Update of the list of QPS‐recommended biological agents intentionally added to food or feed as notified to EFSA 4: suitability of taxonomic units notified to EFSA until March 2016
2016; Wiley; Volume: 14; Issue: 7 Linguagem: Inglês
10.2903/j.efsa.2016.4522
ISSN1831-4732
Tópico(s)Genetically Modified Organisms Research
ResumoEFSA JournalVolume 14, Issue 7 e04522 StatementOpen Access Update of the list of QPS-recommended biological agents intentionally added to food or feed as notified to EFSA 4: suitability of taxonomic units notified to EFSA until March 2016 EFSA Panel on Biological Hazards (BIOHAZ), EFSA Panel on Biological Hazards (BIOHAZ)Search for more papers by this author EFSA Panel on Biological Hazards (BIOHAZ), EFSA Panel on Biological Hazards (BIOHAZ)Search for more papers by this author First published: 18 July 2016 https://doi.org/10.2903/j.efsa.2016.4522Citations: 20 Correspondence: biohaz@efsa.europa.eu Requestor: EFSA Question number: EFSA-Q-2014-00697 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 Threlfall and Helene Wahlström Acknowledgements: The Panel wishes to thank the members of the Working Group on QPS: Pablo S. Fernandez Escamez, Lieve Herman, Miguel Prieto Maradona, Amparo Querol, Güenter Klein, Ingvar Sundh, Juan E. Suarez, Luisa Peixe, Pier Sandro Cocconcelli and Just Vlak for the preparatory work on this scientific output, and EFSA staff member Sandra Correia for the support provided to this scientific output. Amendment: In Table B.1, p. 26, the text on the qualification of the taxonomic unit Pasteuria nishizawae has been cancelled, following the decision taken by the BIOHAZ Panel at the meeting held on November-December 2016. This change does not materially affect the statement. The previous version of the statement has been removed from the website, but is available on request as is a version showing all the changes made. Adopted: 8 June 2016 Amended: 12 September 2017 Erratum: The following parts of the statements have been corrected: Table 1 on p. 9 to correct FEED/FEEDAP values for Bacteria and Yeast as well as the Grand total, due to an erroneous classification of Pichia as bacterium instead of yeast; Appendix B on p. 26 has been corrected to include missing text under qualification of Yeasts for Saccharomyces cerevisiae and to exclude footnote (j) on Paenibacilus lentus. 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. This publication is linked to the following EFSA Journal article: DOI: 10.2903/j.efsa.2013.3449 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 EFSA was requested to assess the safety of a broad range of biological agents 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 to provide a harmonised generic preassessment to support safety risk assessments performed by EFSA's scientific Panels. The safety of unambiguously defined biological agents (at the highest taxonomic unit appropriate for the purpose for which an application is intended) and the completeness of the body of knowledge were assessed. Safety concerns identified for a taxonomic unit are, where possible and reasonable in number, reflected as 'qualifications' in connection with a recommendation for a QPS status. A total of 129 biological agents were notified to EFSA between September 2015 and March 2016. From these, 34 biological agents already had a QPS status and did not require further evaluation, and 63 were not included as they are filamentous fungi or enterococci, biological groups which have been excluded from the QPS activities since 2014. Five notifications for species belonging to Streptomyces genus, one for Paenibacillus lentus, four for Escherichia coli and one for one species of Actinomadura were not evaluated for QPS status because these species were recently assessed and considered not suitable for QPS status. Furthermore, it was agreed not to include nine notifications from Pesticides Unit as the respective dossiers (including the literature review) were not yet received. Therefore, there were 12 notifications related to 12 taxonomic units that were evaluated for QPS status. Pediococcus parvulus, Bacillus flexus and Lactobacillus diolivorans may be recommended for the QPS status. Candida rugosa, Cellulosimicrobium cellulans, Geobacillus caldoproteolyticus (Anoxybacilluscaldiproteolyticus), Aeribacillus pallidus (ex-Geobacillus pallidus), 'Chryseobacterium proteolyticum', Klebsiella pneumoniae, Paenibacillus macerans, 'Protaminobacter rubrum' and Pullulanibacillusnaganoensis are not recommended for the QPS list. 