Qualified Presumption Of Safety Research Articles

Metataxonomic insights in the distribution of Lactobacillaceae in foods and food environments

Members of the family Lactobacillaceae, which now includes species formerly belonging to the genera Lactobacillus and Pediococcus, but also Leuconostocaceae, are of foremost importance in food fermentations and spoilage, but also as components of animal and human microbiota and as potentially pathogenic microorganisms. Knowledge of the ecological distribution of a given species and genus is important, among other things, for the inclusion in lists of microorganisms with a Qualified Presumption of Safety or with beneficial use. The objective of this work is to use the data in FoodMicrobionet database to obtain quantitative insights (in terms of both abundance and prevalence) on the distribution of these bacteria in foods and food environments.We first explored the reliability of taxonomic assignments using the SILVA v138.1 reference database with full length and partial sequences of the 16S rRNA gene for type strain sequences. Full length 16S rRNA gene sequences allow a reasonably good classification at the genus and species level in phylogenetic trees but shorter sequences (V1-V3, V3-V4, V4) perform much worse, with type strains of many species sharing identical V4 and V3-V4 sequences. Taxonomic assignment at the genus level of 16S rRNA genes sequences and the SILVA v138.1 reference database can be done for almost all genera of the family Lactobacillaceae with a high degree of confidence for full length sequences, and with a satisfactory level of accuracy for the V1-V3 regions. Results for the V3-V4 and V4 region are still acceptable but significantly worse. Taxonomic assignment at the species level for sequences for the V1-V3, V3-V4, V4 regions of the 16S rRNA gene of members of the family Lactobacillaceae is hardly possible and, even for full length sequences, and only 49.9 % of the type strain sequences can be unambiguously assigned to species.We then used the FoodMicrobionet database to evaluate the prevalence and abundance of Lactobacillaceae in food samples and in food related environments. Generalist and specialist genera were clearly evident. The ecological distribution of several genera was confirmed and insights on the distribution and potential origin of rare genera (Dellaglioa, Holzapfelia, Schleiferilactobacillus) were obtained.We also found that combining Amplicon Sequence Variants from different studies is indeed possible, but provides little additional information, even when strict criteria are used for the filtering of sequences.

Developing a single-stage continuous process strategy for vitamin B12 production with Propionibacterium freudenreichii

BackgroundVitamin B12 is a widely used compound in the feed and food, healthcare and medical industries that can only be produced by fermentation because of the complexity of its chemical synthesis. Besides, the use of Generally Recognized as Safe (GRAS) and Qualified Presumption of Safety (QPS) microorganisms, like Propionibacterium freudenreichii, especially non-GMO wild-type producers, are becoming an interesting alternative in markets where many final consumers have high health and ecological awareness. In this study, the production of vitamin B12 using the Propionibacterium freudenreichii NBRC 12391 wild-type strain was characterized and optimized in shake flasks before assessing several scale-up strategies.ResultsInitial results established that: (i) agitation during the early stages of the culture had an inhibitory effect on the volumetric production, (ii) 5,6-dimethylbenzimidazole (DMBI) addition was necessary for vitamin B12 production, and (iii) kinetics of vitamin B12 accumulation were dependent on the induction time when DMBI was added. When scaling up in a bioreactor, both batch and fed-batch bioprocesses proved unsuitable for obtaining high volumetric productivities mainly due to carbon source limitation and propionic acid inhibition, respectively. To overcome these drawbacks, an anaerobic single-phase continuous bioprocess strategy was developed. This culture strategy was maintained stable during more than 5 residence times in two independent cultures, resulting in 5.7-fold increase in terms of volumetric productivity compared to other scale-up strategies.ConclusionOverall, compared to previously reported strategies aimed to reduce propionic acid inhibition, a less complex anaerobic single-phase continuous and more scalable bioprocess was achieved.

Safety evaluation of the food enzyme 1,4-α-glucan branching enzyme from the non-genetically modified Geobacillus thermodenitrificans strain TRBE14.

