TECHNICAL REPORT APPROVED: 17 January 2017 doi:10.2903/sp.efsa.2017.en-1166 Abstract Horizon 2020: EFSA s Priority Research Topics European Food Safety Authority (EFSA), Georges Kass, Jeffrey Moon and Tobin Robinson In 2011, the European Commission established Horizon 2020, the next Framework Programme for Research and Innovation and the first calls for research projects were launched in 2014. Horizon 2020 has three main research priorities Part I: Excellent Science; Part II: Industrial Leadership; Part III: Societal Challenges. In this context, EFSA s activities and the related research areas fall under Societal Challenges and the continuation of identifying research priorities and communicating these priorities to Director-General Research and Innovation (DG-R&I), Director-General Research Agriculture and Rural development (DG-AGRI) and Director General for Health and Food Safety (DG-SANTE) is an important aspect of EFSA s Science Strategy. In order to support the Commission in this activity, EFSA has consulted with the Advisory Forum (AF), the Scientific Committee (SC), and EFSA s scientific panels and units. This technical report summarises the results of this consultation. It identified five priority research topics in the food and feed safety area. The selection of the priority topics was from a total of 60 proposals received after screening against the following criteria: Horizon 2020 prioritisation strategy, innovation and EFSA s 2020 strategy and existing priorities. The following priority topics were identified: 1. Microplastic and nanoplastic particles in food; 2. Honey bee health; 3. Foodborne viruses; 4. Risk assessment methodologies; 5. Development of European Cloud-based integrated data collection, data management, data analysis and reporting system for food safety. EFSA will continue to support the European Commission in identifying priority research topics in the food and feed safety area through a biannual consultation of the AF, SC and its panels and units. European Food Safety Authority, 2017 Key words: Horizon 2020, EFSA consultation, priority topics, research, scientific panels, advisory forum, scientific committee Requestor: EFSA Question number: EFSA-Q-2015-00090 Correspondence: scer@efsa.europa.eu www.efsa.europa.eu/publications EFSA Supporting publication 2017:EN-1166
Horizon 2020: EFSA s Priority Research Topics Acknowledgements: EFSA wishes to thank the following for the support provided to this scientific output: the members of the Advisory Forum, the members of the Scientific Committee, the members of all scientific panels and units. Suggested citation: EFSA (European Food Safety Authority), Kass G, Moon J and Robinson T, 2017. Horizon 2020: EFSA s Priority Research Topics. EFSA supporting publication 2017:EN-1166. 11 pp. doi:10.2903/sp.efsa.2017.en-1166 ISSN: 2397-8325 European Food Safety Authority, 2017 Reproduction is authorised provided the source is acknowledged. www.efsa.europa.eu/publications 2 EFSA Supporting publication 2017:EN-1166
Table of contents Abstract... 1 1. Introduction... 4 1.1. Background and Terms of Reference as provided by EFSA... 4 2. EFSA s priority topics for Horizon 2020... 5 2.1. Introduction... 5 2.2. Results of the 2016 consultation... 6 2.3. Selection criteria for the proposals received... 6 2.4. Results of the 2016 Consultation: EFSA s Priority Topics... 6 3. Conclusions and recommendations... 9 References... 10 Abbreviations... 11 www.efsa.europa.eu/publications 3 EFSA Supporting publication 2017:EN-1166
1. Introduction 1.1. Background and Terms of Reference as provided by EFSA The identification of research priorities and the communication of such priorities to Commission services (Director-General for Research and Innovation (DG-R&I) and Director-General Research for Agriculture and Rural development (DG-AGRI), Directorate General for Health and Food Safety (DG- SANTE) and the Joint Research Centre (JRC) as well as the Member States is an important aspect of EFSA s Science Strategy as defined in the document entitled EFSA Strategy 2020: Trusted science for safe food. 1 Horizon 2020 is the current Framework Programme for Research and Innovation (2014-2020) as a follow-up to the 7th research Framework Programme (FP7). Its work programme is complemented by the separate work programmes for the European Research Council, Euratom, the Joint Research Centre and the Strategic Innovation Agenda for the European Institute of Innovation and technology (EIT). Funding opportunities under Horizon 2020 are set out in multiannual work programmes, which cover the large majority of support available. The work programmes are prepared by the European Commission within the framework provided by the Horizon 2020 legislation and through a strategic programming process integrating EU policy objectives in the priority setting. Horizon 2020 is now entering its final phase, work programmes 2018-2020. Horizon 2020 has three main research priorities (corresponding to three Sections in the programme document) namely: Part I: Excellent Science Part II: Industrial Leadership Part III: Societal Challenges Overall, part III of Horizon 2020 Societal challenges is of high relevance to EFSA s remit and is structured under two main headings and sub-headings as following