http://sgpwe.izt.uam.mx/files/users/uami/acym/articulo_1.pdf

Food fermentations: Microorganisms with technological beneficial use

The safety of probiotics is tied to their intended use, which includes consideration of potential vulnerability of the consumer or patient, dose and duration of consumption, and both the manner and frequency of administration. Unique to probiotics is that they are alive when administered, and unlike other food or drug ingredients, possess the potential for infectivity or in situ toxin production. Since numerous types of microbes are used as probiotics, safety is also intricately tied to the nature of the specific microbe being used. The presence of transferable antibiotic resistance genes, which comprises a theoretical risk of transfer to a less innocuous member of the gut microbial community, must also be considered. Genetic stability of the probiotic over time, deleterious metabolic activities, and the potential for pathogenicity or toxicogenicity must be assessed depending on the characteristics of the genus and species of the microbe being used. Immunological effects must be considered, especially in ...

https://www.tandfonline.com/doi/pdf/10.4161/gmic.1.3.12127

Safety assessment of probiotics for human use

Members of the genus Bacillus are known to produce a wide arsenal of antimicrobial substances, including peptide and lipopeptide antibiotics, and bacteriocins. Many of the Bacillus bacteriocins belong to the lantibiotics, a category of post-translationally modified peptides widely disseminated among different bacterial clades. Lantibiotics are among the best-characterized antimicrobial peptides at the levels of peptide structure, genetic determinants and biosynthesis mechanisms. Members of the genus Bacillus also produce many other nonmodified bacteriocins, some of which resemble the pediocin-like bacteriocins of the lactic acid bacteria (LAB), while others show completely novel peptide sequences. Bacillus bacteriocins are increasingly becoming more important due to their sometimes broader spectra of inhibition (as compared with most LAB bacteriocins), which may include Gram-negative bacteria, yeasts or fungi, in addition to Gram-positive species, some of which are known to be pathogenic to humans and/or animals. The present review provides a general overview of Bacillus bacteriocins, including primary structure, biochemical and genetic characterization, classification and potential applications in food preservation as natural preservatives and in human and animal health as alternatives to conventional antibiotics. Furthermore, it addresses their environmental applications, such as bioprotection against the pre- and post-harvest decay of vegetables, or as plant growth promoters.

Diversity and applications of Bacillus bacteriocins

[Table: see text]. Abstract This guidance document is intended to assist the applicant in the preparation and the presentation of an application, as foreseen in Article 7.6 of Regulation (EC) No 1831/2003, for the authorisation of additives for use in animal nutrition. It specifically covers the characterisation of microorganisms used as feed additives or as production organisms.

https://efsa.onlinelibrary.wiley.com/doi/pdf/10.2903/j.efsa.2018.5206

Guidance on the characterisation of microorganisms used as feed additives or as production organisms

Monitoring of verotoxigenic Escherichia coli (VTEC) and identification of human pathogenic VTEC types 1 Scientific Opinion of the Panel on Biological Hazards

SUMMARY A wide variety of microbial species are used in food and feed production. Some have a long history of apparent safe use, while others are less well understood and their use may represent a risk for consumers. Experience has shown that there is a need for a tool for setting priorities within the risk assessment of those microorganisms used in food/feed production referred to EFSA and consequently the subject of a formal assessment of safety. To meet this need a system was proposed for a pre-market safety assessment of selected groups of microorganisms leading to a “Qualified Presumption of Safety (QPS)”. In essence this proposed that a safety assessment of a defined taxonomic group (e.g. genus or group of related species) could be made based on four pillars (establishing identity, body of knowledge, possible pathogenicity and end use). If the taxonomic group did not raise safety concerns or, if safety concerns existed, but could be defined and excluded (the qualification) the grouping could be granted QPS status. Thereafter, any strain of microorganism the identity of which could be unambiguously established and assigned to a QPS group would be freed from the need for further safety assessment other than satisfying any qualifications specified. Microorganisms not considered suitable for QPS would remain subject to a full safety assessment. EFSA asked its Scientific Committee to consider whether this system could be used to harmonise approaches to the safety assessment of microorganisms across the various EFSA scientific panels. If so, the Committee was requested to develop a strategy for the introduction of an assessment system based on the QPS concept.

Introduction of a Qualified Presumption of Safety (QPS) approach for assessment of selected microorganisms referred to EFSA 1 Opinion of the Scientific Committee

SUMMARY The founding Regulation of EFSA 3 requires the Authority to contribute to a high level of protection of human life and health, and in this respect to take account of animal health and welfare. EFSA is committed to a proactive animal welfare approach, based on sound scientific principles and the need to ensure that adequate data are available for a reliable risk assessment. In this context, EFSA and its Scientific Committee recognise the importance to stimulate the use of food and feed assessment approaches that would not only minimise the number of experimental animals and any suffering, but also work towards their replacement. The present Opinion gives an overview of the legislation and guiding principles on the use of animals for experimental purposes and explains the principles of scientific validation of toxicity tests for regulatory purposes. It summarises possibilities for replacement, reduction and refinement (Three Rs) of toxicological animal testing within the different areas of EFSA’s activities. Finally, integrated testing and risk assessment strategies are considered and recommendations are given to implement better animal welfare within EFSA’s activities. Most of the assessments conducted by EFSA’s Scientific Committee and Scientific Panels require experimental data. The complete replacement of animal experiments while maintaining the same level of food and feed safety is not possible at present. However in the meantime, considerable improvements can be made to promote better animal welfare. In this 1 For citation purposes: Opinion of the Scientific Committee on a request from EFSA on existing approaches incorporating

Scientific Opinion of the Scientific Committee "Existing approaches incorporating replacement, reduction and refinement of animal testing: applicability in food and feed risk assessment" 1

In about ten years of activity, the Scientific Committee of EFSA has been successful in addressing a number of challenging areas of increasingly complex nature related to scientific and procedural aspects of risk assessment in the food and feed chain. The scientific outputs adopted so far by the Scientific Committee are summarised and assigned to the three main areas of responsibility that the Scientific Committee covers: (i) opinions dealing with innovative risk assessment methodologies; (ii) opinions aiming at ensuring transparency and improving quality of specific components of risk assessment; and (iii) opinions addressing risk assessment of specific multisectoral issues. The main future challenge for the Scientific Committee will be in assisting EFSA to implement its ‘Science Strategy’ for the years 2012-2016, a recently developed and highly sophisticated approach: (i) to further develop EFSA’s scientific excellence, and other core values, such as openness, transparency, independence and responsiveness; (ii) to optimise the use of European risk assessment capacity across the EU; (iii) to develop and harmonise methodologies and approaches to assess risks associated with the food/feed chain; and (iv) to strengthen the scientific basis for risk assessment and risk monitoring in the food/feed chain.

https://efsa.onlinelibrary.wiley.com/doi/pdf/10.2903/j.efsa.2012.s1001

Ada Knaap

Papers

Introduction of a Qualified Presumption of Safety (QPS) approach for assessment of selected microorganisms referred to EFSA 1 Opinion of the Scientific Committee

Scientific Opinion of the Scientific Committee "Existing approaches incorporating replacement, reduction and refinement of animal testing: applicability in food and feed risk assessment" 1

Main achievements and challenges of the EFSA Scientific Committee since its inception