Scientific Opinion on the maintenance of the list of QPS biological agents intentionally added to food and feed (2011 update)

Abstract

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) assessment 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 and the completeness of the body of knowledge are assessed. Identified safety concerns for a taxonomic unit are where sensible reflected as ‘qualifications’ when a recommendation for the QPS list is given. The list of QPS recommended biological agents is reviewed and updated annually. Therefore, the only valid list is the one in the most recent scientific opinion. The 2011 update reviews microorganisms previously assessed including bacteria, yeasts, filamentous fungi and viruses used for plant protection purposes and confirms the previous recommendations. The anamorph yeast form Phaffia rhodozyma of Xanthophyllomyces dendrorhous was included on the QPS list and to the qualification for yeasts ‘absence of resistance to antimycotics used for medical treatment of yeast infections’, the sentence was added that ‘in the case of Saccharomyces cerevisiae this qualification applies for yeast strains able to grow above 37 °C’. The body of knowledge of filamentous fungi and enterococci was updated and their ineligibility for the QPS list confirmed.

Antibiotic resistance in probiotic bacteria

“…Bifidobacterium infections are extremely rare and have involved immunocompromised patients in a few cases (Ohishi et al, 2010; Barberis et al, 2012; Jenke et al, 2012), but, to the best of our knowledge, the five species of Bifidobacterium with QPS status ( B. adolescentis , B. animalis , B. bifidum , B. breve , and B. longum ; EFSA, 2012) have not been linked to any infective processes in healthy individuals. However, several strains displaying antibiotic resistance phenotypes have been characterized, and in many cases the phenotype has been linked to specific antibiotic resistance genes, representing a potential risk of transfer to other bacteria in the intestinal ecosystem (Ammor et al, 2008b).…”

“…Furthermore, several Bacillus species have been employed for centuries in the manufacture of traditional, fermented dishes in Africa and Asia (Sarkar et al, 2002). Nowadays, certain Bacillus strains are used as feed additives, plant production products, biomass for animal feed, or enzyme/vitamin production (SCAN, 2000; Hong et al, 2005), and several species are included on the EFSA QPS list (EFSA, 2012). Many characteristics of probiotic Bacillus strains differ from those of other probiotic bacteria, including its ability to sporulate and the mechanisms of interaction with the human intestinal mucosa (Sánchez et al, 2009).…”

“…Those probiotics belonging to species included in the EFSA QPS list (EFSA, 2012) have excellent safety records, and detrimental effects produced as a consequence of their ingestion are very scarce (Gouriet et al, 2012). Undoubtedly, a full safety assessment begins with a proper identification of the strain and an in vitro evaluation of the potential risks.…”

Risk Assessment of Lactobacillus salivarius W24 Used as "Other Substances"

“…The list of the microorganisms have been (and will be) regularly updated by EFSA (EFSA, 2007(EFSA, , 2008(EFSA, , 2009(EFSA, , 2010(EFSA, , 2011(EFSA, , 2012(EFSA, , 2013.…”

Scientific Opinion on the maintenance of the list of QPS biological agents intentionally added to food and feed (2013 update)

“…A literature review was carried out for each taxonomic unit that was notified to EFSA either for the QPS Opinions in 2007, 2009b, 2011a. QPS recommended taxonomic units (Table 1) and those which represent an important part of the notifications are annually reviewed.…”