Identification of emerging risks: an appraisal of the procedure trialled by EFSA and the way forward

Transcription

1 TECHNICAL REPORT APPROVED: 9 June 2015 PUBLISHED: 12 June 2015 Identification of emerging risks: an appraisal of the procedure trialled by EFSA and the way forward European Food Safety Authority Abstract This report describes the evolution of the current procedure of the European Food Safety Authority (EFSA) for identifying emerging risks in the food chain by reviewing and appraising achievements since the inception of EFSA. In particular, the report addresses the evolution of the conceptual definition of emerging risk, developmental steps of the procedure, and the main results of the piloting phase. The report concludes with a proposal for a way forward to improve the current emerging risk identification procedure. European Food Safety Authority, 2015 Key words: Emerging risks, emerging issues, hazard identification, driver. Requestor: EFSA Question number: EFSA-Q Correspondence: scer@efsa.europa.eu EFSA Supporting publication 2015:EN-824

2 Acknowledgements: EFSA wishes to thank the members of the Standing Working Group on Emerging Risks: Qasim Chaudry, Patrick Du Jardin, David Gott, Jean-Claude Grégoire, Arie Havelaar, Klaus-Dieter Jany, Gijs Kleter, Robert Luttik, Matthew Macleod, Alberto Mantovani, Birgit Nørrung, Hildegard Przyrembel, Jan Schans, Ivar Vågsholm, Vittorio Silano, Matthew Wright, and Josef Schlatter for the preparatory work on this scientific output, and EFSA staff member(s): Andrea Altieri, Jean-Lou Dorne, Raquel Garcia-Matas, Andrea Germini, Tilemachos Goumperis, Caroline Merten, Tobin Robinson, Agnes Rortais for the support provided to this scientific output. Suggested citation: EFSA (European Food Safety Authority), Identification of emerging risks: an appraisal of the procedure trialled by EFSA and the way forward. EFSA supporting publication 2015:EN pp. European Food Safety Authority, 2015 Reproduction is authorised provided the source is acknowledged. 2 EFSA Supporting publication 2015:EN-824

3 Summary According to the founding regulation of the European Food Safety Authority (EFSA), the Authority is required to undertake action to identify and characterise emerging risks in the field of food and feed safety. Over the last years, EFSA has carried out extensive expert consultations and a testing phase to develop a transparent procedure. Following the adoption of a definition of emerging risk in 2007, ad hoc working groups along with a network of EU Member States have been convened to discuss and test data collection and evaluation methods in such a procedure. The assessment of emerging risks must remain distinct from the assessment of risks under emergency (or crisis) conditions, which are dealt with through specific established European Commission procedures. The current EFSA procedure for emerging risk identification includes three main steps: 1) preliminary identification of priority emerging issues, 2) identification of appropriate data sources and data collection, 3) evaluation of the collected information and identification of emerging risks. The experience gained by EFSA indicates that the identification of an emerging risk should be based on expert judgement given the considerable data gaps generally characterising such risks. Between 2012 and 2014, out of 53 issues that were evaluated, 18 had follow-up actions either as mandates received by EFSA from the European Commission or Member States, or self-tasked activities, e.g. as outsourced projects. Several different European Agencies and international organisations have been assigned tasks related to emerging risks within their respective areas of competence. EFSA s efforts in developing networks on emerging risks focussed on Member States national authorities and stakeholders with a specific mandate or interest in food and feed safety. The current procedure for emerging risk identification should continue to be systematically applied and concentrated primarily on risks relevant for human, animal and plant health. The involvement of all EFSA Panels and the Scientific Committee on emerging risks identification should be improved. In particular, the cooperation between Panels on cross-cutting issues is envisaged; new mandates of EFSA should be checked for their relevance to emerging risks and, if appropriate, communicated to the Scientific Committee and the Scientific Committee and Emerging Risks Unit. It is recommended that EFSA should reconsider the Scientific Committee definition of emerging risk in order to provide sufficient guidance for its practical application. The definition should be applicable for all areas in the remit of EFSA, including environmental risks and plant health, and being more specific in the area of biological hazards. Attention should be given to establishing consistent criteria for the definition of an emerging serious risk (as in Directive 2001/195/EC) in consultation with the Commission. It is recognized that the identification of an emerging serious risk will require a close and time-effective interaction between risk assessors and risk managers. For the identification and evaluation of drivers of emerging risks and their interactions, it is recommended that EFSA considers broadening the current approaches with food chain analysis involving socio-economic and trade experts. Moreover, research needs and any relevant data gaps resulting directly from EFSA emerging risk identification procedure should be characterised and communicated as such. 3 EFSA Supporting publication 2015:EN-824

4 Table of contents Abstract... 1 Summary Introduction Background and Terms of Reference as provided by EFSA Conceptual definition of emerging risks and regulatory implications Development of the EFSA procedure for ERI Networks developed by EFSA The Standing WG on Emerging Risks Achievements and present activities on ERI Issues identified and follow-up activities Pilot project on the identification of emerging chemical risks in the food/feed chain Pilot study on drivers of emerging risks in the domain of biological risks Examples of activities carried out by Panels and linked to ERI Animal and plant health Biological hazards Chemical hazards The way forward Appraisal Conclusions Recommendations References Abbreviations EFSA Supporting publication 2015:EN-824