The food enzyme 1,4-α-glucan branching enzyme ((1-4)-α-d-glucan:(1-4)-α-d-glucan 6-α-d-[(1-4)-α-d-glucano]-transferase; EC 2.4.1.18) is produced with the non-genetically modified Geobacillus thermodenitrificans strain TRBE14 by Nagase (Europa) GmbH. The production strain has been shown to qualify for the qualified presumption of safety (QPS) approach. The food enzyme is intended to be used in cereal-based processes, baking processes as well as meat and fish processing. Dietary exposure to the food enzyme-total organic solids (TOS) was estimated to be up to 0.29mg TOS/kg body weight (bw) per day in European populations. Toxicological studies were not considered necessary given the QPS status of the production strain and the nature of the manufacturing process. A search for the similarity of the amino acid sequence of the food enzyme to known allergens was made and no match was found. The Panel noted that the food enzyme contains lysozyme, a known allergen. Therefore, allergenicity cannot be excluded. Based on the data provided, the Panel concluded that this food enzyme does not give rise to safety concerns, under the intended conditions of use.

Safety evaluation of the food enzyme α-amylase from the genetically modified Bacillus subtilis strain AR-651.

The food enzyme α-amylase (4-α-d-glucan glucanohydrolase; EC 3.2.1.1) is produced with the genetically modified Bacillus subtilis strain AR-651 by AB Enzymes. The genetic modifications do not give rise to safety concerns. The food enzyme is considered free from viable cells of the production organism and its DNA. It is intended to be used in baking processes. Dietary exposure to the food enzyme-total organic solids (TOS) was estimated to be up to 1.19 mg TOS/kg body weight (bw) per day in European populations. The production strain carries known antimicrobial resistance genes and consequently, it does not fully fulfil the requirements for the qualified presumption of safety (QPS) approach to safety assessment. However, considering the absence of viable cells and DNA from the production organism in the food enzyme, this is not considered to be a risk. As no other concerns arising from the microbial source and its subsequent genetic modification or from the manufacturing process have been identified, the Panelconsiders that toxicological tests are not needed for the assessment of this food enzyme. A search for similarity of the amino acid sequence of the food enzyme to known allergens was made and three matches with respiratory allergens were found. The Panelconsidered that, under the intended conditions of use, the risk of allergic sensitisation and elicitation reactions by dietary exposure cannot be excluded, but the likelihood for this to occur is considered to be low. Based on the data provided, the Panelconcludes that this food enzyme does not give rise to safety concerns, under the intended conditions of use.

Update of the list of qualified presumption of safety (QPS) recommended microorganisms intentionally added to food or feed as notified to EFSA

The qualified presumption of safety (QPS) provides a generic pre-assessment of the safety of microorganisms intended for use in the food or feed chains, to support the work of EFSA's Scientific Panels. QPS assessment allows a fast track evaluation of strains belonging to QPS taxonomic units (TUs): species for bacteria, yeast, fungi, protists/microalgae and families for viruses. QPS TUs are assessed for their body of knowledge and safety. Safety concerns related to a QPS TU are reflected, when possible, as ‘qualifications’, which should be tested at strain and/or product level. Based on the possession of potentially harmful traits by some strains, filamentous fungi, bacteriophages, oomycetes, streptomycetes, Enterococcus faecium, Escherichia coli and Clostridium butyricum are excluded from the QPS assessment. Between October 2019 and September 2022, 323 notifications of TUs were received, 217 related to feed additives, 54 to food enzymes, food additives and flavourings, 14 to plant protection products and 38 to novel foods. The list of QPS-recommended TUs is reviewed every 6 months following an extensive literature search strategy. Only sporadic infections with a few QPS status TUs in immunosuppressed individuals were identified and the assessment did not change the QPS status of these TUs. The QPS list has been updated in relation to the most recent taxonomic insights and the qualifications were revised and streamlined. The qualification ‘absence of aminoglycoside production ability’ was withdrawn for Bacillus velezensis. Six new TUs received the QPS status: Bacillus paralicheniformis with the qualification ‘absence of toxigenic activity’ and ‘absence of bacitracin production ability’; Bacillus circulans with the qualifications for ‘production purposes only’ and ‘absence of cytotoxic activity’; Haematococcus lacustris (synonym Haematococcus pluvialis) and Ogataea polymorpha, both with the qualification ‘for production purposes only’; Lactiplantibacillus argentoratensis; Geobacillus thermodenitrificans with the qualification ‘absence of toxigenic activity’.

Update of the list of qualified presumption of safety (QPS) recommended microbiological agents intentionally added to food or feed as notified to EFSA 17: suitability of taxonomic units notified to EFSA until September 2022.

