Qualified Presumption Of Safety Research Articles

Statement on the update of the list of QPS‐recommended biological agents intentionally added to food or feed as notified to EFSA. 2: Suitability of taxonomic units notified to EFSA until March 2015

EFSA is 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 pre-assessment 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 are assessed. Identified safety concerns 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 85 biological agents were notified to EFSA between October 2014 and March 2015. From those, 35 biological agents already had a QPS status and were not further evaluated, and 45 were also not included as they are filamentous fungi or enterococci, biological groups which have been excluded from the QPS activities since 2014. Two notifications referred to two taxonomic units which were evaluated for the QPS status, one of which was recommended for the QPS list: Xanthomonas campestris, only for the production of xanthan gum, while the other, Bacillus circulans, was not due to insufficient body of knowledge on a safe history of use in foods and feeds. Three notifications belonging to the genus Streptomyces were not evaluated for the QPS status, because the genus was recently considered not suitable for the QPS approach.

Sugar-coated: exopolysaccharide producing lactic acid bacteria for food and human health applications.

The human enteric microbiome represents a veritable organ relied upon by the host for a range of metabolic and homeostatic functions. Through the production of metabolites such as short chain fatty acids (SCFA), folate, vitamins B and K, lactic acid, bacteriocins, peroxides and exopolysaccharides, the bacteria of the gut microbiome provide nutritional components for colonocytes, liver and muscle cells, competitively exclude potential pathogenic organisms and modulate the hosts immune system. Due to the extensive variation in structure, size and composition, microbial exopolysaccharides represent a useful set of versatile natural ingredients for the food industrial sector, both in terms of their rheological properties and in many cases, their associated health benefits. The exopolysaccharide-producing bacteria that fall within the 35 Lactobacillus and five Bifidobacterium species which have achieved qualified presumption of safety (QPS) and generally recognised as safe (GRAS) status are of particular interest, as their inclusion in food products can avoid considerable scrutiny. In addition, additives commonly utilised by the food industry are becoming unattractive to the consumer, due to the demand for a more 'natural' and 'clean labelled' diet. In situ production of exopolysaccharides by food-grade cultures in many cases confers similar rheological and sensory properties in fermented dairy products, as traditional additives, such as hydrocolloids, collagen and alginate. This review will focus on microbial synthesis of exopolysaccharides, the human health benefits of dietary exopolysaccharides and the technofunctional applications of exopolysaccharide-synthesising microbes in the food industry.

Safety Assessment of Starters for Traditional Korean Fermented Foods

Most microorganisms have been used for foods for such a long period of time with no question posed for their safety. However, the progress of food processing technology has activated international food trades, and the consumers and authorities of import countries have come to question the safety of microorganisms used in foods. At present, the most widely known safety standards are Generally Recognized as Safe (GRAS) status from the US Food and Drug Administration (FDA) and Qualified Presumption of Safety (QPS) status by the European Food Safety Authority (EFSA). GRAS status is not for the safety of microorganisms themselves but for the permissibility of strains or cultures in specific food uses. QPS provides a qualified generic approval to a defined taxonomic unit. The increase of commercialized traditional fermented foods in Korea has spurred the starter development for traditional food fermentations. However, starter development in Korea has been carried out based on the technological properties of microorganisms with no research on developing a standardized tool for safety assessment. In the globalization of traditional Korean fermented foods, technological properties as well as safety of future starters should be guaranteed, and establishment of the safety assessment regulation for microorganisms used for foods is necessary.

Scientific Opinion on a Qualified Presumption of Safety (QPS) approach for the safety assessment of botanicals and botanical preparations

The Qualified Presumption of Safety (QPS) approach, initially developed for the assessment of microorganisms referred to EFSA and added to the food chain is equally applicable to the assessment of botanicals or botanical preparations. Using the principles to establish the suitability of a botanical preparation for QPS status, it has been possible to develop a structured assessment scheme that provides a practical method for assessing botanicals and botanical preparations for which an adequate body of knowledge exists and therefore without the need for further testing. Reiterative applications of the assessment scheme to related botanicals or different botanical preparations obtained from the same plant variety can allow a QPS status to be derived for specific groupings. However, the particularity of botanicals that may be presented in a wide variety of forms or whose morphology and chemical composition may be markedly affected by geographical and environmental factors, makes the possibility to establish QPS status at high taxonomic levels quite limited. Still, the above-mentioned structured approach for the assessment of botanicals and botanical preparations represents a considerable advancement in the development of a comprehensive, systematic and transparent methodology. The Scientific Committee recommends its use as an extension of the 2009 EFSA guidance for the safety assessment of botanicals and botanical preparations intended to be used in food supplements.