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). In 2014, the BIOHAZ Panel decided to change the evaluation procedure: instead of publishing the overall assessment of the taxonomic units previously recommended for the QPS list annually, as prior to 2013, it will be now carried out after 3 years in a scientific opinion of the BIOHAZ Panel (December 2016). Meanwhile, that list of microorganisms will be maintained and frequently checked based on the evaluation of extensive literature searches that will be updated regularly with data from new publications. 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 Feed Unit, the Food Ingredients and Packaging (FIP) Unit, the Nutrition Unit or the Pesticides Unit. Evaluations of these notifications will be compiled in a single Statement for periods of around 6 months. The main results of these assessments will also be included in the scientific opinion of the BIOHAZ Panel to be published in December 2016. The '2013 updated list of QPS status recommended biological agents for safety risk assessments carried out by EFSA scientific Panels and Units' will be updated with the inclusion of new recommendations for the QPS status and is appended to each new Panel Statement. The first ToR requires ongoing updates of the list of biological agents being notified, in the context of a technical dossier to EFSA Units (such as Feed, FIP, Nutrition and Pesticides), for intentional use in food and/or feed or as sources of food and feed additives, enzymes and plant protection products. The list was updated with the notifications received since the latest review and the new ones were included in a table appended to the current Statement (Appendix C). Notifications considered for the current Statement were received between September 2015 and March 2016. Within this period, 129 notifications were received from those four Units, of which 21 were from Feed, 67 from FIP, two from Nutrition and 39 from Pesticides. The second ToR concerns the revision of the taxonomic units previously recommended for the QPS list and their qualifications (especially the qualification regarding antimicrobial resistance) when new information has become available and to update the information provided in the previous Opinion published in November 2013 where appropriate. The work being developed in order to meet this ToR is not reflected in the current Statement, but will be published in a scientific opinion of the BIOHAZ Panel, in December 2016. 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 this ToR by including the individual assessments of the taxonomic units not previously included in the 2013 QPS list and that were notified to EFSA between September 2015 and March 2016. Of the 129 notifications received, 34 biological agents already had a QPS status and did not require further evaluation in this Statement. From the remaining 95 (without a QPS status), 63 were not further assessed as they are filamentous fungi or enterococci, biological groups which have been excluded from QPS activities since 2014. Five notifications for species belonging to Streptomyces genus, one for a species of Actinomadura and one for Paenibacillus lentus, were not included because the corresponding taxonomic units have already been evaluated in the previous Statement of December of 2014 and found unsuitable for QPS. Four notifications of strains belonging to the species Escherichia coli were not included because the species had also been re-evaluated in the previous Statement and was considered not suitable for the QPS approach. Furthermore, it was agreed not to include nine notifications from Pesticides Unit as the respective dossiers (including the literature review) were not yet received. Twelve notifications were assessed for the suitability of the respective taxonomic units for inclusion on the QPS list. Lactobacillus diolivorans and Pediococcus parvulus were notified to the Feed Unit and Bacillus flexus, Cellulosimicrobium cellulans, 'Chryseobacterium proteolyticum', Geobacillus caldoproteolyticus (Anoxybacillus caldiproteolyticus), Aeribacillus pallidus (ex-Geobacillus pallidus), Klebsiella pneumoniae, Paenibacillus macerans, 'Protaminobacter rubrum', Pullulanibacillus naganoensis and Candida rugosa were notified to the FIP Unit. After the assessment, which is included in the current Statement, Lactobacillus diolivorans and Pediococcus parvulus may be recommended for the QPS status. Bacillus flexus may be also