The qualified presumption of safety (QPS) approach was developed to provide a regularly updated generic pre-evaluation of the safety of microorganisms, intended for use in the food or feed chains, to support the work of EFSA's Scientific Panels. The QPS approach is based on an assessment of published data for each agent, with respect to its taxonomic identity, the body of relevant knowledge and safety concerns. Safety concerns identified for a taxonomic unit (TU) are, where possible, confirmed at the species/strain or product level and reflected by 'qualifications'. In the period covered by this Statement, new information was found leading to the withdrawal of the qualification 'absence of aminoglycoside production ability' for Bacillus velezensis. The qualification for Bacillus paralicheniformis was changed to 'absence of bacitracin production ability'. For the other TUs, no new information was found that would change the status of previously recommended QPS TUs. Of 52 microorganisms notified to EFSA between April and September 2022 (inclusive), 48 were not evaluated because: 7 were filamentous fungi, 3 were Enterococcus faecium, 2 were Escherichia coli, 1 was Streptomyces spp., and 35 were taxonomic units (TUs) that already have a QPS status. The other four TUs notified within this period, and one notified previously as a different species, which was recently reclassified, were evaluated for the first time for a possible QPS status: Xanthobacter spp. could not be assessed because it was not identified to the species level; Geobacillus thermodenitrificans is recommended for QPS status with the qualification 'absence of toxigenic activity'. Streptoccus oralis is not recommended for QPS status. Ogataea polymorpha is proposed for QPS status with the qualification 'for production purposes only'. Lactiplantibacillus argentoratensis (new species) is included in the QPS list.

Safety evaluation of the food enzyme β-galactosidase from the non-genetically modified Kluyveromyces lactis strain AE-KL.

The food enzyme β‐galactosidase (β‐d‐galactoside galatohydrolase, EC 3.2.1.23) is produced with the non‐genetically modified Kluyveromyces lactis strain AE‐KL by Amano Enzyme Inc. As the production strain meets the requirements for a Qualified Presumption of Safety (QPS) approach to safety assessment and as no other issues of concern were identified, the Panel considered that toxicological tests were not needed for the assessment of this food enzyme. The food enzyme is intended to be used for lactose hydrolysis in milk processing (including infant formulae), production of fermented milk products and manufacture of galacto‐oligosaccharides (GOS). The dietary exposure to the food enzyme–total organic solids (TOS) was estimated to be up to 7.933 mg TOS/kg body weight (bw) per day in European populations. A search for similarity of the amino acid sequence of the food enzyme to known allergens was made and no match was found. The Panel considered that, under the intended conditions of use, the risk of allergic reactions by dietary exposure cannot be excluded, but the likelihood for this to occur is considered to be low. Based on the QPS status of the production strain and the data provided, the Panel concluded that this food enzyme does not give rise to safety concerns, under the intended conditions of use.

Safety evaluation of the food enzyme β-galactosidase from the genetically modified Kluyveromyces lactis strain KLA.

The food enzyme β‐galactosidase (β‐d‐galactoside galactohydrolase; EC 3.2.1.23) is produced with the genetically modified Kluyveromyces lactis strain KLA by DSM Food Specialties B.V. The genetic modifications did not give rise to safety concerns. The food enzyme was considered free from viable cells of the production organism and its DNA. The food enzyme is intended to be used for the lactose hydrolysis in milk processing, production of fermented milk products and whey processing. It is also intended for lactose hydrolysis in milk products at home. Dietary exposure to the food enzyme–total organic solids (TOS) was estimated to be up to 11.876 mg TOS/kg body weight per day in European populations. The production strain of the food enzyme fulfils the requirements for the Qualified Presumption of Safety (QPS) approach to safety assessment. As no concerns arising from its genetic modification or from the manufacturing process have been identified, the Panel considered that toxicological tests are not needed for the assessment of this food enzyme. A search for similarity of the amino acid sequence of the food enzyme to known allergens was made and no match was found. The Panel considered that, under the intended conditions of use, the risk of allergic reactions by dietary exposure cannot be excluded, but the likelihood for this to occur is low. The Panel concluded that this food enzyme does not give rise to safety concerns under the intended conditions of use.

Safety and efficacy of a feed additive consisting of endo-1,4-β-xylanase produced by Komagataella phaffiiDSM 33574, and viable spores of Bacillus velezensisDSM 21836 and Bacillus licheniformisATCC 53757 (EnzaPro) for chickens for fattening, chickens reared for laying/breeding, turkeys for fattening, turkeys reared for breeding and growing minor poultry species (BioResource International (BRI), Inc.).

