Scientific Opinion on the maintenance of the list of QPS biological agents intentionally added to food and feed (2010 update)


EFSA Journal 2010;8(12):1944 [56 pp.].
EFSA Panel on Biological Hazards (BIOHAZ)
Panel Members
John Daniel Collins, Birgit Noerrung, Herbert Budka, Olivier Andreoletti, Sava Buncic, John Griffin, Tine Hald, Arie Havelaar, James Hope, Günter Klein, James McLauchlin, Christine Müller-Graf, Christophe Nguyen-The, Luisa Peixe, Miguel Prieto Maradona, Antonia Ricci, John Sofos, John Threlfall, Ivar Vågsholm and Emmanuel Vanopdenbosch

The Panel wishes to thank the members of the Working Group on the maintenance of the list of QPS biological agents intentionally added to food or feed (2010 update): Pier Sandro Cocconcelli, Florence Richard Forget, Günter Klein, Tine Licht, Peixe Luisa, Christophe Nguyen-The, Amparo Querol, Juan Evaristo Suarez, Ulf Thrane, Just M. Vlak and Atte von Wright for the preparatory work on this scientific opinion and EFSA staff: Renata Leuschner for the support provided to this scientific opinion.

Opinion of the Scientific Committee/Scientific Panel
On Request From
Question Number
9 December 2010
14 December 2010
European Food Safety Authority (EFSA), Parma, Italy
Article (382.97 KB)382.97 KB

EFSA is requested to assess the safety of a broad range of biological agents (including microorganisms and viruses) 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) concept was developed by EFSA for its own use to provide a generic risk assessment approach applicable across EFSA’s scientific Panels, for biological agents notified for intentional use in the whole food chain. The safety of unambiguously defined biological agents at the highest taxonomic unit that is appropriate for the purpose for which an application is intended are assessed, considering if the body of knowledge is sufficient. Identified safety concerns for a taxonomic unit could be reflected as ‘qualifications’ when considered appropriate for an inclusion on the QPS list. The list of QPS recommended biological agents is reviewed and updated annually. The 2010 update reviews the previously assessed microorganisms including bacteria, yeasts, filamentous fungi and viruses used for plant protection purposes. The recommendations of biological agents of the previous year were confirmed in the current update. Qualifications relating to the agents recommended for QPS were reviewed, clarified and updated where necessary. Specific sections dealing with antibiotic resistance relevant for QPS recommended microorganisms and yeast were included. The methodology used for carrying out the annual review of the list of QPS recommended biological agents was detailed. A list of microbial species from previous notifications and as notified to EFSA, annexed in this opinion, includes information on taxonomic units which are or are not recommended for the QPS list. This list of notifications aims to summarize and maintain important information for future assessments and updates.


The European Food Safety Authority (EFSA) asked the Panel on Biological Hazards (BIOHAZ) to deliver a Scientific Opinion on the maintenance of the list of QPS biological agents (microorganisms and viruses) intentionally added to food or feed (2010 update).

The Opinion reviews the previous assessments of biological agents in the context of a proposal for a qualified presumption of safety (QPS). The previous list of QPS biological agents that was published in 2009 was reviewed and confirmed. Qualifications of QPS recommended agents were reviewed and updated. Antibiotic resistance with regards to QPS recommended microorganisms were included in the current review and update.

The list of biological agents (microorganism and viruses) notified to EFSA remained the same as in the 2009 QPS Opinion. Since the previous Opinion, important information for each taxonomic unit was included in the notification table.

Following the annual review, there was no modification to the list of QPS recommended biological agents while changes were introduced with regards to the qualifications. A generic qualification concerning antimicrobial susceptibility was included for bacteria and yeasts. The qualification concerning Bacillus species was simplified and the qualification concerning production purposes for Corynebacterium species and the yeast species was clarified with regard to amino acid and enzyme production, respectively.

Isolation of lactobacilli and bifidobacteria in clinical cases remains a rare event, but maybe also underreported due to isolation difficulties. Especially for bifidobacteria the isolation difficulties are of importance. Within the Lactobacillus group, L. rhamnosus proved to be the most important species related to clinical cases. However, considering the circumstances and number of reports at the moment no update to the QPS recommendation for lactobacilli or bifidobacteria is necessary. Similarly, one clinical case caused by a Bacillus species was reported but due to the rarity of these infections and of the existence of important predisposing factors in the host, no modification of the QPS list for Gram-positive spore forming bacteria is necessary.

Resistance to therapeutic antimicrobials, some potentially transmissible, has been reported among microbial species recommended for the QPS list. These resistant isolates would have been detected by the qualification on antimicrobial resistance.

Saccharomyces cerevisiae and Kluyveromyces species have been isolated from infections but there are no indications that food isolates contributed to these. More information on the characteristics of the isolates involved in clinical aspects would be needed. In addition, these infections remained very rare compared to Candida albicans and no change in the QPS list is necessary.

Some microbial species not included on the QPS list have been notified only once to EFSA, and will no longer be assessed in the future maintenance of the list, until a new notification. This is indicated in the updated list of microbial species notified to EFSA. Some microbial species not included on the QPS list will no longer be assessed in the future maintenance of the list because increasing evidence of pathogenicity precludes any future inclusion in the QPS list. This is indicated in the updated list of microbial species notified to EFSA. Filamentous fungi and enterococci are not on the QPS list. However their regular assessment permits a yearly update of the body of knowledge on the numerous fungal and enterococcal strains notified to EFSA.

The QPS list has permitted a simplification and a harmonisation of the assessment for micro-organisms notified to the Panels and Unit of EFSA. However, many microbial species notified to EFSA are not on the QPS list and their safety may not be assessed as consistently as for QPS species.

Qualified presumption of safety, QPS, microorganisms, viruses
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