Update of the list of QPS‐recommended biological agents intentionally added to food or feed as notified to EFSA 6: suitability of taxonomic units notified to EFSA until March 2017
2017; Wiley; Volume: 15; Issue: 7 Linguagem: Inglês
10.2903/j.efsa.2017.4884
ISSN1831-4732
AutoresAntonia Ricci, Ana Allende, Declan Bolton, Marianne Chemaly, Robert Davies, Rosina Gironés, Kostas Koutsoumanis, Roland Lindqvist, Birgit Nørrung, Lucy J. Robertson, Giuseppe Ru, Pablo Salvador Fernández Escámez, Moez Sanaa, Marion Simmons, Panagiotis Skandamis, Emma Snary, Niko Speybroeck, Benno Ter Kuile, John Threlfall, Helene Wahlström, Pier Sandro Cocconcelli, Luísa Peixe, Miguel Prieto Maradona, Amparo Querol, Juan Evaristo Suárez, Ingvar Sundh, Just M. Vlak, Sandra Correia, Lieve Herman,
Tópico(s)Pesticide Residue Analysis and Safety
ResumoEFSA JournalVolume 15, Issue 7 e04884 StatementOpen Access Update of the list of QPS-recommended biological agents intentionally added to food or feed as notified to EFSA 6: suitability of taxonomic units notified to EFSA until March 2017 EFSA Panel on Biological Hazards (BIOHAZ), EFSA Panel on Biological Hazards (BIOHAZ)Search for more papers by this authorAntonia Ricci, Antonia RicciSearch for more papers by this authorAna Allende, Ana AllendeSearch for more papers by this authorDeclan Bolton, Declan BoltonSearch for more papers by this authorMarianne Chemaly, Marianne ChemalySearch for more papers by this authorRobert Davies, Robert DaviesSearch for more papers by this authorRosina Girones, Rosina GironesSearch for more papers by this authorKostas Koutsoumanis, Kostas KoutsoumanisSearch for more papers by this authorRoland Lindqvist, Roland LindqvistSearch for more papers by this authorBirgit Nørrung, Birgit NørrungSearch for more papers by this authorLucy Robertson, Lucy RobertsonSearch for more papers by this authorGiuseppe Ru, Giuseppe RuSearch for more papers by this authorPablo Salvador Fernandez Escamez, Pablo Salvador Fernandez EscamezSearch for more papers by this authorMoez Sanaa, Moez SanaaSearch for more papers by this authorMarion Simmons, Marion SimmonsSearch for more papers by this authorPanagiotis Skandamis, Panagiotis SkandamisSearch for more papers by this authorEmma Snary, Emma SnarySearch for more papers by this authorNiko Speybroeck, Niko SpeybroeckSearch for more papers by this authorBenno Ter Kuile, Benno Ter KuileSearch for more papers by this authorJohn Threlfall, John ThrelfallSearch for more papers by this authorHelene Wahlström, Helene WahlströmSearch for more papers by this authorPier Sandro Cocconcelli, Pier Sandro CocconcelliSearch for more papers by this authorLuisa Peixe, Luisa PeixeSearch for more papers by this authorMiguel Prieto Maradona, Miguel Prieto MaradonaSearch for more papers by this authorAmparo Querol, Amparo QuerolSearch for more papers by this authorJuan Evaristo Suarez, Juan Evaristo SuarezSearch for more papers by this authorIngvar Sundh, Ingvar SundhSearch for more papers by this authorJust Vlak, Just VlakSearch for more papers by this authorSandra Correia, Sandra CorreiaSearch for more papers by this authorLieve Herman, Lieve HermanSearch for more papers by this author EFSA Panel on Biological Hazards (BIOHAZ), EFSA Panel on Biological Hazards (BIOHAZ)Search for more papers by this authorAntonia Ricci, Antonia RicciSearch for more papers by this authorAna Allende, Ana AllendeSearch for more papers by this authorDeclan Bolton, Declan BoltonSearch for more papers by this authorMarianne Chemaly, Marianne ChemalySearch for more papers by this authorRobert Davies, Robert DaviesSearch for more papers by this authorRosina Girones, Rosina GironesSearch for more papers by this authorKostas Koutsoumanis, Kostas KoutsoumanisSearch for more papers by this authorRoland Lindqvist, Roland LindqvistSearch for more papers by this authorBirgit Nørrung, Birgit NørrungSearch for more papers by this authorLucy Robertson, Lucy RobertsonSearch for more papers by this authorGiuseppe Ru, Giuseppe RuSearch for more papers by this authorPablo Salvador Fernandez Escamez, Pablo Salvador Fernandez EscamezSearch for more papers by this authorMoez Sanaa, Moez SanaaSearch for more papers by this authorMarion Simmons, Marion SimmonsSearch for more papers by this authorPanagiotis Skandamis, Panagiotis SkandamisSearch for more papers by this authorEmma Snary, Emma SnarySearch for more papers by this authorNiko Speybroeck, Niko SpeybroeckSearch for more papers by this authorBenno Ter Kuile, Benno Ter KuileSearch for more papers by this authorJohn Threlfall, John ThrelfallSearch for more papers by this authorHelene Wahlström, Helene WahlströmSearch for more papers by this authorPier Sandro Cocconcelli, Pier Sandro CocconcelliSearch for more papers by this authorLuisa Peixe, Luisa PeixeSearch for more papers by this authorMiguel Prieto Maradona, Miguel Prieto MaradonaSearch for more papers by this authorAmparo Querol, Amparo QuerolSearch for more papers by this authorJuan Evaristo