Horizon 2020 headings: 1. Health, Demographic change and wellbeing 1.1. Personalising health and care 1.2. Coordination activities 1.3. Other activities 1.4. Scientific Panel for Health 1.5. Horizon Prize for better use of antibiotics 1.6. R&I performers 2. Food Security, Sustainable Agriculture and Forestry, Marine, Maritime and Inland Water Research and the Bioeconomy 2.1. Agriculture and forestry 2.2. Agri-food sector for a safe and healthy diet 2.3. Bio-based industries The approach being taken with Horizon 2020 is one which involves cross cutting actions which will lead to interactions between the areas of Excellent Science, Industrial Technologies and Societal Challenges. The continuation of identifying research priorities and communicating these priorities to DG-R&I, DG- AGRI, DG-SANTE is an important aspect of EFSA s Science Strategy relating to strengthening the scientific evidence for risk assessment and risk monitoring. In order to support the European Commission in this activity, EFSA has consulted on multiple occasions over the period 2010-2016 the Advisory Forum (AF), the Advisory Forum Communication Working Group (AFCWG), the Scientific 1 http://www.efsa.europa.eu/sites/default/files/corporate_publications/files/strategy2020.pdf www.efsa.europa.eu/publications 4 EFSA Supporting publication 2017:EN-1166
Committee (SC), and EFSA s scientific panels and units. These consultations have resulted in four annual-biannual reports identifying priority areas that were communicated in the form of an internal report and a letter to DG-R&I, DG-AGRI and DG-SANTE. From the 2012 consultation, eight priority areas were identified and following dialogue with the DG- R&I and the DG-AGRI, these eight thematic research priorities were rearranged under the appropriate Horizon 2020 headings and communicated to DG-R&I, DG-AGRI and DG-SANTE. In 2013, a new round of consultation was performed at EFSA between February and April 2013, the consultation reaffirmed the eight topics of priority and identified all together 56 topics under the Horizon 2020 headings and sub-headings. A technical report describing the 56 topics was submitted to the directors of DG-R&I, DG-AGRI and DG-SANTE. The report recommended a similar yearly consultation exercise at EFSA to provide timely support to the priority areas of Horizon 2020 and for the launching of the first specific Horizon 2020 calls. This multiannual project deals with a the yearly consultation of EFSA panels, units, the Scientific Committee and the Advisory Forum regarding priority research topics to support the European Commission in identifying priority areas and launching calls for Horizon 2020 in the areas of EFSA s remit. TERMS OF REFERENCE AS PROVIDED BY EFSA The SCER unit is invited, on an annual basis and up to the final call related to the work programme 2018-2020 within Horizon 2020, to: -Publish a technical report summarising areas of research that are a priority for EFSA. The report should be produced through consultation with all EFSA scientific panels, EFSA units, the Scientific Committee and the Advisory Forum, and communicated to DG-SANTE, DG-AGRI, DG-R&I, DG-ENV. 2. EFSA s priority topics for Horizon 2020 2.1. Introduction This technical report summarises the 2016 consultation exercise of EFSA panels and units, the Scientific Committee and the Advisory Forum regarding priority research topics to support the European Commission in identifying priority areas for the upcoming work programme 2018-2020 for Horizon 2020 in the areas of EFSA s remit. The consultation was performed during the summer and autumn of 2016 and each of EFSA panels and units, the Scientific Committee and the Advisory Forum were requested to identify research priority areas as high level projects, taking into account the prioritisation criteria outlined below, and to arrange these priority topics under the appropriate headings of Horizon 2020 to provide greater clarity on how these work areas and themes link to the overall structure of Horizon 2020. The Horizon 2020 programme will be entering its final phase in the form of the work programme 2018-2020. EFSA s report is aimed at providing suggestions to be considered during the drafting phase of the 2018-2020 Work Programme, which will be the final programme round of Horizon 2020. From the feedback received from the European Commission, the strategy used for the 2016 consultation exercise was to identify a limited number of top priority projects that fall within EFSA s Science Strategy as defined in the document entitled EFSA Strategy 2020: Trusted science for safe food. 2 The selection criteria also took into account the evolution of the priorities and approach within the Horizon 2020 that has occurred since the start of the programme (see below). 2 http://www.efsa.europa.eu/sites/default/files/corporate_publications/files/strategy2020.pdf www.efsa.europa.eu/publications 5 EFSA Supporting publication 2017:EN-1166