Following a request from the European Commission, the EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) was asked to deliver a scientific opinion on the safety and efficacy of the product EnzaPro containing viable cells/spores of strains of Bacillus velezensis (DSM 21836) and Bacillus licheniformis (ATCC 53757) and an endo‐1,4‐β‐xylanase produced by a genetically modified strain of Komagataella phaffii (DSM 33574) as a zootechnical additive in chickens for fattening, chickens reared for laying/breeding, turkeys for fattening, turkeys reared for breeding and minor poultry species for fattening or raised to the point of lay. The strains B. velezensis DSM 21836 and B. licheniformis ATCC 53757 were considered to meet the qualified presumption of safety (QPS) requirements. The K. phaffii xylanase production strain is genetically modified. No viable cells and no recombinant DNA of the genetically modified production strain were detected in the final product. Therefore, the Panel concluded that the additive does not pose any safety concern regarding the xylanase production strain. EnzaPro is safe for all poultry species for fattening or reared to the point of lay at the proposed conditions of use. The FEEDAP Panel concluded that the use of EnzaPro in animal nutrition is safe for the consumers and the environment. EnzaPro is not a skin irritant but should be considered an eye irritant and a respiratory sensitiser. No conclusions could be drawn on the potential of the additive to cause skin sensitisation. Due to the lack of data, the FEEDAP Panel could not conclude on the efficacy of EnzaPro for the target species. EnzaPro is compatible with diclazuril, halofuginone and nicarbazin.

Safety evaluation of the food enzyme β-galactosidase from the non-genetically modified Kluyveromyces lactis strain GAL.

The food enzyme β‐galactosidase (β‐d‐galactoside galactohydrolase; EC 3.2.1.23) is produced with the non‐genetically modified Kluyveromyces lactis strain GAL by DSM Food Specialties B.V. It is intended to be used for the lactose hydrolysis in milk processing, production of fermented milk products and whey processing. It is also intended to be used for lactose hydrolysis in milk products at home. Dietary exposure to the food enzyme‐total organic solids (TOS) was estimated to be up to 10.78 mg TOS/kg body weight per day in European populations. As the production strain of K. lactis strain GAL qualifies for the Qualified Presumption of Safety (QPS) approach to safety assessment and no issue of concern arose from the production process, no toxicological data are required. A search for similarity of the amino acid sequence of the food enzyme to known allergens was made and no match was found. The Panel considered that, under the intended conditions of use, the risk of allergic reactions by dietary exposure cannot be excluded, but the likelihood for this to occur is low. Based on the data provided, the Panel concluded that this food enzyme does not give rise to safety concerns under the intended conditions of use.

An Extensive Review on Production, Purification, and Bioactive Application of Different Classes of Bacteriocin

Lactic Acid Bacteria (LAB) synthesize various metabolites during their growth phase and are Generally Recognized as­­ Safe (GRAS) and Qualified Presumption of Safety (QPS). Ribosomally synthesized Antimicrobial Peptides (AMP) or Bacteriocins from the genera of Lactic Acid Bacteria and other prokaryotic genera are cationic, heat-stable, amphiphilic and the membrane permeabilizing peptides built with an excess amount of lysyl and arginyl residues. Antimicrobial compounds produced by LAB depend on the physical and biological conditions of microbial culture. Different classes of bacteriocin are produced by both Gram-positive and Gram-negative bacteria. The production of bacteriocin is influenced by various environmental factors. Bacteriocin has a wide variety of applications in various fields. The application spectrum of bacteriocins can be expanded in various domains such as food processing, biomedical, and personal care due to the increase in the number of newly discovered bacteriocins. Bacteriocins acquire a wide spectrum of antimicrobial activity with minimal level of cytotoxicity. In addition, bacteriocins were studied for their anticancer activity against different cancer cell lines. Selective binding of bacteriocins (cationic) towards cancer cells (anionic) increases the cytotoxicity of cancer cells. Bacteriocin peptides initiate necrosis by communicating with the cell surface which selectively targets and kills the cells with tumor formation and does not cause any damage to the normal healthy cells. In this review, the bacteriocins synthesized from lactic acid bacteria along with their interaction with cancer cell lines and other applications are discussed along with a few examples of other bioactive compounds produced by LAB.