5 1. Introduction 1.1. Background and Terms of Reference as provided by EFSA According to the founding regulation of EFSA 1, the Authority is required to undertake action to identify and characterise emerging risks in the field of food and feed safety. The Scientific Committee and Emerging Risks Unit (SCER) contributes to this mission by supporting the establishment of a procedure for screening and analysis of information with a view to identifying emerging risks in the fields of food and feed safety, and animal and plant health. To achieve this objective, EFSA has carried out extensive expert consultations and a testing phase to develop a transparent procedure for emerging risk identification (ERI). Following the adoption of a definition of emerging risk by EFSA in 2007, ad hoc Working Groups (WG) along with a Network of Member States (MS), have been convened to discuss and test data collection and evaluation in such a procedure. In 2011, the WG on Methodology for ERI, established to support EFSA in the development of a transparent procedure, assessed the performance of the procedure and provided recommendations for improvement. The WG proposed a simplified procedure including three main steps: 1) identification of emerging issues 2, 2) identification of appropriate data sources and data collection, 3) evaluation of the collected information and identification of emerging risks (EFSA, 2012a). Emerging issues should be identified at the beginning of the procedure, preferably through expert consultations. The WG on Methodology recognised that ERI requires a high level of expertise, as it is typically based on scattered information with major data gaps. The need for direct accessibility to experts from the Scientific Committee (SC) and Panels was identified as one of the major constraints on the efficiency of the procedure piloted by EFSA. This was deemed to be crucial for efficient identification of specific issues for focussed monitoring and a meaningful expert evaluation of the issues identified. It was recommended that the entire ERI procedure should be coordinated by SCER with the support of the SC, who will be responsible for the endorsement of any final report on a particular emerging risk. Experience in operating the pilot phase of the ERI procedure at EFSA has shown a need to improve the decision procedure for attributing resources to follow-up on identified emerging risks. Thus, it was requested that SCER initiated a Standing WG of the SC on Emerging Risks (SWG-ER), to provide scientific support to EFSA throughout the entire ERI procedure. Furthermore, experience in operating the pilot phase of the ERI procedure at EFSA has shown a need to improve the decision and priority making procedure for attributing resources to follow-up on identified emerging risks. To this end, the SWG-ER should report to the SC. The SC is then responsible for providing recommendations to conclude on the follow-up actions. The objective(s) of the SWG-ER is to collaborate with the SCER unit on the ERI procedure, i.e. from the identification of priority emerging issues that merit further consideration to the final identification of emerging risks. The outcome of this work will be submitted to the SC for consideration. The specific tasks of the WG will be to: 1. Assist in the identification of emerging issues: Through the systematic application of the adopted scientific criteria, prioritize the identified emerging issues, indicating those for which specific reports should be further developed; Contribute to reports on specific issues; Liaise with the Panels in order to both identify new emerging issues as well as to provide feedback on the issues under evaluation; 1 Article 23(f) Reg. 178/2002/EC 2 Emerging issues are identified at the beginning of the ERI procedure as issues that may merit further investigation and additional data collection. Emerging issues can include specific issues (e.g. specific chemical substance or a pathogen), as well as general issues such as drivers of change (e.g. climate change). Risk management issues resulting from a lack of compliance with existing regulations should be excluded. 5 EFSA Supporting publication 2015:EN-824

6 Develop draft conclusions and recommendations on the emerging issues identified and present them to the SC for endorsement and confirmation or not of an emerging risk; Contribute to EFSA s work on the identification of research priorities. 2. Assist in the review of the ERI procedure: Following experience gained in the operation of the procedure: Review the data sources already identified for the identification of emerging issues and, if needed, to suggest additional ones; Review the scientific criteria already identified to screen data sources to identify the emerging issues and, if needed, to suggest additional ones; Review the scientific criteria to analyse the emerging issues deserving further consideration and, if needed to suggest additional ones; Recommend further modifications to the procedure to take it forward. In 2013, the SWG-ER was established to assist EFSA in identifying emerging risks and reviewing the procedure under development. This technical report appraises the procedure for ERI developed by EFSA by reviewing its evolution and achievements since the inception of EFSA. In particular, the report addresses (i) the evolution of the conceptual definition of emerging risk; (ii) steps of procedure development; (iii) the main results of the pilot phase, and (iv) a proposal to improve the current procedure. This technical report also summarises the outcomes of WGs, networks and other tools trialled by EFSA to deal with emerging risks as well as the work of the SWG-ER carried out from 2013 to Conceptual definition of emerging risks and regulatory implications The need to establish a structured, reliable and functional procedure for ERI was identified as a priority for EFSA by the SC soon after the establishment of the Authority. EFSA s SCER unit has contributed to this mission by supporting the establishment of structures for the screening and evaluation of information with a view to identify emerging risks in the fields of food and feed safety, and animal and plant health. To achieve this objective EFSA has carried out extensive expert consultations and a testing phase to develop a transparent procedure. Following the adoption of a definition of emerging risk in 2007, ad hoc WGs along with a Network of MS have been convened to discuss and test data collection and evaluation methods in such a procedure (EFSA, 2007; Robinson, 2012; EFSA, 2014). In 2007, the EFSA SC adopted a definition of emerging risk (EFSA, 2007) 3. An emerging risk is understood to be associated with the probability of a harm (i.e. injury or damage or adverse response) to human, animal and/or plant health, resulting from a newly identified hazard which may be a physical, chemical or biological agent to which a target organism may be significantly exposed, or from an unexpected new or increased significant exposure and/or susceptibility to a known hazard. Environmental health plays a key role in the food chain and should also be included in the definition of emerging risks. In the domain of biological risks, this definition also covers the emergence in the EU of a known hazard in a geographical area formerly not affected (e.g. African swine fever in Russia, Poland, Baltic states, Ukraine, Belarus, started in Georgia in 2007), and the transformation of species (e.g. vectors, prion emerging as mad cow disease in 1987, or a virus jumping to new species such as Ebola and influenza viruses) (Engering et al., 2013). In addition, ERI may be formalised according to different timelines (i.e. short, medium and long term). Article 34 of Regulation (EC) 178/2002 establishes that (European Union, 2002): 3 an emerging risk to human, animal and/or plant health is understood as a risk resulting from a newly identified hazard to which a significant exposure may occur or from an unexpected new or increased significant exposure and/or susceptibility to a known hazard. 6 EFSA Supporting publication 2015:EN-824