2.2. Results of the 2016 consultation Following the call launched on 30 June 2016, 60 proposals were received from EFSA s units, the scientific panels, the Scientific Committee and EFSA s Advisory Forum. An overview of the proposals received can be found under Appendix A. The distribution of the proposals received is shown in Figure 1. Units Panels/SC AF Figure 1. Source of the proposals received during the 2016 Horizon 2020 consultation. SC, Scientific Committee; AF, Advisory Forum 2.3. Selection criteria for the proposals received All proposals received were checked against the following three groups of criteria. a. Criteria of the Horizon 2020 programme Since the start of the Horizon 2020 programme, there has been an evolution in the approach to define priority areas and the types of project calls. Emphasis is placed on: Long-term projects (e.g. 4-5 years). While there is always a need to address acute priorities, there is need to reflect on strategic topics providing durable long-term solutions. Tangible deliverables for the EU. Particular focus should be made on the impact that projects in the areas presented can have. The potential for the areas to deliver market-creating innovation. b. Innovation In the past, a considerable number of recommendations had already been addressed in past calls under FP6 and 7. All submitted proposals were checked against the CORDIS database (http://cordis.europa.eu/) to ensure the proposed project has not already been funded through past calls by the EU. c. EFSA s strategy and existing priorities The submitted proposals were screened against EFSA s strategic priorities as set in in the document entitled EFSA Strategy 2020: Trusted science for safe food 3 and other initiatives, such as the research needs identified in the scientific workshop on foodborne viruses organised jointly by EFSA and the UK Food Standards Agency. 4 2.4. Results of the 2016 Consultation: EFSA s Priority Topics The 60 proposals received covered areas as diverse as nanomaterials, natural toxins, pathogens from food, risk assessment methodologies and science communication. A list of the submitted topics can be found under Table 1. 3 http://www.efsa.europa.eu/sites/default/files/corporate_publications/files/strategy2020.pdf 4 Cefas, 2016. Report of the Joint FSA/EFSA Workshop on Foodborne Viruses. EFSA supporting publication 2016:EN-1103. 47 pp. www.efsa.europa.eu/publications 6 EFSA Supporting publication 2017:EN-1166
Table 1. Overview of the subject areas covered by the submitted proposals Microplastic and nanoplastic particles in food Epigenetics in chemical risk assessment Endocrine active substances and food safety Mixture of substances with same MOA or same target tissues: toxicology and exposure Honey bee health Antimicrobial and antibiotic resistance Bacterial pathogens in food and feed Viral pathogens in food Risk assessment methodologies: o Evidence-based methods in the area of food safety o Development and validation of micronucleus assay techniques in tissues other than bone marrow and peripheral blood o The use of non-animal test methods for the exploration and evaluation of developmental neurotoxicity Food crises and risk communication strategies Environmental risk assessment: persistent chemicals Pesticides: resistance, persistence and exposure Plant pests Non-plastics in Food Contact Materials (FCM) Natural toxins (microbial and fungal) Exposure monitoring Nanomaterials in food Development of European Cloud-based integrated data collection, data management, data analysis and reporting system for food safety Following the screening of the proposals against the selection criteria outlined under (2.3.) including their prioritisation against EFSA s strategy and existing priorities, the following priority topics were identified. 1. Microplastic and nanoplastic particles in food This proposal is aimed at characterising exposure and hazards from microplastic and nanoplastic particles in food. Recent evaluations indicate an emerging risk for the marine environment and possible threat to human health. On top of that, there is a general lack of data on occurrence of microplastic and nanoplastic particles in food, in part due to a lack of suitable analytical methods for the detection and quantification of such particles in food. There is a gap of information on the toxicity and toxicokinetics of both microparticles and nanoparticles, including on adsorbed substances such as biocides. Research programmes aiming at generating data on presence and toxicity of microplastic and nanoplastic particles in food would are necessary for a comprehensive risk assessment. 2. Honey bee health This proposal is addressing the development, validation and implementation of a Health Status Index to assess and compare honeybee colony health in time and space. There is a worldwide decline in honey bee populations and colonies due to the impact of multiple stressors, including pesticides. Honey bees are critically important in the environment, sustaining biodiversity by providing essential pollination for a wide range of crops and wild plants. They contribute to human wealth and wellbeing directly through the production of honey and other food and feed supplies such as: pollen, wax for food processing, propolis in food technology, and royal jelly as a dietary supplement and ingredient in food. EFSA s HEALTHY-B scientific opinion (EFSA, 2016) provides an overview of the available tools that can be used to assess the health status of managed honeybee colonies in a standardised manner across the EU. It is explained how a Health Status Index could be generated to integrate data of several bee health indicators and factors from the environment that determine the health status of the colony. This would allow comparing the evolution of bee health in time and across geographical locations (from apiary to EU level) and might in the future be able to predict changes in the health status of a colony. However, collaboration amongst beekeepers, bee inspectors and scientists is required (combination of applied research, statistical analysis and organisation of training) at the EU level to further develop, validate and implement such a Health Status Index. www.efsa.europa.eu/publications 7 EFSA Supporting publication 2017:EN-1166