recommended but with a qualification of the absence of toxigenic activity (applied to all strains of Bacillus species recommended to the QPS list). Candida rugosa, Cellulosimicrobium cellulans, Geobacillus caldoproteolyticus (Anoxybacillus caldiproteolyticus), Aeribacillus pallidus (ex-Geobacillus pallidus), 'Chryseobacterium proteolyticum', Klebsiella pneumoniae, Paenibacillus macerans, 'Protaminobacter rubrum' and Pullulanibacillus naganoensis are not recommended for the QPS list. 1 Introduction A wide variety of microorganisms are 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, the European Food Safety Authority (EFSA) is requested 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 been revised and updated. Taxonomic units were included in the QPS list either following notifications to EFSA or following proposals made by stakeholders during a public consultation in 2005, even if they were not yet notified to EFSA (EFSA, 2005). For the 2014 update, it was decided to change the procedures. The publication of the overall assessment of the taxonomic units previously recommended for the QPS list (EFSA BIOHAZ Panel, 2013) will be carried out every 3 years through a scientific opinion by the Panel on Biological Hazards (BIOHAZ). In any case, the recommendations provided concerning that list of microorganisms will be maintained and frequently checked based on the evaluation of extensive literature reviews which will be updated regularly with new publications. 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 Feed, Food Ingredients and Packaging (FIP), Nutrition or Pesticides units. Evaluations of these notifications will be compiled in single Statements for periods of around 6 months. The results of these assessments will also be included in the scientific opinion to be published in December of 2016. The '2013 updated list of QPS status recommended biological agents for safety risk assessments carried out by EFSA Scientific Panels and Units' to which new recommendations of taxonomic units for the QPS will be included, and will be appended to each Panel Statement. QPS entered the European Union (EU) law with the publication of a new Commission Implementing Regulation (EU) No 562/20121 amending Commission Regulation (EU) No 234/20112 with regard to specific data required for risk assessment of food enzymes. If the microorganism used in the production of a food enzyme has a status of QPS according to the most recent list of QPS recommended biological agents adopted by the EFSA, the enzyme application should not be required to include toxicological data. If residues, impurities and degradation products linked to the total enzyme production process (production, recovery and purification) could give rise for concern, the Authority, pursuant to Article 6(1) of Regulation (EC) No 1331/2008,3 may request additional data for risk assessment, including toxicological data. 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 chain, either directly or as a source of additives or food enzymes or plant protection products. EFSA is requested to assess the safety of these biological agents in the context of applications received by EFSA for market authorisation as sources of food and feed additives, enzymes and plant protection products. The 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 QPS,4,5 consisting of 48 species of Gram-positive non-sporulating bacteria, 13 Bacillus species and 11 yeast species. Filamentous fungi were also assessed but none was recommended for QPS status. The Scientific Committee recommended that a QPS approach should be implemented across EFSA and applied equally to all safety considerations of microorganisms that EFSA is required to assess. The Scientific Committee recognised that there would have to be continuous provision for reviewing and modifying the QPS list. The BIOHAZ Panel took the prime responsibility for this and annually reviewed the existing QPS list as recommended by the Scientific Committee. In the first annual QPS review and update,6 the existing QPS list was reviewed and EFSA's initial experience in applying the QPS approach was described. The potential application of the QPS approach to microbial plant protection products was discussed in the 2009 review.7 In 2009, viruses and bacteriophages were assessed for the first time leading to the addition of two virus families used for plant protection purposes to the QPS list. Bacteriophages were not considered appropriate for the QPS list. After