Lactobacillus plantarum as a Strategy for an In situ Production of Vitamin B2

Lactobacillus plantarum as a Strategy for an In situ Production of Vitamin B2 The European Food Safety Agency (EFSA) has recently introduced a system for a pre-market safety assessment of selected taxonomic groups of microorganisms leading to a Qualified Presumption of Safety (QPS), European equivalent of the Generally Recognized as Safe (GRAS) status. Several species of food-related lactic acid bacteria (LAB) associated with food, have obtained a QPS status.

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

EFSA is 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 pre-assessment 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 are assessed. Identified safety concerns for a taxonomic unit are, where possible and reasonable in number, reflected as ‘qualifications’ in connection with a recommendation for a QPS status. The list of QPS recommended biological agents is reviewed and updated periodically. Therefore, the only valid list is the one in the most recently published scientific opinion. The 2013 update reviews previously assessed microorganisms including bacteria, yeasts, filamentous fungi, oomycetes and viruses used for plant protection purposes. All taxonomic units previously recommended for the QPS list had their status reconfirmed. The new notifications since the last QPS update were reviewed. Gluconobacter oxydans and Alphaflexiviridae were assessed for the first time and were recommended for the QPS list. The information of the previous opinion was updated for the taxonomic units on the QPS list. Qualifications for the taxonomic units included in the QPS recommended list were reviewed and confirmed. Filamentous fungi and enterococci were not recommended for the QPS list following updating and reviewing of current scientific knowledge.

Characterization of Lactococcus lactis isolates from bovine mastitis

Lactococcus lactis is a widely used mesophilic dairy starter and has been included in the Qualified Presumption of Safety (QPS) list of the European Food Safety Authority. However, it is increasingly found as the cause of human or animal infections, such as bovine mastitis, probably due to the improvement of the identification of the infective microorganisms. Since there are some grounds to suspect that at least certain variants of L. lactis may cause animal or human diseases, it is important to properly identify the differences between the strains associated with infections and the safe starter strains. Bovine mastitis isolates and dairy starter strains were genotypically characterized and clustered by the 16S rRNA gene sequence and RAPD-PCR fingerprint patterns, and phenotypically characterized by their tolerance to different stress conditions typically found in the intestinal tract of mammals, the carbohydrate- and antibiotic resistance profile, as well as the in vitro adhesion capacity to udder epithelial cells. Genotypically, there were no differences between the mastitis isolates and the dairy starter strains. However, there were clear phenotypic distinctions between mastitis isolates and typical starter strains, the former showing an increased tolerance to temperature, lysozyme, bile salts, pH and antibiotics, as well as improved carbohydrate fermentation capacity, and in vitro adhesion to udder epithelial cells. Although these differences might not be considered as actual virulence factors, they improve the ability of the strain to survive in the body of homeothermic animals and, interestingly, are also typical properties associated with potential probiotic strains.

EFSA's Qualified Presumption of Safety (QPS) risk assessment approach reduces toxicological data requirements

EFSA's Qualified Presumption of Safety (QPS) risk assessment approach reduces toxicological data requirements

Scientific Opinion on the maintenance of the list of QPS biological agents intentionally added to food and feed (2012 update)

EFSA is 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 for safety risk assessments to provide a harmonised generic pre-assessment to support 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 are assessed. Identified safety concerns for a taxonomic unit are where possible and reasonable in number reflected as ‘qualifications’ with a recommendation for the QPS list. The list of QPS recommended biological agents is reviewed and updated annually. Therefore, the only valid list is the one in the most recently published scientific opinion. The 2012 update reviews microorganisms previously assessed including bacteria, yeasts, filamentous fungi and viruses used for plant protection purposes. The BIOHAZ Panel confirmed all taxonomic units previously recommended for the QPS list. The notifications were reviewed. Bacillus firmus was re-evaluated and not recommended for the QPS list. A new recommendation was made for Leuconostoc pseudomesenteroides. Carnobacterium maltaromaticumwas assessed for the first time and not recommended for the QPS list. Qualifications for the taxonomic units included in the QPS recommended list were reviewed and confirmed. Filamentous fungi and enterococci were not recommended for the QPS list following updating and reviewing of current scientific knowledge. For Enterococcus faeciumrecent data indicate a possible distinction between pathogenic and non-pathogenic strains. This is considered too recent knowledge for a QPS recommendation, considering the recent information on the evolution of the epidemiology of Enterococcus infections in humans.