3. Viral Pathogens in Food The problem of foodborne viruses is addressed in this proposal. Illness associated with microbial contamination of food has been known for decades and risks from bacterial contamination of foods have been, in many cases, well characterised and risk-managed. However, it has been recognised that the particular risks posed by viruses, which may behave very differently than bacteria, are rather more poorly characterised and controlled. In many cases, the control methods applied for bacterial contamination of foods are inadequate for the control of viruses. In 2007, the World Health Organisation Food and Agriculture Office (WHO/FAO) identified that hepatitis A virus and norovirus in bivalve shellfish, fresh produce, and prepared foods were identified as the highest risk pathogens and commodities. The key areas that would benefit from a major EU-wide and coordinated research programme with a major impact on human health and the EU economy are: 1. Development and validation of direct and indirect methods for assessment of hepatitis E virus infectivity; 2. Establishing how the detection of norovirus in foodstuffs relates to public health risks; 3. Development of methods to evaluate norovirus and hepatitis A infectivity from food samples; 4. Development of standard methods and ISO methods for detection of hepatitis E virus in meat and meat products; 5. Establishing the burden of hepatitis E virus infections in humans in Europe. 4. Risk assessment methodologies The work of EFSA and other international risk assessment agencies requires robust and trusted risk assessment methodologies. The three proposals described below address key methodological areas that are expected to have a major long term impact on risk assessment methodologies and approaches. a. Development and validation of micronucleus assay techniques in tissues other than bone marrow and peripheral blood Genotoxicity evaluation is the first step in the toxicity assessment of chemicals. The chromosomal aberration assay is not recommended for investigating aneugenicity, and at present, the only validated in vivo method to test for both clastogenicity and aneugenicity is the micronucleus assay in erythrocytes from bone marrow or peripheral blood. However, many substances cannot reach the bone marrow due to their absorption, distribution or metabolism. Consequently, a negative micronucleus assay in bone marrow with no evidence that the substance has reached the bone marrow cannot be taken as evidence for an absence of genotoxic potential. Therefore, the micronucleus assay needs developing and validating for use in other tissues of the body. This is to allow investigating the genotoxicity of chemicals in their most appropriate tissue(s), according to the mode of action of the substance of interest. The development of the assay would greatly improve the assessment of genotoxicity by reducing current uncertainty associated with the in vivo risk assessment of potentially aneugenic compounds in many areas, including food and feed safety, drug safety, etc.. Furthermore, the possibility to perform the micronucleus assay in different tissues of the same animal or to integrate the test, e.g. in repeated dose studies, would be of benefit for the reduction and refinement of animal testing (according to the 3R principle). The nature of the project would necessitate a multi-laboratory, multi-country and multi-substance approach, and would greatly benefit from an EU-wide and EU-coordinated approach. b. The use of non-animal test methods for the exploration and evaluation of developmental neurotoxicity A consensus exists among academic scientists and regulatory risk assessors that current data requirements for developmental neurotoxicity (DNT) testing are not sufficient to screen and characterise potentially hazardous compounds. Agreement also exists on the need to generate a sufficient body of data for the effects of chemicals on the developing nervous system through the systematic use of a standardised in vitro testing battery. The need for more effective DNT screening is driven by the scientific fact that the developing nervous system is particularly sensitive to chemical exposures. In addition, recent societal concerns have been www.efsa.europa.eu/publications 8 EFSA Supporting publication 2017:EN-1166