7 1. The Authority shall establish monitoring procedures for systematically searching for, collecting, collating and analysing information and data with a view to the identification of emerging risks in the fields within its mission. 2. Where the Authority has information leading it to suspect an emerging serious risk, it shall request additional information from the Member States, other Community agencies and the Commission. The Member States, the Community agencies concerned and the Commission shall reply as a matter of urgency and forward any relevant information in their possession. 3. The Authority shall use all the information it receives in the performance of its mission to identify an emerging risk. 4. The Authority shall forward the evaluation and information collected on emerging risks to the European Parliament, the Commission and the Member States. Paragraph 2 introduces the term emerging serious risks, which has never been defined by Regulation (EC) 178/2002 or EFSA, and it is required only if, on the basis of systematic data collection of paragraph 1, a serious risk is suspected to emerge. Serious risk is defined, in the risk management context, in 2001/195/EC as "any risk, including those the effects of which are not immediate, requiring rapid intervention by the public authorities. Guideline documents for potential serious risks of pharmaceutical and veterinary products including a definition of serious were published by the European Commission (EC) (2006/C 132/08 and 2006/C 133/05). The type and amount of scientific knowledge needed to identify an emerging risk and to establish whether it is serious is not defined in the legislation. The experience gained by EFSA indicates that the evaluation of the seriousness of an emerging risk should be based on expert judgement given the considerable data gaps generally characterising such risks. In fact, reliable data on health effects of and exposure to new agents are not generally available at short times since the inception of exposure. Therefore, establishing a clear threshold for the seriousness of an emerging risk may not always be feasible on pure scientific grounds. An emerging serious risk may thus have to be defined in dialogue with risk managers. Regulation (EC) 178/2002 has two main objectives: firstly to allow decisions on specific measures by the EC justified according to the precautionary principle (see Art. 7), and secondly, to allow the EC to produce additional data for a full risk assessment. Therefore, it is important that on each emerging serious risk identified, EFSA provides information with a clear indication of the level of uncertainty and additional data needs. The assessment of emerging risks should not be confused with the assessment of risks under emergency (or crisis) conditions, as the latter are dealt with through specific established EC procedures 4. This means that food fraud and bioterrorism based on known hazards as well as non-compliance with existing food safety regulation should not be part of ERI. Other important considerations on the EFSA definition of emerging risk, including the interpretation of important qualifiers such as newly identified hazard, significant exposure, and differentiation between emerging risk, emerging issue have been addressed in detail in a previous report (EFSA, 2012b). The main conclusions were that the assessment of what can be considered as a new hazard can be difficult (e.g. type and amount of scientific evidence needed, such as one animal study?, one human study?, one report on detection of rare marine biotoxins in European waters?, animal diseases reported in neighbour countries?, human cases detected in the EU?, etc.). Thus, several difficulties have been identified for the practical identification of emerging risks according to the EFSA definition, including: Interpretation of the concept of emerging serious risk; 4 Corrigendum to Commission Decision 2004/478/EC of 29 April 2004 concerning the adoption of a general plan for food/feed crisis management. OJ L 212/60, , p EFSA Supporting publication 2015:EN-824