Suarez, Juan Evaristo SuarezSearch for more papers by this authorIngvar Sundh, Ingvar SundhSearch for more papers by this authorJust Vlak, Just VlakSearch for more papers by this authorSandra Correia, Sandra CorreiaSearch for more papers by this authorLieve Herman, Lieve HermanSearch for more papers by this author First published: 25 July 2017 https://doi.org/10.2903/j.efsa.2017.4884Citations: 22 Correspondence: biohaz@efsa.europa.eu Requestor: EFSA Question number: EFSA-Q-2016-00827 Panel members: 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 Threlfal, and Helene Wahlström. Amendment: An editorial correction was carried out that does not materially affect the contents or outcome of this scientific output. In Appendix B the text has been revised so as to clarify that the 2016 updated list of QPS status recommended biological agents in support of EFSA risk assessment will be published in the 2016 Scientific Opinion of the BIOHAZ Panel and on the Knowledge Junction at: https://doi.org//10.5281/zenodo.1146566. 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. Adopted: 7 June 2017 Amended: 24 January 2018 AboutSectionsPDF ToolsExport citationAdd to favoritesTrack citation ShareShare Give accessShare full text accessShare full-text accessPlease review our Terms and Conditions of Use and check box below to share full-text version of article.I have read and accept the Wiley Online Library Terms and Conditions of UseShareable LinkUse the link below to share a full-text version of this article with your friends and colleagues. Learn more.Copy URL Share a linkShare onFacebookTwitterLinkedInRedditWechat Abstract The qualified presumption of safety (QPS) concept was developed to provide a harmonised generic pre-evaluation to support safety risk assessments of biological agents performed by EFSA's scientific Panels. The identity, body of knowledge, safety concerns and antimicrobial resistance of valid taxonomic units were assessed. Safety concerns identified for a taxonomic unit are, where possible and reasonable in number, reflected as 'qualifications' which should be assessed at the strain level by the EFSA's scientific Panels. No new information was found that would change the previously recommended QPS taxonomic units and their qualifications. Between the end of September 2016 and March 2017, the QPS notification list was updated with 87 applications for market authorisation. From these, 32 biological agents already had a QPS status, and 37 were not included in the evaluation as they are filamentous fungi or enterococci. Streptomyces species (Streptomyces cinnamonensis, Streptomyces mobaraensis and Streptomyces violaceoruber), Bacillus circulans (three notifications) and Escherichia coli (seven notifications) were re-confirmed not suitable for QPS. Streptomyces rubiginosus and Streptomyces netropsis, not evaluated within the previous mandate, were also not recommended for QPS. Streptomyces spp. and E. coli will be excluded from further QPS evaluations within the current QPS mandate. Hyphomicrobium denitrificans, which has never been evaluated before, was not recommended for the QPS list and for Pseudomonas amyloderamosa, the QPS assessment was not applicable because it is not a validated species. Lactobacillus animalis was a new taxonomic unit recommended to have the QPS status. Summary 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 qualified presumption of safety (QPS) biological agents intentionally added to food or feed. The request included three specific tasks as mentioned in the Terms of Reference (ToR). The QPS was developed to provide a harmonised generic pre-evaluation to support safety risk assessments of biological agents performed by EFSA's scientific Panels. The taxonomic identity, body of knowledge, safety and antimicrobial resistance of biological agents are assessed. Safety concerns identified for a taxonomic unit are, where possible and reasonable in number, reflected as 'qualifications' which should be assessed at the strain level by the EFSA's scientific Panels. A generic qualification for all QPS bacterial taxonomic units applies in relation to the absence of acquired genes conferring resistance to clinically relevant antimicrobials and therefore this needs to be checked at strain level. The evaluation is undertaken every 3 years in a scientific Opinion of the BIOHAZ Panel. Meanwhile, the list of microorganisms is maintained and around every 6 months re-evaluated in a Panel Statement. If new information would be retrieved from extended literature search or expert knowledge that would change the QPS status of a microbial species or its qualifications, this would be published in the Panel Statement. The Panel Statement also includes the evaluation of microbiological agents notified to EFSA within the 6-month period for an assessment for feed additives, food enzymes, food additives and flavourings, novel foods or plant protection products. The main results of these assessments done from 2017 