raised linking the rise in children s neurodevelopmental disorders (e.g., learning disabilities) to chemical exposures. A clear deficit exists in knowledge concerning potential chemical related DNT owing to the complexity of accepted guideline studies: time- and cost-intensive, use large numbers of experimental animals, methodological and scientific uncertainties. A complementary in vitro testing battery conducted in a relevant cell system using humanderived cells will reduce the uncertainties in using an in vitro system for regulatory decision making. The expected outcome of the project, i.e. testing a large number of chemical substances in the whole battery, will provide empirical evidence for definition of the specificity and sensitivity of the testing battery. This is an essential condition for the application of the testing battery for regulatory uses. Reduction and refinement of animal use is also an expected outcome. Reduction in number will be immediate as the testing battery will be based on human derived cell systems. However the development of the battery requires substantial testing of chemical substances to understand the performance of the whole battery and decrease the uncertainties in data interpretation allowing a fit-for purpose regulatory application. This can only be achieved through a multi-country, multi-laboratory collaborative effort that should be EU-wide and EU-coordinated. c. Development of new methods to measure nanomaterials in food This proposal addresses the development of new methods to measure nanomaterials in food matrices and assess their bioavailability. The use of engineered nanomaterials for use in different food matrices and the implications for food safety is attracting considerable attention. The impact of new methods to measure nanomaterials in food matrices and assess their bioavailability will be crucial for the safety assessment of engineered nanomaterials for use in different food matrices. The approach to this project would be multi-disciplinary as it would range from the measuring of the physicochemical properties of nanomaterials in food matrices to the bioavailability and risk characterisation of (engineered) nanomaterials in the food matrix. 5. Development of European Cloud-based integrated data collection, data management, data analysis and reporting system for food safety The design, development and testing of an integrated system for harmonising, collecting, analysing and sharing data based on the web concept of cloud. The system should be developed and tested in the analytical data in the domain of food safety (monitoring of chemical contaminants or residues and biological hazards), but it would be equally applicable in other domains like other food data or environmental data. Harmonised data generation, collection and storing is crucial for the optimisation of sharing and use of data. The present systems for data in the domain of food safety (monitoring of chemical contaminants and residues and biological hazards) are only blocks of a building, but the level of integration and the time span between the planning and the availability of data for use are far from being optimal. The proposed system would offer a powerful and technologically cutting-edge full data solution also to national authorities and other data stakeholders with weak infrastructures and difficult data governance. The cooperative development of the system would allow to optimise the data validation and the possibility of interacting with the different actors involved in the data lifecycle would improve the data culture and dramatically shorten the effort and time needed for high quality data generation. Once developed and tested, the system might become the harmonised EU platform for data in the domain of food safety, with capability of serving the needs on data at EU level as well as National level. The potential impact in terms of harmonisation, efficiency, and savings at national level is enormous. 3. Conclusions and recommendations This technical report summarised the 2016 consultation exercise of EFSA panels and units, the Scientific Committee and the Advisory Forum for which five research priority areas and topics were identified for the food safety area. It is recommended that EFSA continues to consult the Advisory Forum, the Scientific Committee and its panels and units to further support the Commission in identifying priority topics, and optimise the communication of such research priority areas. However, considering the Horizon 2020 programme cycle renewed input from EFSA will not be needed before 2018. www.efsa.europa.eu/publications 9 EFSA Supporting publication 2017:EN-1166
References EFSA AHAW Panel (EFSA Panel on Animal Health and Welfare), 2016. Scientific opinion on assessing the health status of managed honeybee colonies (HEALTHY-B): a toolbox to facilitate harmonised data collection. EFSA Journal 2016;14(10):4578, 241 pp. doi:10.2903/j.efsa.2016.4578 www.efsa.europa.eu/publications 10 EFSA Supporting publication 2017:EN-1166
Abbreviations AF Advisory Forum AFCWG Advisory Forum Communication Working Group CIP Competitiveness and Innovation Framework Programme DG-AGRI Director-General Research Agriculture and Rural development DG-R&I Director-General Research and Innovation DG-SANTE Director General for Health and Food Safety FP6 6th research Framework Programme FP7 7th research Framework Programme SC Scientific Committee of EFSA www.efsa.europa.eu/publications 11 EFSA Supporting publication 2017:EN-1166