Food systems microbiome-related educational needs.

Within the European-funded Coordination and Support Action MicrobiomeSupport (https://www.microbiomesupport.eu/), the Workshop 'Education in Food Systems Microbiome Related Sciences: Needs for Universities, Industry and Public Health Systems' brought together over 70 researchers, public health and industry partners from all over the world to work on elaborating microbiome-related educational needs in food systems. This publication provides a summary of discussions held during and after the workshop and the resulting recommendations.

Preparing for future challenges in risk assessment in the European Union.

In light of the new EU policy targets (e.g., Farm to Fork strategy) and the revised legal framework (Transparency Regulation), the European Food Safety Authority (EFSA) needs to invest further in preparedness in regulatory and communication science for food safety. To achieve this, EFSA has established a process of advancing selected scientific themes to anticipate future challenges.

Emerging technologies and their impact on regulatory science.

There is an evolution and increasing need for the utilization of emerging cellular, molecular and in silico technologies and novel approaches for safety assessment of food, drugs, and personal care products. Convergence of these emerging technologies is also enabling rapid advances and approaches that may impact regulatory decisions and approvals. Although the development of emerging technologies may allow rapid advances in regulatory decision making, there is concern that these new technologies have not been thoroughly evaluated to determine if they are ready for regulatory application, singularly or in combinations. The magnitude of these combined technical advances may outpace the ability to assess fit for purpose and to allow routine application of these new methods for regulatory purposes. There is a need to develop strategies to evaluate the new technologies to determine which ones are ready for regulatory use. The opportunity to apply these potentially faster, more accurate, and cost-effective approaches remains an important goal to facilitate their incorporation into regulatory use. However, without a clear strategy to evaluate emerging technologies rapidly and appropriately, the value of these efforts may go unrecognized or may take longer. It is important for the regulatory science field to keep up with the research in these technically advanced areas and to understand the science behind these new approaches. The regulatory field must understand the critical quality attributes of these novel approaches and learn from each other's experience so that workforces can be trained to prepare for emerging global regulatory challenges. Moreover, it is essential that the regulatory community must work with the technology developers to harness collective capabilities towards developing a strategy for evaluation of these new and novel assessment tools.

Regulatory landscape of nanotechnology and nanoplastics from a global perspective.

Nanotechnology and more particularly nanotechnology-based products and materials have provided a huge potential for novel solutions to many of the current challenges society is facing. However, nanotechnology is also an area of product innovation that is sometimes developing faster than regulatory frameworks. This is due to the high complexity of some nanomaterials, the lack of a globally harmonised regulatory definition and the different scopes of regulation at a global level. Research organisations and regulatory bodies have spent many efforts in the last two decades to cope with these challenges. Although there has been a significant advancement related to analytical approaches for labelling purposes as well as to the development of suitable test guidelines for nanomaterials and their safety assessment, there is a still a need for greater global collaboration and consensus in the regulatory field. Furthermore, with growing societal concerns on plastic litter and tiny debris produced by degradation of littered plastic objects, the impact of micro- and nanoplastics on humans and the environment is an emerging issue. Despite increasing research and initial regulatory discussions on micro- and nanoplastics, there are still knowledge gaps and thus an urgent need for action. As nanoplastics can be classified as a specific type of incidental nanomaterials, current and future scientific investigations should take into account the existing profound knowledge on nanotechnology/nanomaterials when discussing issues around nanoplastics. This review was conceived at the 2019 Global Summit on Regulatory Sciences that took place in Stresa, Italy, on 24-26 September 2019 (GSRS 2019) and which was co-organised by the Global Coalition for Regulatory Science Research (GCRSR) and the European Commission's (EC) Joint Research Centre (JRC). The GCRSR consists of regulatory bodies from various countries around the globe including EU bodies. The 2019 Global Summit provided an excellent platform to exchange the latest information on activities carried out by regulatory bodies with a focus on the application of nanotechnology in the agriculture/food sector, on nanoplastics and on nanomedicines, including taking stock and promoting further collaboration. Recently, the topic of micro- and nanoplastics has become a new focus of the GCRSR. Besides discussing the challenges and needs, some future directions on how new tools and methodologies can improve the regulatory science were elaborated by summarising a significant portion of discussions during the summit. It has been revealed that there are still some uncertainties and knowledge gaps with regard to physicochemical properties, environmental behaviour and toxicological effects, especially as testing described in the dossiers is often done early in the product development process, and the material in the final product may behave differently. The harmonisation of methodologies for quantification and risk assessment of nanomaterials and micro/nanoplastics, the documentation of regulatory science studies and the need for sharing databases were highlighted as important aspects to look at.