8 Practical interpretation and assessment of qualifiers such as new hazard, new or increased exposure ; The inclusion in the definition of the aspect of importation and the mutation or re-assortment of species in the domain of biological risks; The inclusion in the definition of environmental risks and risks for food producing animals and plants. 3. Development of the EFSA procedure for ERI Table 1 lists the main reports published by EFSA on emerging risks since These include reports discussing definitions and methodologies for the ERI, a series of reports testing data collection and evaluation, and a series of reports appraising the efficacy of the procedure of ERI under development. A brief summary of the main conclusions of these reports is provided in the following paragraphs. Table 1: Main EFSA s reports on the development of a procedure for ERI published since Title of the report Content Year Report of the EFSA Service Contract EFSA/SC/Tender/01/2004 "Forming a Global System for Identifying Food-Related Emerging Risks - EMRISK" Outsourced project on available methods and a blueprint for EFSA Opinion of the SC related to the early identification of emerging risks Methodology 2006 Definition and description of Emerging Risks within the EFSA s mandate Definitions 2007 Report of the EFSA Scientific Cooperation (ESCO) Working Group on Emerging Risks Development of web monitoring systems for the detection of emerging risks Establishment and maintenance of routine analysis of data from the RASFF EFSA's Scientific Colloquium on Emerging Risks in food: from identification to communication Development and implementation of a system for the early identification of emerging risks in food and feed EFSA's 16th Scientific Colloquium on Emerging Risks in Plant Health: From Plant Pest Interactions to Global Change 2006 Methodology 2009 Development of tools Development of tools Definitions, Methodology Appraisal 2010 Definitions, Methodology Data collection for the identification of emerging risks related to food and feed Methodology 2011 Towards a methodological framework for emerging risk identification Evaluation of a system for the scanning of Eurostat s data to detect trends in trade Appraisal, Methodology Development of tools EFSA Supporting publication 2015:EN-824

9 Title of the report Content Year Piloting a procedure for Emerging Risk Identification: Lessons learnt and next steps EFSA s procedure to identifying emerging risks in food and feed: taking stock and looking forward Appraisal, Methodology, development of tools 2012 Appraisal 2012 Update on EFSA's activities on Emerging Risks Appraisal 2014 In 2006, an EFSA s external report was published describing a blueprint of a procedure for the establishment of an early warning system based on the results of an outsourced project (VWA et al., 2006). The recommendations of the contractor were, in particular, directed to using existing expertise and networks (e.g. EFSA s scientific panels/sc, Community agencies such as ECDC and EEA, and EFSA stakeholders), identifying reliable indicators 5, and assigning more EFSA staff to fulfil the provisions of Article 34 of the Regulation (EC) 178/2002. The SC noted that the ambitious approach proposed by the external contractor was based on a complex methodological procedure of data collection, collation and evaluation requiring significant resources and the collaboration of a number of institutional organisations to evaluate and validate the many indicators identified (EFSA, 2006). The procedure was deemed difficult to be fully implemented, but some methodological prescriptions (e.g. some indicators, media monitoring, and establishment of networks) were tested by EFSA. In 2009, the report of the EFSA Scientific Cooperation WG on Emerging Risks proposed an ERI procedure relying mainly on monitoring of indicators (EFSA, 2009a). The indicators should be considered as primary markers when screening appropriate data sources electronically by means of a real-time central data collection facility. The assessment of indicators and signals was tested in subsequent years using selected data sources (i.e. trade, price, data of the Rapid Alert System for Food and Feed (RASFF), the screening of scientific publications on new hazards and new exposures, and media monitoring). However, the exercise proved to be difficult, because the screening of the literature for new hazards required a considerable amount of resources and expertise, and reliable and quantifiable indicators to detect and interpret signals of emerging risks in the food chain could not be identified. The main conclusion was that more research is needed to clarify how indicators can be reliably used to identify emerging risks in the food chain, and that the screening of the scientific literature should be guided by experts in order to be efficient (EFSA, 2012b). In 2010, international experts discussed methods for ERI at the EFSA Scientific Colloquium on Emerging Risks (EFSA, 2011a). The main outcomes of the colloquium were that a broad horizon scanning approach was too time consuming and lacked focus for EFSA, and that the procedure should start by the identification of specific emerging issues or topics of potential concern by expert judgment prior to the selection of strategic sources of information for data collection. ERI should be carried out by applying a multidisciplinary approach based on scenario building, in combination with quantitative empirical data analysis guided by experts in the field. At the same time, it was recommended that EFSA should benefit more from the existing knowledge networks of MS and intergovernmental agencies sharing national experiences and information. 5 In this context, an indicator is a component of risk assessment and is comprised of a focused selection of parameters, directly or indirectly related to the food chain that can be measured/calculated qualitatively and/or quantitatively. Ideally, an indicator should be reliable, sensitive, quantifiable, and should provide the information on the nature of the hazard (agent/procedure involved) and the source of the risk. A signal is identified as a temporal or spatial trend in an indicator value. 9 EFSA Supporting publication 2015:EN-824