will be included in the scientific Opinion of the BIOHAZ Panel to be published by the end of the current mandate in December 2019. Appended to each Panel Statement, the '2016 updated list of QPS status recommended biological agents for safety risk assessments carried out by EFSA scientific Panels and Units' is updated with the inclusion of new recommendations for QPS status (Appendix B). The first ToR requires ongoing updates of the list of biological agents notified to EFSA, in the context of a technical dossier, for intentional use in food and/or feed or as sources of food and feed additives, enzymes and plant protection products for safety assessment. The list was updated with the notifications received since the latest review in September of 2016. The new notifications received since then and March 2017, were included in a table appended to the current Statement (Appendix C). Within this period, 87 notifications were received by EFSA, of which 35 were from feed additives, 49 from food enzymes, food additives and flavourings, one from novel foods, and two from plant protection products. The second ToR concerns the revision of the taxonomic units previously recommended for the QPS list and their qualifications when new information has become available and to update the information provided in the previous Opinion adopted in December 2016. Although the main work for replying to this ToR will be published in an Opinion in December of 2019, according to experts' knowledge, no new information that would affect those QPS taxonomic units and their qualifications was found. The third ToR requires a (re)assessment of the suitability of taxonomic units notified to EFSA not present in the current QPS list for their inclusion in the updated list. The current Statement focuses on the assessments of the taxonomic units that were notified to EFSA between the end of September 2016 and March 2017. Of the 87 notifications received, 32 biological agents already had the QPS status and did not require further evaluation in this Statement. From the remaining 55 (without a QPS status), 37 were not further assessed as they are filamentous fungi or enterococci, which have been excluded from QPS. Eleven notifications related to seven taxonomic units dealing with food enzymes, food additives and flavourings, six related to three taxonomic units dealing with feed additives and one dealing with a novel food were evaluated for the QPS status. Three Streptomyces species (Streptomyces cinnamonensis, Streptomyces mobaraensis and Streptomyces violaceoruber), Bacillus circulans (three notifications) and Escherichia coli (seven notifications) were previously considered not suitable for QPS status and now re-confirmed. Two Streptomyces species not evaluated previously (Streptomyces rubiginosus and Streptomyces violaceoruber) were also not recommended for a QPS status. It was agreed that Streptomyces spp. and E. coli will be excluded from further QPS status evaluations within the current mandate. Hyphomicrobium denitrificans which has never been evaluated before is not recommended for the QPS list, and Pseudomonas amyloderamosa, for which does not exist a validated taxonomic unit name, the QPS assessment is not applicable. Lactobacillus animalis is a new taxonomic unit recommended to have a QPS status. 1 Introduction A wide variety of microorganisms is intentionally added at different stages into the food chain, either directly or as a source of food and feed additives, enzymes or plant protection products. In the context of applications for market authorisation of these biological agents, EFSA is requested by the European Commission, National Competent Authorities or Applicants to assess their safety. The qualified presumption of safety (QPS) approach was developed by the EFSA Scientific Committee to provide a generic concept to prioritise and to harmonise risk assessment within EFSA of microorganisms intentionally introduced into the food chain, in support of the respective Scientific Panels and Units in the frame of authorisations (EFSA, 2007). The list, first established in 2007, has continuously been revised and updated. The publication of the overall assessment of the taxonomic units previously recommended for the QPS list is carried out every 3 years through a scientific Opinion by the Panel on Biological Hazards (BIOHAZ). The recommendations provided concerning that list of microorganisms will be maintained and every 6 months re-evaluated based on extensive literature reviews and experts knowledge. Intermediate deliverables in the form of a Panel Statement will be produced and published, should an assessment for a QPS classification of a microbiological agent notified to EFSA be requested by the Units dealing with feed additives, food enzymes, food additives and flavourings, novel foods, and plant protection products. Evaluations of these notifications will be compiled in single Panel Statements for periods of around 6 months. The main results of these assessments will also be included in the scientific opinion to be published in December of 2019. 