Regulatory landscape of dietary supplements and herbal medicines from a global perspective.

The number of Individuals that use dietary supplements and herbal medicine products are continuous to increase in many countries. The context of usage of a dietary supplement varies widely from country-to-country; in some countries supplement use is just limited to general health and well-being while others permit use for medicinal purposes. To date, there is little consensus from country to country on the scope, requirements, definition, or even the terminology in which dietary supplement and herbal medicines categories could be classified. Transparent science-based quality standards for the ingredients across these regulatory frameworks/definitions becomes even more important given the international supply chain. Meanwhile, there has been a rapid advancement in emerging technologies and data science applied to the field. This review was conceived at the Global Summit on Regulatory Sciences that took place in Beijing on September 2018 (GSRS2018) which is organized by Global Coalition for Regulatory Science Research (GCRSR) that consists of the global regulatory agencies from over ten countries including the European Union. This review summarizes a significant portion of discussions relating to a longitudinal comparison of the status for dietary supplements and herbal medicines among the different national jurisdictions and to the extent of how new tools and methodologies can improve the regulatory application.

Advancing biological hazards risk assessment.

This paper focusses on biological hazards at the global level and considers the challenges to risk assessment (RA) from a One Health perspective. Two topics - vector-borne diseases (VBD) and antimicrobial resistance (AMR) - are used to illustrate the challenges ahead and to explore the opportunities that new methodologies such as next-generation sequencing can offer. Globalisation brings complexity and introduces drivers for infectious diseases. Cooperation and the application of an integrated RA approach - one that takes into consideration food farming and production systems including social and environmental factors - are recommended. Also needed are methodologies to identify emerging risks at a global level and propose prevention strategies. AMR is one of the biggest threats to human health in the infectious disease environment. Whereas new genomic typing techniques such as whole genome sequencing (WGS) provide further insights into the mechanisms of spread of resistance, the role of the environment is not fully elucidated, nor is the role of plants as potential vehicles for spread of resistance. Historical trends and recent experience indicate that (re)-emergence and/or further spread of VBD within the EU is a matter of when rather than if. Standardised and validated vector monitoring programs are required to be implemented at an international level for continuous surveillance and assessment of potential threats. There are benefits to using WGS - such as a quicker and better response to outbreaks and additional evidence for source attribution. However, significant challenges need to be addressed, including method standardisation and validation to fully realise these benefits; barriers to data sharing; and establishing epidemiological capacity for cluster triage and response.

EFSA's third Scientific Conference 'Science, Food, Society': concluding remarks.