Scientific Opinion on the safety and efficacy of Prostora Max (Bifidobacterium animalis) as a feed additive for dogs

Prostora Max is a feed additive based on a strain of Bifidobacterium animalis that has never been authorised in the EU. It is intended to be used in dogs at a proposed dose of 1.0 × 109 colony-forming units (CFUs)/day in the form of a supplemental treat. The species B. animalisis considered by EFSA to be suitable for the qualified presumption of safety (QPS) approach to safety assessment, if its identity is confirmed and the absence of resistance to antibiotics of human and veterinary clinical significance demonstrated. However, the B. animalisstrain is resistant to the antibiotic clindamycin. In the view of the FEEDAP Panel the antibiotic resistance qualification of the B. animalisstrain has not been met and the QPS approach cannot therefore be applied. Although the applicant, on the basis of a bioinformatic analysis, could exclude the presence of many known antibiotic resistance genes, the genetic basis of the resistance to clindamycin was not established. In the absence of information on the genetic basis of this resistance, the extent of the risk of horizontal gene transfer to other bacteria in the food chain and in the environment cannot be established. All the excipients of the additive are authorised for food or feed use or feed materials. The product is in a tablet form so exposure to the mucous membranes and respiratory system of users is unlikely. Some skin exposure might occur, as the cocoa butter would melt at body temperature, but skin exposure would be limited. Treatment with Prostora Max at least 1 × 109 CFUs/day had an effect on gastrointestinal-related parameters in dogs. In two studies this took the form of an improved faecal score. However, in one study this improvement was marginal and of questionable biological/practical value. Therefore, taking into consideration the results of all three studies assessed, the FEEDAP Panel cannot conclude on the efficacy of Prostora Max for dogs.

Safety of a probiotic cheese containing Lactobacillus plantarum Tensia according to a variety of health indices in different age groups

Safety of the probiotic Lactobacillus plantarum strain Tensia (DSM 21380) was tested in vitro, in semihard Edam-type cheese, in an animal model and after consumption of the probiotic cheese in double-blind randomized placebo-controlled human intervention studies with different age groups. The susceptibility of L. plantarum Tensia to 8 antibiotics, and the presence of tetracycline (tet M, S, O, K, L) genes and class 1 integron was assessed by applying epsilometer-test and PCR-based methods. Production of biogenic amines by the probiotic strain in decarboxylation medium containing 1% of l-histidine, l-glutamine, l-ornithine, l-arginine, or l-lysine and in cheese was tested by gas chromatography. The biosafety of L. plantarum Tensia was evaluated on National Institutes of Health-line mice fed cheese containing Tensia at a concentration of 9.6 log cfu/g for 30 consecutive days. In human intervention trials in adults and the elderly, the effects of different doses of Edam-type cheese and the probiotic bacterium on BW, gut functionality indices, and host metabolism were evaluated. The strain L. plantarum Tensia was susceptible to all tested antibiotics and did not possess the tetracycline resistance-determining genes tet(L), tet(S) and tet(O), nor did it contain the integron (Int1) gene. However, the strain was tet(K) and tet(M) positive. Lactobacillus plantarum Tensia did not produce potentially harmful biogenic amines, such as histamine or cadaverine. The amount of tyramine produced in the cheese environment during ripening and after 15 wk of storage was below the clinically significant content. In the animal model, no translocation of the administered strain or other microbes into the blood or organs of mice was detected. No harmful effect was observed on body mass index, inflammatory markers, or serum lipidograms during human intervention trials with different age groups at a daily dose of 10.3 or 8.17 log cfu/serving for 3 wk. No negative effect on gastrointestinal welfare was observed, but the consumption of 100g/d for 3 wk caused hard stools from the second week of the trial. The content of total lactobacilli increased in feces, and the presence of the ingested probiotic strain was confirmed after the consumption of cheese. Thus, L. plantarum strain Tensia is suitable for generally recognized as safe (GRAS) and qualified presumption of safety (QPS) criteria because it did not have any undesirable characteristics. The regular semihard Edam-type cheese (fat content of 26%) with the probiotic additive at a daily dose of 50g or in excess (100g) and with a probiotic daily dose of 10 log cfu for 3 wk was safe.