1.1 Background and Terms of Reference as provided by EFSA 1.1.1 Background as provided by EFSA A wide variety of microorganisms are intentionally added at different stages into the food and feed chain. In the context of applications for market authorisation of these biological agents used either directly or as sources of food and feed additives, food enzymes and plant protection products, EFSA is requested to assess their safety. Several taxonomic units (usually species for bacteria and yeasts, families for viruses) have been included in the qualified presumption of safety (QPS) list either following notifications to EFSA or proposals made initially by stakeholders during a public consultation in 2005, even if they were not yet notified to EFSA (2005).1 The EFSA Scientific Committee reviewed the range and numbers of microorganisms likely to be the subject of an EFSA Opinion and in (2007) published a list of microorganisms recommended for the QPS list.2 In 2007, the Scientific Committee recommended that a QPS approach should provide a generic concept to prioritise and to harmonise safety risk assessment of microorganisms intentionally introduced into the food chain, in support of the respective Scientific Panels and EFSA Units in the frame of the market authorisations. The same Committee recognised that there would have to be continuing provision for reviewing and modifying the QPS list and in line with this recommendation, the BIOHAZ Panel took the prime responsibility for this and started reviewing annually the existing QPS list. In 2008, the first annual QPS update3 was published and EFSA's initial experience in applying the QPS approach included. The potential application of the QPS approach to microbial plant protection products was discussed in the 2009 update.4 Also in 2009, bacteriophages were assessed and were not considered appropriate for the QPS list. After consecutive years of reviewing the existing scientific information, the filamentous fungi (2008–2013 update) and enterococci (2010–2013 update) were not recommended for the QPS list. The 2013 update5 of the recommended QPS list included 53 species of Gram-positive non-spore-forming bacteria, 13 Gram-positive spore forming bacteria (Bacillus species), one Gram-negative bacterium, 13 yeast species and three virus families. In 2014, the BIOHAZ Panel, in consultation with the Scientific Committee, decided to change the revision procedure: the overall assessment of the taxonomic units previously recommended for the QPS list (EFSA BIOHAZ Panel, 2013)5 was no longer carried out annually but over the last 3-year period and it was adopted in a scientific Opinion of the BIOHAZ Panel in December of 2016 (EFSA BIOHAZ Panel (2017a,b). The QPS list of microorganisms has been maintained and frequently checked based on the evaluation of extensive literature searches. In the meantime and every 6 months, a Panel Statement, compiling the assessments for a QPS status of the microbiological agents notified to EFSA requested by the Feed Unit, the Food Ingredients and Packaging (FIP) Unit, the Nutrition Unit or by the Pesticides Unit, has been produced and published. In the follow up of the 2013 update,5 the Scientific Committee agreed to exclude some biological groups (filamentous fungi, bacteriophages and enterococci) notified to EFSA from the QPS assessment because it was considered unlikely that any taxonomical units within these groups would be granted QPS status in the foreseeable future. Thus, the assessment of members of these biological groups needs to be done at a strain level, on a case-by-case basis, by the relevant EFSA Unit. The QPS provides a generic safety pre-assessment approach for use within EFSA that covers risks for human, animals and the environment. In the QPS concept, a safety assessment of a defined taxonomic unit is considered independently of any particular specific notification in the course of an authorisation process. The QPS concept does not address hazards linked to the formulation or other processing of the products containing the microbial agents and added into the food or feed chain. Although general human safety is part of the evaluation, specific issues connected to type and level of exposure of users handling the product (e.g. dermal, inhalation, ingestion) are not addressed. Genetically modified microorganisms are similarly not taken into account. Assessment of potential allergenicity to microbial residual components is beyond the QPS remit; however, if there is science-based evidence for some microbial species it is reported. These aspects are assessed, where applicable, separately by the EFSA Panel responsible for assessing the notification. Antimicrobial resistance was introduced as a possible safety concern for the assessment of the inclusion of bacterial species in the QPS list published in 2008 QPS Opinion (EFSA, 2008).3 In the 2009 QPS Opinion (EFSA BIOHAZ Panel, 2009)4, a qualification regarding the absence of antimycotic resistance for yeasts was introduced. 