Safety Assessment Systems for Microbial Starters Derived from Fermented Foods.

Microorganisms involved in food fermentation not only improve the aroma and taste of the food, but also enhance its preservation. Thus, they are added as starter cultures to boost the final product quality of commercial fermented foods. Although these microorganisms originate from fermented foods and have a long history of consumption, the European Union recently applied the concept of Qualified presumption of Safety (QPS), which is a safety evaluation system for microorganisms used in food or feed in Europe. The QPS system is a species-level safety system and shares results with the European Novel Food System, a strain-level safety evaluation system. In the United States, microorganisms added to fermented foods are considered as food additives or Generally Recognized as Safe substance. In Korea, food microbe lists are presented at the species level. Moreover, the nation has established a strain-oriented evaluation system that applies temporary safety evaluation methods for food raw materials as well as new raw materials. However, when it comes to microorganisms isolated from traditional fermented foods and other fermented food products, there is no definition of the term "species," and there is a lack of an evaluation system at the species level. Therefore, such an evaluation system for microbial species used in Korean fermented foods is necessary.

Fermentation of NaHCO3-treated corn germ meal by Bacillus velezensis CL-4 promotes lignocellulose degradation and nutrient utilization.

Sodium bicarbonate pretreatment and solid-state fermentation (SSF) were used to maximize the nutritional value of corn germ meal (CGM) by inoculating it with Bacillus velezensis CL-4 (isolated from chicken cecal contents and capable of degrading lignocellulose). Based on genome sequencing, B. velezensis CL-4 has a 4,063,558bp ring chromosome and 46.27% GC content. Furthermore, genes associated with degradation of lignocellulose degradation were detected. Pretreatment of CGM (PCGM) with sodium bicarbonate (optimized to 0.06g/mL) neutralized low pH. Fermented and pretreated CGM (FPCGM) contained more crude protein (CP), soluble protein of trichloroacetic acid (TCA-SP), and total amino acids (aa) than CGM and PCGM. Degradation rates of cellulose and hemicellulose were reduced by 21.33 and 71.35%, respectively, after 48h fermentation. Based on electron microscopy, FPCGM destroys the surface structure and adds small debris of the CGM substrate, due to lignocellulose breakdown. Furthermore, 2-oxoadipic acid and dimethyl sulfone were the most important metabolites during pretreatment. Concentrations of adenosine, cytidine, guanosine, S-methyl-5'-thioadenosine, and adenine decreased significantly after 48h fermentation, whereas concentrations of probiotics, enzymes, and fatty acids (including palmitic, 16-hydroxypalmitic, and linoleic acids) were significantly improved after fermentation. In conclusion, the novel pretreatment of CGM provided a proof of concept for using B. velezensis CL-4 to degrade lignocellulose components, improve nutritional characteristics of CGM, and expand CGM lignocellulosic biological feed production. KEY POINTS: • Sodium bicarbonate (baking soda) can be used as an economical and green additive to pretreat corn germ meal; • Fermentation with B. velezensis degrades the cellulose and hemicellulose component of corn germ meal and improves its feed quality; • As a novel qualified presumption of safety (QPS) strain, B. velezensis should have broad potential applications in food and feed industries.

Safety and efficacy of a feed additive consisting of Bifidobacterium longum CNCM I-5642 (PP102I) for cats and dogs (Nestlé Enterprises S.A.).

Following a request from the European Commission, the Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) was asked to deliver a scientific opinion on the safety and efficacy of Bifidobacterium longum CNCM I‐5642 (PP102I) when used as a feed additive for cats and dogs. The product under assessment consists of viable cells of a strain of B. longum, a species considered suitable for the qualified presumption of safety (QPS) approach to safety assessment. The strain was unambiguously identified as B. longum and was shown not to harbour antimicrobial resistance determinants for antibiotics of human and veterinary importance, thus meeting the QPS requirements. Following the QPS approach to safety assessment and since no concerns are expected from maltodextrin, the other component of the additive, PP102I was considered safe for the target species and the environment. Owing to the lack of data, no conclusions could be drawn on the skin/eye irritancy potential of PP102I. However, it should be considered a skin and respiratory sensitiser. The Panel was not in the position to conclude on the efficacy of PP102I for the target species.