Sequencing and Transcriptional Analysis of the Biosynthesis Gene Cluster of Putrescine-Producing Lactococcus lactis

Lactococcus lactis is a prokaryotic microorganism with great importance as a culture starter and has become the model species among the lactic acid bacteria. The long and safe history of use of L. lactis in dairy fermentations has resulted in the classification of this species as GRAS (General Regarded As Safe) or QPS (Qualified Presumption of Safety). However, our group has identified several strains of L. lactis subsp. lactis and L. lactis subsp. cremoris that are able to produce putrescine from agmatine via the agmatine deiminase (AGDI) pathway. Putrescine is a biogenic amine that confers undesirable flavor characteristics and may even have toxic effects. The AGDI cluster of L. lactis is composed of a putative regulatory gene, aguR, followed by the genes (aguB, aguD, aguA, and aguC) encoding the catabolic enzymes. These genes are transcribed as an operon that is induced in the presence of agmatine. In some strains, an insertion (IS) element interrupts the transcription of the cluster, which results in a non-putrescine-producing phenotype. Based on this knowledge, a PCR-based test was developed in order to differentiate nonproducing L. lactis strains from those with a functional AGDI cluster. The analysis of the AGDI cluster and their flanking regions revealed that the capacity to produce putrescine via the AGDI pathway could be a specific characteristic that was lost during the adaptation to the milk environment by a process of reductive genome evolution.

Scientific Opinion on the safety and efficacy of selenium in the form of organic compounds produced by the selenium-enriched yeastSaccharomyces cerevisiaeNCYC R645 (SelenoSource AF 2000) for all species

SelenoSource AF 2000 is a selenium-containing inactivated yeast (Saccharomyces cerevisiae NCYC R645) enriched during the fermentation process with selenium, intended to be used as nutritional additive for all animal species and categories. Saccharomyces cerevisiae qualifies per se for Qualified Presumption of Safety (QPS); however, the FEEDAP Panel retains that, in this case, the mixture of selenocompounds in the additive is the subject of the evaluation, therefore the QPS approach does not apply. In the absence of data specific to the additive under consideration, and the very limited published data made available by the applicant on the tolerance of animal species to selenised yeast, the FEEDAP Panel is unable to conclude on the safety of SelenoSource AF 2000 in target animals. The FEEDAP Panel reiterates its former conclusion that the use of any selenised yeast would result in similar selenium deposition in animal tissues and products. To ensure consumer safety from consumption of tissues and products of animals treated with SelenoSource AF 2000, the FEEDAP Panel concludes that dietary selenium supplementation from this additive, as for other selenised yeasts, should not exceed a maximum of 0.2 mg Se/kg complete feed. In the absence of relevant information, the FEEDAP Panel could not assess the safety for the user. The use of SelenoSource AF 2000 in feed does not pose a additional risk to the environment, compared to other sources of selenium for which it will substitute. Based on the response of glutathione peroxidase activity and tissue/product deposition of selenium in poultry and pigs, the FEEDAP Panel considers SelenoSource AF 2000 an effective source of selenium for all species. © European Food Safety Authority, 2011

Scientific Opinion on the safety and efficacy of Bacillus subtilis PB6 for chickens reared for laying, ducks for fattening, quails, pheasants, partridges, guinea fowl, pigeons, geese for fattening and ostriches