1.1.2 Terms of Reference as provided by EFSA ToR 1: Keep updated the list of biological agents being notified in the context of a technical dossier to EFSA Units such as Feed, Pesticides, Food Ingredients and Packaging (FIP) and Nutrition, for intentional use directly or as sources of food and feed additives, food enzymes and plant protection product for safety assessment. ToR 2: Review taxonomic units previously recommended for the QPS list and their qualifications when new information has become available. The latter is based on a review of the updated literature aiming at verifying if any new safety concern has arisen that could require the removal of the taxonomic unit from the list, and to verify if the qualifications still efficiently exclude safety concerns. ToR 3: (Re)assess the suitability of new taxonomic units notified to EFSA for their inclusion in the QPS list. These microbiological agents are notified to EFSA and requested by the Feed Unit, the FIP Unit, the Nutrition Unit or by the Pesticides Unit. 2 Data and methodologies 2.1 Data Only valid taxonomic units (TUs) covered by the relevant international committees on the nomenclature for microorganisms are considered for the QPS assessment. For the TUs associated with the notifications compiled within the time period covered by this Statement (from end of September 2016 until March 2017), the literature review considered the identification, the body of knowledge, history of use, the antimicrobial resistance and the potential safety concerns. Relevant databases such as PubMed, Web of Science, CasesDatabase, CAB Abstracts or Food Science Technology Abstracts (FSTA) and Scopus were searched. More details on the search strategy, search keys and approach are described in Appendix A. 2.2 Methodologies In response to ToR1, the EFSA Units have been asked to update the list of biological agents being notified to EFSA. Eighty-seven (87) notifications were received between the end of September 2016 and the beginning of March 2017, of which 35 were from a feed additive, 49 from food enzymes, one from a novel food and two from plant protection products (Table 1). In response to ToR3, out of 87 notifications, 32 biological agents already had the QPS status and did not require further evaluation; neither did the 37 filamentous fungi or enterococci, which have been excluded from QPS activities in the follow up of a recommendation of the QPS 2013 update (EFSA BIOHAZ Panel, 2013, 2014). A total of eighteen notifications were considered in the current Statement. Three notifications for Streptomyces species (Streptomyces cinnamonensis, Streptomyces mobaraensis and Streptomyces violaceoruber), three for Bacillus circulans and seven for Escherichia coli were evaluated for QPS status during the last QPS mandate and were considered not suitable for QPS status but were re-evaluated within the current mandate. Five notifications related to five taxonomic units were evaluated for QPS status for the first time: Streptomyces rubiginosus, Streptomyces netropsis, Hyphomicrobium denitrificans, Lactobacillus animalis and Pseudomonas amyloderamosa. They were notified for an assessment by the food enzymes/food additives/flavourings area (B. circulans, E. coli, P. amyloderamosa, S. mobaraensis, S. netropsis, S. rubiginosus, S. violaceoruber), by the feed additives area (E. coli, L. animalis, S. cinnamonensis) and by the novel foods area (H. denitrificans). Table 1. Notifications received by EFSA, per risk assessment area, by biological group from September 2016 until March 2017 Risk assessment area Not evaluated in this Statement Evaluated in this Statement Total Biological group Already QPS Excluded in QPSa Feed additives 22 7 6 35 Bacteria 19 1 6 26 Filamentous fungi 6 6 Yeasts 3 3 Novel foods 1 1 Bacteria 1 1 Plant protection products 2 2 Filamentous fungi 2 2 Food enzymes, food additives and flavourings 10 28 11 49 Bacteria 10 11 21 Filamentous fungi 28 28 Total 32 37 18 87 a The number includes filamentous fungi and enterococci excluded from QPS evaluation in the 2013 QPS Opinion. 3 Taxonomic Units evaluated during the previous QPS mandate and re-evaluated in the current Statement 3.1 Bacillus circulans 3.1.1 Identity Bacillus circulans is a valid species name (Skerman et al., 1980), belonging to the genus Bacillus. It is a facultative anaerobe, motile, Gram-positive, endospore forming, rod-shaped bacterium. Spores are ellipsoidal and produced in swelling sporangia. B. circulans is phylogenetically closely related to Bacillus firmus (Logan and De Vos, 2009). Nakamura and Swezey (1983) noted that B. circulans species contained many misclassified strains. This was confirmed by Guinebretière et al. (2001) and Berge et al. (2002) who showed that many strains identified as B. circulans using phenotypic features actually belonged to Paenibacillus spp. The body of knowledge on B. circulans and related safety concerns should be considered cautiously, their reliability strongly depending on the methods used for strain identification. 