From 18-21 September 2018, EFSA hosted its third Scientific Conference on Science, Food and Society in Parma, Italy. This paper summarises the overall recommendations on future actions and research priorities of the conference and complements the earlier multi-authored papers in this issue. The conference started and closed with the plenary sessions 'where science meets society: putting risk assessment in context' and 'staying relevant in a changing world', respectively. In between, there were seven breakout sessions five of which aimed at advancing risk assessment science in the areas of human health, the environment, biological hazards, nutrition and managing evidence, and two of which were dedicated to the societal aspects of risk assessment: engaging with society and envisioning the expertise of the future. During the 4 days of the event, participants addressed the complex interplay between science, risk assessment, policy and society, and explored how to advance food safety risk assessment to address the challenges of a changing world and ensure preparedness. Acknowledging that good science alone is no longer sufficient to ensure fit-for-purpose food safety risk assessments, EFSA must further build on its current five Strategic Objectives. To ensure that its risk assessments remain scientifically robust and sound, EFSA should strive for robust and fit-for-purpose risk assessments; consider food in the context of safety, nutrition and sustainability; and explore further how EFSA can work with other organisations to achieve the One Health/One Environment goals. In addition, EFSA should base scientific risk assessments on reliable science while capitalising on scientific advances; address scientific uncertainties; and fully publish the evidence and data used. In line with societal expectations, EFSA, in coordination with risk managers, should frame risk assessments through clear policy goals and problem formulation; be explicit about value judgements; communicate clearly and consistently and in coordination with risk assessors and risk managers; involve society; avoid conflicts of interest; and follow trustworthy processes.

Emerging technologies for food and drug safety.

Emerging technologies are playing a major role in the generation of new approaches to assess the safety of both foods and drugs. However, the integration of emerging technologies in the regulatory decision-making process requires rigorous assessment and consensus amongst international partners and research communities. To that end, the Global Coalition for Regulatory Science Research (GCRSR) in partnership with the Brazilian Health Surveillance Agency (ANVISA) hosted the seventh Global Summit on Regulatory Science (GSRS17) in Brasilia, Brazil on September 18-20, 2017 to discuss the role of new approaches in regulatory science with a specific emphasis on applications in food and medical product safety. The global regulatory landscape concerning the application of new technologies was assessed in several countries worldwide. Challenges and issues were discussed in the context of developing an international consensus for objective criteria in the development, application and review of emerging technologies. The need for advanced approaches to allow for faster, less expensive and more predictive methodologies was elaborated. In addition, the strengths and weaknesses of each new approach was discussed. And finally, the need for standards and reproducible approaches was reviewed to enhance the application of the emerging technologies to improve food and drug safety. The overarching goal of GSRS17 was to provide a venue where regulators and researchers meet to develop collaborations addressing the most pressing scientific challenges and facilitate the adoption of novel technical innovations to advance the field of regulatory science.

Estimating the public health impact of setting targets at the European level for the reduction of zoonotic Salmonella in certain poultry populations.

In the European Union (EU), targets are being set for the reduction of certain zoonotic Salmonella serovars in different animal populations, including poultry populations, within the framework of Regulation (EC) No. 2160/2003 on the control of zoonoses. For a three-year transitional period, the EU targets were to cover only Salmonella Enteritidis and S. Typhimurium (and in addition S. Hadar, S. Infantis and S. Virchow for breeding flocks of Gallus gallus). Before the end of that transitional period, the revision of the EU targets was to be considered, including the potentially addition of other serovars with public health significance to the permanent EU targets. This review article aims at providing an overview of the assessments carried out by the Scientific Panel on Biological Hazards of the European Food Safety Authority in the field of setting targets for Salmonella in poultry populations (breeding flocks of Gallus gallus, laying flocks of Gallus gallus, broiler flocks of Gallus gallus and flocks of breeding and fattening turkeys) and their impact in subsequent changes in EU legislation.

Pros and cons of carcass decontamination: The role of the European Food Safety Authority.