10 The efficiency and the development of the EFSA procedure for ERI has been reviewed several times, in parallel with the development of the procedure (EFSA, 2010a). This included the assessment of selected sources of information and tools for the collection and filtering of relevant information, the assessments of the knowledge networks for sharing information, and the further development of a methodological framework. In order to explore the potential use of certain data sources, IT tools were developed and assessed for media monitoring, detection of trends in trade, food price data and incident reporting in the RASFF (EFSA, 2009b, 2010b; EFSA, 2012). In conclusion, these sources of information were thoroughly assessed and evaluated in terms of utility in ERI with the general conclusion that they were poorly relevant. The possibility of establishing a structured data collection procedure was evaluated by a WG in 2011 (EFSA, 2011b). The WG proposed a procedure to identify, assess, rank and prioritise data sources, defining a list of priority sources of information and suitable strategies and tools to gather relevant signals indicative of emerging risks. However, the WG concluded that such a procedure should encompass first the selection of priority areas or topics of interest in terms of emerging risks, and then the identification of appropriate indicators and associated data sources. Finally, in 2012 a procedure for ERI was streamlined including three main steps: 1) preliminary identification of priority emerging issues, 2) identification of appropriate data sources and data collection, 3) evaluation of the collected information and identification of emerging risks (EFSA, 2012a). Priority emerging issues should be identified preferably through expert consultations and via exchange of information with qualified organisations (e.g. sister agencies and other competent organisations). For selected issues prioritised by EFSA with the support of external experts, data collection was then started. On the basis of the data collected, the decision whether an issue prioritised was actually an emerging risk should have been taken by EFSA s SC. That report also provided recommendations on how to improve the efficiency and transparency of the procedure to collect information, the prioritization of the issues identified, and the formalisation of the outputs and follow-up actions. The general principles provided in that report have been implemented by EFSA and are part of the procedure currently used by EFSA. 4. Networks developed by EFSA Several different bodies in the EU, such as the European Centre for Disease Prevention and Control (ECDC), the European Environment Agency (EEA), the European Chemicals Agency (ECHA), the Joint Research Centre (JRC), the Institute for Prospective Technological Studies (IPTS) Team Working in European Foresight, and the European Agency for Safety and Health at Work (EU-OSHA) have been assigned tasks related in some way to ERI within their respective areas of competence. However, the individual scopes of these activities tend to be significantly different from each other. For example, ECDC is mostly focussed on crisis preparation, response and outbreak investigation, EEA on long term drivers, JRC-IPTS on IT technological foresight, ECHA on the identification of substances of very high concern based on their toxicological and environmental characteristics such as persistence, dispersive use and bioaccumulation, EU- OSHA on any occupational risk that is both new and increasing. The Food and Agriculture Organization of the United Nations (FAO) focusses on early warning and emergency prevention in relation to food security. Thus, EFSA s efforts in developing networks on emerging risks focussed on MS national authorities and stakeholders with a specific mandate or interest in food and feed safety. In order to facilitate the collaboration and the exchange of information between EFSA, the MS and the Stakeholders, EFSA has developed collaborative networks with other organisations to ensure the acquisition of relevant information already screened by those organisations in the framework of their activities. These include the Emerging Risks Exchange Network (EREN), the Stakeholders Consultative Group on Emerging Risks (StaCG-ER), and the SWG-ER. The establishment by EFSA of these networks has also resulted in new approaches to deal with emerging risks less focussed on methodological issues and more on sharing of relevant initiatives and evaluations EFSA Supporting publication 2015:EN-824

11 Emerging Risks Exchange Network (EREN) EFSA established in 2010 EREN to exchange information with MS on possible emerging risks for food and feed safety. The Network is currently composed of delegates from 21 MS and an EFTA country (Norway) designated through the Advisory Forum of EFSA and observers from the EC, EU pre-accession countries, the Food and Drug Administration of the USA (FDA) and FAO. EREN members are requested to provide information on the issues identified. The first report of EREN was published in 2011 (EFSA, 2011c). In 2013, the Network met 3 times and discussed a total of 16 signals of potential emerging issues that were presented and assessed using a standard briefing note template developed by the EFSA s SCER unit (EFSA, 2014a). Out of these signals, 10 originated from EFSA and 6 from MS. The issues discussed were from the areas of microbiological hazards, biotoxins, chemical hazards, food fraud, new consumer consumption trends, new technologies and processes, animal health, environmental pollution, new analytical methods and new food packaging technology. The issues meriting further consideration according to EREN evaluation were then submitted to the EFSA s SWG-ER. The briefing note template is a tool developed to collect information on emerging issues in a standardised and structured manner in order to support an expert evaluation. The template includes a general description of the issue, as well as information on the evaluation criteria defined according to the EFSA s definition of emerging risk (e.g. information documenting why it is considered a new hazard or a new/increased exposure). The information provided in the briefing notes is not comprehensive and is intended as a quick summary and a point of departure. The objective is to assess via expert judgment whether the issue under evaluation is compliant or not with the EFSA definition of emerging risk and to decide whether the issue under evaluation merits further data collection. The template and the evaluation criteria have been described in detail in a previous report (EFSA, 2012b). The Stakeholders consultative group on emerging risks (StaCG-ER) The StaCG-ER was established by EFSA in 2010 in order to improve the exchange of information on ERI and to enhance communication and dialogue on issues pertaining to emerging risks. Members of StaCG-ER were selected by EFSA upon nominations made through the EFSA s Stakeholder Consultative Platform (SCP) for representatives of industry and consumers associations (including food and feed producers, farmers, traders and consumers). The group was asked to provide information related to ERI under three headings, namely (i) current methods (ii) data sources and tools and (iii) future procedure to be developed. ERI was indicated as part of the daily activities in the food and feed sector organisations, mainly undertaken through regular monitoring of various data sources by expert groups combined with information received through the organisations networks. Whilst data sources vary according to the scope of each organisation and therefore are sector specific, some generalities were identified, e.g. expertise of individual scientists which are employees, members or collaborators of these organisations and scientific literature, institutional reporting and the RASFF as frequently used data sources. There was consensus on the need for a multidisciplinary approach to assist in the interpretation and impact assessment of newly reported issues and signals. ERI should include clear criteria and definitions for the interpretation of signals against the backdrop of the drivers identified, leading to a proportionate response. The group suggested a model to frame and structure the above mentioned system which should use as criteria: (i) quantitative data concerning human exposure through the food chain; (ii) the potential severity of the outcome of exposure on human health; and (iii) the magnitude (across sectors) of the presence of the potential hazard in the food chain. These criteria should include different levels of concern, including cases where the information for one or more criterion is missing and a grading system (EFSA, 2014). 5. The Standing WG on Emerging Risks The SWG-ER was established in 2013 under the umbrella of the SC, and sought the participation of EFSA Scientific Panels to emphasise the multidisciplinary effort needed to identify and appraise emerging risks. The remit of the SWG-ER has been to support EFSA throughout the ERI procedure, from the identification of 11 EFSA Supporting publication 2015:EN-824

