterologous production in Komagataella phaffii (Pichia pastoris). Applied Microbiology and Biotechnology, 101, 2931–2942. 10.1007/s00253-016-8050-2 - DOI - PubMed
    1. EFSA (European Food Safety Authority), 2005. Opinion of the Scientific Committee on a request from EFSA related to a generic approach to the safety assessment by EFSA of microorganisms used in food/feed and the production of food/feed additives. EFSA Journal 2005;3(4):226, 12 pp., 10.2903/j.efsa.2005.226 - DOI
    1. EFSA (European Food Safety Authority), 2007. Introduction of a Qualified Presumption of Safety (QPS) approach for assessment of selected microorganisms referred to EFSA – Opinion of the Scientific Committee. EFSA Journal 2007;5(12):587, 16 pp., 10.2903/j.efsa.2007.587 - DOI
    1. EFSA (European Food Safety Authority), 2008. Scientific Opinion of the Panel on Biological Hazards on the maintenance of the list of QPS microorganisms intentionally added to food or feed. EFSA Journal 2008;6(12):923, 48 pp., 10.2903/j.efsa.2008.923 - DOI
    1. EFSA BIOHAZ Panel (EFSA Panel on Biological Hazards), 2009. Scientific Opinion on the maintenance of the list of QPS microorganisms intentionally added to food or feed (2009 update). EFSA Journal 2009;7(12):1431, 92 pp. 10.2903/j.efsa.2009.1431 - DOI

LinkOut - more resources