Safety evaluation of the food enzyme phosphoinositide phospholipase C from the genetically modified Bacillus licheniformis strain NZYM-DI.

The food enzyme phosphoinositide phospholipase C (1‐phosphatidyl‐1D‐myo‐inositol‐4,5‐bisphosphate inositoltrisphosphohydrolase, EC 3.1.4.11) is produced with the genetically modified Bacillus licheniformis strain NZYM‐DI by Novozymes A/S. The genetic modifications did not give rise to safety concerns. The production strain has been shown to qualify for the qualified presumption of safety (QPS) status. The food enzyme was co nsidered free from viable cells of the production organism and its DNA. It is intended to be used for degumming of fats and oils. Since residual amounts of total organic solids are removed during washing and purification steps applied during degumming, dietary exposure was not estimated. As the production strain B. licheniformis NZYM‐DI qualifies for the QPS approach to safety assessment and no issue of concern arose from the production process, no toxicological data were required. A search for similarity of the amino acid sequence of the food enzyme to known allergens was made and no match was found. The Panel considered that, under the intended conditions of use, the risk of allergic sensitisation and elicitation reactions by dietary exposure could not be excluded, but the likelihood for this to occur was considered low. Based on the data provided, the Panel concluded that this food enzyme does not give rise to safety concerns, under the intended conditions of use.

Safety evaluation of the food enzyme chymosin from the genetically modified Kluyveromyces lactis strain CHY.

The food enzyme chymosin (EC 3.4.23.4) is produced with the genetically modified Kluyveromyces lactis strain CHY by DSM Food Specialties B.V. It is intended to be used in milk processing for cheese production and for production of fermented milk products. Dietary exposure was estimated to be up to 0.69 mg total organic solids (TOS)/kg body weight (bw) per day in European populations. The production strain contains multiple copies of known antimicrobial resistance genes and consequently, it does not fully fulfil the requirements for the qualified presumption of safety (QPS) approach to safety assessment. However, considering the absence of viable cells and DNA from the production organism in the food enzyme, this is not considered to be a risk. As no other concerns arising from the microbial source and its subsequent genetic modification or from the manufacturing process have been identified, the Panel considered that toxicological tests were not needed for the assessment of this food enzyme. Similarity of the amino acid sequence of the food enzyme to those of known allergens was searched and four matches were found. The Panel considered that, under the intended conditions of use, the risk of allergic sensitisation and elicitation reactions by dietary exposure, although unlikely, cannot be excluded, particularly for individuals sensitised to cedar pollen allergens. Based on the data provided, the Panel concluded that this food enzyme does not give rise to safety concerns under the intended conditions of use.

Safety evaluation of the food enzyme α-amylase from the genetically modified Bacillus licheniformis strain NZYM-AY.

The food enzyme α‐amylase (4‐α‐d‐glucan glucanhydrolase; EC 3.2.1.1) is produced with the genetically modified Bacillus licheniformis strain NZYM‐AY by Novozymes A/S. The genetic modifications do not give rise to safety concerns. The food enzyme is considered free from viable cells of the production organism and its DNA. It is intended to be used in starch processing for the production of glucose syrup and other starch hydrolysates, and distilled alcohol production. Since residual amounts of total organic solids are removed by distillation and by the purification steps applied during the production of glucose syrups, dietary exposure estimation was considered unnecessary. The production strain of the food enzyme fulfils the requirements for the qualified presumption of safety (QPS) approach to safety assessment. As no other concerns arising from the manufacturing process have been identified, the Panel considers that toxicological tests are not needed for the assessment of this food enzyme. A search for similarity of the amino acid sequence of the food enzyme to known allergens was made and one match was found. The Panel considered that, under the intended conditions of use (other than distilled alcohol production) the risk of allergic sensitisation and elicitation reactions by dietary exposure cannot be excluded, but the likelihood for this to occur is considered to be low. Based on the data provided, the Panel concluded that this food enzyme did not give rise to safety concerns under the intended conditions of use.

Safety and efficacy of a feed additive consisting of Pediococcus acidilacticiCNCM I-4622 for all animal species (Danstar Ferment AG).