3.1.2 Body of knowledge A search for the body of knowledge on B. circulans was done in the Web of Science Core collection, using a range of search terms in relation to food and feed, combined with 'Bacillus circulans' (search strings in Appendix A). One hundred and six references were screened. Most publications concerned synthesis of enzymes for production or modification of polysaccharides that could be used in foods (e.g. Li et al., 2014). Some publications reported the use of B. circulans strains as a probiotic in fish (Ghosh et al., 2003; Bandyopadhyay and Mohapatra, 2009; Geraylou et al., 2013; Naseri et al., 2013). Another set of publications report the presence of B. circulans in fermented foods, beverages and condiments, typically from tropical countries (Sarkar et al., 2002; Coulin et al., 2006; Almeida et al., 2007; Agbobatinkpo et al., 2013; Chakrabarty et al., 2014). B. circulans was also identified in pasteurised milk, raw milk and fermented sausages (Dommett, 1992; Encinas et al., 1996; Matta and Punj, 1999; Mayr et al., 1999; Coorevits et al., 2008). Some of these studies used only phenotypic identification methods and the strains may have been misidentified. In particular, the cold tolerant B. circulans may rather be Paenibacillus spp., as Guinebretière et al. (2001) found that among food isolates, B. circulans were mesophilic whereas the Paenibacillus erroneously identified as B. circulans by phenotypic systems were cold-tolerant. B. circulans has been described to produce the antimicrobial butirosin, a 2-deoxystreptamine aminoglycoside (Kudo et al., 2005). 3.1.3 Safety concerns A search for safety concerns was done in the Web of Science Core collection, using a range of search terms in relation to toxins and diseases (search strings in Appendix A), combined with 'Bacillus circulans'. Eighteen articles were found, and they demonstrated that B. circulans has been isolated from several cases of human infection. Examples were fatal sepsis, endophthalmitis, endocarditis, interphalangeal joint infection, cholecystitis, and wound infections, with some but not all in immunocompromised individuals (Gatermann et al., 1991; Goudswaard et al., 1995; Khatib et al., 1995; Krause et al., 1999; Tandon et al., 2001). None of these cases was linked to food consumption. B. circulans was also reported to produce lipopeptides (Das et al., 2008) and butirosin, an aminoglycoside antimicrobial (Howells et al., 1972; Kudo et al., 2005). In other Bacillus species, some lipopeptides are suspected to be the cause of food-borne poisoning (EFSA FEEDAP Panel, 2014). B. circulans has been reported to produce the same enterotoxins as Bacillus cereus (Phelps and McKillip, 2002; Manzano et al., 2010). B. circulans has also been considered as a plant pathogen causing diseases on date palm seedlings (Leary and Chun, 1989). The uncertainties on the identity of strains identified as B. circulans mentioned in the 'body of knowledge' also apply to the safety concerns. 3.1.4 Antimicrobial resistance The aminoglycoside phosphotransferase gene was described in butirosin-producing B. circulans strains (Dowding and Davies, 1975; Herberts et al., 1986), indicating the possibility of antimicrobial-producing strains to act as a source of certain resistance determinants (Herberts et al., 1986; Trieucuot and Courvalin, 1986). Moreover, the acquisition of a vanA gene cluster conferring resistance to glycopeptides was reported on a clinical isolate identified as B. circulans by conventional biochemical methods (Ligozzi et al., 1998). 3.1.5 Conclusions on a recommendation for the QPS list As with many other Bacillus species, B. circulans is a rare cause of opportunistic human infections, although presumably not linked to the food chain. It also seems to have the potential of infecting wounds in human tissues. Its presence in foods has been shown in a few studies, with some uncertainties due to the identification methods used. B. circulans has been widely studied as a producer of enzyme with potential application as food additives, but there are no reports of its particular usage in human food or animal feed that could indicate an absence of safety concerns. B. circulans was also reported to produce butirosin, an aminoglycoside antimicrobial. Some evidence support the possibility that B. circulans strains can act as a source of an aminoglycoside phosphotransferase for other bacteria. B. circulans is not recommended for the QPS list due to the possible production of metabolites with antimicrobial activity and uncertainty on virulence features. 3.2 Escherichia coli 3.2.1 Identity Escherichia coli are Gram-negative, facultative anaerobic bacteria, belonging to the family Enterobacteriaceae, which are taxonomically placed within the gamma subdivision of
Referência(s)