consecutive years of updating the existing scientific knowledge, the filamentous fungi (2008–2013 updates) and enterococci (2010–2013 updates) were not recommended for the QPS list. The 2013 update of the recommended QPS list includes 53 species of Gram-positive non-sporulating bacteria, 13 Gram-positive spore-forming bacteria (Bacillus species), one Gram-negative bacterium (Gluconobacter oxydans), 13 yeast species and three virus families. No QPS recommended species has been taken down from the list following six (2008–2013 updates) annual reviews. Based on the above information, the BIOHAZ Panel at their plenary meeting in January 2014 made a proposal for future QPS activities that was discussed at the Scientific Committee meeting in March 2014. The Scientific Committee agreed to exclude some biological groups (filamentous fungi, bacteriophages and enterococci) in future QPS activities, while an extensive literature review of the QPS recommended list could be done less frequently. The deadline for the assessment of the suitability of new taxonomic units notified to EFSA for inclusion in the QPS list would be tailored to the needs of the requesting EFSA Units and/or Scientific Panels. 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 and Nutrition), for intentional use in food and/or feed or as sources of food and feed additives, enzymes and plant protection products. ToR 2: Review taxonomic units previously recommended for the QPS list and their qualifications (especially the qualification regarding antimicrobial resistance) when new information has become available. Update the information provided in the previous opinion where appropriate. ToR 3: (Re)assess the suitability of taxonomic units notified to EFSA not present in the current QPS list for their inclusion in that list. 2 Data and methodologies 2.1 Data For the taxonomic units associated with the notifications compiled within the time period covered by this Statement (from end of September 2015 until March 2016), the literature review considered the identity, the body of knowledge, history of use and the potential safety concerns. Relevant databases, such as PubMed, Web of Science, CasesDatabase, CAB Abstracts or Food Science Technology Abstracts (FSTA), Scopus were searched. More details on the search strategy, search keys and approach followed are described in Appendix A. In February 2016, it was agreed to improve the assessment of the QPS status and its applicability for the Pesticide Unit by taking into account the data provided to EFSA within the applicant's dossier (that is required to include an extensive systematic literature review of the peer reviewed scientific literature). This will bring additional experts' views on specific issues related to microorganisms being evaluated. 2.2 Methodologies In response to ToR1, the EFSA Units have been asked to update the list of biological agents being notified to EFSA. A total of 129 notifications were received between September 2015 and March 2016, of which 21 from Feed, 67 from FIP, two from Nutrition and 39 from Pesticides (Table 1). Table 1. Notifications received by EFSA Units (Feed, FIP, Nutrition, and Pesticides) by biological group from September 2015 until March 2016 Unit/Panel Not QPS Already QPS Grand total Biological group Not evaluated Evaluated Excluded in QPS 2013a Previously evaluatedb Evaluation in stand by Feed/FEEDAP 5 5 2 9 21 Bacteria 5 2 7 14 Filamentous fungi 5 5 Yeasts 2 2 Nutrition/NDA 2 2 Bacteria 2 2 Pesticides 18 3 9 9 39 Bacteria 3 6 3 12 Filamentous fungi 18 18 Viruses 6 6 Yeasts 3 3 FIP/CEF 40 3 10 14 67 Bacteria 3 9 11 23 Filamentous fungi 40 40 Yeasts 1 3 4 Total 63 11 9 12 34 129 CEF: EFSA Panel on Food Contact Materials, Enzymes, Flavourings and Processing Aids; FEEDAP: EFSA Panel on Additives and products or Substances used in Animal Feed; FIP: EFSA Food ingredients and packaging unit; NDA: EFSA Panel on Dietetic Products, Nutrition and Allergy; QPS: Qualified Presumption of Safety. a The number includes biological agents that belong to filamentous fungi or enterococci (excluded from QPS evaluation in the 2013 QPS Opinion). b The number includes biological agents that have been recently evaluated. Five notifications for species belonging to Streptomyces genus were not included because they have already been evaluated in the previous Statement of December of 2014 and found unsuitable for QPS (EFSA BIOHAZ Panel, 2014). Four notifications corresponding to four strains of E. coli were not included