12 priority issues that merit further consideration to the final identification of emerging risks. Thus, one of the major tasks of the SWG-ER has been to evaluate and to provide recommendations on the issues identified by EFSA, EREN and StaCG-ER. Table 2 includes the list of issues discussed by EFSA, EREN, StaCG-ER and SWG-ER between 2012 and 2014, and the issues for which the evaluation of SWG-ER was sought. Overall, 53 issues were discussed in areas related to environmental and chemical contamination, nutrition, zoonoses, animal diseases, and new technologies. Issues evaluated up to 2013 (i.e. up to number 45 in Table 2) were discussed in a previous report (EFSA, 2014). Overall, SWG-ER evaluated 16 issues, which were selected by EFSA, StaCG-ER, or EREN and presented by EFSA. The issues were selected through a qualitative evaluation based on expert judgment and on a set of agreed criteria documented in the briefing notes described in Section 3. The evaluation procedure and the selection criteria are based on the EFSA definition of emerging risk and have been described in detail in a previous report (EFSA, 2012a). The conclusion of the SWG-ER on the issues evaluated is that the issues presented for evaluation are not compliant with the EFSA definition of emerging risk or emerging issue. The main reason is that either the issue is not considered new or the evidence presented is too limited to take a decision. According to the SWG-ER several of the issues presented are risk management issues, such as non-compliances with existing legislation and were related to known hazards. Other issues are clearly related to new methods and new technologies. Whilst these are not emerging risks per se, the SWG-ER is of the opinion that they can have implications for the future detection of new hazards. The SWG-ER considered the issues presented for evaluation as interesting scientific issues and provided inputs on possible follow-up actions for the topics discussed. The SWG-ER spent considerable time discussing whether a topic that was tabled represented an emerging risk or not because the EFSA definition did not seem to provide sufficient guidance for its practical application. The SWG-ER concluded that there is a need to improve the definition of emerging risk to make it easier to apply in an operational setting. In addition, the SWG-ER decided to work on methods for the ERI in the area of chemical and biological hazards. In the chemical area, the activities focussed on the use of existing information sources on chemical production/use in its widest sense with a view to identifying in a non-biased manner, potential contamination of the food and feed chain by chemicals that have not yet been considered in formal food/feed chain risk assessments. In the domain of biological risks, relevant expertise is found in EFSA in the Animal health and welfare (AHAW) and Biological hazards (BIOHAZ) Panels. Thus, the SWG-ER decided to conduct an expert consultation with these Panels. The current status of these two initiatives is summarised in chapter Achievements and present activities on ERI 6.1. Issues identified and follow-up activities Between 2012 and 2014, out of 53 issues that were evaluated, 18 had follow-up actions either as mandates received by EFSA from the EC or MS, or self-tasked activities, e.g. as outsourced projects. Table 2 includes a list of issues for which follow-up has been carried out or is on-going. For the other issues, follow-up actions were either not recommended or those already initiated by EFSA were deemed to be appropriate. Follow-up activities have been previously described (EFSA, 2014). A short summary of the most recent activities is provided below. Concerning chemical hazards, follow-up actions focussed on the potential introduction of industrial chemicals into the food chain, cyanotoxin contamination in certain food and food supplements, and masked mycotoxins. Risk assessment of chemical mixtures was confirmed as an issue in need of further 12 EFSA Supporting publication 2015:EN-824

13 investigation. This is being followed up through reviewing existing approaches and gathering data for evidence of cumulative effect mechanisms (additive, antagonistic interactive and/or synergistic). It builds on the work already carried out in the pesticides area by EFSA, with the aim of providing a roadmap for a strategy which can be adopted across ESFA s risk assessment of chemical hazards. Concerning biological hazards, the main issues identified with follow-up action included lumpy skin disease, and the possible risks of pathogen importations through bush meat. Bee health was confirmed to be an issue of concern with several questions remaining to be clarified, including the quantification of the impact of multiple stressors. Some drivers of change with a potential impact on the food chain in the mid- or long-term perspective were identified. These include the emergence of new and emerging technologies such as the application of synthetic biology to the food chain and the introduction of 3D-food printing to print food, but also new methods which could influence the ability to identify new and emerging risks such as omics technologies and utilising human biomonitoring data for exposure assessment EFSA Supporting publication 2015:EN-824