Bacillus subtilis PB6 is the trade name for a feed additive based on viable spores of a strain of Bacillus subtilis. It is presently authorised for use with chickens for fattening at a minimum dose of 1 × 107 CFU/kg of complete feedingstuffs. The applicant is now seeking authorisation for use with chickens reared for laying, ducks for fattening, quails, pheasants, partridges, guinea fowl, pigeons, geese for fattening and ostriches. B. subtilis is a species that is considered by EFSA to be suitable for Qualified Presumption of Safety (QPS) approach to safety assessment. The sensitivity to antibiotics and the absence of toxigenic potential qualified the strain for QPS status. On this basis the product can be presumed safe for chickens reared for laying, ducks for fattening, quails, pheasants, partridges, guinea fowl, pigeons, geese for fattening, and ostriches, for consumers of products derived from these species, and for the environment. Safety for users was examined in the course of the assessment made for chickens for fattening. In the view of the FEEDAP Panel the use with the additional avian species will not introduce hazards not already considered. Evidence that Bacillus subtilis PB6 has the potential to be efficacious in chickens for fattening can be directly extended to include chickens reared for laying when used at the same dose. By extrapolation from results obtained with a physiologically-similar major species (chickens for fattening) the product is considered efficacious when used with ducks for fattening and quails, pheasants, partridges, guinea fowl, pigeons, geese for fattening and ostriches at a minimum dose of 1 × 107 CFU/kg complete feedingstuffs.

Scientific Opinion on the maintenance of the list of QPS biological agents intentionally added to food and feed (2010 update)

EFSA is requested to assess the safety of a broad range of biological agents (including microorganisms and viruses) in the context of notifications for market authorisation as sources of food and feed additives, enzymes and plant protection products. The qualified presumption of safety (QPS) concept was developed by EFSA for its own use to provide a generic risk assessment approach applicable across EFSA's scientific Panels, for biological agents notified for intentional use in the whole food chain. The safety of unambiguously defined biological agents at the highest taxonomic unit that is appropriate for the purpose for which an application is intended are assessed, considering if the body of knowledge is sufficient. Identified safety concerns for a taxonomic unit could be reflected as ‘qualifications’ when considered appropriate for an inclusion on the QPS list. The list of QPS recommended biological agents is reviewed and updated annually. The 2010 update reviews the previously assessed microorganisms including bacteria, yeasts, filamentous fungi and viruses used for plant protection purposes. The recommendations of biological agents of the previous year were confirmed in the current update. Qualifications relating to the agents recommended for QPS were reviewed, clarified and updated where necessary. Specific sections dealing with antibiotic resistance relevant for QPS recommended microorganisms and yeast were included. The methodology used for carrying out the annual review of the list of QPS recommended biological agents was detailed. A list of microbial species from previous notifications and as notified to EFSA, annexed in this opinion, includes information on taxonomic units which are or are not recommended for the QPS list. This list of notifications aims to summarize and maintain important information for future assessments and updates.

Safety and regulation of yeasts used for biocontrol or biopreservation in the food or feed chain

Yeasts have been important components of spontaneous fermentations in food and beverage processing for millennia. More recently, the potential of utilising antagonistic yeasts, e.g. Pichia anomala and Candida spp., for post-harvest biological control of spoilage fungi during storage of plant-derived produce ('biopreservation') has been clearly demonstrated. Although some yeast species are among the safest microorganisms known, several have been reported in opportunistic infections in humans, including P. anomala and bakers' yeast, Saccharomyces cerevisiae. More research is needed about the dominant pathogenicity and virulence factors in opportunistic yeasts, and whether increased utilisation of biopreservative yeasts in general could contribute to an increased prevalence of yeast infections. The regulatory situation for yeasts used in post-harvest biocontrol is complex and the few products that have reached the market are mainly registered as biological pesticides. The qualified presumption of safety (QPS) approach to safety assessments of microorganisms intentionally added to food or feed, recently launched by the European Food Safety Authority, can lead to more efficient evaluations of new products containing microbial species with a sufficient body of knowledge or long-term experience on their safety. P. anomala is one of several yeast species that have been given QPS status, although the status is restricted to use of this yeast for enzyme and metabolite production purposes. With regard to authorisation of new biopreservative yeasts, we recommend that the possibility to regulate microorganisms for food biopreservation as food additives be considered.

Assessment of antibiotic resistance in probiotic strain Lactobacillus brevis KB290.