as the species has been previously evaluated and found unsuitable for QPS (EFSA BIOHAZ Panel, 2014). One notification corresponding to Actinomadura roseorufa and one to Paenibacillus lentus were not included because it was already evaluated in December 2014. In response to ToR3, from those 129 notifications, 34 biological agents already had a QPS status and did not require further evaluation; neither did the 63 biological agents that are 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). Five notifications for species belonging to Streptomyces genus, one for a species of Actinomadura and one for Paenibacillus lentus were also not included because they have already been evaluated in the Statement of December 2014 and were found unsuitable for QPS (EFSA BIOHAZ Panel, 2014). Four notifications of strains belonging to Escherichia coli were not included as this species has been previously re-evaluated and found unsuitable for QPS (EFSA BIOHAZ Panel, 2014). Furthermore, it was agreed with the Pesticides Unit (see explanation above) not to include nine notifications as the respective dossiers (including the literature review) were not yet received. Twelve biological agents were assessed for their suitability for inclusion in the QPS list as the species were not previously assessed. They were notified to the Feed Unit (Lactobacillus diolivorans, Pediococcus parvulus) and to the FIP Unit (Bacillus flexus, Cellulosimicrobium cellulans, 'Chryseobacterium proteolyticum', Geobacillusc caldoproteolyticus (Anoxybacillus caldiproteolyticus), Aeribacillus pallidus (ex-Geobacillus pallidus), Klebsiella pneumoniae, Paenibacillus macerans, 'Protaminobacter rubrum', Pullulanibacillus naganoensis and Candida rugosa). The procedure followed for this assessment is the same as in the previous QPS 2013 update of the scientific Opinion (EFSA BIOHAZ Panel, 2013) and in the Panel Statements published in December 2014, and June and December 2015 (EFSA BIOHAZ Panel, 2014, 2015a,b). 3 Bacteria 3.1 Bacillus flexus 3.1.1 Identity Bacillus flexus was originally described by Batchelor (1919), and validated as revived species name (sp. nov., nom. rev.) by Priest et al. (1988). B. flexus is most closely related to Bacillus paraflexus (16S rRNA gene sequence similarity 98.1%), although also phylogenetically closely related to Bacillus nealsonii (95%), Bacillus niabensis (95%) and Bacillus azotoformans (94%) (Chandna et al., 2013). B. flexus can be identified through 16S rRNA gene sequencing and differentiated from its closest phylogenetic neighbour B. paraflexus with standard phenotypic tests. 3.1.2 Body of knowledge Bacillus flexus has been used for production of enzymes, e.g. β-amylase in food production8 and of alkaline amylase, lipase and protease for detergent formulations (Niyonzima and More, 2014). It has also been used for the production of exopolysaccharides (EPS) (Singh et al., 2013) and for bioremediation (Sivaprakasam et al., 2008; Pal et al., 2014; Das et al., 2016). Zhang et al. (2014) sequenced the whole genome of B. flexus strain T6186-2 isolated from the formation water sample of an oilfield. 3.1.3 Safety concerns A recent outbreak of wound infections in burned patients was reported (Uçar et al., 2016). The outbreak was associated with contaminated swabs for wound sampling. Isolate identification procedures and virulence features characterisation were not presented in the study, neither was the relation between the infection and the B. flexus strain. To our knowledge, there are no reports of any virulence feature or disease associated with B. flexus, further supporting the absence of pathogenicity potential in a non-compromised host. 3.1.4 Antimicrobial resistance Genes encoding resistance to vancomycin (vanB), fosfomycin (fosB) and tetracycline (tetA) were described in a B. flexus strain (Zhang et al., 2014). Nevertheless, it was not possible from the data presented to assess if these genes are part of the chromosomal core genome and therefore present in all members of this species or associated with mobile resistance elements. Moreover, it is not possible to infer if they confer resistance to the mentioned antimicrobials. 3.1.5 Conclusions on a recommendation for the QPS list Bacillus flexus can be recommended for the QPS list with a qualification of absence of toxigenic activity (as applied to all strains of Bacillus species recommended to the QPS list). 