The maintenance of the list of QPS microorganisms intentionally added to food or feed Scientific Opinion of the Panel on Biological Hazards

Following a request from EFSA, the Panel on Biological Hazards was asked to review the list of Qualified Presumption of Safety (QPS) microorgansisms and to update the antimicrobial resistance criteria used to judge the safety of food/feed use microorganisms. The QPS approach was previously developed for use within EFSA, for carrying out risk assessments on microoorganisms deliberately introduced into the food chain either directly or as a source of additives or food enzymes. The taxonomic units already included in the QPS list were reviewed: Recent clinical studies or intervention studies indicated no new safety problems with Lactobacillus rhamnosus. Human infection by L. rhamnosus is possible but remains rare and mainly affects immunocompromised patients or those with serious underlying disease. Therefore it is recommended that L. rhamnosus remains in the QPS list, but should remain a topic for surveillance. "Lactobacillus zeae" is removed from the QPS list as it is now included in the species L. casei which is already in the QPS list. Lactobacillus coryneformis is added to the list of QPS microorganisms. Bacillus spp. other than Bacillus cereus are a rare cause of foodborne intoxication, due to the production of toxins by some strains. The QPS status for the Bacillus species listed in the previous EFSA QPS opinion is maintained, with the qualification "absence of food poisoning toxins, absence of surfactant activity, absence of enterotoxic activity". However, the possibility that new virulence factors, not detected by the qualification proposed, could be discovered should be kept under attention. Bacillus spp. also cause rare local or systemic infections which too should remain a topic for surveillance. Rare opportunistic infections have been caused by Saccharomyces cerevisiae and Kluyveromyces marxianus, both QPS yeast. No information since the previous EFSA QPS opinion indicate a need to change their QPS status. The QPS status is maintained for the yeast listed in the previous QPS opinion. The history of use of Pichia species included in the QPS list concerns mainly use in enzyme production. A qualification is added to the QPS status to this effect. Enterococcus spp. are a major cause of various kinds of infections, and were not included in the previous QPS list. The inclusion, with some qualifications, of enterococci in the QPS list, in the light of new information, was assessed. Many virulence factors have been identified, but it is still not possible to differentiate between virulent and avirulent strains. No taxonomical unit within the Enterococcus genus can be considered as being free from infectious strains. Therefore Enterococcus spp. are not added to the QPS list. The possible addition to the QPS list of new species or new taxonomic groups, among notifications received by EFSA, was assessed. Some of the new taxonomic groups proposed or notified to EFSA were out of the current scope of EFSA, most notably those for which only a direct food use exists today such as starter cultures. Others did not have the necessary body of knowledge in relation to their safety when introduced in the food chain, or were known producers of secondary metabolites and antibiotics. None of the new taxonomic groups proposed or notified to EFSA are proposed for QPS status. The possibility to use the QPS concept for the assessment of microorganisms used as plant protection products was evaluated. The QPS concept could simplify and improve the assessment of consumer safety for microorganisms used as plant protection products. However, it will not cover all the safety aspect of plant protection products and it will presumably concern only a minority of the plant protection agents (i.e. Bacillus spp and some yeasts). The guidelines updated by the FEEDAP Panel in 2008 elaborated to eliminate the possibility that micro-organisms introduced in the food chain could carry transmissible resistances to antimicrobials, applies to all the QPS granted bacterial species and could be used as the basis for a qualification. However, no such guide lines exist concerning yeast resistance to antimycotics.