Our purpose was to investigate the safety of the probiotic strain Lactobacillus brevis KB290. The European Qualified Presumption of Safety (QPS) evaluation approach was applied to the strain. We determined the strain's antibiotic resistance, verified it at the genetic level, and determined whether it could be transferred to intestinal microflora. Of 14 antibiotics tested, 11 showed MICs within the limits of the QPS criteria. However, the L. brevis KB290 MICs of ciprofloxacin (a fluoroquinolone), tetracycline, and vancomycin were two, four, and eight times, respectively, the breakpoint MICs suggested by the European Scientific Committee on Animal Nutrition, and the MIC of tetracycline was eight times the breakpoint MIC suggested by the European Scientific Panel on Additives and Products or Substances Used in Animal Feed. Using analysis of gapped-genome sequences, we found no known transferable determinants for tetracycline or vancomycin resistance, and we found no mutations in the quinolone resistance-determining regions of the genes encoding GyrA or ParC for ciprofloxacin resistance associated with insertion sequences, integrons, or transposons. These data were confirmed by using PCR primers specific for the respective genes. We assessed the transferability of the resistance traits in conjugation experiments with enterococci and obtained no transconjugants, strongly suggesting that the resistance traits were not transferable. This study demonstrated that the antibiotic resistance observed in L. brevis KB290 was due not to dedicated mechanisms but to intrinsic resistance. According to the QPS criteria, these results provide safety assurance for the ongoing use of L. brevis KB290 as a probiotic.

A Qualified Presumption of Safety approach for the safety assessment of Grana Padano whey starters

A Qualified Presumption of Safety (QPS) approach was applied to dominant lactic acid bacteria (LAB) associated with Grana Padano cheese whey starters. Thirty-two strains belonging to Lactobacillus helveticus, Lactobacillus delbrueckii subsp. lactis, Streptococcus thermophilus, and Lactobacillus fermentum, and representing the overall genotypic LAB diversity associated with 24 previously collected whey starters [Rossetti, L., Fornasari, M.E., Gatti, M., Lazzi, C., Neviani, E., Giraffa, G., 2008. Grana Padano cheese whey starters: microbial composition and strain distribution. International Journal of Food Microbiology 127, 168–171], were analyzed. All L. helveticus, L. delbrueckii subsp. lactis, and S. thermophilus isolates were susceptible to four (i.e. vancomycin, gentamicin, tetracycline, and erythromycin) of the clinically most relevant antibiotics. One L. fermentum strain displayed phenotypic resistance to tetracycline (Tet R), with MIC of 32 µg/ml, and gentamycin (Gm R), with MIC of 32 µg/ml. PCR was applied to this strain to test the presence of genes tet(L), tet(M), tet(S), and aac(6' )-aph(2' )-Ia, which are involved in horizontal transfer of Tet R and Gm R, respectively but no detectable amplification products were observed. According to QPS criteria, we conclude that Grana cheese whey starters do not present particular safety concerns.

Introduction of a Qualified Presumption of Safety (QPS) approach for assessment of selected microorganisms referred to EFSA - Opinion of the Scientific Committee

Introduction of a Qualified Presumption of Safety (QPS) approach for assessment of selected microorganisms referred to EFSA - Opinion of the Scientific Committee

Safe use of genetically modified lactic acid bacteria in food. Bridging the gap between consumers, green groups, and industry

Within the European Union (EU), the use of genetically modified organisms (GMOs) in food production is not widely applied and accepted. In contrast to the United States of America, the current EU legislation limits the introduction of functional foods derived from GMOs that may bring a clear benefit to the consumer. Genetically modified lactic acid bacteria (GM-LAB) can be considered as a different class of GMOs, and the European Union is preparing regulations for the risk assessment of genetically modified microorganisms. Since these procedures are not yet implemented, the current risk assessment procedure is shared for GMOs derived from micro organisms, plants, or animals. At present, the use of organisms in food production that have uncontrolled genetic alterations made through random mutagenesis, is permitted, while similar applications with organisms that have controlled genetic alterations are not allowed. The current paper reviews the opportunities that genetically modified lactic acid bacteria may offer the food industry and the consumer. An objective risk profile is described for the use of GM-LAB in food production. To enhance the introduction of functional foods with proven health claims it is proposed to adapt the current safety assessment procedures for (GM)-LAB and suggestions are made for the related cost accountability. A qualified presumption of safety as proposed by SANCO ( EU SANCO 2003 ), based on taxonomy and on the history of safe use of LAB applied in food, could in the near future be applied to any kind of LAB or GM-LAB provided that a series of modern profiling methods are used to verify the absence of unintended effects of altered LAB that may cause harm to the health of the consumer.