14 Table 2: List of issues evaluated by SCER, EREN, StaCG-ER and the SWG-ER in and follow-up actions. # Issue evaluated 8 Identified SCER EREN StaCG-ER SWG-ER Follow-up by 1 Potential chemical contamination of food from recycled paper EFSA X X X X 2 Zoonotic viruses associated with illegally imported wildlife products 6 EFSA X X 3 First report of indigenous ciguatera fish poisoning in EU EFSA X X X X Possible follow-up under evaluation. 4 Salmonella in paan (betel) leaves MS X X 5 Indian milk adulteration MS X X 6 Use of banned, unauthorised and counterfeit pesticides MS X X X 7 Potential epidemiological link of cancer risk to meat and poultry workers EFSA X X X 8 Combined toxicity of melamine and cyanuric acid EFSA X X X 9 Import of stray dogs and new parasitic diseases MS X X 10 Mycotoxins in Swedish crops 7 MS X X 11 Undereporting of foodborne norovirus in older adults MS X X 12 Drivers and pathways of antimicrobial resistance: foodborne extendedspectrum MS X X beta-lactamase (ESBL) 13 Zoonotic potential of Usutu virus EFSA X X 14 Colorectal cancer and possible link to dietary and cooking habits of red EFSA X X X X meat consumption 15 Animal illnesses linked to jerky pet treats EFSA X X X 16 Pharmaceuticals and personal care products (PPCPs) in the environment and possible human exposure through the food chain EFSA X X X X 17 The use of the ECHA s register of chemical substances to identify emerging industrial chemical risks in the food chain EFSA X X X X Procurement to test the procedure proposed by the SWG-ER (ongoing) 18 Insects as food and feed 8 EFSA X X X X Mandate of the EC to the EFSA SC for a scientific opinion (ongoing) 19 Food packaging residues in feed 9 StaCG-ER X X 20 Alternatives to bisphenol A for food contact material applications EFSA X X X X 21 Food chain contamination from environmental pollution of micro plastic particles MS X X X Mandate of the EC to the EFSA CONTAM Panel for a scientific opinion (ongoing) 22 Possible applications of synthetic biology in the food chain EFSA X X X Mandate of the EC to the SCENIHR 6 Related to issue The issue was discussed for the first time in This issue was discussed in The issue was shared for information only, without the use of the standard briefing note template; no comments received from other members EFSA Supporting publication 2015:EN-824

15 # Issue evaluated 8 Identified by SCER EREN StaCG-ER SWG-ER Follow-up for a scientific opinion (finished) 23 Clostridium difficile as a potential zoonotic or foodborne pathogen EFSA X X X 24 Increase of Cryptosporidium infections in the Netherlands, the UK and EFSA X X X Germany in Lumpy skin disease into the EU StaCG-ER X X X Mandate from the EC to the EFSA AHAW Panel for a scientific opinion 26 Cyanotoxins contamination in food supplements EFSA X X X Self-tasking mandate with a procurement (ongoing) 27 An example of potential synergistic toxicity: cadmium and chlorpyrifos EFSA X X X 28 Wheat crop: low quality and poor yield EFSA X X X 29 Fish substitution and mislabelling EFSA X X X 30 Masked mycotoxins EFSA X X X Mandate from the EC to the EFSA CONTAM Panel for a scientific opinion (finished) 31 Epigenetic endpoints in chemical risk assessment regulatory testing EFSA X X X 32 Regulation (EU) 1169/2011 and information to consumers StaCG-ER X X 33 3d-food printing to print food MS X X 34 Extraintestinal pathogenic Eschericia coli (ExPEC) MS X X 35 Opisthorchis felineus in Italy EFSA X X 36 Cinnamon challenge: consumption of large quantities of cinnamon MS X X within a short time 37 Increased norovirus activity associated with emergence of a new variant of genotype II EFSA X X 38 Imported flowers as a vector for spreading honey bees infectious diseases EFSA 10 X Mandate of the EC to EFSA for a scientific opinion (finished). 39 Chemical mixtures EFSA X Procurement for a systematic review on metabolic interactions and synergistic effects of chemical mixtures for human risk assessment (ongoing). Internal science project on international frameworks dealing with the human risk assessment of chemical mixtures (finished). Procurement for the development 10 The issue was discussed in EFSA Supporting publication 2015:EN-824

16 # Issue evaluated 8 Identified by SCER EREN StaCG-ER SWG-ER Follow-up of a framework for the risk assessment of chemical mixtures and a toxicological database on relevant chemical mixtures to food safety (ongoing). 40 Human biomonitoring EFSA X Procurement for a review of human biomonitoring for chemical substances and its applications to human exposure assessment for food safety (ongoing). 41 Non-monotonic-dose-response chemical effects EFSA X Procurement for a review of nonmonotonic dose-responses of substances for human risk assessment (ongoing). 42 Bee health EFSA X Procurement on toxicity of exposure to multiple chemicals in bees and modelling the effects on bee population dynamics using DEB-TOX models (ongoing). Internal Bee Task Force for the pre-screening and assessment of the information collected outside EFSA (finished). Scientific Colloquium XVIII Towards approaches for a holistic risk assessment of multiple stressors in bees (finished). Inventory of studies conducted on bees, inside and outside EFSA, to identify cross-cutting issues and further research needs for a more integrated approach on the evaluation of risks to bees and their ecosystem services (finished). 43 Omics technologies in food safety risk assessment EFSA X Procurement on a foresight study on emerging technologies: state of the art of Omics technologies and potential applications in food and feed safety (finished) EFSA Supporting publication 2015:EN-824