3.2 Cellulosimicrobium cellulans 3.2.1 Identity The genus Cellulosimicrobium was first proposed by Schumann et al. (2001) for the bacterium previously classified as Cellulomonas cellulans (basonym Nocardia cellulans, embracing the misclassified species Cellulomonas cartae, Brevibacterium lyticum, Brevibacterium fermentans, Arthrobacter luteus and Oerskovia xanthineolytica). 16S rDNA sequencing and the unique combination of chemotaxonomic properties led to the reclassification of this Gram-positive rod to the genus Cellulosimicrobium of the family Promicromonosporaceae, suborder Micrococcineae, order Actinomycetales, class Actinobacteria. Currently, two sequenced genomes of C. cellulans LMG 16121 (NZ_CAOI00000000.1) and C. cellulans J36 (NZ_JAGJ00000000.1) are available. 3.2.2 Body of knowledge The ecological distribution of Cellulosimicrobium strains not only includes mainly mesophilic environments, such as soil, marine sponges and clinical materials, but also extreme environments, including hot springs (Sharma et al., 2014) and Antarctic snow (Antony et al., 2009). Different enzymes with relevant activity have been described in C. cellulans strains, including chitinase (Fleuri et al., 2009), β-1,4-xylanase (Walia et al., 2014), proteases and β-1,3-glucanase. The glucanase activity could be useful for the degradation of cell wall in fungi, yeasts and higher plants. Applications of β-1,3-glucanases includes clarification of slimy must, degradation of barley β-glucan that accumulates during the brewing process, as feed additives in animal production and in treatment of fungal diseases (Pang et al., 2004). 3.2.3 Safety concerns Cellulosimicrobium cellulans is a rare opportunistic pathogen in humans causing infections (bacteraemia, peritonitis, endocarditis and infections in other tissues, e.g. joints, ocular and soft tissue) mostly in patients with immunocompromised status and the presence of a foreign body (Rowlinson et al., 2006; Magro-Checa et al., 2011; Petkar et al., 2011; Sug Kim et al., 2015). Recent analysis of two available C. cellulans genomes (LMG 16121 and J36) revealed 49 genes with known association with a human pathogenicity potential (Sharma et al., 2016). These genes were associated with pathogenicity islands which are not known to be present in C. cellulans strains. Equine abortion and premature birth associated with C. cellulans infection have also been described (Bolin et al., 2004). 3.2.4 Antimicrobial resistance Cellulosimicrobium cellulans strains have been described as resistant to penicillins, aminoglycosides, macrolides and cephalosporins (Harrington et al., 1996; Petkar et al., 2011). No data are available on the presence of genetic determinants for antimicrobial resistance in C. cellulans. 3.2.5 Conclusions on a recommendation for the QPS list Safety concerns regarding Cellulosimicrobium cellulans have not excluded the possibility of ill effects developing during its manipulation for enzyme production. Therefore, the organism cannot be awarded QPS status. 3.3 'Chryseobacterium proteolyticum' 3.3.1 Identity The species 'Chryseobacterium proteolyticum' has been proposed by Yamaguchi and Yokoe (2000), describing a single strain of the phylum Bacteroidetes, isolated from soil, which produces a protein-deamidating enzyme. DNA–DNA relatedness data and 16S rDNA sequence analysis indicated that this strain belongs to the genus Chryseobacterium, but not to an already described species. However, the species 'Chryseobacterium proteolyticum' is not an approved bacterial name with standing in nomenclature. 3.3.2 Body of knowledge The body of knowledge is limited. A search was done considering all years available in the literature databases, using the species name as search terms. Eight papers were retrieved and all refer to the strain producing the protein glutaminase enzyme. 3.3.3 Safety concerns No safety concerns have been addressed for this microorganism. Scheuplein et al. (2007) evaluated the pathogenicity and toxigenic potential of the strain by intravenous and oral inoculation studies in mice. No evidence of adverse effect was detected in this study. 3.3.4 Antimicrobial resistance No information related to the presence of antimicrobial resistance determinants has been identified in 'Chryseobacterium proteolyticum'. 3.3.5 Conclusions on a recommendation for the QPS list 'Chryseobacterium proteolyticum' is not a valid species name and all the studies refer to a single strain. Consequently, this taxonomical unit cannot be considered for the QPS list. 3.4
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