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.