17 # Issue evaluated 8 Identified SCER EREN StaCG-ER SWG-ER Follow-up by 44 Energy drinks 11 EFSA X Procurement for a European-wide survey on energy drinks consumption (finished). Mandate of the EC to EFSA for a scientific opinion on caffeine intake, including caffeine from energy drinks (finished). 45 Emerging methodologies and tools for hazard assessment of chemicals in humans EFSA X Self-tasking mandate to prepare a scientific report comprising a critical review of the state of the science of the modern and emerging methodologies and tools: biologicallybased models, omics, for the hazard identification and characterisation of chemicals in humans (finished). 46 Food emulsifier, the gut microbiome and long term health effects MS X X 47 Detection of Aethina tumida in Southern Italy MS X X Mandate from the EC to EFSA ALPHA Unit for a scientific opinion concerning the risk of introduction and spread of the small hive beetle (Aethina tumida) and Tropilaelaps in the EU (finished). 48 Long term effects of food emulsifiers on intestinal barriers MS X X 49 Bush meat and potential importation of Ebola Virus into the EU EFSA X X X Mandate from the EC to EFSA to the BIOHAZ and AHAW Panel for a scientific opinion (one finished and one ongoing) 50 Novel phleboviruses MS X X 51 Heat-generated food contaminants MS X X 52 Okadaic acid in Manila clams in Italy MS X X 53 Fluorinated alternatives to perfluoroalkyl sulfonate PFAS MS X X Self-tasking mandate of the biological hazards and contaminants unit for an extensive literature search and provision of summaries of studies related to the oral toxicity of 11 The issue was discussed in EFSA Supporting publication 2015:EN-824

18 # Issue evaluated 8 Identified by SCER EREN StaCG-ER SWG-ER Follow-up perfluoroalkylated substances (PFASs), their precursors and potential replacements in experimental animals and humans (finished) EFSA Supporting publication 2015:EN-824

19 6.2. Pilot project on the identification of emerging chemical risks in the food/feed chain The SWG-ER proposed a procedure for the systematic identification of emerging risks in the food/feed chain associated with intentionally and non-intentionally produced industrial chemicals and natural contaminants (EFSA, 2014). This proposed procedure uses, in a structured manner: (i) a variety of data sources that have become available on industrial chemicals produced in and imported into the EU, or on the environmental occurrence of chemical contaminants; and (ii) software models for the prediction of the environmental behaviour, biological activity and toxicity of specific chemicals from their molecular structures and physico-chemical properties. As a follow-up to this proposal a project has been outsourced to test and validate this procedure, focusing initially on some industrial chemicals drawn from the ECHA database of register substances. The final report of the project is expected by the end of Pilot study on drivers of emerging risks in the domain of biological risks The outcomes of a pilot study of the SWG-ER for the identification of drivers of emerging risks and their interactions in the domain of biological risks to animal, plant and human health are described in detail in a technical report (EFSA, 2014b). Steps were taken towards a structured procedure for the identification of drivers of emerging biological risks and their interactions. Step 1 involved a consultation with the AHAW and BIOHAZ Panels through an adapted Delphi procedure. The overall objective of the Delphi procedure was to identify drivers and emerging issues. It was found that the identified drivers are highly connected, but may show effects on different timescales, and that the further investigation of possible implications of several drivers (i.e. economy, consumer preferences, industrial innovation) in terms of emerging risks require expertise not covered within EFSA Panels. Step 2 involved a workshop using a General Morphological Analysis (GMA) to structure the complex domain of drivers of emerging risks and their interaction. A prototype GMA model was developed, which needs to be further developed in order to be a practical working tool to identify and prioritize drivers of emerging risks. The next step would be continue the investigation of on the possible role of the drivers and their interactions involving a larger number of experts, in particular expertise on food systems, trade, economics, social sciences for the identification of drivers should be included. Furthermore, EFSA should continue to explore other tools to identify emerging biological risk (e.g. scenario building techniques, text mining tools etc.) for the evaluation of the possible impact of drivers on the food chain. It was recommended that EFSA should consider broadening the approach to the entire food chain. The next step would be to engage experts on food systems, trade, economics, social sciences, etc. Thus, a food chain analysis could be a helpful tool or approach in this regard. The WG reflected on the EFSA definition of emerging risks in the context of biological hazards. The WG concluded that the definition can be made more applicable to emerging biological risks by considering any risk as new if it has not yet been observed in the EU territory and may require attention by EU risk managers, and by further differentiating the category of new exposures to include species jumps and geographic jumps of an agent EFSA Supporting publication 2015:EN-824