Following a request from the European Commission, the Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) was asked to deliver a scientific opinion on the safety and efficacy of Pediococcus acidilactici CNCM I‐4622 when used as a technological additive (acidity regulator and hygiene condition enhancers) for all animal species. The product is intended for use in mash compound feeds and/or solid feed materials used for the preparation of liquid feeds at a minimum inclusion level of 1 × 109 CFU kg feed. The bacterial species is considered by EFSA to be eligible for the qualified presumption of safety (QPS) approach. As the identity of the strain has been clearly established and it did not show acquired resistance to antibiotics of human and veterinary importance, the use of this strain in animal nutrition is considered safe for the target species, consumers and the environment. The additive is considered to be a respiratory sensitiser but is not irritant to eyes/skin or a skin sensitiser. Pediococcus acidilactici CNCM I‐4622 at 1 × 109 CFU/kg complete feed showed the potential to reduce the pH and the growth of coliforms in liquid feeds. Pediococcus acidilactici CNCM I‐4622 is compatible with halofuginone, diclazuril, decoquinate and nicarbazin at the highest authorised levels for chickens for fattening.

ANTIBIOTIC RESISTANCE PROFILE OF THE NEWLY ISOLATED LACTIC ACID BACTERIA STRAINS FROM TRADITIONAL FERMENTED FOODS

The use of antibiotics is a major problem everywhere around the globe and in step with this, there's currently an increased public and scientific interest. Microbial resistance is a vital issue for the organizations like EFSA, WHO, FDA, and FAO because it is developing rapidly and is an increasingly serious health concern within the world. Microbial resistance comes as a result of continuous exposure of microorganisms to antibiotics. Lactic acid bacteria (LAB) constitute a really important group of microorganisms that can inhabit different conditions and environments, as the different parts of the gastrointestinal tract of humans and animals, and are an important element of the microbiota of fermented foods. The FDA and EFSA authorities have given them the status referred to as GRAS (Generally Recognized as Safe) and QPS (Qualified Presumption of Safety). Continuous exposure of LAB to environments with antibiotics may prompt them to become an intrinsic or extrinsic reservoir of genes accountable for antibiotic resistance. Knowledge of antibiotic susceptibility of bacteria with probiotic potential is important. Also, it's essential to define their resistance profile. Ten newly isolated strains from traditional fermented foods were used for determining the antibiotic resistance profile. The resistance to antibiotics varied among the examined strains and a few of the antibiotics resulted in complete resistance. Chromosomal DNA of LAB was analyzed for the antibiotic resistance genes. Only five of eight vancomycin-resistant strains have shown that they contain the resistance gene in chromosomal DNA. None of the genes that determined the resistance to other antibiotics have been detected in chromosomal DNA.

Update of the list of QPS-recommended microbiological agents intentionally added to food or feed as notified to EFSA 16: suitability of taxonomic units notified to EFSA until March 2022.

The qualified presumption of safety (QPS) approach was developed to provide a regularly updated generic pre‐evaluation of the safety of microorganisms, intended for use in the food or feed chains, to support the work of EFSA's Scientific Panels. The QPS approach is based on an assessment of published data for each agent, with respect to its taxonomic identity, the body of relevant knowledge, safety concerns and occurrence of antimicrobial resistance. Safety concerns identified for a taxonomic unit (TU) are, where possible, confirmed at the species/strain or product level and reflected by ‘qualifications’. In the period covered by this statement, no new information was found that would change the status of previously recommended QPS TUs. Of the 50 microorganisms notified to EFSA in October 2021 to March 2022 (inclusive), 41 were not evaluated: 10 filamentous fungi, 1 Enterococcus faecium, 1 Clostridium butyricum, 3 Escherichia coli and 1 Streptomyces spp. because are excluded from QPS evaluation, and 25 TUs that have already a QPS status. Nine notifications, corresponding to seven TUs were evaluated: four of these, Streptococcus salivarius, Companilactobacillus formosensis, Pseudonocardia autotrophica and Papiliotrema terrestris, being evaluated for the first time. The other three, Microbacterium foliorum, Pseudomonas fluorescens and Ensifer adhaerens were re‐assessed. None of these TUs were recommended for QPS status: Ensifer adhaerens, Microbacterium foliorum, Companilactobacillus formosensis and Papiliotrema terrestris due to a limited body of knowledge, Streptococcus salivarius due to its ability to cause bacteraemia and systemic infection that results in a variety of morbidities, Pseudonocardia autotrophica due to lack of body of knowledge and uncertainty on the safety of biologically active compounds which can be produced, and Pseudomonas fluorescens due to possible safety concerns.