Various intervention strategies to control foodborne pathogens have been identified and applied through the whole food chain. Physical, chemical, biological treatments applied alone or in combination have been studied and proved to reduce the number and the prevalence of bacterial contamination of meat surfaces such as carcasses. The various treatments have their own advantages and disadvantages. In EU, chemical decontamination was not permitted until the recent revision of European food hygiene legislation which allows the use of substances other than water for the removal of meat surface bacterial contamination. The European Commission will authorise the use of such substances after the European Food Safety Authority (EFSA) has provided a chemical and a microbiological risk assessment. For this purpose, EFSA issued a guidance document which points out the major components and prerequisites that a study/dossier should contain in order to prove that the substance intended to be used for the removal of microbial surface contamination of foods of animal origin (i) would not pose any appreciable risk to the public health (safety or chemical assessment) and (ii) would result in a significant reduction of the prevalence and the numbers of pathogenic target bacteria when compared to the control and when this reduction is at the same time of relevance to human health (efficacy or microbiological risk assessment). The current paper deals only with microbiological safety issues.

Risk assessment of biological hazards in the European Union.

International, community and national food safety law and any subsequent decision-making practices aim to be based on risk analysis--a process consisting of risk assessment, risk management and risk communication. With the appointment of the European Food Safety Authority as an independent scientific point of reference in risk assessment, there is a clear functional separation between risk assessment and risk management in the European Union food safety context. When a food safety question on microbiological hazards is to be answered--which is under the remit of the EFSA's Scientific Panel on Biological Hazards (BIOHAZ)--extensive dialogue and interactions covering the clarity of the question, the acceptability of the deadline and the availability of all necessary information take place with both the risk managers who ask the question and the stakeholders. During the first mandate of the BIOHAZ Panel (2003-2006), the scientific opinions were mainly based on qualitative and in some cases semi-quantitative microbiological risk assessment. In the second mandate of the BIOHAZ Panel, and as a first step towards developing a European approach on Quantitative Microbiological Risk Assessment (QMRA), EFSA is preparing to carry out a QMRA on Salmonella in pigs, at European level through a consortium of European institutes.

Starter cultures and high-pressure processing to improve the hygiene and safety of slightly fermented sausages.

The effectiveness of selected starter cultures and high hydrostatic pressure after ripening was evaluated to improve the safety and quality of slightly fermented sausages. Inhibition of common foodborne pathogens, spoilage bacteria, and biogenic amine content was studied. Random amplification of polymorphic DNA and plasmid profiles were used to monitor the competitiveness of the starter cultures during fermentation and ripening. Lactobacillus sakei CTC6626 and Staphylococcus xylosus CTC6013 dominated L. sakei CTC6469 and S. xylosus CTC6169 independently of the product assayed. Starter cultures were able to control the growth of Listeria monocytogenes, Enterobacteriaceae, Enterococcus, and the biogenic amine content. A pH decrease below 5.3 at the seventh day of fermentation was crucial. Salmonella spp. counts decreased significantly during ripening independently of the use of starter culture and product. High hydrostatic pressure treatment was necessary to ensure absence of Salmonella spp. in final products.

Control of Listeria monocytogenes in model sausages by enterocin AS-48.

In this work we describe the control of Listeria monocytogenes CECT 4032 in sausage by adding the enterocin AS-48 producer strains Enterococcus faecalis A-48-32 and Enterococcus faecium S-32-81, and also by adding a semi-purified preparation of the bacteriocin. Addition of preformed AS-48 caused a significant decrease (P<0.01) in the number of viable listeria even at the lowest bacteriocin concentration tested (112 AU/g). At a higher concentration (225 AU/g) listeria were below the detection level (1.99 log units/g) in meat at 3 days of incubation but growth of listeria was observed again after 9 days. For an AS-48 concentration of 450 AU/g, no viable listeria were detected after 6 and 9 days of incubation. When E. faecalis A-48-32 was used as inoculum at approximately 10(7) cfu/g, listeria counts decreased progressively from start of experiment, being below detection level at day 9. The best results were obtained with E. faecium S-32-81, since listeria were undetectable at 6 days of incubation. Bacteriocin concentrations in samples reached concentrations of 60 and 80 AU/g for strains A-48-32 and S-32-81, respectively. These results clearly indicate that AS-48 can be used in the control of L. monocytogenes in sausages.