BIOHAZ statement on QPS: suitability of taxonomic units notified until March 2016


safety; QPS ;bacteria;yeast; Lactobacillus diolivorans ; Pediococcus parvulus ; Bacillusflexus ; Cellulosimicrobium cellulans ; Chryseobacterium proteolyticum ; Geobacillus caldoproteolyticus ; Anoxybacillus caldiproteolyticus ; Aeribacillus pallidus ; Geobacillus pallidus ; Klebsiella pneumoniae ; Paenibacillus macerans ; Protaminobacter rubrum ; Pullulanibacillus naganoensis ; Candida rugosa
First published in the EFSA Journal
18 July 2016
8 June 2016
Last Updated
6 June 2017. This version replaces the previous one/s.
12 September 2017. This version replaces the previous one/s.

The following parts of the statements have been corrected: Table 1 on p. 9 to correct FEED/FEEDAP values for Bacteria and Yeast as well as the Grand total, due to an erroneous classification of Pichia as bacterium instead of yeast; Appendix B on p. 26 has been corrected to include missing text under qualification of Yeasts for Saccharomyces cerevisiae and to exclude footnote (j) on Paenibacilus lentus. To avoid confusion, the older version has been removed from the EFSA Journal, but is available on request, as is a version showing all the changes made.


EFSA was requested to assess the safety of a broad range of biological agents in the context of notifications for market authorisation as sources of food and feed additives, enzymes and plant protection products. The qualified presumption of safety (QPS) assessment was developed to provide a harmonised generic preassessment to support safety risk assessments performed by EFSA's scientific Panels. The safety of unambiguously defined biological agents (at the highest taxonomic unit appropriate for the purpose for which an application is intended) and the completeness of the body of knowledge were assessed. Safety concerns identified for a taxonomic unit are, where possible and reasonable in number, reflected as ‘qualifications’ in connection with a recommendation for a QPS status. A total of 129 biological agents were notified to EFSA between September 2015 and March 2016. From these, 34 biological agents already had a QPS status and did not require further evaluation, and 63 were not included as they are filamentous fungi or enterococci, biological groups which have been excluded from the QPS activities since 2014. Five notifications for species belonging to Streptomyces genus, one forPaenibacillus lentus, four for Escherichia coli and one for one species of Actinomadura were not evaluated for QPS status because these species were recently assessed and considered not suitable for QPS status. Furthermore, it was agreed not to include nine notifications from Pesticides Unit as the respective dossiers (including the literature review) were not yet received. Therefore, there were 12 notifications related to 12 taxonomic units that were evaluated for QPS status. Pediococcus parvulus, Bacillus flexus and Lactobacillus diolivorans may be recommended for the QPS status. Candida rugosa, Cellulosimicrobium cellulans, Geobacillus caldoproteolyticus (Anoxybacilluscaldiproteolyticus), Aeribacillus pallidus (ex-Geobacillus pallidus),Chryseobacterium proteolyticum’,Klebsiella pneumoniae, Paenibacillus macerans,Protaminobacter rubrumand Pullulanibacillusnaganoensis are not recommended for the QPS list.

Panel members at the time of adoption
Ana Allende, Declan Bolton, Marianne Chemaly, Robert Davies, Pablo Salvador Fernandez Escamez, Rosina Girones, Lieve Herman, Konstantinos Koutsoumanis, Roland Lindqvist, Birgit Nørrung, Antonia Ricci, Lucy Robertson, Giuseppe Ru, Moez Sanaa, Marion Simmons, Panagiotis Skandamis, Emma Snary, Niko Speybroeck, Benno Ter Kuile, John Threlfall and Helene Wahlström
Panel on Biological Hazards
biohaz [at]
EFSA Journal 2016;14(7):4522 [37 pp.].
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